March 2015

GENERALSURGERYNEWS.COM

March 2015 • Volume 42 • Number 3

The Independent Monthly Newspaper for the General Surgeon

Opinion

Navigating the Complex World Of Breast Cancer Genetics

The Power of The Bean

Surgeon Covers Which Tests in Which Patients and When, And What To Do With the Results Once You Have Them

B Y F REDERICK L. G REENE , MD

R

ecently I have had a great deal of positive feedback to support my excessive drinking habit—caffeinated coffee, that is!

It seems that there may be great therapeutic benefit emanating from the coffee bean or whatever other magical nutrients nu that may appear in coffee. Althou ugh dark chocolate may be goood for the heart, imbibin ng caffeinated coffee in llarge quantities seems destined to be a good d neoplastic preventative. n There have been many T studiees that boast the health benefitss of coffee. Here are just a few of the results supporting the notion that caffeinated coffee reduces risks of certain types of cancer: • Oral cancer: More than four cups of coffee per day decreases oral and head cancers by 39% (Can Epidemiol Bio Prev, June 2010).

• Uterine cancer: Women who drink more than two cups of coffee per day have less chance of developing uterine cancer (Can Epidemiol Bio Prev, January 2015).

• Prostate cancer: Men who have six cups of coffee per day reduce their prostate cancer risk by 60% (Sci Daily, December 2009).

• Brain cancer: At least five cups of coffee per day prevents certain types of THE BEAN page 22

Lower BMI Patients See Major Improvements in Comorbidities

B Y C HRISTINA F RANGOU B Y K ATE O’R OURKE SAN FRANCISCO—Twenty--five years ago, a young professoor at the University of Califoornia, Berkeley, demonstrated forr the first time that a single genee on chromosome 17 was the culprit behind many breast and ovarian cancers.

Dr. Mary-Claire Kingg’s discovery of the gene,, which eventually becamee known as BRCA1, led th he way for a revolution in how we think about breast caancer.

For the first time, evidencee confirmed that cancer was, at least in part, genetic. see BREAST GEN NES page 13

Enhanced Recovery Program for Hernias Yields Improvements Improved Pain Control, Intestinal Recovery in Complex Cases

BOSSTON—Bariatric surgery is safe and d effective at reducing weight and comoorbidity burden, including diabetes, in obese patients with a body mass indeex (BMI) less than 35 kg/m2, accordingg to a study of more than 1,000 patients. Currently, C patients with a BMI less than 35 kg/m2 are not considered candidatees for bariatric surgery, and clinicians saay it is time to revise the criteria for surrgery.

“This is the largest series, to my knowledgge, of [bariatric surgery] patients with a BM MI under 35. Metabolic benefits are achievable in this cohort utilizing the standaard bariatric operations, without undue or threatening weight loss,” said Henry Bu uchwald, MD, PhD, professor of surgeryy and biomedical engineering, University of Minnesota, Minneapolis, who was not involved with the study.

“We have reams of affirmative data at this time for using metabolic bariatric surgery to treat type 2 diabetes. In see BARIATRIC GUIDELINES page 10

B Y C HRISTINA F RANGOU

A

n Enhanced Recovery After Surgery (ERAS) program improved patient outcomes after abdominal wall reconstruction at one of the country’s largest hernia centers, according to a

pilot study.

Although prospective evaluations of the ERAS pathway are still needed, “we believe ours or similar ERAS pathways will soon become standard for the vast majority of patients undergoing abdominal wall surgery,” said

INSIDE In the News

On the Spot

Surgeons’ Lounge

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Survey: Anesthesiologists Want Greater DecisionMaking Role in the Operating Room

Data Suggest Lowering Bar for Bariatric Surgery

Women in Surgical Leadership— Where Are They?

Colleen Hutchinson Queries a Panel of Women Surgeons

Endoscopic foreignbody removal of the foregut; bariatric surgery in patients with renal failure

see HERNIA RECOVERY page 28

NEW PRODUCT ANNOUNCEMENT Eyezoom: The First And Only Adjustable Magnification Loupe see page 31

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Learn more: visit zenapro.cookmedical.com.

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In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MARCH 2015

Survey: Anesthesiologists Want Greater Decision-Making Role in OR B Y B RIAN D UNLEAVY NEW YORK—Most anesthesiologists believe they should be in charge of key decisions in the operating room (OR) regarding resource and personnel allocation, despite a lack of training in these areas, according to a recent survey.

Researchers asked attendees at the 68th New York State Society of Anesthesiologists’ (NYSSA) PostGraduate Assembly (PGA) if they thought anesthesiologists should serve as “OR directors.” Respondents were also asked whether they thought anesthesiologists had the leadership skills, ability to gather data and knowledge of necessary interventions needed to take on the role. The survey results were posted on the last day of the PGA. More than 11% of the 3,069 attendees responded, and 94.2% said anesthesiologists should be OR directors.

“The OR can either be a major source of revenue for a hospital or a major drain on its operating budget,” said lead investigator Steven Boggs, MD. “In order to maximize revenues, there needs to be a coordinated effort to increase quality and efficiency, and we believe as a profession that anesthesiologists are best suited to take a leadership role in this effort.”

Dr. Boggs, OR director and chief of anesthesiology, James J. Peters VA Medical Center, New York City, acknowledged that the PGA survey enrolled a “self-selected population” that did not include the

perspectives of surgeons and nurses on this issue. He and the co-authors of the study—Elizabeth A.M. Frost, MD, clinical professor of anesthesiology at Mount Sinai Hospital, New York City, and Jessica Feinleib, MD, PhD, assistant professor of anesthesiology at Yale School of Medicine, New Haven, Conn.— emphasized that they do not view the findings as a referendum on the American Society of Anesthesiologists’ Perioperative Surgical Home (PSH) model because the survey addressed a specific aspect of the potential leadership function for anesthesiologists in the OR: resource and staff management. However, they noted that their findings were particularly striking because other studies suggest recent graduates of residency programs are not adequately trained in OR financial and personnel management.

“At our centers, we’ve really seen a dramatic improvement in all of the major OR productivity metrics since anesthesiology assumed the role of OR director,” said Dr. Boggs. “We’ve seen that anesthesiologists really offer the attention to detail and can handle the learning curve this shift entails. But there are fundamental questions for the profession as a whole, particularly in light of the [PSH] model. Are we preparing our young anesthesiologists to assume this leadership role?”

Another issue is whether or not the other specialists working in the OR—namely the surgeons and nurses—are ready and willing to defer leadership to their colleagues in anesthesiology. According to the study

J. Barry McKernan, MD

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Editorial Advisory Board Maurice E. Arregui, MD Indianapolis, IN

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James Forrest Calland, MD Philadelphia, PA

Edward Felix, MD Fresno, CA

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authors, surgeons in their respective centers have been “happy” to cede this management role and the additional work and responsibilities it entails to anesthesiologists—especially surgeons who handle complex surgical cases, such as orthopedic surgeons and neurosurgeons. They said anesthesiologists are logical managers of surgical cases in these settings given their extensive responsibilities in preoperative optimization and postoperative recovery of the patients involved.

On the other hand, anesthesiologists can still improve efficiency in the OR without being permanently assigned as an OR director, according to Frederick L. Greene, MD, FACS, former chairman of surgery and residency program director at Carolinas Medical Center in Charlotte, N.C. Dr. Greene said his institution implemented a system that established a “surgeon of the day” to manage the OR. In this system, a surgeon is effectively appointed OR director for a specific day and given responsibility for making OR staffing and scheduling decisions and managing efficiency. The surgeon serving in this role is not assigned surgical cases for the day. The anesthesiologist in this system coordinates the provision of anesthesia and oversees patient care in the postanesthesia care unit.

“I’ve also worked in several institutions where anesthesia personnel have taken a leadership role in OR activities,” said Dr. Greene. “However, I wouldn’t say it’s in the bailiwick of the surgeons or the anesthesiologists to take on a sole leadership role. I think the best of both worlds is shared leadership.”

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In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MARCH 2015

Study Finds Limited Role for Analgesic Pumps in Lap Sleeve Gastrectomy Benefits in Open Procedures Not Shared by Laparoscopic Cases B Y K ATE O’R OURKE BOSTON—A double-blind, randomized controlled trial has concluded that in patients undergoing laparoscopic sleeve gastrectomy, a continuous infusion of local anesthetic via an anterior abdominal wall catheter does not improve pain control and does not reduce the use of narcotics, the use of antiemetics or hospital length of stay (LOS).

“Our study does not support the increased cost of using the continuous infusion [analgesic] catheters,” said Elaine Cleveland, MD, a general surgeon at William Beaumont Army Medical Center, in El Paso, Texas. She presented the study at Obesity Week 2014 (abstract A102).

The proposed benefits of continuous analgesic infusion catheters include better pain control in the perioperative setting, which can reduce the use of narcotics and their associated side effects. “This can lead to a more comfortable recovery with faster return to normal activity, decreased length of stay and possibly decreased costs,” Dr. Cleveland said.

These benefits have been shown in several studies. In a randomized, placebocontrolled study involving 70 patients, a continuous analgesia infusion pump of 0.5% bupivacaine after midline laparotomy reduced average daily patient-controlled analgesia (PCA) morphine by 25 mg (33.7 vs. 60 mg; P P=0.03) (J Am Coll Surgg 2006;202:297-305). In a 21-patient, placebo-controlled study, continuous administration of 0.2% ropivacaine

Table. Comparison of Outcomes Between Patients Receiving Ropivacaine and Placebo Ropivacaine

Placebo

P Value

Total narcotic, morphine equivalents

51.8

55.17

0.63

Patient-controlled analgesia attempts

61.95

73.74

0.59

Ondansetron, mg

10.6

10.6

0.98

Promethazine, mg

11.7

6.83

0.10

Hospital time, h

37.45

38.19

0.77

for 48 hours after open colorectal resection for cancer reduced average daily morphine by 36 mg and decreased LOS, pain scores and antiemetic use ((Anesthesiologyy 2007;107:461-468).

Studies evaluating the use of these pumps in laparoscopic procedures, however, have provided mixed results, and to date, no studies have evaluated their use in laparoscopic surgery. To fill this knowledge gap, surgeons at William Beaumont Army Medical Center randomized patients undergoing laparoscopic sleeve gastrectomy to receive either 0.2% ropivacaine or 0.9% normal saline via an intraoperatively placed continuous pain catheter. Dr. Cleveland said the pumps cost $710 and are placed either in the preperitoneal space or in subcutaneous tissue.

Postoperatively, catheter rates were set at 7 mL per hour and patients received PCA with hydromorphone plus IV antiemetics. On the morning of postoperative day 1, patients were started on oral nausea and pain medications, and the catheter infusion rates were decreased to 4 mL per hour. Patients were discharged when they were ambulatory and oral medications could control their pain and nausea.

After discharge, clinicians recorded total narcotic use, total antiemetic use, pain scores, LOS and adverse events.

To be enrolled in the study, patients were required to have a body mass index (BMI) greater than 40 kg/m2 or a BMI greater than 35 with comorbidities.

Patients were excluded if they had revision surgery, single-port surgery or an allergy to local anesthetic. Only 7% of patients in the study were male; the average age was about 35 years. The study was halted early after an interim analysis showed that an additional 20 patients would not change the outcomes.

The investigators identified no benefit of catheter use. “The continuousinfusion catheter provided no benefit regarding narcotic usage, pain scores, PCA attempts, antiemetic usage or hospital stay in the setting of laparoscopic sleeve gastrectomy,” Dr. Cleveland said (Table). Adverse events were minimal, with no hypoxia or ileus in either group; urinary retention was identified in three patients, two in the ropivacaine group.

Dr. Cleveland said the study was limited in that it was performed at a single institution and most of the patients were young females, which may not represent

the typical bariatric population.

So, why are analgesia pumps beneficial in open but not laparoscopic procedures?

“In open surgeries, the catheters are placed directly in the incision, delivering local anesthetic into the operative site. In laparoscopic surgeries, the catheters are placed near the incisions, but may not directly deliver anesthetic to these small trocar sites,” Dr. Cleveland said. “Additionally, open surgeries tend to have increased pain compared to laparoscopic surgeries, and with that, local anesthetic can have a greater impact in reducing pain.”

Kelvin Higa, MD, director of minimally invasive and bariatric surgery, Fresno Heart and Surgical Hospital, in Fresno, Calif., said the study was important in an era when emphasis is placed on value-based care.

“Today, the environment in which we practice is changing. As surgeons, we were only taught to think about quality at any cost, and now we are charged with talking about value … and cost-effectiveness. This research is something that any of us can do on a local level and can make a significant impact on the care of our patients.”

End-of-Life Talks With Elderly Trauma Patients Lacking, Study Shows B Y C HRISTINA F RANGOU SAN FRANCISCO—A trauma surgeon and palliative medicine physician is asking her peers to speak with their older trauma patients about end-of-life care.

Palliative care is not just for patients likely to die after trauma but should be for anyone who is seriously injured, who is frail or who has other lifelimiting illness, said Anne C. Mosenthal, MD, chair of surgery at Rutgers New Jersey Medical School, and a trauma surgeon and palliative medicine physician at University Hospital in Newark, in a press statement.

“A conversation about what older trauma patients desire in end-of-life care should occur sooner rather than later,” she said. She recommends that trauma centers and hospitals perform a multidisciplinary palliative care assessment of elderly patients with severe trauma within 24 hours of

admission.

A recent study by Dr. Mosenthal and her colleagues indicates that not enough surgeons speak with older trauma patients about end-of-life care.

In a presentation at the 2014 American College of Surgeons (ACS) Clinical Congress, the investigators reported that half of older adults who sustained injuries severe enough that they could die in the hospital or become unable to function independently were not asked in the ICU if they wished to speak with a palliative care specialist about their preferences for end-oflife care.

The investigators reviewed the medical records of 92 trauma patients, aged 55 years or older, who were admitted to University Hospital’s surgical ICU from June to December 2012.

The researchers determined that patients who see PALLIATIVE Care page 6

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*1. Pyrek K. Education in electrosurgery technology is key for patient safety. Infection Control Today. htttp://www. infectioncontroltoday.com/articles/2002/07/education-in-electrosurgery-technology-is-key-for.aspx.. Accessed April 10, 2013.

2. Bishoff JT, Allaf ME, Kirkels W, Moore RG, Kavoussi LR, Schroder F. Laparoscopic bowel injury: incidence and clinical presentation. J Urol. 1999;161(3):887-890.

3. Nduka CC, Super PA, Monson JR, Darzi AW. Cause and prevention of electrosurgical injuries in laparoscopy. J Am Coll Surg. 1994;179(2):161-170.

4. Southern Surgeons Club New England Journal of Medicine 1991 Nov 21;325(21):1517.

5. Polychronidis A, Tsaroucha AK, Karayiannakis AJ, et al. Delayed perforation of the large bowel due to thermal injury during laparoscopic cholecystectomy. J Int Med Res. 2005;33(3):360-363.

6. Brill AI, Feste JR, Hamilton TL, et al. Patient safety during laparoscopic monopolar electrosurgery - prrinciples and guidelines.

JSLS. 1998;2(3):221-225.

7. AHRQ. Patient safety quality indicators composite measure workgroup final report. http://www.quallityindicators.ahrq.gov/ Downloads/Modules/PSI/PSI%20Composite%20Development.pdf. Accessed October 30, 2013

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In the News PALLIATIVE CARE jContinued from page 4

would benefit from a palliative care evaluation included those who later died in hospital; were discharged to a care facility such as inpatient rehabilitation, skilled nursing or long-term care; or had a poor functional outcome at discharge, as found by a Glasgow Outcome Score of 3 or lower, indicating dependence on others to perform activities of daily living.

Nineteen of the 92 trauma patients died in the hospital. Of the 73 survivors, 46 patients were discharged to a facility (including 11 who went to a long-term care facility and two who went to a hospice facility) and 27 went directly home.

Only 32 of the 65 patients (49%) found to warrant a palliative care consultation received one. Although 17 of the 19 patients who later died did receive a palliative care evaluation, only 15 of the 46 patients (33%) discharged to a facility did.

The researchers found certain admission factors that could help identify patients who potentially would benefit from palliative care. These factors were associated with a significantly increased risk for a patient dying or being discharged to a facility. These characteristics included age 75 years or older and/or having an altered level of consciousness (Glasgow Coma score of 13 or lower), high injury severity or multiple injuries, a traumatic brain injury or a blood transfusion.

Based on the study results, Dr. Mosenthal said her team wants to develop a standardized care protocol in which all trauma patients over age 65 will be offered early palliative care interventions and asked about advance directives.

Geoffrey P. Dunn, MD, a general surgeon and medical director of the Palliative Care Consultation Service, UPMC Hamot Medical Center, Eric, Pa., said every department of surgery, including trauma, should set its own triggers for referrals to palliative care.

“My advice would be to find a common ground that they are comfortable with and build around that,” Dr. Dunn said.

In the mid-1990s, Dr. Dunn was one of the first surgeons in the United States to champion palliative care. Since then, attitudes have changed tremendously, he said.

“There isn’t any debate about the need for palliative care services anymore in the house of surgery. It’s an expectation on the boards, a part of residency training.”

Despite this change, there remains some hesitation about palliative care, from individual surgeons and, in particular, from patients and their families.

“This is something we need to do better. We still run into families who are very startled when you mention palliative care, and it will take a while for this to be assimilated so people don’t give this a second thought.”

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MARCH 2015

‘Palliative care services can facilitate some of the things that patients and families need, but surgeons might not to be able to do it on their own because they’re too maxed out.’

—Geoffrey P. Dunn, MD He stressed that palliative care services improve the quality of life

for patients and take some stress off busy trauma surgeons.

“Palliative care services can facilitate some of the things that patients and families need, but surgeons might not to be able to do it on their own because they’re too maxed out,” Dr. Dunn said.

The trauma ICU presents some of the most difficult challenges to the integration of palliative care, according to previous

research. Patients may be young, and they and their families unprepared for catastrophic illness. The mortality rate for critically injured patients averages from 10% to 20%, and survivors face serious and permanent disabilities. As a result, the ACS Surgical Palliative Care Task Force has called for closer collaboration among palliative care specialists, critical care staff and surgeons to enhance palliative care.

Drs. Mosenthal and Dunn are members of the ACS Surgical Palliative Care Task Force.

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See the evidence and full product information at www.Ethicon.com *Results for 77 patients from the International Hernia Mesh Registry, a prospective, longitudinal study of patients receiving hernia repair with ETHICON SECURESTRAP® Absorbable Strap Mechanical Fixation Device. The Carolinas Comfort Scale™ defines symptomatic pain as a score greater than 1 (mild but not bothersome symptoms) for at least 1 question within the domains of severity of pain, sensation of mesh, or movement limitation.1J †

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References: 1. Data on file. Ethicon, Inc. A. Holste J-L, Muench T, Shnoda P, Wohlert S, McRoy L. A preclinical evaluation of the tissue separation and abdominal wall integration properties of ETHICON PHYSIOMESH™ Flexible Composite Mesh. PHYSM 336-10-8/12. B. Holste J-L, Muench T, Shnoda P, Wohlert S, McRoy L. An evaluation of ETHICON PHYSIOMESH™ Flexible Composite Mesh in the prevention of adhesions in a rabbit model of abdominal hernia repair: a comparative study. PHYSM 335-10-8/12. C. Cardinale M. Angle fire competitive test. AST 2010-0199. D. Cardinale M, Jacinto G, Cohn S, Rauso J, McRoy L. Comparison of acute holding strength of an absorbable strap fixation device in porcine flank at various implantation angles (technical report). E. Ethicon Hernia Dashboard 2014. F. Final Report, PSE Accession No. 13-0058, Project No. 12736. May 19, 2014. G. Final Report, PSE Accession No. 14-0099, Project No. 12736. November 14, 2014. H. Final Report, PSE Accession No. 13-0041, Project No. 12736. July 29, 2013. I. Report for 510k Testing for ETHICON PHYSIOMESH™ Open Flexible Composite Mesh Device, Version 2.

May 14, 2014. J. Early outcomes using an absorbable fixation device for mesh fixation (IHMR data analysis). 2. ETHICON PHYSIOMESH Open Flexible Composite Mesh Device. Instructions for Use. Ethicon, Inc. 3. Klosterhalfen B, Junge K, Klinge U. The lightweight and large porous mesh concept for hernia repair. Expert Rev Med Devices. 2005;2(1):103-107. 4. Cobb WS, Kercher KW, Heniford BT. The argument for lightweight polypropylene mesh in hernia repair. Surg Innov. 2005;12(1):63-69.

5. Junge K, Klinge U, Prescher A, Giboni P, Niewiera M, Schumpelick V. Elasticity of the anterior abdominal wall and impact for reparation of incisional hernias using mesh implants. Hernia. 2001;5:113-118. 6. Roy S, Shnoda P, Savidge S, Hammond J, Panish J, Wilson M. Reduction in fixation time and related surgical stress with the use of ETHICON SECURESTRAP™ Open Absorbable Strap Fixation Device in the deployment of intra-peritoneal onlay mesh (IPOM) for open ventral hernia repair.

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In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MARCH 2015

Surgical Site Infections Drop by 19% in the United States B Y M ARIE R OSENTHAL

B

etween 2008 and 2013, U.S. hospitals saw a 19% decrease in surgical site infections (SSIs) related to 10 specific procedures, including hip and knee arthroplasty, colorectal surgery, abdominal and vaginal hysterectomies, several cardiovascular procedures and two neurosurgeries, according to a recent report from the Centers for Disease Control

and Prevention (CDC).

The Healthcare-associated Infections (HAI) Progress Report issued by the CDC details the progress that acute care hospitals are making in reducing HAIs, which are “a major, yet often preventable, threat to patient safety,” the agency said.

The CDC described the report as a snapshot of how well the country as a whole and individual states are doing in eliminating six types of infection that hospitals are required to report.

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The report summarizes data submitted to the CDC’s National Healthcare Safety Network, a tracking system that is used by more than 14,500 health care facilities in all 50 states, Washington, D.C., and Puerto Rico.

This year’s report describes significant reductions at the national level in 2013 for nearly all infections. The greatest progress occurred in reducing central line–associated bloodstream infections (CLABSI), which decreased

by 46% between 2008 and 2013. There was also an 8% decrease in bacteremias caused by methicillin-resistant Staphylococcus aureus and a 10% decrease in Clostridium difficile infections in the same period.

One condition that is measured, catheter-associated urinary tract infections (CAUTI), had a significant increase of 6%, according to the CDC. The report also looked at changes from 2012 to 2013 for SSIs, and found no significant change in almost all of the SSIs. Colon surgery infections were an anomaly. Although overall, there was a decrease of 8% since 2008, colon operations showed an increase in SSIs of 14% from 2012 to 2013.

The apparent increase in colon surgery infections may be an artifact of a change in the way attribution is made for each SSI, rather than a real increase in colon surgery infections, explained Melissa Brower, public affairs specialist, Division of Healthcare Quality Promotion at CDC. The CDC’s National Healthcare Safety Network (NHSN), a tracking system that is used by more than 14,500 health care facilities, changed its SSI protocol in 2013, and infections that might have been attributed to a different surgical site in previous years were attributed to colon surgery.

Specifically, percentage reductions for the 10 procedures that are tracked for SSIs are: • Hip arthroplasty (27%) • Knee arthroplasty (40%) • Colon surgery (8%) • Rectal surgery (21%) • Abdominal hysterectomy (14%) • Vaginal hysterectomy (19%) • Coronary artery bypass graft (40%) • Other cardiac surgery (44%) • Peripheral vascular aneurysm repair (43%) • Abdominal aortic aneurysm repair (70%) On a given day, one in 25 patients in this country suffer at least one infection contracted during his or her hospital stay. Although hospitals are making progress in reducing HAIs, there is still more work to be done, according to Tom Frieden, MD, MPH, director of the CDC. “Hospitals have made real progress to reduce some types of health care– associated infections. It can be done,” Dr. Frieden said in a press release. “The key is for every hospital to have rigorous infection control programs to protect patients and health care workers, and for health care facilities and others to work together to reduce the many types of infections that have not decreased enough.”

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In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MARCH 2015

Small GIST Lesions Increasingly Amenable to Endoscopic Resection B Y C AROLINE H ELWICK SAN FRANCISCO—Recent advancements in technology and techniques—flexible endoscopy, endoscopic resections, hybrid approaches—are allowing endoscopists to play an increasing role in the management of small gastrointestinal stromal tumors (GISTs).

Endoscopists benefit by participating in cancer care, as do patients, whose

tumors in the past were treated by open gastrectomy—a more morbid procedure.

At the 2014 Clinical Congress of the American College of Surgeons, a panel of experts discussed the growing role of endoscopy and areas for improvement in managing GISTs. Panel member David A. Kooby, MD, professor of surgery at Emory University School of Medicine, in Atlanta, called the minimally invasive approaches to GIST “really innovative, really

wonderful stuff.

“Where we are now, and where we will be in five to 10 years, are very different. The use of endoscopy for lowerrisk tumors would be a great advantage over our standard approach, which is to remove a big portion of the stomach.

If we can do this minimally invasively, as these speakers have described, and adhere to oncologic principles, this will really optimize treatment.”

“Flexible endoscopy is proving to be

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a critical surgical tool in GI surgery, and this will only increase with time,” said panelist Lee L. Swanstrom, MD, clinical professor of surgery at Oregon Health & Science University, and director of GI and minimally invasive surgery for Legacy Health System, both in Portland.

“We are seeing more small GISTs due to increased screening, and these will be amenable to hybrid [endoscopy/laparoscopy] or pure endoscopic resection,” Dr. Swanstrom said. “Endoscopic resection is demanding, but it has been shown to be safe and feasible for the right indications. Improvements in flexible endoscopic tools will make such resections quicker and easier in the near future.”

Should GISTs Be Resected?

Chandrajit P. Raut, MD, associate professor of surgery at Harvard Medical School, in Boston, noted that GISTs are “exceedingly common, but most are clinically irrelevant.” In one study, submucosal, microscopic GISTs, those smaller than 0.5 cm, were identified in more than 35% of gastrectomy specimens, he said.

“Certainly, these don’t all require surgery,” Dr. Raut said. For GISTs larger than 2 cm, resection is recommended for lesions that are symptomatic, ulcerated and enlarging. For smaller tumors without high-risk features—irregular borders, cystic spaces, ulceration, echogenic foci and heterogeneity—endoscopic surveillance at six- to 12-month intervals can be considered, according to the guidelines of the National Comprehensive Cancer Network (NCCN).

Field F. Willingham, MD, MPH, director of endoscopy and assistant professor of medicine at Emory University School of Medicine, agreed that surveillance is appropriate for a patient with a submucosal mass smaller than 2 cm and no suspicious features on endoscopic ultrasound. “The NCCN has adopted this, and we think it’s a reasonable way to go for these small lesions,” he said.

Dr. Raut said surgery is indicated when GISTs increase in size or cause symptoms. There is a need for a better way to identify aggressive lesions smaller than 2 cm, but current radiology, endoscopy, histopathology and molecular diagnostics fall short of being able to do so, he added.

“Endoscopic biopsy using standard biopsy forceps is not usually helpful for submucosal tumors. Mitotic count can help identify which to resect but cannot be accurately assessed on endoscopic ultrasound-guided fine-needle aspiration specimens. Tumors less than 2 cm versus those greater than 2 cm have an excess of wild-type cases versus known mutations,

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MARCH 2015

’If we can do this minimally invasively, as these speakers have described, and adhere to oncologic principles, this will really optimize treatment.’

—David A. Kooby, MD

so they appear to be a different subpopulation with less proliferation potential,” Dr. Raut said.

to go beyond mucosal resection,” he said.

ESD is still relatively uncommon in the United States, but it is widespread in Asia, where more than 50% of foregut digestive cancers are treated using flexible endoscopy rather than surgical resection, according to Dr. Swanstrom.

Dr. Swanstrom cautioned that endoscopic resection of GISTs is limited to lesions that are smaller than 5 cm, located in the esophagus or stomach, and demonstrate low-risk characteristics.

Performing ESD for GISTs requires full-thickness resection, but this can be done, he added.

“As our instrumentation in flexible endoscopy becomes more sophisticated, with better ways to control energy, and with oncologic tools such as specimen retrieval sacs, we will see an expansion of ESD,” Dr. Swanstrom predicted.

“We no longer fear doing full-thickness resections in the gut as we once did.”

Dr. Raut also added a note of caution: “Ultimately, GIST is a cancer, and oncologic principles trump whatever observational or operative approach we use.

We need to do what’s most appropriate oncologically.”

He does not advocate for a pure

9

endoscopic excision, and this is not performed at his institution. Instead, he favors a laparoscopic or combined laparoendoscopic approach that allows for removal of the tumor with a margin of normal tissue.

Dr. Swanstrom receives research and education support from and/or consults for Apollo, Aponos Medical, Boston Scientific, Cardica, Covidien, Endogastric Solutions, Fractyl Laboratories, Olympus, Stryker and Titan. Drs. Willingham, Raut and Kooby reported no relevant financial relationships.

Methods of Endoscopic Resection Drs. Swanstrom and Willingham also described methods of endoscopic resection that are still novel in North America.

One of these, a hybrid approach, combines endoscopic and laparoscopic techniques for resection, as Dr. Willingham and his Emory colleagues reported in 2012 (Gastrointest Endoscc 2012;75:905912). He said the technique grew out of their efforts to offer less invasive treatments to GIST patients.

“To resect lesions at the GE [gastroesophageal] junction and in the proximal cardia surgically may require a total gastrectomy, so that is a particularly difficult area, especially for small nonaggressive tumors. This led us to think of ways we could work together [with surgeons] to offer less invasive therapy in this area,” Dr. Willingham said.

“We developed a technique, as an extension of our hybrid work, to address the deep margins of the tumors,” he said.

They have dubbed the technique “pushpull endoscopic and laparoscopic fullthickness resection,” and they reported their results at Digestive Disease Week 2014 (abstract Su1847).

Their series included four patients with challenging tumors: near the GE junction, endophytic, and/or difficult to identify laparoscopically. The hybrid procedure was successful, without complications or conversions to open resection. Mean operative time was 162 minutes.

“The advantages of this technique are that it is minimally invasive, does not require major organ resection, and provides a full-thickness resection of the involved deep margin,” Dr. Willingham explained.

Endoscopic submucosal dissection (ESD) is another emerging approach to GIST. Although ESD is used mainly for resecting mucosa-based lesions, ESD techniques can be extended in the submucosal plane, Dr. Swanstrom said.

“With the addition of newer technologies from the NOTES [natural orifice transluminal endoscopic surgery] toolbox, it is becoming increasingly feasible

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

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In the News BARIATRIC GUIDELINES jcontinued from page 1

contrast, nonsurgical therapy has reams of data on negative results,” Dr. Buchwald said. “Metabolic bariatric surgery should be considered a standard procedure for the treatment of type 2 diabetes.

It is time for the NIH [National Institutes of Health] in our country to change its perspective and policy.”

According to the 1991 NIH consensus conference on gastrointestinal surgery for severe obesity, patients are candidates for bariatric surgery if they have a BMI greater than 40 kg/m2 or a BMI greater than 35 kg/m2 with comorbidities such as diabetes or hypertension. Various studies, however, have suggested that patients with lower BMIs also may benefit from surgery ((Ann Intern Medd 2006;144:625633; Diabetes Caree 2012;35:1420-1428).

To shed further light on the issue, investigators led by Camilo Boza, MD, Department of Digestive Surgery, Pontifical Catholic University of Chile, Santiago, conducted a retrospective review of 1,160 obese patients with a preoperative BMI of less than 35 kg/m² who underwent a Roux-en-Y gastric bypass (n=292) or a laparoscopic sleeve gastrectomy (n=868). The study was presented at Obesity Week 2014 (abstract A103).

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MARCH 2015

‘Metabolic bariatric Table 1. Comorbidities at Baseline surgery should be Comorbidity Patients, % considered a standard 31 procedure for the treatment Dyslipidemia 54 13 of type 2 diabetes. It is time GERD 48 for the NIH in our country to Insulin resistance 3 change its perspective Sleep apnea syndrome and policy.’

Type 2 diabetes 12 —Henry Buchwald, MD, PhD

GERD, gastroesophageal reflux disease

Table 2. Change in Comorbidities 12 mo After Surgery Remission, %

Improvement, Remained Worsened, % Stable, % %

Diabetes

69

21

5

5

Dyslipidemia

35

35

22

8

Hypertension

61

10

29

0

Insulin resistance

82

9

0

9

The average age was 38.9 years, and 85% were women. The average preoperative BMI was 32.8 kg/m². Researchers assessed comorbidity burden at baseline (Table 1) and postoperatively.

The follow-up at one year was 68%. “It is not the best follow-up, but it has been

very difficult to follow these patients,” said Dr. Boza. One year after surgery, the patients as a group had a drastically lower BMI, at 24.8 kg/m². The average percentage of excess body weight loss was 103%.

Significant improvements also were seen in comorbidity burden at one year, with

remission rates of 69% for diabetes, 61% for hypertension, 82% for insulin resistance and 35% for dyslipidemia (Table 2).

At three years, with a follow-up of 40% of the patients, the average BMI was 26 kg/m². “Most patients achieved a normal weight,” said Dr. Boza. With a less than 5% reoperation rate and no deaths, the researchers categorized bariatric surgery in this patient population as safe.

Dr. Boza concluded that bariatric surgery has a “powerful role” in the management of patients with class I obesity, defined as a BMI of 30 to 35 kg/m2.

Many other clinicians agree. In 2013, the American Society for Metabolic and Bariatric Surgery (ASMBS) issued a statement saying that for patients with a BMI of 30 to 35 kg/m2 who do not achieve substantial and durable weight and comorbidity improvement with nonsurgical methods, bariatric surgery should be an available option for suitable individuals (Surg Obes Relat Diss 2009;5:425-428).

“The existing cutoff of BMI, which excludes those with class I obesity, was established arbitrarily nearly 20 years ago,” wrote the ASMBS Clinical Issues Committee. “There is no current justification on grounds of evidence of clinical effectiveness, cost-effectiveness, ethics or equity that this group should be excluded from lifesaving treatment.”

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MARCH 2015

Ultrasound Finds Cancers Missed by Mammogram in Dense Breasts B Y K ATE O'R OURKE SAN ANTONIO—Results from a Connecticut study have some clinicians proclaiming that all women with dense breasts who have a negative mammogram should be offered an ultrasound.

The study, presented at the 2014 San Antonio Breast Cancer Symposium (SABCS; abstract S5-01), found that ultrasound identified an additional 3.2 cancers per 1,000 women.

“It is time to think of a new paradigm of utilizing screening ultrasound,” said the lead author of the study Jean Weigert, MD, a radiologist and director of Breast Imaging at the Hospital of Central Connecticut, in New Britain.

Since October 2009, Connecticut law has required clinicians to use certain language when providing mammographic results to women with dense breasts (approximately 40%-50% of women). Clinicians are required to say, “Your mammogram demonstrates that you have dense breast tissue, which could hide small abnormalities, and you might benefit from supplementary screening tests, which can include a breast ultrasound screening or a breast [magnetic resonance imaging] examination, or both, depending on your individual risk factors.”

Connecticut is one of 19 states, to date, that mandate that clinicians include information on breast density when providing mammogram results to patients, according to Jafi Lipson, MD, assistant professor of radiology at Stanford University Medical Center, in Palo Alto, Calif. Additionally, Dr. Lipson said, “Insurance coverage for supplemental tests is now mandated [for patients with dense breasts] in four states, and there is federal legislation pending at this point.”

This flurry of legislation was spurred, in part, by a multicenter 3,000-patient study that demonstrated that adding a single, bilateral screening ultrasound to mammography detected an additional 4.2 cancers per 1,000 in women with

dense breast tissue and a family history or prior history of breast cancer ((JAMA 2008;299:2151-2163). This almost doubled the number of cancers found by mammography alone.

In the new study, researchers evaluated the effect of the new Connecticut law at two radiology practices with multiple sites in the state during the first four years after the legislation was enacted. Overall, 30% of women with

dense breasts and a negative mammogram chose to have an ultrasound, and this rate was steady over the four years.

“This may be due to lack of education and insurance issues,” said Dr. Weigert, who thought the rate should have been higher. “There are many high-deductible plans, and women do not want to pay for the test.”

The positive predictive value (PPV) of ultrasound improved over time,

indicating that, as expected, there was a learning curve in determining which identified lesions needed to be followed and which needed to be biopsied (Table, page 12). By year 4, the PPV was 17.2%, with 3.2 additional cancers detected per 1,000 women. “The first three years, we were still doing a significant number of biopsies on patients with findings that we didn’t know whether they were see BREAST ULTRASOUND page 12

11

12

In the News BREAST ULTRASOUND

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MARCH 2015

Table. Positive Predictive Value of Ultrasound in Connecticut Practices Studied

jContinued from page 11

positive or negative, but in the fourth year, there was a significant [improvement],” said Dr. Weigert.

The cancers detected were of all histologic grades but predominantly grade 2 and 3, hormone-positive and nodenegative. Very few patients had risk factors other than dense breast tissue.

Cancers were detected in patients who were in their mid-40s to mid-70s.

Although the study was limited in

Year

PPV of Ultrasound, %

Screening Mammogram

Screening Ultrasound

BIRADS 1 or 2

BIRADS 3

BIRADS 4 or 5

Positive Biopsy

1

7.1

30,679

2,706

2,377

174

151

11

2

6.1

32,500

3,351

3,000

168

180

11

3

8.1

32,230

4,128

3,819

168

148

13

4

17.2

27,937

3,331

2,889

358

53

11

BIRADS, Breast Imaging Reporting and Data System; BIRADS 1, negative; BIRADS 2, benign; BIRADS 3, probably benign; BIRADS 4, suspicious abnormality; BIRADS B DS 5,, highly g y suggest suggestivee malignancy; a g a cy; PPV,, pos positive t e ppredictive ed ctt e value a ue

‘The true clinical impact of finding these additional cancers is really unknown.’

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—Jafi Lipson, MD that it did not include a cost analysis, she pointed out that it is easier and less costly to treat a cancer if it is detected at an early stage, noting that in patients who returned for an ultrasound in a subsequent year, the cancers detected were extremely small, typically less than 1 cm.

A recent study estimated that supplemental ultrasonography screening for women with extremely dense breasts would cost $246,000 per quality-adjusted life-year gained (Ann ( Intern Med 2014 Dec 9. [Epub ahead of print]). This is well above $50,000, often touted as a reasonable threshold for cost-effective care (N Engl J Med 2014;371:796-797).

Dr. Lipson, who served as the discussant of the Connecticut study, pointed out that most of the PPV improvement in Dr. Weigert’s study was due to a shift of patients from a recommendation for biopsy to a recommendation for shortterm follow-up, and this could be seen as a benefit or harm. “It’s not that the patient is returned to annual screening.

She is kind of sucked into a vortex of short-term follow-up,” said Dr. Lipson.

Dr. Lipson also noted that none of the breast cancer ultrasound studies conducted so far have used a control group, and none have long-term follow-up. “The true clinical impact of finding these additional cancers is really unknown,” Dr. Lipson said. “Specifically,” she added, “would these additional cancers otherwise be detected at the next mammography screen while still small, node-negative, and at the early stage, and does the detection of these early cancers have an impact on mortality?”

Dr. Weigert disclosed being on the advisory board for Tractus. Dr. Lipson reported no relevant financial relationships.

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MARCH 2015

BREAST GENES jcontinued from page 1

Since Dr. King’s report, geneticists have added to the list of genes associated with breast cancer. Today, BRCA2, PALB2, TP53, PTEN, CDH1, Chk2, ATM M and others have been implicated in breast cancer.

This knowledge creates new challenges for breast cancer surgeons and their patients. With each discovery of another gene come more questions about what to do with this information. What gene tests should be done? In whom? And once the results are in, what to do with the findings?

“This whole issue has become increasingly complex,” said Doreen Agnese, MD, associate professor of surgical oncology and human genetics at the The Ohio State University, Department of Surgery, in Columbus.

Dr. Agnese is the only known specialty-trained cancer geneticist and surgical oncologist in the United States. And she is the first to say that, often, the best course of action for a woman with breast cancer and her family is not clear.

“There are more and more genes being described that have some role but how much of a role that is, and what are the specific cancer risks and what to do with that information is the problem because some of these genes we don’t know as much about as BRCA1 and BRCA2,” said Dr. Agnese.

She cited the ATM M gene as an example. ATM M causes ataxia-telangiectasia in individuals who inherit two abnormal copies. When a woman inherits a mutation in only one copy, it increases her risk for breast cancer. However, the literature is spread on how much precisely is her increased risk for breast cancer, with reports suggesting anywhere from 20% to 60% increased risk compared with women without the mutation.

Without more information on risk, there’s little understanding of how the presence of the mutation should affect cancer treatment, said Dr. Agnese.

“We don’t know that much about how likely someone with breast cancer who has an ATM M mutation is to get another breast cancer. So I don’t know if knowing that the ATM M gene caused that woman’s cancer is just for academic purposes or if it has an impact on the care you provide.”

Right now, Dr. Agnese has two patients with mutations in the ATM M gene. One, a younger woman with a strong family history of breast cancer, underwent a bilateral preventative mastectomy. For the other, an older woman with a unilateral breast cancer and no family history, it is unclear whether she will have a bilateral mastectomy. “I said to her that we don’t have any data on the risk with her other breast. We have to take care of the cancer

she has, not the cancer she may or may not ever geet.

“That’s the distiinction: Where do you w walk on that line? Because in my mind, if you’re going tto get a test, you should be able too do something with the resultts that are going to affect how you care for your patient.”

Today, there are no wellestablished guidelines for how to manage patients who have genetic mutations that predispose di them h to breast or other cancers, said Steven

‘If you’re going to get g a test, you should be able to shou something with do so the results that are going to affect hhow you care for your patient.’

As a result, there’s broad variation in how and when women undergo genetic testing for hereditary cancers.

“Right now, I would say a lot of people who are good candidates for testing are not tested. But the irony is, of course, there are also a lot of people who are not good candidates —Doreen Agnese, MD who do get tested.”

“Genetic testing is underChen, MD, MBA, a surgeon aand vice utilized except where it’s overutilized,” president id off Clinical Cli i l Affairs Aff i at Avelas he quipped.

Biosciences, La Jolla, Calif. see BREAST GENES page 14

Experience the ENTEREG EFFECT ENTEREG is indicated to accelerate the time to upper and lower gastrointestinal (GI) recovery following surgeries that include partial bowel resection with primary anastomosis.1

› In clinical trials, ENTEREG added to an accelerated care pathway (ACP) was more effective than an ACP alone1 – ENTEREG improved mean time to GI recovery by 11-32 hours vs. placebo1* – ENTEREG also reduced time to discharge order written by 13-22 hours1,2*

ENTEREG improved mean time to GI recovery by up to 20% compared to placebo1* *Data are from 5 multicenter, randomized, double-blind, placebo-controlled studies in patients undergoing bowel resection and 1 study in patients undergoing radical cystectomy. Patients were administered ENTEREG 12 mg or placebo 30 minutes to 5 hours prior to surgery and twice daily after surgery until discharge or a maximum of 7 days. Patients who received more than 3 doses of an opioid (regardless of route) during the 7 days prior to surgery and patients with complete bowel obstruction or who were scheduled for a total colectomy, colostomy, or ileostomy were excluded.1

Important Safety Information for ENTEREG

› ›

WARNING: POTENTIAL RISK OF MYOCARDIAL INFARCTION WITH LONG-TERM USE: FOR SHORT-TERM HOSPITAL USE ONLY Increased incidence of myocardial infarction was seen in a clinical trial of patients taking alvimopan for long-term use. No increased risk was observed in short-term trials Because of the potential risk of Myocardial Infarction, ENTEREG is available only through a restricted program for short-term use (15 doses) called the ENTEREG Access Support and Education (E.A.S.E.®) ENTEREG REMS Program

Contraindications

› ENTEREG Capsules are contraindicated in patients who have

taken therapeutic doses of opioids for more than 7 consecutive days immediately prior to taking ENTEREG

Warnings and Precautions

› There were more reports of myocardial infarctions in patients

treated with alvimopan 0.5 mg twice daily compared with placebo-treated patients in a 12-month study of patients treated with opioids for chronic pain. In this study, the majority of myocardial infarctions occurred between 1 and 4 months after initiation of treatment. This imbalance has not been observed in other studies of alvimopan, including studies of patients undergoing bowel resection surgery who received alvimopan 12 mg twice daily for up to 7 days. A causal relationship with alvimopan has not been established

› ENTEREG should be administered with caution to patients receiving more than 3 doses of an opioid within the week prior to surgery. These patients may be more sensitive

to ENTEREG and may experience GI side effects (eg, abdominal pain, nausea and vomiting, diarrhea)

› ENTEREG is not recommended for use in patients with severe hepatic impairment, end-stage renal disease, complete gastrointestinal obstruction, or pancreatic or gastric anastomosis, or in patients who have had surgery for correction of complete bowel obstruction

Adverse Reactions

› The most common adverse reaction (incidence ≥1.5%) occurring with a higher frequency than placebo among ENTEREG-treated patients undergoing surgeries that included a bowel resection was dyspepsia (ENTEREG, 1.5%; placebo, 0.8%)

E.A.S.E.® Program for ENTEREG

› ENTEREG is available only to hospitals that enroll in the

E.A.S.E. Program. To enroll in the E.A.S.E. Program, the hospital must acknowledge that: – Hospital staff who prescribe, dispense, or administer ENTEREG have been provided the educational materials on the need to limit use of ENTEREG to short-term, inpatient use – Patients will not receive more than 15 doses of ENTEREG – ENTEREG will not be dispensed to patients after they have been discharged from the hospital Please see following brief summary of Prescribing Information for ENTEREG.

References: 1. ENTEREG [package insert]. Lexington, MA: Cubist Pharmaceuticals U.S.; 2014.

2. Lee CT, Chang SS, Kamat AM, et al. Eur Urol. 2014; 66(2):265-272. ©2014 Cubist Pharmaceuticals ENTEREG and E.A.S.E. are registered trademarks of Cubist Pharmaceuticals. www.ENTEREG.com ENT-0229 November 2014

13

14

In the News BREAST GENES jcontinued from page 13

Practical Guidance To clear up some of the confusion about genetic testing for breast cancer, Dr. Agnese spoke with General Surgery News to offer surgeons some practical guidance for how, when and what to test for in women with breast cancer.

To start, she recommends that all women with breast cancer and women with strong family histories should consider genetic testing. On that, she differs from Dr. King, who discovered

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MARCH 2015

BRCA1. Dr. King has called for BRCA testing in all women, including those without breast cancer. Dr. King’s recommendation was based on early studies done in Ashkenazi Jewish women in whom there is a founder effect, and the frequency of carrying the BRCA A mutation is about one in 40 to one in 80. But in the general population, the frequency is much lower, one in 400 to one in 800, said Dr. Agnese.

“I think that’s just not a commonsense strategy to screen all women for such a rare condition, although it does have important implications.”

The U.S. Preventive Services Task Force (USPSTF) recomm mends that clinicians screen women n who have family members with brreast, ovarian, tubal or peritoneall cancers with one of several screen ning tools designed to identify a family history that may be associiated with an increased risk for BRCA1 or BRCA2. According to the USPSTF recommendation, woomen with positive screening reesults should receive genetic counseling and, if indicated after counseling, BRCA A testingg.

BRIEF SUMMARY OF PRESCRIBING INFORMATION

ENTEREG® (alvimopan) capsules, for oral use The following is a brief summary only; see full prescribing information for complete product information.

WARNING: POTENTIAL RISK OF MYOCARDIAL INFARCTION WITH LONG-TERM USE: FOR SHORT-TERM HOSPITAL USE ONLY There was a greater incidence of myocardial infarction in alvimopan-treated patients compared to placebo-treated patients in a 12-month clinical trial, although a causal relationship has not been established. In short-term trials with ENTEREG®, no increased risk of myocardial infarction was observed.

Because of the potential risk of myocardial infarction with long-term use, ENTEREG is available only through a restricted program for short-term use (15 doses) under a Risk Evaluation and Mitigation Strategy (REMS) called the ENTEREG Access Support and Education (E.A.S.E.®) Program.

INDICATIONS AND USAGE ENTEREG is indicated to accelerate the time to upper and lower gastrointestinal recovery following surgeries that include partial bowel resection with primary anastomosis.

CONTRAINDICATIONS ENTEREG is contraindicated in patients who have taken therapeutic doses of opioids for more than 7 consecutive days immediately prior to taking ENTEREG. WARNINGS AND PRECAUTIONS Potential Risk of Myocardial Infarction with Long-term Use There were more reports of myocardial infarctions in patients treated with alvimopan 0.5 mg twice daily compared with placebo-treated patients in a 12-month study of patients treated with opioids for chronic non-cancer pain (alvimopan 0.5 mg, n = 538; placebo, n = 267). In this study, the majority of myocardial infarctions occurred between 1 and 4 months after initiation of treatment.

This imbalance has not been observed in other studies of ENTEREG in patients treated with opioids for chronic pain, nor in patients treated within the surgical setting, including patients undergoing surgeries that included bowel resection who received ENTEREG 12 mg twice daily for up to 7 days (the indicated dose and patient population; ENTEREG 12 mg, n = 1,142; placebo, n = 1,120). A causal relationship with alvimopan with long-term use has not been established.

ENTEREG is available only through a program under a REMS that restricts use to enrolled hospitals.

E.A.S.E. ENTEREG REMS Program ENTEREG is available only through a program called the ENTEREG Access Support and Education (E.A.S.E.) ENTEREG REMS Program that restricts use to enrolled hospitals because of the potential risk of myocardial infarction with long-term use of ENTEREG. Notable requirements of the E.A.S.E. Program include the following: ENTEREG is available only for short-term (15 doses) use in hospitalized patients. Only hospitals that have enrolled in and met all of the requirements for the E.A.S.E. program may use ENTEREG. To enroll in the E.A.S.E. Program, an authorized hospital representative must acknowledge that: hospital staff who prescribe, dispense, or administer ENTEREG have been provided the educational materials on the need to limit use of ENTEREG to short-term, inpatient use; patients will not receive more than 15 doses of ENTEREG; and ENTEREG will not be dispensed to patients after they have been discharged from the hospital.

Further information is available at www.ENTEREGREMS.com or 1-877-282-4786.

Gastrointestinal-Related Adverse Reactions in Opioid-Tolerant Patients Patients recently exposed to opioids are expected to be more sensitive to the effects of μ-opioid receptor antagonists, such as ENTEREG. Since ENTEREG acts peripherally, clinical signs and symptoms of increased sensitivity would be related to the gastrointestinal tract (e.g., abdominal pain, nausea and vomiting, diarrhea). Patients receiving more than 3 doses of an opioid within the week prior to surgery were not studied in the postoperative ileus clinical trials. Therefore, if ENTEREG is administered to these patients, they should be monitored for gastrointestinal adverse reactions. ENTEREG is contraindicated in patients who have taken therapeutic doses of opioids for more than 7 consecutive days immediately prior to taking ENTEREG. Risk of Serious Adverse Reactions in Patients with Severe Hepatic Impairment Patients with severe hepatic impairment may be at higher risk of serious adverse reactions (including dose-related serious adverse reactions) because up to 10-fold higher plasma levels of drug have been observed in such patients compared with patients with normal hepatic function.

Therefore, the use of ENTEREG is not recommended in this population.

End-Stage Renal Disease No studies have been conducted in patients with end-stage renal disease. ENTEREG is not recommended for use in these patients.

Risk of Serious Adverse Reactions in Patients with Complete Gastrointestinal Obstruction No studies have been conducted in patients with complete gastrointestinal obstruction or in patients who have surgery for correction of complete bowel obstruction. ENTEREG is not recommended for use in these patients.

Risk of Serious Adverse Reactions in Pancreatic and Gastric Anastomoses ENTEREG has not been studied in patients having pancreatic or gastric anastomosis.

Therefore, ENTEREG is not recommended for use in these patients.

ADVERSE REACTIONS Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be compared directly with rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The adverse event information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.

The data described below reflect exposure to ENTEREG 12 mg in 1,793 patients in 10 placebo-controlled studies. The population was 19 to 97 years old, 64% were female, and 84% were Caucasian; 64% were undergoing a surgery that included bowel resection. The first dose of ENTEREG was administered 30 minutes to 5 hours before the scheduled start of surgery and then twice daily until hospital discharge (or for a maximum of 7 days of postoperative treatment).

Among ENTEREG-treated patients undergoing surgeries that included a bowel resection, the most common adverse reaction (incidence ≥1.5%) occurring with a higher frequency than placebo was dyspepsia (ENTEREG, 1.5%; placebo, 0.8%). Adverse reactions are events that occurred after the first dose of study medication treatment and within 7 days of the last dose of study medication or events present at baseline that increased in severity after the start of study medication treatment.

DRUG INTERACTIONS Potential for Drugs to Affect Alvimopan Pharmacokinetics An in vitroo study indicates that alvimopan is not a substrate of CYP enzymes. Therefore, concomitant administration of ENTEREG with inducers or inhibitors of CYP enzymes is unlikely to alter the metabolism of alvimopan.

Potential for Alvimopan to Affect the Pharmacokinetics of Other Drugs Based on in vitroo data, ENTEREG is unlikely to alter the pharmacokinetics of coadministered drugs through inhibition of CYP isoforms such as 1A2, 2C9, 2C19, 3A4, 2D6, and 2E1 or induction of CYP isoforms such as 1A2, 2B6, 2C9, 2C19, and 3A4.

In vitro, ENTEREG did not inhibit p-glycoprotein.

Effects of Alvimopan on Intravenous Morphine Coadministration of alvimopan does not appear to alter the pharmacokinetics of morphine and its metabolite, morphine-6-glucuronide, to a clinically significant degree when morphine is administered intravenously. Dosage adjustment for intravenously administered morphine is not necessary when it is coadministered with alvimopan.

Effects of Concomitant Acid Blockers or Antibiotics A population pharmacokinetic analysis suggests that the pharmacokinetics of alvimopan were not affected by concomitant administration of acid blockers or antibiotics. No dosage adjustments are necessary in patients taking acid blockers or antibiotics.

USE IN SPECIFIC POPULATIONS Pregnancy Pregnancy Category B Risk Summary: y There are no adequate and/or well-controlled studies with ENTEREG in pregnant women. No fetal harm was observed in animal reproduction studies with oral administration of alvimopan to rats at doses 68 to 136 times the recommended human oral dose, or with intravenous administration to rats and rabbits at doses 3.4 to 6.8 times, and 5 to 10 times, respectively, the recommended human oral dose. Because animal reproduction studies are not always predictive of human response, ENTEREG should be used during pregnancy only if clearly needed.

Animal Data: Reproduction studies were performed in pregnant rats at oral doses up to 200 mg/kg/day (about 68 to 136 times the recommended human oral dose based on body surface area) and at intravenous doses up to 10 mg/kg/day (about 3.4 to 6.8 times the recommended human oral dose based on body surface area) and in pregnant rabbits at intravenous doses up to 15 mg/kg/day (about 5 to 10 times the recommended human oral dose based on body surface area), and revealed no evidence of impaired fertility or harm to the fetus due to alvimopan.

Nursing Mothers It is not known whether ENTEREG is present in human milk. Alvimopan and its ‘metabolite’ are detected in the milk of lactating rats. Exercise caution when administering ENTEREG to a nursing woman.

Pediatric Use Safety and effectiveness in pediatric patients have not been established.

Geriatric Use Of the total number of patients in 6 clinical efficacy studies treated with ENTEREG 12 mg or placebo, 46% were 65 years of age and over, while 18% were 75 years of age and over. No overall differences in safety or effectiveness were observed between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. No dosage adjustment based on increased age is required.

Hepatic Impairment ENTEREG is not recommended for use in patients with severe hepatic impairment.

Dosage adjustment is not required for patients with mild-to-moderate hepatic impairment.

Patients with mild-to-moderate hepatic impairment should be closely monitored for possible adverse effects (e.g., diarrhea, gastrointestinal pain, cramping) that could indicate high drug or ‘metabolite’ levels, and ENTEREG should be discontinued if adverse events occur.

Renal Impairment ENTEREG is not recommended for use in patients with end-stage renal disease. Dosage adjustment is not required for patients with mild-to-severe renal impairment, but they should be monitored for adverse effects. Patients with severe renal impairment should be closely monitored for possible adverse effects (e.g., diarrhea, gastrointestinal pain, cramping) that could indicate high drug or ‘metabolite’ levels, and ENTEREG should be discontinued if adverse events occur.

Race No dosage adjustment is necessary in Black, Hispanic, and Japanese patients. However, the exposure to ENTEREG in Japanese healthy male volunteers was approximately 2-fold greater than in Caucasian subjects. Japanese patients should be closely monitored for possible adverse effects (e.g., diarrhea, gastrointestinal pain, cramping) that could indicate high drug or ‘metabolite’ levels, and ENTEREG should be discontinued if adverse events occur.

ENTEREG and E.A.S.E. are trademarks of Cubist Pharmaceuticals. Any other trademarks are property of their respective owners.

Distributed by: Cubist Pharmaceuticals U.S. Lexington, MA 02421 USA © Cubist Pharmaceuticals. All rights reserved.

October 2014 ENT-0232

Surgeons are doing their patients a disservice if they order a test without having someone who can understand the implications and can share that with the family.

—Doreen Agnese, MD Dr. Agnese called on surgeons to evaluate patients and their families carefully to determine whether they should have genetic testing. It is important to take a detailed medical and family history, including a threegeneration pedigree and all types of cancer on the paternal and maternal sides of the family with specifics such as whether cancers were bilateral and ages of diagnosis. Whenever possible, supplement the history with medical records, she advised.

“I’ve had a lot of women report that someone had stomach cancer. To them, stomach cancer is used to describe anything in the abdomen. It’s not necessarily the stomach, it could be the ovaries.”

She stressed that family histories change with time, and need regular updating. For a surgeon following a breast cancer patient for years after her surgery, that means checking repeatedly for new developments in her family history. On first meeting, a woman diagnosed with breast cancer at 50 years might not appear to be a concerning case for heredity. But during her follow-up, if her sister were to be

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MARCH 2015

diagnosed with ovarian cancer, that development suggests a possible BRCA CA A mutation in the family, saaid Dr. Agnese.

When n a physician decides that a paatient and/or her family shou uld undergo genetic testing, it iss becoming increasingly complicaated to figure out what test to order,, said Dr. Agnese.

The number of labs offering genetic tests, aand the kinds of tests offered, has ggrown considerably in the past few years. In 2014, Myriad Genetics’ p patent was overturned, allowing ccompeting companies to provide BRCA A1 and BRCA2 testing.

Also, newer tech hnologies using nextgeneration sequeencing are now on the market, making iit possible for multiple genes to be testeed in a single sample.

The tests can an nalyze between six and 53 genes, and cosst between $1,500 and $6 000 $6,000.

But more genes tested does not equate to better information provided, said Dr. Agnese. Sometimes, the information gleaned from these tests fails to help with clinical decision making. Many tests include “intermediatepenetrant” genes, which confer relative cancer risks from 1.5 to 5 and are of unclear actionability. The testing may reveal some variants of unknown significance that geneticists do not know how to interpret.

Moreover, commercially available tests differ in number of genes tested, turnaround time, cost and insurance coverage. A long turnaround time may mean that the results will not be available in the window needed to make treatment decisions. And in some cases, particular mutations may be missed by next-generation sequencing because of insufficient coverage of a gene, requiring repeat panel testing.

Dr. Agnese suggested that surgeons start with single-gene tests for patients who meet criteria for a single hereditary syndrome. If the test comes back negative, surgeons should consider obtaining another single-gene test or go to a multiple-gene panel. A multiple-gene panel has a greater chance of finding a mutation in patients who fail to meet specific criteria for a syndrome, she said. Studies have shown that up to 17% of BRCAnegative breast cancer families and up to 24% of BRCA-negative ovarian cancer families will have a mutation detected with multiple-gene testing.

In patients who do not meet criteria for a single syndrome, those who meet criteria for multiple syndromes, or those whose insurance may only cover one round of genetic testing, multiplegene testing may be a cost- and timeeffective strategy, said Dr. Agnese.

“For example, a woman under 35 [years of age] with breast cancer would meet criteria for both BRCA A testing as well as p53 testing, and so a panel that includes both these genes could be obtained in a more timely and cost-effective fashion. We also might find more than one gene that could have implications for that patient and her family.”

Decisions about genetic testing should be made after a thorough discussion with the patient regarding the risks, benefits and limitations, said Dr. Agnese. “You need to ask, why are they

doing the test? What is the time frame the tests are needed? Does the patient understand these variants of uncertain significance? Does the patient understand that some of the genes may have only moderate risks for breast cancer and the other risks may be unclear at this time?”

She emphasized that genetic testing should only be done in conjunction with genetic counseling, carried out by a professional with training in cancer genetics. Surgeons are doing their patients a disservice if they order a test without having someone who can

understand the implications and can share that with the family, she said.

She recommended that surgeons who are interested in counseling their patients should get training. California’s City of Hope Cancer Center offers a series of courses in clinical cancer genetics. More details are available at www.cityofhope.org.

For surgeons who would like to find a genetic counselor, the National Society of Genetic Counselors (www. nsgc.org) has posted an online list of counselors available throughout the United States.

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On the

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MARCH 2015

{Spot}With Colleen Hutchinson Women in Surgical Leadership—Where Are They?

Participants Robin Blackstone, MD, is medical director, Scottsdale Healthcare Bariatric Center, Scottsdale, Arizona.

Jennifer Denne, MD, is attending surgeon, general and advanced laparoscopic surgery, Bryn Mawr Hospital, Bryn Mawr, Pennsylvania.

Angelita Habr-Gama, MD, is professor of surgery, University of São Paulo School of Medicine, São Paulo, Brazil.

Tari King, MD, is associate attending surgeon, Breast Service, Memorial Sloan-Kettering Cancer Center, New York City.

Marina Kurian, MD, is medical director of New York Minimally Invasive Surgery, associate clinical professor, Department of Surgery, NYU Langone Medical Center, New York City.

Katherine Lamond, MD, is assistant professor of surgery, University of Maryland Medical Center, Baltimore.

Emma J. Patterson, MD, is founder of Oregon Weight Loss Surgery and medical director of bariatric surgery, Wilshire Surgery Center, Portland, Oregon.

I was inspired to cover this topic when a female reader of On the Spott asked why I don’t have more women featured as thought leader contributors. I received her email, and immediately a quote from Madeleine Albright came to mind: “There is a special place in hell for women who don’t help other women.”

My initial thought, and the true answer, is that I invite those who are at the forefront of the topic that I am covering—that’s my only criterion for selection. In contemplating the question and thinking about the pool of potential contributors, though, I began to think about the lack of female thought leaders in certain areas of medicine, specifically surgery.

Interestingly, for a column I created for Clinical Oncology News, the breast cancer expert panel was equally balanced with regard to gender, and my palliative care column panel in that newspaper was composed of almost all women. So maybe it is an issue of specialty, and does that mean that most women gravitate toward certain areas of medicine and subspecialties of surgery, or can the general imbalance we see now in both leadership roles and academia be attributed to both the evolution of women in surgery and biases that still exist? Many questions arose: Will women catch up in terms of representation? Why are there so few female authors and presenters at conferences?

What are the challenges and obstacles that female surgeons face?

On the following pages, we hear from women surgeons who share their candid, varying experiences that have served to shape informed

{

Statement: There is a lack of female role models or lack of mentors for females who want to enter surgery on an academic path.

Dr. Habr-Gama: Agree.

Dr. Blackstone: Agree.

Most female role models or mentors available are those who adopted a male behavior in order to achieve academic success. It is unclear whether women are currently willing to give up “women behavior” for that purpose.

This was absolutely true when I was at University of Colorado in the early 2000s—perhaps less true now. I can cite a number of outstanding women mentors; however, there are still too few.

More women are needed who are willing to make the necessary trade-offs in their lives in order to participate on an academic level.

Women can be great surgeons and community leaders; when they step up to also do research, write papers and mentor students, it adds to their already full plate. Combined with family responsibilities, the obvious time conflicts are unavoidable. Unique solutions are necessary and will likely be found by the very women affected rather than from the outside. The quality of surgical care and expertise cannot be sacrificed or diminished with the other responsibilities. Women have to be willing to stand up to criticism because they are using unique solutions to be able to participate in academic medicine.

Dr. King: On the fence.

Susan Pories, MD, is associate professor, Harvard Medical School, Boston, Massachusetts.

Aurora Pryor, MD, is professor of surgery and vice chair for clinical affairs; chief, bariatric, foregut and advanced GI surgery; director, Bariatric and Metabolic Weight Loss Center, Department of Surgery, Stony Brook School of Medicine, Stony Brook, New York.

perspectives. Interestingly, the biggest dissenter on statements describing perceived obstacles to female academic and leadership success is also the youngest person on this panel. Katherine Lamond, MD, who first contributed to On the Spott in 2011, as a laparoscopic fellow at Johns Hopkins, lends arguably the most optimistic perspective here— seeing no barriers to female surgical leadership, for instance, or seeing no lack of female mentors.

It is an encouraging observation because if, as some contributors here state, the tide is turning, then that progress is reflected in Dr. Lamond’s experience and responses as the youngest panelist.

That said, there are clearly still challenges and obstacles, and there’s work to be done—on the part of institutions, individual clinicians in positions of authority, associations and the individuals who wield power within them, on the part of people like me to try to achieve a better balance, and most importantly, on the part of current female surgeons and all females who are pursuing that path—which takes us back to the Madeleine Albright quote. Between these lines lies a roadmap to success: Look to overcome the obstacles discussed here, push yourself forward with resolve and the belief that you can achieve what you want (with some extra effort toward balance), and you will position yourself best to reap the rewards of the effort it takes for a female surgeon to be successful in academia and leadership.

Thank you for reading. Please share comments online. I can be reached at colleen@ cmhadvisors.com.

—Colleen Hutchinson

In some surgical subspecialties (breast surgery), there are a number of female role models and mentors, whereas in other surgical disciplines, female mentors are more difficult to find.

Dr. Pories: Disagree.

There are many successful women in surgery today and most of them are very willing to help other women along the way. Getting involved with the Association of Women Surgeons is a great way to connect with role models and mentors.

On the Spot

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MARCH 2015

Gut Reaction: Women in Surgery Association of Women Surgeons (AWS)

In-hospital childcare for surgeon-parents

Guess how many women currently hold surgery chair positions in the United States

Best advice to the female medical student on her path forward as it relates to gender

Best advice to the female community surgeon who would like to become more involved in association leadership and research/ publication

Difference between the male resident or fellow and the female resident or fellow

Time magazine’s inclusion of the word “feminist” in its banned word list of 2015

The fight for equal pay for women and a place at the table in the surgical career setting, 2015

Not necessary

Super important!

Fewer than deserved

It is going to be tough; don’t give up, and find your own balance.

Not impossible

No difference

Perfect

Should not stop; it is only the beginning

Robin Blackstone, MD

Relevant, not well publicized

Essential for both genders

Four

Ignore it, move toward your personal goals.

Join a committee, work hard, engage.

Both are valued.

Don’t need it; mainstream ourselves in leadership roles

No excuse for unequal pay; women strengthen organizations

Jennifer Denne, MD

Excellent group for promoting women in surgery

Would be a miracle; why doesn’t it exist?

Four; certainly not enough

Trudge forward; work hard.

Attend meetings, network, find mentors, male or female.

The ability to multitask, different level of compassion

Interesting, on the fence

A worthy cause and long battle

Tari King, MD

Good intentions

Awesome

Three

Gender is only an issue if you allow it to be.

Just do it.

Genitalia

How do you ban a word?

Advocate for yourself.

Marina Kurian, MD

Great welcom- A great idea if ing and pertiyou need it nent association

Habr-Gama, MD

Katherine Lamond, MD

Five (including other Do what you love! departments, 15)

Join committees!

Only in the OR Get medical students conversation to help you write.

Everyone should be supportive of women. Everyone was nurtured within a woman. Let’s all be humanists!

Not just in surgery; there is one salary for the same job.

Not at my hospital!

Two

Forget about gender!

Join local chapter of ACS.

Too bad “feminist” became a bad word.

Equal pay for equal work

Emma J. Patterson, MD

I used to be a member.

That would be absolutely incredible.

Two

Find a mentor, and have Offer to teach resibalance. dents and collaborate in research.

Gender

A mistake

It’s a hard fight.

Susan Pories, MD

Great networking organization

Would be wonderful

Seven

Do what you love and ignore the naysayers.

Become involved in AWS and start networking.

The women still have to work harder and balance more.

A rose by any other name

Long overdue

Aurora Pryor, MD

I am an inactive member.

Great idea.

Needs to be 24/7.

10

Choose what you like and do it well.

Show up and ask to get involved.

XX versus XY

Agree it’s a dated concept

Unfortunately still necessary

Dr. Pryor: On the fence.

Although this has been true even in the recent past, we are seeing women at all levels of surgical leadership now. However, I still think many women are hesitant to reach out to these leaders for advice and guidance.

Dr. Denne: Agree.

This will only change with time. As we see medical school classes are now 50% women, it is encouraging that this will change. The number of women in surgical residencies has also increased. Female mentors in academics will be crucial to this process, but the change will not be seen for a number of years as these female residents graduate from training and move into attending and leadership roles.

Dr. Lamond: Disagree.

There are plenty of female role models and mentors in academic medicine, and they may be more willing than men to play a mentorship role.

Dr. Kurian: Agree.

That is clear, since the questions are about how few women are in surgery. ;) But a shout-out to my surgical mentors who saw an opportunity to teach a resident

and never cared what sex I was. There are mentors who encourage young surgeons irrespective of sex.

Dr. Pryor: Disagree.

While this may have been true historically, it is no longer the case. There are many great role models for young women who want to consider careers in math and/or sciDr. Patterson: Agree. ence. What we need, however, is a better track into leadThere aren’t many. ership. Women early in their careers need to actively seek Statement: Much of the sex discrimination opportunities for speaking, teaching and networking to or inequality that does still exist is now less in the build a foundation for later success. Opportunity needs to be sought; it will not be handed to you. stages of hiring and promotion of women in the academic medical community, and instead takes Dr. Pories: Disagree. place earlier in the lives of females—with expecAlthough early childhood experiences are important, tations and attitudes on gender, math and ability this is difficult to study and even more difficult to influleading to the propensity for children and teenage males to be drawn into math-intensive sciences ence. We need to continue to focus on hiring and promotion of women in the academic medical community and females into non-math intensive sciences. to help women advance to leadership positions.

Dr. Habr-Gama: Disagree.

Sex discrimination is much less intense in earlier steps of people’s lives and much more intense in the hiring and promotion of women in the academic medical community.

Dr. Patterson: Agree.

I think those stereotypes are still present and are an influence on our children.

Dr. Denne: On the fence.

I think this is changing, and these “standard” male and female strengths are now being recognized as inaccurate. We do still need to ensure that girls and boys are treated with equality and recognized for their individual strengths, as well as exposed to career paths that suit them, regardless of gender.

Continued ON page 18

17

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On the Spot jcontinued from page 17

Dr. Blackstone: Disagree.

I think the lack of mentoring and support once a woman is hired is still an issue. I have read about the early emphasis on math for men; however, while this may be true, it is not clear to me that it can be changed by the efforts of women in medicine or that a person who does a math-intensive science versus a different discipline will result in a more gifted physician, teacher or educator.

Many of the sciences that are driving modern medical disease—inflammation,

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MARCH 2015

obesity and diabetes—are not specific to math. Rather, I think that mentoring women in the best way to think through and approach a problem: logic, philosophy and some of these more “thinking” sciences may be a more productive fit. In addition, many of the natural skills women have—team building, mentoring and organizational skills—these tactical skills are very valuable. In general, though, guiding women to develop strategic skills will be the deciding difference in their futures.

Dr. King: Disagree.

Children growing up in today’s world of

“open access” have many opportunities to explore their own career preferences.

Dr. Kurian: Disagree.

I was drawn to math and science from third grade on, as likely were many of my female contemporaries in surgery. My parents never deterred me from what I could study as well as my inherent self-worth/esteem never allowed me not to pursue what I wanted. I have seen the studies about girls and how they deal with math, and this was never me or any of my colleagues.

Statement: In an effort to improve the gender gap in certain surgical disciplines, it is fair to say that academic institutions, medical associations, and health care facilities in general could do more to better encourage or make a path more available for women to be more active in academic surgery and leadership roles.

Dr. Patterson: Agree.

I have seen many examples where I thought they could have done better.

Dr. Kurian: Agree.

Setting New Standards Through Innovation

Unlike in corporate America where some responsible companies try to increase women in leadership positions, this is not something that is occurring across the United States or internationally. Even in New York City, the number of women full professors in surgery is few. Actually, at NYU, we have the largest female surgical faculty in the United States, thanks to the leadership of our egalitarian chair, H. Leon Pachter, MD.

Dr. Lamond: Disagree.

Restoring Natural Vision and Depth Perception without Compromise

It isn’t the responsibility of the institutions, associations and health care facilities to make the path more available. It is up to women to choose the path.

Dr. Pryor: Agree.

Good managers should understand that women are less likely to ask for promotion and opportunity, but are not necessarily less deserving. By encouraging female representation in all visible areas (leadership, invited speakers, grant support), we continue to suggest these things are reachable goals for others as well.

Dr. King: Agree.

There are still many situations in which the “old boys school” mentality persists and well-qualified women are overlooked for leadership opportunities.

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Dr. Habr-Gama: Disagree.

The problem of gender inequities is probably not solved by explicitly encouraging or making paths more available for women. These institutions should make an effort to provide equal opportunities for men and women based on merit rather than specific gender.

Dr. Blackstone: Agree.

To contact an Olympus representative call 800-848-9024 or visit www.medical.olympusamerica.com/gsur © 2014 Olympus America Inc. Trademark or registered Trademark of Olympus and its affiliated entities in the U.S. and/or other countries of the world. All patents apply. OAIURO0414AD12969

I think this will happen naturally as more qualified and interested women begin to bubble up through the system.

Mentoring and promotion of qualified women is essential at all levels. This often requires champion female surgeons who can lead the charge to increase the support and mentoring of women who want to pursue this route.

On the Spot

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MARCH 2015

I am also sensitive to the fact that we cannot forget that the vast majority of male and female surgeons do not take the academic route. I am not sure that we are doing a very good job at supporting either men or women surgeons who are not taking the course in the academic world, but can play a leadership role in their community hospitals in quality and many other areas. Frankly, there are many leadership opportunities for female surgeons in the community settingâ&#x20AC;&#x201D;many community hospitals are having to evaluate data on procedures and try to improve value through decreasing complications (improving quality) and decreasing cost.

These are ideal leadership positions for women whose skill sets in leadership lend themselves to team leadership.

Dr. Kurian: On the fence.

Dr. Blackstone: Disagree.

This really depends on the support structure for the surgeon. I have an incredibly supportive husband and parents to help with my children, and to egg me on with all aspects of my career.

I think that surgeons, regardless of gender, have a difficult time managing their personal life and work responsibilities; in the environment of a surgical trainee, it is even more exaggerated. The demands of patient care, whether in residency, fellowship or practices, are extreme. No reasonable solution between the necessities of experience versus personal time has been able to be articulated. It is true that the female surgeon experiences the actual physical limitations of pregnancy unlike her male counterpart, but both suffer, as do their families. Somehow we must reach

Dr. Pories: Agree.

The woman often takes more responsibility for the home and children and ends up carrying a heavier load than her male counterparts. Of course, this can all be managed with appropriate help at home, such as nannies and housekeepers, but it does require careful planning and organization.

for a solution that is gender-neutral and maximizes the personal experience and life experience of each resident/fellow/ surgeon as well as the experience necessary to become a safe surgeon with excellent judgment in difficult environments.

Dr. Pryor: On the fence.

I think this is very dependent on your spouse and how you divide responsibility at home. I am very lucky to have a husband who takes care of most of the traditionally female household roles to allow me more flexibility at work. I think these Continued ON PAGE 20

Dr. Denne: Agree.

I donâ&#x20AC;&#x2122;t feel there has to be a specific path for women, but more importantly, women need to see female role leaders and mentors to know that leadership roles and academic positions are achievable and feasible. Women should be required to have the same credentials as men to fulfill these positions.

Dr. Pories: Agree.

Every academic institution and health care facility can do more to encourage women. Child care should be available.

Mentoring programs, faculty advisors and networking events are also important components of a supportive environment.

Statement: The female surgeon, or surgeon in training, who is married with children has more of an uphill battle to achieve the same academic career goals than that of a male surgeon, or surgeon in training, who is married with children and is pursuing the same goals.

Dr. Patterson: Agree.

Just the physical commitment of pregnancy and nursing alone adds a whole other element to the life of a female surgeon with children.

Dr. Lamond: Disagree.

The battles for males and females married with children are equalâ&#x20AC;&#x201D;it just depends on a personal support network and spousal/family involvement, although maternity leave may put you a few weeks behind.

Dr. Habr-Gama: Agree.

The current family model is still based on differences in expectations from men and women. Women are expected to dedicate more time to family than to work compared to the expectations placed on men.

Next stop: G GeneralSurgeryNews.com Ge eneralS u r g e r y N e w s . c o m Your Grand Central Station for all the latest new ws, opinions and analysis in surgery.

19

20

On the Spot jcontinued from page 19 things should be negotiated early on in a relationship so that appropriate expectations can be set.

Dr. Denne: Agree.

Whether we want to admit it or not, most women have more family responsibilities than their male counterparts and find it more difficult to achieve a good work–home life balance. I am hopeful that as the traditional roles of the mother and father in the family change, this becomes less of an issue.

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MARCH 2015

Dr. King: Agree.

Statement: There are certain gender gaps that have been identified in academic setThe life-work baltings in health care and continue to exist. Women are well represented in breast cancer ance is challenging for surgery versus other surgical disciplines. Men are underrepresented in education, nursfemale surgeons, and it ing, social work, palliative care careers and what some call “helping” professions. The is often difficult to fulidea that women are more attracted to “helping” and “people-related” professions is fill all the expectations likely biology versus social and cultural norms and expectations, and therefore these of being a wife, a mothgaps, to a degree, are unlikely to change or evolve with time. er, and an academic surgeon—inevitably one Dr. King: Agree and disagree. hernia surgery, pancreatic surgery, trauma, piece gets less attention It only takes one great role model to neurosurgery or any other surgical specialthan the others. Women influence the next generation of “helpers.” ty as they are in breast surgery. with young children in particular frequently feel as if they have Dr. Pories: Disagree.

Dr. Habr-Gama: Agree. to make a choice between family Women can be and are just as successDifferences in behavior among and career. ful in cardiac surgery, colorectal surgery, men and women may result in such

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On the Spot

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MARCH 2015

differences and not evolve over time.

However, there may well be females with male behavior and vice versa.

Dr. Blackstone: Disagree.

Dr. Patterson: On the fence.

As individuals, women and men will be good in all these areas. Women may choose what is perceived as less demanding surgical areas in order to accommodate family or research interests. In general, having the number of women in surgery reach a critical mass or tipping point will diversify the pool of women who make different choices in their career paths. The tipping point is around 33%.

I think there may be some biological component, but social and cultural norms and expectations play a big role, too, and I think they slowly evolve.

The gender gaps exist. The reason may be “nature” rather than “nurture.” However,

Dr. Pryor: Disagree.

Although I think we will continue to see more female breast surgeons and more male urologists, I think it is based on societal expectations and not biology.

Dr. Denne: On the fence.

societal perceptions and expectations must change so that males and females are encouraged to pursue any career path or specialty they desire. Younger students should be exposed to all specialties, not just the ones traditionally associated with their gender.

biggest determinant other than female surgeons having one specialty “call” to their inner being.

Dr. Lamond: On the fence.

Biology is a good thing.

Dr. Kurian: Disagree.

All of medicine is about helping people. That is not gender-specific.

There are many male Ob/Gyns as well, including mine! Lifestyle considerations can impact choice of subspecialty in surgery, though. That may be the

—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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Opinion THE BEAN

jContinued from page 1 brain cancer by 40% (Can Epidemiol Bio Prev, January 2010).

• Colon cancer: At least two cups of coffee per day can cut colon cancer risk by 25% (AACR meeting abstract, 2014).

• Breast cancer: At least three cups of coffee per day can prevent or delay the onset of certain types of breast cancer (Sci Daily, April 2008).

• Liver cancer: A recent study showed that one to three cups of coffee per

GENERALSURGERYNEWS.COM LSURGE EWS.CO / GEN GENERALL SURG SURGERY NEWS / MARCH 2015

day reduces the risk for developing hepatocellular carcinoma by 29% (Clin Gastroenterol Hepatol, 2013).

• Melanoma: Coffee users who drink four cups or more per day are 20% less likely to develop malignant melanoma than non–coffee drinkers ((JNCI, January 2015).

• Pancreatic cancer: A reduced risk of pancreatic cancer was seen in men who drank at least three cups of coffee per day. This effect was not seen in women (World J Gastroenterol). l A new study funded by the National Institutes of Health, covering more than

I never dreamed that the excessive caffeine or other cccult substances I was enjoying could have such benefits.

450,000 women, reports that four cups of coffee (or more) per day could help to lower the risk for developing endometrial cancer by as much as 18%. This study actually found that, at least in these women, those who drank four or more

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

cup ps of coffee per day, every day, d coould have this red duced risk. The study considered 83 other food ds to examine potential healt health benefits, but found no other compelling arguments to recommend an increase of other foods except for coffee.

Dr. Robert Morgan, professor of medical oncology at City of Hope Comprehensive Cancer in Duarte, Calif., reports that this new study validates other studies that show “coffee has a beneficial effect in decreasing endometrial cancer,” but cautioned that previous studies have failed to show any link, so this is going to need more study.

When I began drinking excessive quantities of coffee as a surgical resident and as a Navy surgeon aboard a nuclear aircraft carrier, I never dreamed that this practice might actually improve my immune competence or potentially increase my natural killer cell function. In addition, I didn’t consider that the antioxidant effect of coffee could prevent or slow cell damage.

Over many years of interminably waiting in the surgeons’ lounge for delayed cases to begin, I never dreamed that the excessive caffeine or other occult substances I was enjoying could have such benefits.

We have all learned, however, that just because studies appear heralding the benefits of nutrients, it does not necessarily follow that we should become devotees ourselves or jump on the bandwagon as a patient education strategy. Obviously, nutrition is important epidemiologically for many illnesses, not just malignancy.

Although studies touting the evils or benefits of certain foods or drinks get much press and capture our interest, the effects of anything ingested in excess should be considered with caution.

That said, I have derived some psychological benefit from the recent coffee studies. It is always pleasurable when you do something enjoyable that also has a health benefit. We must always remember, however, the admonition “caveat emptor.” If it is too good to be true, well ….

It is reasonable to keep abreast of certain nutrition headlines, because they may be important for us, for our families and for our patients. I suspect we will have more information in the future regarding the coffee saga. Until then, the current positive studies and press are justifying my own craving. I also anticipate that next year, when we watch Super Bowl L, we might see a glitzy Starbucks commercial doing some cause-directed marketing and aimed at a health care theme!

—Dr. Greenee is clinical professor of sur— gery, University of North Carolina School of Medicine, Chapel Hill, N.C.

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MARCH 2015

23

Readmissions After Bariatric Surgery: Room for Improvement Study Identifies Potentially Avoidable Factors for Return to Hospital in Bariatric Patients

of 45 or greater,” Ms. Patterson said.

“Only about 5% had a complication during their original surgery; 50% had hypertension; 30% had diabetes without complications; and 20% had chronic pulmonary disease.”

The statewide PPR rate was 5.3%, and the all-cause readmission rate was 5.9%.

“Of the 10,448 bariatric surgeries performed in 2012, 552 were followed by at least one PPR. Those 552 surgeries

B Y K ATE O’R OURKE BOSTON—Roughly 5% of hospital inpatient readmissions after bariatric surgery are potentially avoidable, according to an analysis of 2012 data from New York hospitals. The new report also identified factors, such as type of surgery and patient characteristics, that are associated with higher rates of readmissions.

“Our potentially preventable readmission rate was 5.3%,” said Wendy Patterson, MPH, New York State Department of Health, Albany, N.Y., who presented the research at 2014 Obesity Week (abstract A203). “There is a lot of room to decrease the potentially preventable readmission rate.”

Patients who underwent laparoscopic bypass were 1.8 times more likely to have a potentially preventable readmission than laparoscopic banding.

The Statewide Planning and Research Cooperative System (SPARCS) database allows researchers to track patients over time. In their analysis of this database, the researchers included adult inpatient bariatric surgical discharges from all hospitals in New York between Jan. 1, 2012 and Dec. 31, 2012. Patients were defined by an International Classification of Diseases-9-CM principal diagnosis code for overweight or obese and a principal procedure code for bariatric surgery.

The investigators used the potentially preventable readmission (PPR) logic developed by 3M Health Information Systems to identify readmissions that were clinically related to previous hospitalizations and therefore may have been preventable.

“The 3M software excludes most types of admissions related to cancer, traumas and burns; ob-gyn patients; and any patient whose care ended abruptly: left against medical advice or were transferred to another hospital,” Ms. Patterson said. A logistic model was used to analyze the data by gender, age, race/ethnicity, payor, body mass index (BMI), surgical approach, complications and comorbidities.

Patients were mainly female (80%), more than 40 years old, white non-Hispanic, and covered by commercial insurance. “Roughly 45% of them had a BMI

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Surgeons’ Lounge

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MARCH 2015

Dear Readers,

Welcome to the March issue of The Surgeons’ Lounge. This issue features not one, but two guest experts! John Morgan Cosgrove, MD, FACS, attending surgeon, Eastern Long Island Hospital, Greenport, N.Y., discusses removal of foreign bodies in the foregut in the emergency room, and Jorge Ortiz, MD, associate professor, Department of Surgery, surgical director of Transplantation, University of Toledo, Ohio, addresses bariatric surgery in patients with renal failure.

We welcome your questions and comments!

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

Question for John Morgan Cosgrove, MD From David Nguyen, MD Ross University, Dominica, West Indies

Which service handles foreign body ingestion at your institution? Can you describe some cases of foreign body removal that you have treated in the emergency room?

Dr. Cosgrove’s

Reply

I am at a 90-bed community hospital on the eastern end of Long Island, N.Y. Although we have a gastroenterologist available 24/7 for call, I have established myself as a capable endoscopist, such that I am now getting calls from the emergency room for foregut foreign bodies.

During the weekend of July 4, 2014, I had two colon emergency cases and two emergency endoscopies. One case was an esophageal food impaction that was successfully relieved after intubation and general anesthesia.

The other case was a 34-year-old man presenting to the ER with a chief complaint of epigastric abdominal pain, which he said began acutely the evening before, after eating at a barbecue. The patient described the pain as 8 out of 10. The patient had no past medical or surgical history; his vital signs were stable; and the abdominal exam revealed a flat, soft abdomen with positive bowel sounds and 2+/4+ epigastric tenderness. White blood cell count was 5.8; hemoglobin/hematocrit was 13.5/41.6; with 48% neutrophils. The abdominal flat and upright x-rays were negative. A computed tomography (CT) scan showed a 2.5-inch, needle-like, metallic density identified in the antral region of the stomach (Figure 1). The patient was admitted to the surgery service, received IV fluids and antibiotics, and was brought to the operating room, where he underwent intubation and general anesthesia. Esophagogastroduodenoscopy was performed to the second part of the duodenum.

The metallic object, a wire bristle for cleaning a grill, was found in the first part of the duodenum (Figure 2).

A polypectomy snare was used to remove the foreign body without difficulty. Completion endoscopy showed

Figure 1. Computed tomography scan showing a 2.5inch, needle-like metallic density in the antral region of the stomach.

Figure 2. The metallic object (a wire bristle) was found in the first part of the duodenum.

no bleeding or hematoma. The patient was discharged My recommendation for a patient presenting to the home after a second dose of antibiotics, tolerating an emergency department with abdominal pain after eatoral diet and with a benign abdomen. ing barbecue food is to obtain a CT scan. If a metallic Foreign bodies in the aerodigestive tract are common object is found, book the patient for general anestheand can have significant consequences. Perhaps the sia (with mandatory endotracheal intubation). Intragreatest proponent of all time of endoscopic removal of venous fluids and antibiotics should be administered. foreign bodies is Chevalier Jackson, MD (1865-1958). In addition, unless there is some compelling issue, the He was a Philadelphia otolaryngologist who developed patient can wait six to eight hours if the food ingestion techniques and instruments for safely removing foreign occurred recently. bodies from the aerodigestive tract. There is a permaThe recommendation I now give to patients whom I nent exhibit at the Mutter Museum in Philadelphia, know have outdoor barbecues (which means everyone commemorating this great physician. in this semirural area!) is to examine the grill surface Until recently, reports of wire bristle foreign body carefully for the presence of bristles before cooking. In ingestion were unusual. However, there is more aware- fact, the grill should be wiped with a moist towel before ness now that these objects can pose a serious problem using. Also, the public needs to be aware of the need to to those who use outdoor barbecues to cook. The sever- shop around for a good brush. There are spiral brushes ity of injury can range from asymptomatic passing of and bronze wire brushes that may afford more protecthe wire to the need for emergent surgery for gastroin- tion against accidents. testinal tract perforation.

McMullen et al reported three patients with wire bristle foreign bodies between 2009 and 2011 ((Am J Otolaryngol 2012;33:731-734). Each patient had pain for Jorge Ortiz, MD after the ingestion of barbecued food. In From David Fumo, MD one patient, a complex deep space neck Postdoctoral research associate, Department of abscess was found, making ENT backup Urology, University of Toledo, Ohio necessary at times. Harlor et al reported six cases of wire bristle ingestion (Laryngoscope A 48-year-old woman with a body mass index (BMI) of 40 kg/m2 2012;122:2216-2218). The problem occurs wanted to be evaluated as a candidate for bariatric surgery. She frequently enough for the Centers for Dishad a 10-year history of diabetes mellitus type 2 and hypertenease Control and Prevention to have issued sion, and was being followed by a nephrologist for stage 4 chronic an alert in the Mortality and Morbidirenal failure (CRF). Her most recent laboratory screening showed ty Weekly Reportt in 2012 (MMWR Morb +1 proteinuria and a serum creatinine of 2.4 mg/dL, an increase Mortal Weekly Rep 2012;61:490-492).

Continued ON page 26

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Surgeons’ Lounge jcontinued from page 24 from 1.9 mg/dL six months before. Her nephrologist recently discussed treatment options if her renal function continued to decline. She was told that her morbid obesity would likely exclude her as a transplant candidate, and dialysis was her only option.

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MARCH 2015

renal disease (ESRD), would she still be a candidate for bariatric surgery?

Which bariatric surgical procedure is best in this scenario?

• What are the results of patients who undergo bariatric surgery after renal transplantation?

Questions

Dr. Ortiz’s

• What are the renal complications of bariatric surgery, particularly in those with preexisting kidney disease?

• If she were to progress to end-stage

Reply

Question 1 The incidence of obesity-related cases of diabetes, hypertension and kidney disease is expected to increase. Obesity is an independent risk factor for CRF. Studies have shown that patients with a BMI of more than 30 kg/m2 are 1.2 to 3.2 times more likely to develop CRF. Furthermore, CRF is 4.4 times more likely1,2 in those with a BMI of more than 35 kg/ m2. Bariatric surgery also carries a risk for renal complications postoperatively. Historically, jejunoileal bypass (a procedure largely abandoned) was marred

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Supported by an educational grant from Merck.

Tricia Meyer, PharmD, MS, FASHP Departments of Pharmacy and Anesthesiology Scott and White Memorial Hospital Texas A&M University System HSC College of Medicine Temple, Texas

by the occurrence of malabsorption complications, including renal failure.3 Other documented renal side effects after bariatric surgery include acute kidney injury (AKI), rhabdomyolysis and nephrolithiasis.4 A recent presentation reported an increased rate of complications with renal disease.5 This retrospective study evaluated 74 patients with CRF who underwent laparoscopic bariatric surgery at three major London hospitals and found that 16 of 74 patients experienced adverse events, the most common of which was AKI (4%). Another study of 491 patients undergoing bariatric surgery found that 8.5% of patients developed AKI. This untoward event was associated with hyperlipidemia, preoperative use of angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, intraoperative hypotension and increased BMI.6 Rhabdomyolysis is strongly associated with operative time.7 Rhabdomyolysis is a well-known cause of AKI, and therefore these two complications often go hand in hand. Although discrepancies exist in the reported incidence of rhabdomyolysis, it is likely that shorter operative times associated with laparoscopic procedures have led to a decreasing incidence.4 Nephrolithiasis is also a significant complication after bariatric surgery. Fat malabsorption in the intestinal lumen leads to calcium–lipid complexes, which increase the amount of free oxalate available for absorption. This leads to hyperoxaluria and the formation of calcium oxalate stones. Stone formation is associated more strongly with gastric bypass procedures such as the Roux-en-Y. One study demonstrated that banding procedures showed no significant increase in risk compared with a control group and carried significantly less risk than malabsorptive procedures.8 It is important to note that obesity itself is associated with nephrolithiasis, likely related to insulin resistance, hyperinsulinemia, metabolic derangement and hyperoxaluria.9,10

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Both systematic reviews and more recent prospective studies have demonstrated that nonsurgical weight loss can lead to improved renal parameters in obese patients with kidney disease, and point to the potential of bariatric surgery in this arena. Although literature on patients with kidney disease undergoing bariatric surgery consists of small series and case reports, there is some evidence that weight loss can lead to reduced proteinuria and serum creatinine in these patients.4 The effect on progression of CRF and development of ESRD is less clear.11 For patients who are dependent on dialysis, a paradoxical relationship has

Surgeons’ Lounge

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MARCH 2015

been demonstrated in which a BMI of more than 37 kg/m2 was found to have a protective effect.12 However, this may be due to a low nutritional reserve in patients with a low BMI at the initiation of dialysis, and is not necessarily an indicator that intentional weight loss while on dialysis is detrimental. Although large studies have not been conducted, there are reports of improved renal function in dialysis-dependent patients.13 An important indication for bariatric surgery with ESRD is for patients who are medically ineligible for transplant due to their BMI. Many studies have demonstrated higher complication rates in obese kidney transplant patients.

A high BMI has been associated with higher incidences of graft loss, patient mortality, infection, urologic complications and ischemic heart disease.14 In a study of 21 patients with ESRD who underwent bariatric surgery, 16 became wait list–eligible, two were transplanted, and two of eleven demonstrated remission of type 2 diabetes.15 In an analysis of the United States Renal Data System (USRDS), 20 of 29 patients (69%) who underwent bariatric surgery while on the wait list proceeded to transplant.14 These studies concluded that bariatric surgery for patients with ESRD yields an acceptable risk-to-benefit ratio and is a reasonable treatment option. Most of these patients underwent Roux-en-Y gastric bypass. Although it has been suggested that banding or restrictive procedures (such as sleeve gastrectomy) may be beneficial to ameliorate malabsoption complications in patients with ESRD, future prospective trials are necessary.15

substantial benefit to obese patients with CRF. Many are able to achieve substantial weight loss that allows them to qualify for kidney transplant, while some even show improvement in renal function.

Post-transplant patients stand to benefit from decreased graft loss and patient mortality. Although complication rates in all groups were not negligible, the risk-to-benefit ratio suggests that bariatric surgery should be considered in these populations. It would appear that the evolution away from malabsorptive procedures may lead to decreased renal complications after bariatric surgery.

Future prospective studies are needed to elucidate complication rates and longterm outcomes, and to compare the risks and benefits of banding versus bypass procedures.

References 1.

2.

3.

4.

5.

JAMA. 2004;291:844-850.

Arch Intern Med. d 2009;169:342-350.

Surg Endosc. 2008;22:2281-2300.

Obes Surg. 2011;21:528-539.

Medscape Medical News. Kidney Week 2013: Medscape Multispecialty; 2013.

6. Clin J Am Soc Nephrol. 2007;2:426-430.

7. Obes Surg. 2006;16:1365-1370.

8.

9.

10.

11.

12.

13.

14.

15.

16.

17.

18.

19.

Urology. 2010;76:826-829.

Semin Nephrol. 2008;28:163-173.

Urology. 2000;55:825-830.

Curr Opin Nephrol Hypertens.

2006;15:481-486.

Am J Clin Nutr. 2004;80:324-332.

Surg Obes Relat Dis. 2009;5:237-241.

Transplantation. 2009;87:1167-1173.

Surg Obes Relat Dis. Abstract published online 2014 Oct 1. http://dx.doi. org.10.1016/j.soard. 2014.09.022.

Nephrol Dial Transplant.

2010;25:3142-3147.

J Am Diet Assoc. 2010;110:633-638.

Surg Obes Relat Dis. 2009;5:662-665.

J Endourol. 2004;18:418-424.

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Question 3 In a recent meta-analysis of nearly 200 kidney transplants, recipients demonstrated substantial weight loss after bariatric surgery. Although complication rates were not negligible, they were comparable to some trials among patients without kidney disease.14 Laparoscopic gastric banding procedures may provide an additional benefit in post-transplant patients. Several cases have been reported with no perioperative mortality, although technical complications such as band slippage, erosion and obstruction did occur.16-18 There is also concern that bypass procedures may affect the pharmacodynamics of immunosuppressive medications. One study reported a need to increase the dosage of the main immunosuppressive drugs, including tacrolimus, sirolimus and mycophenylate, to maintain satisfactory levels after Rouxen-Y gastric bypass procedures.19 Gastric banding has the potential to eliminate these concerns.

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In the News HERNIA RECOVERY jcontinued from page 1

Yuri W. Novitsky, MD, director of the Case Comprehensive Hernia Center at Case Western Reserve University, Cleveland, and his colleagues in their report, published in the journal Plastic and Reconstructive Surgery (2014;134:151S-159S).

ERAS programs are designed to reduce patient morbidity and hospital length of stay (LOS) after surgery by providing optimal pain management and accelerating patients’ intestinal recovery. ERAS have been shown to significantly shorten LOS after colorectal surgery, for which they were first implemented, as well as in a growing number of general surgical procedures. This is the first time that ERAS have been reported in abdominal wall reconstruction.

In a pilot study of 42 consecutive patients undergoing open incisional hernia repair requiring myofascial release in a clean surgical field compared with historical controls, implementation of the ERAS pathway resulted in a faster return to tolerance of solid food and passage of stool by 1.4 days (5 vs. 3.6; P<0.0001) and a mean reduction in LOS by 1.4 days (5.8 vs. 4.4; P<0.0001). Since the ERAS program was started, 97% of patients have remained on the pathway.

Dr. Novitsky said the pathway was designed to achieve two goals: optimal pain management and accelerated

READMISSIONS jcontinued from page 23

actually had 711 readmissions. So, of all the patients who had a readmission after surgery, on average they had 1.3 readmissions,” Ms. Patterson said. “Roughly 69% only had one readmission; 20% had two; and 11% had three or more.”

The most common bariatric surgical approach was laparoscopic gastric bypass (46%), followed by sleeve gastrectomy (41%), laparoscopic banding (8%) and open gastric bypass (5%).

Open gastric bypass procedures had the highest PPR rate per 100 operations (8.8), followed by laparoscopic bypass (6.1), sleeve gastrectomy (4.3) and laparoscopic banding (3.3). Patients who underwent open gastric bypass surgery were 2.4 times more likely to have a PPR than those undergoing laparoscopic banding (P<0.05). Patients who underwent laparoscopic bypass were 1.8 times more likely to have a PPR than laparoscopic banding (P<0.05).

“It would be expected that laparoscopic banding, a minimally invasive procedure, would result in a lower PPR

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MARCH 2015

intestinal recovery. The team provided multimodal pain control with an emphasis on reduced opiate use and application of a precise intraoperative nerve block with longer-acting local anesthetic, bupivacaine liposome (Exparel, Pacira). Accelerated intestinal recovery was achieved through use of oral µ-opioid receptor antagonist alvimopan (Entereg, Cubist), early feeding and judicious IV fluid administration.

Dr. Novitsky said the team developed the ERAS based on work done by colleagues in the Colorectal Surgery

In an accompanying editorial, Bruce Ramshaw, MD, chairman of the Halifax Health general surgery residency program and co-director of Advanced Hernia Solutions, Daytona Beach, Fla., said that the authors should be lauded for their practical approach to “real-world clinical quality improvement.

“To consider a more complex set of solutions beyond opioid agonists and strive to make a major abdominal operation relatively pain-free and with minimal effects on bowel function is a very patientcentered goal,” he said, noting that mul-

‘We see a large portion of patients benefit greatly from this approach. It’s very impressive to see somebody wake up from an operation in little or no pain.’

—Bruce Ramshaw, MD Department of Case Western Reserve University, who pioneered the use of ERAS. They adopted the validated colorectal ERAS to make it applicable to abdominal wall reconstruction.

“The process does have challenges,” Dr. Novitsky said, in an interview. “For surgeons, it’s a bit of a leap of faith. All surgeons have individual quirky things and that has to be worked out. You make changes that go against what you used to do.”

But, he added, “having the pathway has made it better and easier for everyone involved.”

‘While it is not always appropriate to select a less effective procedure based solely on readmission rate, we do feel that it is something that should be considered.’

Wendy Patterson, MPH rate and that open bypass, a more invasive procedure, would have a higher PPR rate,” Ms. Patterson said.

Other factors that increased the risk for a PPR were black non-Hispanic ethnicity rather than white non-Hispanic (odds ratio [OR], 2.0), complications during surgery (OR, 1.9), chronic pulmonary disease (OR, 1.5), diabetes with chronic complications (OR, 1.9), diabetes without chronic complications (OR, 1.3) and rheumatoid arthritis/collagen disease (OR, 1.8) (P<0.05 for all).

“While it is not always appropriate to select a less effective procedure based solely on readmission rate, we do feel

timodal approaches to pain is a growing trend in hernia surgery.

“We see a large portion of patients benefit greatly from this approach. It’s very impressive to see somebody wake up from an operation in little or no pain,” he said.

Both multimodal pain control and ERAS require more study, he cautioned.

In this report, the authors did not present important details on costs of care and long-term outcomes. “What about hernia recurrence, chronic pain incidence and other long-term complications? What about the overall costs of care for this care process, including these long-term issues?”

that it is something that should be considered,” Ms. Patterson said.

John Morton, MD, president of the American Society for Metabolic and Bariatric Surgery and director of bariatric surgery at Stanford University School of Medicine, Stanford, Calif., served as the discussant for the study.

He said his group presented a similar paper at a meeting of the American College of Surgeons (ACS) that identified an all-cause readmission rate of 5.22% among patients who had bariatric surgery. His study was based on the ACS National Surgical Quality Improvement Program. Studies appear to be providing consistent results, he said.

“Readmissions are becoming an increasingly important metric to look at. In regard to some of the risk factors you presented, I was taken by the chronic pulmonary disease and rheumatoid arthritis as risk factors. They are comorbidities that might be affected by steroid use, and that is a potentially modifiable risk factor,” Dr. Morton said.

“In addition, increasing pre-op ambulation and incentive spirometer use may also help [decrease readmission rates].”

The ERAS pathway calls for an intraoperative transversus abdominis plane block with bupivacaine liposome injection (20 mL diluted to 120 mL), followed by hydromorphone patient-controlled analgesia at 0.2 mg every six minutes as needed and a 1 g dose of IV acetaminophen (Ofirmev, Mallinckrodt Pharmaceuticals) every six hours for 48 hours, with oral oxycodone 5 to 10 mg every four hours as needed for breakthrough pain.

Patients receive oral gabapentin 300 mg three times a day as soon as they can tolerate oral intake, which is continued until discharge. The authors also recommend gabapentin in patients with incisional pain lasting beyond 30 days, especially for pain related to lateral dissection or fixation sutures in the lateral abdominal course.

Nonsteroidal anti-inflammatory drugs are not given routinely due to the risk for postoperative acute kidney injury.

Patients receive ice chips and sips of water after surgery, followed by limited clear liquids on postoperative day (POD) 1, unlimited clear liquids on POD 2 and a regular diet on POD 3.

Since the publication, the investigators have made some adjustments to the pathway, including dropping diazepam from pain management and further accelerating patients’ return to a regular diet, said Dr. Novitsky.

Updated details on the ERAS program will be presented in April at the First World Conference on Abdominal Wall Hernia Surgery.

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Opinion

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MARCH 2015

Do You Make This Mistake Concerning Customer Value?

B Y M ARK F. W EISS , JD

I

magine! A “celebrity” economist stymied by the fact that a medical procedure, a hip replacement, for example, costs an insurer $X if performed at one facility, yet $X + $Y if done at another. His assumption: Some providers are just

better at negotiating than others—and that that was somehow “unfair.”

My guess is that he’d be happy if the government simply deemed the price, and happier still if he were the czar appointed to do the deeming.

I’m sure I’m not the first to point out that economics is not a science and that celebrity economists are simply a subset of entertainers, but I’m left to wonder whether our economist ever thought about why one fast food place sells a

mediocre burger for a dollar or two, while a few blocks away, Chez Whatever prices a slightly larger one at 13 times more and sells them like, well, hotcakes.

We’re talking the same beef, too, not some exotic breed that’s fed craft beer twice a day and regularly attended to by licensed massage therapists.

Getting back to hip replacement, certainly, some facilities might deploy better negotiation techniques than a multibillion-dollar insurer. But there are several

Expertise tamped down by the impact of a poor environment is worthless in terms of creating relationships with patients, referral sources and facilities. larger, and more likely, things going on here, such as location and reputation—the carrier simply has to have those facilities and its associated providers on its panel.

For physicians, the lesson to be drawn is the importance of developing what I call an Experience Monopoly, providing such a valuable experience to patients, referral sources, and facilities that they deem you their preferred partner, one that they can’t see themselves doing without.

You’ve deemed many businesses with this status yourself—perhaps the dry cleaner who always greets you by name and helps you carry your clothes to your car, or the restaurant with the wonderful outdoor heated patio (heated floor, large wood-burning fireplace and radiant heat lamps), delicious cuisine, and incredibly attentive service, that you both frequent and recommend to everyone (contact me, I’ll give you its name).

Although an Experience Monopoly is a “soft” concept, for the economists in the crowd there’s a way to describe its strength in the language of math: E + Phe + PQenv = Strength of Unique Experience Where: E = actual level of medical expertise and skill.

Phe = strength of the perceived human experience.

PQenv = degree of the perceived quality of the environment.

Although I said I was writing in math, be warned that this is not a formula like 2+2 = 4. Unlike our economist friends, I am not pretending that fluid circumstances and subjective determinations can lead to an actual equation that can be proven and repeated with scientific accuracy.

Rather, it’s just the view from another perspective, describing the relationship among the factors that lead to an Experience Monopoly in your practice.

For example, a physician with a very acceptable level of expertise, say, 7 on a scale of 10, who delivers a fantastic experience from a bright, cheery, modern office, may have a far more successful practice in terms of patient satisfaction than an extremely competent physician, a 10 out of 10 in terms of expertise, who delivers a dismally perceived human experience in

Opinion

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MARCH 2015

an unwelcoming atmosphere.

Particularly important is an understanding that the environmental factor does not refer simply to the physical environment, over which, in some settings, you may have little to no control; it also refers to the relationship environment in which you provide services.

Years ago, I developed a bump on my right wrist. I asked several physician-clients to recommend a hand surgeon. They all suggested Dr. X. I made an appointment with Dr. X. When I arrived to see him, I was shown into a small exam room, really only enough space for two simple chairs and a small table in between.

After sitting for at least 20 minutes twiddling my thumb (the other one hurt too much to twiddle), with not a single magazine to read in sight, not even a sixmonth-old issue of “Good Housekeeping,” in walked Dr. X. Without introducing himself, he sat down, manipulated my wrist, and said, “Our opinion is that you have a ganglion cyst.” Never one to be shy, I pretended to look all around the minuscule room and then asked him, “Excuse me, but do you see anyone else in here?”

I did have the surgery and, although it’s been more than 20 years, I have not had a problem with my wrist since. But have I ever recommended Dr. X to anyone?

No way! Professional expertise: excellent.

Perceived quality of the environment: low.

Perceived human experience factor: dismal. Strength of unique experience: zero, or perhaps even negative.

Of course, the goal is for you to increase the level of performance within your medical group across each of the components. Note especially that you must focus on the human experience and environmental factors. All physicians understand the importance of medical expertise. Yet that expertise alone, and, certainly, that expertise tamped down by the impact of a poor environment and an even poorer experience, is worthless in terms of creating relationships with patients, referral sources and facilities that over a career will prove extremely valuable. That’s the case not only in terms of the strength of those relationships, but also in connection with the impact those relationships will have on the perception of quality for purposes of “value-based purchasing” as advocated by both Medicare and private payors.

And last, there’s the issue of price, the element that attracted the economist’s comments in the first place. Experience monopolies don’t exist in a vacuum. They are dependent on the value that your customer, whether it’s a hospital, a referral source or a patient, places on them. In other words, pricing, or value, is determined at the customer level.

Simply put, some customers will not place as much value on your offering as

others. The challenge is providing the level of experience that your targeted customers value. Wendy’s and Shake Shack don’t target the same customer, and neither should you.

—Mark F. Weiss, JD, is an attorney — who specializes in the business and legal issues affecting physicians and physician groups. He served as a clinical assistant professor of anesthesiology at USC Keck School of Medicine and practices with The Mark F. Weiss Law Firm, a firm with offices in Dallas, Los Angeles and Santa Barbara, Calif. He can be reached at markweiss@advisorylawgroup.com.

31

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