General Surgery News

CONVENTION ISSUE:

Pre-American College of Surgeons Clinical Congress

GENERALSURGERYNEWS.COM

September 2013 • Volume 40 • Number 9

The Independent Monthly Newspaper for the General Surgeon

Opinion

Endoscopic Procedures Control Reflux Well in Trials

Scopes II B Y D AVID C OSSMAN , MD

I

n a celebrated legal case in 1925, charges were brought against a high school teacher, John Thomas Scopes, for violating the Butler Actt that outlawed the teaching of evolution in public schools in Tennessee.

Scopes was a substitute teacher who collaborated with the American Civil Liberties Union (ACLU) to purposefully violate the “creationism only” law to draw public attention to the state of education in the Bible belt. Scopes—represented by Clarence Darrow—lost, and had to pay $100, but the decision was reversed on appeal and the rest is, as they say, history.

But not quite. The world is a different place now. I fully expect the ACLU to reverse course, and petition the school boards to delete the study of evolution from high school curricula. Although Darwinism and its central theses might have resonated with a robust and

The Endo GIA ATM Radial Reload With Tri-StapleTM Technology For HAL LAR

Axilla Radiotherapy Called New Breast Cancer Standard

B Y T ED B OSWORTH

B Y T ED B OSWORTH

ORLANDO, FLA.—Data on two endoscopic procedures for treating gastroesophageal reflux disease (GERD) show that the procedures are capable of eliminating, or greatly reducing, dependence on proton pump inhibitor (PPI) therapy. Findings were presented at the 2013 Digestive Disease Week meeting.

One of the procedures, EsophyX2, a transoral fundoplication technique, has outcome data available for six months post-procedure. The other procedure, Stretta, a radiofrequency technique that augments the integrity of the

CHICAGO—In patients with early-stage invasive breast cancer with a positive sentinel node, axillary radiotherapy (AxRT) provides comparable protection against relapse but a lower risk for lymphedema relative to axillary lymph node dissection (ALND), according to results of a randomized trial with a median follow-up of more than six years.

Although the trial was ultimately underp powered because of an unexpecctedly low rate of relapse in both arrms, the results were still charaacterized as practice-changing.

“Both axillary lymph node dissection and axillary radiottherapy provide excellent and coomparable locoregional control in b breast cancer patients with positive sentinel s nodes, but radiotherapy produces less edema and can be considered the standard,” said lead author Emiel J. Rutgers, MD, PhD, a surgical oncologist at Netherlands Cancer Institute in Amsterdam.

In the European Organisation for

see ANTIREFLUX PAGEE 18

see SCOPES II page 34

PROCEDURAL BREAKTHROUGH

®

In Study, Transvaginal NOTES Causes No Sexual Dysfunction B Y M ONICA J. S MITH

see RADIOTHERAPY page 33

see page 6

REPORT Clinical Performance and Economic Analysis of GORE® BIO-A® Tissue Reinforcement See insert at page 20

BALTIMORE—A recent small study finding that natural orifice transluminal endoscopic surgery (NOTES) through the vagina does not affect sexual function or the patient’s ability to deliver a baby vaginally, and reduces postoperative pain and the risk for

INSIDE Code of the Month

Stitches

On the Spot

10

13

28

Are We Treating the Whole Patient? The Importance of Specificity of Diagnosis

A Talk With Eddie Joe Reddick, MD: Laparoscopy Pioneer, Recording Artist

The Art of Herniology, Part 2: randomized trials; sportsman hernia; lightweight, large-pore synthetic mesh vs. biologic mesh

complications, may assuage the concerns of some providers and patients.

“NOTES surgery provides an obvious aesthetic advantage and a potential to reduce trocar site complications; still, many potential patients see NOTES page 25

REPORT Teflaro® (ceftaroline fosamil) for the Treatment of Community-Acquired Bacterial Pneumonia Caused by Designated Susceptible Bacteria See insert at page 28

GSN Editorial

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / SEPTEMBER 2013

What’s in a Name?

Frederick L. Greene, MD, FACS Clinical Professor of Surgery UNC School of Medicine Chapel Hill, North Carolina

W

hen I started medical school, I was always intrigued by the use of eponyms and enjoyed remembering the eponymous contributions and name recognition associated with both commonplace and arcane syndromes, diseases and triads. Terms like “Down’s syndrome” and “Addison’s, Crohn’s and Cushing’s” diseases, as well as many others, were fascinating to me and challenged me to learn something about the person associated with the process.

Historically, an eponym has been used in medical terminology to commemorate the importance of an individual’s contribution. In recent years, there has been a vigorous debate over the issue of whether medical eponyms should be abandoned since they “lack accuracy, lead to confusion, and hamper scientific discussion in a globalized world” (Br Med J 2007;335:424-425). A more curious discussion has centered on whether the possessive or the nonpossessive form of the eponym should be used in spoken and written formats. A 1975 Canadian National Institutes of Health conference dealing with the naming of diseases was summarized in The Lancet, and concluded, “The possessive use of an eponym should be discontinued, since the author

neither had nor owned the disorder.”

In our electronic age, the issues at stake are not trivial because the ability to retrieve data may depend on whether the “apostrophe s” is present or absent. Studies have shown that American publications have tended to prefer the nonpossessive form, leaving out the “apostrophe s,” whereas our European colleagues tend to gravitate more toward the possessive form of the eponym.

In both my reading of medical and surgical articles and reviewing manuscripts for journals, it is interesting to note the haphazard use of the possessive and nonpossessive forms of eponyms, with seemingly no uniform standard being used. Recently, however, there has been a push to make the nonpossessive form of an eponym more journalistically correct as recommended by the American Medical Association’s AMA Manual of Style and other important reference works.

Now, we surgeons tend to be traditionalists, and the concept of using the term “Crohn disease” rather than “Crohn’s disease” will be difficult at best. We tend to think of the eponym in the possessive form, and it is abhorrent to avoid this norm in discussion at conferences and in our reading of and contributions to the medical literature. Thank goodness that in some circumstances, a nonpossessive form is irrelevant such as with Zollinger-Ellison syndrome. In the use of toponyms (naming after a place such as Lyme disease), a nonpossessive form also is standard practice.

The authorities who work for the World Health Organization (WHO) in naming diseases would

suggest that the possessive forms of medical eponyms are often unwarranted, redundant and confusing. In the WHO 10th revision of the International Statistical Classification of Diseases and Related Health Problems (ICD-10), a clear preference for avoiding the possessive form of eponyms appears. Proofreaders would suggest that the nonpossessive eponymous form is more efficient with fewer letters and no punctuation. Although one might feel initially awkward dropping the “apostrophe s” from Parkinson’s disease or Barrett’s esophagus, we can take some solace in our acceptance of the terms Apgar score and Cochrane review.

As you read the medical literature, it will be interesting to see whether the nonpossessive form of an eponym is catching on. I would suggest that those of us who contribute to the medical literature consider using the nonpossessive form since this is destined to be the benchmark in the not-too-distant future. The Council of Science Editors has been a staunch advocate for harmonization of stylistic standards and has adopted the posture that “the possessive form be eliminated altogether from eponymic terms so that they can be clearly differentiated from true possessives.”

Alas, I admit that the possessive form of the eponym that we grew up using will be difficult to abandon. We will, however, ultimately need to accept the audible and visual effect of Crohn disease, Hodgkin lymphoma and Alzheimer disease as we use these terms in our everyday lexicons. It is hard to know what’s right. I know for myself, I have already started missing the apostrophe!

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INFECTIOUS DISEASE SPECIAL EDITION

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In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / SEPTEMBER 2013

Single-Port Liver Resection Safe, Feasible in Selected Patients B Y V ICTORIA S TERN

S

urgeons have been performing laparoscopic liver resections since the late 1980s, but the standard approach to managing liver malignancies is still open surgery.

“Liver resection has been one of the last areas where we’ve applied minimally invasive techniques,” said T. Peter Kingham, MD, Department of Surgery, Hepatopancreatobiliary Service, Memorial Sloan-Kettering Cancer Center, New York City. “It’s a challenge to safely perform the same liver resection laparoscopically, as open, in all segments of the liver.”

A new study, led by Mitsuhiro Asakuma, MD, Department of General and Gastroenterological Surgery, Osaka Medical College, Takatsuki City, Japan, demonstrated the safety and feasibility of single-port laparoscopic liver resection using a surgical glove port in 19 patients, all of whom recovered quickly and experienced minimal postoperative pain. The new research, presented at the 21st International Congress of the European Association for Endoscopic Surgery (EAES) in June, won the Olympus EAES Award for best oral presentation on single-port surgery.

“I think this is a well-done study,” said Dr. Kingham, who was not involved in this research. “The surgeons’ surgical glove method, in particular, is novel and applicable in most hospitals because it does not require any extra equipment.”

Other recent efforts have shown promise for a single-port approach to liver resection in selected patients. In 2011, Dr. Kingham and his colleagues published information on a small series of single-port liver resections, in which they reported the safety and feasibility of left-liver wedge resection through a single port (Surg Endoscc 2011;25:14891494). Research by surgeons in Japan showed the success of single-port laparoscopic hepatectomy in eight patients, none of whom experienced wound pain or liver dysfunction after a two-week follow-up (Surg Endoscc 2012;26:16961701). Another recent study from Korea found single-port laparoscopic liver resection to be feasible in “well-selected cases” (Surg Endoscc 2012;26:1602-1608).

In this study, of the 24 patients with hepatocellular carcinoma who underwent the single-port procedure, two were converted to multiport laparoscopic hepatectomy due to limitations of the instrument length and four were converted to open surgery.

In the current prospective study, Dr.

Surgical glove port for single-port liver surgery as used by a team of surgeons in Takatsuki City, Japan.

‘The single-port technique is very limited to the superficial left sides of the liver. Our team, for instance, is focusing more on developing laparoscopic techniques that we can use anywhere in the liver, including the harder-to-reach right side.’

—T. Peter Kingham, MD

Asakuma and his colleagues completed 339 single-port procedures from June 2009 to May 2013 at their hospital, 19 of which were single-port hepatectomies— eight partial resections, seven lateral sectionectomies, three fenestrations and one mast cell tumor. (The series also included 293 cholecystectomies, three cholecystectomies with common bile duct stones, 12 appendectomies, five colectomies and three additional operations.)

Dr. Asakuma’s team performed the procedures using a surgical glove port, which they previously found was an effective and low-cost tool to facilitate single-port surgery (World J Surg 2010;34:2487-2489). During the surgery, the team created a 2-cm incision along the umbilicus to insert the port and extract the specimens. The resection surface was a flat plane in nine cases and a curved plane in six. All but three patients had malignancies on the left side of the liver.

Of the eight patients undergoing partial resection, operative time ranged from

60 to 225 minutes and bleeding occurred in one patient (800 mL). For the seven patients undergoing lateral sectionectomy, operative time ranged from 50 to 155 minutes and bleeding was minimal, also occurring in only one patient (330 mL). No blood transfusions were needed and the resection margins remained clear. Patients resumed an oral diet and regained full mobility on postoperative day 1.

The authors concluded that the singleport liver resection is an achievable technique, especially for lateral segments, and comes with several benefits to patients.

“The estimated advantages of the [single-port approach] are less postoperative pain, better cosmetic results and greater patient satisfaction,” said Dr. Asakuma.

“Potential disadvantages are sacrifices to safety, which we aim to eliminate.”

According to Dr. Asakuma, the next step is to conduct a randomized controlled trial comparing the single-port approach to liver resection with laparoscopic and open approaches. Dr.

Asakuma believes that, although singleport surgery for liver resection was born just three years ago, it has the potential to replace laparoscopic or open techniques through patient demand.

However, Dr. Kingham is more skeptical of the benefits of single-port liver resection beyond cosmesis.

“The single-port technique is very limited to the superficial left sides of the liver,” Dr. Kingham noted.

“Our team, for instance, is focusing more on developing laparoscopic techniques that we can use anywhere in the liver, including the harder-to-reach right side.”

As instrumentation improves and allows for more maneuverability, single-site liver resection may be applied to more parts of the liver, but is unlikely to become the standard of care, Dr. Kingham added. “I believe, however, that it’s important to show that single-site is possible. That is how the field of surgery truly advances.”

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / SEPTEMBER 2013

Endoscopic Approach Good Option for Early Breast Cancer Negative Margins, Better Cosmesis; Main Drawback Is Longer Procedure Time B Y V ICTORIA S TERN

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new single-port pretumoral approach has shown promise in treating early breast cancer, according to a new study presented at the 21st International Congress of the European Association for Endoscopic Surgery (EAES).

This pretumoral transaxillary retromammary (TARM) approach to video-assisted breast surgery (VABS) performed on 20 patients was safe and effective. The approach also resulted in excellent cosmetic outcomes, preserving the original shape of the breast, said lead author Koji Yamashita, MD, PhD, Department of Breast Surgery, Nippon Medical School, Tokyo. He presented the results at the EAES meeting in Vienna, in June.

Currently in the United States, the standard of care for breast-conserving surgery includes lumpectomy, partial mastectomy and quadrantectomy, but these methods require a long incision above the tumor and can significantly scar or deform the breast.

Endoscopic breast surgery, developed in Japan in 1995 to reduce the number of incisions and improve cosmesis, has continued to gain popularity in Asian countries.

Several endoscopic procedures have emerged, including endoscopic nipple-sparing mastectomy ((Ann Surg Oncoll 2009;16:3406-3413) and approaches that involve a periareolar incision, an axillar incision or both. VABS, for instance, requires two small incisions that can be hidden along the axilla and at the edge of the areola, and TARM-VABS is less invasive, requiring only one incision in the axilla, which avoids wounding the breast skin altogether.

“Aesthetics is an important factor, and studies show endoscopic approaches are both oncologically safe and show better cosmetic results,” said Eisuke Fukuma,

MD, PhD, director of Breast Center, Kameda Medical mesh. Average follow-up time was 48 months.

Center, Kamogawa City, Japan, who was not involved With the pretumoral TARM-VABS approach, all in the current research. patients had negative surgical margins and no seriIn 2008, Dr. Yamashita reported the initial success ous complications after surgery. Minor complications of the TARM-VABS technique on 12 patients (Chin included small subcutaneous hemorrhage and tempoMed J [Engl]] 2008;121:1960-1964), and 20 patients rary mild inflammation around the resected area of the ((Am J Surgg 2008;196:578-581), and, two years later, breast. Average operative time was 127 minutes and on 120 patients with early stage I and II breast can- resected volume was 24.5%. Patients also experienced cer (Cancer Res 2010;70:P4-10-08). In all three stud- high levels of satisfaction six months after the operaies, Dr. Yamashita and his colleague Kazuo Shimizu, tion, rating their aesthetic outcomes an average of 13.8 MD, FACS, reported that although the of 15 total points.

TARM-VABS approach took 45 min- ‘Endoscopic surgeries Despite the promising results, utes longer than conventional VABS, all endoscopic breast surgery is not represent good TARM-VABS patients showed negayet standard of care in clinical options and we must practice. tive surgical margins and better cosmetic outcomes.

“To allow this approach to continue to educate The TARM-VABS approach is techbecome a standard of care, I doctors in these nically feasible, but can be difficult to have to improve the manipulatlearn and perform, which is why Dr. ing devices to perform this opermethods.’

Yamashita recently developed a pretuation more easily and introduce moral TARM-VABS approach to sim- —Eisuke Fukumura, MD this surgery to more surgeons and plify the technique. patients,” Dr. Yamashita said. He “In TARM-VABS, the cutting manipalso is planning to perform a proulation is difficult from the backside of the mammary spective study comparing the TARM-VABS approach gland through the single axillary port.” The pretumor- with conventional breast-conserving surgery. al approach is easier to perform because it requires Dr. Fukuma believes that a nonsurgical approach for later dissection behind the mammary gland, said Dr. treating small breast cancers called cryoablation may be Yamashita. the future of care. Cryoablation for breast cancer involves In the current study, Dr. Yamashita and his col- freezing and killing small tumors (≤1 cm), using ultraleagues performed the pretumoral TARM-VABS sound guidance and local anesthesia. Since 2006, Dr. approach on 20 patients with early-stage breast cancer, Fukuma and colleagues have used cryoablation to treat who were aged 50.2 years, on average, and had a mean 58 patients with breast cancer (2013 American Society tumor size of 2.2 cm. After endoscopic sentinel lymph of Breast Surgeons annual meeting; abstract 0106). The node biopsy, Dr. Yamashita’s team made a 2.5-cm axil- procedure is safe, and no local tumor recurrence or dislary skin incision and marked the cut margins with tant metastases have occurred. blue dye. The surgeons dissected the subcutaneous tis“We hope to expand this approach for larger breast sue above the tumor and cut the mammary gland with tumors,” said Dr. Fukuma. “But currently endoscopic clear surgical margins, removing the tumor through surgeries represent good options and we must continue the axillary port using EndoCatch (Covidien). After to educate doctors in these methods.” tumor removal, they reconstructed the breast, filling Drs. Fukuma and Yamashita reported no relevant the tumorless area with absorbable fiber cotton or conflicts of interest.

FDA Approves New Test for Faster Confirmation of Medical Device Sterilization

T

he FDA recently granted permission for marketing of the Verify Cronos Self Contained Biological Indicator (SCBI), a new test that can help speed the determination of the effectiveness of steam sterilization of reusable medical devices.

According to the test’s manufacturer, Steris Corporation, the Verify Cronos SCBI is the first biological indicator test that gives test results in two hours.

“This is a novel and innovative use of recombinant DNA technology in biological indicator tests,” said Christy Foreman, director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health. “By providing faster confirmation of sterilization, this innovation may help health care facilities provide their medical staff

with a faster turnaround of their sterilized reusable devices.”

The test is used in reprocessing—a multistep process to clean and disinfect or sterilize reusable medical devices, such as endoscopes. For steam sterilization, medical devices are loaded into a chamber that is sealed and filled with steam.

Specific conditions, such as temperature, exposure time and chamber pressure, must be maintained throughout the process to kill microorganisms that may be present on the reusable medical devices.

Like other biological indicator tests, the Verify Cronos SCBI consists of a vial containing dried spores from the heatresistant bacteria Geobacillus stearothermophilus. Before the sterilization cycle begins, the reprocessing technician places the vial inside the sterilization chamber,

along with the devices to be sterilized.

After the sterilization cycle is complete, the spores are incubated in “recovery medium,” a liquid that provides an ideal environment for the growth of any surviving bacteria, and monitored for spore growth. The Verify Cronos SCBI test uses a genetically engineered strain of G. stearothermophilus that produces an enzyme that fluoresces in reaction with the recovery medium if test microorganisms are present after the sterilization process.

Genetically engineered d G. stearothermophilus that survive a sterilization cycle will start growing and producing the enzyme within two hours, providing results to the reprocessing technicians much sooner than the 24 hours normally needed with a natural bacterial strain. Growth of bacteria indicates that sterilization has failed.

To support its FDA petition, Steris conducted a number of tests to assure the performance of the Verify Cronos SCBI. This included subjecting more than 300 Verify Cronos SCBIs to a partial sterilization cycle and then comparing results after two hours and at seven days of incubation. The results showed that samples that fluoresced at two hours also exhibited growth at seven days.

The FDA reviewed the data for Verify Cronos SCBI through the “de novo classification” premarket review regulatory pathway for low- to moderate-risk medical devices that are not substantially equivalent to an already legally marketed device.

—Based on a press release from the FDA

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THE SCIENCE BEHIND POSITIVE PATIENT OUTCOMES

The Endo GIA™ Radial Reload With Tri-Staple™ Technology for HAL LAR Saumitra R. Banerjee, MD, FACS Colon & Rectal Surgeons of Greater Hartford Bloomfield, Connecticut

Theodoros Voloyiannis, MD Chair, Surgery Service Memorial Hermann Southeast Hospital Memorial Hermann Medical Group Clinical Assistant Professor of Surgery University of Texas Health Medical School Houston, Texas

and fire the stapler in either the sagittal or coronal approach.

In HAL LAR, even if you have a hand inside, it can be difficult to pass the stapler below,” said Dr. Voloyiannis. He added that there is quite a bit of variation in how surgeons can place a stapler to reach below the tumor in HAL LAR. Some surgeons place the hand port into the lower right quadrant, the lower left quadrant, or the suprapubic area, whereas others place it through a Pfannenstiel incision in the pubic symphysis.

But with all the variations in the placement of hand ports and/or additional ports, the limitations of linear staplers remain the same. “It’s hard to go vertically into the rectum and divide it,” Dr. Voloyiannis said. “We might end up doing tangential division, which leads to the need for firing multiple loads to divide the rectum completely. Once you fire more than 2 or 3 loads into the rectum, you end up overlapping staple lines, which might increase your risk for anastomotic leak.”

Endo GIA™ Radial Reload Introduction Lower anterior resection (LAR) has advantages over abdominal perineal resection, particularly in terms of patient quality of life due to preservation of the anal sphincter muscle.1 As with most surgeries that can be performed with either an open or laparoscopic approach, the latter tends to spare patients from pain and excess hospitalization, and it speeds their return to normal life functions.2 “There are multiple advantages for laparoscopic LAR. When you open the belly, the immune system goes down, so the chances of infection and issues related to the immune system go up,” said Saumitra R. Banerjee, MD, FACS, Colon & Rectal Surgeons of Greater Hartford in Bloomfield, Connecticut.

But LAR can be challenging because of patient anatomy and instrumentation. Laparoscopic procedures inherently require the surgeon to work with a reduced degree of tactile feedback. To this end, hand-assisted laparoscopy (HAL) can offer a satisfactory trade-off, restoring the surgeon’s sense of touch and depth while exposing the patient to moderately sized incisions. Studies have shown that the hand-assisted approach improves outcomes for colorectal cancer in areas such as intraoperative blood loss, hospital length of stay, and operative time.2-4 “With HAL LAR, you have to make an incision big enough to take the colon out because it averages 2.5 inches. You can take advantage of that incision to put a port through the area and put a hand inside. There are cases where a procedure could not be performed entirely laparoscopically, but once you have a hand inside, it can be done and the advantages are exactly the same,” said Dr. Banerjee.

However, LAR remains challenging even with the handassisted approach. In some patients, particularly men who have undergone radiation to shrink a tumor, the lower pelvis can be especially hard to access. “The anatomy is difficult. If the tumor is in the mid or lower rectum below the cul-de-sac or peritoneal reflection, there is a challenge on how to achieve a distal margin of 2 cm below the tumor,” said Theodoros Voloyiannis, MD, chair, Surgery Service, Memorial Hermann Southeast Hospital in Houston, Texas.

“For a long time, technology has challenged our access to the lower margin. It’s hard to go behind or below a tumor

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GENERAL SURGERY NEWS • SEPTEMBER 2013

To address some of the challenges of LAR, Covidien developed the Endo GIA™ Radial Reload, a uniquely curved instrument designed with a shallow profile to allow for greater maneuverability and accessibility (Figure 1). The latest in the company’s portfolio of colorectal surgical devices, it is designed with Covidien’s Tri-Staple™ technology, offering progressive staple heights and a stepped cartridge face.

The Endo GIA™ Radial Reload is designed to accommodate a wide range of tissue thicknesses, rotate 360 degrees,5 and

allow surgeons to achieve greater depths in the pelvis.6 The Radial Reload is compatible with all Endo GIA™ Universal, Ultra Universal, and iDrive™ Ultra powered handles.

“The fundamental change we are seeing [with Endo GIA™ Radial Reloads] is for the first time we are going away from another variation on a linear stapler. The concept in LAR is to try to hook the entire rectal wall with one load and to fire a single load and divide the rectum … to go below the tumor more easily by using a sagittal or coronal approach, depending on the case. The rectal wall is suitable for a 60 mm stapler, but you have to have it all within your staple line grasp or you will need multiple loads,” said Dr. Voloyiannis.

“That’s what the Radial Reload was designed for: to reach lower and gain the extra 1 or 2 cm you need to get below where the linear staplers can’t, to offer easier access with less effort, and to be able to divide the rectum in a single load,” he added.

Clinical Experience As an early adopter of Endo GIA™ Radial Reload, Dr. Banerjee and his colleagues invented a hand-assisted approach using the instrument for HAL LAR. “Basically, when you’re doing HAL you can put the shaft of the stapler through a trocar, then take the curved distal part and, with your hand, hook it up inside of the abdominal cavity. But instead of using another 10 or 12 mm trocar, we just put the whole thing inside through the gel port without losing Progressive staple heights, unique tapered cartridge face

Staples and transects tissue

Unique tissue retention feature

Narrow profile 360 degree rotation

Tri-Staple™ technology Compatible with all Endo GIA™ Universal, Endo GIA™ and Ulltra Universal handles Operates in both coronal and sagittal planes

Figure 1. The Endo GIA™ Radial Reload with Tri-Staple™ technology.

Supported by

Figure 2. Use of the Radial Reload through a gel port.

Figure 3. Connecting the Radial Reload via the gel port.

Image courtesy of Theodoros Voloyiannis, MD

Image courtesy of Theodoros Voloyiannis, MD

Umbilical Approach “When you do HAL through the umbilicus, you have the option of placing the Radial Reload through a separate port in the right lower quadrant or through the suprapubic area.

The reason you have to place a 12 mm port and put the shaft through that is because it is hard to put the stapler through the gel and have it go all the way in. Your hand is already through the gel cup,” Dr. Voloyiannis explained.

When the hand port is placed in the umbilicus, Dr. Voloyiannis’s preference is to use a 12 mm suprapubic port. “Then you open the gel cap of the hand-assist port in the umbilicus, and introduce the staple load through the wound protector,” he said. Once both pieces have been introduced through their respective ports, the surgeon reconnects them within the patient’s abdomen. “Then you close the gap with your hand in, re-insufflate, hold the rectum with your hand, navigate the stapler to the distal margin, and fire it,” said Dr. Voloyiannis, noting that this technique is best used with a sagittal approach.

The other option when the hand port is in the umbilicus is to place the 12 mm port into the right lower quadrant. “That gives you this extra oblique approach that most surgeons use for HAL to fire below the peritoneal reflection with a linear stapler. They place the shaft through a right lower quadrant port and assemble the two pieces through the wound protector/retractor and fire. But suprapubic [port placement] works better,” said Dr. Voloyiannis.

Suprapubic Approach For surgeons who place the hand port in the suprapubic area with a Pfannenstiel incision, the technique is quite a bit different, Dr. Voloyiannis explained. “If you place your handassist port through the suprapubic area and do the entire operation from there—your sigmoid colon mobilization, your rectal mobilization, then your total mesorectal excision—you go down as far as you have to go for a lowlying tumor. When it comes time to divide, you have the luxury to uncap the gel port and place your assembled Radial Reload inside and divide the rectum,” he said. “In other words, you don’t need to do it laparoscopically. You already have the suprapubic wound protector/retractor and the rectum is right in front of you.”

Even in cases where he feels the Radial Reload offers little advantage over linear staplers in terms of reaching low in the pelvis, Dr. Voloyiannis believes it still provides an advantage by cleanly dividing the rectum with fewer firings. “That makes a huge difference when you’re doing LAR,” he said.

Cancer is not the only application for the Radial Reload, added Dr. Voloyiannis. “Any type of surgery where you are doing an ileoanal pouch anastomosis for ulcerative colitis, the Radial Reload is a perfect instrument for dividing at the level of the dentate line,” he said.

Future Applications: Single-Incision Surgery Dr. Voloyiannis, who teaches single-port surgery across the country and considers it his niche, envisions the Radial Reload as an important tool for this procedure. “The single port is a purple gel port [in the umbilicus]. You open the cup, introduce the Radial Reload into the abdomen, pass the shaft through and connect it with the staple load [Figure 3], cap the gel into the wound protector, insufflate, and then go all the way down to the rectum and divide it,” he said.

“I have also used a single-port approach via the right lower quadrant in cases where I’ve done a LAR where the patient needs a temporal diverting ileostomy—such as for low rectal cancer after preoperative neoadjuvant chemoradiation—by passing the stapler through the right lower quadrant single port,” he said. “The same thing you do in hand assist, you can do in single port. Or you can add your suprapubic 12 mm port, put your shaft through that, and connect the stapler load just

as with the hand port. But instead of having a hand inside, you have a laparoscopic grasper to grasp the bowel and retract it when firing the stapler. That suprapubic port site can be used for the placement of a pelvic drain upon completion of the single-port laparoscopic procedure. I think that’s the next application of single-port technology. I’ve done several cases and I’m very happy with it,” said Dr. Voloyiannis.

Conclusion The design of the Endo GIA™ Radial Reload may alleviate some of the technical demands that surgeons face during laparoscopic or HAL LAR. “[For] surgeons who have a hard time accessing the lower pelvis with linear staplers, who have had to fire multiple loads to achieve a division at the distal rectum and achieve distal margins, or who have had complications from anastomotic leaks, the Radial Reload could offer an alternative,” Dr. Voloyiannis said.

Dr. Voloyiannis recommended that surgeons new to using the Radial Reload should try it out in a couple of open cases before proceeding to HAL. “It gives you all these options, and because it gives you this extra depth access you may consider using it in LAR just to see if it works better for you,” he said.

References 1.

National Cancer Institute. http://training.seer.cancer.gov/colorectal/ treatment/rectum.html. Accessed July 10, 2013.

2.

Aalbers AG, Doeksen A, Van Berge Henegouwen MI, Bemelman WA. Hand-assisted laparoscopic versus open approach in colorectal surgery: a systematic review. Colorectal Dis. 2010;12(4):287-295.

3.

Yano H, Ohnishi T, Kanoh T, et al. Hand-assisted laparoscopic low anterior resection for rectal carcinoma. J Laparoendosc Adv Surg Tech A. 2005;15(6):611-614.

4.

Kang JC, Chung MH, Chao PC, et al. Hand-assisted laparoscopic colectomy vs open colectomy: a prospective randomized study.

Surg Endosc. 2004;18(4):577-581.

5.

Endo GIA Radial Reload with Tri-Staple Technology—Technical Guide.

P110024 Covidien; 2012.

6.

Pelvic depth, access, and rectal transection comparative human cadaver study between Radial Reload versus the CONTOUR® stapler.

Study conducted on 12 cadavers to compare performance of two stapling devices in the distal rectum. Study sponsored by Covidien in 2011.

Disclosures: Dr. Banerjee reported that he has worked as a consultant for and served on the speakers’ bureau of Cubist Pharmaceuticals. Dr. Voloyiannis reported that he has received honorarium from Applied Medical, Inc.

GENERAL SURGERY NEWS • SEPTEMBER 2013

BB131

our pneumoperitoneum,” he said. “You avoid the insertion of another trocar, which costs money and can cause complications such as bleeding or risk for hernia.”

Dr. Voloyiannis has found that the Radial Reload enables him to access deeper areas within the pelvis than other devices (Figure 2). “In women, there is no question you can get down to the levator muscles or dentate line. In the male population it seems like it gives you perfect access, an extra 1 or 2 cm, to reach the levator muscles and dentate line compared with the linear instrument,” he said.

Dr. Voloyiannis described two different ways to use the Endo GIA™ Radial Reload during HAL, depending on where the surgeon chooses to place the hand port: in the umbilicus or in the suprapubic area.

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Sleeve Compares Favorably With Other Options for Morbid Obesity B Y G EORGE O CHOA

A

large, statewide study of laparoscopic sleeve gastrectomy (SG) showed that the procedure was a valuable treatment option for morbid obesity, as it demonstrated better weight loss results than laparoscopic adjustable gastric banding (LAGB), and lower complication rates than laparoscopic Roux-en-Y gastric bypass (RYGB). Noting that some payors have been reluctant to cover SG, the study, and an accompanying editorial, recommend such coverage on the basis of the new data.

“This is a very high-quality study, with an appropriate propensity-score matched study design that highlights that SG is safe and effective and should be a covered benefit by private and public payors,” said Matthew M. Hutter, MD, MPH, medical director of the Codman Center for Clinical Effectiveness in Surgery and a bariatric surgeon in the Department of Surgery, Massachusetts General Hospital, Boston, in an interview with General Surgery News. Dr. Hutter, who wrote the editorial, added, “It’s a large regional study of almost 3,000 patients

who underwent SG. The study includes patient-centered outcomes and propensity-score matching that allows for appropriate comparisons, and follows patients for up to three years.”

The study by Carlin et al in Annals of Surgeryy (2013;257:791-797; editorial 798-799), used data from the Michigan Bariatric Surgery Collaborative, a consortium of hospitals and surgeons.

The researchers matched 2,949 morbidly obese patients who had undergone SG with equal numbers of RYGB and LAGB patients who were well balanced on baseline characteristics.

The overall complication rate of 6.3% among SG patients, within 30 days of surgery was lower than the rate for RYGB (10%; P<0.0001), but higher than the rate for LAGB (2.4%; P<0.0001). Rates for serious complications were similar for SG (2.4%) and RYGB (2.5%; P P=0.736) but higher than for LAGB (1%; P<0.0001).

Excess body weight loss at one year was 13% lower for SG (60%) than for RYGB (69%; P<0.0001) but 77% higher for LAGB (34%; P<0.0001). SG also was closer to RYGB than to the lowerranking LAGB with regard to remission

of several obesity-related comorbidities, such as non–insulin-dependent diabetes, sleep apnea and hypertension.

“Our study findings are similar to the results of previous trials, but our study was much larger than earlier studies and was also matched, so it was able to control for a large number of patient characteristics, similar to a trial,” senior study author, Nancy J.O. Birkmeyer, PhD, associate professor of surgery, Department of Surgery, and senior scientist, Center for Healthcare Outcomes and Policy, University of Michigan, Ann Arbor, said in an email. Dr. Birkmeyer said it was important to find an alternative to RYGB and LAGB because “there are tradeoffs between the risks and benefits of those procedures. RYGB is more effective than LAGB but it is also considerably more risky.” SG, she said, represents a middle option: “SG has a lower risk for complications than RYGB but better weight loss and comorbidity resolution than LAGB.” In the editorial, Dr. Hutter said SG “should be a tool in the surgical toolbox,” however, in an interview he said, “But questions remain. What is the right operation for which patient? What will

the long-term effects be?” The principal limitation of the study, he said, is “that patients are lost to follow-up. The follow-up observation at three years captured only 28% of the patients.” Dr. Birkmeyer agreed that loss to follow-up is “the main limitation of our study.”

The study results already have influenced payors to cover SG. The study’s lead author, Arthur M. Carlin, MD, FACS, head of the Division of General Surgery, Henry Ford Health System, Detroit, who also is associate professor of surgery, Wayne State University, also in Detroit, said in an email that presentation of the data to the region’s Medicare administrative contractor persuaded the organization to provide Medicare coverage for SG in Michigan and eight other states. “Private payors tend to follow Medicare guidelines, although there were private payors covering SG when Medicare was not,” Dr. Carlin said.

According to Dr. Hutter, “[SG is] a newer procedure, and certain payors are looking for further evidence as to whether they should cover it … this further evidence could support coverage decisions by both public and private payors.”

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Limited-Calorie Diet May Have Same Benefits as Eucaloric in ICU B Y C HRISTINA F RANGOU

A

new study suggests that a limited calorie diet may offer just as much benefit as the standard eucaloric diet to patients requiring nutritional support in a surgical intensive care unit (SICU).

In a randomized study presented at the 2013 annual meeting of the Surgical Infection Society, the eucaloric diet was no better at preventing infections, reducing patients’ ICU or hospital length of stay (LOS) or maintaining glucose control than hypocaloric feeding in SICU patients.

The study also demonstrated no survival benefit for the eucaloric diet.

Lead author Eric Charles, MD, a general surgery resident at the University of Virginia in Charlottesville, said the study suggests the eucaloric diet, the current gold standard for SICU patients, might not be ideal for critically ill patients.

“In fact, less may be better. If not better, then patients are likely not harmed if they do not receive their full daily calculated amount of calories,” said Dr. Charles.

The randomized, single-institution study was conducted at the University of Virginia. Investigators randomized 84 adult patients to receive a eucaloric diet of 25 to 30 kcal/kg per day (n=42) or a hypocaloric diet of 12.5 to 15 kcal/kg per day (n=42). Patients on both diets received 1.5 g/kg of protein each day. All patients were admitted to the SICU and deemed appropriate for nutritional support.

The primary outcomes of the study were the presence of infection, the number of infections per patient, the infection site and the causative organism. Secondary outcomes included a measurement at 6 a.m. of blood glucose levels, insulin requirements, ICU and hospital LOS, and in-hospital mortality.

Analysis revealed no difference in any of the primary or secondary outcomes.

The study did not examine the potential economic advantages or time-saving benefits for either diet.

Current guidelines call for critically ill patients to receive 25 to 30 kcal/kg per day with 1.5 g/kg of protein. Nutrition should be initiated 24 to 48 hours from admission with the goal of providing at least 50% to 65% of calories to achieve clinical benefit.

But results from this study suggest otherwise. “Maybe the goal should be different,” said William G. Cheadle, MD, professor of surgery and program director in the Division of General Surgery, University of Louisville, in Kentucky.

When patients receive nutritional

feeding, they are at increased risk for aspiration of tube feeds; diarrhea for enteral feeds; and infection, fluid overload, hyperglycemia and central line complications for parenteral nutrition, he said.

“These risks are lessened if the amount of calories needed were less than the traditional amounts. Thus, this study shows that feeding less in the ICU may be better, as overall morbidity was the same,” Dr. Cheadle said.

The study could not identify optimal caloric amounts for patients in the SICU, Dr. Charles stressed. The researchers are currently setting up a large multicenter randomized trial to compare the two diets.

“Right now, we have data that show there is no benefit or risk to hypocaloric feeding. There are no advantages that we know of at this time for patients receiving as many calories as they do. We have shown no difference

between standard amounts and 50% of that value,” said Dr. Charles.

A handful of small studies have shown that some critically ill patients, including obese patients and those with multiple traumas, may benefit from permissive underfeeding (Ann Surg 1992;215:503-511). This is the first randomized controlled trial to examine the benefits of low-calorie feeding in SICU patients.

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The Problem Medical research shows discordance rates of ϯϭй ƚŽ ϱϮй ŝŶ ƚŚĞ ŝĚĞŶƟ Į ĐĂƟ ŽŶ ŽĨ ƐƉĞĐŝŵĞŶ ŵĂƌŐŝŶƐ ďĞƚǁĞĞŶ ƐƵƌŐĞƌLJ͕ ƉĂƚŚŽůŽŐLJ ĂŶĚ ƌĂĚŝŽůŽŐLJ͘2,3 ZĞͲĞdžĐŝƐŝŽŶ ƌĂƚĞƐ ĞdžĐĞĞĚ ϮϬй ŝŶ ďƌĞĂƐƚ ƐƵƌŐĞƌLJ͘4

dŚĞ ^ŽůƵƟ ŽŶ͗ DĂƌŐŝŶDĂƌŬĞƌ ĂŶĚ ŽƌƌĞĐƚ ůŝƉƐ sĞĐƚŽƌ ^ƵƌŐŝĐĂů͛Ɛ Ɵ ƐƐƵĞ ŽƌŝĞŶƚĂƟ ŽŶ ƐLJƐƚĞŵ ƉƌŽǀŝĚĞƐ ƐĞĐƵƌĞ ĂŶĚ ĂĐĐƵƌĂƚĞ ĚĞƐŝŐŶĂƟ ŽŶ ŽĨ ƐƉĞĐŝŵĞŶ ŵĂƌŐŝŶƐ͕ ĐŽŶƚƌŝďƵƟ ŶŐ ƚŽ͗ Fewer unnecessary re-excisions;

ƉƌĞǀĞŶƚƐ ĚĞůĂLJ ŽĨ ĐƌŝƟ ĐĂů ĂĚũƵǀĂŶƚ therapy More accurate re-excisions Lower cancer recurrence /ŵƉƌŽǀĞĚ ĐŽƐŵĞƐŝƐ /ŵƉƌŽǀĞĚ KZ ƐĂĨĞƚLJ WůĞĂƐĞ ǀŝƐŝƚ ƵƐ Ăƚ

ŵĞƌŝĐĂŶ ŽůůĞŐĞ ŽĨ ^ƵƌŐĞŽŶƐ ůŝŶŝĐĂů ŽŶŐƌĞƐƐ ϮϬϭϯ džŚŝďŝƚ ϰϰϰ ®

+1 (262) 798-7970 ZĞĨĞƌĞŶĐĞƐ͗ ;ϭͿ ŽŽůĞLJ͕ t͘ ĂŶĚ WĂƌŬĞƌ͕ :͘ ͞hŶĚĞƌƐƚĂŶĚŝŶŐ ƚŚĞ DĞĐŚĂŶŝƐŵƐ ƌĞĂƟ ŶŐ &ĂůƐĞ WŽƐŝƟ ǀĞ >ƵŵƉĞĐƚŽŵLJ DĂƌŐŝŶƐ͘͟ American Journal of Surgery ϭϵϬ ;ϮϬϬϱͿ͗ ϲϬϲͲϲϬϴ͘ ;ϮͿ ƌŝƩ ŽŶ͕ W͘ ͖͘ ^ŽŶŽĚĂ͕ >͘/͖͘ zĂŵĂŵŽƚŽ͕ ͘<͖͘ <ŽŽ͕ ͖͘ ^ŽŚ͕ ͖͘ ĂŶĚ 'ŽƵĚ͕ ͘ ͞ ƌĞĂƐƚ ^ƵƌŐŝĐĂů ^ƉĞĐŝŵĞŶ ZĂĚŝŽŐƌĂƉŚƐ͗ ,Žǁ ZĞůŝĂďůĞ ƌĞ dŚĞLJ͍͟ European Journal of Radiology ϳϵ ;ϮϬϭϭͿ͗ ϮϰϱͲϮϰϵ͘ ;ϯͿ DŽůŝŶĂ͕ D͘ ͖͘ ^ŶĞůů͕ ^͖͘ &ƌĂŶĐĞƐĐŚŝ͕ ͖͘ :ŽƌĚĂ͕ D͖͘ 'ŽŵĞnj͕ ͖͘ DŽī Ăƚ͕ &͘>͖͘ WŽǁĞůů͕ :͖͘ ĂŶĚ ǀŝƐĂƌ͕ ͘ ͞ ƌĞĂƐƚ ^ƉĞĐŝŵĞŶ KƌŝĞŶƚĂƟ ŽŶ͘͟ Annals of Surgical Oncology ϭϲ ;ϮϬϬϵͿ͗ ϮϴϱͲϮϴϴ͘ ;ϰͿ DĐ ĂŚŝůů͕ >͘ ͖͘ ^ŝŶŐůĞ͕ Z͘D͖͘ ŝĞůůŽ ŽǁůĞƐ͕ ͘:͖͘ &ĞŝŐĞůƐŽŶ͕ ,͘^͖͘ :ĂŵĞƐ͕ d͘ ͖͘ ĂƌŶĞLJ͕ d͖͘ ŶŐĞů͕ :͘D͖͘ ĂŶĚ KŶŝƟ ůŽ͕ ͘ ͘ ͞sĂƌŝĂďŝůŝƚLJ ŝŶ ZĞĞdžĐŝƐŝŽŶ &ŽůůŽǁŝŶŐ ƌĞĂƐƚ ŽŶƐĞƌǀĂƟ ŽŶ ^ƵƌŐĞƌLJ͘͟ :ŽƵƌŶĂů ŽĨ ƚŚĞ ŵĞƌŝĐĂŶ DĞĚŝĐĂů ƐƐŽĐŝĂƟ ŽŶ ϯϬϳ͘ϱ ;ϮϬϭϮͿ͗ ϰϲϳͲϰϳϱ͘ Ξ ϮϬϭϯ sĞĐƚŽƌ ^ƵƌŐŝĐĂů >>

ŶŶŽƵŶĐŝŶŐ ŽƵƌ ŶĞǁ ǁĞďƐŝƚĞ ǁǁǁ͘ǀĞĐƚŽƌƐƵƌŐŝĐĂů͘ĐŽŵ

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10

Code of the Month

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / SEPTEMBER 2013

The Whole Patient? The Importance of Specificity of Diagnosis B Y L UCIAN N EWMAN III, MD, FACS

F

rom our first days in medical school, we are taught to respect the human form and learn to understand the diseases that lead to its ultimate demise. When needed, physicians intervene to impede these conditions,

whether they be infectious, traumatic, idiopathic, genetic or the inevitable result of aging. “Comorbidity” can be defined as the effect of all other diseases an individual patient might have other than the primary disease of interest. We quickly realize that no single condition stands alone. Instead, each patient possesses an array of risk factors that affects the other conditions. Consider the myriad effect of diabetes or immunosuppressive disorders. We are challenged with treating the

whole patient precisely because each disorder may affect another. The research done to study the effects of medical and surgical treatments often shows results that are unintended and unanticipated.

Even with the level of sophistication seen in the modern practice of medicine, perfection of care is not possible, in part due to a lack of understanding of differences attributable to each individual patient and his or her comorbidities, both known and unknown.

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Medicine is becoming increasingly complex.

As physicians treat a narrower spectrum of disease, their comfort level in describing the whole patient decreases.

As our society searches for the optimum way to care and pay for our population, a more intense focus on costs is natural. Generally, there are wide variations in expenditures based on the age, lifestyle, comorbidities and even geographical location of the patient.

Although controlling the variables is difficult, simply knowing the variables is possible by aggregating all descriptions and treatments attributable to individuals. Accuracy in this endeavor is paramount, and this is the cornerstone of documentation and coding-improvement projects that are so important today. Payment mechanisms based on diagnosisrelated groups (DRGs) reward facilities and physicians for describing the care of sicker patients generally limited to three levels of care. Newer initiatives will likely create more levels, and also will consider quality metrics and satisfaction scores to arrive at reimbursement totals. The physician’s role is paramount and increasing in these models.

Medicine is becoming increasingly complex. As physicians treat a narrower spectrum of disease, their comfort level in describing the wholee patient decreases.

Nevertheless, we are responsible for taking into account many variables before recommending both medical and surgical treatments. No physician is capable of knowing everything, but he or she should be capable of assembling information that is known and searching for unknowns, particularly in their respective discipline. The language of medicine does not always translate into the appropriate classification code assigned to describe the condition, or the language is not specific enough to distinguish between code options. The revision in the International Classification of Diseases [ICD]-10 codes requires greater specificity, but it is needed because our advances have outstripped our ability to describe the disorders specifically. There are many ways to criticize the move to ICD-10, but understanding that the ICD system was created to foster a better understanding of disease and death should be recognizable by all health care providers (although I’m not convinced

SEPTEMBER

2013

11 that knowing whether an injury was caused by a raccoon or the pilot of a spacecraft is germane).

A sound argument can be made for higher reimbursement to those facilities and physicians who are responsible for higher-acuity patients. Determining what constitutes meaningful differences in acuity, and thereby justifying a higher or lower payment, would seem to be more difficult. Payment variables also now involve the level of patient satisfaction including 1% at risk for Medicare services. Satisfaction ratings are a part of Medicare plans by linking a small percentage of reimbursements to “value-based purchasing.” Comparing hospitals against their clinical performance guidelines (70%) and on patients’ perception of the quality of care (30%) will generate a basis for bonus or penalty.

The Hospital Consumer Assessment of Healthcare Providers and Systems (or HCAHPS) form is the vehicle used to generate information by communicating with patients. The survey, which has 27 questions and is not limited to the discharge of Medicare patients, is conducted between two days and six weeks after discharge. (The survey and guidelines are available at www.hcahpsonline.org.)

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A sound argument can be made for higher reimbursement to those facilities and physicians who are responsible for higher-acuity patients.

Many physicians are frustrated by the intrusion into their relationships with their patients and the time spent with them. Each new directive, requirement or protocol requires a level of understanding and commitment, and often changes the status quo. Even the “meaningful use” set of standards has been shunned by some physicians who object to it on many levels. Clearly, the near future of medicine requires some adjustments to most health care practices. Attention to details previously ignored will be suggested, if not absolutely required. As responsibility for management shifts, the physician’s autonomy may disappear.

The ICD-10 codes will be introduced on Oct. 1, 2014. For further information, visit the Centers for Medicare & Medicaid Services at http://www.cms. gov/Medicare/Coding/ICD10/index. html?redirect=/icd10.

—Dr. Newman is founder and CMO — of ComplyMD (complymd.com), a company that provides procedural documentation solutions. He is a general surgeon in Gadsden, Alabama.

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In the News

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The DIN Around DCIS: Treat All Patients or Watch and Wait?

NATIONAL HARBOR, MD—Over the past 40 years, the incidence of ductal carcinoma in situ (DCIS) has skyrocketed in the United States, accounting for 1% of all detected breast cancers in the 1970s and 25% in 2009. Although the National Comprehensive Cancer Network (NCCN) guidelines recommend treating DCIS, some experts argue that watchful waiting is appropriate for some patients. At the Society of Surgical Oncology’s annual meeting, two surgeons tackled this subject in a pro–con debate.

Treat All Thomas Julian, MD, professor of surgery at Drexel University College of Medicine and Temple University School of Medicine, Philadelphia, and director of Breast Surgical Oncology West Penn Allegheny Health System, in Pittsburgh, argued that all patients benefit from standard therapy: mastectomy or lumpectomy with or without radiation.

“DCIS is a precursor to the development of invasive breast cancer,” said Dr. Julian. The two share common biomarkers and taxonomy. Although some DCIS cases are aggressive and others may never cause problems, clinicians cannot differentiate between the various types, and therefore all DCIS patients should be treated, he said.

Around the world, mastectomy has been used to treat 35% to 60% of patients with DCIS and is close to 100% effective. No randomized clinical trials have compared mastectomy with breast-conservation therapy in patients with DCIS, but numerous studies have evaluated adding radiation to lumpectomy. For example, the NSABP (National Surgical Adjuvant Breast and Bowel Project) B-17 trial randomized 818 patients with DCIS to receive lumpectomy with or without radiation. Radiation reduced the risk for noninvasive ipsilateral breast tumors (IBT) (13.4% vs. 8.2%; P=0.007) and invasive IBT (13.4% vs. 3.9%; P<0.0001) at eight years of follow-up (J ( Clin Oncol 1998;16:441452). In a meta-analysis of NSABP B-17 and three other randomized trials, adding radiation to lumpectomy reduced the absolute 10-year risk for any ipsilateral breast event (IBE) by 15.2% (P<0.00001), but did not affect breast cancer mortality, mortality from causes other than breast cancer or all-cause mortality ((J Natl Cancer Inst Monogrr 2010;41:162-177). Numerous other studies have shown that adding radiation to lumpectomy improves IBE rates.

‘Cases of DCIS that will not progress to invasive cancer during an individual’s lifetime still seem to be difficult to predict overall.’

—Thomas Julian, MD Randomized trials also have demonstrated the benefit of adding tamoxifen to estrogen receptor (ER)positive patients with DCIS who receive lumpectomy plus radiation. In NSABP B-24, adding tamoxifen significantly reduced subsequent breast cancer at 10

years (hazard ratio [HR], 0.49; P<0.001) ((J Clin Oncol 2012;30:1268-1273).

Several studies, including the Eastern Cooperative Oncology Group study E5194 and Radiation Therapy Oncology Group 9804, have attempted to identify low-risk patients who might not benefit from radiation. These studies showed limited benefit without radiation therapy. However, at the 2011 San Antonio Breast Cancer Symposium, researchers presented validation data for Oncotype DX Breast Cancer Assay for DCIS (Genomic Health), which predicts risk for an IBE after surgery for DCIS. The DCIS score uses information from 12 of the 21 genes in the Oncotype DX test and an algorithm to predict recurrence.

Dr. Julian said this test is the first real progress made toward identifying low-risk patients who may not need radiation, but further studies are needed.

“Cases of DCIS that will not progress to invasive cancer during an individual’s lifetime still seem to be difficult to predict overall,” said Dr. Julian, and therefore clinicians are not at a clear point where they can select patients for watchful waiting.

Watchful Waiting E. Shelley Hwang, MD, MPH, professor and chief of breast surgery at Duke Cancer Institute, Duke University Health System, Durham, N.C., “hates” overtreatment of DCIS. “The treatment of DCIS has not reduced the incidence of invasive cancer and not all DCIS will become invasive,” she said. “[Treatment] comes with a cost, not only to the medical system but to the patient.”

She argued that the heterogeneity of DCIS necessitates a tailored treatment approach. “We are diagnosing more and more entities and calling them a cancer,” she said, and some do “not go on to cause symptoms or death within a span of a patient’s normal lifetime.

“At some point in time, [DCIS] may develop into invasive cancer, but it is a nonobligate precursor, meaning we don’t know when it will progress or if it will progress … because we are picking lesions up way too early to know what their behavior is going to be like,” Dr. Hwang said.

DCIS is part of a continuum of pathologic change and determining the boundaries between normal ductal epithelial cells, atypical hyperplasia, DCIS and invasive cancer is sometimes difficult. Different pathologists often have different interpretations.

Because clinicians are diagnosing more DCIS, one would expect invasive breast cancer rates to go down, but, in fact, they are going up. Analyzing the Surveillance Epidemiology and End Results database and modeling different scenarios, Dr. Hwang said the only reasonable conclusion to be drawn is that between 60% and 80%

of patients with DCIS who are treated with standard care are being treated for something that would never harm them in their lifetime. This is based on the assumption that 20% of DCIS progresses, which “is in line with what some of the studies have shown,” said Dr. Hwang.

She believes clinicians should start selecting patients who might not need treatment. The first echelon of tools to help in this endeavor is clinical data (tumor grade, size, ER/progesterone receptor and HER2 status) and patient characteristics (age, comorbidities, etc.). The Van Nuys Prognostic Index also can help. More recently, doctors at Memorial Sloan-Kettering Cancer Center, New York City, have developed a nomogram that predicts the likelihood of recurrence for different subtypes of DCIS using 10 different variables.

‘The treatment of DCIS has not reduced the incidence of invasive cancer and not all DCIS will become invasive.’

—E. Shelley Hwang, MD, MPH Clinicians also can use emerging molecular tests, such as the Oncotype DCIS, to select patients who are candidates for minimal therapy. Dr. Hwang has used this test and found it useful.

“When a patient sees a number of projected risk, five-year risk of recurrence and 10-year risk of recurrence, it really helps to ground some of their decision making,” she said. Additional studies of the tool, however, are needed. Other molecular markers such as P16 and KI67 being researched at the University of California, San Francisco look promising for DCIS. Dr. Hwang said doctors should be aware that terminology affects patient treatment decisions. At Duke, researchers administered a survey to 400 individuals testing their response to a scenario in which they were told they had noninvasive breast cancer, abnormal cells or a lesion and then asked whether they wanted surgery, medication or active surveillance. The side effects of each choice were described. All patients were given information on how their choice affected their chance of developing breast cancer or dying in the next 10 years. Patients were more likely to undergo active surveillance if the term lesion or abnormal cellss was used (48%) rather than noninvasive breast cancer (33%).

Dr. Hwang and her colleagues are currently developing a tool for DCIS that is similar to Adjuvant! Online.

Also under way is a cooperative group trial to examine the average change in magnetic resonance imaging (MRI) tumor volume from pretreatment to trial completion in ER-positive DCIS patients who have received six months of preoperative endocrine therapy.

Dr. Hwang hopes that in the future, patients with DCIS will be given the option of watchful waiting, if they have a brisk MRI response to drug therapy.

“I hope that the NCCN guidelines eventually include active surveillance,” said Dr. Hwang.

Dr. Hwang disclosed being on the advisory board of Genomic Health.

Stitches

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A Talk With Eddie Joe Reddick: Laparoscopy Pioneer, Recording Artist B Y V ICTORIA S TERN

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oon after leaving the army in 1984, general surgeon Eddie Joe Reddick, MD, moved to Nashville, Tenn., and began practicing surgery at a small community hospital. In his spare time, Dr. Reddick explored his childhood passion for writing music and playing guitar.

“I moved to Nashville, in part, because I loved the music,” Dr. Reddick said. “I signed with a publishing company and cut a couple of songs back in 1984. Moving here gave me the opportunity to play in some of the clubs.”

On the surgical front, Dr. Reddick spent much of his time working with the gynecologists in his hospital, many of whom were doing laparoscopic work. Soon, Dr. Reddick got wind that surgeons were taking gallbladders out through the belly button. At a local gynecology meeting in Augusta, Ga., Dr. Reddick met J. Barry McKernan, MD, PhD, and gynecologist William Saye, MD, for drinks and the trio discussed the possibility of removing a gallbladder laparoscopically.

“We couldn’t find anyone who was actually doing this, so we decided to attempt it ourselves,” Dr. Reddick recalled.

When he returned home, Dr. Reddick began investigating how to perform a laparoscopic cholecystectomy. However, before he could do the procedure, he needed certain tools and found there were very few available. “The insufflators I initially used only provided 3 mm Hg of pressure and created a lot of smoke inside the belly. We couldn’t see well and had to suck out the smoke,” he said. Dr. Reddick settled for an insufflator at 5 mm Hg, which was not ideal, but did the trick.

Dr. Reddick also needed a clip applier to ligate the cystic duct and artery. Dr. McKernan was tying the cystic duct and artery together by hand, but Dr. Reddick thought that would be too difficult to do in every case, so he decided to fashion his own.

“We took an old straight clip applier, bought some epoxy glue at Walmart and glued the clip applier to a round tube,” Dr. Reddick recalled. “This makeshift clip applier would only last for about two cases, so every night when I went home, I had to build two more clip appliers to use the next day.”

In September 1998, Dr. Reddick and his partner, general surgeon Douglas Olsen, MD, performed their first laparoscopic cholecystectomy, the second ever done in the United States. (Drs. McKernan and Saye performed the first one several months earlier; see “The ‘Cowboys’ of Lap Chole,” General Surgery News, July 2013, page 1).

For their first case, Drs. Reddick and Olsen found the ideal, low-risk candidate. The patient was thin, had no gallbladder inflammation and had never undergone surgery before.

“She was psyched for the surgery,” Dr. Reddick recalled. “We thought the worst thing that would happen is we’d have to open her up, and I set my trocar site so I could do that, if needed.”

The procedure took about 80 minutes to complete and the patient recovered quickly, walking around the hospital and eating shortly after the surgery. To be safe, Dr. Reddick kept her in the hospital for four days to make sure no complications occurred.

Despite the success of the surgery, Dr. Reddick could see this was not going to be an easy road. “As far as I know, this was the first time in history that medical skills were being taught outside of medical school,” Dr. Reddick said. “Before that, you would have to go through residency to learn such surgical techniques.

As a result, there was a lot of skepticism and negativity surrounding this operation.”

Some surgeons, Dr. Reddick said, went as far as to contact the news media in New York City to inform them of this “very dangerous” new operation. This warning prompted Peter Jennings at ABC News to do a special report on laparoscopic cholecystectomy.

“I received a call about proctoring a surgeon in Bridgeport, Connecticut, to do a laparoscopic cholecystectomy at that hospital,” Dr. Reddick said. “I was flown to Bridgeport from LaGuardia [Airport] via helicopter to help with the operation.”

would watch a few cases initially, then assist and finally do the operation themselves.

“The people who came to the courses were just ecstatic,” Dr. Reddick said. “These surgeons saw something they could build a practice with, something that was better for the patients and better for them. It was a win-win situation.”

As laparoscopic cholecystectomy took off, Dr. Reddick was invited to teach all over the world, visiting 21 countries and giving countless lectures and demonstrations. Patients sought out his expertise both within the United States and internationally. The manufacturers of the laparoscopic tools saw their stock rise quickly, and the tools continued to improve.

“The innovation of the instrumentation was wonderful,” Dr. Reddick recalled. “Before laparoscopic cholecystectomy came along, most instrument companies were not interested in laparoscopy, but when we added 700,000 gallbladder cases ‘The people who came to the courses were just every year to the mix, companies like US Surgical Corporaecstatic. These surgeons saw something they could tion and Ethicon, Inc., joined build a practice with, something that was better for the in. These companies were a major driving force behind the patients and better for them. It was success of the procedure.” a win-win situation.’

Even while practicing surgery full time in Nashville and —Eddie Joe Reddick, MD teaching courses in Augusta on the weekends, Dr. Reddick The patient, a young woman, was not an ideal continued to write songs, and candidate for the surgery, Dr. Reddick said. She periodically got one cut. had undergone surgery before and was a little over“It was never something weight due to her recent pregnancy. Nevertheless, really big,” he said. “I was the surgery was a success. The operation took one mainly writing songs and hour, and the patient experienced minimal postopplaying on writers’ nights.” erative pain.

Dr. Reddick did have the “She stayed in the hospital overnight and walked Eddie Joe Reddick, MD, occasional success. While in out the next day carrying her new baby,” Dr. Red- in 2010 Nashville in the mid-1980s, dick said. “All of this was caught on camera and covDr. Reddick’s song, “I’m Lisered on the ABC evening news. Millions of Americans tening to Hank” actually hit the No. 70 slot on the saw this report [which aired on July 12, 1990]. After Billboard country music chart. that, practically every surgeon wanted to be trained However, Dr. Reddick admits, “I was kind of a midimmediately.” dle-of-the-road guitar player and songwriter. SomeSurgeons in Dr. Reddick’s hospital were eager to times you’re just not as good as you think you are, learn the surgical technique and started scrubbing in especially when compared with the people here in with him during his laparoscopic cholecystectomies. “I Nashville, who are top-notch players.” started off teaching surgeons one on one, but that got In 1992, Dr. Reddick decided to leave his lucrato be very time-consuming, and when I realized how tive practice and start a music publishing company in many patients would need this operation, it became order to pursue country music full-time. He continclear there had to be a better way to train surgeons.” ued to write music but his company never took off, so Dr. Reddick had performed 16 cases before develop- a few years later when a laparoscopy instrument coming a pig training laboratory in Nashville. Four people pany called Surgical Sense, Inc., came knocking on Dr. attended the first course, but this number quickly grew Reddick’s door, he responded. to 40 in subsequent courses. On the first day, Dr. Red“The company was interested in a new type of herdick would give a two-hour lecture, and the next day he nia repair and wanted teachers, so I decided to go back would perform surgery with a volunteer from the lec- into practice,” he said. “I got all of my credentials back ture while the rest observed the procedure on a monitor. and started working on this project. After that, I went “The audience actually applauded when the gall- into private practice and retired in 2005.” bladder popped out of the belly button,” Dr. Reddick Reflecting on the history of laparoscopic surgery, said. “I think many surgeons who came to the cours- Dr. Reddick said, “What was exciting about the time es were still somewhat dubious about the procedure.” of laparoscopic cholecystectomy was that each of us The demand for laparoscopy courses continued added to the knowledge base because everything we to grow. Drs. Reddick and Saye moved the cours- did was ‘the first time’ it had been done. And look at es to a bigger laboratory in Atlanta, and partnered what has happened since. We’ve started doing endoswith instrument-manufacturing company, US Surgi- copy for all types of joints, for hernia repair, for colon cal Corporation, which provided them with pigs every resection, to name a few. It was laparoscopic cholecysSaturday morning. Surgeons attending the courses tectomy that opened the door for this future.”

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The Physician as CEO, Once Again More Doctors Fusing Clinical, Business Sides of Medicine in Leadership Roles; Will This Lead To Better Health Care?

B Y V ICTORIA S TERN

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he number of physicians in leadership roles has been diminishing for more than a century. In the early 1900s, physicians ran more than one-third of

hospitals in the United States, but this number has steadily dwindled over the years (Vasc Endovasc Surg 2008;42:8894). Today, the majority of hospital administrators are nonphysicians, with one study estimating that of 6,500 hospitals in the United States, only 235 or 3.6% are physician-led (Acad ( Med 2009;84:1348-1351).

“In the early days, physicians often ran the business side of hospitals and medical organizations because it was

simpler,” said Chalmers Nunn Jr., MD, MMM, CPE, FACPE, practicing gastroenterologist and CEO at Gastroenterology Associates of Central Virginia, Lynchburg. “As our society evolved and more money infused into the medical system, physicians began to hire cheaper nonphysician administrators to run the business.”

But in the past few years, the pendulum appears to be swinging back in the direction of the clinician leader. As

at th oo 3 r b 01 ou S 2 1 sit C 63 Vi A #

Introducing

the business and clinical sides of medicine have become more multifaceted, “we have started to need physician leadership to run both fronts again,” Dr. Nunn said.

Dhruv Khullar, medical student and class president at Yale School of Medicine who is seeking his master’s in public policy at Harvard University’s Kennedy School, also has observed this shift among his classmates and colleagues.

“The number of students taking time to pursue research or another degree is growing so quickly that [my colleagues] joke that medical school is now five years with an option for four,” Mr. Khullar said. “I think this [cross-disciplinary focus] comes from a strong recognition of the broader societal influences on and impacts of health care in this country.”

James Mandell, MD, CEO of Boston Children’s Hospital and practicing surgeon agrees that “more clinicians are becoming interested in leadership positions and are getting advanced degrees in administration or business, but whether that will translate into a large-scale leadership change remains to be seen.”

Preference for Physician Managers

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The key to effectively managing a medical organization is being “intimately familiar with the health care delivery challenges that doctors and other providers encounter on a day-to-day basis,” Mr. Khullar said. Thus, although hospitals can be run equally well by physicians and nonphysicians, physicians may have a distinct advantage because they are naturally more in tune with the medical landscape.

Dr. Mandell believes that “having physician leadership in the top echelons of medical institutions is very important, but whether that role is at the CEO level or another level is relatively unimportant as long as physicians have the

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‘More clinicians are becoming interested in leadership positions and are getting advanced degrees in administration or business, but whether that will translate into a large-scale leadership change remains to be seen.’

—James Mandell, MD

ability to influence decision making in the organization.”

In an editorial, Lord Ara Darzi, MD, FRCSI, FRCS, Paul Hamlyn Chair of Surgery at Imperial College, London, observed that clinicians in the United States can provide unique insights about where health care resources should be allocated and should become more active in implementing these changes (N Engl J Medd 2009;361:e8). To this end, Dr. Darzi called for more clinicians in the country to take on leadership roles in the health care system, instead of allowing bureaucrats and insurance companies such extensive control.

Robert J. Fitzgibbons, MD, Harry E. Stuckenhoff Professor of Surgery, Creighton University School of Medicine, Omaha, Neb., agreed that physician leaders are well equipped to bring together the clinical and administrative sides of a health care organization because they “have perspective on what is going on in the trenches.”

Now empirical evidence is emerging that supports this move toward trained physician managers. One 2010 study, which surveyed 1,200 hospitals across seven countries, including the United Kingdom, Germany and Canada, found that hospitals with clinician managers had the most effective management practices (“Management in Healthcare: Why Good Practice Really Matters,” www.worldmanagementsurvey.org).

Another recent study that explored whether hospitals perform better when led by doctors (Soc Sci Medd 2011;73:535539), found a similar relationship. Using the 2009 U.S. News & World Report’s Best Hospitals ranking system, lead author Amanda Goodall, PhD, senior lecturer at Cass Business School in London and research fellow at IZA Institute for the Study of Labor, Germany, identified the top 100 U.S. hospitals in three

specialties—cancer, heart and heart surgery, and digestive disorders—and classified the 300 CEOs as physician or nonphysician managers. In all three fields, the results showed that hospitals with higher rankings were led disproportionately by physicians (P<0.001): For cancer, 51 of the 100 top-ranked hospitals were physician-led; for heart and heart surgery and digestive disorders, 37 of 100 and 34 of 100 top-ranked hospitals, respectively, were run by

physicians. Dr. Goodall makes it clear, however, that “the findings do not prove that doctors make more effective leaders than professional managers,” and hopes her study will fuel further investigation.

Physician CEOs Over the past 10 years, Dr. Mandell has observed complex changes to the models of care and payment systems in the United States, and has had to deal with the internal challenges of information technology (IT) and ongoing patient safety and quality initiatives, as see PHYSICIAN CEO page 16

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In the News PHYSICIAN CEO jcontinued from page 15

well as the external forces of the private payor and government.

“These are complex issues that require talent and a clinician’s voice,” Dr. Mandell said. As a CEO and practicing surgeon, “I get a good bird’s-eye view of the problems practicing in a large institution and the difficulties involved in supporting nurses and doctors in their roles.”

In his roles as CEO and practicing gastroenterologist, Dr. Nunn has

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / SEPTEMBER 2013

worked extensively to improve the quality and efficiency of Gastroenterology Associates and to foster strong relationships between colleagues, nonphysicians, IT and the local health system.

One of first things Dr. Nunn did as CEO was improve electronic medical records (EMR), which he characterizes as one of the biggest challenges any manager faces.

“The biggest mistake health systems make is under resourcing this,” Dr. Nunn said. “You have to invest in implementing and customizing an EMR system, it can’t just be an add-on

project. Doctors have to get involved and engaged, and organizations have to understand it’s never-ending work to update this system.”

Dr. Nunn worked with his IT staff to develop order sets and templates to help standardize the practice’s approach to electronic records, and built in specific treatment protocols to help manage specific illnesses better. “Only a physician has the knowledge to make those kinds of changes,” Dr. Nunn said.

To help strengthen relationships among his staff, Dr. Nunn also organized a retreat with the practice’s eight

‘You have to invest in implementing and customizing an EMR system, it can’t just be an add-on project. Doctors have to get involved and engaged, and organizations have to understand it’s never-ending work to update this system.’

—Chalmers Nunn Jr., MD physicians to develop a strategy for the coming year, which included how to expand the practice, improve patient satisfaction and negotiate better with payers. “It’s important to educate and incorporate physicians in the goals and decision making of a practice,” he said.

Need for Training

New Wave Surgical

Despite the growing clamor for more clinician managers, most physicians cannot take on a managerial role without extensive training.

“If a practicing physician who’s never had any business training or experience is just thrust into a managerial role, that physician will not be as good as a nonphysician who has the commitment, training and experience in business,” Dr. Nunn said. “Most physicians are unconsciously incompetent when it comes to business. In other words, doctors are very smart and have outstanding training, but many don’t realize that today the business side of medicine is as complex as neurosurgery or general surgery and you need years of training and experience to be able to perform well.”

This is why many medical organizations are establishing programs for physicians to gain leadership and business experience. Institutions, such as the Cleveland Clinic, Mayo Clinic and Hartford HealthCare, as well as specialty associations, including the American College of Physician Executives (ACPE) and the American College of Healthcare Executives, have implemented such programs.

Two years ago, Hartford HealthCare introduced a 10-month program to provide its physicians formal leadership training.

“Hartford HealthCare’s missions to drive quality and safety is completely dependent on the quality and depth of physician leadership,” said Rocco Orlando III, MD, general surgeon and chief medical officer (CMO) for Hartford HealthCare, in Connecticut. “We are bringing a class of physician leaders through this process together in the hopes that they will build relationships that will help them in their careers at

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Hartford HealthCare, and because the traditional model of doctors providing clinical care only is insufficient to be successful in this increasingly complex world.”

The curriculum, which borrows components from the ACPE program, is centered on enhancing leadership behaviors and technical skills, such as quality and safety, marketing and strategic planning for doctors and basic health care finance. The curriculum also requires participants to work on realworld problems, including the gap in interprovider communication.

Physicians who have practiced for years are also pursing master’s degrees.

Sumeet Mittal, MD, associate professor of surgery in the Department of Surgery at Creighton University School of Medicine, is receiving MBA training at Creighton University so he can become more engaged in all aspects of medicine and eventually take on administrative roles at the hospital and university.

“The MBA will allow me to change the conversation,” said Dr. Mittal. “I most likely won’t transition into fulltime administrative work for many years to come—because I love surgery too much to leave—a business degree will allow me to take on a more active role, ask the right questions, advocate for the patients, and generally be on a level playing field with the administrators in program development and cost analysis, rather than simply listen to their decisions. Ultimately, only physicians can put the profit–loss ratio in the correct perspective of patient care.”

Mr. Khullar plans to work at the interface of medicine and government when he completes his degrees in medicine and public policy. “I think it’s important to infuse the clinical perspective into policy debates, and likewise bring larger cost and access concerns to everyday clinical practice,” he said. “The problems we face in the health system, and more broadly in society, are becoming increasingly complex and will require interdisciplinary solutions to address them. I think being able to understand the various medical, policy and economic players—and speak the language of each—will be vital in the future.”

The Future Despite the push for more physicians in leadership roles, taking on two demanding careers can have its downsides. One study, in which investigators interviewed 30 clinicians in management positions in Norwegian hospitals, found that many participants found themselves “thrown” into the position, without being sufficiently trained, and had to learn management “on the fly,” while some expressed frustration because of increasing administrative

workloads and minimal opportunities to delegate responsibilities (BMC Health Serv Res 2012;12:421).

“Although doctors can get burned out clinically, I’m starting to see physicians become burned out administratively as well,” said Dr. Nunn.

Now that more doctors are becoming involved in running health systems, there are physicians practicing all day and then going to meetings all night.

“That’s what’s concerned me most about this integration,” Dr. Nunn added. “Yes, we want to get doctors more involved in administration, but without a better

balance of duties and time, they’re going to get doubly burned out.”

Seeking a second degree while practicing medicine is indeed demanding: Dr. Mandell balances his dual career by performing clinic duties and operations on two half-days a week, and Dr. Mittal tends to clinical duties during the day while only taking one evening or online class at a time.

“Burnout is a concern,” said Dr. Mandell. “The work is increasingly hard and the challenges are not going away. I think it’s important to get clinician input at the administrative level,

but I’m realistic enough to know that it’s not an easy job.”

Finding the right balance between clinical and administrative duties will be key for the growing ranks of physician leaders, although the benefit of having both skill sets is undeniable. “For me, being an administrator has made me a better physician,” Dr. Nunn said.

“I now understand patient satisfaction, quality improvement, standardizing care, what makes things work, whereas before I didn’t.”

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ANTIREFLUX

jcontinued from page 1 lower esophageal sphincter (LES), has been in clinical use long enough to generate outcome data at 10 years.

EsophyX2 In a randomized, multicenter study for EsophyX2, the primary end point of complete elimination of GERD symptoms was achieved in 62% of patients compared with 5% of those who were placed on a maximal dose of PPIs. Of those treated with EsophyX2, 90% were completely off PPIs at six months.

The key eligibility criteria for parp ticipation in the EsophyX2 trial were persistent, trroublesome, daily GERD D symptoms and a reg-imen of PPI therapy for at least six months. Exclusion criteria included a hiatal hernia greater than 2 cm in axial length; esophagitis of o grade C or higher; or obesity. Patients weree randomized in a 2:1 ratioo to underunder go EsophyX2 or to increase to a full PPI dosage.

The EsophyX2 procedure involves creating a circumferential valve at the gastroesophageal junction. Physicians do require training but the procedure is not considered technically challenging. In this study, EsophyX2 was performed by both surgeons and gastroenterologists, and the average length of the procedure was 38 minutes. All procedures were completed without significant adverse events (AEs), such as blood transfusion or hospital readmission.

Of the 196 patients screened for the study, 63 were randomized and the outcomes of 60 were available for analysis after three patients were lost to followup, according to lead investigator, Karim S. Trad, MD, clinical professor of surgery, George Washington University Medical Faculty Associates, Washington, D.C. When evaluated with 48-hour pH monitoring, pH was normalized in 54% of patients who underwent the procedure and were off all PPI treatments versus 52% in the control group on maximum of doses PPIs. Healing of esophagitis was achieved in 90% of those patients treated with transoral fundoplication compared with 38% of those who remained on PPIs (P=0.004). According to patient questionnaires, 72% of patients in the EsophyX2 group were satisfied with the procedure compared with 5% of patients in the PPI group.

EsophyX2 also was significantly favored

‘Stretta demonstrates a significant sustained improvement measured in quality imp off lif life, patient satisfaction, and reduced need for PPIs. Overall, 64% of patients either eliminated or reduced pre-Stretta PPI use.’

—Mark Noar, MD on specific quality-of-life measures.

According to Dr. Trad, this procedure “avoids the undesirable post-fundoplication AEs such as bloating, flatulence, or dysphagia.” However, Dr. Trad did acknowledge that 10% of patients in that group were back on PPIs at the last follow-up, but he noted, “They were now responding better to therapy, so [surgery] still seems to be a useful adjunct in this group.”

Although much longer follow-up studies are needed to verify a sustained benefit of EsophyX2, Dr. Trad said that up to two years of follow-up from an earlier series of patients does exist and has not shown any significant deterioration in benefit.

Dr. Trad also said that a study using a sham procedure is now under way that “will not burn any bridges,” so that other procedures, including conventional fundoplication, can be performed in the event of an inadequate response.

Stretta An open-label, prospective study of 217 patients provided long-term outcome data on the Stretta procedure. A single endoscopist performed all of the procedures, the first of which was performed in August 2000. A subgroup

of patients had been followed for more than 10 years.

“Stretta demonstrates a significant sustained improvement measured in quality of life, patient satisfaction and reduced need for PPIs,” said Mark Noar, MD, Heartburn and Reflux Center, Endoscopic Microsurgery Associates, Towson, Md. “Overall, 64% of patients either eliminated or reduced pre-Stretta PPI use.”

Stretta emerged at a time when a variety of endoscopic procedures were proposed to increase the barrier function of the LES. Almost all of these have subsequently been abandoned, but Stretta, which received FDA approval in 2000, is still available.

By one count, 32 studies have been conducted to evaluate Stretta, and the procedure also is included in the guideline recommendations of the Society of American Gastrointestinal and Endoscopic Surgeons for the treatment of GERD. In the most recent study, patient satisfaction scores showed no substantial diminution at intervals of one, two, three, four and 10 years in the data presented by Dr. Noar.

Based on the long-term benefit of Stretta in a patient population with inadequate GERD control despite

twice-dailyy PPI use, Dr. Noar called tthis “mature endoscopic proceedure … safe, clinically effeective and economically efffective.”

Asked to comment aabout these procedures, JJoel Richter, MD, director of the Division d oof Digestive Diseases and Nutrition, Univeersity of South Florida, Tam mpa, was cautious about both studies. With regard to the EsophyX2 device, Dr. Richter saaid that normalization of aci acid id occurred occurr only in about 50% of pattients, whereas in other procedurees—notably the Linx Reflux Management System—normalizaM ttion has been achieved in almost 70% of patients. With 10% of EsophyX2 patients back on PPIs at six months, he also suggested that long-term followup will be crucial to confirm that u th his rate remains low.

Regarding the Stretta results, Dr. R Richteer said that the study was a singlecenter eexperience from a private practice, and that Stretta remains poorly supported by evidence.

“There are lots of abstracts, but few peer-reviewed articles.”

Dr. Richter added it was worth noting that few Stretta procedures are performed in academic centers of excellence.

Asked for a surgeon’s perspective, Reginald Bell, MD, founder of SurgOne Foregut Institute, Englewood, Colo., and principal investigator of a study with up to two years of follow-up data for EsophyX, said that previous studies have typically recruited patients who have responded positively to PPIs and then randomized them to continued PPIs or surgery. He noted that poor response to PPIs often predicts poor response to surgery. In contrast, this study recruited poor responders to PPIs, which Dr. Bell said typically represent the largest pool of candidates for surgery.

The high response rate “is a very important finding because we can recommend this therapy to patients with documented GERD, even if their response to PPI therapy is poor,” he said.

He added that the most recent data on the Linx Reflux Management System (Ganz RA et al. N Engl J Med 2013;368:719-727) showed normalization of acid in 58% of patients at year 1, which is similar to that achieved with the EsophyX system.

Dr. Trad is a consultant for EndoGastric Solutions. Dr. Noar is a consultant for Mederi Therapeutics Inc. Dr. Bell has received a research grant from EndoGastric Solutions. Dr. Richter reported no conflicts of interest.

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20

Surgeons’ Lounge

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / SEPTEMBER 2013

Welcome to the September issue of The Surgeons’ Lounge. In this issue, our guest experts are Andreas G. Tzakis, MD, PhD, director, Transplant Center at Cleveland Clinic Florida, Weston and Cristiano Quintini, MD, and Kareem Abu-Elmagd, MD, PhD, both from the Digestive Disease Institute, Center for Gut Rehabilitation and Transplant (CGRT), Cleveland Clinic, Ohio. They discuss the case of a patient with intestinal failure and complications secondary to total parenteral nutrition. Also, check out the reply to the August challenge— how did you do? If that wasn’t challenging enough, see the new challenge in this issue!

We are pleased to announce our next guest expert will be John McNelis, MD, FACS, FCCM, chairman, Department of Surgery, North Bronx Health Network, Jacobi Medical Center, North Central Bronx Hospital, New York City.

I look forward to your questions, comments and feedback.

Surgeon’s Challenge From August 2013 Issue

A

44-year-old woman with a past medical history of idiopathic thrombocytopenic purpura had a symptomatic ventral hernia from a previous midline incision.

She underwent a partial hysterectomy and a concomitant ventral hernia repair with synthetic mesh in January 2012.

Severe bleeding for which she needed a blood transfusion complicated her postoperative recovery. She developed a seroma and had 1.3 L of serosanguineous fluid percutaneously drained in March 2012, and another 600 mL percutaneously drained in April 2012. In December 2012, she was found to have leukocytosis of 20 K, and an abdominal computed tomography (CT) showed that the hernias had recurred. The CT also confirmed an inflammatory process. She was taken to the operating room and biologic mesh was used to replace the synthetic mesh already in place. She was discharged with multiple drains. After the drains were removed, the seroma recurred. A subsequent CT scan in April 2013 showed that the seroma was now loculated and only 400 mL of fluid was removed percutaneously (Figures 1 and 2).

Challenge question: What is the best course of action at this time?

Sincerely, Samuel Szomstein, MD, FACS Editor, The Surgeons’ Lounge Szomsts@ccf.or Dr. Szomstein n is associate director, Bariatric Institute, Section of Minimally Invasive Surgery, Department of General and Vascular Surgery, Cleveland Clinic Florida, Weston.

Figure 1. Preoperative view.

1

2

Figure 1. CT abdomen, sagittal view, showing largest extent of seroma

Figure 2. CT abdomen showing transverse view of abdominal wall and seroma.

Answer to Challenge he patient underwent surgery for possible seroma drainage, removal of mesh and repair of the recurrent incisional hernia. During the procedure, a longitudinal incision was made and immediately a large amount of serosanguineous fluid was aspirated and there was extensive necrotic tissue.

Several samples of the tissue and fluid were obtained for culture and pathology tests. All tissue that appeared

necrotic was extensively debrided and the cavity was copiously irrigated with antibiotic solution using a pulse irrigator. The biologic mesh was intact but was stretched and resembled a pseudohernia. New flaps of fascia from the edges of the previously placed biologic mesh (underlay) were created using electrocautery. The newly created flaps of healthy fascia were approximated primarily and the pseudosac was reduced. After more copious irrigation, three Blake drains were placed in the

cavity (two in the subcutaneous space and one between the primary approximated fascial flaps and the reduced biologic mesh). The skin was closed with staples and sterile dressings were applied. The patient tolerated the procedure well and was admitted.

During her postoperative hospitalization, the patient remained asymptomatic and hemodynamically stable, and the leukocytosis that was noted on admission trended down. Abdominal

Figure 2. Postoperative view.

cultures were identified as Enterococcus faecalis, and the patient was treated accordingly. Her postoperative recovery was otherwise unremarkable and she continued to be stable. The patient was discharged on postoperative day 4 with the drains in place and on oral antibiotics. At her last three-month postoperative follow-up visit, all drains were removed and the patient was doing well.

Surgeons’ Lounge

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / SEPTEMBER 2013

Question for Drs. Tzakis, Quintini and Abu-Elmagd Mayank Roy, MD, PGY-3 surgical resident,

Figure. Computed tomography scan of the abdomen showing dilated large and small bowel.

Cleveland Clinic Florida at Weston

A 50-year-old woman with multiple abdominal operations was admitted with recurrent abdominal pain, dysphagia and poor oral intake. Her past surgical history included an open gastric bypass, cholecystectomy, an incarcerated incisional hernia repair and bowel resection, and a right hemicolectomy for cecal volvulus. She was subsequently diagnosed with colonic dysmotility (Figure) and underwent a diverting loop ileostomy. Because of her significant lifestyle limitations, the patient insisted the ostomy be reversed. The patient was warned about the high likelihood of recurrent symptoms of colonic dysmotility.

On the current admission, an esophagogastroduodenoscopy showed esophageal and gastrojejunal (GJ) stenosis due to chronic ulceration. The patient underwent resection of the gastric pouch and revision of the GJ to esophagojejunal anastomosis. The patient’s remaining length of small bowel was less than 75 cm in the absence of an ileocecal valve. Her upper gastrointestinal symptoms resolved since her surgery; however, her oral intake remained marginal.

Her past medical history was significant for

Drs. Tzakis, Quintini and Abu-Elmagd

hypertension and hypothyroidism. Her current medications included quetiapine, irbesartan, levothyroxine, methadone and narcotics. The patient did not have any history of alcohol abuse, smoking or drug abuse. Her prealbumin level was less than 10.

The patient had been on total parenteral nutrition (TPN) for the past two years (since she underwent a hemicolectomy) because of poor oral intake.

She had had multiple line infections and had been treated for line-related deep venous thrombosis.

Question 1. What are the patient’s options for nutritional support?

Reply

(comprising 50% to 60% complex carbohydrates) with small, frequent meals and liberal use of salt while limiting simple sugars. Patients also are encouraged to sip on 1 to 2 L of an oral rehydration solution between meals, including approximately 75 mEq of salt and 20 g sugar per liter of flavored water, to minimize osmotic losses and dumping sympAndreas Tzakis, MD, Cristiano Quintini, MD Kareem Abu-Elmagd, toms. Antidiarrheal treatment is PhD maximized in all cases, with up to MD, Phd three agents, to minimize output Question 1. when a stoma or high-transit malPatients with intestinal failure secondary to cata- absorption are present. The patient in this case study strophic complications of obesity surgery represent most likely has lost all her bile salt storages and is among the most challenging patients from a nutri- at high risk for fat malabsorption, therefore she may tional perspective, as often they combine major short benefit from pancreatic enzymes supplementation. bowel syndrome (SBS), metabolic disturbances, liver Small bowel bacterial overgrowth often is underdidisease and psychosocial issues. Multiple studies agnosed in these patients, despite the fact that it is suggest that these patients have a better long-term quite frequent, particularly when there is no ileoceoutcome when treated by a team that is able to pro- cal valve, and dysmotility and dilated small bowel vide a wide spectrum of treatment including aggres- loops are present. For the treatment of this condisive medical and surgical intestinal rehabilitation, tion, we would use nonenteric absorbable antibiotlong-term management of home parenteral nutri- ics (e.g., metronidazole [Flagyl, Pfizer], rifaximin tion (HPN) and intestinal transplantation in select- [Xifaxan, Salix]). Octreotide (Sandostatin, Novartis) ed cases. could be trialed via parenteral nutrition to potentialIn most patients with SBS, we would start with ly stimulate bowel motility and decrease intestinal aggressive dietary modifications and medication secretions; however, this should be used with cautherapy aimed at reducing bowel secretions and tion as it could cause obstructive symptoms and an slowing bowel motility, with the goal of maximizing increase in liver function tests. absorption. The intestinal rehabilitation regimen is When all these interventions fail or do not provide based on an empiric high-calorie, high-starch diet the patient with adequate nutritional independence,

Question 2. In view of her intestinal failure and complications secondary to TPN, would she be considered a candidate for a small bowel transplant?

Question 3. What kind of complications can be expected if she does undergo a small bowel transplant?

Question 4. What is your experience with intestinal transplantation?

we would then escalate to enteral nutrition. Because this patient is likely to fail, it may be worth trying a jejunal feeding tube for slow nocturnal enteral feeding of a semi-elemental formula high in mediumchain triglycerides for optimal absorption.

Question 2.

Small bowel transplant has become a standard indication for patients on TPN with recurrent lifethreatening catheter-related bloodstream infections (CRBSIs); central line–related thrombosis of two or more central veins (particularly involving the upper extremities); recurrent severe dehydration; low acceptance of HPN; and life-threatening underlying disease. In a recent study of four patients evaluated for intestinal transplantation at our institution for complications of obesity surgery, infection represented a major determinant for listing. Three of the four patients developed CRBSIs with at least one episode of fungemia, and two patients had more than one episode of CRBSIs despite the use of ethanol lock therapy, which is proven extremely effective in preventing line sepsis. Interestingly, candidemia, which has an incidence of approximately 1% in our general TPN population, was found in as many as 66% of the morbidly obese patients on HPN who had bariatric surgery. Therefore, based on Medicare criteria, the patient in question would meet the criteria for small bowel transplant evaluation. However, a few considerations need to be made.

The patient presents with dilated small bowel, which makes her a good candidate for a continued ON PAGE 22

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Surgeonsâ&#x20AC;&#x2122; Lounge jcontinued from page 21

intestine is a very immunogenic organ; therefore, potent immunosuppressive regimens have to be impleserial transverse enteroplasty procedure (STEP). This mented at the time of transplant. With the introduclengthening procedure has been shown in recent years tion in the past decade of B- and T-cellâ&#x20AC;&#x201C;depleting to be a viable option in patients with SBS and dilat- monoclonal antibodies used at the time of transplant ed bowel. It increases the length of the bowel, and also to promote tolerance, rejection rates have decreased decreases its diameter, thereby enhancing absorption of dramatically with only slightly higher infection rates. nutrients, improving motility and decreasing the like- The diagnosis of rejection is clinical and histologlihood of small bowel bacterial overgrowth. Seventy ic due to the lack of established serologic markers of centimeters of dilated residual small bowel could easily rejection. From a clinical standpoint, the symptomreach a length of 100 to 120 cm followatology is vague, making the diagnosis ing a successful STEP procedure, offer- The most common challenging at times. Malaise, nauing the patient a chance to be weaned off sea, vomiting and increased stool outcomplications TPN, particularly because the majority put are the most common symptoms of the colon is still in place in addition following intestinal of rejection. Fever is usually present to an intact rectum and anus. In cases in the most severe forms of rejection transplantation where the colon is diseased, a STEP and reflects disruption of the bloodprocedure followed by an end-stoma or are rejection and enteric barrier with a subsequent baca J-pouch with ileorectal anastomoterial translocation. Intestinal biopsies infection. sis could still be an option. To answer are performed either through a stoma the question about whether this patient (which is usually present in the first meets the criteria for intestinal transnine months after the transplant, after plant, we have not yet exhausted all of her medical and which continuity is restored), or an upper or lower surgical options. Studies have shown that in patients endoscopy where results are obtained on the same day. requiring TPN, tunneled catheters carry a lower infec- Zoom endoscopy provides a real-time morphologic tion rate than other types of long-term access, and that analysis of the villi; however, histologic diagnosis is the higher the number of lumens, the higher the infec- always obtained before treatment is started. An intertion rate. esting subject of increasing research is serum citrulline. Citrulline is an amino acid produced exclusively Question 3. by the villi, and its levels (citrulline <13 mmol/L) The most common complications following intes- have been correlated with acute intestinal transplant tinal transplantation are rejection and infection. The rejection or other processes that cause loss of villi.

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / SEPTEMBER 2013

Interestingly, rejection episodes are less frequent and less severe if the patient receives a liver along with an intestinal graft due to the immune-protective property conferred by the liver. Infections are a consequence of the immunosuppression necessary to prevent or treat rejection and involve bacterial, viral and fungal microorganisms. An effective prophylactic regimen in the short- and long-term management of intestinal transplant patients has tremendously decreased the incidence of new as well as recurrent episodes of infections. Other less common complications include post-transplant lymphoproliferative disorder, a form of immunosuppressive-induced lymphoma often triggered by Epstein-Barr virus infection and graft-versus-host disease, which almost always is lethal.

Question 4.

Dr. Tzakis: I have been involved in intestinal transplantation since the late 1980s, when the first successful transplants were performed at the University of Pittsburgh under the guidance of transplant pioneer Thomas Starzl, MD. Refinement of the surgical technique, and most importantly the introduction in clinical transplantation of tacrolimus, a potent immunosuppressive agent, transformed this procedure from experimental to a very effective treatment for patients with complex intestinal failure. Approximately 2,700 intestinal transplants have been performed around the world with one- and five-year survival rates approaching 90% and 75%, respectively, in selected programs.

Surgeons’ Lounge

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / SEPTEMBER 2013

Surgeon’s Challenge Submitted by: S. Al-Bahri, MD, M. Casasanta, MD, and E. McCarron, MD from the Department of Surgery, MedStar Union Memorial Hospital, Baltimore, Md

n 80-year-old woman with a history significant for hypertension, pneumonia and coronary artery disease, as well as a remote history of hysterectomy for symptomatic fibroids, was admitted for hydration and a work-up for pneumonia. During her hospital stay, she developed diarrhea and abdominal pain for which a computed tomography (CT) scan of the abdomen and pelvis was obtained. A pelvic mass of unclear origin was seen; tumor markers CEA and CA 125 were well within normal limits. Attempts were made to perform an imageguided biopsy, but were unsuccessful due to the mobile nature of this mass. A recent colonoscopy field to show any significant pathologic process originating in the colon.

The patient recovered from the acute infectious process and was scheduled for exploratory laparotomy. Upon entering the peritoneal cavity, all surfaces were free of any pathology. The mass, originating off of the transverse colon, was readily identified. It had several serpentine arteries feeding into it from the mesentery of the bowel (Figure).

Suggested Reading Abu-Elmagd KM, Costa G, Bond GJ, et al.

Five hundred intestinal and multivisceral transplantations at a single center: major advances with new challenges. Ann Surg.

2009;250:567-581.

Hibi T, Nishida S, Garcia J, et al.

Citrulline level is a potent indicator of acute rejection in the long term following pediatric intestinal/ multivisceral transplantation.

Am J Transplant. 2012;12(suppl 4):S27-S32.

John BK, Khan MA, Speerhas R, et al. Ethanol lock therapy in reducing catheter related blood stream infections (CRBSIs) in home parenteral nutrition patients.

Gastroenterology. 2010;138:S39.

Abstract.

King B, Carlson G, Khalil BA, et al. Intestinal bowel lengthening in children with short bowel syndrome: systematic review of the Bianchi and STEP procedures. World J Surg.

2013;37:694-704.

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Opilla MT, Kirby DF, Edmond MB. Use of ethanol lock therapy to reduce the incidence of catheter related blood stream infections in home parenteral patients. JPEN J Parent Enteral Nutr. 2007;31:302-305.

Parekh N, Moccia L, Pogatschnik C. Intestinal dysmotility: diagnosis and treatment options. Support Line.

2012;34(3):12-21.

Rhoda KM, Parekh NR, Lennon E, et al. The multidisciplinary approach to the care of intestinal failure at a tertiary care facility. NCP. 2009;25(2):183-204.

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Figure. Peritoneal mass cavity, originating from the transverse colon with several serpentine arterties feeding into it from the mesentery of the bowel.

Challenge question

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will maintain antimicrobial effectiveness for at least 48 hours.4,5 References: 1. Saltzman MD, Nuber GW, Gryzlo SM, Marecek GS, Koh JL. Efficacy of surgical preparation solutions in shoulder surgery. J Bone Joint Surg Am. 2009;91(8):1949–1953. 2. Ostrander RV, Botte MJ, Brage ME. Efficacy of surgical preparation solutions in foot and ankle surgery. J Bone Joint Surg Am. 2005;87(5):980–985. 3. Adler MT, Brigger KR, Bishop KD, Mastrobattista JM. Comparison of bactericidal properties of alcohol-based chlorhexidine versus povidone-iodine prior to amniocentesis. Am J Perinatol. 2012;29(6):455–458. Epub 2012 Mar 7. 4. Denton GW. Chlorhexidine. In: Block SS. Disinfection, Sterilization, and Preservation. 5th ed. Philadelphia, Pa: Lippincott Williams & Wilkins; 2001:321–336. 5. Hibbard JS. Analyses comparing the antimicrobial activity and safety of current antiseptic agents: a review. J Infus Nurs.

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In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS WS / SEPTEMBER 2013

Physicians Recommend Forensic Health Services Researc Applying Health Care Research to Problem of Health Care Fraud B Y A SHLEY T AYLOR

W

hen federal officials announced in May an eight-state mass arrest of nearly 100 doctors and nurses charged with Medicare fraud, the accusations were relatively straightforward: bogus prescriptions, kickbacks for motorized wheelchairs, billed but undelivered care and other misdeeds that, officials claimed, bilked the government insurance program out of some $223 million.

But beyond these black-and-white cases is a gray area of services that, although not blatantly egregious, do not meet professional standards or are not medically necessary.

Considered health care abuse by the Centers for Medicare & Medicaid Services (CMS), which administers these federal health care programs, it is also a legal gray area. Cases of health care abuse are not necessarily taken to court, as are more obvious cases of deliberate fraud.

These cases represent an untapped area of regulation and potential savings.

Medicare expenditures rose by 6.2% in 2011 according to federal data; its yearly expenditure growth has been as high as 18.8% since 2000. Abuse of national health care programs represents at least some share of that spending. Although the increases in overall health care expenditures, which have risen 3.9% each year from 2009 to 2011, have slowed since 2002, there is no doubt that cutting these costs is desirable.

To this end, internists Laurence McMahon Jr., MD, MPH, and Vineet Chopra, MD, MSc, both from the University of Michigan Health System, in Ann Arbor, have proposed using existing methods for studying trends in patient care data—health services research—to detect health care fraud and abuse. They introduced this concept, which they call forensic health services research, in a commentary in the American Journal of Managed Care (2013;19:e71-3).

“If we’re going to be serious about addressing the cost of health care and the value of the care we provide,” Dr. McMahon said, “we need to be fairly forthcoming in the fact that we do provide services that have little value to patients.” Many of these services, he said, represent fraud and abuse, yet are not recognized as such.

The current system for catching and prosecuting health care fraud is what

many see as an inefficient collaboration among the CMS and the Office of Inspector General (OIG), both within the U.S. Department of Health and Human Services, and the Department of Justice (DOJ), including the FBI. BI. Working together, these agenagen cies audit health care providers, provi review claims and prosecute fraudulent part rties using an approach know wn as “pay and chase”—try rying to recover money paaid out for fraudulent c laims rather than denyingg the claims in the first place ce— which a 2012 report by th the U.S. Government Accoun ntability Office (GAO), cit ited by the authors, called ineff ffective. Less than $20 million of the $102 million spent on audits from fro 2008 to 2012 was recovered, accordin ing to a June report by the GAO. During fiscal year 2012, the DOJ convicted 826 defendants of health care fraud, and the OIG excluded 3,331 pro roviders or entities from federally funded ed health care programs, 912 of them for crimes related to Medicare or Medicaid.

“Every specialty has procedures currently done that haven’t been shown to be beneficial to patients,” Dr. McMahon said.

The OIG handles settlements, fines and exclusions but would not comment on charges and convictions, citing lack of prosecutorial authority. The DOJ did not return repeated requests for comment.

Health services research has been around for 30 years, Dr. McMahon said, and investigators already are using its methods to detect cases in which Medicare and Medicaid pay for unwarranted procedures.

“This data is out there, it’s known by everyone,” Dr. McMahon said. “It’s not something we just found, it’s published leading journals. But the question is how do you look at it in the context of fraud and abuse.” The commentary gave several examples of health services research papers documenting unnecessary or unsupported procedures, from too-frequent colonoscopies to placement of defibrillators in cases where they were not proven to have a benefit. Currently, these kinds of cases are not prosecuted as fraud and abuse, Dr. McMahon said.

Hays Gorey Jr., JD, of the law firm GeyerGorey, LLP, which specializes in white-collar crime, confirmed that assessment.

“There may be conduct that is short

‘I assume the physicians who are performing screening colonoscopy too frequently have managed to convince themselves that they are doing the right thing.‘ —James Goodwin, MD

of fraud that may fall intoo a category called abuse. If it involves involv false claims, of course, then that would be one thing, butt if it falls short of being actual knowing fraud, fra then I don’t know of any way, either that that would be prosecutable under the law.” Mr. Gorey added that there might be other ways, such as new regulations, to deal with abuse.

The False Claims Act, a Lincolnera statute, allows not only the government but also individuals acting on the government’s behalf to sue for restitution of payments for knowingly fraudulent claims to the government. These can include bills for worthless services, a category that may include procedures with no medical value.

“The claim, or one of the claims, could be that the services were medically not necessary, or that the services were worthless. That’s pretty close to saying the same thing,” Mr. Gorey said.

But cases of medically unnecessary procedures would not necessarily be prosecutable under the False Claims Act. For example, one could not successfully sue a doctor, based on the act, for performing colonoscopies too frequently without more information, Mr. Gorey said.

“If that’s all you do, the answer is pretty clearly no. It may be a lead to conduct further inquiry.” In order to make a case, he said, one would have to determine that the bills “amounted to knowingly false or fraudulent

claims.” In other words, a doctor with best intentions in mind is not committing fraud under current laws.

James Goodwin, MD, professor of geriatric medicine at the University of Texas Medical Branch at Galveston, and lead author of the colonoscopy study cited in the commentary, said prosecuting doctors for performing unnecessary procedures is not the answer. “I assume the physicians who are performing screening colonoscopy too frequently have managed to convince themselves that they are doing the right thing. If Medicare refused reimbursement for those procedures, the problem would disappear overnight,” he said.

Overall, however, Dr. Goodwin said forensic health services research is “a good idea. The distinction between ‘fraud’ and ‘abuse’ can be debated endlessly, but there is no doubt that using administrative data to identify clinics and providers with ‘abuse-like’ profiles for further scrutiny could have a major impact on overuse of tests, procedures and treatments.”

GSN is now on

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / SEPTEMBER 2013

NOTES

jcontinued from page 1 and providers have concerns regarding potential sexual dysfunction and gynecologic problems,” said Garth R. Jacobson, MD, of the University of California, San Diego, who presented his team’s findings at the 2013 meeting of the Society of American Gastrointestinal and Endoscopic Surgeons (abstract S104).

Dr. Jacobson and his colleagues retrospectively evaluated the outcomes of 34 procedures performed using NOTES at their institution between 2007 and 2012, including 34 cholecystectomies, three appendectomies and three sleeve gastrectomies. The patients had a mean age of 40 years (23-63), mean body mass index of 27 kg/m2 (16-43), and an ASA classification of 2 or lower.

The hybrid transvaginal approach consisted of the conventional laparoscopic approach followed by transvaginal organ extraction at the end of the procedure.

“This point we believe is important in NOTES access surgery: Our entry is under direct laparoscopic visualization in order to prevent complications,” Dr. Jacobson said.

After dilating the patient’s cervix and inserting a uterine mobilizer, the surgeons place a 15-mm trocar in the posterior cul-de-sac of the vagina under direct view. Then they place an endoscope through the vaginal trocar along with a snare for organ extraction. Once the extraction is complete, the defect is closed with a single figure-of-eight absorbable stitch.

Operative times in this series were 93, 78 and 132 minutes, respectively, for cholecystectomy, appendectomy and sleeve gastrectomy. A single-night hospital stay was mandated by the institutional review board, and length of stay averaged one night. There were no reoperations, conversions or deaths, and the complications that occurred in six patients (18%) were relatively minor, consisting of spotting or heavy menses, which were successfully treated by conventional means.

Notably, using a visual analog scale to rate pain, with zero being no pain and 10 being worst pain, patients reported almost no pain by the end of the first week. During the mean follow-up period of 18 months, there were no trocar site–related complications, no sexual dysfunction or dyspareunia, and two patients became pregnant and had successful vaginal deliveries.

“Our initial experience with transvaginal organ extraction suggests the approach is safe and effective and without pelvic organ dysfunction in the short

term. The operation has the potential to improve upon postoperative pain, trocar site complication infections and herniations,” Dr. Jacobson said, noting that further evaluations from randomized studies, such as the NOSCAR trial, and long-term follow-up are needed to corroborate their findings.

“The data presented by the San Diego group are certainly encouraging, and reflect that the introduction of NOTES has been a thoughtful and methodical process where investigators have enrolled patients on IRB-approved protocols,” said Steve D. Schwaitzberg,

MD, chief of surgery, Cambridge Health Alliance; associate professor of surgery, Harvard Medical School, Boston; and co-principal investigator, NOSCAR prospective randomized trial.

The leadership for this approach is the result of a joint effort between SAGES and the American Society for Gastrointestinal Endoscopy through the development of the NOSCAR consortium, Dr. Schwaitzberg said. “This approach has led to careful study, first in the laboratory and then in the clinical milieu,” a model that has continued to be followed worldwide.

“Despite the need for better funding and a coordinated streamlined pathway, the approach taken by the leading medical and surgical societies in this realm should be considered a success and the model for the responsible introduction of future innovation,” Dr. Schwaitzberg said.

He noted that regardless of outcomes of any NOTES trials, it would be but one alternative to the minimally invasive treatment of disease. “Some women are simply not interested in transvaginal access; transgastric access still needs more development,” he said.

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Opinion

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / SEPTEMBER 2013

When Settled Isn’t Settled: A Guide to Medical History B Y S TEVEN K RON , MD

S

ettled science, a term currently used by some politicians to describe the facticity of global warming, leaves me a little, well, unsettled. The pages of history are littered with examples of Absolutely Irrefutable Truths that eventually are discarded and replaced by new ones that in turn seem quaint, even downright silly today.

Examples in physics include Newton’s laws, which replaced the 2,000-year-old Aristotelian theories, only to be in turn replaced in astrophysics by Einstein’s special and general relativity. The subsequent development of quantum mechanics and its unfortunate incompatibility with relativity has produced a yet unfulfilled search for a “theory of everything” that would explain away their differences. Einstein himself believed that the universe was infinite in time and space, although today we know that, following its appearance from nothing at the Big Bang, it is expanding at a phenomenal and accelerating speed.

It was widely believed that scientific advances proceeded in a gradual step-by-step fashion. In 1962, with the publication of his “The Structure of Scientific Revolutions,” Thomas Kuhn turned that theory on its head. Kuhn differentiated “normal science” in which one discovery is layered on a prior one, and “paradigm shifts” that occur when the existing paradigm or generally accepted view no longer explains the data and a new theory is put forth to supplant the old.

The alternative is often the work of an individual who challenges the existing belief. Subsequent to its acceptance, the more mundane practitioners of normal science tinker with it, dotting the i’s and crossing the t’s until this new hypothesis proves inadequate to explain fresh data and is replaced by yet another paradigm.

Over the past few centuries, the practice of medicine in general and anesthesiology in particular has changed dramatically. Unlike theoretical physics, discoveries in our field are put to immediate practical use. Most of them reflect the less unique processes of normal science, but I believe that some are true paradigm shifts changing how we look at and practice our specialty.

Following the precedent of the late-night comics, I submit my personal list of 10 Best Anesthesia Paradigm Shifts. Some of my choices, although perhaps not exclusive to anesthesiology or even the science of medicine, are critical to its everyday practice:

10. The stethoscope:

In 1816, hesitant to use direct ear auscultation on the chest of a buxom young woman, René Laennec, of cirrhosis fame, echoing children playing with hollow sticks, rolled up a stack of papers and used it to examine her. Following this success, he made wooden stethoscopes, some of which are still in existence. Although a few French physicians resisted the device, fearing that the stethoscope would distance them from the patient, it ultimately gained universal acceptance. The modern stethoscope soon became the most unique semiotic identifier of a doctor. In the past decade or so, it has become ubiquitous and may be found dangling out of the pocket or slung around the neck of just about anyone.

9. The sphygmomanometer: This

device was invented by von Basch in 1881 and improved by Riva-Roci, who popularized it using Laennec’s device.

8.

The electrocardiogram (ECG): Although invented by Einthoven in 1895, it did not achieve regulaar use in the operating room until well into the 20th century, primarilyy because of flammable and explosive anesthetics. Many anesthesia providers believed that the feel of the patient’s pulse was just as good a diagnostic tool as the ECG. As a resident in the 1970s, I was admonished by my attendingss for using leads on short cases.

7.

The anesthesia record: We’ve come a long way since 1895 when medical students/anesthesia providers Harvey Cushing and Michael Codman began recording sleeping patients’ respiration and pulse. Of great interest to the Joint Commission, critical-incident review committees and lawyers, the anesthesia record has increased in detail and complexity. In addition to chronicling vital signs, my institution’s anesthesia record requires my signature, date and time in a dozen places, status of β-blocker and antibiotic administration on two different pages, boxes for multiple other details and so on. Much of that information is repeated on a separate quality assurance document and a charge record.

It keeps both hands pretty busy. Luckily, they are now available because no one under the age of 40 does mask cases any more because of …

6. The laryngeal mask airway (LMA): Invented by

Archie Brain in 1981, LMA sales are not yet a threat to those of Big Macs, but are well on the way.

5.

The circle system: The first system based on rebreathing that incorporates elimination of carbon dioxide was invented in 1924 by the father and son team of Heinrich and Bernhard Dräger.

4. Direct laryngoscopy (DL) and endotracheal intuba-

tion: Chevalier Jackson first reported DL and endotracheal intubation in 1913.

3. Local anesthetics: In 1882, Karl Koller, a 25-year-

old ophthalmologist and friend of Sigmund Freud, noted the tongue numbness produced by “eating cocaine” (!) and proceeded to test its use as a local anesthetic on frogs, then on his own eyes.

2. The hollow needle: Although Christopher Wren

experimented with injection using goose quills, Alexander Wood is credited for producing the first needle– syringe combination in 1853. Charles Hunter, a surgeon, coined the term “hypodermic”” and was involved in legal actions against Wood for the credit, thus setting up an unfortunate precedent for number 1 …

1.

Inhalation anesthesia: Without doubt the most significant discovery in anesthesia is that inhalation of nitrous oxide, and ether produce it. To whom does the credit go? Morton or Wells (or Long, Jackson, Davy,

Faraday or Simpson)?

Whose is the paradigm shift and whose is the normal science? A sad story of madness and greed with which we are all familiar, brought about what is certainly one of the greatest discoveries in medicine.

Honorable Mention Health insurance—the Baylor Plan: Although the idea of limiting the cost of a bad event such as loss of a ship is ancient, insuring against illness is a much newer concept.

Before the 20th century, medical costs were low, primarily because there wasn’t much doctors could do for most patients and few deemed insurance necessary. Furthermore, fearing adverse selection of people with preexisting conditions, insurance companies had little interest.

Although sicknesss insurance existed in the United States from the time of the Civil War, this protected lost income rather than the cost of paying doctors and hospitals. In 1929, a group of Dallas teachers contracted with Baylor Hospital to provide 21 days of hospital care for $6: the precursor of Blue Cross. Blue Shield followed shortly after as did other commercial insurers. In 1965, creating Medicare and Medicaid, the federal government entered the insurance business.

Health insurance dollars funded much of the spectacular technological and pharmacologic innovations of the past century but, by distorting medical economics, caused unintended consequences as well. Income disparities disproportionately drew doctors into specialties where, assured of reimbursement, they were able to perform expensive procedures. Meanwhile, protected from the costs that were largely absorbed by the payor, patients demanded the “newest and best.”

That inflated bubble has been leaking and is ready to burst. Much of the financial burden of illness is being shifted back to the patient, as is the personal responsibility for wellness. Now we must bypass McDonald’s as we schlep our smoke-free lungs and titanium joints to the gym under the all-knowing and watchful eye of a benevolent government.

—Dr. Kron is an anesthesiologist in Hartford, Conn..

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O nthe

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / SEPTEMBER 2013

Spot

The 2013 Art of

with Colleen Hutchinson

Herniology Part 2

This month in Part 2 of the Art of Herniology, I am focusing on topics such as the need for randomized controlled trials in hernia care; treatment of sportsman hernia; and biologic mesh versus lightweight, large-pore synthetic mesh in contaminated situations.

As with Part 1 [February 2013], responses highlight the variability in hernia management and the difficulty for these thought leaders to agree or disagree with any of these statements without

qualifying their responses. Although in some areas of hernia management, there is a place for standard processes and procedures as well as for a collection of longitudinal data to analyze the effects of these processes, these surgeons’ responses also illustrate the difficulty of generalizing therapy approaches among subpopulations of hernia patients whose treatment needs vary, as well as defining gold standards and standards of care in this area, and in medicine in general.

These contributors have informed opinions from which we all can learn, and the result of their collective thinking is a balanced look at the issues and the complex variables that also must be considered.

One other note: I asked participants to weigh in on the most overrated new technology in surgical care for the Gut Reaction table on page 29, and after reading the responses, you will see there is clearly consensus on one point (hint: the robot). That said, there is discussion to

be had on this topic, and in an upcoming issue, On the Spot will tackle the relevant debates in robotics for a balanced look at this new and intriguing technology.

Please feel free to email me (colleen@cmhadvisors.com) with any ideas for debate in hernia and other areas of general surgery, thoughts on this month’s column, or general feedback and comment online as well. I always like hearing from you!

—Colleen Hutchinson

PARTICIPANTS Parviz Amid, MD, FACS, is clinical professor at UCLA Lichtenstein-Amid Hernia Clinic, David Geffen School of Medicine at UCLA, Los Angeles.

Karl A. LeBlanc, MD, MBA, FACS, is associate medical director at Our Lady of the Lake Physician Group, director and program chair of Fellowship Program, Minimally Invasive Surgery Institute, Baton Rouge, Louisiana.

Bruce Ramshaw, MD, is co-founder, chairman and chief medical officer at Transformative Care Institute, and director, Advanced Hernia Solutions, Daytona Beach, Florida.

Steven Bowers, MD, is assistant professor of surgery, Mayo Clinic, Jacksonville, Florida.

Adrian Park, MD, is chair, Department of Surgery, AAMC Surgical Specialists, Annapolis, Maryland.

William Richards, MD, FACS, is professor and chair, Department of Surgery, University of South Alabama, Mobile.

David Chen, MD, MD, FACS, is assistant clinical professor at UCLA Lichtenstein-Amid Hernia Clinic, David Geffen School of Medicine at UCLA, Los Angeles.

Alfons Pomp, MD, FACS, FRCSC, is chief of laparoscopy and bariatric surgery, vice chairman, Department of Surgery, and the Leon C. Hirsch Professor of Surgery and attending surgeon at NewYork-Presbyterian Hospital/Weill Cornell Medical Center, New York City.

Michael J. Rosen, MD, FACS, is associate professor of surgery and chief of the Division of GI and General Surgery at University Hospitals of Cleveland, Case Medical Center, and the director of the Case Comprehensive Hernia Center, Cleveland, Ohio.

Benjamin S. Powell, MD, FACS, is with Mid-South Center for Minimally Invasive Surgery, Germantown, Tenn., and is assistant professor of surgery, University of Tennessee Health Science Center, Memphis.

Michael G. Sarr, MD, FACS, is the J.C. Masson Professor of Surgery and vice chair of research in the Department of Surgery at Mayo Clinic, Rochester, Minnesota.

Aurora D. Pryor, MD, is professor of surgery and vice chair for clinical affairs, chief, general surgery director, Bariatric and Metabolic Weight Loss Center, Department of Surgery, Stony Brook University School of Medicine, Stony Brook, New York.

Guy R. Voeller, MD, is professor of surgery, University of Tennessee Health Science Center, Memphis.

Neil Hutcher, MD, is chairman, Board of Directors, and chief medical officer and vice president of clinical quality and compliance, Surgical Review Corporation, Raleigh, North Carolina.

Jarrod P. Kaufman, MD, FACS, is general and advanced laparoscopic surgeon, Advanced Surgical Associates of Central Jersey, Freehold, New Jersey.

On the Spot

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / SEPTEMBER 2013

Gut Reaction: Topics in Surgery Contributor

The most embarrassing moment in my career …

The most overrated new surgical technology is ...

The most obscure but important lesson I have learned in my work experience is …

Dr. Park

How could I not jump at the chance to think about the stupidest surgical thing I’ve done and share it with the whole world?

Robotic single port

To try and manage each patient encounter in light of the realization that a “day of at the office” for me is often a seminal event in the life of my patient

Dr. LeBlanc

Because of my lack of height, I stand on stepstools to operate.

Falling off my required stepstools is embarrassing (every time).

Robotic surgery

Trying to take shortcuts in the OR actually makes the cases take longer and with not always as satisfactory a result

Dr. Rosen

Can I get back to you on this one?

The robot

It is incredibly important to achieve balance in life. A good surgeon must find a way to dedicate as much to his patients as he does to his family.

Dr. Ramshaw

I’ve had many, but the one that stands is the time I was moderating a session with Jerry Young at an American Hernia Society meeting. Guy Voeller had just instructed us on the importance of keeping the speakers on time. The timer was set at 15 minutes, the standard for invited talks. Parviz Amid was the first speaker and 15 minutes into the talk, he was obviously not nearly finished. After I warned him he was over his limit, Parviz responded that he had 30 minutes. I then checked the program and realized he had one of the few honorary 30-minute lectures. I was very embarrassed, but Parviz was a true gentleman and never made me feel bad about it.

Health care management structure/philosophy (RVU targets)

I hope this will not be obscure for long, but I’ve learned we are working in a health care system that is an extremely complex and biologic system, but our thinking and our management and organization structures are designed for mechanical systems. Unlike the aviation industry, which is mainly a complex mechanical system, the health care system is mainly a complex biologic system. The same mechanical solutions (standardization, checklists, etc.) that worked for improving aviation safety will have limited impact on improving patient safety. Until we learn and apply that understanding, we will continue to get the results that our health care system is producing.

Dr. Richards

Being sutured by my own resident after being kicked by a horse

The robot

Spend more time with the patient who has a complication

Dr. Powell

Calling a patient the wrong name

Robotic general surgery

Always be willing to ask for help.

Dr. Kaufman

Making the incorrect assumption that a new patient who was moderately obese was pregnant

Robotics for most general surgical procedures

Ironically, patients who are near death often express the most gratitude for the medical care we deliver to them.

Dr. Voeller

The most embarrassing moment does not stand out to me as I reflect on the past 25 years. It is probably good that I am somehow able to repress those moments enough to not pick out “the most.”

The robot

I had no idea how a busy surgical practice over 25 years, especially with the poor ergonomics of laparoscopy, could so physically destroy one’s body.

Dr. Pomp

There are too many to count; and I am not sharing …

The robot (no question)

“If it’s hard, it’s because you aren’t doing it right.” —Kelvin Higa’s dad

Dr. Hutcher

Not recognizing my bariatric patients (including relatives) after weight loss

Robotics

Surgical arrogance is always punished.

Drs. Amid/Chen

Advocating plug repair

All innovation if better is good—just expensive

“New” is not always better.

Dr. Sarr

Too many to count

The robot, natural orifice translumenal endoscopic surgery and single-incision laparoscopic surgery

Listen to others with good ideas no matter what their position is— medical students, surgical techs in the OR, and, of course, your spouse.

Dr. Pryor

Breaking the heel off my shoe at the ACS and not having time to fix it before a talk

The robot

It’s OK to ask for help.

Dr. Bowers

Did diagnostic laparoscopy and missed 7” of knife blade broken off in the abdominal wall

The robot

Call your wife back right after the case.

Colleen Hutchinson

Attempting to give my first presentation at the 2006 ACS with a broken PowerPoint slide deck and malfunctioning microphone

I’m doing an upcoming column on the robot, so stay tuned!

1. Adversity is sometimes the most valuable experience, because we learn from it and grow stronger.

2. Building a career in work we enjoy with people we like and admire is a blessing.

3. As my father has always told me, the only constant is change!

29

On the Spot jcontinued from page 28

DR. BOWERS: It takes several years to complete and publish the results from such trials, but the technologies involved in hernia repair change substantially every year. The U.S. surgeon generally performs the procedure that is best for him or her to perform. Regarding hernia repair, surgeons should only do what they do well.

more attention to long-term longitudinal or observational studies. Now that quality is the key issue in surgery, we can learn a lot from a surgeon who does hundreds of the same operation a year and has superb results. We don’t need a controlled trial to tell us he or she has a “gold standard.”

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The gold standard for determining the best procedure or hernia mesh for hernia repair is the prospective, randomized controlled clinical trial.

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DR. VOELLER: I have said for years there is no one best procedure or mesh for hernia repairs. There are many excellent repairs and meshes that give good results. The controlled trial often leaves many questions unanswered and poses new ones. Trials are important but very difficult to do well. I think we must pay

DR. SARR: Unfortunately, I think it probably is in 2013 primarily because the population that everyone studies is so heterogeneous, especially for the biologics.

The study would have to have very strict entry criteria.

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DR. POMP: International currency is no longer based on a “gold standard” and the term is outdated. Laparoscopic and “open” expertise varies and, as the VA trial showed [N Engl J Medd 2004;350:18191927], comparing types of repair and establishing superiority in a heterogeneous population is difficult. There are several different types of hernia repair that give good outcomes when done by proficient surgeons. Bilateral and recurrent hernia after a previous open approach is likely done better laparoscopically (TEP [totally extraperitoneal] or TAPP [transabdominal preperitoneal]) by an experienced surgeon; otherwise, the literature can (and does) show support for many types of repair.

‘Now that quality is the key issue in surgery, we can learn a lot from a surgeon who does hundreds of the same operation a year and has superb results. We don’t need a controlled trial to tell us he or she has a “gold standard.”’

—Guy Voeller, MD DR. ROSEN: Agree—I think that today that is the correct answer. However, any good, prospective randomized trial really asks a very specific question and the results are not always applicable to everyday practice. If surgeons are going to use the data from a randomized trial to guide their practices, it is important they look very closely at the inclusion and exclusion criteria to see if their clinical situation is actually addressed in the study. The current problem with using randomized controlled trials to guide our practice is that it is very hard to complete these trials, including obtaining funding and enrolling patients in a timely fashion. I think the only way we will ever get to this level is if every surgeon decides he or she will not use a new product, mesh or technique until there is some higher level of data to support its use. This will force medical device companies (like pharmaceuticals) to provide adequate data to support their claims.

DR. PRYOR: Although I completely agree that prospective, randomized clinical trials are the highest level of scientific rigor available, they are not practical for many facets of the rapidly evolving and variable field of hernia management.

Mesh choices are constantly evolving and new techniques are coming to the forefront in ventral hernia repair, for example. Large clinical trials are difficult in these circumstances. However, for specific applications such as uncomplicated

On the Spot

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / SEPTEMBER 2013

DR. POWELL: Theoretically yes, but that is difficult to do. Not all hernias are uniform in nature, and it can be difficult to compare apples to apples. The other issue is continuing long-term follow-up on a lot of these patients.

DR. KAUFMAN: Prospective randomized trials are the appropriate way to prove efficacy and/or superiority (or inferiority) of comparable treatments or devices and minimize the bias. They are the best way to test items head to head, but these studies are also costly to administer and require a large number of ancillary staff to assist in completing these types of tasks.

However, it becomes increasingly difficult to accrue patients to certain types of trials in the modern health care environment.

DR. PARK: The “ultimate” gold standard to determine best hernia repair or any other intervention is, in fact, the multicenter, randomized prospective trial.

These are extremely difficult to design and execute, and it is why so few such hernia studies have been successfully performed, with adequate accrual, etc. So we often are left with lesser levels of evidence—more practically achieved—to inform our hernia management decisions.

DR. RICHARDS: Agreed, there is no question that these types of clinical trials have been instrumental in demonstrating best methods for approaching the repair of hernias.

opposed to rest and medical treatment.

The tricky part is seeing exactly which patients will likely benefit from repair. These patients really should go to a center that has a multidisciplinary approach to athletic pubalgia to tailor a recovery program that is best for the athlete.

DR. VOELLER: On the fence.

Depends on pathology and surgeon.

Both approaches are important, but nonoperative therapy frequently fails. If you are using the term “sportsman hernia” as created by Malycha in 1992 to mean a

re e

Regarding the treatment of sportsman hernia, rest and medical treatment is the preferred method of care over surgery.

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DR. RAMSHAW: Disagree. Until now, the prospective, randomized controlled, clinical trial has been considered the gold standard for medical research.

This type of scientific tool is a product of reductionist science. It works well for simple and complex mechanical systems. However, it is severely inadequate to explain complex adaptive or biologic systems. To determine what mesh, technique, etc., is best for which patient subpopulation will require the tools that are being developed from complexity science, like clinical quality improvement research (which is actually what we should be doing as a normal part of our care delivery). I recommend watching Malcolm Gladwell’s TED talk about spaghetti sauce to help understand how these concepts were applied to the consumer food industry several decades ago.

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inguinal hernia, prospective randomized studies are more reasonable and do help us define ideal management.

DR. PRYOR: I recommend rest and nonsteroidal [anti-inflammatory drug] therapy for most patients with sports hernia as firstline treatment. For patients presenting with severe pain or with an acute onset of symptoms and a tearing sensation, surgery should be considered earlier.

DR. ROSEN: No-brainer! I think

that all surgeons should take a serious pause and put the knife away for a disease that really makes no sense if you think about it!

DR. POWELL: I feel that there is still some controversy in this area. Some studies show that athletes who undergo repair have a higher chance of returning to full activity in three months as

see HERNIA page 32

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DR. RICHARDS: Agreed, surgery should be reserved for true hernias.

DR. RAMSHAW: Agree and disagree. If it worked in a reasonable time period, I think everyone would agree that conservative treatment would be preferred over surgery. However, there can’t be a “preferred method” that will work for all patients. Some patients will not be able to return to their sport or activity without more aggressive treatment, including surgery. It will be best when we can identify the subpopulation of patients who would respond well to conservative therapy and those who would require surgery to return to a full quality of life.

‘There is … a problem with the

diagnosis of “sports hernia,” and not all surgeons are talking about the same etiology/pathogenesis! We need a classification system for the spectrum of diseases of sports hernia.’

—Michael Sarr, MD DR. SARR: Disagree. Virtually all studies have shown that operating is better and gets the patient back to normal function much faster. There is, however, a problem with the diagnosis of “sports hernia,” and not all surgeons are talking about the same etiology/pathogenesis! We need a classification system for the spectrum of diseases of sports hernia.

DR. BOWERS: Acute tears should be repaired if they do not respond to a course of rest and medical therapy, but chronic tears are unlikely to respond to conservative measures.

Lightweight, large-pore synthetic mesh performs better than biologic mesh in contaminated situations.

DR. POMP: I will leave the discussion of this hernia to the experts, but the correction of attenuated fascia over exercise (or medication)-induced hypertrophic muscle may well require surgical repair.

DR. POMP: Biologic mesh in a severely contaminated wound inevitably becomes expensive biologic slush and this approach should mostly be condemned.

Lightweight, large-pore synthetic mesh may tolerate infection surprisingly well. The option of synthetic (cheaper) resorbable mesh should remain part of the surgeon’s armamentarium.

DR. VOELLER: We should know soon with trials now ongoing. My own bias for several years has been a strong yes. I was never a biologic mesh user. I did not believe the hype. After Jåne’s work in 2004 on stoma hernia prevention [[Arch Surgg 2004;139:1356-1358], I have used large-pore synthetics to prevent parastomal hernia in my colon surgery and have never had a mesh infection. Additionally, I have many cases of onlay mesh repair of large ventral hernias with lightweight polypropylene mesh in contaminated situations. If a wound infection occurs, I open the wound and place a wound VAC [vacuum-assisted closure], and the mesh is covered quickly with granulation tissue and never lost.

DR. RICHARDS: Although the lightweight, largepore mesh has shown to be superior to older mesh types, the use of biologic mesh is still preferred in contaminated fields.

DR. SARR: I know of no good data to support this one way or the other. I trust many surgeons are uncomfortable putting an alloplastic prosthetic into an infected field. This topic needs a controlled trial study!

‘I think we have learned the onesize-fits-all thinking is not a reality to produce the best value in health care.’

DR. KAUFMAN: In general, I agree with this statement, and accuracy of diagnosis for these types of patients is critical as this type of hernia tends to be “overdiagnosed.” The diagnosis can be made with physical examination and sometimes is aided by MRI [magnetic resonance imaging]. If after six to eight weeks of rest and physical therapy the patient still has severe pain to palpation and/or activity, then surgical intervention should be considered and can be done with either an open or laparoscopic approach.

DR. POWELL: If one looks at the literature, the answer would likely be yes. Today’s lightweight, largepore mesh seems to do fairly well in certain situations.

However, I would still hesitate to use a permanent synthetic in a grossly contaminated field such as feculent peritonitis. Biologic mesh does not seem to be the answer for long-term hernia repair.

DR. PARK: It is certainly the preferred initial course of treatment. Although our surgical approach of choice is laparoscopic, the difficulty in dealing with these patients is obviously not the technique or conduct of the repair, but rather appropriate patient work-up, selection for and timing of surgery.

DR. PRYOR: Most hernia surgeons find contaminated fields a challenge. However, I think we are seeing increasing evidence that lightweight, large-pore synthetic mesh may be a good solution in these situations. Although biologic mesh has been used, longterm results are disappointing.

—Bruce Ramshaw, MD

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weak inguinal floor onlyy with no other pathology, then repairing this weakness gives good results in the majority (not all) of cases. Surgery also is indicated in some of the other causes of groin pain in the athlete.

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DR. ROSEN: Too early to tell at this point. There is a very compelling retrospective case series that suggests in certain circumstances, these lightweight synthetic materials can withstand contaminated situations.

Whether that will result in a long-term advantage or a decrease in hernia recurrence rates is unknown at this time. Our group is actually performing an FDA-monitored, prospective, randomized trial evaluating lightweight polypropylene mesh versus a biologic mesh for the repair of clean-contaminated and contaminated ventral hernias. Until this trial is completed, I think it’s too early to make any conclusive statements.

DR. RAMSHAW: Disagree. I think we have learned the one-size-fits-all thinking is not a reality to produce the best value in health care. Neither biologic mesh nor lightweight polypropylene is “better” for contaminated situations. We also need to look at overall value for the long-term outcomes, not just short-term quality measures. There are now coated lightweight polypropylene options that may allow better durability, long-term resorbable meshes that are less costly than biologics and might work well in these situations, and the potential for next-generation biologics, such as nanoparticle crosslinking materials, which might add value to the use of a biologic mesh.

DR. BOWERS: Intraperitoneal mesh of any type is unlikely to perform well in contaminated situations, and retrorectus biologic and lightweight synthetic meshes are both likely to perform well in contaminated cases.

My experience with lightweight synthetics are that they can almost always be salvaged in case of infection, provided the mesh is flat, extraperitoneal, has viable muscle coverage, and negative pressure therapy would be appropriate.

DR. KAUFMAN: A well-designed, randomized controlled trial will be the optimal way to answer this very question. In some cases, this is accurate and can be achieved without major consequences with concurrent use of antibiotics and appropriate drainage and lavage of the contaminated surgical field. Depending on the degree of contamination and the clinical scenario (i.e., extent of tissue loss), I still would prefer a biologic mesh in most of these instances, unless there is minimal contamination.

DR. PARK: Not yet, although performance of biologic in this situation is still variable.

—Colleen Hutchinson is a communications consultant who specializes in the areas of general surgery and bariatrics. She can be reached at colleen@cmhadvisors.com.

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / SEPTEMBER 2013

RADIOTHERAPY jcontinued from page 1

Research and Treatment of Cancer (EORTC) AMAROS (After Mapping of the Axilla: Radiotherapy Or Surgery) trial, which was presented as a latebreaker at the 2013 annual meeting of the American Society of Clinical Oncology (ASCO), patients with invasive early clinically node-negative breast cancer of less than 5 cm in size (T1,2) were randomized before surgery to receive ALND or AxRT if the sentinel node was positive. Of the 4,806 patients randomized, 1,425 were found to have a positive sentinel node and underwent axillary treatment with the assigned treatment. Of those patients randomized to ALND or AxRT, 90% also received adjuvant systemic treatment, which was initiated after ALND or AxRT. The primary outcome was recurrence at five years, which occurred in 1.19% of those randomized to AxRT, 0.43% of those randomized to ADLN, and 0.8% in patients who were sentinel node–negative. This unexpectedly low number prevented a planned noninferiority analysis. There were no significant differences between the two treatment groups for secondary end points of disease-free survival (P=0.18) and overall survival (P=0.34).

The differences in the rates of lymphedema, another secondary end point, were significant. Consistent with measures taken at one and three years, the rate of lymphedema at five years was more than twice as high in the ALND arm (28% vs. 13.6%; P<0.0001). When restricted to those with lymphedema requiring therapy, such as lymph drainage or compression sleeves, the rates remained twice as high after ALND relative to AxRT (16.8% vs. 6.6%).

The additional secondary outcomes of shoulder function and quality of life (QoL) did not differ significantly. Although AxRT was associated with a nonsignificant trend toward greater restriction of shoulder movement at one year, this difference dissipated. Despite a trend favoring AxRT for a subscale within the QoL instrument (swollen arm) and a trend favoring ALND for another subscale (arm movement), the lower rate of lymphedema after ALND did not translate into a significant overall QoL advantage at any time point.

At ASCO, Monica Morrow, MD, the chief of the Breast Surgical Service at Memorial Sloan-Kettering Cancer Center in New York City, questioned the value of routinely providing either therapy. She noted that no additional positive nodes were detected in 67% of patients in the ALND arm. Assuming

The study may establish a new standard for sentinel lymph node—positive early breast cancer; however, it also raises questions about which patients should undergo biopsy, and of those, who should and should not receive treatment. that the proportion was similar in the AxRT arm, approximately two-thirds of those receiving axilla treatment “got no benefit but only toxicity,” Dr. Morrow observed.

In the context of the Z11 trial ((JAMA 2011;305:569-575)—which showed very low recurrence rates in a similar sentinel node–positive breast cancer population when no additional therapy

to the axilla was offered—Dr. Morrow suggested some further selection process is needed.

Agreeing with this premise, Dr. Rutgers responded that he would not necessarily recommend a sentinel node biopsy in every patient. If a biopsy is taken, he considers whether therapy of the axilla is needed based on characteristics of the primary tumor and the sentinel lymph node biopsy. If treatment is chosen, he would then offer AxRT as the first-line therapy if radiotherapy to the breast or chest wall is indicated.

Read the #1 general surgery publication in the country anywhere, anytime.

33

34

Opinion SCOPES II

jcontinued from page 1 energetic early 20th-century industrial America, the concepts of “survival of the fittest,” “natural selection” and “adaptation” are antithetical to the central tenets of today’s kinder, gentler world that values inclusion, tolerance, diversity and a “level playing field” over the rough and tumble imperatives of classical evolution.

Giraffes with short necks should and can be accommodated. The fortunate ones with long necks can bend a little because it’s the right thing to do.

The ACLU will propound that students are frightened by competition and the possibility of failure. Their parents no longer accept the anachronistic obsession with hard work and success, and disavow any connection between the two. We don’t have to step on each other to reach the coveted middle ground of mediocrity.

In rejecting evolution, the ACLU will endorse, ironically enough, “intelligent design”—without the deity, of course. A 15-member lay board will pull the puppet strings that inform action and define culture in our society. As a concession to the Bible belt, the myth of Adam and Eve will be preserved. They will live blissfully in Eden with a hyphenated last name in co-gender equality. No snakes.

No apple. No hocus-pocus.

Evolution does not comport with the values or aspirations of the “Me Generation” because it is not anthropomorphic.

Science, philosophy and beliefs embraced by the “Me Generation” require man to be permanent, in control and responsible for everything that happens. Any “science” that does not comport with these requirements will eventually be rejected. It’s no accident that Freud can’t find his way into a college syllabus anymore.

At first glance one would think the “Me Generation” would be in love with the endless Freudian obsession with self, but Freud, like evolution, doesn’t market well to consumers who don’t want to work hard or get buffeted by forces beyond their control. Why spend 15 years trying to be happy when you can take a pill?

It’s not necessarily the science that makes global warming a compelling idea for so many. It’s that we’re heating up the planet ourselves and can stop at any time we come to our senses. We seem to be able to accept the idea that the sun will burn out a billion years from now but won’t even consider that monstrous sun storms today are heating up our solar system. Science that is incompatible with obsessive anthropomorphism has no place in the intelligent design world.

It’s why the space program is dead and unfunded. We’ve lost our interest in the beyond because it makes man irrelevant

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / SEPTEMBER 2013

and small. Nothing that makes the “Me Generation” feel impermanent and unimportant gets any traction anymore.

Extinction, a core principle of evolution, is too frightening to contemplate, even if we’re just talking about the Delta smelt in the central valley of California.

Protecting the delta smelt from extinction is nothing more than modern man’s expression of his own supremacy over the natural order that decides between perpetuation and extinction.

Darwinism is too harsh a concept for a world in which perpetually helmeted kids lathered in sunscreen play baseball in Little League, where, increasingly, keeping score is forbidden because it’s discriminatory and insensitive. If you think coddling is a mistake because it ill prepares kids for the real world, you have underestimated how rapidly the new architects of intelligent design can change the real world to look like Little League. The military has resisted transformation, but virtually every other institution of American life, including and especially surgery, has been altered by the architects of intelligent design who value participation, civility, tolerance and “work–life work life balance balance” over outdated con concepts like achievement, hard work and success. The latter breed stratification that is intrinsically “unfair.”

Surgery capitulated to intelligent design and its coda of calculated mediocrity when it accepted the 80-hour workweek. It’s not that

you can’t learn everything in 80 hours or less; one can. There’s a lot of dead time in training. Acceptance of the 80-hour mandate was the surrender of traditional surgical values of rigor and excellence to current obsession with the level playing field. Exalting “work–life balance” guarantees the death of exceptionalism. Demanding senior residents and uncompromising professors of surgery have been instructed to ratchet it down so that young doctors find the training experience nurturing and unthreatening.

Apparently, we must be losing too much young talent to dermatology.

Evidence abounds that documents the official abandonment of the rigorous surgical training experience as a method of natural selection that favors the fittest and weeds out the weak and uncommitted. There has been a slow but noticeable drift of scientific papers and presentations away from scientific rigor toward topics that demonstrate that surgery has embraced the values of the“Me Generation.” Authors’ names will be withheld to protect their reputations, but here’s a sampling of what I come across these days trying to keep up with the literature: “The The Effects of On OnDuty Napping on Intern Sleep Time and Fatigue,” “Why Do

‘Giraffes with short necks should and can be accommodated. The fortunate ones with long necks can bend a little because it’s the right thing to do.’

Residents Leave General Surgery: The Hidden Problem in Today’s Programs” (probably work), and my favorite, “How Medical Students Navigate the Interplay Between Explicit Curricula, Implicit Curricula and Extracurricula to Learn Curricular Objectives.” Where were the articles on work–life balance when residents were on call every other night for seven years? The presumption in these titles is that there is still too much work in the life–work balance to suit the popular taste. In the post-evolutionary world, no one is going to be happy until work becomes what used to be called a hobby.

The preoccupation with civility in the workplace is another indication of the decadent mentality that informs the surgical workplace. It was inevitable that civility be linked to safety to justify the strange obsession with it, but the literature that supports the link is loose and anecdotal and diminishes the peerreviewed journals in which these articles appear. The predictable narrative is that team members who aren’t medical doctors are afraid to speak up in a hierarchical system that suppresses equal participation when they witness mistakes that only they know are about to happen. It’s just another empty paean to the team concept of health care delivery that assumes all stakeholders are equal in knowledge and experience. The link between civility and safety stretches credulity, but not being on board comes at great peril if you serve at someone else’s pleasure. Does the surgical establishment honestly believe citizenship is a substitute for competence, or rest is more important than knowledge and experience?

It clearly doesn’t pay to run afoul of any of the cherished cultural ideals that have redefined the modern surgical training programs that pattern themselves after other declining American institutions that pioneered a gradual descent into mediocrity. Ask Lazar Greenfield.

Ironically enough, his unfortunate Valentine’s Day editorial in the American College of Surgeons’ ACS Surgery News (February 2011) was actually about the evolution of physical attraction between males and females with citations from Science and Nature, but it was offensive to some, a capital crime for which there is no redress. Apparently, as editor of ACS Surgery News, the Greenfield filter failed, so he lost everything, including the presidency of the ACS. Shakespeare was too charitable when he observed that the “good that man does is oft interred with their bones.” We don’t wait for death if someone makes so much as an intimation that violates the sensibilities of the invisible power structure that controls thought and action.

It should come as no surprise that the painful Greenfield saga was picked up by mainstream media that has specially

Opinion

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / SEPTEMBER 2013

trained antennae for grievances. At first, the gallant ACS tried to expunge the story from its archives as if it didn’t exist.

But sadly for the ACS, nothing dies in the digital world, and in 12 hours The New York Timess was all over the story. As appeasement, a metaphorical stake was driven through Dr. Greenfield and he was picked clean in an impromptu sky burial.

On the other hand, it is shocking that mainstream media, with its insatiable appetite for stories like the Greenfield debacle, seems to have little interest in three recent bombshell announcements from the specialty boards that document the decline in the quality of current graduates of training programs. The American Board of Internal Medicine just released the results of the pass–rate for first-time test takers and inexplicably, to them, the pass–rate has dropped from 90% to 84%.

The American Board of Thoracic Surgery just reported that the flunk rate on oral boards almost doubled from 12% in the 2000-2006 period to 21% during the ensuing five years. Worse still, a recent survey presented to the American Surgical Association indicates that graduates of traditional five-year training programs don’t possess the requisite skills to perform routine surgical procedures.

Several explanations are offered by both boards, like the 80-hour workweek (kicking the dog) and the fact that with all information being just a click away, it’s no longer necessary for trainees to actually know anything. It is taboo to discuss whether or not the explanation relates to less-qualified people entering training programs, or alternatively, what I believe to be the case, that trainees are every bit as qualified as their predecessors but less is expected from them because of the gradual erosion of the traditional rigorous culture of surgical training to make it look more like Little League.

Flunking tests doesn’t hurt anyone but the test taker, and that problem can be eliminated by making the tests easier, permitting infinite retakes (a strategy adopted by the American Board of Surgery a few years back), or eliminating them altogether, a preference chosen by many colleges to disguise the fact that students aren’t learning much (for 50 large annually).

At some point, however, the declining competence of trainees in surgery will be impossible to ignore, and judging from the recent lead article in the ACS Surgery News (May 2013), that point has arrived.

A recent survey of surgical subspecialty fellowship program directors conducted

by Samer Mattar, MD concluded: “Many new (surgical) fellows must gain basic and fundamental skills before they can commence to benefit from the advanced skills that they originally came to obtain. The current high demand for fellowship training (80% of graduates of five-year general

‘Graduates need to know how to get the nose up in a hurry when it counts. A good nap and an A grade in citizenship will not cut it.’ surgery programs seek additional training) and the lack of readiness, upon completion, of general surgery residencies, should be a call to action for all stakeholders in surgical training.” Translation: Across the country, residency program directors and department chiefs are signing graduation

certificates for hundreds of newly minted surgeons who cannot operate and fail to take “ownership” of caring for a surgical patient because they were protected in training from personal accountability by the “team” concept of patient care.

In defense of surgical trainees, it’s hard to learn to do surgery when open surgery is disappearing. Being a surgeon increasingly is becoming similar to being a pilot where the machine is more important than the pilot. I never liked the surgery-cockpit analogy, but the analogy is becoming more apt as the surgeon is slowly yielding control to computer-guided instruments.

However, there is a cautionary tale in what happened to the Asiana Airlines pilots in San Francisco recently as they confronted system failure with a skill set that had been compromised over time by technology dependence. We are in an awkward period in surgery where dependence on “the machine” exceeds its ability to consistently deliver, and the backup human skills necessary to salvage emergent situations are underdeveloped because of shrinking opportunities to hone them, both during and after training.

That being the case, the appropriate see SCOPES II page 36

35

36

Opinion SCOPES II

jcontinued from page 35 response would be to make training â&#x20AC;&#x153;harderâ&#x20AC;? rather than easier, so that when confronted with difficult surgical pathology, we donâ&#x20AC;&#x2122;t feel like the Asiana pilots approaching a sea wall at 150 mph. Graduates need to know how to get the nose up in a hurry when it counts. A good nap and an A grade in citizenship will not cut it. Feeling coddled and protected by â&#x20AC;&#x153;the teamâ&#x20AC;? doesnâ&#x20AC;&#x2122;t cut it either. Neither does a learning environment that refuses to reward excellence and punish failure. Like it or not, fear motivates.

Unfortunately, this does not appear to be the direction we are headed. In this post-evolutionary world, there seems to be a conscious attempt to make surgical training as unthreatening as possible. When I began my internship, I thought everyone was better, smarter, more skilled and harder working than I was. I was told, in no uncertain terms, that I had entered a dog-eat-dog world where it was survival of the fittest.

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / SEPTEMBER 2013

Surgical pathology was uncompromising and unforgiving, and the training to learn how to deal with it would reflect that reality. It was a harsh but exciting world. The ground rules appealed to me. When my mom dropped me off at my Little League games, she said â&#x20AC;&#x153;drag theirâ&#x20AC;&#x201D;â&#x20AC;&#x201D;â&#x20AC;&#x201D;in the dirt.â&#x20AC;? I was readyâ&#x20AC;&#x201D; and remain convinced to this dayâ&#x20AC;&#x201D;that the culture of surgical training drew everything I had out of me.

I thought my professors of surgery were gods. I wanted to act like them.

I wanted to be like them, whatever it took. No doubt this view was partly inaccurate and a product of youth, but it motivated me to be more than I otherwise would have been had the message been to relax and enjoy life on the level playing field where all reasonable needs would be accommodated. In retrospect, it was clear that surgical culture made a choice to maximize the skills and attributes of people like me even if it meant weeding out others disinclined to subject themselves, or their families, to such an intense experience.

Somewhere along the way, the leaders

of surgery, pressured by the norms of the outside world, changed their minds, and now they are finally being confronted with the consequences of that decision. Unfortunately, technology and automation have not come quickly enough to disguise the lack of readiness in surgery graduates. Program directors and department chairs find themselves in the unenviable position of certifying surgeons not yet ready for prime time.

Ultimately, however, blame goes beyond program directors and department chiefs and resides with surgical leadership that endorsed the 80-hour workweek. They sent the signal that surgery, once the mighty discipline, was ready to capitulate to all the norms of the post-evolutionary world that endorsed accommodation over adaptation. The â&#x20AC;&#x153;Me Generationâ&#x20AC;? would not find surgical training a stressful experience and did not have to choose dermatology to achieve workâ&#x20AC;&#x201C;life balance.

How ironic that the quest for workâ&#x20AC;&#x201C; life balance has now extended surgical training by one, two or three years just to achieve competence. Extending

surgical training would not be necessary if programs had the same intensity as they used to. An honest debate about the root causes of the general decline in surgical training is not even permitted. Disguising failure that results from declining standards has become a growth industry in the United States. There will be no retreat from the groveling obeisance to the level playing field no matter what the consequences. Giraffes with short necks will thrive. It has been decreed: Evolution is dead. Intelligent design has constructed for us all a happier, less judgmental place where we all can thrive. Only our patients are at risk.

For those of you who read this and disagree, kindly express your displeasure in a warm and nurturing way. â&#x20AC;&#x201D;Dr.Cossman is a vascular surgeon in Los Angeles, Calif.

khorty@mcmahonmed.com.

Letters to the Editor

Hat or Miss To the Editor: I read with interest [Dr. Lauren Kosinskiâ&#x20AC;&#x2122;s] article, â&#x20AC;&#x153;CMS Directives: Hat or Missâ&#x20AC;? [ July 2013, page 1].

Some years ago I wrote an essay on this very subject.

I think it was when a state surveyor had directed us to get rid of the hats and replace them with bowl covers.

We did until he was gone, and then replaced the surgeonâ&#x20AC;&#x2122;s hat on the shelf next to the bowl cover bouffants. There is not one shred of scientific evidence that shows the bouffant is safer. In fact, the skullcap allows for a better use of headlights and loupes, which do not stay in place as well on a bouffant. There is a reason for the CMS [Centers for Medicare & Medicaid Services] rule. It started years ago when the much-desired takeover of the practice of medicine began. It started with doctors being lumped in with lab techs, venipuncturists, nurses and everyone else in anyway involved in patient care. We all became health care providers. This took away our specialness as well as some of our power. With every new rule and regulation we gave up power and position. The removal of the skullcap makes the surgeon like every other doctor, and was necessary since we all know surgeons are more cantankerous and obstreperous than other doctors. This [CMS mandate] has nothing to do with safety and everything to do with control.

Who knows what could be next. Perhaps the internists should be wary of draping their stethoscopes around their necks on their way from ICU to the supermarket!

Larry Monn, MD Indiana

To the Editor: My hospital recently tried to do this in one day and failed due to a massive uprising. It was in part pushed by a need to explain an infection that supposedly had a

hair in it. Somehow the fact that the patient had a ruptured colon was overlooked. It was an example of who really is driving the ship we are on. Surgeons were kings and queens not long ago, and there is no way this would have been attempted 25 years ago. I agree with Dr. Kosinskiâ&#x20AC;&#x2122;s comments that being disengaged only hurts us in the end. However, we as a group have grown soft.

Leadership is protectionâ&#x20AC;&#x201D;protection from the administratively insane.

Garth Olds, MD, FACS Bozeman, Montana (MCW General Surgery Grad 2001)

To the Editor: I was astonished to read the article by Dr. Kosinski echoing my feelings on the useless rulings and mandates that continuously pour from the mouths and pens of bureaucrats from the various agencies that presume to supervise and regulate us. In my experience, there are no better champions of patient care than surgeons. For each law written, a liberty is lost and these bureaucrats obviously have no idea how these seemingly tiny mandates add up to decreased quality of life for surgeons and physicians and increase the burden of care of individual patients. Kudos to Dr. Kosinski for relating this so eloquently.

Craig Swafford, MD LCDR (SEAL) Ret. Assistant Professor of Surgery UT College of Medicine Chattanooga

The Dangers of Prescription Painkillers To the Editor: Iâ&#x20AC;&#x2122;m writing in response to a recent report on prescription painkiller overdoses from the Centers for Disease

Control and Prevention. The report, which showed that more women die from prescription painkillers than from car crashes, is alarming. It is imperative that physicians and patients explore alternatives to narcotics for pain management.

Many people are aware that prescription painkillers cause serious side effects such as respiratory depression, nausea and vomiting, and mental confusion. Prescription narcotics are also associated with the development of dependence and addiction in some people. And although opioids are frequently prescribed for postoperative pain management, a real risk for the development of narcotic overuse does exist. Physicians need to minimize this risk for their patients. In addition, many patients are already asking for alternatives to prescription narcotics for pain management to avoid the negative effects of opioids.

In response, many hospitals are implementing narcotic reduction programs that use innovative alternatives to opioids for postsurgical pain management. One option is a portable pain pump, which can help manage postsurgical pain by delivering an automatic and continuous, regulated flow of a non-narcotic, local anesthetic through a catheter near the surgical site.

Options such as these help reduce the reliance on opioids to relieve pain after surgery, and can also reduce many narcotic-related side effects, speed recovery and improve the overall patient experience compared with narcotics alone. Hospitals benefit via a reduction in adverse events, shorter hospital stays, fewer readmissions and improved patient satisfaction.

This report sheds light on the dire need for alternative solutions to treat pain. Itâ&#x20AC;&#x2122;s critical that physicians educate their patients, involve them in decisions about pain management and give them options.

Rita Hadley, MD Dayton, Ohio Dr. Hadley is a speaker for I-Flow, manufacturer of the On-Q Painbuster Post-op Pain Relief System.

37

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SEPTEMBER 2013

REPORT Integrating Surgical Rib Fixation Into Clinical Practice A Report From the Rib Fracture Consensus Meeting Participants Jose J. Diaz Jr, MD, CNS, FACS, FCCM

Vicente H. Gracias, MD, FACS

*Adam M. Shiroff, MD, FACS

Professor of Surgery Chief, Division of Acute Care Surgery R. Adams Cowley Shock Trauma Center University of Maryland School of Medicine Baltimore, Maryland

Medical Director, Trauma and Surgical Care Robert Wood Johnson University Hospital Professor of Surgery, Chief, Trauma/Surgical Critical Care Rutgers Robert Wood Johnson Medical School New Brunswick, New Jersey

Chief of Trauma Jersey Shore University Medical Center Neptune, New Jersey Assistant Professor of Surgery Rutgers Robert Wood Johnson Medical School New Brunswick, New Jersey

Mario Gasparri, MD, FACS

Lawrence Lottenberg, MD, FACS

Timothy Pohlman, MD, FACS

Associate Professor Cardiothoracic Surgery Medical College of Wisconsin Milwaukee, Wisconsin

Senior Attending Surgeon Division of Acute Care Surgery Department of Surgery Associate Professor of Surgery and Anesthesiology University of Florida College of Medicine Gainesville, Florida

Director, Trauma Critical Care IUHealth Methodist Hospital Indianapolis, Indiana

Michael Bemelman, MD

Andrew R. Doben, MD, FACS

Surgeon/Trauma and Orthopedic Surgeon St. Elisabeth Hospital Tilburg, Netherlands

Associate Professor of Surgery Baystate Medical Center: Tufts University School of Medicine Springfield, Massachusetts

John G. Edwards, PhD, FRCS Glasg/(C/Th) Consultant Thoracic Surgeon Sheffield Teaching Hospital NHS Trust Northern General Hospital Sheffield, United Kingdom

Brian D. Kim, MD

Thomas W. White, MD, FACS

Senior Associate Consultant Mayo Clinicâ&#x20AC;&#x201D;Rochester Rochester, Minnesota

Trauma/Critical Care Surgeon Intermountain Medical Center Salt Lake City, Utah

*Contributed to Special Report, did not attend consensus meeting.

Supported by

REPORT In June 2013, DePuy Synthes hosted a Rib Fracture Consensus Meeting where national and international experts gathered to discuss the issues regarding surgical rib fixation and attempted to outline an effective approach to treatment. This monograph outlines the Consensus Meeting’s findings, and provides expert commentary from some of the attendees as well as surgeons in clinical practice.

Note: This report contains descriptions of multiple patient cases. Results from case studies are not predictive of results in other cases. Results in other cases may vary.

E

ach year in the United States, almost 200,000 people suffer rib fractures, often in conjunction with other injuries, as a result of blunt trauma (Figure 1).1-3 Patients with rib fractures tend to be more severely injured than trauma patients without rib fractures, have a 50% higher risk for pneumonia, spend more time in the hospital with longer intervals in the ICU, and spend more time on a ventilator.4-6 For the vast majority of these patients, however, treatment options for their rib fractures consists of little more than rest and pain relief.3 The relatively recent availability of fixation technology specifically tailored to rib fixation presents a potential option toward a more effective approach to managing rib fractures when compared with past surgical strategies. In the past decade, a small number of randomized trials have found that surgical rib stabilization of selected patients with flail chest resulted in reduced ventilator dependence, fewer days in the ICU, less pneumonia, better eventual pulmonary function, and faster return to work.6,7 Despite the potential advantages of early surgical intervention, surgical rib fixation in the United States is just beginning to take hold.3 Its acceptance will require a paradigm shift in a direction that is counterintuitive to medical evolution’s shift toward fewer open procedures.

Issues With Conventional Treatment Over the past century, treatment of fractured ribs shifted from skeletal traction to “internal pneumatic stabilization”

to today’s standard of care, favoring analgesia and pulmonary hygiene, with surgical treatment considered as salvage therapy by a level 3 recommendation in cases of severe flail chest, according to the guidelines of the Eastern Association for the Surgery of Trauma.3,8 Although a handful of centers around the world have been investigating the role of surgical treatment for the past 50 years,9 a universal protocol has not been established in the United States; thus, treatment focuses only on underlying injuries and pain.

“The majority of patients with rib fractures today are managed the way they have been for the last 30 or 40 years,” said Jose Diaz Jr, MD, CNS, FACS, FCCM, professor of surgery, University of Maryland School of Medicine, who also works for the university’s Trauma Center.

For many of these patients, the delay in receiving more aggressive treatment may result in developing further complications, including pneumothorax and hemothorax.3,10 “It is well known that the major immediate risk for rib fractures is a pneumothorax or hemothorax; later risks are pulmonary complications like pneumonia or respiratory insufficiency. The need for endotracheal intubation and mechanical ventilator support can result in prolonged mechanical ventilation and the potential need for tracheostomy,” Dr. Diaz added. “That, of course, dovetails into the added risk for ventilator-associated pneumonia.”

The standard treatment for these patients, whose injuries often are the result of car accidents, falls, and industrial accidents, is pain management administered intravenously or orally, or through the use of blocks such as individual rib blocks, paraspinous blocks, or epidurals.3 “The traditional paradigm assumes if you support the patients’ other underlying injuries—their lung injuries or whatever injuries to the extremities they may have—and give them enough pain control, eventually the rib fractures will heal and they will be fine,” said Mario Gasparri, MD, associate professor of cardiothoracic surgery, Medical College of Wisconsin, Milwaukee.

This approach decreases the risk for some complications, but may cause other challenges in managing affected patients.

“You have to be in the hospital to be on IV narcotics, you have to be in the hospital to have epidurals, and there are limitations on how long you can have an epidural or paraspinous block,” said Dr. Diaz. “An individual rib block is performed with longlasting, local pain medication, but these have 7 to 14 hours of effectiveness at the most.”

Inconsistency in Defining a Flail Chest

Figure 1. CT scan of a rib fracture in a patient involved in an industrial rollover accident.

Courtesy of Adam M. Shiroff, MD

2

Perhaps one of the most severe types of rib fracture is a flail chest injury, accounting for about 10% of patients with rib fractures.5 Despite the extent of the injury, clinicians find it challenging to classify a flail chest. “The difficulty in defining flail chest is that it is now considered only as an anatomy problem. But we often operate on people because of physiology, not just anatomy,” explained Adam M. Shiroff, MD, FACS, chief of trauma, Jersey Shore University Medical Center and assistant professor of surgery at Rutgers Robert Wood Johnson Medical School. “There can be patients with a flail chest as

REPORT defined by several ribs in sequence with 2 fractures who have minimal pain and may not have any respiratory compromise, whereas other patients with multiple fractures in a row not considered flail chest have an enormous amount of pain, have ventilator-dependent respiratory failure, and act the way you would expect a patient with classic flail chest to act.”

This inconsistency is problematic in a few ways, not the least of which is reimbursement—how can surgeons bill for a procedure not considered the standard of care? “If you define flail chest simply as an anatomy problem, you run the risk of excluding patients who would otherwise need the surgery, but physicians and hospitals may not be reimbursed for it,” said Dr. Shiroff.

Suboptimal Quality of Life The traditional paradigm of treating patients with rib fractures simply falls short in optimizing outcomes and overall well-being.11 Studies have shown that 69% of patients with rib fractures experience long-term morbidity.5 “When patients have flail chest or multiple ribs broken in multiple spots, a lot of people die, and those who survive often have long-term disability,” said Dr. Gasparri.

“They may have chronic shortness of breath or chronic pain, and they may never return to work.”

In patients with flail chest after traumatic injury, 49% to 64% experience long-term chronic morbidity, such as chest wall deformities and pain, and 39% are unable to return to any type of work.12-14 Timothy Pohlman, MD, FACS, director of trauma critical care at IUHealth Methodist Hospital in Indianapolis, confirmed these observations with a recent patient who passed the test of being able to breathe on his own and was sent home with painkillers. “When he returned 2 weeks later, still able to breathe, he couldn’t lie down on the examining table because of the pain. Nor could he work,” he said. “He was a mailman, so if [he] can’t deliver the mail, [he’s] out of a job. I think that’s the point. We can talk about [hospital] lengths of stay, and a little less time on the ICU floor, but the salient point is how fast can we get people back to work.”

Concerns Regarding Surgical Intervention The slow adoption of treating rib fracture patients more aggressively is understandable, especially for surgeons who have not been exposed to the latest technologies that have made strides in overcoming the problems associated with earlier surgical interventions, nor have they received the appropriate training to perform these procedures.

Misconceptions Regarding Technology Data from the 1970s showed that surgery resulted in as many complications and risks as nonintervention, explained Dr. Diaz.9 “In the 1970s, we made big incisions, we had significant chest wall exposure, and all we had available was basically the surgical wire we used to close sternums. You would run the wire around a rib or several ribs to hold them in place, or you would try to sew the rib together, or run some type of K-wire or pin into the medulla of the rib,” he said. This approach failed to stabilize the rib adequately and left patients with a large incision and the potential complications associated with such incisions.9 Before the advent of plates designed specifically to stabilize ribs, Dr. Gasparri recalled using pretty much anything he could get his hands on to set these fractures. “Rib fixation isn’t necessarily new. People have been talking about rib stabilization since the 1970s, even the 1960s,” said Dr. Gasparri.

Prior to the availability of rib fixation systems, “we were using whatever we could find. I’ve used wires, various plates, and screws that were not meant for ribs. I think that was a big impediment [to surgical intervention],” he said. “When you don’t have a good tool, it’s hard to do a good job, and I think that’s why we haven’t had a ton of enthusiasm for rib stabilization for so long. Now that we have plates specifically indicated for rib fixation, it is not necessary to use devices that are not designed for the rib.”

Identifying Appropriate Patients for Surgery In recent years, there has been a shift toward rib stabilization in patients with more severe injuries and early surgical intervention, but there is some controversy in this approach because there is no evidence to support one approach over another, or proof of which patients are the ideal candidates for surgery.15 Surgery is only a level 3 recommendation in patients with flail chest8; its role in severely injured patients not identified as having flail chest is even less defined.

The challenge is determining who should be undergoing surgery. “That’s what everyone is trying to sort out these days,” said Dr. Gasparri. “It’s clear that not every rib fracture or flail chest should be operated on. You can have rib fractures and have absolutely zero pain. [Such patients] have minimal pain or the pain is well controlled, and they’re moving around and breathing well. I can’t make someone who has no symptoms better with surgery.”

“On the other end of the spectrum, you have patients who can’t take a breath. If you don’t fix them, they’re going to die,” explained Dr. Gasparri. “But most patients are in the middle, and that’s where the controversy is and where we need to sort things out: Who benefits, who doesn’t, and what’s the time frame.”

Lack of Clinical Evidence One of the problems plaguing proponents of taking on a more aggressive approach to rib fractures is the lack of compelling evidence.8 “I am firmly convinced that early operative fixation has improved not only [our] ability to get patients off the ventilator, out of the ICU, and out of the hospital, but functionally—when these patients come back 4 to 6 weeks later, after they heal—they’re phenomenally much improved,” said Lawrence Lottenberg, MD, FACS, associate professor of surgery and anesthesiology, University of Florida, College of Medicine, Gainesville. “But there has not been a large, multicenter study comparing operative fixation with nonoperative repair. There are some prospective randomized studies, but they had very small numbers in the patient groups and were not well powered.”

Few would argue that large randomized controlled trials (RCTs) are essential to legitimize any procedure or device in the minds of the scientific and medical communities, and that the evidence generated by these trials paves the way toward payor recognition and reimbursement. But there are numerous practical and philosophical challenges in any such trial. Such a trial would require many centers to enroll enough patients to power the trial sufficiently, and it would be quite expensive.9 In developing RCTs, randomizing patients to more aggressive treatment poses an ethical question. Dr. Pohlman said he came to surgical rib fixation rather late, after suffering rib fractures himself and experiencing unbearable pain firsthand. “If you had proposed randomizing me to operative or nonoperative repair, I would have called you unethical,” he said.

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REPORT For any clinical trial to meet ethical standards, there has to be equipoise among the researchers, and that may not be possible in this situation. “If you want to have a good, prospective RCT, the researchers, surgeons in this case, have to lack bias. They can’t know which one is better,” said Dr. Gasparri. “But if you’ve done 1 or 2 or 10 or 100 of these, as most of us have, you’ve seen the benefits. I think surgeons who know how to do it wouldn’t randomize to not undergoing surgery, and [those surgeons] who are skeptical about operative rib fixation wouldn’t start the study because they don’t believe in it.”

Dr. Shiroff acknowledged that surgeons may hesitate to integrate rib fixation as protocol in the absence of RCTs validating the science. “On occasion, innovation outpaces academics,” he said. “[Surgeons] who don’t want to do rib fixation can hide behind the lack of an RCT, but if you look around the country, this is a procedure that some centers are doing and doing a lot of, and there’s a reason for that. I think it will only get more popular, but that acceptance will take longer than it should because of the issues surrounding a major scientific trial.”

Validating Surgical Intervention The most compelling argument for surgical intervention is that it significantly reduces patient pain, allowing patients to breathe normally, reduce the use of mechanical ventilation, minimize the time in the ICU, and return to work faster.6,9,11,15,16 “[These patients] go into the operating room broken, in pain.

The way I explain it to their families, every time they take a breath, it’s like walking on a broken leg. Except you don’t have to walk, but you have to breathe. Every time they take a breath, those ribs move—they click, they rub. Rib fixation immediately takes that movement away,” explained Dr. Shiroff. “The day after surgery, people who couldn’t roll over even with an ICU nurse’s help, get out of bed and shake your hand.”

In addition to facilitating normal breathing, fixation re-establishes the architecture of the chest, allowing the muscles to move in a normal, functional way, particularly for patients who are on a ventilator because of mechanical problems with the lungs or chest wall.16 Studies also have shown surgical fixation to be cost-effective compared with conventional treatment.2,6 A third argument in favor of surgical rib fixation is the potential economic effect associated with patients returning to work faster.6,9,11 “This is probably the biggest, but least studied and talked about benefit of rib fixation—getting people back to work,” Dr. Shiroff said. “I’ve had 50 or 60 profound examples of getting people back to their business, being productive members of society, as opposed to ending up with long-term disability and on pain medication.”

Surgical intervention is supported further by the improvement in plating technology.15 “The plates are titanium based and lower-profile than other plates used in the past. There is much more knowledge now about the anatomy of ribs in humans, and the plates have been worked at the industry level to be much more applicable to the human anatomy,” said Vicente H. Gracias, MD, FACS, medical director, trauma and surgical care at Robert Wood Johnson University Hospital and chief of trauma/surgical critical care and professor of surgery at Rutgers Robert Wood Johnson Medical School. “In the last 5 years or so, the technique of how to do rib plating has really taken off, and we are now able to marry the surgical technique to the industry technology and have created what we consider to be a very good procedure.”

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Reaching a Consensus on Rib Fractures The goal of the Rib Fracture Consensus Meeting was to bring together experts in the field to compare clinical experience and to develop a national protocol in defining the severity of the fracture and determining when to use surgical rib fixation. “I think all of us who have done a lot of [rib fixations] have had parallel experiences, so I’m curious to see if we can reach a consensus. In some respects, we’re all just flying blind, but perhaps we have developed similar practice patterns or protocols,” said Dr. Gasparri.

Integrating a Treatment Protocol In the absence of a nationally accepted standard in treating patients with rib fractures, some institutions have created their own practice patterns or protocols for identifying which patients would benefit from surgery, when to perform surgery, and what type of care patients should receive if they don’t meet the criteria for surgical intervention.

“We evaluate any patient who has 3 or more rib fractures in a row,” said Dr. Shiroff. “This means monitoring how they are doing from a respiratory standpoint, and assessing [the patient’s] pain tolerance—how they’re doing when they get out of bed. Obviously, a patient who is on a ventilator is in a much higher risk category, but we consider anyone with 3 or more rib fractures for fixation if they meet the respiratory or pain criteria.”

Dr. Gasparri first considers anatomic criteria—does the patient have 3 or more fractures with significant overlap or a flail component? Then he assesses for symptoms: “intractable pain: if, despite all the pain medicines, their pain is poorly controlled and you can see that they are not taking a deep breath,” he said.

When patients are already on a ventilator, some of these criteria can be difficult to assess. “Sometimes they have head injuries or other reasons [for being] on a ventilator,” explained Dr. Gasparri. “But I’ll still consider them for stabilization. I think it’s reasonable to proceed. This is anecdotal, but a lot of our rehabilitation team members have noted that patients who go through rib stabilization progress through rehab and recovery a lot faster than those who haven’t.”

Dr. Gracias and his colleagues have specific protocols for patient selection. “We see hundreds of patients a year with rib fractures, so we have a standard protocol in place. First, we use standard oral narcotics and IV narcotics to see if we can improve the overall respiratory function, using incentive spirometry as a guide.”

Patients who do well on pain management generally do not need surgery, noted Dr. Gracias; however, those who fail to advance despite heavy narcotic use are placed into more aggressive therapy with epidural and subcutaneous anesthesia. “We’ve learned that people with 4 or more rib fractures or with flail chest are the ones who may benefit from surgical fixation. If they don’t improve after aggressive narcotic and epidural use, we select them for an operation,” he said.

The more injured patients are, the quicker they tend to fail to respond to pain medicine, but on average Dr. Gracias and his colleagues identify surgery candidates within 72 hours.

“Patients with very bad chest wall injuries are intubated right away, and these are the patients we tend to be very aggressive with early on because they’ve already failed,” he said.

“But by 72 hours, we know which patients are going to do well on their own and which ones are failing and will need to be

REPORT

Trauma Center: arrival, admission, clinical assessment

No

Crepitus or tenderness Deformity CXR evidence Chest tube or intubation

Yes

Contour defect, overlapping, displaced, or bilaterality

3D reconstruction of chest wall

CT Chest

Yes

SubQ heparin (only)

Yes

SICU admit

No

No

â&#x2030;Ľ3 rib fractures Intrapleural deformity or flail

Yes

Intubated No

IMC, floor admit Enoxaparin SubQ Analgesia PO IS

Rib fracture pathway assessment: Q1d IS volume Pain Cough

Rib fracture management pathway 1. APS consult within 6-12 h 2. CCM/RT ventilator support 3. PT/OT consult (mobility) 4. Nutrition DHT consult (assess, optimize) 5. TRE assess other injuries 6. NS assess brain injury 7. Orthopedic assessment of other bone injuries 8. Rib Plating within 48 h

Yes

Pain score >6 IS <10 mL/kg or cough >1

No

No

Hospital discharge

Yes

End

PO analgesia or PCA

Figure 2. The University of Florida algorithm on rib fracture management.

Courtesy of the Division of Acute Care Surgery, University of Florida College of Medicine APS, acute pain service; CXR, chest x-ray; CCM, critical care medicine; CT, computed tomography; DHT, Dobhoff tube; IMC, intermediate care unit; IS, incentive spirometry; NS, neurosurgery; OT, occupational therapy; PCA, patient-controlled analgesia; PO, orally; PT, physical therapy; RT, respiratory therapy; SICU, surgical intensive care unit; SubQ, subcutaneous; TRE, trauma service

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REPORT Clinical Indications 3 or more rib fractures with rib displacement of more than 1 rib cortical diameter Flail segment Pulmonary worsening with progressive volume loss on x-ray Intubation/mechanical ventilation Use of IV narcotics Uncontrolled pain when using analgesia or VAS score >6 Lung impalement Open chest defect Stabilization on retreat of thoracotomy Pulmonary herniation

Figure 3. Consensus on clinical indications for rib fixation.

VAS, visual analog scale

placed on a breathing machine. Those are the patients we try to select out and operate on to give them the best chance of not being placed on a breathing machine except in the operating room, or to be placed on a breathing machine for as short a time as possible.”

According to Dr. Lottenberg, the University of Florida’s protocol involves plating ribs, but also includes specific and exact management of the trauma patients who arrive at the hospital.

Their protocol begins with admission of the patient through the trauma center (Figure 2, page 5).17 Once rib fractures are identified through the initial chest x-ray or physical examination, the patients proceed to computed tomography (CT) scan; a 3-dimensional reconstruction of the chest wall on CT scan is ordered for any patient with 3 or more rib fractures.17 The patient is immediately given an incentive spirometer.

Patients who cannot inhale 750 cc or more on a single inhalation are put into the high-risk category for having rib fracture repair. Patients also are seen immediately by the trauma center’s anesthesia management service.

“We have 24-hour availability of anesthesiologists who will come to the bedside, see the patient, evaluate the patient for placement of catheters in the epidural space or in the paravertebral space, place the catheters, and put the patient on continuous infusion of anesthetic agent immediately to begin to relieve their pain so that they can breathe much better and hopefully avoid being put on the ventilator,” said Dr. Lottenberg.

In establishing the protocol, Dr. Lottenberg and his colleagues concluded that the sooner surgical candidates are operated on, the better the outcome. “In our experience at the University of Florida, which is now approaching 100 patients whose ribs have been plated, we find that the optimum time to plate the ribs is within the first 48 hours,” he said. “If you wait

6

longer than 48 hours, the patient may develop pneumonia and need higher levels of sophisticated ventilation, and the window for operative fixation is lost.”

Even with a protocol in place, however, the management of patients with rib fractures includes a fair amount of clinical decision making. In cases where a patient has isolated rib fractures, the repair may be fairly straightforward. But in those with multisystem injuries, including brain injuries, other abdominal organ injuries, multiple pelvic fractures, or multiple long bone fractures, doctors have to weigh the risk of anesthesia and surgical treatment against the management of those injuries. “With multiply injured patients comes a decision-making process that involves the gestalt of the trauma surgeon to determine whether early rib fracture fixation should be used as part of the overall treatment of the patient,” explained Dr. Lottenberg.

This may be part of the reason why a national protocol has yet to be issued. “I think most of us who treat rib fracture patients on a regular basis do have a protocol, but a lot of these protocols aren’t really published—they’re suggested,” said Dr. Lottenberg. “We hope, after we publish the review of our 100 cases, to put our protocol out there for people to look at it and show that our patients do much better—fewer days in the ICU, on a ventilator, and in the hospital overall.

“But the protocol is not just operative fixation. Any protocol for the management of rib fractures has to include appropriate respiratory care, respiratory therapy, and analgesic and anesthesia pain management related to the rib fractures themselves,” he said.

Establishing the Clinical Indications And Timing for Rib Fixation During the Rib Fracture Consensus Meeting, the attendees agreed on the clinical indications for rib fixation in the acute setting which included 3 or more rib fractures with rib displacement of more than 1 rib cortical diameter; flail segment; and being in uncontrolled pain despite adequate analgesia (Figure 3).

The Consensus Meeting group also defined flail chest as being 3 or more consecutive ipsilateral, segmental fractured ribs identified radiographically, in which the outward manifestation is the classic paradoxical motion. The condition also can manifest clinically as impaired pulmonary mechanics leading to diminished cough, ineffective ventilation, and increased atelectasis. Additionally, the experts agreed that multiple consecutive rib fractures may be associated with a similar pattern of unstable chest wall mechanics and impaired function.

An assessment was made on the timing of rib fixation, with the group agreeing that it is best to treat patients within 48 to 72 hours after admission assuming other potentially life-threatening injuries have been treated. Surgical fixation should occur as soon as possible after resuscitation and after triage of other injuries, preferably within 72 hours. The group acknowledged, however, that benefits also may be realized with delayed plating.

For patients with chronic rib pain (ie, non-union pain), gross deformities may result over time when only analgesia is used.14 Thus, surgical intervention may provide efficacious results in repairing fractures.

REPORT The DePuy Synthes MatrixRIBTM Fixation System In the United States, there currently are 2 rib fixation systems: Acute Innovations RibLoc System and the DePuy Synthes MatrixRIB™ Fixation System (Figure 4). MatrixRIB is indicated for the fixation and stabilization of rib fractures, fusions, and osteotomies of normal and osteoporotic bone.18 It consists of strong and flexible titanium alloy locking plates precontoured to fit the average rib locking screws and intramedullary splints.15,18 Please refer to the MatrixRIB technique

guide and package insert for full indications, contraindications, instructions for use, warnings and/or precautions.

“DePuy Synthes [MatrixRIB Fixation] system’s plates are fairly lengthy and can bridge multiple fractures in a single rib; they’re fitted for both the right and left side of the chest, and for individual ribs based on computer evaluation of human ribs,” explained Dr. Lottenberg. “It’s a very strong but simple system that involves contouring the plate and simply drilling and placing locking screws through both cortices of the rib,” he said. “I’ve been able to plate as high as rib 3, all the way down to rib 10 quite easily with these plates. I found the system to be quite easy to pick up, and it did not require a lot of prior technical work.”

Dr. Gracias appreciated the malleability of the DePuy Synthes plates, which he thought makes the system easy to use, especially for surgeons building a skill set for rib fixation. The educational platform and approach to training enables surgeons to gain a better understanding on ideal patients for rib fixation. “I think DePuy Synthes has done a good job of educating and creating a very solid product, and those 2 things together have helped surgeons become comfortable and proficient in the current techniques that benefit patients,” he said.

Conclusion

Figure 4. The MatrixRIBTM Fixation System.

Courtesy of Thomas W. White, MD

Before surgical rib fixation becomes more widely accepted, surgeons will have to be open to the idea of a more aggressive treatment approach. “I think people are reluctant because this is a paradigm shift, asking surgeons to operate on something that, for as long as surgeons now can remember, we haven’t operated on,” said Dr. Shiroff. “It’s almost the

Figure 5. CT scans of a patient who was kicked by a horse (a) before rib fixation and (b) after the procedure.

Courtesy of Adam M. Shiroff, MD

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REPORT polar opposite of the direction other surgical fields have gone, doing fewer open procedures, interventional radiology, and stopping bleeding from the inside. I think that goes against a lot of what some surgeons see as the evolution of less is more. But I think we’ve been missing the boat with these rib fracture patients for years.”

Surgeons who accept the concept also will need to embrace the challenge of becoming adept at performing surgical rib fixation. “This means doing the right evidence review, training yourself through courses, and staying robust in your surgical education,” said Dr. Gracias. “This is a developing field, and people are constantly pushing the envelope to advance surgical techniques, so staying on top of the latest and best approaches to these patients will be one of the challenges.”

The Consensus Meeting made several strides in identifying clinical indications for rib fixation and defining flail chest— 2 developments that establish the foundation of surgical rib fixation and help define an appropriate patient population for this procedure. With an established protocol, further considerations—the classification of rib fractures and correlation with clinical outcomes; which surgical approach is best; which rib fixation system is best; and whether or not each fracture in a flail chest should be stabilized—will need to be addressed.9

Dr. Gracias noted that care of rib fracture patients goes well beyond stabilizing their ribs. “We need pain management, social work, and trauma center resources to resocialize these patients.

Trauma surgeons don’t just operate on the rib—they operate on the whole patient.”

For surgeons already well versed in surgical rib stabilization, however, the rewards are quickly apparent (Figure 5, page 7).

To reinforce the benefit of rib fixation, Dr. Lottenberg described a patient who sustained rib fractures in a horseback riding accident.

“She came back to our clinic last week, enamored of the difference in the way she felt. She was overwhelmed at how well she’d done after the repair of her injuries,” he said. “This lady, no doubt in my mind, will be back on a horse within the month.”

References 1. HCUPNET. http://hcupnet.ahrq.gov/HCUPNET.jsp. Accessed July 8, 2013.

10. Todd SR, McNally MM, Holcomb JB, et al. Am J Surg. 2006; 192(6):806-811.

2. Bhatnager A, Mayberry J, Nirula R. J Am Coll Surg. 2012;215(2): 201-205.

11. Kerr-Valentic MA, Arthur M, Mullins RJ, Pearson TE, Mayberry JC. J Trauma. 2003;54(6):1058-1063, discussion 1063-1064.

3. Liman ST, Kuzucu A, Tastepe AI, Ulasan GN, Topçu S. Eur J Cardiothorac Surg. 2003;23(3):374-378.

12. Landercasper J, Cogbill TH, Lindesmith LA. J Trauma. 1984;24(5): 410-414.

4. Sirmali M, Türüt H, Topçu S, et al. Eur J Cardiothorac Surg. 2003; 24(1):133-138.

13. Beal SL, Oreskovich MR. Am J Surg. 1985;150(3):324-326.

5. Fabricant L, Ham B, Mullins E, Mayberry J. Am J Surg. 2013;205(5): 511-515, discussion 515-516.

14. Granetzny A, Abd El-Aai M, Emam E, Shalaby A, Boselia A. Interact Cardiovasc Thorac Surg. 2005;4(6):583-587.

6. Tanaka H, Yukioka T, Shimizu S, et al. J Trauma. 2002;52(4); 727-732.

15. Gasparri MG, Tisol WB, Haasler GB. Eur J Trauma Emerg Surg.

2010;36(5):435-440.

7. Marasco SF, Davies AR, Cooper C, et al. J Am Coll Surg. 2013; 216(5):924-932.

16. Ahmed Z, Mohyuddin Z. J Thorac Cardiovasc Surg. 1995;110(6): 1676-1680.

8. Simon B, Ebert J, Bokhari F, et al; Eastern Association for the Surgery of Trauma. J Trauma Acute Care Surg. 2012; 73(5 suppl 4):S351-S361.

17. Rib Fracture Management. University of Florida College of Medicine; 2012.

9. Nirula R, Diaz JJ Jr, Trunkey DD, Mayberry JC. World J Surg.

2009;33(1):14-22.

18. MatrixRIB. Stable fixation of normal and osteoporotic ribs.

Technique guide. West Chester, PA: DePuy Synthes CMF; 2013.

Learn More

Dr. Diaz reported that he is a consultant for DePuy Synthes, LifeCell, and Acute Innovations. Dr. Gasparri reported that he is a consultant for and has received honoraria from DePuy Synthes. Drs. Shiroff and White reported that they are consultants and speakers for DePuy Synthes. Drs. Gracias, Lottenberg, and Pohlman reported that they are consultants for DePuy Synthes.

Disclaimer: This monograph is designed to be a summary of information. While it is detailed, it is not an exhaustive clinical review. McMahon Publishing, DePuy Synthes, and the authors neither affirm nor deny the accuracy of the information contained herein. No liability will be assumed for the use of this monograph, and the absence of typographical errors is not guaranteed. Readers are strongly urged to consult any relevant primary literature.

Copyright © 2013, McMahon Publishing, 545 West 45th Street, New York, NY 10036. Printed in the USA. All rights reserved, including the right of reproduction, in whole or in part, in any form.

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SR1325

Disclosures: All surgeons who attended the consensus meeting were under consulting agreement with DePuy Synthes.

J12578-A

Come hear from the Rib Fracture Consensus Meeting participants at special industry sessions at the annual meetings of the American Association for the Surgery of Trauma (9/19 at 5:00 PM ) and the American College of Surgeons (10/8 at 11:25 AM ), and stop by the DePuy Synthes CMF booth.

Brought to You by

SEPTEMBER 2013 RP1606

REPORT Clinical Performance and Economic Analysis of GORE速 BIO-A速 Tissue Reinforcement Faculty

James J. Chao, MD, FACS Director of Plastic Surgery, OasisMD Clinical Professor, Plastic and Reconstructive Surgery University of California, San Diego School of Medicine San Diego, California

B. Todd Heniford, MD, FACS Professor of Surgery Chief, Division of Gastrointestinal and Minimally Invasive Surgery Director, Carolinas Hernia Center Co-Director, Carolinas Laparoscopic and Advanced Surgery Program University of North Carolina at Chapel Hill Charlotte, North Carolina

Garth Jacobsen, MD, FACS

Brent Matthews, MD, FACS

Program Director, General Surgery Director, Hernia Center University of California, San Diego Department of Surgery San Diego, California

Chief, Minimally Invasive Surgery Co-Director, MIS Institute Professor of Surgery Washington University School of Medicine St. Louis, Missouri

Supported by

REPORT

he development of synthetic, biosynthetic, and biologic surgical meshes to provide reliable tissue reinforcement has been driven in part by the high rate of recurrent incisional hernias after laparotomy.1 Use of surgical meshes has reduced recurrence rates overall which has led to their widespread use,2 although no one type of mesh has been proven to be beneficial for all patients or procedure types. Risk for infection, adhesions, and fistulas can be high for synthetic meshes,3 particularly when used in contaminated surgical fields.4 Switching to a biologic mesh has been shown to reduce these risks versus no mesh use5 while ensuring a lowered rate of hernia recurrence,6 but are offered at a significantly higher cost than other mesh types.7 The third option for hernia repair, biosynthetic mesh, was first introduced by W. L. Gore & Associates, Inc. in 2008 as GORE® BIO-A® Tissue Reinforcement (Figure 1).8 Composed of a bioabsorbable material which has years of positive outcomes data supporting its use,9 GORE® BIO-A® Tissue Reinforcement has been developed to provide clinical results at

T

Figure 1. GORE® BIO-A® Tissue Reinforcement.

Image courtesy of W. L. Gore & Associates, Inc.

2

considerable economic value over biologic meshes, making it a preferable choice for soft tissue reconstruction. This report will present an analysis of the available clinical performance, scientific, and economic data in the literature along with a discussion by faculty with experience in using various mesh types, including GORE® BIO-A® Tissue Reinforcement.

Background—Clinical Need The use and study of surgical mesh has been concentrated in repair of midline abdominal incisions primarily because this is the area of greatest clinical need. Thus, tissue reinforcement material capable of reducing incisional hernia risk or hernia recurrence has great implications not only for circumventing the risks for reoperation, but also for circumventing the risk for long-term complications, including an adverse effect on such quality-of-life measurements as pain, discomfort, and the ability to perform normal activities of daily living.10 “The clinical need for tissue reinforcement in repairs of the abdominal wall is apparent in persistently high recurrence rates independent of surgical technique or where the surgery is performed,” said Garth Jacobsen, MD, FACS, program director of general surgery and director of the Hernia Center at the University of California, San Diego Department of Surgery in San Diego. To reduce recurrence rates, “there is no practical alternative to some form of tissue reinforcement for large defects or in patients who have had previous recurrent hernias,” he said.

In the formation of tissue reinforcement, there has been an intensive effort to identify materials that reduce the risk for recurrence without introducing a new set of hazards.

At most recent count, there are more than 200 surgical meshes commercially available in the United States.11 These products generally can be divided into 3 major categories: biologic, biosynthetic, and synthetic. These product types differ fundamentally in character. Biologic prostheses employ human cadaver or animal tissue processed to provide a scaffold for repopulation by host cells.12 Biosynthetic prostheses employ biodegradable polymers for the same goal.13 Synthetic prostheses, unlike those formed with biologic or biosynthetic material, are not designed only to induce autologous cell repair or be resorbed, but remain as a permanent fixation device.

“Synthetic prostheses can be engineered for strength, but there are numerous short- and long-term complications associated with foreign bodies,” explained Brent Matthews, MD, FACS, professor of surgery, chief of the Section of Minimally Invasive Surgery (MIS), and co-director of the MIS Institute at Washington University School of Medicine in St. Louis, Missouri. “Whether with biologics or biosynthetics, the concept of providing a scaffold on which native cells can repopulate to

REPORT

increase strength in tissue underlying the repair, but without any permanent foreign body, is attractive.”

As previously mentioned, the limitations of nonbiodegradable synthetic mesh have been greatest in clean-contaminated or contaminated surgical fields where they impose a high risk for late infection, foreign-body reactions, fistula formations, and adhesions.4,14 These risks have persisted across an array of nonbiodegradable materials, such as polypropylene, multifilament polyester mesh, and polytetrafluoroethylene.15

Mesh Alternative: Bioabsorbable GORE® BIO-A® Tissue Reinforcement The first products of biodegradable mesh were composed of human or animal tissue. Examples of biologics in current use include those derived from human cadaver dermis, decellularized porcine small intestinal submucosa, and decellularized crosslinked porcine dermis. These varieties also differ in how they are processed and treated, which can affect their performance and risk for adverse events, such as potential inflammation or foreign body reaction, which can alter the speed of cellular infiltration.

As an alternative to biologics, GORE® BIO-A® Tissue Reinforcement was introduced to build on one of the key advantages of biologics, which is resorption. Biosynthetic meshes are designed to provide a matrix or scaffolding for ingrowth of native tissue that will potentially reduce hernia recurrence.12

A

Consequently, the eventual absorption of exogenous material after healing aims to avoid the long-term complications of an indwelling foreign body.

Furthermore, a bioabsorbable prosthesis like GORE® BIO-A® Tissue Reinforcement can be offered at a lower cost and possesses characteristics that have the potential to lower the risk for reherniation without the associated cleansing processes used by biologic manufacturers to remove any potential viruses or contaminants from the cellular structure.16 Plus, as a biosynthetic product, GORE® BIO-A® Tissue Reinforcement does not require the tracking, storage, and preparation procedures required by biologics.

Supporting Evidence on the Use of Biosynthetic Mesh Although biosynthetic meshes have emerged as a less costly and potentially similarly effective alternative to biologic meshes, the absence of level 1 data that establish a relative benefit of biologics over synthetic meshes means that there is no clear standard against which to compare biologics with each other or biosynthetic devices with biologics. Recent animal data have compared the efficacy of a biosynthetic mesh to a biologic mesh and shown an increase in cellular and vascular ingrowth and collagen deposition when examining implanted GORE® BIO-A® Tissue Reinforcement against a biologic mesh at up to 180 days (Figures 2-4).17

B

Figure 2. H&E stain showing tissue ingrowth at 30 days for (A) GORE® BIO-A® Tissue Reinforcement and (B) FLEXHD ® Mesh (Ethicon) for comparison.17

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“There is a general consensus that a biodegradable mesh is preferable to permanent synthetic mesh in clean-contaminated and contaminated surgical fields because of the evidence that the risk for infection is lower, but there have been very few data with which to evaluate the relative efficacy of biologics and biosynthetics,” said B. Todd Heniford, MD, FACS, chief of the Division of Gastrointestinal and Minimally Invasive Surgery at Carolinas Medical Center in Charlotte, North Carolina. “We are now collecting the data to resolve these questions. Other than the difference in infection rates derived from noncomparative studies, the movement toward using biologic meshes in contaminated fields has been based more on theory than on actual comparative data.”

The theory is well supported by the high risk for adhesions and fistulas associated with permanent synthetic mesh placed in contaminated wounds.3 The ability of biologics to lower or circumvent these risks is based on promising evidence 5 ; resorption may take place before these complications develop. Resorption of biosynthetics would be expected to deliver a comparable benefit. However, controlled multicenter studies to specify where different types of surgical meshes perform best have never been conducted.

“There are a lot of data from single-center case series, but it is difficult to draw strong conclusions about the relative performance of one mesh over another when so many variables,

A

including the patient mix and the surgeon’s skill, may affect outcome,” noted James Chao, MD, FACS, professor of Plastic and Reconstructive Surgery in the Department of Plastic Surgery at the University of California, San Diego School of Medicine in San Diego. “Ideally, the scaffolding allows remodeling in which native tissue is restored to prevent weakness at the site of abdominal repair, but performance has been difficult to judge objectively from case series alone because biologics are more likely to be used in contaminated fields where the risk for complication is greater,” Dr. Chao added.

A multicenter, prospective, single-arm trial, the Repair of Infected or Contaminated Hernias (RICH) study investigated the use of a non-crosslinked, porcine acellular dermal matrix for ventral hernia repair in a contaminated setting. Researchers found that after 2 years, greater than 70% of patients had experienced a successful mesh repair; 22 out of 80 patients had hernia recurrences (28%), and presence of infection was seen in 24 patients.18 A growing body of experimental and clinical data generated from studies conducted with currently marketed biologic mesh prostheses also exists; however, data contrasting product types and conflicting data within each type often leave clinicians with choices based on their own interpretation of relative advantages and disadvantages of different kinds of mesh.

“In patients at low risk for infection and clean surgical

B

Figure 3. Hirovici stain showing new collagen deposition (blue) at 30 days for (A) GORE® BIO-A® Tissue Reinforcement and (B) FLEXHD ® Mesh (Ethicon) for comparison.17

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fields who need a mesh, we are still likely to employ a permanent synthetic because of the lower cost. In patients with clean-contaminated or contaminated wounds, choice between a biosynthetic and a biologic is less clear. At our center, we reserve biologics for patients with a contaminated surgical field, but the supportive data are circumstantial,” Dr. Heniford said. “There is a large advantage in cost with a biosynthetic relative to a biologic, so data that allow us to understand the relative performance has the potential to change our practice.”

Data on GORE® BIO-A® Tissue Reinforcement— The COBRA Study Data are now being collected prospectively in one of the largest and most comprehensive clinical studies undertaken with any bioabsorbable mesh, whether a biologic or a biosynthetic. The prospective study, called COBRA (Complex Open Bioabsorbable Reconstruction of the Abdominal Wall), began enrolling patients at 9 participating centers in the United States and Europe in March 2011.19 Eligibility requirements included a hernia defect of at least 9 cm2 and a clean-contaminated or contaminated operative field.19 In preliminary data of 104 patients, the majority of

patients (77%) treated had a contaminated field and more than one-third of patients (42%) had a previously implanted mesh.

Over one-fourth (27%) were undergoing removal of infected mesh.19 A standardized laparotomy technique with retrorectus or intraperitoneal placement of the mesh and fascial closure is being employed. Outside of infected mesh removal, the most common reasons for concomitant procedures were bowel resection (28%) and reversal of ostomy (22%).19 Whereas final results will be presented when 2 years of followup are available for all enrollees, preliminary findings presented at several scientific meetings, including the 2013 American Hernia Society (AHS)19 and the 2012 American College of Surgery (ACS) meeting,20 are promising. Early results indicate a low rate (4%) of hernia recurrence at 210-day mean follow-up.19 Other events, such as wound infections, seroma formation, and bowel obstruction, also are being monitored and will be evaluated in the final report. So far, surgical site infections were observed in 18% of patients, with no removals of infected bioabsorbable material required, and wound complications, other than infection, have occurred in less than 5% of cases.19 “Findings from COBRA will provide objective data on performance. When the results become available, we will no longer be debating the theoretical advantages of specific design

GORE® BIO-A® Tissue Reinforcement

Grade

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FLEXHD® Mesh (Ethicon)

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STRATTICE Mesh (LifeCell)

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PERMACOL Mesh (Covidien)

2 1 0 7

14

30

60

Days

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180

Grade Total Ingrowth (% mesh thickness) 1 0-20% 2 20-40% 3 40-60% 4 60-80% 5 80-100%

Figure 4. Total cellular ingrowth.17

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characteristics but will have actual data. I am not aware of an equivalent multicenter study being performed with any other mesh,” Dr. Matthews said. “We need this kind of data for evidence-based practice.” When completed, the COBRA study will provide one of the most comprehensive evaluations of any surgical mesh, and it will be particularly useful for clarifying the efficacy of GORE® BIO-A® Tissue Reinforcement in both clean-contaminated and contaminated wounds.

Also, this study has been designed to collect relevant information on a broad range of preoperative and perioperative variables, including baseline comorbidities, such as diabetes mellitus, inflammatory bowel disease, or obesity, as well as procedure time.19 These may permit meaningful stratifications at the final data analysis.

Biosynthetic Engineering: GORE® BIO-A® Tissue Reinforcement The single most important feature of biologics, particularly relative to tissue reinforcement with synthetic material, is resorption. Elimination of the mesh avoids many of the long-term complications associated with indwelling exogenous material. Biosynthetic mesh shares this important feature but has the potential to offer greater efficacy at a lower cost. Human and animal tissues from which biologic meshes

Figure 5. Large and interconnected pores of GORE® BIO-A® Tissue Reinforcement (100x magnification).

Image courtesy of W. L. Gore & Associates, Inc.

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are processed do not necessarily offer the optimal characteristics for ingrowth of native tissue. Engineering of biosynthetic materials has the potential to deliver characteristics that biologics are unable to provide, including more consistency, mesh sheets in larger sizes, and the opportunity to alter material composition to improve dynamics, such as stretch, that may facilitate handling. Biosynthetics avoid the costs of acquiring, sterilizing, and processing human or animal tissue, which is an explanation for the high costs of biologics.

Material Characteristics GORE® BIO-A® Tissue Reinforcement is produced from a co-polymer of polyglycolic acid and trimethylene carbonate (PGA:TMC),16 for which extensive clinical experience in bioabsorbable sutures and staple line reinforcement already existed before the construction of a surgical mesh. The favorable safety, tolerability, and absorption characteristics of absorbable staple line reinforcement produced with PGA:TMC have been published in a broad range of applications including bariatric,9 colorectal,21 and abdominal surgery.22 In the construction of surgical mesh with PGA:TMC, a 3-dimensional matrix has been engineered to provide open, interconnected pores (Figure 5) with biocompatible fibers that allow pore size to be optimized for ingrowth.16 In experimental studies, the ability to manipulate such characteristics as pore size of the polymer fibers has been shown to alter the rate and degree to which native tissue is incorporated into the scaffolding as well as the rate at which the prosthesis is bioabsorbed.23,24 Both results may have implications for the speed and quality of the wound repair and relative protection against reherniation as well as infection or complication risk.

The value of the specific features of any structural characteristic ultimately is demonstrated in long-term clinical performance, but theoretical advantages can be derived from experimental studies. In a 1-year comparison of 5 different surgical mesh types with different characteristics, the outcomes were revealing. Conducted in rabbits with large (11×4 cm) abdominal wall defects, the study included a crosslinked biologic mesh (PERMACOL Mesh, Covidien), a non-crosslinked biologic mesh (SURGISIS Mesh 4-ply, Cook), a matrix biodegradable mesh employing 2 fibers purported to provide fast and slow absorption (TIGR® Mesh, Novus), a polypropylene synthetic mesh (BARD Mesh, Davol), and GORE® BIO-A® Tissue Reinforcement.24 The only small recurrent hernias occurred in the non-crosslinked biologic. TIGR ® Mesh had a higher rate of foreign-body reaction and adhesion formation similar to the polypropylene mesh. GORE ® BIO-A® Tissue Reinforcement provided the optimal tissue remodeling and was completely resorbed.24

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“When we compare biologic to biosynthetic, it is imperative to remember that the products within these categories vary substantially,” Dr. Matthews noted. “These products have not been interchangeable. Often, it is a question of a balance, such as strength versus pliability versus resorption profile. The best product for one patient may not be the best for another.”

Rapid Cellular Infiltration and Vascularization The specifications of the mesh, including the composition of PGA to TMC (67% and 33%, respectively), the pore size, and the structure were all selected on the basis of bioengineering and tests performed in experimental modeling. The goal is to sustain a matrix long enough for new tissue to build but without risk of permanent material present. Experimental studies support a defined mechanism with a predictable rate of resorption.

“We know from experimental data that pore size does matter,” Dr. Chao said. “Pore size that is too small will yield less ingrowth with suboptimal tissue characteristics. Although we may look for different physical characteristics from a biosynthetic mesh for different repairs, such as relative strength or pliability, there has been some progress in understanding what features are likely to affect outcome.”

In an ex vivo histologic evaluation of tissue in an animal model of abdominal repair conducted 1, 3, and 6 months after placement of GORE® BIO-A® Tissue Reinforcement, tissue specimens demonstrated enhanced fibroproliferation, gelatinolytic activity, and angiogenesis when compared with suture-only repairs.25 The prosthesis was still discernible by 3 months, but was nearly fully degraded by 6 months, at which time the tensile strength was greater at the wound site among animals receiving the prosthesis compared with those that did not.25 “The science over the past 10 years has advanced markedly. Experimental evidence has been important for identifying the characteristics that influence collagen deposition, rate of bioabsorption, and other features that we would expect to improve protection against recurrent hernias while reducing risk for long-term complications,” Dr. Heniford said. “Understanding these characteristics has been important for a rational approach to mesh design.”

GORE® BIO-A® Tissue Reinforcement Performance Versus Biologics Relative to biologics, which are constrained by the characteristics of the underlying tissue—whether human or animal origin—biosynthetics have the potential to be engineered not only to optimize growth, but also to offer favorable handling characteristics. Unlike biologic surgical mesh, which only can

be produced in limited sheet sizes and typically requires preoperative soaking, GORE® BIO-A® Tissue Reinforcement comes in sizes as large as 20×30 cm and does not require soaking or tissue tracking.16 GORE® BIO-A® Tissue Reinforcement also is easy to manipulate in both open and endoscopic procedures even relative to other biosynthetics.

“From a practical perspective, GORE® BIO-A® Tissue Reinforcement is easy to use. It holds sutures well; it can be cut for fit; and it is easy to grasp and handle for positioning,” Dr. Chao said. “There are differences in the features of biosynthetic products. GORE® BIO-A® Tissue Reinforcement is somewhat thicker than some alternative biosynthetics. We use GORE® BIO-A® Tissue Reinforcement often at our center because it provides a good balance of the characteristics relevant to performing the procedure and to outcome.”

For all bioabsorbable products, rate of resorption is a critical issue. Although there is no clear clinical evidence that a rapid rate of resorption increases the risk for recurrent hernias, one theory explaining a potentially higher rate of failure with biologics in complicated cases is that bacterial processes accelerate resorption of this type of tissue.26,27 High rates of failure would be expected if the scaffolding degrades before tissue ingrowth provides adequate strength to prevent reherniation.

Engineering of biosynthetic materials has the potential to permit greater control over this variable. With a 3-D matrix of highly interconnected pores, GORE® BIO-A® Tissue Reinforcement provides pores for cell migration, resulting in a structure that is similar to a collagen fiber network. The co-polymer, non“biologic” material has a predictable degradation profile and is less susceptible to premature degradation by collagenase.

Therefore, GORE® BIO-A® Tissue Reinforcement maintains scaffolding for a long enough duration until ingrowth of native tissue is viable; however, the material still achieves resorption before an increased risk occurs for late complications from indwelling exogenous material.

GORE® BIO-A® Tissue Reinforcement undergoes a relatively consistent and predictable hydrolytic degradation so that the resorption is complete in approximately 6 to 7 months.16 For example, in one study, a biosynthetic that had not been resorbed completely by 1 year induced a similar risk for foreign-body reactions as a synthetic mesh for which there was no degradation over this period.24 Resorption of GORE® BIO-A® Tissue Reinforcement, which also was included in that study, was complete prior to the 1-year analysis mark and was not associated with any inflammation or adhesion formation.24 “Clinical outcomes comparing biologics to biosynthetics may vary relative to the long-term recurrence rate,” Dr. Matthews said. “This is why we need to compare these meshes over periods of 4 to 5 years. The most significant

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difference between bioabsorbables, whether biologics or biosynthetics, may be the quality of the tissue they leave behind after reabsorption.”

Some of the performance characteristics of surgical meshes, such as shape memory and ease of placement, are difficult to quantify, but are empirically understood by surgeons who work with these materials frequently. “In the early days of tissue reinforcement, we used heavyweight synthetic meshes. Strength was considered an important criterion,” Dr. Chao noted. “Biologics provided an opportunity to orchestrate tissue restoration, but these meshes still need to maintain sufficient mechanical strength to avoid early failure of the repair. With an array of biologic and biosynthetic meshes now available, there is an appreciation for ease of use in the surgical field.”

GORE® BIO-A® Tissue Reinforcement: Clinical Outcomes The scarcity of prospective data from a large series of patients treated at multiple centers has been the limiting factor in resolving the debate about specific features of surgical mesh materials overall, and the relative efficacy of biologic and biosynthetic meshes specifically.

“Many of the specific design features of biologic and biosynthetic meshes that are now available may be important, but they are largely marketing concepts until we have the data to demonstrate that they influence outcome. Many of the biologic meshes have been available for more than 10 years with very little clinical evidence with which to judge efficacy.

The same is now occurring with biosynthetic products,” Dr. Matthews said. “As a company willing to evaluate their product with a prospective trial, the manufacturers of GORE® BIO-A® Tissue Reinforcement, at this point, stand alone.” Although COBRA does not include a biologic mesh arm, outcome data with GORE® BIO-A® Tissue Reinforcement will provide a benchmark for mesh performance.

There is a small case series supporting comparable benefit from GORE® BIO-A® Tissue Reinforcement relative to a biologic mesh, such as a single-center experience that found GORE® BIO-A® Tissue Reinforcement easier to use, as effective, and far less costly than a biologic mesh,8 but the quality of currently available data on biologics and biosynthetics has frustrated many experts in this area.

“We and others have been involved in extensive animal studies with different mesh materials, but we have had very little in the way of clinical outcomes data. This is why there is so much interest in the COBRA study,” Dr. Heniford said. “The need for data is particularly great in contaminated wounds because

8

many use biologics in these cases largely based on how this field evolved, but not on the basis of objective data. Practice would change if there were better evidence that biosynthetic mesh provided reliable outcomes in this group.”

The stratifications in COBRA also may provide insight about performance of GORE® BIO-A® Tissue Reinforcement in groups known to have an increased risk for reherniation.

“In an otherwise healthy population, infection rates after a laparotomy are low, but they climb steeply with welldefined risk factors, such as smoking, diabetes, or obesity. The relative risk for infection is an outcome relevant to comparing surgical mesh products, and these may differ,” Dr. Heniford added.

Importance of Follow-Up Data For clinicians active in this field, including Drs. Matthews, Chao, Jacobsen, and Heniford, one source of data has been their own patient series. Data on ventral hernia repair are being systematically collected at all 4 of the centers where they practice. For several, follow-up data with GORE® BIO-A® Tissue Reinforcement now extends to 3 years or more. Their interest in the COBRA results is driven in part by an experience that has been encouraging.

“We presented an abstract at the recent AHS meeting in which we reported on 98 cases in which we used GORE® BIO-A® Tissue Reinforcement surgical mesh. Seventy-five percent of the cases were clean, and the remaining were either clean-contaminated or contaminated. There have been no unexpected late complications, and the recurrence rates have been as good or better with the amount of follow-up so far when compared with our experience with biologics,” Dr. Jacobsen reported. “In a few cases where we have obtained biopsies at the site of repair, we have seen a reassuring degree of collagen deposition and vascularization.” However, he suggested that 5-year data might be more revealing because of the risk for late recurrences with any hernia repair and the potential for a biosynthetic to perform better than a biologic mesh at this time point.

Drs. Matthews, Chao, and Heniford, who also periodically have reviewed their own outcomes data with GORE® BIO-A® Tissue Reinforcement as well as other surgical meshes, made similar remarks. Each suggested that there have been no unexpected complications so far, but feel that at least 5 years of follow-up data are prudent to judge whether one mesh type is superior to another.

“Late failures are common with mesh repairs, so long-term results are needed. If we can show greater durability of the repair with a biosynthetic, then this would be a significant advantage,” Dr. Matthews said.

REPORT

Substantial clinical experience with GORE ® BIO-A® Tissue Reinforcement has been presented at society meetings and forums. In a retrospective comparison of GORE® BIO-A® Tissue Reinforcement with no tissue reinforcement for ostomy closure, the rate of infections was low but similar in both groups. However, the authors noted that opening of the wound to treat the infection did not require removal of the mesh. All 3 recurrences in a study of 28 patients occurred in those who did not receive GORE® BIO-A® Tissue Reinforcement.28 In an early series of 34 cases of hernia repair with GORE ® BIO-A® Tissue Reinforcement, of which 47% were recurrent hernia repairs, there were no recurrences in up to 2 years of follow-up. Although only a few patients in this series had contaminated wounds, outcomes were not different in this subgroup.29 In a smaller study of abdominal wall reconstruction in a series of 5 patients, all of whom had a contaminated surgical field, there were no complications or recurrences at 6 months.30 In 2 complicated patients, who required relatively large sheets of GORE® BIO-A® Tissue Reinforcement mesh, reported outcomes also were favorable.31 One patient had a small bowel obstruction and perforation with numerous intraabdominal abscesses. In the other, an abscess and enterocutaneous fistula required drainage before placement of the mesh. No complications were observed in a 7-month follow-up, according to the authors.31 The authors noted the low cost of GORE® BIO-A® Tissue Reinforcement in relation to biologics and the ability to place the mesh without soaking or other preparation were listed as potential advantages over biologic prostheses.31 Together, these experiences, which document a growing clinical experience with GORE® BIO-A® Tissue Reinforcement in diverse settings and patient types, have provided the impetus for larger, systematic studies with long-term follow-up. When such studies are stratified for important variables, such as the size of the wound repair, patient comorbidities, and the relative contamination status of the operative field, the data have the potential to provide an evidence base for surgical mesh selection.

GORE® BIO-A® Tissue Reinforcement: Experience in Hiatal Hernias and Beyond The advantages of a bioabsorbable biosynthetic mesh in abdominal wall repair are likely to be applicable to other surgical repairs where tissue reinforcement may be of value but where a permanent prosthesis poses an unacceptable risk for complications. Published studies and clinical series presented in abstract form have chronicled the experience with GORE ® BIO-A® Tissue Reinforcement for a variety of

applications. The greatest experience has been in hiatal hernia repairs,32 but large paraesophageal repairs, stoma fixation, and repair of traumatic injuries also have been published 33 or are being pursued.

“The experience with GORE® BIO-A® Tissue Reinforcement at many centers has been largely confined to ventral hernia repair, but the qualities of resorption are attractive for other types of surgeries. This is an area where we may see an expansion of the use of this product and other biosynthetic meshes,” Dr. Heniford said.

Other clinical applications where tissue reinforcement may be of benefit, such as stoma or traumatic wound repair, have been proposed. In such procedures, the value of synthetic mesh has been limited by concern for complications from permanent placement of foreign-body material. With biosynthetic mesh that offers predictable performance—particularly complete resorption—at a lower cost than biologic meshes, the clinical applications may expand. The growing experience with biosynthetic mesh in hiatal hernia repair has provided evidence of good short-term results for this indication but may be equally important for suggesting that this material has potential applications outside of abdominal wall repair.

Economics of Tissue Reinforcement The relative efficacy of different types of surgical mesh under specific clinical circumstances has enormous implications for health care costs. Although the acquisition costs of surgical mesh products range widely, total costs are informed by a long list of variables ranging from operating time to failure rates. The difference in cost has been important motivation for developing biosynthetic surgical mesh as an alternative to biologics. The acquisition cost of a square centimeter of biologic mesh has been estimated to be approximately 5 times greater than that of a biosynthetic mesh.7 If surgical outcomes achieved with biosynthetic mesh are comparable to those achieved with biologic prostheses, the relative cost advantage of the biosynthetic material may be beyond the cost of acquisition. Unlike biologic mesh, which often requires preoperative preparation that may affect operating room (OR) efficiency,34 a biosynthetic mesh such as GORE® BIO-A® Tissue Reinforcement is designed to be used without having to perform preoperative tasks, such as soaking.16 “Cost was a major driver for us to move away from biologics in cases where we feel that biosynthetic mesh will perform as well. At our center, the cost of a biosynthetic mesh is a small fraction of that of a biologic,” Dr. Jacobsen reported.

Mesh costs have a potentially large effect on the bottom line in hospitals where a high number of ventral hernia repairs are performed, according to a recent financial analysis. In this

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study of 415 patients undergoing ventral hernia repair, net revenue, direct costs, and indirect costs were evaluated.34 The analysis revealed a median net financial loss of $8,370 for repairs performed with a biologic mesh. In contrast, the repairs with synthetic mesh were characterized as budgetneutral (small median net profit).35 As a result of widespread use of biologics, hernia repair was being provided, on average, at a net loss from the perspective of the tertiary medical center where the study was conducted.35 Although this analysis ignores the impact of hernia recurrence with either type of mesh from the patient’s perspective, the data illustrate the effect of mesh choice for hospital costs.

“Costs are complicated because reoperation may be the largest cost of all if you are evaluating the higher acquisition cost of a prosthesis that will provide a lower rate of recurrence,” Dr. Chao said. “However, it is difficult to consider the price of a mesh in isolation from all the variables that establish the value of one product over another.”

Mesh acquisition costs drive economic comparisons from the hospital perspective, but relative rates of recurrence dominate mesh cost comparisons from the payor perspective. In a retrospective review of costs of placing a biologic mesh at a single institution, the authors concluded that the high rate of recurrence with biologic prostheses, despite their theoretical advantages in complex repairs, did not justify the expense.26 The unusually high rate of recurrence, which resulted in reoperation in 70% of the patients in a median follow-up of 24 months, 26 was the key factor behind this conclusion.

The long-term durability of ventral hernia repair with a biologic mesh also was questioned in a study using the product type in contaminated settings. Results showed that out of 128 patients, 40 experienced hernia recurrence (31.3%) at approximately 21 months follow-up.36 While a majority of recurrences were asymptomatic and did not require additional surgery, repair was performed for 7 patients (17%) with a recurrence, which led authors to deem the performance of the biologic as less favorable overall.36 These results underline the potential distance between actual outcomes and theoretical advantages.

“There is the risk that a price differential will be misunderstood as a quality differential. We are willing to use biologic meshes in the most complicated cases despite its cost because of the expectation that this will provide a better result. The problem is that this has never been shown directly,” Dr. Matthews said. “GORE® BIO-A® Tissue Reinforcement only has to perform as well as biologic mesh to become the standard because of the cost advantage.”

In ventral hernia repair, outcomes drive costs. High rates of recurrence have driven the development of surgical mesh

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devices and ultimately define their value independent of cost.

For payors, relapse requiring reoperation is a negative outcome from a cost perspective, but symptomatic recurrent hernias are a poor outcome for patients whether or not reoperation is required. “Working at an academic center, we think first about how a product performs and secondly about how much it costs,” Dr. Chao said. “Biosynthetic prostheses are attractive for the same principles that drew attention to biologics. It is critical that we compare these over the long term, at which time costs can be understood in terms of relative clinical benefit.”

Next Steps: Improving Care The optimal method of tissue reinforcement may not be the same for all indications or for patients stratified by comorbidities or other factors that influence outcome, but bioabsorbable mesh introduces the possibility of a physiologic repair.

By encouraging tissue growth to reinforce sutured repair for restoring the integrity of the abdominal wall,16 there may be an opportunity for a sustained and permanent repair that is not possible with permanent synthetic devices in complex cases.

“We have learned a lot about biosynthetics, and I believe that polymer mesh products will prove to be more effective than biologics ultimately,” Dr. Matthews said. He cited studies that have helped define the optimal pore size in 3-D matrix scaffolds, progress in mixing polymers to control and vary rates of degradation, and the potential to vary mesh flexibility to suit specific applications. Based on evidence that biologics and GORE® BIO-A® Tissue Reinforcement do induce viable ingrowth and vascularization,16 another potential advance is to enhance these qualities.

Patient-related factors also may increase the desirability to use a biosynthetic product. Fully resorbable biosynthetic prostheses may be preferable for patients resistant to animal or cadaver material driven by personal choice. Also, patients may want to avoid stretching observed with select biologics, which can lead to visible abdominal bulges and, in some cases, the need for reconstruction.37 Thus, the use of a biosynthetic product may assuage those concerns.

Nevertheless, measurable progress derived from any innovation depends on outcomes data against established devices with known risk–benefit ratios. Surgical mesh development has advanced largely in the absence of clinical studies capable of establishing benchmark performance meaningful for outcomes such as long-term freedom from hernia recurrence. In clean-contaminated and contaminated ventral hernia repairs, the prospective COBRA study with GORE ® BIO-A® Tissue Reinforcement will provide a meaningful demonstration of biosynthetic mesh repair.

REPORT

Conclusion The high recurrence rates after abdominal wall repair following laparotomy have provided a basis for innovation in tissue reinforcement.1 The limitations of synthetic materials, particularly in potentially contaminated surgical fields, have driven the effort to create a bioabsorbable mesh that will be resorbed after providing support at the site of repair. One of the most studied currently available biosynthetic prosthetics, GORE® BIO-A® Tissue Reinforcement, has the potential to offer more reliability in hernia repair than biologic mesh. The COBRA study19 study will provide more evidence on the efficacy in hernia repair. GORE® BIO-A® Tissue Reinforcement offers proven clinical outcomes at considerable economic value, making it a preferable choice in soft tissue reconstruction.

References 1. Luijendijk RW, Hop WC, van den Tol MP, et al. A comparison of suture repair with mesh repair for incisional hernia. N Engl J Med. 2000;343(6):392-398.

2. Klosterhalfen B, Junge K, Klinge U. The lightweight and large porous mesh concept for hernia repair. Expert Rev Med Devices.

2005;2(1):103-117.

3. van’t Riet M, de Vos van Steenwijk PJ, Bonjer HJ, et al. Mesh repair for postoperative wound dehiscence in the presence of infection: is absorbable mesh safer than non-absorbable mesh?

Hernia. 2007;11(5):409-413.

4. Meintjes J, Yan S, Zhou L, et al. Synthetic, biological and composite scaffolds for abdominal wall reconstruction. Expert Rev Med Devices. 2011;8(2):275-288.

5. Ko JH, Wang EC, Salvay DM, et al. Abdominal wall reconstruction: lessons learned from 200 “components separation” procedures.

Arch Surg. 2009;144(11):1047-1055.

6. Bhangu A, Fitzgerald JE, Singh P, et al. Systematic review and meta-analysis of prophylactic mesh placement for prevention of incisional hernia following midline laparotomy. Hernia. 2013 May 28. [Epub ahead of print] 7. Doerhoff CR. Use of biosynthetic absorbable mesh instead of biologics. Presented at: 14th Annual Hernia Repair Meeting; March 16-19, 2011; San Francisco, CA. Abstract P-1021.

8. W.L. Gore & Associates, Inc. Gore changes landscape in soft tissue repair with GORE BIO-A Tissue Reinforcement. www. gore.com/en_xx/news/bio-a.html. Accessed July 25, 2013.

9. Nguyen NT, Longoria M, Welbourne S, et al. Glycolide copolymer staple-line reinforcement reduces staple site bleeding during laparoscopic gastric bypass: a prospective randomized trial.

Arch Surg. 2005;140(8):773-778.

10. de Vries Reilingh TS, van Goor H, Charbon JA, et al. Repair of giant midline abdominal wall hernias: “components separation technique” versus prosthetic repair: interim analysis of a randomized controlled trial. World J Surg. 2007;31(4):756-763.

11. Le D, Deveney CW, Reaven NL, et al. Mesh choice in ventral hernia repair: so many choices, so little time. Am J Surg. 2013; 205(5):602-607, discussion 607.

12. Hodde J, Hiles M. Constructive soft tissue remodelling with a biologic extracellular matrix graft: overview and review of the clinical literature. Acta Chir Belg. 2007;107(6):641-647.

13. Gupta A, Zahriya K, Mullens PL, et al. Ventral herniorrhaphy: experience with two different biosynthetic mesh materials, Surgisis and AlloDerm. Hernia. 2006;10(5):419-425.

14. Rosen MJ. Polyester-based mesh for ventral hernia repair: is it safe? Am J Surg. 2009;197(3):353-359.

15. Robinson TN, Clarke JH, Schoen J, et al. Major mesh-related complications following hernia repair: events reported to the Food and Drug Administration. Surg Endosc. 2005;19(12):1556-1560.

16. W.L. Gore & Associates, Inc. GORE® BIO-A® Tissue Reinforcement product brochure. www.goremedical.com/resources/dam/ assets/AQ3037-EN2.pdf. Accessed July 25, 2013.

17. Zemlyak AY, Colavita PD, Tsirline VB, et al. Absorbable glycolic acid/ trimethylene carbonate synthetic mesh demonstrates superior ingrowth and collagen deposition. Presented at: 2012 Abdominal Wall Reconstruction Conference; June 13-16, 2012; Washington, DC. 18. Itani KM, Rosen M, Vargo D, et al; RICH Study Group. Prospective study of single-stage repair of contaminated hernias using a biologic porcine tissue matrix: the RICH Study. Surgery. 2012;152(3): 498-505.

19. Rosen M, Bauer J, Carbonel A, et al. Quality of life improves after complex ventral hernia repair using a bioabsorbable material: preliminary results of a prospective, multicenter study. Presented at: 15th American Hernia Society Annual Hernia Repair Conference; March 13-16, 2013; Orlando, FL. 20. Rosen M, Bauer J, Carbonel A, et al. Complex ventral hernia repair using a bioabsorbable material: preliminary outcome of a prospective, multicenter study. Presented at: 2012 American College of Surgeons Annual Clinical Congress; September 30–October 4, 2012; Chicago, IL. 21. de la Portilla F, Zbar AP, Rada R, et al. Bioabsorbable staple-line reinforcement to reduce staple-line bleeding in the transection of mesenteric vessels during laparoscopic colorectal resection: a pilot study. Tech Coloproctol. 2006;10(4):335-338.

22. Tucker JG, Copher JC, Reilly JP, et al. The use of bioabsorbable Seamguard during laparoscopic appendectomy. Surg Laparosc Endosc Percutan Tech. 2007;17(2):83-85.

23. Pascual G, Sotomayor S, Rodriguez M, et al. Repair of abdominal wall defects with biodegradable laminar prostheses: polymeric or biological? PLoS One. 2012;7(12):e52628.

24. Peeters E, van Barneveld KW, Schreinemacher MH, et al. Oneyear outcome of biological and synthetic bioabsorbable meshes for augmentation of large abdominal wall defects in a rabbit model.

J Surg Res. 2013;180(2):274-283.

25. Lopez-Cano M, Armengol M, Quiles MT, et al. Preventive midline laparotomy closure with a new bioabsorbable mesh: an experimental study. J Surg Res. 2013;181(1):160-169.

11

REPORT

26. Blatnik J, Jin J, Rosen M. Abdominal hernia repair with bridging acellular dermal matrix—an expensive hernia sac. Am J Surg.

2008;196(1):47-50.

27. Candage R, Jones K, Luchette FA, et al. Use of human acellular dermal matrix for hernia repair: friend or foe? Surgery.

2008;144(4):703-709, discussion 709-711.

28. Ramanujam P, Najafian H, Motamedi P, et al. The use of bioabsorbable mesh in ostomy closure. Presented at: 2012 Society of American Gastrointestinal and Endoscopic Surgeons; March 7-10, 2012; San Diego, CA. Poster P066.

29. Jacobsen G. A new alternative to traditional biologics in complex abdominal wall reconstruction. Presented at: 14th Annual Hernia Repair Meeting; March 16-19, 2011; San Francisco, CA. Abstract P264.

30. Weiss C, Voeller G. Bioabsorbable synthetic mesh for abdominal wall reconstruction in a complex operative field. Presented at: 5th International Hernia Conference; March 28-31, 2012; New York, NY. Abstract P-1441.

31. Doerhoff CR, Teget P. New synthetic bioabsorbable mesh in open abdomen. Presented at: 33rd International Congress of the

European Hernia Society; May 10-13, 2011; Ghent, Belgium.

Abstract P-074.

32. Reich J, Strom K, Pasquariello J, et al. Routine hiatal hernia repair in laparoscopic gastric banding. Surg Technol Int. 2010; 20:163-166.

33. Zehetner J, Demeester SR, Ayazi S, et al. Laparoscopic versus open repair of paraesophageal hernia: the second decade.

J Am Coll Surg. 2011;212(5):813-820.

34. Rosen MJ. Biologic mesh for abdominal wall reconstruction: a critical appraisal. Am Surg. 2010;76(1):1-6.

35. Reynolds D, Davenport DL, Korosec RL, et al. Financial implications of ventral hernia repair: a hospital cost analysis.

J Gastrointest Surg. 2013;17(1):159-166, discussion 166-167.

36. Rosen MJ, Krpata DM, Ermlich B, et al. A 5-year clinical experience with single-staged repairs of infected and contaminated abdominal wall defects utilizing biologic mesh. Ann Surg. 2013; 257(6):991-996.

37. Bluebond-Langner R, Keifa ES, Mithani S, et al. Recurrent abdominal laxity following interpositional human acellular dermal matrix.

Ann Plast Surg. 2008;60(1):76-80.

Refer to the Instructions for Use for a complete description of all warnings, precautions, and contraindications.

Products listed may not be available in all markets.

PERMACOL™ is a trademark of Covidien AG or its affiliate. FLEXHD™ is a trademark of Ethicon Inc. STRATTICE ® is a trademark of LifeCell Corporation.

GORE®, BIO-A®, and designs are trademarks of W. L. Gore & Associates. © 2012 W. L. Gore & Associates, Inc. Gore products referenced within, if any, are used within their FDA approved/cleared indications. Gore does not have knowledge of the indications and FDA approval/clearance status of non-Gore products. Gore makes no representations as to the surgical techniques, medical conditions or other factors that may be described in the article(s). The reader is advised to contact the manufacturer for current and accurate information. AQ0061-EN1.

Disclosures: Dr. Chao reported that he is a consultant for Novus Scientific; has received honoraria from LifeCell and Gore; and has received speaker fees from Boston Scientific. Dr. Heniford reported no relevant financial conflicts of interest. Dr. Jacobsen reported that he is a consultant to Ethicon, and has received grant/ research funding from Atrium Medical, Gore, and Linx Pharmaceutical. Dr. Matthews reported that he is a paid consultant for Gore; has received honoraria for speaking at educational forums for Gore; has received grant/research funding from Atrium Medical, Covidien, and Gore; and has received speaker fees from Atrium Medical, Bard, and Gore. Dr. Matthews has participated in the COBRA Trial as a co-investigator.

Copyright © 2013, McMahon Publishing, 545 West 45th Street, New York, NY 10036. Printed in the USA. All rights reserved, including the right of reproduction, in whole or in part, in any form.

12

SR1138

Disclaimer: This monograph is designed to be a summary of information. While it is detailed, it is not an exhaustive clinical review. McMahon Publishing, Gore, and the authors neither affirm nor deny the accuracy of the information contained herein. No liability will be assumed for the use of this monograph, and the absence of typographical errors is not guaranteed. Readers are strongly urged to consult any relevant primary literature.

Brought to You by

SEPTEMBER 2013

REPORT Teflaro® (ceftaroline fosamil) for the Treatment of Community-Acquired Bacterial Pneumonia Caused by Designated Susceptible Bacteria Community-acquired pneumonia Streptococcus pneumoniae is the Faculty (CAP) is a common illness that causes most common cause of CAP; comsignificant morbidity and mortality, bined with Staphylococcus aureus, Donald Low, MD particularly among elderly individuals these 2 organisms account for more Chief, Department of Microbiology and in those with serious comorbidithan 50% of cases. Several GramMount Sinai Hospital ties.1 CAP can be caused by bacterial negative pathogens, including HaeToronto, Ontario, Canada mophilus influenzae and Klebsiella pathogens or certain respiratory pneumoniae, are common etiologies viruses, and the etiology is often of CAP.5 unknown initially. For cases with a confirmed bacterial etiology, the FDA uses a more precise Over the past several decades, trends in antimicrobial designation: community-acquired bacterial pneumonia susceptibility patterns have complicated the treatment of (CABP). Despite the availability of potent treatment options CAP.6 For example, mutations to penicillin-binding proand effective vaccines, an estimated 5.4 million cases of teins (PBPs) have resulted in an increased resistance to CAP occur in the U.S. each year, leading to 1.2 million hosβ-lactam antibiotics among strains of S. pneumoniae.7 2,3 4 pitalizations and 53,692 deaths. The cost to treat CAP in The pneumococcal conjugate vaccine (PCV), first introthe U.S. is estimated to exceed $17 billion annually.2 duced in the latter half of 2000, has also led to changes

INDICATION

IMPORTANT SAFETY INFORMATION

• TEFLARO (ceftaroline fosamil) is indicated for the treatment of community-acquired bacterial pneumonia (CABP) caused by susceptible isolates of the following Gram-positive and Gram-negative microorganisms: Streptococcus pneumoniae (including cases with concurrent bacteremia), Staphylococcus aureus (methicillin-susceptible isolates only), Haemophilius influenzae, Klebsiella pneumoniae, and Klebsiella oxytoca, and Escherichia coli.

Contraindications • TEFLARO is contraindicated in patients with known serious hypersensitivity to ceftaroline or other members of the cephalosporin class. Anaphylaxis and anaphylactoid reactions have been reported with ceftaroline.

Please see additional Important Safety Information throughout and brief summary of Prescribing Information on page 8.

Sponsored by

REPORT TEFLARO (ceftaroline fosamil): A Treatment Option for CABP Caused by Designated Susceptible Bacteria

in the susceptibilities of S. pneumoniae due to vaccine selection pressure.8 The organisms have evolved to avoid immunization efforts by trading genetic properties, thus creating new serotypes. Implementation of the PCV7 has resulted in an increased prevalence of strains that are not included in the vaccine and are resistant to β-lactams, such as serotype 19A.8 One analysis found that the incidence of S. pneumoniae infections caused by nonvaccine serotypes rose from 6.1 to 7.9 cases per 100,000 population between 1999 and 2007; moreover, the incidence of disease caused by serotype 19A rose from 0.8 to 2.7 cases per 100,000 population during that same time period.9 Another factor in the changing landscape of CAP is that pneumococcal isolates can transfer genetic traits when cocolonized with different strains of bacteria within the nasopharynx. This opens up the potential to create new serotypes and resistance profiles.7,10 A 2010 study of 64 bacterial isolates found that following the introduction of the PCV7, pneumococcal cocolonization rates were unaffected and often comprised low-prevalence serotypes not included in the PCV7.10 This may lead to the emergence of previously rare or nonexistent serotypes as gene transfer continues unabated.10 These evolving resistance profiles and vaccine replacement serotypes underscore the need to develop safe and effective agents for the treatment of CAP. Ceftriaxone, a third-generation cephalosporin, is often used in combination with a macrolide for patients with CAP who require hospitalization.6 However, this agent has shown decreased activity for S. pneumoniae isolates, particularly after the introduction of the PCV7.11 In 1998, approximately 3% of S. pneumoniae isolates were nonsusceptible to ceftriaxone; by 2009, more than 12% of isolates exhibited this resistance profile.11 This ceftriaxone nonsusceptibility has been demonstrated in vitro, but it has not been demonstrated clinically.

The incidence of CAP caused by S. aureus is an estimated 10.2%,5 although some researchers have observed even higher rates. A study of hospitalized patients not admitted to the ICU found that 16.5% of CAP cases (55 of 333) were caused by methicillin-susceptible S. aureus (MSSA).12

TEFLARO (ceftaroline fosamil) is the prodrug form of ceftaroline, a cephalosporin indicated for the treatment of CABP in adults caused by susceptible isolates of the following Gram-positive and Gram-negative microorganisms: S. pneumoniae (including cases with concurrent bacteremia), S. aureus (MSSA only), H. influenzae, K. pneumoniae, Klebsiella oxytoca, and Escherichia coli.13 TEFLARO exhibits a high affinity for S. pneumoniae PBP2x, which leads to its bactericidal activity for this organism13 ; however, it should be noted that in vitro activity does not necessarily correlate with clinical activity.

The efficacy and safety of TEFLARO for the treatment of CABP were evaluated in 2 randomized, multicenter, multinational, double-blind, noninferiority trials: FOCUS (Ceftaroline Community-Acquired Pneumonia Trial vs Ceftriaxone in Hospitalized Patients) 1 and 2. The study population consisted of patients hospitalized (but not admitted to the ICU) with CAP who were classified as Pneumonia Patient Outcomes Research Team (PORT) Risk Class III or IV.12 Patients were randomized to receive either 600 mg of IV TEFLARO twice daily or 1 g of IV ceftriaxone per day during a treatment period of 5 to 7 days.12 Patients in FOCUS 1 also received 500 mg of oral clarithromycin twice on day 1.12 Those with known or suspected MRSA infections were excluded from both studies.

TEFLARO and ceftriaxone were assessed for clinical response rates on Day 4 using a microbiological intent-to-treat (mITT) population from the FOCUS studies. This subgroup only included patients with a confirmed bacterial pathogen at baseline. Subjects were required to meet the sign and symptom criteria at Day 4 of therapy: a responder had to both (A) be in stable condition according to consensus treatment guidelines, and (B) show improvement from baseline on at least 1 symptom of cough, dyspnea, pleuritic chest pain, or sputum production, while not worsening on any of these 4 symptoms.13 In FOCUS 1, Day-4 response rates for TEFLARO and ceftriaxone were 69.6% vs 58.3%.13 In FOCUS 2, these rates were 69% vs 61.4%, respectively (Figure 1).13 Neither trial

USAGE

IMPORTANT SAFETY INFORMATION (continued)

• To reduce the development of drug-resistant bacteria and maintain the effectiveness of TEFLARO® and other antibacterial drugs, TEFLARO should be used to treat only CABP that is proven or strongly suspected to be caused by susceptible bacteria.

Warnings and Precautions Hypersensitivity Reactions

• When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

• Serious and occasionally fatal hypersensitivity (anaphylactic) reactions and serious skin reactions have been reported with beta-lactam antibacterials. Before therapy with TEFLARO is instituted, careful inquiry about previous hypersensitivity reactions to other cephalosporins, penicillins, or carbapenems should be made. If this product is to be given to a penicillin- or other beta-lactam-allergic patient, caution should be exercised because cross sensitivity among betalactam antibacterial agents has been clearly established.

• If an allergic reaction to TEFLARO occurs, the drug should be discontinued. Serious acute hypersensitivity

2

Please see additional Important Safety Information throughout and brief summary of Prescribing Information on page 8.

REPORT established that TEFLARO (ceftaroline fosamil) was statistically superior to ceftriaxone in terms of clinical response rates.

The primary end point of the FOCUS studies was clinical cure rates at the test of cure (TOC), which occurred 8 to 15 days after treatment discontinuation. Clinical cure was defined as the resolution of all signs and symptoms of pneumonia or improvement sufficient to discontinue antimicrobial therapy.12 The TOC populations included a modified intent-to-treat efficacy (MITTE) group, which was defined as participants who were randomized to receive any amount of the study drug and

were classified as PORT Risk Class III or IV.12 There also was a clinically evaluable (CE) population, which included all subjects in the MITTE group who met the minimal disease criteria for CABP and for whom sufficient information regarding the CABP was available to determine the patient’s outcome.12 In FOCUS 1, clinical cure rates for TEFLARO and ceftriaxone in the CE population at TOC were 86.6% vs 78.2%.13 In FOCUS 2, clinical cure rates were 82.3% vs 77.1%, respectively ( Figure 2).13 Neither trial established that TEFLARO was statistically superior to ceftriaxone in terms of clinical response rates.

TEFLARO (ceftaroline fosamil) Demonstrated Clinical Response at Day 4 (mITT) in Community-Acquired Bacterial Pneumonia

CABP

Treatment Difference 11.2 (95% CI: –4.6, 26.5)

FOCUS 1

69.6% TEFLARO

(48/69)

58.3% Ceftriaxone

(42/72)

Treatment Difference 7.6 (95% CI: –6.8, 21.8)

FOCUS 2

69.0% TEFLARO

(58/84)

61.4% Ceftriaxone 0

(51/83) 20

40

60

80

100

Clinical response, % (n/N)

Neither trial established that TEFLARO was statistically superior to ceftriaxone in terms of clinical response rates.

Figure 1. Clinical responses at Day 4.* Patients with known or suspected MRSA were excluded from both trials. * Performed in the mITT population, which contained only subjects with a confirmed bacterial pathogen at baseline.

CABP, community-acquired bacterial pneumonia; CI, confidence interval; FOCUS, Ceftaroline Community-Acquired Pneumonia Trial vs Ceftriaxone in Hospitalized Patients; mITT, microbiological intent-to-treat; MRSA, methicillin-resistant Staphylococcus aureus Based on reference 13.

IMPORTANT SAFETY INFORMATION (continued) Hypersensitivity Reactions (continued) (anaphylactic) reactions require emergency treatment with epinephrine and other emergency measures that may include airway management, oxygen, intravenous fluids, antihistamines, corticosteroids, and vasopressors as clinically indicated.

Clostridium difficile-associated Diarrhea • Clostridium difficile-associated diarrhea (CDAD) has been reported for nearly all systemic antibacterial agents, including TEFLARO, and may range in severity from mild diarrhea to fatal colitis. Careful medical history is necessary because CDAD has been reported to occur more than 2 months after the administration of antibacterial agents. If CDAD is

suspected or confirmed, antibacterials not directed against C. difficile should be discontinued, if possible.

Direct Coombs’ Test Seroconversion • Seroconversion from a negative to a positive direct Coombs’ test result occurred in 120/1114 (10.8%) of patients receiving TEFLARO and 49/1116 (4.4%) of patients receiving comparator drugs in the four pooled Phase 3 trials. No adverse reactions representing hemolytic anemia were reported in any treatment group. If anemia develops during or after treatment with TEFLARO, drug-induced hemolytic anemia should be considered. If drug-induced hemolytic anemia is suspected, discontinuation of TEFLARO should be considered and supportive care should be administered to the patient if clinically indicated.

Please see additional Important Safety Information throughout and brief summary of Prescribing Information on page 8.

3

REPORT There are insufficient historical data to establish the magnitude of drug effect for antibacterial drugs compared with placebo at a TOC time point. Therefore, comparisons of TEFLARO ( ceftaroline fosamil) to ceftriaxone based on clinical response rates at TOC cannot be utilized to establish noninferiority.

An integrated analysis of the FOCUS studies investigated clinical cure rates for the common etiologies of CABP in the microbiologically evaluable (ME) population, which was comprised of all patients in the CE group who had at least 1 typical bacterial pathogen identified at baseline from an appropriate

microbiological specimen (eg, blood, sputum, or pleural fluid).

At the TOC, select pathogen-specific clinical cure rates for TEFLARO and ceftriaxone were: S. pneumoniae (85.7% vs 69.5%, respectively), S. aureus (MSSA; 72% vs 56%, respectively), H. influenzae (83.3% vs 85%, respectively), K. pneumoniae (100% vs 83.3%, respectively), K. oxytoca (83.3% vs 87.5%, respectively), and E. coli (83.3% vs 75%, respectively; Table).13 Patients with confirmed or suspected CABP caused by methicillin-resistant S. aureus (MRSA) were excluded from the FOCUS studies because ceftriaxone has no activity

TEFLARO (ceftaroline fosamil) Demonstrated Efficacy at TOC (CE) in Community-Acquired Bacterial Pneumonia

CABP

Treatment Difference 8.4 (95% CI: 1.4, 15.4)

FOCUS 1

86.6% TEFLARO

(194/224)

78.2% Ceftriaxone

(183/234)

Treatment Difference 5.2 (95% CI: –2.2, 12.8)

FOCUS 2

82.3% TEFLARO

(191/232)

77.1% Ceftriaxone 0

(165/214) 20

40

60

80

100

Clinical response, % (n/N)

Neither trial established that TEFLARO was statistically superior to ceftriaxone in terms of clinical response rates.

Figure 2. Clinical cure rates at TOC.* Patients with known or suspected MRSA were excluded from both trials. * There are insufficient historical data to establish the magnitude of drug effect for antibacterial drugs compared with placebo at a TOC time point. Therefore, comparisons of TEFLARO to ceftriaxone based on clinical response rates at TOC cannot be utilized to establish noninferiority.

CABP, community-acquired bacterial pneumonia; CE, clinically evaluable; CI, confidence interval; FOCUS, Ceftaroline Community-Acquired Pneumonia Trial vs Ceftriaxone in Hospitalized Patients; MRSA, methicillin-resistant Staphylococcus aureus; TOC, test of cure Based on reference 13.

IMPORTANT SAFETY INFORMATION (continued) Development of Drug-Resistant Bacteria

Adverse Reactions

• Prescribing TEFLARO in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

• In the four pooled Phase 3 clinical trials, serious adverse events occurred in 98/1300 (7.5%) of patients receiving TEFLARO and 100/1297 (7.7%) of patients receiving comparator drugs. Treatment discontinuation due to adverse events occurred in 35/1300 (2.7%) of patients receiving TEFLARO and 48/1297 (3.7%) of patients receiving comparator drugs with the most common adverse events leading to discontinuation being hypersensitivity for both treatment groups at a rate of 0.3% in the TEFLARO group and 0.5% in the comparator group.

Drug Interactions • No clinical drug-drug interaction studies have been conducted with TEFLARO. There is minimal potential for drug-drug interactions between TEFLARO and CYP450 substrates, inhibitors, or inducers; drugs known to undergo active renal secretion; and drugs that may alter renal blood flow.

4

• No adverse reactions occurred in greater than 5% of patients receiving TEFLARO. The most common adverse

Please see additional Important Safety Information throughout and brief summary of Prescribing Information on page 8.

REPORT against this pathogen. Neither trial established that TEFLARO ( ceftaroline fosamil) was statistically superior to ceftriaxone in terms of clinical response rates.

Clinical Use Based on the clinical responses at Day 4 of therapy, the FDA subsequently approved TEFLARO for the treatment of CABP

caused by susceptible isolates of S. pneumoniae (including cases with concurrent bacteremia), S. aureus (MSSA only), H. influenzae, K. pneumoniae, K. oxytoca, and E. coli in adults aged 18 years and older.13 The recommended dose for CABP is 600 mg every 12 hours by IV infusion administered over 1 hour (adjusted as necessary for patients with renal impairment).13 In January 2012, TEFLARO was officially added to the

Table. Clinical Cure Rates by Pathogen TEFLARO (ceftaroline fosamil) Demonstrated Clinical Cure Rates at TOC a Across a Broad Range of Gram-positive and Gram-negative Pathogens

CABP Pathogen

Pooled clinical cure rates in ME patients, % (n/N) TEFLARO

Ceftriaxone

S. pneumoniae

85.7 (54/63)

69.5 (41/59)

S. aureus (MSSA) b

72.0 (18/25)

56.0 (14/25)

H. influenzae

83.3 (15/18)

85.0 (17/20)

Gram-positive

Gram-negative

K. pneumoniae

100.0 (12/12)

83.3 (10/12)

K. oxytoca

83.3 (5/6)

87.5 (7/8)

E. coli

83.3 (10/12)

75.0 (9/12)

Neither trial established that TEFLARO was statistically superior to ceftriaxone in terms of clinical response rates. a

There are insufficient historical data to establish the magnitude of drug effect for antibacterial drugs compared with placebo at a TOC time point. Therefore, comparisons of TEFLARO to ceftriaxone based on clinical response rates at TOC cannot be utilized to establish noninferiority. b

Clinical efficacy of TEFLARO in treating CABP due to methicillin-resistant S. aureus has not been studied.

CABP, community-acquired bacterial pneumonia; ME, microbiologically evaluable; MSSA, methicillin-susceptible S. aureus; TOC, test of cure Based on reference 13.

IMPORTANT SAFETY INFORMATION (continued) Adverse Reactions (continued) reactions occurring in >2% of patients receiving TEFLARO in the pooled Phase 3 clinical trials were diarrhea, nausea, and rash.

Use in Specific Populations • TEFLARO has not been studied in pregnant women.

Therefore, TEFLARO should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus.

• It is not known whether ceftaroline is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when TEFLARO is administered to a nursing woman.

• Safety and effectiveness in pediatric patients have not been established.

• Because elderly patients, those ≥65 years of age, are more likely to have decreased renal function and ceftaroline is excreted primarily by the kidney, care should be taken in dose selection in this age group and it may be useful to monitor renal function. Dosage adjustment for elderly patients should therefore be based on renal function.

• Dosage adjustment is required in patients with moderate (CrCl >30 to ≤50 mL/min) or severe (CrCl ≥15 to ≤30 mL/ min) renal impairment and in patients with end-stage renal disease (CrCl <15 mL/min).

• The pharmacokinetics of ceftaroline in patients with hepatic impairment have not been established.

Please see additional Important Safety Information throughout and brief summary of Prescribing Information on page 8.

5

REPORT Specifications Manual for National Hospital Inpatient Quality Measures as a recommended β-lactam antibiotic for community-acquired in immunocompetent, non-ICU patients.14 Please see Important Safety Information for TEFLARO ( ceftaroline fosamil) below and on previous pages. Please also see accompanying brief summary of the Prescribing Information on page 8.

Conclusion TEFLARO was shown to be effective for the treatment of CABP due to designated susceptible bacteria. Additionally, its broad-spectrum activity makes it a viable option for patients presenting to the emergency room or hospital.

IMPORTANT SAFETY INFORMATION Contraindications • TEFLARO is contraindicated in patients with known serious hypersensitivity to ceftaroline or other members of the cephalosporin class. Anaphylaxis and anaphylactoid reactions have been reported with ceftaroline.

Warnings and Precautions Hypersensitivity Reactions • Serious and occasionally fatal hypersensitivity (anaphylactic) reactions and serious skin reactions have been reported with beta-lactam antibacterials. Before therapy with TEFLARO is instituted, careful inquiry about previous hypersensitivity reactions to other cephalosporins, penicillins, or carbapenems should be made. If this product is to be given to a penicillin- or other beta-lactam-allergic patient, caution should be exercised because cross sensitivity among beta-lactam antibacterial agents has been clearly established.

• If an allergic reaction to TEFLARO occurs, the drug should be discontinued. Serious acute hypersensitivity (anaphylactic) reactions require emergency treatment with epinephrine and other emergency measures that may include airway management, oxygen, intravenous fluids, antihistamines, corticosteroids, and vasopressors as clinically indicated.

Clostridium difficile-associated Diarrhea • Clostridium difficile-associated diarrhea (CDAD) has been reported for nearly all systemic antibacterial agents, including TEFLARO, and may range in severity from mild diarrhea to fatal colitis. Careful medical history is necessary because CDAD has been reported to occur more than 2 months after the administration of antibacterial agents. If CDAD is suspected or confirmed, antibacterials not directed against C. difficile should be discontinued, if possible.

Direct Coombs’ Test Seroconversion • Seroconversion from a negative to a positive direct Coombs’ test result occurred in 120/1114 (10.8%) of patients receiving TEFLARO and 49/1116 (4.4%) of patients receiving comparator drugs in the four pooled Phase 3 trials. No adverse reactions representing hemolytic anemia were reported in any treatment group. If anemia develops during or after

6

treatment with TEFLARO, drug-induced hemolytic anemia should be considered. If drug-induced hemolytic anemia is suspected, discontinuation of TEFLARO should be considered and supportive care should be administered to the patient if clinically indicated.

Development of Drug-Resistant Bacteria • Prescribing TEFLARO in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Adverse Reactions • In the four pooled Phase 3 clinical trials, serious adverse events occurred in 98/1300 (7.5%) of patients receiving TEFLARO and 100/1297 (7.7%) of patients receiving comparator drugs. Treatment discontinuation due to adverse events occurred in 35/1300 (2.7%) of patients receiving TEFLARO and 48/1297 (3.7%) of patients receiving comparator drugs with the most common adverse events leading to discontinuation being hypersensitivity for both treatment groups at a rate of 0.3% in the TEFLARO group and 0.5% in the comparator group.

• No adverse reactions occurred in greater than 5% of patients receiving TEFLARO. The most common adverse reactions occurring in >2% of patients receiving TEFLARO in the pooled Phase 3 clinical trials were diarrhea, nausea, and rash.

Drug Interactions • No clinical drug-drug interaction studies have been conducted with TEFLARO. There is minimal potential for drugdrug interactions between TEFLARO and CYP450 substrates, inhibitors, or inducers; drugs known to undergo active renal secretion; and drugs that may alter renal blood flow.

Use in Specific Populations • TEFLARO has not been studied in pregnant women. Therefore, TEFLARO should only be used during pregnancy if the potential benefit justifies the potential risk to the fetus.

• It is not known whether ceftaroline is excreted in human milk.

Because many drugs are excreted in human milk, caution should be exercised when TEFLARO is administered to a nursing woman.

• Safety and effectiveness in pediatric patients have not been established.

• Because elderly patients, those ≥65 years of age, are more likely to have decreased renal function and ceftaroline is excreted primarily by the kidney, care should be taken in dose selection in this age group and it may be useful to monitor renal function. Dosage adjustment for elderly patients should therefore be based on renal function.

• Dosage adjustment is required in patients with moderate (CrCl >30 to ≤50 mL/min) or severe (CrCl ≥15 to ≤30 mL/ min) renal impairment and in patients with end-stage renal disease (CrCl <15 mL/min).

• The pharmacokinetics of ceftaroline in patients with hepatic impairment have not been established.

Please see additional Important Safety Information throughout and brief summary of Prescribing Information on page 8.

REPORT References 1.

Brar NK, et al. Management of community-acquired pneumonia: a review and update. Ther Adv Respir Dis. 2011;5(1):61-78.

2.

File TM, et al. Burden of community-acquired pneumonia in North American adults. Postgrad Med. 2010;122(2):130-141.

9.

Pilishvili T, et al. Sustained reductions in invasive pneumococcal disease in the era of conjugate vaccine. J Infect Dis. 2010;201(1):32-41.

10. Brugger SD, et al. Multiple colonization with S. pneumoniae before and after introduction of the seven-valent conjugated pneumococcal polysaccharide vaccine. PLoS One. 2010;5(7):e11638.

3.

DeFrances CJ, et al. 2006 National Hospital Discharge Survey.

Nat Health Stat Rep. 2008;5:1-20.

4.

Kochanek KD, et al. Deaths: final data for 2009. Nat Vital Stat Rep. 2011;60(3):1-167.

5.

Echols RM, et al. Clinical trial design for mild-to-moderate community-acquired pneumonia—an industry perspective.

Clin Infect Dis. 2008;47(suppl 3):S166-S175.

6.

Mandell LA, et al. Infectious Diseases Society of America/American Thoracic Society consensus guidelines on the management of community-acquired pneumonia in adults. Clin Infect Dis. 2007;44(suppl 2):S27-S72.

12. File TM Jr, et al. Integrated analysis of FOCUS 1 and FOCUS 2: randomized, doubled-blinded, multicenter phase 3 trials of the efficacy and safety of ceftaroline fosamil versus ceftriaxone in patients with community-acquired pneumonia. Clin Infect Dis. 2010;51(12):1395-1405.

7.

Johnsborg O, et al. Regulation of natural genetic transformation and acquisition of transforming DNA in Streptococcus pneumoniae. FEMS Microbiol Rev. 2009;33(3):627-642.

13. TEFLARO (ceftaroline fosamil) [prescribing information].

St. Louis, MO: Forest Laboratories, Inc.; 2012.

8.

Brueggmann AB, et al. Vaccine escape recombinants emerge after pneumococcal vaccination in the United States. PLoS Pathog. 2007;3(11):1628-1636.

11. Jones RN, et al. Update on antimicrobial susceptibility trends among Streptococcus pneumoniae in the United States: report of ceftaroline activity from the SENTRY Antimicrobial Surveillance Program (1998-2011). Diagn Microbiol Infect Dis. 2013;75(1):107-109.

14. Specifications Manual for National Inpatient Quality Measures, version 4.0. http://www.jointcommission.org/assets/1/6/ SpecsManual4.0PDF.zip. Accessed February 1, 2013.

Acknowledgments Financial support: This article was sponsored by Forest Laboratories, Inc (“Forest”). Dr. Low is a paid consultant for Forest and received funding for his participation.

Disclaimer: This monograph is designed to be a summary of information. While it is detailed, it is not an exhaustive clinical review. McMahon Publishing, Forest Laboratories, Inc., and the authors neither affirm nor deny the accuracy of the information contained herein. No liability will be assumed for the use of this monograph, and the absence of typographical errors is not guaranteed. Readers are strongly urged to consult any relevant primary literature.

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Please see additional Important Safety Information throughout and brief summary of Prescribing Information on page 8.

SR1314

Copyright © 2013, McMahon Publishing, 545 West 45th Street, New York, NY 10036. Printed in the USA. All rights reserved, including the right of reproduction, in whole or in part, in any form.

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REPORT TEFLARO® (ceftaroline fosamil) injection for intravenous (IV) use Rx Only Brief Summary of full Prescribing Information Initial U.S. Approval: 2010 INDICATIONS AND USAGE: Teflaro® (ceftaroline fosamil) is indicated for the treatment of patients with the following infections caused by susceptible isolates of the designated microorganisms. Acute Bacterial Skin and Skin Structure Infections - Teflaro is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following Gram-positive and Gram-negative microorganisms: Staphylococcus aureus (including methicillin-susceptible and -resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Escherichia coli, Klebsiella pneumoniae, and Klebsiella oxytoca. Community-Acquired Bacterial Pneumonia - Teflaro is indicated for the treatment of community-acquired bacterial pneumonia (CABP) caused by susceptible isolates of the following Gram-positive and Gram-negative microorganisms: Streptococcus pneumoniae (including cases with concurrent bacteremia), Staphylococcus aureus (methicillin-susceptible isolates only), Haemophilus influenzae, Klebsiella pneumoniae, Klebsiella oxytoca, and Escherichia coli. Usage - To reduce the development of drug-resistant bacteria and maintain the effectiveness of Teflaro and other antibacterial drugs, Teflaro should be used to treat only ABSSSI or CABP that are proven or strongly suspected to be caused by susceptible bacteria.

Appropriate specimens for microbiological examination should be obtained in order to isolate and identify the causative pathogens and to determine their susceptibility to ceftaroline. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

CONTRAINDICATIONS: Teflaro is contraindicated in patients with known serious hypersensitivity to ceftaroline or other members of the cephalosporin class. Anaphylaxis and anaphylactoid reactions have been reported with ceftaroline.

WARNINGS AND PRECAUTIONS: Hypersensitivity Reactions - Serious and occasionally fatal hypersensitivity (anaphylactic) reactions and serious skin reactions have been reported in patients receiving beta-lactam antibacterials. Before therapy with Teflaro is instituted, careful inquiry about previous hypersensitivity reactions to other cephalosporins, penicillins, or carbapenems should be made. If this product is to be given to a penicillin- or other betalactam-allergic patient, caution should be exercised because cross sensitivity among betalactam antibacterial agents has been clearly established. If an allergic reaction to Teflaro occurs, the drug should be discontinued. Serious acute hypersensitivity (anaphylactic) reactions require emergency treatment with epinephrine and other emergency measures, that may include airway management, oxygen, intravenous fluids, antihistamines, corticosteroids, and vasopressors as clinically indicated. Clostridium difficile-associated Diarrhea - Clostridium difficile-associated diarrhea (CDAD) has been reported for nearly all systemic antibacterial agents, including Teflaro, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of C. difficile. C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin-producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary because CDAD has been reported to occur more than 2 months after the administration of antibacterial agents. If CDAD is suspected or confirmed, antibacterials not directed against C. difficile should be discontinued, if possible. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated [see Adverse Reactions]. Direct Coombs’ Test Seroconversion - Seroconversion from a negative to a positive direct Coombs’ test result occurred in 120/1114 (10.8%) of patients receiving Teflaro and 49/1116 (4.4%) of patients receiving comparator drugs in the four pooled Phase 3 trials. In the pooled Phase 3 CABP trials, 51/520 (9.8%) of Teflaro-treated patients compared to 24/534 (4.5%) of ceftriaxonetreated patients seroconverted from a negative to a positive direct Coombs’ test result.

No adverse reactions representing hemolytic anemia were reported in any treatment group.

If anemia develops during or after treatment with Teflaro, drug-induced hemolytic anemia should be considered. Diagnostic studies including a direct Coombs’ test, should be performed. If druginduced hemolytic anemia is suspected, discontinuation of Teflaro should be considered and supportive care should be administered to the patient (i.e. transfusion) if clinically indicated.

Development of Drug-Resistant Bacteria - Prescribing Teflaro in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

ADVERSE REACTIONS: The following serious events are described in greater detail in the Warnings and Precautions section: Hypersensitivity reactions; Clostridium difficile-associated diarrhea; Direct Coombs’ test seroconversion. Adverse Reactions from Clinical Trials Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be compared directly to rates from clinical trials of another drug and may not reflect rates observed in practice. Teflaro was evaluated in four controlled comparative Phase 3 clinical trials (two in ABSSSI and two in CABP) which included 1300 adult patients treated with Teflaro (600 mg administered by IV over 1 hour every 12h) and 1297 patients treated with comparator (vancomycin plus aztreonam or ceftriaxone) for a treatment period up to 21 days. The median age of patients treated with Teflaro was 54 years, ranging between 18 and 99 years old. Patients treated with Teflaro were predominantly male (63%) and Caucasian (82%). Serious Adverse Events and Adverse Events Leading to Discontinuation - In the four pooled Phase 3 clinical trials, serious adverse events occurred in 98/1300 (7.5%) of patients receiving Teflaro and 100/1297 (7.7%) of patients receiving comparator drugs. The most common SAEs in both the Teflaro and comparator treatment groups were in the respiratory and infection system organ classes (SOC). Treatment discontinuation due to adverse events occurred in 35/1300 (2.7%) of patients receiving Teflaro and 48/1297 (3.7%) of patients receiving comparator drugs with the most common adverse events leading to discontinuation being hypersensitivity for both treatment groups at a rate of 0.3% in the Teflaro group and 0.5% in comparator group. Most Common Adverse Reactions - No adverse reactions occurred in greater than 5% of patients receiving Teflaro. The most common adverse reactions occurring in > 2% of patients receiving Teflaro in the pooled phase 3 clinical

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trials were diarrhea, nausea, and rash. Table 4 in the full prescribing information lists adverse reactions occurring in ≥ 2% of patients receiving Teflaro in the pooled Phase 3 clinical trials (two in ABSSSI and two in CABP). The first value displays the percentage of patients in the pooled Teflaro trials (N=1300) and the second shows the percentage in the Pooled Comparatorsa trials (N=1297). Gastrointestinal disorders: Diarrhea (5%, 3%), Nausea (4%, 4%), Constipation (2%, 2%), Vomiting (2%, 2%); Investigations: Increased transaminases (2%, 3%); Metabolism and nutrition disorders: Hypokalemia (2%, 3%); Skin and subcutaneous tissue disorders: Rash (3%, 2%); Vascular disorders: Phlebitis (2%, 1%) a Comparators included vancomycin 1 gram IV every 12h plus aztreonam 1 gram IV every 12h in the Phase 3 ABSSSI trials, and ceftriaxone 1 gram IV every 24h in the Phase 3 CABP trials.

Other Adverse Reactions Observed During Clinical Trials of Teflaro - Following is a list of additional adverse reactions reported by the 1740 patients who received Teflaro in any clinical trial with incidences less than 2%. Events are categorized by System Organ Class. Blood and lymphatic system disorders - Anemia, Eosinophilia, Neutropenia, Thrombocytopenia; Cardiac disorders - Bradycardia, Palpitations; Gastrointestinal disorders - Abdominal pain; General disorders and administration site conditions - Pyrexia; Hepatobiliary disorders - Hepatitis; Immune system disorders - Hypersensitivity, Anaphylaxis; Infections and infestations Clostridium difficile colitis; Metabolism and nutrition disorders - Hyperglycemia, Hyperkalemia; Nervous system disorders - Dizziness, Convulsion; Renal and urinary disorders - Renal failure; Skin and subcutaneous tissue disorders - Urticaria.

DRUG INTERACTIONS: No clinical drug-drug interaction studies have been conducted with Teflaro. There is minimal potential for drug-drug interactions between Teflaro and CYP450 substrates, inhibitors, or inducers; drugs known to undergo active renal secretion; and drugs that may alter renal blood flow [see Clinical Pharmacology in the full prescribing information].

USE IN SPECIFIC POPULATIONS: Pregnancy Category B. - Developmental toxicity studies performed with ceftaroline fosamil in rats at IV doses up to 300 mg/kg demonstrated no maternal toxicity and no effects on the fetus. A separate toxicokinetic study showed that ceftaroline exposure in rats (based on AUC) at this dose level was approximately 8 times the exposure in humans given 600 mg every 12 hours. There were no drug-induced malformations in the offspring of rabbits given IV doses of 25, 50, and 100 mg/kg, despite maternal toxicity.

Signs of maternal toxicity appeared secondary to the sensitivity of the rabbit gastrointestinal system to broad-spectrum antibacterials and included changes in fecal output in all groups and dose-related reductions in body weight gain and food consumption at ≥ 50 mg/kg; these were associated with an increase in spontaneous abortion at 50 and 100 mg/kg. The highest dose was also associated with maternal moribundity and mortality. An increased incidence of a common rabbit skeletal variation, angulated hyoid alae, was also observed at the maternally toxic doses of 50 and 100 mg/kg. A separate toxicokinetic study showed that ceftaroline exposure in rabbits (based on AUC) was approximately 0.8 times the exposure in humans given 600 mg every 12 hours at 25 mg/kg and 1.5 times the human exposure at 50 mg/kg. Ceftaroline fosamil did not affect the postnatal development or reproductive performance of the offspring of rats given IV doses up to 450 mg/kg/day. Results from a toxicokinetic study conducted in pregnant rats with doses up to 300 mg/kg suggest that exposure was ≥ 8 times the exposure in humans given 600 mg every 12 hours. There are no adequate and well-controlled trials in pregnant women. Teflaro should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nursing Mothers - It is not known whether ceftaroline is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Teflaro is administered to a nursing woman. Pediatric Use - Safety and effectiveness in pediatric patients have not been established. Geriatric Use - Of the 1300 patients treated with Teflaro in the Phase 3 ABSSSI and CABP trials, 397 (30.5%) were ≥ 65 years of age. The clinical cure rates in the Teflaro group (Clinically Evaluable [CE] Population) were similar in patients ≥ 65 years of age compared with patients < 65 years of age in both the ABSSSI and CABP trials. The adverse event profiles in patients ≥ 65 years of age and in patients < 65 years of age were similar. The percentage of patients in the Teflaro group who had at least one adverse event was 52.4% in patients ≥ 65 years of age and 42.8% in patients < 65 years of age for the two indications combined. Ceftaroline is excreted primarily by the kidney, and the risk of adverse reactions may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection in this age group and it may be useful to monitor renal function. Elderly subjects had greater ceftaroline exposure relative to non-elderly subjects when administered the same single dose of Teflaro.

However, higher exposure in elderly subjects was mainly attributed to age-related changes in renal function. Dosage adjustment for elderly patients should be based on renal function [see Dosage and Administration and Clinical Pharmacology in the full prescribing information].

Patients with Renal Impairment - Dosage adjustment is required in patients with moderate (CrCl > 30 to ≤ 50 mL/min) or severe (CrCl ≥ 15 to ≤ 30 mL/min) renal impairment and in patients with end-stage renal disease (ESRD – defined as CrCl < 15 mL/min), including patients on hemodialysis (HD) [see Dosage and Administration and Clinical Pharmacology in the full prescribing information].

OVERDOSAGE: In the event of overdose, Teflaro should be discontinued and general supportive treatment given. Ceftaroline can be removed by hemodialysis. In subjects with ESRD administered 400 mg of Teflaro, the mean total recovery of ceftaroline in the dialysate following a 4-hour hemodialysis session started 4 hours after dosing was 76.5 mg (21.6% of the dose). However, no information is available on the use of hemodialysis to treat overdosage [see Clinical Pharmacology in the full prescribing information].

Distributed by: Forest Pharmaceuticals, Inc. Subsidiary of Forest Laboratories, Inc. St. Louis, MO 63045, USA Teflaro® is a registered trademark of Forest Laboratories, Inc. IF95USCFR06 Revised: October 2012 © 2010-2012 Forest Laboratories, Inc. All rights reserved.

Please also see full Prescribing Information at www.teflaro.com.

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