CONVENTION ISSUE:
Abdominal Wall Reconstruction Conference
GENERALSURGERYNEWS.COM
June 2013 • Volume 40 • Number 6
The Independent Monthly Newspaper for the General Surgeon
Opinion
Petting the Tiger: The Age of Regulopathy
Bureaucracy Main Culprit In Physician Burnout Survey Outlines Rates, Reasons Among Different Specialties
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Ultrasound as Gold Standard for Hernia Diagnosis? Group Finds It Better Than CT; But Will It Be Widely Adopted?
B Y V ICTORIA S TERN B Y P ETER K. K IM , MD
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recently took care of a young man who had jumped into the tiger pit at the Bronx Zoo. He had studied tigers extensively and had posters of tigers lining his bedroom. He just wanted to get closer to them. As the tiger was gnawing on his leg, he reached out and petted the soft fur. He felt if he could survive this challenge, he could achieve anything in life. The excited residents debrided and washed out his claw and bite wounds, repaired his foot and shattered pelvis (injuries he sustained primarily from the 30-foot fall), and he survived. Currently, there is a witch-hunt to root out lurking evil in our hospitals that reside in the lining of Foley catheters. These devices, so commonly used during every laparotomy and laparoscopic appendectomy, now have the administrative spotlight as the culprit that will potentially bankrupt the hospital if we fail to achieve benchmarks of pay-for-performance
G
eneral surrgeons and gastroenterologists experience high levels of burnout, t due in large part to an overabund dance of bureaucratic tasks and overwhelming work hours, accoording to findings from Medscape’s d 2013 physician lifestylee survey. The online ssurvey collected responses from om 24,216 U.S. physicians in 255 specialties, 2% of whom were gastroenterologists (GIs) and 2% of whom were general surgeon ns. Of the survey respondents, 83% % of general surgeons and GIs were meen; 60% or more were 45 years and older; aand the majority were board certified (84% (8 of general surgeons and 94% off GI GIs) GIs). )
see page 4
B Y C HRISTINA F RANGOU ariatric surgery patients continue to show significant improvements over their baseline diabetic status, glycemic control and cardiovascular risk up to nine years after surgery, according to the results of a new study.
INSIDE Stitches
Clinical Review
Surgeons’ Lounge
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The First Lap Chole in Europe: A ‘Criminal’ Is Vindicated
More than 85% of patients met the goals set out by the American Diabetes Association nearly 10 years later. However, the study also showed that 20% of patients had a recurrence of their type 2 diabetes mellitus (T2DM) after an initial remission,
urgeons from Vanderbilt University are recommending that dynamic abdominal sonography for hernia (DASH) replace computed tomography (CT) as the gold standard for the radiographic identification and characterization of incisional hernia. “The DASH examination is an accurate alternative to the CT scan for diagnosing abdominal wall hernias, with additional benefits of no radiation exposure and instant bedside interpretation,” concluded Benjamin K. Poulose, MD, MPH, assistant professor of general surgery, Vanderbilt University Medical Center, Nashville, Tenn., and his colleagues in a report published in the March edition of the Journal of the American College of Surgeons (216:447-453). Dr. Poulose, co-author William B. Beck and their colleagues studied 181 patients who underwent surgeon-performed DASH, as well as CT scans of the abdomen and pelvis. Surgeons and radiologists read the CT results. Analysis showed the DASH examination accurately identified incisional hernias, with a positive predictive value of 91% and negative predictive value of 97%. Moreover, DASH exams identified clinically apparent hernias missed by surgeon-interpreted CT.
see BARIATRIC OUTCOMES page 19
see ABDOMINAL SONOGRAPHY page 9
see BURNOUT page 15
Diabetes Recurrence Remains Issue, but Positive Effects Prevail
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XCM BIOLOGIC® Tissue Matrix for Recurrent Hernia Repairs
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Positive Outcomes for Bariatric Surgery Stretch Nine Years in Study
see PETTING THE TIGER page 26
PROCEDURAL BREAKTHROUGH
B Y C HRISTINA F RANGOU
Postoperative Pain Coverage of the 12th Management in Annual Surgery of Anorectal Surgery the Foregut Symposium GSN is now on
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GSN Editorial
GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JUNE 2013
A Great Read Frederick L. Greene, MD, FACS Clinical Professor of Surgery UNC School of Medicine Chapel Hill, North Carolina
As a former English major, I often have been wracked with self-criticism for failing to read enough good books during my medical career. Too much of my time has been spent perusing medical journals and absorbing surgical texts and other related material. But on occasions, I have strayed from this traditional habit and have read both fiction and nonfiction, which has been rewarding and has even added to my ability to engage in conversation with friends and nonmedical colleagues. I also have become particularly intrigued when a fellow surgeon authors a nonmedical work. This always piques my interest and arouses the enviable thought that maybe I could write like that! Such is the feeling engendered in Cliff Walkingg (Cedar Ledge Publishing, 2011) by Stephen Russell Payne, MD. Steve Payne, a practicing surgeon from
Vermont, has published fiction, nonfiction and poetry in a number of northeastern periodicals. His first novel, Cliff Walking, is a spellbinding tale of love, domestic violence, rural bigotry, courtroom intrigue and mentoring relationships that unfolds in an idyllic community on the rocky coast of Maine. The characters are superbly crafted with the artfulness of a painter as Steve Payne creates each with brush strokes that engender warmth, admiration, sympathy, fear or loathing. The story line is woven with a meticulous yet rapidly flowing style that creates a sense of unstoppable energy with the turn of every page. The juxtaposition of the physician and storyteller is not unique. Some who come to mind are Anton Chekhov (multiple short stories and The Cherry Orchard), d Robin Cook (Coma), Michael Crichton (The Andromeda Strain), Arthur Conan Doyle (The Adventures of Sherlock Holmes), Khaled Hosseini (The Kite Runner) r and Abraham Verghese (Cutting For Stone). I especially have admired those who blend their work as physicians and authors. Steve Payne continues to be an active
Senior Medical Adviser Frederick L. Greene, MD Charlotte, NC General Surgery, Laparoscopy, Surgical Oncology
Editorial Advisory Board Maurice E. Arregui, MD Indianapolis, IN General Surgery, Laparoscopy, Surgical Oncology, Ultrasound, Endoscopy
Kay Ball, RN, CNOR, FAAN Lewis Center, OH Nursing
Philip S. Barie, MD, MBA New York, NY Critical Care/Trauma, Surgical Infection
L.D. Britt, MD, MPH Norfolk, VA General Surgery, Trauma/Critical Care
David Earle, MD Springfield, MA General Surgery, Laparoscopy
James Forrest Calland, MD Philadelphia, PA General Surgery, Trauma Surgery
Edward Felix, MD Fresno, CA General Surgery, Laparoscopy
Robert J. Fitzgibbons Jr., MD Omaha, NE General Surgery, Laparoscopy, Surgical Oncology
David R. Flum, MD, MPH Seattle, WA General Surgery, Outcomes Research
Michael Goldfarb, MD
Leo A. Gordon, MD Los Angeles, CA General Surgery, Laparoscopy, Surgical Education
Gary Hoffman, MD Los Angeles, CA Colorectal Surgery
Namir Katkhouda, MD Los Angeles, CA Laparoscopy
surgeon while following his passion as a writer. Cliff Walkingg depicts the beauty of the coast of eastern Maine and the unique individuals whoo intersect in this envi-ronment. More impor-tantly, the monograph’’s title refers to the “fin ne line� and the precipicees that we all traverse thaat could cause us to lose baalance if we are not careful. ul Those of you who are faithful readers of GSN N will recognize the significant departure of this editorial from my usual opinion dialogues about our lives as surgeons. I felt so moved by Payne’s book that I wanted to make sure that my fellow surgeons could take the opportunity to be as moved. One pervasive theme in Payne’s novel is the nightmare and global consequences brought about by domestic abuse. We, as surgeons, have seen the traumatic and emotional consequences resulting from abusive relationships. Unfortunately, our total experience
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Š 2013 by McMahon Publishing, New York, NY 10036. All rights reserved. General Surgery News (ISSN 1099-4122) is published monthly by McMahon Publishing, Sales, Production and Editorial Offices: 545 W. 45th 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.
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is fr frequently in the emergency department or operating rooom. This intervention is obvviously too late. Our colleaagues in primary care have higghlighted the prevention, orr at least early recognition, off this syndrome. My conceern is that the signs and syymptoms of a battered patient may easily escape p us in the outpatient setu tting unless we are sensitive aand open to the diagnosis (see my GSN N editorial, December 2012, page 3). The theme of Cliff Walkingg brings this concept to the boiling point. Kudos to Stephen Payne for his successful surgical career and for telling a story that saddened me to reach the final page. The author blends his many surgical experiences in caring for women with breast cancer, helping those suffering from the ravages of abusive relationships and understanding the consequences of addiction to create a compelling and unforgettable story. Experience it for yourself—Cliff Walkingg is a great read.
Mission Statement It is the mission of General Surgery News 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.
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.
INFECTIOUS DISEASE SPECIAL EDITION
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THE SCIENCE BEHIND POSITIVE PATIENT OUTCOMES
XCM BIOLOGIC® Tissue Matrix for Recurrent Hernia Repairs Juvonda Hodge, MD General Surgeon University of South Alabama Health System Assistant Professor of Surgery University of South Alabama Mobile, Alabama
Introduction Although ventral hernia is a frequent complication of abdominal surgery, there are many surgical approaches for reconstructing the abdominal wall. Compared with suture repairs, mesh repairs have been shown to be more effective with regard to recurrence,1,2 and the use of mesh is standard in all but the smallest defects.3 Surgeons can select from a number of available synthetic meshes and biologic grafts, although mesh selection is influenced by patient- and wound-related factors. Synthetic mesh has been associated with complications, particularly in complex repairs,2,4 ranging from short-term morbidity to high recurrence rates—a worrisome prospect for surgeons and patients alike. High complication rates with synthetic mesh have led to the development of biologic grafts, which provide an extracellular matrix (ECM) scaffolding that is necessary for tissue repair.2,5 A prerequisite for good clinical outcomes in mesh repairs is constructive tissue remodeling, which is more likely to occur with the use of a biologic material.6 Tissue remodeling is clinically characterized by revascularization and incorporation of the mesh into native tissue, thus offering good prospects for durable, effective outcomes. XCM BIOLOGIC Tissue Matrix, a sterile, noncrosslinked 3-dimensional ECM derived from porcine dermis, offers strength and properties to facilitate soft tissue healing with good host acceptance and is available in a range of sizes (2 × 4 cm to 20 × 30 cm).7,8 XCM BIOLOGIC Tissue Matrix undergoes a proprietary manufacturing process that removes cells and DNA, and minimizes damage to native tissue architecture.7
Planning for Successful Repair Durable repair of ventral hernia requires the surgeon’s attention to a myriad of details perioperatively, according to Juvonda Hodge, MD, assistant professor of surgery at the University of South Alabama in Mobile, Alabama. Patients referred to
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Dr. Hodge often have recurrent hernias that are associated with substantial scarring. In some cases, she has to remove previously implanted mesh before conducting the repair. Dr. Hodge attempts to determine the reasons for recurrence to guide her selection of surgical approach and materials. “One of the most difficult things in dealing with recurrent hernia is first to figure out why the patient recurred,” she said. A review of the operative report may provide clues as to why the repair failed; possible explanations can include suturing technique or insufficient overlap at the attachment.3 “The key thing is preoperative preparation—getting all the information that you can about the patient, whether it’s computed tomography scans, the old operative report, the patient’s comorbidities, and whether you can get those in better control,” Dr. Hodge said. Visceral bowel adhesions are a predictable complication with mesh repairs. Biologic meshes, due to their origin, lack the materials known to stick to the bowel like polypropylene.4,9,10 Morbidity from mesh-related infection can be serious (eg, enterocutaneous fistulas, reoperation),11 and infection is a risk factor for hernia recurrence.3
Working With a Biologic Mesh Implant Surgeons repairing midline defects face the dual task of repairing the abdominal wall and achieving cutaneous coverage.12 Dr. Hodge visualizes a 3-part procedure: getting into the abdomen and locating different hernia pockets, taking down adhesions, and placing the mesh. Intraoperative vigilance is required, taking care to avoid any break in technique and irrigating and closely inspecting the field so as not to overlook any inadvertent bowel injury. Dr. Hodge generally places mesh as an underlay, ideally with reapproximation of the rectus in the midline and using components separation as needed, achieving moderate
GENERAL SURGERY NEWS • JUNE 2013
Figure 1. Creation of elevated flaps to expose the fascia. Image courtesy of Juvonda Hodge, MD.
tension. Care is taken to debride tissue where necessary and to irrigate the abdomen. She places 2 or 3 drains to minimize development of seroma. “Anytime you develop flaps or separate components, patients are going to develop seromas, so that’s probably one of the most important steps when using a biologic,” said Dr. Hodge. She closes subcutaneous tissue with 0-polypropylene mesh sutures in an interrupted fashion and closes skin with a staple. Biologic grafts can be classified by source material (human- or animal-derived), differential processing techniques, and handling characteristics.2,6 Among animalderived grafts, strength is a major concern to surgeons because of the potential effect on the durability of the ventral hernia repair as well as functional outcome. XCM BIOLOGIC Tissue Matrix was evaluated in preclinical studies that demonstrated effectiveness throughout the healing process, during which it sustained tensile strengths in the surgical site that were greater than those of native tissue and demonstrated good suture pullout strength.7,8,13 Manufacturing processes also have been shown to affect outcomes in preclinical
studies. In a primate study that evaluated functional outcomes and host responses to mesh implants that underwent various decellularization methods, some processed meshes led to modified collagen matrices and were associated with scarring, inflammatory responses, graft pleating, and poor resorption.14 Preclinical evaluations performed in animals of XCM BIOLOGIC Tissue Matrix demonstrated that it exhibits cellular infiltration, minimal inflammatory response, and low surgical site morbidity.13 Many cytokines and growth factors that are present in native tissue are retained in XCM BIOLOGIC Tissue Matrix after decellularization.15 In Dr. Hodge’s experience, XCM BIOLOGIC Tissue Matrix is easy to use and effective, even in complex repairs. “It incorporates very well; that’s one of the good things about it,” she said. “It has some stretch but not so much that you worry about your repair failing, as was the case with some of the earlier biologics.” Dr. Hodge also appreciates that XCM BIOLOGIC Tissue Matrix is easy to suture, prehydrated, and “is ready to go from the package,” thus eliminating preparation time and risk for contamination during soaking.
Supported by
Figure 2. Underlay technique to secure XCM BIOLOGIC.
Figure 3. Fascia closure overlying XCM BIOLOGIC following repair.
Image courtesy of Juvonda Hodge, MD.
Image courtesy of Juvonda Hodge, MD.
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abdominal binder and the seroma did not recur with any significance. The remaining drain, binder, and staples were removed at the next visit.
Conclusion The patient’s recovery was good and he was able to return to work approximately 3 weeks postoperatively. XCM BIOLOGIC Tissue Matrix was selected for this complex abdominal reconstruction on the basis of evidence and experience supporting its demonstrated balance of strength and integration. The manufacturing process allows retention of cytokines, growth factors, and ECM components with minimal damage to tissue architecture. Preclinical studies demonstrate that XCM BIOLOGIC Tissue Matrix facilitates tissue repair throughout the postoperative period, sustained strength greater than native tissue, and minimal inflammatory response.
References
4. Gaertner WN, Bonsack ME, Delaney JP. Experimental evaluation of four biologic prostheses for ventral hernia repair. J Gastrointest Surg. 2007;11(10):1275-1285. 5. Badylak SF. The extracellular matrix as a scaffold for tissue reconstruction. Semin Cell Dev Biol. 2002;13(5):377-383. 6. Rosen MJ. Biologic mesh for abdominal wall reconstruction: a critical appraisal. Am Surg. 2010;76(1):1-6. 7. XCM biologic tissue matrix [general brochure]. West Chester, PA: Synthes, Inc.; 2010. 8. Data on file. Kensey Nash Corporation; 2010. 9. Gaertner WB, Bonsack ME, Delaney JP. Visceral adhesions to hernia prostheses.Hernia. 2010; 14(4):375-381. 10. Dinsmore RC, Calton WC Jr, Harvey SB, et al. Prevention of adhesions to polypropylene mesh in a traumatized bowel model. J Am Coll Surg. 2000;191(2):131-136. 11. Kingsnorth A. The management of incisional hernia. Ann R Coll Surg Engl. 2006;88(3):252-260. 12. Dumanian GA. In: Grabb WC, Thorne CH, eds. Grabb & Smith’s Plastic Surgery. 6th ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2007:670-675. 13. Hackett ES, Harilal D, Bowley C, et al. Evaluation of porcine hydrated dermis augmented repair in a fascial defect model. J Biomed Mater Res B Appl Biomater. 2010;96(1):134-138.
1. Burger JW, Luijendijk RW, Hop SCJ, et al. Long-term follow-up of a randomized controlled trial of suture versus mesh repair of incisional hernia. Ann Surg. 2004;240(4):578-585.
14. Sandor M, Xu H, Connor J, et al. Host response to implanted porcine-derived biologic materials in a primate model of abdominal wall repair. Tissue Eng Part A. 2008;14(12):2021-2031.
2. Harth KC, Rosen MJ. Repair of ventral abdominal wall hernias. In: Ashley SW, Wilmore SW, eds. ACS Surgery: Principles and Practice. Ontario, Canada: Decker Intellectual Properties; 2010:1-20.
15. Hoganson DM, O’Doherty EM, Owens GE, et al. The retention of extracellular matrix proteins and angiogenic and mitogenic cytokines in a decellularized porcine dermis. Biomaterial. 2010;31(26):6730-6737.
3. Luijendijk RW, Hop WCJ, Van den Tol P, et al. A comparison of suture repair with mesh repair for incisional hernia. N Engl J Med. 2000;343(6):392-398.
J12289-A
A 50-year-old obese man with 3 prior laparotomies was referred for recurrent ventral hernia repair, secondary to an emergent colostomy for perforated diverticulitis. Initial hernia developed after stoma takedown and had been repaired with fascia put to the midline with a synthetic mesh prosthetic; a second hernia developed approximately 9 months later. The patient worked at a sedentary desk job. Although loss of abdominal domain was noted, comorbidities were not remarkable and included anxiety. The patient was taken into surgery and the abdominal wall was entered. Peak airway pressures were monitored at the outset to ensure they were not more than 10 mm Hg. Broad-spectrum antibiotics were administered preoperatively. No infection of the synthetic prosthetic mesh was observed intraoperatively; however, the patient was found to have extensive and very dense adhesions of the bowel to the prosthetic mesh, necessitating a small bowel resection, anastomosis, and repair of midline hernia and repair of hernia at the stomal site. Elevated flaps were created to expose fascia (Figure 1); overlying fat was removed from the fascia to facilitate reapproximation of the fascia to the midline. The abdomen was irrigated and as much pooled blood as possible was removed.
Abdomen was inspected to minimize risk from unrecognized enterotomy. XCM BIOLOGIC Tissue Matrix mesh was placed in underlay position (Figure 2), and native tissue reapproximated with 5 cm of overlap on either side of the defect (Figure 3). Suturing with 0-polypropylene mesh was done in interrupted fashion; subcutaneous drains were placed. Because of concerns about patient’s weight and loss of domain, peak airway pressures again were checked and found to be less than 10 mm Hg. A nasogastric tube was placed to monitor gastrointestinal function, and an abdominal binder was applied. The immediate perioperative period was uneventful. The patient was hospitalized for several days and received a standard regimen of enoxaparin for prophylaxis of deep vein thrombosis; early ambulation was demonstrated and no thrombosis was detected. Postoperative edema was not significant; spirometer-measured pulmonary function was good. After bowel function returned, the patient was discharged home with drains intact. He was seen postoperatively several times. The patient inadvertently dislodged one drain, but no attendant complications were observed. A small seroma developed subsequently in the mid-portion of the wound and was drained successfully without sequelae. The patient was placed back in the
BB136
Case Presentationa
Results from case studies are not predictive of results in other cases. Results in other cases may vary.
GENERAL SURGERY NEWS • JUNE 2013
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In the News
GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JUNE 2013
Investigational Device Prolongs Survival Of Livers for Transplantation May Increase Availability of Donor Livers B Y V ICTORIA S TERN
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atients who need a new liver to survive must hope that they are one of the approximately 13,000 liver transplant recipients in the United States and Europe each year. But with 30,000 people on waiting lists, and with only ice keeping livers for transplantation viable for up to 14 hours, the odds are not always in the patients’ favor. Each year, more than 2,000 livers don’t survive the journey to their new home. “Preserving organs by cooling them down is far from perfect,” said Peter J. Friend, MD, director of transplantation surgery, Nuffield Department of Surgical Sciences, Oxford Transplant Centre, U.K. “Although cooling the organ on ice slows its metabolism by a factor of 10, the liver continues to metabA liver 30 seconds after connection to the OrganOx Metra device. Parts olize slowly and deteriorates as a result. It’s hard to of the organ are still cold, while other parts are warm and perfused with tell which organs will work and which ones won’t.” red cell solution. Now, however, Dr. Friend and his colleague Constantin Coussios, PhD, professor of biomedical engineering at the University of Oxford, have devised a novel technology that may be a game changer: A machine that allows the liver to function for up to 24 hours, as though it were still inside a human body. On March 15, the team of engineers and physicians announced the preliminary success of this machine, which has safely transported livers to two transplant recipients at King’s College Hospital in London. “The first two cases went very well,” said Dr. Friend. “They weren’t exceptionally high risk, but the machine did what it was supposed to do.”
Long Time in the Making In 1994, Drs. Friend and Coussios devised the idea for the technology, but faced several engineering challenges while developing it. The co-inventors needed to create an artificial environment, that could simulate the key functions of the human body, including pumping blood and providing nutrition to the organ. These functions not only had to be automated to make it possible for transplant surgeons around the globe to use the technology, but also small enough for easy transportability. After 15 years of developing and tweaking the design, Drs. Friend and Coussios have created a technology that appears to meet these requirements. The liver’s main blood vessels are connected to tubes on the machine, which automatically regulate the environment around the liver. The device maintains the liver at body temperature and infuses it with oxygenated red blood cells, nutrition such as glucose and amino acids, and other chemicals to create a physiologic environment that mimics the human body. The liver is not only kept alive, but it continues to produce bile as well. Additionally, the machine is compact. “It’s about the size of a supermarket trolley [shopping cart], which means it can go in back of ambulance, small plane or helicopter,” Dr. Friend said. “Size was very important because we knew there was no point in making a machine if it couldn’t fit in the back of a vehicle.”
The liver 5 minutes after connection to the OrganOx Metra, now fully perfused and at physiologic temperature.
The King’s College Hospital, Oxford University and OrganOx team successfully connects the first human liver for transplantation to the OrganOx Metra device.
Notably, the machine also may allow the liver to recover from injuries it sustained during or before removal, Dr. Friend pointed out. This function of the device is particularly important because it could expand the number of viable livers for transplantation. In recent years, the demand for livers has grown, as liver disease has become more common, whereas the quality of donor livers has diminished. “More and more, donors tend to be older, and have a high body mass index or coexisting major health problems,” Dr. Friend noted. “Because of the increasing demand for livers, we are having to use organs we would have once said no to.” Now with the machine, transplant surgeons can test how well the liver is working during preservation. “If the liver works on the pump, then we can assume it will work in the recipient,” said Maria B. Majella Doyle, MD, MBA, associate professor of surgery at Washington University School of Medicine, St. Louis, who specializes in liver transplantation. Dr. Doyle was not involved in developing this pump, but she is performing research to develop a different liver pump system, one that also keeps the liver at physiologic temperature. In April 2008, Drs. Friend and Coussios cofounded a company called OrganOx Ltd., to continue their University of Oxford research. With financial support from the Royal Society and several venture capital funds in the United Kingdom, the company has been working to bring the technology to patients. Although promising, the device still needs more testing. The U.K. team has begun a pilot trial at King’s College Hospital to test the ability of the machine to transport livers to 20 transplant patients. If the trial is successful, OrganOx then could apply for marketing authority, which would make the device commercially available in Europe. “If the machine is as good as we believe, we would expect a significant increase in patients who get liver transplants,” Dr. Friend said. According to Dr. Doyle, the group is “ahead of the game.” To her knowledge, two other teams are developing physiologic-temperature liver pump systems—Dr. Doyle and her colleagues William Chapman, MD, and Vijay Subramanian, MD, at Washington University, and Constantino Fondevila, MD, PhD, at the University of Barcelona—but both are at more preliminary stages. “The U.K. team is the first to produce human data with the pump and show it’s safe and viable as a liver transplantation device. Now, it’s important to make sure the technology is foolproof and cost-effective,” Dr. Doyle said. “The U.K. team needs to be highly commended. The pump is a great achievement.”
Stitches
GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JUNE 2013
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The First Lap Chole in Europe: A ‘Criminal’ Is Vindicated B Y V ICTORIA S TERN
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erman surgeon Carl Johann August Langenbuch, MD, performed the first open cholecystectomy in Berlin in July 1882. More than 100 years later, on Sept. 12, 1985, Erich Mühe, MD, a surgeon from a small town in Germany, performed the first laparoscopic cholecystectomy. Although it took more than a century for the gallbladder to be removed laparoscopically, the procedure soon spread like a firestorm and helped transform the field of surgery, said Edward Felix, MD, assistant clinical professor of surgery at the University of California, and director of bariatric surgery, Clovis Hospital, Fresno, Calif. But Dr. Mühe’s contributions were not recognized until years later because he encountered stifling resistance from the academic community in Germany. During that time, laparoscopic cholecystectomy caught on in France, the United States and soon the rest of the world, eventually becoming standard practice. “Dr. Mühe introduced laparoscopic cholecystectomy, but was vilified for his work,” said Frederick Greene, MD, FACS, clinical professor of surgery, University of North Carolina School of Medicine, Chapel Hill, and former president of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES). “Eventually, he was exonerated and given appropriate praise. Although his contributions were greatly important, Dr. Mühe’s experience goes to show you what happens when you’re a little ahead of your time.” Dr. Mühe was born on May 23, 1938, and graduated from medical school in 1966, at 28 years old. He became an assistant in the surgical clinic at the University of Erlangen, Germany, where he completed his surgical training in 1973. In September 1980, Dr. Mühe learned that a German gynecologist, Kurt Semm, MD, had performed an appendectomy laparoscopically, and he became intrigued by minimally invasive surgery. By 1982, Dr. Mühe had moved to Böblingen, Germany, a small town several hours west of Munich, known primarily for its automobile and computer industries, to take over as the head of surgery at Böblingen County Hospital. After learning laparoscopy from German gynecologist, Willi-Rinehard Braumann, MD, Dr. Mühe wondered whether it would be possible to remove a gallbladder using Dr. Semm’s technique. But Dr. Mühe noted that Dr. Semm’s equipment seemed too narrow for a bloated gallbladder to squeeze through (J ( Minim Access Surgg 2011;7:165-168).
One day, Dr. Mühe, who was an avid cyclist, realized he could access the abdomen through a tube shaped much like the one on his bicycle. Using this framework, he collaborated with Hans Frost, who worked at the German manufacturing company WISAP (now called Blue Cap AG) to develop a laparoscope through which he could fit a gallbladder. Together, the men created the could could could could “galloscope,” which Dr. Mühe used to perform the first laparoscopic cholecystectomy. During the procedure, Dr. Mühe inserted the galloscope, fitted with sideviewing optics, through the umbilicus and into the peritoneal cavity to insufflate the abdomen with carbon dioxide. He made two or three more small incisions of 3 to 4 cm in the lower abdomen, inserting a pistol grip applier with hemoclips to ligate and pistol grip scissors to cut between the cystic duct and artery. He then removed the gallbladder through the galloscope. Dr. Mühe described his pioneering effort in Endoscopy (1992;24:754-758). Dr. Mühe modified his technique after performing six procedures, eliminating the need for pneumoperitoneum and the lens. Instead, he accessed the gallbladder at the right costal margin, which made a “roof ” directly over the gallbladder, creating just one 2.5-cm incision. He used a trocar sleeve and a light cable to perform “open tube” cholecystectomies, which he thought was a simpler technique that also provided better cosmesis.
In April 1986, after performing 94 procedures, Dr. Mühe presented his laparoscopic cholecystectomy technique to the German Surgical Society (GSS) Congress. In October, Dr. Mühe gave a lecture on cholecystectomy without laparotomy to the Lower Rhine-Westphalian Society. In both instances, the audience reacted with vehement disapproval, said J. Barry McKernan, MD, PhD, the surgeon credited with performing the first laparoscopic cholecystectomy in the United States. The academic elite in Germany considered Dr. Mühe’s work as dangerous. By 1987, Dr. Mühe had performed many laparoscopic cholecystectomies without a hitch. In March of that year, however, he faced a problem with a particularly difficult gallbladder. His patient was moved to the ICU, which was run by an anesthesiologist who said the patient was too sick to be operated on. The patient died of complications soon after. “Instead of the malpractice cases we have in the United States, Dr. Mühe was brought before the criminal court for manslaughter,” said Michael Kavic, MD, professor of surgery at Northeastern Ohio Universities College of Medicine in Rootstown, Ohio, and founding member of the Journal of the Society of Laparoendoscopic Surgeons. “He was dragged through courts for several years, and was harassed and hounded. Those years almost broke him.” To add fuel to the fire, in a June 1986 article, a German magazine, Medical Review, suggested that Dr. Mühe had
‘Instead of the malpractice cases we have in the United States, Dr. Mühe was brought before the criminal court for manslaughter. He was dragged through courts for several years, and was harassed and hounded. Those years almost broke him.’ —Michael Kavic, MD
The “Galloscope” of Mühe had side-view optics, an instrumentation channel with valves, light conductor, and duct for creating pneumoperitoneum. From: JSLS. 1998;2(4):341-346.
actually taken his bicycle frame and used it to perform his laparoscopic cholecystectomies, Dr. Kavic said. It took a few years, but in 1990, Erich Mühe, MD Dr. Mühe finally From: JSLS. 1998;2(4):341-346. found vindication. A group of his peers had recognized that the patient had not died as a result of the procedure itself, but because of negligence by those who ran the ICU. By that time, laparoscopic cholecystectomy had spread across the United States, and the medical community outside of Germany knew little to nothing of Dr. Mühe’s contribution. Years later, SAGES recognized Dr. Mühe for performing the first laparoscopic cholecystectomy, and invited him to present on his experience in March 1999 at its annual meeting in San Antonio. Each country was isolated from the other,” Dr. Kavic said. “No one really knew what was going on in Germany, France, the United States, because back then the revolution in personal communication had not yet taken place. Making a transatlantic telephone call was a huge deal and a huge expense, and if you had published an article in France or Germany, it stayed there.”
Lap Chole in France For a time, surgeons in France were hailed as the first to perform laparoscopic cholecystectomy. In 1988, Francois Dubois, a surgeon practicing in Paris, was performing mini-laparoscopic cholecystectomies, removing the gallbladder through a one-inch incision using a headlight for illumination, recalled Dr. McKernan. Dr. Dubois bragged to the nurse in the operating room, asking her whether anybody had ever seen a gallbladder come out through such a small incision. This nurse, who had worked previously with a surgeon in Lyon, France, Phillipe Mouret, MD, replied that yes, in fact, she had. Dr. Dubois called Dr. Mouret immediately, and the two met in Paris. Dr. Mouret brought a video and pictures of the procedure. Soon after the meeting, Dr. Dubois was performing laparoscopic cholecystectomy using Dr. Mouret’s technique, and was the first to publish on the technique in France. Several months earlier, on March 17, 1987, Dr. Mouret had performed his first laparoscopic cholecystectomy on a 50-year-old woman suffering from painful pelvic adhesions and symptomatic gallbladder lithiasis. He was scheduled to perform two operations: gynecologic see LAP CHOLE page 8
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STITCHES 2013
LAP CHOLE
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adhesiolysis, and cholecystectomy. According to an article he wrote on his experience ((Ann Acad Medd 1996;25:744747), Dr. Mouret used a hook dissector to free the gallbladder, and then sealed the cystic artery and clipped the cystic duct with a clip applier. Because there was no video on which to view the inside of the abdomen, Dr. Mouret had to lie on the patient’s thigh in order to look through the laparoscope ((J Minim Access Surgg 2011;7:165-168). In 1988, Jacques Perissat, MD, a renowned gastrointestinal and laparoscopic surgeon who worked at Bordeaux Segalen University in France, saw Dr. Dubois’ laparoscopic cholecystectomy. Dr. Perissat helped modify the technique by using extracorporeal shock wave lithotripsy to break up gallstones in a noninvasive way. With Dr. Perissat’s support, the procedure gained credibility in France’s academic climate, which normally resisted change, Dr. Kavic said. Dr. Mühe finally received the GSS Anniversary Award for his pioneering work in endoscopic surgery in 1992, the same society that had rejected his ideas six years earlier. The president of GSS, Franz Gall, MD, called Dr. Mühe’s work in laparoscopic cholecystectomy “one of the greatest original achievements of German medicine in recent history” ((JSLS S 2001;5:89-94). By this time, the laparoscopic revolution was in full force. “Many things had come together at the same time,” Dr. Kavic recalled. “We had the laparoscope, a camera that could videotape procedures and enabled surgeons to teach and spread the word among colleagues who didn’t speak the same language.”
In the News
GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JUNE 2013
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Unlike CT, DASH can be performed without exposing patients to ionizing radiation. Additionally, DASH provides realtime results available to both the surgeon and patient for clinical decision making. Speaking at the 2013 Annual Hernia Repair Meeting in Orlando, Fla., Dr. Poulose said DASH has the potential to change clinical practice and significantly improve research in the field of hernia. Currently, no reliable, cost-effective means of detecting hernias exists. “Using clinical exams alone, we may be missing 20% to 30% of recurrences and follow-up CT scanning is prohibitively expensive with a concomitant radiation risk. DASH could easily facilitate longterm follow-up of hernia patients,” said Dr. Poulose. The patients studied had a prior abdominal or pelvic operation performed via incision of the anterior abdominal wall. All had a viewable CT scan of the abdomen and pelvis in the six months before enrollment in the study. A surgeon who successfully completed the American College of Surgeons Ultrasound for Surgeons Basic Course performed DASH. DASH results were then compared with the gold standard, surgeon-interpreted CT, along with the clinical exam results and radiologist interpretations of the CTs. DASH exams revealed 107 incisional hernias, including four missed by the surgeon-interpreted CT scans. All missed hernias were in patients with “fairly thick” hernia sacs that were difficult to distinguish radiographically from healthy adjacent fascia, although these hernias were clinically obvious. As well, DASH identified 28 incisional hernias in patients who were deemed not to have hernias based on history and physical exam alone. The most challenging hernias to detect with DASH were small umbilical hernias in obese patients. Investigators said CT could help with diagnosis in difficult situations. The U.S. machine varies in cost between $15,000 and $30,000, depending on its age and its features. Investigators argue that clinical practices can offset the cost through billing for the procedure itself. Surgeons also can use machines already installed in their practices by adapting the machines to evaluate the anterior abdominal wall, said investigators. They caution, however, that practitioners need to meet the credentialing and billing requirements of their institution. Internal data from Vanderbilt indicates that about 100 DASH exams need to be performed to recoup the initial cost of the machine and maintenance fees. Robert J. Fitzgibbons Jr., MD, professor of surgery and chief of general surgery
at Creighton University in Omaha, Neb., said the DASH test appears to be a viable option but may have difficulty gaining widespread acceptance. “There are two limitations to adoption of this technology: the large up-front outlay of cash required to purchase the hardware and the fact that ultrasonography really has not caught on with surgeons. “I’ve thought throughout my career that ultrasonography would play a much larger role in general surgery practice. It is a natural. The surgeon has a unique perspective in that the examination can be obtained and the findings unequivocally confirmed
‘I sometimes wonder if surgeons have trouble thinking in the twodimensional world of ultrasound while working in the three-dimensional environment of surgery.’ —Robert E. Fitzgibbons Jr., MD or denied with a subsequent open procedure. … But it has never really caught
on outside of breast surgery. I sometimes wonder if surgeons have trouble thinking in the two-dimensional world of ultrasound while working in the three-dimensional environment of surgery.” DASH requires formal training via the American College of Surgeons Ultrasound for Surgeons Basic Course. Seventeen patients in the study were evaluated to assess interrated reliability with three surgeons performing DASH and evaluating the corresponding CT images. Identical results were obtained for two surgeons with discordant results found in three patients with the third surgeon.
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Clinical Review
GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JUNE 2013
Postoperative Pain Management in Anorectal Surgery New Techniques: Antidotes or Anecdotes? B Y G ARY H. H OFFMAN , MD S TEPHEN Y OO , MD
AND
L OS A NGELES C OLON AND R ECTAL S URGICAL A SSOCIATES
A
norectal surgery: often a painful cure; and worse, the performance of the curative operation is only 50% of the battle. Sleepless nights await both the patient and the surgeon once the cure has been inflicted. Postoperative pain relief represents the other 50% of the battle. Thirty-five million ambulatory surgical procedures are performed annually in
the United States.1 Effective pain control is essential for recovery, improved wound healing and reduced hospital admission rates. In evaluating hospital admission data for 20,817 patients undergoing same-day surgery, 1.5% returned to the hospital in the postoperative period.2 Pain was the most common reason. There has been little progress in addressing this challenge.
Can We Do B Better?? Surveys from 1993, 2003 and 2012 have demonstrated that postsurgical pain is common and that a similar distribution of the quality of perceived pain has remained unchanged.3-5 Patient pain scores are now being used as metrics in measuring the adequacy of care. Surveys from the Hospital Consumer Assessment of Healthcare Providers and Systems during 2008 and 2009 confirmed the need for improving postoperative pain management. Mean pain management scores were 68 of 100 in 3,765 participating hospitals. The government and other third-party payers may use data of this type in determining reimbursement rates. Surgeons and hospitals alike are being pushed to demonstrate improvement.
Educating Patients
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Several areas of improvement can help to reduce postsurgical pain. A first line of defense involves managing patient expectations. Patient education goes far in this regard. Preoperatively, patients should be advised that their postoperative discomfort may occur along a spectrum of intensity and that their pain intensity and frequency may change constantly until healing is final. Allowing patients to “prepare for the worst� actually helps with their expectations rather than hinders them. A frank discussion about postoperative pain management options reassures patients and helps them to understand that relief is available. With the advent of newer pain management techniques, procedures are available that may allow for sophisticated postoperative strategies to handle any discomfort. Transdermal patches, epidural injections and new oral pain medications are but a few strategies that will allow the patient and the surgeon to sleep in the days and weeks following anorectal surgery. A preoperative consultation with a pain management specialist may be worth its weight in sleep. Initiating the use of stool softeners before the operation may help in easing the pain of the first postoperative bowel movement.
Educating the Operating Team
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Urinary retention is the bane of the anorectal surgeon. The discomfort of urinary retention adds to the pain from the operation. It is recommended that the operation be performed using a safe but limited volume of IV fluids. Should retention be encountered postoperatively, an attempt to void while sitting in a warm tub may be all that is necessary to achieve symptomatic relief. However,
Clinical Review
GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JUNE 2013 G
p prolonged urinary retention may worsen matters and might indicate a more serim oous underlying problem. Patients should be instructed to contact their surgeon earb llier rather than later in their course.
Educating the Surgeon Another area of improvement has evolved through the efforts of surgeons and industry working together to develop less traumatic procedures. An example of this collaboration has been in the area of the hemorrhoidectomy. Procedure for prolapse and hemorrhoids (PPH) and transarterial hemorrhoidal dearterialization (THD) have been associated with diminishing, although not vanishing, postoperative pain. Procedures such as these are performed proximal to the dentate line and result in less pain because of the paucity of pain fibers in this region. These procedures require careful patient selection and are best suited for stage II/ III hemorrhoids with prolapse and a limited external hemorrhoidal component. When PPH and THD are compared with the Milligan-Morgan technique for stage IV hemorrhoids, the duration and depth of pain after the excisional hemorrhoidectomy (Milligan-Morgan technique) is typically longer and more severe. Although considered to be an advance in hemorrhoidal operations, the adoption of these newer techniques has been slow because special training is required. Traditionally, multimodality and multidisciplinary pharmacologic techniques have been used to help in the management of the patient’s recovery. Opioids have been a cornerstone in the management of postoperative pain. However, narcotics may be accompanied by numerous well-known adverse events (AEs) such as nausea, vomiting, constipation, respiratory depression, ileus, itching and dependence/tolerance. AEs related to opioids have been reported in 12% to 48% of patients.6 In the inpatient setting, opioid-related AEs account for a 3.3-day increase in hospital length of stay. Several options exist to help decrease the dependence on narcotics. Nonsteroidal anti-inflammatory drugs (NSAIDs) and acetaminophen (APAP) have been shown to help control postoperative pain. NSAIDs may be started before surgery and continued through the recovery period. Many studies have demonstrated a diminution in pain scores when up to 1,000 mg of APAP, 600 mg of ibuprofen or 30 mg of intravenous ketorolac were given immediately after surgery.7 NSAIDs aid in reducing and managing the inflammatory response. Cyclooxygenase-2 inhibitors, ketamine, clonidine and steroids also have demonstrated benefit. Many surgeons have patients begin taking NSAIDs preoperatively and continue taking the medication throughout the recovery period. As NSAIDs may be
In the inpatient setting, opioid-related adverse events account for a 3.3-fold increase in hospital length of stay. associated with postoperative bleeding, their use must be evaluated with a preoperative assessment of various patient risk factors. Some institutions are using gabapentin/pregabalin in fast-track recovery
protocols for abdominal surgery. Several studies have demonstrated that administering 1,200 mg of gabapentin or 300 mg of pregabalin preoperatively yields a decrease in adjunctive narcotic requirements.8 Some surgeons will administer the medication for up to two to three days postoperatively. Larger doses have been associated with sedation and dizziness. There are no established studies evaluating the use of these medications after anorectal surgery. Anecdotal reports abound, however, testifying to their effectiveness. This is an area ripe for larger, randomized trials.
Local Pain Control: The Basics Any anesthetic agent that is able to inhibit the excitatory process in the nerve ending will block the perception of pain. The nerve membrane is a lipid and protein structure. The two key elements in pain control are the anesthetic potency and duration of action. These are related to the lipid and protein structure of the nerve membrane. Anesthetic potency is correlated with lipid solubility. Anesthetic duration is related to the degree of protein binding at the membrane level, with a longer duration of anesthesia being the see PAIN MANAGEMENT page 12
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Clinical Review PAIN MANAGEMENT jcontinued from page 11
GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JUNE 2013
Liposomes are laboratory-prepared, microscopic lipid bilayer membranes that encapsulate an aqueous core. A lipid bilayer is essentially a double-thickness layer of phospholipid molecules. Each of the two layers is one molecule in thickness. This dual-layer system is common in nature and serves to keep substances positioned where they are needed, thus preventing these substances (proteins or ions) from diffusing away from their target area. Cell membranes are composed of lipid bilayers. The idea behind using a liposomal system is that the liposomes can be formulated into a multivesicular system, with the active anesthetic agent being held in
in cumulative pain and a 45% reduction in opioid consumption were seen in the study. The safety profile of the formulation has been studied in dose levels of 66 to 532 mg (with the FDA-approved dose at 266 mg), and cardiac safety has been demonstrated in supratherapeutic doses as high as 665 mg in healthy volunteers. Studies evaluating ER bupivacaine in the setting of open and laparoscopic colectomies, ileostomy reversal, breast augmentation, inguinal hernia repairs and total knee replacement demonstrated similar favorable results.13-17 It seems that the medication may be of benefit in many procedures requiring the use of local anesthesia.
Lip
result of a greater binding activity. Both pH and the type and size of the nerve fibers also play a role in the anesthetic effects of various agents. Local anesthetics are more effective in more basic pH environments. Smaller nerves with lighter myelin coatings are more easily blocked than are larger, more heavily myelinated nerves. Pain is most commonly the first sensation to be blocked and the last to recover, followed by temperature sensation, touch and pressure. Anesthetic agents can be degraded by hydrolysis or by enzymatic activity. As bupivacaine is metabolized slowly, its anesthetic effects are longer To date, 100% of our patients have been lasting. Lidocaine is rapidly metabalmost pain-free for the entire six-day olized and is a short-acting agent. These two drugs are the most comperiod. Opioid use has been minimal mon local anesthetic agents used in both during the six-day period and anorectal procedures. Local anesthetics are used rouafter the six-day period. tinely and are extremely effective for completely blocking pain sensation intraoperatively. Administered in each vesicle and slowly released to the tarthe form of a pudendal block, coupled get area over time. The anesthetic agent, with direct injections into the operative bupivacaine, is not new; the delivery syssites before beginning the operation, local tem is the apparent innovation. The anesanesthetics also are effective in managing thetic system is marketed under the name pain in the postoperative setting. Their of Exparel (Pacira Pharmaceuticals). os benefit, however, is limited by their duraThe microvesicular liposomal preparaom e tion of effectiveness. Bupivacaine and tion theoretically results in a drug release lidocaine have established durations of pattern showing an increased stabiliaction of less than 12 hours, even with ty and a prolonged duration of medicathe use of epinephrine. Because of this, tion release. The pharmacokinetics result Practical Considerations there have been attempts to improve the in a sevenfold increase in the Tmax, and a Liposomal bupivacaine comes in sinduration profile of local anesthetics. Elas- 9.8 times increase in the half-life of the gle-use 20-cc vials containing 266 mg of tomeric pain pumps and catheter systems medication. The manufacturer states that bupivacaine that must be stored between have been shown to help ameliorate the the medication has a duration of up to 72 36 F and 46 F. A temperature indicator pain for several days postoperatively. Ide- hours of delivery and effectiveness. The will change from green to white if the ally, the pumps should deliver a steady onset of action is immediate, as there is medication has been exposed to excesdose of the anesthetic for one to seven free bupivacaine in the solution along sively low or high temperatures. The days, depending on the size of the pump. with the microvesicular preparation. medication may be stored at room temHowever, there have been technical probperature for up to 30 days. lems reported, including catheter dis- The Antidote? The liposomal structure may be altered lodgement and infections.9 Recent FDA approval of the liposomal if the preparation is exposed to lidocaine Epidural anesthesia is a reliable way to bupivacaine formulation has been granted or other anesthetics and liposomal bupiensure a pain-free postoperative recovery. for use in hemorrhoidectomies and bun- vacaine should not be mixed with other The catheters can remain in place for up ionectomies. Gorfine et al performed a preparations. Liposomal bupivacaine may to five days after a procedure. Although multicenter, double-blind, placebo-con- used without dilution or may be mixed most often used in the hospital setting, it trolled study in patients undergoing hem- with up to 280 cc of preservative-free, is theoretically possible to use this type of orrhoidectomies.12 The use of 300 mg of sterile saline. It should not be diluted system on an outpatient basis. Adoption the liposomal bupivacaine was compared with water or any other hypotonic soluof this technique has been hampered by with a saline placebo, and evaluated over tion that might disrupt the delivery systhe need for periodic infusion of the anes- a period of 72 hours. Pain intensity scores tem. The profile of adverse events for thetic, catheter dislodgement, various sys- were significantly lower in the extend- liposomal bupivacaine is that of the partemic side effects and the potential for a ed-release (ER) group versus the place- ent drug, bupivacaine, and the surgeon delay in the diagnosis of a possibly serious bo group. At 12 hours, 59% of patients must be familiar with the adverse event catheter-related infection. in the ER group were opioid-free com- profile and treatment of bupivacaineThe topical application of local anes- pared with 14% in the placebo group. At related adverse events. thetics is of marginal and unpredictable 72 hours, 28% of patients in the ER group efficacy. were opioid-free compared with 10% in The Anecdote About the Antidote: the placebo group. In patients requiring Curbside Consultations and A Leap Forward? More Basics opioids, median time to first use was 14.3 Operating Room Experience Liposomal depot formulations of hours in the liposomal bupivacaine group bupivacaine have shown promise in the compared with 1.2 hours for the placeThe use of liposomal bupivacaine has management of postoperative pain.10,11 bo group. Ultimately, a 30% reduction been the topic of many surgical lounge
discussions and intraoffice surgical debates. As Exparel is expensive, much thought has gone into the decision to purchase and use it clinically. We have discussed this topic with colleagues, drug representatives and the surgeons in our group. We decided to try liposomal bupivacaine in our own, unscientific trial. Our results have been impressive. Our protocol has been to administer the medication in the more dilute form using a pudendal block and a local infiltration in the perianal area and around the anal verge. The medication is typically diluted 2:1 and infiltrated just after the surgical time-out is performed, with the patient under IV sedation. We have not experiienced any anesthetic failures during thee intraoperative period. At the conclusion n of the procedure, a bolus of 30 mg kketorolac is given by IV route to th hose patients without any contrain ndications to its use. In the first threee postoperative days, no oral or other adjunctive medications arre used unless the patient feels tthe need for supplemental pain rrelief. After three days, patients aare given ketorolac, 10 mg orallly every six hours for 12 doses. To date, 100% of our patients T haave been almost pain-free for the entire six-day period. Opioid use haas been minimal both during the six-dayy postoperative period and after the six six-day day period. In all of our cases, the operative anorectal procedures have been extensive. We have not used liposomal bupivacaine in procedures that we considered to be of a minor nature. Our patients have not experienced any adverse events.
The Tale of the Traveling Salesman Perhaps most interesting is one of our patients, a traveling salesman. He was due to leave town immediately after his office visit, for an important three-day sales trip. The pain from his acute thrombotic hemorrhoid had almost crippled him. Because of his impending trip, he was not amenable to surgical drainage or removal. He was desperate for pain relief and refused to consider canceling his trip. He was offered an injection of liposomal bupivacaine and he agreed to try it. The medication was diluted to 40 cc and the local injection was made through a 25-gauge needle around and deep to the thrombotic hemorrhoid. The injection of most local anesthetics in an awake patient is uncomfortable at best and the salesman’s expletives attested to this. Fortunately his office visit was at the end of the day when no other patients were nearby to hear his rather loud comments during the injection. Yet, he left the office without any pain. He returned three days later in a mood bordering on euphoria. He had had see PAIN MANAGEMENT page 14
Every matrix has a story. Ours is based on outcomes. As demonstrated in peer-reviewed publications:
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Because Outcomes Matter B ecause O utcomes M atter
14
Clinical Review PAIN MANAGEMENT jcontinued from page 12
no pain since the initial injection. Unfortunately for him, he lost the sale. Because he had incorrectly accounted for the time zone change during his flight, he arrived an hour late for his presentation and was denied a chance to make his pitch. This time, however, his expletives were directed at himself rather than the injection of Exparel. Surgeons cannot fix everything.
Antidote or Anecdote? Judge for Yourself We have been happy with our results to date. Patients have been happy with their results to date. But our trial is only anecdotal. Although supported by clinical trials, our results may not be the same as those of other surgeons. Time and experience will be the final arbiter of clinical efficacy. But liposomal bupivacaine, although expensive, may be a useful medication in combating pain following anorectal operations. The authors have no financial or other relationships with any of the maufacturers of any of the drugs mentioned in this review.
GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JUNE 2013
References 1. Cullen KA, Hall MJ, Golosinkiy A. Ambulatory surgery in the United States, 2006. Natl Health Stat Report. 2009;11:1-25. 2. Coley KC, Williams BA, DaPos SV, et al. Retrospective evaluation of unanticipated admissions and readmissions after same day surgery and associated costs. J Clin Anesth. 2002;14:349-353. 3. Warfield CA, Kahn CH. Acute pain management. Programs in U.S. hospitals and experiences and attitudes among U.S. adults. Anesthesiology. 1995;83:1090-1094. 4. Apfelbaum JL, Chen C, Mehta SS, Gan TJ. Postoperative pain experience: results from a national survey suggest postoperative pain continues to be undermanaged. Anesth Analg. 2003;97:534-540. 5. Gan TJ, Habib AS, White W, Miller T. Postoperative pain continues to be undermanaged [abstract]. Presented at: Annual Fall Pain Meeting and Workshops of the American Society of Regional Anesthesia and Pain Medicine; November 15-18, 2012; Miami Beach, FL. 6. Oderda G, Gan T. Effect of opioid-related adverse events on outcomes in selected surgical patients. J Pain Palliat Care Pharmacother. 2012. 2013;27:62-70. 7. Pyati S, Gan TJ. Perioperative pain management. CNS Drugs. 2007;21:185-211. 8. Dauri M, Faria S, Gatti A, et al. Gabapentin and pregabalin for the acute post-operative pain management. A systematic-narrative review of the recent
9.
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clinical evidences. Curr Drug Targets. 2009;10:716-733. Brown SL, Morrison AE. Local anesthetic infusion pump systems adverse events reported to the Food and Drug Administration. Anesthesiology. 2004;100:1035-1037. Chahar P, Cummings KC. Liposomal bupivacaine: a view of a new bupivacaine formulation. J Pain Res. 2012;5:257-264. Candiotti K. Liposomal bupivacaine: an innovative nonopioid local anesthetic for the management of postsurgical pain. Pharmacotherapy. 2012;32:19S-26S. Gorfine SR, Onel E, Patou G, Krivokapic ZV. Bupivacaine extended-release liposome injection for prolonged postsurgical analgesia in patients undergoing a hemorrhoidectomy: a multicenter, randomized, double-blind, placebo-controlled trial. Dis Colon Rectum. 2011;54:1552-1559. Smoot JD, Bergese SD, Onel E, et al. The efficacy and safety of DepoFoam bupivacaine in patients undergoing bilateral, cosmetic, submuscular augmentation mammoplasty: a randomized, doubleblind, active-control study. Aesthet Surg J. 2012;32:69-76. Minkowitz HS, Onel E, Patronella CK, Smoot JD. A two-year observational study assessing the safety of DepoFoam bupivacaine after augmentation mammoplasty. Aesthet Surg JJ. 2012;32:186-193. White PF, Schooley G, Ardeleanu M. Analgesia following a single administration of depobupivacaine intraoperatively in patients undergoing inguinal
herniorraphy: preliminary dose-ranging studies. Presented at: Annual Meeting of the International Anesthesia Research Society: March 14-17, 2009, San Diego, CA. 16. Langford RM, Chappell GM, Karrasch JA. A single administration of depobupivacaine intraoperatively results in prolonged detectable plasma bupivacaine and analgesia in patients undergoing inguinal hernia repair. Presented at: 62nd Postgraduate Assembly in Anesthesiology; December 12-16, 2008; New York, NY. 17. Bramlett KW, Jones RK, Pink M, Pink T. A single administration of depobupivacaine intraoperatively provides analgesia and reduction in use of rescue opiates compared with bupivacaine HCl in patients undergoing total knee arthroplasty [poster]. Presented at the XXXVI Biennial World Congress of the International College of Surgeons; December 3-6, 2008; Vienna, Austria.
â&#x20AC;&#x201D;Dr. Hoffman is attending surgeon in the division of colorectal surgery at Cedars-Sinai Medical Center, and attending surgeon in the division of general surgery and associate clinical professor of surgery at the David Geffen School of Medicine, University of California, Los Angeles. He is a senior member of Los Angeles Colon and Rectal Surgical Associates; Dr. Yoo is attending surgeon in the division of dolorectal surgery at Cedars-Sinai Medical Center and associate clinical professor of surgery at the David Geffen School of Medicine, University of California. He is a member of Los Angeles Colon and Rectal Surgical Associates (www.lacolon.com).
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BURNOUT
jcontinued from page 1 According to the survey, 42% of general surgeons and 37% of GIs reported being burned out, which Medscape defined as feeling any or all of the following: cynicism, loss of enthusiasm for work or low sense of personal accomplishment. These findings match well with a 2012 national survey on physician burnout, which found that about 45.8% of physicians experienced at least one symptom of burnout ((Arch Intern Medd 2012;172:1377-1385). General surgeons were among 10 specialties that reported the highest rate of burnout, with emergency medicine (52%) and critical care (50%) taking the top two spots. Gastroenterologists were among 10 specialties that experienced the lowest percentage of burnout, which included pediatricians (35%), psychiatrists (33%) and pathologists (32%). “Surgeons are at particular risk for burnout as we are taught early on that exhaustion is perceived as a status symbol and to base our self-worth on being productive,” said Henry Kuerer, MD, PhD, FACS, professor of surgery at the University of Texas MD Anderson Cancer Center, Houston. “I worry that the burnout rate may be higher, as the survey might not capture even more harried physicians or those who have left their profession.” In terms of severity of burnout, general surgeons ranked highly, with a mean score of 3.9 (1 being “does not interfere with my life” and 7 being “so severe that I am thinking of leaving medicine altogether”). Only two specialties reported more severe levels of burnout: OB/GYN at 4.1 and pathologists at 4. Gastroenterologists had slightly less severe burnout than general surgeons, with a mean score of 3.6. For both general surgeons and GIs, too many bureaucratic tasks and hours at work as well as the impact of the Affordable Care Act topped the list of main stressors leading to burnout, garnering scores above 4.5 (1 meaning “not at all important” and 7 meaning “extremely important”). The least important stressors for both specialties were problems with employers, compassion fatigue and difficult colleagues or staff (Figure, page 16). “The introduction of EMR [electronic medical records] has contributed to the problem of physician burnout to the extent that some of my colleagues have quit because of it,” said Robert J. Fitzgibbons, MD, Harry E. Stuckenhoff Professor of Surgery, Creighton University School of Medicine, Omaha, Neb. “EMR has increased the amount of paperwork tremendously, and what’s particularly disturbing, EMR is a poor way of keeping records.” Dr. Fitzgibbons noted that the electronic forms often provide choices that do not adequately reflect patient information
and each form takes about 30 minutes to fill out. After seeing 25 patients a day, Dr. Fitzgibbons has hours of paperwork to complete at home. “I spend a lot of time inputting patient information, yet I get a worse record, whereas in the past it took five minutes to dictate a summary of the patient visit,” he said. Although long hours likely contribute to career dissatisfaction, John Maa, MD, FACS, noted that another reason for burnout may be perceived diminished rewards (financial and societal prestige) for certain surgeons. “After long years of arduous training,
some older general surgeons in practice have become concerned about the sustainability of the current residency training paradigm, the future practice of general surgery, and feel that the years of investment they made are not returning the rewards they had anticipated.” Dr. Maa is assistant professor, University of California, San Francisco Division of General Surgery, and director of the UCSF Surgical Hospitalist Program. Dhruv Khullar, a student and class president at the Yale School of Medicine and a student at Harvard University’s Kennedy School, agreed that many
factors contribute to burnout—namely high workloads, long hours, loss of autonomy and an increasing amount of administrative work—but believes these are symptoms of a greater problem. “I think what’s at the heart of the problem is that these challenges make it difficult for trainees and physicians to continue to focus on the reasons they got into the profession,” he said. “In the midst of the day-to-day grind, it can be easy to lose one’s enthusiasm and drive for providing the highest-quality, compassionate care.” see BURNOUT page 16
15
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Too many bureaucratic tasks Spending too many hours at work Present and future impact of Affordable Care Act
BURNOUT
Feeling like just a cog in the wheel
jcontinued from page 15 The Medscape survey also revealed that the rate of burnout is lowest among the youngest and oldest general surgeons and GIs, peaking in midlife, with 35% of burned-out general surgeons between the ages of 46 and 55 years and 33% of burned-out GIs between the ages of 36 and 45; this percentage decreases to 11% of general surgeons and 5% of GIs after age 65, probably related to retirement or reduced hours. Consistent with most specialties,
Income not high enough Lack of professional fulfillment Inability to provide patients with quality care Too many difficult patients 1 = Not at all important 7 = Extremely important
Increasing computerization of practice Difficult colleagues or staff Compassion fatigue Difficult employer 0
1
2
3
4
5
6
7
Figure. Causes of physician burnout. Source: Medscape.com
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female general surgeons appeared to be slightly more burned out than their male counterparts (43% vs. 39%). Medscape proposed that women may experience greater burnout because of more conflicts between work and home life. In terms of physical health, the survey found that burned-out physicians tended to weigh more and exercised less than their less stressed counterparts: 55% of burnedout general surgeons reported being overweight or obese (vs. 46% of their peers not experiencing burnout), and 55% of burned-out general surgeons claimed to exercise two times per week (vs. 67% of their peers). Drinking and smoking habits as well as religiousness did not appear to be associated with level of burnout. Other studies examining physician lifestyle have observed emotional exhaustion to be a major reason for physician burnout. A 2009 study that surveyed 3,233 general surgeons and 4,628 surgical subspecialists found that 41% of general surgeons reported burnout, which included high levels of emotional exhaustion and depression and low ratings of mental quality of life (Ann ( Surgg 2009;250:463-471). Another study that looked at the degree of stress and burnout in 410 endoscopists found that emotional exhaustion was the major contributor to burnout, reported in 30% to 63% of respondents ((Am J Gastroenteroll 2011;106:1734-1740). The complexity of procedures and age were also main reasons for burnout, with interventional GIs and younger attendings reporting higher levels.
Effect of Burnout Although the impact of burnout is not well understood, it may be serious, in some instances resulting in medical errors and physicians leaving medicine. “We do not know the full impact of stress and burnout in gastroenterologists, but prior studies have shown that higher levels of burnout tend to result in early retirement; thus, those physicians with the most experience may prematurely leave medicine,” said Rajesh N. Keswani, MD, assistant professor in medicine-gastroenterology and hepatology at Northwestern University Feinberg School of Medicine,
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Chicago. “Even more concerning, it has been suggested in the surgical literature that higher levels of burnout were associated with medical errors (although unclear if the burnout was the cause of increased errors).” Supporting this idea, a survey of more than 7,900 members of the American College of Surgeons showed that the number of hours worked and nights on call per week have a strong impact on surgeons’ level of burnout, depression and career satisfaction ((JACS S 2010;211:609619). For instance, surgeons who worked more than 80 hours per week reported more medical errors than those who worked fewer than 60 hours per week (10.7% vs. 6.9%; P<0.001), and these overworked surgeons were twice as likely to attribute the error to burnout (20.1% vs. 8.9%; P=0.001). P “There is an unhealthy scarcity mentality that is becoming pervasive in health care systems. Not enough patients, money, time, reimbursements, etc.,” Dr. Kuerer said. “Hospitals and their physicians are afraid that they will not be able to compete. To some extent this promotes innovation, but also has the risk of demoralizing and demotivating not only physicians but all employees in the system.”
Burnout Survey and Beyond Commenting on the usefulness of the Medscape survey, Dr. Fitzgibbons said, “I don’t put much faith in these questionnaires because they’re not objective enough. I could see myself answering the questions very differently from one day to the next.” But, he added, “I think burnout is an important issue, which is on the increase as medicine changes.” Lawrence Cohen, MD, a gastroenterologist and clinical professor of medicine at Mount Sinai School of Medicine, New York City, believes the survey overrated the number of GIs who suffer from burnout based on how Medscape defined the term. “I define physician burnout as physical and emotional exhaustion combined with diminished sense of personal satisfaction and accomplishment,” said Dr. Cohen. “Based upon my anecdotal experience, I would say that fewer than 10% of GIs [not 37%] suffer from true burnout. While I do believe that the vast majority of GIs are working harder than previously, they remain fully engaged in their professional activities, are satisfied emotionally and continue to be rewarded intellectually.” Dr. Maa thinks such surveys can be helpful if they “provide constructive feedback on how to make improvements” and “raise awareness with patients, the federal government and other quality improvement organizations of the demands being placed upon physicians across specialties.” The key next step to understanding the problem of physician burnout is
developing ways to combat it. Many studies have demonstrated that the increased levels of burnout in physicians may be reversible with a variety of focused interventions. “The studied interventions generally consist of counseling and mindfulness-based stress reduction exercises,” Dr. Keswani said. “Perhaps more intriguing is the potential use of senior physicians as mentors to prevent burnout in junior colleagues.” Mr. Khullar believes that an important component of the solution is to create an environment that focuses on the
importance of patient care and allows doctors to process and feel energized by these encounters. “At my medical school, there was an option to attend weekly sessions at which students discussed what they were enjoying or struggling with in their training,” he said. “Similarly, a friend recently told me of an attending that always made sure his team took time to thoroughly discuss a patient’s death or other difficult experiences on the wards. Things like that go a long way [toward] preventing burnout and maintaining professional satisfaction.” Dr. Maa agreed that acknowledging
burnout in colleagues and oneself may help reduce it, but he also proposed taking actions that extend beyond the hospital. “I believe the crucial next steps are for surgeons to vigorously engage in the health care reform debate, and pave new career paths and goals, particularly in the fields of government and public policy,” he said. Although the problem of burnout is important, what keeps Dr. Fitzgibbons motivated is simple: loving the job. “One can always complain, but in the end being a surgeon is a wonderful job,” he said. “I would never want to have another career.”
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New Guidelines Broaden Eligibility for Bariatric Surgery Stronger Emphasis on Diabetes; Sleeve Gastrectomy Gets Nod B Y C HRISTINA F RANGOU
I
n a major shift in policy, three major medical societies have changed their formal guidelines for bariatric surgery and expanded eligibility to include patients with mild to moderate obesity and diabetes or metabolic syndrome. Additionally, the societies—the American Society for Metabolic and Bariatric Surgery, the American Association of Clinical Endocrinologists and the Obesity Society—upgraded sleeve gastrectomy from investigational status to a “proven surgical option.” The changes will bring the U.S. guidelines in line with practices increasingly used around the country and reflect evidence that has emerged in the four years since the previous guideline was developed. “We’ve gleaned important new insights, cautions and best practices based on the thousands of studies that were published in medical journals in just the last four years alone, and these are reflected in the new guidelines,” said Daniel B. Jones, MD, professor of
surgery, Harvard Medical School, Boston, and one of a 12-member panel that developed the guidelines. “Our goal was to make it a little easier for the practitioner to understand how strong the data are in favor of a practice, whether that be a psychological evaluation or a preoperative check of calcium and thiamine levels.” The guidelines were published online March 25 in the journals of the three organizations: Endocrine Practice, Obesity and Surgery for Obesity and Related Diseases. They cover perioperative nutritional, metabolic and nonsurgical support for bariatric surgery patients. Among the 74 evidence-based recommendations, the panel called for the broadening of surgical eligibility for bariatric surgery. Patients with a body mass index (BMI) of 30 to 34.9 kg/m2 and diabetes or metabolic syndrome may be offered a bariatric procedure, “although current evidence is limited by the number of subjects studied and lack of long-term data demonstrating a net benefit,” said the authors. Two years ago, the International
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Diabetes Federation (IDF) was the first major organization to list surgery as a treatment option for patients with a BMI between 30 and 35 kg/m2 when diabetes cannot be adequately controlled by an optimal medical regimen. Despite the IDF’s recommendation, the notion of surgery for individuals with a BMI of less than 35 kg/m2 has remained quite controversial, especially among physicians and endocrinologists, said Francesco Rubino, MD, a metabolic and bariatric surgeon at the Catholic University of Rome, Italy. Dr. Rubino welcomes the new indication, saying the medical community must move away from a BMI cutoff for bariatric surgery. “BMI per se does not measure health or disease. You never see a diabetologist, for instance, using BMI as a guide for diagnosis or treatment of diabetes.” Dr. Jones said the guideline will make surgery accessible to people who are struggling with many comorbidities of obesity but do not meet the previous BMI threshold. “As a bariatric surgeon and medical doctor, you hate to say to a patient, ‘you’re still too thin for surgery,’ especially when we know that the longer that they have diabetes, the more they weigh, the less likely that they will have a durable result.” The panel noted that there is currently insufficient evidence for recommending a bariatric surgical procedure specifically for glycemic control alone, lipid lowering alone or cardiovascular disease risk reduction alone, independent of BMI criteria. The panel also made a major addition to its list of “proven” primary bariatric and metabolic procedures by adding laparoscopic sleeve gastrectomy. The list now includes laparoscopic adjustable gastric banding, laparoscopic Roux-en-Y gastric bypass and laparoscopic biliopancreatic diversion (BPD), BPD/duodenal switch, along with laparoscopic sleeve gastrectomy. The guidelines do not recommend one primary procedure over another. Each procedure poses different risks and benefits, the panel said, and surgeons should select a surgical method based on each patient’s goals and motivations and the surgeon and institution’s expertise and experience. The authors did, however, observe that laparoscopic procedures are preferred over open bariatric procedures due to lower early postoperative morbidity and mortality, a finding supported by grade B evidence. On the controversial issue of endoscopic and emerging bariatric procedures, the panel noted that other procedures are gaining attention, “such as gastric
AT A GLANCE A 12-member panel recommends that patients with a body mass index of 30 to 34.9 kg/m2 and diabetes or metabolic syndrome may be offered a bariatric procedure. Laparoscopic sleeve gastrectomy was added to the “proven” list of primary bariatric and metabolic procedures. Laparoscopic procedures are preferred over open bariatric procedures due to lower early postoperative morbidity and mortality. Emerging procedures such as gastric plication, electrical neuromodulation and endoscopic sleeves lack sufficient outcome evidence and remain investigational.
plication, electrical neuromodulation and endoscopic sleeves.” But, they said, these procedures lack sufficient outcome evidence and remain investigational. The panel dropped 90 recommendations from the 2008 edition, revised 56 and added two. The quality of evidence improved significantly in the past five years, with 40.4% of studies now considered high quality compared with only 16.5% in the previous version. In other new recommendations, the panel advised that women should avoid pregnancy before surgery and for 12 to 18 months after surgery. Women who do become pregnant after surgery should have nutritional surveillance and laboratory screening for deficiency every trimester, including iron, folate and B12, calcium and fat-soluble vitamins. The guidelines also recommend that patients undergo age- and risk-appropriate cancer screening before surgery. “It’s really just good medicine. It may be obvious to screen for sleep apnea in a patient who is obese; cancer is maybe not as obvious. Now, we have data showing that the cancer rate may be higher with obesity, and bariatricians and internists really need to be screening for that,” said Dr. Jones.
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BARIATRIC OUTCOMES jcontinued from page 1
Patients most likely to relapse were those who had been diabetic for the longest time, those who lost less weight initially and those who had greater weight regain in the long term. “Although some would consider the recurrence of diabetes a failure, our data and others must be measured against the known risks of poorly controlled diabetes in patients who do not undergo bariatric surgery,” he said. Dr. Brethauer presented the study in Indianapolis at the 133rd Annual Meeting of the American Surgical Association. “Patients who experience long-term remission or improvement—and patients who have recurrence but improved glycemic control—need to look at these longterm results in a positive light.” The study analyzed 217 patients with T2DM who underwent bariatric surgery between 2004 and 2007 and had at least five years of follow-up. Patients in the study had a mean excess weight loss of 54.9±26.7%. Results showed that, at a median follow-up of six years, 24% of patients maintained complete remission of their T2DM, whereas 26% had partial remission. One-third of patients (34%) had improvements in their diabetic control. In the study group, 19% of patients who had a remission of their T2DM in the first five years after surgery eventually had their disease recur. The authors used a strict definition of remission: a glycated hemoglobin (A1c) of less than 6% and fasting blood glucose less than 100 mg/dL off diabetic medications. “This study was extremely well done, scientifically of the highest order,” said Walter J. Pories, MD, professor of surgery, biochemistry and kinesiology at East Carolina University in Greenville, N.C.
below 7%. In this study, 80% met that goal at a median of six years after surgery, including 86% of gastric bypass patients. Before surgery, only 40% had an A1c lower than 7%. Study investigators stressed that patients who underwent a bariatric procedure experienced long-term improvements in cardiovascular and diabetic markers. Long-term control rates of low high-density lipoprotein, high low-density lipoprotein, hypertriglyceridemia and hypertension were 73%, 72%, 80% and 62%, respectively. The patients most likely to experience
a return of their diabetes were those who had been diabetic for the longest time period, those who lost less weight initially and those who had greater weight regain in the long term. Three-fourths of patients studied underwent Roux-en-Y gastric bypass, the bariatric procedure associated with the highest rates of weight loss and diabetic remission. Investigators said the study involved too few patients who had the increasingly popular sleeve gastrectomy or gastric banding to draw conclusions about long-term diabetic outcomes with non-bypass techniques.
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demonstrating that improvements fade somewhat over time. Lead study author Stacy Brethauer, MD, a bariatric and laparoscopic surgeon at the Cleveland Clinic in Ohio, acknowledged that the long-term remission rates are slightly lower than the short-term results that were previously reported. He stressed, however, that the study definitively shows that patients continue to experience markedly better diabetic control, improvements in diabetic nephropathy and control of cardiovascular risk factors compared with their presurgery status.
Medical specialists from outside the bariatric surgery field have been calling for strong evidence supporting the claim that surgery has lasting metabolic effects. Dr. Pories said this paper provided some of that evidence. “Keep in mind,” he said, “diabetes has doubled in prevalence over the last 10 years. That’s incredible.” According to the most recent data from the National Health and Nutrition Examination Survey, 52% of people with T2DM treated in the United States achieve the American Diabetes Association’s therapeutic goal of A1c
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Coverage of the 12th Annual Surgery of the Foregut Symposium All articles by Yaniv Cozacov, Clinical Fellow, Minimally Invasive and Bariatric Surgery, Cleveland Clinic Florida
Dear Readers, Welcome to the June issue of The Surgeons’ Lounge. This issue we feature stories from the 12th Annual Surgery of the Foregut Symposium that was hosted by Dr. Raul Rosenthal from the Cleveland Clinic Florida, Weston. We hope you u enjoy these articles that summarize the presentations from some of the world leaders in the diagnosis and management of diseases of the foregut. Sincerely, Samuel Szomstein, MD, FACS Editor, The Surgeons’ Lounge Szomsts@ccf.org
The Future of Gastric Banding: A Critical Review
Sincerely, Raul J. Rosenthal, MD, FACS, FASMBS Director, Bariatric Institute, Section of Minimally Invasive Surgery, Department of General and Vascular Surgery, Cleveland Clinic Florida, Weston.
Other 2% Adjustable 2% 6%
Dear Readers, It is my privilege to share with you some of the most outstanding lectures presented during the 12th Annual Surgery of the Foregut Symposium that was held in Coral Gables, Florida, in February. The Robert Hermann Annual Lecture was presented by Matthew Walsh, MD, FACS, who reviewed the critical topic of the evaluation and treatment of pancreatic cystic neoplasms. Jaime Ponce, MD, current president of the American Society for Metabolic and Bariatric Surgery (ASMBS), presented a critical review of the future of adjustable gastric banding. Sung-Soo Park, MD, associate professor at Korea University College of Medicine in Seoul, analyzed the state of the art in managing gastrointestinal stromal tumors of the stomach. Finally, Thomas Rice, MD, gave a wonderful presentation of esophagectomy in patients with Barrett’s esophagus and high-grade dysplasia. I am certain you will enjoy their presentations. I also would like to extend a welcome to all readers to the 13th Annual Surgery of the Foregut meeting, which will be held February 16-19, 2014. For more details, please check our website at http://my.clevelandclinic.org/florida/education/continuing_medical_education_programs.aspx.
gastric banding to other procedures and it is up to the surgeon to be educated and prepared to give the best possible outcome for these patients. Dr. Ponce suggested that, in the future, the use of the gastric band should probably be limited to centers that have dedicated physicians and teams that can assist with the intensive follow-up required, and where a more selective patient process can take place. More stringent selection criteria, or guidelines, to identify patients who would most likely benefit from a gastric band should include patients who have a body mass index, preferably under 50 kg/m2; patients without diabetes; younger patients, those who are active; and most importantly patients who have the understanding and ability to attend the intensive follow-up needed to optimize their results.
safety
A Message From the Director
The future of gastric banding seems uncertain, especially with the great advantages other procedures can offer. A gastric band requires maintenance, frequent follow-up (sometimes more than once a month for the first year postsurgery) and frequent hiatal crural repair during its placement, Dr. Ponce said. Moreover, great variability exists among centers and in patients in the maintenance of care, which is reflected in the different outcomes reported. However, marketing surveys show that 20% to 34% of patients who have had gastric banding said they would not have had any other procedure if banding had not been available, and 19% of patients willing to have surgery, but with no specific procedure in mind, preferred a band. Patients indicated that the most important factors influencing their decision were the surgical safety profile and the fact that banding is considered less invasive. Other less important factors included the perceived reversibility of the procedure, the adjustability and the relative nutritional safety (Obes Surgg 2005;15:202-206) (Figure). Unlike patients undergoing Roux-en-Y gastric bypass (RYGB), attending follow-up appointments is crucial to gastric banding patients in order to positively affect their weight loss outcome; however, Dr. Ponce noted, there still is great inconsistency among patients regarding the amount of weight loss. In the past few years, gastric banding has fallen out of favor with bariatric surgeons. In the last quarter of 2012, it was reported that only 4.1% of total bariatric procedures performed in academic institutions were gastric banding. In contrast, laparoscopic sleeve gastrectomy has experienced exponential growth and is reported to comprise one-third of the market. RYGB is the preference of 60% of weight loss patients. Nonetheless, the band is here to stay, according to Dr. Ponce. In some cases, patients prefer adjustable
ional
Dr. Szomstein n is associate director, Bariatric Institute, Section of Minimally Invasive Surgery, Department of General and Vascular Surgery, Cleveland Clinic Florida, Weston.
Jaime Ponce, MD, FACS, medical director for the bariatric surgery program at Hamilton Medical Center, Dalton, Ga., discusses the future of laparoscopic adjustable gastric banding, and provides a critical review of the subject.
Nutrit
20
%
le
12
sib
r
ve
Re
Less invasive 46% Surgical safety 32%
Figure. Factors that influence patient choice for laparoscopic gastric banding.
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Surgeons’ Lounge
GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / JUNE 2013
Laparoscopic Approaches to Gastrointestinal Stromal Tumors Sung-Soo Park, MD, associate professor at Korea University College of Medicine, in Seoul, discussed how to determine the optimal laparoscopic approach when performing a wedge resection of gastric submucosal tumors. Dr. Park presented his experience with almost 60 patients, of whom twothirds underwent an exogastric wedge resection (EWR) and the remaining one-third underwent a transgastric wedge resection (TWR) for gastric submucosal tumors (J Am Coll Surg 2012;215:831-840). His team compared the clinical outcomes for both EWR and TWR approaches, and Dr. Park provided an analysis of the factors affecting selection. In most cases, the diagnosis of gastric submucosal tumors was incidental and approximately 80% turned out to be gastrointestinal stromal tumors (GISTs). Preoperative assessment of the degree of potential malignancy was insufficient, and complete surgical resection was needed for comprehensive diagnosis and prognostic evaluation. As a result, positive margin–free wedge resection of submucosal tumors was the standard of care. Dr. Park reported that EWR was safe and effective, and simple to perform, and required a short operative time. Although TWR allowed direct visualization of the lesion via gastrostomy (thus providing better control of the surgical margins), the gastrostomy procedure itself may pose a risk for intraperitoneal cross-contamination
with gastric flora. Furthermore, the need for gastric wall closure prolongs the operating time. Of the two approaches, surgeons use EWR more frequently. The major factors to consider when choosing between TWR and EWR include tumor size, location and growth pattern, Dr. Park said (Figure). Regarding tumor size, EWR should be performed if the tumor is greater than 2.5 cm, regardless of the other factors, because with a larger tumor it is easier for the surgeon to locate it by simple manipulation. For tumors smaller than 2.5 cm, EWR should be performed in all tumor locations except for the upper or lower thirds of the stomach; near the esophagogastric junction; the pylorus; or in hidden areas such as the posterior wall and lesser curvature of the circular location of the stomach, which have both a relatively narrow field of vision and limited space for manipulation. EWR should be performed for tumors with an exophytic growth pattern, and TWR should be carried out for tumors with an endophytic growth pattern. The surgical approach for tumors with an endomural growth pattern depends on the surgeon’s preference, Dr. Park said.
Laparoscopic Approaches to Gastrointestinal Stromal Tumors Submucosal Tumor
Size
≤2.5 cm
Location
High or low in HA
Growth pattern
Endophytic growth
Appropriate operation
Transgastric wedge resection
Exogastric wedge resection
The therapeutic strategy for submucosal tumors of the stomach. Red arrows indicate positive results, and gray arrows indicate negative results. *Surgical approach for endomural growth pattern depends on the surgeon’s preference. HA, hidden areas
Evaluation and Treatment of Pancreatic Cystic Neoplasms R. Matthew Walsh, MD, Chair, Department of General Surgery at Cleveland Clinic, Ohio, discusses a new paradigm for pancreatic cystic neoplasm. Before the implementation of cross-sectional imaging modalities, pancreatic cystic neoplasms were encountered infrequently, according to Dr. Walsh. Recent reports showed an incidence of only 10%, which is incorrect. There has been a shift from referring a patient with pancreatic pseudocysts to a surgeon to more and more referrals for cystic neoplasms. Dr. Walsh added that, as more pseudocysts are treated endoscopically, the surgeon faces even less of these compared with cystic neoplasms. Distinguishing between pancreatic pseudocysts
and pancreatic cystic neoplasms is important, because treatment is completely different for each one and not always straightforward, Dr. Walsh said. It also is important to note that cystic neoplasms may cause pancreatitis. Patients who present with acute abdominal pain and are subsequently found to have concomitant pancreatitis make diagnosis even more challenging. Pancreatitis may occur if the cyst communicates with the pancreatic duct, where the efflux of mucin may temporarily block the duct and cause pancreatitis. Extrinsic compression of the pancreatic duct by the cystic neoplasm
also may occur. If a patient presents with acute pancreatitis, distinguishing a pseudocyst from a cystic neoplasm could be aided by examining the patient’s history for past episodes of pancreatitis or its underlying risk factors. The incidence of pancreatic cystic neoplasms is increasing, according to Dr. Walsh. Autopsy studies have shown an overall incidence of 25%, and up to a 30% incidence in individuals aged more than 80 years. Magnetic resonance imaging (MRI) screening of patients without any abdominal symptoms shows a 12% incidence of cystic neoplasia in patients aged more than 70 years. MRI results have continued ON PAGE 24
Another Successful Year For the McMahon Group
2012
to recognize the best of an outstanding group of empployees. Now into its fifth decade, the company continues to publish best-read medical newspapers and must-view meddical websites covering several clinical areas, and also creates medical education platforms for physicians, nurses andd pharmacists. All of which proves yet again that a company powered pow wered by talented people will necessarily generate success. suuccess
Here is a review of the winners of the 2012 employee awards: MANAGEMENT/SUPPORT/IT/FINANCE/PRODUCTION
MANAGEMENT/SUPPORT/IT/FINANCE/PRODUCTION
Each year employees are asked to select two outstanding mem mbers representing these diverse departments. The first winner was DIANE LODISE, who is both the director of facilities managemeent, overseeing the facilities owned by the company, and the conveentions coordinator, planning the many details of our extensive convenntion coverage.
The second winner was HYON NG KWON, the company’s development manager for IT, for his continuuing efforts in improving the company’s digital presence.
MAX GRAPHICS PERSON OF THE YEAR
MOST IMPROVED SALESPERSON OF THE YEAR
BLAKE DENNIS was recognized for her excellence as art directtor for Anesthesiology News as well as her graphic design of a varietyy of special projects. Blake is dedicated to creating the most visually appeaaling projects possible.
BRIAN HIGGINSON, publicatioon director for Gastroenterology & Endoscopy News, was recogniized for the increase in that publication’s sales in 2012, which in part ledd to one of its most profitable years ever. His dedication to his clients’ needs and understanding of their products ensure his continued success in sales.
ASSOCIATE/SENIOR/PROJECTS EDITOR OF THE YEAR
MANAGING EDITOR OF THE YEAR
Editorial director of the special projects division, division KATHERINE REIDER was recognized for her contributions as an editor and for providingg leadership and direction to the members of the department. Her diplomacy skills and focus on process have helped ensure that projects are devveloped with the highest level of accuracy and in a timely manner. Katherinee also was recognized for her 10 years of service at McMahon.
GEORGE OCHOA was voted ed editor of the year for his efforts and dedication to McMahon Groupp through his exemplary writing and editing. His stories appear in every McMahon Group publication and on every website and provide the manaaging editors with articles that exemplify editorial excellence.
SALES ACHIEVEMENT AWARD
SALESPERSON OF THE YEAR
The publication director for General Surgery News, MICHAEL ENRIGHT, T was selected for this award in recognition of his strong commitment to his clients and his innovative thinking to create unique marketing platforms, which included the publication’s first international edition as well as the initiation of a website video arcade.
For an unprecedented seventhh year in a row, RICHARD TUORTO earned the salesperson of the year aw ward. Unlike the other awards, which are decided by peer votes, this aw ward is presented to the individual who brings in the most revenue in the calendar year. Richard manages the Anesthesiology News and Painn Medicine News teams as senior group publication director.
THE MCMAHON GROUP PERSON OF THE YEAR
PARTNERS’ AWARD
The top award each year is for the person of the year, which gooes to the employee who goes above and beyond the call throughout thee year. JEANNIE MOYER, associate director of human resources, received the honor this year. Jeannie oversees personnel and works tirelessly to provide the best possible atmosphere for employees each day. She is integral to helping McMahon Group continue to grow every year.
From time to time, the partner--owners of the company recognize the contributions of those who havee had a significant effect on the company’s success through the years. The 22012 award was given to WARD BYRNE, who served as publication director foor Anesthesiology Newss for several years, starting in the early 1990s. He w was responsible for the excellent growth of that newspaper, which today dominates the market. Ward eventually left McMahon Group to start what would be ann 11-year career working at a medical education company, after which he returneed to his true love — teaching. Today, Ward teaches special education in thee New Jersey school system.
Surgeons’ Lounge
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High-Grade Dysplasia: Esophagectomy or Endoscopic Therapy? Thomas Rice, MD, section head, Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Ohio, compares esophagectomy with endoscopic therapy as a treatment modality for esophageal high-grade dysplasia.
CONTINUED FROM PAGE
but the rate is only 80% after endoscopic therapy. Once patients cross the threshold of expected early recurrence (approximately two to three years), recurrence is rare: In Dr. Rice’s study, the last recurrence was reported at 37 months (Figure). Dr. Rice said that although esophagectomy is more successful and effective in this setting compared with endoscopic therapies, it is not as safe. Treatment decisions require balancing the possibility of patient harm with ineffective cancer treatment, so a comprehensive patient selection process is crucial. Esophagectomy as a treatment modality should be ascribed to patients in whom complete and durable eradication of the cancer is paramount, and who also are at low risk for any procedure-related morbidity. When the risk associated with esophagectomy outweighs the benefits, endoscopic therapy should be considered. In reality, a risk–benefit analysis is usually poorly performed, as the main determinant of which therapy the patient will undergo largely depends on who performed the first evaluation: the surgeon or the gastroenterologist. Dr. Rice concluded that, in high-grade dysplasia in older patients with poor pulmonary function, endoscopic therapy is favorable. However, in young patients with excellent pulmonary function, the decision becomes more difficult, and all the benefits of cancer-free survival, weighed against morbidity, should be discussed with the patient.
Recurrence (%/year)
The introduction of less-invasive techniques Although overall survival rates are generally simiinto the therapeutic armamentarium of intramu- lar for esophagectomy and endoscopic therapy, cancosal lesions has brought into question the use of cer-free survival is found to be worse after endoscopic esophagectomy, an invasive procedure for esopha- therapy. Recurrence of cancer after esophagectomy is geal high-grade dysplasia. Dr. Rice discussed the uncommon, and typically occurs soon after surgery, experience of patients at the Cleveland Clinic that whereas recurrence after ablative therapy occurs later included 164 patients treated with esophagectomy and is a continuous problem. A five-year, cancer-free over a span of almost 30 years (Eur J Cardiothorac survival rate of 97% is achievable after esophagectomy, Surg 2011;40:113-119). His team reported excellent outcomes with esophagectomy. Although there is Recurrence rates after esophagectomy a risk for mortality in the early stages 100 after the procedure, that risk subsequent4 ly declines to similar levels for the general Freedom From Recurrence population. Patient characteristics associat80 ed with early mortality include patients of 3 older age at the time of esophagectomy and poor lung function associated with respi60 ratory complications, particularly pneumonia. In terms of late mortality, cancer 2 Hazard recurrence and second non-esophageal 40 cancers were found to be risk factors. Dr. Rice noted that approximately half of the 1 20 patients experience a complication after esophagectomy, whereas treatment-associated mortality is rarely reported after endo0 scopic therapy and risk for complications 5 10 15 Years is approximately less than 50% compared with esophagectomy.
Freedom From Recurrence (%)
24
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identified cystic neoplasms with significantly smaller lesions in an increasing number of patients. How to manage this increasing number of incidental lesions is of great practical interest, Dr. Walsh said. It was thought previously that all mucinous lesions should be resected, so determining mucinous versus serous lesions was important. This is no longer the case, Dr. Walsh said. The most common types of pancreatic cystic neoplasms are serous cystadenoma, mucinous cystic neoplasm and intraductal papillary mucinous neoplasm (IPMN). Each is a distinct form, with subtypes. Mucinous cystic neoplasms follow a benign-to-malignant sequence, similar to a colon polyp-to-cancer sequence. Pathologically, they are classified as adenoma, borderline and malignant forms. Of note, this is not recognized by the World Health Organization definition, as their classification includes only invasive or noninvasive
carcinoma. Dr. Walsh noted that this is unfortunate because, in addition to these classifications, the natural history of the disease also differs in its benign and malignant forms. It is important to be aware of this when reading the literature, as groups of patients may be lumped together, even though they do not share the same natural disease history, Dr. Walsh said. The same is true for IPMN, which has the adenoma-to-carcinoma sequence. IPMN can be subdivided into morphologically distinct subtypes if the main duct or a side branch is affected. The main duct variety pathognomonically includes a patulous ampulla with mucin from the orifice and presents symptoms similar to chronic pancreatitis. A side branch could show a cyst and the mixed type has features of both: a dilated duct and a cyst component away from the main duct. Dr. Walsh pointed out that these
different types possess different risks for invasive cancer and are important to recognize. Determining the best treatment option is difficult. Surgeons have different approaches in recommending surveillance, and aggressive versus selective approaches have been variously employed. Presently, consensus guidelines are limited by a lack of data, Dr. Walsh said. Evaluation of a symptomatic lesion is straightforward because cross-sectional imaging, with the appropriate clinical characteristics, indicates resection. Despite improvements in surgical mortality, however, significant morbidity occurs, and choosing when to aggressively treat asymptomatic patients is challenging. Dr. Walsh undertook a natural history study that monitored the progress of asymptomatic patients, who did not undergo surgery as long as their disease was deemed low-risk for progression. Risk was based on fluid cyst aspiration,
after devising an endoscopic ultrasound-guided technique to reduce any cyst spillage. The results of the study described the natural history for asymptomatic patients with follow-up of less than five years: • Multiple side-branch IPMN without worrisome features can be followed sequentially with low risk for cancer. • Patients with symptomatic lesions, main duct IPMN or mixed type IPMN, mucinous cystic neoplasms, or highrisk side-branch IPMNs with mural nodules or atypical cells should all undergo resection. • After resection, the remnant should be followed up for at least 10 years. Proteomics or molecular markers could be used to predict occurrence at an early stage but the current challenge is better patient selection, Dr. Walsh said.
GSN Bulletin Board
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Opinion PETTING
THE
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GENERALSURGERYNEWS.COM / GENERAL SU URGERY NEWS / JUNE 2013
TIGER
(P4P, please excuse the pun) for urinary tract infections (UTIs). Daily “Foley rounds” are now made, coffee in hand, lifting sheets and searching for these insidious devils that rest between the thighs of unsuspecting patients like Burmese pythons in the Everglades. “Aha!” the yells are heard down the inpatient hallways, “We found one!” Quickly, the five-page orders are punched into the electronic medical record, red flags are averted and a cracker-jack team of simulator-trained and credentialed experts arrive to deactivate the Foley catheter before the clock strikes 48 hours post-op. Capt. SCIP (Surgical Care Improvement Project) triumphs again, and a potential UTI has been averted. Multiply this by the number of patients who get Foley catheters and yes, comrade, we project a net savings for the hospital of at least $1 million in fiscal year 2013. But hold on a second, Doctor Deeds. The walls of the hospital suddenly swell and reverberate with my favorite general surgery mantra: No good deed goes unpunished. No good deed goes unpunished. Over the first few months of our successful program, the UTI rate per Foley catheter-day (UTIRpFCD) has risen dramatically. Do the math! We have reduced FCDs (the denominator) and
our UTIR also has decreased, but the change in the numerator is not as profound. Therefore, we now have to honestly and publicly report a rise of our UTI rate. Ding! Ouch. Welcome to the Age of Regulopathy. I like this term coined by the trauma surgeon Michael Rhodes, MD. I heard him speak at an acute care surgery meeting where he prognosticated that our health care ship is heading for the perfect storm. Administrators who look and dress like George Clooney are now telling us how to practice surgery. Wounds are left open after colon surgery to decrease surgical site infections. Antibiotics are ceremoniously given by bullied anesthesiologists before every case, violently tampering with the microbiome of our colons where I am told at least 50% of the resident cells in our body (i.e., bacteria and “germs”) do not contain our own human
Antibiotics are ceremoniously given by bullied anesthesiologists before every case, violently tampering with the microbiome of our colons. … We look up at the ceiling lights in the operating room and wonder why the Clostridium difficile rate has gone up.
DNA. We look up at the ceiling lights in the operating room and wonder why the Clostridium difficilee rate has gone up. My patients are undernourished because we don’t want to increase our central line–associated and fungal infection rates with parenteral nutrition. Wounds fall apart and patients are readmitted in droves. As Homer Simpson put it best, “D’oh!” Somebody has to do something. As I start a master’s program in medical management, I am trying to wrap my tiny brain around financial accounting and health care marketing. I was a math whiz in high school, but balance sheets and income statements intimidate me. Since I finished medical school, I have trouble doing simple calculations. As I have grown older, I
increasingly rely on mnemonics m and old habits to do everythin ng from estimating toxic doses of local anesthesia (weight in kilograms equals toxic dose of 0.25% Marcaine in milliliters) to making latenight sandwiches, “Oh, oh, oh, to touch and feel ….” I can’t balance my checkbook without a calculator and my wife handling the finances. How am I going to learn about managing health care? Learning management and business for a surgeon is like that guy wanting to jump into the tiger pit just to pet a large, maneating cat. I feel if I can do this, I can achieve anything. —Dr. Kim is assistant professor of — surgery, Albert Einstein College of Medicine, Yeshiva University, New York City.
Letters to the Editor
Patients Should Share Responsibility for Their Outcomes To the Editor: The Centers for Medicare & Medicaid Services has implemented the Hospital Value-Based Purchasing program this year in an effort to improve the quality of hospital care. The innovative program links health care payments with certain performance outcome measures, providing a financial incentive for quality improvement. The measures that come into effect for 2013 are based on the “clinical process of care” and the “patient experience of care.” An additional set of measures relating to mortality, hospitalacquired conditions, patient safety and inpatient quality are slated to be included in the program for 2014. It is clear that the field of outcomes research is gaining a more prominent role in health care management decisions. Historically, surgeons always have been at the forefront of outcomes research. These studies are intuitively a
more practical alternative to clinical trials. However, the heterogeneity of factors leading to outcomes cannot be understated. Surgical results are a composite of surgical skill and experience, the quality of ancillary support staff and infrastructure, and patient-related factors. Patientrelated factors can be summarily divided into modifiable and nonmodifiable risk factors. The concept of modifiable risk factors presents as much a challenge to the health care system as it does to the patient. The entire onus of health care should not rest with the system that provides it. There are certain factors under the direct control of the patient, such as lifestyle choices, high-risk behaviors and adherence to medication, just to name a few. These are possible confounders when it comes to outcomes and patient surveys. But they are not factored in when making a decision about payment for health care.
Some of the patient-related facThere are certain factors under tors are easy to measure. Glycosylated hemoglobin [HbA1c], for the direct control of the patient, example, can be used as a marker such as lifestyle choices, highfor adherence to antidiabetic medications. HbA1cc was found to be risk behaviors and adherence to a powerful predictor of in-hospimedication, just to name a few. tal death and morbidity after coronary artery bypass grafting. But how does one quantify the effect of nonadherence to psychiatric medications health care and lifestyle choices, and conor missed clinic visits? Does an attitude sequently should share the responsibility of noncompliance in one area affect other for outcomes. areas, and ultimately, outcomes? As the reliance on outcomes data Mohan Mathew John, MD increases, all possible variables will need Surgery Resident to be taken into account to make an equiNew York City table evaluation of the quality of health care. The contribution of these patientrelated factors to outcome has not been We would like your opinion. well studied and deserves consideration. Please send letters to: The “empowered patient” has the right khorty@mcmahonmed.com. to make his or her own decisions about
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