The March2012 Digital Edition of General Surgery News

®

GeneralSurGerynewS.com

The Independent Monthly Newspaper for the General Surgeon March 2012 • Volume 39 • Number 3

opinion

Spam in a Can II: Another Perspective B y e dwaRd M. C Opeland III, Md

I

always enjoy the opinion columns written by David Cossman, MD. His opinions usually reflect the constructive criticisms that I would get from the private sector as I traveled around the country in my various capacities as a representative of the leadership of the American College of Surgeons (ACS).

Often these criticisms took the form of “what have you done for me lately?” or were made with minimal background information. I have been gone from a leadership role in the ACS now for more than five years and cannot comment on the views of the members of the current Board of Regents.

What I can say is that I am a member of the “then” generation and Tom Russell, MD, became a member of the “now” generation. These views put us into conflict. From Dr. Russell’s position as the executive director of the ACS, he was able to see the “now” generation of surgeons and health care see Spam II page 39

SpECial rEport ProGripTM Mesh: Self-Gripping Mesh for Hernia Repair see InSeRt at page 6

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Large Variation Found In Payment for Nine Common Surgical Procedures

B y K ate O’R OuRKe

estimated payment per hour

Procedure Lap gastric bypass

$707

Thyroidectomy

$693

Lap gallbladder with cholangiogram

$541

Lap Nissen fundoplication

$481

Partial mastectomy

$453

Lap appendectomy

$443

Inguinal hernia repair

$326

Umbilical hernia repair

$321

Partial colectomy with anastomosis

$188

Major Flaws in Reimbursement Formulas, Researchers Say B y C hRIstIna F RangOu san Francisco—A new study reveals vast discrepancies in surgeons’ hourly payment for some common general surgery procedures—a finding that demonstrates significant failings in the current reimbursement formula.

Researchers compared the total care time and payment per unit of time for nine common inpatient and outpatient procedures using Current Procedural Terminology (CPT) see ReImbuRSement page 36

Study of Accelerated Partial Breast Irradiation Sparks Debate new study has spurred some doctors to urge caution in selecting patients for accelerated partial breast irradiation (APBI) and angered others who say the study is flawed and could derail a Phase III clinical trial testing APBI. The

Houston—Can hospitals drive their rates of central-line bloodstream infections to zero? Although it sounds like a pipe dream, multidisciplinary team approaches are making great strides in dramatically reducing rates, new research has found.

At the University of Massachusetts Memorial Medical Center in Worcester, for example, a team of clinicians dedicated to preventing centralline infections in eight of the hospital’s intensive care units (ICUs) cut the rate by almost 90% over a seven-year period. Similarly, a team effort at the Ohio State University Medical Center in Columbus, decreased infection rates in a 25-bed ICU by roughly 33% in one year. Researchers presented details of the two approaches at the 2012 annual meeting of the Society of Critical Care Medicine (abstracts see CentRal-lIne page 22

SpECial rEport

B y K ate O’R OuRKe

A

Team Approach Reduces CentralLine Infections

retrospective study, presented at the recent San Antonio Breast Cancer Symposium (SABCS), concluded that APBI with brachytherapy is associated with inferior effectiveness and increased toxicity compared with

Addressing Current Challenges in Managing Postsurgical Pain With EXPAREL®, a New DepoFoam® Formulation of Bupivacaine see InSeRt at page 26

nEw produCt announCEmEnt

see paRtIal bReaSt IRRadIatIon page 50

see page 38

INSIDE

In the News Statewide Data Initiative Reveals Clues To Improving Outcomes .......................................... 4

Clinical Review

Catheter-related Bloodstream Infections ....................... 7

Obesity Care

Study Shows Plateauing of Obesity, Conflicting With Earlier Studies ............ 26

GSn editorial

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The Proliferation of Gowns and Gloves Frederick L. Greene, MD Chairman, Department of General Surgery Carolinas Medical Center Charlotte, N.C.

T

he other day while making rounds on a patient who was in her fourth postoperative day after a colectomy for diverticular disease, I was struck by a new collection of gowns and gloves on her door, along with multiple other signs indicating an infection control issue. As I looked up and down the hall, I noticed that almost every door on the surgical unit had the same collection of yellow gowns and blue gloves with signage indicating some form of isolation. Although I didn’t know anything about the other patients on the unit, I did know that my own patient had no particular bacterial issues when admitted and there were certainly no intra- or postoperative infection control stigmata that would warrant new signage and the proliferation of gowns and gloves.

I asked a nursing student who was in the throes of putting on a gown and gloves in front of my patient’s door if she knew anything about the infection control issue. She mentioned that there was a reference somewhere in the electronic medical record that in 2008 my patient “may have had” a culture of methicillin-resistant Staphylococcus aureus (MRSA). I then proceeded to

go into my patient’s room, donning all of the appropriate accoutrements of the infection control guidelines, and asked my patient whether she had any recollection of any infectious issues. She assured me that she had never had any involvement with MRSA and said she was rather surprised that the gowns and gloves all of a sudden appeared on her fourth postoperative day.

I use this little scenario to highlight a potential problem that seems to be proliferating throughout my hospital and perhaps yours as well. Although I am certainly not against appropriate infection control measures and have always supported the guidelines as to when these measures should be deployed, I feel that we are seeing an increase in patient isolation that may be inappropriate and that may actually foster poor infection control because of the ubiquitous nature of these protective measures. I think this is representative of the “boy who cried wolf ” syndrome. If we employ this process too frequently and potentially indiscriminately, then appropriate infection control measures may be ignored.

It amazes me to see the number of doors in the inpatient unit covered with signs indicating a variety of infection control measures and I wonder whether these types of measures are well founded or potentially placed at the whim of a well-meaning ID [infectious disease] nurse without appropriate information to justify these actions. Again, before any readers accuse me of not wanting to follow appropriate guidelines, I feel that we are now in some ways overusing these measures with

Joseph J. Pietrafitta, MD Minneapolis, MN General Surgery, laparoscopy, Colon and Rectal Surgery, laser Surgery

Frederick L. Greene, MD

Los Angeles, CA General Surgery, laparoscopy, Surgical Education

Gary Hoffman, MD

Barry A. Salky, MD

Editorial Advisory Board

Los Angeles, CA Colorectal Surgery

New York, NY laparoscopy

Maurice E. Arregui, MD

Namir Katkhouda, MD

Paul Alan Wetter, MD

Indianapolis, IN General Surgery, laparoscopy, Surgical Oncology, ultrasound, Endoscopy

Kay Ball, RN, CNOR, FAAN

Los Angeles, CA laparoscopy

Miami, FL Ob/Gyn, laparoscopy

Youngstown, OH General Surgery, laparoscopy

Editorial Staff

Philip S. Barie, MD, MBA

Peter K. Kim, MD Bronx, NY Emergency General Surgery

Kevin Horty

New York, NY Critical Care/Trauma, Surgical Infection

L.D. Britt, MD, MPH

Raymond J. Lanzafame, MD

David Earle, MD

Rochester, NY General Surgery, laparoscopy, Surgical Oncology, laser Surgery, new Technology

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 Long Branch, NJ laparoscopy, Telemedicine

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San Francisco, CA Surgical hospitalist

Elizabeth Zhong

Gerald Marks, MD Wynnewood, PA Colon and Rectal Surgery, Colonoscopy

J. Barry McKernan, MD Marietta, GA laparoscopy

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the resultant unintended consequences.

The overall cost of having multiple gowns, gloves, masks and other infection control methods instituted without appropriate indicators to warrant their use also must be eschewed. I cringe sometimes to see how much waste is collected each day as a consequence of using these expensive disposable items, and I believe that in our culture we tend to give little thought to the waste that is generated and the overall cost that is engendered.

Another possible byproduct of indiscriminate use of infection control guidelines is worse patient care:

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

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INFECTIOUS DISEASE SPECIAL EDITION

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In the news

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Statewide Data Initiative Reveals Clues To Improving Outcomes nSQIP in Tennessee; a First Step in Improving Outcomes B y V ICtORIa s teRn Cofer, MD, listened with rapt Joseph attention as Skip Campbell, MD,

shared his first data from the National Surgical Quality Improvement Program (NSQIP) at the 2004 American College of Surgeons (ACS) meeting, in Boston.

Dr. Campbell, Henry King Ransom Professor of Surgery, and chief of staff and senior associate director of the University of Michigan Hospitals and Health Centers, in Ann Arbor, said that a significant barrier to process improvement was the lack of reliable data for identifying problems and changing procedures.

That is why Dr. Campbell and his colleagues developed NSQIP to understand how best to develop quality initiatives that would enhance surgical care in Michigan.

Before this project, validated prospective data with 30-day outcomes did not exist.

“Hearing this talk was an epiphany,” said Dr. Cofer, professor of surgery and surgery residency program director in the Department of Surgery, University of Tennessee College of Medicine, Chattanooga. “It was clear to me this is what surgeons needed to be doing to improve care and cut costs. We had never had anything like this before.”

Dr. Cofer went home and spoke with the CEO of Erlanger Hospital, in Chattanooga, about immediately enrolling Erlanger in NSQIP to collect data on surgical processes and outcomes and the CEO agreed. By 2005, Erlanger Hospital as well as St. Francis Hospital in Memphis and Vanderbilt Hospital in Nashville had joined NSQIP. Based on the experience of Dr. Campbell and the NSQIP statewide collaborative, the Tennessee State Chapter of the ACS decided to form a Tennessee statewide collaborative.

By 2008, Dr. Cofer had spearheaded a three-way collaboration between Blue Cross/Blue Shield in Tennessee, The Tennessee Hospital Association and the Tennessee ACS. Blue Cross/Blue Shield

agreed to fund this initiative. In the summer of 2009, seven more hospitals in Tennessee enrolled, for a total of 10. Blue Cross/Blue Shield agreed to increase their funding to about $3 million over three years and the Tennessee Surgical Quality Collaborative (TSQC) was formed.

“If you have no data, you can’t change anything,” Dr. Cofer noted. “Once you get your data, you can see where the warts are and can change your hospital’s practices. Data drives process change.”

Dr. Cofer’s initial goal was to track surgical outcomes from the 10 participating hospitals and identify trends so that he could ultimately determine best practices among these hospitals. The results of this initiative, published online Jan. 19 in the Journal of the American College of Surgeons, examined postoperative complications in 20 categories and 30-day mortality rates, and hospital costs associated with postoperative complications in 14,205 surgical cases in 2009 and 14,901 surgical cases in 2010.

The investigators compared complications and hospital costs associated with complications per 10,000 procedures.

The investigators saw significant decreases in postoperative complications from 2009 to 2010 in several categories: acute renal failure (–25.1%; P=0.023), graft/prosthesis/flap failure (–60.5%; P<0.0001), ventilator use longer than 48 hours (–14.7%; P=0.012), surgical site infection (–18.9%; P=0.0005) and wound disruption (–34.3%; P=0.011).

They also tracked significant increases in complications in three categories: deep venous thrombosis (DVT)/thrombophlebitis (34.9%; P=0.05), pneumonia (23.1%; P=0.05) and urinary tract infections (41.8%; P=0.001). Mortality also went up slightly (2.3%) from 2009 to 2010, despite the overall reduction in postoperative complications.

The improvements led to a net savings

of over $4 million per 10,000 general and vascular procedures. But, when taking into account the costs associated with the increased complications, the net savings—costs avoided minus costs from increased complications—was just over $2.2 million per 10,000 general and vascular surgery cases. If applied to all general and vascular surgery cases in the 10 hospitals, the total estimated costs avoided would rise to more than $8 million in 2010 compared with 2009, Dr. Cofer estimated.

’If you have no data, you can’t change anything.’

—Joseph Cofer, MD “We were surprised to see how much improvement we had,” Dr. Cofer said. “We met four times a year to identify problems and discuss them, but we’re not really sure why certain outcomes improved [and others did not].”

Dr. Cofer noted that better outcomes for skin and soft tissue/wound disruption and ventilator management may have occurred because surgeons and staff identified and solved problems rapidly. It’s also possible, he added, that some of the improvements could have been due to the Hawthorne effect—surgeons may have performed better simply because they knew they were being evaluated.

Although the mortality rate increased from 2009 to 2010, from a statistical standpoint there was no difference. “If you look at all our cases over the last three years in our TSQC, the mortality rate has actually dropped,” Dr. Cofer said.

Hiram C. Polk Jr., MD, Ben A. Reid Senior Professor of Surgery at the University of Louisville Department of Surgery, in Kentucky, complimented Dr. Cofer’s efforts, but isn’t celebrating yet.

“Dr. Cofer understands surgery inside out and saw many improvements [over time], but the fact that postoperative complications with pneumonia, DVT and urinary

New Book To Call Attention to Women Surgeons’ Stories B y C hRIstIna F RangOu

F

emale surgeons are now being called on to write and submit stories for a new book that will highlight the experiences of women surgeons.

Preeti John, MD, project organizer and critical care surgeon in Baltimore, said there are remarkably few books written by women in the surgical field. As a result, she decided to compile an anthology of stories and articles

from female surgeons.

The goal is to collect about 50 contributions from surgeons across the United States who are in private practice or academic surgery as well as from surgical residents-intraining. Selected contributions will be compiled into a book and published sometime next year.

Dr. John is seeking contributions from women in the form of anecdotes, essays, biographies and even poems.

The stories can recount experiences during training and

tract infection were up significantly shows how hard this business is,” he said.

Dr. Polk added, “The real question is why did they succeed on some measures and fail on others? How did they get things right? Without knowing the answers to these questions, it’s difficult to make lasting improvements.”

Going forward, the investigators want to address the gaps in postoperative care.

“Now we’re in the process of identifying exemplars—hospitals that are statistically better than any other—and we’re going to these hospitals to export best practices,” said Dr. Cofer. “We’re trying to make this up as we go along.” Next year, TSQC will include 21 hospitals. “We have put into place a system that improves the care of surgical outcomes. Our driving force is to do a better job of treating patients."

David Flum, MD, MPH, professor in the Schools of Medicine and Public Health, and director of the Surgical Outcomes Research Center at the University of Washington, in Seattle, would like to take this type of initiative to the next level. “[Universal surveillance] is what the surgical community should be doing,” said Dr. Flum, also medical director of the Surgical Care and Outcomes Assessment Program, a program providing hospitalspecific data feedback and best practices regarding processes of care and outcomes across the Pacific Northwest. “We need to do a better job of determining what’s working and what’s not working. Currently, only 5% of hospitals nationwide are using clinical registries to monitor performance—that needs to change.”

Dr. Flum believes that surgeons and surgical systems need surveillance to improve performance. For example, knowing that mortality is too high isn’t very helpful, he said, but “if I’m told my patients with diabetes aren’t being managed well, that becomes the focus of my efforts to deliver better care. “When it comes to the science about what works and what’s worth investing in, we’re far away from understanding that,” Dr. Flum added. “There’s not going to be one answer or one size that fits all.” It’s more of an evolution, he said.

work as well as from life outside surgery. Women also can choose to be interviewed about their story if they do not have time to devote to writing an original article.

“These stories deserve to be shared to encourage and inspire young women, and to sensitize and educate a broader public, not just in the United States, but across the globe,” she said.

Dr. John asks anyone interested to contact her by email at preeti.john@va.gov. Original contributions have no specific guidelines and there is no word limit. The deadline for draft submissions is April 30, 2012.

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Overall Cancer Deaths Down, Incidence of Some Cancers Up B y g eORge O ChOa

I

n the past two decades, the overall death rate from cancer decreased by 22.9% in men and 15.3% in women, according to the most recent annual report on cancer incidence from the American Cancer Society (ACS; CA Cancer J Clin 2012;62:10-29). More than 1 million cancer deaths were avoided between 1990 and 2008, the report said.

For 10 years with available data (19982008), death rates continued to decrease for all four major cancer sites—lung, colorectum, breast and prostate—with colorectal cancer accounting for much of the decline in both men and women.

“Among men, 78% of the [overall] decline is due to decreases in the top three cancer sites (lung, prostate and colorectal cancers); while among women, 56% of the decline is due to decreases in death rates

for breast and colorectal cancers,” said lead author Rebecca Siegel, MPH, an ACS epidemiologist based in Atlanta. “Lung cancer death rates have been declining among men since 1990, due to the reduction in tobacco use over the past 50 years,” she said, noting that the mortality decline has been smaller for women than for men because of the lag in decline in the lung cancer death rate among women. Smoking prevalence among women peaked 20

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years later than among men.

“Decreases in prostate, female breast and colorectal cancer death rates largely reflect improvements in early detection and/or treatment,” Ms. Siegel added.

Howard Sandler, MD, MS, chair of radiation oncology and Ronald H. Bloom Family Chair in Cancer Therapeutics at Cedars-Sinai Medical Center, in Los Angeles, attributed the long decline in cancer death rates to a “combination of factors,” including a declining number of smokers, effective methods of early cancer detection and better treatments.

Dr. Sandler did not believe the novel, targeted cancer therapies had a great effect on cancer mortality rates, in part because those therapies are usually administered to patients who have “fatal cancer.” Such drugs are more important for increasing survival time than for changing the death rate, said Dr. Sandler, executive editor of CancerProgress.net, the American Society of Clinical Oncology Web site.

Despite the decline in overall cancer mortality, incidence of some less common cancers have been increasing, according to a second article from the ACS (CA Cancer J Clin 2012 Jan 4. [Epub ahead of print]). Authors of that study documented increases in cancers of the pancreas, liver, thyroid and kidney, as well as esophageal adenocarcinoma, melanoma and some throat cancers associated with human papillomavirus infection.

“The reason for the increasing rates is unknown, but the obesity epidemic is probably associated with increases for some of these cancers,” Ms. Siegel said.

“Increases in early detection practices are a likely contributor as well.”

Dr. Sandler described several factors that may account for the observed increases in cancer incidence rates: gastroesophageal reflux associated with obesity for esophageal adenocarcinoma, hepatitis C and B virus infections for liver cancer, and increased sun exposure for melanoma of the skin. The increase in melanoma incidence was particularly sharp, he noted.

Ms. Siegel added that the increase in thyroid cancer incidence was the largest, and the increase in kidney cancer incidence was unexpected. “Although most of the increases were confined to whites, rates of kidney cancer increased among men and women of every racial/ethnic group, except it was not statistically significant among American Indian/Alaska Native men.”

Regarding mortality rates, Dr. Sandler expressed hope that the downward trend in deaths from cancer will continue.

Dr. Sandler and Ms. Siegel reported no relevant conflicts of interest.

clinical review

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Catheter-related Bloodstream Infections Cybele l. abad, Md

Nasia safdar, Md, phd

Section of Infectious Diseases University of Wisconsin Madison, Wisconsin

Assistant Professor Section of Infectious Diseases Department of Medicine University of Wisconsin Madison, Wisconsin

H

ealth care–associated infections (haIs) are an important cause of morbidity and mortality and place a significant economic burden on the health care system.1-3 an estimated 1.7 million haIs (4.5 infections per 100 hospital admissions) occurred in the united States in 2002, resulting in nearly 100,000 deaths.4 Catheter-related bloodstream infections (CRBSIs), most of which are associated with central venous catheters (CVCs), account for 11% of all HAIs.4-6 Agencies such as the National Healthcare Safety Network (NHSN; formerly the National Nosocomial Infections Surveillance System) of the Centers for Disease Control and Prevention (CDC) were formed in response to the growing awareness that HAIs are urgent public health and patient safety issues.1 The recent action plan proposed by the Department of Health and Human Services identified CRBSIs as a priority area for prevention.7 In 2002, the National Quality Forum created and endorsed a list of Serious Reportable Events (SREs) to increase public accountability and consumer access to critical information about health care performance. These SREs soon became known as “never events.”

Following this lead, in 2007 the Centers for Medicare & Medicaid Services

(CMS) declared it would no longer reimburse HAIs such as CRBSIs, increasing the urgency for rational and effective prevention and treatment strategies to reduce the morbidity, mortality, and costs associated with them.8 The policy, which went into effect in late 2008, was created to help improve the care of patients by incentivizing hospitals to prevent serious hospitalassociated adverse events. Beginning in January 2011, CMS mandated that hospitals report CRBSI rates through the NHSN. This new CMS regulation makes CRBSI reporting a national requirement to receive full Medicare inpatient payments; facilities that fail to report will not receive the annual 2% Medicare payment increase.

Intravascular catheters play a central role in the care of critically and chronically ill patients; an estimated 5 million CVCs are inserted in patients each year. However, more than

250,000 central line–associated bloodstream infections (CLABSIs) also occur annually, with an estimated mortality rate of 12% to 25%.3 A recent metaanalysis of patients in the intensive care unit (ICU) found that mortality rates were significantly higher when a CRBSI occurred (random effects model: odds ratio [OR], 1.96; 95% confidence interval [CI], 1.25-3.09).9 Each episode significantly increases hospital length of

methods requiring cVc removal

methods not requiring cVc removal

Table 1. Diagnosis of crBSIs Diagnostic method

Description

criteria for Positivity

Sensitivity, %

Specificity, %

Qualitative blood culture through device

One or more blood cultures drawn through CVC

Any growth

87

83

Quantitative blood culture through device

Blood culture drawn through CVC, processed by pour-plate methods or a lysis-centrifugation technique

≥100 CFU/mL

77

90

Paired quantitative blood cultures

Simultaneous cultures drawn through CVC and percutaneously

Both cultures positive with CVC culture yielding 5-fold higher or more than peripherally drawn culture

87

98

Differential time to positivity

Simultaneous blood cultures drawn, through CVC and percutaneously, and monitored continuously

Both cultures positive with CVC positive ≥2 h earlier than peripherally drawn culture

85

81

Qualitative catheter segment culture

Segment from removed CVC is immersed in broth media and incubated for 24-72 h

Any growth

90

72

Semiquantitative catheter segment culture

A 5-cm segment from removed CVC is rolled 4 times across a blood agar plate and incubated

≥15 CFU

85

82

Quantitative catheter segment culture

Segment from removed CVC is flushed or sonicated with broth, serially diluted, plated on blood agar, and incubated

≥1,000 CFU

83

87

CFU, colony-forming units; CRBSI, catheter-related bloodstream infection; CVC, central venous catheter Adapted from reference 22.

stay, with additional health care costs ranging from $4,000 to $56,000 per episode.6,10,11 The NHSN has published surveillance criteria for defining CRBSIs. The criteria for patients older than 1 year of age are the following: isolation of a recognized pathogen from blood culture(s), the presence of clinical signs of sepsis and/or shock (eg, fever, chills, or hypotension), a determination that the infection is not from other sources, and confirmation that the organism is not a contaminant.1 Intravascular devices (IVDs) include peripheral vascular catheters (venous and arterial), pulmonary artery catheters, midline catheters, peripherally inserted central catheters (PICCs), and various CVCs, including tunneled (usually longterm devices) and nontunneled catheters (percutaneously placed CVCs commonly used in ICUs).3,5,6,12 This review covers the pathogenesis, microbiology, and treatment of CRBSIs, highlighting advances in the areas of prevention and government policy.

microbiology Antimicrobial resistance, now considered a global crisis, continues to loom large, and the organisms that cause CRBSIs are no exception. In the past 2 decades, the proportion of CRBSIs caused by antimicrobial-resistant organisms, such as methicillin-resistant Staphylococcus aureus (MRSA), multidrug-resistant gram-negative bacilli, and fluconazole-resistant Candida species, has been increasing at an alarming rate.3,13-15 Overall, the organisms most frequently responsible for nosocomial see bloodStReam InfeCtIonS page 8

7

8

clinical review

GEnERalSuRGERynEWS.COM / GEnERal SuRGERy nEWS / MaRCh 2012

bloodstreaM iNfeCtioNs Continued from page 7

Complicated

CLABSIs are coagulase-negative staphylococci (CoNS) (31%), S. aureus (20%), enterococci (9%), Escherichia coli (6%), Klebsiella species (5%), and Candida species (9%). A large prospective surveillance study using data from SCOPE (Surveillance and Control of Pathogens of Epidemiological Importance) that included 24,179 cases of CRBSIs from a 7-year period at 49 hospitals found that the rates of MRSA isolates increased from 22% in 1995 to 57% in 2001 (P<0.001).

Rates of ceftazidime-resistant Pseudomonas aeruginosa isolates increased from 12% in 1995 to 29% in 2001 (P<0.001), and 60% of isolates contained vancomycin-resistant Enterococcus faecium.15

Pathogenesis The pathogenesis of CRBSIs can be attributed to 2 primary causes: bacterial colonization of the device and contamination of the fluid being administered.16 Contaminated infusate leads to the majority of epidemic IVD-related BSIs, but it is rare.16,17 Colonization of the device may be either extraluminal (from surrounding skin or hematogenous seeding of the catheter tip) or intraluminal (caused by an organism adhering to the device

Uncomplicated

Endocarditis, septic thrombosis, osteomyelitis, etc.

Coagulase-negative Staphylococcus

Staphylococcus aureus

Short-term CVC/AC and long-term CVC/port: Remove, SATª for 4-6 wk or 6-8 wk for osteomyelitis Tunnel infection or port abscess: Remove, SAT for 7-10 d

Short term CVC/AC: Remove, SAT for 5-7 d OR Retain,b SAT + ALT for 10-14 d Long-term CVC/ port: Retain,b SAT + ALT for 10-14 d

Short-term CVC/AC: Remove, SAT for minimum of 14 d Long-term CVC/port: Remove,c SAT for 4-6 wk

figure. MaNageMeNt

of

Enterococci

Short-term CVC/AC: Remove, SAT for 7-14 d Tunneled CVC/port: Retain,b SAT + ALT for 7-14 d

Gram-negative bacilli

Candida species

Short-term CVC/AC: Remove, SAT for 7-14 d Long-term CVC/port: Remove, SAT for 10-14 d OR Retain, SAT + ALT for 10-14 d, remove if no response

Short-term CVC/AC and long-term CVC/port: Remove, SAT for 14 d after first negative blood culture

Crbsis.

AC, arterial catheter; ALT, antibiotic lock therapy; CRBSIs, catheter-related bloodstream infections; CVC, central venous catheter; SAT, systemic antimicrobial therapy a

Choose most appropriate systemic antimicrobial therapy based on current published guidelines.

b

Remove retained catheter if there is clinical worsening, relapsing, or persisting infection.

c

Current guidelines recommend considering catheter salvage therapy; however, outcomes may be poor.

Adapted from reference 19.

followed by the creation of a biofilm, a process responsible for persistent infections and hematogenous spread).3,16,17 In short-term devices, the extraluminal route

is more frequent, whereas the intraluminal route is more common in long-term devices (≥10 days) or short-term devices left in longer than 4 to 7 days.16,18

Diagnosis The clinical diagnosis of CRBSIs is difficult because both the sensitivity for clinical signs of inflammation at

clinical review

GEnERalSuRGERynEWS.COM / GEnERal SuRGERy nEWS / MaRCh 2012

the catheter site and the specificity for signs of systemic infection are low.19,20 Blood culture specimens from the catheter should be drawn from all available lumens to avoid missed infections. In a recent retrospective analysis of CRBSIs at a single institution, 27.2% would have been missed if only one lumen of the double-lumen catheter had been sampled.21 A number of techniques for the diagnosis of CRBSIs have been studied, including catheter-sparing and non–catheter-sparing methods (Table 1, page 7).

A recent meta-analysis found that paired quantitative blood cultures were the most accurate diagnostic test, followed by quantitative blood cultures through the CVC and quantitative or semiquantitative catheter segment cultures.22 Paired quantitative blood cultures are labor-intensive and cost almost twice as much as standard blood cultures. The widespread availability of radiometric blood culture systems (eg, BACTEC, Becton Dickinson)—in which blood cultures are continuously monitored for microbial growth (approximately every 20 minutes)—has led to their use in detecting CRBSIs.23 The differential time to positivity (the detection of positivity in a culture of blood drawn from an IVD 2 hours or more before the detection of positivity in a culture of blood drawn simultaneously from a peripheral site) was an accurate predictor for CRBSIs in studies of short- and long-term devices.12,23-25 Newer diagnostic techniques, including acridine orange leucocyte cytospin and endoluminal brush, are currently being investigated and have shown promise.12,26-30

CoNS if systemic antibiotics are given in conjunction with antibiotic lock therapy (ALT).19 In CRBSIs associated with tunneled or implantable devices, the catheters also require removal for any complicated infections (eg, thrombosis, endocarditis, osteomyelitis), tunnel or pocket infections and port abscesses, and all infections caused by S. aureus and Candida species.

According to the recent guidelines, catheter salvage regimens—including the use of ALT—may be attempted when necessary for infections caused by organisms other than S. aureus, fungi,

P. aeruginosa, Bacillus species, Micrococcus species, propionibacteria, and mycobacteria.19 Although device-sparing regimens with longer treatment durations and using antibiotic lock solutions have been attempted for uncomplicated S. aureus, gram-negative bacilli, and even fungal pathogens, the data supporting its efficacy are scant—we do not recommend catheter salvage for S. aureus and other virulent organisms.12,19,31-42 The duration of therapy varies based on the organism and whether or not the device has been removed.

Systemic therapy for CoNS infections

ranges from 5 to 7 days when the catheter is removed and from 10 to 14 days when it is retained in conjunction with ALT. With catheter removal and uncomplicated infections, the duration of systemic therapy for CRBSIs caused by S. aureus is greater than 14 days, 7 to 14 days for gram-negative bacilli infections, and 14 days from the first negative blood culture for Candida infections (Figure).12,19 Transesophageal echocardiography (TEE) should be performed in all patients with a CRBSI caused by S. aureus because see bloodStReam InfeCtIonS page 10

A Valuable Alternative to Biologics

management The management of CRBSIs relies on 2 major clinical decisions: 1) the appropriate and timely administration of systemic antimicrobial treatment (SAT) and 2) catheter removal or catheter salvage treatment. SAT should be selected based on the suspected or proven presence of causative agents in accordance with published guidelines and resources.19 The decision to remove the catheter is based on the type of catheter being used and the organism in question. This decision becomes more complex when specific patient characteristics are considered, such as the type of device required (tunneled or implanted) and the ease of venous access. Guidelines from the Infectious Diseases Society of America (IDSA) recommend the removal of nontunneled catheters in all complicated infections (eg, thrombosis, endocarditis, osteomyelitis) and in all infections caused by S. aureus, gram-negative bacilli, Enterococcus species, and Candida species. The catheter may be retained with

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9

clinical review

Prevention The Healthcare Infection Control Practices Advisory Committee (HICPAC) of the CDC has published extensive guidelines for the prevention of CRBSIs, with a recent update released in 2011.2,3 They emphasize the following: 1) educating and training all health care personnel who insert and maintain catheters; 2) using maximal sterile barrier precautions during CVC insertion; 3) using a greater than 0.5% chlorhexidine skin preparation with alcohol for antisepsis; 4) avoiding routine replacement of CVCs as a strategy to prevent infection; and 5) using antiseptic/antibiotic-impregnated short-term

Design

of

Crbsis

Technology

outcome

Meta-analysis

Vancomycin-containing locks vs heparin

50% risk reduction (RR, 0.49; 95% CI, 0.26-0.95)

Yahav et al, 200854

Systematic review and meta-analysis

Various antibioticsa Antibiotic plus antisepticb Antisepticc

Antibiotic solutions: RR, 0.44; 95% CI, 0.38-0.5 Non-antibiotic antiseptic solutions + other prevention methodsd: RR, 0.25; 95% CI, 0.13-0.5 Non-antibiotic antiseptic solutions alone: RR, 0.9; 95% CI, 0.48-1.69

Sanders et al, 200884

Double-blind randomized trial

Ethanol-containing locks vs heparin

OR, 0.18; 95% CI, 0.05-0.65

Veenstra et al, 199953

Meta-analysis

Antiseptic-impregnated CVCse

OR, 0.56; 95% CI, 0.37-0.84

Ramritu et al, 200850

Systematic review

Antibiotic-impregnated CVCsf

RR, 0.39; 95% CI, 0.17-0.92

Crnich et al, 20025

Meta-analysis

Silver-impregnated CVCs

RR, 0.40; 95% CI, 0.24-0.68

Ramritu et al, 200850

Systematic review

Antibiotic vs first-generation antiseptic-impregnated CVCs

RR, 0.12; 95% CI, 0.02-0.67g

Hockenhull et al, 200981

Systematic review

Anti-infective CVCs (all types)

OR, 0.49; 95% CI, 0.37-0.64h

Ho et al, 200648

Meta-analysis

Chlorhexidine-impregnated dressing vs placebo or povidone-iodine dressing

Catheter or exit-site colonization: 14.3% vs 27.2%; OR, 0.4; 95% CI, 0.26-0.61 CRBSIs: 2.2% vs 3.8%; OR, 0.58; 95% CI, 0.29-1.14; P=0.11

Timsit et al, 200980

Randomized controlled trial

Chlorhexidine-impregnated dressing vs standard dressing

0.4 vs 1.3 CRBSIs per 1,000 catheter-days; HR, 0.024; 95% CI, 0.09-0.65; P=0.005

Chaiyakunapruk et al, 200247

Meta-analysis

Chlorhexidine vs povidone-iodine

RR, 0.49; 95% CI, 0.28-0.88i

Tacconelli et al, 200352

Meta-analysis

Mupirocin prophylaxis in dialysis patientsj

Decrease in S. aureus bacteremia in hemodialysis patients by 78%; RR, 0.22; 95% CI, 0.11-0.42

Silva et al, 201090

Meta-analysis

Daily chlorhexidine bathing (impregnated cloths or solution) compared with soap and water baths

Decrease in risk for bloodstream infection (RR, 0.32; 95% CI, 0.22-0.46; P<0.0001, fixed-effects; I2=17%)

antimicrobial lock solution

When the need to retain an existing long-term catheter in a patient with a CRBSI is significant, salvage can be attempted by using ALT as an adjunct to systemic therapy.12,19,44 Approximately 2 mL of solution is infused into the lumen of the catheter and remains there for a certain amount of time per day during the course of treatment.12,44 Solutions consist of the appropriately selected antibiotic combined with heparin (if compatible). In the lock, antibiotic concentrations range from 100 to 1,000 times the usual systemic concentrations. This increased concentration has a greater likelihood for killing organisms embedded in biofilm.44 Current guidelines recommend that antibiotic lock solution be used for 10 to 14 days in conjunction with SAT.19 Vancomycin, cefazolin, and ticarcillin-clavulanic acid (Timentin, GlaxoSmithKline)—all in combination with heparin—have excellent stability when used in ALTs, retaining 90% of their activity after 10 days of dwell time in the presence of susceptible organisms.45 CRBSIs caused by Candida species necessitate prompt removal of the catheter; however, this may not always be immediately possible. A solution of ethylenediamine tetraacetic acid (EDTA) with amphotericin B lipid complex showed promise during an in vitro model of a Candida biofilm formation, but more research is urgently needed.46 We do not recommend catheter salvage in the setting of S. aureus CRBSIs because of the high risk for metastatic infection and the slim likelihood of cure without removal of the catheter.

Study

preveNtioN

Safdar et al, 200651

antimicrobial catheters

catheter Salvage Strategies

Strategy

for the

chlorhexidine dressings

of the propensity of this organism to cause endocarditis. Rosen et al determined that screening all patients who had a clinically uncomplicated CRBSI caused by S. aureus with TEE was a cost-effective way to determine duration of therapy—as short as 2 weeks if the TEE result was negative.43

table 2. Novel strategies

cutaneous antisepsis

Continued from page 9

mupirocin prophylaxis

bloodstreaM iNfeCtioNs

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chlorhexidine bathing

10

CI, confidence interval; CVC, central venous catheter; HR, hazard ratio; OR, odds ratio; RR, relative risk a Gentamicin; gentamicin + citrate; gentamicin + vancomycin; gentamicin + cefazolin; cefotaxime. b Minocycline with ethylenediamine tetraacetic acid. c Citrate; citrate with taurolidine. d Nasal mupirocin and exit-site iodine dressing. e Chlorhexidine-silver sulfadiazine. f Minocycline and rifampin. g Reduced risk with antibiotic catheters. h Reduced risk with anti-infective catheters: all types combined, see text for subgroup analysis. i Reduced risk with chlorhexidine. j Six studies used intranasal mupirocin 2 to 3 times daily for 5 to 14 days with various maintenance schedules; 4 studies used mupirocin applied to catheter exit site.

CVCs and chlorhexidine-impregnated sponge dressings if the rate of infection is not decreasing despite adherence to prior strategies. The guidelines also emphasize performance improvements by implementing bundle strategies and documenting and reporting the compliance rates for all components of the bundle as benchmarks for quality assurance and performance improvement.2 Novel strategies for the prevention of CRBSIs are summarized in Table 2.5,47,48,50-54,80,81,84,90 Highlighted below are important topics for the prevention of CRBSIs. The

recommendations are rated based on the strength of evidence supporting them as follows: IA, strongly recommended for implementation and strongly supported by well-designed experimental, clinical, or epidemiologic studies; IB, strongly recommended for implementation and supported by some experimental, clinical, or epidemiologic studies and a strong theoretical rationale; IC, required by state or federal regulations, rules, or standards; and II, suggested for implementation and supported by suggestive clinical, or epidemiologic studies or a theoretical rationale.3

cutaneous antisepsis Historically, iodophors, such as 10% povidone-iodine, have been the most widely used skin antisepsis agents in the United States.5,55,56 However, recent studies demonstrate that a 2% chlorhexidine preparation is the superior agent for preventing CRBSIs. A meta-analysis of 4,143 catheters found that chlorhexidine preparations reduced the risk for CRBSIs by 49% (95% CI, 0.28-0.88) compared with povidone iodine.47 Also, see bloodStReam InfeCtIonS page 14

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the Science Behind PoSitive Patient outcomeS

Endo GIA™ Reloads With Tri-Staple™ Technology and Endo GIA™ Ultra Universal Staplers in Minimally Invasive Liver and Pancreatic Resections An Interview With: David A. Iannitti, MD

Chief of Hepatobiliary Surgery Program Director of Hepatobiliary Surgery Fellowship Carolinas Medical Center Charlotte, North Carolina

Introduction The minimally invasive hepatic resection procedure has become widely adopted by hepatobiliary (HPB) and liver transplant surgeons following its introduction by Gagner and colleagues in 1992.1 The availability and development of surgical stapling technology and endovascular energy devices to transect and adequately seal tissue may have fostered the adoption of this technique. “When we started using staplers and stapling technology on the liver and pancreas in the mid-1990s, that was a big jump forward in HPB surgery,” said David A. Iannitti, MD, chief of hepatobiliary surgery and program director of the Hepatobiliary Surgery Fellowship at the Carolinas Medical Center in Charlotte, NC. “Before then, it was clamp and tie, clamp and tie, clamp and tie,” he said. “You could go through 100 ties on the liver,” which increased the time of surgical procedures and caused other effects on surgery and outcomes. “Are the staplers perfect? No. There are issues with them, but relative to non-stapling technology, they’re great in my opinion.”

Over time, research has shown that the use of staplers in HPB surgery is safe and effective, dramatically reducing operating time with complication rates comparable to the use of staplers in other approaches.2-4 Although limitations exist regarding stapler use, as Dr. Iannitti noted, the latest advancements in stapling technology may address these prior shortcomings when used in HPB procedures.

according to Dr. Iannitti. “We had an opportunity to use it in some animal labs before it was released, and I was very impressed,” Dr. Iannitti said. In his first use of the instrument in an animal model, he successfully fired a vascular/medium (tan) load across a pig stomach. “It was ridiculous, in a good way,” he noted. Attempts to fire blue and green loads across the thick structure had not been very effective: “[The staple line] fell apart,” he added. “Then I used a [tan load] with the Tri-Staple™ technology and it [fired complete intact staple lines], no problem.”

In his typical procedures, Dr. Iannitti must transect a wide variety of tissue thicknesses. “In HPB surgery, a lot of what we do is vascular transection,” he explained. “I used every staple size and type. We used [tan loads]. For regular tissue we used blue loads and for thicker tissue, green loads,” he said. However, the variability of tissue can make the selection of the optimal cartridge a challenging one. “Most tissues in the human body are not uniform. The thickness of tissue in the liver and stomach can change dramatically in a short distance; that variability will require different staple heights. Every patient is different and every part of the liver in an individual patient is different, so we always struggled with exactly what is the right load to use,” he added. “Even experienced surgeons in my field are challenged by that decision.”

Endo GIA™ Reloads with Tri-Staple™ technology have been designed to resolve some of that indecision. For example, surgeons using the Endo GIA™ Reloads without Tri-Staple™ technology had to choose among 3 different reloads: white, blue, or green, the last of which requires a 15-mm port. With Tri-Staple™ reloads, cartridges are available in tan or purple, both of which can be used through a 12-mm port. Black reloads, for use across very thick tissue, can be used

Tan Reload for Vascular/Medium Tissue Reload a

through a 15-mm port (Figure 1). “With the Tri-Staple™ technology, there is pretty good overlap between the staple reloads,” Dr. Iannitti said. “There was not much overlap with blue and green reloads, but now we have more cushion to work with.”

The overlap between the currently available cartridges may help reduce the learning curve for residents by easing the selection process. Also, fewer inappropriately selected cartridges may help reduce waste in the operating room. “Everyone tries to minimize waste and be thoughtful, but if you choose the wrong staple and realize it is not going to work, you ask for a different one,” Dr. Iannitti said.

Minimizing Adverse Events by Using Tri-Staple™ Technology New surgical staplers have a stepped cartridge face with 3 rows of titanium staples at staggered heights, which are meant to facilitate better hemostasis and a cleaner staple line. “When you’re dealing with tissues of varying thickness that may be sensitive, if you clamp down with too small a load you may crush the tissue and it may bleed and leak,” Dr. Iannitti said.

Leaks are unwelcome during any surgery, particularly during HPB surgery. The Endo GIA™ Reloads with TriStaple™ technology appear to reduce this risk, according to Dr. Iannitti. “In my experience with progressive staple heights, we are finding this leads to more successful stapling, more formed staples, and fewer misfires, which is huge,” Dr. Iannitti said.

The latest model has better compression and tissue retention than previous models, according to Dr. Iannitti, who has found that the stapler does not shift during

Purple Reload for Medium/Thick Tissue Reload a

Black Reload for Extra-Thick Tissue Reload a

Endo GIA™ Reloads With Tri-Staple™ Technology Endo GIA™ Reloads with Tri-Staple™ technology and the Endo GIA™ Ultra Universal stapler debuted in the surgical community in 2010 at the 27th Annual Meeting of the American Society for Metabolic and Bariatric Surgery. These devices were designed to be used across a broader range of tissue thicknesses than previous models could accommodate, and they possess many enhanced features.

Carolinas Medical Center is one of 11 accredited HPB surgery training programs in North America, and often tests new technology before it is widely available,

12

General SurGery newS

March 2012

Figure 1. Endo GIATM reloads with stepped cartridge face and varied-height staples. a

Products depicted are not actual size.

Supported and approved by

A

Some of the tan (vascular/medium tissue) and purple (medium/thick tissue) reloads come with an option of a gold-colored curved tip. The curved tip reload provides enhanced visualization and aids in tissue manipulation and blunt dissection.

transection, and the blade cuts evenly through tissues of all thicknesses. “You suffer when your stapler won’t lock down.

That would lead you to use a larger staple height, which would lock down but then you’d potentially leak or bleed through it,” Dr. Iannitti said. “[The Endo GIA™ Reloads with Tri-Staple™ technology] give you graduated compression and a formed staple line with a good seal.”

Device Design Leading to Improved Surgical Technique With the introduction of this Tri-Staple™ technology, Dr. Iannitti believes there has been an improvement in the firing force over the previous generation of staplers, and how the jaws of the stapler close as the surgeon closes his or her hand. “We used to have this progressive locking, and for thick tissue the jaw might bend,” Dr. Iannitti said. “Now when you squeeze, the handle is locked down once you go to fire the blade. It’s nice and smooth.”

Dr. Iannitti also is pleased with the design of the anvil, which is slim and fixed.

This facilitates maneuvering around target tissue. “In a laparoscopic procedure, you

A

don’t have a hand [to articulate] in there, so you are dependent on the stapler and angle to maneuver around a critical structure like portal or hepatic veins. That rigidity helps tremendously.”

The Endo GIA™ Reloads with TriStaple™ technology and the Endo GIA™ Ultra Universal stapler incorporate a one-handed grasping mechanism, which makes it easier for surgeons to grasp and manipulate tissue. “In liver surgery, you may have bleeding and you have to move quickly,” Dr. Iannitti said. “The grasping mechanism allows you to grab the tissue with the same hand while using the other to hold something back, open the jaws, [and] quickly re-grab. It’s a huge advantage.”

Some Endo GIA™ Reloads with TriStaple™ technology are available with a curved tip option, which Dr. Iannitti finds valuable in certain procedures (Figure 2).

“The curved tip is an advantage in liver surgery,” he said. “When you are in a really tight space and need to get around something, it can be very difficult when your stapling device is straight. With the curved tip, you can hook it and slide forward.” In addition to being easier to

B

Figure 3. The tan curved tip enhances visibility and maneuverability. A) Tan curved tip dividing the extrahepatic right portal vein. B) Intrahepatic stapling of a portal pedicle using the tan curved tip.

Photos courtesy of David a. Iannitti, MD.

Tri-StapleTM Technology Ensures Graduated Compression During Pancreatic Surgery Dr. Iannitti has found the Endo GIA™ Extra-Thick (black) Reload with TriStaple™ technology particularly well suited for pancreatic surgery. “You have to be careful not to crush the tissue when you put a stapler on it, which may put patients at risk for bleeding and pancreatic leaks.” The key to successful use of a stapler on a pancreas is graduated compression and a completely formed staple line. “You typically can’t drop a vascular load across the pancreas. On the pancreas neck, you may be able to use a blue [cartridge], but more often you’d use a green [one],” Dr. Iannitti said.

Prior to the availability of the Endo GIA™ Extra-Thick (black) Reloads, Dr. Iannitti and his team used staple-line reinforcement and SEAMGUARD® Bioabsorbable Staple Line Reinforcement (W.L. Gore & Associates, Inc.) to operate on the pancreas. “The black [reload] gives you a more gradual level of compression and the different staple heights give you a nicely formed staple line. For use across the thicker parts of the pancreas, of all staples from any manufacturer, the black one is my preference,” added Dr. Iannitti (Figure 4).

A) Stapler across the pancreas before firing.

B

B) Stapler after firing with visualization of the formed staple line.

Figure 4. Two Tri-StapleTM black loads across a thick pancreas in an open distal pancreatectomy operation.

Photos courtesy of David a. Iannitti, MD.

Conclusion

References

Although perfection in a stapler may not yet be attainable, Dr. Iannitti is quite pleased with his latest option. “It really is an advancement in stapling technology: The varying staple heights and the way the jaws close and compress make it better and easier for serious cases,” he said. “If you do a bowel resection, that’s pretty straightforward. But in HPB [surgery], we are so dependent on those staples to form; it’s the difference between massive blood loss and no blood loss with every fire, so it’s kind of a big deal.”

1. Gagner M, rheault M, Dubuc J. laparoscopic partial hepatectomy for liver tumor. Surg Endosc.

1992;6(2):99.

2. Kaneko h, Otsuka y, Takagi S, Tsuchiya M, Tamura a, Shiba T. hepatic resection using stapling devices. Am J Surg. 2004;187(2):280-284.

3. Schemmer P, Friess h, Dervenis c, et al. The use of endo-GIa vascular staplers in liver surgery and their potential benefit: a review. Dig Surg.

2007;24(4):300-305.

4. nanashima a, Sumida y, Oikawa M, et al.

Vascular transection using endovascular stapling in hepatic resection. Hepatogastroenterology.

2009;56(90):498-500.

Developed and authored by General Surgery News with the assistance of David A. Iannitti, MD, through funding from Covidien.

General SurGery newS

March 2012

13

BB1037

Figure 2. Curved tip reloads.

maneuver around critical structures, such as portal or hepatic veins, the curved tip makes the instrument easier to visualize (Figure 3). “You always want to see the back arm of your stapler,” Dr. Iannitti explained. “When you see the top of the curve, you know you are completely around what you need to divide.”

14

clinical review bloodstreaM iNfeCtioNs Continued from page 10

an economic decision analysis based on available evidence suggested that the use of chlorhexidine rather than povidone iodine for CVCs would result in a 1.6% decrease in the incidence of CRBSIs, a 0.23% decrease in the incidence of mortalities, and cost savings of $113 per catheter used.57 Currently, the CDC recommends a 2% chlorhexidine preparation as the first choice agent for cutaneous antisepsis (rating IA).2

Topical antimicrobials The HICPAC/CDC guidelines specifically recommend against the use of topical antibiotic ointments or creams at the catheter insertion site (except in the case of hemodialysis catheters) to avoid promotion of fungal infections and antimicrobial resistance (rating IA).2,3 The guidelines also discourage the administration of intranasal antimicrobials before insertion or during the use of a catheter as a means to prevent colonization or CRBSIs (rating IA).3 A metaanalysis of mupirocin prophylaxis to prevent S. aureus infections in patients undergoing dialysis showed a 63% reduction (95% CI, 50%-73%) in the rate of overall S. aureus infections.52 The study population included both hemodialysis and peritoneal dialysis patients. Of the 10 studies, 6 used intranasal mupirocin 2 to 3 times per day for 5 to 14 days with various maintenance schedules, and 4 used mupirocin applied to the catheter exit site. Among patients undergoing hemodialysis, S. aureus bacteremia was reduced by 78% (relative risk [RR], 0.22; 95% CI, 0.11-0.42). However, the differences in site, frequency, and duration of mupirocin treatment in these studies and the resulting clinical heterogeneity make it difficult to draw robust conclusions. A randomized, double-blind, placebo-controlled trial evaluating

GEnERalSuRGERynEWS.COM / GEnERal SuRGERy nEWS / MaRCh 2012

mupirocin prophylaxis for nosocomial S. aureus infections in nonsurgical patients found that routine cultures for S. aureus nasal carriage at admission and subsequent intranasal mupirocin use did not prevent nosocomial S. aureus infections.58 Additionally, reports of emerging mupirocin resistance are becoming commonplace.59-64 Routine use of topical or intranasal mupirocin for prophylaxis against CRBSIs is not recommended.

The limitations of mupirocin suggest that other topical approaches for the prevention of CRBSIs should be studied.

One such agent is honey. The antibacterial properties of some types of honey have made this a promising agent to study.

The effect of 3-times-weekly Medihoney (commercially available; pooled antibacterial honey including Leptospermum species honey; Medihoney Pty Ltd, Brisbane, Australia) on infection rates in 101 patients receiving hemodialysis via tunneled, cuffed CVCs was compared with topical mupirocin in a randomized controlled trial (RCT). The investigators found similar catheter-associated bacteremia rates in the 2 arms (0.97 vs 0.85 episodes per 1,000 catheter-days, respectively; P>0.05).65 Although the preliminary results are promising, a larger trial powered to show equivalence or superiority is needed to establish the utility of Medihoney for the prevention of CRBSIs in patients receiving hemodialysis through tunneled, cuffed catheters.

maximal Barrier Precautions Maximal barrier precautions, including cap, sterile gown, mask, large sterile drape, and sterile gloves, significantly reduce the rate of CRBSIs when used during catheter insertion.3,66 In a study comparing maximal barrier precautions with control precautions (eg, sterile gloves and small drape), the rate of CRBSIs was 6.3 times higher in the control group (P=0.06).66 The HICPAC/CDC guidelines recommend that maximal barrier precautions be used for all CVC insertions (rating IB).2,3

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Introducing eXParel®: non-opioid Postsurgical Pain control For up to 72 Hours Q: what is eXParel (bupivacaine liposome injectable suspension)?

a: EXPAREL is a local analgesic that uses bupivacaine and is indicated for administration into the surgical site to produce postsurgical analgesia. A single dose given at the close of surgery provides up to 72 hoursa of analgesia with reduced opioid requirementsb and without the need for catheters and pumps.

Q: what does eXParel do?

a: In a pivotal soft-tissue trial compared with placebo, in which all patients with inadequate pain control received opioids for rescue pain relief, EXPAREL demonstrated a 30% reduction in cumulative pain scores and a 45% reduction in opioid consumptionb through 72 hours.c

Q: How does eXParel work?

a: EXPAREL uses DepoFoam®, a multivesicular drug delivery technology, to release bupivacaine over time. Other formulations of bupivacaine should not be administered within 96 hours following the administration of EXPAREL.

Q: How is eXParel administered?

a: EXPAREL is infiltrated into the surgical site using the same technique surgeons already use to infiltrate local anesthetics for postsurgical analgesia, and can be administered using needles as narrow as 25 gauge. The recommended dose is based on the surgical site and the volume required to cover the area; the maximum dose should not exceed 266 mg (or one 20 mL vial).

Q: How is eXParel supplied?

a: EXPAREL is available in 1.3%, 20 mL single-use vials. EXPAREL can be used as supplied or diluted with up to 280 mL of normal saline to accommodate administration into larger surgical sites.

Q: what important safety considerations should I know before using eXParel?

a: EXPAREL is contraindicated in obstetrical paracervical block anesthesia and should not be used in patients under 18 years old.

As with other local anesthetic products, patients should be monitored for cardiovascular and neurological status, and vital signs should be performed during and after injection of EXPAREL. Because amide-type local anesthetics such as bupivacaine are metabolized by the liver, EXPAREL should be used cautiously in patients with hepatic disease. Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at a greater risk for developing toxic plasma concentrations.

The most common adverse reactions (incidence ≥10%) following administration of EXPAREL were nausea, constipation and vomiting.

Q: why is a new non-opioid option for postsurgical pain management valuable?

a: More than 90 million surgical procedures are performed every year in the United States.d Surveys have indicated that postsurgical pain often is undertreated, with as many as 80% of patients reporting pain after surgery.e Current options to prolong postsurgical analgesia rely heavily on medication delivery devices.

Although effective, these devices can be prone to catheter-related issues and often deliver opioids, which are associated with a range of unwanted and potentially costly side effects.f As the only single-dose local analgesic capable of providing pain control for up to 72 hoursa with a reduced reliance on opioids,b EXPAREL has the potential to play an important role in the management of postsurgical pain.

Please see brief summary of Prescribing Information on adjacent insert.

For more information, visit www.EXPAREL.com or contact: Pacira Pharmaceuticals, Inc. 5 Sylvan Way Parsippany, NJ 07054 Phone: (855) RX-EXPAREL (855-793-9727) email: medinfo@pacira.com a Pivotal studies have demonstrated the safety and efficacy of EXPAREL in patients undergoing bunionectomy or hemorrhoidectomy procedures; additional studies are under way to further demonstrate the safety and efficacy in other procedures. b The clinical benefit of the attendant decrease in opioid consumption was not demonstrated. c Gorfine SR, et al. Dis Colon Rectum. 2011;54:1552-1558. d Cullen KA, et al. Natl Health Stat Report. 2009(11):1-25. e Apfelbaum JL, et al. Anesth Analg. 2003;97:534-540. f Adamson RT, et al. Hosp Pharm. 2011;46(6 Suppl 1):1-8.

EXP-AP-0037-201201

clinical review

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Insertion Site According to the HICPAC/CDC guidelines, the preferred insertion site of nontunneled CVCs for adult patients is the subclavian vein (rating 1B).2,3 The femoral site is associated with higher rates of catheter colonization as well as increased risk for deep vein thrombosis.3,67-70 In an RCT comparing the femoral and subclavian sites, use of the femoral site was associated with a higher overall rate of infectious complications (19.8% vs 4.5%, respectively; P<0.001).70 The internal jugular site has been associated with higher rates of CRBSIs than the femoral and subclavian sites in several studies.3,69,71 However, a recent RCT comparing the jugular and femoral sites found no difference in the rate of CRBSIs between the 2 sites (2.3 vs 1.5 per 1,000 catheterdays, respectively; P=0.42).72 A prospective, observational study comparing the subclavian, internal jugular, and femoral insertion sites found colonization lowest at the subclavian site but found no difference in rates of infection between sites.73 Using real-time ultrasound guidance for catheter insertion decreases associated mechanical complications and infection.2,74 In a randomized study comparing real-time ultrasound guidance with the landmark technique for catheter placement in the internal jugular vein, the latter resulted in significantly fewer complications, including fewer CRBSIs (P<0.001).74 A meta-analysis revealed that the use of ultrasound for insertion at the internal jugular and subclavian vein sites decreased failure (RR, 0.32; 95% CI, 0.18-0.55), complications during catheter placement (RR, 0.22; 95% CI, 0.10-0.45), and the need for multiple placement attempts (RR, 0.60; 95% CI, 0.45-0.79) in comparison with the landmark technique.75 Although no RCT to date has compared the 3 insertion sites, based on available data, we recommend the subclavian site as the preferred site for CVC insertion along with the use of real-time ultrasound to minimize mechanical complications.

Simulation-based Training A recent observational study at an urban teaching hospital evaluated the impact of a simulation-based educational intervention on the rates of CRBSIs in the medical ICU.76 Ninety-two second- and third-year internal medicine and emergency medicine residents completed the education program, which included a pretest, an instructional video on proper CVC insertion techniques, ultrasound training, hands-on practice with the simulator device, and a post-test with a minimum score requirement. There were 3.2 infections per 1,000 catheter-days in the 16 months prior to the intervention in the hospital’s medical ICU. There were 4.86 infections per 1,000 catheter-days in the hospital’s surgical ICU during this preintervention period. The rate of CRBSIs in the medical ICU during the 16-month intervention period, when all second- and third-year residents had completed the training, decreased to 0.5 per 1,000 catheter-days. The rate in the surgical ICU, where no rotating residents completed the simulation training, remained stable at 5.26 per 1,000 catheterdays during the same 16-month time period.76 The cost savings attributed to simulation training recently were evaluated using data from both the year before and the

year after training.77 The annual net savings from the simulation-based training, after accounting for the cost of the program, was more than $700,000 (2008 dollars), which translated into a 7 to 1 rate of return on investment for the training program (based on the training cost of $112,000). The use of simulation-based training exemplifies cutting-edge methods for the successful education of health care personnel regarding proper CVC insertion, which fulfills an important recommendation of the recently updated HICPAC/CDC guidelines.2

chlorhexidine-Impregnated Dressings The placement of a chlorhexidineimpregnated sponge dressing (BioPatch, Ethicon, Inc.) over the CVC insertion site has been shown to decrease CRBSIs in several randomized trials.5,78-80 A large, open RCT compared chlorhexidine dressings with standard sterile dressings in 601 chemotherapy patients (9,731 total catheter-days). The study found a significant reduction in CRBSIs in the intervention group (6.35%; 19 of 300) compared with the control group (11.3%; 34 of 301; P=0.016; RR, 0.54; 95% CI, 0.31-0.94).79 Similarly, an RCT conducted in the ICU found that the use of chlorhexidine-impregnated dressings led to significantly fewer CRBSIs than the use of standard sterile dressings (hazard ratio, 0.024; 95% CI, 0.09-0.65; P=0.005).80 The recent HICPAC/CDC guidelines for the prevention of CRBSIs recommend the use of chlorhexidine-impregnated sponge dressings with short-term CVCs in patients older than 2 months when institutional rates of CRBSIs are higher than the institutional goal, despite the consistent use of now-standard prevention measures (using well-trained personnel, chlorhexidine skin antisepsis, and maximal barrier precautions; rating 1B).2

antimicrobial-Impregnated catheters The HICPAC/CDC guidelines recommend the use of antimicrobial-coated catheters if the device is expected to remain in place longer than 5 days if, despite use of a comprehensive CRBSI reduction strategy, the rate of infections is not decreasing (rating IA).2,3 However, the majority of the studies have focused on the use of antimicrobial-coated CVCs used as short-term devices; few data are available on their use as long-term devices.18,50 Several types of antimicrobial-impregnated catheters are available: catheters coated either externally (first generation) or externally and internally (second generation) with chlorhexidine and sulfadiazine silver (CH-SS), catheters coated with minocycline or rifampin, and silver-impregnated catheters.12 Silvercoated catheters include silver-, platinum-, and carboncoated catheters and silver ion/alloy catheters.5 A meta-analysis of externally CH-SS–coated catheters found that they decreased the incidence of both catheter colonization (OR, 0.44; 95% CI, 0.36-0.54) and CRBSIs (OR, 0.56; 95% CI, 0.37-0.84) compared with uncoated catheters.53 A recent meta-analysis found a reduced risk for CRBSIs when first-generation CH-SS–coated catheters (RR, 0.66; 95% CI, 0.470.93) were compared with uncoated catheters, but no significant risk reduction among patients in the ICU (RR, 0.77; 95% CI, 0.53-1.13).50 The second-generation CH-SS–coated catheters significantly reduced

CRBSIs in ICU patients (RR, 0.70; 95% CI, 0.301.62). Minocycline- and rifampicin-coated catheters were significantly more effective than chlorhexidine gluconate/silver sulfadiazine (CHG/SSD) catheters (RR, 0.12; 95% CI, 0.02-0.67).50 The most recent meta-analysis of 27 trials evaluating anti-infective catheters found a significant reduction in CRBSIs with their use when all types were analyzed (OR, 0.49; 95% CI, 0.37-0.64).81 Subgroup analysis based on catheter type revealed reductions in CRBSIs for nearly all types compared with standard catheters: CH-SS–impregnated (5 trials; OR, 0.51; 95% CI, 0.26-1.0), silver-impregnated (6 trials; OR, 0.55; 95% CI, 0.33-0.92), minocycline-rifampin (5 trials; OR, 0.26; 95% CI, 0.15-0.47), miconazole-rifampin (1 trial; OR, 0.12; 95% CI, 0-6.07), benzalkonium chloride– impregnated (1 trial; OR, 1; 95% CI, 0.06-16.45), and CH-SS–coated (9 trials; OR, 0.62; 95% CI, 0.4-0.98).81 The choice of which catheter to use is governed by many factors, including efficacy, cost, cost-effectiveness, and risk for promoting drug resistance. A 2008 analysis found an estimated cost savings of approximately $227 for every anti-infective catheter inserted.82 Antibiotic resistance is a particular concern with antibiotic-impregnated catheters, although trials assessing the efficacy of minocycline-rifampin–coated catheters found no evidence of the emergence of drug resistance.50

antibiotic lock Solutions The major mechanism for CRBSIs in patients with long-term devices is intraluminal colonization. For this reason, antibiotic lock solutions have been considered as a logical step to prevent colonization of the intraluminal surfaces of long-term devices and thereby reduce the rate of CRBSIs. A small amount of the antibiotic solution is instilled into the lumen of the catheter and allowed to remain for a specific amount of time, after which it is either flushed or removed. A meta-analysis of 7 randomized trials (primarily involving cancer patients) demonstrated a significantly reduced risk for CRBSIs (RR, 0.49; 95% CI, 0.26-0.95) when vancomycin-containing lock solutions were used.51 A recent systematic review and meta-analysis of patients undergoing hemodialysis included data on several lock solutions: various antibiotic combinations, minocycline with EDTA, and nonantibiotic antiseptic solutions including citrate and citrate with taurolidine. All lock solutions included in this meta-analysis showed benefit for the prevention of CRBSIs.54 Ethanol also has been shown to be safe and effective as an antibiotic lock solution.49,83,84 A recently published prospective, double-blind, randomized trial comparing ethanol with heparinized saline in immunosuppressed hematology patients showed a 4-fold decrease in the number of CRBSIs in the ethanol group compared with controls (OR, 0.18; 95% CI, 0.05-0.65).84 Although a number of new antibiotics have shown promise as lock solutions during in vitro studies, more research on their efficacy is needed.85 In general, antiseptic lock solutions are preferred over antibiotic lock solutions because of their greater spectrum of activity and smaller risk for promoting antibiotic resistance.

The HICPAC/CDC guidelines include a recommendation for the use of antibiotic/antiseptic lock solutions in patients with long-term catheters who have had multiple CRBSIs despite good aseptic technique (rating II).2 The use of antibiotic lock solutions is also see bloodStReam InfeCtIonS page 16

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recommended for the prevention of CRBSIs in longterm devices for patients with episodes of CRBSIs and a high risk for recurrence, such as those on hemodialysis.

Chlorhexidine bathing has been proposed and evaluated as a strategy for reducing rates of CRBSIs.86-89 Bleasdale and colleagues compared daily chlorhexidine bathing (n=391; 2,210 patient-days) with soap and water bathing (n=445; 2,119 patient-days) among patients in 2 medical ICUs in a 2-arm crossover trial.86 There was a significant reduction in the risk for CRBSIs associated with the use of chlorhexidine bathing compared with the control group (4.1 vs 10.4 infections per 1,000 patient-days; incidence difference, 6.3; 95% CI, 1.2-11.0). A recent meta-analysis of RCTs and quasiexperimental studies evaluating chlorhexidine bathing versus a control bathing method (soap and water) demonstrated a significant reduction in the risk for CRBSIs with chlorhexidine bathing (pooled RR, 0.32; 95% CI, 0.22-0.46; P<0.0001, I2=17%).90 However, a separate retrospective analysis evaluating the effect of switching from soap and water bathing to daily chlorhexidine cleansing in a surgical ICU found no difference in the rates of CRBSIs when the different periods were compared.91 The HICPAC/CDC guidelines recommend daily chlorhexidine bathing as a strategy for reducing the rates of CRBSIs (rating II); however, the conflicting results of recent studies warrant further research in this area.2

coated luer-activated Devices In addition to the previously described protection measures, the role of needleless connectors warrants attention. Needleless connectors were developed in response to demands for the improved safety of health care workers (to prevent needlestick injuries) and are integral components of infusion systems across North America. Although needleless connectors, when properly used, clearly reduce the risk for needlestick injuries during access of an IVD or injection port,92-95 reports published over the past decade have raised concerns about their potential to increase the risk for iatrogenic BSIs.96-101 Most of these studies have been retrospective and uncontrolled; suboptimal manipulation of the device, rather than the device itself, may have been responsible for the increased incidence of CRBSIs in some settings. Typically, health care personnel disinfect the connector with 70% (v/v) isopropyl alcohol before IV administration. Although needleless connectors appeared to reduce contamination compared with standard caps,102 a recent study by Menyhay et al found that conventional methods of disinfection may not prevent microbial entry if the luer-activated device (LAD) is heavily contaminated, which may account for the increased risk for CRBSIs observed in some reports.103 The HICPAC/CDC guidelines made no recommendation for or against LADs, given the lack of RCTs on this device. However, chlorhexidine may be the preferred agent for cleaning the ports of needleless devices.2 A recent study evaluated the effect of switching to chlorhexidine for this purpose in a pre-post intervention design on a pediatric hemopoietic stem cell transplant ward.104 In this study, switching from 70% isopropyl alcohol alone to 2% chlorhexidine in 70% isopropyl alcohol for catheter connector antisepsis was associated with a reduction in the rates of CRBSIs from 12 to 3 per 1,000 catheter-days (P=0.004).

Novel technologies have been developed to address

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the association of these devices with increased rates of CRBSIs. The V-Link with VitalShield (Baxter Healthcare), which recently received FDA approval, is LAD protected, with an interior and exterior antimicrobial coating (silver). Recent in vitro studies compared the V-link with VitalShield with control devices. The studies demonstrated that the antimicrobial coating is more than 99.99% effective in killing the most common organisms responsible for CRBSIs. It also prevented downstream spread and intra-device biofilm formation when Enterobacter cloacae was inoculated and allowed to dry on the septal membrane, followed by the infusion of Lactated Ringer’s running solution at 0.5 mL per minute for 72 hours through the connected device.105 Another promising device, the Saralex-CL (Menyhay Healthcare Systems), is an antimicrobial-barrier cap that threads onto the end of a needleless LAD system. A recent prospective, in vitro study compared standard disinfection techniques for common LADs using 70% isopropyl alcohol with the Saralex-CL.106 The Saralex-CL, which uses a solution of 0.25 mL of 2% chlorhexidine gluconate in 70% isopropyl alcohol to bathe the connector septum, was effective in preventing transmission of pathogens across the membranes of precontaminated LADs compared with standard techniques (positive control = 100% transmission, standard technique = 20 of 30; 67% transmission; Saralex-CL = 1 of 60; 1.6% transmission; P<0.001). Data on the clinical efficacy of antimicrobial-coated LADs and antimicrobial-barrier caps are awaited.

catheter Securement Sutureless securement devices avoid disruption around the catheter entry site and may decrease the degree of bacterial colonization.107 Catheter stabilization also helps decrease the risk for phlebitis and catheter migration/dislodgement while diminishing the risk for needlestick injury to the health care provider.2 Device securement options include sutures, tape, and catheter-specific devices such as the StatLock (Venetec International, Inc., a subsidiary of CR Bard). Sutures may be uncomfortable for the patient, pose a risk for needlestick injury to the provider, and foster inflammation at the catheter insertion site, increasing the risk for infection. StatLock, a sutureless catheter securement device, reduces catheter-related complications, including CRBSIs.107-109 A randomized trial comparing sutures with StatLock for PICC securement found significantly fewer CRBSIs in the StatLock group than in the suture group (2 vs 10, respectively; P=0.032).107 The HICPAC/CDC guidelines recommend the use of a securement device for all intravascular catheters (rating II).2

Intensive Insulin Therapy The appropriate level of glycemic control for critically ill patients is controversial. A large RCT of 1,548 critically ill patients in a surgical ICU compared intensive insulin therapy (maintenance of blood glucose level between 80 and 110 mg/dL) with conventional insulin therapy (insulin given only for blood glucose levels >215 mg/dL and maintenance of levels between 180 and 200 mg/dL).110 The study found that intensive treatment reduced overall mortality rates (8% with conventional treatment vs 4.6% with intensive treatment;

P<0.04); the greatest mortality reduction was observed in patients with multi-organ failure caused by a septic focus. A similar study in medical ICU patients found no reduction in mortality or difference in rates of bacteremia using intensive therapy.111 A meta-analysis that included 29 RCTs and 8,432 patients found no difference in hospital mortality rates with tight glucose control (21.6% vs 23.3%; RR, 0.93; 95% CI, 0.85-1.03), and the results did not change when patients were stratified by ICU type: surgical, medical, or medical-surgical. However, tight glucose control was associated with a reduced risk for septicemia (10.9% vs 13.4%; RR, 0.76; 95% CI, 0.59-0.97).112 In the NICE-SUGAR (Normoglycaemia in Intensive Care Evaluation and Survival Using Glucose Algorithm Regulation) study, a large RCT of 6,104 adult ICU patients, intensive glycemic control (goal, 81-108 mg/dL) caused increased mortality compared with conventional control (goal, ≤180 mg/dL; OR, 1.14; 95% CI, 1.021.28; P=0.02).113 The study population included more medical than surgical ICU patients (intensive group: 36.9% surgical, 63.1% medical; conventional group: 37.2% surgical, 62.8% medical).

Severe hypoglycemia (≤40 mg/dL) was significantly more common in the intensive control group (6.8% vs 0.5%; P<0.001).113 A meta-analysis of 26 trials including 13,567 patients—with data from the NICE-SUGAR trial— found no reduction in mortality using intensive insulin therapy for critically ill patients (pooled RR of death with intensive vs conventional therapy, 0.93; 95% CI, 0.83-1.04).114 However, when analyzed separately, surgical ICU patients did have a benefit, whereas patients in nonsurgical ICUs did not (RR, 0.63; 95% CI, 0.44-0.91).114 A recent meta-analysis of 20 RCTs evaluated the effect of intensive insulin therapy on the incidence of infections in medical and surgical ICU patients. The analysis revealed an overall reduction in the incidence of infections among all pooled studies (RR, 0.80; 95% CI, 0.71-0.90; P=0.0002; I2=53.5%).115 Subgroup analysis revealed significantly fewer infections in surgical ICU patients in the intensive insulin therapy group compared with standard therapy (11 studies; pooled RR, 0.66; 95% CI, 0.57-0.76; P<0.001). However, no difference in infection rates among medical ICU patients was observed.

Pending the results of ongoing and future research, the use of intensive glycemic control for surgical ICU patients to reduce the risk for HAIs, particularly CRBSIs, is recommended. However, avoiding severe hypoglycemia is crucial, and a glycemic target that can be safely achieved should be used.

multifaceted approach using a checklist A multifaceted approach must be used to effectively reduce the risk for CRBSIs. The Institute for Healthcare Improvement (IHI) developed the concept of “bundles” to aid risk reduction. According to the IHI, a bundle is a structured way of improving the processes of care and patient outcomes using a checklist of 3 to 5 practices that, when performed collectively and reliably, have led to improved patient outcomes.116 The IHI-recommended evidence-based bundle for CVC care includes the following: 1) hand hygiene; 2) see bloodStReam InfeCtIonS page 18

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maximal barrier precautions upon insertion; 3) chlorhexidine skin antisepsis; 4) optimal catheter site selection, with the subclavian vein as the preferred site for nontunneled catheters; and 5) daily review of line necessity with prompt removal of unnecessary lines.116 A large multicenter study by Pronovost et al that used evidence-based interventions nearly identical to the IHI CVC bundle for 18 months found a significant reduction in CRBSIs from baseline. The incidence rate of CRBSIs at 0 to 3 months was 0.62 (95% CI, 0.47-0.81) and 0.34 at 16 to 18 months (95% CI, 0.23-0.5).117 These numbers represented up to a 66% reduction in the rates of CRBSIs, a reduction that also was maintained 18 months after the intervention period. The intervention was incorporated into standard practice at the individual centers, as described in a recent follow-up publication.118 Bhutta et al undertook a prospective quasi-experimental study in a children’s hospital, which included the stepwise introduction of interventions over a 5-year period.119 The interventions included maximal barrier precautions, transition to antibiotic-impregnated CVCs, annual hand-washing campaigns, and use of chlorhexidine in lieu of povidone-iodine. Significant reductions in CRBSI rates occurred over the intervention period, and were sustained over the 3-year follow-up. Annual rates decreased from 9.7 per 1,000 catheter-days in 1997 to 3 per 1,000 days in 2005 (RR reduction, 0.75; 95% CI, 0.35-1.26). The investigators agreed that multifaceted interventions of this nature reduce the rates of CRBSIs but require a multidisciplinary team and institutional support.

The recent implementation of a multifaceted approach in a pediatric cardiac ICU, which included CVC insertion and maintenance bundles, chlorhexidine-impregnated dressings, nurse and physician education, and the addition of a unit-based infection control nurse, resulted in a reduction in the rates of CRBSIs from 7.8 to 2.3

infections per 1,000 catheter-days in less than 2 years.120 The HICPAC/CDC guidelines recommend that multifaceted performance improvement strategies be “bundled” to enhance compliance with evidence-based best practices (rating IB).2

“Getting to Zero”: The crBSI mandate The concept of “Getting to Zero” was first applied by the IHI for ventilator-associated pneumonia.

Since then, the concept has been used for other HAIs, including CRBSIs. In the effort to “get to zero,” the CMS recently partnered with the NHSN and listed CRBSIs as a “never event.” This partnership creates greater transparency, builds accountability within the health care system, and promotes support for infection control programs and professionals.121 Certainly, by making CRBSI rates available, the public has the opportunity to make informed decisions regarding health care. However, there are both concerns and controversy surrounding the concept of “getting to zero” and the CRBSI mandate.

Infection control experts have shared concerns that “getting to zero” is an oversimplification of the complexity of HAIs and does not convey the important message that although the majority of HAIs are preventable, some are not.122 A commentary by Victoria Fraser, MD, Washington University School of Medicine in St. Louis, MO, pointed out that this slogan is controversial because it seems scientifically unrealistic. Moreover, patients and the general public may misinterpret the message to mean that any HAI is the result of an error or a suboptimal process.123 The concern regarding the CRBSI mandate stems mainly from the CDC’s definition of a CRBSI itself.

The definition is highly sensitive but poorly specific. The high sensitivity allows it to capture all cases of CRBSIs, but the low specificity causes it to suffer from the inclusion of infections that may not be CRBSIs. In a

thoughtful commentary by Sexton et al,124 this limitation of the surveillance definition is highlighted by specific examples where it seemed that the assignation of cases as CRBSIs was done by default (ie, simply because of the absence of proof for a secondary source of infection). The low specificity also greatly undermines the reliability of the publicly reported data on CRBSI rates. The authors then emphasize the need to change and validate the existing definition. They propose the inclusion of an “indeterminate source” category for some CRBSIs, which is “more epidemiologically and clinically useful than data derived from current definitions, which are inconsistent with common clinical practice.”124 Similarly, in a recent retrospective cohort study involving 4 medical institutions, Lin et al125 assessed whether or not surveillance data are consistent across institutions, contending that public reporting and interhospital comparisons of infection rates are only valid if the surveillance methods are uniform. The authors compared a computer algorithm reference standard for CRBSI rates with reported rates from the institution’s infection preventionists. The expected rate varied significantly by medical center, suggesting that there is indeed local variation among medical centers. This then raises doubt as to the validity of comparing published rates of CRBSIs among various institutions.125 The “getting to zero” initiative has many advantages.

It has spurred dialogue about CRBSI prevention, propelled institutions to devote more resources to CRBSI prevention, and increased awareness of these infections.

However, the campaign to publicly report CRBSIs should incorporate a uniform application of standardized definitions in institutions and a greater emphasis on process measures known to reduce the overall incidence of CRBSI.

For complete references, please visit www.generalsurgerynews.com. references 1.

2.

3.

4.

5.

6.

7.

8.

9.

10.

11.

12.

13.

14.

15.

16.

17.

18.

19.

20.

21.

22.

23.

24.

25.

26.

27.

28.

29.

30.

31.

32.

33.

Am J Infect Control. 2008;36(5):309-332.

Am J Infect Control. 2011;39(4 suppl 1):S1-S34.

Infect Control Hosp Epidemiol. 2002;23(12):759-769.

Public Health Rep. 2007;122(2):160-166.

Clin Infect Dis. 2002;34(9):1232-1242.

Mayo Clin Proc. 2006;81(9):1159-1171. http://www.hhs.gov/ophs/initiatives/hai/draft-haiplan-01062009.pdf. Accessed February 24, 2012.

Pear R. Medicare says it won’t cover hospital errors.

New York Times. August 18, 2007.

Crit Care Med. 2009;37(7):2283-2289.

JAMA. 1994;271(20):1598-1601.

Am J Infect Control. 2008;36(10):S173.e1-S173.e3.

Lancet Infect Dis. 2007;7(10):645-657.

Crit Care Med. 2007;35(10):2424-2427.

Clin Infect Dis. 2002;35(5):627-630.

Clin Infect Dis. 2004;39(3):309-317.

Intensive Care Med. 2004;30(1):62-67.

J Clin Microbiol. 1985;21(3):357-360.

Clin Infect Dis. 2002;34(10):1362-1368.

Clin Infect Dis. 2009;49(1):1-45.

Crit Care Med. 2002;30(12):2632-2635.

Clin Infect Dis. 2010;50(12):1575-1579.

Ann Intern Med. 2005;142(6):451-466.

Lancet. 1999;354(9184):1071-1077.

Pediatr Infect Dis J. 2008;27(8):681-685.

J Clin Microbiol. 1998;36(1):105-109.

JPEN J Parenter Enteral Nutr. 2003;27(2):146-150.

Curr Infect Dis Rep. 2005;7(6):413-419.

J Clin Pathol. 1997;50(4):278-282.

Lancet. 1999;354(9189):1504-1507.

JPEN J Parenter Enteral Nutr. 1996;20(3):215-218.

Am J Med. 1991;90(1):128-130.

Nephrol Dial Transplant. 1993;8(3):231-234.

Clin Infect Dis. 1998;27(3):478-486.

34.

35.

36.

37.

38.

39.

40.

41.

42.

43.

44.

45.

46.

47.

48.

49.

50.

51.

52.

53.

54.

55.

56.

57.

58.

59.

60.

61.

62.

63.

64.

65.

66.

67.

Intern Med J. 2005;35(suppl 2):S45-S62.

Cancer Invest. 2002;20(7-8):1105-1113.

Infect Control Hosp Epidemiol. 2004;25(8):646-649.

Pediatr Infect Dis J. 1994;13(10):930-931.

Medicine (Baltimore). 2009;88(5):279-283.

Arch Intern Med. 1995;155(22):2429-2435.

Infect Control Hosp Epidemiol. 1998;19(11):846-850.

Clin Infect Dis. 1999;29(1):102-105.

Nephron. 1997;75(3):354-355.

Ann Intern Med. 1999;130(10):810-820.

Ann Pharmacother. 2005;39(2):311-318.

Antimicrob Agents Chemother. 1999;43(8):2074-2076.

Int J Antimicrob Agents. 2008;32(6):515-518.

Ann Intern Med. 2002;136(11):792-801.

J Antimicrob Chemother. 2006;58(2):281-287.

JPEN J Parenter Enteral Nutr. 2007;31(4):302-305.

Am J Infect Control. 2008;36(2):104-117.

Clin Infect Dis. 2006;43(4):474-484.

Clin Infect Dis. 2003;37(12):1629-1638.

JAMA. 1999;281(3):261-267.

Clin Infect Dis. 2008;47(1):83-93.

Am J Infect Control. 1995;23(1):5-12.

Lancet. 1991;338(8763):339-343.

Clin Infect Dis. 2003;37(6):764-771.

Ann Intern Med. 2004; 140(6):419-425.

J Clin Microbiol. 2009;47(7):2279-2280.

Ren Fail. 2008;30(4):417-422.

Infect Control Hosp Epidemiol. 2008;29(3):284; author reply 284-285.

Jpn J Infect Dis. 2008;61(2):107-110.

Mil Med. 2008; 173(6):604-608.

Euro Surveill. 2008;13(14):pii=8084.

J Am Soc Nephrol. 2005;16(5):1456-1462.

Infect Control Hosp Epidemiol. 1994; 15 (4 pt 1):231-238.

Infect Control Hosp Epidemiol. 1998;19(11):842-845.

68.

69.

70.

71.

72.

73.

74.

75.

76.

77.

78.

79.

80.

81.

82.

83.

84.

85.

86.

87.

88.

89.

90.

91.

92.

93.

94.

95.

96.

97.

98.

Chest. 2000;117(1):178-183.

Am J Med. 1991;91(3B):197S-205S. JAMA. 2001;286(6):700-707.

J Clin Microbiol. 1990;28(11):2520-2525.

JAMA. 2008;299(20):2413-2422.

Intensive Care Med. 2008;34(6):1038-1045.

Crit Care. 2006;10(6):R162.

Crit Care Med. 1996;24(12):2053-2058.

Arch Intern Med. 2009;169(15):1420-1423.

Simul Healthc. 2010;5(2):98-102.

Maki D, Mermel LA, Kluger DM. Presented at: 40th Interscience Conference on Antimicrobial Agents and Chemotherapy; September 17-20, 2000; Toronto, Ontario.

Ann Hematol. 2009;88(3):267-272.

JAMA. 2009;301(12):1231-1241.

Crit Care Med. 2009;37(2):702-712.

Health Technol Assess. 2008;12(12):iii-iv, xi-xii, 1-154.

Infect Control Hosp Epidemiol. 2005;26(8):708-714.

J Antimicrob Chemother. 2008;62(4):809-815.

Ann Pharmacother. 2009;43(2):210-219.

Arch Intern Med. 2007;167(19):2073-2079.

Crit Care Med. 2009;37(6):1858-1865 Infect Control Hosp Epidemiol. 2009;30(11):1031-1035.

Infect Control Hosp Epidemiol. 2009;30(10):959-963.

Silva GLM, Safdar N. Presented at: Fifth Decennial International Conference on Healthcare-Associated Infections; March 18-22, 2010; Atlanta, GA. Intensive Care Med. 2010;36(5):854-858.

J Healthc Mater Manage. 1993;11(8):44-46, 48-49.

Infect Control Hosp Epidemiol. 1997;18(3):175-182.

Infect Control Hosp Epidemiol. 1998;19(6):401-406.

Am J Infect Control. 1993;21(1):39-41.

Infect Control Hosp Epidemiol. 1998;19(1):23-27.

J Infect Dis. 1999;179(2):442-448.

J Pediatr. 1996;129(5):711-717.

99.

100.

101.

102.

103.

104.

105.

106.

107.

108.

109.

110.

111.

112.

113.

114.

115.

116.

117.

118.

119.

120.

121.

122.

123.

124.

125.

Infect Control Hosp Epidemiol. 1998;19(10):772-777.

Clin Infect Dis. 2007;44(11):1408-1414.

Infect Control Hosp Epidemiol. 2007;28(6):684-688.

J Hosp Infect. 2003;54(4):288-293.

Infect Control Hosp Epidemiol. 2006;27(1):23-27.

Am J Infect Control. 2009;37(8):626-630.

Clin Infect Dis. 2010;50(12):1580-1587.

Am J Infect Control. 2008; 36(10):S174.e1-S174.e5.

J Vasc Interv Radiol. 2002;13(1):77-81.

Infus Nurs. 2006; 29(1):34-38.

J Infus Nurs. 2006;29(4):225-231.

N Engl J Med. 2001;345(19): 1359-1367.

N Engl J Med. 2006;354(5):449-461.

JAMA. 2008;300(8):933-944.

N Engl J Med. 2009; 360(13):1283-1297.

CMAJ. 2009;180(8):821-827.

Safdar N, Ziegler M, Abad C, Silva G. Presented at: Fifth Decennial International Conference on Healthcare-Associated Infections; March 18-22, 2010; Atlanta, GA. http://www.ihi.org/IHI/Topics/CriticalCare/IntensiveCare/ImprovementStories/WhatIsaBundle.htm.

Accessed February 24, 2012.

N Engl J Med. 2006;355(26):2725-2732.

BMJ. 2010;340:c309.

BMJ. 2007;334(7589):362-365.

Pediatrics. 2008;121(5):915-923. http://www.infectioncontroltoday.com/articles/zerotolerance.html. Accessed February 24, 2012.

Infect Control Hosp Epidemiol. 2009;30(1):71-73.

Infect Control Hosp Epidemiol. 2009;30(1):67-70.

Infect Control Hosp Epidemiol. 2010;31(12):1286-1289.

JAMA. 2010;304(18):2035-2041.

Drs. Abad and Safdar reported no relevant conflicts of interest.

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22

In the news CeNtral-liNe continued from page 1

583 and 584).

Involving caregivers at all levels and providing frequent, regular feedback on infection rates to hospital staff are two key elements that have made these programs a success, experts said.

Matthias Walz, MD, chief of vascular anesthesiology at UMASS Medical Center, said the guidelines at his facility were developed by a small task force and then approved by the institution’s Critical Care Operations Committee prior to implementation. “From the ICU physicians to the ICU nurses, respiratory therapists, pharmacy team, occupational therapists ... everybody is at the table.”

Because all disciplines were involved in creating the guidelines, all caregivers feel they have a stake in the process, he said.

Although the landmark study by Peter Pronovost, MD, and colleagues is an example of a success story—a reduction in central-line infection rates of 66% in 18 months (N Engl J Med 2006;355:2725-2732)—the UMASS project is unique for its long follow-up, Dr. Walz said.

Infection rates steadily declined throughout the study period, from 5.86 per 1,000 catheter-days in 2004 to 0.6 per 1,000 in 2011. Studies have shown that although programs can be successful in reducing the number of centralline infections, compliance can drop off over time (Arch Surg 2004;139:131-136).

GEnERalSuRGERynEWS.COM / GEnERal SuRGERy nEWS / MaRCh 2012

The new study demonstrates a program with stamina.

In the UMASS program, ICUs receive data on their infection rates on a monthly basis, allowing for timely reaction. The program includes elements of the Pronovost study, such as the use of a dedicated catheter cart for supplies, checklists to ensure adherence to infection-control procedures, empowering nurses to halt a procedure if checklist elements are not followed and removal of unnecessary catheters.

Clinicians also rely on a preprocedural timeout, and they use chlorhexidine sponges and antibiotic-impregnated catheters. Re-education is key. “If you don’t continue to re-educate your staff and monitor progress, rates will creep back up again,” Dr. Walz said.

In both the UMASS and Ohio State approaches, researchers investigate any identified infections to determine if opportunities to prevent them were missed. At Ohio State, infection rates fell from 2.9 per 1,000 catheter-days in 2009 to 1.95 per 1,000 in 2010. The researchers noted that their data for 2011 were incomplete but appeared to indicate further reductions in infections.

The Ohio State approach includes weekly surveillance of infection rates from its clinical epidemiology unit.

“Previously, we would get quarterly data and you would hear that you had three central-line infections, but you wouldn’t hear who the patients were, and you were so far removed from the events that no one could remember what actually happened,” said Mathew Exline, MD,

‘I think the use of teams works so well because there is a lot of wisdom that you can get from individuals with different experiences.’

—Trish Perl, MD

associate director of the ICU at the institution. “Now, you can go to the nurse who drew the blood culture and you can go to the physician who put in the line and ask them questions about the event, because it is still fresh in everyone’s mind.”

Ohio State also incorporates components of the Pronovost study with an emphasis on re-education regarding line insertion and maintenance, the use of daily checklists to increase adherence to guidelines and identifying noncompliance with evidence-based guidelines.

“Unless you really have someone who is a champion who says ‘this is really

important, we need to focus on it,’ there are so many things going on in the ICU, that it is easy for the checklist to fall by the wayside,” Dr. Exline said.

Trish Perl, MD, professor of medicine, pathology and epidemiology at Johns Hopkins University, in Baltimore, said the two studies add to the growing evidence that teamwork can reduce central line–related blood infections.

“I think the use of teams works so well because there is a lot of wisdom that you can get from individuals with different experiences. For example, my perspective may be very different from somebody who is in the trenches,” Dr. Perl said. And she echoed the importance of having a champion.

“If you have a really good and engaged champion, it makes a lot of difference,” Dr. Perl said. “If people really believe low rates are achievable and it is an expectation and the institution and employees have accountability and hence really facilitate the interventions, it makes a lot of difference.”

New Technique Could Improve Pancreatic Cancer Staging, Treatment laparoscopy using Fluorescent Markers and lED light B y C hRIstIna F RangOu

A

new laparoscopic technique that uses fluorescent antibody markers and an LED light source has the potential to improve pancreatic staging and treatment, according to a report presented at the 2011 Clinical Congress of the American College of Surgeons.

Researchers took two antibodies commonly expressed by pancreatic cancer and tagged them with a fluorescent marker, making the cancer cells light up in bright green or red. The researchers then administered the fluorescent antibodies into mice and studied the mice under LED light and during traditional laparoscopy.

Analysis showed that the LED light vividly identified the primary and metastatic tumors, with a sensitivity rate of 96% compared with 40% for traditional laparoscopy. Fluorescent laparoscopy rendered fewer false-positives than traditional laparoscopy and was sensitive enough to illuminate metastatic lesions

The leD light improves visualization of both the tumor and surrounding anatomy in the abdominal cavity.

smaller than 1 mm, which are not visible with a standard laparoscope.

The combination of fluorescent markers and LED light potentially could sharpen how surgeons detect and treat pancreatic cancer in human patients, said investigators Michael Bouvet, MD, and Robert M. Hoffman, PhD, both professors of surgery at the University of California, San Diego (UCSD).

The LED light improves visualization of both the tumor and the surrounding anatomy in the abdominal cavity of the mice. “You can see both the normal background of the anatomy plus the fluorescent tumor signal at the same time,” said Dr. Bouvet, in a press release.

The technology also could be used to target tumor cells for treatment with drugs, but the work is still in early stages. The surgeons plan to join forces with industry to secure FDA approval for clinical trials of the fluorescent antibodies in humans.

The research was funded by a five-year grant to UCSD and AntiCancer, Inc. from the National Cancer Institute. The UCSD team worked with AntiCancer Inc. on the mouse model and with laparoscopic technicians at Stryker Corporation.

In the news

GEnERalSuRGERynEWS.COM / GEnERal SuRGERy nEWS / MaRCh 2012

Study Details Risks for Contralateral Cancer in BRCA1/2 B y K ate O’R OuRKe A study has provided some hard statistics regarding the risk that women carrying BRCA1/2 mutations will develop a contralateral breast cancer (CBC) and how factors, such as age and a triple-negative diagnosis, affect that risk. The findings provide risk estimates that doctors can use to counsel patients when discussing

treatment options.

“Medical decision making weighs the risks and benefits of the situation at hand. For a woman with breast cancer to make a decision on the management of the nonaffected breast, it is important to quantify the risk for developing contralateral breast cancer,” said Catherine Van Poznak, MD, medical oncologist at the University of Michigan,

in Dearborn, who was not involved with the study. “The data generated in this study aids that risk assessment.”

Researchers have known for years that the risk that a woman will develop CBC is higher than an average woman’s risk for developing a first cancer; this risk is even greater if the woman carries the BRCA1/2 mutation. But until this study, CBC risk estimates for a large unselected population

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‘when looking only at the first five years, the effect is significant.’

—Alexandra van den Broek did not exist, said Alexandra van den Broek, doctoral candidate at the Netherlands Cancer Institute who presented the work at the San Antonio Breast Cancer Symposium (abstract S4-2).

In the study, a consecutive series of patients with invasive breast cancer were tested for BRCA mutations. The study included women who were diagnosed before the age of 50 from 1970 to 2003 in 10 different hospitals throughout the Netherlands. Of the 5,061 women in the study, about 4% were BRCA carriers; 3.04% had BRCA1 mutations and 1.13% had BRCA2 mutations.

The cumulative 10-year CBC risk was 6% for noncarriers compared with 11.1% for BRCA2 carriers (P<0.05) and 20.3% for BRCA1 carriers (P<0.01). Age at diagnosis was a significant predictor of cumulative 10-year risk for CBC in BRCA carriers: 26% in women diagnosed younger than age 41 and 11.6% in women diagnosed between the ages of 41 and 50.

The cumulative 10-year CBC risk was 18.9% in patients with triple-negative status compared with 11.2% in patients who were not triple-negative, but this was not statistically significant. “When looking only at the first five years, the effect is significant,” said Ms. van den Broek.

The analysis allowed the researchers to define subgroups of BRCA1/2 carriers with decreased and increased 10-year risk for CBC. “The low-risk subgroup [3.5%] were the patients with a non–triple-negative first breast cancer diagnosed between the ages of 41 and 50, which had almost similar risk to the noncarriers,” said Ms. van den Broek. She defined two high-risk groups. The first group was women with triple-negative breast cancer who were first diagnosed between the ages of 41 and 50; they had a 15% risk. The second group was women with a first breast cancer diagnosed before the age of 41; this group had a 26% risk.

This information should help doctors counsel patients, Ms. van den Broek said. “The analysis ... suggests that risks for contralateral breast cancer within 10 years may be estimated based on age and BRCA1/2 status,” she said. If the results are confirmed, age criteria and receptor status of the first breast cancers might be included in guidelines for prophylactic measures and screening in the follow-up of BRCA1/2 mutations carriers.

23

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Issues for the BarIatrIc & MetaBolIc ProfessIonal

Extended Quarterly Coverage

Endoscopic Bariatric Therapies Gain Traction With Paper B y C hRIstIna F RangOu

E

ndoscopic bariatric therapies may become an accepted outpatient alternative to bariatric surgery, according to a new white paper supported by the American Society for Gastrointestinal Endoscopy (ASGE) and the American Society for Metabol-ic and Bariatric Surgery (ASMBS).

The two societies set up a joint task force to identify opportunities where endoscopic treatments could play a role in improving patient outcomes and reducing costs associated with obesity.

The task force, which included both gastroenterologists and surgeons, laid out the criteria for success as endoscopic technologies and procedures are developed, addressing treatment classification, potential indications and efficacy, said Gregory G. Ginsberg, MD, president and chair of the ASGE/ASMBS task force on endoscopic bariatric therapies. To date, however, the technologies are still considered investigational; longterm studies involving significant numbers of patients are still lacking.

The white paper is published in both Gastrointestinal Endoscopy (2011;74:943-953), the peer-reviewed scientific journal of the ASGE, and Surgery for Obesity and Related Diseases (2011;7:672-682), the peer-reviewed scientific journal of the ASMBS. “This is an important paper. It does an excellent job of defining the issues and challenges of endoscopic bariatric therapies and provides a framework for the field to move forward,” said Stacy Brethauer, MD, staff surgeon at the Cleveland Clinic in Ohio, who was not involved in writing the paper.

The field of endoscopic bariatric therapy needs to advance because it fills a gap between medical therapy and surgery, he said. The white paper lays out a clear pathway to develop these therapies and establishes initial benchmarks for their development.

‘This is an important paper.

It does an excellent job of defining the issues and challenges of endoscopic bariatric therapies and provides a framework for the field to move forward.’

—Stacy Brethauer, MD

Moreover, the paper marks an important collaboration between gastroenterologists and bariatric surgeons.

“We need to work together on this issue and combine their technical and clinical expertise to provide better care for the obese patient,” said Dr. Brethauer.

The white paper describes several endoscopic bariatric therapies currently being developed, including gastric restriction or manipulation by endoscopic placement of a space-occupying device, endoscopic stapling or suturing, as well as malabsorptive techniques, such as endoscopic placement of a duodenal-jejunal barrier sleeve, or neurohormonal alterations. Although promising, these approaches are still in the very early stages of development.

Endoscopic techniques may be applicable to a wide range of obese patients, more than traditional primary bariatric surgery, provided that studies can validate the techniques, said the authors.

“Endoscopic therapy has the potential to be applied across the continuum of obesity and metabolic disease,” said Bipan Chand, MD, chairman of the ASMBS Emerging Technology and Procedure Committee and co-chair of the ASGE/ASMBS task force.

Dr. Chand noted that endoscopic modalities must achieve weight loss superior to medical and intensive lifestyle interventions. A technique also will have to have a “favorable risk–benefit profile and scientific evidence to support its use,” he said.

As outlined in the white paper,endoscopic bariatric therapies can be used as a primary weight loss procedure, or as a pre- or

as endoscopic techniques for bariatric patients are developed, programs will need to be modified to accommodate patients who qualify for these treatments. endoscopy suites will need updating to treat bariatric patients and their families.

postsurgical procedure. The procedures also could be used as an early intervention or preemptive obesity therapy for patients with less severe obesity or as a bridge therapy to ready very obese patients for follow-up interventions, such as bariatric or orthopedic surgery or organ transplants.

Endoscopic bariatric therapy also could be justified in patients with less severe obesity as a metabolic therapy, the task force found. Obese patients who lost 5% of their total body weight benefited from significant reductions in diabetes and cardiovascular risk factors.

An endoscopic procedure that could produce a minimum 5% of total body weight loss could be used for this kind of therapy, the authors said.

Endoscopic modalities must meet standards for risk and efficacy, the report’s authors stressed. Higher-risk endoscopic modalities must yield more

substantial improvements in weight loss. The authors set out clear markers for risk versus weight. For example, they found that an endoscopic treatment designed for primary weight loss must have a Grade III weight loss rating, which is equivalent to gas gastric banding, or achieve a minimum of 25% excess weight loss, have a moder moderate safety risk and have durable effects.

In contrast, an acceptable bridge proce procedure would require total weight loss of about 5% or the same as medical thera therapy, and a minimal safety risk, much like colonoscopy, or six-month duration.

As endoscopic techniques for bariatric patients are developed, programs will need to be modified to accom accommodate patients who qualify for these treatments. Endoscopy suites will need updating to treat bariatric patients and their families. Nutritional support, experienced nursing care, behavior behavioral medicine specialists and physicians experienced in the management of obese patients will be essential to these programs, said the authors. Additionally, any practitioner who is interested in performing endoscopic bariatric techniques also should be educated in the clinical management of obese patients.

Currently, endoscopic therapies are only offered to patients in feasibility trials. Patients are eager to try lessinvasive procedures, and primary care physicians are excited about the possibility of referring patients for this lessinvasive approach, said Dr. Brethauer.

“These therapies have great potential to get effective therapy to many more patients.” However, he added, “They will not replace surgery in the foreseeable future.”

Dr. Brethauer is a consultant for Apollo Endosurgery and BARD/Davol, and serves as a consultant and scientific advisory board member for Ethicon EndoSurgery. The authors of the white paper reported the following disclosures: Dr. Chand serves in an advisory role for Apollo Surgery, BARD, Covidien and HourGlass, and has an advisory role and consultant position for Ethicon Endo-Surgery.

Dr. Nguyen is a consultant to Covidien, Ethicon and Reshape Medical. Dr. Pryor has an ownership interest in BaroSense and TransEnterix, has received research support and honoraria from Covidien, and has received honoraria from Olympus.

Dr. Thompson reported relationships with Apollo Endosurgery, BARD, BaroSense, Beacon Endoscopic, Boston Scientific, Covidien, Olympus, USGI Medical, ValenTx and Vysera. All other authors of the white paper disclosed no relevant financial relationships.

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Study Shows Plateauing of Obesity, Conflicting With Earlier Studies B y g eORge O ChOa

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wo new articles by researchers from the Centers for Disease Control and Prevention (CDC) suggest that obesity has been plateauing in the United States in recent years, in contrast to the rising trend that has long characterized the problem. Although this news would appear to be promising, it conflicts with other studies that suggest obesity rates are not only rising but will continue to increase for years to come.

The new articles, which report that obesity trends are leveling off, are based on data from the National Health and Nutrition Examination Survey (NHANES).

One trial found that from 2009 to 2010, obesity prevalence in adults aged 20 years or older was 35.5% among men and 35.8% among women, with no significant change compared with 2003 to 2008 (P=0.08 for men and P=0.24 for women; JAMA 2012;307:491-497). Over the 12-year period from 1999 to 2010, obesity did not increase significantly among women (annual change in odds ratio [AOR], 1.01; 95% confidence interval [CI], 1.00-1.03; P=0.07), but did slightly for men (AOR, 1.04; 95% CI, 1.021.06; P<0.001). Additionally, increases in obesity were statistically significant for non-Hispanic black and Mexican American women (P=0.04 and P=0.046, respectively).

“There’s been no [large or notable] change in recent years,” said Cynthia L. Ogden, PhD, MRP, epidemiologist and branch chief in the Division of Health and Nutrition Examination Surveys, National Center for Health Statistics, CDC, Hyattsville, Md., and lead author of the study.

The other study found no difference in obesity prevalence among men or women between 2007-2008 and 2009-2010 (P=0.62 and P=0.65, respectively). The obesity prevalence in children and adolescents between 2009 and 2010 was 16.9% (JAMA 2012;307:483-490). But the analysis over a 12-year period indicated a significant increase in obesity prevalence from 1999-2000 to 2009-2010 in males aged 2 to 19 years (OR, 1.05; 95% CI, 1.01-1.10) but not in females (OR, 1.02; 95% CI, 0.98-1.07).

Overall, the plateau of obesity rates represents a marked change from the past, the study authors noted, reporting a substantial increase in population prevalence of obesity of almost 8% from 1980 to 1994, and a similar increase from 1994 to 2000.

“Our data suggest [obesity among U.S. adults] is plateauing,” said Katherine M. Flegal, PhD, senior research scientist, National Center for Health Statistics, and investigator on both studies.

The results from several other recent studies, however, conflict with those from JAMA. A Lancet trial projected that there will be 65 million more obese adults in the United States by 2030 (2011;378:815825). Additionally, a study presented at the 2011 American Heart Association Scientific Sessions by Mark Huffman, MD, MPH, used trends based on NHANES data from 1988 to 2008 to make forward linear projections to 2020. Applying these methods, the researchers estimated that 43% of men and 42% of women would be obese by 2020.

Dr. Huffman, assistant professor in the Departments of Preventive Medicine and Medicine-Cardiology, Northwestern University Feinberg School of Medicine, Chicago, said in an email that he stands

‘note that both the current prevalence as well as our projections of obesity prevalence are both unacceptably high and lead to substantial premature death and disability....’

—Mark Huffman, MD, MPH by his 2020 estimates “based on past projections.” He observed that an increasing obesity trend among males aged 2 to 19 years between 1999 and 2010 “may increase the prevalence of obesity among adults 20 years and older, despite recent trends. Note that both the current prevalence as well as our projections of obesity prevalence are both unacceptably high and lead to substantial premature death and disability, necessitating populationand individual-level interventions.”

Michael Nusbaum, MD, chief of bariatric surgery, Morristown Medical Center, Morristown, N.J., and president, New

Jersey chapter of the American Society for Metabolic & Bariatric Surgery, said in an interview, “I would agree that the level of rise in obesity has decreased. The growth curve has started to flatten out, though not completely.”

However, Dr. Nusbaum added, “There’s such a push against obesity, we should be seeing a decrease and we aren’t.” An obesity prevalence rate of about 35% “is alarming and we shouldn’t downplay it.”

Asked about studies projecting a continuing increase in obesity, Dr. Flegal said, “We don’t predict the future.” But lead author of the Lancet study, Y. Claire Wang, MD, ScD, assistant professor, Department of Health Policy & Management, Columbia Mailman School of Public Health, New York City, asked in an email: “Can we really avoid making any projections? Or are we equally confident that the trend will go flat from now on so we don’t need to anticipate or prepare for the increase in disease burdens?”

Drs. Flegal, Huffman, Nusbaum, Ogden and Wang reported no relevant financial disclosures.

Bariatric Surgery Associated With Reduced Risk for CV Events and Deaths B y g eORge O ChOa

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ompared with usual care, bariatric surgery is associated with a reduced number of cardiovascular (CV) deaths and lower incidence of CV events in obese adults, according to the results of a Swedish study (JAMA 2012;307:56-65).

In the prospective, nonrandomized controlled trial, 2,010 obese patients underwent bariatric surgery (gastric bypass, banding or vertical banded gastroplasty) and 2,037 controls received usual care. Patients were recruited over a 13-year period and followed for a median of 14.7 years. Body mass index (BMI) was at least 34 kg/m² in men and at least 38 kg/m² in women.

There were 28 CV deaths in the surgery group

versus 49 in the control group (P=0.002). The number of total first-time fatal or nonfatal CV events (myocardial infarction or stroke, whichever came first) was lower in the surgery group (199 events) than in the control group (234 events; P<0.001).

“The main finding, based on predefined aims, is that bariatric surgery is in fact reducing the incidence of CV events,” lead author Lars Sjöström, MD, PhD, professor, Institution of Internal Medicine, University of Gothenburg and Sahlgrenska University Hospital, Gothenburg, Sweden, wrote in an email. “This will further strengthen the position of bariatric surgery as an important obesity treatment.”

In post hoc analyses, a higher baseline insulin concentration, but not preoperative BMI, was associated

with better outcome of bariatric surgery on CV events.

Weight loss after surgery was not related to reduced incidence of CV events. Dr. Sjöström expressed hope that his study findings will “stimulate further research trying to identify mechanisms behind weight change– independent favorable effects of bariatric surgery.”

Dr. Sjöström reported the following financial disclosures: unrestricted Swedish Obese Subjects grants from Sanofiaventis and Johnson & Johnson since 2007; lecture and consulting fees from AstraZeneca, Biovitrum, BristolMyers Squibb, GlaxoSmithKline, Hoffmann LaRoche, Johnson & Johnson, Lenimen, Merck, Novo Nordisk, Sanofi-aventis, and Servier; and holding stocks in Lenimen. He is also chairman of the board for Lenimen.

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Obesity and Chronic Pain Linked in Large-Scale Study B y g eORge O ChOa

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bese individuals are more prone to daily pain, new data show. In a study of more than 1 million randomly selected individuals in the United States, a clear association between body mass index (BMI) and pain was seen, even after controlling for demographic variables (Obesity [Silver Spring]; 2012 Jan 19. [Epub ahead of print]).

Previous studies have suggested an association between obesity and pain, but “with data on over 1 million participants, this is likely the largest epidemiological examination of the pain–obesity relationship,” wrote Niloofar Afari, PhD, associate professor in the Department of Psychiatry, University of California, San Diego, in an email.

‘There’s been some investigation of the link between obesity and pain, but there’s still lots to be known in terms of the mechanisms that underlie the relationship.’

—Niloofar Afari, PhD Dr. Afari, senior author of a previous study (Pain 2010;11:628-635) that analyzed twin data to determine the relationship between chronic pain and overweight and obesity, commented: “Like our own paper, this [new one] is a population-based study, meaning that the findings are likely not due to health care seeking.” However, Dr. Afari added, “Their finding of a modest relationship between pain and obesity, which is not accounted for by specific pain conditions, contributes to the literature [on the topic].”

The new study analyzed telephone survey data on 1,062,271 adults collected from 2008 to 2010 by the Gallup Organization. Survey questions included height and weight, allowing researchers to calculate BMI, questions about pain conditions in the past year and a query about pain experience in the past day. The

participants were categorized by escalating BMI: lownormal group (BMI <25 kg/m2); overweight group (BMI 25-30); obese I group (BMI 30-35); obese II group (BMI 35-40); and obese III group (BMI >40).

The researchers found that 19.2% of the participants were in the low-normal BMI range, 21.4% were classified as overweight and the remaining 59.4% were in the three obese categories. Compared with the low-normal BMI group, the overweight group reported 20% more pain, and the obese I, II and III groups reported 68%, 136% and 254% more pain, respectively. The association held for both men and women and was stronger in older age groups. Women presented a steeper trend as BMI increased than the men.

The authors concluded that “BMI and daily pain are positively correlated in the United States,” adding that the association is “robust” and persists after controlling for several pain conditions and across gender and age.

Arthur A. Stone, PhD, distinguished professor and vice-chair, Department of Psychiatry and Behavioral Science, Stony Brook University, Stony Brook, N.Y., wrote that his article is an advance on the previous literature in at least two ways. “First, prior studies demonstrating this association were limited by their small sample sizes and, often, by their restriction to certain geographic areas. This study is representative of the entire United States and has a very large sample size. … Second, pain was measured with a relatively new technique of asking respondents about their pain ‘yesterday.’ This measurement technique avoids distortion in the results due to biases associated with imperfect recall.”

Much remains unclear about the relationship between obesity and pain, Dr. Afari noted. “There’s been some investigation of the link between obesity and pain, but there’s still lots to be known in terms of the mechanisms that underlie the relationship.”

Dr. Stone said, “[We] speculate that certain hormones associated with body fat could impact inflammatory processes, which themselves are associated with increased pain. [F]uture research will have to confirm that speculation.”

Michael Nusbaum, MD, chief of bariatric surgery,

Morristown Medical Center, Morristown, N.J., and president of the New Jersey chapter of the American Society for Metabolic & Bariatric Surgery, noted the role of musculoskeletal pain. “Morbidly obese patients carry much more weight, and are subject to joint pain and back pain,” Dr. Nusbaum said. “Morbidly obese people also suffer from a chronic inflammatory response as a result of being obese.”

Drs. Afari and Nusbaum reported no relevant financial disclosures. Dr. Stone reported the following relevant financial disclosures: senior scientist with the Gallup Organization, senior consultant with PRO Consulting and member of the Scientific Advisory Board of Wellness & Prevention, Inc.

GERD on the Sharp Rise in Norway, with Obesity a Likely Culprit B y g eORge O ChOa

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n Norway, the prevalence of gastroesophageal reflux disease (GERD) symptoms has risen almost 50% in the past decade, and the main suspect is increased obesity, according to a population-based cohort study in Gut (published online Dec. 21; 10.1136/ gutjnl-2011-300715).

Because GERD can lead to esophageal cancer, “in a public health view the increasing occurrence of GERD is alarming,” commented lead author Eivind NessJensen, MD, PhD student, HUNT Research Centre, Department of Public Health and General Practice, Norwegian University of Science and Technology, and Department of Internal Medicine, Levanger Hospital, Nord-Trøndelag Hospital Trust, Levanger, Norway.

Conducted within the Nord-Trøndelag Health Study, a longitudinal series of population-based health surveys in a single county, the Gut study asked 59,000 participants from 1995 to 1997 and 45,000 from 2006 to 2009, “To what degree have you had heartburn or acid regurgitation during the previous 12 months?” and “If you have had heartburn or acid regurgitation during the previous 12 months, how often do you have complaints?”

During the intervening years, the prevalence of any, severe and at least weekly GERD symptoms increased, respectively, by 30%, 24% and 47%, according to the researchers. The average annual incidence of any and severe GERD symptoms in the study was, respectively, 3.07% and 0.23%. Age was an important risk factor for incidence of GERD symptoms among women but not men. Average annual spontaneous loss of any

symptoms was 2.32%.

Increased obesity is believed to be the main factor contributing to the increase in GERD symptoms. Dr. Ness-Jensen noted in an email that this “is based on a strong and consistent association between GERD and obesity in other population-based studies, clinical studies and experimental studies. Other lifestyle factors probably contribute as well, but to a lower degree.”

Asked whether weight loss in obese people would reduce the risk for GERD and esophageal cancer, Dr. Ness-Jensen replied, “We are doing a study on this now, and hope to publish our results during this spring.”

Dr. Ness-Jensen reported no financial disclosures relevant to this article.

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Obese Children Require Less Propofol, Study Suggests B y M IChael V lessIdes cHicago—Contrary to what many anesthesiologists may think, the effective dose of propofol is significantly lower for obese children than their non-obese counterparts, a new study suggests. These findings become even more important, the researchers said, given that propofol decreases systemic vascular resistance, and unnecessarily large doses may result in moderate to severe hypotension.

“As we all know, there’s an increasing number of obese children presenting for surgery,” said study leader Olutoyin A. Olutoye, MD, staff anesthesiologist at Texas Children’s Hospital, in Houston.

“As anesthesiologists, we’re faced with the challenge of how to exactly dose intravenous anesthetics in this subset of patients.”

As much as 75% of excess weight in obese children is fat, which alters the distribution of lipophilic drugs such as propofol.

For their study, Dr. Olutoye and her

colleagues enrolled 40 obese and 40 nonobese children (aged 3-17 years), all of whom were presenting for ambulatory surgical procedures. Obesity was defined as a body mass index above the 95th percentile for age.

Each patient was assigned to receive a dose of propofol between 1 and 4.25 mg/kg, based on the previous patient’s response. “If a patient did not fall asleep with their assigned dose, the next patient received the next higher dose in the sequence,” Dr. Olutoye explained. “If a patient fell asleep, the next patient was randomized using a prestudy randomization process with a 95% probability to receive the same dose or 5% probability to receive the next lower dose. We didn’t really know what we would find when we designed the study, so we started at the lowest dose of propofol where we did not expect a response,” said Dr. Olutoye, who presented her group’s findings at the 2011 annual meeting of the American Society of Anesthesiologists (abstract 048). “That way, we would be able to increase the dose until we got the

Low BMI Associated With Higher Postoperative 30-Day Mortality B y V ICtORIa s teRn

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atients with a lower than normal body mass index (BMI) appear to have a higher 30-day mortality risk following surgery than overweight or heavy patients, according to a study published in Archives of Surgery (doi:10.1001/archsurg.2011.310).

According to the U.S. Centers for Disease Control and Prevention, a BMI below 18.5 kg/m2 is underweight, between 18.5 and 24.9 kg/m2 is normal, 25 to 29.9 kg/m2 is overweight, and 30 kg/m2 and above is obese.

With a growing obese population in the United States, Florence Turrentine, PhD, RN, Department of Surgery at the University of Virginia, Charlottesville, and colleagues wanted to determine the mortality risks associated with operating on overweight patients.

The team of researchers retrospectively assessed the relationship between BMI and 30-day mortality risk among 189,533 cases of general and vascular surgical procedures performed at 183 sites between 2005 and 2006. Patient information came from the participant use data file database of the American

College of Surgeons National Surgical Quality Improvement Program.

Using multivariate logistic regression analysis, the team calculated the statistical significance of the relationship between BMI and mortality, adjusting for differences in overall mortality risk and procedure type. Overall, the researchers found that 3,245 patients (1.7%) died within 30 days of surgery; however, patients with a BMI less than 23.1 kg/m2 demonstrated a 40% greater risk for death postsurgery, a significant increase compared with heavier patients with a BMI range of 26.3 to 29.6 kg/m2.

Although the improved mortality risk in heavier patients was independent of type of surgery and a patient’s overall expected risk for death, the investigators did not know why being overweight appeared to be protective after surgery.

desired effect.”

The effective dose for 95% of patients (ED95) was significantly lower in obese patients (1.99 mg/kg; 95% confidence interval [CI], 1.745-2.183 mg/kg) than in non-obese patients (3.183 mg/kg; 95% CI, 2.681-3.225 mg/kg). “The confidence intervals of both groups did not show any overlap,” Dr. Olutoye said.

“This suggests that there’s a statistically significant difference between the ED95 of both groups of patients.”

The researchers also measured blood pressure throughout the procedures, given propofol’s well-documented hemodynamic effects. Obese patients had a higher baseline blood pressure than nonobese patients. Moreover, both systolic and diastolic blood pressures were significantly lower two minutes after propofol therapy in both groups of patients.

“We should bear this in mind, because propofol decreases blood pressure, and if these patients get an unnecessarily large dose to induce loss of consciousness— particularly in patients who have been fasting prior to surgery—they could have

an exaggerated decrease in blood pressure,” Dr. Olutoye said.

Cheryl K. Gooden, MD, associate professor of anesthesiology and pediatrics at Mount Sinai School of Medicine, in New York City, said the results were impressive. “It is not part of my routine practice to administer less propofol to my obese pediatric patients on a milligram-per-kilogram basis as compared with non-obese patients,” Dr. Gooden told General Surgery News. “However, after reviewing the results of this study, I would definitely consider giving less propofol on a milligram-per-kilogram basis to my obese patients.”

The results of this study are compelling for two reasons, Dr. Gooden continued. “First, the ED95 of propofol in the obese patient group is significantly less.

Next, with no overlap of the confidence intervals, this is indicative of results that are relevant,” she said. “However, we must keep in mind that this is one study and that more studies comparing these two patient populations are necessary.”

Peer Support Found To Spur Weight Loss B y V ICtORIa s teRn Social pressures are known to affect how we dress or interact with others, but these peer influences also may help us lose weight.

According to a new study, team members who participated in a weight loss competition significantly influenced each other’s weight loss (Obesity 2012 Feb 7. [Epub ahead of print]). Investigators found that participants not only lost similar amounts of weight, but also reported that the support and encouragement from their teammates helped motivate them to shed the pounds.

“This is the first study to show that in these team-based campaigns, who’s on your team really matters,” lead author Tricia Leahey, PhD, researcher with The Miriam Hospital’s Weight Control and Diabetes Research Center and assistant professor of psychiatry and human behavior at Alpert Medical School, both in Providence, R.I, said in a statement.

“Being surrounded by others with similar health goals all working to achieve the same thing may have really helped people with their weight loss efforts.”

In recent years, online team-based weight loss interventions have been

popping up with more frequency to help encourage weight loss in large groups of people. This study is the first to examine the effects of teammates on individual weight loss during one such competition.

The findings are based on the results of the Shape Up Rhode Island 2009 campaign, a 12-week online program open to adult residents of the state. Participants joined a team and competed with others in weight loss, physical activity and pedometer steps. The program included 3,330 individuals who were overweight or obese. There were 987 teams; 76% of participants were women with an average body mass index of 31.2 kg/m2 (±5.3 kg/m2).

The investigators found that overweight or obese individuals who completed the competition reported losing 4.2% (±3.4%) of their initial body weight.

Weight loss was similar among teammates (P<0.001), and those who lost at least 5% of their body weight tended to be on the same team (P<0.001). Those who reported being more highly influenced by their peers had an increased likelihood of achieving a 5% weight loss (odds ratio, 1.20). Additionally, team captains also lost more weight than team members, possibly due to their increased motivation and engagement in the campaign.

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Manufacturer Halts Sales of Lap-Band to Certain Centers Decision Follows FDa Warning about Misleading lap-Band ad Campaigns B y V ICtORIa s teRn

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n Feb. 2, Allergan Inc., announced that it would no longer sell its LapBand Adjustable Gastric Banding System to surgical centers affiliated with the 1-800-GET-THIN marketing company.

The device maker will, however, continue to sell the Lap-Band to other medical facilities and bariatric surgeons.

Less than one week after Allergan issued the statement, two Los Angelesâ&#x20AC;&#x201C; area ambulatory surgery centersâ&#x20AC;&#x201D;Valley Surgical Center in West Hills and New Life Surgery Center in Beverly Hillsâ&#x20AC;&#x201D;said they were temporarily halting all Lap-Band weight loss operations and thoroughly reviewing their surgical procedures.

â&#x20AC;&#x153;While we are disappointed by Allerganâ&#x20AC;&#x2122;s decision, we remain committed to the health and welfare of our patients interested in weight-loss solutions, of which a Lap-Band implant is one option,â&#x20AC;? said a statement from the surgery centers affiliated with the 1-800-GET-THIN marketing firm. â&#x20AC;&#x153;Our experienced surgeons receive certification training from Allergan on proper Lap-Band procedures, and they have performed thousands of successful weight loss surgeries at the

Save the Date

JOIN

Your colleagues in beautiful San Diego for the 29th Annual Meeting of the ASMBS.

This yearâ&#x20AC;&#x2122;s program will exceed all expectations.

Anticipate more collaborative postgraduate courses designed for both the surgeon and the integrated health teams.

Youâ&#x20AC;&#x2122;ll see more symposiums, debates and videos. Plan to participate in lively and interactive discussions in both the Integrated Health Main Session as well as the Plenary Session.

This yearâ&#x20AC;&#x2122;s Mason Lecturer, Dr. John Birkmeyer, will speak on Composite Measure in Bariatric Surgery, and Basic Science invited lecturer, Dr. Robert Oâ&#x20AC;&#x2122;Rourke, will speak RQ 2EHVLW\ ,QĂ DPPDWLRQ DQG &DQFHU

LODGING N INFOR RMATION N Rising 30 stories above the edge of San Diego Bay the Hilton San Diego Bayfront hotel is downtown San Diegoâ&#x20AC;&#x2122;s newest waterfront hotel.

Hilton San Diego Bayfront Hotel 1 Park Boulevard San Diego, California USA 92101 Tel: +1-619-564-3333 Fax: +1-619-564-3344 Reserve your room now at www. ww w.20 2 12 20 12.a .asm s bs bs.o .org rg

YOU DONâ&#x20AC;&#x2122;T WANT TO MISS IT! SEE YOU IN SAN DIEGO! Visit www.2012.asmbs.org for more information

The American Society for Metabolic and Bariatric Surgery designates this educational activity for a maximum of 35.75 AMA PRA Category 1 Credit(s)â&#x201E;˘ . Physicians should only claim credit commensurate with the extent of their participation in the activity.

1XUVLQJ &UHGLWV XS WR &( FRQWDFW KRXUV DUH SURYLGHG E\ 7D\ORU &ROOHJH /RV $QJHOHV &DOLIRUQLD SRVVLEO\ PD\ QRW EH DFFHSWHG IRU QDWLRQDO FHUWLĂ&#x20AC;FDWLRQ

APA credits and NASW credits for the ASMBS Masters in Behavioral Health Course are pending approval by Amedco. This course will be co-provided by Amedco and American Society for Metabolic and Bariatric Surgery.

American Society for Metabolic & Bariatric Surgery 100 SW 7th Street, Gainesville, Florida 32607 Tel: 352.331.4900 | Fax: 352.331.4975 | www.asmbs.org

â&#x20AC;&#x2DC;while we are disappointed by allerganâ&#x20AC;&#x2122;s decision, we remain committed to the health and welfare of our patients interested in weight-loss solutions.... implant is one option.â&#x20AC;&#x2122; â&#x20AC;&#x201D;Statement from the surgery centers centers and other outpatient facilities and hospitals since 2009.â&#x20AC;?

The surgery centersâ&#x20AC;&#x2122; statement, provided to General Surgery News by a lawyer representing the companies continued: â&#x20AC;&#x153;Pending the results of a full independent medical and operational review, we have voluntarily stopped scheduling new LapBand surgeries at two of our centers. We look forward to sharing the results of this review with Allergan and others to ensure complete confidence.â&#x20AC;?

General Surgery News contacted Allergan for a statem ent. Allergan declined to comment, stating that the companyâ&#x20AC;&#x2122;s corporate policy does not allow it to discuss its customer relationships with third parties.

This news comes on the heels of an FDA reprimand against eight California surgical centers and the marketing firm behind a surgical weight loss marketing campaign. As detailed in the February issue of General Surgery News warning letters from the FDA were sent to the companies in December for failing to inform consumers about the serious risks associated with the weight loss surgery (see â&#x20AC;&#x153;FDA Squeezes California Surgery Centers, Marketing Firm for Improper Promotion of Gastric Banding,â&#x20AC;? by Victoria Stern. 2012;39:1).

Several of the companies are facing other accusations. Two former employees and 11 patients of the surgical centers filed a lawsuit in January claiming that the centers performed Lap-Band and other medical procedures with unqualified staff, in unsanitary facilities and using unsafe equipment. Specifically, the lawsuit alleges that centers did not preserve equipment or own ventilators large enough for obese patients; had a high incidence of postoperative infections because of poor sanitation; employed nurses as surgeons and allowed unsupervised administration of anesthesia; carried out needless procedures; and one centerâ&#x20AC;&#x201D;the Beverly Hills Surgery Centerâ&#x20AC;&#x201D;is alleged to have covered up events leading up to the death of a patient.

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Bariatric Surgery Boosts Cognitive Function, New Study Finds B y l OuIse g agnOn Montreal—Patients who underwent bariatric surgery showed a significant difference in memory function after one year compared with patients who did not have the surgery, according to a study presented at the 40th International Neuropsychological Society meeting.

“We know from our past work that people who are bariatric surgery candidates are at higher risk for problems with memory and other types of thinking,” said principal investigator John Gunstad, PhD, associate professor of psychology at Kent State University, in Kent, Ohio.

However, no study has examined the effects of bariatric surgery on cognitive function. Thus, Dr. Gunstad wanted to see whether bariatric surgery helped reverse these cognitive problems. “The question is that if excessive weight causes these problems, can losing the weight solve these problems,” said Dr. Gunstad.

In the new study, the investigators examined 137 patients, 95 of whom underwent bariatric surgery and 42 of whom served as obese controls. The mean age for the surgery group was 43 years and for the control group, 39.9 years.

Bariatric surgery patients were part of the Longitudinal Assessment of Bariatric Surgery parent project. Both surgical patients and controls completed selfreport measurements and a cognitive test battery prior to surgical intervention, and at the 12-week and 12-month marks after surgery. Investigators measured cognitive function over time and used statistical modeling to explore possible mechanisms of change in the surgical patients. The majority of patients underwent gastric bypass, while the rest underwent gastric banding, but the study’s sample size did not permit a comparison of the effects of the two procedures on cognition.

The investigators observed that surgical patients performed better on memory indices postsurgery than obese controls (P=0.02). The effect on memory was mainly attributable to the surgery itself and not changes in comorbid conditions like sleep apnea, diabetes and hypertension, Dr. Gunstad said. The authors plan to follow the patients for five years postsurgery to determine whether the effects are long-lasting.

“We wanted to know if there were continual gains [in cognition] after surgery, and there were,” said Dr. Gunstad, but the specific mechanisms of change remain unknown. “The results are encouraging and demonstrate that the negative impact that obesity can have on cognition may be reversed with weight loss.”

Robin Blackstone, MD, bariatric

surgeon, president of the American Society of Metabolic and Bariatric Surgery, medical director of Scottsdale Healthcare Bariatric Center, Arizona, said “There is a lot of interest in this [area]. We know the way in which [gastric bypass] works is primarily through changes in neural and hormonal signaling between the gut and the brain.”

Shedding excess weight may influence other variables that could improve

cognition such as reducing sleep apnea and hypertension and improving blood sugar control. Surgery also may affect hormone levels. It is important to separate the real, independent effect of the surgery itself from the positive effects of remission of diseases like sleep apnea, diabetes and hypertension, said Dr. Blackstone.

A future study should be designed to look at the effect of particular surgical interventions, whether gastric bypass,

gastric banding or sleeve gastrectomy, on cognition, said Matt B. Martin, MD, FACS, bariatric surgeon with Central Carolina Surgery in Greensboro, N.C. “It’s an intriguing study,” said Dr. Martin.

“The limitation from a surgical standpoint is that they did not look at the impact [on cognition] of each surgical intervention. It would be important to know what kind of operation [patients] had and see if there’s any difference across groups.”

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Issues for the BarIatrIc & MetaBolIc ProfessIonal

Extended Quarterly Coverage

Too Many Tacks Associated With Postoperative Hernia Pain Caution advised against liberal use of Tacks, Regardless of Type B y C hRIstIna F RangOu

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ixing hernia meshes with more than 10 tacks, even if they are absorbable, doubles the risk for early postoperative pain while having no benefit on reducing rates of recurrence, suggests a review published in the Annals of Surgery.

Moreover, surgeons are more likely to use tacks liberally when using the absorbable variety, the study showed (2011;254:709-715).

“Absorbable tacks take months to degrade, and in the short-term, these tacks are just as liable to induce postoperative pain as their permanent counterparts,” wrote Igor Belyansky, MD, a fellow in laparoscopic surgery at Carolinas Medical Center, Charlotte, N.C., and colleagues in their report.

Dr. Belyansky and colleagues used the International Hernia Mesh Registry (IHMR) to compare postoperative quality of life in patients undergoing laparoscopic totally extraperitoneal (TEP), transabdominal preperitoneal (TAPP) or modified Lichtenstein (ML) hernia repairs.

The IHMR is a prospectively collected, multicenter database with more than 30 participating sites in the United States, Europe and Canada. “Patients

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are allowed to enter their own qualityof-life data and this is the first study to directly compare quality-of-life outcomes of TEP, TAPP and open repair in such a manner,” said Dr. Belyansky.

Investigators studied almost 2,000 patients who underwent inguinal hernia repairs completed between 2007 and 2010. The distribution of unilateral procedures was TEP (n=217), TAPP (n=331) and open repair (n=953), with bilateral repairs in 413 patients.

Analysis showed that one month after surgery, patients in whom absorbable tacks were used experienced higher rates of postoperative pain than those in whom nonabsorbable tacks were used (25.7% vs. 11.5%; P=0.015).

However, further investigations found that absorbable tacks were, on average, applied in greater quantities than nonabsorbable tacks (P=0.001).

When using absorbable tacks, surgeons placed more than 10 tacks in 33% of cases compared with 2.7% of cases with permanent tacks. When controlling for the number of tacks, no difference was observed in pain levels during early or long-term follow-up between absorbable and permanent tacks. That suggests it is the number of tacks used, and not the materials used in the absorbable tacks, that account for the higher rates of postoperative pain.

There was no difference in recurrence rates when more tacks were used or with the application of absorbable or permanent tacks, the study showed.

Investigators encouraged surgeons to use the same degree of caution with absorbable tacks as they would with permanent ones.

Absorbable tacks do carry certain advantages, including the reduction of adhesion-related complications, but it’s their overuse that is problematic, said Todd Heniford, MD, principal investigator in the study and chief of gastrointestinal and minimally invasive surgery at Carolinas Medical Center.

Some surgeons now use surgical glues alone for mesh fixation in order to reduce postoperative discomfort, said Dr. Heniford. This helps mitigate pain in the early postoperative phase, although their unpublished data now demonstrate that these patients complain of significantly more discomfort in prolonged follow-up than tack patients.

“With further investigation, we have found that with at least a year followup, nearly three times as many patients whose mesh was fixated with glue believe that their hernia has recurred because of increased symptoms and quality-of-life limitations,” said Dr. Heniford.

The finding needs to be validated

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Issues for the BarIatrIc & MetaBolIc ProfessIonal

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‘we hope this body of work will encourage hernia surgeons to reassess their current practice of peritoneal closure when performing a TaPP repair.‘ —Igor Belyansky, MD

with randomized studies, said Robert J. Fitzgibbons, MD, the Harry E. Stuckenhoff Professor of Surgery, Creighton University School of Medicine, Omaha, Neb. “It’s interesting that surgeons use absorbable tacks more liberally and I’m sure I’m guilty of that myself,” he said.

However, the investigators used a database to which surgeons can voluntarily submit data, which may skew the results.

“Before I really trust the conclusions or make any practice changes, I’d want to see a randomized trial,” said Dr. Fitzgibbons.

The investigators note that the study was carried out among regional and national hernia specialists. Of any group studies, patients undergoing TAPP repair had the highest frequency of symptoms after one month, as measured by the Carolinas Comfort Scale (CCS).

More than 16% of first-time unilateral TAPP repair patients and 40.7% of recurrent unilateral repair patients had CCS scores greater than 1.

Similar scores were reported by 8.9% of first-time and 21.4% of recurrent TEP repair patients and 16.5% and 20% of unilateral and current ML repair patients.

Subgroup analysis showed more tacks were used in patients who underwent TAPP repairs. In all, 18.2% of TAPP patients had more than 10 tacks compared with only 2.3% of TEP repairs.

Tacks are not generally used for an ML repair: Only 0.2% of these patients received any tacks. When controlling for number of tacks, no difference in symptoms was observed between TEP and TAPP methods.

Some surgeons may choose to use tacks more often for TAPP repairs because of the need to close the peritoneum, said the authors.

“Excess tacks cause patients early postoperative discomfort and diminish some of the central benefits of the laparoscopic approach. We hope this body of work will encourage hernia surgeons to reassess their current practice of peritoneal closure when performing a TAPP repair,” said Dr. Belyansky.

Alternative methods for mesh fixation exist, including sutures, fibrin glue

and no fixation as mesh is placed in the preperitoneal space.

One surgeon expressed concern about the simplified pain score used in the analysis. “Your abstract suggests causality with the use of tacks; you cannot, of course infer that from your data set,” said Dion Morton, MD, professor of surgery, University of Birmingham, United Kingdom.

Previous studies have shown that tacks in inappropriate locations or in excess can contribute to pain following laparoscopic hernia repair. Absorbable tacks were developed in hopes

that the dissolution of the tack would reduce incidence of long-term pain and adhesions.

The study also showed that repair of recurrent hernia was a strong predictor of postoperative pain. “The difference in quality-of-life outcomes may be secondary to extensive tissue trauma caused by dissection of reoperative, scarred area,” the authors concluded.

Bilateral inguinal hernia repairs also were associated with higher pain levels during the early postoperative period when compared with unilateral repairs.

Here, too, use of more than 10 tacks

on each side was associated with higher frequency of symptomatic patients in the first month.

There was little difference in recurrence between the three operative methods. Recurrence rates ranged from 0.5% to 1.4%.

The authors are currently investigating predictors of chronic pain after undergoing an inguinal hernia repair.

After the key factors contributing to chronic pain are identified, they plan to develop an algorithmic model that can be used in the preoperative setting.

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Surgery Society Updates Guidelines on Breast Cancer Care B y C hRIstIna F RangOu

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new study is already providing additional evidence that axillary lymph node dissection (ALND) does not add benefit to sentinel lymph node resection in clinically node-negative breast cancer patients with minimal sentinel lymph node involvement, supporting one of the new consensus statements issued by the American Society of Breast Surgeons (ASBS) in August, examining controversial issues in breast cancer care.

The guidelines, available at www. breastsurgeons.org, address four key areas of debate: management of the axilla and of borderline or high-risk lesions seen on image-guided breast biopsy, accelerated partial breast irradiation and screening mammography. The ASBS’s updated position on management of the axilla in patients with invasive breast cancer was based on recent data from the American College of Surgeons Oncology Group (ACOSOG) Z0011 trial. The Z0011 trial showed that ALND “may no longer be routinely required” for patients who meet all the following criteria: T1-2 tumors; one to two positive sentinel lymph nodes without extracapsular extension; completion of whole breast radiation therapy; and completion of adjuvant therapy, including hormonal, cytotoxic or both. The results do not directly apply to patients who have T3 tumors, have more than two positive nodes, or are undergoing mastectomy or partial breast irradiation.

Now new results from an update of the Phase III International Breast Cancer Study Group’s (IBCSG) trial 23-01, presented at the San Antonio Breast Cancer Symposium (abstract S3-1), showed no difference between patients randomized to receive ALND or no ALND in the primary end point of disease-free survival and for the secondary end point of overall survival (see General Surgery News, February 2012, page 1). “Our findings are consistent with those of the ACOSOG Z0011 trial,” said Viviana Galimberti, MD, of the European Institute of Oncology, in Milan, Italy. Since then, surgeons gradually have been adopting the more conservative approach to surgery, and the two trials together should change clinical practice, Dr. Galimberti said.

“These consensus statements can be very helpful to providers of breast care; however, they are not published to establish or change the standard of care in a legal sense but to provide guidelines for patient care,” said Victor Zannis, MD, medical director of the Breast Care Center of the Southwest, Phoenix, and past president of the ASBS. “Because medical care can and should be influenced by

innumerable factors that make each clinical case unique, it is important for practitioners to also use their clinical acumen to make decisions and not use the guidelines in a vacuum,” he added.

Among the other highlights, the ASBS reiterated its support for annual screening mammography for women aged 40 years and older. That policy runs counter to the 2009 guidelines from the U.S. Preventive Services Task Force (USPSTF), which call for biennial screening mammography for women aged 50 to 74 years. The USPSTF recommendations, which exclude a small group of women with unusual risk factors for breast cancer, are aimed at reducing harm from overtreatment.

But the ASBS, like other oncologic societies, points to studies demonstrating that screening mammography leads to improved survival due to earlier detection of breast cancer, including in women between the ages of 40 and 49.

According to the guideline, patients who are node-negative based on clinical examination, radiologic examination and/ or fine needle aspiration “may undergo sentinel lymph nodes biopsy” after preoperative systemic therapy at the same time as their surgery for primary breast cancer.

It remains unclear whether patients with a positive clinical examination before preoperative systemic therapy are candidates for sentinel lymph node biopsy if they have axillary downstaging after therapy. But a multicenter, randomized controlled trial, currently under way in Europe, may alter future treatment recommendations, according to the report.

The board also issued a guideline to help health care providers manage benign and borderline breast lesions diagnosed on needle biopsy of the breast. These lesions often cause difficulty for providers and patients when it comes to laying out a treatment plan. Sometimes the breast

‘new technologies have been introduced, and this is definitely a time where breast surgeons have to really incorporate a lot of new information rapidly to their practice to make sure they are delivering state-of-the-art care.’

—Funda Meric-Bernstam, MD

Deanna Attai, MD, a breast surgeon in private practice and ASBS board member, said the ASBS developed its statement as a response to the USPSTF recommendations. “While we all realize that screening mammography has limitations, especially in younger women with dense breast tissue, it does remain the most cost-effective and practical screening tool for the early detection of breast cancer,” said Dr. Attai. “Many women were confused and angered by the USPSTF recommendations. We acknowledge the issues regarding dense breast tissue and young women; mammography is not a perfect tool, but it is the best screening test we have now.”

Controversy exists over the use of sentinel lymph node biopsy after preoperative systemic therapy because selective sterilization of lymph nodes may occur, possibly leading to reduced accuracy and high false-negative rates. The board found data that suggest a similar accuracy and falsenegative rates for sentinel lymph node biopsy after neoadjuvant systemic therapy for clinically node-negative patients. But the data are less clear on the use of sentinel lymph node biopsy after neoadjuvant systemic therapy in patients with clinically positive nodes at presentation.

core needle biopsy demonstrates a benign histology while the clinical or imaging findings point to a possible malignancy. Additionally, some core needle biopsy findings are considered “borderline” because the biopsy indicates a nonmalignant diagnosis but cancer might be present at the biopsy site.

The ASBS recommends further evaluation in both of these instances. Discordant assessment should be followed by a repeat core needle biopsy, surgical excisional biopsy or clinical and imaging surveillance. Borderline lesions should be compared with imaging and clinical findings to determine concordance, followed by an action plan to either exclude malignancy or establish a plan of follow-up.

Multidisciplinary action is key for these patients, and should involve pathology, radiology and surgery to ensure adequate imaging and histologic tissue sampling of the targeted lesion, according to the guideline: “This approach optimizes the accuracy of diagnosis, prevents delays in cancer diagnosis and determines observational and treatment planning.”

The authors also identified what kinds of benign and borderline lesions are at risk for upgrading to malignancy, such as

atypical ductal hyperplasia, lobular neoplasia, columnar cell lesions, papillary lesions, radial scar, fibroepithelial lesions with cellular stroma, and spindle cell lesions. Management of all nonmalignant lesions should be individualized on a caseby-case basis, they said.

In a final statement, the ASBS outlined the patient criteria and appropriate techniques for accelerated partial breast irradiation. “Maturing data is increasingly supportive of the use of partial breast irradiation as an alternative to whole breast irradiation,” said Dr. Zannis.

The ASBS recommends that all patients who are treated with accelerated partial breast irradiation as a sole form of radiation therapy in lieu of whole breast irradiation be aged 45 years and older with invasive cancer or aged 50 years and older for ductal carcinoma in situ, have a total tumor size of less than or equal to 3 cm, have negative microscopic surgical margins on excision and are sentinel lymph node-negative.

The ASBS board noted that several techniques can deliver this therapy, including multiple catheters placed through the breast, a balloon catheter or multicatheter single-insertion device placed into the lumpectomy cavity, localized three-dimensional conformal external beam radiation, bead or seed implants and single-dose intraoperative treatment.

All patients should be monitored to identify adverse events and local recurrences, according to the report, and continuous long-term, outcomes-based monitoring is “desirable.”

Funda Meric-Bernstam, MD, welcomed the guidelines, saying they come at a time when surgical management of breast cancer is undergoing major changes. “This is a very important initiative on the part of the ASBS. We are very lucky in that this is a very exciting time and a lot of clinical trials have come to fruition,” said Dr. Meric-Bernstam, professor of surgical oncology and medical director of the Institute of Personalized Cancer Therapy, University of Texas MD Anderson Cancer Center, in Houston. “New technologies have been introduced and this is definitely a time where breast surgeons have to incorporate a lot of new information rapidly to their practice to make sure they are delivering state-of-the-art care.”

The field’s understanding of lymph node status and management has evolved in recent years, and the guidelines will help surgeons make the necessary practice changes, Dr. Meric-Bernstam said.

They underscore the fact that many of the changes in practice are applicable only to specific patient populations. “That’s a critical element,” she added.

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In the News ReimbuRsement Continued from page 1

codes for the 2009 fiscal year. The analysis showed incongruities in payment for procedures, ranging from a low of $188 per hour for partial colectomy to a high of $700 per hour for laparoscopic gastric bypass. These figures do not include time spent in operative planning, administrative matters or overhead.

Still, “the discrepancy should be considered a red flag,” said lead author Abhishek Chatterjee, MD, MBA, a senior resident in plastic surgery at

GeneralSurGerynewS.com / General SurGery newS / march 2012

Dartmouth-Hitchcock Medical Center, in Lebanon, N.H., who presented the study at the 2011 Clinical Congress of the American College of Surgeons.

The wide range in hourly compensation reflects major flaws in the formula used to set compensation rates, Dr. Chatterjee said. The formula is based on subjective assessments of physician work rather than hard data, he said. As a result, some procedures are reimbursed much better than others, regardless of case difficulty.

“I’m not saying the RVU [relative value unit] system should be thrown

out the door. It has its strengths, but the physician’s time element needs to be better objectively assessed.”

The relative value scale used for CPT reimbursement is based on a formula composed of 52.5% physician work, 43.6% practice expense and 3.9% professional liability. The physician work aspect covers mental effort, technical skill, judgment and physician’s time.

Physician’s time includes operating time, hospital days and follow-up clinic days in 15- or 30-minute segments.

The investigators reviewed physician payments for nine operations at a level

The study ‘opens up a can of worms’ about inequities in payments to physicians.

Clearly, discrepancies exist in general surgery.

—Warren D. Widmann, MD 1 tertiary care academic health center.

They analyzed five common outpatient procedures: laparoscopic gallbladder surgery with cholangiogram, inguinal hernia repair, umbilical hernia repair, thyroidectomy and partial mastectomy with

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lymph node dissection, and four inpatient procedures: laparoscopic Nissen fundoplication, laparoscopic gastric bypass, partial colectomy with anastomosis and laparoscopic appendectomy.

For each procedure, the investigators compared incision time, postoperative days per case, follow-up days, additional hours, total care hours and physician payment per case. The investigators then broke down the fee into payment per hour for each procedure.

Gastric laparoscopic bypass topped the reimbursement list at $707 per hour, followed by thyroidectomy at $693 and

laparoscopic gallbladder with cholangiogram at $541. Laparoscopic Nissen fundoplication, partial mastectomy with lymph node dissection and laparoscopic appendectomy were reimbursed at similar rates of $481, $453 and $443 per hour, respectively. Near the bottom of the list were umbilical hernia repair at $321 and inguinal hernia repair at $326 per hour.

Far below all other operations was partial colectomy with anastomosis at $188 per hour. Additionally, the study showed no noticeable differences in reimbursement between inpatient and outpatient procedures.

Dr. Chatterjee emphasized that the study was not designed to assess whether surgeons make too much money or not enough for each procedure. In fact, the dollar value per hour for each procedure does not accurately reflect what a surgeon earns each hour. It fails to take into account many things such as the time spent with patients doing informed consent or answering phone calls in the middle of the night.

But what the study does clearly demonstrate is a lack of consistency in reimbursements from one procedure to the next, Dr. Chatterjee said.

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Samuel Szomstein, MD, FACS Associate Director, The Bariatric and Metabolic Institute and Section of Minimally Invasive and Endoscopic Surgery Director, Bariatric Endoscopy Cleveland Clinic Florida Weston, Florida Associate Professor of Surgery Florida International University Miami, Florida Clinical Assistant Professor of Surgery Nova Southeastern University Fort Lauderdale, Florida

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The study is “important and timely,” said Warren D. Widmann, MD, professor of clinical surgery at the State University of New York Downstate Medical Center, in New York City.

The finding comes as fee schedules are under reassessment and global fees for the care of patients are becoming more common. The study should be a warning for policymakers that they need to set fee schedules “on the basis of solid data rather than historical use of subjective estimates,” said Dr. Widmann.

The study also “opens up a can of worms” about inequities in payments to physicians. Clearly, discrepancies exist in the field of general surgery, he said. But there are inequalities, too, among different specialists such as general surgeons, neurosurgeons, vascular surgeons and even internal medicine specialists and radiologists who perform invasive procedures. That raises the issue of whether physicians in all specialties should be compensated equally for their work.

“Currently, there is a trend for all specialties to require five or six years of postgraduate training. Thus, it is reasonable to think about leveling the overall playing field for all proceduralists.”

Vascular surgeons conducted a similar study in 2010, which compared reimbursements for endovascular and open procedures (J Vasc Surg 2010;52:10941098). The study showed that the average reimbursement was $316 per hour for open procedures and $556 per hour for endovascular. Procedures reimbursed at higher rates included visceral endovascular procedures ($701 per hour) and caval filters ($751 per hour), which was reimbursed at more than the rates for lower extremity bypass ($292 per hour), dialysis access ($268 per hour) and lower extremity amputations ($223 per hour).

One of the most common practices used to measure time is historical surveys of surgeons, asking them how much time they take to do a procedure, said Dr. Chatterjee. “With surveys, there’s an immense subjectivity, response bias, recall bias. You take what should be a very objective measure and make it very subjective.”

Dr. Chatterjee suggested that policymakers should use real data collected by national societies. The societies could set a figure for average total care times or bestpractice total care time. The worth or value of the physician’s work aspect of an RVU then would be set based on national average total care time, thereby influencing reimbursement rates.

Dr. Chatterjee also called on other specialties to do more studies looking at reimbursement across different procedures. “This clearly needs to be taken to another level looking at measures, national measures that incorporate time and payment per unit time so that there’s a standard which you use,” he said.

37

38

In the news

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FDA Warns of Risk for C. difficile–Associated Diarrhea With PPI Use Expert Offers Tips for using PPIs In light of FDa Warning B y g eORge O ChOa

I

n a safety alert dated Feb. 8, the FDA warned that proton pump inhibitors (PPIs) may be associated with an increased risk for Clostridium difficile–associated diarrhea (CDAD).

The alert affects both prescription and

over-the-counter (OTC) PPI products.

Evidence of a potential association between PPI use and risk for CDAD has been accumulating for some time.

“The FDA reacted to a string of publications showing that PPI therapy is associated with C. difficile and C. difficile colitis,” commented Ronnie Fass, MD, professor of medicine, University of Arizona College of Medicine, and director, GI Motility Laboratory, University of Arizona Health Sciences Center,

both in Tucson. “It makes sense to me, and I think it is timely.”

Despite the warning, the FDA cautioned that patients should not stop taking prescription PPIs without first consulting their health care providers.

Patients taking OTC PPIs should pay careful attention to the directions for use in the package inserts of those drugs, the FDA advised.

“Recommendations to avoid PPIs as a therapeutic class are unwarranted,” stated

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Karen R. Mahoney, an FDA representative, in an email to General Surgery News. “Since there are many causes of diarrhea, FDA is recommending that PPI users with diarrhea that does not improve should contact their health care professional to be evaluated for the possibility that their symptoms could represent CDAD.” The FDA says it is working with manufacturers of PPIs to expand drug labels to include information about the increased risk for CDAD with PPI use.

The FDA also is reviewing the risk for CDAD associated with the use of histamine H2 receptor blockers.

“PPIs are a therapeutic class of drugs which have known efficacy and safety profiles, having a therapeutic benefit for many patients with the labeled indications,” Ms. Mahoney noted.

The FDA recommends that clinicians consider a diagnosis of CDAD in patients taking PPIs who develop diarrhea that does not improve. The agency also advises that patients taking PPIs seek immediate medical care if they develop watery stool that does not resolve, abdominal pain and fever. PPI therapy should be limited to the lowest dose and the shortest duration appropriate for the condition being treated, according to the FDA. Mark Reid, MD, a hospitalist at Denver Health Medical Center, and associate professor of medicine, University of Colorado Health Sciences Center, both in Denver, observed that the FDA alert is “worded very gently.” He believes this is appropriate because at present only an association exists between PPI use and C. difficile; causation has not been proven.

“It’s a notification of a possibility of increased risk,” he said. “The wording fits the level of information we have.”

Dr. Reid added that “it’s reasonable to suspect, with the information we have now, that a patient on PPIs may be more likely to get C. difficile infection than a patient who is not on these medications.

It’s a good time for clinicians to start looking at their own practice, to scrutinize their use of these medicines.”

Dr. Fass speculated that the FDA alert was not more specific because more studies need to be done. For example, age, high dosing and duration of PPI therapy also are suspected risk factors, he said, but there is “no sufficient evidence to state that clearly.

“This warning will be the impetus for further research,” he predicted.

Drs. Fass and Reid reported no relevant financial disclosures.

opinion

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spaM ii

continued from page 1 legislation coming at us “then” generation of surgeons like a freight train without brakes. He did an outstanding job of attempting to integrate the “then” and “now” philosophies for the changing membership of the ACS. Possibly he did not project his leadership through this changing medical landscape as well as he potentially could have. This was the source of our conflict. I was in favor of fighting as good a battle as possible for the “then” generation, who made up the more “at-risk” members of the ACS, while working in the background to bring the ACS into the “now” generation, which was rapidly expanding. The former battle was doomed to failure from sources outside the influence of the ACS. The better use of ACS resources was to position the membership into a position of influence within an evolving medical system that was going to be unpleasant for all of us.

As to this last point, anyone who read Dr. Cossman’s opinion piece should move their eyes to the immediate right to read the article entitled “ACOs: The Latest Experiment in Health Care Delivery.”

Recorded here is the excellent job being done by your ACS representatives, especially Andrew Warshaw, MD, and John Armstrong, MD, in this ever-changing landscape of health care delivery, which will not begin to be resolved until after November 2012.

A common misconception of members of the private sector throughout my career as an academic surgeon on the faculty of the University of Florida [Gainesville] was that my salary and support came from the state of Florida. In fact, my state salary support was $8,000 (and yes, I made more than a total of $8,000). The salaries of the surgical faculty members along with medical malpractice premiums, travel funds, etc., came from the private practice of surgery. The more competitive we were, the more we made. Any change in reimbursement was as detrimental to us as it was to you (the private sector). Our income supported the secretarial and clinic staff and the dean’s office. I would trade dean’s office support for office rent anytime. At least if the private sector paid for office space, the physicians usually had a say in what the space would look like! I record this information to substantiate my claim to be a part of the “then” generation.

In December 2008, I was fortunate to have an opinion column entitled “Health Care Delivery: Its Origin and Dilemma” published in General Surgery News. In it, I speculated as to what entity will control health care delivery in the future.

My conclusion was hospitals because the reimbursement system favored the

accumulation of medical reimbursement dollars on the hospital side of the business, which would soon force physicians into an employee role.

This financial accumulation continues today and is abhorrent to the “then” generation for the reasons enumerated by Dr. Cossman and I added several more in my presidential address before the ACS in 2006. The dissolutions of continuity of care and of pride of “ownership”

The better use of acS resources was to position the membership into a position of influence within an evolving medical system that was going to be unpleasant for all of us. of the patient were the “biggies.”

Dr. Cossman wonders why specialty societies continue to remain members of the ACS. I will admit that a wonderful

opportunity to bring the societies together with the ACS was lost when the organizational abilities of Gerald Healy, MD, a pediatric otolaryngologist, were not fully employed by the ACS when he was president in 2007. This fault lies with the ACS leadership, not with Dr. Healy.

Nevertheless, the ACS with all its baggage remains the best resource for all of surgery to influence current and future directions of medical services for all surgeons. To remain fragmented accomplishes nothing. Let me be quick to point out that no ACS officer receives any form of see Spam II page 40

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opinion spaM ii

continued from page 39 personal reimbursements from the ACS and travel is tourist class. Those of us in academic surgery, at least at the University of Florida, have had surgical partners who recognized the importance of having a national surgical leader in the department and were willing to subsidize my salary from their patient reimbursements.

This subsidization has not always been the case in the private sector and too often excellent, qualified members of the private

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a $250 donation from each member of the acS would generate more money than is available from the lobbying efforts of the trial lawyers. sector have been precluded from involvement at the national level. Hats off to people in the private sector like Chuck Mabry, MD, Jim Elsey, MD, LaMar McGinnis,

MD (who, by the way, has been president of both the ACS and the American Cancer Society), Gary Timmerman, MD, Randy Bailey, MD, Dick Sabo, MD, and several others who have been able to be extremely influential in national, medical politics while maintaining a private practice.

The apathy toward the ACS is expressed, as Dr. Cossman suggests, in the poor response to the ACS Political Action Committee (PAC) request for donations.

A $250 donation from each member of the ACS would generate more money than is available from the lobbying efforts of the trial lawyers. Of course trial lawyers’

donations often come from the pooled resources of the firm and not directly from the pockets of the individuals, as has been the case until now for surgeons. Maybe one salutary effect of the “now” generation of surgeons is that they will convince their employer to donate money to the ACS PAC. —Dr. Copeland is emeritus distinguished professor of surgery at the University of Florida College of Medicine, Gainesville, and past president of the American College of Surgeons.

Letters to the Editor change or risk extinction To the Editor: Natural selection applies not only to the evolution of species, but also to the survival of professions. Over the centuries, innumerable industries have been rendered obsolete by their inflexibility (or unwillingness) to change. The field of surgery finds itself, in 2012, presented with the opportunity to change for the better, or to be relegated to relative extinction by continuing on a path leading toward irrelevance. Capitol Hill has grown weary of an older generation of surgeons who speak wistfully of a past era that was not patient-centered. Indeed, it was the patients and society who felt as if they were the ones being treated like “spam in a can” back “then,” and who rebelled and are now forcing our profession to change. As Dr. Cossman rightly asserts, the political process in Washington D.C., has changed little over the decades, and physicians have had minimal impact in health advocacy both “then” and “now.” I would encourage Dr. Cossman to venture to the front lines of Capitol Hill, where he would likely discover that calling for a return to the past and criticizing his fellow surgical colleagues are largely ineffective against the powerful forces aligned in opposition to the days of “that was then” in surgery.

—John Maa, MD, FACS, San Francisco, California Member of General Surgery News editorial advisory board

+

We would like your opinion.

Please send letters to: khorty@mcmahonmed.com.

letters to the editor

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Comments on “Spam in a Can” To the Editor: [Re: Spam in a Can, January 2012, page 1] The most recent Cossman editorial in General Surgery News is a sad and frankly embarrassing rant by an aging, cranky surgeon who pines for the “good old days” and who is clearly out of touch with modern medicine. Why you continue to have him as a commentator is puzzling and diminishes the quality of your otherwise excellent product.

—James P. Morris, MD San Francisco, Calif.

the newly graduated surgeons are becoming employed by the local hospitals, which puts tremendous financial pressure on us private guys. These systems can just keep hiring more and more competition for us, and because they are simultaneously buying primary care practices as well, they can drive all the referrals to their own employed surgeons. The private practice surgeon is becoming a dinosaur. I’m determined to fight until the end though!

—Posted Feb. 2, 2012

Dr. Cossman, you’re 100% correct but the problem is that you're talking to the few of us who want to be small businessmen and run their own show. Hospitals have the gold and they make the rules, sorry to say. I, like you, are in the twilight of my career and my only option after retiring from my own practice was to become an employee of a hospital, which is awful but allows me to stay active and not be hammered by all the worries of an office and malpractice.

The young have no clue, have large debts and want lifestyle over excellence.

The fact that the hospital pays 10% of what my malpractice bill used to be while I’m doing the same operations is the government’s way of screwing the individual. Keep your chin up and your writing. Remember, the pen is mightier than the sword!

—Posted Jan. 20, 2012

More effective than iodine-based products at eliminating skin microorganisms.

The following letters were posted at generalsurgerynews.com

Period.

[For more responses to this issue, visit www.generalsurgerynews.com and click on “Recent Comments” in the upper right-hand corner.]

Dr. Cossman, once again you have hit the nail on the head. As a young general surgeon in solo practice, I see nearly all of my fellow young surgeons opting for employed positions. But this is not something that has happened overnight.

The employment of physicians has been growing slowly for some time. I am not usually a conspiracy theorist, but I truly think that this is the way that the government has planned to control us. If they can get us to give up our independence and become part of the “labor” side, then it will be much easier for them to force changes in reimbursement, standards, etc.

If we are in private practice, then the process is somewhat like herding cats. Once we all are in the employed side, then as a condition of employment, we will have to comply with all of the new standards, maintenance of certification, meaningful use, cookbook medicine etc. Just a thought, but one that unfortunately seems to be coming true.

—Posted Jan. 19, 2012 I wholeheartedly agree with you, Dr. Cossman. I’m a 41-year-old general and bariatric surgeon in private practice in southern New Jersey. More and more of

ChloraPrep® products have been shown to outperform iodine-based products.1,2 The evidence is in. When it comes to eliminating bacteria from the skin, there is a difference. ChloraPrep® skin antiseptic is becoming a new standard of care for preoperative skin antisepsis.

“Chlorhexidine gluconate is superior to povidoneiodine for preoperative antisepsis for the patient and surgeon.” 3

References: 1. Saltzman MD, Nuber GW, Gryzlo SM, Marecek GS, Koh JL. Efficacy of surgical preparation solutions in shoulder surgery. J Bone Joint Surg Am. 2009;91(8):1949–1953. 2. Ostrander RV, Botte MJ, Brage ME. Efficacy of surgical preparation solutions in foot and ankle surgery. J Bone Joint Surg Am. 2005;87(5):980–985. 3. Fletcher N, Sofianos DM, Berkes MB, Obremskey WT. Prevention of perioperative infection. J Bone Joint Surg Am. 2007;89(7):1605–1618.

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© 2012 CareFusion Corporation or one of its subsidiaries. All rights reserved.

CHLORAPREP is a registered trademark of CareFusion Corporation or one of its subsidiaries. ADV-Period1211

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Surgeons’ lounge

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Dear readers, Welcome to the March issue of The Surgeons’ Lounge. We welcome back our guest expert, Raul Rosenthal, MD, professor of surgery and chairman, Section of Minimally Invasive Surgery and The Bariatric and Metabolic Institute, as well as director of the General Surgery Residency Program and of fellowship in Minimally Invasive and Bariatric Surgery at Cleveland Clinic Florida, Weston. Dr. Rosenthal is questioned regarding a patient with a bile leak following robotic laparoscopic cholecystectomy. Read on to see how this case is managed! The April issue will feature Jaime Garcia, MD, and Elias Chousleb, MD, both from Florida International University Herbert Wertheim College of Medicine, in Miami. Take the Surgeon’s Challenge, and see what our experts say about laparoscopic cholecystectomy as an outpatient procedure in the Expert Express!

We look forward to your comments and questions.

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

Szomsts@ccf.org

Question

Surgeon’s challenge From the February 2012 issue A 79-year-old male patient presents with abdominal pain and has a known umbilical hernia. To date, the patient has been able to selfreduce the hernia. On presentation, there is a very hard, tender mass noted at the umbilical hernia site, which cannot be reduced in the emergency room. The patient is taken to the operating room where a small midline laparotomy incision is placed about 5 cm above and 2 cm below the umbilicus. The hernia sac is opened and Figure 1. adherent bowel in “S” formation. there is approximately 7 inches of incarcerated bowel with evidence of ischemia and suffering.

However, there is no evidence of necrosis; there is good peristalsis along the incarcerated segment of bowel; and after a brief observation period, the ischemic segment looks well perfused. A partial omentectomy is performed and the bowel and the remaining omentum are reduced back into the abdominal cavity. The hernia sac is then excised. The defect is closed with 1 PDS [polydioxanone] interrupted sutures. On postoperative day 2, the patient’s abdomen is markedly distended, and a nasogastric tube is placed. The Figure 2. excised bowel in “S” formation. output is approximately 2.5 L over 24 hours. The white blood cell count is 8 K/mcL with no shift, no fever and no abdominal pain. A computed tomography scan is ordered on postoperative day 3 and the impression is ileus versus partial bowel obstruction. The patient is comfortable, although the abdomen is still markedly distended and the nasogastric tube output is more than 1 L per shift. The patient’s vitals and labs are all normal. What would you do?

reply The patient was observed for an additional 24 hours. He said he was relatively comfortable, although the abdomen was still distended; his labs were normal; and he was passing a small amount of gas. The nasogastric tube output continued to be more than 2 L every 24 hours. Consequently, the patient was taken to the operating room for re-exploration of a possible partial bowel obstruction. Access to the abdomen occurred through the previous laparotomy incision, and markedly distended bowel was evident with distal collapsed loops of bowel. On further exploration, a transition area of approximately 10 inches of adherent bowel loops in an “S” formation was noted (Figures 1 and 2). This segment was resected and a primary anastomosis was fashioned. The patient’s recovery was uneventful and he was discharged home after re-exploration and the initial laparotomy.

for Dr. Rosenthal From abraham Fridman, DO Lutheran Medical Center, New York City

A

n 84-year-old patient arrived at the emergency room complaining of abdominal pain, which started one week before and was localized to the right upper quadrant.

The patient was seen six days previously by a health care provider and underwent robotic laparoscopic cholecystectomy. “My 78-year-old wife also had it last year, but with a single incision,” he added. He remained hospitalized for three days and was discharged home not feeling well, complaining of abdominal pain, nausea, anorexia and edema in the lower extremities. The abdominal pain continued for several days.

On arrival in the emergency room, the pain was described as diffuse and of moderate severity. The patient denied vomiting, fever or diarrhea. On physical examination, the patient was in no acute distress and on abdominal examination, moderate diffuse tenderness was noted.

Laboratory tests showed significant results. White blood cell count was 17.80 K/mcL; hemoglobin was 12.9 g/dL; hematocrit was 39.7%; total bilirubin was 1.1 mg/dL (0.21.0); aspartate aminotransferase was 58 U/L; and aminotransferase was 72 U/L. Lipases and amylase were within normal ranges. Results of a computed tomography scan are shown in Figures 1 and 2. The patient was diagnosed with bile leak (probable common bile duct leak) and was managed with stent placement after endoscopic retrograde cholangiopancreatography.

Several questions were raised regarding this patient: • Should robotic surgery be used in acute settings?

• Is age a contraindication for robotic surgery?

• Do you feel there is any benefit in performing robotic surgery on an 84-year-old man or a single incision laparoscopic surgery (SILS) procedure in a 76-yearold woman?

• What are the most appropriate indications for robotic surgery?

• Should the robotic technique be included in general surgery training programs?

ContInued on

page 44

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Surgeons’ lounge continued from page 42

• •

Does robotic surgery need to be performed as part of a research protocol? What is the ethical perspective?

What is your opinion regarding the introduction of new techniques such as SILS or robotics?

Dr. Rosenthal’s

Reply

I thank Dr. Szomstein for the opportunity to comment on this controversial case and answer several very important questions related to robotic surgery and SILS. I would like to start by answering the last question posed.

what is your opinion regarding the introduction of new techniques such as SIlS or robotics?

In recent years, I have had, on many occasions, the opportunity to express my opinion regarding the introduction of SILS, robotic surgery and several other new surgical approaches that have been marketed by both industry and surgeons. One could imagine that my sometimes “rigid” position against these new surgical approaches is the result of many years of training in Germany, where changes in standards are very difficult to introduce. However, I actively participate in numerous trials aimed to develop new approaches and technologies in surgery. My caveat is that all trials are using an institutional review board (IRB)approved protocol or are conducted as part of an FDA trial. Does the fact that these new approaches follow IRB protocol or are part of an FDA trial make them safer? Of course not, but it does let the patient know what the risks are when embracing research protocols and new technologies that are under investigation.

We teach our residents and fellows that, in surgery, the most difficult part is not the technical aspect of the operation, but rather the indication of when to and when not to operate. Furthermore, I teach my residents and fellows that a good surgeon not only knows

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when (indication) and how (technique) to operate, but equally important, can recognize and manage the complications that might ensue after what is considered a sound and uneventful surgical procedure.

The case presented in this issue of The Surgeons’ Lounge obliges me to address another very important point when defining what is the most important quality of a “good surgeon”—honesty. Honesty in admitting gaps in knowledge for diagnosing and defining an indication for surgery is essential. In that case, why not ask your chairman, senior or mentor for advice if you don’t know? Honesty in admitting to not having the necessary skills to carry out a procedure in a safe and sound fashion is just as critical. Why not request an expert’s assistance (your partner or a dear colleague) to help you in the operating room when tackling a difficult or unusual case?

As mentioned in one study, robotic surgery has been used by many, if not most, surgeons and hospitals as a way to attract business (J Healthc Qual 2011;33:48-52).

The literature showing the benefits of this robotic approach over conventional ones (laparoscopy) is scant.

But I can hardly imagine that a surgeon or hospital requires a robot to lure a patient to the emergency room or a private practice when that patient has gallstones and is requesting a cholecystectomy.

A surgeon who performs a robotic cholecystectomy on an 84-year-old patient, who subsequently develops a bile leak, brings all the tenets of what a “good surgeon” is into question. One has to wonder what the symptoms were at presentation when a cholecystectomy was indicated for this patient. What went through this surgeon’s mind (or what was the surgical algorithm) when deciding to use a robot to remove a gallbladder? Would a robot make surgery faster? Safer? Result in less pain or a decreased hospital stay? How long did the operation take? What was the code used to bill the insurance? Why was an 84-yearold patient sent home with a symptomatic abdomen after undergoing a “non-standard” approach?

I also wonder if an intraoperative cholangiogram (IOC) was performed, and if not, was it because of the robot? The literature supports, loud and clear, that patients over 65 years of age have a higher incidence of biliary tract pathology and common bile duct stones than younger patients. Although IOC does not completely remove the risk for a common bile duct injury, it does help identify abnormalities and decrease the injury level, resulting in less harm to the patient.

Finally, and to follow the four most important qualities of what I consider to be a good surgeon (indication, technical skills, recognition and management of complications, and honesty), how was this patient educated for informed consent?

I can hardly imagine that a surgeon or hospital requires a robot to lure a patient to the emergency room or a private practice when that patient has gallstones and is requesting a cholecystectomy.

Should robotic surgery be used in acute settings?

I personally do not use robots in my practice because I do not see any benefit for my patients undergoing acute or elective foregut surgery. However, there is literature to support the benefits in trauma patients undergoing robotic-assisted procedures near the battlefield and away from major medical centers. In this scenario, the benefit is to allow the expert to be included in the treatment algorithm, despite being far away (and sometimes out of harm’s way) from the operating room.

Is age a contraindication for robotic surgery?

I do not believe that in 2012, age per se should be considered a contraindication to any surgical approach, provided there are sound benefits to its use. Nevertheless, we should be conscious that as we get older, we get sicker, and the big question we cannot answer is how much gas do we have left in our tank to go the extra mile if there is a complication? A good aphorism I learned a while ago is “Elderly people tolerate surgery but not complications.” In summary, when operating on the elderly, one should be mindful not to innovate unless there is a good reason to do so.

Do you feel there is any benefit in performing robotic surgery in an 84-year-old man and a SIlS procedure in a 76-year-old woman?

I am unsure what the profession of the 76-yearold woman was at the time of surgery, using the SILS approach. Unless she was a bikini model and did not want to show a couple of 5 mm scars for a period of three months in her upper abdomen, I do not see any reason to choose this approach. Those who advocate SILS know full well that cosmetic results are temporary (scars will heal) and, in the long term, the results are probably similar to those found with the conventional laparoscopic approach. Five-millimeter trocar site scars will heal and disappear over time. All that remains is an umbilical incision that is most likely larger in the SILS

Surgeons’ lounge

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approach. Additionally, those performing SILS in 2012 often violate the major tenets of what is good surgical technique: good visibility, traction and counter-traction, and saving time under anesthesia.

what are the most appropriate indications for robotic surgery?

Reviewing the current literature, the most popular approach seems to be total prostatectomy. I have to emphasize, however, that I have not seen a prospective randomized controlled trial comparing the outcomes of laparoscopic versus robotic prostatectomy.

Should the robotic technique be included in general surgery training programs?

Currently, 99.9% of surgical procedures are carried out via laparoscopy or open surgery. Why train a surgeon in an approach that he or she will not be able to use when going into practice? Our goal should be to deliver the safest and most efficient surgeons to our community. To date, robots have not proven to add safety in general surgery. So, the answer is probably not yet.

Having said that, I am certain that in the near future robots in surgery may allow surgeons to improve their quality assessment pathways. With simulation and robots, we can better plan and prepare our residents and ourselves for performing surgery.

We also have to mention that the robots we currently have are very expensive remote-directed arms and not smart robots. If there is no surgeon behind the console, there is no surgery. I believe that robotic surgery will thrive and continue to improve, but it should be conducted under strict IRB-approved protocols or as part of FDA trials.

Does robotic surgery need to be performed as part of a research protocol? what is the ethical perspective?

I believe this question was partly answered above. According to Laurence B. McCullough, PhD, surgical innovation should undergo five stages before being introduced: innovation (the new idea), development, exploration, assessment and long-term implementation.

The idea comes from thinking of a new procedure prompted by the need for a new solution to a clinical problem in a patient. The implementation of a new technique should indeed be done under an IRB-approved protocol, or under the guidance and oversight of what many believe should be newly developed “Innovation Committees” (J Am Coll Surg 2002;194:792-802).

Those who advocate SIlS know full well that cosmetic results are temporary (scars will heal) and, in the long term, the results are probably similar to those found with the conventional laparoscopic approach.

Let me conclude by adding a brief comment on the paradigm of the aviation industry and surgery. We surgeons strive to achieve the standards that the aviation industry has achieved. There are two situations in life when we are not in control of our destiny: when undergoing general anesthesia (surgery) and when boarding a plane. You just have to trust that whoever takes over for you or your loved ones is not only good but honest as well.

Why do we never ask the airline we choose to fly with who the pilot is?

Which planes are they flying? Why are they choosing one route over another?

The reason is a very simple one. The difference between performing surgery and flying is that pilots are the first ones to arrive at the crash scene. They will not innovate unless they know it is safe and effective.

In surgery, however, we can operate and go home to spend time with our families and rest. I sometimes wonder how some of our colleagues, like the one depicted in this issue of The Surgeons’ Lounge, taking care of this patient, go home and sleep at night.

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Money for Drugs

Part 3 of a 3-Part Series

Should Physicians Be Paid for Pharmaceutical Development and Clinical Investigations?

[Editor’s Note: The following article was originally published in Missouri Medicine, September/October 2011;108:321. It has been edited slightly for in-house style.]

YES

B y C haRles w. V an w ay III, Md, MsMa

ongratulations on well-reasoned C commentaries from all of the authors in this debate. Because I agree

substantially with Ms. Powell (February 2012, page 40), let me address the arguments of Drs. Bohigian (December 2011) and Gale (February 2012, page 40).

Dr. Bohigian has focused largely on the support of physician speakers on behalf of pharmaceutical companies.

I have little disagreement with him.

This area has great potential for abuse.

Indeed, I cited speakers’ bureaus as the “most troublesome facet of this issue.”

It is in this particular area that we must be the most careful, both as speakers and as audiences. And Dr. Bohigian’s comments on the need for physician-researchers to be independent of the company sponsoring a research

project are exactly correct. I have a bit more concern about Dr. Gale’s comments, which are unremittingly negative. He cites extensively the books by Drs. Angell and Kassirer, but he fails to mention their substantial conflicts of interest. Both of these authors were editors of a highly respectable journal that derives a great deal of its income from pharmaceutical advertising. One is tempted to speculate that their books derive from a feeling of guilt, but perhaps that goes too far. The important point, as Dr. Gale notes, is that both of their books are directed to the public, not physicians. Simply repeating these well-known arguments adds little to this discussion. In short, his passion for morality on this issue is clear.

But while moral outrage may be admirable, it provides few guidelines for our conduct in the future.

Dr. Van Way III is a professor of surgery and the Sosland/ Missouri Endowed Chair of Trauma Services at the University of Missouri, Kansas City.

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ransparency and common sense are the keys to solving the dilemma “that physicians must remain independent of the pharmaceutical industry.”

Furthermore, physicians should not profit from drug companies, medical device makers, lectures or CME [continuing medical education] efforts. I do agree in part with my colleague, Dr. Charles Van Way (Dec. 2011), when he states, “We are having a national discussion over the propriety of the physician relationship with industry and that we need more transparency.”

Our trade journals are filled with biased articles written by physicians with pharmaceutical companies. In contrast, well-recognized peer-reviewed journals are more scientifically based, but are supported by advertisements from drug companies.

This conflict is apparent and transparent to any journal reader.

Frequently, the response to new

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public policy tends to allow the pendulum to swing too far to one side.

Common sense is essential. One of the potential impending problems with the new pharmaceutical rules is the lack of samples for indigent patients, especially at university clinics. As stated, all information should be transparent. Honesty and openness by the pharmaceutical industry and physicians are the keys.

The guiding principle should be that physicians always act as whatever is in the best interest of the patient.

Ethical collaboration between physicians and the pharmaceutical industry is essential for the development of new treatments. Transparency is an integral component of ethical collaboration. Hopefully, common sense will prevail in the future evolution of new state and federal rules and regulations.

However, as Mark Twain said, “Common sense is not that common.”

Dr. Bohigian is a professor of clinical ophthalmology in the Department of Ophthalmology and Visual Sciences at Washington University in St. Louis.

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UW faculty engage in teaching, research, and service. The candidates must have an MD (or equivalent) and be board certified or board eligible (or equivalent) in surgery. Graduates of foreign medical schools must have completed the U.S. Medical Licensing Exam (USMLE), Step 3 or equivalent as determined by the Secretary of Health and Human Services.

The University of Washington is an affirmative action, equal opportunity employer. Applicants should submit their curriculum vitae, a cover letter, and references to: Brant K. Oelschlager, MD Byers Endowed Professor in Esophageal Research Department of Surgery, General Surgery Division University of Washington 1959 NE Pacific Street, Box 356410 Seattle, Washington 98195-6410

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49

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In the news

GEnERalSuRGERynEWS.COM / GEnERal SuRGERy nEWS / MaRCh 2012

partial breast irradiatioN continued from page 1

whole breast irradiation (WBI) in older patients (abstract S2-1).

“From 2000 through 2007, older women in the United States treated with brachytherapy experienced higher risk for losing the breast, postoperative infection, postoperative wound complications, breast pain and fat necrosis,” said Benjamin Smith, MD, assistant professor in the Department of Radiation Oncology at the University of Texas MD Anderson Cancer Center in Houston, who presented the study. He pointed out that the study results do not apply to APBI delivered by external beam.

Press headlines following SABCS included “Quicker Radiation Therapy Doubles Mastectomy Risk” (Reuters) and “Mastectomy Risk High With Brachytherapy for Breast Cancer” (Medscape). These articles infuriated some APBI investigators, including Robert Kuske, MD, radiation oncologist at Arizona Breast Cancer SpecialistsScottsdale, who says that the treatment’s effectiveness is measured by recurrence rates and survival after treatment, not future mastectomies.

“The consequences of this information out of the MD Anderson analysis are potentially damaging. If the randomized NSABP [National Surgical Adjuvant Breast and Bowel Project]-39 clinical trial fails to reach its goal of 4,300 patients because of this misinformation, this would be a tragedy because real answers to all of our questions will come out of this scientifically pure study,” said Dr. Kuske, a principal investigator of this ongoing randomized Phase III trial, which is expected to provide a rigorous comparison of APBI and WBI. In the SABCS study, researchers analyzed Medicare records of 130,535 women diagnosed with invasive breast cancer between 2000 and 2007 who were treated with lumpectomy followed by either WBI (n=123,244) or APBI with brachytherapy (n=7,291). To assess safety and effectiveness, Dr. Smith and his colleagues compared overall survival, the risk for subsequent mastectomy, postoperative complications and post-radiation toxicities.

The investigators did not identify any difference in survival, but brachytherapy was associated with an increased risk for mastectomy (4% vs. 2.2%; P<0.001).

Patients undergoing brachytherapy had a higher rate of infectious postoperative complications (16% vs. 10%; P<0.001) and noninfectious postoperative complications (16% vs. 8%; P<0.001), such as a surgical wound breakdown, postoperative bleeding or seroma formation.

mammosite balloon inside tumor resection cavity. courtesy of Hologic, Inc.

‘The consequences of this information out of the mD anderson analysis are potentially damaging.’

—Robert Kuske, MD Complications occurring within five years after the start of radiation therapy that also increased with brachytherapy included breast pain (15% vs. 12%; P<0.001) and fat necrosis (9% vs. 4%; P<0.001).

“Fat necrosis may not have much clinical significance, but generally is considered a marker of tissue injury from either surgery and/or radiation therapy,” said Dr. Smith. Radiation pneumonitis, however, was more common in patients receiving WBI (0.1% vs. 0.8%; P<0.001).

Study under a Scope Critics say the study has many limitations. First, it is a retrospective analysis examining Medicare patients who were treated at the discretion of thousands of physicians, said Dr. Kuske. As such, it could not take into account tumor characteristics, margin status or a patient’s general medical condition. “We do know that women received more chemotherapy in the whole-breast irradiation group of patients,” Dr. Kuske said. “This, by itself, could account for the small 1.8% difference in mastectomy rates between the two groups.”

He added that factors such as diabetes, obesity or smoking history were not taken into account and could have contributed to the higher complication rates.

Potentially significant factors, he said, are controlled and recorded in greater detail in randomized trials such as the NSABP-39 trial. Dr. Kuske also pointed out that the rate of biopsy-proven breast cancer recurrence in the two groups was not stated, and there are many noncancer reasons for subsequent mastectomy, such as testing positive for the BRCA

gene or a false-positive magnetic resonance imaging scan.

Another limitation is that the SABCS trial analyzed procedures that used early-generation brachytherapy techniques and not the more advanced techniques used today.

In response to the study, the American Society for Radiation Oncology (ASTRO) issued a statement saying it was concerned about the potential misinterpretation of the data. “There are limitations to the interpretation of the data, given that it was drawn from records of patients [with] varying risk factors and stage treated between 2000 and 2007,” the statement reads. “Since that time, technology has dramatically improved, including the use of newer multichannel applicators with tighter dose constraints.”

The statement also noted that although statistically significant, the rate of mastectomy is very low in either treatment group. Many patients, said Dr. Kuske, would accept a 1.8% difference in order to have a shorter treatment that exposes less normal tissue to ionizing radiation.

‘The study stated that subsequent mastectomy is a validated surrogate for local failure. However, I am unaware of any literature that states this.’

—Peter Beitsch, MD According to Peter Beitsch, MD, numerous retrospective studies and two prospective randomized studies have shown no difference in survival, locoregional cancer recurrence rates and complications between APBI and WBI. Dr. Beitsch is co-principal investigator of the American Society of Breast Surgeons (ASBS) MammoSite Registry, which includes information on 1,440 patients who were given APBI brachytherapy with the MammoSite balloon

catheter device through 2004. Information gleaned from this registry shows a low rate of complications and a fiveyear local recurrence rate of less than 5%, which is comparable to that of WBI. Several single-institution randomized and nonrandomized studies using another APBI technique, multiple interstitial catheters, also report rates of local recurrence comparable to WBI. Dr. Beitsch also took issue with a study end point. “The study stated that subsequent mastectomy is a validated surrogate for local failure. However, I am unaware of any literature that states this,” he argued, adding that APBI often is used in older, sicker patients who may not be candidates for the six to seven weeks of WBI. This factor could introduce bias in the MD Anderson study results.

In response, Dr. Smith said the twofold increased risk for subsequent mastectomy was found “even after adjusting for patient age, race, comorbidity, treatment with chemotherapy, surgical assessment of the axilla and axillary lymph node involvement.” Nevertheless, he added, “the absolute risk for subsequent mastectomy in patients treated with brachytherapy was still quite small at only 4%, and was consistent with the risks for subsequent mastectomy reported by the ASBS MammoSite Registry Study.”

According to Bruce Haffty, MD, professor and chairman of radiation oncology at the University of Medicine and Dentistry, New Jersey-Robert Wood Johnson Medical School in New Brunswick, the SABCS study should provide an additional incentive for physicians to adhere to ASTRO’s APBI consensus statement. This 2009 statement, which he and Dr. Smith helped author, outlines criteria for selecting patients to be treated with APBI outside of a clinical trial.

While awaiting results from the NSABP-39 trial and six other ongoing randomized trials comparing APBI and WBI, oncologists may find themselves inundated by questions from patients who have heard about the retrospective study. They can point patients to the statements issued by ASTRO and ASBS. According to ASBS, “The evidence in the MD Anderson study should be considered in presurgical counseling, but is not strong enough to preclude the use of WBI in properly selected patients.”

Dr. Beitsch has received lecture fees from companies making brachytherapy equipment. Dr. Kuske disclosed receiving teaching and lecture fees from companies making both external beam and brachytherapy equipment. Dr. Smith disclosed research funding from Varian Medical Systems, which makes a variety of radiation equipment, including WBI and APBI instruments. Dr. Haffty reported no relevant disclosures.

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Gowns and Gloves ď&#x201A;&#x2C6;Continued from page 3

Health care workers may avoid entering a patientâ&#x20AC;&#x2122;s room because of the need to gown and glove and perhaps because of their own fear of picking up some ethereal organism. We also must ensure that caregivers discuss fully with the patient the need to launch infection control guidelines. The sudden appearance of gowns and gloves hanging on the door and signs indicating isolation guidelines might stress out even the most stal-

My plea is that if infection control is being used, we need to have a solid reason for employing it.

The global utilization and proliferation of gowns, gloves and masks may not accomplish our goal. wart patient and his or her family. Many times these events occur without full disclosure to the patient or without gaining additional information that might be helpful in avoiding an indiscriminate application.

My plea is that if infection control is being used, we need to have a solid reason for employing it. The global utilization and proliferation of gowns, gloves and masks may not accomplish our goal.

Like universal precautions in the operating room, we may get to the point where everyone has the obligate box of gloves and gowns and other paraphernalia hanging on their door. I certainly hope this does not come to pass and would urge that good science and common sense be employed in all of our infection control guidelines.

Take a look at your own hospital corridors and your patientsâ&#x20AC;&#x2122; doors. Are you satisfied that there are good reasons for isolation and the donning of gowns and gloves? Perhaps all of us should be willing to ask the appropriate questions and to inquire as to why these measures have been instituted. Also, make sure that you are familiar with the actions that are needed (nasal swab, etc) at your institution to have a patient removed from questionable isolation. Good infectious disease practices are important, but they can be detrimental if used indiscriminately.

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