September 2014 by McMahon Group

CONVENTION ISSUE:

Pre-American College of Surgeons Clinical Congress

GENERALSURGERYNEWS.COM

September 2014 • Volume 41 • Number 9

The Independent Monthly Newspaper for the General Surgeon

Opinion

Deconstructing Veterans Health Care B Y J ON C. W HITE , MD

s a long-serving surgeon in the U.S. Department of Veterans Affairs (VA), I find the recent controversy disheartening. Let me start by pointing out that patient satisfaction with the VA system is as high or even higher than that of the private health care system in the United States. An estimated 80% of the 9 million veterans receiving health care at the VA are satisfied. To cull from this population a minority of dissatisfied people who report negative things about the VA is not responsible investigative reporting; it is just tabloid journalism. Employing sound bites to link “secret lists” to an undocumented number of patient deaths is, at best, disingenuous. The tenor of this investigation has turned a legitimate conversation about health care access into a media circus. I hope that, after the circus leaves town, calm heads will prevail and we can have a frank discussion about what is good and what is bad about the VA system. see VETERANS S HEALTH page 3 31

PROCEDURAL BREAKTHROUGH Application of the Weck® Hem-o-lok® Polymer Ligation System see page 8

Team Creates Protocol for Handling OR Emergencies SALT LAKE CITY— —The worst moments in the operating room, accordin ng to surgeon David Earle, are the quiet ones that settle in during intraooperative emergencies, when second ds drag on for minutes and minutees for hours. “Anyone involved in a surgi-cal procedure knows those timess, particularly when the patient iss bleeding, the room is quiet, and d the team is waiting for the circu ulator to return with the appropriate supplies and equipment,” said Dr. Earle, MD, director of min nimally invasive surgery at Baystate Medical Center, Springfield, Mass. Dr. Earle believes that those moments shoould not occur. Operating room (OR) teams can prevvent v

M ONICA J. S MITH

see OR EMERGENCY pag g 34 ge

U.S. Panel of Surgeons Says ‘No’ to Noncompliant Hernia Patients B Y C HRISTINA F RANGOU

INSIDE In the News

Stitches

On the Spot

Study Quantifies Risk of Surgery for Metastatic Metastat Breast Diseas ease

Ach Achieves Similar Results To Removval of Axillary Lymph Nodes

B Y C H RISTINA F RANGOU

LAS VEGAS—Expert hernia surgeons ns are asking patients to adheree to strict preoperative regimens that include weightt loss, smoking cessation and d nutritional supplementation n before surgery.

The Birth of Natural Orifice Transluminal Endoscopic Surgery

Developments in Approaches to Liver Resection: Colleen Hutchinson Speaks With Experts in the Field

Radiotherapy Less Morbid Than Dissection

L AS V EGAS —Groundbreaking r research presented at the 2014 annual meeting of the American Society of Breast Surgeons shows radiotherapy of the axillary lymph nodes causes significantly less morbidity and fewer complications than traditional axillary dissection or removal. d The international, prospective, mullticenter AMAROS (After Mapping of the Axilla: Radiotherapy Or Surgeryy?) trial randomized breast cancer patientss with a positive sentinel lymph node (S SLN) to axillary lymph node dissection (ALND) or axillary radiotherapy (ART). The primary objective of the trial was to demonstrate noninferiority in terms of axillary recurrence rate of ART to ALND, which although it provides excellent regional control, is associated with high rates of short- and long-term side effects. A secondary end point of the see RADIOTHERAPY page 16

If patients fail to comply, s surgeons say they will not operate or will postpone op su urgery, contending that th he risks for infection or ffailure are too high.

Clinical and Cost Considerations for Managing Postsurgical Pain: Elastomeric Pumps and Continuous Catheters, or a Single-Dose Non-Opioid Local Analgesic

see NONCOMPLIANCE page 28

See insert at page 18

REPORT

GSN Editorial

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / SEPTEMBER 2014

A ‘Wake-Up’ for Sleep and Fatigue Frederick L. Greene, MD, FACS Clinical Professor of Surgery UNC School of Medicine Chapel Hill, North Carolina

ince 2003, issues of sleep deprivation and fatigue have been discussed logarithmically, especially in terms of resident work hours and the need to legislate and adjudicate the time trainees spend in hospitals. Although countless discussions, editorials, letters, surveys and studies have been published on the topic, there is no clear consensus as to the effect of controlling sleep and fatigue through strict resident work hours and any relationship on parameters of patient safety in teaching hospitals. As with many of my surgical colleagues, I have strong feelings regarding this issue and have never believed that legislating sleep and fatigue would improve overall resident performance. I would like to think that the approach by the Accreditation Council for Graduate Medical Education (ACGME) has at least created a more balanced and enjoyable lifestyle for trainees, but I cannot

provide any hard evidence for this! As many of us realize, the shift-work patterns established over the past decade have led to problems dealing with constancy and handoffs of responsibility for patient care. Perhaps more solid information will come as a result of the prospective study initiated by the American Board of Surgery (ABS) and the American College of Surgeons (ACS) beginning July 1 of this year that, using metrics from the National Surgical Quality Improvement Program, randomly compares surgical training programs that follow current strict duty hours with those programs in which work hours have been relaxed. I salute Frank Lewis, MD, executive director of the ABS, and David Hoyt, executive director of the ACS, as well as other surgical leaders, for proposing this study, and I eagerly await the results. I am further delighted that the Board of Regents of the ACS has now espoused an official statement dealing with the recognition and mitigation of fatigue that surgeons may experience (Bull Am Coll Surg, August 2014). In this statement approved in June, the ACS leadership recognized that surgeon fatigue is an important issue and outlined

specific factors that should be considered in defining and improving this issue for surgeons. The statement recognized that “surgical practice requires decisive surgical judgment; operative intervention involving mental, physical and tactile skills; and comprehensive thoughtful postoperative care.” There is very little question sleep deprivation and fatigue can affect these essential characteristics. The document further categorized several issues involved with fatigue and sleep deprivation: “prolonged reaction time, decreased vigilance, impaired decision making and delayed recognition of critical situations.” The ACS statement was particularly careful to recognize also that all surgeons are not equal when fatigue and sleep deprivation are considered. Preexisting conditions such as stress in the workplace and at home as well as biological modifiers come into play. The ACS statement also stated clearly that “restricted work hours for residents have not been linked to demonstrable improvements in patient safety and better outcomes or improved education of trainees.” This is an important concept that I am hopeful other organizations

Any approach to the issue of physician fatigue must recognize that legislation and a ‘one-size-fits-all’ mentality will never work and in fact will be detrimental to clinical patient care. will echo as future statements on physician fatigue are developed. Any approach to the issue of physician fatigue must recognize that legislation and a “one-size-fits-all” mentality will never work, and in fact will be detrimental to clinical patient care. This has been well demonstrated by the approach of the ACGME regarding resident work hours and issues involving trainees. The important point stressed by the ACS statement is that physicians and institutions have a shared responsibility in developing effective strategies to define parameters of fatigue and sleep deprivation and to create education and counseling strategies within their respective institutions to handle issues that might arise. The see SLEEP page 30

Mission Statement

Sales

Senior Medical Adviser

Michael Goldfarb, MD

J. Barry McKernan, MD

Frederick L. Greene, MD

Long Branch, NJ

Marietta, GA

Charlotte, NC

Leo A. Gordon, MD

Joseph B. Petelin, MD

Los Angeles, CA

Shawnee Mission, KS

Gary Hoffman, MD

Richard Peterson, MD

Los Angeles, CA

San Antonio, TX

Namir Katkhouda, MD

Joseph J. Pietrafitta, MD

Los Angeles, CA

Minneapolis, MN

Jarrod Kaufman, MD

David M. Reed, MD

Freehold, NJ

New Canaan, CT

Michael Kavic, MD

Barry A. Salky, MD

Youngstown, OH

New York, NY

Peter K. Kim, MD

Paul Alan Wetter, MD

Bronx, NY

Miami, FL

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

Kay Ball, RN, CNOR, FAAN Lewis Center, OH

Philip S. Barie, MD, MBA New York, NY

L.D. Britt, MD, MPH Norfolk, VA

David Earle, MD Springfield, MA

James Forrest Calland, MD Philadelphia, PA

Edward Felix, MD Fresno, CA

Robert J. Fitzgibbons Jr., MD Omaha, NE

David R. Flum, MD, MPH Seattle, WA

Lauren A. Kosinski, MD Milwaukee, WI

Editorial Staff

Raymond J. Lanzafame, MD, MBA

Kevin Horty Group Publication Editor khorty@mcmahonmed.com

Rochester, NY

Timothy Lepore, MD Nantucket, MA

John Maa, MD San Francisco, CA

Gerald Marks, MD Wynnewood, PA

mcmahonmed.com © 2014 by McMahon Publishing, New York, NY 10036. All rights reserved. General Surgery Newss (ISSN 1099-4122) is published 11 times per year by McMahon Publishing, Sales, Production and Editorial Offices: 545 W. 45th

James Prudden Group Editorial Director Robin B. Weisberg Manager, Editorial Services Elizabeth Zhong Associate Copy Chief

Michael Enright Group Publication Director (212) 957-5300, ext. 272 menright@mcmahonmed.com Kate Carmody Manager of Publication Sales (212) 957-5300, ext. 278 kcarmody@mcmahonmed.com Nancy Parker Classified Advertising Sales (917) 715-1147 nparker@mcmahonmed.com

It is the mission of General Surgery Newss to be an independent and reliable source of news and analysis about the current state of surgery. It strives to provide a venue for discussion and opinions, from all viewpoints, on the issues most important to surgeons.

Disclaimer Opinions and statements published in General Surgery Newss are those of the individual author or speaker and do not necessarily represent the views of the editorial advisory board, editorial staff or reporters.

Art/MAX Graphics & Production Staff

Change of Address Procedure

Michele McMahon Velle Creative Director

All U.S. general surgeons, colorectal surgeons, vascular surgeons, surgical oncologists and trauma/critical care surgeons should receive General Surgery News free of charge. If you are changing your address or name, you must notify the AMA at (800) 262-3211 or the AOA (if appropriate) at (800) 621-1773 to continue receiving GSN. You need not be a member; however, they maintain the ultimate source of our mailing addresses. If you are not a general surgeon or other specialist listed above and would like to subscribe, please send a check payable to General Surgery News. Please allow 8-12 weeks for the first issue. Subscription: $70 per year (outside U.S.A., $90). Single copies, $7 (outside U.S.A., $10). Send checks and queries to: Circulation Coordinator, General Surgery News, 545 West 45th Street, 8th Floor, New York, NY 10036. Fax: (212) 664-1242.

Deanna Cosme Art Director James O’Neill Senior Systems Manager Dan Radebaugh Director of Production and Technical Operations Brandy Wilson Circulation Coordinator McMahon Group Raymond E. McMahon, Publisher & Managing Partner Van Velle, President, Partner Matthew McMahon, General Manager, Partner Lauren McMahon Smith, Michael McMahon, Michele McMahon Velle, Rosanne C. McMahon, Partners

St., 8th Floor, New York, NY 10036, Tel. (212) 957-5300. Corporate Office: 83 Peaceable St. West Redding, CT 06896. Periodicals postage paid at New York, NY, and at additional mailing offices. POSTMASTER: Please send address changes to General Surgery News, 545 W. 45th St., 8th Floor, New York, NY 10036. McMahon Publishing is a family-owned medical publishing and medical education company. McMahon publishes seven clinical newspapers and nine annual or semiannual Special Editions.

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / SEPTEMBER 2014

Study Quantifies Risk of Surgery for Metastatic Breast Disease B Y M ONICA J. S MITH LAS VEGAS—Breast surgery in patients with stage IV metastatic disease is not a rare occurrence in the United States, but the survival benefit is not known, and patients may be at greater risk for complications and death, according to data presented at the American Society of Breast Surgeons’ (ASBrS) annual meeting. Of the nearly quarter of a million women diagnosed with breast cancer in North America in 2012, about 3% to 5% had metastatic cancer. Several randomized controlled trials are currently investigating the survival benefit of surgery to the primary tumor, but until now there had been no investigations of the risks associated with such surgery. “The objective of our study was to assess women with metastatic breast cancer undergoing primary surgery for their breast cancer, looking at their 30-day morbidity and mortality rates to examine whether metastatic disease is a predictor of postoperative morbidity,” said lead author Erin Cordeiro, MD, a breast surgery oncology fellow at the University of Toronto, in Ontario, Canada. She and her colleagues conducted an analysis of data from the National Surgical Quality Improvement Program on women diagnosed with invasive breast cancer between 2005 and 2012, comparing those with metastatic disease to those without metastatic disease. They found 68,316 patients who met their inclusion criteria, of whom 1,031 (1.5%) had evidence of metastatic disease. There were several significant differences in the women’s baseline characteristics. “The most important ones were that the metastatic group tended to have received chemotherapy and radiotherapy more frequently before surgery than the non-metastatic group, which would be expected,” Dr. Cordeiro said. Also, patients in the metastatic group were more likely to undergo a mastectomy, more likely to have axillary lymph node dissection (ALND) rather than sentinel lymph node dissection, more likely to have inpatient surgery, and had longer hospital stays than the non-metastatic patients.

The initial unadjusted analysis comparing overall 30-day morbidity between the two groups showed it to be 7.5% in the metastatic patients and 3.7% in the non-metastatic patients, indicating a twofold increase for those with stage IV disease. “Similarly, the 30-day allcause mortality rate also was significantly higher in the metastatic group, 1.8% compared with 0.1% in the he nonnon metastatic group,” Dr. Cordeiro said.

‘Surgical resection of the breast tumor in these situations is considered, and requires shared decision making between the surgeon and patient.’ —Judy C. Boughey, MD The specific complications experienced by the metastatic group included infections such as sepsis; respiratory complications such as pneumonia; thromboembolic complications such as deep vein thrombosis or pulmonary embolism; and cardiac or bleeding complications requiring transfusion. “As well, they had a higher 30-day unplanned readmission rate,” Dr. Cordeiro said. A multivariable logistic regression analysis showed the presence of metastatic cancer to result in a 1.6 higher odds ratio of 30-day morbidity. Other factors that increased morbidity included older age, diabetes, obesity, American Society of Anesthesiologists physical status of 3 or 4, mastectomy, ALND and longer operating time. Preoperative chemotherapy and/or radiation did not increase morbidity. “In conclusion, we found that breast surgery in the setting of metastatic disease had a 1.6 times higher odds of postoperative complications compared with women undergoing breast surgery in the setting of non-metastatic disease,” Dr. Cordeiro said.

“These findings are important for discussing the risks and benefits of performing breast surgery on our patients with metastatic disease, and they’re also important in considering the role of preoperative prophylactic medications for complications like infections and thromboembolism.” Judy C. Boughey, MD, professor of surgery, Department ent of Surgery, Mayo Medical School, Rochester, Minn inn., noted that the role of surgery in stage IV disease remains controversial, with most of the di stu tudies to date being retrospective with signifi ficant selection bias. “There is a lack of strong data regardin ng any survival advantage from surgical reesection of the breast primary in women wiith stage IV disease,” Dr. Boughey said. “H However, surgical resection of the breast tum mor in these situations is considered, and requ equires shared decision making between the surgeon and patient.” sur To guide this decision in her own clinical practice, Dr. Boughey considers the location of the metastatic disease (e.g., bone, brain, liver), whether it is limited to one site or several, and the number of metastatic diseases in each site. Patients are usually treated first with systemic therapy; their response determines what happens next. “If the patient responds well to the systemic therapy, resection of the breast primary may be worth considering. If there is progression of disease on systemic therapy, I would not recommend surgical resection of the breast primary,” Dr. Boughey said. She is open with patients about the controversial role of surgery in this setting, about the potential advantages and disadvantages and about the lack of concrete data. “The study presented [by Dr. Cordeiro] at the ASBrS annual meeting … provides data for the breast surgeon to include in the discussion of the pros and cons of considering surgical resection of the breast primary in women with stage IV disease,” she said. “Women, together with guidance from their surgeon, will need to balance the complication risk with the unknown impact on survival and decide on the best choice for them.”

Cartoon by Walter Pories, MD

The Simple Answer Well, it has happened again: We’ve been instructed to “run the medical school like a business.” Frankly, we’d love to and invite any of the business leaders to show us how to do it, given the rules imposed on us. We can’t price our product; neither the doctors (the sellers) nor the patients (the buyers) are allowed to see the price of the product, or to know, in advance, how much insurance will cover and what the final remaining balance will be. We must provide the product for free to those who choose not to pay for insurance or are too poor. We have to give away our best and most expensive product to all, even when the situation is hopeless, or we will be sued for more than a physician may earn in 10 years. We are forced to document our transactions on the “elec- “My faculty agrees with you that we need to run this center ‘like a busitronic medical record,” an inadequately developed, ness.’ Accordingly, we voted to shut down our medical school and invest expensive, inefficient and dangerous spreadsheet. the reserves.”

Neither the doctors nor the patients are allowed to negotiate with pharmaceutical or insurance companies. Please call us anytime. We are open 24 hours a day, seven days a week. Walter J. Pories, MD, FACS, FASMBS, FACC, FACG Professor of Surgery, Biochemistry and Kinesiology Department of Surgery Brody School of Medicine East Carolina University Greenville, N.C. poriesw@ecu.edu

Move beyond to the next generation of biologic grafts.

BIODESIGN

A D V A N C E D T I S S U E R E PA I R

PROVEN

T E C H N O L O GY

COST

REDUCED

EFFECTIVE

RECURRENCE

The evolution of a proven technology, y Biodesign can help provide reduced recurrence rates in comparison to other biologic grafts. That’s because Biodesign is completely remodeled into tissue that maintains long-term strength. Learn more: visit www.cookbiodesign.com.

www.cookmedical.com © COOK 2014

SUR-BMRADV-BB2GSN-EN-201404

Stitches

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / SEPTEMBER 2014

The Birth of Natural Orifice Transluminal Endoscopic Surgery Through Sometimes Clandestine Beginnings and Vacillating Enthusiasm, Researchers Continue Steady Quest for Improvement B Y V ICTORIA S TERN

n 1998, a woman presented to Daniel A. Tsin, MD, FACOG, suffering from infertility and intense pelvic pain. Dr. Tsin, a gynecologist specializing in minimally invasive techniques, planned to perform minilaparoscopy to diagnose and treat her problem. During the procedure, Dr. Tsin found endometriosis and a diseased appendix. “We opened the vaginal port to prep the base of the appendix for removal, and took out the appendix through the vagina,” he recalled of his first transvaginal endoscopic appendectomy.

‘The surgeons in my hospital were divided. We had a few defenders but a majority thought we were delirious.’ —Daniel A. Tsin, MD Dr. Tsin’s idea to extract organs through the vagina came several months earlier during experiments in the animal lab. “I was trying to overcome the limitations of minilaparoscopy,” said Dr. Tsin, currently the director of minimally invasive surgery at Mount Sinai Hospital of Queens, Astoria, N.Y. “The problem is that it’s impossible to remove an appendix, ovary or gallbladder through 3- to 5-mm ports.” Dr. Tsin saw a solution in culdoscopy, a technique that provides a view of the pelvic viscera after a culdoscope is inserted through the vagina. However, Dr. Tsin took the technique a step further, combining minilaparoscopy with culdoscopy. He used the vaginal port not only to visualize organs but also to operate on and extract them. Dr. Tsin’s first transvaginal appendectomy in a human patient was a success: The woman had no visible scarring, required almost no pain medications and recovered quickly. Just a few months later, she became pregnant. “The team spirit of collaboration was incredible, and we all recognized we were doing things differently than traditional laparoscopy,” Dr. Tsin recalled. By 1999, Dr. Tsin’s team performed the first transvaginal endoscopic cholecystectomy in humans, using a custom-made 46-cm-long laparoscope with a 30-degree angle view ((JSLS S 2003;7:171-172), and several months later, Dr. Tsin had completed a small series of three culdolaparoscopic appendectomies and three culdolaparoscopic cholecystectomies. In November 1999, Dr. Tsin presented the results of the first six cases of culdolaparoscopy at the 28th annual meeting of the American Association of Gynecologic Laparoscopists, but his work was largely ignored. “My team and I were aware of the potential future of flexible technology, but the surgical community at the time was not ready for the transvaginal endoscopic approach for cholecystectomy or appendectomy,” Dr. Tsin said. “The surgeons in my hospital were divided. We had a few defenders, but a majority thought we were delirious.”

On March 8, 2000, Dr. Tsin’s work came under scrutiny and a special committee decided to ban the transvaginal procedures. Dr. Tsin was allowed to continue culdolaparoscopy, but only for gynecologic procedures. Despite this setback, Dr. Tsin had some supporters in the surgical community, including Paul A. Wetter, MD, chairman of the Society of Laparoendoscopic Surgeons, whose encouragement motivated Dr. Tsin to continue his work. Dr. Tsin subsequently published a range of papers in peer-reviewed journals. For instance, in 2001, Dr. Tsin reported on the feasibility of culdolaparoscopy and completed five oophorectomies, four myomectomies, three salpingo-ophorectomies and one salpingectomy using the technique (J ( Am Assoc Gynecol Laparoscc 2001;8:438441; JSLS S 2001;5:69-71). In 2007, when natural orifice transluminal endoscopic surgery (NOTES) was gaining traction in the surgical community, Dr. Tsin published a series on the first 100 minilaparoscopy-assisted natural orifice surgeries, noting only one complication related to antibiotics ((JSLS 2007;11:24-29). “Finally, by 2007, when NOTES began to take off, people started to recognize my contribution to the field,” Dr. Tsin noted.

NOTES Emerges In 1997, while Dr. Tsin was experimenting with culdolaparoscopy, gastroenterologist Anthony N. Kalloo, MD, and six colleagues formed the Apollo Group, an international think tank of gastroenterologists and surgeons from different medical and academic centers. The group included Peter Cotton, MD, Christopher Gostout, MD, Robert Hawes, MD, Sydney Chung, MD, Pankaj Jay Pasricha, MD, and Sergey Kantsevoy, MD, PhD. The members of the Apollo Group wanted to take therapeutic endoscopy to the next level, diagnosing and potentially treating gastrointestinal disorders through a natural orifice. “If you think about the way surgery evolved, it started off as very invasive 100 years ago,” Dr. Kalloo said. “With the advent of laparoscopic surgery, we saw that small incisions were better and patients recovered more quickly. Now, we hoped for endoscopy to go to the next level with no incisions at all.”

‘I was amazed at how easily I could see organs and get from one point to another. This procedure appeared to be a logical next step in the evolution of minimally invasive techniques.’ —Anthony Kalloo, MD In 1998, Dr. Kalloo was asked to give a talk at Digestive Disease Week (DDW) regarding the future of endoscopy. “I introduced the concept of breaching the gastric wall to enter the peritoneal cavity and perform surgery,” said Dr. Kalloo, The Moses and Helen Golden Paulson Professor of Gastroenterology and director in the Division of Gastroenterology & Hepatology, Johns Hopkins Hospital, Baltimore. “I believed that the future of endoscopy was beyond the wall, in the peritoneal and chest cavity.” After presenting his novel concept, Dr. Kalloo began experimenting with the natural orifice technique in pigs

to determine the feasibility of a transgastric approach to entering the peritoneal cavity for liver biopsy. “When we first tried this approach, it was thrilling,” Dr. Kalloo recalled. “To look at organs in the peritoneal cavity without making an incision across the abdomen was so exciting. We were fearful, however, about how people would respond and we initially did these surgeries in secret.” In the initial feasibility studies, Drs. Kalloo and Kantsevoy successfully entered the peritoneal cavity of a dozen 50-kg pigs through the mouth and obtained liver biopsies. The pigs recovered without any leakage or infection, and the team concluded that the procedure was technically feasible. In survival studies, Dr. Kalloo and his colleagues obtained adequate liver biopsy specimens in five pigs. To help bring the infection rate close to zero, they administered IV antibiotics pre- and postoperatively, cleaned the oral cavity and irrigated the stomach with antibiotic solution. All pigs survived, ate heartily the next day and gained weight. Two weeks later, endoscopy revealed the pigs’ stomachs appeared normal. “I was amazed at how easily I could see organs and get from one point to another,” Dr. Kalloo recalled. “This procedure appeared to be a logical next step in the evolution of minimally invasive techniques.” Dr. Kalloo initially presented the results at DDW in 2000, and published them four years later (Gastrointest Endoscc 2004;60:114-117).

Beyond the Animal Model The next major step for NOTES was moving from animal models to humans. In 2003, G.V. Rao, MS, MAMS, FRCS, chief of surgical gastroenterology and minimally invasive surgery, and D. Nageshwar Reddy, MD, DM, chief of gastroenterology and therapeutic endoscopy, Asian Institute of Gastroenterology in Hyderabad, India, performed the first transgastric appendectomy in a human, removing the appendix through the mouth. The patient was a young man admitted to the ICU with extensive anterior wall burns. He had developed acute appendicitis. “We realized that the only way to remove his appendix was orally through the stomach,” Dr. Reddy said. The procedure took 1.5 hours under general anesthesia, and the patient did very well, returning home after 48 hours. “Of course, it was a nervous time for us as there was a lot of apprehension about performing the procedure, but this was the only option for the patient,” recalled Dr. Reddy. “We got praised and criticized for our work.” On one hand, there were conservative surgeons and physicians who felt this procedure was too radical, but on the other hand, the duo also received support from the minimally invasive surgeons and gastroenterologists. After his first presentation at the Digestive Disease Week in 2003, Dr. Reddy recalled a prolonged ovation and a lot of curiosity. Drs. Rao and Reddy’s accomplishment was a boon for NOTES. “This advance in humans generated a lot of excitement and pushed the procedure forward,” Dr. Kalloo said.

Guidelines and Challenges Despite the potential for NOTES, Dr. Hawes,

Stitches

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / SEPTEMBER 2014

Timeline of Firsts for NOTES Transvaginal cholecystectomy (Surg Innov 2007;14:279-283)

Transgastric and transvaginal gastrectomy

NOTES procedure, swine model (Gastrointest Endosc

Transgastric cholecystectomy

Transvaginal splenectomy

(J Surg Oncoll 2007;96:678-683)

(Surg Innov 2009;16:218-222)

2004;60:114-117)

Transanal NOTES radical sigmoidectomy, human cadavers

NOTES transanal rectal cancer resection, first human experience, November 2009 (Surg Endosc

Transvaginal cholecystectomy, rigid instruments (JSLS 2003;7:171-172)

(J Gastroint Surg g 2008;12:1717-1723)

POEM, swine model (Endoscopyy 2007;39:761-764)

2003

1998 1999 Transvaginal appendectomy, rigid instruments (J Am Assoc

2008

2010 2009

2007

Transgastric appendectomy (Reddy and Rao)

Gynecol Laparosc 2001;8:438-441)

2010;24:1205-1210)

Transvaginal appendectomy

(Surg

Endosc 2008;22:1343-1347)

NOTES peritoneoscopy

Transvaginal incisional hernia repair (Hernia 2010;14:89-91)

(Surg Endosc

2008;22:16-20)

POEM in humans

(Endoscopy

2010;42:265-271)

Transvaginal donor kidney extraction

POEM, peroral endoscopic myotomy

president of the American Society for Gastrointestinal Endoscopy (ASGE), and David Rattner, MD, president of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES), wanted to ensure that the technique developed in a safe manner. “Dr. Rattner and I were very enthusiastic about NOTES, but also aware it could go badly,” said Dr. Hawes, of the Center for Interventional Endoscopy, Florida Hospital Orlando. “We wanted to avoid the feeding frenzy that occurred in the early days of laparoscopic cholecystectomy, which resulted in unnecessary complications. I thought a similar frenzy might occur with NOTES before the procedure was ready for prime time.” With the intention of advancing NOTES in a responsible fashion, Drs. Hawes and Rattner gathered 14 leaders from ASGE and SAGES in July 2005, and formed Natural Orifice Surgery Consortium for Assessment and Research (NOSCAR). In October of that year, Dr. Hawes published a white paper on NOTES, identifying the barriers to developing the technique and outlining guidelines to move forward (Gastrointest Endosc 2006;63:838-839; Surg Endoscc 2006;20:329-333). The potential challenges of developing NOTES included gaining safe access to the peritoneal cavity, preventing infection and securing closure of the gastric incision, as well as providing adequate training and developing enabling technologies. Given the success of laparoscopic cholecystectomy, transvaginal cholecystectomy became the primary procedure investigated to further the science of NOTES. NOSCAR declared that anyone performing a NOTES procedure would need approval from an institutional review board. “The purpose was to ensure that people were qualified to use the technique and were answering the questions that would move NOTES forward,” Dr. Hawes said. “We formed a research committee, vetted grant requests and received funding, which allowed researchers to explore the science of NOTES and investigate potential obstacles as well as how to solve them.” For instance, there was initial worry about infection

in the peritoneal cavity because as soon as an endoscope comes into contact with the mouth, there are thousands of bacteria; however, research soon quelled these concerns, showing that this infection risk was negligible. Enthusiasm for NOTES started to soar among surgeons and gastroenterologists interested in pursuing the next cutting-edge surgical technique after laparoscopy. As in the early days of laparoscopy, there was an influx of interest and funding from corporations, such as Ethicon, Covidien and Boston Scientific, which helped fuel advances in NOTES research and development.

Evolution of NOTES: 2007 to Present After Drs. Rao and Reddy’s initial success in humans and with the guidelines set forth by NOSCAR, physicians worldwide began cautiously testing the feasibility of NOTES for a variety of procedures. In 2007, Jeffrey Ponsky, MD, Department of Surgery, Case Medical Center, Cleveland, published the first NOTES procedure in humans: a percutaneous endoscopic gastrostomy rescue. That year, Jacques Marescaux, MD, from University Louis Pasteur, France, performed the first transvaginal NOTES cholecystectomy ((Arch Surgg 2007;142:823-826), and shortly after, a team in Brazil and one in Italy did the same technique in a small series of patients (J ( Laparoendosc Adv Surg Tech A 2008;18:345-351; Surg Endoscc 2008;22:542547). General surgeon Lee Swanstrom, MD, conducted the first human transgastric cholecystectomy (J ( Surg Oncoll 2007;96:678-683). A string of other NOTES firsts occurred, including a transvaginal appendectomy in 2008 (Surg Endoscc 2008;22:1343-1347) and a NOTES transanal rectal cancer resection in 2009 (Surg Endosc 2010;24:1205-1210). A 2012 review examined the NOTES landscape from 2007 to 2011, describing 48 studies of various NOTES procedures in humans (Minim Invasive Surg 2012;2012:189296). Field F. Willingham, MD, MPH, director of endoscopy in the Division of Digestive Diseases, Emory University, Atlanta, and his colleagues reported that complication rates varied by procedure

and access site. Transvaginal appendectomy, transgastric and transvaginal gastrectomy, and transvaginal splenectomy and incisional hernia repair came with very few complications, whereas transvaginal cholecystectomy (1.5%-25%), transgastric cholecystectomy (18%) and transgastric appendectomy (33.3%) were associated with more complications. The most common NOTES procedure was cholecystectomy (75%) and the most common approach was transvaginal (79%). Additionally, 46% of the procedures were pure NOTES, whereas the other 54% employed hybrid NOTES techniques. Dr. Willingham concluded that NOTES has progressed, but barriers remained that limited its wider acceptance in patients, namely the development of NOTES-specific technologies as well as evidence that NOTES offers benefits, beyond cosmesis and reduced pain, over laparoscopic approaches.

The Future of NOTES As NOTES evolved, the initial excitement began to wane. Headlines that once asked, “Is NOTES the Next Laparoscopy?” (GSN, June 2007) now pondered, “Natural Orifice Surgery: Is the Thrill Gone?” (GSN, March 2012). Although Drs. Kalloo and Reddy believe that NOTES is ahead of its time, they acknowledge that it has not followed the striking trajectory of laparoscopy. “I think what’s happened is that some people think NOTES is taking a long time and hasn’t done what we expected it to do,” Dr. Kalloo said. “To that, I’d say NOTES is evolving at just the pace it’s supposed to: slowly and surely. Most importantly, NOTES has not come with any significant complications or any deaths.” However, the slow progress of NOTES caused industry’s enthusiasm to fade. “Despite the reduced pain and cosmetic benefits of NOTES, companies began to see that it wouldn’t provide the quantum leap that many had hoped and decided to invest in other techniques, such as single-incision laparoscopy,” said Dr. Hawes. “Without support from industry, it’s been difficult to continue to see NOTES page 10

THE SCIENCE BEHIND POSITIVE PATIENT OUTCOMES

Application of the Weck® Hem-o-lok® Polymer Ligation System: Performing Laparoscopic Cholecystectomy With Confidence Jamie Loggins, MD, FACS, FASMBS Chief of Surgery Medical Director of Bariatric Surgery Central Maine Medical Center Lewiston, Maine

David Bryan Price, MD, FACS Grace Surgical Pittsburgh, Pennsylvania

Introduction The integration of laparoscopy offered several advantages to the improvement of patient care. In particular, the shift from open surgery to minimally invasive techniques resulted in less blood loss, shorter hospital length of stay, and faster recovery.1,2 The benefits of a less-invasive approach have been significant, particularly for cholecystectomy—one of the most common surgical procedures in the United States.2 Traditional vessel-sealing methods (eg, suturing, stapling, and metal clips) pose significant challenges in terms of applying the technology, training requirements, associated costs, and potential complications.3-5 With the Weck® Hem-o-lok® polymer ligation system, surgeons have a more secure ligation modality over metal automatic clip appliers (Figure 1).6 The Weck® Hemo-lok® polymer ligation system consists of permanent, non-absorbable, non-conductive, polymer clips that are secure and easy to use in surgery.5 The Weck® Hem-o-lok® clips have a distal locking mechanism and grooves that enable them to securely ligate vessels from 2 to 16 mm in size depending on the size of the clip.5 The recent addition of the Weck® Auto Endo5® clip applier allows surgeons to ligate 3- to 10-mm vessels using 5-mm trocars to further the minimal approach without sacrificing jaw aperture (Figure 2). This article discusses the use of the Weck® Auto Endo® 5 clip applier to provide secure ligation in laparoscopic cholecystectomy.

However, Dr. Loggins was looking for a more secure medium-large clip. “As we were making ports smaller, we didn’t want to put in a 10-mm port just to use a 10-mm clip applier,” he said. “The challenge was finding a reliable 5-mm metal clip. I just didn’t see the same level of security with the 5-mm clips in the performance of a cholecystectomy as I did with the 10-mm metal clips, and I wasn’t happy with that lack of security.” Before using the Weck® Auto Endo5® clip applier, David Bryan Price, MD, FACS, a laparoscopic surgeon in private practice with Grace Surgical, who operates in conjunction with the University of Pittsburgh Medical Center’s Passavant Hospital and Mercy Hospital, used titanium clips in laparoscopic cholecystectomy, but had concerns over using these clips. Dr. Price found it necessary to use multiple ligation techniques to securely ligate. “A 5-mm vessel will have some pulsation,” he said. “If you put a metal clip across the vessel, that continuous pulsation will be enough to work the clip off, so I would always tie or suture a vessel that had a metal clip on it.”

Benefits of the Weck® Hem-o-lok® Ligation System With the Weck® Auto Endo5® clip applier, surgeons performing a laparoscopic cholecystectomy are able to ligate 3- to 10-mm vessels through a 5-mm port with a medium-large clip. Additionally, a broad

range of clip sizes also are available for manual ligation (medium, medium-large, large, and extra-large), as well as an array of applier lengths and angles (including 45-cm endoscopic appliers) to provide surgeons more options when ligating. This nonabsorbable polymer clip has a lock engagement feature, as well as teeth in the jaws that provide good security.5 A flexible hinge seats the clip firmly in the applier’s jaws, while tactile feedback confirms jaw seating and secure vessel placement.7 “That probably is what gives you the greatest sense of security—the palpable, and often audible feedback you get when you feel that clip lock—you know it’s not going anywhere,” Dr. Loggins said. Although the Weck® Hem-o-lok® clips lock in place, they are easy to remove if necessary. “Taking them off is a simple process,” said Dr. Loggins. “You can use a clip remover that unhinges the clip so that it opens back up and straightens it out. Then you can just retrieve it.”

Minimizing Thermal Spread Thermal spread to other organs is another concern when ligating tissue. “When we were cauterizing around the area of a clip, there was the risk that a metal clip could conduct electricity and necrose tissue under the clip,” Dr. Price said. “With the polymer clip, that does not happen.” As a cool ligation modality, the Weck® Hem-o-lok® ligation

Radiolucency Metal clips may compromise the magnetic resonance image (MRI) quality if the area of interest is in the same vicinity as the position of metal clips.8 “Initially the radiologists were afraid that putting a new clip in the MRI scanner could dislodge it. There also is some scatter with the metal clip in MRI,” Dr. Price said. As a non-absorbable polymer clip, the Weck® Hem-o-lok® clip is non-conductive and therefore considered MRI safe posing no known hazards in all MRI environments.8 Surgeons have expressed concern that polymer clips are transparent in an x-ray. A metal clip will be highly visible. “Someone might think, ‘we’re going to do an x-ray, or maybe the patient will have an ERCP [endoscopic retrograde cholangiopancreatography], and a metal clip will show up right there in the upper quadrant,’” Dr. Loggins said. “Their concern is, ‘if I can’t see my clip, how will I know where it is or if it’s fallen off?’” Dr. Loggins believes that this is a moot point. “A clip doesn’t need to migrate very far to be the difference between an occluded cystic duct stump or one that is no longer clipped and is now leaking,” he said. “If a clip moves 2 mm, you could have a bile leak. But you’re not going to appreciate that discreet a migration based on any kind of imaging study. You may see metal clips in the right upper quadrant, but that doesn’t tell you much about what is going on. Being able to see a clip on an x-ray has never changed the management of a postoperative complication I’ve had to treat.”

Enhancing Secure Ligation With The Weck® Auto Endo5®

Assessing the Challenges of Using Clips James Loggins, MD, FACS, FASMBS, chief of surgery and medical director of bariatric surgery at Central Maine Medical Center, previously used metal clips, usually the titanium Endo Clip™ III applier. In an effort to reduce the size of incisions and surgical ports, he used the Endo ClipTM III applier because it fit through a 5-mm port.

system is not at risk for conducting electricity and therefore does not spread thermal energy to other organs or tissues.7

Figure 1. Weck® Hem-o-lok® clip seated in the Weck® Auto Endo5® applier jaws.

GENERAL SURGERY NEWS • SEPTEMBER 2014

The availability of the Weck® Auto Endo5® enhances ligation by giving surgeons an automatic applier equipped with 15 medium-large clips to be used for 3- to 10-mm vessels. The Weck® Auto Endo5® complements the manual use of Hem-olok® by providing the same benefits of Hemo-lok® clips, but on an automatic platform. “I knew I felt comfortable with the locking mechanism of the traditional Weck® Hemo-lok® clip, so when the Weck® Auto Endo5® was introduced, offering a locking clip in a 5-mm [automatic] applicator, I suspected it would give me the same security I could get with a larger clip applier,” Dr. Loggins said. “Being able to put it through a smaller trocar would help me do a more minimally invasive

Supported and approved by

the most cost-effective,” Dr. Loggins said. “The Weck® Auto Endo5® costs my organization much less than a traditional multifire metal clip applier. I think it’s the best product, and it also makes the most economical sense.”

of an adjustment. But that’s probably the only change a surgeon would experience in shifting from a metal clip applier to the Weck® Auto Endo5®.”

Considerations When Using the Weck® Auto Endo5®

The addition of the Weck® Auto Endo5® clip applier to Weck’s portfolio of minimally invasive products allows for the benefits of Weck® Hem-o-lok® polymer clips in an automatic platform during laparoscopic cholecystectomy. The applier’s ability to ligate vessels efficiently and securely makes it a safe and practical option for ligation. The device’s capacity to ligate up to 10-mm vessels through a 5-mm port makes it possible for surgeons to use smaller trocars and keep the procedure as minimally invasive as possible.9 “What makes me so passionate about this system is that I think that the Weck® Hem-o-lok® clip is ideally suited for the ligation we require with cholecystectomy,” Dr. Loggins said.

Surgeons transitioning to the Weck®Auto Endo5® clip applier will find it to be straightforward without a prolonged learning curve. Dr. Loggins found that it is not necessary to make any significant adjustments when using the Weck® Auto Endo5® clip applier during laparoscopic cholecystectomy with a clean dissection of the cystic artery and cystic duct. “When you use metal clips, you can just fire them in place without having to remove the clip applier off the tissue,” he said. “With the Weck®Auto Endo5®, you do have to back the tip off your structure to reload the next clip and put it on the structure. That may be somewhat

Conclusion

Endo Clip is a trademark of Covidien Limited Partnership. Ligaclip and Ligamax are trademarks or registered trademarks of Johnson & Johnson Corporation. Teleflex, Endo5, Hem-o-lok, and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates. © 2014 Teleflex Incorporated. All rights reserved. MC-000095

References 1. Ramirez P. Laparoscopic and robotic techniques for radical hysterectomy in patients with early-stage cervical cancer. Gynecol Oncol. 2008;110(3 suppl 2): S21-S24. 2. Edwards C, Bradshaw A, Ahearne P, et al. Singleincision laparoscopic cholecystectomy is feasible: initial experience with 80 cases. Surg Endosc. 2010;24(9):2241-2247.

4. Papaioannou T, Daykhovsky L, Grundfest WS. Safety evaluation of laparoscopically applied clip. J Laparoendosc Surg. 1996;6(2):99-107. 5. Aminian A, Khorgami Z. Hem-O-Lok clip is safe in minimally invasive general surgery: a single center experience and review of data from Food and Drug Administration. J Minim Invasive Surg Sci. 2012;1(2):52-57. 6. Data on file (2013 internal study), Teleflex Incorporated, Report #D001591.

Figure 2. Weck® Auto Endo5® medium-large clip applier.

7. Hem-o-lok - Polymer Locking Ligation System. Hem-o-lok - Polymer Locking Ligation System. Teleflex, n.d. Web. 31 July 2014.

The Weck® Hem-o-lok® ligation system provides an effective approach with secure ligation and leak resistance. A recent ex vivo benchtop study using porcine carotids compared the Weck® Hem-o-lok® polymer clips with leading metal competitor clips in lateral pull-off, axial pull-off, and leak pressure.6 The results showed that the Weck® Hem-o-lok® clips required significantly higher axial pull-off force compared with other clips; were significantly more secure in lateral pull off; and did not leak at the maximum pressure of 1,300 mm Hg.6 The testing demonstrated that the medium-large Weck® Hem-o-lok® clip is at least 5 times more secure in lateral pull-off force, 1.8 times more secure in leak pressure testing, and at least 1.3 times more secure in axial pull-off force compared with the leading competitors (Figure 3).6

The Weck®Auto Endo5® may be more costeffective than other modalities surgeons may use in laparoscopic cholecystectomies. “This is one of those rare situations where the product I think is the best one to use is also

Hem-o-lok Ligating Clips are contraindicated for use in ligating the renal artery during laparoscopic donor nephrectomies.

3. Kapoor R, Singh KJ, Suri A, et al. Hem-o-lok clips for vascular control during laparoscopic ablative nephrectomy: a single-center experience. J Endourol. 2006;20(3):202-204.

Comparative Testing

Economic Considerations

Hem-o-lok Ligating Clips are not intended for use as a fallopian contraceptive tubal occlusion device.

8. Gill A, Shellock FG. Assessment of MRI issues at 3-Tesla for metallic surgical implants: findings applied to 61additional skin closure staples and vessel ligation clips. J Cardiovasc Magn Reson. 2012;14(3):1-7.

3.5

9. Colak E, Kement M, Ozlem N, et al. A comparison of nonabsorbable polymer clips and endoloop ligatures for the closure of the appendicular stump in laparoscopic appendectomy: a prospective, randomized study. Surg Laparosc Endosc Percutan Tech. 2013;23(3):255-288.

3.0 2.5 2.0

Developed and authored by Katherine Reider, MPH, editorial director-special projects, McMahon Publishing Group, with the assistance of Jamie Loggins, MD, FACS, FASMBS, and David Bryan Price, MD, FACS, through funding by Teleflex Incorporated.

1.5 1.0

Financial Disclosures: Ms. Reider has nothing to disclose. Drs. Loggins and Price have received honoraria from Teleflex Incorporated.

0.5 0.0

Ethicon® LIGAMAXTM5

Ethicon® 10mm LIGACLIP®

Covidien® Endo ClipTM lll

Weck® Auto Endo5®

Figure 3. Lateral pull-off test (medium-large clips).a a

Disclaimer: This article is designed to be a summary of information. While it is detailed, it does not constitute a clinical review. The authors neither affirm nor deny the accuracy of the information contained herein. No liability will be assumed for the use of this article, and the absence of typographical errors is not guaranteed. Readers are strongly urged to consult primary literature. Instruction for Use should be consulted prior to the use of any medical device.

Pull-off and leak pressure testing conducted by Teleflex Incorporated. Clinical significance of testing results are undetermined. Testing pressures range beyond physiologic pressures. Based on reference 6.

GENERAL SURGERY NEWS • SEPTEMBER 2014

BB1327

procedure. It allows me to make smaller incisions, which should equate to improved cosmesis and possibly less pain for the patient.” With high-definition 5-mm video equipment, Dr. Loggins said he no longer feels the need to use a 10-mm port in a reduced-port cholecystectomy. “It was really a perfect confluence of situations. The availability of the Weck® Auto Endo5® meant I could do a single-incision cholecystectomy with the same degree of confidence as if I had used 4 ports because I could use the same clip applier whether I was doing 4-port, reduced-port, or single-port surgery.” Using the Weck® Auto Endo5® applier, Dr. Loggins said that the instrument prods surgeons performing cholecystectomy to follow best surgical practices. “This may be an offshoot benefit of the Weck® Auto Endo5®. We were all taught to get a clean, critical view with a nicely dissected cystic duct and cystic artery,” he said. “The Weck® Auto Endo5® does not allow us to do sloppy dissections and throw clips on tissue when we’re not certain we’ve adequately exposed the tissue we need to see.” Dr. Price also has found the Weck® Auto Endo5® applier to be useful in securing the catheter during a cholangiogram. “When I do a cholangiogram, I’ll use the Weck® Auto Endo5® to hold the cholangiocatheter in position,” he said. “When I’m done with the cholangiogram, all I have to do is extract the cholangiocatheter from the duct, leaving the clip in place. With a metal clip, it would close down as much as it could, but when I’d take the catheter out it would loosen and just fall off.”

Stitches NOTES

jcontinued from page 7 make progress.” Dr. Hawes believes that for NOTES to take off, it will need a home-run application, like laparoscopic cholecystectomy was for laparoscopic surgery. “My prediction is that transanal colon resection will be the first true NOTES procedure and may propel NOTES back into the limelight,” Dr. Hawes said. Patricia Sylla, MD, FACS, FASCRS, a colorectal surgeon at Massachusetts General Hospital and assistant professor of

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / SEPTEMBER 2014

surgery at Harvard Medical School, Boston, and Antonio M. de Lacy, MD, chief of gastrointestinal surgery at the Hospital Clínic of Barcelona, Spain, pioneered a transanal approach to colorectal surgery. In 2009, Drs. Sylla and de Lacy performed the first NOTES transanal rectal cancer resection successfully on a 76-year-old woman with locally advanced rectal cancer using a transanal endoscopic microsurgery (TEM) platform and laparoscopic assistance (Surg Endosc 2010;24:1205-1210). Dr. Sylla’s interest in a transanal approach to colorectal surgery began in

2007 at a NOSCAR conference in Boston, when she attended a presentation by Mark Whiteford, MD, FACS, FASCRS, on transanal radical sigmoid colectomy in human cadavers using TEM instrumentation (Surg Endoscc 2007;21:1870-1874). “No one in the audience really responded, but if you understood the TEM platform, you could see the true potential of this approach,” Dr. Sylla recalled. “I saw this as the future of colorectal surgery.” Back at Massachusetts General, Dr. Sylla experimented with the transanal approach to colorectal surgery on pigs and human cadavers (J ( Gastrointest

Setting New Standards Through Innovation Restoring Natural Vision and Depth Perception without Compromise

Fastest Cutting with Best-in-Class Vessel Sealing from a Single Instrument

Please visit our booth #1025 at the 2014 ACS Clinical Congress in San Francisco, October 26–30. 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

Surgg 2008;12:1717-1723; Surg Endosc 2010;24:2022-2030; Surg Endosc 2013;27:74-80). However, performing a pure NOTES procedure proved difficult, mostly due to limitations in the available instrumentation. “There are several cases in the literature of pure transanal NOTES colorectal operations, but this has been in very thin patients,” Dr. Sylla noted. “Once we get more innovative, longer and flexible instruments, we will be able to perform more pure transanal NOTES procedures, but a hybrid approach appears to be safest at this time.” Currently, Drs. Sylla and de Lacy have demonstrated the feasibility and preliminary safety of laparoscopy-assisted transanal NOTES total mesorectal excision for rectal cancer in 28 patients (Surg Endosc 2013 Mar. [Epub ahead of print]; Surg Endoscc 2013 Apr. [Epub ahead of print]; Surg Endoscc 2013;27:339-346). Other techniques may have potential to propel NOTES forward. Although not a pure NOTES procedure, some believe that peroral endoscopic myotomy (POEM), a cross between laparoscopic surgery and therapeutic endoscopy, may be the first sentinel application to come out of NOTES, Dr. Willingham said. In 2010, Haruhiro Inoue, MD, a gastroenterologic surgeon, brought POEM to humans, performing the first series to treat esophageal achalasia (Endoscopy 2010;42:265-271). NOTES also may pave the way for hybrid procedures that blend flexible endoscopy with minimally invasive laparoscopic techniques. “Many surgeons don’t have extensive experience with flexible endoscopy and gastroenterologists don’t typically train in laparoscopy,” Dr. Willingham said. “So we are currently examining whether gastroenterologists and surgeons can work together to develop a novel solution when the current approach is not good.” For instance, Dr. Willingham and his colleagues have developed a hybrid laparoscopic and endoscopic approach to removing mass lesions of the foregut, offering a vast improvement over total gastrectomy (GIE E 2012;75:905-912). Currently, it’s important to show that a pure or hybrid NOTES procedure offers significant benefits over the standard open or laparoscopic approach to help justify the costs and training associated with investment in a new procedure, Dr. Sylla said. Looking to the future, Dr. Kalloo sees surgery becoming increasingly minimally invasive. “I see a future unfolding in which fewer incisions are the norm,” Dr. Kalloo said. “One hundred years from now, we’ll look back at open and laparoscopic surgery and say how barbaric that was, actually creating a big hole across the abdominal wall to help patients.”

Stitches

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / SEPTEMBER 2014

Women in Surgery:

Angelita Habr-Gama, MD, Pioneer in Colorectal Surgery B Y V ICTORIA S TERN

ngelita Habr-Gama, MD, helped pave the way for future generations of women in surgery. During the 1940s and 1950s, few women entered the medical profession and still fewer became surgeons. Despite the paucity of women, Dr. Habr-Gama knew that surgery was her calling. In the early 1950s, Dr. Habr-Gama worked tirelessly until she was accepted to the top medical school in Brazil, The University of São Paulo School of Medicine. She was one of a handful of female students in her class. Unfazed by the imbalance, she continued to pursue her passion. Throughout her career, Dr. HabrGama has accrued an impressive list of firsts. In 1958, she was the first female resident in general surgery at the University of São Paulo School of Medicine Clinics Hospital (FMUSP). In 1961, she became the first female fellow at the St. Mark’s Hospital in England, although it took two years of applying before she was accepted to the all-male program. By 1966, she finished her doctoral degree and became one of the first female surgeons in Brazil. After completing her thesis in 1972, which focused on a new technique to conserve the anus in patients with rectal cancer, Dr. Habr-Gama was promoted to associate professor at FMUSP. Twenty-six years later, in 1998, Dr. HabrGama became the first female full professor at the university, a post that she still holds. Before this time, FMUSP had not allowed women to become full professors. But after years of petitioning for equality, Dr. Habr-Gama was finally awarded the title. Currently, Dr. Habr-Gama is also director of the Department of Gastroenterology and the Colorectal Unit at FMUSP. Among her many accomplishments, Dr. Habr-Gama introduced colonoscopy, mechanical suturing and video laparoscopy to Brazil; pioneered advances in the field of coloproctology; and developed Brazil’s first anorectal physiology laboratory. She was also the first, and so far the only, woman to become president of the Latin American Association of Coloproctology and the Brazilian Society of Coloproctology as well as vice president of the Brazilian College of Surgeons and governor of the American College of Gastroenterology in Brazil. Throughout her career, Dr. HabrGama has been a strong advocate of the controversial “watch-and-wait” approach for patients with anal and rectal cancer who have achieved a complete clinical

response following neoadjuvant chemoradiation ((Ann Surgg 2004;240:711-718; Dis Colon Rectum 2013;56:1109-1117; Int J Radiat Oncol Biol Physs 2014;88:822828). She has participated in the Genome Project and the Human Cancer Genome Program (PNAS S 2013;100:1341813423). More recently, she has been an active spokeswoman for colorectal cancer

prevention ((Arq Gastroenteroll 2005;42:23; Nutr Hospp 2005;20:18-25). General Surgery Newss recently interviewed Dr. Habr-Gama to learn more her about her accomplished career in surgery and medicine. GSN:: Where did you grow up? Dr. Habr-Gama: I was born on Ilha see PIONEER page 12

Dr. Habr-Gama accepts full professorship at Sao Paulo School of Medicine Clinics Hospital in 1998.

MarginMarker & CorrectClips ®

The New Standard ĨŽƌ dŝƐƐƵĞ KƌŝĞŶƚĂƟ ŽŶ® MarginMarker ^ƚĞƌŝůĞ ƐŝǆͲĐŽůŽƌ ŝŶŬ Ŭŝƚ͖ the surgeon applies ink to designate each margin for pathology

^ƵƉĞƌŝŽƌ

Lateral

Medial

ŽƌƌĞĐƚ ůŝƉƐ ^ƚĞƌŝůĞ ƌĂĚŝŽŐƌĂƉŚŝĐ ĐůŝƉƐ͖ ƚŚĞ surgeon applies clips to orient specimen on the image

Inferior

The Surgeon Orients in the OR for More Accurate Margin Analysis /Ŷ ĐĂŶĐĞƌ ƐƵƌŐĞƌǇ͕ ƚŚĞ ƐŝŶŐůĞ ŵŽƐƚ ŝŵƉŽƌƚĂŶƚ ƉƌĞĚŝĐƚŽƌ ŽĨ ůŽĐĂů ƌĞĐƵƌƌĞŶĐĞ ŝƐ ƚŚĞ Ɵ ƐƐƵĞ ŵĂƌŐŝŶƐ͘1 Research shows ĚŝƐĐŽƌĚĂŶĐĞ ƌĂƚĞƐ ĂƐ ŚŝŐŚ ĂƐ ϱϮй ŝŶ ƚŚĞ ŝĚĞŶƟ Į ĐĂƟ ŽŶ ŽĨ ƐƉĞĐŝŵĞŶ ŵĂƌŐŝŶƐ͘2-3 Re-excision rates exceed 20% in ďƌĞĂƐƚ ƐƵƌŐĞƌǇ͘4 Vector Surgical’s MarginMarker and CorrectClips can result in:

50% fewer unnecessary re-excisions

&ĞǁĞƌ ĚĞůĂǇƐ ŽĨ ĐƌŝƟ ĐĂů ĂĚũƵǀĂŶƚ ƚŚĞƌĂƉǇ

Lower cancer recurrence

/ŵƉƌŽǀĞĚ ĐŽƐŵĞƐŝƐ

More accurate re-excisions

sŝĞǁ ^ƵƌŐĞŽŶ ĞŵŽŶƐƚƌĂƟ ŽŶƐ ͮ ZĞƋƵĞƐƚ Ă ^ĂŵƉůĞ ͮ sĞĐƚŽƌ^ƵƌŐŝĐĂů͘ĐŽŵ ͮ нϭ ;ϮϲϮͿ ϳϵϴͲϳϵϳϬ

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

Stitches PIONEER

jcontinued from page 11 de Marajó, an island in the middle of the Amazon River in Brazil. At age 7, I moved to São Paulo with my family and I continue to reside there today. GSN:: When did you know you were interested in medicine? Was your family supportive of this? Dr. Habr-Gama: Since I was a teenager I knew that I did not want to become a schoolteacher, which was the expected occupation for women at that time and a profession my parents approved of. However, my strong interest in biology and human sciences led me to choose medicine despite being against my family’s wishes. GSN:: Was the transition from your desire to be a doctor to actually attending medical school a difficult one as a woman? Dr. Habr-Gama: Yes, it was very difficult. Women hardly entered medical schools at that time—six women a year on average. There were few medical schools in São Paulo and only two public universities. However, I turned difficulties into challenges and I studied hard to enter the most highly regarded medical school in Brazil: The University of São Paulo School of Medicine. After overcoming this initial barrier, I must say I did not suffer much discrimination throughout my medical career. GSN:: When during medical school did you gravitate toward surgery? Dr. Habr-Gama: I felt especially attracted to gastroenterology and cardiology, but during my internship, which corresponded to the sixth medical year, I rotated in the surgery ward. During one surgery, the resident doctor offered me the opportunity to close the patient’s abdominal wall. At that moment, I knew I had discovered my actual vocation. GSN: What was your experience training in such a male-dominated world? Dr. Habr-Gama: My experience training in a male-dominated world was very interesting. Patients would sometimes ask me, “When will the surgeon come?” When I would answer, “I am the surgeon,” some patients became very anxious. One of my greatest difficulties was being accepted by nurses, particularly in the operating room setting. It was even difficult to get gowns in my size (some cutting was often necessary) and to go to restrooms. Slowly over time, these attitudes and impediments changed and people gained confidence in my abilities. GSN:: Why the interest in colorectal surgery specifically? Dr. Habr-Gama: My interest in colorectal surgery developed after a fellowship at St. Mark’s Hospital in London. I was the first woman accepted as a fellow, which was not an easy feat. The

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / SEPTEMBER 2014

first answer I received when I applied for the scholarship was that St. Mark’s was a hospital for men, not women. However, my repeated efforts were rewarded and, after two years of applying, I was accepted. GSN:: Can you describe a few of your most notable accomplishments that propelled your career? Dr. Habr-Gama: There were several pivotal points in my career. The first was being a resident in the Surgery Department headed by Professors Alipio Correa Neto and Arrigo Raia. Both men were outstanding surgeons and professors.

Patients would sometimes ask me, ‘When will the surgeon come?’ When I would answer, ‘I am the surgeon,’ some patients became very anxious. One of my greatest difficulties was being accepted by nurses, particularly in the operating room setting.

They had a special sense of leadership, and did their best to help us improve our knowledge and achieve success. My time as a fellow at St. Mark’s Hospital was also a turning point in my career. After my fellowship, I started being accepted by my professor, colleagues and patients. GSN:: What about significant publications? Dr. Habr-Gama: I have been publishing throughout my career, but the most relevant scientific papers came in the 1990s (e.g., Dis Colon Rectum 1998;41:1087-1096).

ULTRAPRO® Mesh is proven to get patients back to their lives comfortably The comprehensive ULTRAPRO® Portfolio of macroporous, partially absorbable mesh solutions are based on the latest ideas in open inguinal hernia repair • A study of a device made from ULTRAPRO Mesh showed that it delivers significant pain reduction versus heavyweight mesh1 • Long-term improvement in quality of life, with significant relief from movement limitations at 1-year postsurgery versus presurgery (P<.001)2 • The ULTRAPRO Portfolio offers low rates of recurrence (<2%) for a lasting repair2-4* • Leaves behind 65% less foreign material compared with heavyweight mesh after partial absorption5

Visit Ethicon.com for more information. *Data from a prospective, longitudinal study of 71 patients receiving open hernia repair with ULTRAPRO® Plug from the International Hernia Mesh Registry. Two additional patient-reported recurrences could not be medically confirmed by a clinician.4 References: 1. Tsirline VB, Colavita PD, Belyansky I, Zemlyak AY, Lincourt AE, Heniford BT. ULTRAPRO Hernia System versus conventional Lichtenstein repair for inguinal hernia system: results from the multinational registry. Abstract presented at 5th International Hernia Congress; March 28-31, 2012; New York, NY. 2. Berrevoet F, Tollens T, Romanowski C, Jones P, McRoy L. Open macroporous partially absorbable flat mesh — 12 month outcomes. Poster presented at 15th Annual Hernia Repair; March 13-16, 2013; Orlando, FL. 3. Lorenz R, Koch A, Wiese M, Born H. Gilbert repair — a new gold standard? First results of 2792 patients of a multicentric German quality control study. Poster presented at 15th Annual Hernia Repair; March 13-16, 2013; Orlando, FL. 4. Doerhoff C, Lydon P, Hammond J, Romanowski C, Jones P. 12 month outcomes following open hernia repair with a partially absorbable plug and patch device. Abstract presented at the 36th Annual International Congress of the European Hernia Society; May 28-31, 2014; Edinburgh, Scotland. 5. Data on file. Mesh Specifications. Ethicon, Inc. For complete indications, contraindications, warnings, precautions, and adverse reactions, please reference full package insert. © 2014 Ethicon, Inc. All rights reserved. 017076-140616

Stitches

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / SEPTEMBER 2014

Dr. Habr-Gama in the operating room.

I have devoted part of my efforts to colorectal cancer prevention and to changing rectal cancer management (Updates Surgg 2013;65:43-52; CA Cancer J Clin 2012;62:173-202; Tech Coloproctoll 2011;15:45-51), and have always been interested in sphincter preservation (Hepatogastroenterology 2004;51:1703-1707). GSN:: Can you describe the impetus for the controversial watch-and-wait protocol? Dr. Habr-Gama: My thesis to obtain the title of associate professor in 1972 was on coloanal anastomosis for the treatment

of rectal cancer, a technique intensely debated at the time. As of 1981, like many other specialists, I started using multimodal treatment with neoadjuvant chemotherapy, particularly to manage distal rectum tumors. After performing radical surgeries, either abdominoperineal amputation of the rectum or rectosigmoidectomies with coloanal anastomoses, and observing no tumor in the surgical specimen, I changed the protocol. With their consent, patients with apparent complete clinical response to neoadjuvant chemoradiation therapy did not undergo surgery but were kept under close observation.

NEW ULTRAPRO COMFORT PLUG™ Partially Absorbable Hernia Repair Device

ULTRAPRO® Hernia System

ULTRAPRO® Partially Absorbable Lightweight Mesh

These patients were informed about the possibility of tumor recurrence, and knew if that happened, they would require surgery. When local recurrence occurs, if it is detected early, a salvage operation may be possible with good results. This watchand-wait protocol remains a controversial issue and has been heavily criticized. However, gradually, some colleagues have accepted this strategy and have reported results similar to ours. GSN:: What are some of the things you’re most proud of in your career? Dr. Habr-Gama: I am very proud of numerous aspects of my career. Among these, I have prized caring for an uncountable number of patients not only from São Paulo but also from many other cities in Brazil. I have loved teaching and being a mentor to students, residents and fellows throughout South America, and I have continued to work on assimilating new advances, continuously improving my knowledge and making new friendships. I am also proud of founding the Brazilian Association for Colorectal Cancer Prevention in 2004. This association was the first in Brazil to start an awareness program centered on the importance of colorectal cancer prevention, and I have been its president since 2004. We constructed a giant colon, which people of all ages can go inside and visualize different lesions and listen to explanations about colon cancer prevention from a character called Dr. Preventino. This giant colon has been exhibited in many cities all over Brazil, and also in 2006, Sidney Winawer, MD, invited us to exhibit it in Montreal during the World Congress of Gastroenterology and in other cities in Canada. After this, the Canadian Society of Coloproctology built a model similar to our giant colon, using the voice of Dr. Preventino. GSN: How did you meet your husband, Joaquim Gama-Rodrigues? Dr. Habr-Gama: I met him in medical school when we were students. He was an excellent student and great athlete, representing Brazil in the South American championships. However, only after we finished residence in surgery and began assisting Dr. Raia in operations did we start dating and later got married. My husband is also professor of surgery at the University of São Paulo School of Medicine. We both have the same academic titles and share the same interests. GSN: You have enjoyed many years of marriage. How have you balanced career and relationship so successfully? Dr. Habr-Gama: Yes, we have been married for nearly 50 years. My husband has always had a superior mindset; he admires women’s activities and never needed to compete with me because he trusts himself and his competence. At the social and family level, we have the same see PIONEER page 30

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / SEPTEMBER 2014

‘Goldilocks’ an Alternative to Breast Reconstruction for Some Patients B Y M ONICA J. S MITH

or a selected group of breast cancer patients, the Goldilocks mastectomy may be a respectable option, or “just right,” for those who won’t undergo reconstruction but also don’t want the flat silhouette left by a standard mastectomy. “People are feeling their way around what its place should be and what its

significance is,” said Heather Richardson, MD, of Piedmont Hospital, Atlanta, who conceptualized the procedure and co-authored the first study describing its use (Int J Surgg 2013;10:522-526). “This is an additional option for a small subset of women and is not meant to replace other existing techniques,” she said. This subset includes patients whose comorbidities contraindicate full reconstruction, or who don’t want implants or multiple operations, but

who want to retain some breast shape. Dr. Richardson’s first experience with the Goldilocks mastectomy occurred as a happenstance. One patient scheduled for unilateral mastectomy declined reconstruction, even after consulting with plastic and reconstructive surgeon Grace Ma, MD, FACS, of Peachtree Plastic Surgery, also in Atlanta. But the patient did make a unique request: that Dr. Ma close the mastectomy incision at the end of the surgery.

On the day of the procedure, Dr. Richardson found that Dr. Ma had drawn a Wise pattern on the patient’s breast instead of the more typical elliptical pattern. She performed the mastectomy through a periareolar incision, which resulted in a lot of redundant skin. The procedure had gone quickly, so she decided to de-epithelialize the lower portion of the skin-sparing mastectomy flap that she thought Dr. Ma intended to remove and discard.

‘Some patients wanted unilateral mastectomies, some wanted bilateral; we worked out what was best for them, and we’ve had some really happy patients.’ —Heather Richardson, MD “As I was playing around with it, folding it on itself, I realized that when closed, it really did emulate a breast. [This closure] brought the fold lift medially and centrally in the mastectomy site, as opposed to standard amputation mastectomy,” she said. “Having removed the glandular tissue, we felt safe leaving the residual subcutaneous tissue that we would ordinarily incorporate into a reconstruction anyway. Dr. Ma reassembled this inferior mastectomy tissue and covered it with the superior mastectomy flap in such a way that it resembled a breast reduction.” The patient was delighted with the result. “We asked if she wanted to have the contralateral breast reduced to achieve symmetry, but she was satisfied and declined additional surgery,” Dr. Richardson said. “She told us that when she wears a bra, she has tissue to keep the bra in place and [the use of ] a small prosthesis balances her out.” Most patients, however, do prefer more symmetrical outcomes, which can be achieved with either a bilateral Goldilocks mastectomy or a reduction mammoplasty on the other side. Dr. Richardson and her colleagues realized that this approach was a good compromise for patients with manageable expectations. “These are usually older women who simply want to look normal in their clothing,” she said. From 2010 to April 2014, Dr. Richardson and her colleagues performed the Goldilocks mastectomy in 54 patients (84 breasts). “Some patients wanted unilateral mastectomies, some wanted bilateral; we worked out what was best for them, and we’ve had some really happy patients.” In the first two years offering the Goldilocks mastectomy, Dr. Richardson’s team performed it on just over 5%

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / SEPTEMBER 2014

Bilateral Goldilocks mastectomy in 94-year-old patient with ductal carcinoma in situ, before (left) and after. Photo courtesy of Heather Richardson, MD.

of their breast cancer patients. It’s not a huge patient population, but the numbers do add up. “If you extrapolate that to the hundreds of thousands of women who have breast cancer, it turns into a significant number of patients.” The savings in health care dollars also could be significant. “We’re not going to be able to give every patient thousands of dollars’ worth of multiple surgeries. This is a reasonable approach: Rather than discarding the safe mastectomy flap flesh, you can reapproximate it so that it looks like a natural breast,” Dr. Richardson said. “It’s sort of the ultimate in recycling.” Shawna Willey, MD, FACS, professor of clinical surgery, director of the MedStar Regional Breast Health Program, and vice-chair of the Department of Surgery, MedStar Georgetown University Hospital, Washington, D.C., has been intrigued with the procedure since learning about it at a presentation. She recently added the Goldilocks to her armamentarium after identifying a few unique patients who were not ideal candidates for mastectomy alone or mastectomy with reconstruction. As far as body habitus goes, these are often heavier women with larger breasts, for whom the procedure may eliminate one of mastectomy’s unpleasant characteristics. “One of the biggest complaints from mastectomy patients without reconstruction is that they feel this wad of tissue under their arm, which they universally hate,” Dr. Willey said. “When there is a lot of redundant tissue, not just in the anterior chest wall but under the arm, we can move that tissue forward and arrange it to create the breast mound and obviate that problem.” Not all candidates for the Goldilocks mastectomy are generously proportioned. Dr. Willey recently discussed the procedure with a patient who had previously undergone mastectomy with reconstruction, but was worried about her implants and wanted them removed. “She is quite thin and she would be very flat, but if we can just give her a bit of a breast mound so that she will look small-breasted but normal in clothing, I think that will be a good choice for her,” Dr. Willey said. The Goldilocks requires basic

surgical skills: the ability to cut and sew. Although it doesn’t necessarily demand formal training, it does take some forethought and planning. “It’s a different way of thinking about the incision and rearranging the tissue,” Dr. Willey said. “This is something we partner well with our plastic surgeons to do. We look at the patient; we look at the tumor; we figure out what would be the best thing to do; and then we work together as a team to offer that to the patient.”

NOT ALL HEROES CARRY WEAPONS. MY HERO CARRIES A SCALPEL. “The day my hero joined the U.S. Army Reserve Medical Corps I wasn’t even a Soldier yet. The day I was injured in combat, it was a Reserve doc who stabilized my injuries and saved my life. I carry scars, but I carry on.” SGT Summers (deployment: Afghanistan) “Military Service isn’t for everyone. I hope that this trend will change. I decided to start with me. At the end of the day, this is a chance to serve with medical colleagues second to none while caring for the most deserving patients ever. To get back to your roots. To get back to the practice of medicine and away, if only brieﬂy, from the administrative distractions of modern medical practice. For those who consider entry in the Reserves, I can assure you, you will never regret your decision.” COL Brucker — Orthopedic Surgeon

UNMATCHED EXPERIENCE IN SERVICE TO COUNTRY. 800-983-8176 www.GoArmyReserveDocs.com

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / SEPTEMBER 2014

RADIOTHERAPY jcontinued from page 1

trial was a comparison of overall and disease-free survival, as well as morbidity and quality of life. “The objective of this substudy that I am presenting was to analyze morbidity in both treatment groups, focusing on the short-term surgical complications, lymphedema of the ipsilateral arm and shoulder function,” said lead researcher Mila Donker, MD, Netherlands Cancer Institute, Antoni Van Leeuwenhoek Hospital, Amsterdam. The research involved nearly 5,000 patients from countries with various standards of care, “so the study reflects the real world of clinical practice. It has important implications for treatment going forward,” Dr. Donker said. Of the 1,425 patients who were SLN-positive, 744 were randomized to ALND and 681 to ART. The axillary recurrence rate was 0.43% in those who underwent ALND and 1.19% in those who underwent ART, a difference that did not reach statistical significance. Comparing complications in those who underwent ALND and the ART group, whose surgery was limited to the SLN biopsy, the differences were fairly striking: Complications were seen in 23% of the ALND group compared with 9% of the ART group. Hemorrhage occurred in 3.1% and 1.7%, postoperative infection occurred in 10.7% and 3.8%, and persistent seroma was seen in 10.4% and 1.3%, respectively. “Also, early lymphedema, within three months after surgery, was significantly increased after a lymph node dissection,” Dr. Donker said. “Any of the above complications were more than twice as high in the ALND group compared with patients treated only by sentinel node biopsy.”

‘I believe that as a result of this trial, radiotherapy of the nodes will begin to replace surgery. The results are that definitive and significant for patients’ quality of life.’ —Mila Donker, MD To analyze the incidence of lymphedema, the patients were divided into three groups: those who underwent ALND, those who underwent ART, and a small group of 27 patients who had more than four positive nodes after ALND and received subsequent ART. At one year, lymphedema was seen in 15%, 25% and 59% of those treated with ART, ALND, and ART with ALND. At five years, the rates had dropped slightly to 10%, 21% and 58%. “The incidence of lymphedema was almost twice as high in the patients who had ALND compared with those treated only with radiation to the axilla; and in

those who underwent both treatments, the incidence of lymphedema was almost three times that of patients who underwent only ART,” Dr. Donker said. “And this persisted to five years after treatment.” Both treatment groups experienced a temporary decrease in shoulder mobility, particularly in the first year after treatment. There seemed to be a slight difference favoring patients who underwent ALND in the first year after treatment, but that difference was not significant and disappeared by year 5. “This data strongly supports radiotherapy as the preferred treatment, and that combined therapy should if possible be avoided,” Dr. Donker said. “I believe that as a result of this trial, radiotherapy of the nodes will begin to replace surgery. The results are that definitive and significant for patients’ quality of life.” Deanna Attai, MD, assistant clinical professor, Department of Surgery, David Geffen School of Medicine, University of California, Los Angeles, noted that although the overall number of ALNDs is decreasing, due largely to increased detection of early-stage disease and expanded indications for SLN biopsy alone, ALND is still performed with some frequency despite its significant association with such morbidity as pain, numbness, limitation of arm range of motion and lymphedema. “Radiation therapy also has potential complications, but at a lower rate than surgery,” Dr. Attai said. “To me, this reinforces that we all need to discuss cases at a multidisciplinary conference to decide on the best treatment approach for each patient. We continue to move toward more individualized therapy, and one physician should not be making the treatment decisions alone.”

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / SEPTEMBER 2014

Colectomy for Chronic Constipation: A Rising Trend Causes Alarm CHICAGO—Colectomy as a treatment for chronic constipation is on the rise, but the surgery puts patients at risk for potentially serious perioperative complications with little evidence for long-term benefit, new research shows. Anwar Dudekula, MD, of the University of Pittsburgh Medical Center, who helped conduct the study, said treatment guidelines include the use of surgical approaches, with subtotal colectomy and ileorectal anastomosis in patients with slow-transit constipation. However, he questioned whether surgical modalities are worth the associated risks, and suggested that the recommendations warranted reconsideration in light of the new findings. “As a functional disorder, constipation may have a significant impact on quality of life, but it does not come with truly relevant morbidity or mortality,” Dr. Dudekula said. “Thus, the risks of more aggressive interventions need to be weighed against this generally benign prognosis.” Dr. Dudekula and his colleagues analyzed changing patterns in the use of colectomy for constipation and the rate of perioperative complications by examining the Nationwide Inpatient Sample for 1998 to 2011, as well as the State Inpatient Database and State Emergency Department Database for California and Florida for 2005 to 2011. They included patients with diagnostic codes for total intraabdominal colectomy, either open or laparoscopic, and total abdominal colectomy of unspecified nature, as well as a primary diagnosis of constipation, slow-transit constipation and outlet dysfunction constipation. They excluded patients with gastrointestinal hemorrhage or blood in stool, diverticulitis of the colon, diverticulosis with hemorrhage, lower gastrointestinal tract cancer and colitis. The analysis identified 2,220 women and 157 men with these diagnoses; almost 90% were aged 25 to 64 years. Nearly 90% of the procedures were elective, and most were performed in large, urban teaching hospitals in the South and Midwest. The analysis confirmed that while the numbers are still small, colectomy for constipation has increased dramatically since 1998—rising from 104 in 1998 to 311 in 2011. In Florida and California, the 181 colectomy patients in the databases logged 2,540 total health care visits, and they were followed for a median of 630 days before surgery and 446 afterward. Visits to the emergency department and hospital admissions did not change

appreciably after colectomy. Emergency department visits totaled 293 before colectomy and 223 afterward. Hospital admissions numbered 318 and 390, respectively. “The longitudinal data demonstrated continuing use of health care resources, dominated by gastrointestinal complaints, and this suggests that the apparent risk of surgery is not offset by improved longterm outcomes” Dr. Dudekula reported at Digestive Disease Week 2014 (abstract

MAQUET is a registered trademark of MAQUET GmbH • ProLite, ProLite Ultra, ProLoop, C-QUR, C-QUR TacShield, C-QUR V-Patch and C-QUR CentriFX are trademarks of Atrium Medical Corporation • VitaMESH and VitaMESH Blue are trademarks of Proxy Biomedical Ltd. • MCV00026056 REVA CAUTION: Federal (US) law restricts this device to sale by or on the order of a physician. Refer to Instructions for Use for current indications, warnings, contraindications, and precautions.

B Y C AROLINE H ELWICK

Sa2009). “Also, while surgery was mostly performed in the young [population], perioperative complications were common.” Approximately 40% of patients developed a perioperative complication. Urinary and pulmonary problems together accounted for about 50% of these events, he said. The consequences of the complications were unclear. “We came up with a very conservative estimate, excluding patients that may

have had other, likely harmless problems, such as diverticulosis, and still the number of these radical operations performed doubled within about a decade,” Dr. Dudekula told General Surgey News. “If indeed health care resource utilization goes up instead of down, it does not indicate true success and improved quality of life, which is the key target in managing functional disease. Thus, it is time to slow down and reassess these guidelines.”

YOUR FULL LINE HERNIA MESH PROVIDER C-QUR MOSAIC™ Strength and handling with an O3FA coating

VITAMESH™ Light-weight macroporous PP surgical mesh

VITAMESH™ BLUE C-QUR TACSHIELD™ Symmetrical fixation apron with an O3FA coating

C-QUR V-PATCH™ Anchoring & deployment with an O3FA coating

Light-weight macroporous PP surgical mesh

PROLITE™ MESH Bare polypropylene

C-QUR CENTRIFX™

PROLITE ULTRA™ MESH

Anatomically shaped 3D design with O3FA

Ultra light-weight bare polypropylene

PROLOOP™ PLUG C-QUR™ FX MESH O3FA filament coated mesh

Light-weight 3D polypropylene plug

Your Total Solutions Partner. Understanding the need to meet financial goals with dependable products, we are a full-line hernia mesh provider, delivering economically y and clinically y valuable solutions for all hernia procedures.

MAQUET will donate $250 to Make-A-Wish® for any single purchase order of $50,000 or more (before tax, shipping and install) received between March 1, 2014 and February 28, 2015, with a minimum guaranteed contribution of $50,000, up to a maximum of $150,000. For more information about Make-A-Wish visit wish.org.

www.maquetusa.com

On the

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / SEPTEMBER 2014

{Spot} With Colleen Hutchinson Developments in Approaches to Liver Resection

Participants Joseph Buell, MD, is the director of the Tulane Transplant Institute and the Children’s Hospital of New Orleans and hepatobiliary surgeon; Dr. Buell hosted the first International Consensus Conference on Laparoscopic Liver Surgery, in Louisville, and was the first author on the consensus statement. David Geller, MD, is the Richard L. Simmons Professor of Surgery, chief of the Division of HPB Surgery, and director of the UPMC Liver Cancer Center, University of Pittsburgh.

Horacio Asbun, MD, is professor of surgery at Mayo Medical College, chairman of the General Surgery Division, and co-director of HPB Program, Mayo Clinic, Florida; Executive Council member of the American Hepato-PancreatoBiliary Association; board member of SAGES; and editor-in-chief of the American College of Surgeons Multimedia Atlas of Surgery Series. Thomas Aloia, MD, is a husband and a father to the two most wonderful kids in the world, a recovering transplant surgeon, HPB and MIS surgeon at University of Texas MD Anderson Cancer Center, in Houston. Motto: With a plan, comes hope. Allan Tsung, MD, is the Roberta Simmons Associate Professor of Surgery at the University of Pittsburgh Medical Center.

William Jarnagin, MD, is attending surgeon, Enid A. Haupt Chair in Surgery, and chief of the Hepatopancreatobiliary Service, Memorial Sloan-Kettering Cancer Center; and professor of surgery, Cornell University Weill College of Medicine, New York City. Disclosures: Dr. Geller: Consultant to Medtronic (course director for annual Laparoscopic Liver Resection course). Dr. Tsung: Instructor at Laparoscopic Liver Course sponsored by Medtronic (2014). Dr. Aloia: Guilty of tweeting: @mdahpbaloia

I really enjoyed working on this month’s column on liver resection because it allowed me to collaborate on something new with Drs. David Geller and Horacio Asbun, with whom I work on the ACS Multimedia Atlas of Surgery: Liver. Dr. Geller had asked me about “On the Spot” and mentioned that an area of surgery rife with debate now is the approach to liver resection, and now here we are! Collaboration on this column with these renowned experts was rewarding. What I’ve learned about the approach to liver resection is this: Some doctors believe that the open approach is best (for some procedures), and

{

some believe laparoscopy—which has been slow to evolve in this area of surgery—is proven the better choice, and then there are surgeons who now approach some liver resections robotically. We hear from all sides in this installment. I would like to thank Dr. Geller for his effort in helping me understand the evolution of approaches that lies behind these different perspectives. Thank you to all of this month’s contributors for sharing their expertise. Please feel free to email me at colleen@cmhadvisors.com with any ideas or comments. —Colleen Hutchinson

Statement:

Oncologic results with laparoscopic liver section (LLR) of hepatocellular carcinoma (HCC) or etastatic colorectal cancer are comparable to open liver section.

Dr. Geller: Agree. Numerous studies have reported comparable five-year overall survival for LLR of HCC or limited metastatic colorectal cancer (one or two tumors) in case–cohort matched studies comparing LLR to open liver resection. Of note, there have been no prospective, randomized controlled trials published comparing laparoscopic to open hepatic resection, and it is important to recognize that inherent selection bias exists, even in well-matched case–cohort series.

Dr. Aloia: On the fence. There are competing oncologic issues related to surgical approach. Experience indicates that laparoscopically, it is more difficult to assess the liver and less liver comes out of the patient. From margin and missed lesion perspectives, this is likely to be oncologically unfavorable. However, as we learn more about the immunosuppressive effect of surgery, we may find that less invasive approaches have an intrinsic oncologic benefit. Also, laparoscopic approaches may win in terms of the return to intended oncologic therapy (RIOT) rate [J [ Surg Oncoll 2014; in press]. With our current level of understanding, however, one has to come back to this: “Biology is King. Selection is Queen. Technical maneuvers are the Prince and Princess. Occasionally the prince and princess try to overthrow the powerful forces of the King and Queen, sometimes

with temporary apparent victories, but usually to no long-term avail.” —Blake Cady, MD

Dr. Tsung: Agree. Although there were initial concerns of adequate margins and tumor seeding for LLR of malignant tumors, there have been no significant differences in margin-free resection and five-year overall survival in multiple studies comparing LLR and open liver resection for either HCC or metastatic colorectal cancer. There are currently prospective, randomized trials ongoing that will confirm whether oncologic results are similar.

Dr. Buell: Agree. The publications produced from the Louisville Consensus clearly demonstrated comparable oncologic outcomes in the short term for colorectal [cancer] and HCC patients undergoing laparoscopic hepatic resections compared with open cohorts. This is with the caveat that laparoscopic hepatic resection is performed by surgeons who are well trained and experienced in sound oncologic liver surgery, and should be utilized in appropriate cases—ie, tumors smaller than 5 cm. This tumor size was advocated by the Louisville Consensus group and will be a point of discussion at the second consensus meeting in Japan this coming October, and may, in fact, be increased. As far as the oncologic integrity of laparoscopic hepatectomy, in the right hands, the procedure is a sound one.

On the Spot

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / SEPTEMBER 2014

Dr. Jarnagin: Agree. There are no published data to suggest the superiority of one approach over the other for these diseases. We must remember, however, that the only data available for analysis are derived from uncontrolled, retrospective studies that are laden with bias regarding patient selection for minimally invasive procedures. Prospective randomized data are lacking.

Dr. Asbun: Agree. Even though there are no prospective, randomized trials, the available literature favors the statement that oncologic results are equal between laparoscopic and open surgery. There is an implicit selection bias, however, and a key component to attaining adequate oncologic resection is appropriate patient selection.

{

Statement: Patients who undergo LLR experience greater clinical benefits and decreased perioperative morbidity compared with open liver resection. Dr. Geller: Agree.

This is supported in the literature with advantages consisting of less estimated blood loss (EBL), less need for packed red blood cell (PRBC) transfusion, less postoperative pain, less narcotic use and shorter length of stay [LOS] in the hospital. Many, but not all, studies show decreased postoperative morbidity.

Dr. Asbun: Agree. In the right hands, for the right case, in the right patient. There is a need for prospective trials, but realistically this may not be feasible or practical. Establishing a laparoscopic hepatic registry can be accomplished; interestingly, it should not be limited to the laparoscopic approach. As for laparoscopy, open liver surgery outcomes should be monitored and evaluated equally.

Anyone doing laparoscopic or major open liver surgery should do so following their outcomes and ideally maintaining a prospective database. —Horacio Asbun, MD Dr. Aloia: On the fence. In their book, “Redefining Health Care,” Porter and Teisberg have described well three tiers of patient-centered value in health [cancer] care. In lay terms, they are: 1) Did you hurt me? 2) To what level did I recover function? and 3) Am I cured? With regard to No. 1, laparoscopic approaches are thought to result in fewer complications; however, if you let a skilled surgeon do 100 open liver wedge resections, his or her complication rate would be pretty low, too. To date, for hepatectomy, we have not compared minor-to-minor versus major-to-major well enough to know which approach wins the complication race for sure. With regard to No. 2, laparoscopic approaches likely win on earlier return to normal function, although enhanced recovery protocols are significantly leveling the playing field. We are now doing open major liver surgery using Enhanced Recovery In Liver Surgery

Patients who undergo laparoscopic partial hepatectomy appear to have less perioperative morbidity and shorter LOS compared with patients submitted to open resection, but in most studies, the groups are not comparable. —Allan Tsung, MD (ERILS) protocols with recovery trajectories equivalent to laparoscopic approaches. With regard to No. 3, until the oncologic question is definitively answered, I will be having my liver metastasis resection [done] open.

Dr. Tsung: Agree. Similar to other minimally invasive operative procedures, LLR has been shown to improve immediate postoperative outcomes, including pain control, time to oral intake and LOS. Importantly, future studies will investigate whether timing to chemotherapy is also faster following LLR compared with open resection, and whether this translates to oncologic benefits.

Dr. Jarnagin: On the fence. It is true that patients who undergo laparoscopic partial hepatectomy appear to have less perioperative morbidity and shorter LOS compared with patients submitted to open resection, but in most studies, the groups are not comparable. Open procedures are more often undertaken for disease that is more advanced or for resections that are more difficult technically than is generally undertaken laparoscopically. High-quality prospective data are not available to adequately address this question.

Dr. Buell: Agree. Decreased operative times, lower blood losses, early postoperative recovery and rapid return to normal activities have been confirmed by multiple studies. In a recent review of nearly 700 resections, with the majority being laparoscopic, we identified a lower incidence of complications in our laparoscopic group. Both groups had an equivalent incidence of major resections, redo hepatectomies and cirrhotic resections. This study also confirmed that a laparoscopic approach reduced complications in overweight and obese patients.

{

Statement: LLR has a steep learning curve and should only be performed in high-volume centers of excellence. Dr. Aloia: Agree. Period! Dr. Asbun: Agree.

I would agree with the statement that “high-volume surgeons/institutions” are usually associated with decreased morbidity. A minimum number of major resections per year should be entertained as a requirement. A key mandatory component is multispecialty coordinated care. Anyone doing laparoscopic or major open liver surgery should do so following their outcomes and ideally maintaining a prospective database.

[I am] on the fence with the designation of centers of excellence. There is a precedent in other areas that the designation of centers of excellence is not necessarily associated with better outcomes. This may depend, however, on the appropriate selection of qualifications to become a center of excellence.

Dr. Tsung: Agree. Laparoscopic liver surgery is complex due to the vascular and biliary structures of the liver, difficulties with access as a result of its location underneath the rib cage, and potential for bleeding during parenchymal resection. Surgeons performing LLR should have expertise in both liver surgery and minimally invasive techniques.

Dr. Buell: Agree. LLR has a steep learning curve and should be approached carefully, selecting smaller and less complex resections first rather than jumping into larger and often more complex resections initially. Surgeons who possess the appropriate expertise should proceed along the learning curve in a slow manner.

Dr. Geller: Agree. The learning curve is 50 to 60 cases, and requires ongoing high volume to be facile. For laparoscopic major hepatectomy, a team approach is required and [it] should only be performed in high-volume hepatobiliary centers of excellence.

Dr. Jarnagin: Agree. LLR should be undertaken only by surgeons with substantial experience with open liver resection and advanced laparoscopic techniques. Liver resection, in general, remains a complex procedure that requires specialized training to master; this is particularly true of major resections. Expertise in laparoscopic surgery alone does not equate to competence in laparoscopic liver procedures. It is impossible for a surgeon to anticipate the potential difficulties that may be encountered during LLR, unless he or she has been trained in open liver resection.

{

Statement: Robotic liver resection is becoming increasingly common and is warranted. Dr. Jarnagin: On the fence.

I agree that robotic liver surgery is being performed more commonly, but whether or not it is warranted is debatable. There are many unanswered questions regarding the role of robotic liver surgery, most notably the adequacy of the instruments, the added cost, and the ability to rapidly convert to an open procedure in the event of major vascular injury. The introduction of new technology into practice remains problematic. We learned this lesson the hard way with laparoscopic cholecystectomy, which was associated with horrific bile duct injuries in many patients early in its history. We face the same issue with robotic liver surgery. It is my opinion that the robotic approach is not as adaptable to hepatic resection compared with laparoscopy; it currently has a limited role; and it should be used only by surgeons with great experience with open and laparoscopic liver surgery. see LIVER RESECTION page 20

On the Spot

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / SEPTEMBER 2014

LIVER RESECTION

For major hepatectomy, you still need to make an incision to get the specimen out, so why struggle for hours laparoscopically in a pseudosafe environment when you are going to make an incision anyway? (And please don’t answer ‘cosmesis!’)

jcontinued from page 19

Dr. Asbun: On the fence. At this stage, there is no evidence that robotic surgery results in better outcomes. But it is not about the robot versus laparoscopy—it is about doing it right either laparoscopically or robotically assisted. Surgeons learning the procedure should not think of the robot as a shortcut; they should be committed to putting forth the effort to learn it well either way. The future for robotics in

—Thomas Aloia, MD liver surgery is very promising, however. Augmented reality and better identification of structures by computer-enhanced imaging will be a key factor in making robotic-assisted liver surgery the better

approach. In 2014, though, we are not there yet.

Dr. Aloia: Agree. Conceptually, we need to understand

NEW PRODUCT

Visit ACS Booth

417

the advantages of using instruments with the ability to “wrist” and rotate in multiple planes. The robot has clear utility in hard-to-reach places that require fine movements, namely the porta hepatis and the right superior and posterior liver. However, there are three main issues with the robot in liver surgery: 1) We need to maintain a healthy respect for the vascularity in and around the liver. Bottom line: If you make a hole in the cava, can you get that machine out of your way in time to save the patient? 2) The operative times are long, and even in the most experienced hands, they reduce to a plateau that is longer than other approaches; and 3) You still need to make an incision to get the specimen out.

Pure LLR appears to provide the most significant benefit with the least surgical trauma. —Joseph Buell, MD

m i ni m a l ly I N VA S I V E

Dr. Tsung: On the fence. The application of robotic technology to liver surgery has grown because it has the potential to overcome many limitations of conventional laparoscopy (e.g., [three-dimensional] view, “wristed” instruments, easier suturing). Currently, there are multiple downsides, such as increased cost and longer operative times, compared with the laparoscopic approach that should be considered. However, future advances in its technology, more experience and decrease in cost may potentially further facilitate minimally invasive liver surgery and improve clinical and economic outcomes.

I N M O R E W AY S T H A N O N E .

Our philosophy is simple - make great devices to improve patient outcomes & offer customized solutionss that reduce cost.

Dr. Buell: Agree.

Imagine a bright future of quality surgical devices as minimally invasive e to your patients as they are to your bottom line. ConMed offers a complete *bladed

e, line of trocars, including EntriPort Mini 5mm as well as bladed, reposable, and disposable options.

DETACHATIP® III

UNIVERSAL PLUS®

3DHD & 2DHD

SYSTEM

MULTIFUNCTION SYSTEM

VISUALIZATION SYSTEM

a suite of high-performance, reliable and cost-effective multi-use laparoscopic instruments

an electrosurgical and high-volume suction/irrigation system designed for endoscopic procedures

ConMed’s leading-edge capital equipment

ACS

Exhibit Dates October 27-29, 2014

Moscone Center

Contact ConMed today to discover a customizable suite of tools for your facility. Customer Service: 1-800-448-6506 | International Sales: +1(315) 797-8375 www.entriport.conmed.com

San Francisco, CA

Robotic liver surgery has been adopted increasingly by multiple centers due to several recent advances, including optics, instrument motion and now a singleaccess platform. I have adopted robotic liver surgery for small anterior and left lateral sectionectomy to refine a technique for single-port robotic resection. Robotic surgery is innately more complex and costly, but in certain instances, such as single-port surgery, it simplifies the procedure, reducing operative times. There are several large-volume centers around the world that have adopted routine use of the robot, but these are also centers with extensive laparoscopic resection experience. Robotics has a current and future role in liver resection.

Dr. Geller: On the fence. Even though robotic liver resection is

On the Spot

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / SEPTEMBER 2014

becoming more common, it is definitely more expensive than LLR. The robot excels at a few tasks, such as sewing and working in tight spaces. Hopefully, as costs come down (if they ever do) and instrumentation improves, the robot will become cost-effective.

Statement: LLR is superior to hybrid/hand-assisted approaches.

Dr. Geller: Agree. Although patients with hand-assisted or hybrid liver resection still do better than open liver resection, patients who have pure LLR seem to do the best. They have less pain and shorter LOS, often going home on postoperative day 1 or 2. There are also less wound infections/hernias with a pure laparoscopic approach.

There is no such thing as a superior or inferior approach. The approach should be tailored to the patient, the type and location of the lesion, and surgeon experience. Horatio Asburn, MD Dr. Aloia: Disagree. For subsegmental hepatectomies, because the specimen is small, these are likely best done with a totally laparoscopic approach. In contrast, larger resections benefit from a hybrid/handassisted approach for several reasons. Oncologically, identification of small subcapsular lesions missed on preoperative imaging is facilitated by liver palpation. With a hand in the abdomen, the speed of the operation is faster, while the safety is increased as manual compression of bleeding is the most effective temporizing measure and inflow occlusion is simplified. As well, for major hepatectomy, you still need to make an incision to get the specimen out, so why struggle for hours laparoscopically in a pseudosafe environment when you are going to make an incision anyway? (And please don’t answer “cosmesis!”) Last but not least, the presence of a hand port allows me to teach trainees in a more controlled setting, as I know that I can rapidly rescue them from trouble without forcing conversion to open surgery.

cases for safety, and now after nearly 400 laparoscopic cases, the majority of cases are now purely laparoscopic. The hybrid and hand-assisted techniques are alternative strategies that can minimize the learning curve, providing an extra safety measure or “training wheels.” Pure LLR appears to provide the most significant benefit with the least surgical trauma. Whether it’s hybrid, handassisted or pure laparoscopy, we are all heading toward the same operation with excellent surgical technique and being oncologically sound.

Dr. Asbun: When feasible,

For On the Spot‘s “Gut Reaction,“ see next page.

the goal should be to do the procedure totally laparoscopically. However, there is no such thing as a superior or inferior approach. The approach should be tailored to the patient, the type and location of the lesion, and surgeon experience. In fact, conversion from laparoscopic to hand-assisted, hybrid or open approach should never be considered a complication. It usually shows good judgment.

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

Hernia Outcomes How do you compare? Compare your outcomes to the Collaborative outcomes • • • •

Post-op complications Risk factors Mesh type utilization Wound class

• • • •

Total patients Laparoscopic operations Total operations Myofascial release

The Americas Hernia Society Quality Collaborative aims to improve the value in hernia care delivered to patients. AHSQC utilizes concepts of continuous quality improvement to advance outcomes and optimize costs through patient-centered data collection, ongoing clinician performace feedback, and analysis of collected data and collaborative learning.

Don’t get left behind... Join today and see how your outcomes stack up against other surgeons and improve patient safety

Dr. Buell: Agree. LLR was developed by the French to emulate traditional open techniques using pure laparoscopy. I initially used a hand-assist device in the majority of

Participation is FREE for AHS members Help Advance Hernia Care www.ahsqc.org

On the Spot

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / SEPTEMBER 2014

jcontinued from page 21

Gut Reaction: Liver Resection and More IBM’s Watson

Americas HepatoPancreato-Biliary Association

Best advice to the community surgeon about liver resection

FDA’s approval process for medical devices

The one thing resi- The best part of dents and fellows my job is … forget most is …

The most challenging part of my job is …

David Geller, MD

Doubt I will ever use it

Best meeting of the year

Don’t do it; refer to me.

Reasonable

Use both hands.

Going on vacation

Knowing when to The laparoscope say no

Horacio Asbun, MD

Good start, but not there yet

Growing strong. Fun. Got message on globalization and partnered on it

Don’t do it unless you Good intentions but would do it on a mem- has become a hurdle to ber of your family innovation (who you like).

We were all residents once. We remember the aspirations, anxieties and tricks.

Helping and touching people’s lives while having fun doing surgery

William Jarnagin, MD

Incredible technology with great potential

Dynamic society, great resource for all HPB surgeons

Make sure you have adequate resources and back-up.

No comment

Learning surgery is easy; caring for patients is hard.

Taking care of patients

All unnecessary My hands regulation/paperwork: an obstacle to progress, innovation and efficiencyy Taking care of For liver surpatients’ families gery, TissueLink, Aquamantys

Thomas Aloia, MD

Without MD input, likely to be a max fail

Mis amigos, organizing just one e cooperative prospective trial would put us on top

Biopsy (tumor and non-tumor liver) photograph, Seprafilm, refer

Adequate, but surgeons/ societies also have professional responsibility for safety and cost evaluation of new technology

To examine the patient

No two liver operations are the same.

Getting through the paperwork

My physician assistant

Great HPB society

Need to be adequately trained

Slow

Training does eventually end.

Seeing a patient at postoperative visit happy

Dealing with complications

Good retractor

Allan Tsung, MD Hopefully won’t replace surgeons

One medical device/ instrumentation I can’t live without

Joseph Buell, MD

Power of the A core group microprocessor

Care and attention

Protracted

Respect the liver.

Patients

Insurance

Stapler

My favorite answers

Tsung

All of these!

Buell

Jarnagin

Geller

Tsung

Aloia

Asbun

BETTER TOGETHER. ReliaTack device ™

Symbotex mesh ™

Now, a stronger degree of certainty ReliaTack™ Articulating Fixation Device

1. Mesh Overlap Claims Testing Report R0054140 P-value=0.007 (March 2014) 2. ReliaTack™ Perpendicular Tack Deployment and Shear Pull Test Report R0048913 P-value=0.00 (March 2014) 3. Symbotex™ composite mesh - Type 3DS textile - Balanced textile properties that meet reinforcement and physiological needs - Covidien internal report TEX043 (July 2013) 4. D. Weyhe, W. Cobb, D. Lomanto et al, Comparative analysis of the performance of a series of meshes based on weight and pore size in a novel mini-pig hernia model - EHS 2013 (SC130037) £ In comparison to AbsorbaTack™ fixation device † Compared to Absorbable Fixation Devices, SecureStrap™* and Sorbafix™*, when the shaft is angled at 30, 45, and 60 degrees § Per case savings over SecureStrap™* and Sorbafix™* per case savings when 30-60 tacks are needed COVIDIEN, COVIDIEN with logo, COVIDIEN logo and positive results for life are U.S. and internationally registered trademarks of Covidien AG.™* Trademark of its respective owner. Other brands are trademarks of a Covidien company. ©2014 Covidien. 6.14 US140001

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / SEPTEMBER 2014

The following advertorial has been provided by Covidien and is designed to support the advertisement presented below.

SymbotexTM Composite Mesh for Laparoscopic Ventral Hernia Repair Kent Van Sickle, MD Associate Professor and Chief General and Minimally Invasive Surgery UT Health Science Center

Q: What is the most challenging aspect of handling a mesh during a laparoscopic ventral hernia repair? How does Symbotex™ composite mesh simplify this part of the procedure? A: Accurately placing the mesh over the defect can be challenging due to the differences in patient hernia characteristics and surgeon placement techniques. Symbotex™ mesh has large pores and a center orientation marker. This makes it easy to visualize the defect and accurately place the mesh, which could potentially reduce the risk for recurrence. Additionally, the ability to place large meshes through a 10- or 12-mm port is critical to avoid the need to enlarge port-site incisions. Once the mesh is inserted, it is important that it is easily unrolled, positioned against the abdominal wall and

that the barrier stays intact. Symbotex™ mesh offers all of these advantages; it is easy to deploy and handle, and the collagen barrier is unlikely to be sheared off during positioning or fixation. Q: What is the most challenging aspect of fixating the mesh? How does ReliaTack™ articulating reloadable fixation device simplify this part of the procedure? A: It is notoriously difficult to get adequate tack purchase of mesh and peritoneum, which is best accomplished by having the tacker interface with the abdominal wall at a 90-degree angle. This is especially difficult when attempting to tack the mesh on the ipsilateral side to the camera, particularly in midline abdominal wall defects. ReliaTack™ device’s ability to articulate improves the surgeon’s ability to achieve the ideal 90-degree interface between the tack and abdominal wall. Q: Why does mesh burst/tear strength matter to you? How does Symbotex™ mesh address your concern? A: The true clinical significance of mesh burst strength is unclear, given the variability in hernia sizes, abdominal wall dynamics and patient-related factors,

such as obesity or chronic disease. However, it is clear that any mesh material that is chosen for hernia repair will be subjected to significant stress regardless of placement technique. Preclinical data shows that Symbotex™ mesh has robust burst and tear strength properties, demonstrating that the 3D mesh construct compares favorably to multifilament polyester and monofilament polypropylene meshes. Additionally, in my own experience, I have had great clinical outcomes with Symbotex™ mesh. Q: Why does tack fixation strength matter to you? How does ReliaTack™ device help you achieve more tack fixation strength than current absorbable fixation devices? A: Tack fixation strength is critical in the early postoperative period to keep the mesh in place and allow for the tissue ingrowth process to occur. Suture fixation adds stability to the process, and I think it is also critical for mesh fixation, but fullthickness abdominal wall fixation sutures can cause substantial pain, and can be a source of long-term discomfort for the patient. The mechanics of the ReliaTack™

device enables the surgeon to consistently achieve perpendicular tack deployment and should minimize the need for additional fixation sutures. Q: Why should other surgeons choose ReliaTack™ device and Symbotex™ mesh for laparoscopic ventral hernia repair? A: Symbotex™ composite mesh offers all of the “pros” for the ideal mesh product in ventral hernia repair—a strong, monofilament barrier-coated mesh with polyester’s known properties for tissue ingrowth and incorporation. Additionally, Symbotex™ mesh is easy to insert, unroll, position, and can be trimmed to accommodate any size hernia, which are all plusses. ReliaTack™ device has the ability to consistently deploy tacks at the ideal 90-degree angle. It is also reloadable, which may eliminate waste. All of this comes from Covidien, which has a proven track record in hernia repair and a reputation for leading innovation in medical devices and health care. Dr. Kent Van Sickle is a Covidien consultant.

for hernia repair.

†,3

Symbotex™ Composite Mesh

65º articulation improves access and delivers stronger ﬁxation£,†,1,2 3D textile reinforces mesh strength and tissue ingrowth3,4 ReliaTack™ device and Symbotex™ mesh deliver strength and ease of use.3,†

| HERNIA CARE | MESH • FIXATION • PERMACOL • DISSECTION TM

CALL YOUR LOCAL COVIDIEN REPRESENTATIVE TO LEARN MORE. Or visit www.covidien.com/hernia.

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / SEPTEMBER 2014

Rectal Cancer Care Varies by Region, Other Factors, Study Shows B Y C HRISTINA F RANGOU

eople living in the midwestern region of the United States are nearly 30% more likely to receive neoadjuvant chemoradiation for rectal cancer than those who reside in the South. Furthermore, patients treated in hospitals that perform more than 30 rectal cancer resections annually are more likely to receive neoadjuvant chemoradiation.

So, too, are people who are younger, who earn more than $46,000 annually, who graduated from high school and who undergo treatment at academic centers. Variations in delivery of rectal cancer care are numerous and significant, with only 75% of patients receiving care that meets the 2002 guidelines of the National Comprehensive Cancer Network (NCCN), according to a study presented at the 2014 annual meeting of the American Surgical Association (ASA).

“There is clear evidence of unexplained variability in care delivery in rectal cancer,” said study co-author John R. T. Monson, MD, professor of surgery at the University of Rochester School of Medicine, in Rochester, N.Y. As a result, Dr. Monson and surgeons from more than 50 other institutions formed a group, the OSTRiCh (Optimizing the Surgical Treatment of Rectal Cancer) Consortium. The group aims to eliminate discrepancies in rectal cancer

SIMPLICITY DOESN’T REPLACE

EFFICACY The truth about EXPAREL

(bupivacaine liposome injectable suspension) EXPAREL is promoted as providing pain control that lasts for up to 72 hours without the need for catheters and pumps.1 Sound too good to be true? It is. ®

In fact, based on further analysis of the data,4 after 12 hours there was minimal to no difference between EXPAREL and placebo (normal saline) treatments on mean pain intensity as demonstrated in their two pivotal studies.2-3 ®

EXPAREL’s studies only demonstrate 12 hours of pain relief.2-4

Get the facts and download studies about EXPAREL® at factvsﬁction.info/gsn3, or call 1-800-448-3569 for more information. ON-Q*: Effective post-op pain management. For over 3.5 million patients and counting. Controllable. Long-lasting. Proven.4

Every day without

costs you more 4 A K I M B E R L Y- C L A R K H E A L T H C A R E C O M PA N Y

care by establishing centers of excellence (COEs) in rectal cancer. All designated centers would adhere to five “core principles” of evidence-based rectal cancer care, principles that organizers believe will improve national outcomes in rectal cancer. The five core principles are: 1. Total mesorectal excision 2. Measurement of surgical quality by specific techniques of pathology assessment 3. Specialist imaging techniques to identify patients at high risk for local recurrence 4. Use of newer neoadjuvant and adjuvant therapies including radiotherapy and chemotherapy 5. A multidisciplinary team approach to treatment on a patient-bypatient basis Patricia L. Roberts, MD, professor of surgery at Tufts University School of Medicine, Boston, and chair of the Division of Surgery at Lahey Clinic, Burlington, Mass., said regionalization of cancer care may help ensure that rectal cancer patients in the United States are given all the options for treatment. “Here we are, 12 years after the NCCN guidelines, and one-quarter of patients are not getting neoadjuvant chemoradiation. Of these who didn’t get it, for whatever reason, it just wasn’t planned. The question is how can we do better?” said Dr. Roberts, who was the official discussant on the paper. She is also a member of the OSTRiCh Consortium. “I think the center of excellence concept is a good one for rectal cancer.” The OSTRiCh Consortium estimates that about 100 to 120 COEs are needed across the country to meet the needs of Americans with rectal cancer. That would mean a reduction from about 2,000 hospitals currently caring for these patients. “The ultimate model is one that has more patients treated in fewer centers, but at centers that have better outcomes,” Dr. Monson said. “It’s time to move forward from an entirely unregulated system that’s simply not good enough for the patient.” Dr. Monson said the organizers hope that the American program would be modeled after a program in the United Kingdom that helped improve shortand long-term outcomes for rectal cancer patients during the past decade. He acknowledged that the British experience coincided with significant developments in the field of rectal cancer, that improved survival and reduced morbidity for patients. But, he said, that country’s program of regionalizing cancer care helped ensure that patients were treated at hospitals that possessed the

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / SEPTEMBER 2014

infrastructure and the personnel needed to deliver optimal treatments for patients. Members of OSTRiCh believe that a corresponding program could produce similar results in the United States. “Based on European data, it is possible to reduce the local recurrence of rectal cancer by 15% to 20% if all rectal cancer cases were treated at Centers of Excellence,” they argued in a report this past winter (Dis Colon Rectum 2014;57:252-259). OSTRiCh started with 16 centers in 2011, and has nearly tripled during the past three years. Despite this progress, it is not clear what the final model will be for rectal cancer care in the United States. As with similar programs created to accredit centers that perform bariatric surgery or breast cancer surgery, OSTRiCh’s proposal for COEs in rectal cancer will require some patients to travel to major centers for treatment. Heidi Nelson, MD, professor of surgery at Mayo Clinic, in Rochester, Minn., said the difficulty is in finding a balance between access for patients and the highest quality of care, “which is always the dilemma.” She applauded the OSTRiCh Consortium’s efforts to advance care for patients with rectal cancer and agrees with the guidelines. She added that she would be interested in exploring alternatives to the COE approach. Other options could make greater use of existing accreditation bodies or create referral networks to allow patients to move up a chain of affiliated centers based on their individual needs and preferences. “Rectal cancer is unique in that for most patients, it requires 10 months of care. You’re going to disrupt someone’s life, their family, their work. This is not to say that they should get low-quality care so that they can be close to home, but these are factors to consider. I would like to see a broader and deeper understanding of the patient, family and provider issues sorted out before we settle on a one-size-fits-all answer.” One thing is clear: Treatment, and consequentially outcomes, for rectal cancer vary wildly across the country. In a 2011 study that looked at proctectomies in 11 states between 2003 and 2004, 40% of surgeons performed only nonrestorative abdominoperineal resection

(Dis Colon Rectum 2011;54:12101215). The same report noted that local recurrence rates, which have been reported between 0% and 13% for colorectal surgeons, are in the range of 21% to 37% for patients treated by general surgeons. Mortality rates hover around 1.4% for patients operated on by colorectal surgeons, and increase to 7% for patients treated by general surgeons. Data presented at the ASA meeting showed that the highest rates of neoadjuvant chemoradiation were observed at academic centers (radiation 79%; chemotherapy 78%), whereas the lowest

rates occurred in community programs (radiation 71% and chemotherapy 70%; P<0.001). This variation was mirrored by geographic location. “This is suboptimal for the United States,” Dr. Monson said. Surgeons interested in OSTRiCh can find more information at www.ostrichconsortium.org. “Registering on the website doesn’t make [your institution] a COE, but it does bring you into the community of discussion about how to move forward in what is really a very important issue,” Dr. Monson said.

The consortium is in dialogue with the American College of Surgeons (ACS) about establishing rectal cancer as the next ACS program for COE accreditation. The ACS currently administers COE programs in breast cancer and bariatric surgery. OSTRiCH had applied for funding from the Centers for Medicare & Medicaid Services, but the request was denied. This year marked the 134th annual meeting of the American Surgical Association. Established in 1880, the American Surgical Association is the oldest surgical association in the United States.

Outcomes Up. Costs Down. Value All Around.

Finally – an alternative to biologics! GORE® BIO-A® Tissue Reinforcement is a unique non-biologic scaffold that is gradually absorbed by the body. The open, highly interconnected 3D pore structure facilitates cell inﬁltration and growth. Vascularization begins quickly within one to two weeks. • 100% synthetic, bioabsorbable tissue scaffold • Rapid cell population and vascularization • Versatile for numerous applications • Available in large sizes up to 20 cm x 30 cm With a three-year shelf life and no soaking, refrigeration or tracking required, this versatile material is the easy-to-use, performance-proven alternative that offers value for surgeons and hospitals. Gore. Because material really does matter.

W. L. Gore & Associates, Inc. • Flagstaff, AZ 86004 • goremedical.com Products listed may not be available in all markets. GORE®, BIO-A®, PERFORMANCE THROUGH INNOVATION, and designs are trademarks of W. L. Gore & Associates. ©2013, 2014 W. L. Gore & Associates, Inc. AS1932-EN2 JANUARY 2014

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / SEPTEMBER 2014

‘I Am No Longer a Surgeon’ Surgeon Returns to Work After Losing Fingers and Enduring a Grueling Rehabilitation B Y C HRISTINA F RANGOU

t started as a perfect summer morning at a farmhouse just outside Kingston, Ontario, Canada, in August 2009. Pediatric surgeon Sarah Jones, her anesthesiologist husband Ramiro Arellano, and their two young kids were working outside in the sunny yard of their country home, readying wood to stockpile for the winter. Wearing heavy gloves to protect her hands, Dr. Jones tossed piece after piece of wood into a rented woodcutter. Then, in one quick second, the day switched from idyllic to nightmarish. Dr. Jones’ three middle fingers on her right hand, her dominant hand, were missing, caught by the woodcutter. Dr. Jones remembers very little of those first hours but she does recall the first thing that came to her mind. “The first thing I thought was, ‘I am no longer a surgeon. I’ll never operate again,’” she said. The next few minutes passed in a frenzied blur. Dr. Arellano put pressure on his wife’s arm to cut off the circulation. They hurried into the house, called 911 and sent their kids to the neighbor’s house. Then, with Dr. Jones holding her right arm up in the air, the couple ran almost a mile to the main road. They knew that most GPS systems didn’t direct to their country address correctly and the ambulance was likely to get lost. By the time they got to the road, Dr. Jones was on the verge of fainting. Several times, Dr. Jones repeated to her husband, “I will never be a surgeon again.” Otherwise, she didn’t say anything. Dr. Arellano carried a small bag with ice, water and the fingers from her hand, which he’d retrieved from inside her glove. Within hours, Dr. Jones, Kingston’s only pediatric surgeon, was in the operating room. Her colleagues in plastic surgery spent the next 12 hours painstakingly reattaching her fingers. “To have this traumatic event happen to a colleague was dramatic,” plastic surgeon Kimberley Meathrel, MD, said in an interview with Canada’s CBC Radio. “[To] know this was another surgeon’s fingers and operating on someone I know and like and respect was really upsetting. I had to go take a walk around, calm down.” Dr. Jones spent two weeks in the hospital after the surgery, where her treatment included leech therapy to keep the

blood flowing to her fingers. Her fingers hurt but otherwise didn’t seem to belong to her body. Moving them was impossible. Those first weeks, Dr. Jones didn’t discuss her surgical career with anyone. “I looked at the other things I loved to do, like being a mother. I couldn’t say anything about it. My husband knew how much being a surgeon meant to me. You’re not a sole pediatric surgeon on call 24/7 without it meaning a lot to you.” Dr. Jones started physiotherapy as soon as the wires were removed from her hand six weeks after surgery. The day she met her occupational therapist, Juliana Lacocerie Salgado, Dr. Jones told the therapist that she hoped to be able to use a cross-country ski pole, to garden and to play with her kids. Neither woman felt Dr. Jones would return to surgery. “At that first encounter, I was struck by how much Sarah’s heart was in her job. But I did not believe that she would return to surgery, given how serious the injury was,” said Ms. Salgado. Nearly every morning for the next few months, Dr. Jones and Ms. Salgado spent one to two hours together. They focused on improving Dr. Jones’ dexterity with her left hand, and exercising the fingers on her right. They worked to train Dr. Jones’ brain to recognize the feeling of cold and hot, smooth and rough with her right fingers. All sensations registered as pain. Dr. Jones repeated the exercises again at home in the afternoon. Physio became a full-time job. Five months after the accident, she had made no progress in getting her fingers to move. Dr. Arellano encouraged her to get a second opinion. Dr. Jones struggled with the idea. “It’s hard to be on the receiving end when someone gets a second opinion after you’ve put a lot of time in with a patient. It’s also hard to be on the doing end,” she said. In the end, she agreed. Dr. Arellano called Dr. Bing Siang Gan, a plastic surgeon he knew at the Hand and Upper Limb Centre at the University of Western Ontario in London, Canada. Dr. Gan operated on Dr. Jones three times. With each procedure, Dr. Jones noticed a big difference in her fingers, most importantly, the ability to move them. “When your fingers don’t move, then all of a sudden, they move, it’s an incredible experience,” she said. Between each operation, she kept up a rigorous physiotherapy regimen with Ms. Salgado, learning to fish objects from bowls of rice, popcorn and quinoa. Still, returning to surgery seemed unlikely. Her middle finger was considerably shorter than all the rest. Ergonomically, it couldn’t do much. She

‘[To] know this was another surgeon’s fingers and operating on someone I know and like and respect was really upsetting. I had to go take a walk around, calm down.’ —Kimberley Meathrel, MD could not bend the finger at the proximal joint. So Dr. Jones applied for a position, and was hired, as the hospital’s new head of pediatrics. At home one afternoon, just over a year after the accident, Dr. Jones found a hemostat tucked into a kitchen drawer. Curious, she picked it up and found that she could open and close the instrument. The next day, she asked Ms. Salgado for a suture kit. “I tried it and found that I was able to sew,” she said. “At the time, I still didn’t know what that meant. Even though you can sew and cut and use a hemostat, you’re still a long way from being able to operate.” After the accident, she had trained herself to become left-hand–dominant. Now, to improve the dexterity of her right hand, she forced herself to switch back. The only skill she couldn’t master with the right was knot tying, so she learned to do it with her left hand. Dr. Jones felt that she needed to prove to herself and her colleagues that she was still a safe surgeon. It had been less than two years since her accident. As such, she wasn’t required to undergo an independent review. Still, Dr. Jones wanted to be evaluated in a safe environment. Three months after discovering the hemostat in her kitchen, she traveled to Halifax, where she had completed her general surgery residency and fellowship at Dalhousie University several years earlier. Her first day back, she assisted an attending for her first case, assisted a fellow for her second and did the third on her own. Two weeks later, she returned to Kingston and resumed

her surgical practice. Her first case at home was a hernia repair in a 2-year-old boy. Dr. Jones explained her situation to the boy’s parents, offering to arrange for him to be operated on outside of the city. “They said no. We went on. I never had to have that conversation again,” she said. In an interview with Canadian radio, Dr. Meathrel described Dr. Jones’ outcome as “quite unbelievable.” “What we expect with multiple grafts is that someone will have an assist hand. … For her to regain the kind of dexterity required for her to operate is quite remarkable and quite unheard of,” she said. (Dr. Meathrel was unavailable for an interview with GSN.) Today, Dr. Jones is a pediatric surgeon at the University of Western Ontario. She has learned to work around her shortened right finger and relies on her left hand more than she did before. She holds instruments differently than she did previously. The only real challenge is the cautery, she said, but only if it isn’t passed to her at a certain angle. She offered some advice for surgeons who find themselves in predicaments similar to hers. “Be fair on yourself. There are some things you can’t do the same as other people will do them, but that doesn’t mean you can’t do them well.” She also asks all surgeons to recognize how difficult it is for patients to ask for a second opinion. “It’s extremely hard to say, ‘I need to speak with someone else.’ My experience really taught me a lot. Sometimes, it’s not about a change in management but just to have peace of mind.”

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / SEPTEMBER 2014

The following advertorial has been provided by RF Surgical and is designed to support the advertisement presented below.

RF Assure Detection System Q: Are retained surgical sponges (RSSs) a problem? A: Retained surgical items (RSIs) are objects left unintentionally inside a patient’s body during and after surgery. These “never events” represent a significant medical risk to affected patients and, as a result, significant financial liability for hospitals and medical staff. Despite rigorous counting protocols as well as medical society–driven awareness efforts, RSS are still unintentionally left inside patients after wound closure. RSIs occur 39 times per week in the United States,1 with surgical sponges being the retained item in 69% of these occurrences.2 Q: What is the RF Assure e Detection System, and how does it prevent retained sponges? A: The RF Assuree Detection System uses a reliable, low-energy radiofrequency design to deliver unparalleled detection of misplaced surgical sponges through blood, dense tissue, bone and near metal. The system consists of three easy-to-use components: the user-friendly RF Assure console; the ConformPlus II Detection Mat, which offers hands-free scanning for in vivo sponge detection in 15 seconds; and the Blair-Port Wand, the handheld scanner that extends the detection range of the mat and quickly locates missing sponges in and around the sterile field. RF Assure is the preferred retained sponge prevention solution in more than 4,500 operating room (OR), trauma, and labor and delivery suites nationwide, including most topranked U.S. hospitals and trauma centers. Q: How does the system enhance OR efficiency? A: Searching for missing sponges lengthens procedure time, increases the risk for infection, and exposes the patient to x-ray and prolonged anesthesia. Most hospitals use x-rays in an attempt to ensure that the missing sponge is not located within the surgical field, a method that can take 20 minutes to resolve a miscount.3 Alarmingly, nearly 88% of RSS incidents occur when the sponge counts are thought to be correct.4 With the RF Assure, e staff can confirm the missing sponge is not inside the patient, and quickly locate missing sponges in linen and trash bins and drapes. Clinical research has demonstrated that the system’s ability to help quickly rectify miscounts through sponge detection in and around the sterile field has led to a 16-minute reduction in surgical procedure length.3 Q: How cost-effective is the system? A: There are a number of key economic factors that make the use of the RF Assure

a smart, cost-effective choice in the surgical suite. While rectifying incorrect sponge counts increases procedure length and x-ray costs, retained sponges result in costly reoperative expenses, legal battles and compromised hospital reputation. By reducing OR procedure delays associated with reconciling sponge counts, the RF Assuree provides a cost savings averaging $1,000 per procedure.3 Eliminating x-rays from the sponge-count protocol increases

OR efficiency and imparts additional savings amounting to more than an estimated $150,000 annually.3 However, the financial liability of RSS extends beyond the OR. With nonreimbursable readmission fees and legal costs estimated at $441,534 per incident, the system is clinically proven to offer a combined cost savings and potential cost avoidance that is three times the cost of the system itself.3

References 1. Mehtsun WT, Ibrahim AM, Diener-West M, et al. Never events in the United States. Surgery. 2013;153:465-470. 2. Gawande AA, Studdert DM, Orav et al. Risk factors for retained instruments and sponges after surgery. N Engl J Med. 2003;348:229-235. 3. Williams TL, Tung DK, Steelman VM, et al. Retained surgical sponges: findings from incident reports and a cost-benefit analysis of radiofrequency technology. J Am Coll Surg. 2014 May 10. [Epub ahead of print] 4. Romano PS, Geppert JJ, Davies S, et al. A national profile of patient safety in US hospitals. Health Aff (Millwood). 2003;22:154-166.

THE POWER TO DETECT IS THE POWER TO PREVENT. The leap forward in patient safety and efficiency is here—and it means your hospital no longer has to rely on counting protocols alone. RF Assure® Detection Technology empowers you to elevate care and safeguard your hospital from risk and liability by preventing retained surgical sponges via patient-centric technology.

PREVENTION WITHOUT COMPROMISE • Enhances patient safety by virtually eliminating retained sponges1 • Increases cost savings by improving workflow efficiency2 • Reduces the risk of costly legal and reimbursement losses2 • Earns top satisfaction scores for ease of use and implementation3 • Adopted as the solution of choice for top US hospitals and trauma centers

DISCOVER WHAT THE POWER OF DETECTION CAN MEAN FOR YOU AND YOUR HOSPITAL. Learn more about game-changing RF Assure Detection Technology at RFSurg.com.

REFERENCES: 1. Steelman et al. The American Journal of Surgery; 2011. 2. Williams et al. J Am Coll Surg; 2014. 3. Rupp et al. J Am Coll Surg; 2012

R F SU RG I C AL SYSTEM S, I N C . | 855.522 .7027 |

W W W. R FS U RG.C O M

The patented RF Assure Detection System has received FDA clearance. It has been tested and certified to meet the following requirements and standards: IEC 60601-1, Medical Electrical Equipment General Requirements for Basic Safety and Essential Performance IEC 60601-1-2, Medical Electrical Equipment General Requirements for Basic Safety-Electromagnetic Compatibility. CAUTION: Federal (United States) law restricts this device to sale by or on the order of a physician. The RF Surgical Systems logo, RF Assure and Verisphere are all trademarks or registered trademarks of RF Surgical Systems, Inc.

In the News NONCOMPLIANCE jcontinued from page 1

“I make a deal with patients: When we go to the operating room, I will be an A-plus and you will be an A-plus. That’s just non-negotiable. If they want to meet those goals, then we talk about surgery,” said Michael Rosen, MD, a hernia surgeon and professor of surgery at Case Western Reserve University, in Cleveland. Dr. Rosen was one of a group of hernia surgeons who spoke at a panel session during the 2014 annual meeting of the Americas Hernia Society (AHS). All six panelists said they have adopted preoperative protocols that require patients to comply with various steps before surgery. When Dr. Rosen meets with a patient for the first time, he limits the conversation to a discussion of the patient’s smoking habits and obesity.

‘I think the biggest mistake all of us make as surgeons is thinking, “I’m just a better technical surgeon at every level,” but the truth is you’re not. It’s going to catch up to you. For me, I stack the deck in my favor. Smoking cessation is part of that.’ —Michael Rosen, MD “We don’t talk about the operating room. We don’t talk about any of that. Without those two things, you don’t get to go to the next step. We talk about goals. We achieve those goals. It’s simple to me.” He sees the patient again three months later. Then, provided the patient has quit smoking and lost the recommended amount of weight, he will discuss surgical options. Not all surgeons focus on the same processes, although most gave high priority to weight loss and smoking cessation. “We have protocols in place, particularly pertaining to smoking and achieving optimal weight loss before proceeding to surgery,” said Brent D. Matthews, MD, AHS president and professor of surgery and chief of minimally invasive surgery, Washington University School of Medicine, St. Louis. “We have a whole series of protocols for patients,” said Robert Martindale, MD, PhD, professor of surgery and chief of general surgery at Oregon Health & Science University, Portland. “We don’t use all of them on everybody. We prioritize them.” It is a practice that falls into a

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / SEPTEMBER 2014

‘If we can get the patient optimized, we will wait to get them optimized. That’s one thing people miss—just because you can do a component separation, doesn’t mean you should [do it] right away.’ —Parag Bhanot, MD

longstanding controversy in general surgery: Is a surgeon ethically obligated to operate on a noncompliant patient? In January, when Frederick Greene, MD, General Surgery News’ chief medical adviser, suggested that surgeons “take a hard line, especially for elective operations” with patients who refuse to quit smoking [page 1], several readers criticized the approach. One called this argument “deeply repugnant.” But others agreed, saying surgeons must consider many factors before taking a patient to the operating room: notably, the risk for postoperative complications or the need for reoperations. Hernia surgeons contend that, particularly for abdominal wall reconstructions, the risks associated with doing surgery outweigh the benefits in patients who continue to smoke or fail to lose excess weight. “If we can get the patient optimized, we will wait to get them optimized. That’s one thing people miss—just because you can do a component separation, doesn’t mean you should [do it] right away,” said Parag Bhanot, MD, associate professor of surgery at Georgetown University School of Medicine, in Washington, D.C. In a telephone interview, William W. Hope, MD, assistant professor of surgery, University of North Carolina-Chapel Hill, Wilmington, said surgeons are asking patients to take a bigger role in their health care “because these hernias are so

difficult to treat. “The complication rate is high. If patients are not going to take part in their health care, if they aren’t going to do something to help, then a lot of times these hernias are not fixable or not fixable in a good way. We can withhold surgery or postpone surgery,” said Dr. Hope, who was not one of the panelists at the AHS session. Dr. Martindale said as many as 30% to 40% of patients who undergo abdominal wall reconstruction experience complications, putting these procedures in the same high-risk group as major gastrointestinal procedures like pancreatic surgery and esophageal surgery. With rates so high, surgeons need to identify areas where they can reduce complications, said Dr. Martindale. He argued that there are numerous opportunities to reduce risk for complications in the preoperative period. “There is growing data, certainly lots of data now that we can prevent some [complications] with preoperative planning.” The panelists at the AHS meeting said they considered smoking cessation one of the most critical steps that patients should take before undergoing hernia repair. Multiple studies demonstrated that preoperative smoking cessation makes a difference in surgical outcomes. One of the best-known studies to look at this issue, published in 2003 in Annals of Surgery, showed that smokers have a much higher wound infection rate than

never-smokers, at 12% versus 2%. Notably, smokers who quit four weeks before surgery reduced their wound infection rate to a level similar to never-smokers ((Ann Surg 2003;238:1−5). “Smoking is simply non-negotiable,” said Dr. Rosen. “II think th the th biggest mistake all of us make aas surgeeons is thinking, ‘I’m just a better techniccal surgeon at every level,’ but the truth is you’re not. It’s going to catch u up to yoou. For me, I stack the deck in my favor. Smoking S cessation is part of that.”” At Oreegon Health & Science A Univversity, Dr. Martindale requires patiients too undergo a complete methicilllin-resisstant Staphylococcus aureus protoocol and d get their body mass index (BMI)) below w 50 kg/m2 before surgery. He plaans to loower the BMI cutoff to 45 in the near fu uture. “W We neeed to have patients lose weigh ht,” he said. “Now, some patients do and d some don’t.” In a preesentation outlining the researcch on preoperative optimization of pattients, Dr. Martindale said the only h hard datta demonstrating a surgical benefit from preoperative weight loss is in the bariatrric surgery literature. Cou untless studies show that patients with h an elevated l BMI face a substantially increased risk for complications after surgery compared with other patients. This is particularly true for complex abdominal wall reconstructions. Thus, surgeons believe that patients who lose weight before these major operations have a greater likelihood of achieving a better outcome. The cross-sectional ratio of fatto-lean body mass is also a very good predictor of surgical outcomes, specifically for pancreatic, colorectal, lymphoma and esophageal operations, said Dr. Martindale, an expert in surgical and nutritional patient care. His own unpublished research indicates the ratio of fat-to-lean body mass is predictive in abdominal wall reconstruction, as well. He recommended screening patients with the Nutritional Risk screening (NRS 2002), a tool popular in Europe but not in the United States. Patients who are nutritionally depleted should undergo a “nutritional tune-up” before surgery, he said. Randomized studies have shown that metabolic modulation reduces infectious and noninfectious complications, and shortens hospital length of stay. This trend is particularly pronounced in patients undergoing major open gastrointestinal surgery ((Ann Surg 2012;255:1060-1068). Dr. Martindale suggested that patients have a target for perioperative blood glucose between 140 and 180 mcg/dL and preoperative hemoglobin see NONCOMPLIANCE page 30

LOOKING FOR A PUSH THROUGH P.E.G. KIT?

For over 20 years Moss Tubes has provided the ultimate in safety, efficiency, and ease of use with P.E.G. kits featuring our three unique components: 1. Moss gastrostomy tube for feeding and decompression (simpliďŹ ed tube available as well) 2. Custom designed Anchor gun 3. Stainless steel break-away dilator/introducer

...AND WE STILL DO! Speed Patient Recovery with Moss Tubes Feeding patients immediately after surgery has been proven to accelerate-

MOSS T U B E S

healing and shorten hospital stays. The best way to adminster post-operative feeding is with Moss Gastrostomy Tubes. Their patented design permits delivery of nourishment directly to the distal duodenum while providing 12 to 14 times more effective decompression than conventional gastric suction devices. In short, Moss Tubes help patients maximise nutritional absorption, experience greater comfort, and enjoy a quicker return to health. For more information, call (800) 827-0470 or fax (518) 674-8067 Moss Tubes, Inc. P.O. Box 378, West Sand Lake, NY 12196-0378

www.mosstubesinc.com

Made in the U.S.A.

In the News P IONEER jContinued from page 13 interests. We travel together a lot, especially to scientific congresses, courses and specialized centers. We share the same interest in music, movies, theater, literature and sports, especially tennis and walking. We decided to have no children so that we could devote all our time to our careers, which we have always valued so much. However, we have a lot of nephews and nieces as well as groups of beloved assistants who are always by our side, filling our life with enthusiasm and

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / SEPTEMBER 2014

renovation. GSN:: How do you see the evolution of woman in surgery? Do we still have a way to go before men and women are on equal footing? Dr. Habr-Gama: The evolution of women in surgery has been very slow. Nowadays, our numbers are bigger and growing, but even so there are not as many women as men surgeons. There are ways for men and women to be on equal footing, but since the roots of inequality are mostly cultural, it will take longer to get there.

GREENE

jContinued from page 3 use of fatigue risk management systems (FRMS) methodology may give appropriate opportunities to have oversight in this important area. The ACS statement clarifies the characteristics of an FRMS, which include â&#x20AC;&#x153;being evidence-based, data-driven and cooperative.â&#x20AC;? The statement of the ACS is an important step forward in recognizing the intricacies and relationships of fatigue and the surgical management of patients. It is the responsibility of all

surgeons, and especially those in leadership positions in their departments and hospitals, to take the ACS statement to its next step as a benchmark and to create individual strategies that will have specific importance for each institution. The importance of creating educational programs in all of our institutions regarding sleep deprivation and fatigue cannot be underestimated. This cannot be left up to one organization creating an isolated position statement, but should be considered a defining standard and template for all of our surgical sites and especially those in which future surgeons are trained.

NONCOMPLIANCE

Rationale, Reversal, and Recovery Of Neuromuscular Blockade Part 2: Ongoing Challenges and Opportunities Case Study Dennis is a 68-year-old man undergoing open abdominal surgery (colectomy). Current Symptoms Â&#x2021; Dyspnea Vital Signs Â&#x2021; Height: 175 cm Â&#x2021; Weight: 85 kg 6LJQLÂżFDQW 0HGLFDO +LVWRU\ Â&#x2021; Hypertension Â&#x2021; Congestive heart failure Â&#x2021; Obstructive sleep apnea &XUUHQW 0HGLFDWLRQV Â&#x2021; Metoprolol 100 mg PO Â&#x2021; Ramipril 2.5 mg PO Laboratory Results Â&#x2021; Apnea hypopnea index: 26/h Â&#x2021; Left ventricular ejection fraction: 30%-35% Anesthesia is induced with sufentanil, propofol, and 0.6 mg/ kg rocuronium based on total body weight and maintained ZLWK GHVĂ&#x20AC;XUDQH LQ DLU R[\JHQ DQG VXIHQWDQLO 6XUJLFDO FRQGLWLRQV DUH GLIÂżFXOW ZLWK D ODFN RI DEGRPLQDO ZDOO PXVFOH relaxation and poor paralysis. An extra dose of rocuronium is administered for deeper neuromuscular block (NMB), and fewer than 2 train-of-four (TOF) responses are noted.

Global Education Group and Applied Clinical Education are pleased to introduce part 2 of a 3-part interactive CME series featuring challenging cases in NMB. Each activity presents a clinical scenario that you face in your daily practice. After reading the introduction to the case, consider the challenge questions, and then visit ZZZ &0(=RQH FRP QPE WR ÂżQG out how your answers stack up against those of our multidisciplinary faculty panel. Access the activities on your desktop, laptop, or tablet to explore the issues surrounding safe, effective, NMB reversal via a unique multimedia learning experience and earn 1.0 AMA PRA Category 1 Credit.â&#x201E;˘ Complete the whole series and earn a total of 3.0 AMA PRA Category 1 Credits.â&#x201E;˘ This activityâ&#x20AC;&#x2122;s distinguished faculty

6RULQ - %UXOO 0' Professor of Anesthesiology Mayo Clinic College of Medicine Jacksonville, Florida

&ODXGH 0HLVWHOPDQ 0'

Challenge Questions 1. What would you do if, at the end of the case, the TOF count is zero? 2. What would you do if, at the end of the case, the TOF count is 2?

Medical Director, Manager New Medical Center Nancy, France

Access this activity at ZZZ FPH]RQH FRP QPE

This activity is jointly sponsored by Global Education Group and Applied Clinical Education. 6XSSRUWHG E\ DQ HGXFDWLRQDO JUDQW IURP 0HUFN

jcontinued from page 28

A1c lower than 8% â&#x20AC;&#x153;or even 7.5% if you want to push it.â&#x20AC;? Elective procedures in patients with higher levels should be rescheduled for a later date when their glucose is under control, he said. Another recommendation from the panel dealt with carbohydrate loading. Dr. Martindale suggested giving patients an isotonic glucose solution the night before surgery and again two to three hours presurgery. When patients are kept NPO after midnight, their bodies will burn through their carbohydrate reserves, Dr. Martindale said. The stress of surgery bumps their insulin, inhibiting lipolysis and causing the body to burn more lean body tissue to supply gluconeogenic substrate to those tissues requiring carbohydrates. Carbohydrate-loading strategies have been embraced in colorectal surgery and form part of the Enhanced Recovery After Surgery protocol (World J Surg 2013;37:259-284). Guidelines from the European Society for Clinical Nutrition and Metabolism stipulate that carb loading is an accepted form of metabolic preparation. â&#x20AC;&#x153;In this country now, there are various solutions being marketed that you can purchase. I basically use a commercially available athletic drink that has been diluted to isotonic levels,â&#x20AC;? Dr. Martindale said. Dr. Martindale also recommended testing vitamin D levels and placing patients with levels below 30 on a vitamin D protocol. Dr. Martindale and his colleagues published a detailed review of strategies for effective preoperative nutrition optimization in 2013 and 2014. The manuscripts are available in the journal Nutrition in Clinical Practice (2014:29:10-21) and Surgical Clinics of North America 2013.

Opinion

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / SEPTEMBER 2014

VETERANS HEALTH jcontinued from page 1

VA health care is an example of entirely socialized medicine, and its successes and failures suggest how elements of socialized medicine might fare were they to be adopted more generally in the United States. Thoughtful observers have already recognized that features of socialism such as medical insurance, Medicare, capitated care, diagnosisrelated groups and, more recently, elements of the Affordable Care Act have been introduced into the U.S. health care system over the past 100 years. Let me also state up front that as a VA provider, I do not think that the entire country should adopt VA-style socialized medicine without significant changes. I hasten to add that VA health care is a fine system that has many important aspects that should be used as a model for developing a national health care system. In this sense, VA health care represents an initial direction for our country but not our final destination. The VA system should be deconstructed to reveal the things that it does very well as well as certain things that must be changed.

What Works It is not an exaggeration to say that the VA is one of the most innovative health care systems in the country. It has pioneered or has been quick to adopt new ways to deliver health care to its patients, who tend to be sicker than the rest of the population and are scattered widely across the continental United States and beyond. It should be noted that 153 VA hospitals cover the same geographic area served by the 5,700 U.S. hospitals registered with the American Hospital Association. This is no insignificant feat. In the 1990s, the VA began to replace its traditional model of hospital-based health care delivery with a system of more than 700 community-based outpatient clinics feeding into its major referral hospitals. This model, which has come to be known as an accountable care organization, is similar to those adopted to a lesser extent by some of the best health care systems in the country such as Geisinger Health System (Danville, Pa.), Intermountain Healthcare (Salt Lake City) and Mayo Clinic (Rochester, Minn.). The system employs primary care physicians (PCPs), who each manage and promote the health of a panel of patients. The VA has smoking cessation clinics, substance abuse clinics, post-traumatic stress disorder clinics, obesity clinics, health fairs, wellness clinics, and many other programs intended to promote healthy living and to avoid or minimize hospitalization. The PCPs see patients in the community and even encourage them to stay home and make

contact online. The main focus is to avoid hospitalization by keeping patients healthy rather than rescuing them when they become ill. The VA excels in data-driven, transparent self-reporting. In the early 1990s, VA surgeons introduced risk-adjusted reporting of their surgical results, which has evolved into the VA Surgical Quality Improvement Program (VASQIP). Over the ensuing 23 years, VA surgeons have monitored their own results and learned from their adverse outcomes. As a consequence, operative mortality has dropped by 70% while morbidity has fallen by

It is still axiomatic that non-VA physicians profit most when patients are sick and require their services (capitated care is an exception). Non-VA physicians, in general, do not get financial compensation for keeping patients well.

50%. The results of this program were so impressive that VASQIP engendered a similar program sponsored by the American College of Surgeons, the National Surgical Quality Improvement Program. Many other aspects of care at the VA hospital are tracked by quality data analysis including hemoglobin A1c levels for diabetic control, blood pressures and suicide rates. Like the VASQIP data, most metrics that are tracked have improved over time, and those that have not remain under intense scrutiny. Compared with non-VA care across the see VETERANS HEALTH page 32

Now Available!

Read the

Our brand new iPad app!

#1 surgery publication in the country anywhere, anytime

U P DAT E D A P R I L 2 0 1 4

Omentum Surgery Explored For Alzheimer’s Disease By Victoria Stern

abak Gayour watched his father, a prominent mathematician and physicist in Iran, become someone he no longer knew. “My father’s brain had become a shell,” Mr.

Surgical Patients Show Higher Mortality From Hospital Harms

Trauma Patients See an Upward Trend in Radiation Exposure

Study Provides Snapshot of Recent Bariatric Demographics, Outcomes Despite major shake-ups in insurance coverage of bariatric surgery since 2007, the demographics of patients who undergo these procedures have not changed, a new study shows. stable

Laparoscopic Techniques for Hernia Repair: Ups and Downs

Trauma patients at a Nebraska hospital who underwent computed tomography (CT) scans and other diagnostic tests faced an upswing in

Optimized p for f mobile devices Always available online

@gensurgnews

Opinion

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / SEPTEMBER 2014

VETERANS HEALTH jcontinued from page 31

country, the clinical results obtained by the VA are equivalent and more often superior to those reported by the private sector. In 2005, the Rand Corporation reported that the VA outperformed non-VA health care in most of the 294 health care markers measured. To manage the enormous amount of data generated by these metrics and coordinate clinical care, the VA introduced its electronic medical record (EMR) system, Veterans Health Information Systems and Technology Architecture (VistA) in 1998. Its clinical arm, the Computerized Patient Record System (CPRS), is the oldest, and, in my judgment, still the most effective EMR in use. An effective EMR is an essential component of an accountable care organization, and VistA and CPRS have filled this role for years. Many other EMRs that have been developed are mainly used for billing and administrative purposes, but CPRS was developed by front-line providers for patient care. In 2006, VistA won Harvard University’s prestigious Innovations in American Government Award. The VA’s tort arbitration works within the confines of the U.S. legal system and is an improvement over what occurs outside of the VA. Malpractice claims brought against VA physicians are reviewed by noninvolved physicians and specialists in the VA network, and legal defense is provided by government lawyers. The medical reviewers are selected from appropriate specialists working within the VA who have real expertise in the fields and who also have access to all of the medical records through CPRS. These reviews help the VA legal office defend the accused physician, but providers who are found to be at fault are reported to the National Practitioner Data Bank. Errors are acknowledged up front, and veterans are given complete access to the U.S. legal system. The physicians, who know that the system is fair, practice less defensive medicine than their nonVA counterparts. Several inherent features of the VA system also make it a more effective way to deliver health care. The most important of these is universal coverage, which aims to get qualified veterans all of their care at appropriate times and in the appropriate clinics. Although recently the system has been overwhelmed by a massive influx of veterans, the VA’s stated mission is to provide the “right care, at the right place at the right time.” Another important feature of the VA system is that it has long-term relationships with its patients, which allows the VA to spend resources on health maintenance and preventative care. Because the VA reaps the rewards, it is in its best interest, financially as well as medically, to keep the patients healthy. Most physicians in my experience are hard-working, compassionate and devoted to the well-being of their patients. It is still axiomatic that non-VA physicians profit most when patients are sick and require their services (capitated care is an exception). Non-VA physicians, in general, do not get financial compensation for keeping patients well. This brief account demonstrates the tremendous strides the VA has made over the past two decades and why in many aspects the VA has consistently outperformed the rest of the health care industry. Although it has proven to be a good system for caring for a challenging group of aging and wounded individuals, the system has problems that must be addressed.

What Doesn’t Work In my opinion, VA socialized health care suffers

One of the advantages the VA had over the private sector is that it did not need a third-party insurance bureaucracy. Unfortunately, it is replacing that private-sector bureaucracy with a less nimble government bureaucracy. from the same affliction that plagues most socialized government programs and that is, simply stated, a lack of capitalism-driven incentives. The results of the great socioeconomic experiment of the 20th century—socialism versus capitalism—was revealed in 1985 when the Berlin Wall came down. I believe that capitalism turned out to be the more successful political and economic philosophy. It resulted in greater productivity, more discriminating consumerism and better services. Socialism’s indiscriminate consumption and low productivity very quickly leads to problems with access. The most critical charge against the VA currently is that access is limited and wait times are longer than in the private sector. It is this issue that caused the VA to link bonuses to reducing wait times, which in turn caused officials in Phoenix, and other medical centers, to game the system. Fortunately, the VA recognizes this problem and is moving toward a relative value unit–based productivity model. Linking productivity to compensation will go a long way toward solving the nagging issue of low productivity. The VA also has a limited policy of meanstested copays for consumers, which might be applied more broadly and to more veterans. Such a means-based policy would give the consumer “skin in the game” and have the dual benefit of encouraging responsible use of the system and promoting healthy habits. These two measures alone would inject a little needed capitalism into the system, because in this country we have no chance to control medical costs without employing principles of capitalism to make health care both better and cheaper. Another factor that makes the VA less effective is its dependence on a large and increasingly removed government bureaucracy. Ken Kizer, the visionary VA

Under Secretary who is frequently credited with the dramatic turnaround of VA health care in the 1990s, wrote a recent editorial in which he pointed out that the VA of the late 1990s had 800 employees in its central office; that number increased to 11,000 by 2012. One of the advantages the VA had over the private sector is that it did not need a third-party insurance bureaucracy. Unfortunately, it is replacing that private-sector bureaucracy with a less nimble government bureaucracy. Clearly, all has not been ideal with VA health care. My observations are not the misty-eyed musings of a sentimental VA provider. There is well-documented and credible evidence that the VA does some things better than anyone else, but it must be recognized that there are other aspects in which the VA lags behind the private sector. It would be a mistake to dismiss its true accomplishments, but it also would be a mistake to be blind to its shortcomings. The VA should serve as an example of how an accountable health care organization that is dedicated to patient wellness; has an effective EMR; practices data-driven, evidence-based care; uses a sensible tort review process; provides universal coverage; and has a lifelong relationship with its patients can deliver superior care. It is also a cautionary tale about the limitations of socialism that cannot match the productivity of the private sector. The events in Phoenix and other related revelations have certainly dirtied the bath water, but the baby should not be thrown out as well. —Dr. White is Professor of Surgery, — George Washington University, Chief of Surgical Services, Veterans Affairs Medical Center, Washington, D.C.

GSN Bulletin Board

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / SEPTEMBER 2014

As a surgeon you have options.

As a healthcare leader, we have opportunities. For a wide range of options, talk with a team that can offe ff r a wide range of opportunities. We W are one of the nation’s leading operators of general, acute-care hospitals. Our affiliates operate more than 200 hospitals in 29 stat a es and these locat a ions could provide ideal env n ironments fo f r your profe f ssional success. Comp m ensation packag ages may a include: • Flexible and generous start-up incentives • Medical education debt assistance • Va V rious practice typ y es

For more r info f rmat a ion vi v sit i : www. w ch c smedcare r ers r .com Email: docj c obs@chs.net or Call: 800-367-6813

We’re in a

position

SURGICAL & WOUND CARE SURGEONS NEEDED FOR EXPANDING NATIONWIDE SURGICAL PRACTICE: • Full time or part time positions available • Add revenue to your current practice • Flexible schedule, complete autonomy • No call

* Competitive Pay

to fill your

position For classified advertising: contact Craig Wilson 212-957-5300 x235 cwilson@mcmahonmed.com

SURGEONS NEEDED IN: Alabama • Huntsville • Birmingham • Mobile

Arizona • Tucson • Phoenix

California

New Jersey New York • Westchester

Louisiana • Baton Rouge • Monroe • New Orleans • Shreveport

• Bakersfield • Los Angeles • San Francisco • San Diego • San Bernardino • Inland Empire • Central Valley

Pennsylvania

Colorado

• Dallas • Houston • Lufkin/Nacogdoches • Paris • Waco

• Denver • Front Range

• Harrisburg • Pittsburgh • Philadelphia

Oregon • Portland

Texas

Connecticut Delaware District of Columbia Virginia • Northern VA Hawaii Washington Maryland • National Capital Region

• Seattle • Tacoma • Vancouver

Please contact us for more information:

Phone: 1.877.878.3289 • Fax: 1.877.817.3227 Email: Jobs@AdvantageWoundCare.org • www.AdvantageWoundCare.org

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / SEPTEMBER 2014

OR EMERGENCY jcontinued from page 1

them by having a practiced plan of action for emergencies, similar to those for cardiac arrest and fire, he said. “All hospitals have codes for those emergencies, but almost none have formalized protocols for dealing with high-risk intraoperative emergencies. “These events might happen to a surgeon once a year and still, no one has a plan,” he said. “When there is an urgent, unexpected change in the operative plan,

even the best teams are strained to perform efficiently, and that’s precisely when peak performance of the team is essential.” He and his colleagues developed a protocol for intraoperative emergencies. Over several months, the team simulated emergencies in the OR to figure out what is needed during these events. The mock operations were videotaped and assessed by all members of the OR team. After extensive debriefs of the videos, the team created a protocol known as C-STAT. The keystone of the C-STAT

‘When there’s an emergency, the first thing that happens is everybody’s attention is diverted away from the operative field just at the critical time when everybody’s attention needs to be on the patient.’ —Diane Betti, MSN, RN, CNOR

Members of an OR team at Baystate Medical Center conduct C-STAT training session, a protocol for OR emergencies.

Optimizing the Prevention and Management of Postsurgical Adhesions To participate in this FREE CME activity, log on to

www.CMEZone.com and enter keyword “MN125” Release date: December 1, 2012

Chair

Jon Gould, MD Chief, Division of General Surgery Alonzo P. Walker Chair in Surgery Associate Professor of Surgery Medical College of Wisconsin Senior Medical Director of Clinical Affairs Froedtert Hospital Milwaukee, Wisconsin

Faculty

Michael J. Rosen, MD Associate Professor of Surgery Division Chief, General Surgery University Hospitals Case Medical Center Cleveland, Ohio

Statement of Need Adhesions are the most common complication of abdominopelvic surgery, developing postoperatively in 50% to 100% of all such interventions. They can lead to serious medical complications, substantial morbidity, high monetary costs, large surgical workloads, dangerous and difficult reoperations, and an increasing number of medicolegal claims. An official definition of the Sponsored by

Expiration date: September 1, 2014 condition has not been established, and an unequivocally effective prevention method has not been identified. A standardized classification for adhesion assessment and scoring also is lacking, as are guidelines for diagnosis and management. To close these gaps, clinician education is necessary.

Goal The goal of this educational activity is to provide surgeons with up-to-date, clinically useful information concerning the prevention and management of postoperative adhesions.

Learning Objectives 1 Review the pathophysiology and complications of postoperative adhesion formation. 2 Summarize current strategies used to prevent postoperative adhesion formation. 3 Describe the various types of barrier materials used to prevent postoperative adhesion formation.

Intended Audience The intended audience for this educational activity includes general surgeons, vascular surgeons, colon and rectal surgeons, critical care surgeons, surgical oncologists, trauma surgeons, and thoracic surgeons. Supported by an Educational Grant from

Estimated Time for Completion: 60 minutes Course Format Monograph (print and online)

Accreditation Statement This activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of the Medical College of Wisconsin and Applied Clinical Education. The Medical College of Wisconsin is accredited by the ACCME to provide continuing medical education for physicians.

Designation of Credit Statement The Medical College of Wisconsin designates this enduring material for a maximum of 1.0 AMA PRA Category 1 Credit™. t Physicians should only claim credit commensurate with the extent of their participation in the activity.

Method of Participation There are no fees for participating in or receiving credit for this activity. To receive CME credit, participants should read the preamble and the monograph and complete the post-test and evaluation. A score of at least 70% is required to complete this activity successfully. Distributed via

protocol is a rapid technical response team that can be summoned to the OR in an emergency. When an emergency alert is sounded, any OR staff not currently performing a critical patient care duty is expected to stop what they are doing and attend. The primary circulating nurse quickly assigns roles to the first people to arrive. To eliminate confusion about who is responsible for what, every member of the rapid response team carries a card tucked into the back of his or her hospital identification badge. The card outlines the assigned tasks for every person on the C-STAT team. For instance, the first nurse who comes to the OR and assumes the role of C-STAT RN sees the following on the back of his or her card: responsible for ordering blood and setting up additional equipment. As members of the C-STAT team assume their duties, the primary operative team stays focused on the immediate needs of the operative field, said Dr. Earle, who presented details of C-STAT at a panel session on patient safety during the 2014 annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons. The C-STAT protocol takes confusion out of emergencies, said Diane Betti, MSN, RN, CNOR, director of the Daly OR, who helped develop the program. “When there’s an emergency, the first thing that happens is everybody’s attention is diverted away from the operative field just at the critical time when everybody’s attention needs to be on the patient. Now, there’s an increased ability to focus on the operative field because everyone in the room knows exactly what needs to be done,” Ms. Betti said.

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / SEPTEMBER 2014

‘By practicing the drills, orchestrating the team, they are able to respond like Navy Seals in a very coordinated fashion. More likely than not, it would achieve a higher level of care.’ —Daniel B. Jones, MD

Anne Lidor, MD, MPH, associate professor of surgery at Johns Hopkins Hospital, Baltimore, said all hospitals should have programs like C-STAT and practice regularly, “just like we do for trauma and [advanced cardiovascular life support].” But it poses a major challenge to take these programs from concept into reality, she added. “This is something that people should think about and should do. But how to initiate it, how to get people to buy into it— that’s another story. It’s not just surgeons that need to be onboard. It’s everybody in the OR: nurses, techs, OR assistants.

You’d have to have a lot of people willing to participate, and you need some sort of impetus to get this done.” This is the first known report of a rapid response team developed for intraoperative emergencies. These teams have been used widely in other areas of the hospital ever since the Joint Commission made rapid response teams a National Patient Safety Goal in 2009. Studies on the effectiveness of these teams have found mixed results, showing benefits, no benefits or ambiguous outcomes (Crit Care Medd 2014 Apr 16 [Epub ahead of print]).

BRIEF SUMMARY ®

ENTEREG (alvimopan) Capsules 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

Based on the results of their simulation exercises, the Baystate group also developed a conversion pack for cases that require switching from laparoscopic to open surgery. “It’s crazy that a conversion pack didn’t exist before, that we were running around every single time,” Dr. Earle said. “But I don’t think it’s that uncommon.” Emilia Scala, RN, CNOR, service coordinator for Baystate operating rooms, said the C-STAT team typically gets called about once a month. “We had an activation last week. … We were nearing the end of a long operation on a patient with a pancreatic tumor. There was tumor stuck to an artery, and the patient started bleeding. We called for the C-STAT team, and everyone knew exactly what to do,” Ms. Scala said. The C-STAT team has been in existence at Baystate for about seven years. For that period, they have not tracked activations, patient outcomes and staff satisfaction with the program. But even without supporting data, other surgeons say there is a role for programs like C-STAT. “You don’t need to spend a lot of [research] dollars to understand that a team that’s practiced, rehearsed what they are going to do and are geared up together to address problems are going to be better than the folks caught off guard trying to manage that same situation in an operating room,” said Daniel B. Jones, MD, professor of surgery at Harvard Medical School, Boston. In a crisis, OR team members often have different ideas “of what needs to be done next, where the supplies are, who is doing what,” Dr. Jones said. “But by practicing the drills, orchestrating the team, they are able to respond like Navy Seals in a very coordinated fashion. More likely than not, it would achieve a higher level of care.”

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 [see Warnings and Precautions (5.1)]. ] 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 [see Warnings and Precautions (5.1) and (5.2)]. ] 1

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. 4 CONTRAINDICATIONS ENTEREG is contraindicated in patients who have taken therapeutic doses of opioids for more than 7 consecutive days immediately prior to taking ENTEREG [see Warnings and Precautions (5.3)]. 5 WARNINGS AND PRECAUTIONS 5.1 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 [see Warnings and Precautions (5.2)]. 5.2 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 [see Warnings and Precautions (5.1)]. 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. 5.3 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. 5.4 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. 5.5 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. 5.6 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. 5.7 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. 6 ADVERSE REACTIONS 6.1 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. 7 DRUG INTERACTIONS 7.1 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. 7.2 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.

7.3

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. 7.4 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. 8 USE IN SPECIFIC POPULATIONS 8.1 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. 8.3 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 [see Clinical Pharmacology (12.3)]. 8.4 Pediatric Use Safety and effectiveness in pediatric patients have not been established. 8.5 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 [see Clinical Pharmacology (12.3)]. 8.6 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 [see Warnings and Precautions (5.4) and Clinical Pharmacology (12.3)].] 8.7 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 [see Clinical Pharmacology (12.3)]. 8.8 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 [see Clinical Pharmacology (12.3)]. 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis: g Two-year carcinogenicity studies were conducted with alvimopan in CD-1 mice at oral doses up to 4000 mg/kg/day and in Sprague-Dawley rats at oral doses up to 500 mg/kg/day. Oral administration of alvimopan for 104 weeks produced significant increases in the incidences of fibroma, fibrosarcoma, and sarcoma in the skin/subcutis, and of osteoma/osteosarcoma in bones of female mice at 4000 mg/kg/day (about 674 times the recommended human dose based on body surface area). In rats, oral administration of alvimopan for 104 weeks did not produce any tumor up to 500 mg/kg/day (about 166 times the recommended human dose based on body surface area). Mutagenesis: g Alvimopan was not genotoxic in the Ames test, the mouse lymphoma cell (L5178Y/TK+/−) forward mutation test, the Chinese Hamster Ovary (CHO) cell chromosome aberration test, or the mouse micronucleus test. The pharmacologically active ‘metabolite’ ADL 08-0011 was negative in the Ames test, chromosome aberration test in CHO cells, and mouse micronucleus test. Impairment p of Fertility: y Alvimopan 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) was found to have no adverse effect on fertility and reproductive performance of male or female rats. 17 PATIENT COUNSELING INFORMATION 17.1 Recent Use of Opioids Patients should be informed that they must disclose long-term or intermittent opioid pain therapy, including any use of opioids in the week prior to receiving ENTEREG. They should understand that recent use of opioids may make them more susceptible to adverse reactions to ENTEREG, primarily those limited to the gastrointestinal tract (e.g., abdominal pain, nausea and vomiting, diarrhea). 17.2 Hospital Use Only ENTEREG is available only through a program called the ENTEREG Access Support and Education (E.A.S.E.) Program under a REMS that restricts use to enrolled hospitals because of the potential risk of myocardial infarction with long-term use of ENTEREG. Patients should be informed that ENTEREG is for hospital use only for no more than 7 days after their bowel resection surgery. 17.3 Most Common Side Effect Patients should be informed that the most common side effect with ENTEREG in patients undergoing surgeries that include bowel resection is dyspepsia.

ENTEREG and E.A.S.E. are registered trademarks of Adolor Corporation, a wholly owned subsidiary of Cubist Pharmaceuticals, Inc. Any other trademarks are property of their respective owners. Manufactured for: Cubist Pharmaceuticals, Inc. Lexington, MA 02421 USA October 2013

SEPTEMBER SEPTEMBER 2014 2014

Brought g to yyou by y

REPORT Clinical and Cost Considerations For Managing Postsurgical Pain: Elastomeric Pumps and Continuous Catheters, or a Single-Dose Non-Opioid Local Analgesic Faculty Susan E. Downey, MD, FACS

John Pilcher, MD, FACS, FASMBS

Clinical Associate Professor of Surgery (Plastic) Department of Surgery University of Southern California Keck School of Medicine Los Angeles, California

Medical Director, Bariatric Surgery TexSan Heart Hospital San Antonio, Texas

Jacob Hutchins, MD

Andrew Rogalski, PharmD, BCPS

Director, Regional and Acute Pain Program Department of Anesthesiology University of Minnesota Medical Center

Clinical Pharmacy Specialist Program Director, Pharmacy Practice (PGY1) Residency University Medical Center of Princeton at Plainsboro Plainsboro, New Jersey

Minneapolis, Minnesota

ostsurgical pain is a common phenomenon and can have a significant effect on patient outcomes and health care costs. For example, in 2003, Apfelbaum and colleagues1 conducted a survey of 250 adults who recently had undergone surgical procedures, and reported that 80% of patients experienced acute pain after surgery; 86% reported moderate, severe, or extreme pain. Furthermore, 23% of patients who received pain

medications experienced adverse effects (AEs). More recently, Gan and colleagues2 conducted a survey of a random sample of 300 adults who had undergone surgery within the previous 5 years. Approximately 86% experienced pain after surgery and of these, 75% had moderate or extreme pain during the immediate postsurgical period (Figure 1).1,2 After being discharged from the hospital, 74% reported a continuation of these pain levels.

Supported by

REPORT

as respiratory depression, also were noted.8 In 2012, the Joint Commission issued a Sentinel Event Alert regarding the use of opioids in the inpatient setting. This alert described several populations that were at particularly high risk for experiencing AEs in response to opioids, including the elderly, patients with morbid obesity, and those with sleep apnea.9-11 One strategy to obviate the effect of opioid-related AEs is to employ a multimodal analgesic approach.12 Multimodal analgesia, the use of different classes of analgesics that act on different pathways and receptors, has gained increased acceptance and use over the past decade as a potential strategy for managing postsurgical pain while simultaneously reducing the incidence of AEs related to any single analgesic agent.13-15 Several studies have reported that a multimodal approach that reduces opioid use may result in improved outcomes, increased patient satisfaction, and lower cost of care.6,14,16 These benefits have led both the American Society of Anesthesiologists and the Joint Commission to endorse the use of multimodal analgesia in postsurgical patients.4,9

Undermanaged postsurgical pain has broad implications for clinical care.3-5 Indeed, various studies have demonstrated that undermanaged pain after surgery is associated with longer hospital lengths of stay, a higher rate of complications (including cardiovascular, pulmonary, renal, and psychological sequelae), increased risk for developing chronic pain syndromes, and decreased patient satisfaction.3,5 Because health care utilization organizations are tracking pain-related end points as measures of quality of care in surgical patients (eg, within the Hospital Consumer Assessment of Healthcare Providers and Systems survey), these suboptimal outcomes may have a direct effect on hospital reimbursements.6 Opioids are the current mainstay of postsurgical pain management but have idiosyncratic or dose-limiting side effects that can be serious.7,8 The study by Gan and colleagues showed that 88% of postsurgical patients received analgesic medication after surgery and that opioids were the most commonly administered.2 However, 80% of those patients reported AEs. Although the most common AEs were not severe (eg, drowsiness and constipation), serious AEs, such

100

Gan et al. Apfelbaum et al.

86 82

Patients, %

60 45

40 25

13 8

Any Pain

Slight

Moderate

Severe

Extreme

Figure 1. Percentage of patients reporting various postsurgical pain levels in 2 different studies. Based on references 1 and 2.

REPORT

Elastomeric Pumps and Continuous Catheters er strategy that uses local anesthetics or other agents in an effort to augment pain control while simultaneously avoiding the AEs associated with opioids.17-19 However, the duration of action of traditional local anesthetics, such as bupivacaine HCl, does not match the time course of postsurgical pain.1,20 In order to offer longer-lasting pain relief compared with that offered by traditional local anesthetics infiltrated into tissue that may or may not be associated with a nerve block, elastomeric pumps and catheters for continuous infusions of local anesthetics were introduced in the 1990s and are increasingly used in the inpatient postsurgical setting.21-23 The utility of these strategies is promoted by the fact that these analgesic routes can be continued even when the patient is discharged from the hospital. Continuation of these advanced analgesic strategies after hospital discharge more closely mirrors the prolonged time course of postsurgical pain.

However, the use of an indwelling catheter for continuous delivery of local anesthetics has several defined disadvantages (Table). 21,24-32 Indwelling catheter use carries a risk for catheter-related complications, such as dislodgment, migration, infection, or bleeding. 24-26 Additionally, continuous delivery using a pump and catheter incurs financial costs associated with the equipment and the resources needed to safely manage these systems both inside and outside the hospital setting.27

Concerns Raised by the FDA and ISMP Both the Institute for Safe Medication Practices (ISMP) and the FDA have raised concerns about the safety of elastomeric pumps in clinical practice.28,29 In May 2009, the ISMP published a report noting an association between the ON-Q速 system and cartilage destruction, especially in cases in which local anesthetic is infused into a joint rather than the surrounding tissue.28 Similarly, the FDA recommended that elastomeric infusion devices not be used for continuous intra-articular infusion in patients after orthopedic surgery due to the risk for chondrolysis.29

Table. Drawbacks, Limitations, and Safety Issues Associated With Use of Elastomeric Pumps and Indwelling Catheters for Postoperative Analgesia Elastomeric pumps Variable infusion rates and concentrations Administration of additional medications instead of analgesic alone Extended use and refilling may result in infection Premature emptying of the bulb Not suitable for outpatient use for individuals with suboptimal health literacy or who live alone Costs associated with the equipment and the resources needed to safely manage these systems

Indwelling catheters Catheter dislodgment Catheter migration Infection and/or bleeding Potential for cartilage destruction, especially in cases in which local anesthetic is infused into a joint rather than the surrounding tissue Based on references 21 and 24-32.

REPORT

Easypump ((n=300) Infusor LV5 (n=130)

Expected Flow Rate, %

-30

-60

Sept.

Nov.

Jan.

Mar.

May

200 300 Number of Elastomeric Pumps p

400

-90

100

Figure 2. Elastomeric pumps are associated with a significant incidence of out-of-target flow rates. The gray area represents the theoretical normal range (±15%) of the set flow rate (5 mL/h). Based on Remerand F, et al. Elastomeric pump reliability in postoperative regional anesthesia: a survey of 430 consecutive devices. Anesth Analg. 2008;107(6):2079-2084. Reprinted with permission.

In July 2009, the ISMP followed up with a report calling for safer practices with the use of ON-Q elastomeric pumps.28 In this report, the ISMP noted several other issues regarding the use of these pumps, including variable infusion rates and concentrations, administration of medication including the vasoconstrictor epinephrine instead of analgesic alone, and extended use and refilling that may result in infection.28 The ISMP warned that elastomeric pump devices are filled outside of the pharmacy, typically in the operating room (OR), which raises concerns regarding accurate filling, labeling, and documentation of the administered medication.28

Clinical Experience In a review of experience at a major regional level 1 trauma center, Birrer and colleagues experienced firsthand many of the issues outlined in the ISMP alert.21 The investigators reported that the hospital’s pharmacy and therapeutics committee did not review the use of the ON-Q system because the pumps used a medication already on the formulary

(bupivacaine). Therefore, there was a lack of training or education in use of the device, leading to a lack of involvement from the pharmacy team and increased human error by the OR staff. As a result, there were several serious incidents. In one incident, a physician inserted 2 pumps with 4 lumens into a patient with traumatic brain injury and rib fractures. In another incident, the pump’s infusion rate was unpredictable, leading to the clearing of the pump’s bulb in 36 hours, despite the fact that it was expected to last 72 hours.21 In a small pilot study evaluating the use of the Homepump Eclipse for the management of acute and chronic pain, 30 investigators reported several safety incidents when using the pumps, including premature emptying of the bulb and variations in drug delivery times. They also highlighted the importance of patient selection when choosing an elastomeric pump, noting that patients with suboptimal health literacy or those who live alone are not good candidates for this strategy. 30 Capdevila and colleagues studied the use of continuous

REPORT

peripheral nerve block to manage pain in 1,416 patients after orthopedic surgery. 24 They reported that this strategy was associated with a significant risk for AEs, most of which were related to the catheter and its associated devices (eg, kinked catheter, inadvertent withdrawal of the catheter, and undesired stoppage of the pump). Bacterial colonization of the catheters also was a common occurrence.24 Grant and colleagues also reviewed their experience with 32 elastomeric pumps.31 After excluding data from 1 pump due to a leak, the investigators reported a pattern of over infusion in 7 of the pumps in the first hour after refilling. Furthermore, they reported that pump infusion flow-rate accuracy was variable over time.31 In a study of 430 pumps, Remerand and colleagues found a variety of issues with both the pumps and the catheters (Figure 2).33 For example, 20.5% of pumps did not deflate correctly, and 2 catheters were obstructed. Spontaneous deflation occurred in 40 cases at 6 to 43 hours after connection. These dysfunctions were associated with a decrease in analgesic efficacy during the first postsurgical night, leading to many catheters being removed by the anesthesiologist after 11 to 72 hours.33

EXPAREL—A Long-Acting Single-Dose Formulation of Bupivacaine The bupivacaine in EXPAREL® (bupivacaine liposome injectable suspension) is encapsulated within multivesicular liposomes (DepoFoam® ) that slowly break down and release the agent over a longer period of time than with a conventional bupivacaine formulation, thereby producing longer-lasting analgesia without the need for a continuous catheter.34,35 Due to the DepoFoam carrier matrix, there is only minimal uptake of bupivacaine into the lymphatics and systemic circulation after injection, reducing systemic exposure and toxicity.34 In several studies, administration of EXPAREL led to prolonged concentrations of bupivacaine through 72 hours with plasma levels detectable up to 96 hours, which more closely matches the time course of postsurgical pain.20,36 EXPAREL has demonstrated safety and efficacy in 2 pivotal Phase III trials of patients undergoing bunionectomy or hemorrhoidectomy.37,38 In both cases, EXPAREL was delivered via wound infiltration at the conclusion of the surgical procedure. Results showed that patient satisfaction and pain scores were significantly better for EXPAREL than for placebo at the primary end point (72 hours for hemorrhoidectomy, 24 hours for bunionectomy), and the opioid requirements were reduced when compared with placebo.37,38 In another study, pooled safety data were generated from an analysis of 10 randomized, double-blind studies including 823 patients who received EXPAREL at the surgical site.39 The most common AEs in the EXPAREL arms were nausea, constipation, and vomiting.39 Serious AEs were reported in 2.7% of patients receiving EXPAREL, and in 5.4% and 1.1% of patients who received bupivacaine HCl and placebo, respectively. Additionally, 6.4% of patients experienced a cardiac

AE consisting of either tachycardia or bradycardia; however, the cardiac events were mild or moderate in severity, and none required therapeutic intervention.39 Studies of EXPAREL suggest that it does not adversely affect wound healing. For example, in a review of all 10 Phase II and III studies of the efficacy and tolerability of EXPAREL when administered into the surgical site, investigators found that EXPAREL did not adversely affect wound or bone healing for up to 2 years in some patients. There were also no reported instances of chondrolysis, although the number needed to detect this is quite large.40 Additionally, the investigators reported that infections occurred in 5% of patients administered bupivacaine HCL, 3% of patients administered EXPAREL, and 2% of patients administered placebo.40 These are all critical factors to consider when choosing the optimal postsurgical analgesic regimen. Based on these and other studies, the FDA approved the use of EXPAREL in October 2011 for single-dose infiltration into the surgical site to produce postsurgical analgesia.41 EXPAREL is supplied in a ready-to-use aqueous suspension.42 The volume can be expanded with up to 280 mL preservative-free normal sterile saline as necessary to accommodate administration into a larger surgical site, allowing for a single maximum dose containing 20 mL of EXPAREL without the need for a catheter or pump.43

A Review of the Recent Literature Several studies in 2013 and 2014 reported more recent experience with EXPAREL since its approval for clinical use. For example, Hollander and colleagues compared the efficacy of EXPAREL (diluted with 40 mL normal saline and injected subfascially before closure of the fascia) versus subfascial continuous local anesthesia (SFCLA; subfascial tunneled catheters and a ropivacaine pump) and patient-controlled analgesia (PCA; morphine) in 195 patients undergoing laparoendoscopic single-site donor nephrectomy.32 Patients managed with PCA required more supplemental narcotics than those on EXPAREL (63.3 vs 29.4 mg; P<0.01) or SFCLA (vs 32.9 mg; P<0.01), but narcotic use was similar between patients treated with EXPAREL and those receiving SFCLA. Pain control (as demonstrated by maximal pain score according to the visual analog scale [VAS]) was comparable between patients receiving EXPAREL and SFCLA (6.3 vs 6.2). Operating time was longer for SFCLA compared with EXPAREL (219.8 vs 199.3 minutes; P<0.01) and PCA (vs 202 minutes; P<0.01). Based on these data, the investigators concluded that EXPAREL was as effective as SFCLA for perioperative analgesia and also was associated with decreased costs and operative time, likely due to its comparative ease of administration.32 Emerson and colleagues compared continuous femoral nerve block (FNB) to wound infiltration with EXPAREL as part of a multimodal pain program in 72 patients undergoing total knee replacement.44 On average, patients receiving EXPAREL required significantly lower amounts of opioid medication during their inpatient stay than those treated with an FNB (hydrocodone equivalent doses: 82.2 vs 176.6 mg; P<0.001), and

REPORT

requested fewer narcotic doses (7.5 vs 14.3; Figure 3).44 There was a trend (P=0.09) toward lower inpatient VAS pain scores with EXPAREL compared with FNB (1.8 vs 2.3; P=0.09). In the EXPAREL group, investigators found no incidence of quadriceps weakness, a common drawback to administering traditional local anesthetics via continuous FNB. The investigators concluded that wound infiltration with EXPAREL yielded equivalent postsurgical analgesia compared with a continuous FNB and with significantly less narcotic medication. As a result, they suggested that use of EXPAREL would replace the traditional opioid-reliant model of postsurgical analgesia.44 In another study, Richard and colleagues compared EXPAREL to the ON-Q system in controlling pain at the extraction and stapler insertion sites in patients undergoing

laparoscopic sleeve gastrectomy and Roux-en-Y gastric bypass (RYGB).45 Patients in the EXPAREL group used significantly less narcotics (hydrocodone/acetaminophen) in the immediate postsurgical period than patients in the ON-Q group (<10 vs 30 mg; P= 0.001).45 Additionally, in a single-institution, single-surgeon, retrospective study of 108 patients undergoing robotic-assisted laparoscopic urologic surgeries, Walker and colleagues compared the efficacy of 0.5% ropivacaine delivered via an ON-Q pump (through 2 catheters placed under the fascia at the wound sites at the end of the surgery) versus wound infiltration with EXPAREL (injected subcutaneously into the incision sites and circumferentially along the trocars above and below the fascia down to the peritoneum).46 The investigators

200

186.0 Mean Time to First Opioid Use, min

Average Narcotics Used, mg

176.6

150

100

82.2 P<0.001

100

63.9 P=0.0043 50

EXPAREL

FNB

Figure 3. Patients receiving EXPAREL required significantly lower amounts of opioid medication during their inpatient stay than those treated with an FNB (hydrocodone equivalent doses: 82.2 vs 176.6 mg; P<0.001). FNB, femoral nerve block Based on reference 44.

150

EXPAREL

ON-Q

Figure 4. Comparison of the efficacy of wound infiltration with EXPAREL versus 0.5% ropivacaine delivered via the ON-Q system following robotic-assisted laparoscopic urologic surgery. Based on reference 46.

REPORT

reported that the mean morphine equivalent dose was less in the EXPAREL group than in the ON-Q group (23.8 vs 65.9; P<0.0001). Furthermore, the mean time to first opioid use was delayed in favor of EXPAREL (186.0 vs 63.9 minutes; P=0.0043; Figure 4).46 Of particular note, 5 patients in the EXPAREL group and 1 in the ON-Q group did not require any supplemental opioids. Based on these data, the investigators concluded that the use of EXPAREL was an effective strategy for postsurgical analgesia in patients undergoing minimally invasive surgery and was associated with a significant reduction in narcotic use.46

Conclusion Postsurgical pain is common and is associated with worse patient outcomes and higher health care costs. Although the use of local anesthetics as part of a multimodal analgesic approach can reduce opioid use and its associated AEs, the use of elastomeric pumps and continuous catheters needed to

match the protracted time course of postsurgical pain is associated with a variety of potential complications for the patient and can be generally inconvenient and costly to clinicians and institutions. Furthermore, some patients may not be sufficiently health care literate to manage these devices on their own after being discharged, and the devices may require valuable time in the office to be removed if the patient prefers not to do so. The duration of action of EXPAREL more closely matches the time course of postsurgical pain through a single administration. Multiple trials, both clinical and â&#x20AC;&#x153;real world,â&#x20AC;? have demonstrated that wound infiltration with EXPAREL is effective at reducing pain for up to 72 hours after surgery while simultaneously reducing opioid requirements. Furthermore, EXPAREL administered via wound infiltration obviates the need for elastomeric pumps and continuous catheters and their associated complications and limitations. As a result, EXPAREL is well suited for use as a part of the multimodal analgesic approach across a wide range of patients and procedures.

Case Study 1 A 66-year-old woman presented for open total abdominal hysterectomy, bilateral salpingooophorectomy, periaortic lymphadectomy, and omentectomy for ovarian cancer. Jacob Hutchins, MD

he patient had a history of an abnormal right ovary with elevated CA-125. She had no other past medical history and this was her first surgery. She declined to have an indwelling catheter to manage postsurgical pain because neither she nor her husband felt comfortable removing it at home. The decision was made to provide postsurgical analgesia with bilateral classic transversus abdominal plane (TAP) infiltration with EXPAREL. Before surgery, in the preoperative block area, the patient received bilateral ultrasound-guided TAP infiltration. She received 30 mL total volume per side (10 mL EXPAREL and 20 mL normal saline). She was then taken to the OR where she was induced with 100 mg propofol, 100 mcg fentanyl, 100 mg lidocaine, and 50 mg rocuronium. She received a total of 400 mcg of fentanyl intraoperatively and 1 mg hydromorphone for a procedure that lasted 264 minutes. Final pathology showed stage IIc adenocarcinoma of the right fallopian tube. The patientâ&#x20AC;&#x2122;s postoperative pain was well controlled, with her maximal pain score in the postanesthesia care unit (PACU) at 3 out of 10 on the NRS. While in the PACU, she received 50 mcg fentanyl and 1 mg hydromorphone IV. During her first 24 hours postoperatively, her maximal pain score was 3 out of 10 and she received 0.1 mg IV hydromorphone, 5 mg oxycodone, 30 mg IV ketorolac, and 325 mg oral acetaminophen.

During the first postoperative 24 to 48 hours, her maximal pain score was 4 out of 10 and she used only 15 mg ketorolac IV and 1,200 mg ibuprofen. She denied nausea or vomiting during the entire postoperative period. She was discharged home with oral opioids and enoxaparin injections 40.15 hours after surgery. When contacted on postoperative day (POD) 2, she reported continued good pain control without the need for additional opioids and was satisfied with the method of pain management.

Commentary Continuous TAP instillation with a pump and catheter provides incisional pain coverage and can be continued once discharged, but may be contraindicated or not desired in certain patients. By using TAP infiltration with EXPAREL instead of a continuous catheter and pump, a similar duration of analgesia can be provided and all postoperative anticoagulation needs can be met. Additionally, those with limited mental ability or assistance can still receive up to 72 hours of incisional pain relief. This technique also eliminates the potential for accidental catheter removal. With the change to EXPAREL, we have been able to provide postoperative incisional pain control to a more diverse population of total abdominal hysterectomy patients.

REPORT

Case Study 2 A 44-year-old man undergoing a skin graft following multiple surgeries. Susan E. Downey, MD, FACS

he patient was previously healthy and had developed chest pain. His medical history was notable for hypertension but he was not on medication. Stress test confirmed an ascending aortic aneurysm. He underwent elective ascending aortic replacement with a femoral artery cut down and repair. Later that same day he began to complain of severe calf pain and was found to have a compartment syndrome in his left calf. He was taken back emergently to the OR and underwent fasciotomies of the calf. A week later, he developed shortness of breath and was found to have a pericardial effusion. This required another return to the OR and subxiphoid drainage. Two weeks later, a plastic surgery consultation was obtained for a skin graft for the fasciotomy wounds on his calf. The nursing staff and the rest of his medical team were concerned about his postoperative pain management because he had been on narcotics in the ICU for several weeks. Due to his many complications and surgical procedures in such a short period of time, the patient was having pain control issues. The Palliative Care Department had been consulted and was following him with the diagnosis of â&#x20AC;&#x153;intractable pain.â&#x20AC;? He was maintained on a hydromorphone PCA 0.9 mg per hour continuous drip with 0.3 mg every 10 minutes as needed and a 3-mg per hour lockout. The patient was taken to the OR and a split-thickness skin graft was harvested from his upper thigh using a dermatome.

The dermatome was set at 18/100,000 of an inch. EXPAREL 20 mL with 40 mL saline (total volume 60 mL) was injected into the donor site. The donor site was dressed with xeroform and a bulky dressing. The skin graft was secured to the recipient site with staples and Adaptic gauze. No local anesthetic was injected into the recipient site. Immediately after the skin graft procedure, the PCA was stopped and the patient was switched to hydromorphone IV push 0.5 mg every 3 hours as needed for pain. Oxycodone/ acetaminophen was administered for breakthrough pain. He was discharged home 2 days after the skin graft procedure on oral oxycodone/acetaminophen alone.

Commentary When harvesting skin grafts, the donor site can be as painful as a second-degree burn. It can take days or even weeks for the pain to subside, and an injection of marcaine or lidocaine only lasts a few hours. A pain pump cannot be used because the harvesting of the skin graft does not leave a cavity for a catheter. The patient was informed that EXPAREL would be used in the donor site before surgery to minimize his postoperative pain. After surgery, the patient was found to be resting comfortably and reported no pain in the donor site.

Case Studies 3 and 4 53- and 46-year-old women undergoing Roux-en-Y gastric bypass. John Pilcher, MD, FACS, FASMBS

The 53-Year-Old Woman: Using an ON-Q Pump and Catheter

he patient suffered from many years of weight gain despite regular diet and exercise. Her medical problems included hypertension, hyperlipidemia, asthma, chronic low back pain, and knee pain. She had previously undergone laparoscopic cholecystectomy and total abdominal hysterectomy. She also had a history of atrial fibrillation and spontaneous deep vein thrombosis 4 years before her initial encounter with the bariatric surgical team. She took ibuprofen regularly for moderate knee and back pain, but was not taking any narcotic pain medication before surgery. Her height was 163 cm and her weight was 113 kg, with a body mass index (BMI) of 43 kg/m2. Medications before surgery included lisinopril,

metoprolol, spironolactone, atorvastatin, and cetirizine. The bariatric surgical team recommended RYGB to treat the patientâ&#x20AC;&#x2122;s progressive metabolic obesity disease. The surgery was performed laparoscopically, without any unusual events. The gastrojejunal anastomosis was accomplished using a size 25 circular stapler, which was introduced into the abdomen by removing the left flank trocar and dilating the site to accommodate the device. At the end of the procedure, the fascia and muscle at the site that had been dilated were closed using a single vicryl suture. The other trocars (all nonbladed) were simply removed and no fascial closure was deemed necessary. No drains were deemed necessary.

REPORT

Bupivacaine 0.5% plus epinephrine was infiltrated preemptively at each trocar site after the abdomen was prepped and draped, and an additional 20 mL was infiltrated at the end of the procedure into the left flank fascia where the suture closure was accomplished. An ON-Q catheter was threaded into the preperitoneal plane on the left flank, lateral to the site of the suture closure. The 48-hour elastomeric ON-Q pump was charged with a 120-mL volume of bupivacaine 0.25%, which infused gradually through the catheter during the 2-day hospital stay. The patient received the standard postoperative pain and nausea regimen, which included 2 mg PCA morphine in 10-minute intervals with 30/4-hour lockout; 15 to 30 mL of hydrocodone/acetaminophen elixir (7.5/500 mg per 15 mL) orally every 4 hours as needed for pain; 4 doses of 30 mg IV ketorolac every 8 hours beginning at 4 hours postsurgery; 4 doses of 4 mg IV ondansetron every 6 hours (standing), then 8 mg IV every 6 hours as needed for nausea; and 10 mg of IV metoclopramide every 6 hours as needed for nausea, if ondansetron was not effective.

The postoperative stay was unremarkable, and the patient was discharged home on POD 2. During her hospital stay she received 26 mg morphine via PCA, 120 mL hydrocodone/acetaminophen elixir; ketorolac as scheduled; ondansetron as scheduled followed by 2 additional doses of ondansetron as needed; 20 mg of metoclopramide (2 doses as needed as backup for ondansetron); and bupivacaine via ON-Q catheter, with catheter removal just before discharge. At time of discharge, the patient received a standard prescription for additional hydrocodone/acetaminophen elixir. At her first follow-up visit, the patient reported that she took the as-needed prescription “very regularly” for the first few days at home, obtained the permitted refill (each fill = 1 pint), then used “about one-fourth” of the second pint. Approximately 1 week post-discharge the patient experienced very severe constipation, requiring 2 enemas and self-disimpaction. In long-term follow-up, the patient had experienced substantial weight loss and health improvement. There was no longterm pain, nausea, or constipation sequelae.

The 46-Year-Old Woman: Using EXPAREL

he patient presented to the bariatric clinic for consideration of bariatric surgical intervention. Her height was 170 cm and her weight was 129 kg, with a BMI of 45 kg/m2. Her medical history included gastroesophageal reflux disease, hypertension, obstructive sleep apnea, and depression. She also had longstanding chronic back and knee pain, for which she took approximately 15 mg hydrocodone per day as-needed. Other medications included lisinopril, duloxetine, and zolpidem. She had previously undergone right total knee replacement, and lumbar laminectomy. RYGB was selected in this case as well. The operation was accomplished laparoscopically according to routine. In the same manner as the previous case, the gastrojejunal anastomosis was accomplished using a size 25 circular stapler with dilation of the skin and muscle at the left flank trocar site. The fascia at this location was closed using a single vicryl suture, and suture closure of the other trocar sites was deemed unnecessary. No drain was deemed necessary. A 20 mL dose of EXPAREL was combined with 100 mL sterile normal saline. Approximately 60 mL was infiltrated preemptively at the skin level and the fascia level at each trocar placement site at the beginning of the case. When the procedure was complete, 30 mL was infiltrated into the left flank fascia at the site of suture closure, and 30 mL was

infiltrated into the left TAP lateral to this fascial site. Following surgery, this patient received an updated postoperative pain and nausea regimen, which included 2 to 4 mg morphine every 2 hours as needed for pain (not PCA); 15 to 30 mL of hydrocodone/acetaminophen elixir (7.5/500 mg per 15 mL) orally every 4 hours as needed for pain; 4 doses 30 mg of IV ketorolac every 8 hours beginning at 4 hours postoperatively; 4 doses of 4 mg IV ondansetron every 6 hours (standing) followed by 8 mg IV every 6 hours as needed for nausea; and 10 mg of IV metoclopramide every 6 hours for nausea, if ondansetron was not effective. The postoperative stay was unremarkable, and the patient was discharged home on POD 1. During her hospital stay she received 8 mg morphine; 75 mL hydrocodone/acetaminophen elixir; ketorolac as scheduled; ondansetron as scheduled, no as-needed doses required; and metoclopramide was available but not required. At time of discharge, the patient received a standard prescription for additional hydrocodone/acetaminophen elixir. At her first follow-up visit she reported that she took the as-needed medication only twice, and was pleasantly surprised at how little pain she experienced. In long-term follow-up, the patient had experienced substantial weight loss and health improvement. There was no long-term pain, nausea, or constipation sequelae.

Commentary Although these are 2 different patients, they underwent similar procedures. However, when EXPAREL was

administered, less narcotics were used, resulting in fewer postsurgical side effects.

REPORT

A Pharmacist’s Clinical Perspective Andrew Rogalski, PharmD, BCPS ur institution began using EXPAREL in 2012, and it is now used in general, orthopedic, and gynecologic procedures by multiple practitioners. We have seen a number of advantages throughout the institution since making it a part of our multimodal pain control strategy. In discussions with providers, caregivers, and patients there has been a nearly universal description of reduction in requirements for rescue narcotics in the postoperative period, with consistent results into POD 3. Our nurses have even reported narcotic-free PACU discharges for several same-day procedures. Operationally, we had been using considerable numbers of elastomeric infusers and CADD infusers for regional anesthesia and nerve blocks. Many of our surgeons have abandoned these modalities and adopted EXPAREL for its superior simplicity with excellent results. When accounting for costs, we found that the acquisition costs for the infusion devices and standard anesthetics were

initially slightly less than EXPAREL, but when the cost of the catheters, tubing, and preparation time were tabulated, the costs were essentially equivalent. For example, preparation of infusers required a minimum of 12 hours of pharmacy technician resources each week, which have now virtually been eliminated. We have elected to provide EXPAREL at room temperature in a centrally located automated dispensing cabinet (Pyxis) within the OR core. Because of frequency of use, we have encountered no issues with the limited beyond-use dating when removed from refrigeration. Speculative concerns for look-alike issues with propofol have not been observed in our practice; however, as a precaution, our circulating nurses retrieve the EXPAREL and our anesthesiologists have no role in its administration. Our organization has seen many successes with the adoption of EXPAREL as part of our multimodal approach to pain management. When drug, device, and operational costs are considered in totality, we have found it to be at least cost-neutral to other regional anesthetic modalities.

Important Safety Information EXPAREL is contraindicated in obstetrical paracervical block anesthesia. EXPAREL has not been studied for use in patients younger than 18 years of age. Non–bupivacaine-based local anesthetics, including lidocaine, may cause an immediate release of bupivacaine from EXPAREL if administered together locally. The administration of EXPAREL may follow the administration of lidocaine after delay of 20 minutes or more. Other formulations of bupivacaine should not be administered within 96 hours following administration of EXPAREL. Monitoring of cardiovascular and neurological status, as well as vital signs should be performed during and after injection of EXPAREL as with other local anesthetic products. Because amide-type local anesthetics, such as bupivacaine, are metabolized by the liver, EXPAREL should be used cautiously in patients with hepatic disease. Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at a greater risk of developing toxic plasma concentrations. In clinical trials, the most common adverse reactions (incidence ≥10%) following EXPAREL administration were nausea, constipation, and vomiting. Please see full Prescribing Information for EXPAREL.

REPORT

References 1.

Apfelbaum JL, Chen C, Mehta SS, et al. Postoperative pain experience: results from a national survey suggest postoperative pain continues to be undermanaged. Anesth Analg. 2003;97(2):534-540.

17.

White PF. The changing role of non-opioid analgesic techniques in the management of postoperative pain. Anesth Analg. 2005; 101(5 suppl):S5-S22.

Gan TJ, Habib AS, Miller TE, et al. Incidence, patient satisfaction, and perceptions of post-surgical pain: results from a US national survey. Curr Med Res Opin. 2014;30(1):149-160.

18.

White PF. The role of non-opioid analgesic techniques in the management of pain after ambulatory surgery. Anesth Analg. 2002;94(3): 577-585.

Morrison RS, Magaziner J, McLaughlin MA, et al. The impact of post-operative pain on outcomes following hip fracture. Pain. 2003; 103(3):303-311.

19.

Kvolik S, Kristek J, Sakic K, et al. A wound infiltration as a method of postoperative analgesia. Periodicum Biologorum. 2009;111(2):241-246.

Joshi GP, Ogunnaike BO. Consequences of inadequate postoperative pain relief and chronic persistent postoperative pain. Anesthesiol Clin North America. 2005;23(1):21-36.

20.

Hu D, Onel E, Singla N, et al. Pharmacokinetic profile of liposome bupivacaine injection following a single administration at the surgical site. Clin Drug Investig. 2013;33(2):109-115.

American Society of Anesthesiologists Task Force on Acute Pain Management. Practice guidelines for acute pain management in the perioperative setting: an updated report by the American Society of Anesthesiologists Task Force on Acute Pain Management. Anesthesiology. 2012;116(2):248-273.

21.

Birrer KL, Anderson RL, Liu-DeRyke X, et al. Measures to improve safety of an elastomeric infusion system for pain management. Am J Health Syst Pharm. 2011;68(13):1251-1255.

22.

Food and Drug Administration. 501(k) Premarket Notification. Painbuster Infusion System. 1999. https://www.accessdata.fda. gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K980558. Accessed August 4, 2014.

23.

Food and Drug Administration. 501(k) Premarket Notification. Homepump (Disp. Elastomeric Infusion Device). 1990. https:// www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn. cfm?ID=K896546. Accessed August 4, 2014.

24.

Capdevila X, Pirat P, Bringuier S, et al; French Study Group on Continuous Peripheral Nerve Blocks. Continuous peripheral nerve blocks in hospital wards after orthopedic surgery: a multicenter prospective analysis of the quality of postoperative analgesia and complications in 1,416 patients. Anesthesiology. 2005;103(5):1035-1045.

25.

Holmström B, Rawal N, Axelsson K, et al. Risk of catheter migration during combined spinal epidural block: percutaneous epiduroscopy study. Anesth Analg. 1995;80(4):747-753.

26.

Marhofer D, Marhofer P, Triffterer L, et al. Dislocation rates of perineural catheters: a volunteer study. Br J Anaesth. 2013;111(5): 800-806.

Centers for Medicare & Medicaid Services (CMS). Hospital Consumer Assessment of Healthcare Providers and Systems. http:// www.cms.gov/Medicare/Quality-Initiatives-Patient-AssessmentInstruments/HospitalQualityInits/HospitalHCAHPS.html. Accessed August 4, 2014.

Oderda GM, Said Q, Evans RS, et al. Opioid-related adverse drug events in surgical hospitalizations: impact on costs and length of stay. Ann Pharmacother. 2007;41(3):400-406.

Wheeler M, Oderda GM, Ashburn MA, et al. Adverse events associated with postoperative opioid analgesia: a systemic review. J Pain. 2002;3(3):159-180.

Joint Commission. Sentinel event alert: use of opioids in the inpatient setting. http://www.jointcommission.org/assets/1/18/SEA_49_ opioids_8_2_12_final.pdf. Accessed August 4, 2014.

10.

Jarzyna D, Jungquist CR, Pasero C, et al. American Society for Pain Management Nursing guidelines on monitoring for opioidinduced sedation and respiratory depression. Pain Manag Nurs. 2011;12(3):118-145.e10.

11.

Dahan A, Aarts L, Smith TW. Incidence, reversal, and prevention of opioid-induced respiratory depression. Anesthesiology. 2010;112(1): 226-238.

27.

Elvir-Lazo OL, White PF. The role of multimodal analgesia in pain management after ambulatory surgery. Curr Opin Anaesthesiol. 2010;23(6):697-703.

12.

Kehlet H, Dahl JB. The value of “multimodal” or “balanced analgesia” in postoperative pain treatment. Anesth Analg. 1993;77(5): 1048-1056.

28.

13.

Ritchey RM. Optimizing postoperative pain management. Cleve Clin J Med. 2006;73(suppl 1):S72-S76.

Institute for Safe Medication Practices (July Alert). Process for handling elastomeric pain relief balls (ON-Q Painbuster and others) requires safety improvements. https://www.ismp.org/newsletters/ acutecare/articles/20090716.asp. Accessed August 4, 2014.

29.

Food and Drug Administration. Chondrolysis reported with continuously infused local anesthetics (marketed as bupivacaine, chlorprocaine, lidocaine, mepivacaine, procaine, and ropivacaine). http:// www.fda.gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm190496.htm. Accessed August 4, 2014.

30.

Ganapathy S, Amendola A, Lichfield R, et al. Elastomeric pumps for ambulatory patient controlled regional analgesia. Can J Anaesth. 2000;47(9):897-902.

14.

Joshi GP. Multimodal analgesia techniques and postoperative rehabilitation. Anesthesiol Clin North Am. 2005;23(1):185-202.

15.

Jin F, Chung F. Multimodal analgesia for postoperative pain control. J Clin Anesth. 2001;13(7):524-539.

16.

Kehlet H, Wilmore DW. Multimodal strategies to improve surgical outcome. Am J Surg. 2002;183(6):630-641.

Grant CR, Fredrickson MJ. Regional anaesthesia elastomeric pump performance after a single use and subsequent refill: a laboratory study. Anaesthesia. 2009;64(7):770-775.

32.

Hollander AB, Scovell JM, Mercado MA, et al. Perioperative injection of liposomal bupivacaine reduces narcotic medication requirement after laparo-endoscopic single site donor nephrectomy with shorter operating time than sub-fascial continuous local anesthesia. J Urol. 2014;191(suppl 4S):e828-e829.

33.

34.

35.

40.

Baxter R, Bramlett K, Onel E, et al. Impact of local administration of liposome bupivacaine for postsurgical analgesia on wound healing: a review of data from 10 perspective, controlled clinical studies. Clin Ther. 2013;35(3):312-320.

41.

Remerand F, Vuitton AS, Palud M, et al. Elastomeric pump reliability in postoperative regional anesthesia: a survey of 430 consecutive devices. Anesth Analg. 2008;107(6):2079-2084.

Pacira Pharmaceuticals, Inc. Announces US FDA Approval of EXPAREL for Postsurgical Pain Management [news release]. Parsippany, NJ. Oct 31, 2011. http://investor.pacira.com/phoenix. zhtml?c=220759&p=irol-newsArticle&ID=1913495&highlight=. Accessed August 4, 2014.

42.

Howell SB. Clinical applications of a novel sustained-release injectable drug delivery system: DepoFoam technology. Cancer J. 2001; 7(3):219-227.

Pacira Pharmaceuticals, Inc. EXPAREL Website. About DepoFoam. http://www.exparel.com/how-to-use/about-depofoam.shtml. Accessed August 4, 2014.

43.

Angst MS, Drover DR. Pharmacology of drugs formulated with DepoFoam: a sustained release drug delivery system for parenteral administration using multivesicular liposome technology. Clin Pharmacokinet. 2006;45(12):1153-1176.

Pacira Pharmaceuticals, Inc. EXPAREL Website. How to use. http://www.exparel.com/how-to-use.shtml. Accessed August 4, 2014.

44.

Emerson RH, Barrington JW, Olugbode S. Comparison of a continuous femoral nerve block to long-acting bupivacaine wound infiltration as part of a multi-modal pain program in total knee replacement. International Congress for Joint Reconstruction. http://icjr.net/log_in.htm?island=L3RhZ3MvdGFnNDA0Lmh0bQ==. Accessed August 4, 2014.

45.

Richard F, Duperier T. Pain control in bariatric patients: a prospective trial comparing the effectiveness of Exparel to the On Q pain ball. Proceedings and Abstracts of 2013 Scientific Session of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES), Baltimore, Maryland, April 17-20, 2013. Poster 423.

46.

Walker PW, White MA, Morales EE, et al. Improving postoperative pain following robotic-assisted and laparoscopic urologic surgeries: a comparison of liposome bupivacaine to ropivacaine delivered by the On-Q pain relief system. Proceedings and Abstracts of the 31st World Congress of Endourology, New Orleans, Louisiana, October 22-26, 2013. Abstract MP2B-24.

36.

White PF, Ardeleanu M, Schooley G, et al. Pharmacokinetics of depobupivacaine following infiltration in patients undergoing two types of surgery and in normal volunteers. Proceedings and Abstracts of the 2009 Annual Meeting of the. International Anesthesia Research Society. March 14-17, 2009, San Diego, CA.

37.

Golf M, Daniels SE, Onel E. A phase 3, randomized, placebo-controlled trial of DepoFoam® bupivacaine (extended-release bupivacaine local analgesic) in bunionectomy. Adv Ther. 2011;28(9): 776-788.

38.

Gorfine SR, Onel E, Patou G, et al. Bupivacaine extendedrelease liposome injection for prolonged postsurgical analgesia in patients undergoing hemorrhoidectomy: a multicenter, randomized, double-blind, placebo-controlled trial. Dis Colon Rectum. 2011;54(12):1552-1559.

39.

Viscusi ER, Sinatra R, Onel E, et al. The safety of liposome bupivacaine, a novel local analgesic formulation. Clin J Pain. 2014; 30(2):102-110.

Disclosures: Dr. Downey reported that she has acted as a consultant for Allergan, Inc. and Ethicon, Inc. Dr. Hutchins reported that he has received research grants, honoraria, and has served as a consultant for Pacira Pharmaceuticals, Inc. He also reported that he has served on the speakers’ bureaus for I-Flow, LLC and Pacira Pharmaceuticals, Inc. Dr. Pilcher reported that he has served as a consultant for Ethicon, Inc., Intuitive Surgical, Inc., and Pacira Pharmaceuticals, Inc. Dr. Rogalski reported that he has received honoraria from the American Society of Health-Systems Pharmacists and Pacira Pharmaceuticals, Inc. Disclaimer: This monograph is designed to be a summary of information. While it is detailed, it is not an exhaustive clinical review. McMahon Publishing, Pacira Pharmaceuticals, Inc., and the authors neither affirm nor deny the accuracy of the information contained herein. No liability will be assumed for the use of this monograph, and the absence of typographical errors is not guaranteed. Readers are strongly urged to consult any relevant primary literature. Copyright © 2014, McMahon Publishing, 545 West 45th Street, New York, NY 10036. Printed in the USA. All rights reserved, including the right of reproduction, in whole or in part, in any form.

SR1423

31.

PP-EX-US-0242Δ6

REPORT