November 2013

The American Society for Metabolic and Bariatric Surgery (Obesity Week)

CONVENTION ISSUE:

GENERALSURGERYNEWS.COM

November 2013 • Volume 40 • Number 11

The Independent Monthly Newspaper for the General Surgeon

Opinion

Denial, Depression And Health Care [Editor’s note: In Part 1 of this series (October 2013, page 1), Dr. Ramshaw discussed complexity science as applied to patient care. Here he continues with a discussion on how denial can impede improvements.]

Medical Tourism: Rewards Not Without Risks GSN N Reporter Travels to Mexico To Speak With a Patient About Bariatric Surgery Gone Bad, and the Doctors Who Saved His Life

F

see DENIAL page 28

PROCEDURAL BREAKTHROUGH Laparoscopic Suturing Using the Covidien V-Loc™ Wound Closure Reload For the Endo Stitch™ and SILS™ Stitch Suturing Devices see page 6

B Y G ABRIEL M ILLER JUAREZ, MEXICO—Before he lost his life savings; before he spent a month in the ICU and a year in and out of the hospital; before he was wheeled, in septic shock and on a ventilator, across the bridge at the U.S.–Mexico border; before all of this happened, in early 2008 Jose Sanchez decided to have his bariatric surgery in Ciudad Juarez, Mexico, and not in El Paso, Texas, where he’d been living since he was 15.

“All throughout my life, I’ve been taking care of my health issues with

INSIDE GSN is now on ISSUES FOR THE BARIATRIC & METABOLIC PROFESSIONAL

Extended Quarterly Coverage

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Debating the Gastric Band and Need for Centers of Excellence

Falls a Rising Trend in TraumaRelated Fatalities B Y C HRISTINA F RANGOU

T

B Y B RUCE R AMSHAW , MD rancis Winslow Taylor is considered one of the earliest and best-known management consultants. He described a strategy known as “scientific management,” which was also the title of his book published in 1911. The basic principles include one in which the worker should be supervised by managers who oversee specific tasks based on rules and productivity targets. Managers measured tasks, and the worker was paid more for higher productivity targets.

Sound familiar?

As one might expect, overall productivity tended to improve initially, but over time, many problems developed between the workers and management, eventually leading to poorer working conditions and

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doctors over there. To me, there was nothing to it. So when the decision was made to get the surgery done, I figured you know, why not?

Just research doctors and try to find a good one. It should work like it’s worked all my life, right? Unfortunately, it didn’t quite work that way.”

There is no accurate count of the number of patients from the United States who travel abroad for bariatric surgery, but the number is almost certainly rising. In terms of overall see MEDICAL TOURISM page 22

rauma centers in the United States are experiencing a major shift in the most common causes of trauma-related fatalities—changes that may necessitate new strategies for trauma prevention and treatment, according to experts.

A new study showed that, if current trends continue, falls would soon account for more deaths than either motor vehicle collisions or firearms.

“This fact poses an interesting public health challenge, namely, preventing falls in the elderly,” said Christopher C. Baker, MD, chair of surgery at the Carilion Clinic in Roanoke, Va. He was the official discussant of the paper when it was presented at the opening session of the 2013 annual meeting of the American Association for the Surgery of Trauma (AAST).

The study showed that, since 2002, deaths due to motor vehicle collisions have declined by 27% due to improvements in car safety, public see TRAUMA TRENDS page 30

REPORT Techniques for Using Biologic Mesh in Hernia Repair: Clinical Experience With VERITAS Collagen Matrix See insert at page 16

GSN Editorial

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / NOVEMBER 2013

Hospital Employment: Look Before You Leap Frederick L. Greene, MD, FACS Clinical Professor of Surgery UNC School of Medicine Chapel Hill, North Carolina

It should not be surprising that in this era of shaky economic growth, funding sequestration, Congressional discord over the Affordable Care Act (ACA) and government closings, a majority of acute care hospitals are facing a precarious future with the specter that many will be downsized or not survive at all.

Many institutions have taken drastic steps to reduce their budgetary shortfall by cutting payrolls through layoffs of physician and nonphysician personnel alike. Falling insurance payments and reduced inpatient visits, specifically caused by reductions in elective surgical procedures, have triggered these events.

So far in 2013, health care institutions have reported more than 41,000 layoffs, exceeded only by personnel reductions in the financial and industrial sectors.

Even with the presumed positive

effect of the ACA that launched on Oct. 1—creating opportunities for increased coverage for at least 30 million uninsured Americans—the negative effects of a poor economy and reduced payments by programs such as Medicare and Medicaid serve to add to an already shaky hospital-based economy. Increased layoffs will continue until some economic upturn is noted. These layoffs will affect all segments of health care workers.

There are several major factors at play that create economic uncertainty for hospital solvency: • The Centers for Medicare & Medicaid Services and private insurers are restricting hospital reimbursement.

The creation of funding sequestration by legislative fiat has reduced Medicare reimbursement by 2%.

• Using benchmarks of quality care including hospital readmission rates, a number of hospitals have already witnessed and will be targeted for more reduction in Medicare payments.

• Research dollars aimed at academic

centers have been reduced by 5% as a byproduct of sequestration, resulting in the layoff of those supporting research efforts.

• The overall number of inpatient hospital days fell by 4% between 2007 and 2011 as a result of the economic downturn and reduced numbers of elective surgical procedures.

• With increased numbers of “baby boomers,” a greater segment of the population consuming health care is being reimbursed at Medicare rates, which are lower than private insurance.

• Hospitals depending on Medicare and Medicaid dollars for support of physicians-in-training (disproportionate share funding) will be especially at risk because this traditional economic support is slated to end or to be severely limited in the very near future. This will especially weaken “safety net hospitals” that depend on residents to provide a significant portion of patient care.

These negative factors should be of

Hospital-employed physicians are not immune to the economic exigencies that institutions are facing. particular concern for surgeons who already have joined or are considering becoming employees of hospitals.

Hospital-employed physicians are not immune to the economic exigencies that institutions are facing. All physicians need to understand the factors that are negatively affecting the hospital margin.

My concern is there will continue to be a continuous erosion of hospital finances despite the strong lobbying activity of physicians and hospital associations.

Surgeons contemplating employment by hospitals need to be acutely aware of these factors and at least should be able to ask the right questions during contractual discussions and be capable of understanding the metrics that represent the bellwethers of hospital economics and success.

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In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / NOVEMBER 2013

Playing Devil’s Advocate for Medication Over Surgery for GERD B Y M ONICA J. S MITH BALTIMORE—Tasked with creating a lecture for the American Society of Gastrointestinal and Endoscopic Surgeons (SAGES) to fit the title, “PPIs Are Just as Good as Anti-reflux Surgery for GERD,” Christy M. Dunst, MD, needed to set aside her prosurgery bias.

“It was a good opportunity to really review the literature with an antisurgical point of view,” said Dr. Dunst, an esophageal surgeon with the Oregon Clinic and director of research and education at the clinic’s Division of Gastrointestinal Minimally Invasive Surgery.

“Overall, I do agree that medical management is an effective treatment for garden-variety reflux disease for patients who respond well to it,” Dr. Dunst said. “But for the patients who don’t respond, we need to do a better job.”

An estimated 19 million Americans suffer from gastroesophageal reflux disease (GERD), which is the most common gastrointestinal diagnosis leading to a doctor visit. In 2010, more than 53 million prescriptions for omeprazole

were filled and $6.3 billion was spent on Nexium alone. Despite the scope of the problem, however, only 1% of sufferers receive surgical treatment.

Why is that? The prevailing attitude is that proton pump inhibitors (PPIs) are just as good as surgery but with fewer side effects, as demonstrated by the findings of the LOTUS (LongTerm Usage of Esomeprazole vs Surgery for Treatment of Chronic GERD) trial, funded by AstraZeneca, in which 554 reflux patients were randomized to laparoscopic Nissen fundoplication or medical therapy with ezomeprazole ( (JAMA A 2011;305:1969-1977).

“Both groups had excellent control of heartburn,” Dr. Dunst said. “Overall, remission rates of GERD for both groups was excellent, and it approaches significance favoring PPIs at five years.”

The catch is that all 554 participants in the LOTUS trial were complete responders to PPIs to begin with.

So what happens to the estimated 30% to 60% of PPI users who do not achieve remission of symptoms with medication?

One study found that 28% of the patients seeking alternative treatment for

A “credible” alternative. The LINX® System is designed to keep the lower esophageal sphincter closed. The system expands temporarily to allow food and liquid to pass.

GERD technically did not have reflux ((J Gastrointest Surgg 2006;10:787-796).

“They have normal bile exposure, normal acid exposure and normal EGD [esophagogastroduodenoscopy],” Dr. Dunst said. “If you apply that number to [previous data], we can estimate about 12% of dissatisfied GERD patients don’t have GERD. But that leaves 33% of 19 million patients unhappy. Why

aren’t they responding?”

The literature reveals a number of reasons, the biggest being lack of compliance or inadequate suppression.

“But the more likely reason is that refractory patients have more severe or complicated disease such as longer duration of symptoms, persistent regurgitation, hiatal hernia, obesity, motility disorders (esophageal or gastric) or

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GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / NOVEMBER 2013

atypical symptoms,” Dr. Dunst said.

Surgical treatment is an option for patients who don’t take their PPI or who can’t gain control of their symptoms with one, but according to the current American College of Gastroenterology (ACG) guidelines for management of refractory GERD, the first step for these patients is to give them more medicine.

Extrapolating from studies looking at the composition of reflux, more than half of dissatisfied PPI users have a non-acid component of reflux.

“You can add more medicine if you want, but it’s unlikely to do anything for this group of patients,” Dr. Dunst said.

“PPI therapy does not change the number of reflux episodes; it just neutralizes the acid.”

Surgery, in contrast, does appear to help these patients. A recent study of patients with refractory GERD—those with persistent regurgitation or heartburn, a positive symptom score, abnormal pH or abnormal impedance while taking a PPI—showed satisfactory results with laparoscopic Nissen. At three years after surgery, 89% of the 38 patients were in complete remission (Surg Endosc 2013;27:2940-2946).

The ACG pointed out that this was an uncontrolled trial and that it included only carefully selected participants; the ACG does not recommend this approach “except in highly individual circumstances” (Am ( J Gastroenteroll 2013;108:308328). Dr. Dunst agrees with the ACG that the little data available covers only carefully selected patients.

“Nonresponders are a heterogeneous group and definitely demand a comprehensive workup to determine if rebuilding their antireflux barrier is going to work,” she said. “But they shouldn’t be tossed aside just because medical management doesn’t work for them.”

The question, she said, really comes down to whether these patients are unhappy enough for antireflux surgery.

Fundoplication has well-documented side effects: flatulence, bloating, dysphagia and so on. But PPIs are not without risk either: Clostridium difficilee infection, community-acquired pneumonia, vitamin B12 deficiency, hip fracture and so forth.

Of course, obtaining a surgical solution requires knowing that such surgery exists.

“It’s well documented now that 45% to 50% of patients have significant symptoms despite their PPI, but the vast majority of patients never get told that there are alternatives to medication; their primary care doctor doesn’t tell them, their gastroenterologist doesn’t tell them,” said Jeffrey Peters, MD, professor of surgery and chair, Department of Surgery, University of Rochester Medical Center, Rochester, N.Y. “This is likely a history of how antireflux treatment evolved and various

schools of thought. Primary care doctors may never have been educated about the potential for reflux surgery, and gastroenterologists may have more of a resistance to it than is appropriate or necessary,” Dr. Peters said. “So there is a huge gap in patient information and understanding.

Not that surgery should be used [heedlessly], but it probably is underutilized.”

Increasingly, however, patients who aren’t getting satisfactory answers from their doctors are turning to the Internet for solutions. Over the past couple of years, Dr. Dunst has noticed an increase in the number of self-referrals who arrive

at her clinic, informed by online sources such as RefluxMD.com.

“Patients are getting frustrated, and they’re going to the Internet where there is increasingly more information being posted these days,” she said. “With the increased online presence of nonmedical options, the patients are learning, and I think that’s the way to go.”

Dr. Peters suggested the solution to better care for these patients boils down to the increasing recognition among primary care doctors and gastroenterologists that PPIs are not the cure they once were considered to be, and the presence

of better options.

“We need a good alternative that’s relatively straightforward and easy to produce; traditional antireflux is not, which is one of the reasons it hasn’t evolved to larger numbers,” he said. Although it’s too soon to tell, the LINX (Torax Medical, Inc.) system may open an avenue.

“The LINX is a credible alternative slowly percolating into the marketplace,” Dr. Peters said. “I wouldn’t say it’s experimental because there’s pretty good data that it works. The clinical information is just emerging as to the right patient population to use it in.”

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THE SCIENCE BEHIND POSITIVE PATIENT OUTCOMES

Laparoscopic Suturing Using the Covidien V-Loc™ Wound Closure Reload For the Endo Stitch™ and SILS™ Stitch Suturing Devices Dana Portenier, MD Assistant Professor of Surgery Duke University Medical Center Chief of General Surgery Durham Regional Hospital Program Director Duke University Minimally Invasive Bariatric Surgery Fellowship Durham, North Carolina

Introduction Although suturing is considered an essential skill for all surgeons, it can be quite cumbersome given the precision and dexterity needed when using conventional suturing techniques. The availability of new technologies, such as automated suturing, has eased the process of suturing tissues in laparoscopic and minimally invasive procedures.

The Covidien Endo Stitch™ automatic suturing device has made the process more efficient, while providing significant time savings. The recent introduction of the Covidien V-Loc™ wound closure reload simplifies suturing further by combining the automated needle-passing technology of the Endo Stitch™ device with secure, knotless, automated suturing for both intracorporeal and extracorporeal wound closures.

The V-Loc™ wound closure reload is compatible with the Endo Stitch™ 10 mm suturing device, the Endo Stitch™ short suturing device, and the SILS™ Stitch single-use suturing device. It is available with absorbable or permanent sutures with a barb and loop design that eliminates the need for knot tying while the circular shape packaging minimizes the memory needed to secure the position of the needle, further enhancing surgeons’ control over the procedure without requiring assistance (Figures 1 and 2). Using the V-Loc™ wound closure reload with the Endo Stitch™ device allows surgeons to close incisions faster and securely while containing costs.

keep the suture pulled up for you, so you can run a suture line without having anyone help you,” he said.

Using the V-Loc™ wound closure reload allows surgeons to maintain adequate tension, which can be challenging when using the Endo Stitch™ device alone. “With the Endo Stitch™ device, maintaining tension on the suture can be difficult, and the V-Loc™ wound closure reload overcomes that by maintaining its own tension with the barbs,” said Dr. Portenier, “[and takes] away the most difficult challenge a new surgeon has to overcome.”

The V-Loc™ wound closure reload may be particularly appealing to surgeons who perform single-site laparoscopic procedures. “The V-Loc™ wound closure reload may be

Figure 1. The Covidien V-Loc™ wound closure reload offers a barb and loop design that eliminates the need for knot tying in intracorporeal and extracorporeal wound closures.

Simplifying the Approach With the V-Loc™ Wound Closure Reload One of the main challenges in laparoscopic suturing is knot tying. By combining the one-handed automated needlepassing technology of the Endo Stitch™ device with the knotless suturing of the V-Loc™ wound closure reload for the Endo Stitch™ and SILS™ Stitch devices, the user can realize a number of benefits over hand suturing and conventional automated suturing options. The V-Loc™ wound closure reload possesses unidirectional shallow barbs that grasp the tissue at different points to spread the tension across the wound to provide a secure closure. Its welded loop design anchors it at the beginning of the incision line, thus eliminating the need for tying knots.

Acccording to Dana Portenier, MD, assistant professor of surgery at Duke University Medical Center, chief of general surgery at Durham Regional Hospital, and program director of Duke University’s Minimally Invasive and Bariatric Surgery Fellowship, the V-Loc™ wound closure reload gives the surgeon more control by eliminating the need for another set of hands to follow the surgeon’s suturing. “The barbs help

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GENERAL SURGERY NEWS • NOVEMBER 2013

especially worthwhile in those operations, where you don’t have as many hands to retract. When performing an advanced laparoscopic case with the single-incision approach, such as a gastric bypass, we used to have to come up with some very complicated maneuvers to maintain tension on the suture so that it wouldn’t loosen while we were sewing,” explained Dr. Portenier. “But the V-Loc™ wound closure reload really overcomes that. When you pull it up, the barbs pull through the tissue but can’t slide back, thus maintaining tension on the stitch.” Dr. Portenier also notes that the V-Loc™ wound closure reloads have a little memory which helps keep them out of the way while suturing.

Leveling the Learning Curve Although Dr. Portenier still includes freehand suturing in his practice and teaches it to fellows, he believes that the Endo Stitch™ device provides greater precision, visibility, and maneuverability. “Learning to sew with freehand suturing is one of the more difficult tasks in laparoscopic surgery, and being able to manipulate the needle well and place it precisely where you want it can be challenging for [surgeons], especially early on in their learning curves,” he said. “Just tying secure knots can be an issue. I think [the Endo Stitch™ device] offers great precision [and maneuverability] because in the bariatric realm, you’re fighting against the patient’s abdominal wall, and you never drop the needle. It’s always just between the jaws, so it loads up and is ready to go,” he explained.

The Endo Stitch™ device speeds the learning curve and helps surgeons at all levels get through suturing faster.

“Training individuals and trying to get them off to proficiency quickly, [I find] the Endo Stitch™ device provides significant development benefit over freehand suturing.”

With the availability of the V-Loc™ wound closure reload, Dr. Portenier has found that fellows benefit in further enhancing their suturing capabilities. “Based on my experience with [residents], they’ve been able to accomplish the task of closing enterotomies and mesenteric defects in a significantly faster manner using the V-Loc™ wound closure reload on the Endo Stitch™ device compared with just Endo Stitch™ device alone. I think it has made a significant difference in that regard,” he said.

Dr. Portenier suspects that even experienced surgeons will find benefit in using the V-Loc™ wound closure reload, since it eliminates knot tying and allows surgeons to maintain full control and continue to move quickly during the procedure.

“There’s a definite benefit to not having to tie, and not having to rely on a potentially inexperienced assistant to hold tension on your knot,” he said.

Clinical Evidence on Time Savings and Costs

Figure 2. The Endo Stitch™ endoscopic automated suturing device offers considerable suturing time savings in intracorporeal and extracorporeal knot tying.

Several studies investigating the use of the Endo Stitch™ device in various laparoscopic procedures have found that it can reduce laparoscopic suturing time by 45% to 70% compared with conventional suturing.1-4 An investigation of the V-Loc™ wound closure reload suggests its barb and loop design could further enhance time savings by eliminating the need to tie knots.5 In an early clinical review of the Endo Stitch™ suturing device and the V-Loc™ wound closure reload, Dr. Portenier and his colleagues compared in vivo efficacy of absorbable and nonabsorbable sutures with the barbed suturing device

Figure 3. The Covidien V-Loc™ wound closure reload can be used in procedures that require oversewing the staple line.

into the bowel and gastric pouch, creates a 2-cm anastomosis, and uses an absorbable V-Loc™ wound closure reload suture to close the common enterotomy (Figure 4).

“Then we close the Peterson’s defect with a permanent V-Loc™ wound closure reload suture and perform an upper endoscopy across the gastrojejunal anastomosis with the bowel clamp across the Roux limb, blowing it up with air and submerging it with saline to see if air bubbles leak out. As long as they don’t, we have successfully completed the gastric bypass.”

Photos courtesy of Dana Portenier, MD.

Conclusion

Clinical Experience Following the results of their animal study, Dr. Portenier and his colleagues started using the V-Loc™ wound closure reload in their patients and have performed several hundred procedures, including gastric bypass to close mesenteric defects; Nissen fundoplications; and in sleeve gastrectomies or any other procedures with a long staple line where they would want to oversew the staple line (Figure 3). Clinicians are able to use the Endo Stitch™ device and the V-Loc™ wound closure reload in a variety of laparoscopic cases. “We haven’t had any problems with leaking or any other problems that we could attribute to the V-Loc™ wound closure reload in any shape or form,” he said.

For Dr. Portenier, optimizing patient outcomes and reducing operating time are key considerations in selecting what technology to use in surgery. In a gastric bypass procedure, he uses the Covidien VersaStep™ trocar system with which he places 12-mm VersaStep™ trocars in the upper left and upper right quadrants, and 5-mm trocars in the umbilicus and the upper right quadrant. “I used a VersaStep™ trocar because it doesn’t cut the fascia; thus, it has a very low incisional hernia rate,” he explained. After inspecting the abdomen for abnormalities, he grabs the greater omentum and flips it over the top of the colon. “That allows us to identify the ligament of Treitz at the base of the transverse colon mesentery.

We’ll run that down about 50 cm where we divide the small bowel with a Covidien tan

Figure 4. The Covidien V-Loc™ wound closure reload is applied in the closure of common enterotomy of the jejunojejunostomy during Roux-en-Y gastric bypass.

Dr. Portenier advises surgeons interested in the V-Loc™ wound closure reload to work with a Covidien representative or a surgeon facile with the Endo Stitch™ device, and to try the instrument out first in a nonclinical setting. “Use it on a trainer to become familiar with loading the device; experiment with the V-Loc™ wound closure reload so that you know where the barbs begin and end on it so that you know exactly where to start and stop suturing.”

Surgeons will find that the V-Loc™ wound closure reload offers a controlled approach where incisions can be closed with ease.

“Surgeons want to get their patients off the table in a quick and efficient manner, to not have complications, and to get through as many cases as they can in a day as smoothly and quickly as possible,” said Dr. Portenier. By eliminating the use of knot tying, surgeons have more control over the entire procedure without the need for assistance, while reducing suturing time and minimizing costs.

References 1.

Photo courtesy of Dana Portenier, MD.

2.

reload with Tri-Staple™ technology which offers a staple height range of 2.0 to 3 mm,” he said, noting that for the past few months his team has been using the iDrive™ Ultra powered stapling system from Covidien.

Dr. Portenier then divides the mesentery to the base using the monopolar tip of a 44-cm Covidien LigaSure Advance™ laparoscopic sealer. “The distal portion of the bowel will become our Roux limb; we run that down another 50 cm,” he said. He then creates the jejunojejunostomy with another couple of firings of Covidien tan reloads with Tri-Staple™ technology. “We close the mesenteric defect there with a running permanent V-Loc™ wound closure reload on the Endo Stitch™ device. Then we divide the omentum to create less bulk under the Roux limb, attach the Roux limb to the stomach, retract the liver out of the way, and—starting

about 2 vascular bundles down on the lesser curve of the stomach—we staple the stomach into a 30-cc gastric pouch with several firings of the iDrive™ Ultra powered stapling system with a purple reload with TriStaple™ technology, which is appropriate for average stomach tissue thickness. We use black reloads with Tri-Staple™ technology on thicker stomachs, which require a larger staple height.” If they notice a significant hiatal hernia, Dr. Portenier and his team will close the crura using a permanent V-Loc™ wound closure reload suture before creating the gastric pouch.

Once the pouch has been formed, Dr. Portenier makes small enterotomies in the back of the pouch and in the Roux limb using the monopolar tip of the Covidien LigaSure Advance™ laparoscopic sealer, inserts a 45-mm reload with Tri-Staple™ technology

3.

4.

5.

6.

Nguyen NT, Mayer KL, Bold RJ, et al. Laparoscopic suturing evaluation among surgical residents.

J Surg Res. 2000;93(1):133-136.

Pattaras JG, Smith GS, Landman L, Moore RG. Comparison and analysis of laparoscopic intracorporeal suturing devices: preliminary results. J Endourol.

2001;15(2):187-192.

Stringer NH. Laparoscopic myomectomy with the Endo Stitch™ 10-mm laparoscopic suturing device.

J Am Assoc Gynecol Laparosc. 1996;3(2):299-300.

Adams JB, Schulam PG, Moore RG, Patin AW, Kavoussi LR. New laparoscopic suturing device: initial clinical experience. Urology. 1995;46(2): 242-245.

Omotosho P, Yurcisin B, Ceppa E, Miller J, Kirsch D, Portenier DD. In vivo assessment of an absorable and nonabsorbable knotless barbed suture for laparoscopic single-layer enterotomy closure: a clinical and biomechanical comparison against nonbarbed suture. J Laparoendosc Adv Surg Tech A. 2011;21(10):893-897.

Hart S, Hashemi L, Geraci DJ, Sobolewski CJ. Economic outcomes associated with the use of an automated suturing device in total laparoscopic hysterectomies. The 40th Global Congress of Minimally Invasive Gynecology; November 2011; Hollywood, FL.

Disclosures: Dr. Portenier reported that he is a consultant for and has received honoraria from Covidien, Allergen, Teleflex, and Intuitive. He is on the speakers’ bureau for Covidien and Allergen.

GENERAL SURGERY NEWS • NOVEMBER 2013

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and with conventional suturing in canine models.5 They created 3 enterotomies each—1 control, 1 absorbable, and 1 nonabsorbable—in the stomach, jejunum, and colon for a total of 9 enterotomies in 24 canines, euthanizing them at 3, 10, and 21 days for postmortem examination.5 Based on the data analysis, there were no postoperative complications or closure leaks.

There was, however, a significant benefit in amount of time saved with the barbed sutures compared with conventional suturing.5 The researchers concluded that both absorbable and nonabsorbable barbed sutures offer a viable alternative to conventional suturing in gastrointestinal surgery and that this option took significantly less closure time.5 The use of the Endo Stitch™ device has been found to be associated with lower procedure costs. In a recent study of inpatient total laparoscopic hysterectomies (TLH) for benign disease, the use of the Endo Stitch™ device was associated with lower mean total cost (by approximately $2,000), and shorter operating time (by approximately 40 minutes) when compared with robotic-assisted TLH procedures.6

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In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / NOVEMBER 2013

Guidelines on Interval Imaging for Benign Breast Biopsy Questioned B Y M ONICA J. S MITH CHICAGO—The guidelines of the National Comprehensive Cancer Network (NCCN) recommend follow-up imaging six to 12 months after patients undergo a benign breast biopsy, but research conducted at a hospital in Philadelphia, suggests that this practice rarely leads to a cancer diagnosis within one year and is a considerable drain on health care dollars.

“The aim of our study was to review our institutional experience with imageguided breast biopsy over a 12-month period, and to evaluate the cancer yield and cost associated with interval imaging performed less than 12 months after benign concordant breast biopsy,” said Demitra Manjoros, MD, a breast surgery fellow at Bryn Mawr Hospital, who presented the results of her team’s study at the annual meeting of the American Society of Breast Surgeons. (The study was to be published in Annals of Surgical Oncologyy in October).

In 2010, Dr. Manjoros and her team conducted a retrospective chart review of 689 patients who had undergone stereotactic, ultrasound (US)-guided or magnetic resonance imaging (MRI)guided breast biopsy at their Comprehensive Breast Center at Bryn Mawr.

The researchers also evaluated the charts for documentation of radiologic– pathologic concordance (which means the results of an imaging exam can be explained by findings of the pathology laboratory). Discordance between the two findings can suggest that the biopsied tissue sampling was inadequate.

Of the 689 patients, 498 (72.3%) were considered benign and 337 had a documented radiologic–pathologic

‘No malignancy was reported in patients undergoing interval imaging following benign concordant stereotactic or US-guided biopsy, and the cost of detecting this cancer was over $40,000.’

—Demitra Manjoros, MD

concordance assessment. Short-term interval imaging was obtained for 182 of the 337 benign concordant patients, with a median time to imaging of six months. Of those, 36 patients underwent multiple imaging studies, with a total of 220 studies for the entire group.

Most of those patients had undergone a stereotactic or US-guided breast biopsy, and about 15% had an MRIguided biopsy. One hundred seventyfive were ultimately deemed benign as designated by BI-RADS 1, 2 or 3. Two patients were designated as BI-RADS 0 on their initial follow-up mammogram and on US. Both were found to have benign findings after additional MRI imaging.

Five patients had suspicious findings on follow-up imaging designated by BIRADS 4, but ultimately only one cancer was identified, representing 0.5% of the 182 benign concordant patients who underwent short-term interval imaging. The “missed cancer” occurred in a patient who had undergone MRI-guided biopsy that was deemed concordant.

“This cancer occurred in a 39-yearold woman with a history of a left-sided cancer four years prior,” Dr. Manjoros said. The patient was noted to have a 6mm area of enhancement on her screening MRI at a site away from her prior lumpectomy cavity. “Her post-biopsy

MRI demonstrated a hematoma, making the confirmation of lesion retrieval a bit more challenging.”

The patient’s follow-up MRI at six months showed a slight increase in the area of enhancement from 6 to 7 mm.

She ultimately underwent a needlelocalized excision that showed an invasive carcinoma.

The researchers’ cost analysis was based on 2013 Medicare reimbursement rates for imaging studies in the group composed of 182 patients. They calculated that with 220 imaging studies and five subsequent biopsies performed among members of that group, the cost to detect one breast cancer came to $41,813.77.

“In summary, our data demonstrated a high prevalence of carcinoma in patients with discordant pathology.

FDA Approves Perjeta for Early-Stage Breast Cancer The FDA has approved a first-line chemotherapy for preoperative early-stage breast cancer, Genentech announced in a statement on Sept. 30. Pertuzumab (Perjeta) in combination with trastuzumab is the first breast cancer treatment approved for use in a neoadjuvant setting. Pertuzumab also is the first drug to meet accelerated approval using pathologic complete response (pCR) data.

“A new approval pathway has made Perjeta available to people with HER2-positive early breast cancer several years earlier than previously possible,” said Hal Barron, MD, chief medical officer of Genentech.

“Together with the FDA, we’ve charted new territory.”

In 2012, the FDA approved pertuzumab for metastatic, late-stage HER2-positive breast cancer. Pertuzumab now also is intended for patients with HER2-positive early-stage, inflammatory or locally advanced breast

cancer who are at risk for metastasis, relapse or death.

Neoadjuvant therapy with Perjeta, which can range from nine to 18 weeks, would cost an estimated $27,000 to $49,000, according to a Genentech representative.

“We are seeing a significant shift in the treatment paradigm for early-stage breast cancer,” said Richard Pazdur, MD, the director of the FDA’s Office of Hematology and Oncology Products, in a press release.

“By making effective therapies available to high-risk patients in the earliest disease setting, we may delay or prevent cancer recurrences.”

The FDA based its approval on the results of a multicenter randomized Phase II trial, NEOSPHERE (Neoadjuvant Study of Pertuzumab and Herceptin in an Early Regimen Evaluation). Patients with HER2positive early-stage, inflammatory or locally advanced breast cancer (N=417) were randomly assigned a

There was a low rate of cancer detection with follow-up imaging in patients with benign concordant breast biopsy, and this cancer occurred in a high-risk patient who had undergone MRI-guided biopsy,” Dr. Manjoros said. “No malignancy was reported in patients undergoing interval imaging following benign concordant stereotactic or USguided biopsy, and the cost of detecting this cancer was over $40,000.”

Dr. Manjoros and her team concluded that the documentation for radiologic and pathologic concordance following percutaneous breast biopsy, as recommended by the American Society of Breast Surgeons, is essential for preventing delayed diagnosis.

Their data do not, however, support the use of routine short-term interval imaging after benign concordant breast biopsy, although selective use of interval imaging should be considered in cases when confirmation of lesion retrieval is difficult.

“We are all concerned with trying to control costs in health care,” said Peter Beitsch, MD, director, Dallas Breast Center, in Texas. “This study provides evidence that interval imaging is of essentially no value as long as the initial biopsy and imaging studies are in agreement.”

Dr. Beitsch noted that cost is not the only concern, as the extra exposure to radiation, patient anxiety and lost time from work all take a toll. “The recommendation by the NCCN was a consensus of opinions and not based on any data,” he added. “This study puts data to the question and hopefully can result in a change in recommendation with the attendant savings to the patients and society.”

12-week regimen of one of four treatments: pertuzumab plus docetaxel; pertuzumab plus trastuzumab; trastuzumab plus docetaxel; or pertuzumab plus trastuzumab and docetaxel.

The primary end point of NEOSPHERE was the lack of detectable tumors in breast and lymph node tissue, or pCR. About 39% of patients receiving pertuzumab plus trastuzumab and docetaxel—the most efficacious treatment—achieved pCR, followed by 21% of patients who received trastuzumab and docetaxel (P=0.0063).

In the NEOSPHERE trial, adverse events included diarrhea, hair loss, nausea and a decrease in white blood cells. Anaphylaxis, decreased cardiac function, hypersensitivity and infusion-related reactions were other serious side effects. Additionally, the labeling for pertuzumab includes a warning that if it is used during pregnancy it may cause birth defects or fetal death.

—Ben Guarino

Surgeons’ Lounge

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / NOVEMBER 2013

W

elcome to the November issue of The Surgeons’ Lounge. In this issue, Steven B. Perrins Jr., MD, PGY-3, Department of General Surgery, Cleveland Clinic Florida, Weston, summarizes the Cleveland Clinic Florida grand rounds presentation by Bruce Ramshaw, MD, FACS, co-founder, chairman and chief medical officer, Transformative Care Institute; chairman, Halifax Health General Surgery Residencyy Program; and co-director, Advanced Hernia Solutions, D Daytona Beach, Fla. Dr. Ramshaw gave an excellent presentation on “App plying Complexity Science to a Hernia Program To Improve Outcomes.” H He also provided further insight into this topic in an interview with Dr. Perrin.

Plus, check out the “History and Other Facts” section n that describes Alexis Carrel, the “good but not brilliant student,” who by the time of his death was noted as the “French master surgeon” and a prolific scientific philosopher!

I look forward to your questions, comments and feedback.

Sincerely, Samuel Szomstein, MD, FACS Editor, The Surgeons’ Lounge Szomsts@ccf.org

Dr. Szomstein n is associate director, Bariatric Institute, Section of Minimally Invasive Surgery, Department of General and Vascular Surgery, Cleveland Clinic Florida, Weston.

Summary of Dr. Ramshaw’s Presentation “Applying Complexity Science to a Hernia Program To Improve Outcomes” With the academic year welcoming another group of surgical interns, grand rounds at most residency programs provide an opportunity for understanding how even the most basic surgical procedure is wrought with potential pitfalls, often due to uncontrollable patient variables. Dr. Ramshaw discussed how complexity science applies to health care and hernia repair and how it applies also to education, research and improving patient care.

Historically, medicine and surgery have used a straightforward, Newtonian scientific method approach to solving problems: the control of all but one variable when evaluating a theory. If that theory is disproved, it is altered and retested, with most or all variables unchanged. It is now becoming clear that this method of research is ineffective because of how our medical

Figure 1. The “awareness iceberg.”

systems and patient care models are designed.

There is a disconnect among the roles of those providing patient care. Using an “awareness iceberg” as an example (Figure 1), frontline providers and the patients themselves possess full medical awareness of patient care. As one climbs the hierarchy of medicine, less and less medical awareness exists. Managers and top-level corporate executives lack this awareness of patient care simply due to a fragmented and broken system. For example, an emergency department physician may report to the director who subsequently reports to Figure 2. Communication in siloed departments. a chief of staff, and similarly a laboratory technician or phlebotomist may report to a manager who Traditional Medical Practice: subsequently reports to a director of pathology Individual Physician-Focused (Figure 2).

This departmental hierarchy creates a twofold disconnect of care: First, the chief of staff and Secretary director of pathology are significantly less aware of Compliance Nurse the details of everyday patient needs, or “front-line Officer care” than their subordinates, and second, these two department heads do not always communiPhysician cate or work together. Instead, these siloed departments find themselves competing with each other Office Coder/ for resources in an attempt to advance patient care.

Manager Biller The single-physician care model, where a single doctor, surrounded with available resources, delivScheduler ered all of patient care needs was the traditional approach (Figure 3). However, expecting an individual physician to be competent in all diagnoses and management principles is no longer feasible, Figure 3. The single-physician model of patient care. given the vast array of diagnostic and treatment procedures and techniques that exist today. What is required now is a full team approach where each team relates to using one type of mesh, in the same fashmember is designated a specific role. ion, all the time. But patients may respond differently to By definition, standardization does not equate to the same treatment: What may work perfectly for one uniformity. Rather it is a flexible and dynamic pro- patient’s ventral hernia may result in significant morcess, which brings benefit to all those involved, produc- bidity for another. For the other patient, the value of ers and consumers alike. In the age of trying to meet standardization is lost. specific budgets, hospitals have increasingly standardHistorically, the type of mesh used for a hernia repair ized patient treatment. In the case of hernia repair, this continued ON page 10

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Surgeons’ Lounge jcontinued from page 9

index [BMI], mental status, tobacco use, diabetes, hernia complexity); and surgical technique. was chosen based on a surgeon’s preference. However, There are between 50 and 100 types of mesh that with the development of value analysis committees, sur- can be used for hernia repair in the operating room geons are losing this autonomy as the choice of available and as a result, mesh-related complications also have materials is dictated by budget constraints. But this pro- become significantly more complex. Mesh may migrate, cess overlooks the concept of value per patient, defined contract, flex, stiffen and become altered in the body. by cost, quality outcome measures and patient satisfac- Lightweight mesh may fail. Mesh may develop growtion within the care-per-patient cycle. ing seromas or delayed infection even years after repair.

Hernia repair becomes exponentially more complex However, at this point we don’t know why this occurs. when taking account of various factors such as choos- This is where complexity science has a role. ing which mesh to use (material, size of pores, filament Humans are not static machines that are responsive structure, weave); a patient’s profile (age, body mass to uniformity or the conventional definition of standardization. We continually change and adapt. The model in Figure 4 could represent a cell, a body or even a hospital. Using this example, we see how multiple factors provide interactions, information and feedback from which we adapt and learn. As a result of this complexity, the model of care now must not reflect the single-physician model but rather a patient- and disease-specific model around which a multitude of team members are involved to deal with the complexity of a patient’s illness (Figure 5). There are two keys to this working. First, a care coordinator who works throughout the cycle of care is essential in developing a relationship with the patients and managing their care. This role requires an understandFigure 4. Multiple factors influence how we adapt and learn. ing of the entire cycle of care and often

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / NOVEMBER 2013

Integrated Programs: Designing Care Patient-Centered Multidisciplinary Teams

Surgeon Design Expert

Engineer

Nurse

Patient Disease

Improvement Manager Clinical Manager

Internist/ PCPs

Financial/ Scheduler

Figure 5. The new model of patient-centric care. the surgeon is not the best person for this role. Patients with care coordination teams have been shown to have a significant improvement in 10-year mortality rates after myocardial infarction (25% vs. 75% 10-year survival).1 Second, map a process that focuses on valuebased outcomes to improve the process of care instead of controlling inputs or variables. This would require a definition of a process or cycle of care, and specific outcome measures, which would vary for each specific situation. Once defined, we can identify opportunities to improve. Patients must be seen as subpopulations, avoiding the “one-size-fits-all” methodology.

Applying these concepts to hernia repair, is it

Surgeons’ Lounge

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / NOVEMBER 2013

possible to finally understand if there is a “best” or “ideal” product to use for specific patients? Is it possible to adequately control the variables to make this determination? No. We can never apply reductionist science to the real world.

Traditional research is based on our perceived ability to get one “right” answer and apply that to patients. Instead of reverting to this reductionist style of treatment, we need to utilize methods already in use, which are well understood in order to provide complete and multifaceted care.

Better outcomes typically originate with clinical quality improvement projects, which may be complex at the beginning with processes mapped out for multiple patterns and routes of care.

Mapping out costs across the complete cycle of care for a variety of treatments gives a more detailed understanding of a specific treatment cost and therefore treatment value. When starting this process, Dr. Ramshaw’s group noted more than 400 points of data for a single ventral hernia. That number has been reduced to 200 using benchmarks for improvement including readmission rates, recurrence and chronic pain development, to name a few. In the case of Dr. Ramshaw, a laparoscopic ventral hernia repair was most influenced not by BMI, smoking, age or diabetes, but rather by surgical complexity and emotional issues (anxiety, depression, stress) related to their surgery. Once these data were noted, his team interpreted the data to come up with process improvement methods to help minimize stress experienced by the patients in this example.

Based on this understanding, how can we determine which mesh to use for a specific patient? Mesh explants are now being scrutinized to determine why one type may have failed in a specific patient.

Chemical and compliance changes of a multitude of mesh types can be evaluated. Flexibility in specific patients varies even in subpopulations. Data have shown that two pieces of the same mesh may develop 10,000 times more rigidity over a decade for a single patient.

Human diversity requires diverse science with many dimensions and analytics. This allows us to begin to predict which patients will fare better with a specific mesh or approach. Although we are not static, humans do cluster, which allows physicians to manage patient care based on these understood clusters and variability.

In closing, Dr. Ramshaw said that although we care for our patients, we do not know what value is to our patients because it has not yet been fully measured.

We can learn how to drive improvements and although it may not be perfect, we can use these steps to improve the care of our patients, but only if we are all willing

to change how we think. We cannot afford to remain siloed from others.

Interview With Dr. Ramshaw Dr. Perrins: How do you reconcile a system like this in everyday care? How can one take on ultra-complex cases and apply this medicine because it isn’t yet recognized by anybody?

Dr. Ramshaw: Although there is a lack of understanding, it is known that what we are currently doing is not

working. Politicians are not going to be able to figure out how to establish valuebased care. This must come from us, from our research, in order to prove that this is a viable method of management. We will have to bring the value-based research to Washington and show the politicians its benefit.

Dr. Perrins: How do you integrate new technologies, such as robotic surgery, into your practice given the amount of new products we see?

Dr. Ramshaw: Surgeons should have no bias whatsoever. I will use everything available to me, frankly, because one

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should measure the value of every technology (mesh, robotic surgery, etc.). If, after value has been assessed, I find it to have low value, I’ll stop using it. For example, robotic surgery has been marketed toward volume, not value. This allows strong early profits, but eventually, when value data for a new technology catches up, sales will drop and the market will eventually fall off.

Dr. Perrins: What will happen with the new health care initiative and the idea of value-based medicine since they seem to be fully based on cost- and continued on page 13

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Surgeons’ Lounge

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / NOVEMBER 2013

History and Other Facts: Alexis Carrel

A

lexis Carrel (1873-1944) was a surgeon who received the Nobel Prize in Physiology or Medicine, in 1912, “in recognition of his work on vascular suture and the transplantation of blood vessels and organs.”

In 1900, at the age of 27, Carrel received a doctorate in medicine from Lyon University where he was described as a “good but not brilliant student.”

The assassination, in 1894, of Nicolas Leonard Sadi Carnot, president of the French Republic, piqued Carrel’s interest in suturing and transplantation. Carnot was stabbed in the abdomen and as a result he exsanguinated to death from

Figure 1. Carrel examines culture of cells of the heart of a chicken embryo.

a lacerated portal vein. At the time, major vascular injuries were beyond a surgeon’s capability to repair. Carrel, however, felt that anastomosis of blood vessels, as with any other organ, should be possible with the correct technique.

The triangulation technique used in a termino-terminal anastomosis is described as follows: approximation of the two ends should be tension-free (Figure 2). The free edges are first united by three “retaining stitches” at equal distances from each other. By pulling on the retaining stitches at one time, the circular lumen of the artery is transformed into a triangle, of which the size can be adjusted as needed. While keeping the triangle at some tension, the sides of the triangle are stitched.

Carrel was not the first to suture a blood vessel successfully. Another French surgeon, Mathieu Jaboulay, did it before Carrel, but his technique did not work well for small blood vessels.

Carrel realized the need for smaller needles and threads, which he found in a wholesale haberdashery near his home.

In May 1903, Carrel traveled to Lourdes in France, to try to examine what some considered the “miracles” that were occurring as a result of people bathing in the waters at the pilgrim site. On a “sick train” making its yearly trip to Lourdes, Carrel cared for a young woman suffering from peritoneal tuberculosis. Carrel described how her distended abdomen started to reverse within minutes and totally disappeared within 30 minutes of being sprinkled with holy water. Carrel did not accept that the event was

Figure 2. The triangulation technique.

“miraculous,” and called for a scientific investigation of “miraculous” events at Lourdes, a step that resulted in severe personal consequences: Carrel was denied by the church for not accepting an “act of God,” and fellow physicians thought he believed in magic. Ridiculed by the medical community, Carrel failed to obtain a full faculty position at University of Lyon. In 1904, his frustration eventually drove him to Canada with the intent of leaving medicine behind and becoming a cattle rancher.

While in Montreal, he presented his work on vascular anastomosis, which was enthusiastically received and led to an invitation to work at the University of Chicago. The most striking achievement of Carrel’s technique was that “no hemorrhage was ever observed and no stenosis was ever produced … thrombosis had become an altogether unusual complication" (Sade RM. Transplantation at 100 Years: Alexis Carrel, Pioneer Surgeon).

Seeing Carrel’s technique, Harvey Cushing and George Crile (founder of the Cleveland Clinic) invited Carrel to be a guest lecturer at Johns Hopkins University.

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In 1906, at the age of 33, Carrel joined the Rockefeller Institute for Medical Research in New York City. It was the first institution of its kind in the United States that was devoted entirely to medical research, rather than teaching or patient care.

Carrel paved the way for organ transplantation. He stated that it would take only five or six minutes to suture the femoral artery of a man and showed that suturing the ends of two vessels could be performed, not only on relatively large vessels, but also on those with a diameter less than that of a matchstick. It was now possible to divert the circulation in a visceral organ or in one of the limbs in order to facilitate, and even reestablish, blood flow. Treatments for almost any form of arteriosclerosis could now be done, including coronary artery bypass graft (CABG), enhancing circulation to a clotted leg, reversing ischemia and preventing gangrene.

In Chicago and New York, Carrel successfully transplanted many different organs. He also reported a successful limb replantation in 1906, more than 50 years before the first successful human limb replantation was performed in 1962. He preceded the first routine use of saphenous vein bypasses, which did not take place until 1948.

The first successful human renal transplant occurred in 1954. Christiaan Barnard would not perform the first human heart transplant for another 62 years, in 1967.

While working on a vascular prosthesis, Carrel showed that by replacing a patch of an aortic wall with a piece of rubber covered with Vaseline, “a foreign inert substance, under certain conditions, does not produce an obliterative thrombosis, but can indeed be used in the reparation of the wall of a large artery.” This discovery paved the way for the use of nontissue grafts.

Carrel autotransplanted the kidney, which survived and functioned very well, but he discovered that when he homotransplanted from one animal to another, kidney function quickly deteriorated, sometimes immediately. “From a surgical standpoint, the problem of the graft of organs can be considered as having been solved,” Carrel stated, “but from a biological standpoint, no conclusion has thus far been reached because the interactions of the host and of its new organ are still practically unknown.” It was only later that Joseph Murray succeeded in solving the biological problem of organ transplantation (for which he received the Nobel Prize in 1990).

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jContinued from page 11 volume-driven medicine?

Dr. Ramshaw: I’m not a supporter of any political objective. The issue here is the interpretation of these laws. Intent of these policies is to do what I’ve described, but it will not happen overnight.

Dr. Perrins: Integrated care is starting to happen with centers of excellence.

Hernia repair centers are beginning to do this as well. Other institutions are stating they can do this too without being a center of excellence, without replicating this patient-centered model.

How do you avoid this and its potential complications?

Dr. Ramshaw: It is essential to understand the science behind care teams and quality improvement. Centers of excellence have begun to eliminate negative

Carrel also contributed to a new procedure for wound-care management during World War I, that involved surgical debridement and copious irrigation with Carrel-Dakin solution. He also directed and helped in the design of the first mobile army hospital, a forerunner of the mobile army surgical hospital units that were used in the Korean and Vietnam wars.

Carrel supported the ideas of Francis Galton (cousin of Charles Darwin), which included the belief in genetic superiority. In 1935, he published a book entitled “Man, the Unknown,” in which he explained his views on how science should improve society and argued that man is in a position to control his destiny and reach perfection through eugenics, or selective reproduction. The book became a bestseller: More than 900,000 copies were sold and it was translated into 19 languages.

Carrel died on Nov. 5, 1944, at the age of 71. At the time, Timee magazine described him as a “French master surgeon” and scientific philosopher, said to be able to reputedly thrust his thumb and index finger inside a matchbox and tie a catgut knot that was impossible to undo with two hands.

It was also written that his final illness prevented him from being put on trial for collaboration with the Nazis.

Carrel was and still is a source of inspiration for excellence, hard work, supreme laboratory and clinical research. “A few observations and much reasoning lead to error; many observations and a little reasoning to truth,” he once said. His methods opened the gate to transplantation and vascular surgery, reaching operating rooms worldwide and saving the lives of countless patients.

deviants and poor outcomes—mostly surgeons without a team surrounding them.

Conversely, centers of excellence have standardized protocols, but any one surgery cannot be standardized. These should be called “centers of improvement,” because in reality these facilities determine how to provide value-based medicine for their specific subpopulation and improve the value of their care.

Dr. Perrins: Is there any way that the data can be simplified?

Dr. Ramshaw: Over time, maybe.

Locally, it can be streamlined, as we were able to cut in half our necessary data points

based on local information. Once we have a local, subpopulation understanding, we can pool these data with other groups to identify global patterns. These patterns are where the improvements can complement local efforts.

Dr. Perrins: How do you use these data in a real-time setting?

Dr. Ramshaw: We haven’t yet. We are only a year into this. We plan on putting processes and outcomes online. But what works for one subpopulation may not with another, but we plan on making it available for all to see.

Dr. Perrins: How can this apply to

residents and fellows—who — see so many kinds of diseases in their training— g when learning procedures from a variety of surgeons?

Dr. Ramshaw: This can’t be done all at once with all diseases. This needs to happen with each disease, one at a time.

Many surgeons in practice will rotate through teams for which this multicentric approach has been developed. Standardized procedures must be performed on patients from the correct subpopulation.

If another surgical option is available, the patient’s profile must fit the chosen procedure based on value-driven variables.

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O nthe

GENERALSURGERY YNEWS.COM / GENERAL SURGERY NEWS / NOVEMBER 2013

Spot with Colleen n Hutchinson

Debating the Gastric Band and The Need for Centers of Excellence This month’s On the Spott is a collaboration with Jaime Ponce, MD, outgoing president of the American Society for Metabolic and Bariatric Surgery (ASMBS).

We hone in on two issues that have become debate fodder: the current role of the laparoscopic adjustable gastric band and the current role of centers of excellence (COEs).

Colleen Hutchinson: Last year when we did this column, you stated that your goals as ASMBS president were to: 1) finalize and implement our new quality improvement—to improve quality, access and insurance acceptance, and offer quality process to international colleagues; 2) consolidate the new annual “Obesity Week” meeting; and 3) establish guidelines for new procedures to be recognized/approved by ASMBS. How would you say the year turned out, based on those goals?

Jaime Ponce, MD: It has been a busy, challenging and satisfactory year of accomplishments.

The MBSAQIP [Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program] joint program between ACS [American College of Surgeons] and ASMBS went through a process of careful analysis, detailed discussions and evaluation of what we can and can’t do based on both organizations’ structures and governance policies, and now the standards are finalized and ready to be implemented at the beginning of 2014.

We are working on the resources for verification now, including training of more than 100 surgeons to become site inspectors. The data points for the MBSAQIP programs database have been carefully analyzed to eliminate unnecessary data points, ensuring centers and surgeons will not waste time collecting and entering unneeded data. The first national QIP is being released at Obesity Week and will be named DROP [Decreased Readmissions through Opportunities Provided], with the goal of decreasing readmissions by 50%.

Obesity Week is shaping up to be the best ASMBS meeting in history, with a superb program; and in conjunction with The Obesity Society and multiple level 2 and 3 society groups participating, it will be the largest and most comprehensive obesity meeting in the world.

The program committee and ASMBS staff have done a tremendous job in accomplishing this milestone. We also will be celebrating the 30th anniversary of the ASMBS, so please visit www.asmbs30.org for details.

In addition to a new meeting and new accreditation standards, we have released a newsmagazine called “Connect.” We have established new interaction with all our ASMBS state chapters (providing web, administrative, CME and other support), developed a new ASMBS website, and next year will release a new ASMBS textbook.

This year, we worked hard to improve access, establish a process through the research committee to study and recognize new procedures, develop revisional surgery guidelines, build collaboration with other societies, and increase political advocacy and communication with all private payors to align them with our accreditation process, and more.

It has been an honor to serve as president of ASMBS. CH: What would you say incoming president Ninh Nguyen’s biggest challenge(s) will be over the next year, and what advice would you give to him?

Dr. Ponce: I think Ninh will have big opportunities to continue to improve and expand the goals and mission of the ASMBS. Our educational offerings will continue to be the best; implementation of new standards and quality improvement will be better understood; and insurance companies’ alignment with the MBSAQIP will increase. My advice is to continue with a strong collaboration among all parties to gain consensus to improve patient safety and outcomes. And as always, try to be open and transparent with the process to allow everybody to participate!

Ninh will represent us very well as president of ASMBS. CH: What are your thoughts on the two issues in this installment of On the Spot, namely the role of the gastric band and the state of COEs? Dr. Ponce: I agree that the number of LAGB

[laparoscopic adjustable gastric band] procedures has decreased; I believe that it’s still a viable option for some patients, specifically patients with a better understanding, who don’t have geographic or financial limitations for access to care, who are not experiencing severe diabetes, and who have lower body mass index (BMI). Also, it is important that these patients get band adjustments and care at centers that are willing to dedicate the necessary efforts to care for band patients. It is not a procedure for every patient and every center. For many potential patients who are afraid of stapling procedures, the band still is a better option than continuation of failed medical weight loss management.

In regard to accreditation/COE, there’s no question that we have seen tremendous benefits since the concept was established—from hospitals dedicating resources and staff, to establishing a safer patient environment, to now having the ability to gather data at a national level. Bariatric surgery is a complex procedure that is performed in a higher-risk patient who requires more long-term care than with many other surgical procedures. Accreditation is a venue through which to develop and implement the appropriate infrastructure, dedicated staff, specific process of care, and data collection, and is the pathway to establishing quality improvement. I personally think the surgeons from Michigan have created a very good quality collaborative with financial support that, by itself, is their “state accreditation.”

The argument about accreditation decreasing access should be addressed in relation to patient safety. Access will increase as centers become better and safer, as they have via accreditation. The argument about accreditation being an administrative burden is well known, but it exists with private payors’ accreditation requirements as well. The goal will be to work with insurance companies to decrease the burden to programs. Finally, the volume argument will diminish as the new standards require less volume, according to the evidence we have gathered from the data. We have made big improvements in patient safety over the past decade, and we don’t want to see the examples we had in the past with higher mortality among Medicare patients (as described by Flum et al), that showed mortality in the range of 2% [data on Medicare patients having bariatric surgery from 1997 to 2002] ((JAMA A 2005;294:1903-1908). continued ON PAGE 16

Rationale, Reversal, and Recovery of Neuromuscular Blockade Part 1: Framing the Issues Case Study Harold is a 74-year-old man undergoing a video-assisted right upper lobectomy for stage I non-small cell lung cancer.

Current Symptoms • Dyspnea • Coughing with hemoptysis • Chest pain Vital Signs • Height: 177.8 cm (70”) • Weight: 65 kg (143 lb) Signi¿cant Medical History • Hypertension • Chronic obstructive pulmonary disease (moderate) Current Medications • Metoprolol succinate ER 50 mg/d • Tiotropium bromide inhalation powder Laboratory Results • 2-cm lesion in right upper lobe revealed on chest computed tomography (CT) scan; malignancy con¿rmed with needle biopsy • No abnormal bronchopulmonary or mediastinal lymph nodes; brain CT, isotopic bone scan, abdominal ultrasonography negative for distant metastases • Forced expiratory volume in the ¿rst second: 43.6% of predicted value (1.44 L) • Carbon monoxide diffusing capacity: 71.7% of predicted values (20.19 mL/min/mmHg) • Cardiac ultrasonography: normal pulmonary artery pressure (22 mm Hg) At induction, Harold receives propofol 1.5 mg/kg and rocuronium 0.6 mg/kg. During the procedure, movement of the diaphragm interferes with surgery.

This activity is jointly sponsored by Global Education Group and Applied Clinical Education.

Supported by an educational grant from Merck.

Applied Clinical Education is pleased to introduce a new interactive 3-part CME series featuring challenging cases in neuromuscular blockade.

Each activity will present a clinical scenario that you face in your daily practice. After reading the introduction to the case, consider the challenge questions, and then visit www.CMEZone.com/nmb1 to ¿nd out how your answers stack up against those of our multidisciplinary faculty panel.

Access the activities on your desktop, laptop, or tablet to explore the issues surrounding safe, effective, neuromuscular blockade and reversal via a unique multimedia learning experience and earn 1.0 AMA PRA Category 1 Credit.™ Participate in the coming months as well to complete the whole series and earn a total of 3.0 AMA PRA Category 1 Credits.™ This activity’s distinguished faculty Jon Gould, MD Glenn S. Murphy, MD Chief, Division of General Surgery Alonzo P. Walker Chair in Surgery Associate Professor of Surgery Medical College of Wisconsin Senior Medical Director of Clinical Affairs Froedtert Hospital Milwaukee, Wisconsin

Clinical Professor, Anesthesiology University of Chicago Pritzker School of Medicine Director Cardiac Anesthesia and Clinical Research NorthShore University HealthSystem Evanston, Illinois

Challenge Questions 1. What would you do next?

2. What potential postoperative risks does this patient face?

Access this activity at www.cmezone.com/nmb1

On the Spot

Michel Gagner, MD: Agree!

After peaking in 2008 at 42.3% of worldwide procedures, banding has plummeted to 17.8% in 2011 (Obes Surgg 2013;23:427-436). This trend will continue, while sleeve gastrectomy has increased exponentially to fill this gap, from 5.3% to 27.8% in the past three years of that survey. It also took more than 20 years for the Angelchik prosthesis (a silicone ring around the esophagus to treat gastroesophageal reflux disease) to be withdrawn from the market. Any foreign body around the gastrointestinal tract is not a good longterm solution; it is a violation of the basic principles of tissue healing.

We hear a defective ethical and moral discourse, with statements that the procedure has the lowest morbidity and mortality initially, and because we have so many to treat, we should allow it. Really? Why? It is faulty reasoning, because the frequent failures, conversions and reoperations have greater risks and mortality, jeopardizing the success of the next procedures. Although some teams have been successful with their patients, that success is not due to the surgical procedure itself, but rather an intensive follow-up with positive psychological reinforcement, which is not applicable or realistic within most practices around the world. Resources are limited, and the treatment of obesity requires more than just simple adjustable restriction (an attractive concept).

But what is killing the gastric band is that surgeons are tired of observing failures and dealing with “not enough” or “too much” restriction constantly; patients want to have their devices removed and be replaced with something else; and the public sees this shift. An FDA trial permitted a relatively safer introduction of the band in the United States (2001), later than the rest of the world, creating a lag phase of 10 years in the United States. Worldwide, more bands are removed than inserted, and the first country that used it (Sweden) has seen its use disappear. Insurance plans should stop covering it, in favor of more stapling procedures.

Raul Rosenthal, MD: Disagree.

We are experiencing a decrease in banding and bypass cases due to the growing demand for and excellent outcomes of sleeve gastrectomy.

Sleeve gastrectomy most likely will become, by the end of this year, the most popular bariatric procedure worldwide. Gastric banding will remain a valid treatment modality, but the number of cases most likely will stay low for years to come and increase again once we have safe and effective anorectic drugs that we can combine with it.

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The number of laparoscopic adjustable gastric band cases has decreased significantly in the past couple of years, and the band is no longer accepted as a viable option by many.

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Christine Ren-Fielding, MD: I agree. The number of these operations being performed has decreased significantly around the world and the band is no longer accepted by many; however, this does not mean the adjustable gastric band is not or should not be a viable option for the treatment of morbid obesity.

Just like all other bariatric operations, the excitement of the band as a new treatment option was embraced and the number of operations peaked. In addition, many surgeons who performed gastric banding due to financial gain rather than medical care realized that the aftercare is just as important, if not more important, than the operation itself. The time and financial resources necessary to provide this aftercare is consuming and has become unpalatable for many; but without it, the weight loss outcomes are poor and reoperations are high.

Just as the band is not a “quick fix” for the patient, it is not a “quick buck” for the surgeon. Instead, the success of the adjustable gastric band relies on dedicated long-term management by both the surgeon and the patient. This realization over the past decade has clarified the importance of patient selection and surgeon selection, in order to maximize the advantages this operation offers and decreases the disadvantages, thus resulting in an appropriate decrease in the number of cases being performed. This has happened with the gastric bypass and surely will occur with the sleeve gastrectomy.

Paul O’Brien, MD: Yes, gastric band numbers are decreasing across several continents. So too, is gastric bypass. And the rise in the sleeve does not come close to equaling the losses. Bariatric surgery, in general. is not doing well. We are not winning the hearts and minds of the 80 million obese people in the United States or the 300 million-plus people worldwide. We now have better data than ever proving safety, substantial and durable weight loss, clear health benefits, improved quality of life and cost-effectiveness. All current bariatric procedures are effective, yet we are losing ground. Why could this be so?

Perhaps we are expending too much effort trying to prove one approach is better than another and not enough convincing physicians and their patients that bariatric surgery does work. It is, arguably, the most powerful treatment we have in medicine today because it achieves weight loss. The gastric band is a safe, simple outpatient procedure, but it does require significant effort in aftercare to get the best results. It is your call.

You can either say “No, the aftercare is just a bit too hard” and walk away, or like us, you can do it properly and enthusiastically. We are able to do this, both at my clinic in Australia and at the American Institute of Gastric Banding in Texas, where I’m the national medical

‘Perhaps we are expending too much effort trying to prove one approach is better than another and not enough time convincing physicians and their patients that bariatric surgery does work.’

— Paul O'Brien, MD director. If you want to try the second option and you would like some help, please let me know. I am happy to share our methods with you. And please do not blame the patients and say it is their decision. They still want it. At both sites, we are treating more people than ever.

Panelists Justin B. Dimick, MD, MPH is the Henry King Ransom Professor of Surgery, Chief of the Division of Minimally Invasive Surgery, and Associate Chair for Faculty Development at the University of Michigan.

Michel Gagner, MD is senior consultant at the Hopital du Sacre Coeur, University of Montreal, Quebec, and Clinical Professor of Surgery at the Herbert Wertheim College of Medicine, Florida International University, Miami.

John Morton, MD is Director of Bariatric Surgery and Surgical Quality at Stanford Hospital and Chief of Minimally Invasive Surgery at Stanford University, Calif.

Ninh Nguyen, MD is vice-chair of the department of surgery at University of California Irvine School of Medicine, Orange, Calif.

Paul O’Brien, MD is Director of the Centre for Obesity Research and Education (CORE) at Monash University in Melbourne.

Jaime Ponce, MD is the Medical Director for the Bariatric Surgery program at Hamilton Medical Center, in Dalton, Georgia, and Memorial Hospital in Chattanooga, Tennessee. He is the current president of the ASMBS. Christine Ren-Fielding, MD is Professor of Surgery at NYU School of Medicine, Division Chief of Bariatric and Minimally Invasive Surgery, and the Director of the NYU Langone Weight Management Program, New York City.

Raul Rosenthal, MD is Professor and Chairman, Department of General Surgery, Director of Minimally Invasive Surgery and the Bariatric and Metabolic Institute, Cleveland Clinic, Weston, Fla. Matthew Weiner, MD is a solo, private practice surgeon in Commerce Township, Mich., and the president of the Michigan State Chapter of the ASMBS.

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The Bariatric Surgery Center of Excellence accreditation process has been proven to improve safety and outcomes. However, the Centers for Medicare & Medicaid Services (CMS) has just removed its requirement that Medicare patients undergo bariatric surgery procedures at accredited facilities. This decision reflects an incomplete review and analysis of overwhelming scientific evidence and medical opinion that bariatric accreditation programs save lives, improve patient outcomes and enhance patient quality of care, and the proven assertion that accreditation is a critical venue for improving quality measures in bariatric surgery. In addition, this decision will place the higher-risk Medicare population at risk.

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Matthew Weiner, MD: Disagree! The very checkered past of the bariatric surgery community’s experience with accreditation programs has come to an end, thankfully, with the recent CMS decision. Accreditation programs permit surgery at some centers, while forbidding it at others. The exclusionary nature of these programs forces surgeons and hospitals to jump through hoops to get a seat within the inner circle. Accreditation programs are not in our best interest, nor the interest of our patients.

Our experience in Michigan with a quality improvementt program that is open to all surgeons and hospitals and that fosters collegiality between competing centers serves as a model for the entire country. Although many may look at the CMS decision as a crushing blow to the yet to-be-finalized MBSAQIP standards, I predict that it will be viewed historically in a much more favorable light. CMS’s decision to remove the COE requirement will allow the MBSAQIP standards to focus on accurately tracking outcomes and providing feedback to surgeons and hospitals, rather than performing site visits and reviewing meeting minutes and call schedules. It will force the MBSAQIP to become a true quality improvementt program, not another accreditation program enforcing meaningless processes that discourage the creation of new programs in a time when we need to ensure better access to care for all patients suffering from obesity.

Ninh Nguyen, MD: Agree. In a study comparing outcomes of accredited versus nonaccredited bariatric centers, published in the Journal of the American College of Surgeons in 2012 [215:467-474], our group reported more than a threefold lower mortality rate when bariatric surgery was performed at accredited centers (0.06% vs. 0.21% at nonaccredited centers). The improved outcome was particularly evident for patients who underwent complex procedures such as Roux-en-Y gastric bypass and for higher-risk patients (greater severity of illness).

Medicare patients undergoing bariatric surgery are well known to be a higher-risk group of patients, and would benefit the most if their operations were performed at accredited centers.

Despite this and other scientific evidence, CMS decided to remove the requirement for facility certification that likely will place Medicare patients undergoing bariatric surgery at risk for a higher mortality rate. A decision to support accreditation should

‘I urge Medicare patients to do their homework ... because CMS has eliminated an important mandate that would guide patients toward obtaining optimal and safest bariatric care.’

—Ninh Nguyen, MD always err on the side of caution, putting patient safety first. In this case, the CMS decision errs on the side that removing the accreditation requirement will improve access to care for Medicare beneficiaries.

However, data have shown that access to bariatric surgery for Medicare beneficiaries has actually improved since the 2006 National Coverage Determination.

Another important point to note is that part of the facility certification is the requirement for an annual threshold case volume. The relationship between volume and outcome in bariatric surgery has been well established. With CMS removing the need for facility accreditation, its decision also ignored the data on this volume–outcome relationship. The end point of the decision is that Medicare patients now may potentially receive their bariatric care at a center that is ill-equipped to care for the obese patient, a center without available multidisciplinary team members, and at a center that is inexperienced, where only a few cases annually are performed. I urge Medicare patients to do their homework in selecting where to receive their care, because CMS has eliminated an important mandate that would guide patients toward obtaining the optimal and safest bariatric care.

Justin Dimick, MD: Disagree.

CMS recently conducted a very thorough review of the literature when it reopened the National Coverage Determination for bariatric surgery. The CMS evidence review process is widely accepted as the gold standard for making such coverage decisions. The agency’s staff includes methodological experts who weigh the relative merit of existing studies with the utmost rigor. After completing this process for the CMS bariatric surgery COE program, they summarized the literature as demonstrating no benefit of the COE program for Medicare beneficiaries. I agree with their assessment and have great faith in the rigor of their evidence review.

Two of the key studies in this evidence review were papers published in the Journal of the American Medical Association by our research group [JAMA [ 2010;304:435-442 and 2013;309:792-799]. The first study used clinical registry data from the Michigan Bariatric Surgery Collaborative (MBSC), a regional quality improvement collaborative. This study found no significant differences in outcomes between COEs and non-COEs. Of all the studies on the topic, this was the only one conducted using clinical registry data, and therefore the only one to have the clinical details to provide state-of-the-art risk adjustment, that is, the only one that could claim to compare apples with apples.

The second study, published this past February, was a formal policy evaluation of the CMS COE program. The Achilles’ heel of many studies evaluating the COE program is a failure to fully account for time trends. Bariatric surgery has become much safer over the past decade. A simple before-and-after comparison therefore will not yield an accurate answer—many of the existing studies use this type of study design.

In our February study, we used a rigorous design to fully account for these changes in outcomes over time.

Once these were subtracted out, we found no independent effect of the COE policy on outcomes. It was clear that bariatric surgery outcomes improved dramatically in the past decade, but the decline started well before the COE policy was implemented.

‘The CMS evidence review process is widely accepted as the gold standard for making such coverage decisions ... I agree with their assessment and have great faith in the rigor of their evidence review.’

—Justin Dimick, MD Perhaps most importantly, CMS already has made its decision and abandoned the COE accreditation requirement. Rather than debating the past, we need to work together to create a better future for our patients. That future should include moving beyond COE programs and focusing on improving outcomes at all centers performing bariatric surgery. The data that we collect in our registries need to be used better. The data should be used to generate risk-adjusted reports for hospitals and surgeons. This is a necessary first step, but we also should do more than just measure outcomes. We should develop regional networks of providers, like the MBSC, who can share data, learn from one another, and implement best practices to continue to improve bariatric surgery outcomes at a population level. I think this is a future we can all agree on and work together to achieve.

John Morton, MD: Agree! It is disappointing to have CMS decide to remove the bariatric surgery facility accreditation. I believe that close review of the evidence shows support in abundance for bariatric surgery facility accreditation. I have a clear and present concern for continued ON page 18

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On the Spot

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / NOVEMBER 2013

Gut Reaction from the Panelists Contributor True or false: Bariatrics is a declining market

Obama’s health care reform will …

The best bariatric patient understands that …

Revision bariatric surgery

CMS is …

When we are all retired and a case requires conversion to open surgery, it’s likely that …

My most reliable instrumentation

Bariatric surgery in a 2-year-old

False—busier than ever

Confuse me, then frustrate me

There’s more to life than food.

Limited to failed band patients only

Not interested in our opinion anymore

A few surgeons will still know how.

Aesculap Prestige grasper

An embarrassment to our profession

Dr. Rosenthal

It’s certainly not growing.

Not change bariatrics

He/she needs a lifestyle change.

Just one type of reoperative bariatric surgery

Making the wrong decision

The patient will have a wound infection.

Ultrasonic scalpel

Need more information

Dr. Ren-Fielding

True

No idea what implications are because no one seems to understand what it is

Surgery is a tool.

Is a reality

Misguided

Someone will be able to stumble through it.

Nathanson liver retractor

Someone needs attention (and it’s not the 2-year-old).

Dr. Gagner

No, worldwide Correct injustice parincrease (recession tially; health care is effect in United States) a right.

Best results come from behavioral changes.

Expected as we change phenotypes, not genotypes

First step to a National Healthcare System (NHS)

It will not happen—ask urologists about renal stones.

My operating table, my Iron Intern and my hands

Psychiatrist for the parents, foster care?

Dr. Morton

False. Greater awareness and recognition of obesity as disease and bariatric surgery as a safe and effective intervention will lead to more and better care.

Will provide more coverage for obesity treatment in 22 states but not 28 states, which don’t offer bariatric surgery coverage. We should have one America, not two.

Surgery is a tool.

Patients still have to make good decisions.

Is growing and is a recognition of the chronic nature of obesity

The organization that recognized bariatric surgery accreditation in 2006

We will be safe and do the right thing.

My hands

Insanity and malpractice

Dr. Dimick

False. Effective therapy always has a market.

Increase the number of insured

They must commit to lifestyle changes.

High risk, sometimes high reward

Making sound decisions

It will be fine.

Keeps getting better

Is highly controversial

Dr. Ponce

False

Still be challenging for bariatric surgery

Surgery is a “tool.”

Is part of the continuum of care

A “government” agency

We will be called for advice.

My hands

Is experimental and crazy!

Dr. O’Brien

Yes, it is. Time we smartened up

Bring the United States a little closer to Western world standards

It is a team effort.

It is part of the deal.

Outside of my area of knowledge

It will be done just fine.

A good grasper and Makes me sad, a hook diathermy revolted, deeply concerned

CMS, Centers for Medicare & Medicaid Services

current and future Medicare beneficiaries. Evidence demonstrates that Medicare beneficiaries have higher risk than the general bariatric surgery population. A 2006 Archives of Surgeryy publication, by Livingston, found that Medicare status had an increased odds ratio for mortality of 4.31. It is very clear that accredited facilities will save lives in comparison to nonaccredited centers. In this current climate of patient safety and cost containment, I am dismayed that CMS would remove a quality measure like bariatric surgery facility accreditation, which improves patient safety and lowers cost.

David Flum, MD, in his 2011 Annals of Surgeryy article [141:1115-1120] clearly demonstrates the value of the accreditation process in Medicare beneficiaries.

The 90-day mortality rate pre-accreditation was 1.5%, and post-accreditation was 0.7% (P<0.001). The 90-day readmission rate decreased 25% post-accreditation (from 19.9% to 15.4%; P<0.001). The reoperation rate declined by 33% (from 3.2% to 2.1%), and the cost fell 20% (from $24,363 to $19,746; P<0.001 for both). The 2010 JAMA study from the Michigan Bariatric Surgery Collaborative presumably found no significant differences in outcomes between COEs and non-COEs, but 19 of the 25 centers were COEs. The 2013 JAMA A study asserting that nonaccredited centers had similar outcomes to accredited centers is flawed. That 2013 study found the samee improvement for the Medicare population after the National Coverage Determination as did the Flum study with reductions in any complication (from 12.3% to 7.9%) and serious complications (from 7.5% to 3.4%).

What is stunning is that the improvements in outcomes between Medicare and non-Medicare populations were not significantly different; this is noteworthy given the high comorbid condition of the Medicare population.

The authors utilize a difference-in-differences analysis and make a flawed assumption that the control group of non-Medicare patients wasn’t exposed to the policy change. By 2006, non-Medicare patients already were exposed to the accreditation process given the requirement by private payors for hospital accreditation, and that accreditation by ACS and ASMBS preceded the CMS coverage decision.

In a recent study in Surgical Endoscopyy (2013 Aug 13.

[Epub ahead of print]), Jafari et al address both the utility of facility accreditation and the volume threshold. They used 2006 to 2010 laparoscopic, stapled bariatric surgery data from the Nationwide Inpatient Sample database, and found that inpatient hospital mortality was 0.17% at low-volume centers and 0.07% at high-volume centers.

Within the high-volume population alone, the in-hospital mortality at high-volume nonaccredited centers was 0.22% and at high-volume accredited centers was 0.06%.

When corrected for confounders with multivariate analysis, nonaccredited centers had significantly higher mortality (odds ratio, 3.6). Hallmarks of accreditation include culture of commitment, proven experience, ancillary staff and bariatric-specific resources, which are critical for the rescue of these patients if they encounter complications.

The bariatric surgery accreditation process has a rich legacy of patient safety success and a bright future of

quality improvement. With more than 725 accredited centers, there is broad access to quality care and absolutely no sense of exclusion. While I applaud the Michigan Collaborative efforts at quality improvement, I would like to emphasize that inclusion into the Michigan Collaborative requires significant payor support and has the same components as accreditation, including a volume standard, site visits and a data registry.

The MBSAQIP embraces new centers and quality improvement. In 2014, MBSAQIP will launch a national program to decrease readmissions called DROP. We believe there is no deadline for quality improvement; it is an enduring effort. While robust improvements for bariatric surgery may be due to greater utilization of laparoscopy, increasing surgeon experience and fellowship training, all of these drivers for improvement were accelerated by facility accreditation, which provides a vehicle for hospital resource prioritization.

While we hope that CMS will join all other major insurers in supporting bariatric surgery facility accreditation, we will continue our mission of safeguarding patient safety as we did in 2004, when we established bariatric surgery accreditation two years prior to CMS’s initial and appropriate decision to require accreditation.

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

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In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / NOVEMBER 2013

Sclerotherapy Offers Modest Benefit for Regain After Gastric Bypass Weight Regain Increasingly Reported After Surgery; Search On for Reasons Why B Y M ONICA J. S MITH BALTIMORE—In several studies with short-term follow-up, endoscopic sclerotherapy has shown promise as a treatment for patients who experience weight regain after Roux-en-Y gastric

bypass, but a longer-term examination of the treatment suggests its long-term effects are modest at best.

Weight regain is increasingly being reported in studies of Roux-en-Y gastric bypass patients with long-term follow-up. Sometimes the culprit is a physical complication or adaptation beyond the patient’s control. Dilated gastrojejunostomy (GJ), for example, may lead to loss of satiety due to faster emptying of the gastric pouch.

This problem can be addressed by revisional surgery, but that carries the risk for morbidity or complications associated with the surgery. There also are a few minimally invasive endoscopic procedures, such as suturing, plication, or injections of a sclerosing solution into the submucosa of the GJ that may be effective.

Earlier this year, at the annual meeting of the Society of American Gastrointestinal and Endoscopic

’Even redo bypass surgery doesn’t seem to have the same impact on weight loss as it does the first time.’

—Thadeus Trus, MD

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Surgeons (SAGES), Magdy Giurgius, MD, fellow, Minimally Invasive and Bariatric Surgery, University of Missouri, presented his team’s assessment of the long-term outcomes of endoscopic sclerotherapy on 48 patients who underwent that treatment for dilated GJ diagnosed by upper endoscopy.

The patients, 92% female, had undergone gastric bypass between 1991 and 2007, experiencing an average weight loss of 60.10 kg (SD, 24.87 kg), and a mean weight regain of 20.86 kg (SD, 18.28 kg). Preprocedure measured mean GJ diameter was 20 mm (SD, 3.6 mm) and the average volume of sodium morrhuate injected was 12.8 mL per session (SD, 3.7 mL).

After a session, patients were given narcotics for pain control, proton pump inhibitors, and instructions to adhere to a clear liquid diet for the first five to 24 hours after the procedure. After the first injection, patients returned to the clinic for re-evaluation and were scheduled to receive a second or third sclerotherapy session if needed.

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More than half of the patients, 56.2%, had a year or more of follow-up; about 40% had two or more years of followup, and 15% had four or more years of follow-up. Weight stabilization was seen in 46%, and the mean weight loss after sclerotherapy was 4.3 kg (range, 24.04 kg lost to 15.42 gained), which was not statistically significant.

Those outcomes remained the same on a multivariate analysis even when controlling for patient age, GJ diameter, volume of sodium morrhuate injected, number of sclerosing sessions or length of follow-up.

“In conclusion, the long-term result of sclerotherapy for weight regain after a gastric bypass is only a modest weight loss, which did not achieve significance in our patient population,” Dr. Giurgius said. The researchers were not able to identify any predictors of weight loss.

To date, no stoma-tightening procedure has been shown significantly effective in the long run, said Thadeus Trus, MD, associate professor of medicine, Geisel School of Medicine, Dartmouth Medical School, Hanover, N.H. “There are no good long-term studies. Even redo bypass surgery doesn’t seem to have the same impact on weight loss as it does the first time,” said Dr. Trus, chair of SAGES flexible endoscopy committee.

As researchers struggle to identify the reasons for weight regain, which do not appear to be associated with pouch or stoma size, or preoperative body mass index or HbA1c levels, the

reality is that many patients do regain weight. Most do not regain 100% of their excess weight loss, but it can still feel like a frustrating setback.

The first step for Dr. Trus’s patients with weight regain is a meeting with the staff dietitian to monitor exercise levels and evaluate how their eating has changed over time as they are able to accommodate more and richer foods.

“A lot of patients, once you have them sit down and do a chart, realize how much they’ve backslided since they started the program,” Dr. Trus said.

Care providers also counsel patients

To date, no stoma-tightening procedure has been shown significantly effective in the long run. on the probability of weight gain with age, which is seen across nearly all populations.

After ruling out medical problems that may cause weight gain, such as congestive heart failure or hypothyroidism, they evaluate patients by a swallow or endoscopy for possible

gastrogastric fistula. They generally do not perform revisional operations on patients unless there is a gastrogastric fistula or a vertical banded gastroplasty that has come apart.

Although Dr. Trus and his colleagues have performed stomal-tightening procedures, they have not been satisfied with the outcomes and do not recommend them.

“The results have been all over the map, nothing durable,” he said. “Most patients are paying out of pocket, so we tell them it’s probably not worth their money.”

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medical tourism for any procedure, the most commonly cited figures come from a 2008 survey by the consulting firm Deloitte, which estimated that 750,000 Americans traveled abroad for medical care in 2007 and projected that the number would rise to more than 10 million annually by this year. The same survey suggested that outbound U.S. patients would spend $27 billion this year alone on health care outside the country, a loss of more than $200 billion in revenue for the

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / NOVEMBER 2013

American health care market.

The most commonly cited reason that patients from the United States seek medical care abroad is cost, but the phenomenon is probably better seen as a constellation of factors revolving around availability and access, a concept first suggested by Canadian bariatric surgeon Daniel Birch, MD, in a 2010 paper (Am ( J Surgg 2010;199:604-608). It is not merely a function of bottom-line cost alone, but more likely is driven in part by the policies of health insurance companies. An American patient may not have insurance because of the high cost; or if they do, they

The most commonly cited reason that patients from the U.S. seek medical care abroad is cost, but it is probably better seen as a constellation of factors. do not qualify for coverage of a bariatric procedure. In Canada’s publicly funded system, everyone who qualifies is covered, yet less than 1% of eligible patients are offered a bariatric option. And, a 2009

study found that the average wait time for bariatric surgery in Canada is more than five years (Can J Surgg 2009;52:229-234).

Canada’s access issues mirror regional problems in some areas of the United States, where there are fewer bariatric surgeons or where insurers may deny coverage multiple times. In the U.S. private payor system, it is much more difficult to quantify how often insurers deny patients coverage for bariatric surgery, or how long patients may have to wait for approval.

Aetna, for example, stated it would not provide General Surgery Newss with information on the number of bariatric procedures it approves, or the rate at which it denies patients. UnitedHealthcare and WellPoint, the two largest health insurance companies in the United States, did not respond to similar requests for information.

Despite this, patient surveys and studies by surgeons over the past decade suggest that the rate is probably between 20% and 30%, depending in part on a particular center’s initial eligibility criteria. For example, a 2008 survey of surgeons and patients done by Harris Interactive and funded by the American Society for Metabolic and Bariatric Surgery (ASMBS) found that 25% of patients considering surgery were denied coverage three times before getting approval. A 2010 study presented at the Society of American Gastrointestinal and Endoscopic Surgeons annual meeting found that approximately 21% of patients who satisfied medical and surgical criteria for bariatric surgery failed to receive insurance approval (abstract S096). A study presented that same year at the ASMBS annual meeting by surgeons from the Gundersen Lutheran Health System in La Crosse, Wis., suggested that 30% of candidates for bariatric surgery could not get the procedure because of insurance problems, including “denials or unattainable prerequisites,” one of the study’s authors, Ayman Al Harakeh, MD, said.

“In our area, it’s difficult for patients with Medicaid to get approval even if they meet all of the criteria,” said Scott Shikora, MD, then ASMBS president, at the time. “They seem to arbitrarily reject applications, require lots of paperwork and take a long time to approve anything.”

In total, less than 0.5% of the more than 22 million people in the United States who are medically eligible for bariatric surgery actually undergo an operation, data from the National Health and Nutrition Examination Survey suggest (NHANES; Surg Obes Relat Dis 2010;6:8-15).

The NHANES data is important because it also clarifies the socioeconomics of bariatric surgery: Despite the fact that bariatric eligibility—that is, the need to get surgery—is associated with worse health and lower economic status, most

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bariatric procedures are performed in white patients (75%) with greater median incomes (80%) and private insurance (82%).

For those denied access and pressed financially, bariatric surgery in Mexico is unquestionably cheaper. A 2012 report by Bloomberg put the cost of a gastric bypass in the United States at $32,972 compared with $10,950 in Mexico. Anecdotally, even lower prices can be found. One Tijuana surgery center offers Roux-en-Y gastric bypass for $6,950, a package that includes everything from antibiotics, pain medicine and fees for the hospital, surgeon and anesthesiologist to a “car with driver for sightseeing [and] shopping.”

The Mexican System The Bridge of the Americas connects El Paso and Ciudad Juarez across a concrete basin that holds little more than a trickle of the Rio Grande. It is clogged with human traffic from sunup until sundown. Each day, 14,000 people cross the bridge on foot alone, making it the busiest footpath between the United States and Mexico, according to American officials.

By some estimates, El Paso is the safest big city in the United States, whereas Cuidad Juarez ranks among the most dangerous in the world. Yet, as one drives through Cuidad Juarez, there is little sense of that danger. With the exception of gated entranceways to the nicer neighborhoods, nothing in the high-end suburbs where boutique, tourist hospitals offer their services suggests the cartel violence that has been synonymous with Juarez since 2005.

In Mexico, health care is delivered to patients through one of two very different systems: At one end, there is a public health system that provides all Mexican citizens with care through public hospitals; at the other are private health care organizations, often subsidiaries of larger corporations, that operate entirely in the free market.

Recently, on the east side of Juarez, where construction is booming, the Mexican corporation Grupo Empresarial Angeles (GEA) built a private medical facility, the Hospital Angeles. In addition to 20 hospitals around the country, GEA also owns several financial services companies, radio and television stations, and more than two dozen hotels.

When Mr. Sanchez, who was an independent contractor and did not have health insurance, decided to go ahead with bariatric surgery, an acquaintance referred him to Dr. Jorge Blake, a general surgeon at Hospital Angeles in Juarez.

Like many private hospitals in Mexico, Hospital Angeles has the look and feel of a brand new airport hotel, making it a much more pleasant experience than the typical Catholic-run hospital in the United States.

Across the border. Traffic by both foot and car is persistently heavy between El Paso in the United States and Cuidad Juarez in Mexico. Each day, about 14,000 people cross the bridge on foot alone, making it the busiest footpath between the United States and Mexico.

Photos by Gabriel Miller.

“His office was sort of opulent,” Mr. Sanchez said. “He sounded very professional, he sounded like he knew what he was talking about. He presented an entire package; he presented himself as a team of doctors.”

Mr. Sanchez saw a variety of specialists, and was cleared by all with the exception of the pulmonologist, who asked that Mr. Sanchez, approximately 206 kg (455 lb) at the time, lose weight by swimming every day before surgery. Mr. Sanchez began swimming, but within five weeks he was offered a promising contract for a position in Mexico City, one that might open up business opportunities throughout South America. He told Dr. Blake he would have to postpone the surgery.

“In hindsight, I think that’s what turned a lot of the situation around. I started to get the feeling that I shouldn’t have done the surgery.”

Dr. Blake did not agree. “Before, he was like, ‘You have to go through this entire process and get ready.’ After I said that [I wanted to postpone the surgery], he’s like,

‘No, no, no, let me talk to everybody on the team and we’ll discuss it,’ ” Mr. Sanchez said.

“And he said, ‘You know what, I spoke to everybody and we can do the surgery.’”

A Juarez Surgeon Three miles down Paseo de la Victoria Boulevard from Hospital Angeles stands the office of Jose Rodriguez, MD, one of the most experienced bariatric surgeons in northern Mexico. Like Hospital Angeles, where Dr. Rodriguez formerly practiced and still occasionally does a few cases, his offices at Hospital Star Medica exude comfort and luxury, but for the most part, the similarities end there.

Dr. Rodriguez’s small group at Star Medica now has done nearly 10,000 laparoscopic procedures, including more than 6,000 gastric bands and nearly 2,000 sleeve gastrectomies. At the moment, 70% of his caseload is U.S. citizens, primarily patients who either don’t have insurance or have insurance but have been waitlisted by their insurer or don’t have access to

surgery because of a limited number of surgeons in their area.

“The patients get desperate and they try to figure out another option,” Dr. Rodriguez said.

The complex health care system of the United States works to the advantage of surgeons like Dr. Rodriguez, who, by comparison, have an enormous amount of control over their practices.

Dr. Rodriguez’s family has interests in construction, real estate and agriculture, each of which routinely generates profit margins of between 2% and 12%, Dr. Rodriguez said. His business, with a 12% to 18% margin, is the most profitable among the family’s business holdings.

He does this primarily by keeping costs low, and then passes the savings on to his patients, he said. He negotiates directly with band and staple companies to order in bulk at reduced prices. And, when he found out that banks in the United States were offering medical tourism patients 18% interest rates to pay for procedures in Mexico, he offered financing at lower rates.

Greed in the United States, by surgeons, by insurers, by hospitals, has created the medical tourism market, Dr. Rodriguez said. “Everybody wants 30% to 40% percent of the total amount of the price of the surgery and that’s a big problem. When I started thinking as a businessman, that’s when I figured out the numbers and reduced the price [of operations],” Dr. Rodriguez said.

“It’s not a cheaper price; it’s a fair price,” he added. As one example of the skewed economics, in many cases it is cheaper for a patient to fly from the United States to Juarez to have their gastric band filled than it is to have it filled in their hometown; 50% of Dr. Rodriguez’s band patients choose to have their fills done in his office.

Perhaps most importantly, Dr. Rodriguez’s practice generates 30% of Star Medica hospital’s income, giving him significant influence with the hospital’s ownership. One of the most critical issues, in Dr. Rodriguez’s eyes, was getting Star Medica’s owners to understand that complications, although rare, are part of the business, and that although patients should be responsible for the cost of complications, it is not the patient’s fault and a complication should not ruin a patient financially.

The Operation Although Mr. Sanchez had not finished the course of preoperative exercise that his pulmonologist, Dr. Jose Luis Alvay Perez, had demanded, his surgeon at Hospital Angeles, Dr. Blake, “truly made it sound like it was not that big of a deal,” Mr. Sanchez said.

On May 26, 2008, Mr. Sanchez see MEDICAL TOURISM 24

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In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / NOVEMBER 2013

MEDICAL TOURISM

my kid brother [Eric] and she said, ‘You know what, if we don’t get Pepe out of here, he’s not gonna make the weekend.

We gotta get him out of here.’” Mr. Sanchez’s family made the decision to transport him to the United States with the hope of saving his life.

In order to get him to El Paso, they would have to choreograph and execute a cross-border transfer in which one ICU ambulance would pick up Mr. Sanchez in Juarez and take him to the border, where an ICU ambulance from the United States would be waiting. Mr. Sanchez, critically ill, intubated and on life support, would be wheeled over the Rio Grande and across the border.

Although Mr. Sanchez’s bariatric surgeon, Dr. Blake, gave the family the impression that he would be relieved to release him, Hospital Angeles administrators were not.

“When the ambulance showed up … they didn’t want to release him, they wanted their money first,” Eric Sanchez said. “I went in there, and finally I got upset. I basically told them, ‘You are going to release my brother now.’”

“Their response was well, ‘You’re going to have to pay for everything that he owes,’” Mr. Sanchez said, recounting what he had been told by family members present. “‘And you’re going to have to sign this release.’ So they did. They gave them my credit card, paid them the $60,000 and signed the release form.”

Dr. Blake did not respond to a request for comment, and Hospital Angeles administrators would not provide information on their bariatric surgery program or provide access to their facility.

jcontinued from page 23

underwent gastric bypass surgery. Following the procedure, his first memory is of Dr. Alva y Perez asking him to sit upright.

“I remember that I had my gown on and the gown just started being covered in blood [flowing] out of the six little holes that I had, just like everywhere. They started to take my blood pressure and I kept hearing that ‘beep’ going down and down and down and down, I was losing blood.

I started feeling like they were throwing buckets of cold water on me. It was a cold sweat. That’s the first time I saw concern in somebody’s eyes, and that was Dr. Alva.

He looked at me and he said, ‘You know what, this has nothing to do with me. You need to go to Dr. Blake.’

“I could see everybody in the room running around, it was chaos. I don’t remember exactly the details of how long it took, but … the explanation he gave me is that they left a few ‘leaks,’ and they were going to have to go back in there and fix it,” Mr. Sanchez said. Dr. Blake said the leak repair would be done laparoscopically.

After recovering for several days with drains, Mr. Sanchez’s aunt, a nurse, said she did not like the color of some of the drainage from Mr. Sanchez’s abdomen.

She asked a doctor at Hospital Angeles to culture a sample. Around that time, Mr. Sanchez said his physicians also gave him several glasses of grape juice; having not eaten for nearly a week at this point, he was famished. “Sure enough, the stuff that started coming out of my drains looked purple,” he recalled.

Meanwhile, the nursing staff at Hospital Angeles had contaminated Mr. Sanchez’s culture, losing another two days. By the time they had the results, they realized that Mr. Sanchez may already have been going into septic shock and ordered a third operation, this one an open procedure, to clean out infected tissue. Mr. Sanchez’s last memory in Mexico is of being wheeled into the operating room. He would wake up days later in an ICU in El Paso, Texas.

The Crossing “It was at that point that the doctor– patient relationship got bad, with me specifically,” said Eric Sanchez, Jose’s brother.

As his brother’s condition deteriorated, Hospital Angeles’ luxurious sheen began to wear away.

“It was all a facade,” Eric Sanchez said.

“It’s a really nice hospital; his room had two flat-screen TVs; it was a really large room; it was beautiful. [But] they didn’t have a chair to sit my brother in, they didn’t have a [bariatric hospital] bed. If you’re gonna claim that you’re a bariatric hospital, have a bariatric bed. Don’t have a little bed.”

Mr. Sanchez’s family was forced to

Back in the United States

Above: Hospital Angeles in Juarez, Mexico, where Jose Sanchez experienced major complications after bariatric surgery in 2008. Below: three miles down the road, the interior of Hospital Star Medica and the office of Jose Rodriguez, MD, an experienced bariatric surgeon whose group‘s caseload is made up of 70% U.S. citizens.

Photos by Gabriel Miller.

buy, and transport to Juarez, an electronic medical chair that he slept in. At one point, during which Hospital Angeles physicians thought Mr. Sanchez might have had pneumonia, fluid was aspirated from his chest while Mr. Sanchez was propped up on a waiting room coffee table and held in place by his brother and a cousin.

“This is how ill prepared they were,” Eric Sanchez said.

Eventually, even the relationships among the Hospital Angeles physicians began to visibly fray, according to Mr.

Sanchez’s family.

One physician recused himself entirely from caring for Mr. Sanchez. “It got to the point where he was just like, ‘I’m removing myself from this case,’” Eric Sanchez said. “One of the doctors just flat-out said, ‘I’m out. I’m not agreeing with the way that this is going … I’m out, best of luck.”

One of Mr. Sanchez’s aunts confronted the physicians primarily responsible for his care. “From what she tells me, they both started blaming each other for what had happened, in front of her. And that’s when my aunt, who is a nurse, talked to

In El Paso, intensivist Erasto Cortes, MD, had agreed to take on Mr. Sanchez’s case based in part on his friendship with a member of Mr. Sanchez’s extended family.

Clinically, it was almost certainly a losing proposition; financially, it definitely was.

Dr. Cortes gave Mr. Sanchez a 10% chance of surviving. The bariatric team at Providence Memorial Medical Center diagnosed a leak from the distal stomach at the gastrojejunostomy anastomosis, which eventually, in the context of peritonitis and sepsis, developed into enterocutaneous fistulae.

Bruce Applebaum, MD, an El Paso surgeon who was on the team that saved Jose Sanchez’s life, described Mr. Sanchez as “teetering on the brink,” with anything he ate or drank spilling into his abdominal cavity while sepsis raged throughout his body.

Early in his care, Mr. Sanchez said he was in the operating room three times a week, requiring multiple washouts. Eventually, the team of surgeons reversed the sepsis and applied a split-thickness skin see MEDICAL TOURISM page 26

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MEDICAL TOURISM jcontinued from page 24

graft. For an entire year, Mr. Sanchez survived on IV nutrition. Eventually, surgeons restored his gastrointestinal tract. In a presentation at an annual meeting of the Society of Laparoendoscopic Surgeons, Benjamin Clapp, MD, a bariatric surgeon in El Paso who was part of the surgical team responsible for Mr. Sanchez’s care, estimated the cost to the hospital at $640,000.

Mr. Sanchez and his family paid the hospital $20,000 at the beginning of his

w w w. a m e r i c a n h e r n i a s o c i e t y. o r g

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care, and have made many smaller payments since, and although the entire experience has destroyed Mr. Sanchez financially, he is more or less all paid up at this point.

As for Dr. Cortes, the physician who agreed sight unseen to take a patient with a body mass index of 47 kg/m2, a bariatric leak and in septic shock, Mr. Sanchez says, “I owe him my life. … He accepted to take the case and to this day, I have not received a single bill from that man. I have not paid him any money. Thanks to God and him, I’m alive. I don’t even know what I should

do to show how grateful I am to him.”

A Growing Trend, and Its Unintended Consequences Every source interviewed for this story emphasized that they did not wish to portray surgeons in Mexico, or Mexican health care more broadly, as substandard. Nevertheless, the increase in “bariatric tourism”—which brings complications that are unavoidable for even the most experienced surgeons— raises important questions about how patients, surgeons and professional societies should respond.

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Perhaps the most important clinical issue is variability across practices, often in technical areas that no layperson would routinely know to ask about, like surgical technique.

Dr. Applebaum, who says he often saw complications in medical tourists, has seen a variety of surgical techniques and postoperative complications among those who go across the border for surgery.

“I’ve seen a lot,” Dr. Applebaum said. “We have seen some mind-boggling things occur, like a guy who had a bypass that didn’t have a bypass. They went in, made surgical scars and supposedly did a bypass and nothing actually was done. What took place, what transpired, who knows?”

More often, patients come in with band slippages or needing fills or other routine postoperative care, and do not understand why a U.S. surgeon is reluctant to take a patient who had their bariatric operation done in Mexico.

Not only are U.S. surgeons unfamiliar with the case, they also stand to lose financially because of the reimbursement model for bariatric surgery in the United States, which emphasizes the operation itself over follow-up care. When a surgeon does take a patient with a slipped band, for example, they must either demand cash payment or, oftentimes, fight tooth and nail with an insurer whose system flagged a patient that showed up in their system with bariatric complications but no bariatric operation on record.

Severe complications like leaks and bowel obstructions are far more worrisome. The very nature of medical tourism makes it difficult, if not impossible, to accurately track late outcomes, like weight loss and complications.

“To me, that’s a black box. That’s why it’s so dangerous to encourage people [to get surgery abroad],” Dr. Clapp said.

“You can’t force people not to go, but the problem is that there is no tracking of outcomes—no tracking at all.”

In a free market, the defining principle is caveat emptor, but there often literally is no way for a patient to accurately verify a foreign surgeon’s complication rate.

And when a complication does arise— as can happen even in the most experienced hands—patients do not have the knowledge to assess an ICU, nor are they aware of the financial costs.

“Even the best [surgeons] will have complications and therein lies the problem,” Dr. Applebaum said. “If you do enough of these, you are going to have a complication and the problem is the capacity to deal with the complications.

Do you have the resources to take care of somebody who is very sick for a month?”

During the initial stages of a project to offer medical tourists in Cancun bariatric

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recession had slowed medical tourism in 2007 and 2008, but surveys of patients suggested that the growth rate would return to 35% annually by 2010, and estimated that 1.6 million Americans would be leaving the United States for medical care by 2012. The report also noted that at least four insurers had started medical tourism programs covering patients’ care in Thailand, India and Mexico. And two states, West Virginia and Colorado, had also introduced bills that provided incentives to state employees to travel abroad for medical care. Although neither bill passed, they demonstrate that legislators

view medical tourism as a viable government policy.

Increasingly, surgeons in the United States, as well as other physicians, will be seeing their patients opt for care abroad.

In advising U.S. health care organizations, Deloitte refers to the “growing pains” the medical tourism industry will undergo as it accelerates. For people like Jose Sanchez, these growing pains are life-threatening complications. “[My surgeon in Juarez] truly made it sound like it was not that big of a deal, which is, by the way, completely different than what any doctor here will tell

you,” Mr. Sanchez said at a coffee shop in El Paso.

“What I would like is for people to realize that they really have to think this through and they really do have to think about the fact that there are complications. Things are not easy; it’s a different country. Things are different. And look, I was born there; I was raised there.

I thought I was familiar with the whole thing. And I had these kinds of troubles.

Can you imagine somebody who doesn’t even speak the language, or is completely unaware of how things run over there?”

Jose Rodriguez, MD, an experienced surgeon in Juarez, Mexico, believes lower prices for bariatric surgery in his country are fair, not cheap.

Photo by Gabriel Miller.

operations by U.S. surgeons, Dr. Applebaum toured a private hospital in Mexico touted as one of the nicer, “boutique” hospitals catering to American medical tourists. “You look at an ICU, it’s just different. … It just doesn’t seem to be the same equipment, the same grade of quality, that we have here, so their capacity for handling a major catastrophe or complication, which inevitably is going to occur, I just don’t think they have the ability or resources to take care of it [at those facilities].”

Dr. Applebaum did not continue with the project.

Surgical societies are aware of the trend but may be reluctant to take a firm stand. “The surgical societies, including the American College of Surgeons (ACS), which has a very weak statement on medical tourism, need to be more aggressive,” said Dr. Clapp.

The ASMBS released its statement on “global bariatric health care” in 2011, which goes farther than the ACS’ published position. For example, the ASMBS has taken the position that “extensive travel to undergo bariatric surgery should be discouraged unless appropriate follow-up and continuity of care are arranged and transfer of medical information is adequate.”

Some of the language appears to be directed specifically at insurance companies. Mandatory referral across international borders by insurers is opposed by the ASMBS when a local bariatric program is available. The ASMBS also opposes the creation of financial incentives by insurers that limit patients’ choices and encourage travel abroad for surgery.

Statements like these likely will have little effect on the rise of medical tourism, however. In a 2009 updated report on the state of medical tourism, the consulting firm Deloitte found that the

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DENIAL

jContinued from page 1 dysfunction within an organization. (In fact, Taylor was fired at Bethlehem Steel within three years of implementing his strategy.)

Congressional hearings and the wellknown Hoxie report of 1915 described the dehumanization and harm potentially done to the worker in this management model, despite the possibility of improved wages. The increased productivity was entirely seductive for management, and this in a sense kept them from seeking

better alternatives. One of the conclusions in the Congressional report was that there seemed to be no solution, and that management and labor would need to have regular negotiations to manage the dilemma. It is this sort of management policy that has evolved a global economy in which productivity growth, rather than value, is the goal.

A few decades after Taylor, statistician W. Edwards Deming, PhD, helped evolve the science of organizational management and quality, culminating in what has become known as his Theory of Profound Knowledge. He described the

Instead of facing the problem head-on and with sincere concern, the constant denials and rationalizations resulted in a severe decline in [Ford’s] reputation, and production of the Pinto finally ended in 1980. importance of the worker having the authority to help identify and implement improvements to work processes. Recognizing that the outputs of a system have inherent variability, and that changing the process requires management and front-line input, he described the flaws in blaming the worker for poor process

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output. This was famously demonstrated in his red bead experiment.

With little interest being shown in the United States for moving past the principles of “scientific management,” Dr. Deming joined Gen. Douglas MacArthur to help with reconstruction efforts in Japan after World War II. His theories were embraced by the Japanese organizations that had great interest in the implementation of his principles— particularly in the automobile industry. High-quality Japanese cars would change the industry forever.

As Japanese cars entered the U.S. market, the result was a major shift to smaller, more economical cars. After initial resistance, auto makers in the United States began to produce smaller cars with better gas mileage in an attempt to compete. Humorist Dave Barry gave his account (Dave Barry Does Japan; Ballantine Books 1993) of the American automobile industry’s reaction: [The] U.S. auto makers decided that, OK, they would make small cars. … No, they would make really bad small cars.

The shrewd marketing strategy here was that people would buy these cars, realize how crappy they were, and go back to aircraft carriers. This strategy resulted in cars such as the Ford Pinto, the Chevrolet Vega, and the American Motors Gremlin—cars that were apparently designed during office Christmas parties by drunken mail-room employees drawing on napkins; cars that frequently disintegrated while they were still on the assembly line.

With the increasingg complexity p y of new global competition, and a different concept of the automobile, Ford Motor Company developed a plan to get a compact car on the market within 23 months. This plan was led by Lee Iacocca, who became president of the company

Opinion

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / NOVEMBER 2013

during the implementation of the plan.

Mr. Iacocca demanded that engineers design a car that would weigh less than 2,000 pounds and could be priced at less than $2,000. The Ford Pinto became an instant success, ultimately having more than 3 million sold over the next decade.

However, a problem was identified in the design during initial production: The gas tank was susceptible to fire from rear-end collision, but probably because of a slight difference in costs, it was used despite the fact that Ford actually held a patent for the safer placement of the tank.

Although research findings were inconclusive, there was a popular belief that the Pinto’s safety was seriously flawed.

Then Ford really blundered. They created an internal document weighing the costs of redesigning the Pinto against the costs of fighting the negligence lawsuits and settlements caused by the design flaw. When this paper came to light, Ford’s decision to build the less expensive tank arrangement, together with seeming insensitivity to human life, created a damaging hostility toward the company. Instead of facing the problem headon and with sincere concern, the constant denials and rationalizations resulted in a severe decline in the company’s reputation, and production of the Pinto finally ended in 1980. Mr. Iacocca left and Dr. Deming subsequently was hired by Ford, where he helped apply the principles of listening to the customer, using intrinsic motivation for worker engagement and continuous process improvement, all of which resulted in a more successful organization.

In a much more famous example of denial by an organization after fatal consequences, NASA’s shuttle program was the focus of a Congressional investigation after the Columbia disaster in 2003, in which dislodged foam insulation led to the disintegration of the shuttle as it reentered Earth’s atmosphere. p Manyy p people know that a failed O-ring was the mechanical cause of an earlier shuttle accident (the Challenger in 1986), but few people realize that the initial investigation report actually identified NASA’s management structure and culture as a

problem that could and would lead to subsequent additional accidents.

Partly because funding became the primary focus of NASA’s top management, and partly because of the very same poor communication and leadership patterns revealed in the earlier report, these vital recommendations were ignored. Just as in the case of the first accident, the bureaucratic and rigid decision-making process of upper-level managers led to the denial of the possibility that a piece of foam could damage the wing. To add to the absurdity, as proof, these lesser-trained, but higher management officials offered

the analogy of an empty styrofoam cooler flying out of the back of a pickup truck and hitting the windshield of a car. They gave this explanation despite the fact that engineers using high school–level physics had demonstrated that the foam tile could cause significant and possibly catastrophic damage.

Engineers made three separate requests for Department of Defense (DoD) imaging of the shuttle in orbit to more precisely determine damage. Although the images were not guaranteed to show the damage, the capability existed for sufficient imaging resolution to provide

meaninful examination. NASA management did not honor the requests, and, in some cases, intervened to stop the DoD from assisting.

In health care, we have been facing increasing complexity for decades, yet our management structure is more like the principles of Taylor than Deming. This is so despite the fact that our primary focus is to care for one another, and not to produce a widget. In the Institute of Medicine’s 1999 report, “To Err is Human,” it was estimated that tens of thousands of patients die each year in the see DENIAL PAGE 30

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DENIAL

jContinued from page 29 United States due to preventable hospital errors. Since that time, numerous simplistic attempts at improving patient safety have been implemented: government mandates, hospital quality and compliance departments, center of excellence models, etc. After a decade of these efforts, the most recent estimates of unnecessary deaths are still in the hundreds of thousands of patients per year.

Clearly, we are in denial.

Hospitals and academic medical centers continue to highlight the good that they do for patients and their communities. And clearly, there is wonderful care within these hospitals and institutions. But, as Dr. Deming would have identified, we can all do much better if we can change our thinking and understand the harm done based on the processes we are continuing to use in the face of increasing complexity.

Two surveys were published recently that demonstrate the denial of management in health care and the depression that results from the worker attempting to continue to provide care within that system. The first survey, published in Health Affairs, asked 922 chairmen of hospital boards how their hospital rated on quality and performance measures compared with other hospitals (2010;29[1]:182-187). Of the 722 who responded, 99%

TRAUMA TRENDS jcontinued from page 1

awareness and medical care. But that drop has been offset by a marked increase in fatalities related to falls, the rate of which rose by 46% over an eight-year period.

“It’s clear that the mix of injuries that are currently being seen are substantially different than 10 years ago,” said primary investigator Kristan L. Staudenmayer, MD, MS, assistant professor of surgery in trauma and critical care at Stanford University, Stanford, Calif.

Overall, total trauma-related mortality decreased by 6% between the years 2002 and 2010 (P<0.01). The drop occurred despite an increase in the number of miles driven by Americans and a 10% increase

said their hospital was equal to or better than the average. (It’s the other guy that is the problem; we’re fine.) It is the same kind of denial seen at Ford and NASA in the face of increasing complexity and system failures.

In a survey by the American College of Surgeons of nearly 8,000 U.S. general surgeons, it was documented that more than 30% of us screened positive for depression and more than 40% had symptoms of burnout ((Ann Surg 2011;250:463-471). The most predictive work-related factor in depression and burnout was if the surgeon’s pay was based on fee-for-service (i.e., you eat what you kill).

I believe these trends are, in part, due to increasing complexity with a fragmented system of patient care.

But this is where hope enters. We don’t have to continue to care for patients in a model that is more than a century old. We have a more complete science evolved over the past century as well as lessons from other industries to help us understand, develop and implement an improved patient care model. Doing just that will allow patients and physicians to be cared for in a model that is designed to deal with our increasingly complex world.

In next month’s article, the dialogue will focus on the hope we should embrace for our future. We cannot only rely on the government, the current leadership or even some benevolent dictator. But we can collaborate with one another, with our patients and with those who would like to participate in a transformational effort that can be

in the number of firearm injuries.

Researchers from Stanford examined different data sources for the years ranging from 2002 to 2010: The American College of Surgeons’ National Trauma Data Bank and the Centers for Disease Control and Prevention’s (CDC) National Center for Injury Prevention and Control and its Web-based Injury Statistics Query and Reporting System (WISQARS). The researchers used the Cochran–Armitage test for trend to analyze mortality trends by year.

In 2002, motor vehicle collisions caused about 16 deaths per 100,000 people living in the United States. In the same year, falls caused only about six deaths per 100,000 people. But by 2010, the picture changed markedly. Falls caused almost nine deaths per 100,000 people, whereas motor vehicle deaths had fallen to 12 per 100,000.

Deaths from firearms stayed relatively stable between 2002 and 2010 at 10 per 100,000. Firearm injuries were seen more frequently in hospitals, increasing from a reported 31 to 34 per 100,000 people.

The study was not designed to examine variables like patient frailty or age. Even so, the results strongly suggested that the demographics of patients arriving in trauma bays have changed. Today, trauma patients are older and sicker than a decade ago.

Dr. Staudenmayer said the changing demographics of patients needs to be taken into account when apportioning future trauma resources and

focused on value for the patient, rather than the fear of not hitting productivity targets.

In one example of the hope we can expect in a new model for care and research, investigators at the University of Washington decided to look for help in solving a complex medical research problem: defining a specific retrovirus protein structure that could help identify a new treatment for AIDS. After more than a decade of failure by many labs worldwide, the researcher decided to post the problem on an Internet gaming community site, called the Fold-It community. In three weeks, the gaming community successfully identified the retrovirus structure, for free. In the publication that followed, the third author was the “Fold-It Contenders Group” and the fourth author was “The Fold-It Void CrushersGroup” (Nat Struct Mol Biol.l 2011;18[10]:1175-1177).

My hope lies in the potential that this kind of collaborative effort, especially in actual patient care, can become the norm rather than the exception in health care.

In complexity science, one principle is that transformational system change can only occur when the system is on the verge of chaos. My hope lies in the belief that our health care system is close to that edge.

—Dr. Ramshaw is Chairman and CMO, Transformative — Care Institute (non-profit) and Surgical Momentum LLC (for profit), and Co-director, Advanced Hernia Solutions, Daytona Beach, Fla.

creating prevention strategies.

“The big challenge is that we are going to be dealing with patients who are more frail and have more comorbidities. That’s going to mean that we have to provide not just surgical care, but increasingly more medical care to these patients,” Dr. Staudenmayer said.

“As our population ages, we’re going to have to adjust our resources appropriately and keep close tabs on the trends in trauma-related mortality so we can continue to calibrate our resources against the needs of the population,” she added.

The study confirmed earlier reports that deaths from motor vehicle collisions occur less frequently. Accidents that resulted in injuries also declined, with fewer injuries per accident in 2010 compared with 2002.

This study was the first analysis of national trauma trends using these multiple data sources and the first analysis of its kind that depicted what trauma surgeons are seeing in their emergency rooms.

Experts noted that the study had several significant limitations. The study investigators made comparisons across four different data sets, but each data set had its own limitations and methodologies.

Moreover, investigators could not identify the number of patients who did not seek or receive treatment, nor could they discern the frailty of patients before injury.

Deaths from burns, drowning, poisoning, suffocation and adverse effects were excluded from the study.

This year marked the 75th anniversary of the AAST Annual Meeting.

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