The March2012 Digital Edition of General Surgery News by McMahon Group

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

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

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

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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.

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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Victoria Stern associate Editor (vstern@mcmahonmed.com)

James Prudden

Manager, Editorial Services

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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© 2012 by McMahon Publishing, new york, ny 10036. all rights reserved. General Surgery News (ISSn 10994122) is published monthly by McMahon Publishing. Periodicals postage paid at new york, ny, and at additional mailing offices. POSTMaSTER: Please send address changes to General Surgery News, 545 W. 45th St., 8th Floor, new york, ny 10036.

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David M. Reed, MD New Canaan, CT General Surgery, laparoscopy, Medical Technology Development/assessment

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.

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

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

INFECTIOUS DISEASE SPECIAL EDITION

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

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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In the news

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

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

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

Quantitative blood culture through device

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

≥100 CFU/mL

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

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

Qualitative catheter segment culture

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

Any growth

Semiquantitative catheter segment culture

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

≥15 CFU

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

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

clinical review

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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

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.

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

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

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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

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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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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

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

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,

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

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

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

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) 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

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.”

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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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

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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.

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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.

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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.

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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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2006

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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

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

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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

Now Available... Novel Applications for Biologic Mesh Innovations in Complex Hernia Repair

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Chair

Stephen M. Cohen, MD, FACS, FASCRS Associate Clinical Professor, Department of Surgery Emory University School of Medicine Vice Chairman, Department of Surgery Southern Regional Medical Center Atlanta Colon and Rectal Surgery Atlanta, Georgia

Faculty

Daniel L. Miller, MD

Kanal A. Mansour Professor of Thoracic Surgery Emory University School of Medicine Chief, General Thoracic Surgery Surgical Director, Thoracic Oncology Program Winship Cancer Institute Atlanta, Georgia

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