The May 2013 Digital Edition of General Surgery News by McMahon Group

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GENERALSURGERYNEWS.COM

May 2013 • Volume 40 • Number 5

The Independent Monthly Newspaper for the General Surgeon

Opinion

Doctor Group Claims Drug Purchasing Organizations Causing Chronic Shortages

It’s Not the Economy, Stupid B Y J ON C. W HITE , MD

he 1992 Clinton campaign headquarters had a poster on the wall stating, “It’s the economy, stupid.” This mantra, chanted by his staff for that entire campaign season, is thought to have been the strategy that convinced the U.S. electorate to choose a virtually unknown governor of a small, southern state over a popular, sitting president. The belief that the economy is all-important is shared by health care discussants who point to the increasing difficulties we have in financing our large and complicated industry. Most health care programs, such as

We have to take the long view and imagine new ways to train physicians. Obamacare and Romneycare, or health care strategies, such as fee for service, socialized medicine, managed care and medical savings accounts are just different ways of financing the same industry. I was one of those who had been seduced by the notion that our system would be fine as long as we figured out how to pay for it. The more I study the health care industry, however, the more I see that I was wrong and the industry is not fine. It has problems that are more serious than its high price tag. I am now convinced see NOT THE ECONOMY page 20

Assays Face Off On Breast Cancer Recurrence Risk BCI Outdoes Other Genetic Tests FFor Long-Term Prognosis

B Y T ED A GRES

rustrated d with ongoing shoortages of key drugs, a new grassroots group is calling for the repeal off federal leg-islation thaat permits grroup purchasing organizations (G GPOs) to engage in what they call collusive ll i and d anticompeti itive activities. Several senior U.S. lawmakers have asked the Government Accountability Office (GAO), the investigative arm of Congress, to look into the allegations that

B Y K ATE O'R OURKE

GPOs are at least partly responsible for the nation’s drug shortages. “We are convinced that the anticompetitive contracting and pricing see DRUG SHORTAGE page 10

SAN ANTONIO—The Breast Canceer Index (BCI, bioTheranosticcs) outperforms the Oncotype DX X Recurrence Score (RS; Genomic Heaalth) and the immunohistochemicall (IHC)4 in accurately predicting breeast cancer recurrence risk five to 10 yyears after a disease-free period, accord ding to the TransATAC (Arimidex, Tamoxifen, Alone or in Comid bination) study, presented by Dennis Sgroi, MD, director of breast pathology at Massachusetts General Hospital in Boston, at the San Antonio Breast Cancer Symposium (abstract S1-9).

SAGES Issues Recommendations On Endoluminal Therapies for GERD B Y M AUREEN S ULLIVAN

wo endoluminal treatments for gastroesophageal reflux disease (GERD) were the subject of a recent assessment by the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES). Published in February, the clinical spotlight review recommended Stretta (Mederi Therapeutics), a radiofrequency therapy,

as an appropriate option for patients who meet certain indications for GERD. However, the review committee found insufficient evidence to recommend EsophyX (EndoGastric Solutions), a device used for transoral incisionless fundoplication, as a treatment option.

The ATAC trial 10-year follow-up data demonstrated that late disease recurrence is a hallmark of estrogen receptor (ER)-positive breast cancer, with greater than 50% of recurrences occurring after five years of adjuvant tamoxifen or anastrozole therapy. TransATAC collected tumor blocks for biomarker assessment.

see ENDOLUMINAL page 8

see FACEOFF page 4

INSIDE Surgeons’ Lounge

In the News

Letters to the Editor

Coverage of the 24th Annual International Colorectal Disease Symposium

Antireflux Procedures Increase at Low-Volume Centers, Despite Worse Outcomes Than at HighVolume Centers

Preparedness of Surgical Graduates; Flawed Data on Ambulatory Surgery Centers

GSN Editorial

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MAY 2013

The Radiology Report: Help or Hindrance? Frederick L. Greene, MD, FACS Clinical Professor of Surgery UNC School of Medicine Chapel Hill, North Carolina

ome of the more seasoned readers of General Surgery Newss will remember a time when pathology reports resulting from colectomies, gastrectomies, hepatectomies, lobectomies or pneumonectomies, mastectomies and esophagectomies for malignancies were characterized by several pages of dictation that necessitated careful perusal just to discern the important findings regarding tumor extent, lymph node involvement, margin status, tumor size and other indicators that would reflect the completeness of the surgical resection and the need for possible additional therapy. Not only did these reports present a non-uniform approach to pathologic assessment, but the elements contained in these reports also would be very disparate when any quality indicators were applied. Several years ago, the American Joint Committee on Cancer, the cancer committee of the College of American Pathologists and the American College of Surgeonsâ&#x20AC;&#x2122; Commission on Cancer (COC) Accreditation Program spearheaded a unified effort to introduce a synoptic and an element-specific strategy for pathology reports that reflected findings after operative resection in adult patients with cancer. This standardized approach to

pathology reporting has been dissem- The need for a unified reports (MRI, computed tomograinated and is now required as a qualphy, positron emission tomography, methodology and ity benchmark for the approximately ultrasound, etc.) obviously requires a synoptic approach 30% of hospitals in the United States national and an international stratthat are accredited by the COC. egy and the engagement of surgical, ... is especially Using the success realized in the oncologic and radiologic organizadesirable in the approach to pathology reports, the tions and accrediting bodies (Amertime has come to develop a similar ican College of Radiology, COC). era of neoadjuvant strategy for imaging reports, especialThose of you who manage patients treatment. ly relating to the patient with cancer. I with solid malignancies also can am sure you would agree that current accomplish a great deal toward this reports by our radiology colleagues goal on the local level through ongoreflect a wide spectrum of helpfulness and inclusivity of ing dialogues with radiology colleagues when reviewpertinent features that are essential for diagnosis, multi- ing imaging in the radiology suite, at multidisciplinary disciplinary discussions and eventual surgical treatment treatment planning sessions and traditional tumor conplanning. The need for a unified methodology and syn- ferences. Continue to stress the importance of includoptic approach to these reports is especially desirable ing all the elements needed and the benefit of reporting in the era of neoadjuvant treatment for cancers of the these in a synoptic fashion just as our pathologists are rectum, pancreas, esophagus, breast, liver and head and currently doing. Additionally, we also can begin a critneckâ&#x20AC;&#x201D;sites where accurate assessment and complete ical review of imaging reports by our hospital cancer reporting are critical to eventual surgical management. committees to assess the completeness and readability A recent report (Ann ( Surg Oncoll 2013,20:1148-1155) of these missives at our own institutions. indicated that only approximately 40% of magnetic resJust as surgical, pathology and multidisciplinary onance imaging (MRI) reports contain complete infor- cancer organizations effected the improved quality of mation regarding nodal assessments, circumferential cancer-related pathology reports, we need to begin a resection margin information and the clinical T catego- concentrated effort to assure that oncologic imaging is ry of the primary rectal tumorâ&#x20AC;&#x201D;elements that are crit- meaningful and that the reports generated from these ical in the management of patients with rectal cancer. studies are complete, readable and relevant for us and The realization of a synoptic format for imaging for our patients with cancer.

Senior Medical Adviser Frederick L. Greene, MD Chapel Hill, 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

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INFECTIOUS DISEASE SPECIAL EDITION

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MAY 2013

Poor Results Achieved With Fecal Transplantation for Ulcerative Colitis B Y D AVID W ILD

nly one of five patients with moderate to severe ulcerative colitis (UC) who were treated with fecal transplantation (FT) experienced clinical and endoscopic improvements following the procedure, according to an abstract presented at the 2012 United European Gastroenterology Week (abstract P374). Lead investigator Walter Reinisch, MD, associate professor in the Division of Gastroenterology and Hepatology at the Medical University of Vienna, Austria, conducted the procedure in two women and three men with moderate to severe UC who were resistant to previous other treatments. All participants were undergoing immunosuppressant therapy before FT and discontinued treatment before transplantation. All patients received antibiotics and probiotics for five to 10 days before the procedure and underwent a single bowel lavage immediately before transplantation. Healthy adult fecal donors were screened for enteric pathogens and viral diseases. Dr. Reinisch simultaneously administered a salinediluted fecal solution via a nasojejunal tube (median 23.8

FACEOFF

jContinued from page 1 Previous analyses have shown that RS and IHC4 (ER, progesterone receptor, HER2 and Ki67) predict overall recurrence risk in the TransATAC cohort, beyond the Clinical Treatment Score (CTS), an algorithm consisting of nodal status, tumor size and grade, age and treatment. In the new TransATAC study, researchers evaluated whether BCI adds prognostic information to clinical variables in predicting distant recurrence in ER-positive, lymph node–negative patients with primary breast cancer. The test stratifies patients into three risk groups and combines two independently developed biomarkers: HOXB13:IL17BR gene expression ratio, which is both prognostic and predictive for extended adjuvant hormone therapy, and the molecular grade index, a set of cell cycle–related genes that predicts distant recurrence beyond tumor grade. The study cohort included 665 primary tumor samples. At 10 years of follow-up, BCI distinguished three risk groups with a 10-year rate of distant recurrence of 4.2% in the low-risk group, 18.3% in intermediaterisk patients and 30% in the high-risk group. “In analyzing the comparative prognostic performance over the same time frame [0 to 10 years], one sees that BCI, IHC4 and the recurrence score demonstrate highly significant prognostic performance,” said Dr. Sgroi. “BCI and IHC4 provided equivalent prognostic information and both biomarkers provide greater prognostic information

g) and an enema (median 20 g). All of the patients experienced fever, increased C-reactive protein (CRP) levels and exacerbated UC symptoms during the first procedure, and one recipient also experienced emesis. The procedure was repeated over three consecutive days in all but one patient, whose fever and increases in CRP levels were more severe and required discontinuation of treatment until five weeks after initial administration. During the follow-up period, adverse events included upper respiratory tract viral infection, pruritus, erythema, paresthesia of the hip, fainting and tongue blistering. There was no evidence of bacterial pathogens in blood cultures, Dr. Reinisch reported, and hydrogenglucose breath tests showed that none of the patients had small bowel bacterial overgrowth. Twelve weeks after FT, clinical disease activity had worsened in two patients. The Mayo Scoring System for Assessment of UC Activity showed a decrease in median scores from 11 at baseline to 9 among the three patients who did not experience clinical disease flares and who completed the protocol. One patient experienced a Mayo endoscopic subscore change from 3 to 2.

“Although plenty of donor-derived bacteria were established in all of the patients, successful colonization by beneficial bacteria, such as Faecalibacterium prausnitzii, was achieved only in the one patient who had a good clinical response,” Dr. Reinisch noted. His group is investigating whether patients with milder UC experience a more favorable response to FT, citing positive findings from a case series that included six patients with a less aggressive form of UC (J ( Clin Gastroenterol 2003;37:42-47). Lawrence Brandt, MD, professor of medicine and surgery at Albert Einstein College of Medicine, and emeritus chief of the Division of Gastroenterology at Montefiore Medical Center, both in New York City, did not see similar outcomes in 22 patients with UC that he treated with FT. “I haven’t analyzed data from my patients but my impression is that some respond very well to FT,” he said. “Now the challenge is to discover who and why. There is so much variability in how FT is done, and so much detail was left out of this abstract, that it is difficult to say why the results were poor.”

Table 1. Multivariate Analysis of Prognostic Performance: Early Recurrence (Years 0-5) Likelihood Ratio Statistic

P Value

Breast Cancer Index

15.4

<0.0001

IHC4

28.8

<0.0001

Recurrence Score

18.2

<0.0001

Table 2. Multivariate Analysis of Prognostic Performance: Late Recurrence (Years 5-10) Likelihood Ratio Statistic

P Value

Breast Cancer Index

0.0005

IHC4

1.6

0.2

Recurrence Score

0.5

than the recurrence score.” Dr. Sgroi said recurrence information is valuable in two time frames. The early recurrence time frame is at diagnosis, when one is considering using adjuvant hormone therapy alone or in combination with other systemic therapy. The late recurrence time frame is at five years postdiagnosis, when one is considering extending adjuvant therapy for patients who are disease-free after five years of hormonal therapy. BCI identified two early recurrence risk groups. The first group, 83% of the cohort, consisted of BCI low- and intermediate-risk patients who had an average five-year rate of distant recurrence of less

than 4%. The second group consisted of BCI high-risk patients with a five-year rate of distant recurrence of 18.1%. BCI identified two late recurrence risk groups. The first, 61% of the cohort, consisted of BCI low-risk patients who had a five-year rate of distant recurrence of 3.5%. The second group consisted of intermediate-/high-risk patients who had an average rate of distant recurrence of 13.5%. BCI was a significant prognostic factor beyond CTS for prediction of late distant recurrences (Tables 1 and 2). “In the early recurrence time frame, all three biomarkers demonstrate highly significant prognostic performance in a multivariate analysis adjusted for

the Clinical Treatment Score,” said Dr. Sgroi. “However, when we compared the performance in the late recurrence time frame. … BCI demonstrates sustained prognostic performance in a multivariate analysis, whereas IHC4 and the RS lose their prognostic ability.” A patient with an intermediate BCI score will do well in the first five years with adjuvant hormone therapy, Dr. Sgroi said, but should be considered for extended adjuvant therapy at that point. Mathew Goetz, MD, a medical oncologist and an associate professor of oncology and pharmacology at Mayo Clinic in Rochester, Minn., said the three tests provide different information, with BCI providing “better information in years 5 through 10.” He said the test has been validated in multiple data sets, including the MA.17 trial. From a clinician standpoint, he continued, the lymph node– negative, ER-positive patients are the ones in whom clinicians are least likely to use extended adjuvant hormone therapy, and identifying a high-risk subset in this group in years five through 10 is novel. “I would consider using this test in lymph node–negative, ER-positive patients that have completed five years of tamoxifen,” said Dr. Goetz. He pointed out, however, that many community oncologists are using aromatase inhibitors earlier on, and studies have not defined the benefit of extending aromatase inhibitor therapy in this group. “If we have additional data demonstrating that 10 versus five years of aromatase inhibitors is beneficial, this will really extend the potential ability of this test at that point,” he said.

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In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MAY 2013

As Number of Endoscopies Rise, Deaths From Upper GI Bleeds Drop No Causal Link, But Wider Use of Endoscopy Thought To Play Role B Y D AVID W ILD LAS VEGAS—The past two decades have seen a 50% drop in the number of deaths due to upper gastrointestinal hemorrhage (UGIH), with a coinciding increase in inpatient endoscopies in those individuals, according to epidemiologic findings presented at the 2012 American College of Gastroenterology annual scientific meeting (abstract 2). Although the researchers could not establish a causal link between the two variables, they believe that wider use of diagnostic and therapeutic inpatient endoscopies, along with improved UGIH-specific medical treatment, has played a substantial role in lowering rates of UGIH-related mortality. Sravanthi Parasa, MBBS, an expert in UGI bleeding, of the Department of Internal Medicine at the University of Kansas Medical Center, Kansas City, believes that gastroenterologists and endoscopists should pride themselves on heading off inpatient deaths among

Table. Trends in UGIH-Related Mortality, Endoscopy Use 1989

1994

1999

2004

2009

Mortality among inpatients with UGI hemorrhage

4.69%

3.34%

2.93%

2.43%

2.13%

Total inpatient endoscopy rate

69%

80%

85%

86%

85%

Therapeutic endoscopies as a percentage of total inpatient endoscopies

18%

22%

23%

27%

UGIH, upper gastrointestinal hemorrhage

individuals with UGIH. “This is a very strong study and the findings are reliable, especially because the data were drawn from a nationally representative and validated database,” said Dr. Parasa, who was not involved in the research. Marwan Abougergi, MD, and John Saltzman, MD, researchers in the Division of Gastroenterology at Brigham and Women’s Hospital, Harvard Medical School, in Boston, analyzed information from the Nationwide Inpatient Sample (NIS) collected between 1989 and 2009, dividing the data into five-year intervals. They used International Classification of Diseases (ICD)-9 codes to identify primary diagnoses of UGIH. Their analysis revealed the incidence of UGIH began decreasing in 1994, from 83 cases per 100,000 Americans in that

year to 78 cases per 100,000 Americans in 2009. Rates of inpatient mortality among UGIH patients also dropped, from 4.69% in 1989 to 2.13% in 2009 (Table). The combined use of diagnostic and therapeutic endoscopy increased from 69% to 85% over the study period. As a proportion of all inpatient endoscopies, the percentage of therapeutic endoscopies rose dramatically, from 2% of all UGIHrelated inpatient endoscopies in 1989 to 27% in 2009, they found. Dr. Abougergi also reported the proportion of endoscopies performed within 24 hours of admission increased from 23% in 1989 to 54% in 2009. This might partially account for the drop in hospital lengths of stay from 4.52 days in 1989 to 2.85 days in 2009, he said. One finding that surprised the researchers was that, despite the shorter hospital

stays, the average inflation-adjusted cost of treating a patient with UGIH has risen sharply, from $9,249 in 1989 to $20,370 in 2009. “Although we are not sure why this is, we think it reflects the general increase in per-day hospitalization charges,” Dr. Abougergi said. “Those can be driven by charges for room and board, or charges for the increasingly more costly medications used during treatment, among others.” Dr. Parasa observed that Charlson comorbidity index scores in the analysis increased, from 0.68 in 1989 to 0.93 in 2009. “The results are particularly impressive given that rates of UGIH-related deaths have dropped, despite an increased number of comorbidities,” she said.

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MAY 2013

ICU Checklist May Help Avoid Unplanned Readmissions B Y K AREN B LUM

hen used correctly, a checklist to guide the transfer of patients between the operating room and the ICU can help eliminate unplanned readmissions, Minnesota researchers have found. In a small quality improvement project, Nathan Smischney, MD, a Mayo Clinic Scholar in the Department of Anesthesiology at the Rochester institution, and colleagues set out to develop a tool to address the communication gap between the surgical ICU and the wards. They reviewed medical records from June to October 2011, identifying risk factors for ICU readmission and queried surgical teams in the ICU and receiving teams on the orthopedic, vascular and thoracic services about what they would like to know about incoming patients. The researchers developed a checklist and incorporated it into daily rounds. The checklist featured seven items addressing the clinical plans for pain, delirium, arrhythmias, respiratory support, antibiotics, diuretics, blood products, anticoagulation, antihypertensive management and any nursing concerns. The template was placed in charts accompanying patients to their new units. Dr. Smischney’s team then monitored use of the tool over a five-week period in 2012 and distributed surveys to the receiving hospital floor services to measure the quality of sign-out. The tool was used for 42 of the 141 dismissals during that period (a 30% compliance rate). The researchers identified 17 unplanned readmissions; in none of these cases did the team use the checklist. A preimplementation survey indicated a fairly high understanding of the care plan; a postimplementation survey demonstrated improved communication when the checklist was used. Dr. Smischney presented the findings at the 2013 Annual Congress of the Society of Critical Care Medicine (abstract 163). “It could be considered statistically significant and clinically important regarding a meaningful outcome benefit, however, a cause-and-effect relationship is hard to ascertain due to the small sample size and low compliance rate,” Dr. Smischney told General Surgery News. The low compliance resulted mainly because residents thought it was too long, he said. Still, “the surgical teams were very excited about it, as were we,” Dr. Smischney said. “It created a lot of enthusiasm in the ICU and in the surgery

department, and that’s the reason for continuing its use.” The checklist is being reformed by a group of fellows to shorten it to the most essential components for ICU staff and receiving surgical teams, he said. Eugenie Heitmiller, MD, associate professor of anesthesiology and pediatrics, and vice chair for clinical affairs

at Johns Hopkins School of Medicine, in Baltimore, called the checklist a “helpful communication tool” despite its inconsistent use. “If they study the checklist on u a larger scale with a larger sample ssize, it may very well be shown to be effective.” Dr. Heitmiller, a panelist in a workshop on implementing checklists at the Society for Pediatric Anesthesia’s annual meeting in October 2012,

said that to fully implement a checklist, the physicians and nurses who will use it most must embrace the document. It must be user-friendly, easily available and widely disseminated. “If someone sees this as not worthwhile, they’re not going to use it,” she said. “Checklists are good reminders,” Dr. Heitmiller added. “Even when you do same thing over and over, you can forget something or get distracted. But you have to have it handy.”

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In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MAY 2013

ENDOLUMINAL

jContinued from page 1 The process entailed a comprehensive review and analysis of the available literature on the topic. The clinical evidence to support Stretta achieved the highest possible grade (++++) of SAGES’ four-tier grading system and was conferred a “strong” recommendation. “It is extremely gratifying to have a scientific analysis of the overwhelming body of clinical evidence supporting Stretta issued by an esteemed organization such as SAGES,” said Will Rutan, CEO of Mederi Therapeutics, in a statement. “The grade of ‘strong’ indicates that no further studies are necessary to validate Stretta as a safe and effective treatment for GERD.” The Stretta system treats GERD using radiofrequency ablation to remodel the musculature of the lower esophageal sphincter (LES) and gastric cardia (Figure). According to the review, clinical studies show that the treatment results in “significant reductions in tissue compliance and transient LES relaxations. These mechanisms act to restore the natural barrier function of the LES as well as to significantly reduce spontaneous regurgitation caused by transient inappropriate relaxations to the sphincter.” In its literature review, SAGES cited four randomized controlled studies, a meta-analysis, multiple prospective trials and more than 30 peer-reviewed studies that supported the efficacy and safety of Stretta. They found that treatment outcomes lasted at least 48 months and led to a significant reduction or elimination of the medications required to treat GERD and improvements in quality of life, as measured by the GERD Health-Related Quality of Life scale and Quality of Life in Reflux and Dyspepsia questionnaire. Stretta was recommended as a treatment option for patients over the age of 18 years who have experienced symptoms of regurgitation or heartburn (or both) for more than six months and who have been “partially or completely responsive to antisecretory pharmacologic therapy.” As the SAGES review made clear, making recommendations on a particular therapy does not exclude other options that may be better suited to a particular patient’s needs: “[The recommendations] indicate the preferable, but not necessarily the only acceptable approaches, due to the complexity of the health care environment.” This point was reiterated in a press release by Mederi

In its review of EsophyX, SAGES assigned a low (++) quality-of-evidence rating and a “weak” recommendation, as it concluded that not enough long-term data were available to support its use and several studies reported mixed results including “disappointing outcomes” and “significant untoward events.” “I agree with the recommendation,” Dr. Fass said. “They were cautious because of a lack of long-term trials. One problem with previous endoscopic treatments for GERD that aren’t on the market anymore is that they didn’t demonstrate long-term efficacy.” EsophyX is based on the technique of transoral incisionless fundoplication, which was first approved by the FDA in 2007. Once the device is placed endoscopically, it is deployed in the stomach and “used to creFigure. Stretta delivers low-power, low-temperature radiofrequency ate a full-thickness plication secured energy to remodel the lower esophageal sphincter at the junction of by H-shaped fasteners made from the esophagus and the stomach. polypropylene.” The device underPhoto: PRNewsFoto/Mederi Therapeutics Inc. went a number of revisions: The first technique used the TIF1 device that created a gastrogastric wrap at the gasTherapeutics, which stated that “Stretta therapy does troesophageal junction; according to the review, “critics not preclude further steps with more invasive proce- likened it to a slipped fundoplication.” The TIF2 device dures, if indicated.” was subsequently developed to more closely replicate Furthermore, Stretta is not approved for use in pedi- laparoscopic fundoplication. atric patients, either by its manufacturer or the FDA, The SAGES review stated that “in short-term foland SAGES did not recommend it for treating patients low-up, from six months to two years, EsophyX may with severe esophagitis, hiatal hernias greater than 2 cm be effective in patients with a hiatal hernia of 2 cm in length, long-segment Barrett’s esophagus, dysphagia with typical or atypical GERD,” but long-term studor for those with a history of autoimmune disease, col- ies are needed to “further evaluate device and techlagen vascular disease and/or coagulation disorders. nique safety.” Asked to comment, Ronnie Fass, MD, director “This type of technique should not filter down too of gastroenterology and hepatology and head of the quickly to practicing gastroenterologists or surgeons,” Esophageal and Swallowing Center at MetroHealth Dr. Fass said. “It is better that it stays in expert hands, Medical Center in Cleveland, said, “From the data we for example, esophageal centers, which will ensure that currently have … this technique seems to work, as long those who receive these types of procedures are going as the correct patient population is selected for treat- to be properly evaluated, that they are the right candiment. Stretta can be done successfully by practicing dates. [The health care professionals] who should be gastroenterologists because it is not as complicated as involved are those who have expertise and do enough EsophyX. Still, the patient population that undergoes of these procedures on a regular basis to keep their skills Stretta should be carefully selected and [should be made at a level that will ensure long-term efficacy and prevent aware] that it is nonreversible.” future complications.”

Worse Outcomes for Brachytherapy Than Whole Breast Irradiation B Y G EORGE O CHOA

retrospective, population-based, cohort study in older women has found evidence that brachytherapy is associated with poorer longterm breast preservation and increased complications than whole breast irradiation (WBI), although there is no difference in survival. In the study, published in JAMA (2012;307:1827-1837), the authors, led by Grace L. Smith, MD, PhD, MPH, of the University of Texas MD

Anderson Cancer Center in Houston, used Medicare patient data from 92,735 women aged 67 years or older diagnosed with invasive breast cancer from 2003 to 2007, who ho were treated with lumpectomy follow wed by radiation therapy. After lum mpectomy, 6,952 patients were treated with brachytheerapy and 85,783 with WB BI. Brachytherapy waas associated with a higher risk for subsequent mas-tectomy, with a five-yeaar

cumulative incidence of 3.95% (95% confidence interval [CI], 3.19%4.88%) compared with 2.18% (95% CI, 2.04%-2.33%) in patients who received WBI (P (P<0.001). Brrachytherapy was also associated with higher risks for infectious and noninfectious postoperativve complications within one year of lumpectomy (brachytherapy,, 27.56% vs. WBI, 16.92%; Interrstitial using needles Source: www.aboutbrachytherapy.com

P<0.001). Brachytherapy was also associated with a higher risk for complications within five years of radiation (brachytherapy, 24.96% vs. WBI, 18.80%; P<0.001). Five-year overall survival was similar in both groups: 87.66% (95% CI, 85.94%-89.18%) of patients treated with brachytherapy compared with 87.04% (95% CI, 86.69%-87.39%) of those treated with WBI (P=0.02), a difference that did not persist after multivariable adjustment (HR, 0.94; 95% CI, 0.84-1.05; P=0.26).

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DRUG SHORTAGE jcontinued from page 1

practices, kickbacks and self-dealing of hospital GPOs are the root cause of this public health emergency,” said anesthesiologist Robert A. Campbell, MD, co-chair of the new group, Physicians Against Drug Shortages (PADS). “We’re launching a national campaign to build public awareness of these anticompetitive practices and press Congress to halt them,” said Dr. Campbell, who also is vice president of the Pennsylvania Society of Anesthesiologists and a state delegate to

the American Society of Anesthesiologists (ASA). Dr. Campbell described PADS as “a small group of physicians who met at the recent ASA meeting. After a totally unsatisfactory panel on drug shortages, we chose to exchange emails and explore an economic explanation for drug shortages. Our solution will save at first $35 billion per year in health care costs. Once competitive forces are restored in the health care supply chain, even more savings will be realized.” Any attempt to link GPOs to drug shortages is an “irresponsible and

dangerous distraction,” countered Curtis Rooney, president of the Healthcare Supply Chain Association (HSCA), a trade association representing 14 GPOs, including the nation’s five largest. “The true cause of drug shortages is manufacturing problems, disruptions and barriers to entry in getting new suppliers online when there is a disruption in supply. The fact is that GPOs are taking a variety of creative and innovative steps to reduce drug shortages,” Mr. Rooney said. GPOs negotiate contracts with manufacturers and vendors of pharmaceuticals and other medical products on behalf of

‘We are convinced that the anticompetitive contracting and pricing practices, kickbacks and self-dealing of hospital GPOs are the root cause of this public health emergency.’ —Robert A. Campbell, MD

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their customers, typically hospital groups and other large health care organizations. About 72% of all hospital purchases are made through GPO contracts. GPOs leverage their collective purchasing power in order to keep costs low for their customers. Vendors pay GPOs “administrative” fees, typically based on a percentage of sales and capped by law at 3%. GPOs have been allowed to collect these fees since 1986 through a “safe harbor” provision added to the Social Security Act’s Anti-Kickback statute, which would otherwise prohibit the practice. “By exempting GPOs from criminal prosecution for taking kickbacks from vendors, [the exemption] has given rise to monumental conflicts of interest and perverse incentives that have undermined competition and innovation and inflated costs in the health care supplies, devices and generic drug marketplace— with tragic consequences,” said Phillip L. Zweig, MBA, executive director of PADS. Mr. Zweig worked for medical device companies between 1999 and 2008 but no longer has financial ties to the industry. His current work with PADS is pro bono, he said. “Our goal is to end the generic drug shortage crisis by restoring integrity and free market competition to ... the entire U.S. health care supplies industry,” Mr. Zweig said. “To accomplish that, we’re pushing for the repeal of the Medicare anti-kickback safe harbor provision, which created the GPO ‘pay to play’ scheme in the first place. As a result of this misguided legislation, the GPOs now exert a stranglehold on the entire hospital supplies marketplace. They’ve rigged the market. PADS intends to end their reign of terror.” PADS, Mr. Zweig added, does not want to abolish GPOs, but rather return them to the pre–safe harbor system—“which

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MAY 2013

we need to look at the role GPOs play in the occurrence of drug shortages that could lead to increased reliance on compounding pharmacies,” Mr. Markey said in a statement. Expert practitioners and academics concurred. “This broken generic drug market, which is the direct consequence of unethical GPO drug purchasing contracts legalized by Congress, must be fixed immediately,” said Joel B. Zivot, MD, medical director of the cardiothoracic intensive care unit at Emory University Hospital, in Atlanta, in a statement. “GPOs are a major, if not the primary,

contributor to the market distortions in the health care industry in the United States,” added S. Prakash Sethi, PhD, university distinguished professor at Baruch College, in New York City. “Through exclusive contracting, which has given GPOs effective monopolistic control of this industry, they have contributed to product shortages and disincentives for legitimate producers to manufacture and stock essential drugs. At the same time, they have given rise to unscrupulous manufacturers to produce and market substandard drugs and thereby expose the patient population to serious health risks.”

But Thomas G. Moore, president of Hospira Inc., blamed shortages of injectable drugs on manufacturing problems and disputes any link between drug shortages and the meningitis outbreak or between drug shortages and GPOs. “The practice of hospitals contracting with a GPO in order to aggregate their purchasing power is not a factor in drug shortages,” Mr. Moore wrote in a Nov. 19, 2012, letter to the lawmakers. “It has been Hospira’s experience that GPOs do not limit the manufacturers who can contract with the GPO, especially in the circumstance of a drug shortage.”

Introducing

at th oo 3 r b 01 ou R 2 5 sit W 30 Vi A #

worked fine from the early 1900s to the early 1990s.” But Phil Johnson, oncology director at Premier Inc., the nation’s second largest GPO by purchasing volume, said the accusation that GPOs have eliminated free market forces is “uninformed and wrong.” “In fact, GPOs encourage the free market by competitive bidding and multiple rewards for the best supplier performance,” Mr. Johnson told General Surgery News. “Consider that Premier represents approximately 2,700 hospitals and more than 90,000 non-acute sites. Our members determine the acceptable drugs or medical supplies within a therapeutic category, and Premier obtains strong contracts ensuring multiple vendors and product choices. With GPOs, the best drugs within the category, as determined by our member providers—physicians and pharmacists—develop strong contracts with competitive pricing.” But a June 2012 report by the House Committee on Oversight and Government Reform concluded that GPOs have contributed to the current shortage of generic injectable medications because of pressures that the purchasing organizations exert on manufacturers and suppliers. “Companies that cannot produce a drug at large enough output levels to take advantage of the economies of scale—often because they lack the guaranteed source of demand that GPOs provide—will stop producing the drug or will neglect to enter the market,” the House report stated. The controversy surrounding GPOs is not new. Over the years, hospital systems have claimed that GPOs have saved them billions of dollars annually in purchasing costs, while lawmakers and others have worried about the anticompetitive or unethical practices of GPOs. The GPO industry has adopted voluntary codes of conduct and since 2005, many companies have participated in an annual survey of their contracting practices. In November 2012, six senior members of the House of Representatives asked the GAO to investigate whether GPOs are a “driving cause” of drug shortages. The lawmakers—Democrats Edward J. Markey (Mass.), John Dingell (Mich.), Frank Pallone (N.J.), Diana DeGette (Colo.), and Henry A. Waxman and Anna G. Eschoo (Calif.)—also said that shortages of critical drugs have forced hospitals and other providers to rely on unregulated compounding pharmacies, such as the New England Compounding Center, the Framingham, Mass., firm that has been blamed for last year’s deadly outbreak of fungal meningitis and other infections caused by contaminated epidural steroid injections. “As Congress fully investigates all the causes of the tragic meningitis outbreak in an effort to protect patients in the future,

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Coverage of the 24th Annual International Colorectal Disease Symposium All articles by Yaniv Cosacov, Clinical Fellow, Minimally Invasive and Bariatric Surgery, Cleveland Clinic Florida

Dear Readers, Welcome to the May issue of The Surgeons’ Lounge. Here we feature the first of a twopart series that covers highlights from the 24th Annual Jagelman/34th Annual Turnbull International Colorectal Disease Symposium, hosted by Steven Wexner, MD, from Cleveland Clinic Florida in Weston and Feza Remzi, MD, from Cleveland Clinic. It is always our pleasure to bring you annual updates in the diagnosis and treatment of colorectal diseases from

A Message From the Symposium Director Steven D. Wexner, MD, PhD (Hon), FACS, FRCS, FRCS(Ed) Professor and Chair, Department of Colorectal Surgery Cleveland Clinic Florida, Weston

It is with great pleasure that we present to you a recap of some of the highlights of our recent 24th Annual David G. Jagelman/34th Annual Rupert B Turnbull International Colorectal Disease Symposium that was held at the Marriott Harbor Beach Hotel in Fort Lauderdale, on February 12-17, 2013. Almost 100 lectures were delivered by more than 60 internationally acclaimed faculty. The presentations we have selected represent some of the highlights of the most innovative, controversial and current challenges in colorectal surgery. We wish to thank all of the faculty who participated in our recent course, and in particular to thank the speakers who have taken additional time to contribute to The Surgeons’ Loungee column. As always, we wish to thank Samuel Szomstein, MD, FACS, the column’s editor and Frederick L. Greene, MD, FACS, senior medical adviser of General Surgery News, for allowing us to highlight some of the features of our course in this column. We are in the final stages of completing the program for the silver anniversary (25 years) of the Annual David G. Jagelman /35th Annual Rupert B Turnbull International Colorectal Disease Symposium. This landmark event will be held on February 11-15, 2014, again at the Marriott Harbor Beach Hotel in Fort Lauderdale, Fla. We look forward to seeing all of the readers of General Surgery Newss at this event. In exchange, we can promise you an absolutely unforgettable educational experience, courtesy of the high-quality faculty who will be with us at that time.

the leaders in this field. Stay tuned for the second half of this coverage that will appear in the June issue. Sincerely, Samuel Szomstein, MD, FACS Editor, The Surgeons’ Lounge Szomsts@ccf.org Dr. Szomstein is associate director, Bariatric Institute, Section of Minimally Invasive Surgery, Department of General and Vascular Surgery, Cleveland Clinic Florida, Weston.

Assessment of Technical Competency In Surgery Eric J. Dozois, MD, professor of surgery and program director, Department of Colon and Rectal Surgery at Mayo Clinic in Rochester, Minn., discussed the importance of assessing surgical competency. In the original charter of the Royal College of Surgeons of 1582, it was declared that “no matter of person shall employ our said craft of surgery unless he be worthy and expert in all the subjects belonging to these said crafts and be diligently and advisedly examined.” Thus, the question is: Are we properly assessing, among all areas of qualification and certification, the technical ability of the surgeon? Currently in the United States, once a resident is signed off by the program director, he or she can either go directly into practice or complete a fellowship to become eligible for board certification in a specific surgical specialty. This traditional assessment of technical competency is not objective, and is conducted only through observation. It is not considered valid or reliable. Given that technical expertise is a cornerstone to successful care of patients in the surgical profession, are surgeons comfortable with the current process? Is a better training model needed? Furthermore, should this be in the certification or recertification pathway? How can we do it better? Several approaches to the assessment of technical competency have been evaluated. The most recognized approach is the Objective Structured Assessment of Technical Skills (OSATS), which was developed at the University of Toronto, in Canada, in the mid-1990s. It consists of a “task-specific checklist tool” and a “global rating scale” for assessing performance. This method was found to be valid and reliable to assess technical skills in trainees. The OSATS includes

several operative competency scores: respect for tissues, time and motion, instrument handling, suture handling, flow of operation and final outcome. Other tools that have been developed include the Global Rating Index for Technical Skills (GRITS), the Operative Performance Rating Scale (OPRS) developed by a group at Southern Illinois University, the Hopkins Assessment of Surgical Competency (HASC), and specific Procedure Based Assessments (PBA), which is popular in Europe. All of these tools have focused on objective assessment of technical skills. These assessments take place in either the operating room or a simulated surgical environment. The quality of the tools discussed has been studied, and in a recent review in the British Journal of Surgery, the validity and the reliability of objective methods for technical skills assessment within surgery and gynecology were reported. A total of 104 assessments were included, and 27 consisted of intraoperative evaluation while the rest were simulation-based assessments. Virtual reality and OSATS were the most studied. The conclusion was that most of the tools were valuable for feedback and measuring progress of training, but few could be used for examinations or credentialing. OSATS was the most standardized and validated assessment. The American Board of Colon and Rectal Surgery (ABCRS) has set a goal, to be accomplished over the next five years, to move away from “case numbers” as the marker of technical proficiency and instead use direct, “validated” skills assessment tools to define candidates’ technical competency. The goal is to determine if a single assessment tool could be used for certifying colorectal trainees.

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Laparoscopic Ventral Rectopexy for Rectal Prolapse Syndromes Professor Andre D’Hoore discussed his experience at the University Hospital Gasthuisberg in Leuven, Belgium, for the treatment of rectal prolapse syndromes using the laparoscopic approach for ventral rectopexy. External or internal rectal prolapse and rectocele are the most difficult clinical problems in colorectal surgery. Symptoms vary from obstructive defecation to fecal incontinence, resulting from chronic sphincter damage. Several surgical procedures have been developed in an attempt to restore these conditions. To date, the surgical community has not yet accepted a standard method, although abdominal rectopexy is considered superior to perineal or transanal approaches because of lower recurrence rates and better functional outcomes. However, the induction or worsening of postoperative constipation was observed as the most common side effect of rectopexy. An inherent step in classic rectopexy is the full mobilization of the rectum. Autonomic nerve injury during extensive posterolateral rectosigmoid mobilization may lead to postoperative dysmotility and impaired evacuation. In contrast, transanal partial rectal resection or plication may induce or worsen incontinence. Laparoscopic ventral rectopexy (LVR) using a polypropylene mesh has been introduced to combine the good functional outcome of the abdominal procedure while avoiding both postoperative constipation and incontinence. In a study between January 1999 and December

A pilot study has been designed by members of the ABCRS’ Operative Competency Evaluation Committee to answer whether a reliable and valid objective assessment of colorectal technical skills could be developed, and to evaluate whether an examination could have the ability to discriminate between candidates based on level of training. The study entitled “A Novel Approach to Assessing Technical Competence of Colorectal Surgery Residents: The Development and Evaluation of the Colorectal Objective Structured Assessment of Technical Skills (COSATS)” will be published in Annals of Surgeryy later this year. The study included an eightstation examination of 20 trainees, 10 general surgery residents and 10 colorectal surgery residents. The trainees were examined using a task checklist from the global rating scale. The analysis found that an overall checklist and global rating scores effectively discriminated resident groups. The colorectal surgery residents significantly outperformed general surgery residents in all eight stations. With a pass/fail assessment, nine out of 10 colorectal surgery residents passed compared with three out of 10 general surgery residents. The results were very encouraging, and as a result, a pilot study is in progress where an examination of skills is performed as part of the certification process. Dr. Dozois concluded that the current method of evaluating technical skills only at the completion of training can serve no longer, and if the goal of certification is to ensure that a surgical candidate is competent in all aspects of the surgical profession, it is time to include technical skills assessment as part of surgery credentialing.

Figure 2. The deepest part of the fold of Douglas is retracted and incised. The rectovaginal septum is opened without any lateral dissection.

Figure 1. Dissection starts at the sacral promontory with preservation of the right hypogastric nerve. The caudal extension of the peritoneal incision follows the dotted line. 2008, 405 patients underwent LVR for rectal prolapse syndromes. The median age of participants was 55 years (range, 16-88) and 93% of patients were women. More than 41% (n=168) had undergone previous pelvic surgery, of which 39% were hysterectomies. In 27 patients (6.7%), LVR was performed for recurrent rectal prolapse. Data concerning operative difficulties and conversion, postoperative morbidity, and recurrence were gathered from a prospective database. The mean follow-up was 25 months (range, 6-143). An extensive, institutional questionnaire that assessed symptoms of anorectal and sexual dysfunction was used. Nearly half of the patients suffered from internal rectal prolapse (45.9%; n=186). Other indications were total rectal prolapse (43%; n=174) and isolated rectocele and/or enterocele (11.1%; n=45). In 95 patients (23.5%), laparoscopic dissection of the rectovaginal septum was completed with a small perineotomy to treat a complex supra-anal rectocele.

Figure 3. A strip of polypropylene is sutured to the anterior aspect of the rectum and fixed without traction on the sacral promontory.

Surgical Technique Limited bowel preparation and a single dose of a broad-spectrum antibiotic, as well as thrombophylaxis, were given preoperatively to the patient. The “bean bag” allows steep Trendelenburg in the operating room: A modified lithotomy position with both arms tucked was used. A bladder catheter was inserted, the vagina disinfected, and the camera port was introduced at the umbilicus. Three additional ports were inserted into the right flank (5 mm), the left iliac fossa (5 mm) and the right lower quadrant (12 mm). A 30-degree optic was used and temporary hysteropexy enhanced the pelvic view. The

Figure 4. The posterior vaginal wall is elevated and sutured to the same mesh. continued ON PAGE 15

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The Problem. Although critically important, specimen margins are a source of error in cancer surgery. Margin identification using suture has discordance rates of 31% to 52% when compared across surgery, radiology and pathology.1,2 Incorrect specimen orientation can lead to re-excision of the wrong margin, which, in turn, can result in a higher risk for local recurrence and mortality. Re-excision rates in breast surgery often exceed 20%, and may reach as high as 60%.

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metal clips? A. Sutures mark just one point in space to represent an entire margin plane, which leaves room for misinterpretation. MarginMarker inks define each entire margin. CorrectClips provide more secure orientation on the intraoperative image with minimal tissue obstruction. Q. Our surgeons use nonsterile inks to orient tissue during surgery. How is MarginMarker better? A. Nonsterile inks in multiuse bottles can contain elements that mimic microcalcifications on the radiograph.5 Furthermore, MarginMarker inks adhere more readily than nonsterile inks, allowing more precise margin delineation. Q. How does applying MarginMarker inks during surgery help prevent unnecessary re-excisions? A. The surface of the specimen is often irregular, featuring fissures or flaps that can be misinterpreted as the exterior of the specimen. If they are close to the lesion, they can cause interpretation of insufficient margin. The surgeon knows the true exterior surface of the specimen, and by precisely applying MarginMarker inks, can prevent these areas from being misinterpreted as the exterior. Q. Our hospital uses metal tags to orient specimens on the x-ray. Why should we use CorrectClips? A. Metal tags can block visibility of the lesion, microcalcifications or the metallic marking clip placed during biopsy. This can lead to the need for multiple images, which is expensive and time-consuming. CorrectClips are easy to remove and less damaging to the specimen. Q. I believe these devices are important. How can I convince my hospital to stock them? A. Emphasize the economic return on investment found in fewer re-excisions, surgical time saved, improved safety and elimination of the risk for litigation associated with cancer recurrence when margins are not adequately identified. Note the responsibility of hospitals and physicians to eliminate a known source of error.

References 1. Molina MA, Snell S, Franceschi D, et al. Breast specimen orientation. Ann Surg Oncol. 2009;16:285-288. 2. Britton PD, Sonoda, LI, Yamamoto AK, et al. Breast surgical specimen radiographs: how reliable are they? Eur J Radiol. 2011;79:245-249. 3. Singh M, Singh G, Hogan KT, et al. The effect of intraoperative specimen inking on lumpectomy re-excision rates. World J Surg Oncol. 2010;8.4. 4. Gibson GR, Lesnikoski BA, Yoo J, et al. A comparison of ink-directed and traditional whole-cavity re-excision for breast lumpectomy specimens with positive margins. Ann Surg Oncol. 2001;8:693-704. 5. Lovrics PJ, Cornacchi SD, Farrokhyar F, et al. The relationship between surgical factors and margin status after breast-conservation surgery for early stage breast cancer. Am J Surg. 2009;197:740-746.

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entire small bowel was retracted out of the pelvis. Next, the mesosigmoid was retracted to the left and a peritoneal incision was made over the sacral promontory and caudally extended along the rectum and over the deepest part of the pouch of Douglas (special care was taken to preserve the right hypogastric nerve). The sacral promontory needed to be sufficiently dissected to allow safe mesh fixation (too medial a dissection must be avoided to safeguard the left iliac vein) (Figure 1). The rectovaginal septum was opened after a firm retraction of the deepest part of the fold of Douglas. The Denonvilliers fascia was incised, and the anterior aspect of the rectum was dissected, leaving all fibrous tissue against the posterior vaginal wall (Figure 2). A Marlex mesh (approximately 3×17 cm) was sutured to the ventral aspect of the distal rectum using nonabsorbable sutures to inhibit further rectal intussusception. Extracorporeal suturing seemed the most appropriate in the deepest part. Care was taken to ensure that the mesh lay flat on the rectum to avoid any mechanical erosion due to mesh kinking. The mesh was then fixed to the sacral promontory using an endoscopic "tacker" device, and secured with one stitch of ethibond 2.0. No traction was exerted on the rectum, which remained in the sacrococcygeal hollow (Figure 3). The posterior vaginal apex (vaginal vault) was then elevated and sutured to the same strip of mesh (Figure 4). Two lateral sutures incorporated the remainder of the uterosacral ligament. More suturing may be needed depending on the degree of middle compartment prolapse. Ideally, the sutures should not perforate the vaginal wall. The mesh could be left broader at that site to allow adequate vault suspension. The lateral borders were closed over the mesh using the V-Loc 90 absorbable wound-closure device elevating the neo-Douglas over the colpopexy. This maneuver was important to avoid any later small bowel entrapment and/or erosion. It can be difficult to complete the rectovaginal septum dissection to the pelvic floor level. In treating a complex rectocele, the surgeon may decide to complete the laparoscopic dissection with a small perineotomy. The incision is made immediately dorsal to the vaginal orifice to open the perineal body and dissected to join the laparoscopic dissection plane, allowing mesh fixation in the deepest part of the rectovaginal septum and restoring the perineal body. The perineotomy, however, could be avoided in most patients with a total rectal prolapse. Postoperatively, no drain is needed in most cases, and the patient can be discharged from day 1 onward.

Outcome After Laparoscopic Ventral Rectocolpopexy Conversion to laparotomy was required in eight patients (2%). The mean hospital length of stay (LOS) was 5.1 days and the last 50 patients had an LOS of 3.2 days. Perioperative mortality did not occur. Minor morbidity was noted in 74 patients (18%); urinary tract infection in 23 (5.9%); superficial wound dehiscence in 18 (4.6%); prolonged ileus in12 (3.1%); and postoperative hematoma or bleeding in nine (2.3%). Six patients (1.5%) underwent a re-intervention under general anesthesia within 30 days of surgery.

Ten patients (2.5%) developed dyspareunia. Prolonged neuralgia (six weeks) at the right lower quadrant port was documented in six patients (1.5%). Five patients (1.3%) were seen with mesh erosion. All of the patients underwent a combined approach with perineotomy for a grade III supra-anal rectocele. Five patients (1.3%) had a trocar-site hernia. No major septic complications were observed. Clinical recurrence was noted in 4.6% of 174 patients after LVR for total rectal prolapse. Only four of these eight patients underwent further perineal surgery. Recurrence for internal rectal

prolapse was lower (0.5%), but the need for perineal surgery during follow-up was higher (4.3%). Failure of the mesh fixation onto the sacral promontory was noted in four patients during relaparoscopy. In one patient, dehiscence of the rectal fixation was seen, and in another, incomplete reduction of the prolapse at the time of mesh fixation evidently resulted in a persistent prolapse. Significant improvement in symptoms was reported in 85.6% of patients continued ON PAGE 16

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at final follow-up. Obstructed defecation resolved completely in 71.1%, whereas new-onset constipation was documented in only 10 patients (2.3%). Fecal incontinence improved in 84.5% of patients. Obstructed defecation, which was present in 120 patients with internal rectal prolapse before LVR, had resolved in 59.2%. Constipation was induced in 3%. Fecal incontinence improved in 88.9% of patients with internal rectal prolapse, and at final follow-up, 70.4% of

patients reported improvement of functional outcome. In summary, Professor Dâ&#x20AC;&#x2122;Hoore noted that surgical treatment of rectal prolapse syndromes remains controversial in colorectal surgery. A large number of operations are described in the literature. LVR was developed in an attempt to fulfill the three main objectives of prolapse surgery: restoration of the anatomy in a reliable, safe and reproducible way; improvement of anorectal function; and avoidance of functional sequelae (constipation and incontinence). After LVR for total

rectal prolapse, a significant improvement occurred in 85% of patients at final follow-up. Potential functional problems should be investigated before LVR in patients with internal rectal prolapse. Moreover, mechanical and functional obstruction may coexist. LVR, with or without perineotomy, was found to be safe with relatively low morbidity and functional outcomes supported its efficacy. The indication for LVR in patients with internal rectal prolapse should be optimized.

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Expert Reviews Use of MRI in Rectal Cancer A

review highlighting how magnetic resonance imaging (MRI) could be used in the assessment of rectal cancer to improve patient outcomes was presented by Gina Brown, MD, consultant radiologist and reader in gastrointestinal cancer imaging at The Royal Marsden hospital in England. The core aspects of rectal cancer surgery have changed tremendously over the past few decades. In the Dutch TME and CR07 trials that assessed rectal cancer treatments, one of the problems was the lack of homogeneity of the excised specimens and the challenge this presented in standardizing and auditing the specimen (on which statistics and prognostic criteria are based). These trials found that lymph nodes staying behind are strong predictors of recurrence. Today, entire nodes are removed en blocc with total mesorectal excision (TME). The question is can we still identify predictors for local recurrence and what are the predictors for distant failure? These are important points to consider when optimizing patient selection and outcomes. Dr. Brown explained that best practices for primary surgery should soon be revealed. If a surgeon could efficiently predict that local recurrence would be low, then maybe he or she would not irradiate every patient they see. Or perhaps those at very high risk for distant metastasis or those who probably would not survive even after extensive surgery could be identified. Dr. Brown said that the most important predictor of local recurrence is at the hand of the surgeon and depends on the quality of the TME specimen obtained, which is extremely important for histologic and pathologic assessment of the tumor. A good TME specimen with no positive lymph nodes shows that the patient is at very low risk for local recurrence. It is well known that it is not the T stage of the tumor, but more importantly the marginal involvement of the specimen, which has a fourfold risk for local recurrence, if positive. The latter also is true for MRI: Wherever there is margin involvement, there is increased risk for recurrence and a 3.5 hazard ratio for local recurrence. This is so, regardless of the state of the lymph node involvement. Therefore, the two most important factors with regard to the tumor are its height and margin status. One end point from MERCURY (Magnetic Resonance Imaging in Rectal Cancer European Equivalence Study) was the assessment of the diagnostic accuracy of MRI in predicting circumferential

mrTRG Favorable (n=32) Unfavorable (n=34)

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GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MAY 2013

Surgeonsâ&#x20AC;&#x2122; Lounge

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margin involvement of the tumor and its equivalence to extramural depth of tumor invasion with histopathology. The Figure shows the prediction for those who reported a positive margin and thus an unfavorable prognosis compared with those who had no MRI margin involvement, thus having a favorable prognosis. The latter two were correlated with survival over time. Using MRI allows the surgeon to predict local recurrence according to margin involvement. Another factor that was predictive of local recurrence was the distance of the tumor from the mesorectal fascia. If the tumor was 1 mm or more away from the fascia, then the chances of local recurrence were found to be low. Using the 1-mm cutoff achieved the highest agreement, corresponding best with histopathologic reports. This shows that if a patientâ&#x20AC;&#x2122;s tumor can be seen on MRI with a distance larger than 1 mm, then local irradiation might not be in the patientâ&#x20AC;&#x2122;s best interest as chances for local recurrence are low. Another implication is that neoadjuvant treatment could regress the tumor to negative margins, again making local recurrence less likely. The same is true for nodes involving the fascia where preoperative radiation can take away the node from the fascia, and thus provide better prognosis. This downstaging of the tumor should take into account the low prevalence for nodal involvement of the fascia. Dr. Brown explained that tumors that are less than 5 cm from the anal verge are at a higher risk for margin involvement because of the difficulty in performing the distal TME dissection that goes through the intersphincteric plane, risking tumor perforation. This mostly occurs just above the puborectalis sling. Therefore, another set of data that could help predict prognosis is the extent of tumor involvement of the sphincter complex. The dangerous and high-risk tumors for marginal involvement are classified according to the depth of spread at the level of the sphincter complex. Those tumors extending into the muscularis are classified as stages III and IV, so it is possible to identify patients with low rectal cancer who are at high risk for local recurrence. To tackle the latter problem, a method was developed to allow surgeons to identify

which plane to operate on, using MRI for guidance: the standard TME plane, the

TME plane with sphincter preservation or the extralavator plane. The latter system would help the surgeon lower the risk for and prevent local recurrence. Other preoperative factors that were seen to affect disease-free survival rates using univariate analysis include circumferential resection margin stage, advanced T stage and MRI extramural vascular invasion status, disease in the sidewall compartment, and venous mural involvement. More trials are currently under way in which chemotherapy is given upfront and positron emission tomography imaging is used to identity high-risk patients,

the results of which are should be published soon. Dr. Brown concluded that using MRI to stratify patients with low rectal cancer is crucial for better prognosis of patients and to prevent unnecessary procedures with the understanding that some patients will only need primary surgery with or without combined chemoradiation therapy, whereas others who have tumors that need additional therapy and or more radical surgery. MRI is expected to be an integral part for future preoperative assessment of tumors in patients with low rectal cancers.

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GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MAY 2013

Sacral Neuromodulation and Tibial Nerve Stimulation For Fecal Incontinence

avid C.C. Bartolo, MD, professor of surgery, The University of Western Australia in Perth, explained that fecal incontinence (FI) is a highly distressing condition that affects more people than current data would suggest. For the most part, obstetric injuries, including the use of forceps during childbirth, are responsible. Injury is associated with two pathologies, which may coexist to varying degrees—tearing of the anal sphincter muscle and anal canal or damaging the nerves supplying that region. Repairing a denervated muscle serves little purpose. In the past, the success rates of sphincter repair were greatly exaggerated: Early outcomes were shown to deteriorate with time and patients may have reported better outcomes than actually existed. Also, if the nerve supply to the sphincter is damaged, there is a high probability that there also will be interference with the normal functioning of the rectum and possibly the colon. This means that the coordination between anal muscles and the rectum is altered, which compromises effective continence and defecation. In 1995, Matzel et al published pioneering work on sacral nerve stimulation (SNS). Over the past decade, SNS

has become an established treatment for FI in Europe and recently also has been approved in the United States. Originally, it was believed that an intact external anal sphincter was a prerequisite for SNS since the proposed mechanism of action was an augmented function of a generalized weakened striated anal sphincter. But several observational studies have shown that SNS is successful in some patients with sphincter defects. SNS has had successful results that appear to be multimodal. Local effects on rectal awareness and urgency (and in some studies on sphincter function), and central effects are seen on positron emission tomography (PET) scans and functional magnetic resonance imaging (MRI) studies of the brain. Some studies reported improvement in sphincter pressures whereas others did not, and some described altered rectal awareness, which possibly allowed an earlier perception of the need to defecate. A 2008 study by Michelsen showed that SNS in FI not only induced changes in the left colon (explained by presacral nerve stimulation of the long colonic nerves), but also resulted in changes to the right colon that must be vagally induced. Laurberg et al used

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PET scans to record cerebral blood flow before and after 30 minutes of continuous stimulation. After two weeks of continued stimulation, they repeated the scan before, and 30 minutes after, the arrest of the stimulation. The initial stimulation activated a region of the contralateral frontal cortex and after two weeks of stimulation, during the repeated measurement, activity was found in parts of the ipsilateral caudate nucleus, a region of the brain thought to be involved in learning and reward processing. They concluded that SNS induced changes using the afferent projections of the vagus nerve. LeRoi et al published landmark studies of the crossover by which they turned off the neuromodulation and found persisting benefits in terms of elevated sphincter pressure compared with preimplantation. Thus, the benefits could represent some form of training or long-term modulation. However, loss of benefit over time has been increasingly reported. Although unclear, long-term failure may result from changes around the stimulation leads. A major advantage of SNS is the peripheral nerve evaluation (PNE), which uses a temporary wire attached to a stimulator. Because success rates vary between 50% and 80%, progression to definitive implant is advised only after positive PNE. The most commonly used criterion for a positive PNE test is a 50% reduction in the number of incontinence episodes. Unfortunately, not all positive temporary outcomes translate into permanent ones, and the reason for this is unclear. Thus, some advocate multiple lead testing, which may result in better permanent site selection. Tan et al conducted a meta-analysis of 34 studies on SNS for fecal incontinence published between 1995 and 2008. The researchers evaluated functional, physiologic and quality-of-life (QoL) outcomes. Overall, 944 patients undergoing PNE and 665 patients undergoing permanent SNS were included. Weekly incontinence episodes and incontinence scores were significantly reduced with SNS and the ability to defer defecation was increased. QoL indices improved following SNS, and mean anal pressures increased significantly (P<0.001). Patients under the age of 56 years showed smaller functional—but greater physiologic and QoL—improvements. Results were similar between sphincter-intact and impaired subgroups. The complication rate was 15% for permanent SNS, with 3% resulting in permanent explantation. Another important development is the spread of indications. Initially, SNS was used in patients with an intact anal sphincter, and later in patients with sphincter defects, and comparable outcomes have been achieved with SNS and sphincter

repair in appropriately selected patients. Patients who are functioning poorly after rectal reconstructive surgery, diabetes, various neurologic diseases, prolapse surgery and other etiologies, are now being studied and also could be potentially offered SNS implantation. SNS for irritable bowel syndrome shows improvement in symptoms and QoL, although the mechanism is still not understood. Kamm et al reported on patients with constipation undergoing PNE, in which 73% proceeded to permanent SNS implantation. Of those, 63% achieved a 50% improvement with stool frequency, from 2.3 to 6.6 evacuations per week, which is in the normal reference range. On an intention-to-treat basis, just under two-thirds achieved an improvement of 50%, signifying the importance of further study of the use of SNS in severe constipation. Dinning, Lubowski and colleagues were able to study propagating waves in the colon using a long multiport manometer. They found that stimulation of S3 induced pancolonic propagating sequences. Conversely, S2 stimulation produced an increase in retrograde wave sequences. When comparing SNS with an artificial bowel sphincter (ABS), both have high rates of explantation. Incontinencescores are better with ABS, but this method was associated with more incontinence events. Typically, if SNS fails, one may then consider ABS or muscle transfer. After initial successful PNE, if there is loss of function with the definitive implant, a number of actions should be taken. The device and lead integrity should be checked. If there is loss of sensation, lead replacement may be required, especially if there is high impedance on testing. Percutaneous and/or transcutaneous nerve stimulation (PCTNS) offers a second form of neuromodulation in which the tibial nerve is stimulated. The latter contains sensory fibers that may spread the stimulation through the sacral nerve plexi. PCTNS potentially could be applied at night while the patient is sleeping. Another advantage is the low cost. In a recent report, 144 patients with either tibial stimulation or a sham procedure were compared and no significant benefits for FI or urgency were observed on manometry. The role of PCTNS currently is questionable. Dr. Bartolo said that PNE should be considered for patients with FI, regardless of the cause of the incontinence. The surgeon should know how to evaluate the motor contraction intraoperatively, offering the best site for implantation, perhaps by using multiple leads. The 50% benefit currently noted is still too low, and better results on PNE should be available before performing permanent implantation.

In the News

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MAY 2013

Antireflux Procedures at Low-Volume Centers Increase, Despite Worse Outcomes Than at High-Volume Cent B Y T ED B OSWORTH

he number of antireflux operations performed at high-volume centers has fallen over the past decade while antireflux surgery at low-volume centers has been associated with worse outcomes, including longer hospital stays and fewer routine discharges, according to a retrospective study of U.S. hospitals ((J Gastrointest Surgg 2013;17:6-13). “Despite better outcomes at high-volume centers, low-volume centers have increased their percentage of antireflux operations over time,” said lead author of the study, Paul D. Colavita, MD, Carolinas Medical Center, in Charlotte, N.C. “The urban non-teaching hospitals have experienced the largest gains in caseload.” Dr. Colavita said that there was no difference in mortality between lowand high-volume centers, but just about every other outcome, including cost of the procedure, favored centers that do these procedures more frequently. The study was conducted using data from the Nationwide Inpatient Sample (NIS), which captures about 20% of all hospitalized patients in the United States, and is considered to be representative of hospital practice. To evaluate trends, data collected in 1998-1999 were compared with data collected in 2008-2009, and hospitals were stratified by annual volume into terciles. “Low volume” was defined as 14 or fewer procedures per year, whereas “high volume” was defined as 38 or more procedures per year. The investigators included procedures for control of conditions associated with acid reflux in the analysis; procedures for other indications, such as achalasia, were excluded. Although the investigators presumed there would be increased regionalization of antireflux surgery due to consistent evidence that outcomes are better

for complex operations at centers where they are performed most frequently, the opposite was found. While about onethird of antireflux operations were performed at low-volume centers in the first time period, the proportion was slightly greater than 40% in the second period. High-volume centers, which accounted for 33.4% of the procedures in the first time period, accounted for only 25% of the procedures in the second. Unlike procedures such as complex oncologic resections, the investigators observed that antireflux procedures have not undergone regionalization: One likely factor is that thousands of surgical residents have been trained to perform laparoscopy, and they perform antireflux procedures as part of their education. Many consider these procedures to be part of the general surgeon’s armamentarium, and they are now performing these procedures in a wide variety of centers. A patient’s preference to have surgery close to home also may play a role. The fact that all outcomes, except for mortality, were worse in the second period may be partially attributed to the fact that patients undergoing surgery in the second period were, on average, seven years older and had more comorbidities compared with patients in the first period. However, the fact that outcomes were worse in low-volume centers for both periods was considered the most important factor. For example, after controlling for an array of independent variables, the risk for complications was almost twice as high in low-volume centers (P<0.0001) in both the first and the second periods. In addition, average hospital charges per procedure were about $3,000 higher (P=0.0032) P in low-volume centers. Researchers could not analyze the readmission or re-fundoplication rates because the NIS does not include such information in the database. This

information could have an impact on relative differences between low- and high-volume centers, but Dr. Colavvita indicated that the increased compliccation rate at low-volume centers is coonsistent with other data showing th hat surgical outcomes tend to be better at centers where the surgeries are performed most frequently. He conclud ded that support of regionalization of an ntireflux surgery “may improve outcomess.” Joel Richter, MD, chair of esoph hagology and gastroenterology, Uni-versity of South Florida, Tampaa, co-authored a similar study on thee relationship between volume and d outcomes of antireflux surgery (D Dis Esophagus 2011;24:215-223). There is a need, he said, to set standards forr competency in the performance off fundoplication and for experienceed gastroenterologists in the commun nity setting to perform the necessary worrkup, such as pH testing and motility testing, to confirm that patients are good candidates for surgery. “Why not establish standards for individual surgeons and hospitals regarding the volume of antireflux surgery that should be performed on a yearly basis to maintain competency?” Dr. Richter asked. “Frankly, this is an issue that the surgical societies like SAGES [Society of American Gastrointestinal and Endoscopic Surgeons] should address,” he said. According to Robert D. Fanelli, MD, chair of the SAGES Guidelines Committee, SAGES addressed the learning curve associated with performing high quality laparoscopic antireflux surgery in guidelines published in Surgical Endoscopyy (2010;24:2647-2669) and online at www.sages.org. These guidelines advise surgeons, gastroenterologists and others involved in the evaluation and treatment of patients with GERD toward

Average hospital charges per procedure were about $3,000 higher in lowvolume centers.

appropriate patient selection, evaluation and treatment selection. The guidelines recommend that “surgeons with little experience in advanced laparoscopic techniques and fundoplication in particular should have expert supervision during their early experience with the procedure ...” and that “reoperative antireflux surgery should be performed in a high-volume center by an experienced foregut surgeon.” Dr. Fanelli, who is chief of minimally invasive surgery and surgical endoscopy for The Guthrie Clinic, Ltd., Sayre, Pa., said that his committee found no clear-cut numerical standard for a minimum threshold, but that mentoring by more experienced surgeons during a surgeon’s first 15 to 20 laparoscopic antireflux procedures was supported in some of the literature studied and is presented to readers of the SAGES guidelines.

Sugammadex Speeds Obesity Surgery, Study Finds A

lthough the FDA has pushed back its decision date on the reversal agent sugammadex (Merck), surgery patients throughout the world continue to receive the drug—generating a body of evidence for U.S. regulators to consider. In one recent study, Italian researchers have reported that morbidly obese patients undergoing bariatric surgery recover markedly faster when given sugammadex than when they receive neostigmine. The researchers, from the University of Padova, compared reversal times in 40 women undergoing laparoscopic removal of gastric bands. Half the women

received neostigmine to reverse neuromuscular blockade; half received sugammadex (sold as Bridion in Europe). Although procedure times and anesthetics used were the same in each group, patients who received sugammadex had much shorter total anesthesia times: 47.9 versus 95 minutes, according to the researchers. That difference “was mainly due to a longer time to reach a train-of-four [TOF] ratio” of at least 0.9% for the women given neostigmine (46.6 vs. 3.1 minutes; P<0.0001), they reported. Overall recovery on admission to the postanesthesia

care unit also appeared to be improved for patients who received sugammadex, the researchers said, as measured by ability to swallow, TOF ratio, oxygen levels and other variables. “Sugammadex allowed a safer and faster recovery from profound rocuronium-included [neuromuscular block] than neostigmine did,” the researchers wrote in Obesity Surgery, where they published their findings online this month. “Sugammadex may play an important role in fast-track bariatric anesthesia.” —GSN staff

Opinion

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MAY 2013

NOT THE ECONOMY jContinued from page 1

that the major issue facing us is not how we are going to finance our industry, but how we are going to fundamentally change it so that we can continue to provide high-quality health care for our citizens. In my January editorial (General Surgery Newss 2013;40:1), I discussed the dual problems of the U.S. population growing in both number and age. The U.S. Census Bureau predicts that from the years 2010 to 2050, our population will grow from 310 million to 440 million, and those over the age of 65 years will grow from 40 million to 89 million. Older people have more chronic illnesses than younger people, and their medical problems are not only expensive but are very resource-dependent. Taken together, these statistics present challenges to our profession that will require a change in the way we do business.

Workforce Much has been written about the impending shortage of health care providers. Despite the fact that health care providers in the United States are comparatively well compensated, we have only 24 physicians per 10,000 people, which ranks us as 53rd of the world’s 200 nations! A study by the Association of American Medical Colleges (AAMC) estimates that there will be a nationwide shortage of 100,000 physicians in

nurses in the country working in environments ranging from private-duty practices to large hospitals. Most calculations demonstrate that there are both regional and global shortages; there is increasing job burnout; and the nurse workforce is aging. The American Association of Colleges of Nursing projects a shortage of 260,000 registered nurses by 2025. Currently, we are filling our ranks by importing nurses from countries such as the Philippines—a practice that is siphoning off a vital resource from underserved countries.

Most surgery does not require a lot of formal schooling as much as it does intensive practical training. When we concentrate on didactics and deemphasize training, which seems to be the current trend, we are not producing, in my estimation, the most competent surgeons. the next decade, 46,000 of which will be surgeons. Some observers, such as those of the Dartmouth Atlas Project, suggest that there is a maldistribution of physicians both geographically and by specialty. If you follow their argument for general surgeons, however, redistribution might lessen our current needs but will not even come close to meeting future demand. Although surgical residency training programs have been accepting more foreign medical graduates and foreign-trained surgeons are being encouraged to practice in the United States, almost 700 of our 3,000 counties have no surgeon at all. Meanwhile, the training period is longer, and issues such as the contentious malpractice atmosphere are encouraging earlier retirement. The numbers for nurse shortages are more alarming, but difficult to calculate because there is an estimated 2.7 million

Training Doctors The concept that every physician should be a polymath—knowledgeable in all aspects of medicine, published in the scientific literature, schooled in all subspecialties—and still be an expert in one field, is a romantic but completely impractical notion. Although some of our rural surgeons still have, and use, an amazing repertoire of knowledge and skills, most of us were schooled and trained in a broad range of disciplines only to spend most of our professional lives concentrating on a subspecialty such as cardiac surgery, breast surgery, colorectal surgery, and so on. To master any one of these narrow disciplines, technically and intellectually, should not require years of unfocused exposure to everything. Our training should be shorter and should emphasize depth rather than breadth. I am hearing more

reports of surgeons being unsure of their abilities even after completing seven or eight years of postgraduate training. They feel that it is necessary to apprentice themselves to older surgeons for a few years after residency and fellowship. If we had unlimited financial and human resources, we could continue this liberal arts education approach to surgical training, but unfortunately we don’t. I work with physician assistants who, with far less but more focused training than surgeons, function at extraordinarily high levels. I am also reminded that Vivien Thomas, the surgical assistant with no formal training, is credited with designing surgeon Alfred Blalock’s blue baby operation in the lab. He then assisted in the operating room when the operation was first performed on a human subject. Most surgery does not require a lot of formal schooling as much as it does intensive practical training. When we concentrate on didactics and deemphasize training, which seems to be the current trend, we are not producing, in my estimation, the most competent surgeons. We really do have to revisit our concept of medical education and postgraduate training. We can no longer afford to spend an entire decade training someone to function in a narrowly circumscribed field. I have always loved my job, as well as my broad training and wide exposure to lots of interesting subspecialties. I have cherished memories of participating in pediatric patent ductus arteriosus closures, open prostatectomies, aortic aneurysm resections, and so on. I have never, and will never, perform any of these procedures in my post-training career. Although this wide exposure may give me some perspective on my own specialty, I don’t think that we

I am now convinced that the major issue facing us is not how we are going to finance our industry but how we are going to fundamentally change it so that we can continue to provide high-quality health care for our citizens. have the manpower or womanpower to continue this long and leisurely road to professional competence. And it is not just a fiscal issue. Surgeons should spend more of their careers being surgeons and less of their careers being trained. If our country continues to grow in size and age, the demands on our workforce will be so great that we could import all of the graduates and all of the nurses of foreign medical schools and we would still come up short. We have to rethink the way our industry works and reevaluate the training and the roles of its participants, including its most important participant—the patient.

The Role of Patients The computing industry started 60 years ago when computers were the size of buildings and required a fleet of programmers and operators. If we had predicted back then the amount of computing that we do today, we would have assumed that one out of every 10 buildings of the future would be devoted to computers and one of every 10 professionals would be a programmer. That see NOT THE ECONOMY PAGE 22

GSN Bulletin Board

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MAY 2013

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Letters to the Editor

GENERALSURGERYNEWS.COM / GENERAL SURGERY NEWS / MAY 2013

Preparedness of Surgical Graduates To the Editor: I was very saddened when I read the March edition of General Surgery News [“Are Today’s Surgical Graduates Prepared for ‘Real World’ Practice?”; “Transition to Practice”; both page 1]. As a current general surgery resident, it is disheartening to see the lack of confidence expressed by many established surgeons. All the opinions mentioned reflect the thoughts and beliefs of seasoned surgeons, who are from a different generation and either are reluctant or simply refuse to accept that times have changed.

a forward way of thinking. I have not seen any opinionative letters by current surgery residents. I, for one, feel very confident in my training, as do most of my colleagues, and have no doubt that I will be a safe and competent general surgeon after completing residency.

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lo ersity of Buffa in 2011, Univ te one night CHICAGO—La Gli , on Philip Glick pediatric surge is resa call from his MD, received m that a telling him call, on rpoident been on exxtraco O) FACS child who had (ECM L. G REEN E , MD, oxygenation B Y F REDE RICK real membrane now haad air tracking r when work-hou for several days, venous ca cannula. ince 2003 the trics, launched for back through ssurgery, pedia directives were Council for professor off to a , Glick tion Dr. ment, rushed the Accredita ical Education and manageme OB/GYN m team Graduate Med dited residenICU and his accre ed. bed. the pediatric ’s child the (ACGME) , d the up with programs incl dgathered aroun n he could come ship training no one, inclu d; been fellow baffle and have cy The only optio -lung bypass support. n ing likee it. T Everyone was of this actio , had seen anyth the childd also was on heart during a sessio sess n of consequences organized and ing Dr. Glick multitude of lator, as nting the story ). “The debated in a ÀÞ¶Ê was to turn off the venti he said, recou Surgeons (ACS in the morning,” American College of Ê Ê}i iÀ> ÊÃÕÀ}i O hotline; no “It was 4:30 the ECM of the Êvi ÜÃ « ress t . I called cal Cong ÀÀiVÌ Þ° I sent out a twee the 2012 Clini I was very tired shed. Lastly, 9iÃ]ÊÞ ÕÊ i>À`ÊV O who t to come up. h; nothing publi ssis on ECM sun was abou a PubMed searc had a patient with pertu in the as page 28 did I n. well WITTER T as see explanatio cal venues universe had informal surgi litany of disanyone in the a if g ng askin Amo a. a concern surgical medi nces has been l five-year cussed conseque the traditiona by many that training paradigm is no cal men general surgi t in young uate to resul longer adeq page 33

INSIDE

Training is now limited by duty hours and there is nothing anyone can do about it! Many programs such as my own have learned to deal with the mandated changes in a productive fashion and continue to produce well-trained general surgeons during the five-year span. Surgeons who feel that current trainees are not adequately trained in the current era might need to self-reflect; perhaps the problem does not lie in the duty-hour restrictions but rather in the mindset of the attending surgeons who fail to adapt to the changes. Drs. Frederick Greene and L.D. Britt’s points are well taken, but one should not be quick to place blame with trainees or the Accreditation Council for Graduate Medical Education (ACGME) requirements. Simply put, blaming worse board pass rates on decreased work hours is not

Armin Kamyab, MD General surgery resident, PGY4 Southfield, MI

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It is unfair and unjust for established general surgeons to assume that the new generation of surgical residents will not be adequately trained.

changes, and come up with productive ways of ensuring that residents continue to be adequately trained in the same five-year period, as many programs already do.

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Also, the assumption that general surgery residents pursue fellowship training due to a perceived lack of confidence or ineptitude is wrong. Despite common beliefs, most residents pursue fellowship training simply due to the desire to specialize in a given specialty, either out of interest (hepatobiliary, cardiothoracic) or for the associated lifestyle (plastic, colorectal). It is unfair and unjust for established general surgeons to assume that the new generation of surgical residents will not be adequately trained. There are no data to suggest or support the belief that new general surgeons are any less safe or less competent. General surgeons and residency programs need to learn to cope with the

NOT THE ECONOMY jContinued from page 20

obviously has not happened because the advances in technology have led to a progression of computers, from mainframe to desktop to laptop to iPad to iPhone, which has revolutionized computing. A fifth grader with an iPad can now do what were once functions of unimaginable complexity. By the same token, checkout cashiers, elevator operators, airline counter assistants, gasoline station attendants and bank tellers are being replaced by automation. Technology and automation allow people to do more for themselves and this has fundamentally changed many industries, so why not ours? I am not going to suggest that automation will allow people to do open heart surgery in their garages, but automation

To the Editor: Your recent article “Study Shows Owners of Ambulatory Surgical Centers Do More Surgery” (March 2013, page 32) makes some good points about the number of advantages that ambulatory surgery centers (ASCs) offer over hospitals when it comes to creating a superior patient and physician experience through innovation and efficiency. Unfortunately, the article also reports findings from a study released by the Workers’ Compensation Research Institute (WCRI) in May 2012, that the national Ambulatory Surgery Center Association (see www.ascassociation.org/AboutUs/ PressRoom/ASCADisputesWCRIReport) and many physicians who choose to treat patients in ASCs find seriously flawed based on the researchers’ capricious assumptions about the 10-year-old data that they used for this analysis. Specifically, while the researchers attempt to draw conclusions about the reasons that physician owners of ASCs who provide care to patients inside those ASCs may serve more patients than those who do not, none of the data used in this study actually identifies which of the physicians represented in the data are ASC owners. Instead, the researchers rely on invalid proxies that are unsupportable and unsound. Furthermore, there is nothing in the data on which the WCRI report is based that indicates

could lead to more independent testing such as assaying blood values, measuring vital signs or taking simple radiographic images. Information technology could play an important role insofar as data can be transmitted over distances to be interpreted remotely by a person with very focused training. I am not suggesting either that we will no longer need physicians, but I do think that physicians of the future will be more specifically trained and will serve different roles. They may be supervising a large group of physician extenders or counseling patients on what diagnostics or therapeutics they can perform for themselves. They may be reviewing data collected locally and transmitted centrally. As physician numbers decrease relative to the general population, their role will become more complex and more challenging.

Surgeons who elect to treat their patients in ASCs are routinely able to safely treat more patients in less time than in their local hospitals.

the medical necessity of the procedures performed. With such incomplete information, it is difficult to reach any of the conclusions that these researchers are putting forth. The WCRI report referenced in this article also does not consider adequately the reasons why surgeons would choose to treat more patients in a particular setting. As the physician quoted in this article explains, and I can personally attest, surgeons who elect to treat their patients in ASCs are routinely able to safely treat more patients in less time than in their local hospitals. Knowing this, it’s no surprise that surgeons working at ASCs would be able to perform more procedures. Additionally, ASCs often offer patients more convenient locations, ease in scheduling surgeries and shorter waiting times. Considering all factors, a more valid conclusion based on the actual data at hand is that surgeons operating in a more efficient setting are able to provide care to a higher number of patients in need and to deliver a higher quality of care and service to those patients. Thousands of satisfied doctors and patients who have delivered or received care inside ASCs over many decades can attest to this—a fact with far more value than conclusions drawn based on inappropriate proxies and unsubstantiated assumptions. David Shapiro, MD Immediate Past President Ambulatory Surgery Center Association Tallahassee, Fla.

If Not the Economy…? Although “it’s the economy, stupid” may be an appropriate incantation for politicians and economists trying to finance our current medical system, we, as the stewards of our profession, have to be thinking outside the box. We have to take the long view and imagine new ways to train physicians, create innovative ways to use physician extenders and develop strategies that will allow patients to take a more active role in their own health care. We have to change the way we practice medicine and, in our health care reform headquarters, we should have a poster on the wall stating, “it’s not the economy, it’s the industry, stupid.” —Dr. Whitee is chief of surgical services at the Veterans — Affairs Medical Center and professor of surgery at George Washington University, both in Washington, D.C.

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