The March 2013 Digital Edition of General Surgery News

CONVENTION ISSUE:

The Americas Hernia Society

GENERALSURGERYNEWS.COM

March 2013 • Volume 40 • Number 3

The Independent Monthly Newspaper for the General Surgeon

Opinion

Transition to Practice: A Bold Move B Y F REDERICK L. G REENE , MD, FACS

S

ince 2003 when work-hour directives were launched for the Accreditation Council for Graduate Medical Education (ACGME) accredited residency and fellowship training programs, the consequences of this action have been debated in a multitude of organized and

A fellowship in general surgery?

Yes, you heard correctly. informal surgical venues as well as in the surgical media. Among a litany of discussed consequences has been a concern by many that the traditional five-year general surgical training paradigm is no longer adequate to result in young men see SURGICAL TRAINING page 33

PROCEDURAL BREAKTHROUGH BioSurgical Technology for Incisional Hernia Repair: Use of Tutopatch™ and Tutomesh™ Bovine Pericardium for Complicated Hernias see page 4

PROCEDURAL BREAKTHROUGH Clinical Advances of the Endo GIA™ Radial Reload With Tri-Staple™ Technology in Open LAR see page 14

Is It Time To Get on Twitter?

B Y C HRISTINA INA F RANGOU CHICAGO—Late one night in 2011, University of Buffalo pediatric surgeon Philip Glick, Gli MD, received a call from his is resident on call, telling him m that a child who had been on exxtracorporeal membrane oxygenatioon (ECMO) for several days, now haad air tracking back through the venous ca cannula.

Dr. Glick, a professor off surgery, pediatrics, OB/GYN and manageme ment, rushed to the pediatric ICU and his team m gathered around the child’s bed ed.

Everyone was baffled; no one, incl ncluding Dr. Glick, had seen anything likee it. The only option he could come up with was to turn off the ventilator, as the child d also was on heart-lung bypass support.

“It was 4:30 in the morning,” he said, recounting nting the story during a session sess of the 2012 Clinical Congress of the American College of Surgeons (ACS). “The sun was about to come up. I was very tired. I called the ECMO hotline; no explanation. I did a PubMed search; nothing published. Lastly, I sent out a tweet asking if anyone in the universe had had a patient with pertussis on ECMO who see TWITTER page 28

Are Today’s Surgical Graduates Prepared for ‘Real World’ Practice?

Surgeons Discuss Preparedness of Today’s General Surgeon Trainees in Light of Duty Restrictions, Narrowing Specialty Focus B Y M ONICA J. S MITH

W

hen David M. Mahvi, MD, finished his residency in general surgery in the mid-1980s, he went into practice feeling confident about the skills he had gained in training and he felt well prepared to perform surgery and care for patients.

Surgeons’ Lounge

6

18

Fecal Microbial Transplantation for the Treatment of C. Difficile

Opinion

8

Is This a Way to Make a Center of Excellence?

10

Body Contouring After Bariatric Surgery: Are We Doing Enough for Our Patients?

In the News

22

Operations That Pose the Greatest Incisional Hernia Risk

Randomized Study Hailed as “Landmark” by One Expert B Y G EORGE O CHOA ecal transplant proved more effectivee than vancomycin for the treatment oof recurrent Clostridium difficile infecti tion in a randomized controlled trial al in the Netherlands. The study was published online on Jan. 16, in The New pub England Journal of Medicinee (368:407E 415; doi: 10.1056/NEJMoa1205037).

“This study is critically important,” Lawrence J. Brandt, MD, MACG, AGAF, FASGE, professor of medicine and surgery, Albert Einstein College of Medicine, and emeritus chief, Division of Gastroenterology, Montefiore Medical Center, Bronx, New York City, said in an interview with General Surgery News. Dr. Brandt was not involved with the study.

“I would call it a landmark study—the first randomized controlled trial of fecal transplant in the treatment of recurrent C. difficilee infection. Prior to this publication, although the world’s experience with fecal transplant had been outstanding, see FECAL TRANSPLANT page 7

Transdermal PCA in Acute Postoperative Pain Management: A Critical Evaluation of the Investigational IONSYS System

see SURGEONS-IN-TRAINING page 24

See insert at page 18

A Patient With Persistent Dysphagia After Sleeve Gastrectomy

Opinion

Fecal Transplant Beats Vancomycin For C. difficile

However, established surgeons today have a sense that the present generation of surgeons-in-training is not ready to assume autonomy and responsibility for patients at the end of their training.

INSIDE Clinical Review

®

REPORT

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MARCH 2013

Study Strengthens Case for Surgery After Imatinib Therapy for GIST Nearly Double the ProgressionFree Survival When Surgery Is Performed B Y C HRISTINA F RANGOU SAN FRANCISCO—In a study that affirms a practice widely recommended but never validated, surgeons have shown that patients who undergo surgery to remove residual tumors after imatinib therapy have significantly longer overall and progression-free survival than those who receive imatinib (Gleevec, Novartis) therapy alone. “Many clinicians think that adding surgery is beneficial to the patient if the patient is responsive to imatinib but clinical evidence for this is very scarce,� said lead author Seong Joon Park, MD, a fellow at Asan Medical Center in Seoul, South Korea. “This study suggests that surgery offers a substantial survival benefit for patients with metastatic or recurrent GIST [gastrointestinal stromal tumors].�

At the 2013 Gastrointestinal Cancers Symposium, Dr. Park presented results

from a retrospective study of 134 patients with metastatic or recurrent GIST who were treated with imatinib alone (n=92) or imatinib plus surgery to remove residential tumor lesions (n=42). All patients were responsive to imatinib for at least six months.

Patients who received surgery plus imatinib had double the progression-free survival of patients who received imatinib alone at 87.7 months versus 42.8 months. Overall survival also was significantly better among patients who received surgery, and patients in the imatinib plus surgery group had a 5.5-fold lower risk for death. “This study really provides provocative evidence that taking a surgical approach in addition to medical treatment with imatinib may in fact result in longer survival of patients with GI stromal tumors and controls the disease on the order of years,� said Neal Meropol, MD, chief of hematology and oncology at Case Western Reserve University, Cleveland.

Mitchell Posner, MD, Thomas D. Jones Professor and chief of general surgery and surgical oncology, University of Chicago, said the study is “interesting

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

but not groundbreaking� retrospective study. The because it is not a ran- Having a low initial models included unidomized trial. The study tumor burden was variate and multivariwill not change clinical ate analyses, propensity associated with practice as “almost everyscores and inverse probone� is already resecting ability-weighting adjustlonger survival. patients with residual disment. The analyses ease or those with tumors confirmed that having a that stop responding to imatinib, he said. low initial tumor burden was associated Based on previous retrospective tri- with longer overall survival. Low initial als, most experts agree that patients with tumor burden, female gender and a speGIST benefit from surgical removal of cific alteration in the KIT T gene also were residual tumors. However, the previous associated with delayed disease progresstudies did not provide sufficient evi- sion. Patients with this KIT T alternation dence that surgery is beneficial because typically have better response to imathey assessed clinical outcomes in patients tinib therapy. who had received surgery without comPatients in the surgery group were parison to patients who did not undergo younger (median age of 51 years vs. 58 surgery ((J Clin Oncoll 2006;24:2325-2331; years in the imatinib group; P=0.002) P J Surg Oncoll 2008;98:27-33; Ann Oncol and had fewer tumors metastatic to the 2010;21:403-408). peritoneum (12 vs. 56; P P=0.001). The European investigators recently differences are characteristic of clinical designed a randomized study to exam- practice, said Dr. Park. ine this question prospectively. Howev“Surgery is a very aggressive treatment er, the study was terminated because of strategy, and it’s often considered and poor accrual. recommended in young patients who In Dr. Park’s study, researchers used have good performance status,� he said. several statistical models to correct for Multiple peritoneal metastases make the selection bias inherent in a surgery difficult, he added.

Joseph J. Pietrafitta, MD

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INFECTIOUS DISEASE SPECIAL EDITION

3

THE SCIENCE BEHIND POSITIVE PATIENT OUTCOMES

BioSurgical Technology for Incisional Hernia Repair: Use of Tutopatch™ and Tutomesh™ Bovine Pericardium for Complicated Hernias Christopher David Nocca,Mantyh, MD, PhDMD Chief, GI/Colorectal Surgery

Department of Digestive Surgery Pr Fabre Associate Professor of Surgery Duke University Medical Center Hôpital Saint-Eloi Durham, North Carolina University Hospital of Montpellier Montpellier, France

Emanuele Lo Menzo, MD Department of General Surgery Cleveland Clinic Florida Weston, Florida

Introduction Hernia repair is one of the world’s most common procedures, and accounts for more than 1 million operations performed in the United States each year.1 For years, surgeons have relied on using mesh produced from various types of material to provide reinforcement and prevent hernia recurrence. Synthetic mesh has been shown to reduce the risk for recurrence, but is contraindicated in a contaminated field.

Furthermore, surgeons have discovered that synthetic mesh can shrink or migrate, in turn compromising the repair and causing chronic inflammation. This often leads to quality of life–inhibiting patient discomfort and pain.2 Biologic meshes were developed to satisfy the demand for a material that could avoid complications typically associated with synthetic mesh. Biologic meshes—which function by providing a scaffold into which the patient’s tissue remodels, with the mesh itself being gradually remodeled— come from a variety of sources, such as processed human dermis, porcine dermis and submucosa, and bovine pericardium. The characteristics of each mesh hinge on its material properties and method of processing: Non–cross-linked grafts comprised of bovine pericardium, human dermis, and porcine dermis have been shown to revascularize and remodel, whereas cross-linked mesh may become rigid with calcification that inhibits remodeling.3

Tutopatch™ and Tutomesh™ Implants Derived from bovine pericardium, Tutopatch and Tutomesh grafts (RTI Biologics) are non–cross-linked, acellular, collagen matrices indicated for the reinforcement of soft tissue where weakness exists in general and plastic surgery repair.

Obtained only from bovine spongiform encephalopathy (BSE)–free countries, the raw materials undergo the Tutoplast® tissue sterilization process, which is a validated process of osmotic, oxidative, and alkaline treatments that break down cell walls, inactivate pathogens, and remove bacteria. Solvent dehydration allows for room temperature storage of tissue without damaging the collagen structure; and low-dose gamma irradiation ensures sterility of the final packaged graft

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GENERAL SURGERY NEWS • MARCH 2013

(sterility assurance level 10-6). Comprised of collagen and processed without cross-linking, Tutopatch and Tutomesh grafts provide a resilient scaffold that encourages remodeling. When prepared and used properly, Tutopatch and Tutomesh grafts will be infiltrated by vessels and fibroblasts and eventually be replaced by the patient’s tissue.4 Tutomesh grafts, which have been used widely in Europe for hernia repair, feature fenestrated sheets, whereas Tutopatch implants are available in multiple sizes without fenestrations. Some surgeons have searched for a proven alternative to dermis, in order to meet the needs of specific patients. Often they have found that the thin profile of Tutomesh implants have met their needs in complicated cases where rapid revascularization is important.

Tutopatch and Tutomesh Patient Characteristics and Mesh Indication

authors found that primary closure was possible in 5 patients (17%). A single patch was used in 9 patients (31%) where some skin closure was possible, and in 15 patients (52%), the defect was large and 2 patches were employed to sufficiently cover the defect. All of these patients experienced successful patch/tissue integration.6 Dr. Nocca noted that based on his experience, the use of Tutomesh grafts has reduced the risk for recurrence without increasing the risk for infection. Also, “Tutomesh grafts are sourced with collagen from bovine pericardium from New Zealand—a country that has had no problem with BSE,” he said.

In cases that warranted use of a biologic mesh, Dr. Lo Menzo first used mesh sourced from human cadavers, but switched to another product derived from bovine pericardium for a number of reasons. “First, there was a clinical reason involving the intrinsic properties of the AlloDerm [LifeCell] biologic, the elastin content in particular. The company’s processing of this initial allograft biologic did not address that concern, although I understand that new processing techniques from other companies have emerged that mitigate this issue. The bovine pericardium performs significantly better in my experience than the initial allograft biologic AlloDerm,” Dr. Lo Menzo said. “Another reason I switched to a bovine pericardium product is cost and then, a third reason is size.” While there are larger allograft biologic meshes that have been made available more recently, Dr. Lo Menzo noted that he continues to use bovine pericardium products as “mesh derived from bovine pericardium is easy to store on the shelf and does not need much preparation.”

Despite the utility of mesh products for repair, some patients can have a successful repair without any type of buttressing, according to Emanuele Lo Menzo, MD, general surgeon at Cleveland Clinic in Weston, Florida. Dr. Lo Menzo has extensive experience in weight loss, minimally invasive, and hernia surgery, and has used Tutomesh implants in studies while training in Europe.5 “The indication for hernia repair without mesh is in patients with first-time hernias of 3 cm or less and without comorbidities or conditions that would increase the risk for recurrence, based on several European studies,” Dr. Lo Menzo said. “In that specific category of patient, the results of a primary repair appear equivalent to mesh repair. There is still a potential for recurrence, but it is in the single digits to about 12%, which seems to be acceptable.”

However, for patients who do not fall into the category The Repair of having first-time hernias and presenting without comorIn an ideal ventral hernia repair, Dr. Lo Menzo said that bidities, the rate of recurrence can skyrocket in the absence his goal is to reconstruct the abdominal wall as well as posof a mesh-reinforced repair. “Those studies indicated occur- sible and use mesh only as reinforcement. “If possible, I try rences in up to 50% and even higher when there were mul- to close the defect primarily, adding the mesh either intraabtiple recurrences repaired primarily,” Dr. Lo Menzo said. dominally or in the retro muscular layer. Less ideal would “However, the usual recurrence rate following a synthetic be to place the mesh in an onlay position, but sometimes mesh repair is in the single digits.” that is the only way,” he said. Dr. Nocca stated that he first David Nocca, MD, general surgeon in the Department of frees the abdominal cavity and abdominal wall to achieve Digestive Surgery Pr Fabre at Hôpital Saint-Eloi, University clear exposure of the ventral hernia. “Then, when you use Hospital of Montpellier in France, and his colleagues have the Tutomesh implants, you have to place it on a platform been using biologic meshes in hernia repair for 4 years, and of tissue—and that tissue may be muscle or may be apohave used Tutomesh implants exclusively for 3 years. “Previ- neurosis—that will facilitate the colonization of the mesh,” ously, we used synthetic mesh for ventral hernia repair, but Dr. Nocca said. “You close the hole created by the ventral herwith complicated hernia repair there is a high risk for infec- nia, then reinforce with the biomaterial that will change in tion of the synthetic mesh, and a higher rate of recurrence,” he time to become a new tissue.” said. “The use of biologic meshes has provided us a new way Due to the complex nature of the patients’ hernias, the of treatment for this type of patient.” When compared with recurrence rate Dr. Lo Menzo finds in patients who receive a synthetic mesh, a comparison of strength and other qualities biologic mesh is substantially higher than the approximately depends entirely on context, Dr. Nocca said. “The concept is 2% he sees in low-risk patients who receive a synthetic mesh not the same,” he said. “The aim of the synthetic mesh is to stay for common hernias. “Our recurrence rate is sometimes 15% in place in the wallRadial for life, Reload and to reinforce it. The or 20%, but that’s acceptable in the particular patient popuFigure 1.abdominal Endo GIA™ with Tri-Staple™ Technology. aim of biologic meshes is to facilitate regeneration of a new lation who undergo complicated repairs,” he said. “We do see tissue that will be strong and that will reinforce the abdominal a number of wound breakdowns that are not related to the wall. The biologic meshes may be in place for many months, biologic mesh itself, but to the complexity of the construcbut will be replaced by new tissue over time. Eventually, you tion that goes along with placing the mesh.” will not have any mesh. Instead, you will have tissue.”

Dr. Nocca will soon publish the results of an internaThis effect was found by van Tuil et al (2005), who inves- tional trial he and his colleagues conducted of complicated tigated the use of Tutopatch and Tutomesh implants in ventral hernia repair with or without Tutomesh implants. In 29 newborns with anterior abdominal wall defects. The this study, the first randomized trial to compare the use of a

Supported by

Case Study: Repair of Recurrent Ventral Abdominal Wall Hernia With Use of Tutomesh Prosthesis David Nocca, MD, PhD Department of Digestive Surgery Pr Fabre Hôpital Saint-Eloi University Hospital of Montpellier Montpellier, France

T

he role of biomaterial meshes in the management of ventral hernia remains to be elucidated. This case study presents an experience in the repair of recurrent ventral and incisional hernias using a bovine pericardium mesh under laparotomy. In 2010, a 61-year-old woman (body mass index 40 kg/m2) presented with a ventral and incisional hernia 3 cm above the umbilicus.

Physicians at the University Hospital of Montpellier had treated this hernia 2 years ago by laparoscopic approach (synthetic mesh 10 × 10 cm by inlay technique). In 2012, the patient returned to the hospital and complained about pain and digestive disorders. Computed tomography scan showed shrinkage of the mesh that led to recurrence of the hernia.

Repair of the recurrent ventral hernia using a Tutomesh implant was initiated. The procedure was completed entirely using the laparotomy approach. The contents of the hernial sacs were incarcerated omentum and small bowel. The first step of the procedure was to remove the previous synthetic mesh after a large adhesiolysis. The size of the defect through which incarceration occurred was 5 cm. An inadvertent enterotomy occurred in this case during bowel reduction and adhesiolysis; the operating physicians decided to choose a biomaterial prosthesis in order to decrease the potential risk for mesh infection, and selected a 12 × 16 cm Tutomesh prosthesis. Tutomesh is a xenogenic, non–cross-linked, collagenous graft of bovine origin, which consists predominantly of collagen type I and is fenestrated in a regular pattern (Figure 1).

A sublay technique was used to fix the mesh to the abdominal wall (Figure 2). Overall operative time was 96 minutes. The patient’s postoperative hospital length of stay was 4 days, and no postoperative complications were noted at 1-, 12-, and 24-month follow-ups. The advantages of using the Tutomesh prosthesis were that it was native bovine collagen with nearly unchanged biomechanical properties; histocompatibility; its resistance to bacterial colonization and chronic infection1; and its viroinactivity, noncarcinogenicity, and minimal allergy concerns. The mesh also featured high tensile strength and facilitated tissue regeneration (absorbable mesh). Also, the mesh perforations prevented the formation of seromas and provided excellent adaptability to the anatomy.

This case illustrates that mesh consisting of biomaterial may be an efficient and safe option for treating ventral abdominal wall hernias. Randomized trials are needed to evaluate this treatment further.

The products discussed herein may have different product labeling in different countries. This document contains

A

Figure 1. Rehydration of the Tutomesh implant prior to application.

Courtesy of David Nocca, MD.

B

is better than nothing when you have an uncomplicated hernia repair. For the surgeon, the use of biologic meshes is a new way to improve the treatment of this type of disease.”9-11 Based on his positive experiences with bovine pericardium using Veritas Collagen Matrix [Synovis] in the United States and Tutomesh in Italy, Dr. Lo Menzo intends to bring Tutopatch and Tutomesh implants into his armamentarium once they are available in the US market, and he looks forward to future studies to guide himself and other surgeons in selecting mesh.

“Comparing this product against other biologic products or without mesh I think would be the ideal studies to pursue,” Dr. Lo Menzo said. “Also, I think these meshes perform better in clean contaminated fields. A study surely could be done, but I don’t expect these products to become a panacea to use in purely infected fields—in those cases, I think the solution is still a staged operation.”

The products discussed herein may have different product labeling in different countries. This document contains information about products which may or may not be available in different countries and if applicable, may or may not have received approval or market clearance by a governmental regulatory body for different indications and restrictions in different countries.

References 1. Rutkow IM. Demographic and socioeconomic aspects of hernia repair in the United States in 2003. Surg Clin North Am. 2003;83(5):1045-1051, v-vi.

C Figure 2. Performing an open LAR with the Endo GIA™ Radial Reload with Tri-Staple™ Technology.

Figure 2. The sublay technique for ventral hernia repair using Tutomesh.

Courtesy of David Nocca, MD.

2. Leber GE, Garb JL, Alexander AI, Reed WP. Long-term complications associated with prosthetic repair of incisional hernias. Arch Surg.

1998;133(4):378-382.

3. Rosen MJ. Biologic mesh for abdominal wall reconstruction: a critical appraisal. Am Surg. 2010;76(1):1-6.

4. US Food and Drug Administration. Tutopatch 510(k) premarket notification summary of safety and effectiveness. www.accessdata.fda.gov/ cdrh_docs/pdf/k991296.pdf. Accessed January 31, 2013.

5. Cavallaro A, Lo Menzo E, Di Vita M, et al. Use of biological meshes for abdominal wall reconstruction in highly contaminated fields. World J Gastroenterol. 2010;16(15):1928-1933.

6. van Tuil C, Saxena AK, Willital GH. Experience with management of anterior abdominal wall defects using bovine pericard. Hernia.

2006;10(1):41-47.

7. Data on file.

information about products which may or may not be available in different countries and if applicable, may or may not have received approval or market clearance by a governmental regulatory body for different indications and restrictions in different countries.

Reference 1. D’Ambra L, Berti S, Feleppa C, Magistrelli P, Bonfante P, Falco E. Use of bovine pericardium graft for abdominal wall reconstruction in contaminated fields. World J Gastrointest Surg. 2012;4(7):171-176.

8. Choi JJ, Palaniappa NC, Dallas KB, Rudich TB, Colon MJ, Divino CM. Use of mesh during ventral hernia repair in clean-contaminated and contaminated cases: outcomes of 33,832 cases. Ann Surg. 2012;255(1):176-180.

9. Breuing K, Butler CE, Ferzoco S, et al; Ventral Hernia Working Group.

Incisional ventral hernias: review of the literature and recommendations regarding the grading and technique of repair. Surgery.

2010;148(3):544-558.

10. Novitsky YW, Rosen MJ. The biology of biologics: basic science and clinical concepts. Plast Reconstr Surg. 2012;130(5 suppl 2):9S-17S. 11. D’Ambra L, Berti S, Feleppa C, Magistrelli P, Bonfante P, Falco E. Use of bovine pericardium graft for abdominal wall reconstruction in contaminated fields. World J Gastrointest Surg. 2012;4(7):171-176.

Disclosures outcome stated by Dr. Nocca is that at 1 year, the Tutomesh implant group had significantly fewer recurrences than the primary closure–only repair group. “My feeling is that this study has proven we can use the mesh in complicated ventral hernia repair,” Dr. Nocca said. “In the mind of the surgeon, when you have an infected or contaminated field, you should not use a synthetic mesh.8 But in the history of ventral hernia repair, we have proven that using synthetic mesh

Dr. Lo Menzo reported no relevant financial conflicts of interest. Dr. Nocca reported receiving honoraria from Covidien and Ethicon and grant/research funding from Cook Medical, Ethicon, Novartis, Tutogen, and Vitalitec.

Call 877-612-4287 to coordinate product p availabilityy with your y local representative. p We look forward to seeingg yyou at our booth and symposia y p at AHS in Orlando,, Florida on Wednesday, March 13, 2013 beginning at 12 p.m.

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biomaterial with conventional treatment with no mesh, 69 patients underwent repair with Tutomesh implants and 65 underwent complicated ventral hernia repair without any mesh reinforcement.7 “At 1 month, there was no difference between the 2 groups, and that is very important because it emphasizes that we can put a mesh in without an increase of complication at 1 month,” Dr. Nocca said. The other important

www.rtibiologics.com

GENERAL SURGERY NEWS • MARCH 2013

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Clinical Review

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MARCH 2013

Fecal Microbial Transplantation An Increasingly Important Alternative for the Treatment of C. Difficile B Y A LLEN K AMRAVA , MD, MBA G ARY H. H OFFMAN , MD L OS A NGELES C OLON

AND

AND

R ECTAL

S URGICAL A SSOCIATES

D

espite the hard and fast medical school tenet that Clostridium difficile (C difficile) colitis is not an uncommon after-effect of clindamycin therapy, numerous other antibiotics also are strongly associated with the development of C. difficilee colitis. Beginning in 2000, hypervirulent strains of C. difficile have emerged, which seem to be linked to the increased use of fluoroquinolones and cephalosporins.1 These hypervirulent strains have caused more severe and refractory cases of colitis and have increased the need for ICU treatment, long-term antibiotic therapy and the need for emergent subtotal colectomies.

Although current standards set out by the Joint Commission and the National Surgical Quality Improvement Program have effectively decreased the incidence of surgical site infections, they also may have inadvertently caused the emergence of this hypervirulent C. difficilee strain.

The mechanism of action of these hypervirulent strains of C. difficilee has been shown to be the result of increased production levels of toxins A and B. Recent studies also have isolated the emergence of a new toxin that has been referred to as “binary toxin.”2 These new strains have become epidemic and have been linked to increased use of fluoroquinolones. Populations that previously have been considered to be at low risk for infection are increasingly becoming afflicted with refractory C. difficilee infections.

Traditional Antibiotics: Declining Effectiveness Although the understanding of the bacteriology of the disease has advanced, the rate of improved and more effective antimicrobial therapies has not kept pace. The standard therapy for C. difficilee colitis continues to focus on two antibiotics: metronidazole and vancomycin. The specific uses and modalities of therapy remain the only variables, with some practitioners starting treatment with metronidazole therapy and others with vancomycin therapy. In general, it is advocated that metronidazole be used for milder forms of the disease and vancomycin be reserved for more severe cases. In advanced cases, the two medications may be combined and also can be administered transrectally in the hope of increasing bacteriologic penetration.

completed. Relapses most often occurred within the first sevDr. Hoffman eral days after the completion of antimicrobial therapy.

Recently, a new bacteriocidal antibiotic, fidaxomicin, was introduced to treat C. difficilee colitis. Fidaxomicin is a narrow-spectrum macrolide that inhibits RNA transcription. Its major metabolite, OP-1118, is also therapeutically active. Fidaxomicin is active against virulent forms of C. difficile.4 In an industry-sponsored trial of 629 patients, a cure was achieved in 88.2% of those treated with fidaxomicin, and 85.8% in those treated with vancomycin. Recurrence rates were 15% and 25.3%, respectively.5 Non–industry-sponsored investigations have demonstrated similar responses. Despite

Current indications for FMT use include patients who are found to be refractory to antimicrobial therapy or who have had at least two documented disease recurrences after completing adequate antimicrobial treatment.

The emergent hypervirulent strains have demonstrated resistance to these standard medications. Kelly and LaMont reported that 25% of patients adequately treated with either of these medications experienced a disease recurrence.3 Patients followed one of two clinical pathways. In the first group, despite aggressive therapy, the disease progressed to fulminant colitis, necessitating an emergent subtotal colectomy. In the second group, the disease remained quiescent during the course of antibiotic administration, yet quickly relapsed once therapy was

FMT: Risks and Contraindications • Colonoscopic perforation rates are approximately one per every three to 5,000.

• There is a theoretical risk of transmitting infections when potentially infected stool is transferred from a donor with a transmissible disease to an otherwise uninfected recipient with a C. difficile infection. To mitigate this risk, choosing well-known family members as donors is the best option.

• Absolute contraindications to donor FMT include: • Recent, illlicit drug use; history of incarceration; high-risk sexual activity; known HIV, and tattoos/piercings within the previous six months.

• Antiobiotic use within the previous three months; risk factors for Creutzfeldt-Jakob disease; known past history of inflammatory bowel disease, irritable bowel syndrome, idiopathic constipation or chronic diarrhea.

• Donor blood testing may include screening for hepatitis A, B and C; Helocobacter pylori; human T-lymphotropic virus; and giardia antigen.

the treatment improvements with fidaxomicin, there remains much more to be done in the effort to cure C. difficilee colitis.

The New Kid on the Block—Stool The increasing incidence and refractoriness of C. difficilee infections have prompted the search for alternative therapies. Fecal microbial transplantation (FMT) is one such alternative therapy. FMT is performed by placing a fecal suspension of fresh stool harvested from a healthy individual into the gastrointestinal tract of an individual with a C. difficilee infection. Placement is performed through a standard colonoscope side channel or through a previously placed enteral tube. Enema suspensions also have shown promise.

This is not so much a new therapy as it is an alternative form of therapy. The first reported use of FMT was in the 17th century in veterinary medicine. The first reported use of this novel approach in humans was in 1958, in a four-patient case series by Eiseman.6 In a multicenter study, primary cure rates for FMT have been reported to be 91% after the first course of treatment, and 98% if a second treatment was necessary.7 The study reproduced the results from the only other multicenter study with 317 patients in eight countries that demonstrated a primary cure rate

of 92%.8 The investigators used stool from a healthy, screened Dr. Kamrava donor and infused it via a colonoscope into the recepient’s colon. Several other studies confirmed these results. The investigators noted that the response to FMT was rapid, with improvement of symptoms within three days of treatment in the majority of patients. Although all of the study participants underwent FMT via colonoscopy, other investigators have reported success using enema instillation, nasogastric tube instillation or esophagogastroduodenoscopy instillation.

In a recent study of nasogastric FMT, cure rates were found to be 81% after the first FMT and 94% overall when a second FMT was performed (N Engl J Med. d Jan 16 2013. [Epub ahead of print].

(See story, pages 1 and 7). This study, however, was performed on a highly selected group of patients and further investigation must be done with a broader range of patients. Additionally, unsedated outpatients might be wary of having a nasogastric tube removed after fresh feces had been inserted through the tube. It is in this realm where genetically engineered bacteria might be of use.

The reported cure rates using FMT are higher than those achieved by using vancomycin or the newer agent, fidaxomicin. FMT is clearly a viable treatment option for patients with C. difficile infections. Current indications for FMT use include patients who are found to be refractory to antimicrobial therapy or who have had at least two documented disease recurrences after completing adequate antimicrobial treatment.

FMT therapy should be considered for patients with moderate disease who have not improved symptomatically after one week of therapy. Case reports of the successful use of FMT in ICU patients with advanced disease have prompted calls for further investigation of the use of FMT in the ICU setting.

Risks Associated With FMT There are few risks associated with FMT. The most common is treatment failure, which is estimated to occur in approximately eight of 100 treated patients after a single stool transfer. With a second stool transfer, that number drops to two of 100 patients. The risks associated with colonoscopic FMT in the outpatient setting are considered to be no greater than the risks of standard colonoscopy. Colonoscopic perforation rates are estimated to be approximately one per every three to 5,000. The risk for

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endoscopic perforation increases when FMT is performed in patients with more advanced disease, especially in the ICU setting. Although not prohibitive, this risk should be clearly discussed with patients because a perforation in an acutely inflamed bowel with pseudomembranous colitis will necessitate an emergency total abdominal colectomy.

Absolute contraindications to donor FMT are recent illicit drug use, highrisk sexual activity, known HIV, history of incarceration, tattoo or body piercing within the previous six months, current or known exposure to communicable disease or antibiotic use within the prior three months, travel to an area with known diarrheal disease within the prior six months or risk factors for Creutzfeldt-Jakob disease.

Other contraindications for the donor are a known past history of inflammatory bowel disease, irritable bowel syndrome, idiopathic constipation or chronic diarrhea. Donors should not have been on systemic antineoplastic agents within the prior year, or should not be on major immunosuppressive agents and should not have had a history of a GI malignancy. Donors should notify the physician if there are any symptoms of an infection between the screening time and the time of donation.

Donor blood testing may include screening for hepatitis A, B and C,

Helicobacter pylori, syphilis, HIV, human T-lymphotropic virus, Cryptosporidium antigen and Giardia antigen.

There is a theoretical risk for transmitting infections when potentially infected stool is transferred from a donor with a transmissible disease to an otherwise uninfected recepient with a C. difficilee infection. To mitigate this theoretical risk, patients are advised to solicit donors from well-known family members. The donor stool may be screened and tested for transmissible diseases. These include salmonella, shigella, pathogenic E. coli, 0157:H7, Campylobacter, Entamoeba histolytica, Yersinia enterocolitica, C. difficile, ova and parasites such as Cryptosporidium, Giardia and others. To date, there have been no reported cases of disease transmission from donor to recipient. In the study performed by Brandt et al,9 stool transfers from individuals within the same household demonstrated a significantly higher cure rate than otherwise. Thus, our predilection for using family members as stool donors serves a dual purpose: higher cure rates coupled with the theoretical potential for lower risk for disease transmission.

The Protocol: Patient and Physician Education Is a Must In our practice, a clear protocol has been designed to help patients through

FECAL TRANSPLANT jContinued from page 1

with an average cure rate of 92% for more than 375 cases, there were still people who needed evidence-based data to support their beliefs. They still wanted ‘proof,’ and this, by all standards, is ‘proof,’” said Dr. Brandt.

The researchers randomly assigned patients with recurrent C. difficile infection to one of three treatment groups. One group received an initial vancomycin regimen (500 mg orally four times per day for four days), followed by bowel lavage and an infusion of a donor feces suspension through a nasoduodenal tube. The second group was treated with a standard vancomycin regimen (500 mg orally four times per day for 14 days). The third group received the standard vancomycin regimen with bowel lavage.

The study was stopped after an interim analysis showed an “overwhelming difference between treatment groups,” according to senior author Josbert J. Keller, MD, PhD, a gastroenterologist at Haga Teaching Hospital, The Hague, Netherlands. Of 16 patients in the fecal transplant group, 13 (81%) had resolution of C. difficileassociated diarrhea after the first infusion of donor feces.

The three other patients received a second infusion of feces from a different donor; of these, two were cured, for an overall cure rate of 15 of 16 patients (94%).

In contrast, the group receiving vancomycin alone achieved resolution of C. difficile infection in four of 13 patients (31%), and the group receiving vancomycin with bowel lavage achieved resolution in three of 13 patients (23%) (P<0.001 for both comparisons with the fecal

the entire FMT process. Information packets have been created that address the numerous and most common questions patients may have. We work closely with referring physicians who understand the protocol and who also have their own standard protocol for screening donors. We have attempted to educate the medical community regarding the diagnosis and treatment of resistant or recurrent C. difficilee infections.

The FMT is performed in an outpatient surgical center and patients return home the same day. In most patients, we are able to determine success or failure within several days after the fecal transfer. We are receiving an increasing number of patient requests for FMT as patient awareness has increased and physician education has evolved.

Although an individual’s first reaction to a stool transfer is usually some form of anxiety, most patients who consider this option have reached a frustration point in their failed treatment that they welcome this therapy. With our results and international results as promising as they seem to be, with risks no higher than that of a standard colonoscopy, and with a rapid cure rate after infusion, we have embraced this therapy and will continue to offer its use for the treatment of resistant or refractory C. difficilee infections.

transplant group). Adverse events did not differ significantly among the three groups except for mild diarrhea and abdominal cramping in the infusion group on the day of infusion.

Fecal transplant increased fecal bacterial diversity, making it similar to that of healthy donors. The authors suggested that the mechanism underlying the fecal transplant’s effectiveness is “probably the reestablishment of the normal microbiota as a host defense against C. difficile.”

Although Dr. Keller acknowledged it as a limitation, the small study size was a result of having the study terminated; initially, 120 patients were planned for inclusion. “Fecal transplantation was so effective that the study was prematurely terminated,” said Dr. Brandt. “It would have been ethically improper to continue it. The small size of the study is testimony to the effectiveness of the treatment.”

Dr. Keller cited two reasons for the study’s importance: first, “that it’s the first randomized study of this treatment for patients with C. difficilee infection,” and second, “it shows that this treatment strategy of using donor feces infusion [fecal transplant], which is a kind of a super probiotic, to influence the microflora, can cure people.”

Dr. Keller noted the open-label nature of the study as a limitation. Dr. Brandt said, “The study has no major limitations.”

“I’m doing a randomized controlled trial with Colleen Kelly, MD, of the Miriam Hospital in Providence, R.I.,” added Dr. Brandt. “Under a National Institutes of Health grant, we’re studying patients with at least three

References 1. Gould CV, McDonald LC. Bench-tobedside review: Clostridium difficile colitis. Crit Care. 2008;12(1):203.

2. Blossom DB, McDonald LC. The challenges posed by reemerging Clostridium difficile infection. Clin Infect Dis. 2008;45:222-227.

3. Kelly C, LaMont J. Clostridium difficile—more difficult than ever. N Engl J Med. 2008;359:1932-1940.

4. Louie T, Miller M, Mullane K, et al; OPT-80-003 Clinical Study Group.

Fidaxomicin versus vancomycin for Clostridium difficile infection. N Engl J d 2011;364:422-431.

Med. 5. Dificid [package insert]. San Diego, CA: Optimer; 2011.

6. Eiseman B, Silen W, Bascom GS, et al.

Fecal enema as an adjunct in the treatment of pseudomembranous enterocolitis. Surgery. 1958;44:854-859.

7. Brandt LJ, et al. Long-term follow-up of colonoscopic fecal microbiota transplant for recurrent Clostridium difficile infection. Am J Gastronenterol.

2012;107:1079-1087.

8. Gough E, Shaikh H, Manges AR. Systematic review of intestinal microbiota transplantation (fecal bacteriotherapy) for recurrent Clostridium difficile infection. Clin Infect Dis. 2011;53:994-1002.

9. Brandt LJ, Sheela SR. Fecal microbiota transplant for recurrent Clostridium difficilee infection. J Clin Gastroenterol.

2011;45:S159–S167.

recurrences of C. difficilee infection. The patients get back their own stool or get donor stool in a blinded fashion.

We hope our controlled trial will prove that the technique of fecal microbiota transplantation is rapidly effective and safe.”

Asked how his study could change treatment, Dr. Keller said, “The first and second episodes of C. difficile infection would be treated with antibiotics. The third episode, or the second recurrence, could be treated with antibiotics or you could consider donor feces infusion in certain patients. At the fourth episode, or the third recurrence, consider donor feces infusion as a serious possibility.”

“This will definitely help change the treatment of recurrent C. difficilee colitis,” said Dr. Brandt. “My opinion is that for a third recurrence, fecal transplant is the treatment of choice. I personally believe that it should be used more frequently and widely than is currently practiced. I would use it as first-line [therapy] in severely ill patients who may not be able to wait for vancomycin to take effect. I would prefer fecal transplant to antibiotics for the first episode of C. difficilee because antibiotics perturb the intestinal microbiome and may lead to antibiotic resistance.”

In future studies, Dr. Keller said, “we need to show that enemas are effective, and whether we can use stored feces and frozen feces. We need to determine which bacteria are responsible for the clinical effect and develop a mixture of bacteria to replace donor feces.”

Dr. Brandt reported receiving a grant for research support by Optimer Pharmaceuticals, Inc.. Dr. Keller reported no relevant financial conflicts of interest.

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Opinion

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MARCH 2013

Is This Really an Excellent Way To Make a Center of Excellence?

The Unsettled Story of Bariatric Accreditation Programs and Their True Effect on Patient Care B Y D ANIEL C OTTAM , MD, M ITCHELL R OSLIN , MD

AND

I

f you are a bariatric surgeon with interest in the recent center of excellence (CoE) or accreditation struggle, it is hard to not be cynical.

What our leaders promised us in 2006 has never been fulfilled despite the majority of our practices participating in a CoE process. There has been little useful information shared across practices, and access to care and insurance reimbursement have not increased.

For those unfamiliar, a short recap is necessary. Approximately 10 years ago, it was deemed essential that an accreditation program be created for bariatric surgery. Media reports of poor outcomes created concern that without an active CoE program, bariatric surgery would be in danger of being blacklisted.

After lengthy discussion, both the American College of Surgeons (ACS) and the American Society for Metabolic and Bariatric Surgery (ASMBS) introduced separate programs.

To administer the ASMBS program, a new independent entity called Surgical Review Corporation (SRC) was formed.

A majority of the ASMBS membership and their hospitals decided to participate in the SRC program because it was less expensive. A major reason was that participation in the ACS program for level 1 centers mandated use of the National Surgical Quality Improvement Program (NSQIP), which was very expensive.

Achieving CoE status included the development of pathways, credentialing, documentation of equipment and consultant availability. A volume threshold of 125 cases was mandated. No differentiation was made for case or patient difficulty.

The CoE programs' strongest benefit was the 2006 national coverage decision by the Centers for Medicare & Medicaid Services (CMS), which stated that for coverage for bariatric surgery, the procedure would need to be performed at a center approved by either the ACS or ASMBS. As can be expected with any new process, flaws in the methodology were uncovered. Certainly the system required updating and improvement. However, without collecting feedback from member surgeons or hospitals involved with the SRC, ASMBS leadership decided to end

their contract with SRC. (The members of the ASMBS have never been told what happened or why a new system was needed. Two working systems existed at the time.) Members were told about the great opportunity to unite our program with the ACS. With great enthusiasm, the leaders outlined a system that would be based on the Michigan Surgical Collaborative. An attractive aspect of this system was that doctors were able to share data across practices easily. Discussions with John Birkmeyer, MD, medical director of the Michigan Surgical Collaborative, took place on integrating the ASMBS CoE system into the collaborative. However, it soon became apparent that this was not going to be a practical solution.

As a result, an integrated committee of sincere surgeons comprised of representatives from the ACS and ASMBS was assigned to write new standards for the combined program. However, instead of creating a simple effective process, a very rigid blueprint for bariatric practice was suggested in an attempt to proliferate what they believed to be best-practice standards. Surgeons were told what operations they could do, and when and where they should be performed. Additionally, the proper ages for surgical treatment and which procedures required institutional review board approval were described. Rather than have the center

whether CoE status was necessary and suggesting that CMS should allow Medicare beneficiaries to have bariatric surgery in any facility. He noted that outcomes in bariatric surgery have improved throughout the country. Two large studies showed no improved outcomes at CoE centers compared with non-CoE centers ((Arch Surgg 2009;144:319-325; JAMA A 2010;304:435-442). Therefore, the requirement for coverage that bariatric surgical procedures be performed at a center certified by the ACS or ASMBS should be withdrawn, he argued. Dr. Birkmeyer is well respected and a former adviser to CMS. Based on his letter, CMS decided to open the national coverage decision and ask for public comment on this issue.

Many argue that an accreditation program is essential to maintain the integrity and trust of the public. The question is does it really do this? If we think back to the original stated goals of the CoE process, we would have to say it has not delivered on its promise. determine how to contact patients for follow-up and how to participate in performance improvement, strict adherence to their policy was mandated. Failure to follow these guidelines would result in termination of the CoE designation.

The old program of broad principles to be filled in by the practices was replaced with strict rules. Thankfully, some of our past presidents and members of ASMBS saw this and raised the alarm. Furthermore, our field moves faster than documents like this can be written. As a result, even if we could agree on the best methodology, it would be outdated before it could be disseminated.

During the period of time that we were discussing issues with our new system, Dr. Birkmeyer sent a well-written and researched letter to Medicare questioning

This leads us to the question of whether we need a CoE program in 2013. Many argue that an accreditation program is essential to maintain the integrity and trust of the public. The question is, does it really do this? If we think back to the original stated goals of the CoE process, we would have to say it has not delivered on its promise. Thus, many may believe that we do not need a CoE process.

Unfortunately, what seems simple is often not. The Michigan Collaborative sounds like a perfect system until you peel away the layers. Blue Cross of Michigan, which controls 70% of the insured lives in the state, sponsored the collaborative.

This fact alone makes us even more convinced that we need an independent CoE system. If we do not develop an effective accreditation process, groups like the

collaborative (owned by Blue Cross) will own the only large collection of outcomes data. Data can have multiple interpretations, and if we don’t have other large collections of data we will not have the facts or evidence to oppose whatever the insurance companies say. Thus, an independent physician database (or databases) is our best professional protection.

Although the ASMBS has made errors, it is still our society. It is owned by us, those involved in patient care, and is not sponsored by an insurance company. Likewise, it is not a software company either. We should seek out partners who can aggregate data and share the de-identified data with all members of the society much like we do with our journals.

Surgeons will want to participate because it will make them better surgeons. This means we need to scrap the document that was up for public comment. It was a poor imitation of The Michigan Collaborative that relied on force to achieve compliance.

Instead, we should find a creative method to find a flexible accreditation system that accumulates the relevant data on primary procedures at reasonable cost.

Whether we should combine with the ACS, create an independent solution or resuscitate the SRC should all be discussed and considered. What also needs to be understood is that the cost of failure will be very large in the future. It will mean that the most detailed outcomes on bariatric surgery will be owned by an entity sponsored by Blue Cross. If at some point, they do not have our patients' best interests in mind, we will not have the necessary facts to protect our patients or our practices.

—Dr. Cottam is director of the Surgical — Weight Loss Center of Utah, and the Bariatric Medical Institute, Salt Lake City; Dr. Roslin is chief of bariatric and metabolic surgery, Lenox Hill Hospital/North ShoreLIJ, New York City.

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GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MARCH 2013

Body Contouring After Bariatric Surgery Are We Doing Enough for Our Patients?

B Y A NNA G OLDENBERG S ANDAU , DO

W

ith obesity on the rise, the number of Americans undergoing bariatric surgery has increased exponentially over the past several years. Estimates show that in the United States, doctors perform more than 220,000 bariatric surgeries annually. Although most of the research to date focuses on the physiologic effects of this procedure, very little information is available on the psychological significance of bariatric surgery to the patient. Specifically, most bariatric surgeons do not factor in the influence of body contouring

when measuring the success of bariatric procedures. Therefore, the question remains, should all preoperative bariatric consultations include a trip to the plastic surgeon, and if so, is the medical community behind in our understanding of the psychological and functional significance of body contouring after bariatric surgery?

Losing a massive amount of weight is a life-changing event for a patient, and the effects often unfold over time. Both plastic and bariatric surgeons recommend that a patient should have a stable weight for six to 12 months before undergoing any contouring procedures. During the process of “soft tissue deflation,” most patients experience secondary emotional and physical disability. According to a

study on body image and a patient’s quality of life after massive weight loss, “as increasing numbers of bariatric surgical patients achieve success, they are left with post-weight loss deformaties of loose, ptotic skin envelopes and residual adiposities that compose contour irregularities” (Obesity 2006;14:1626-1636).

These side effects can lead a patient to experience difficulties with hygiene, mobility and sexual health, as well as psychological difficulties. However, plastic surgery can alleviate many of the issues that arise for a patient after bariatric surgery. According to a study by Araco et al, “most of the altered body contours involving the abdomen, thighs and buttocks can be effectively corrected with lipectomy and body-lift procedures.

Figure 1a. Excess arm skin and loss of skin elasticity after weight loss surgery.

Figure 1b. Two months postoperative from brachioplasty with removal of excess skin and fat deposits. Incision is well hidden in the inner arm into the axilla.

Figure 2a. Skin deformity of upper thighs causing significant mobility and hygiene problems.

Figure 2b. After a thigh lift. This has proven to be an effective procedure for tightening loose, sagging skin in the buttocks, posterior thighs, hips, and outer and anterior thighs. Incisions pass from the back around the hips to the inner thighs. Incisions are well hidden in normally occurring anatomic folds.

‘Plastic surgery in all its aspects is about harmony ...

After massive weight loss, this delicate balance is disrupted. Patients simply want to look as good as they feel. Having post-bariatric contouring is a way to achieve this balance.’

—Benjamin Lam, DO Facial and neck skin redundancy can be corrected with rhytidectomy techniques, and mastopexy operations with or without augmentation have been used to lift and fill redundancy of the breast” ((Aesthet Plast Surgg 2006;30:374-376).

Benjamin Lam, DO, director of plastic and reconstructive surgery at Philadelphia College of Osteopathic Medicine, and an expert in body contouring in bariatric patients, believes that “plastic surgery in all its aspects is about harmony.

Body image has both a mental as well as physical component. This is especially true in the bariatric population. After massive weight loss, this delicate balance is disrupted. Patients simply want to look as good as they feel. Having post-bariatric contouring is a way to achieve this balance.” He also believes that patient expectations must be discussed at length before any body contouring is performed.

“Because skin elasticity is often compromised from the weight loss, patients have to be realistic about the final results,” Dr. Lam said.

In 2009, Warner J. et al, at the University of Wisconsin Division of Plastic and Reconstructive Surgery stated, “The surgical treatment of the obese population is multidisciplinary and should include both bariatric and plastic surgeons.”

In a national survey, (Plast Reconstr Surgg 2009;124:926-933), researchers sent out 500 questionnaires to bariatric surgeons. Of the surgeons surveyed, 64% reported that patients asked about body-contouring procedures even before they underwent bariatric surgery. Ninety-six percent of bariatric surgeons had access to plastic surgeons, but only 7% reported referring their patients to a plastic surgeon postsurgery. Fifty-one percent of surgeons reported that those patients who had undergone body-contouring procedures were more satisfied with their decision to undergo bariatric surgery than those who did not have these procedures. Additionally, 85% of bariatric surgeons believed that insurance policies should cover body-contouring procedures after massive weight loss.

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GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MARCH 2013

Figure 3a (left). Overhanging skin after weight loss surgery often leads to unwanted rashes and morbid infections in skin folds.

3b. Post abdominoplasty with plication of the rectus muscles. Removal of excess skin and fat achieves a smooth contour to the abdominal wall and plication tightens the weakened rectus muscles.

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These ideas are further supported by the fact that many bariatric surgery patients are seeking out body-contouring options on their own. Plastic surgeons have reported an increase in the number of patients requesting body contouring. “To many bariatric patients, plastic surgery is the icing on the cake, the end of a long journey. Yet some patients wear the extra skin as badges of honor,” said Marc Neff, MD, FACS, medical director of the Kennedy University Hospital Bariatric Surgery Program in Stratford, N.J. Dr. Neff believes that if patients know they will have to pay out of pocket for extra procedures, they might be deterred from asking about the procedures or seeking insurance coverage options.

Open dialogue between doctor and patient, and within the health care system as a whole, is changing the way the medical community views the effects of bariatric surgery. Many patients report shying away from asking their doctors for a referral to a plastic surgeon for information about body contouring because they are afraid of the potential financial burden. Currently, most insurance policies cover only a very small range of plastic surgery procedures, usually for debilitating rashes or mobility dysfunction. This sobering fact sways many bariatric surgeons away from referring patients to a plastic surgeon. Most studies on post-bariatric body contouring cite “the most frequent reason for not undergoing body contouring is the expense, and second, the lack of awareness regarding the options.” From this evidence, it is clear that health care providers and insurance companies should recognize the psychological and physical disabilities of massive weight loss, which are both functional and aesthetic.

Doctors should routinely engage in discussion about self-image and expectations with every bariatric patient in the early preoperative evaluation phase. They can provide additional information in the form of picture pamphlets, videos or even a free consultation with a plastic surgeon.

Although research has shown that it is important for the medical community to consider the aesthetic aspect of post–bariatric surgery, a lot of work needs to be done before this becomes the status quo.

Further research is necessary to assess the post-bariatric weight loss self-image phenomenon and how body contouring can improve the long-term quality of life for these patients.

—Dr. Goldenberg Sandau is a surgical — resident (postgraduate year-3) at the University of Medicine & Dentistry of New Jersey, Stratford. d Benjamin Lam, DO, and Marc Neff, MD contributed to this article.

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In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MARCH 2013

Research Explores Relationship of the Human Microbiome and Obesity B Y G EORGE O CHOA

L

ong understudied, the human microbiome—the microbes, with their genomes, that dwell in and on the human body—is now under intense scrutiny. It is increasingly clear that “the human indigenous microbial communities … play a larger role in human health and disease than previously recognized” (Nutr Rev v 2012;70:S2-S9).

In August, two studies provided new evidence that antibiotics administered in early life can result in obesity, presumably by disturbing the gut microbiome. Conversely, disturbance of microbial communities in obese individuals can result in beneficial outcomes, as a third study, in October, showed with bariatric surgery.

“The important thing is that there are interesting theories and hypotheses about how the bacterial flora of the stool might contribute to the etiology

of obesity,” Philip Schauer, MD, director, Bariatric and Metabolic Institute, Cleveland Clinic, in Ohio, told General Surgery News. “This is an interesting and early and somewhat speculative area of research. It may challenge the notion that obesity is just due to not eating the right things and not exercising enough.”

Ilseung Cho, MD, MS, assistant professor of medicine, associate program director, Division of Gastroenterology, NYU School of Medicine, New York

‘Knowledge of the importance of the microbiome in human development raises new issues about antibiotic use in children, as such exposures may disrupt the microbial ecology.’

—Authors of study in International Journal of Obesity

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City, wrote by email: “Many investigators who study the gut microbiome think that it plays a significant role in the obesity epidemic in concert with a variety of other risk factors, such as poor dietary habits or a sedentary lifestyle. The microbiome plays a key role in a variety of host functions, including immune response and metabolism.”

Antibiotics and the Mouse Dr. Cho was the lead investigator on a study in mice that demonstrated that antibiotics altered the gut microbiome in such a way as to affect murine metabolism and cause increased adiposity (Nature 2012;488:621-626).

In their drinking water, young mice received subtherapeutic doses of penicillin, vancomycin, penicillin plus vancomycin, or chlortetracycline; a control group received no antibiotic. There were 10 mice per group. After an exposure of seven weeks, the mice did not differ significantly in weight gain, but all four antibiotic-exposed groups had significantly higher total fat mass (P<0.05) compared with controls, and most (with the exception of the vancomycin group) had higher percent body fat (P<0.05).

The antibiotic exposure caused taxonomic changes in the microbiome, with the ratio of the phylum Firmicutes to the phylum Bacteroidetes elevated in the antibiotic-exposed mice. Additionally, there was evidence of metabolic changes. For example, glucose-dependent insulinotropic polypeptide was elevated in the antibiotic-exposed mice, and glucose tolerance tests showed a trend toward hyperglycemia.

“In our paper, we describe a model where, by exposing mice to low-dose antibiotics, we were able to alter their microbiome,” said Dr. Cho. “Altering their microbiome resulted in a metabolic change in the mice that led to increased adiposity. The paper demonstrates that we are able to affect host metabolism by altering the gut microbiome.”

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GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MARCH 2013

A study published in advance online on Oct. 2, 2012 (Pharmacogenomics J; J doi:10.1038/tpj.2012.43) sought to ascertain exactly what happens to the human gut flora in Roux-en-Y gastric bypass (RYGB).

“Postoperative modification of gut microbial composition could be directly related to the metabolic status of the patients,” emailed lead author Juergen Graessler, MD, PhD, Prof. Dr. med., head of the Division of Pathological Biochemistry, and senior author Stefan R. Bornstein, MD, PhD, Prof. Dr. med., director and chair of medicine,

both from the Department of Internal Medicine III, Carl Gustav Carus Medical School, Technical University Dresden, Germany.

The researchers aimed to characterize changes of gut microbial composition within an individual before and three months after RYGB. The six patients examined in this pilot study were morbidly obese (BMI >40 kg/m²) with type 2 diabetes. Through metagenomic sequencing, 1,061 microbial species were identified in the fecal DNA of these patients.

Of these, 22 species (and 11 of 729 genera) were found to be significantly affected

13

by RYGB and were possibly associated with postoperative metabolic changes. Firmicutes and Bacteroidetes were reduced, and the phylum Proteobacteria was increased. The authors observed that the shift to Proteobacteria might bring potential risk for bowel inflammation and colorectal carcinomas.

Dr. Schauer commented: “Just the opposite has been seen. Everything so far suggests that bariatric surgery reduces cancer risk.”

Of the 22 affected species, 10 correlated with plasma total and low-density see MICROBIOME page 16

Antibiotics in Infants In the same month that Dr. Cho and his colleagues published their results about young mice, a related paper about infants exposed to antibiotics was released in advance online (Int J Obess 2012 Aug 21; doi:10.1038/ijo.2012.132).

“Knowledge of the importance of the microbiome in human development raises new issues about antibiotic use in children, as such exposures may disrupt the microbial ecology,” the authors wrote.

In the longitudinal birth cohort study, data were analyzed from 11,532 children.

Exposure to antibiotics during three early-life time windows (ages <6 months, 6-14 months, 15-23 months) was assessed by questionnaires that had been administered to the parents near the measured time interval. Body mass indices (BMIs) were examined at five time points (six weeks, 10 months, 20 months, 38 months and seven years).

Exposure to antibiotics during the period before 6 months of age (and only during that period, of those studied) was found to be consistently associated with increases in BMI from 10 to 38 months. At 38 months, children who had been exposed to antibiotics before 6 months had significantly higher standardized BMI scores (P=0.009) P and were 22% more likely to be overweight than children who had not been exposed (P=0.029).

P The researchers controlled for known social and behavioral risk factors for obesity.

Bariatric Surgery Following the recent evidence that antibiotics can disrupt the microbiome comes new evidence that bariatric surgery can do the same. In this case, the disruption may be a source of health benefits.

“The things we do to the gut in gastric bypass could alter the gut flora in a positive way and could be a major factor in why patients lose weight,” said Dr. Schauer.

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THE SCIENCE BEHIND POSITIVE PATIENT OUTCOMES

Clinical Advances of the Endo GIA™ Radial Reload With Tri-Staple™ Technology in Open LAR Christopher Mantyh, MD Chief, GI/Colorectal Surgery Associate Professor of Surgery Duke University Medical Center Durham, North Carolina

Introduction An alternative to abdominoperineal resection (APR) for the treatment of rectal cancer, lower anterior resection (LAR) is performed by dividing the rectum, removing the tumor or diseased portion, bringing the healthy piece of the colon down, and reattaching it to the rectum.1 Unlike APR, in which the rectum, anus, and lymph nodes are all removed along with the cancer, LAR allows the rectal sphincter to remain intact so the patient can experience relatively normal bowel function and avoid the need for a colostomy.1,2 The ability of surgeons to perform LAR was made possible in part by the availability of surgical staplers,3 but the procedure can be quite challenging because of the anatomic characteristics of the pelvis, which hinder visibility and the surgeon’s ability to maneuver instruments.4,5 “You’re dealing with a very fixed area with a bony pelvis on both sides; you have very limited range of motion,” said Christopher Mantyh, MD, chief, gastrointestinal and colorectal surgery, Duke University Medical Center, Durham, North Carolina.

To address the challenges faced by surgeons performing open LAR, Covidien has developed the Endo GIA™ Radial Reload, the latest of the company’s staplers with Tri-Staple™ technology, and the newest instrument in the company’s portfolio of colorectal surgical devices. The Endo GIA™ Radial Reload’s curved shape and narrow profile are designed to allow better access, greater maneuverability, and enhanced visibility, while the Tri-Staple™ technology, with its progressive staple heights and stepped cartridge face, ensures a secure staple line. The Endo GIA™ Radial Reload can accommodate a wide range of tissue thicknesses (1.5-2.25 mm), can rotate 360 degrees, is compatible with all Covidien universal handles, and can achieve depths up to 2 cm lower in the pelvis than competitive staplers (Figure 1).6

“The biggest problem [surgeons may] have with laparoscopic LAR is getting below the tumor and stapling distally,”said Dr. Mantyh.“You really need to have a very secure staple line. [To achieve this,] most people will do a double staple technique, where they bring an end-to-end anastomosis up through the previous staple line, or endto-side in the case of a colonic J-pouch, and then staple it.”

However, this leads to “multiple fires to staple across the rectum,” and can result in a higher leak rate and possibly a positive margin [in men].9 Although he does perform LARs laparoscopically for upper rectal cancers, Dr. Mantyh prefers to use an open approach for approximately 70% of LAR cases, particularly if the cancer is located lower in the rectum and in larger, male patients as they have narrower pelvises. Yet, like many surgeons, Dr. Mantyh has been frustrated by the limitations

of his previous instruments when performing open LAR. “Some of the staplers out there have a wide head or wide profile,” and “with a narrow pelvis and bulky tumor, it can be tricky to get a stapler [of that size] below the tumor and staple across [the rectum],” he said. “If you staple across a very thick rectum, you can have an incomplete division. It just won’t cut across it and your staples can come apart.”

Tri-Staple™ Technology Dr. Mantyh has been disappointed in the past by the claims and promises of new technology, and understands a surgeon’s hesitation to adopt early. “I was skeptical of a lot of these staplers when they initially came out,” he said. “Some of the instruments that came before just didn’t live up to the hype.”

He was eager to try an instrument that seemed like it

Progressive staple heights, unique q tapered p cartridge g face

Staples and transects tissue

Unique tissue retention feature

Narrow profile

360 degree rotation

Challenges of LAR The benefits of laparoscopic surgery are well known.

Patients who undergo laparoscopic procedures often spend less time in the hospital, tolerate fluid intake, have the first bowel movement earlier, and experience less pain with a lower need for analgesics and epidurals than those who undergo open procedures.7,8 But those benefits mean nothing if the laparoscopic approach compromises the surgeon’s ability to completely remove diseased tissue and create the best scenario for preventing recurrence.

14

GENERAL SURGERY NEWS • MARCH 2013

Compatible with all Endo GIA™ Universal, Endo GIA™ and Ultra Universal handles

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

Data on file. Covidien.

Operates in both Coronal and Saggital planes

Supported by

A

for facilitating this access and for making it a bit easier to maneuver around the tubular shape of the rectum.

“One of the many reasons they made it curved is that at that point in the pelvis, very low down, there is a curvature. You are definitely able to get it lower than [other staplers],” he said.

Dr. Mantyh reported that he is able to reach the levator muscles, and that it may be easier for him to achieve the desired margins with the Radial Reload than with other staplers. “The margin issue with rectal cancer is a moving target. Previously, it was 5 cm,” he said, [but] “more recent data10 suggests 1 cm, and some people have published sub-centimeters. But the real issue with rectal cancer is that it spreads radially, not distally. Having said that, I aim for about a 1 cm margin.”

Dr. Mantyh predicts the Radial Reload will play an increasing role in his armamentarium. “I think I’m going to be using it more and more for mid-to-low rectal cancers, even for upper rectal cancers,” he said. “I think the technology is quite good. It doesn’t add any more time [to the procedure] and it is reasonably priced.”

B

Conclusion

Clinical Experience Dr. Mantyh participated in a trial for the Endo GIA™ Radial Reload in open cases before the product was released.

“Some engineers came in and taught me how it works, so I was pretty familiar with it by the time we actually tried it on a human patient,” he said. (Figure 2) “It worked really well. I like the feel of it, and I like the fact that it fits with the Universal handles so I didn’t have to re-learn how to squeeze it,” he said. “It does have a nice 360-degree rotation, and it cuts, so you don’t have to bring a knife down into the pelvis.”

The Radial Reload is designed to allow surgeons to perform an LAR from both the coronal and sagittal planes, and although Dr. Mantyh has tried the instrument from both planes, he finds the sagittal approach preferable for open LAR. “I initially used it in a coronal fashion, but I’m actually going to the sagittal way of doing it,” he said. “Sagittally, I think you’re able to see the tissue get into the staple line better; you have better visualization of what tissue is in [the stapler], and then you see the tissue being stapled and [divided by the blade].” But there are some situations in which he would use the coronal approach, specifically in female patients. “If you are concerned about the vaginal cuff getting caught in the staple [line], you might want to approach it coronally, then take a tracking device and push up on the vaginal cuff so that you don’t incorporate that,” he said. “It’s a real risk. The vagina lies right on top of the rectum at that point, and you definitely don’t want to catch the cuff of the vagina.”

However, Dr. Mantyh considers the tissue retention feature a helpful element when working in either plane.

C Figure 2. Performing an open LAR with the Endo GIA™ Radial Reload with Tri-Staple™ Technology.

(A) Dr. Mantyh maneuvering the reload into place during an open LAR procedure.

(B) Dr. Mantyh placing of reload around bowel in preparation for distal transection.

(C) Dr. Mantyh demonstrating access and visibility in the deep pelvis when using this reload.

“There is a small black [tissue retainer] on [the Radial Reload] that you can get the tissue into with your finger. If it’s in there, you know it’s going to be a safe staple line and will be the 1 staple [firing] you need,” he said. This springloaded component, located on the distal end of the reload, is intended to aid surgeons in guiding the device into place without trapping any excess tissue. If the tissue exceeds the length of the reload, the retainer will retract, allowing forward extrusion of the excess tissue.6 Dr. Mantyh finds he is able to achieve greater depth in the pelvis with the Radial Reload than he can with other staplers he has used. He credits the curved shape of the Radial Reload

The Radial Reload includes design features unavailable elsewhere and allows for better visibility and greater access, even very low in the rectum, for a successful open LAR. “One of the issues we’ve always had is that we didn’t have a good instrument that could get down to that level and provide a single safe staple line instead of multiple staple lines,” Dr. Mantyh said. “I’ve had good experience with [the Radial Reload]. I think the engineers have spent a lot of time on it, and I think they developed a nice product.”

References 1.

American Cancer Society. Surgery for colorectal cancer. http://www. cancer.org/Cancer/ColonandRectumCancer/DetailedGuide/colorectal-cancer-treating-surgery. Accessed November 13, 2012.

2.

National Cancer Institute. SEER Training Modules. http://training.seer. cancer.gov/colorectal/treatment/rectum.html. Accessed November 13, 2012.

3.

Naef AP. The mid-century revolution in thoracic and cardiovascular surgery: part 3. Interact Cardiovasc Thorac Surg. 2004;3(1):3-10.

4.

Brannigan AE, De Buck S, Suetens P, Penninckx F, D’Hoore A. Intracorporeal rectal stapling following laparoscopic total mesorectal excision. Surg Endosc. 2006;20(6):952-955.

5.

Zmora O, Wexner SD. Part I–Laparoscopic surgery for colon and rectal cancer. Curr Probl Cancer. 2001;25(5)286-309.

6.

Data on file. Covidien.

7.

Veldkamp R, Kuhry E, Hop WC, et al. Laparoscopic surgery versus open surgery for colon cancer: short-term outcomes of a randomised trial.

Lancet Oncol. 2005;6(7):477-484.

8.

Clinical Outcomes of Surgical Therapy Study Group. A comparison of laparoscopically assisted and open colectomy for colon cancer.

N Engl J Med. 2004;350(20):2050-2059.

9.

Kim JS, Cho SY, Min BS, Kim NK. Risk factors for anastomotic leakage after laparoscopic intracorporeal colorectal anastomosis with a double stapling technique. J Am Coll Surg. 2009;209(6):694-701.

10.

Kiran RP, Lian L, Lavery IC. Does a subcentimeter distal resection margin adversely influence oncologic outcomes in patients with rectal cancer undergoing restorative proctectomy? Dis Colon Rectum.

2011;54(2):157-163.

BB1239

could make up for the shortcomings of [other staplers].

“I think [the Radial Reload is] a nice concept,” he said. “It’s a relatively low-profile stapler, and it has 3 staple lines,” as opposed to other devices that feature 2 rows of staples only. The additional staple line afforded by the Tri-Staple™ technology is particularly important to Dr. Mantyh, who has been using Covidien’s Radial Reload in his open cases and laparoscopic colectomies since it became available.

“It’s not just that ‘3 is better than 2.’ There’s actually data behind the Tri-Staple™ technology; the progressive staple height takes pressure off [the tissue] when you fire the staple,” he said. “It provides comfort, the burst pressure strength is higher, the sequential compression it does—I really do believe in it.” Indeed, the varied staple heights of the Tri-Staple™ technology improve burst pressure due to reduced tissue compression, and provide a tighter staple closure as well as enhanced compression while firing.6 Indeed, instruments with Tri-Staple™ technology are designed to optimize the interaction between instrument and tissue. The stepped cartridge face and staggered staple heights deliver graduated compression to the cut line, which reduces stress on the tissue at a point where it is most vulnerable to leaks and trauma. The unique design also assists in retaining fluids, allowing for potentially greater perfusion into the staple line.6

GENERAL SURGERY NEWS • MARCH 2013

15

16

In the News MICROBIOME

jcontinued from page 13 lipoprotein cholesterol levels, five with triglyceride level, and two with hemoglobin A1c level. These data suggest, the authors wrote, that metabolic changes may result not only from RYGB-induced malnutrition but modified gut microbiota composition. All six patients lost weight and showed an improved metabolic situation after three months, with type 2 diabetes alleviated and inflammatory activity reduced.

“This is the first clinical demonstration of a profound and specific intraindividual modification of gut microbial composition by full metagenomic sequencing,” said Drs. Graessler and Bornstein. “A clear correlation exists between microbiome composition and gene function with an improvement in metabolic and inflammatory parameters.” “[The study by Graessler et al] is important and adds to the body of literature that shows microbial alterations postsurgery, ” Elaine Holmes, PhD, head of biomolecular medicine, Imperial College, London, who is not associated with the study, wrote by email. “It is important to try to identify how the microbiome may contribute to the mechanisms of weight

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MARCH 2013

loss or weight gain. If we can mimic this effect pharmacologically without necessity for surgery, then this would be a less invasive and safer option and could be critical in controlling the increasing diabetes epidemic.”

Dr. Holmes was a co-author of studies that reported alterations in the microbiome and metabolism of rats following RYGB (Gutt 2011;60:1214-1223; Front Microbioll 2011 Sep 13; doi:10.3389; fmicb.2011.00183). About those studies, she commented: “Following gastric bypass surgery there is an increase in the Gammaproteobacteriaa and in Enterobacteriaa in particular. This was accompanied by alterations in metabolism including … energy metabolism, gut microbial metabolites such as cresols, and … amino acids and biogenic amines.”

Dr. Holmes is currently engaged in a similar study in humans. “We have compared the results from surgery with nonsurgically achieved weight loss,” she said.

“We have looked at samples up to one year postsurgery and still find a substantially altered microbiome and metabolism. The microbiome is unquestionably altered following bariatric surgery. This has been shown in both rodent models and in man.”

On the study by Graessler et al, Dr.

‘We are just beginning to appreciate how integral the gut microbiome is to human health and disease.’

—David A. Relman, MD Schauer noted: “This is very early stuff, a small set of six patients, basically showing a correlation between surgery and changes in populations of bacteria after surgery. A lot more work needs to be done to show that changes in bacteria are a cause of the improvement.” He also pointed out the lack of a control group in the study.

Dr. Cho also commented on the Graessler study, calling it a “a good study that begins to demonstrate the associations between surgical interventions and the microbiome.” But, he pointed out a limitation of the study, saying that it, like most studies of its kind, only reported associations.

“We will eventually need long-term studies to evaluate whether changes are durable,” Dr. Cho said. “And perhaps more importantly, how those changes affect the host. Associations may exist but may not have any clinical impact, so all

that information remains to be explored.”

The Future Although research on the microbiome, obesity and bariatric surgery is still in its infancy, the general lines it will follow are beginning to be defined.

“The microbiome does bear careful examination in the setting of bariatic surgery (a radical ecological disturbance), and will require time series analyses (with dense sampling before and after the procedure) in a significant number of subjects, in such a manner that a number of confounding variables are controlled,” wrote David A. Relman, MD, in an email.

Dr. Relman is the Thomas C. and Joan M. Merigan Professor, Departments of Medicine and of Microbiology & Immunology, Stanford University, and chief, Infectious Diseases Section, VA Palo Alto Health Care System, Palo Alto, Calif.

“The measurement of functional attributes will be very important,” he said.

“We are just beginning to appreciate how integral the gut microbiome is to human health and disease,” said Dr. Cho. “I think that we will discover far-ranging effects of the microbiome on a wide variety of diseases, including cardiovascular disease, obesity, colorectal cancer and inflammatory bowel disease.”

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MARCH 2013

17

Diet, Exercise Program Fails To Halt Cardiovascular Events in Obese B Y G EORGE O CHOA

T

he Data and Safety Monitoring Board (DSMB) of the National Institutes of Health has recommended that the intervention arm of the Look AHEAD (Action for Health in Diabetes) study be discontinued because it showed that an intensive diet and exercise intervention program, resulting in moderate weight loss, did not reduce major cardiovascular events in overweight and obese adults with type 2 diabetes.

However, the board encouraged the study, which it funds, to follow all Look AHEAD participants to identify longerterm effects of the intervention.

Half of the 5,145 participants in the multicenter study were randomly assigned to the intensive lifestyle intervention arm and the other half to a general program of diabetes support and education, according to the news release. Both study arms received routine medical care by their health care providers. The primary outcome of the study was to measure the aggregate occurrence of major cardiovascular events, including cardiovascular death (such as fatal myocardial infarction and stroke), nonfatal myocardial infarction and stroke, and hospitalized angina.

“Cardiovascular morbidity and mortality—that was the important question,” said Rena Wing, PhD, professor of psychiatry, Alpert Medical School, Brown University, Providence, R.I., and chairwoman of the Look AHEAD study. The study was unique, she said, “in the sense that it was the first randomized trial to see if an intensive lifestyle intervention that resulted in weight loss in individuals with type 2 diabetes would actually help reduce the risk for cardiovascular morbidity and mortality. Patients were followed for up to 11½ years.”

Lee M. Kaplan, MD, PhD, director, Obesity, Metabolism, and Nutrition Institute at Massachusetts General Hospital in Boston, who is not associated with the Look AHEAD study, said in an interview: “Long-term cardiovascular outcomes … are the areas of the greatest risk and danger to patients—the outcomes that can kill you. This study looked at these outcomes with sufficient power to find a difference between study groups, if it had existed.”

Dr. Wing said that the DSMB “concluded that the study had reached its answer. There were no differences between the two groups in the number of participants with cardiovascular morbidity and mortality. The odds that a difference would be detected were very slight at this point.”

However, she noted, “Both study arms

had a much lower risk for developing heart disease than we expected. In both groups, these patients with type 2 diabetes were getting good medical edical management.

Possibly this helped too reduce the risk.”

The intensive lifesttyle intervention did bring heallth benefits, Dr. Wing reported.

“There were fewer symptoms of depression, less use of diabetes

medication, better blood sugar control and improved sleep apnea. The level of physical functioning was better maintained. I would think for most patients it’s important to recommend d lifestyle intervention because of better qualib ty of life.”

Patients in the intervention arm lost 9% of their body weight initially

(almost 20 pounds), and maintained a reduction of 5% of body weight through the end of the trial (about 10 pounds), said Dr. Wing.

Asked whether the Look AHEAD trial had implications for bariatric surgery as an alternative method of weight loss, Dr. Wing said, “Bariatric surgery produces larger weight loss. But there has not yet been a real randomized trial to see if it will reduce cardiovascular morbidity and mortality.”

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18

Surgeons’ Lounge

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MARCH 2013

Dear Readers, Welcome to the "European Quarter" of the The Surgeons’ Lounge, where we present new techniques, discussions and debates regarding surgery from a European perspective. This month we feature our guest expert Jacques Himpens, MD, associate professor of surgery, European School of Laparoscopic Surgery, Saint-Pierre University Hospital, Brussels, Belgium.

Our European collaborator, Ramon Vilallonga, MD, PhD, consultant surgeon, Endocrine, Bariatric and Metabolic Unit, General Surgery Department, University Hospital Vall d’Hebron, Barcelona, Spain, poses the case of a patient with persistent dysphagia after sleeve gastrectomy to Dr. Himpens.

We also bring you the first “Expert Express” of the year: Interval appendectomy: yes or no?

I look forward to your questions, comments and feedback.

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

Question for Dr. Himpens

Dr. Himpens’

Reply

From: Dr. Vilallonga

I

would like your advice regarding a 37-year-old woman who had a sleeve gastrectomy in 2008. At that time, she had a body mass index (BMI) of 55 kg/m2; weight 137 kg and height 157 cm. The patient had an intraabdominal staple-line hemorrhage that was treated conservatively on day 2; at that time, a hematoma was discovered on a computed tomography (CT) scan after a blood sample analysis showed acute anemia.

The patient was discharged, but three weeks afterward developed nausea and vomiting with a complete intolerance to solid food intake. Another CT scan showed minimal residual hematoma but no other abnormalities. A fluoroscopic gastric series (FGS) revealed stenosis in the middle sleeve. A recent esophagogastroduodenoscopy (EGD) swallow showed stenosis in the area of the incisura angularis and a minimal hiatal hernia. After 15 months, the patient had lost 65 kg and had a BMI of 29 kg/ m2. She had undergone five endoscopic dilatations and a general practitioner suggested the possibility of stenting the stenosis or injecting botox in the pylorus area. The patient continues to experience dysphagia to solid food every three to six weeks.

What is your advice for this patient?

Sleeve gastrectomy is gaining a lot of popularity among bariat- Figure. Seromyotomy of the sleeve at the level of the cisura ric surgeons because of its apparent simplicity. However, com- angularis for stenosis. plications such as leaking or bleeding can be life-threatening for the patient and should be avoided at all costs.1,2 Conversely, probably attain further weight loss as well as reversal of the stricture can lead to serious problems for the patient and may dysphagia. require a secondary or even more complex surgery.3 If the patient has lost her target for excess weight loss, The true incidence of stricture after laparoscopic sleeve I would consider a seromyotomy, stricturoplasty or a sleeve gastrectomy (LSG) is unknown but it is estimated at around wedge resection.

3.5%.4 In this case, we should agree that the incisura angulaFinally, I would consider a seromyotomy during the sleeve ris is the most frequent location for stricture formation and procedure itself. This could avoid creating an overly tight could be related to perioperative complications compris- sleeve, despite the bougie, when a stapling angle has been ing one staple-line hematoma and a leak.5 Similar to your inadvertently performed too close to the incisura angularis. patient’s case, different treatment options for strictures have been attempted including observation and endoscopic dila- References tations. In our experience, we have reported the seromyot- 1. Aurora AR, Khaitan L, Saber AA. Sleeve gastrectomy and the risk of leak: a systematic analysis of 4,888 patients. Surg Endosc. omy and the conversion to Roux-en-Y gastric bypass.5,6 We 2012;26:1509-1515. think that endoscopic dilatations should be the first mechanical treatment. We have shown that the feasibility of surgical 2. Lalor PF, Tucker ON, Szomstein S, et al. Complications after laparoscopic sleeve gastrectomy. Surg Obes Relat Dis. seromyotomy appears to carry an increased risk for morbidi2008;4:33-38. ty with leak or no resolution of symptoms. In my experience, 3. Zundel N, Hernandez JD, Galvao Neto M, et al. Strictures after laparoscopic wedge resection, including the stenosis, has been laparoscopic sleeve gastrectomy. Surg Laparosc Endosc Percutan performed in four patients with excellent results.

Tech. 2010;20:154-158.

When dealing with strictures after sleeve gastrecto- 4. Parikh A, Alley JB, Peterson RM, et al. Management options my, many issues have to be considered: previous and curfor symptomatic stenosis after laparoscopic vertical sleeve gasrent BMI, quality of life, expectations and timing. In your trectomy in the morbidly obese. Surg Endosc. 2012;26:738-746. patient, we are dealing with a chronic stricture with a poor 5. Rosenthal RA. International sleeve gastrectomy expert panel or no result on the endoscopy. Intrapyloric botulinum toxin consensus statement: best practice guidelines based on experiinjections have not proven to decrease subjective symptoms ence of >12,000 cases. Surg Obes Relat Dis. 2012;8:8-19. nor to improve objective measurement in patients.7 A pos- 6. Dapri G, Cadière GB, Himpens J. Laparoscopic seromyotomy sible conversion to Roux-en-Y gastric bypass also has been for long stenosis after sleeve gastrectomy with or without duodenal switch. Obes Surg. 2009;19:495-499. recommended as a second step in patients with unexpected weight loss, but it is not the case in our experience.6,8 We 7. Bai Y, Xu MJ, Yang X, et al. A systematic review on intrapyloric botulinum toxin injection for gastroparesis. Digestion. also have treated patients with stenosis with a conversion to 2010;81:27-34. mini-gastric bypass and I would suggest this for your patient, 8.

Himpens J, De Schepper M, Dapri G. Laparoscopic conversion or a mini-gastric bypass with hiatal hernia repair. The gastroof adjustable gastric banding to sleeve gastrectomy: a feasibiljejunostomy should be performed in nonstenotic and nonfiity study.

Surg Laparosc Endosc Percutan Tech. 2010;20:162-165. brotic tissue. With this surgical treatment, the patient could

Surgeons’ Lounge

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MARCH 2013

Expertess Expr

Q. Interval Appendectomy: Yes or No? Natan Zundel, MD: Yes

Estuardo Behrens, MD: Yes

Frederick Greene, MD:

Yes

Alfons Pomp, MD: Depends; if there are symptoms, despite the data, I have a tendency to still do it, Yes

19

— Letter —

‘Group Think’ and Outcomes in Surgery To the Editor: Dr. Steven Kron, in his opinion piece, “A SCIPpery Slope,” yearns for the good old days [November, page 1]. He invokes images of the character Marcus Welby, MD, from the television show of the same name— staunchly independent, free of any scrutiny of his actions.

Dr. Kron’s views remind me of the comments of Dr. Charles Rob critiquing a presentation extolling radical mastectomy and the need to 4 16 27 10 follow Halstedi30 an precepts. Dr. Rob allowed that Halstead H l d was a great man who left footprints in the sands of time. But they were not foxholes to be defended until the last death.

The medical literature over the past 10 years has demonstrated overwhelmingly that better outcomes are achieved when clinical processes are standardized. One only has to look at the results of the National Surgical Quality Improvement Program to realize that the old, ad hoc way of practice should go the way of the dodo.

The good old days were not so good.

Dr. Kron states: “Woe to the anesthesiologist who missed the magic hour before incision” for the dose of prophylactic antibiotics. I would have more sympathy for this attitude if the good doctor were willing to sustain a postoperative wound infection along with the patient. The evidence is quite clear: Timing is important.

Before going to medical school, I was a submarine officer in the U.S. Navy. Upon leaving port, the compartments had to be inspected “rigged for dive.” I was highly trained and experienced, and had performed this chore 50 to 60 times. Even so, we all used a checklist mounted on the bulkhead.

The crew watched this activity as the consequence of a mistake was literally shared by all concerned. I believe the same attitude should prevail in the surgical arena.

Systems, or “group think,” may offend some doctors, but they have been shown repeatedly to reduce human error and improve results. I am 77 and I, too, have fond memories of watching Dr. Welby. I think they should remain just that—fond memories.

Roger E. Alberty, MD Portland, Oregon

40th Anniversary

The Independent Monthly Newspaper

"«

B Y S TEVEN S. K RON , MD

“Essentially, we’re moving from a Jeffersonian ideal of small guilds and independent craftsmen to a Hamiltonian recognition of the advantages that size and centralized control can bring.”

—Atul — Gawande, MD, The New Yorker, r August 11, 2012

I

Ed Phillips, MD: Yes

Bruce Ramshaw, MD: Yes, but with the patient making the final decision p

Ronald Hinder, MD:

Yes

Michael Schweitzer, MD: Yes

Edward Felix, MD: Yes, I still tend to do it, but a randomized study suggests it is unnecessary. I am just old-school; should change my ways

Anthony Petrick, MD: No

Maher Abbas, MD: No

Michael Sarr, MD: No. Provided there is a normal barium enema in those older than 40 years of age

Edward Lin, MD: Yes Ed Daniel Herron, MD: If asymptomatic and a normal CT scan, then No Ashutosh Kaul, MD: Yes A Lee Swanstrom, MD: No Alejandro Gandsas, MD: Yes A

Emanuelle Lo Menzo, MD:

Yes

David Edelman, MD: Yes

t began almost imperceptibly with a small regulation here, a comment there.

Slowly at first and then with relentless speed and force it grew, and like a tsunami overwhelms anything in its path.

By now, every physician who has practiced for more than a few years has noticed the dramatic shifts in the relationship of doctors to the society in which we practice our profession. From relative independence, we are being forced further into group think.

Hardly a day goes by without some new directive from above instructing what and how to perform a task to benefit our patient. Examples abound: The Surgical Care Improvement Project (SCIP) see SCIPPERY SLOPE page 24

Optimizing the Prevention and Management of Postsurgical Adhesions

See insert at page 8

Reversal and Recovery From Neuromuscular Blockade: Examining the Science

See insert at page 16

, -1, ,9 7-° "

for the General Surgeon

32% of Complications Diagnosed After Discharge From Hospital, Study Shows

A SCIPpery Slope

Jeffrey Ponsky, MD: Yes

1972-2012

iVi LiÀÊÓä£ÓÊUÊ6 Õ iÊ Î ÊUÊ Õ LiÀÊ£Ó

Using Modifier 22 With a Detailed Operative Note Detai

Findings Come Amid Increased Public Scrutiny; rutiny; Seeking Level Playing Field in Reporting B Y C HRISTINA F RANGOO U

B Y C HRISTINA F RANGOU

CHICAGO—A new study found d that one in three complications arising from major operations is diagnosed after the patientt leaves the hospital, a finding that adds a new dimension

to the health policy debate surrounding public reporting of complications and readmissions.

The study showed that sig-nificant numbers of postopera rative complications occur afterr the patient is discharged and may acccount for longer, more difficult and d more expensive recoveries, often requiring readmission to the hospital. As a

see COMPLICATIONS page 14

General Surgery Residents Concerned About Duty Limitation B Y G EORGE O CHOA

T

he majority of general surgery residents are concerned about the 16-hour duty limitation for postgraduate year 1 (PGY-1) residents, according to a study presented at the American College of Surgeons’

®

Documentation Can Increase Pay For Complex Cases

C H I CAG O — S u r g e o n s may be missing out on valuable reimbursement dollars because they fail to accurately document thee complexities of some surgic ical procedures.

In n a study presented at the 20122 Clinical Congress of the Amer erican College of Surgeons, researrchers showed that detailed d docum mentation is the key to reiimburs rsement in atyp atypically arrduous us cases. Docuumentat ation can c affect both oth reimbu ursement approv roval and th the speed of reimb bursement, the study showe wed.

And many surgeeons and residents skim m over details in the operative note, particularly those details that justify the modifier 22 claim. see MODIFIER 22 2 pa page 22

annual Clinical Congress in Chicago, and published online on October 5 (J ( Am Coll Surgg doi: 10.1016/j. jamcollsurg.2012.08.005).

Implemented by the Accreditation see DUTY RESTRICTIONS page 5

PROCEDURAL BREAKTHROUGH Advances in Stent Technology for Esophageal Cancer see page 13

INSIDE

In the News

Technique Choice for Anastomosis and Leakage Rate

In the News

Genetic Findings Could Reshape Approach to Breast Cancer

Surgeons’ Lounge

Opinion

Test Your Knowledge Why Do 31% of With Three General Surgery Surgeon’s Challenges Residents Need Remediation?

Opinion

The Day I Knew It Would Be OK To Stop Operating

20

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MARCH 2013

Preoperative Falls in Elderly Patients Predict Surgical Complications off when a patient had fallen at least three times.

Among cardiac patients, 39% of those who sustained a fall preoperatively had two or more postoperative complications compared with 15.2% who did not.

Additionally, patients who reported a preoperative fall spent nearly three times as many days in the hospital as their fall-free counterparts. Furthermore, 59% of those who fell before surgery—compared with 4.2% of those who did not—needed institutional care following their operation.

Significant differences also were shown in patients undergoing cardiac surgical procedures. Session moderator Sandhya A. Lagoo-Deenadayalan, MD, PhD, associate professor of surgery at Duke University Medical Center, Durham, N.C., said that the study highlights an easy test that can be used to identify elderly patients who are at risk for complications.

“Elderly patients are able to do well after er surgery, provided we are able to identify those who are frail and at high risk for postoperative complications. A

B Y C HRISTINA F RANGOU

CHICAGO—Determining whether an elderly patient has recently taken a fall can help surgeons to predict how well that patient will recover from a major operation, according to study findings.

The study showed that preoperative falls in older surgical patients are a powerful predictor of complications, prolonged hospital stays and higher rates of disability.

“It has been shown in previous studies that a history of falls predicts poor long-term outcomes, but we have never looked at immediate preoperative assessment related to postoperative outcomes,” said Teresa Jones, MD, lead study author and surgical resident at the University of Colorado in Denver.

“This is the first time that falls, as a stand-alone risk marker, have been used for predicting [surgical] outcomes in older adults.”

Forty-seven percent of hospital admissions of individuals aged 65 years and older are the result of fallrelated injuries, according to the American College of Surgeons’ National Trauma Databank. The study ‘Older adults have unique was presented during the sixth Geriatric Surgical Forum at the 2012 Annual Clinical Congress of the risk factors that we can American College of Surgeons. look for that suggest theyy Investigators studied 235 patients, with an average age of 74 years, who underwent colorectal or will do poorly after an cardiac surgical procedures at the Denver Veterans operation.’

Affairs Medical Center between 2005 and 2012. As part of their preoperative evaluation, Dr. Jones and —Thomas Robinson, MD her colleagues asked the patients if they had fallen in the six months before their scheduled operation.

One-third of the patients reported falls.

AT A GLANCE Of those patients who reported falling more than once within that time frame, adverse outcomes occurred Of the 81 patients who underwent ntt more frequently. Of the 81 patients who underwent colorectal procedures, 59% fell colorectal procedures, 59% fell sometime before their sometime before their operation and operation and experienced more than one postoperative experienced more than one complication. In comparison, only 27% of those who postoperative complication. In did not fall experienced more than one postoperative comparison, only 27% of those who complication. Complications included cardiac events; did not fall experienced more than stroke; reoperation; and pulmonary, renal, thrombotic and infectious complications. The complication risk one postoperative complication. rose incrementally with the number of falls, but leveled

simple marker that helps identify a high-risk elderly patient can also help in determining which patient needs additional interventions to prevent complications and improve outcomes following surgery.”

At Duke University, elderly patients with a history of falling are given a yellow bracelet on admission to alert the staff that this patient is at a higher risk for recurrent falls and requires more vigilant monitoring in the perioperative period.

Dr. Lagoo-Deenadayalan noted that 98% of the study participants were men, so future studies that have a more even gender distribution are needed.

Dr. Jones said that the research team hopes to assist with pre- and postoperative planning. “If it’s likely that a patient will need to enter a nursing home for several weeks after an operation, the patient and family can evaluate various facilities beforehand to see which one would best address their specific needs. It’s important ffor a patient to be at a place that they’ve been shown aand know what to expect after surgery.”

More than one-third of all operations in the United States are now performed on people U aaged 65 years and older, and the fastest growiing segment of the population undergoing vvarious surgical procedures is adults in their 80s, the researchers said.

“This assessment is very novel in the sense that older adults have unique risk factors that we can look for that suggest they will do poorly after an operation, but these markers are not readily recognized by the wider surgical community,” said study coauthor Thomas Robinson, MD, associate professor of surgery, University of Colorado, Denver.

The researchers said that their ultimate aim is to develop simple tests that will help surgeons to predict how their patients will do after surgery. “I think this study is going to improve care by changing how we counsel older adults prior to these major operations,” said Dr. Robinson. “We want to tailor the patient’s health care plan based on what will be the best possible outcome. We shouldn’t settle for putting people in institutional care facilities for the last six months of their life.”

Course/Meeting Announcements Clinical Performance and Oral Examinations in Surgery Oral Board Review Courses

Surgery (2002) and the Journal of Surgical Education (2012) stress a 97% success rate when course plans are followed.

May 10-15, 2013 Omni Amelia Island Plantation Resort, Amelia Island, Florida

The course features topic questions and provides individual feedback following one-onone testing in the hotel environment, unlike any other review course.

September 8-13, 2013 Stowe, Vermont This very small, interactive course is the oldest existing review course in the United States. It was designed to enhance the testing skills of surgeons preparing to take the Certifying Examination of the American Board of Surgery and impart effective communication skills to young surgeons. Course outcomes reported in the American Journal of

There are limited spaces for residents whom program directors believe would benefit from this type of training early in their careers.

Reduced tuition for residents.

For more information about the course, please contact: PRowland@med.unc.edu PhDsurgery@gmail.com (919) 843-3546

5th Symposium on Cancer Metastasis and the Lymphovascular System and the 8th International Sentinel Node Society Congress May 27-May 29, 2013 Hilton San Francisco Financial District San Francisco, California An internationally renowned faculty will discuss updates in the understanding of cancer metastases, especially sentinel lymph node biopsy concepts and technology, the cancer microenvironment and the molecular mechanisms involved in the progression of cancer cells to metastasis. New developments in biomarker research and their diagnostic and prognostic applications in metastatic disease will be highlighted. .

Visit the website for more details and information: www.sn-cancermets.org

Co-Chairs Armando E. Giuliano, MD, FACS President, International Sentinel Node Society Executive Vice Chair, Surgery Cedars-Sinai Medical Center Los Angeles, California Stanley P.L. Leong, MD, FACS President, Sentinel Node Oncology Foundation Chief of Cutaneous Oncology California Pacific Medical Center and Sutter Pacific Medical Foundation San Francisco, California Presented by California Pacific Medical Center, Cedars-Sinai Medical Center, the International Sentinel Node Society, Sentinel Node Oncology Foundation and the Academy for Continued Healthcare Learning.

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Call 1-800-4ETHICON or visit www.ethiconsecurestrap.com and www.ethiconphysiomesh.com. *Evidence shown in an animal model.

References: 1. Data on file. Ethicon, Inc. ETHICON PHYSIOMESH™ R&D reports. 2. Pascual G, Rodriguez M, Gomez-Gil V,Garcia-Honduvilla N, Bujan J, Bellon JM. Early tissue incorporation and collagen deposition in lightweight polypropylene meshes: bioassay in an experimental model of ventral hernia. Surgery. 2008; 144(3): 427-436. 3. diZerega, G. Peritoneal Surgery. New York, NY: Springer-Verlag; 1999:4-31.

4. Data on file. Ethicon, Inc. ETHICON SECURESTRAP™ R&D reports.

For complete product details, see Instructions for Use. ©Ethicon, Inc. 2013

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22

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MARCH 2013

Operations That Pose Highest Incisional Hernia Risk Identified B Y C HRISTINA F RANGOU CHICAGO—For the first time, a study has quantified the risks for incisional hernia formation from various general surgical procedures.

Research presented at the 2012 Clinical Congress of the American College of Surgeons showed that gastric/small bowel surgery, colon/appendix procedures and clean vascular surgery cases are associated with the highest incisional hernia risk requiring repair at rates of 5.16%, 4.65% and 4.05%, respectively, in a population of adult general surgery patients.

The finding confirms clinical suspicions long held by surgeons.

And now that the high-risk groups have been identified, surgeons may consider hernia prophylactic measures or abdominal wall surveillance in these patients, said lead author Benjamin K. Poulose, MD, MPH, assistant professor of general surgery, Vanderbilt University Medical Center, in Nashville.

“If we can identify patients at risk for hernia, perhaps we can initiate a program to prophylactically prevent hernias or identify their hernias at a much earlier course,” he said.

Previous research from this group has shown that each 1% reduction in hernia recurrence equates to $32 million in health care savings (Hernia 2012;16:179-183).

Dr. Poulose and his colleagues performed an observational cohort study of all adult patients who underwent elective operations in 2005 in four states, each representing a major census region in the United States: Nebraska, California, New York and Florida.

The data used in the study were collected by the Healthcare Cost and Utilization Project, a family of databases sponsored by the Agency for Healthcare Research and Quality. The project includes data from inpatient and outpatient procedures, paid for by different private and public payers.

The investigators looked at seven different procedure types: clean general surgery, clean vascular surgery, gastric/small bowel, colon/appendix, hepatopancreatobiliary (HPB), genitourinary/renal (GU) and gynecologic. Patients were followed for a minimum of two years after their initial operation, and ICD-9 codes were used to calculate rates of incisional hernia repair.

The data showed that 5,272 incisional hernia repairs were performed in the

‘If we can identify patients at risk, ... perhaps we can initiate a program to ... prevent hernias or identify their hernias at a much earlier course.‘ —Benjamin K. Poulose, MD two years after surgery, which represented 3.99% of the 132,287 surgical procedures that met the study criteria.

Gynecologic surgery was associated with the lowest risk for incisional hernia formation requiring repair at 1.41%. The risk rose incrementally with other types of procedures: 2.77% for clean general surgery, 2.92% for HPB surgery and 3.07% for GU surgery. Three procedures posed above-average risk for incisional hernia repair: clean vascular, colon/appendix and gastric/small bowel surgeries.

“This is an important paper that attempts to get at the epidemiology and incidence of incisional hernia following surgical procedures,” said Mary Hawn, MD, professor and chief of gastrointestinal surgery, University of Alabama at Birmingham.

However, the study has significant limitations, she cautioned. The research likely underestimates the incidence of incisional hernia because only repair was measured. Moreover, the investigators were not able to assess which operations were performed with minimally invasive approaches, to determine whether these approaches are associated with reduced risk for subsequent incisional hernia repair.

Of the patients studied, 56% were women. They had a mean age of 56 years and a mean length of stay in hospital of 8.4 days. Two-thirds of the incisional hernia repairs were performed as inpatient procedures.

The researchers are continuing the study. They plan to follow these patients for an additional two years and will evaluate the effect of abdominal wall surveillance by serial clinical and/or radiographic evaluation in a prospective cohort of patients. The patients also may undergo hernia prophylaxis in the form of preemptive reinforcement of the abdominal wall before hernia formation.

“These strategies need further investigation as preventive measures in patients at high risk of hernia formation,” Dr. Poulose said.

Sentinel Node Surgery Accurately Determines Status After Chemo B Y C HRISTINA F RANGOU

S

entinel lymph node (SLN) surgery can identify a woman’s nodal status correctly after treatment with neoadjuvant chemotherapy in 91% of patients who present with node-positive breast cancer, according to a new study.

The finding opens the door for clinicians to consider using SLN surgery alone to evaluate a patient’s response to neoadjuvant chemotherapy following an initial diagnosis of node-positive breast cancer, said lead author Judy C. Boughey, MD, associate professor of surgery at Mayo Clinic, in Rochester, Minn.

She presented the study at the 2012 San Antonio Breast Cancer Symposium.

“If the results of this study are incorporated into clinical practice, fewer women would need to undergo axillary dissection. Some women with node-positive breast cancer (those that convert to node-negative with neoadjuvant chemotherapy) may be able to preserve most of their axillary nodes after completion of chemotherapy.”

The findings come from the American College of Surgeons Oncology Group (ACOSOG) Z1071 trial, which was designed to evaluate the false-negative rate of SLN surgery in women with pathologically proven node-positive breast cancer who received neoadjuvant chemotherapy.

In the study, 708 women with node-positive breast

cancer received neoadjuvant chemotherapy and underwent SLN surgery followed by axillary lymph node dissection. Investigators performed both the SLN biopsy and the axillary dissection to determine the accuracy of the SLN for predicting a negative axilla.

Of these patients, 637 underwent both SLN surgery with identification and removal of the sentinel nodes under the arm and axillary lymph node dissection to remove most of the lymph nodes in the axilla. SLN surgery correctly identified nodal status in 91% of patients, including 255 patients now with node-negative breast cancer and 326 patients with continuing node-positive disease.

The false-negative rate of SLN surgery in women with at least two sentinel nodes resected was 12.6%.

The false-negative rate was slightly lower at 10.8% among the 251 patients who received both blue and radiolabeled colloid. The rate was nearly double at 20% when radiolabeled colloid only was used (10 out of 50) and 22.2% with blue dye alone (two out of nine).

“This rate is lower with use of dual tracer [blue dye and radiolabeled colloid] to identify the SLN, and the false-negative rate is lower the more SLNs are removed.

Therefore, technical factors are important to minimize incorrect nodal staging,” said Dr. Boughey.

When three or more SLNs were examined, the falsenegative rate also was significantly lower at 9.1%.

Until now, it was felt that changes in the tissue due

to neoadjuvant therapy could make identification of the sentinel node inaccurate, and the nodes should be removed to reduce the risk for axillary recurrence even if the sentinel node was found to be negative, said Deanna Attai, MD, a breast surgeon in private practice in Burbank, Calif.

This new study “opens the door for future research to hopefully answer the question regarding the necessity of an axillary dissection in patients who have been found to be converted from node-positive to node-negative on sentinel node biopsy after preoperative chemotherapy.”

The study is also important because it highlights the value of presurgery chemotherapy, said experts. Two out of every five women who had pathologically proven node-positive disease identified at the outset of the study showed a complete pathologic response in the lymph nodes, or eradication of disease in the lymph nodes.

More research is needed before physicians adopt widespread use of SLN surgery alone in these patients, however. Researchers said they need more information about factors associated with false-negative rates, such as clinical response, histologic findings and axillary ultrasound findings.

A trial is being developed by the Alliance for Clinical Trials in Oncology that will investigate whether patients with residual nodal disease after chemotherapy require both axillary dissection and nodal radiation or whether nodal radiation alone can be used.

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In the News jcontinued from page 1

“By the time I was done, I had done a lot of stuff autonomously: I’d managed people in the OR [operating room], I’d managed trauma and I left my training feeling like I was competent, that I could go off and do surgery,” said Dr. Mahvi, professor of surgery, Northwestern University-Feinberg School of Medicine, Northwestern Memorial Hospital in Chicago. “The first couple of years of practice were pretty scary, but I didn’t feel like I didn’t know what I was doing.”

But Dr. Mahvi and other surgeons believe that today’s residents don’t feel quite so secure and, in fact, are not ready to take up the scalpel.

“They’ve dealt with this by doing fellowships, mostly in general surgery, a basic GI [gastrointestinal] surgery, which to me is a warning sign that we are not adequately preparing people,” said Dr. Mahvi. “We need to do something different in the way we are training people so that when they leave [training], they feel comfortable doing surgery.”

Part of the reason for this lack of competence and confidence is the lack of experience that new surgeons obtain in residency. The duty-hour restrictions that came into effect in 2003 and capped residents’ workweek at 80 hours are not the only factor contributing to this problem, but they certainly play a role.

“I’m not supportive of a 120-hour workweek, but there’s something to be said for repetitive involvement, immersive exposure,” said L.D. Britt, MD, MPH, chairman, Brickhouse Professor of Surgery, Eastern Virginia Medical School, Norfolk, who compared the duty-hour restrictions to a Ponzi scheme for their failure to make a return on any investments. Dr. Britt and Dr. Mahvi were both part of a panel discussion, “Crisis in Training and Education,” at the 2012 meeting of the Society of American Gastrointestinal and Endoscopic Surgeons, at which they discussed these and other topics.

“Since duty-hour limitations [were implemented], not one metric has improved. The failure rate on the certifying exam has gone from 14% to 29% or 30% in the past five years. There are more handoff mistakes, and there has been no evidence that patient safety has improved,” Dr. Britt said.

According to Dr. Mahvi, “The residents we’re training now have had very little independence during their five years of surgical training. This is not necessarily because they are better or worse: I think in some ways they are more driven and smarter than we were.

But it’s just not acceptable. The patients won’t accept it, the payers won’t accept

it and the hospitals won’t accept it.

Training needs to change, because every aspect of surgery—from the content of residential programs to what surgeons want and what the public has come to expect—has changed.”

So, what has changed? “I would say the surgeons of the 1990s had a broadbased skills set; they were trained to be the captain of the ship, and they were expected to run things and accept risk,” Dr. Mahvi said. “Surgeons training today, however, want expertise in a narrow area.

They want free time and a sane work– life balance. They don’t want to set up

a billing system and figure out an EMR [electronic medical record].”

Furthermore, there is no evidence that the skills gained in general surgery training will lend themselves to narrow subspecialties: “If you know how to [perform a small bowel resection], you don’t really know how to do a lower anterior resection; if you know how to do a lower anterior resection, you don’t necessarily know how to do an esophageal resection,” Dr. Mahvi said. “I think this is a critical point when you talk about broadbased or narrow-based training. If there isn’t any evidence for transferability [of

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GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS

Pain relief

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Time (h) Sinattra et al (Pain Study 1) Randomized, double-blind, placebo-controlled, single- and repeated-dose 24-h study (n=101). Patients received OFIRMEV 1 g (q6h) + PCA morphine or placebo + PCA morphine the morning following total hip or knee replacement surgery.

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In the News

GENERAL SURGERY NEWS / MARCH 2013

‘Since duty-hour limitations, not one metric has improved. The failure rate on the certifying exam has gone from 14% to 29% or 30% ... There are more handoff mistakes, and there has been no evidence that patient safety has improved.’

—L.D. Britt, MD, MPH

skills], the broad basis of general surgery just doesn’t work.”

The public also wants experts, and it wants them next door. “The public doesn’t want competent surgeons finishing five years of training. They want an expert in whatever disease they have,” said Dr. Mahvi.

The quandary is that residents want to specialize and patients want specialists, but there is still a need for surgeons who can take care of the public in general, ones who take the call and save the patient with a ruptured aneurysm. “If we get too subspecialized, it

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becomes very difficult to do that, especially outside of big cities,” Dr. Mahvi said. “That’s a significant problem that we aren’t really addressing.”

To address the current shortcomings of surgical training, Dr. Mahvi said that residents must be made autonomous at some point in their training and the profession needs to accept the idea of subspecialization and make a decision about what the core of surgery is.

“Everyone should be able to take care of sick people, everyone should be able to deal with GI emergencies, take care see SURGEONS-IN-TRAINING page 26

25

26

In the News SURGEONS

IN

jcontinued from page 25

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MARCH 2013

TRAINING

of trauma patients, and be competent to do endoscopy,” Dr. Mahvi said. Learning complex minimally invasive surgery should be part of residency so that surgeons leave with straightforward skills, and a fellow shouldn’t be [learning how] to do a Nissen [fundoplication]. “Early specialization is really the first step toward training expert GI surgeons; the key thing we want to develop in our surgeons is autonomy.”

Last year, the Accreditation Council

for Graduate Medical Education introduced the Next Accreditation System (NAS), which is due for implementation in general surgery programs by 2014.

NAS is based on the concept of achieving specific milestones based on the six competencies of patient care: professionalism, medical knowledge, interpersonal and communication skills, practice-based learning and improvement; and systemsbased practice. The question is whether this program will help to ensure that residents develop the skills that would lead to autonomy.

“Milestones are surgeons’ aspects,”

said Dr. Britt. “Scouts get merit badges if they achieve certain goals, say, build a campfire. We’re looking at the same thing in surgery, certain benchmarks you have to meet. There’s not necessarily a time limit. If you meet those benchmarks, maybe you can finish sooner than three or four years. The only problem is if you had to stagger with some people finishing sooner than others,” Dr. Britt said. “It would be a nightmare for program directors, but it’s really meritbased. You’re advancing someone based on competency, on their reaching a benchmark.”

Residents will be evaluated on the achievement of specific tasks, for instance, the number of times they put in a central line without complications. “It’s easy to validate, and I like the approach,” Dr. Britt said. “There will need to be more monitoring and recordkeeping, but it’s the right way to do things compared with saying ‘you’ve been in the program for four years and should be able to do certain things,’ but without validating it. We’ve identified what surgeons need to accomplish, and if they haven’t met those benchmarks, maybe they shouldn’t be advanced.”

There is no doubt, Dr. Britt said, that surgery and surgical training are going through a type of renaissance, and that as attractive as merit- and achievementbased training may be, there are still a lot of unanswered questions.

“Will educational standards be met?

Will there be specific metrics? The milestones are generic at best. What happens to residents who don’t meet the milestones? Resident retention? Will it be burdensome and costly? Can the milestones be accomplished within dutyhour limitations? Will all these things improve outcomes? Do we have the resources?” asked Dr. Britt.

“NAS could be either a disaster or a home run.”

Does the fourth year of medical school adequately prepare students for residency?

Some of the variables that make surgical residency more difficult, for example the laparoscopic revolution and more complicated patient cases, may have an effect on students as well as residents, but the argument that the fourth year of medical school does not adequately prepare students who plan to enter a surgical residency is nothing new.

“If you go back to J. Roland Folse— I think it was 1996 in his presidential address to the Central Surgical Association—he said that ‘we have failed to use the fourth year of medical school effectively to prepare our students for … residency education,’” said L. Michael Brunt, MD, Department of Surgery, Section of Minimally Invasive Surgery, Washington University School of Medicine, St. Louis. “So, that was 16 years ago.”

Whereas two decades ago medical students would have been embedded in the overnight call rotation, now they rarely accompany residents to handle acute on-call problems. They spend less time on surgical rotations and,

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GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MARCH 2013

with general surgery being more complex, may be exposed to only a narrow component of general surgery rather than the broad-based exposure received a generation ago.

“As a result, we have to be innovative in our educational program for students to be able to bridge that gap, although I think we’ve been slow to recognize that and make those changes,” Dr. Brunt said.

The fourth year of medical school— when students are not as pressed for time, and are eager to learn the fundamental skills that can help them hit the ground running as residents—may be just the time to address some of these shortcomings. To that end, the Washington University School of Medicine established an accelerated skills preparation for surgical internship in 2006, based largely on Dr. Brunt’s observations of gaps in intern performance and knowledge base.

As of 2012, more than 100 surgical students have participated in the program, which consists of seven, weekly two- to three-hour sessions in the spring of senior year. The sessions’ content includes a short didactic lecture followed by handson training and practice. “The other thing we thought was important was to build assessment into the program, because assessment helps drive learning and performance,” Dr. Brunt said.

The sessions covered basics that Dr. Brunt and his colleagues agreed are essential in surgical training, with a heavy emphasis on suturing and knot tying, knowledge of surgical instruments, basic laparoscopic skills and on-call management problems. A popular feature is the animal labs at the end of the program, where students can practice the techniques they’ve been learning, on live tissue.

“We have them do a laparoscopic access, a lap chole, how to open and close the abdomen and do intestinal resections,” Dr. Brunt said. “They get to do a lot of suturing, cutting, clamping and tying.”

The pre- and post-course skills assessments showed that students significantly improved on all five of the assessed tasks. Videotaped assessments showed that their technical proficiency consistently improved. “What was interesting was that when we compared them to end-of-year R2 residents, the students’ times were not significantly different from the residents’ in three of the five tasks,” Dr. Brunt said.

Although the students rated their confidence as low in each of the five domains before the course, they indicated significant growth in confidence scores for 28 of 45 survey questions after the course. The one area in which they did not improve much was in managing on-call difficulties.

“I think that’s because they don’t have the opportunity to do that in their rotations,” Dr. Brunt said.

Representatives of the American College of Surgeons, the Association for Surgical Education and the Association for Program Directors of Surgery formed a task force to develop a national curriculum for fourthyear medical students modeled on the month-long courses offered at a handful of universities, such as Southern Illinois, the University of Michigan and the University of Minnesota.

“There’s been a tremendous amount of work done by this group already: Curriculum goals and objectives have been developed, and they’re in the process

of identifying the content for the objectives,” Dr. Brunt said. “This is going to be a tremendous resource for institutions and departments looking to develop these types of programs for their fourth-year students going into surgery, and will hopefully serve as a template for how these programs should be structured.”

It is clear from the outcomes of Dr. Brunt’s program, and others like it, that accelerated skills training programs result in improved performance, but such programs won’t address all the issues surrounding the fourth year of medical school.

“There are a lot of deficiencies in the fourth-year curricula at most medical schools in the United States, and I feel strongly that they need to be restructured to address some of these issues, particularly the on-call and night float systems, so that students have this experience before they start internship,” Dr. Brunt said. “Ultimately, I think we need to structure the whole fourth year around specific, measurable milestones and curriculum requirements.

We can do that and still allow students the flexibility to do elective rotations to round out their educational needs.”

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28

In the News TWITTER

jcontinued from page 1 had what I was describing as a pulmonary bronchial pulmonary artery fistula.”

When Dr. Glick woke up a few hours later, he’d received an answer from a surgeon from the Karolinska Institute in Sweden. “He had a series of patients, yet to be published, with pertussis who had similar experiences and he said ‘what you may have is a patient with a totally necrotic lung.’”

That is a real-life example of how Twitter can help surgeons access information not readily available from traditional sources, Dr. Glick said. “This surgeon hadn’t even published this information yet. He knew exactly what was wrong, exactly what I should do and I shared it with my patient and [the child’s] family who needed it.”

One doesn’t have to have a Twitter account to know that this social media platform, based on messages sent in a 140-character format, is revolutionizing the way information is spread. By doing so, it is opening up a new style of conversation about health care, one in which every player—patients, physicians and policymakers—can connect summarily, albeit superficially.

Today, more than 200 million Twitter accounts exist and more than 340 million updates are made per day. According to the Pew Internet and American Life Project, 13% of U.S. Internet users have used or currently use Twitter. Onethird of U.S. consumers have used social media to find health-related consumer reviews of treatments or doctors; one in three have sought information related to other patients’ experiences with their disease; and one in four have posted comments about their health experience.

As for physicians on Twitter, no one has an exact figure. Studies are currently under way examining physician and subspecialty participation in social media.

Not all physicians identify themselves as physicians on Twitter; some use it anonymously, or for strictly personal purposes. Some physicians are represented by their hospital or department tweets. Even

A Twitter Primer What is Twitter? It’s a free social networking site. Users post a message, with a 140-character maximum, called 'tweets' to their followers.

How To Get Started?

Sign up at www.twitter.com. Set up your username and password. You can choose to add a photo and choose to

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MARCH 2013

‘If you follow 20 to 30 really smart people—people who are part of a conversation that you are interested in, be it endoscopy, interventional endoscopy, whatever —you can get a really great signal or feed that will provide you with remarkable information.’

—Bryan Vartabedian, MD self-identified physicians are difficult to track. As of January 2013, nearly 1,200 physicians were registered with the Directory of Twitter Doctors, but it is believed that this number represents only a proportion of the physicians on Twitter.

No studies have looked specifically at the presence of surgeons on Twitter. If their usage is similar to that of oncologists and primary care doctors—the only two groups to have had their social media usage studied in a scientifically rigorous way—one survey suggests about 7% of clinicians use Twitter as part of their lifelong learning, 37% reported that they never plan to use Twitter as part of their lifelong learning and about 50% are on the fence, said Brian McGowan, PhD, a research scientist who specializes in medical education and author of the study ((J Med Internet Ress 2012;14:e117).

However, the proportion of surgeons who use Twitter is growing, according to a recent report in the Bulletin of the American College of Surgeons. From the 2010 Clinical Congress to the most recent, the number of followers of the American College of Surgeons’ Twitter account increased sevenfold. Tweets from attendees at the meeting increased 800%.

When General Surgery Newss informally asked surgeons about their opinions on Twitter, responses varied widely. Said one: “I had no idea when I started how rewarding my Twitter account would be, both personally and professionally.”

And another: “I don’t tweet as it seems remarkably frivolous and something for people with too much time on their hands to do in order to occupy themselves. I

protect your tweets so only approved followers can read your posts. Select the Twitter accounts you want to follow (see “Who To Follow” on page 30 for some surgery-friendly suggestions). In turn, you’ll be able to track who is following your tweets. You also can block specific individuals from following you.

Twitter has a help site to assist new users in setting up their account and

have never mett a su surgeon who had too much time on their hands.” ds ”

How Twitter Can Be Useful Incredible amounts of general surgery and general health care information is being called out in 140-character bits on Twitter—some of it helpful, some not.

For a physician, plucking out the useful information can be difficult but beneficial.

One of the great advantages of Twitter is that it’s a very targeted way to get up-tothe-minute news about things that affect your practice and patients. For instance, organizations like the Centers for Disease Control and Prevention (CDC) and the FDA use their Twitter feeds to send out real-time updates on things like pandemics, emergencies and drug approvals. All of the major surgical professional societies also are on Twitter, tweeting about things like annual meetings, publication of major studies and member-related news. Additionally, every major general surgery and medical journal has a Twitter presence.

When used in this way, Twitter can serve as a highly personalized, continuously updating news feed.

“Many doctors think of Twitter just as a gab site and certainly it can be that. But one of the reasons that I’m attracted to it is it’s a way to screen for information in a very efficient way,” said Marty Makary, MD, associate professor of surgery, Johns Hopkins School of Medicine, Baltimore.

For instance, he said, he can track information coming from the CDC and can monitor the response to CDC reports. Moreover, he receives direct feedback from patients and other health care

finding followers.

Learn the Lingo Retweet: Reposting another person’s tweet Tweeps: Twitter followers @: The ampersat is used to call out user names in tweets. For instance, to address General Surgery News, you’d start the message with @gensurgnews. #: The hashtag is used to mark keywords or topics in a tweet. A few that

providers about his own research. p “I learn from Twitter. I learn from puttin tting ideas out there. And it’s a chance for me to promote articles and issues that I think are relevant to practicth ing surgeons s like myself.”

Bryaan Vartabedian, MD, a pediatric gastroenterologist g at Texas Children n’s Hospital, Baylor College of Medicine, M in Houston, who tweets abo bout the intersection of medicine, soci ocial media and technology on his blog, g, 33charts.com, 3 said that physicians can tailor how they use Twitter to get the ca results they want.

For example, if a physician is interested in only one type of information—say, updates on new drugs or devices—he or she can follow only users who send out information relevant to that topic.

“If you follow 20 to 30 really smart people—people who are part of a conversation that you are interested in, be it endoscopy, interventional endoscopy, whatever—you can get a really great signal or feed that will provide you with remarkable information.”

Dr. Vartabedian stressed that physicians can control what they want to say, if indeed they want to say anything at all.

“I use Twitter more for listening than for speaking, for following than for driving the conversation,” he said.

For individuals who want to use Twitter without being “seen,” that’s also possible. They simply lock the account so that only their “Tweeps” (i.e., Twitter followers who they have approved) can see the account.

On the other end, Twitter can be a great way to network. It’s a way to meet other researchers, advertise upcoming events, improve resident education, drive traffic to a blog or discuss issues in patient care, said Sani Z. Yamout, MD, a pediatric surgery trainee in Buffalo, speaking during an ACS session on social media.

Some surgeons are using Twitter to improve doctor–patient communication, although they are careful to avoid providing specific medical advice.

Deanna Attai, MD, is a private practice see TWITTER page 30

are often used by physicians: #hcsm (health care social media) and #meded (medical education).

Direct messages: Private tweets between the sender and recipient.

Lists: Curated groups of other Twitter users. (Lists are a good way to find physicians.)

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In the News

Who To Follow C OMPILED

BY

C HRISTINA F RANGOU

Surgeons @Atul_Gawande, Atul Gawande, MD: surgeon and writer @bnwomeh, Benedict C. Nwomeh, MD: pediatric surgeon @DrAttai, Deanna Attai, MD: breast surgeon in Los Angeles; moderates a weekly Twitter discussion on breast cancer @DrMartyMD, Martin Makary, MD: surgeon and researcher at Johns Hopkins, Baltimore; author of Unaccountable @drmlb, Mary L. Brandt, MD: professor of surgery, pediatrics and medical ethics at Baylor College of Medicine, Houston; blogger at www.wellnessrounds. org @glicklab, Philip Glick, MD, MBA: professor of surgery, University of Buffalo, N.Y. @globalsurgeon, Adam L. Kushner, MD: surgeon and founder of Surgeons SOS @HeatherLogghe, Heather Logghe, MD: general surgery resident @hjluks, Howard Luks, MD: orthopedic surgeon, blogger at www.howardluksmd.com and advocate for

TWITTER

jcontinued from page 28 breast surgeon in Los Angeles and now one of the most prolific surgeons on Twitter. When she first signed up, she simply followed news and breast cancer organizations without sending out tweets of her own. Surprised by the number of patients turning to Twitter to gain answers to questions that should have been answered by their physicians, Dr. Attai started to engage with patients on Twitter. “I don’t provide specific medical advice, of course, but there is plenty of opportunity to share knowledge and provide support.”

Last fall, she became a co-moderator of a weekly breast cancer support community that meets online once a week. She says this relationship gives her new insight into the patients she sees in her office.

“While I think as physicians we have a good idea of how our patients are tolerating treatments, I quickly realized that our patients hide a lot from us. They don’t always let us in on all of the pain and suffering they go through.

“Twitter has given me an idea of how our treatments and conversations affect all aspects of their lives.

It’s also given me a new appreciation for just how important our words are as physicians, and just how precious the few minutes of an office visit can be to a patient and her family.”

And one more way Twitter is reshaping public knowledge of surgery: Surgeons and hospitals have used Twitter to “live-tweet” operations, giving an online play-by-play as the procedures were under way.

It’s a way of informing the public

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MARCH 2013

patient-centered care @Melanoma_doctor, Eric D. Whitman, MD: surgical oncologist and melanoma specialist @NirajGusani, Niraj J. Gusani, MD: surgical oncologist @PedSurgZn, Sani Z. Yamout, MD: pediatric surgeon at Kaiser Permanente Oakland Medical Center @SkepticalScalpel: surgeon who tweets and blogs about medicine at www.skepticalscalpel.blogspot.com @UCD_ChestHealth, David Tom Cooke, MD: thoracic surgeon @UtahBurnDoc, Amalia Cochran, MD: burn and critical care surgeon in Salt Lake City

Other Physicians @Doctor_V, Bryan Vartabedian, MD: pediatric gastroenterologist and blogger (www.33charts.com) at Texas Children’s Hospital, Baylor College of Medicine, Houston; leader in the health care/social media space @GlassHospital, John Schumann, MD: general internist and medical educator at the University of Oklahoma School of Community Medicine, Tulsa; blogs about the workings of medical practice and how to improve the health care experience for patients (www.glass hospital.com) @kevinmd, Kevin Pho, MD: writer (www.kevinmd. com) and internal medicine physician; leader in health care social media @NightShiftMD, Brian Goldman, MD: ER physician at Mount Sinai Hospital, Toronto; host of CBC’s radio show and podcast White Coat, Black Art;

about a procedure or a condition, and a way to advertise a hospital's or surgeon’s services.

Houston’s Memorial Hermann Hospital first livetweeted a heart surgery in February 2012, followed by a brain surgery that spring. For the latter, as neurosurgeon Dong Kim, MD, removed a cavernous angioma from the side of a woman’s brain, colleague Scott Shepard updated the hospital’s Twitter feed and answered questions about the procedure. Their tweets included video, pictures and commentary.

In explaining the decision to live-tweet the surgery, Dr. Kim said he hoped that Twitter could help to demystify the process of brain surgery.

“So our goal of performing this surgery live via Twitter is to educate the general public about brain tumors and take them into the OR [operating room] to see what happens during a brain surgery. Someone may have a loved one who is considering a similar procedure and perhaps they can glean some information from this Twittercast that may help them make a decision about whether surgery is the right choice for them,” said Dr. Kim in a statement.

Twitter Faux Pas Physicians generally are able to maintain a high degree of professionalism and steer clear of privacy violations on Twitter. This has been shown in a small study published last year in which a group of physicians from the VA Medical Center in Washington, D.C., studied 260 self-identified physicians with 500 or more Twitter followers ((JAMA A 2011;305:566-568).

The investigators tracked physician tweets over a one-month period and coded the results, looking for potentially unprofessional tweets. Of 5,5156

author of The Night Shift

Professional Societies @AmCollSurgeons: American College of Surgeons @AmericanCancer: American Cancer Society @AmerMedicalAssn: American Medical Association @ASBrS: American Society of Breast Surgeons @ASCO: American Society of Clinical Oncology @ASGEendoscopy: American Society for Gastro intestinal Endoscopy @ASMBS: American Society for Metabolic and Bariatric Surgery @AssocAcademicSurgery: Association of Academic Surgery @CDC_Cancer: Centers for Disease Control and Prevention’s Division of Cancer Prevention and Control @FDARecalls: FDA @RCofSurgeons: Royal College of Surgeons of England @SAGES_Updates: Society of American Gastro intestinal and Endoscopic Surgeons @SocSurgOnc: Society of Surgical Oncology @WHO: World Health Organization @WomenSurgeons: Association of Women Surgeons

Publications @Annals of Surgery @BJSurgery: British Journal of Surgery @GenSurgNews: General Surgery News @JAMASurgery: Archives of Surgery @NEJM: New England Journal of Medicine

tweets analyzed, 49% were health- or medical-related, 21% were personal communications, 14% were retweets and 58% contained hyperlinks. Of the tweets, 3% (144 of 5,5156) were categorized as unprofessional: 0.7% of tweets represented potential patient privacy violations, 0.6% contained profanity, 0.3% included sexually explicit material and 0.1% included discriminatory statements. Nine of 10 physicians who sent tweets that included potential privacy violations were identifiable by a full listed name on their profile, profile photograph or full listed name on a linked website.

The investigators concluded that Twitter might be enormously beneficial, but that health professionals could benefit from education and guidelines about use of social media.

Self-identified physicians on Twitter share medical information with the public, with the potential to positively affect health, wrote Katherine C. Chretien, MD, and her colleagues. “Accountability for health professionals, in addition to greater education and guidelines, may be needed to maximize potential societal and professional benefit through engagement with social media.”

Medical schools are getting on board with the idea that educating physicians and aspiring physicians about social media is critical. This year, four medical schools were awarded two-year grants to help educate faculty members and medical students on the use of social media. The project aims to teach faculty, who can then instruct students, on how to use social media sites like Twitter and Facebook to benefit patient care while maintaining professional standards.

“The next generation of doctors needs to understand how social media can be a double-edged sword,” said principal investigator Elizabeth Kitsis, MD, director of bioethics education and assistant professor of epidemiology, population health and medicine at Albert Einstein College of Medicine in New York City, in a statement. see TWITTER PAGE 34

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Study Shows Owners of Ambulatory Surgical Centers Do More Surgery B Y G EORGE O CHOA

O

rthopedic surgeons who were owners and on the board of directors of an ambulatory surgical center (ASC) in Florida did 76 more surgeries per year than nonowners. For every surgery a nonowner performed, an owner completed 1.8. This finding raises the question of why? This question was addressed in a Workers Compensation Research Institute (WCRI) study (http://www. wcrinet.org/result/why_surgeon_owners_do_more_surgery_result.html) that also was the subject of a webinar, “Why Owners of Ambulatory Surgical Centers (ASCs) Do More Surgery,” presented on Oct. 30.

Study author and webinar presenter, Christine A. Yee, PhD, an economist at WCRI in Cambridge, Mass., studied Florida orthopedic surgeons from 1997 to 2004, specifically those who performed outpatient knee, shoulder, and wrist arthroscopies and carpal tunnel surgeries. Surgeons were tracked longitudinally, from when they were not owners to when they were. Owners were identified in three ways: board owners (surgeons

who serve on an ASC’s board of directors), threshold owners (surgeons who referred or performed 30% of procedures at a single ASC) and frequent user-owners (surgeons who collectively accounted for 50% of an ASC’s procedures).

Recruitment of higher-volume surgeons to become owners turned out to be one of the top reasons why ASC owners did more surgery, as well as the presence of entrepreneurial surgeons who might be more likely to start an ASC. “The data would not support teasing out the recruitment effect separately from the entrepreneurial effect and so they were estimated as one effect,” Dr. Yee told General Surgery News. “Entrepreneurial/recruitment was the largest factor, followed by financial incentives.”

There also was an ASC efficiency effect: When a surgeon shifted from a hospital to an ASC, the surgeon could perform more surgery in a given time.

“We can’t tell if a given arthroscopic surgery at an ASC took less time than at a hospital,” said Dr. Yee, “or if more invasive, time-consuming surgeries were taking place at hospitals, leaving less room to schedule arthroscopic surgeries. Surgeons can schedule more surgery at ASCs, but

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we don’t have the data to isolate the reason why.”

Steven Hopson, MD, board member and hernia surgeon at Mary Immaculate Ambulatory Surgery Center in Newport News, Va., emphasized the importance of efficiency. “You increase your surgeries because you’re more efficient. At the ASC, processes are in place to turn cases around quicker. Your volume will go up.”

His ASC, he noted, is a joint venture with Bon Secours Mary Immaculate Hospital.

Dr. Hopson, who was not affiliated with the webinar, did not agree that owners of ASCs perform more surgeries than nonowners. “Nonowners have the same reason as owners to go to an ASC. They’re there to get the cases done and get out of there.” He added, “The incentive is that doing more cases in a shorter amount of time gives general surgeons a better lifestyle. They can be home in time to have dinner with the family.”

The efficiency effect, as well as other effects, was not as prominent in Dr. Yee’s research as the entrepreneurial/recruitment effect and financial incentives. “The efficiency effect, capacity effect (such as when a surgeon adds on an ASC or hospital), and technology/market trends (such as an overall increase in the number of arthroscopies being performed over time) affected both owners and nonowners and as such did not explain as much of the difference,” said Dr. Yee. The ASC efficiency effect was moderate in its contribution size, capacity effect, small, and technology and market trends, smallest.

In contrast, the contribution size of the financial incentives effect was large and that of the entrepreneurial/recruitment effect, largest.

Ownership in ASCs changed surgeons’ practices. The volume of surgeries increased by 15% to 22%; owners shifted 28% to 54% of their surgeries to their owned ASC, and owners treated more patients covered by payers who reimbursed at higher rates, such as workers' compensation. On the issue of the

‘Nonowners have the same reason as owners to go to an ASC. They’re there to get the cases done and get out of there. The incentive is that doing more cases in a shorter amount of time gives general surgeons a better lifestyle. They can be home in time to have dinner with the family.’

—Steven Hopson, MD profitability of patients, Dr. Hopson commented, “I don’t think every ASC is the same. We have to do a certain amount of unpaid charity [procedures]. I do free hernias. We serve the community just as much as a nonprofit.”

Policy implications of her research, Dr. Yee said in the webinar, might include medical costs, access to care, financial stability of hospitals, current regulation on physician ownership and reimbursement rates. For these issues, more data are needed—for example, on whether all the additional surgeries at ASCs are necessary. “We can’t tell if the surgeries were necessary or unnecessary,” said Dr. Yee in the interview.

The study’s main limitation, said Dr. Yee, was its length. “It may be a little long, but it’s hard to tell all sides of the story without such comprehensiveness.” As new directions for research, she suggested, “to find out if the additional surgeries, due to financial incentives, were necessary or unnecessary and increase the scope of the study beyond orthopedic surgeons in Florida.” She added, “New research methods were developed to approach this topic of physician ownership and there are many other directions to go.”

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MARCH 2013

SURGICAL TRAINING jcontinued from page 1

and women who are capable of independent surgical practice (see “Are Today’s Surgical Graduates Prepared for ‘Real-World’ Practice?,” page 1).

Many of my colleagues have lamented that young surgeons in training programs have not realized the opportunity for any degree of autonomy in training programs and have not had the same degree of patient care and operative experience when compared with some of us who were trained in the past. Although these deficiencies cannot be totally attributed to work-hour directives, it has been calculated that these directives, at least for young surgical trainees, have resulted in the loss of approximately one day of training each week. A further negative consequence of reduced clinical experience is the disturbing fact that the pass rate on the American Board of Surgery certifying examination (orals) has dropped to 72% this past year.

Many have suggested that the consequences of loss of autonomy and workhour restrictions must now require a new template to help ameliorate these negative effects and serve as a needed transition to practice. The American College of Surgeons has now recommended the development of the general surgery fellowship—yes, you read that correctly—a general surgery fellowship to be offered after the completion of five years of general surgery residency!

What a sad commentary on our Halstedian tradition of surgical training.

Although I applaud this move by our college, I believe that it serves only as a small gauze dressing for a large traumatic wound inflicted onto the traditional training of general surgeons.

As is the case in other countries where surgical societies actually accredit surgical training programs, our American College of Surgeons or an amalgam of surgical societies should consider the need, opportunity, legality and mechanism to serve as the accrediting body at least for general surgery training in the United States. In my opinion, the approach of the ACGME and the current Residency Review Committee to surgical training is totally out of step and fractured when applied to the needs of young surgeons who are training for the next 30 to 40 years of practice. We cannot follow the same tenets of training for surgeons as we embrace for dermatologists, radiation oncologists, pediatric allergists and other nonsurgical specialties.

I realize that there are many factors contributing to the negative outcomes in general surgical training. The lack of

resident autonomy, fueled by reimbursement constraints, governmental quality benchmark concerns, threats of litigation, credentialing issues, etc., have contributed to the difficulty for many of our trainees to transition to independent surgical practice after only five years of training. The American College of Surgeons leadership has realized this dire situation and has offered a solution— a general surgery fellowship (obviously not ACGME-accredited!) to be offered after five years of general surgery training! Although I applaud the need for this bold move, it serves only as a mild

The approach of the ACGME and the current Residency Review Committee to surgical training is totally out of step and fractured when applied to the needs of young surgeons who are training for the next 30 to 40 years of practice.

panacea for a much more malignant process that can be cured only by an aggressive therapeutic approach.

—Dr. Greene is clinical professor of sur— gery in University of North Carolina School of Medicine at Chapel Hill and serves as the senior medical adviser for General Surgery News.

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follow us @gensurgnews

Experience Surgical Innovation

at www.GeneralSurgeryNews.com

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Surgical Residents: The Modern-Day Jedis B Y M ARC A. N EFF , MD, FACS

O

n May 25, 1977, George Lucas introduced us to his “Star Wars” universe.

Since then, the films alone have grossed more than $4.49 billion. The franchise has grown to encompass six movies, a TV series, books, comics and radio, and has inspired the hearts and minds of an entire generation of wouldbe Jedis. The saga has become the myth of our time.

Recently, Disney purchased Lucasfilm for $4.05 billion.

This saga is the classic embodiment of all aspects of a myth. It involves a hero who falls from grace. He learns he has special powers and goes on a spectacular journey.

Along the way, the hero will meet a wise mentor, have several brushes with death and acquire several unique companions. Finally, there is an ultimate challenge that is overcome despite unbeatable odds. The hero then returns from his trial, successful, and makes the world forever a little bit better.

In the first movie, Luke, a forgotten farm boy, learns he has a special heritage. He is taught to believe in his potential by his mentor, Obi-Wan Kenobi. His magical power is The Force. His companions include droids, Wookies, a smuggler and a princess. He faces insurmountable odds in challenging Lord Vader and the Death Star, but in the end, he is victorious.

I would suggest that surgical residents everywhere are reenacting this myth every day. They start medical school lost in the drudgery of the lecture hall. They spend hours toiling in the library and in books at home. They are much like that poor, forgotten farm boy—or girl, given current residency statistics.

After a time, the medical student progresses to the knowledge that they want to be a surgeon. They commit to the training and begin the application process to a surgical residency. They commit to a life of surgery, or in the Star Wars realm, they would now be considered a Youngling, starting to select a Jedi Academy at which to train. The Youngling starts to recognize that they have some special abilities. Perhaps it surfaces in anatomy lab, or maybe when learning their first procedures such as placing IVs, or finding veins. They recognize that they are not like other medical students. They have a special talent, dexterity, a mental concept of anatomy that not all possess. They recognize that they are, like Jedis, Force-sensitive.

Then, they leave home and embark on a residency.

They often travel to a far-off place or world (a residency

TWITTER

jContinued from page 30 “It can be a great way to provide personalized medical education for patients. However, great attention must be paid to maintaining the principles of professionalism, such as privacy and confidentiality of the physician– patient relationship.”

In 2010, the American Medical Association issued a policy statement to help physicians keep their online experiences positive and preserve the integrity of the patient–physician relationship, including the following recommendations: • Use privacy settings to safeguard personal

program, or in this analogy, a Jedi Academy). There, they meet strange people who will help them in their training. The different residents in emergency medicine, family practice, OB/GYN and the nurses with whom they become friendly are like the different characters in the “Star Wars” saga, the droids, Wookies, smuggler and princess. And although there are many Jedi academies spread across the country, with different Jedi knights and masters, all Padawans study the same techniques from the same tomes of knowledge. They battle the same dark foes (appendicitis, cholecystitis, colon cancer, etc.) and learn to use the same lightsabers (scalpels, laparoscopic instruments, retractors, etc.). All Jedi academies produce Jedis.

But it is the attending surgeon who is the surgical residents’ Obi-Wan Kenobi—their mentor and guide in this strange new world. The attending surgeon often is considered all-knowing, with an ability to know labs and x-ray results with the precognition of a Jedi. They often can influence people with a look or a stare, like the Jedi can with a wave of the hand. They can reach their hand deep into the pelvis and use some unknown power or Force to free up a stuck piece of bowel in an adhesion, or mobilize a splenic flexure high up by the diaphragm.

Of course, there is a hierarchy among surgical attendings (like the hierarchy of the Youngling, Padawan, Jedi, Jedi knight, Jedi master and Jedi grandmaster), where some have more knowledge in lightsaber combat techniques than others. And there is a Jedi Council that decides the fate of the young trainees (the Mortality and Morbidity Conference). At these Jedi academies, there are even evil surgical attendings that often are considered Dark Sith lords, and I suspect some really can shoot Force lightning from their fingertips if they get mad enough. But I digress.

The point of this analogy is that residents are our modern-day Jedis in training. They have to have a singular dedication to their path. As Yoda said in episode I and episode V, “A Jedi must have the deepest commitment, the most serious mind.” They will have several obstacles in their way, many times seemingly impossible to overcome, before they complete their training and can call themselves attendings ( Jedi). They will battle with balancing their career and their social relationships. They will be tempted to take short cuts (not check that x-ray after line placement, but sign it out to someone else, or assign that H+P to a younger level resident) and give in to anger, hate and the allure of the dark side of surgery (of the Force). They will have to face the Jedi Council

several times. They will be apprenticed to several masters before their training is complete. And, in the end, they will have to face numerous tests of their ability (ABSITE exams), before they ultimately face the Death Star (the board exam). But, like Luke, most will re-enact this modern-day mythos and become a true surgical attending (a Jedi)—a powerful hero for good who wields a scalpel (or a lightsaber) in remarkable, unimaginable ways, a superhero who stands against evil in our world (surgical pathology and insurance companies).

If you believe any of what I have written here, then, to the young Jedi in training, I say that even when you are tired, hungry, embarrassed, overwhelmed, mentally exhausted and ready to quit (which happens at least once every six months), remember not to give in to the Dark Side. Remember that it took three movies before Luke could be considered a Jedi. When you are about to give up preparing a five-minute summary on a 200-page chart for the Mortality and Morbidity Conference, remember what Yoda said to Luke in the swamp on planet Dagobah about lifting an X-wing out of the swamp with the Force, “Do or do not, there is no try.” And, when you feel like a dark-side surgical attending has just cut off your hand like Vader did to Luke, or that you will be unable to destroy the Emperor’s new moon-sized battle station, remember what Obi-Wan said to Luke “The Force will be with you … always.”

—Dr. Nefff is medical director of the Kennedy University Hospital Bariatric Surgery Program, Cherry Hill, N.J.

information.

Routinely monitor your own Internet presence to ensure that online personal and professional information is accurate and that content posted by others is accurate and appropriate.

• Maintain appropriate boundaries of the patient– physician relationship online and ensure patient privacy and confidentiality is maintained.

• Consider separating personal and professional content online by opening two separate Twitter accounts.

• Recognize that actions online can negatively affect your reputation among patients and colleagues.

Dr. Vartabedian said that adhering to professional

standards and preventing privacy violations comes down to two simple rules: 1) Never post anything online that you wouldn’t want disseminated among your colleagues, and 2) avoid any mention of specific patient information.

Zack Glick, a web developer and specialist in cyber security who spoke at the ACS session on Twitter, warned physicians to take precautions to keep their Twitter and other social media accounts protected. He recommends using “https” to sign onto Twitter and using a long, complicated password.

Surgeons who do not plan to use Twitter should still sign up and register their name, he said. “That way, no one else can pretend to be you. You want to make sure your credentials are safe.”

•

SU

RGI

C A L R E S I DEN

TS

‘Although there are many Jedi academies spread across the country, with different Jedi knights and masters, all Padawans study the same techniques from the same tomes of knowledge.’

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George Fuhrman, MD; Tari King, MD May 12, 2013 Topics include neoadjuvant chemotherapy, pathology of invasive breast disease, management of high-risk lesions, genetic predisposition syndromes, radiation therapy, management of the axilla, management of ductal carcinoma in situ, breast reconstruction, adjuvant therapy, screen-ing, imaging, benign breast disease and more.

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REPORT Transdermal PCA in Acute Postoperative Pain Management: A Critical Evaluation of the Investigational IONSYS System Despite advances in pain manAcute postoperative pain conChair agement technology, the advent tinues to be undertreated, with of acute pain services, and proup to 75% of patients in the Eugene R. Viscusi, MD fessional practice guidelines United States failing to receive Professor of Anesthesiology aimed at improving postoperative adequate postoperative pain Director, Acute Pain Management pain management, inadequacies relief.1,2 Postoperative pain manThomas Jefferson University and treatment gaps still exist, and agement was revolutionized with improvement remains a priority.7 the introduction of patient-conPhiladelphia, Pennsylvania trolled analgesia (PCA) using IV An analgesic intervention Faculty or epidural delivery routes more that might help to mitigate clinithan 20 years ago.3 Opioids are cian concern is the fentanyl ionJohn Fanikos, RPh, MBA tophoretic transdermal system the primary treatment for acute Director of Pharmacy Business (IONSYS), a credit card–sized, pain management,4 either alone Brigham and Women’s Hospital self-contained, and preproor increasingly as part of a multiBoston, Massachusetts grammed investigational product modal analgesic strategy—charcandidate intended to provide acterized by administration of 2 Michael H. Huo, MD pain relief for adult inpatients or more drugs (eg, opioid and Professor requiring opioids following surnonopioid analgesics, used in Department of Orthopedic Surgery gery.8 It is a needle-free system combination) that act by different UT Southwestern Medical Center mechanisms, and along differthat is applied to the skin on the Dallas, Texas ent pain pathways—an approach upper arm or chest.8 A generally that is recommended by the imperceptible electrical current American Society of Anesthesithen delivers a small dose of fenologists (ASA) and the American Pain Society.5,6 However, tanyl directly through the skin and into the systemic circulation. The FDA approved IONSYS in 2006; however, it existing PCA modalities have limitations that include invawas never launched in the United States due to required sive access, challenges in titration of analgesic effect, changes in manufacturing. The enhanced design will be cumbersome pump technologies, impaired patient mobilreviewed by the FDA in the near future for use in patients ity, and limited drug preparations that have been associwith moderate to severe postoperative pain. ated with programming, medication, and dosing errors.

Supported by

REPORT

PCA Patient variables

Nurse variables Pain

Sedation Patient requests nurse Analgesia Nurse arrives

Pharmacokinetic variables

Nurse evaluates

Absorption Injection administered

Nurse readies injection

Figure 1. PCA’s influence on pain control.

PCA reduces the time it takes to alleviate acute pain in patients.

PCA, patient-controlled analgesia

Burden of Acute Postoperative Pain More than 48 million inpatient surgeries and roughly 35 million outpatient surgeries are performed annually in the United States, and the magnitude of unrelieved acute postoperative pain is substantial.4,9,10 Unrelieved pain can have profound implications and inadequately managed acute postoperative pain can result in negative clinical (eg, myocardial infarction, infection, pneumonia, poor wound healing, demoralization) and medical outcomes (eg, extended hospital length of stay, readmissions, patient dissatisfaction, perception of negative hospital performance, and increased health care utilization costs).4 Given the problem of insufficient pain relief, treatment regimens now include the use of multimodal analgesia to control postoperative pain and potentially improve postoperative recovery.11

Elements of Multimodal Analgesia A multimodal approach that incorporates opioid-based PCA is a principal element of acute pain management during the postoperative period.12 The 2012 ASA Practice Guidelines for Acute Pain Management in the Perioperative Setting recommend the consideration of acetaminophen, oral cyclooxygenase-2 (COX-2) selective nonsteroidal anti-inflammatory drugs (NSAIDs), nonselective NSAIDs, and calcium channel α2δ antagonists (ie, gabapentin and pregabalin) as part of an acute postoperative multimodal pain management regimen.5 Patients should receive around-the-clock (ATC) doses of coxibs,

2

NSAIDs, or acetaminophen unless contraindicated.5 Regional anesthetic techniques, including peripheral nerve blockade, should be considered; dosing regimens, route of administration, and therapy duration should be individualized to balance considerations of effectiveness and risk for adverse events (AEs).5 Drugs with a primary indication other than analgesia (eg, anticonvulsant medications) are sometimes used as part of a multimodal strategy.

While opioids remain an important part of the foundation of pharmacological management of moderate to severe pain during the postoperative period,13 opioid-reducing regimens of ATC nonopioids are considered most appropriate.5 Opioids endure as an important analgesic component for the systemic treatment of postoperative pain,12 but the best delivery route of therapeutic agents depends on many factors including the physician’s level of expertise as well as patient characteristics. Evidence shows that when compared with conventional opioid analgesia (eg, IV, subcutaneous, intramuscular), PCA with opioids provides a greater analgesic effect, even when the amount of opioids consumed is similar between the 2 methods; and it also is the preferred treatment modality among patients.14 PCA also can be used in conjunction with an opioidsparing multimodal treatment regimen.

PCA Modalities and Practices The basic tenet of PCA dictates that patients should have direct control of their pain management14 and may benefit from

REPORT doing so.15 Severe acute pain is best treated with intermittent, small doses of opioids that are delivered immediately when needed (Figure 1). This allows for rapid titration of analgesic effect and provides more effective pain relief than conventional (eg, intermittent bolus intramuscular, IV, subcutaneous) opioid regimens.14,15 The superior analgesic efficacy of IV PCA compared with intermittent intramuscular analgesia was demonstrated in a pooled-data analysis in which the incidence of moderate-severe pain with intramuscular analgesia was 67% (95% confidence interval [CI], 58.1%-76.2%) and severe pain was 29% (95% CI, 18.8%-39.4%). For PCA, the incidence of moderate-severe pain was 36% (95% CI, 31.4%-40.2%) and severe pain was 10% (95% CI, 8%-12.8%), respectively.16 Data also have shown that fewer pulmonary complications are reported with IV PCA compared with other methods of opioid delivery (eg, IV, subcutaneous, intramuscular), and the risk for oversedation is reduced.14,17 After pain control has been established with a loading dose of IV opioids, PCA is used to sustain comfort by selfadministering small amounts of analgesic medication within preset parameters.18 Staff-programmed PCA pump settings regulate medication dosing and dosing frequency, the lockout period between doses, and the maximum allowable dose per hour. Existing PCA modalities including IV PCA, patientcontrolled epidural analgesia (PCEA), and patient-controlled regional anesthesia (PCRA) have varying benefits. For example, IV PCA has an acceptable efficacy and safety profile along with reports of high patient satisfaction.3 Analgesia delivered through the epidural route (eg, PCEA, continuous infusion, bolus injection) supplies rapid analgesia and decreases systemic opioid exposure.3 PCEA also allows patients to selfadminister analgesia based on individual requisites.3 Similarly, PCRA provides analgesia without systemic exposure to opioids and it can conveniently be used in an outpatient setting.3 Similar to IV PCA and PCEA, PCRA also has the advantage of a no first-pass gastrointestinal effect but also a no first-pass hepatic effect.3 The ASA recommends the use of therapeutic options like systemic opioid PCA, central regional (ie, neuraxial) opioids, and peripheral regional techniques after carefully considering patient profiles and clinicians’ experience level, and the use of these modalities is preferred over prescribed as needed intramuscular opioids.5 PCA is a standard of postoperative pain management and current modalities allow for use of complex regimens.

Cost-Effectiveness Related to PCA Medical expenses, unintended morbidity and mo rtality costs, and overhead expenses all affect the total cost of managing pain during the postoperative period. Actual costs associated with postoperative pain management include fixed costs, which remain stable despite volume of activity (eg, IV PCA pumps), and variable costs, which fluctuate according to volume (eg, analgesics, disposable supplies). Because the inadequate treatment of postoperative pain may result in chronic pain, it may be difficult to estimate the actual cost of postoperative pain management. Unfortunately, hospitals and health care providers usually are unaware of the actual costs

associated with providing services, and actual costs do not always equate to compensation for the institution or clinician.

The examination of cost-effectiveness evaluates the total benefits respective to the expenses and resources necessary for advances in pain management. For example, 1 study analyzed cost-effectiveness between PCA and intermittent intramuscular injections. In this study, PCA was the preferred modality compared with intermittent intramuscular injections because it was associated with a lower mean pain level over 24 hours and greater patient satisfaction.19 While the mean drug and equipment cost for PCA was higher per patient compared with intermittent intramuscular injections, PCA retained clinical advantages over the traditional injection such as greater pain relief and patient satisfaction.19 With regard to IV PCA, direct costs include staff time, analgesics, infusion pumps, and tubing. Likewise, intangible costs that are associated with IV PCA include restricted mobility and patient discomfort. Indirect mortality and morbidity expenses for all modalities include expenses associated with insufficient pain management, medication errors, and staff-related injuries such as needlesticks. Examples of opportunity expenses include lost nursing time for pump programming, delays in setting up equipment, and consequent delays in patient discharge from the hospital.

When developing a regimen for postoperative pain management, an analysis of cost-effectiveness that scrutinizes resource utilization and labor costs related to these modalities, along with probable intangible, indirect, and opportunity costs is justified. The potential for pain relief is an important factor to consider when weighing the cost-benefits of a specific treatment modality.

Clinical and Pharmacodynamic Characteristics of Opioids in PCA Currently, opioids are the principal treatment for acute pain.4 Morphine is the most commonly employed opioid in postoperative IV PCA (usual starting dose in opioid-naive patients, 1 mg), followed in usage by hydromorphone (0.2 mg) and fentanyl (10 mcg); all are pure opioid agonists.18 Best practice dictates that approximately equianalgesic dosing of opioids is employed to minimize the impact of medication errors. Although morphine is considered the gold standard for IV PCA,18 its active metabolites—morphine-3-glucuronide and morphine-6-glucuronide—may accumulate insidiously in patients with renal impairment and have toxic effects owing to reduced excretion of the metabolite.20 Hydromorphone may be used as an alternative in morphineintolerant patients or in those with altered renal function. Compared with morphine, hydromorphone is at least 5 times more potent; initial doses should be significantly lower for hydromorphone and ordered in milligrams.15 Meperidine should be avoided for routine PCA because of an association with seizures, confusion and central nervous system stimulation, caused by its metabolism to an active form, normeperidine.15 Fentanyl has no active metabolites20 and is highly lipophilic, which facilitates crossing the blood–brain barrier. 21 Small

3

REPORT

Table. Patient-Controlled Modalities Used for the Management of Acute Postoperative Pain Modality

Conveniences

Limitations

Iontophoresis

Noninvasive; rapid analgesia; convenient, small in size, no required cables or pump; no programming by hospital staff required; no first-pass GI effect; limited time and resources required for administration; patient controlled

Not appropriate for patients with skin disorders or injuries that prevent application; individualization of dosing limited to frequency of dosing

IV PCA

Rapid analgesia; patient controlled; programmable

Invasive; pump apparatus, tubing, and power cables may limit patient mobility; extensive staff time and resources required for administration; requires programming by staff; potential for IV line occlusions, programming and drug errors

PCEA

Rapid analgesia; patient controlled; programmable

Invasive; pump apparatus, tubing, and power cables may limit patient mobility; extensive staff time and resources required for administration; requires programming by staff

PCRA

No first-pass hepatic effect; minimized systemic opioid requirements

Technique generally limited to orthopedic surgery patients; further development of PCRA pumps needed; efficacy and safety needs further evaluation

GI, gastrointestinal; PCA, patient-controlled analgesia; PCEA, patient-controlled epidural analgesia; PCRA, patient-controlled regional analgesia From reference 3.

positively charged molecules are ideal iontophoretic agents.

Hence, fentanyl hydrochloride (HCl) is well suited for iontophoretic delivery.22 Furthermore, fentanyl exhibits a satisfactory AE profile.

Hutchinson and colleagues reported that patients in the postoperative period who received IV PCA fentanyl had a low rate of common opioid-related AEs (eg, nausea, vomiting, pruritus, urinary retention, sedation).23 The same study revealed that during postoperative days 1 and 2, the IV PCA fentanyl group also had an acceptably low median pain score.23 Because the kidneys excrete metabolites of most opioids, the absence of active metabolites with fentanyl may make it a reasonable choice for patients with renal impairment.24 In critically ill patients, fentanyl has a prolonged clearance (half-life up to 25 hours) that should be taken into consideration. In addition to fentanyl, drugs with the relatively safest analgesic pharmacologic profiles for use in patients with impaired kidney function include alfentanil, ketamine, and buprenorphine.24 Drugs also used in the presence of renal failure but with special precautions—usually dose reductions—include amitriptyline, gabapentin, bupivacaine, and clonidine.24 NSAIDs and aspirin should not be used in the presence of chronic renal failure because of the risk for significant toxicity.24 In any patient population, postoperative renal function may differ markedly from preoperative renal function and clinicians should be vigilant for renal function changes.

4

Limitations of IV PCA When accurately prescribed and effectively monitored, PCA is an effective and safe way to control acute pain.15 However, PCA also is complex and prone to error.3 PCA is associated with numerous system-related complications and programming errors.3 In fact, device malfunction is a major cause of reported AEs with IV infusion pumps. Of 2,009 IV PCA-related events reported to the FDA’s Manufacturer and User Facility Device Experience (MAUDE) voluntary medication error reporting program during a 2-year period, 1,590 (79.1%) were classified as possible device-safety events.25 A retrospective analysis of MEDMARX, an Internet-accessible, voluntary medication error reporting program, found that PCA medication errors consequently are associated with higher relative risk for patient harm compared with non-PCA medication errors, and may occur during all phases of the medication use process.26 The increased focus on patient satisfaction in the hospital setting, led by the Centers for Medicare & Medicaid Services and the Agency for Healthcare Research and Quality, emphasizes the need for the optimal delivery of PCA. The Hospital Consumer Assessment of Healthcare Providers and Systems’ (HCAHPS) national standard survey monitors patients’ perspectives on hospital care.27 Increasingly, this survey—which includes an assessment of patient satisfaction—is being used to dictate reimbursement at risk.27 In fact, patient satisfaction with

REPORT pain management in the hospital is one of the 6 summary measurements used to determine the at-risk reimbursement under HCAHPS.28 Complications associated with PCA include a troublesome profile of common μ-agonist opioid-induced AEs including respiratory depression, nausea, vomiting, pruritus, sedation, and confusion.18 There also is the potential for complications related to the IV line itself (eg, occlusions) and catheter infiltration into subcutaneous tissue, or programming and medication errors—any of which can result in potentially serious AEs, including oversedation, respiratory depression, and under-treated pain (Table).3,15 Specific clinical disadvantages of IV PCA are that it is invasive, hinders patient mobility, requires external supplies (eg, tubing, power cables, drug cassettes) and the necessity of pump apparatus and programming, and extensive staff time and resources. In terms of patient comfort, analgesic gaps can occur while patients are waiting for medication during the transition from one analgesic modality to another. PCA delivery also requires a staff of expert clinicians including pharmacists, physicians, nurses, and physician assistants. The infrastructure must be present in order to safely and effectively deliver PCA— thus, a substantial commitment in resources is necessary. Furthermore, PCA by proxy errors, in which an unauthorized party activates the analgesic pump’s dosing mechanism, delivering analgesic medication to the patient, are another potentially serious issue within PCA delivery. PCA by proxy errors can result in serious AEs including oversedation, respiratory depression, and death.17

Limitations of PCEA and PCRA Similar to IV PCA, PCEA requires a staff-programmed pump and a highly qualified anesthesia provider to insert a catheter into the desired epidural location.3 In addition to the need for extensive hospital staff for administration, PCEA also requires manual programming, increasing the risk for serious programming and medication errors.3 PCEA’s pump, tubing, and power cables discourage patient mobility, and there also is a risk for occlusions.3 Analgesic administration via the epidural route also is associated with catheter dislodgement and migration within the epidural space; in fact, 17% of epidural catheters fail due to unexpected dislodgement.29 PCRA also possesses certain limitations. For example, in addition to being invasive, PCRA in an unmonitored setting is associated with an increased risk for complications such as leaking or dislodgement of indwelling catheters and infection.3 PCRA is usually restricted for use in orthopedic surgery patients; this modality also requires an advanced hospital staff to set up perineural catheters.3

Limitations of Other Routes of Opioid Administration While oral administration of opioids for the treatment of moderate to severe pain is both convenient and noninvasive, it is usually contraindicated in the immediate postoperative period.12 Oral opioids also possess a delayed onset of action; poor absorption in the gastrointestinal tract and a powerful first-pass effect cause a variable period of action compared with parenteral opioids.12

As such, greater doses of opioids (eg, morphine and meperidine) are required for oral administration than for the parenteral route.30 Furthermore, because the optimal analgesic dose varies among patients, overdose or the undertreatment of pain are potential risks with this route of administration.

The intramuscular route is associated with painful administration10 as well as ineffective pain control compared with other modalities (ie, PCA, epidural).16 The intramuscular administration of analgesics is characterized by unpredictable absorption as there is a 30- to 60-minute lag to peak effect followed by a sudden drop in action. The intramuscular route has another troubling element—when the opioid finally peaks, patients often are alone and can experience oversedation, vomiting, and aspiration.4

Iontophoretic Transdermal Delivery Transdermal drug delivery, like parenteral delivery, avoids first-pass hepatic metabolism and obstacles associated with oral analgesics following surgery (eg, vomiting, nausea, and difficulty swallowing).31 For the delivery of analgesics, transdermal modalities operate as a drug reservoir that determines the amount of drug transfer.32 Transdermal iontophoresis is a method that employs a subtle electrical current to deliver ionized drug molecules across the skin and into the circulation.31 With iontophoresis, neutral or cationic agents are positioned below an anode and anionic agents are fixed below a cathode, and a low current density and low voltage is applied, causing ions to be repelled through and into the skin.32 The skin acts to complete the circuit as electric currents move from the anode to the cathode.31 Specifically, the anode causes cationic therapeutic agents to be moved into and through the skin, and extracts anions from the tissue beneath the skin back into the anode.32 Within the cathode, anionic buffer ions are sent through the skin and the tissues’ cations migrate into the cathode.32 As such, an active transdermal system that uses iontophoretic drug delivery offers patients control over analgesic dosing along with convenient administration and rapid analgesic delivery without some of the shortcomings associated with IV and epidural routes.31

Iontophoretic PCA IONSYS is a noninvasive device that employs iontophoretic technology and is designed for PCA via the transdermal route (Figure 2).33 IONSYS is adhered to the patient’s skin with an adhesive backing. To deliver a dose of fentanyl, the patient can press the dosing button twice within 3 seconds; an audible tone will signal the start of delivery of each dose; and a rapidly blinking green light will remain on throughout the 10-minute dosing period.33 IONSYS activation produces a small electrical voltage between the anode and cathode. This causes positively charged fentanyl molecules located in the anode hydrogel reservoir to be repelled from the positively charged anode surface and to be delivered through the skin into the systemic circulation.31 In contrast to existing PCA modalities, iontophoretic transdermal delivery does not require infusion pumps or indwelling catheters to deliver medication, which encourages patient mobility in the critically important postsurgical period.3

5

REPORT percentage of human-related errors reported to have inflicted patient harm was 48.1%.25 MAUDE data also indicates that the percentage of device-related errors reported to have inflicted patient harm was 0.5%.25 Furthermore, IONSYS’ compact design also eliminates the necessity for unwieldy equipment that requires nursing staff attention and may restrict patient mobility because the patient is tethered by IV tubing, an IV pole, and the IV PCA pump apparatus.

Clinical Considerations With IONSYS Pharmacokinetic (PK) evaluations of IONSYS in dosing frequency studies have demonstrated that it has a PK profile similar to that of IV PCA fentanyl, but with a slower rise, lower peak level, and less fluctuations.36,37 Systemic absorption of the fentanyl delivered by IONSYS increases as a function of time; this increase appears to be independent of dosing frequency.8 Subtherapeutic passive absorption with IONSYS is minimal compared with transdermal delivery; IONSYS leaves no significant skin depot of fentanyl with discontinuation of the system, and serum levels fall almost immediately (Figure 3).8,38 After 24 hours or 80 doses have been administered, IONSYS deactivates and cannot supply additional doses to the patient.8 IONSYS is designed to be applied to the skin on the upper arm or chest. The quantity of fentanyl HCl delivered by activation of the system has been demonstrated to be independent of patient age, sex, body mass index, or race, but is dependent on the location of the device on the body, with the ideal application sites being the upper outer arm or chest of patients.39

Figure 2. Enhanced IONSYS device.

The credit card–sized, preprogrammed system delivers a small dose of fentanyl through the patient’s skin and into the systemic circulation.

From reference 33.

IONSYS delivers 40 mcg of fentanyl per on-demand dose over a 10-minute period, with up to 6 doses available per hour.8 As such, IONSYS performs for as long as 24 hours or for a maximum of 80 doses, whichever takes place first; additional IONSYS systems can be used after 24 hours if needed for up to 3 days.3 The enhanced IONSYS device features an improved display, which helps clearly show to health care practitioners how many doses have been delivered. IONSYS eliminates IV line complications, which can lead to analgesic gaps, by supplying instantaneous dosing on patient demand, providing consistent analgesia and eliminating potentially painful waiting periods between requests for analgesia and drug administration.

IONSYS also features preprogrammed dosing, which eliminates the potential for medication dosing errors. PCA medication errors have been the focus of hospital-directed safety alerts issued by the Institute for Safe Medication Practices and the Joint Commission, and remain a critical concern.34 For example, using MEDMARX data, the most common cause of IV PCA errors was human-related (accounting for 322.91 errors per 10,000 patients); followed by equipment-related (102.23 overall errors per 10,000 patients).35 Using MAUDE data, the

6

Ensuring Safe and Effective PCA Because IONSYS is intended only for use among hospitalized patients in the acute setting, the potential for misuse may be limited compared with the potential for misuse of the fentanyl transdermal patch or other opioids.3 To ensure proper usage, medical personnel are required to remove the IONSYS system prior to hospital release and dispose of it.8 Nevertheless, appropriate opioid selection can mitigate risks,40 and developing PCA patient-selection criteria (eg, evaluation of medically complicated patients, identification of patients with a need for a basal infusion, such as those who are opioid-tolerant) is one of the most overlooked but effective mechanisms to reduce risk for opioid-related AEs.15 In addition to clarifying the patient groups that are most likely to benefit from a particular PCA modality, targets for intervention in safe opioid analgesia are prescribing errors, staff training on use and protocols, monitoring, and patient education.15

Conclusion Opioids remain the most commonly used analgesics in postoperative pain management, especially for the treatment of moderate to severe pain. A multimodal approach that includes opioid-based PCA is an important tenet in managing acute postoperative pain.12 While the ideal mechanism of delivery depends on physicians’ expertise and the patient, data has shown that when compared with conventional opioid analgesia (eg, IV, subcutaneous, intramuscular), PCA with opioids is the preferred treatment modality among patients.14 However,

REPORT

Serum Fentanyl Concentration, ng/mL

3 IONSYS IV

2.5 2 1.5 1 0.5 0 23

28

33

38

43

48

Time, h

Figure 3. IONSYS vs IV fentanyl during last hour and at termination.

Comparison of IONSYS and IV fentanyl during the last hour and at termination of the following treatment: 40 mcg of IONSYS was administered in 2 sequential doses over 20 minutes every hour for 23 hours and 20 minutes, and 80 mcg of IV fentanyl was administered over 20 minutes every hour for 23 hours and 20 minutes.

From reference 8.

certain PCA modalities have disadvantages, including invasiveness (eg, IV PCA, PCRA), risk for infection (eg, PCRA), and medication or programming errors (eg, IV PCA, PCEA).3 The compact, self-contained, preprogrammed IONSYS system may limit the possibility for a number of medication and system-related events, including manual programming

errors, which have been associated with potentially serious clinical consequences.25,26 Unlike other PCA modalities, IONSYS is noninvasive, which promotes patient mobility during the postsurgical period. Within a multimodal pain management strategy, IONSYS may be a reasonable choice for analgesia in adult patients after a range of major surgical procedures.

References 1. Phillips DM. JCAHO pain management standards are unveiled.

JAMA. 2000;284(4):428-429.

2. Wu CL, Raja SN. Treatment of acute postoperative pain. Lancet.

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3. Viscusi ER. Patient-controlled drug delivery for acute postoperative pain management: a review of current and emerging technologies.

Reg Anesth Pain Med. 2008;33(2):146-158.

4. Wells N, Pasero C, McCaffery M. Chapter 17. Improving the Quality of Care Through Pain Assessment and Management. In: Hughes R, ed. Patient Safety and Quality: An Evidence-Based Handbook for Nurses. Rockville, Md: Agency for Healthcare Research and Quality; 2008.

5. Practice guidelines for acute pain management in the perioperative setting: an updated report by the American Society of Anesthesiologists Task Force on Acute Pain Management. Anesthesiology.

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6. Gordon DB, Dahl JL, Miaskowski C, et al. American Pain Society recommendations for improving the quality of acute and cancer

pain management: American Pain Society Quality of Care Task Force. Arch Intern Med. 2005;165(14):1574-1580.

7. 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.

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8. IONSYS (fentanyl iontophoretic transdermal system) 40 mcg*/ activation prescribing information. http://www.accessdata.fda.gov/ drugsatfda_docs/label/2006/021338lbl.pdf. Accessed January 9, 2012.

9. Cullen KA, Hall MJ, Golosinskiy A. Ambulatory surgery in the US, 2009. Natl Health Stat Report. 2009;11:1-25.

10. Centers for Disease Control and Prevention. Inpatient surgery. http://www.cdc.gov/nchs/fastats/insurg.htm. Accessed January 9, 2012.

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REPORT 12. Rawal N, Langford RM. Current practices for postoperative pain management in Europe and the potential role of fentanyl HCl iontophorectic transdermal system. Eur J Anaesthesiol. 2007;24(4): 299-308.

27. National Association of Public Hospitals and Health Systems (NAPH). HCAHPS survey: patients’ perspectives of care. October 2008. http://www.naph.org/Main-Menu-Category/Publications/ Quality/hcahpsbrief.aspx?FT=.pdf. Accessed January 9, 2012.

13. Carr DB, Goudas LC. Acute pain. Lancet. 1999;353(9169): 2051-2058.

28. Consumer Assessment of Healthcare Providers and Systems (CAHPS). CAHPS hospital survey quality assurance guidelines.

January 2008. http://www.hcahpsonline.org/files/HCAHPS%20 Quality%20Assurance%20guidelines%20version%203.0%20final. pdf. Accessed January 9, 2012.

14. Walder B, Schafer M, Henzi I, Tramer MR. Efficacy and safety of patient-controlled opioid analgesia for acute postoperative pain. A quantitative systematic review. Acta Anaesthesiol Scand.

2001;45(7):795-804.

15. Craft J. Patient-controlled analgesia: Is it worth the painful prescribing process? Proc (Bayl Univ Med Cent). 2010;23(4):434-438.

16. Dolin SJ, Cashman JN, Bland JM. Effectiveness of acute postoperative pain management: I. Evidence from published data. Br J Anaesth. 2002;89(3):409-423.

17. The Joint Commission. Sentinel Event Alert: Patient controlled analgesia by proxy. http://www.jointcommission.org/assets/1/18/ SEA_33.PDF. Accessed January 9, 2012.

18. Grass JA. Patient-controlled analgesia. Anesth Analg. 2005; 101(5 suppl):S44-S61.

19. Chang AM, Ip WY, Cheung TH. Patient controlled analgesia versus conventional intramuscular injection: a cost effectiveness analysis.

J Adv Nurs. 2004:46(5):531-541.

20. Etches RC. Patient-controlled analgesia. Surg Clin North Am. 1999;79(2):297-312.

21. Momeni M, Crucitti M, De Kock M. Patient-controlled analgesia in the management of postoperative pain. Drugs. 2006;66(18):2321-2337.

22. Kalia YN, Naik A, Garrison J, Guy RH. Iontophoretic drug delivery.

Adv Drug Deliv Rev. 2004;56(5):619-658.

23. Hutchison R, Chon E, Tucker W, Gilder R, Moss J, Daniel P. A comparison of a fentanyl, morphine, and hydromorphone patientcontrolled intravenous delivery for acute postoperative analgesia: a multicenter study of opioid-induced adverse reactions. Hosp Pharm. 2006;41(7):659-663.

29. Ready LB. Acute pain: lessons learned from 25,000 patients.

Reg Anesth Pain Med. 1999;24(6):499-505.

30. Sinatra RS, Torres J, Bustos AM. Pain management after major orthopaedic surgery: current strategies and new concepts. J Am Acad Orthop Surg. 2002;10(2):117-129.

31. Power I. Fentanyl HCl iontophoretic transdermal system: clinical application of iontophoretic technology in the management of acute postoperative pain. Br J Anaesth. 2007;98(1):4-11.

32. Rawat S, Vengurlekar S, Rakesh B, Jain S, Srikati G. Transdermal delivery by iontophoresis. Indian J Pharm Sci. 2008;70(1):5-10.

33. Data on file. Incline Therapeutics; 2012.

34. Institute for Safe Medication Practices. Beware of basal opioid infusions with PCA therapy. www.ismp.org/newsletters/acutecare/ articles/20090312.asp. Accessed January 9, 2012.

35. Meissner B, Nelson W, Hicks R, Sikirica V, Gagne J, Schein J. The rate and costs attributable to intravenous patient-controlled analgesia errors. Hosp Pharm. 2009;44(4):312-324.

36. Sathyan G, Zomorodi K, Gidwani S, Gupta S. The effect of dosing frequency on the pharmacokinetics of a fentanyl HCl patient-controlled transdermal system (PCTS). Clin Pharmacokinet. 2005; 44(1 suppl):17-24.

37. Mattia C, Coluzzi F. Acute postoperative pain management: focus on iontophoretic transdermal fentanyl. Ther Clin Risk Manag.

2007;3(1):19-27.

24. Murphy EJ. Acute pain management pharmacology for the patient with concurrent renal or hepatic disease. Anaesth Intensive Care.

2005;33(3):311-322.

38. Heitz JW, Witkowski TA, Viscusi ER. New and emerging analgesics and analgesic technologies for acute pain management. Curr Opin Anaesthesiol. 2009;22(5):608-617.

25. Hankin CS, Schein J, Clark JA, Panchal S. Adverse events involving intravenous patient-controlled analgesia. Am J Health Syst Pharm. 2007;64(14):1492-1499.

39. Gupta SK, Hwang S, Southam M, Sathyan G. Effects of application site and subject demographics on the pharmcokinetics of fentanyl HCl patient-controlled transdermal system. Clin Pharmacokinet. 2005;44(1 suppl):25-32.

26. Hicks RW, Heath WM, Sikirica V, Nelson W, Schein JR. Medication errors involving patient-controlled analgesia. Jt Comm J Qual Patient Saf. 2008;34(12):734-742.

40. Smith H, Bruckenthal P. Implications of opioid analgesia for medically complicated patients. Drugs Aging. 2010;27(5):417-433.

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

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

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Disclosures: Dr. Fanikos reported no relevant financial conflicts of interest. Dr. Huo reported that he is a consultant for Biomet, DePuy, and Stryker. He also serves on the speakers’ bureau for Cadence Pharmaceuticals and Janssen Pharmaceuticals, Inc. Dr. Viscusi reported that he is a consultant for AcelRx Pharmaceuticals, Inc., Cubist Pharmaceuticals, Cumberland Pharmaceuticals, Incline Therapeutics, Inc., Pacira Pharmaceuticals, Inc., and Salix Pharmaceuticals. He also serves on the speakers’ bureau for Cadence Pharmaceuticals, and reported receiving honoraria from Merck.