June 2014

gastroendonews.com

The Independent Monthly Newspaper for Gastroenterologists

Volume 65, Number 6 • June 2014

DDW 2014

ENDOSCOPY SUITE

Surgery Board Sets Endoscopy Requirement

BY CHRISTINA FRANGOU Beginning in 2017, all general surgery residents who apply for certification by the American Board of Surgery (ABS) will need to complete a standardized national curriculum in the use of endoscopic techniques. see Surgical Endoscopy, page 15

NYSGE Leader Remembered

BY MONICA J. SMITH NEW YORK— —The New York Society of Gastrointestinal Endoscopy (NYSGE)’s 2013 annual course, held last December, contained many of see NYSGE, page 20

Lean NAFLD Patients Have Higher Disease-Related Mortality Risk

BY DAVID WILD C H I C AG O — Non - o b e s e patients with nonalcoholic fatty liver disease (NAFLD) have an 11-fold higher risk for early mortality compared with obese patients with NAFLD, according to an international study of nearly 1,100 patients presented at the 2014 Digestive Disease Week (DDW) meeting. The results, which also showed that NAFLD was associated with more severe lobular inflammation in non-obese patients, have led to a shift in the perception that leaner NAFLD patients have a less severe course of disease. “Like many others, I had thought the absence of obesity was favorable,� said Lawrence Friedman, MD, chair of the DDW Council and chair of the Department of Medicine, Newton– Wellesley Hospital, Newton, Mass. “But clearly

these patients should be taken more seriously and encouraged to adopt lifestyle changes. “We still need to see what the other treatment implications of these findings are,� added Dr. Friedman, who was not involved in the study.

Senior study author Paul Angulo, MD, professor of medicine and section chief of hepatology see NAFLD, page 9

I N S I D E

EXPERT ROUNDTABLE

For Complic cated Crohn’s: Drugs?

Endosc copy, Surgery, or Both?

Or All Three?

COMPPILED AND WRITTEN BY DAVID WILD HOLLYW WOOD, FLA.— —When a patient with Crohn’s disease (CD) becomes more complicateed than the run-of-the-mill case, choosing between medical, endoscopic and surgical treeatments can be difficult. Take, for example, the case of a patient with severe disease, an ileal stricture and proximal dilation on computed tomography enterography see IBD RT, page 25 THE SCIENCE BEHIND POSITIVE PATIENT OUTCOMES

Now available!

Brand-New iPad App

PROCEDURAL BREAKTHROUGH

Improving Efficiency in Colonoscopy Using the Olympus ScopeGuide Faculty

see pages 10-11

Steven Alan Gorcey, MD Chief, Division of Gastroenterology Monmouth Medical Center Monmouth Gastroenterology Eatontown, New Jersey Assistant Clinical Professor Drexel University College of Medicine Philadelphia, Pennsylvania

Steven Lichtenstein, DO Director, Division of Gastroenterology Medical Director, Endoscopy/GI Lab Mercy Fitzgerald Hospital Clinical Associate Professor of Medicine Philadelphia College of Osteopathic Medicine Philadelphia, Pennsylvania

Improving Efficiency in Colonoscopy Using the Olympus ScopeGuide Steven Alan Gorcey, MD Steven Lichtenstein, DO

Introduction Colonoscopy is arguably one of the most powerful tools for the diagnosis, management, and prevention of disease in modern medicine. However, this procedure is highly technical, and its success depends on many variables. These include patient- and disease-related factors, operator expertise, and the capabilities of the endoscope and its associated technology.

For example, patient discomfort during the procedure and procedural time in the context of difficult anatomy increases the probability of complications and decreases the probability that procedural goals will be achieved. Factors contributing to patient discomfort during the procedure include loop formation, redundant colons, pelvic or other abdominal adhesions, and difficult or complex flexures.3 Other difficulties in providing effective colonoscopies include administering appropriate amounts of anesthesia and the need to precisely document biopsy sites for serial examinations. These issues also make it harder for endoscopy trainees to achieve proficiency.

This article reviews the use of the Olympus ScopeGuide technology in conjunction with colonoscopy as a mechanism to overcome these obstacles and to improve the success rate of endoscopic procedures, improve training, and reduce complications such as perforation and splenic hematoma.

Difficulties With Loop Formation One problem that limits navigation through the gastrointestinal (GI) tract during colonoscopy is the formation of loops and the difficulty of mitigating or reducing these loops.3 This problem arises, in part, from the inability to precisely map the configuration of the colonoscope as it courses

through the GI tract. The excessive formation of loops can lead to complications such as perforation, trauma to the liver or spleen, or failure to achieve the goals of the procedure. Additionally, reducing looping may reduce patient pain and, therefore, decrease the need for anesthesia.3

Magnetic-Based Endoscopic Representation Technology To improve procedural efficiency, mitigate loop formation, and increase patient comfort during colonoscopy, the magneticbased Olympus ScopeGuide provides a realtime 3-dimensional (3D) representation of the shape and position of the colonoscope inside the body.

Real-time visualization of the course of the scope is made possible through a small number of electromagnetic coils located within the colonoscope itself that generate a weak, low-frequency magnetic field 'JHVSF Once an external receiver dish that is positioned close to the patient detects these pulses, the data are then relayed to a processor to generate a 3D representation of the scope alongside the endoscopic image 'JHVSF The resulting image provides the endoscopist with the precise positioning and orientation of the scope during the proDFEVSF 'JHVSF

Evaluating Loops With ScopeGuide By seeing the shape of the entire scope as it moves through the body, ScopeGuide provides additional visual information that

A

is particularly helpful during difficult colonoscopies. For example, the endoscopist can evaluate the extent and type of looping and get a better sense of which rotational maneuvers will be required to straighten out UIF TQFDJGJD MPPQ GPSNBUJPOT 'JHVSF

In addition to providing critical information for rotational maneuvers, the 3D representation generated by the equipment provides added functionality. For instance, an assistant can use a separate handheld 3D marker to visualize where abdominal pressure will be most effective in reducing loops and facilitating transit of the colonoscope. Specifically, by moving the hand coil across the patient’s abdomen, the assistant is able to locate the precise position of the scope relative to the patient’s body and can then apply hand pressure to the abdomen as needed, thus minimizing the likelihood of MBSHF MPPQT GPSNJOH 'JHVSF

Clinical Studies Several clinical studies have documented the utility of the ScopeGuide technology. In a preliminary study by Ambardar and colleagues, 3 experienced surgical endoscopists used the ScopeGuide technology to perform 78 outpatient colonoscopies over NPOUIT 7 The researchers found that using ScopeGuide helped them discover loops BOE BQQMZ BQQSPQSJBUF QSFTTVSF JO PG cases. In addition, the ScopeGuide technology identified loops, led to the appropriate application of pressure, and facilitated early QPTJUJPO DIBOHFT JO PG UIF FYBNT 7 Furthermore, Ignjatovic and colleagues

B

studied the use of ScopeGuide versus OPO VTF PG 4DPQF(VJEF JO DPOTFDVUJWF QBUJFOUT PMEFS UIBO BHF ZFBST XIP IBE features or history that predicted a difficult colonoscopy.8 Median time taken to complete intubation to cecum in the Scope(VJEF HSPVQ XBT NJOVUFT DPNQBSFE XJUI NJOVUFT GPS QBUJFOUT OPU VTJOH ScopeGuide. There also was a shorter duration of looping with the ScopeGuide techOPMPHZ WT NJO 8

Documenting Procedures The information generated by this technology also can facilitate the functions of other members of the colonoscopy team.

For example, information regarding the location of the colonoscope can help nurses document precise locations of biopsies and samples. Similarly, gastroenterologists can use location-based information to document procedures in the patient’s medical record using endoscopic and ScopeGuide images.9 This type of information can be invaluable if repeat examinations are necessary, or if the patient requires subsequent surgical intervention.

A study by Ellul and colleagues highlights the value of this information. Their team investigated the accuracy in determining the position of cancers detected during colonoscopy with the aid of ScopeGuide. After retrospectively reviewing records of patients in whom cancers were previously identified, the investigators reported that colonoscopy correctly idenUJGJFE UVNPS MPDBUJPO JO PG DBTFT

C

Figure 1. Visualizing the gastrointestinal tract in real time with ScopeGuide.

(A) Real-time visualization of the course of the scope is made possible using built-in electromagnetic coils within the colonoscope that generate a weak low-frequency magnetic field.

(B) An external receiver dish that is positioned close to the patient detects these pulses. These data are then relayed to the processor to generate a 3-dimensional (3D) representation of the scope alongside the endoscopic image, providing the precise position and orientation of the scope during the procedure.

(C) An assistant can use a separate handheld 3D marker to visualize where to place abdominal pressure in order to reduce loops and facilitate transit of the colonoscope.

Images courtesy of Olympus.

12 ("4530&/5&30-0(: &/%04$01: /&84 t +6/&

DIGESTIVE DISEASE WEEK 2014 Coverage begins this month‌ Bariatric Surgery Highly Effective for NAFLD In Severely Obese ........................................................page 12 Most Benign Right-Sided Polyps Do Not Require Colon Resection ...........................................................page 14

2

LETTER FROM THE EDITOR

GASTROENTEROLOGY & ENDOSCOPY NEWS • JUNE 2014

After 10 Years, Moving On… Cynthia J. Gordon, PhD Managing Editor Gastroenterology & Endoscopy News It is with a sense of adventure, but also a heavy heart, that after 10 years at the wheel of Gastroenterology & Endoscopy News, I will be moving on to unmapped territory. This, the June 2014 issue, marks my last issue as managing editor of the publication.

Over the years, I have had the invaluable opportunity to meet the readers of this publication, all of whom have inspired me on a daily basis—readers from all parts of the country, from all types of medical practices, at different stages in their professional careers and with different professional interests. I have spoken with physicians in academic posts, with those in private practice, with physicians in research and with those in society leadership positions. I have met with residents at the beginning of their careers in gastroenterology, and with doctors who have retired from the field. I have seen the pinnacle of optimism in physicians at the forefront of research and in those working on the frontlines taking care of patients on a daily basis. I have seen hope and anticipation among doctors and patients for new therapies and procedures with the potential to alter medical practice and to change lives. Likewise, I have witnessed disappointment and despair among the medical community, as changes in health care policy

Widespread Bias

threaten to change previous practice patterns and ways of life.

All of this has been truly moving, providing the impetus to make this publication worthy of its exceptional readers. My hope is that it has come somewhat close—providing, in some way, something that moves you, that inspires you, as you go about your daily business of saving lives and changing the world.

This publication is a living, breathing extension of you—its readers—brought to life by a cadre of talented writers and a visionary medical advisory board. It is with humble and heartfelt gratitude that I thank them for their dedication, their drive and their guidance. I am leaving the publication in the very capable hands of my colleague at McMahon Publishing, Adam Marcus.

The publication will no doubt continue to grow and thrive under his leadership.

As for me, I will be embarking on a sort of sabbatical—an unplanned, uncharted summer journey across the country, where I hope to meet as many unique and inspiring individuals as I have encountered during my tenure here. Thank you all for a remarkable journey so far.

Re: “Spotting Spin and Bias in Clinical Trials,” by Kate O’Rourke. Gastroenterology & Endoscopy News w April 2014;65:56,57,60.

I would think that one of the responsibilities of a journal’s peer reviewers and editors is to verify the statistics, sampling and bias. In this day and age, when there is evermore to keep up with, I have come to rely on the “peer-reviewed” journals to do that due diligence. But alas, that too seems to be the devil’s work. Money, money, money. Too bad for our patients and for those of us in the trenches. That is part of why I get most of my medical education at conferences. However, could it be that the talking heads at the meetings are just as biased? Could be.

But at least you can hear their voices and see their faces to judge the truth.

Just a country gastroenterologist, thinning and grey on top, and thick in the middle.

Eric May 10, 2014

Vol. 65, No. 6 MEDICAL ADVISORY BOARD MANOOP S. BHUTANI, MD

GARY R. LICHTENSTEIN, MD

Houston, Texas

Philadelphia, Pennsylvania

ALAN F. CUTLER, MD

NIRMAL S. MANN, MD, BSC, MS, PHD, DSC

Farmington Hills, Michigan

FREDRIC DAUM, MD Mineola, New York

STEVEN M. FABER, MD Elizabeth City, North Carolina

RONNIE FASS, MD Cleveland, Ohio

BARBARA B. FRANK, MD Philadelphia, Pennsylvania

FRANK G. GRESS, MD New York, New York

EDITORIAL STAFF

SALES STAFF

CYNTHIA J. GORDON, PHD,

BRIAN J. HIGGINSON, Publication Director, bhigginson@mcmahonmed.com

Managing Editor, Sacramento, California

PETER R. MCNALLY, DO Fort Carson, Colorado

TARUN MULLICK, MD

cgordon@mcmahonmed.com DAVID BRONSTEIN, KEVIN HORTY, ADAM MARCUS, GABRIEL MILLER, DONALD M. PIZZI, SARAH TILYOU,

St. Charles, Illinois

Contributing Editors

JOEL E. RICHTER, MD

JAMES PRUDDEN,

Tampa, Florida

DAVID ROBBINS, MD

DONALD M. PIZZI,

ELLEN J. SCHERL, MD

Editorial Director

PRATEEK SHARMA, MD Kansas City, Kansas

MYRON LEWIS, MD

JEROME H. SIEGEL, MD

Memphis, Tennessee

New York, New York

BRANDY WILSON, Circulation Coordinator

MATTHEW SPOTO, Senior Account Manager, mspoto@mcmahonmed.com

MCMAHON PUBLISHING

LAUREN SMITH, Classified Advertising Sales, lauren@mcmahonmed.com

VAN VELLE, President, Partner

RAYMOND E. MCMAHON, Publisher and Managing Partner

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ART AND PRODUCTION STAFF

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Manager, Editorial Services

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New York, New York

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June 2014

Associate Copy Chief

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OPINION

GASTROENTEROLOGY & ENDOSCOPY NEWS • JUNE 2014

3

Finding the ‘Must Haves’ for Bariatric and Metabolic Surgery [Editor’s note: In the May issue of Gastroenterology & Endoscopy News, Dr. Roslin outlined his thoughts on the problem of the underuse of bariatric surgery in “Bariatric Procedures Decline Despite Rise in Rates of Obesity, Diabetes,” pages 34, 36-38). Here, he offers solutions for improvement.

Mitchell Roslin, MD Chief, Bariatric and Metabolic Surgery Lenox Hill Hospital/ NSLIJ New York, New York Northern Westchester Hospital Center Mt. Kisco, New York

like gallstones, almost every patient pursues a consultation. It is this perception that we have to change. Only then will we be able to counter riders and avoid being squeezed out of the increasingly competitive health care landscape.

Many believe that this has already begun to happen. Last year, The New England Journal of Medicinee published two articles demonstrating a significant improvement from surgery for type 2 diabetes compared with medical therapy (Schauer PR et al. 2012;366:1567-1576; Mingrone G et al. 2012;366:1577-1585).

This should indicate that the treatment of choice for type 2 diabetes is surgery.

Although these articles have certainly

helped with referrals from endocrinologists, they have not allowed us to cross the goal line. The question is why?

With 25 million Americans suffering diabetes and another 75 million with prediabetes, the average person or physician cannot believe that bariatric surgery is the answer for all of them. Similarly, with obesity levels exceeding 30%, it is not practical for stomach stapling to be see Bariatric Surgery, page 12

As a sports fan, I often think in terms of sports analogies. A common quote from football experts goes like this: “If you have two quarterbacks, you really have none.”

I think we are in a similar situation in bariatric surgery. Our procedures produce weight loss, can cause remission of diabetes and reverse sleep apnea. Infertility has been cured after surgery. The list of improvements goes on and on. But—and this is the big but—bariatric surgery is not the undisputed standard of care for any medical entity. There is no condition, body mass index (BMI) or comorbidity for which the majority of physicians agree that the patient should be referred for bariatric surgery. Instead, our procedures

Our procedures ocedures pr produce weight loss, can cause remission of diabetes and reverse sleep apnea. …

The list of improvements goes on and on. But … bariatric surgery is not n the undisputed standard d of care for any medical entitty.

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are presented as reasonable options. Surgery is presented as something to consider, not something that has to be done.

The effect of this, I believe is tremendous.

I estimate that less than 10% of the patients who are referred to our practice by endocrinologists actually come to a seminar or make an appointment. In comparison, when referred for something

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INDICATION SOVALDI is a hepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitor indicated for the treatment of chronic hepatitis C (CHC) as a component of a combination antiviral treatment regimen.

• SOVALDI efficacy has been established in subjects with HCV genotype 1, 2, 3 or 4 infection, including those with hepatocellular carcinoma meeting Milan criteria (awaiting liver transplantation) and those with HCV/HIV-1 co-infection Prescribing Considerations: • Monotherapy of SOVALDI is not recommended.

• Treatment regimen and duration are dependent on both viral genotype and patient population.

• Treatment response varies based on baseline host and viral factors.

CHANGE THE WAY YOU TREAT HCV GT 1 PATIENTS A 12-week regimen of SOVALDI + Peg-IFN + RBV delivered high cure (SVR) rates for GT 1 patients1,a • Overall response in treatment-naïve subjects with GT 1, 4, 5 and 6 was 90%1 • SVR12 was 89% in treatment-naïve GT 1 subjects taking SOVALDI + Peg-IFN + RBV for just 12 weeks1 • Treatment-experienced GT 1 patients can be treated with SOVALDI + Peg-IFN + RBV for 12 weeks, with an estimated SVR of 71%1,b • The most common adverse events (incidence ≥20%, all grades) observed with SOVALDI + Peg-IFN + RBV were fatigue, headache, nausea, insomnia and anemia1 • The discontinuation rate due to adverse events was 2% in NEUTRINO1 a

Sustained virologic response (SVR) was the primary endpoint, which was defined as HCV RNA <25 IU/mL at 12 weeks after the end of treatment.1 Achieving SVR is considered a virologic cure.2

b

The response rate in treatment-naïve subjects with difficult-to-treat factors (n=52) may approximate the response rate in patients who previously failed pegylated interferon and ribavirin therapy. (Difficult-to-treat factors include GT 1 subjects with IL28B non-C/C alleles, HCV RNA >800,000 IU/mL and Metavir F3/F4 fibrosis.)1

NEUTRINO—GT 1, 4, 5 and 6 treatment-naïve adult subjects1 An open-label, single-arm trial evaluating 12 weeks of treatment with SOVALDI in combination with peginterferon alfa 2a (Peg-IFN) and ribavirin (RBV) in treatment-naïve subjects (N=327) with genotype 1, 4, 5 or 6 HCV infection.

IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS • SOVALDI combination treatment with ribavirin or with peginterferon alfa plus ribavirin is contraindicated in women who are pregnant or may become pregnant and men whose female partners are pregnant because of the risk for birth defects and fetal death associated with ribavirin. Contraindications to peginterferon alfa and ribavirin also apply to SOVALDI combination treatment. Refer to the prescribing information of peginterferon alfa and ribavirin for a list of their contraindications.

WARNINGS AND PRECAUTIONS • Pregnancy: Use with Ribavirin or Peginterferon Alfa/Ribavirin: Ribavirin therapy should not be started unless a report of a negative pregnancy test has been obtained immediately prior to initiation of therapy. Female patients of childbearing potential and their male partners must use 2 forms of non-hormonal contraception during treatment and for at least 6 months after treatment has concluded. Routine monthly pregnancy tests must be performed during this time.

Refer to the prescribing information for ribavirin.

• Use with Potent P-gp Inducers: Rifampin and St. John’s wort should not be used with SOVALDI as they may significantly decrease sofosbuvir plasma concentration, reducing its therapeutic effect.

Please see Brief Summary of full Prescribing Information on the following pages.

sovaldi.com/hcp

Dosing information for patients with HCV GT 1 or 41 • The recommended regimen and treatment duration for SOVALDI combination therapy in HCV GT 1 and 4 mono-infected and HCV/HIV-1 co-infected patients is SOVALDI 400 mg (one tablet, taken orally, once daily with or without food) + Peg-IFN alfaa + RBVb for 12 weeks1 • No response-guided therapy is required with SOVALDI1 • 24 weeks of SOVALDI + RBV is the first approved all-oral regimen that can be considered for HCV GT 1 patients who are ineligible to receive an IFN-based regimen1 • If the other agents used in combination with SOVALDI are permanently discontinued, SOVALDI should also be discontinued1 • No SOVALDI dose adjustments are necessary based on advanced age, race, mild or moderate renal impairment (estimated glomerular filtration rate (eGFR) ≥30 mL/min/1.73 m2) or mild, moderate or severe hepatic impairment (Child-Pugh Class A, B, or C). The safety and efficacy of SOVALDI have not been established in patients with severe renal impairment, end stage renal disease (ESRD) or decompensated cirrhosis1 • If a patient has a serious adverse reaction potentially related to peginterferon alfa and/or ribavirin, the peginterferon alfa and/or ribavirin dose should be reduced or discontinued. Refer to the peginterferon alfa and ribavirin prescribing information for additional information about how to reduce and/or discontinue the peginterferon alfa and/or ribavirin dose1 a

See peginterferon alfa prescribing information for dosing recommendation for patients with genotype 1 or 4 CHC. Dose of ribavirin is weight-based (<75 kg = 1000 mg and ≥75 kg = 1200 mg). The daily dose of ribavirin is administered orally in two divided doses with food. Patients with renal impairment (CrCl ≤50 mL/min) require ribavirin dose reduction; refer to ribavirin prescribing information.

b

IMPORTANT SAFETY INFORMATION (CONTINUED) ADVERSE REACTIONS Most common (≥20%, all grades) adverse reactions for: • SOVALDI + peginterferon alfa + ribavirin combination therapy were fatigue, headache, nausea, insomnia, and anemia • SOVALDI + ribavirin combination therapy were fatigue and headache

DRUG INTERACTIONS • In addition to rifampin and St. John’s wort, coadministration of SOVALDI is not recommended with carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifapentine, and tipranavir/ ritonavir. Such coadministration is expected to decrease the concentration of sofosbuvir, reducing its therapeutic effect.

Please see Brief Summary of full Prescribing Information on the following pages.

Use with Potent P-gp Inducers: Drugs that are potent P-gp inducers in the intestine (e.g., rifampin, St. John’s wort) may significantly decrease sofosbuvir plasma concentration leading to reduced Brief summary of full Prescribing Information. Please see full Prescribing Information. therapeutic effect of SOVALDI. Rifampin and St. John’s wort should not be used with SOVALDI. Rx Only.

ADVERSE REACTIONS: Adverse Reactions from Clinical Trials Experience: SOVALDI should be

SOVALDI® (sofosbuvir)

INDICATIONS AND USAGE: SOVALDI is a hepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitor indicated for the treatment of chronic hepatitis C (CHC) as a component of a combination antiviral treatment regimen.

• SOVALDI efficacy has been established in subjects with HCV genotype 1, 2, 3 or 4 infection, including those with hepatocellular carcinoma meeting Milan criteria (awaiting liver transplantation) and those with HCV/HIV-1 co-infection Prescribing considerations: • Monotherapy of SOVALDI is not recommended • Treatment regimen and duration are dependent on both viral genotype and patient population • Treatment response varies based on baseline host and viral factors DOSAGE AND ADMINISTRATION: Adult Dosage: one 400 mg tablet, taken orally, once daily with or without food. SOVALDI should be used in combination with ribavirin or in combination with pegylated interferon and ribavirin for treatment of CHC in adults.

administered with ribavirin or peginterferon alfa/ribavirin. Refer to the prescribing information of peginterferon alfa and ribavirin for a description of adverse reactions associated with their use.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety assessment of SOVALDI is based on pooled Phase 3 clinical trial data (both controlled and uncontrolled) including 650 subjects who received SOVALDI + ribavirin combination therapy for 12 weeks, 98 subjects who received SOVALDI + ribavirin combination therapy for 16 weeks, 250 subjects who received SOVALDI + ribavirin combination therapy for 24 weeks, 327 subjects who received SOVALDI + peginterferon alfa + ribavirin combination therapy for 12 weeks, 243 subjects who received peginterferon alfa + ribavirin for 24 weeks and 71 subjects who received placebo (PBO) for 12 weeks. The proportion of subjects who permanently discontinued treatment due to adverse events was 4% for subjects receiving placebo, 1% for subjects receiving SOVALDI + ribavirin for 12 weeks, <1% for subjects receiving SOVALDI + ribavirin for 24 weeks, 11% for subjects receiving peginterferon alfa + ribavirin for 24 weeks and 2% for subjects receiving SOVALDI + peginterferon alfa + ribavirin for 12 weeks.

Treatment-emergent adverse events observed in ≥15% of subjects in clinical trials are provided in Table 1. A side-by-side tabulation is to simplify presentation; direct comparison across trials should not be made due to differing trial designs. The most common adverse events (≥ 20%) for SOVALDI + ribavirin combination therapy were fatigue and headache. The most common adverse events (≥ 20%) for SOVALDI + peginterferon alfa + ribavirin combination therapy were fatigue, headache, nausea, insomnia and anemia.

Recommended dose and treatment duration for SOVALDI combination therapy for patients with: genotype 1 or 4 CHC is SOVALDI + peginterferon alfa + ribavirin for 12 weeks; genotype 2 CHC is SOVALDI + ribavirin for 12 weeks; and genotype 3 CHC is SOVALDI + ribavirin for 24 weeks. See peginterferon alfa prescribing information for dosing recommendation for patients with genotype 1 or 4 CHC. Dose of ribavirin is weight-based (<75 kg = 1000 mg and ≥75 kg = 1200 mg).

Daily dose of ribavirin is administered orally in two divided doses with food. Patients with renal impairment (CrCl ≤50 mL/min) require ribavirin dose reduction; refer to ribavirin prescribing information.

Table 1 Treatment-Emergent Adverse Events (All Grades) Reported in ≥15% of Subjects in SOVALDI in combination with ribavirin for 24 weeks can be considered as a therapeutic option for Any Treatment Arm CHC patients with genotype 1 infection who are ineligible to receive an interferon-based regimen.

Interferon-free Regimens Interferon-containing Regimens Treatment decision should be guided by assessment of potential benefits and risks for individual patient.

SOVALDI + Patients with Hepatocellular p Carcinoma Awaitingg Liver Transplantation: p SOVALDI in combination Peg-IFN alfa + PBO SOVALDI + SOVALDI + Peg-IFN alfa with ribavirin is recommended for up to 48 weeks or until time of liver transplantation to prevent RBV Va 12 RBV Va RBV Va + RBVb post-transplant HCV reinfection. weeks 12 weeks 24 weeks 24 weeks 12 weeks Dose Modification: Dose reduction of SOVALDI is not recommended.

Genotype yp 1 and 4: If a patient has a serious adverse reaction potentially related to peginterferon alfa and/or ribavirin, the peginterferon alfa and/or ribavirin dose should be reduced or discontinued. Refer to peginterferon alfa and ribavirin prescribing information for additional information about how to reduce and/or discontinue peginterferon alfa and/or ribavirin dose.

Genotype yp 2 and 3: If a patient has a serious adverse reaction potentially related to ribavirin, ribavirin dose should be modified or discontinued, if appropriate, until adverse reaction abates or decreases in severity.

Ribavirin dose modification guideline for coadministration with SOVALDI: Reduce the ribavirin dose to 600 mg/daya in patients with no cardiac disease if hemoglobin is <10 g/dL and discontinue ribavirinb if it is <8.5 g/dL. Reduce the ribavirin dose to 600 mg/daya in patients with history of stable cardiac disease who have ≥2 g/dL decrease in hemoglobin during any 4 week treatment period and discontinue ribavirinb if it is <12 g/dL despite 4 weeks at reduced dose.a Daily dose of ribavirin is administered orally in two divided doses with food.b Once ribavirin has been withheld due to either laboratory abnormality or clinical manifestation, an attempt may be made to restart ribavirin at 600 mg daily and further increase dose to 800 mg daily. It is not recommended that ribavirin be increased to original assigned dose (1000 mg to 1200 mg daily). Discontinuation of Dosing: If other agents used in combination with SOVALDI are permanently discontinued, SOVALDI should also be discontinued.

Severe Renal Impairment and End Stage Renal Disease: No dose recommendation can be given for patients with severe renal impairment (estimated Glomerular Filtration Rate (eGFR) <30 mL/min/1.73m2) or with end stage renal disease (ESRD) due to higher exposures (up to 20-fold) of the predominant sofosbuvir metabolite.

N=71

N=650

N=250

N=243

N=327

Fatigue

24%

38%

30%

55%

59%

Headache

20%

24%

30%

44%

36%

Nausea

18%

22%

13%

29%

34%

Insomnia

4%

15%

16%

29%

25%

Pruritus

8%

11%

27%

17%

17%

Anemia

0%

10%

6%

12%

21%

Asthenia

3%

6%

21%

3%

5%

Rash

8%

8%

9%

18%

18%

Decreased Appetite

10%

6%

6%

18%

18%

Chills

1%

2%

2%

18%

17%

Influenza Like Illness

3%

3%

6%

18%

16%

Pyrexia

0%

4%

4%

14%

18%

Diarrhea

6%

9%

12%

17%

12%

Neutropenia

0%

<1%

<1%

12%

17%

Myalgia

0%

6%

9%

16%

14%

Irritability

1%

10%

10%

16%

13%

CONTRAINDICATIONS: When SOVALDI is used in combination with ribavirin or peginterferon alfa/ Subjects received weight-based ribavirin (1000 mg per day if weighing <75 kg or 1200 mg per ribavirin, contraindications applicable to those agents are applicable to combination therapies. Refer day if weighing ≥75 kg). to prescribing information of peginterferon alfa and ribavirin for a list of their contraindications. b Subjects received 800 mg ribavirin per day regardless of weight.

SOVALDI combination treatment with ribavirin or peginterferon alfa/ribavirin is contraindicated in women who are pregnant or may become pregnant and men whose female partners are pregnant With the exception of anemia and neutropenia, the majority of events presented in Table 1 occurred because of the risks for birth defects and fetal death associated with ribavirin. at severity of grade 1 in SOVALDI-containing regimens.

WARNINGS AND PRECAUTIONS: Pregnancy: Use with Ribavirin or Peginterferon Alfa/Ribavirin: Ribavirin may cause birth defects Less Common Adverse Reactions Reported in Clinical Trials (<1%):: The following ADRs and/or death of the exposed fetus and animal studies have shown that interferons have abortifacient occurred in <1% of subjects receiving SOVALDI in a combination regimen in any one trial. These effects. Extreme care must be taken to avoid pregnancy in female patients and in female partners of events have been included because of their seriousness or assessment of potential causal male patients. Ribavirin therapy should not be started unless a report of a negative pregnancy test relationship. Hematologic Effects:: pancytopenia (particularly in subjects receiving concomitant has been obtained immediately prior to initiation of therapy. When SOVALDI is used in combination pegylated interferon). with ribavirin or peginterferon alfa/ribavirin, women of childbearing potential and their male partners Psychiatric Disorders:: severe depression (particularly in subjects with pre-existing history of must use two forms of effective contraception during treatment and for at least 6 months after psychiatric illness), including suicidal ideation and suicide. treatment has concluded. Routine monthly pregnancy tests must be performed during this time. Laboratory Abnormalities: Changes in selected hematological parameters are described in Table 2.

There are no data on the effectiveness of systemic hormonal contraceptives in women taking A side-by-side tabulation is to simplify presentation; direct comparison across trials should not be SOVALDI, therefore, two non-hormonal methods of contraception should be used during treatment made due to differing trial designs. with SOVALDI and concomitant ribavirin. Refer also to the prescribing information for ribavirin. a

Brief Summary (cont.)

Table 2 Percentage of Subjects Reporting Selected Hematological Parameters Interferon-free Regimens

Interferon-containing Regimens

PBO 12 weeks

SOVALDI + RBV Va 12 weeks

SOVALDI + RBV Va 24 weeks

Peg-IFN + RBVb 24 weeks

SOVALDI + Peg-IFN + RBV Va 12 weeks

N=71

N=647

N=250

N=242

N=327

<10

0

8%

6%

14%

23%

<8.5

0

1%

<1%

2%

2%

1%

<1%

0

12%

15%

0

<1%

0

2%

5%

3%

<1%

1%

7%

<1%

0

0

0

0

0

Hematological Parameters Hemoglobin (g/dL)

Neutrophils (x109/L) ≥0.5 - <0.75 <0.5 9

Platelets (x10 /L) ≥25 - <50 <25 a

Subjects received weight-based ribavirin (1000 mg per day if weighing <75 kg or 1200 mg per day if weighing ≥75 kg). b Subjects received 800 mg ribavirin per day regardless of weight.

USE IN SPECIFIC POPULATIONS: Pregnancy: Pregnancy g y Category g y X: Use with Ribavirin and/or Peginterferon g Alfa/Ribavirin: Extreme caution must be taken to avoid pregnancy in female patients and female partners of male patients while taking this combination. Women of childbearing potential and their male partners should not receive ribavirin unless they are using two forms of effective contraception during treatment with ribavirin and for 6 months after treatment has concluded.

There are no data on the effectiveness of systemic hormonal contraceptives in women taking SOVALDI. Therefore, two effective non-hormonal methods of contraception should be used during treatment with SOVALDI and concomitant ribavirin. In case of exposure during pregnancy, a Ribavirin Pregnancy Registry has been established to monitor maternal-fetal outcomes of pregnancies in female patients and female partners of male patients exposed to ribavirin during treatment and for 6 months following cessation of treatment. Healthcare providers and patients are encouraged to report such cases by calling Ribavirin Pregnancy Registry at 1-800-593-2214. For patients who are HCV/HIV-1 co-infected and taking concomitant antiretrovirals, an Antiretroviral Pregnancy Registry is also available at 1-800-258-4263.

Animal Data:: Significant teratogenic and/or embryocidal effects have been demonstrated in all animal species exposed to ribavirin; and therefore ribavirin is contraindicated in women who are pregnant and in the male partners of women who are pregnant. Interferons have abortifacient effects in animals and should be assumed to have abortifacient potential in humans.

Pregnancy g y Category g y B: SOVALDI: There are no adequate and well-controlled studies with SOVALDI in pregnant women.

Animal Data:: No effects on fetal development have been observed in rats and rabbits at the highest doses tested. In the rat and rabbit, AUC exposure to the predominant circulating metabolite GS-331007 increased over the course of gestation from approximately 5 to 10-fold and 12 to 28-fold the exposure in humans at the recommended clinical dose, respectively.

Nursing Mothers: It is not known whether SOVALDI and its metabolites are present in human breast milk. The predominant circulating metabolite GS-331007 was the primary component observed in the milk of lactating rats, without effect on nursing pups. Because of the potential for adverse reactions from the drug in nursing infants, a decision must be made whether to discontinue nursing Bilirubin Elevations: Total bilirubin elevation of more than 2.5xULN was observed in none of the or discontinue treatment with ribavirin containing regimens, taking into account the importance of subjects in the SOVALDI + peginterferon alfa + ribavirin 12 weeks group and in 1%, 3% and 3% of the therapy to the mother. See also the prescribing information for ribavirin. subjects in the peginterferon alfa + ribavirin 24 weeks, SOVALDI + ribavirin 12 weeks and SOVALDI + ribavirin 24 weeks groups, respectively. Bilirubin levels peaked during the first 1 to 2 weeks of Pediatric Use: Safety and effectiveness of SOVALDI in children less than 18 years of age have not treatment and subsequently decreased and returned to baseline levels by post-treatment Week 4. been established.

These bilirubin elevations were not associated with transaminase elevations.

Geriatric Use: Clinical studies of SOVALDI included 90 subjects aged 65 and over. The response Creatine Kinase Elevations: Creatine kinase was assessed in the FISSION and NEUTRINO trials. rates observed for subjects over 65 years of age were similar to that of younger subjects across Isolated, asymptomatic creatine kinase elevation of greater than or equal to 10xULN was observed treatment groups. No dose adjustment of SOVALDI is warranted in geriatric patients. in <1%, 1% and 2% of subjects in the peginterferon alfa + ribavirin 24 weeks, SOVALDI + Renal Impairment: No dose adjustment of SOVALDI is required for patients with mild or moderate peginterferon alfa + ribavirin 12 weeks and SOVALDI + ribavirin 12 weeks groups, respectively.

Lipase p Elevations: Isolated, asymptomatic lipase elevation of greater than 3xULN was observed renal impairment. The safety of SOVALDI has not been assessed in patients with severe renal 2 in <1%, 2%, 2%, and 2% of subjects in the SOVALDI + peginterferon alfa + ribavirin 12 weeks, impairment (eGFR <30 mL/min/1.73m ) or end stage renal disease (ESRD) requiring hemodialysis.

SOVALDI + ribavirin 12 weeks, SOVALDI + ribavirin 24 weeks and peginterferon alfa + ribavirin 24 Refer also to ribavirin prescribing information for patients with CrCl<50 mL/min. weeks groups, respectively.

Hepatic Impairment: No dose adjustment of SOVALDI is required for patients with mild, moderate DRUG INTERACTIONS: Potential for Drug Interactions: After oral administration of SOVALDI, or severe hepatic impairment (Child-Pugh Class A, B or C). Safety and efficacy of SOVALDI have sofosbuvir is rapidly converted to the predominant circulating metabolite GS-331007 that accounts not been established in patients with decompensated cirrhosis. See peginterferon alfa prescribing for greater than 90% of drug related material systemic exposure, while the parent sofosbuvir information for contraindication in hepatic decompensation. accounts for approximately 4% of drug related material. In clinical pharmacology studies, both Patients with HCV/HIV-1 Co-infection: The safety and efficacy of SOVALDI was assessed in 223 sofosbuvir and GS-331007 were monitored for purposes of pharmacokinetic analyses. Sofosbuvir is HCV/HIV-1 co-infected subjects. See Dosage and Administration for dosing recommendations in a substrate of drug transporter P-gp and breast cancer resistance protein (BCRP) while GS 331007 HCV/HIV-1 co-infected patients. The safety profile in HCV/HIV-1 co-infected subjects was similar to is not. Drugs that are potent P-gp inducers in the intestine (e.g., rifampin or St. John’s wort) may that observed in HCV mono-infected subjects. Elevated total bilirubin (grade 3 or 4) was observed decrease sofosbuvir plasma concentration leading to reduced therapeutic effect of SOVALDI and in 30/32 (94%) subjects receiving atazanavir as part of the antiretroviral regimen. None of the thus should not be used with SOVALDI. Coadministration of SOVALDI with drugs that inhibit P-gp subjects had concomitant transaminase increases. Among subjects not taking atazanavir, grade 3 and/or BCRP may increase sofosbuvir plasma concentration without increasing GS-331007 plasma or 4 elevated total bilirubin was observed in 2 (1.5%) subjects, similar to the rate observed with HCV concentration; accordingly, SOVALDI may be coadministered with P-gp and/or BCRP inhibitors. mono-infected subjects receiving SOVALDI + ribavirin in Phase 3 trials.

Sofosbuvir and GS-331007 are not inhibitors of P-gp and BCRP and thus are not expected to Patients with Hepatocellular Carcinoma (HCC) Awaiting Liver Transplantation: SOVALDI increase exposures of drugs that are substrates of these transporters. The intracellular metabolic was studied in HCV-infected subjects with HCC prior to undergoing liver transplantation in an activation pathway of sofosbuvir is mediated by generally low affinity and high capacity hydrolase open label clinical trial evaluating the safety and efficacy of SOVALDI and ribavirin administered and nucleotide phosphorylation pathways that are unlikely to be affected by concomitant drugs. pre-transplant to prevent post-transplant HCV reinfection. See Dosage and Administration for dosing Potentially Significant Drug Interactions: Alteration in Dose or Regimen May Be Recommended recommendations in patients with HCC awaiting liver transplantation.The safety profile of SOVALDI Based on Drug Interaction Studies or Predicted Interaction: Drug interaction information for and ribavirin in HCV-infected subjects prior to liver transplantation was comparable to that observed SOVALDI with potential concomitant drugs is summarized as follows and the list is not inclusive. The in subjects treated with SOVALDI and ribavirin in Phase 3 clinical trials. drug interactions described are based on potential drug interactions that may occur with SOVALDI. Post-Liver Transplant Patients: The safety and efficacy of SOVALDI have not been established in Anticonvulsants: Coadministration of SOVALDI with carbamazepine, phenytoin, phenobarbital, post-liver transplant patients. oxcarbazepine is expected to decrease the concentration of sofosbuvir, leading to reduced therapeutic effect of SOVALDI. Such coadministration is not recommended. Antimycobacterials: CHC Patients with Genotype 5 or 6 HCV Infection: Available data on subjects with genotype 5 or Coadministration of SOVALDI with rifabutin or rifapentine is expected to decrease the concentration 6 HCV infection are insufficient for dosing recommendations. of sofosbuvir, leading to reduced therapeutic effect of SOVALDI. Such coadministration is not recommended. SOVALDI should not be used with rifampin, a potent intestinal P-gp. Herbal References: 1. SOVALDI [prescribing information]. Foster City, CA: Gilead Sciences, Inc; Supplements: SOVALDI should not be used with St. John’s wort (Hypericum perforatum), a potent December 2013. 2. Ghany MG, Nelson DR, Strader DB, Thomas DL, Seeff LB. An update on intestinal P-gp inducer. HIV Protease Inhibitors: Coadministration of SOVALDI with tipranavir/ treatment of genotype 1 chronic hepatitis C virus infection: 2011 practice guideline by the ritonavir is expected to decrease the concentration of sofosbuvir, leading to reduced therapeutic American Association for the Study of Liver Diseases. Hepatology. y 2011;54:1433-1444. effect of SOVALDI. Coadministration is not recommended.

Drugs without Clinically Significant Interactions with SOVALDI: In addition to the drugs listed above, the interaction between SOVALDI and the following drugs was evaluated in clinical trials and no dose adjustment is needed for either drug: cyclosporine, darunavir/ritonavir, efavirenz, emtricitabine, methadone, raltegravir, rilpivirine, tacrolimus, or tenofovir disoproxil fumarate.

SOVALDI, the SOVALDI Logo, GILEAD and the GILEAD Logo are trademarks of Gilead Sciences, Inc., or its related companies. ©2014 Gilead Sciences, Inc. All rights reserved. SVDP0069 05/14

DDW 2014

GASTROENTEROLOGY & ENDOSCOPY NEWS • JUNE 2014

9

NAFLD continued from page 1

in the Division of Digestive Diseases and Nutrition, University of Kentucky, Lexington, and his colleagues examined clinical, laboratory and histologic features in 125 lean patients with NAFLD (body mass index [BMI] <25 kg/m2) and 965 overweight or obese individuals with NAFLD (BMI ≥25 kg/m2). Lean patients with NAFLD were more likely to be men and had a lower prevalence of diabetes, hypertension, hypertriglyceridemia, higher high-density lipoprotein cholesterol levels, less central obesity and metabolic syndrome (P<0.004 for all). Additionally, lean NAFLD patients had significantly lower levels of alanine aminotransferase (ALT), lower insulin resistance, lower degree of steatosis and less advanced fibrosis compared with overweight and obese individuals with NAFLD (P<0.03 for all). However, lean patients had more severe lobular inflammation, the researchers found (P<0.03).

Statistical analyses controlling for a range of factors revealed that lean

NAFLD patients had a risk for mortality 11.8 times higher than overweight and obese patients during an average follow-up period of 133±81.3 months (hazard ratio, 11.8; 95% confidence interval, 2.8-50.1; P=0.001).

P “These findings really surprised me,” Dr. Angulo said during a DDW press confer‘These findings really surprised me. I had ence. “I had thought that since thought that since these patients have a these patients have a healthier metabolic profile at presentahealthier metabolic profile at presentation, tion, they’d have a lower morthey’d have a lower mortality rate.’ tality rate.”

—Paul Angulo, MD Dr. Angulo said his team is studying a larger population of lean and obese NAFLD patients. One central intraabdominal versus peripheral Like Dr. Friedman, Dr. Angulo said factor they will be examining is the effect subcutaneous fat has. Based on results that clinicians should aim to increase of fat distribution on mortality risk. from animal studies and scant human insulin sensitivity in their lean patients “The only feature we utilized to distin- studies, I think lean people might tend with NAFLD through diet modification guish lean from obese patients was BMI, to have more intraabdominal fat, which and increased physical activity.

■ which doesn’t reveal anything about fat we know is associated with fatty liver to a distribution,” Dr. Angulo noted. “It will greater extent, as compared with periphDrs. Angulo and Friedman reported no be interesting to determine what effect eral subcutaneous fat.” relevant conflicts of interest.

From the Literature

Patients With Type 1 Diabetes Benefit From Bariatric Surgery in Small Study But With More Complications Than Other Bariatric Patients

BY CHRISTINA FRANGOU Overweight patients with poorly controlled type 1 diabetes can experience significant improvements in glycemic status and comorbid conditions after bariatric surgery, a small study suggests.

“These patients will enjoy the metabolic benefits of bariatric surgery even if we can’t put their diabetes in remission,” said lead author Stacy A. Brethauer, MD, a bariatric surgeon at the Cleveland Clinic in Ohio.

In a letter published in the journal Diabetes Care, Dr. Brethauer and colleagues describe 10 morbidly obese patients with poorly controlled type 1 diabetes who underwent laparoscopic bariatric surgery between 2005 and 2012.

Patients included one man and nine women with a mean age of 45.6 years and a mean baseline body mass index of 41.6 kg/m2. Most had been diagnosed with diabetes more than two decades earlier. They were considered higher-risk patients as each had approximately 10 obesity- or diabetes-related comorbidities.

Following surgery, nine of 10 patients achieved an excess weight loss greater than 60%, a rate similar to that expected for a general bariatric surgery population.

Patients who lost weight experienced improvements in key diabetic measures, including reductions in glycated hemoglobin (10%±1.6% vs. 89%±1.1%; P P=0.039) and daily insulin requirements (0.74±0.32 vs. 0.40±0.15 U/ kg per day; P P=0.004). They also improved in low-density

lipoprotein (–23±19.3; P P=0.007) and triglycerides (–30.5±17.1 mg/dL; P P=0.007). Hypertension resolved or improved in five of seven patients and albuminuria resolved in one of the two patients with preoperative microalbuminuria.

Sivamainthan Vithiananthan, MD, associate professor of surgery (clinical) and chief of bariatric surgery at Brown University, said the findings could have significant implications for the 15% to 20% of individuals with type 1 diabetes who are obese.

“These patients, who are often young or adolescents, don’t have just type 1 diabetes when they are obese but may have some degree of type 2 diabetes as well, meaning they have insulin resistance on account of their weight. It becomes a vicious cycle.

“What bariatric surgery can do is help stop that process

by addressing the obesity and adiposity that’s driving their insulin resistance. Therefore, they can be at a much lower dosage of insulin, have better control of their sugar and experience better long-term outcomes.”

Dr. Vithiananthan, who was not involved with the study, has performed bariatric surgery on people with type 1 diabetes. Generally, these patients are referred after an event like a heart attack or failing kidneys. “Hopefully, this study will encourage people to send people for surgery earlier rather than after an event,” he said.

Patients with type 1 diabetes who underwent bariatric surgery do have a higher risk for postoperative complications compared with other bariatric patients, a trend expected with a sicker patient population, said Dr. Brethauer. Five postoperative complications occurred including diabetic ketoacidosis, one deep vein thrombosis, an ulcer at the gastrojejunal anastomosis, esophageal dysmotility and persistent nausea.

Physicians should monitor these patients carefully after surgery to watch for ketoacidosis as they adapt to a new diet, said Dr. Brethauer.

No intraoperative complications were reported and no patient was converted to laparotomy.

Before this study, fewer than 12 cases of bariatric surgery in type 1 diabetes were reported in the literature.

The reports generally showed significant weight reduction and glycemic control, although the reports were not consistent.

Dr. Brethauer said the favorable metabolic effects of bariatric surgery may facilitate medical management of type 1 diabetes in the setting of morbid obesity. But the true role of bariatric surgery in these patients requires longer follow-up studies, he said.

“The take-home point is that type 1 diabetics may be candidates for surgery. You can have good metabolic outcomes in these patients even though they may be higher risk from a medical standpoint.”

■

THE SCIENCE BEHIND POSITIVE PATIENT OUTCOMES

Improving Efficiency in Colonoscopy Using the Olympus ScopeGuide Faculty Steven Alan Gorcey, MD Chief, Division of Gastroenterology Monmouth Medical Center Monmouth Gastroenterology Eatontown, New Jersey Assistant Clinical Professor Drexel University College of Medicine Philadelphia, Pennsylvania

Steven Lichtenstein, DO Director, Division of Gastroenterology Medical Director, Endoscopy/GI Lab Mercy Fitzgerald Hospital Clinical Associate Professor of Medicine Philadelphia College of Osteopathic Medicine Philadelphia, Pennsylvania

Introduction Colonoscopy is arguably one of the most powerful tools for the diagnosis, management, and prevention of disease in modern medicine. However, this procedure is highly technical, and its success depends on many variables. These include patient- and disease-related factors, operator expertise, and the capabilities of the endoscope and its associated technology.1,2 For example, patient discomfort during the procedure and procedural time in the context of difficult anatomy increases the probability of complications and decreases the probability that procedural goals will be achieved. Factors contributing to patient discomfort during the procedure include loop formation, redundant colons, pelvic or other abdominal adhesions, and difficult or complex flexures.3 Other difficulties in providing effective colonoscopies include administering appropriate amounts of anesthesia and the need to precisely document biopsy sites for serial examinations. These issues also make it harder for endoscopy trainees to achieve proficiency.4,5 This article reviews the use of the Olympus ScopeGuide technology in conjunction with colonoscopy as a mechanism to overcome these obstacles and to improve the success rate of endoscopic procedures, improve training, and reduce complications such as perforation and splenic hematoma.

Difficulties With Loop Formation One problem that limits navigation through the gastrointestinal (GI) tract during colonoscopy is the formation of loops and the difficulty of mitigating or reducing these loops.3 This problem arises, in part, from the inability to precisely map the configuration of the colonoscope as it courses

10

through the GI tract. The excessive formation of loops can lead to complications such as perforation, trauma to the liver or spleen, or failure to achieve the goals of the procedure. Additionally, reducing looping may reduce patient pain and, therefore, decrease the need for anesthesia.3

Magnetic-Based Endoscopic Representation Technology To improve procedural efficiency, mitigate loop formation, and increase patient comfort during colonoscopy, the magneticbased Olympus ScopeGuide provides a realtime 3-dimensional (3D) representation of the shape and position of the colonoscope inside the body.4 Real-time visualization of the course of the scope is made possible through a small number of electromagnetic coils located within the colonoscope itself that generate a weak, low-frequency magnetic field (Figure 1).4,6 Once an external receiver dish that is positioned close to the patient detects these pulses, the data are then relayed to a processor to generate a 3D representation of the scope alongside the endoscopic image (Figure 2).6 The resulting image provides the endoscopist with the precise positioning and orientation of the scope during the procedure (Figure 1).4,6

Evaluating Loops With ScopeGuide By seeing the shape of the entire scope as it moves through the body, ScopeGuide provides additional visual information that

A

is particularly helpful during difficult colonoscopies. For example, the endoscopist can evaluate the extent and type of looping and get a better sense of which rotational maneuvers will be required to straighten out the specific loop formations (Figure 2).6 In addition to providing critical information for rotational maneuvers, the 3D representation generated by the equipment provides added functionality. For instance, an assistant can use a separate handheld 3D marker to visualize where abdominal pressure will be most effective in reducing loops and facilitating transit of the colonoscope. Specifically, by moving the hand coil across the patient’s abdomen, the assistant is able to locate the precise position of the scope relative to the patient’s body and can then apply hand pressure to the abdomen as needed, thus minimizing the likelihood of large loops forming (Figure 1).6

Clinical Studies Several clinical studies have documented the utility of the ScopeGuide technology. In a preliminary study by Ambardar and colleagues, 3 experienced surgical endoscopists used the ScopeGuide technology to perform 78 outpatient colonoscopies over 5 months.7 The researchers found that using ScopeGuide helped them discover loops and apply appropriate pressure in 28% of cases. In addition, the ScopeGuide technology identified loops, led to the appropriate application of pressure, and facilitated early position changes in 33% of the exams.7 Furthermore, Ignjatovic and colleagues

B

studied the use of ScopeGuide versus non-use of ScopeGuide in 44 consecutive patients older than age 60 years who had features or history that predicted a difficult colonoscopy.8 Median time taken to complete intubation to cecum in the ScopeGuide group was 6.6 minutes compared with 9.1 minutes for patients not using ScopeGuide. There also was a shorter duration of looping with the ScopeGuide technology (2.2 vs 4.3 min).8

Documenting Procedures The information generated by this technology also can facilitate the functions of other members of the colonoscopy team.

For example, information regarding the location of the colonoscope can help nurses document precise locations of biopsies and samples.4 Similarly, gastroenterologists can use location-based information to document procedures in the patient’s medical record using endoscopic and ScopeGuide images.9 This type of information can be invaluable if repeat examinations are necessary, or if the patient requires subsequent surgical intervention.10 A study by Ellul and colleagues highlights the value of this information. Their team investigated the accuracy in determining the position of cancers detected during colonoscopy with the aid of ScopeGuide. After retrospectively reviewing records of patients in whom cancers were previously identified, the investigators reported that colonoscopy correctly identified tumor location in 93.75% of cases

C

Figure 1. Visualizing the gastrointestinal tract in real time with ScopeGuide.

(A) Real-time visualization of the course of the scope is made possible using built-in electromagnetic coils within the colonoscope that generate a weak low-frequency magnetic field.

(B) An external receiver dish that is positioned close to the patient detects these pulses. These data are then relayed to the processor to generate a 3-dimensional (3D) representation of the scope alongside the endoscopic image, providing the precise position and orientation of the scope during the procedure.

(C) An assistant can use a separate handheld 3D marker to visualize where to place abdominal pressure in order to reduce loops and facilitate transit of the colonoscope.

Images courtesy of Olympus.

GASTROENTEROLOGY & ENDOSCOPY NEWS • JUNE 2014

Supported by

using the ScopeGuide technology, whereas abdominopelvic computed tomography localized 82.5% of colon cancers.4 Based on these data, the investigators concluded that ScopeGuide enabled accurate localization of cancers at colonoscopy and the technology may increase clinicians’ confidence when localizing polypectomy sites that have not been tattooed.4

Safety With ScopeGuide As with the use of any device that discharges electrical current or that is associated with a magnetic field, there is a concern that these devices can interfere with implanted pacemaker or cardioverter defibrillator function.12 In that regard, Corbett and colleagues performed a preliminary

1

2

3

4

1

2

3

4

1

2

3

4

1

2

3

4

Reduce with a clockwise twist.

Figure 2. ScopeGuide display.

Reverse Alpha Loop

The ScopeGuide-generated image of the colonoscope’s location is displayed alongside the intraluminal image captured by the endoscope itself.

Reduce with a counterclockwise twist.

Image courtesy of Olympus.

N Loop Advance carefully and reduce with a clockwise twist if there is a spiral component.

study of ScopeGuide in patients with permanent pacemakers or implantable cardioverter defibrillators.12 After verifying that the magnetic field from ScopeGuide had no effect on the function of unimplanted cardiac devices ex vivo, investigators placed a colonoscope employing ScopeGuide on the abdomen over clothing of 100 patients with implanted cardiac devices. Cardiac monitoring and device interrogation were performed before, during, and after the mock procedure. There was no evidence of interference on device leads or change in programming following exposure to the electromagnetic field generated by ScopeGuide.12 However, further study is needed before any definitive conclusions are reached regarding the safety of ScopeGuide technology in patients with implanted cardiac devices.

Conclusion The formation of loops in the GI tract can hinder colonoscopy, making it more timeconsuming and painful for patients, and cause severe and often life-threatening complications. ScopeGuide is designed to provide a real-time, 3D image of the shape and configuration of the colonoscope during a procedure. By seeing the shape of the entire scope as it moves through the body, ScopeGuide provides additional visual information that is unavailable with conventional colonoscopes, and is particularly helpful during difficult colonoscopies and training. Furthermore, this technology can enhance an easy colonoscopy by giving precise locations of polyps and lesions.

Most importantly, the endoscopist is able to see loops form in real time and apply prophylactic pressure to reduce severe complications. Preventing large loops from forming enhances patient comfort, which may reduce anesthesia needs.

Spiral Sigmoid Loop Reduce with a clockwise twist.

Figure 3. Maneuvers to mitigate loop formation.

Images courtesy of Olympus.

References 1.

Witte TN, Enns R. The difficult colonoscopy. Can J Gastroenterol. 2007;21(8):487-490.

8.

2.

Rex DK, Petrini JL, Baron TH, et al; ASGE/ACG Taskforce on Quality in Endoscopy. Quality indicators for colonoscopy. Am J Gastroenterol.

2006;101(4):873-885.

Ignjatovic A, Thomas-Gibson S, Suzuki N, et al.

Does scopeguide improve caecal intubation?

A randomised controlled trial. Gut. 2011;60:A191.

9.

Olympus. ScopeGuide Interactive Brochure. 2013.

10.

D’Annabale A, Serventi A, Orsini C, et al. Locating polyps by endoscopy with or without videolaparoscopy, radioguided occult colonic lesion identification or magnetic endoscopic imaging: the way forward to complete polyp removal. Tech Coloproctol. 2004;8(2):S295-S299.

11.

Kaltenbach T, Leung C, Wu K, et al. Use of the colonoscope training model with the colonoscope 3D imaging probe improved trainee colonoscopy performance: a pilot study. Dig Dis Sci. 2011;56(5):1496-1502.

12.

Corbett GD, Lim YC, Lee JC, et al. Safety of the colonoscope magnetic imaging device (ScopeGuide) in patients with implantable cardiac devices. Endoscopy. 2014;46(2):135-138.

3.

Brooker JC, Saunders BP, Shah SG, et al. A new variable stiffness colonoscope makes colonoscopy easier: a randomised controlled trial. Gut. 2000;46(6):801-805.

4.

Ellul P, Fogden E, Simpson C, et al. Colonic tumour localization using an endoscope positioning device. Eur J Gastroenterol Hepatol.

2011;23(6):488-491.

5.

Raman M, Donnon T. Procedural skills education – colonoscopy as a model. Can J Gastroenterol. 2008;22(9):767-770.

6.

Olympus ScopeGuide. http://medical.olympusamerica.com/technology/scopeguide.

Accessed April 25, 2014.

7.

Ambardar S, Arnell TD, Whelan RL, et al. A preliminary prospective study of the usefulness of a magnetic endoscope locating device during colonoscopy. Surg Endosc. 2005;19(7):897-901.

Disclosures: Dr. Gorcey reported that he has served as a consultant for Olympus. Dr. Lichtenstein reported that he has served on the speaker’s bureau for Takeda Pharmaceuticals, Santarus Inc., and Salix Pharmaceuticals, and as a consultant for Olympus.

GASTROENTEROLOGY & ENDOSCOPY NEWS • JUNE 2014

11

SP0996V01

The technology also affords a unique opportunity to augment training efficacy for residents and subspecialty fellows who conduct endoscopic procedures. ScopeGuide provides visual cues to help trainees become proficient in estimating the configuration and orientation of the scope, as well as in rotational strategies designed to mitigate potential obstacles (Figure 3).11 Kaltenbach and colleagues performed a study to assess the influence of the ScopeGuide technology on trainee colonoscopy performance.

Blinded supervisors measured performance before and after individualized half-day sessions using a colonoscope training model and a colonoscope equipped with ScopeGuide.11 Following the intervention, the colonoscopy performance score improved from 4.4±2.3 to 5.9±2.4 (P=0.005). Trainees had a 76% cecal intubation rate after the session with ScopeGuide compared with 43% before training (P=0.004), and procedural times were reduced from 18±11 minutes to 14±7 (P=0.056). Furthermore, less sedation and anesthesia were used after training with ScopeGuide (P>0.05).11 Based on these data, the investigators concluded that colonoscopy simulation using the colonoscope training model and ScopeGuide immediately improved trainee colonoscopy performance in this small sample of trainees.11 ScopeGuide also may enhance patient comfort during colonoscopy. In the study

by Ignjatovic and colleagues described earlier, median patient pain score in the ScopeGuide group was 4. However, when ScopeGuide was not used, the median pain score was 15.8 Greater patient comfort and quicker procedural times might lead to a decrease in the need for patient sedation and anesthesia, as was indicated in the study

by Kaltenbach and colleagues.11

Alpha Loop

BB1414

Improving Efficiency in Training And Patient Comfort

Loop Identification

12

DDW 2014

GASTROENTEROLOGY & ENDOSCOPY NEWS • JUNE 2014

Bariatric Surgery Highly Effective for NAFLD in Severely Obese

BY DAVID WILD CHICAGO—Bariatric surgery should be the first line of treatment for nonalcoholic fatty liver disease (NAFLD) in patients with severe obesity, investigators said at the 2014 Digestive Disease Week (DDW) meeting. The 160-patient study showed that bariatric surgery and its related weight loss led to either complete or partial resolution of many cases of NAFLD-related steatosis, fibrosis, lobular inflammation, chronic portal inflammation and steatohepatitis.

“The extent of improvement we found surprised us,” said senior investigator Michel Murr, MD, director of bariatric surgery at the University of South Florida, Tampa. “Given the magnitude of improvement, we believe NAFLD patients with a body mass index [BMI] between 35 and 40 [kg/m2] should consider bariatric surgery, especially if they have not had success with medical treatments and diet modification.”

Dr. Murr’s team prospectively examined paired liver biopsies from 160 severely obese patients (mean preoperative BMI 52±10 kg/m2) who had undergone bariatric surgery between 1998 and 2003 and had histologically proven

NAFLD. The time between the initial biopsy, which was taken intraoperatively, and the subsequent biopsy was a mean of 29 months (±22 months). The patients had a mean age of 46 years at the time of first biopsy, and 82% were women.

The first set of biopsies revealed steatosis in 78% of patients, lobular inflammation in 42%, chronic portal inflammation in 68%, steatohepatitis in 33%, grade 2 to 3 fibrosis in 41% and cirrhosis in 2%. At postoperative follow-up, patients had lost an average of 62% of excess body weight. Follow-up biopsies revealed complete resolution of steatohepatitis in 88% of patients (44 of 50) as well as resolution of 70% (82 of 118) of steatosis cases, 74% (46 of 62) of cases of lobular inflammation and 32% (32 of 99) of cases of chronic portal inflammation.

“More importantly, grade 2 and 3 fibrosis was resolved or improved in 65% of patients,” Dr. Murr noted.

Of 52 patients with preoperative grade 2 fibrosis, 31% (16 of 52) had complete resolution, 31% (16 of 52) had improvement and 29% (15 of 52) had no change in fibrosis grade. In 10 patients with grade 3 fibrosis, one individual experienced

‘Given the magnitude of improvement, we believe NAFLD patients with a body mass index [BMI] between 35 and 40 should consider bariatric surgery, especially if they have not had success with medical treatments and diet modification.’

—Michel Murr, MD

resolution and seven showed improvement in fibrosis. One of three patients with preoperative cirrhosis experienced improvement, Dr. Murr reported.

Lawrence Friedman, MD, chair of the DDW Council and chair of the Department of Medicine at Newton–Wellesley Hospital, Newton, Mass., said that most individuals with severe obesity (BMI >40 kg/m2) have NAFLD. “Clearly, bariatric surgery is appropriate

in these patients,” said Dr. Friedman, who was not involved in the research.

“In less obese patients who have a BMI between 35 and 40 [kg/m2], I would say that having NAFLD should be a factor in the decision to proceed with surgery and should be weighed against the risks of bariatric surgery.”

■ Drs. Murr and Friedman reported no relevant conflicts of interest.

Bariatric Surgery continued from page 3

the solution for a sizable proportion. Instead, it is my contention that we focus on smaller subgroups—find areas in which popular opinion holds that surgery is strongly recommended, and not just that it should be considered.

If we continue to target all people with severe and morbid obesity, diabetes and sleep apnea, I believe that we will continue to encounter opposition. A common complaint and major issue are the barriers placed for precertification for a bariatric procedure. Often there are requests for documented diets lasting six months, psychological evaluation and serial weights. Although not stated, the real intent is to create barriers and

ration bariatric surgery. By making the process arduous, numerous individuals who start the process drop out.

Another sad by-product of this system is that it makes it difficult for those with life-threatening, yet treatable, issues to navigate the broken system. The real reason this system continues to exist is the large potential market for bariatric surgery. Each year, only so many people will develop symptomatic gallstones or be diagnosed with colon cancer. Barriers are placed for bariatric surgery, otherwise it would bankrupt the system if every potential candidate underwent surgery.

As a result, a system has developed that limits access; perpetuates patient fears; makes no allowances for the

sickest individuals; and where the most determined, not the most deserving, make it through the process. It is time that we changed the debate. Instead of striving for coverage for patients with lower BMIs, our efforts should be focused on finding areas in which surgical care offers undisputable benefit for conditions that already have coverage.

Suggested areas of concentration should be the following: • Individuals with type 2 diabetes, BMI greater than 30 kg/m2 and on injectable therapy or two or more oral hypoglycemic medications with hemoglobin A1c greater than 8; • Patients with moderate to severe sleep apnea, as documented by an apnea-hypopnea index greater than 15, and BMI greater than 35 kg/m2; • Patients with documented coronary artery disease and BMI greater than 35 kg/m2; • Patients requiring joint replacement who have BMI greater than 35 kg/m2; • Women with infertility from polycystic ovary syndrome who have BMI greater than 35 kg/m2.

There are probably several more categories that could be suggested. The point is the same: We need to make our procedures a must-have for certain indications, not just an option.

It is my hope that if we can find these areas, then the certification for patients who meet these criteria can be simplified. Our program currently certifies more than see Bariatric Surgery, page 23

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DDW 2014

GASTROENTEROLOGY & ENDOSCOPY NEWS • JUNE 2014

Most Benign Right-Sided Polyps Do Not Require Colon Resection

BY DAVID WILD CHICAGO—Difficult-to-remove colon polyps often are treated with partial colon resection but a small, randomized study presented at the 2014 Digestive Disease Week (DDW) meeting suggests laparoscopic-assisted colonoscopic polypectomy (LACP) requires fewer resources and is just as effective. The 34-patient study showed that LACP took significantly

less time to perform than laparoscopic hemicolectomy (LHC), and was associated with a faster recovery, shorter hospital stay and less blood loss.

“Anytime you can find a way to conserve resources while achieving comparable outcomes, that approach is worth studying further,” said Lawrence Friedman, MD, chair of the DDW Council and chair of the Department of Medicine, Newton–Wellesley Hospital, Newton,

Mass. “Long-term outcomes will need to be studied, but these data look quite promising,” said Dr. Friedman, who was not involved in the study.

Lead investigator Jonathan Buscaglia, MD, associate professor of medicine and director of Interventional Endoscopy, Division of Gastroenterology, Stony Brook University, Stony Brook, N.Y., said that LHC often is used to remove difficult-to-remove colon polyps. To

with the best-read gastroenterology publication.

‘The biggest roadblock to performing laparoscopicassisted colonoscopic polypectomy is the ability of a surgeon and gastroenterologist to coordinate their schedules.

You need a good relationship between the two departments, and schedules that can accommodate being in the operating room at the same time. It’s not always the easiest thing to do.’

—Jonathan Buscaglia, MD

♦

high readers

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average issue readers

♦

total readers

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high readers (% total readers)

♦

average page exposures Based on data from Kantar Media, June 2013

determine whether LACP can be used in place of LHC for this indication, Dr. Buscaglia and his colleagues randomized 34 patients with benign right-sided polyps to undergo either LACP or LHC. The two groups were similar in age and gender distribution, average body mass index, American Society of Anesthesiology class and history of previous abdominal surgery; polyp morphology, location, size and histology were similar between the two groups.

Dr. Buscaglia reported that physicians were able to remove polyps in 92.9% of patients assigned to LACP, with one patient requiring conversion to LHC. In the group randomized to LHC, four patients required conversion to laparotomy. His team also found that LACP required less time than LHC (95 vs. 179 minutes; P P=0.001) and LACP patients lost less blood (13 vs. 63 mL; P=0.001). LACP patients also required P see Resection, page 15

ENDOSCOPY SUITE

GASTROENTEROLOGY & ENDOSCOPY NEWS • JUNE 2014

Surgical Endoscopy continued from page 1

“The new requirement will give the public greater assurance that ABS-certified general surgeons have obtained sufficient training in the use of endoscopy to treat gastrointestinal diseases,” according to the statement released by the ABS. Endoscopy is one of the top five procedures performed by ABS-certified general surgeons and in many areas general surgeons are the only available providers of endoscopic services, the ABS said in the announcement.

The new program was developed partly in response to earlier criticisms from

gastroenterology societies that surgery residents fail to receive adequate training in endoscopy. In 2011, the gastroenterology societies issued a statement calling the ABS requirement of 50 colonoscopies and 35 upper endoscopies “inadequate to achieve training and/or competency, and should not be considered as part of training criteria for surgery.”

The new ABS curriculum does not specify numbers on how many procedures a resident should perform. The ABS and other surgical societies feel that case numbers fail to reflect a surgeon’s skill or proficiency, said Gerald Fried, MD, the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) president

Instead of focusing on numbers, the new curriculum requires residents to pass national tests of knowledge and endoscopic skills.

Resection continued from page 14

less IV fluids (2.1 vs. 3.1 L; P P=0.049), took less time to pass flatus (1.44 vs. 2.88 days; P P=0.002), resumed solid food intake sooner postoperatively (1.69 vs. 3.94 days; P<0.001) and were discharged earlier (2.63 vs. 4.94 days; P<0.001).

Rates of postoperative complications, hospital readmissions and reoperations were similar in the two groups. Although the investigators did not conduct a

and chair of the Department of o Surgery at Montreal’s McGill University, in Canada.

“It may take one person 100 cases to get really good at something, it may take someone 200 cases and it may take a third person 50 cases. It’s highly variable,” said Dr. Fried.

“Although case numbers are still an important aspect off tracking a resident’s experiencee, whether that is the best measu ure of the type of proficiency we’ree trying to ensure our trainees gett, I personally question,” he said.

Instead of focusing on numbers, the new curriculum requires resid dents to pass national tests of knowledge and d endod scopic skills.

The program was developed in collaboration with SAGES, the American Society of Colon and Rectal Surgeons, the American Society for Metabolic and Bariatric Surgery and the Society for Surgery of the Alimentary Tract. It is expected to cost approximately $250 per resident to implement.

One of the final milestones in the curriculum is the Fundamentals of Endoscopic Surgery program (FES), created

by SAGES several years ago. The FES program provides an objective, validated assessment of a surgeon’s competency in flexible endoscopy and includes didactic materials, a multiple-choice examination and a hands-on skills test that must be performed on a virtual reality simulator at a certified testing site. Preparation for the skills test can be achieved using resources already available at all residency programs and do not require purchase of a simulator.

FES is modeled on SAGES’ Fundamentals of Laparoscopic Surgery (FLS) program, which the ABS made a requirement for board certification five years ago. Multiple studies have confirmed FLS is a reliable and valid tool for teaching and evaluating laparoscopic surgery.

O. Joe Hines, MD, chief of general surgery and program director for general surgery at UCLA’s David Geffen School of Medicine, Los Angeles, said he expects the new endoscopic curriculum will raise the level of endoscopic training

cost-savings analysis, there could be significant differences in that measure, Dr. Buscaglia noted.

During a press conference where he presented the findings, Dr. Buscaglia said that although LACP has clear benefits, adoption of the procedure has been slow, in part because of a paucity of well-designed studies.

“Until now, there have been only a handful of published case series on LACP,” he said.

Physicians also may find it more challenging to schedule an LACP, he added.

“The biggest roadblock to performing LACP is the

15

ffor surgery residents id t across the th country. t Today, residents at various institutions receive vastly different exposure to endoscopy, he said. At UCLA, for instance, gastroenterologists perform most endoscopy procedures. “So it’s been a challenge for our residents to get a quality experience and learn how to do endoscopy,” said Dr. Hines.

“For us, this new curriculum is going to be a very good thing because it provides a framework for education and refocuses our efforts for residents in this area.”

He added that the new program sends a strong message to the public that new surgeons have achieved uniform standards for competency in endoscopy. “They’ll know that surgeons who go into the community across the country can do endoscopy.”

A decade-long debate has gone on among surgeons, gastroenterologists and family medicine physicians regarding who should perform endoscopic procedures and how these practitioners should be trained.

Dr. Fried said flexible endoscopy now represents a “very big part” of a general surgeon’s practice and he expects it will grow further as endoscopy becomes more interventional.

“We’re now treating diseases endoscopically that were traditionally treated by surgeons with traditional surgical techniques. Just as we’ve evolved from open techniques to laparoscopy for surgical care, we’re evolving to use endoscopy as another important tool for surgical treatments.” ■

ability of a surgeon and gastroenterologist to coordinate their schedules,” Dr. Buscaglia said. “You need a good relationship between the two departments, and schedules that can accommodate being in the operating room at the same time. It’s not always the easiest thing to do.”

Dr. Buscaglia said patients in the study will undergo surveillance colonoscopies to determine whether there are any differences in their long-term outcomes.

■ Drs. Buscaglia and Friedman reported no relevant conflicts of interest.

16

GASTROENTEROLOGY & ENDOSCOPY NEWS â&#x20AC;˘ JUNE 2014

ENDOSCOPY SUITE

Why We Need Anesthesia Providers, Not Robots Or RNs, in GI Settings Pushing Medications

.B Z Vis %% it us 8 C PP UI B U

Re: â&#x20AC;&#x153;Use, Cost of Anesthesia for Endoscopy Increasing,â&#x20AC;? by Monica J. Smith.

Gastroenterology & Endoscopy News May 2012;63:1,26-27.

H E PAT O L O G Y

Much to the chagrin of U.S. gastroenterologists who had praised the European Society of Anesthesiology (ESA) for its rigor and fairness, the society recently decided to retract its endorsement of guidelines for nonâ&#x20AC;&#x201C;anesthesiologist-administered propofol (Pelosi P. Eur J Anaesthesiol 2012;29:208). see Retraction, page 32

From the Literature

Use, Cost of Anesthesia For Endoscopy Increasing The authors of a study gauging the use of anesthesia services for endoscopy and colonoscopy say their research accomplished a couple of firsts, but to those familiar with the ongoing sedation saga, the main findingâ&#x20AC;&#x201D;that anesthesia services have

Kim Riviello, DNP, MBA/HCM, CRNA President, Anesthesia Services Group Tipp City, Ohio As a certified nurse anesthetist (CRNA), I am horrified at the thought that we could have robots pushing potentially lethal medications. Oh, yesâ&#x20AC;&#x201D;it is going to be used on healthy patients. I forgot.

Our population is growing older and sicker. I just completed my dissertation on this topic, in which I reviewed 3,200 charts and proved that there is a definite trend in increased comorbidities in patients being seen not only in gastroenterology settings but also ambulatory surgery centers (ASCs). The following is a brief excerpt from my dissertation, which has been edited for publication in Gastroenterology & Endoscopy News:

A Retrospective Study of a Gastroenterology Facility: Are the Patients Sicker?

There has been substantial growth in the number of ASCs across the United States.

With the advancement in technology for noninvasive procedures and shorter-acting anesthetics, more patients are being seen in freestanding surgery facilities. However, the trend in patient comorbidities (e.g., obesity, diabetes, cardiac respiratory diseases) also has risen, increasing the risk for an anesthesia-related event, even when low-risk procedures are performed. The most common malpractice claims have been associated with diagnostic procedures performed in ASCs under monitored anesthesia care (MAC) with patient comorbidities as contributing factors. The morbidity and mortality of ambulatory surgery patients has led to an increased concern for patient safety in freestanding facilities. Of particular concern is sedation, specifically in gastroenterology (GI) centers. Yet, the Journal of the American Medical Association recently reported that two-thirds of the anesthesia procedures provided during colonoscopies and esophagogastroduodenoscopies (EGDs) were on â&#x20AC;&#x153;low-risk patients,â&#x20AC;? suggesting a lack of need for professionally administered anesthesia in GI facilities and implying that specialist-monitored anesthesia would contribute to the increased cost of these procedures (Liu H et al. JAMA

2012;307:1178-1184). This study is a retrospective chart review of 3,252 patients, conducted at a GI center over a 10-month period in 2011. The patientsâ&#x20AC;&#x2122; ages ranged from 18 to 95 years. Procedures involved were either an EGD and/or a colonoscopy with MAC. The preoperative assessment and anesthesia record was used to gather information on each patient. A data analysis table was developed to log comorbidities on a monthly basis (total number and percentages). The comorbidities of the MAC patients were correlated with the American Society of Anesthesiologists (ASA) physical classification system to stratify patients based on disease entities.

These data were then compared to provide evidence of an increased trend in the percentage of high-risk patients and associated morbidity and mortality.

In 1983, there were approximately 239 freestanding surgery facilities in the United States (Durant G. Medical Group Management Journal 1989;36:16-18,20).

By 2003, there were more than 3,300 (Casalino LP et al. Health Afff 2003;22:5667; Winter A. Health Aff 2003;22:68-75) and by 2010, the number increased by 61% to 5,316 (â&#x20AC;&#x153;ASC Services,â&#x20AC;? 2012).

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F O C U S

BY CHRISTINA FRANGOU SAN FRANCISCOâ&#x20AC;&#x201D;For several months, it has been one of the most pressing questions among clinicians who treat patients with hepatitis C: How well do the two FDA-approved direct-acting antivirals (DAAs) perform in the patients who are most in need of a new form of therapy?

The answer, based on evidence presented at The Liver Meeting 2011, appears to be that these therapies improve sustained viral response (SVR) rates in hepatitis C patients with cirrhosis and those who have previously failed standard therapy, but these patients still lag far behind others, with SVR rates that dip below the 50% mark. Two factorsâ&#x20AC;&#x201D;previous response to treatment and fibrosis stageâ&#x20AC;&#x201D;appear to be the most important

predictors of achieving SVR. But experts have yet to reach a consensus on the best treatment for difficult-to-treat patients. see DAAs, page 10

From the Literature continued from page 1

increased dramatically in gastroenterology (GI)â&#x20AC;&#x201D;is only noteworthy because it has been published in the prominent Journal of the American Medical Association (Liu H. 2012;307:1178-1184). â&#x20AC;&#x153;The findings of this study are neither surprising nor novel,â&#x20AC;? commented Lawrence B. Cohen, MD, associate professor, Mount Sinai School of Medicine, New York City. â&#x20AC;&#x153;If it had been published in Gastrointestinal Endoscopy, you wouldnâ&#x20AC;&#x2122;t know anything about it,â&#x20AC;? added Douglas K. Rex, MD, professor in the Department of Medicine at Indiana University School of Medicine and director of endoscopy at Indiana University Hospital, Indianapolis. â&#x20AC;&#x153;And the truth is, if you look at this reference list here, it has been published in Gastrointestinal Endoscopy [Inadomi JM et al. 2010;72:580-586].â&#x20AC;?

Increased Use, Increased Cost With the financial support of Ethicon Endo-Surgery (EES), researchers from the RAND Corporation compiled a retrospective analysis of claims data for 1.1 million Medicare patients and 5.5 million privately insured adults to assess trends in the use of anesthesiologists and nurse anesthetists for upper endoscopy and colonoscopy, and to examine regional variation in the use of anesthesiology services and payment for these services.

The investigators found that in both the Medicare and privately insured populations, the proportion of those using anesthesia services increased from about 14% in 2003 to more than 30% in 2009, and that two-thirds of those services were delivered to patients considered low risk based on their American Society of Anesthesiologists (ASA) status. Regional variation was substantial, with anesthesia services used least frequently in the West (around 13%) and most frequently in the Northeast (59%).

Not surprisingly, as use of anesthesia services grew, so did the expense of the procedure. The addition of anesthesia services increased the cost of a procedure by $150 if the patient received Medicare, and by $500 if the patient was privately insured. The researchers estimated that the use of anesthesia services for these procedures amounted to $1.1 billion in 2009.

The researchers noted the link between the uptick in use of anesthesia services and the increasing popularity of propofol, which must be administered only by persons trained to administer

I N S I D E

CMS Unveils Major Changes for ASCs

Anesthesia general anesthesia according to both the Centers for Medicare & Medicaid Services (CMS) and the FDA. The researchers stated that to the best of their knowledge, their study is the first to quantify spending on anesthesia services for outpatient GI procedures in both government-insured and privately insured patients, and that they were the first to stratify anesthesia use by ASA status.

They concluded that the number of GI procedures and use of anesthesia services climbed considerably between 2003 and 2009; that the regional variation and use of anesthesia services in low-risk patients suggests much of the spending could be considered discretionary; and that colonoscopy screening programs will increasingly come under the scrutiny of payers and policymakers as costs continue to climb.

Can We Afford â&#x20AC;&#x2DC;Discretionaryâ&#x20AC;&#x2122; Anesthesia?

In a related editorial, â&#x20AC;&#x153;Assessing the value of â&#x20AC;&#x2DC;discretionaryâ&#x20AC;&#x2122; clinical care: the case of anesthesia services for endoscopy,â&#x20AC;? Lee A. Fleisher, MD, from the Department of Anesthesiology and Critical Care at the Perelman School of Medicine, and Leonard Davis Institute of Health Economics at the University of Pennsylvania, Philadelphia, noted possible explanations for the escalated use of anesthesiology services (JAMA 2012;307:1200-1201).

One is that use of anesthesia services and deep sedation might allow endoscopists to perform exams in less time, and to conduct potentially more thorough exams, noting that the latter is of some debate. Another reason might be patient acceptance or preference, although this too, is hard to quantify. â&#x20AC;&#x153;At the Hospital of the University of Pennsylvania [HUP], only about 30% of our low-risk outpatients get anesthesia; the rest receive moderate sedation,â&#x20AC;? Dr. Fleisher told Gastroenterology & Endoscopy News. â&#x20AC;&#x153;But in one of our satellites, itâ&#x20AC;&#x2122;s 100%. Is this really patient-driven?

Our endoscopists donâ&#x20AC;&#x2122;t feel that everyone needs anesthesia, and they make rational decisions about who requires it at HUP.â&#x20AC;?

The widespread geographic variability the study reported also gave Dr. Fleisher pause. â&#x20AC;&#x153;This says thereâ&#x20AC;&#x2122;s something else going on. Do people in the Northeast believe you need anesthesia more than

people in the Southwest? Or is this really about different payment schemes, and if so, whoâ&#x20AC;&#x2122;s driving this?â&#x20AC;?

â&#x20AC;&#x2DC;Endoscopy currently has a certain amount of [relative value units] related to moderate sedation, which does not go away

â&#x20AC;&#x153;I think the real question is not that health care is paying for discretionary services, but how can our health care system provide high-quality sedation service for patients undergoing endoscopy in a cost-effective manner,â&#x20AC;? Dr. Cohen said. A further question is not whether propofol is appropriate, but who should be administering it, he added.

Modest Pay Increases; Quality Reporting Mandate what is your opinion?

BY CHRISTINA FRANGOU Gastroenterology & Endoscopy News is now accepting

Major changes are under way in the The CMS 2012 final rule increased opinion Centers for Medicare & pieces.

Medicaid payment rates to ASCs by 1.6% this year, thoughtsand to rates the editor at:Outpatient ProspecServices (CMS) Send system your of payments under the to ambulatory surgical centers (ASCs) tive Payment System rose by 1.9%. mail: 545 West 45th Street, 8th Floor and hospital outpatient departments. see CMS, page 59

when [endoscopists] use anesthesia services. So there is

fax: e-mail:

payment for sedation for the endoscopist, and the anesthesia payment.â&#x20AC;&#x2122; â&#x20AC;&#x201D;Lee A. Fleisher, MD

New York, New York 10036 212.957.7230

H E PAT O L O G Y

Dr. Fleisher believes the increa ased use of anesthesiology services is be eing driven by endoscopists and facilitated d by anesthesiologists. â&#x20AC;&#x153;There is no financial disincentive e to use anesthesia services,â&#x20AC;? Dr. Fleissher said. But this trend, he said, is financ cially untenable. â&#x20AC;&#x153;Endoscopy currently has a cerrtain amount of [relative value units] rela ated to moderate sedation, which does not go away when [endoscopists] use an nesthesia services. So there is paymentt for sedation for the endoscopist, and the anesthesia payment,â&#x20AC;? Dr. Fleisher said. â&#x20AC;&#x153;I donâ&#x20AC;&#x2122;t think we can afford this. We donâ&#x20AC;&#x2122;t want to change things so much that people will stop getting colonoscopy scre eening, but we need to come up with more rational payment schemes.â&#x20AC;?

In his editorial, Dr. Fleisher suggessted bundling of services as a payment opttion.

This would require the anesthesiolo ogist and gastroenterologist to establish a value for their services. â&#x20AC;&#x153;In such a system, there are appro opriate incentives for the gastroenterolo ogist and facility to decide if everyone rece eives anesthesia and its attendant costs, or if only a subset of patients require anessthesia,â&#x20AC;? he said.

Dr. Cohen and colleagues noted the regional differences in use of anesthesia services years ago, and attributed it to patterns of influence. â&#x20AC;&#x153;In the early 2000s, we conducte ed a large survey of practitioners across the country. There were pockets in the country where this was done, and pockets where it was not. If one or two doctors introduced propofol, the whole area would quickly adopt that practice. Thatâ&#x20AC;&#x2122;s how it went from a negligible amount of anesthesia utilization 20 years ago, to nearly 50% today.â&#x20AC;?

ffee es, bill for their services and pocket the es d ference between what they bill and diff w at they pay,â&#x20AC;? Dr. Rex said. â&#x20AC;&#x153;That can wh b a really substantial source of income. be T ere are a lot of people in the GI comThe mu unity i who h lik like this, hi and d itâ&#x20AC;&#x2122;s i â&#x20AC;&#x2122; perfectly f l leg gal.â&#x20AC;? g Dr. Rex has long been involved in the D pollitics and science of propofol, and orig ginally delivered it to patients through nurrse-administered propofol sedation.

He and his colleagues had to discontinu ue this practice in early 2010 due to CM MS regulations. â&#x20AC;&#x153;â&#x20AC;&#x153;Now we use anesthesiologists, too.

We eâ&#x20AC;&#x2122;ve produced a lot of evidence and don ne a lot of studies, but this is not about evidence, itâ&#x20AC;&#x2122;s about other issues that are outt of our control,â&#x20AC;? he said.

â&#x20AC;&#x2DC;I think the real question is not that health care is paying for discretionary services, but how can our health care Define â&#x20AC;&#x2DC;Discretionaryâ&#x20AC;&#x2122; Dr. Cohen found the presentation of data in the article and its conclusion somewhat misleading, and objected to use of use of the word â&#x20AC;&#x153;discretionary.â&#x20AC;? â&#x20AC;&#x153;It implies that the anesthesia provision of propofol is optional or even unnecessary,â&#x20AC;? he said. â&#x20AC;&#x153;The pharmaceutical properties of propofol are such that it is the ideal agent for sedation of patients undergoing short, rather abbreviated ambulatory procedures. Use of a benzodiazepine and an opioid in the 21st century is really sort of antiquated.

system provide high-quality â&#x20AC;&#x153;We just need to figure out the appropriate financial models. The dollars are there in health care: Theyâ&#x20AC;&#x2122;re paying for colonoscopy, theyâ&#x20AC;&#x2122;re paying for biopsy, theyâ&#x20AC;&#x2122;re paying for facility fees,â&#x20AC;? Dr. Cohen said. â&#x20AC;&#x153;Itâ&#x20AC;&#x2122;s just a matter of how you can configure the dispersal of those dollars to cover the additional cost of sedation.â&#x20AC;?

sedation service for patients

Complex Issue

Dr. Rex agrees with Dr. Fleisher that the escalation of anesthesia services in GI due to financial considerations is unlikely to change unless reimbursement systems do.

The increasing use of anesthesia services and the questions of which sedating agent should be used, who should be receiving it, who should be administering

extraction of lens (3.1 million) and insertion of prosthetic lens (2.6 million). General anesthesia was performed in 30.7% of freestanding surgery facilities, with greater than 20.8% providing MAC (Cullen KA et al. National Health Statistics Reports Number 11. Revised. Hyattsville, MD: National Center for Health Statistics: 2009). The Medicare Payment Advisor Commission reported that in 2010, 3.3 million Medicare beneficiaries were seen in freestanding surgery facilities (â&#x20AC;&#x153;ASC Services,â&#x20AC;? 2012).

Metzner et al performed a closed claims analysis in areas outside hospital operating rooms (ORs), but within the hospital setting, to determine the risk associated with anesthesia being performed in these remote locations (Curr Opin Anaesthesiol 2009,22:502-508). They thought that even though the procedures were relatively noninvasive, serious outcomes could occur.

They analyzed claims in the ASA Closed Claims database (1990-1999), comparing injuries associated with care in remote sites (n=87) and hospital ORs (n=3,286).

Patients in remote locations were more than 70 years old (>20%), sicker (69%; ASA status 3-5) and underwent more emergent procedures (36%), compared with patients in hospital settings. The predominant anesthetic in these locations was

undergoing endoscopy in a cost-effective manner.â&#x20AC;&#x2122; â&#x20AC;&#x201D;Lawrence B. Cohen, MD

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With the advancement in technology for noninvasive procedures and shorter-acting anesthetics, more patients are being seen in freestanding surgery facilities. However, the trend in patient comorbidities also has risen, increasing the risk for an anesthesia-related event, even when low-risk procedures are performed.

The U.S. Department of Health and Human Services conducted a study in 2006, to determine the number of surgical and nonsurgical (diagnostic) procedures performed in outpatient settings and freestanding surgery facilities. They collected the data using the 2006 National Survey of Ambulatory Surgery. The sample was composed of 398 freestanding surgery facilities; 295 (74.1%) responded to the survey.

The National Survey of Ambulatory Surgery estimated that 53.3 million surgical and nonsurgical (diagnostic) procedures were performed in ASCs, with 14.9 million occurring in freestanding surgery facilities. The most frequently performed procedures were colonoscopies (5.7 million), upper endoscopies (3.5 million),

see Anesthesia, page 26

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â&#x20AC;&#x153;Episode-based care would probably change it immediately, with the caveat that the anesthesia profession is probably the best organized of all the specialties i l i in i regard d to lobbying l bb i and d to their h i behavior with insurance companies,â&#x20AC;? he said. â&#x20AC;&#x153;They also have a very large [political action committee], and the [ASA] very effectively lobbies for and protects the interests of the anesthesia community with regard to the financial issues.

Thatâ&#x20AC;&#x2122;s what a lot of professional societies in medicine do, but I think theyâ&#x20AC;&#x2122;re one of the more effective ones.â&#x20AC;?

SEDASYS According to David J. Shaffer, director of worldwide communications for EES, the medical device company financed the current study to gain marketing knowledge for a computer-assisted personalized sedation system they have been developing. â&#x20AC;&#x153;We funded this study to better understand the health care environment in which this product, if approved, would be used,â&#x20AC;? he said in an email.

The SEDASYS System keeps check on a patient undergoing propofol sedation by measuring a number of physiologic parameters, such as blood pressure, heart rate, electrocardiography, oxygen saturation level and capnography. It also communicates with the patient throughout the procedure and asks the patient to repeatedly press a handheld button. â&#x20AC;&#x153;The idea is that if they donâ&#x20AC;&#x2122;t answer by pushing the button, the machine will stop infusing the drug,â&#x20AC;? Dr. Rex said.

In a randomized controlled trial comparing SEDASYS with fentanyl and midazolam, patients sedated by the former were less likely to be deeply sedated,

and both patients and doctors preferred the computerized system (Pambianco DJ et al. Gastrointest Endosc 2011;73:765772). The authors concluded that the system provided id d a safe f and d effective ff i onlabel way for endoscopistâ&#x20AC;&#x201C;nurse teams to deliver propofol.

In spring 2010, the FDA rejected EESâ&#x20AC;&#x2122;s application for approval of the SEDASYS System, despite its having been recommended for approval by an advisory panel in an 8 to 2 vote. In February of this year, EES received an approvable letter from the FDAâ&#x20AC;&#x2122;s Center for Devices and Radiological Health (CDRH) that outlines conditions that must be met in order to receive FDA approval. â&#x20AC;&#x153;[This] largely reflects an agreement EES reached in November 2011 with the CDRH on a path forward to permit continued review of the Premarket Approval Application,â&#x20AC;? Mr. Shaffer wrote. â&#x20AC;&#x153;We are pleased to have reached this milestone in our efforts to bring this important innovation to market, because we believe the SEDASYS System, if approved, has the potential to benefit patients, physicians and nurses.â&#x20AC;?

EES is not proposing that the system would replace anesthesia professionals. â&#x20AC;&#x153;Our intended use is to enable physicianâ&#x20AC;&#x201C;nurse teams to provide minimal to moderate sedation with propofol during colonoscopy and esophagogastroduodenoscopy procedures,â&#x20AC;? Mr. Shaffer wrote. The system is meant to be used during routine screening and diagnostic colonoscopy and esophagogastroduodenoscopy for patients classified as ASA classes I and II. â&#x20AC;&#x153;There will always be a need for anesthesiologists in higher-risk endoscopy procedures.â&#x20AC;?

MAC, which resulted in eightfold more claims compared with OR procedures (50% vs. 6%, respectively). The locations most commonly involved in claims were GI suites (32%) and cardiac catheterization laboratories (25%). The severity of injury was greater in remote locations than in ORs, with mortality almost doubled.

Adverse respiratory events, oxygen/ventilation being the most common, occurred in both remote and OR locations, but remote locations had sevenfold greater occurrences. Respiratory depression caused by oversedation and loss of airway was responsible for 26 remote-location claims; more than half occurred in the endoscopy suite. Patient factors contributing to oversedation and loss of airway were obesity, sleep apnea, ASA status 3 to 4 and age greater than 70 years.

In February 2006, a closed claims analysis of cases with MAC found that patients who were older (>70 years) and sicker (ASA status 3-4) had more claims associated with morbidity and mortality (40%; Bhananker SM et al. Anesthesiologyy 2006;104:228-234). Bishop et al also examined malpractice claims, comparing outpatient (freestanding and hospitalbased) and OR procedures from 2005 to 2009 ((JAMA A 2011;305:2427-2431). In the outpatient setting, the most common claim was diagnostic procedures under MAC (45.9%).

The ASA scoring system is a valuable tool in evidence-based anesthesia practice, helping to determine intraoperative and postoperative complications for patients based on their overall health status. It is also valuable in ascertaining quality outcome measures and patient see Anesthesia, page 18

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GASTROENTEROLOGY & ENDOSCOPY NEWS • JUNE 2014

ENDOSCOPY SUITE

Anesthesia continued from page 16

safety indicators based on comorbidities.

Tracking of risk indicators in hospitals has been an important tool to improve quality of patient safety and is now an incentivized program for hospitals (Centers for Medicare & Medicaid Services, “Hospital Initiatives,” 2011). However, this has not occurred in freestanding surgery facilities.

A 2009 study surveyed diagnosis-based

risk adjustment for surgical and procedural outcomes in ASCs. Seven-day mortality rates for hospital-based outpatient surgery and freestanding facilities were examined. The study revealed that hospital-based outpatient surgery centers reported comorbidities more frequently than freestanding facilities: 59.6% versus 8.7%, respectively, in cataract patients and 90% versus 45%, respectively, in GI patients (Chukmaitov AS et al. Health Care Manag Sci 2009;12:420-433).

The requirement for these data from

freestanding facilities could be a valuable tool in determining the future morbidity and mortality of patients being seen in these facilities. Studies have demonstrated that freestanding facilities have definitive risks associated with patient comorbidities and the type of anesthesia provided, with diagnostic centers and endoscopy centers providing MAC sedation having the most associated claims.

Yet, in the 2006 National Survey of Ambulatory Surgery data, there was no information on the comorbidities of the

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14.9 million people seen in freestanding facilities and the risk associated with anesthesia. The National Survey of Ambulatory Surgery report stated that procedures in freestanding facilities and outpatient hospital-based facilities increased by 300% over a 10-year period. If this trend continues, by 2016, 44.7 million people will be seen in freestanding facilities. Six million will be older than 65 years and undergoing gastrointestinal procedures (Cullen KA et al. National Health Statistics Reports Number 11. Revised. Hyattsville, MD: National Center for Health Statistics; 2009). In this study, more than 50% of the patient population seeking GI procedures were between the ages of 51 and 70 years.

Comorbidities most frequently observed were hypertension, hyperlipidemia, sleep apnea, gastroesophageal reflux disease, diabetes, smoking, coronary artery disease and chronic obstructive pulmonary disease; these comorbidities increased over time, and the increase was statistically significant. Body mass index did not change over time in a statistically significant manner. ASA status 3 cases increased over the study period; changes in ASA status 2 cases were not significant, and ASA status 1 represented only 2.58% of cases.

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Studies have demonstrated that freestanding facilities have definitive risks associated with patient comorbidities and the type of anesthesia provided, with diagnostic centers and endoscopy centers providing MAC sedation having the most associated claims.

Liu et al reported that 66% of anesthesia administered in GI facilities is to “low-risk” patients ((JAMA A 2012;307:11781184). They found that the combination of ASA 1 and 2 cases represented 43.5% of patients receiving anesthesia. Studies have shown that the higher the ASA classification, the greater the odds ratio for developing a postoperative complication.

Mortality rates have been reported to be 0.3% to 1.4% for ASA 2, 1.8% to 5.4% for ASA 3, and 7.8% to 25.9% for ASA 4 (Wolters U et al. Br J Anaesth 1996;77:217222). In a more recent study, Bishop et al reported that major injury and death occurred in the outpatient setting 36.1% and 30.6% of the time, respectively (JAMA ( 2011;305:2427-2431). As the number of ASA 3 patients seen in freestanding facilities continues to increase over time, are the risks associated with these patients acceptable? Unfortunately, as the study indicates, this is the trend in our society, with the

19

GASTROENTEROLOGY & ENDOSCOPY NEWS â&#x20AC;˘ JUNE 2014

largest generation now aged between 50 and 75 years. The safety of these patients is determined by comorbidities and the assessment performed by the anesthesia clinician and the consultants they deem necessary to determine what is best for each patient. The ASA classification system is subjective in classifying patient risks; however, the anesthesia professional is trained to make this determination with the patientâ&#x20AC;&#x2122;s safety in mind.

With the continued increase in demand for freestanding facilities, analysis and documentation of patient comorbidities should be tracked to gain a better understanding of the type of patients being seen in these isolated locations and how to address associated patient safety issues.

Administrators and federal and state agencies need to be aware of the level of risk associated with these diseases to ensure that the proper clinician is determining which patients are or are not at risk from a procedure. Bishop et al suggested that because of the high percentage of claims linked to diagnostic procedures with MAC anesthesia, safety initiatives should be developed focusing on the outpatient setting ((JAMA A 2011;305:2427-2431).

Chukmaitov et al recommended that federal and state agencies mandate hospital-based outpatient surgery centers and freestanding facilities to provide comprehensive information on all patients related to comorbidities to help determine patient safety guidelines and risk-adjustment measures (Health Care Manag Sci 2009;12:420-433). A performance measure recommended by the Medicare Payment Advisory Commission states that incentives should not discourage providers from accepting riskier or more complex patients, yet the outcome measures that they encouraged the Centers for Medicare & Medicaid Services to incorporate for ASCs do not require any risk adjustment. Patient falls and burns, and wrong site, wrong side, wrong patient, wrong procedure, and wrong implant procedures, as well as hospital transfer/admission errors and surgical site infections are all preventable outcome measurements and are not affected by a patientâ&#x20AC;&#x2122;s health status (â&#x20AC;&#x153;ASC Services,â&#x20AC;? 2012). Quantifying patient comorbidities and ASA classifications, as exemplified in this study, would help evaluate risk adjustments as the acuity of the patient population increases. The advantage of having anesthesia during GI cases has been demonstrated through preoperative screening, intraprocedural safety and postoperative satisfaction (Hass W. AnesthesiaReviews Blog, 2013; www. physynergy.com/blog-anesthesia-services/ bid/143340/Anesthesia-Services-ShouldBe-Used-For-GI-Endoscopy). This study revealed that most of the patients receiving anesthesia were classified as ASA 3.

ENDOSCOPY SUITE

As the number of ASA 3 patients seen in freestanding facilities continues to increase over time, are the risks associated with these patients acceptable?

So, is cost still an issue, knowing that the majority of the patients are sick? According to Lui et al, by advocating patient safety, anesthesia is helping to decrease the cost of health care by decreasing intraoperative and postoperative complications ( (JAMA A 2012;307:1178-1184). Hass found

that examining cost and procedural factors alone only represents a hindrance to anesthesia; it is through a comprehensive analysis of patient assessments that the societal advantages of patient safety and satisfaction can be found (AnesthesiaReviews Blog, 2013; www.physynergy.com/

blog-anesthesia-services/bid/143340/ Anesthesia-Services-Should-Be-UsedFor-GI-Endoscopy). Anesthesia intervention is pivotal in freestanding facilities, including GI centers, to ensure proper evaluation of patient comorbidities and risk factors, ascertaining the appropriate anesthetics are administered, and patients remain safe.

Regardless of the practice environment, patients should be assured that they are receiving a safe and quality anesthetic from an anesthesia professional. â&#x2013;

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GASTROENTEROLOGY & ENDOSCOPY NEWS • JUNE 201 2014 14

ENDOSCOPY SUITE

NYSGE continued from page 1

the features visitors anticipate every year: provocative lectures, satellite symposia, hands-on workshops and a touch of holiday spirit amid the bustle of midtown Manhattan. But within that was a pang of melancholy for the loss of Florence Lefcourt, the society’s former executive editor and long considered its heart and soul, who died in October at the age of 98.

“When you walked into the course this year and saw that big poster of her, the first indication that this woman is not here, that this is really final, it felt different,” said Felice Schnoll-Sussman, MD, who expressed hope that the NYSGE will continue to be imbued with Ms. Lefcourt’s sense of purpose and dedication to its mission.

“It’s like when you lose a grandparent. You hope that what they created—that sense of who you are and what you want to be—will stay with you forever,” said Dr. Schnoll-Sussman, who is associate professor of clinical medicine at Weill Cornell Medical College and director of The Jay Monahan Center for Gastrointestinal Health, both in New York City.

“Florence was the collective memory of the society,”

‘Florence was the collective memory of the society. She knew what was going on currently, and knew better than anyone else what went on in the past. I think it’s going to be tough without her.’

—Jerome Waye, MD

added Jerome Waye, MD, clinical professor of medicine, Icahn School of Medicine at Mount Sinai, New York City. “She knew what was going on currently, and knew better than anyone else what went on in the past. I think it’s going to be tough without her.”

Ms. Lefcourt was born Florence Feinblatt on June 21, 1915, in Newark, N.J. Shortly thereafter, her family moved to New York City, eventually settling in old

Florence Lefcourt traveling abroad (left), and dancing in 1993 (right).

‘Florence had a knack for introducing people. She made it a priority to include people in everything we were doing, which created a very warm feeling in the NYSGE. It’s a very unusual society in that respect.’

—Sidney Winawer, MD Jewish Harlem. Her parents owned and ran a popular restaurant, Feinblatt’s Roumanian Rotisserie, in which Ms. Lefcourt and her three sisters grew up. In 1937, she married Stanley Lefcourt, and they raised two children, Marc and Alan.

In 1968, while working as an administrative assistant at Memorial Sloan-Kettering Cancer Center (MSKCC), New York City, Ms. Lefcourt was assigned to the office of Sidney Winawer, MD. “She was actually the administrator for the whole gastroenterology service,” recalled Dr. Winawer, the Paul Sherlock Chair in Medicine at MSKCC. “As soon as she came on the scene she just took over—she organized the office assistants, she organized everybody’s schedule. She knew—and knew about—everybody.”

A few years later, Dr. Winawer and seven others decided to launch a regional gastroenterology society, inspired by one that was forming in southern California.

“We sat around Richard McCray’s apartment and decided who would be president, vice president treasurer. … I said OK to being secretary between bites of a sandwich,” Dr. Winawer said.

Ms. Lefcourt got involved immediately.

“She liked the idea and had a vision for it—this was going to be something good,” Dr. Winawer said. “So the two of us worked together to get the NYSGE organized. She arranged the meetings, the courses—everything.”

When Ms. Lefcourt retired from MSKCC in 1982, she ramped up her involvement with the NYSGE, becoming its executive secretary. She was instrumental

in putting together every society event and function, especially the annual course.

“For years the course was organized on Mom’s dining table,” said her son, Marc. “She and Dr. David Falkenstein would sit around that table putting together the syllabus and signage for the course, and they did it by cutting and pasting. I’m talking scissors and glue.”

Now, the annual course, which now routinely attracts approximately 800 local, national and international faculty and attendees, tends to feel like a big family reunion, largely due to Ms. Lefcourt’s influence.

“Florence had a knack for introducing people,” Dr. Winawer said. “She made it a priority to include people in everything we were doing, which created a very warm feeling in the NYSGE. It’s a very unusual society in that respect.”

Ms. Lefcourt also was known for her devotion to fellows.

“She organized every seminar throughout the year—the summer fellows course, the first-year fellows course and about eight others,” said Mr. Lefcourt.

“That’s what gave her the most pleasure—watching the fellows come up through the society, then go out into the world and come back to the course every December.”

For many doctors-in-training, Ms. Lefcourt was their initial connection with the society, the face of the NYSGE. “If you train in New York, your first encounter with the NYSGE is when you give case presentations to see NYSGE, page 22

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GASTROENTEROLOGY G ASTROENTEROLOGY & ENDOSCOPY NEWS • JUNE 2014

NYSGE

ENDOSCOPY SUITE

Florence Lefcourt with Sidney Winawer, MD, and Jerome Waye, MD, in 2011.

continued from page 20

the gastroenterology community,” said Michelle Kang Kim, MD, MSc, associate director of endoscopy and assistant professor of medicine at Mount Sinai Medical Center. “At that time, you might not know a lot of the attendings, and there can be a bit of separation. Florence was always accessible and visible.”

Ms. Lefcourt was especially pleased by the growing numbers of women in gastroenterology and their increasing involvement in the NYSGE. “A lot of the men have said that Florence loved her guys. She loved her gals, too,” said Dr. Kim. “Florence was never more thrilled than to see a woman speaking, moderating or leading a session.”

‘That’s what gave her the most pleasure—watching the fellows come up through the society, then go out into the world and come back to the course every December.’

Read the No. 1 publication in the

—Marc Lefcourt

gastroenterology market,

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As loved as she was for her supportive nature, caring manner and sweet personality, Ms. Lefcourt was also deeply revered for her wisdom, and her opinions were taken seriously.

“I learned pretty quickly to listen to absolutely everything she had to say.

Her instincts were amazing,” said David Greenwald, MD, gastroenterology fellowship training director and associate division director at Montefiore Medical Center in the Bronx, N.Y. “She had a wisdom that everyone respected. Her wisdom came not only from a wealth of experience, but also from a lifetime of dealing with people with very strong opinions,” Dr. Greenwald said. “She had a special talent for listening very carefully and then voicing her opinion, and ultimately making sure that people did what she thought was right.”

In the past few years, Ms. Lefcourt became less involved with the day-today activities of the NYSGE, but stayed strongly present, taking phone calls, sending email, giving advice and offering her opinion on proposed changes and ideas.

“It was immediately obvious from the first time you met her that when Florence spoke, you needed to pay careful attention,” Dr. Greenwald said. “Sometimes the society would plow forward with an idea that Florence had said she was not in favor of, only to find in the end that she had been correct. In fact, she was almost always correct. We will all miss her guidance, her charm and her love.”

■

OPINION

GASTROENTEROLOGY & ENDOSCOPY NEWS • JUNE 2014

23

Bariatric Surgery continued from page 12

600 patients annually. We have three full-time employees whose primary responsibility is to obtain insurance certification. The cost is excessive. It would be far more efficient and productive if we could have immediate approval for patients who fit into narrower classes than the present system allows.

Fear of Surgery Another factor that has been suggested for the failure of bariatric surgery to grow is fear. When surgery is suggested, patients often respond that they know someone who had surgery who almost died, or did die, or regained all their weight. At that point, the discussion is usually dropped.

We need to change the

results than other invasive modalities for diseases and conditions that already are being treated.

From a marketing perspective, there also will be advantages to this approach.

Often, we try to approach the largest population possible for a particular service or product. Marketers often are “clumpers,” trying to gather the largest potential group that can benefit.

Patients, however, are “splitters.” They

see specialists in each area. They separate their issues based on the different doctors they see. They see an endocrinologist for their diabetes and a cardiologist or their primary care physician for their hypertension. A different physician is seen for each area of their body, even if obesity is the underlining cause of all their medical issues. Thus, our message has a much better chance of reaching their core if the information is tailored for their sentinel

condition. Many do not see obesity as being the root of the majority of their issues. Whether this is denial or ignorance is hard to ascertain. But, how often have we heard from a patient, “I am the healthiest fat person you have ever seen”?

The Role of the ASMBS This past year has been quite dynamic for the American Society for Metabolic see Bariatric Surgery, page 24

The #1 best-read gastroenterology publication in the USA. Anytime. Anywhere.

discussion and demonstrate that the procedures we offer

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provide better results than other invasive modalities for

H E PAT O L O G Y IN F O C U S

diseases and conditions that already are being treated.

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BY VICTORIA STERN

BOSTON—Recent evidence suggests that nonalcoholic fatty liver disease (NAFLD) is emerging as a significant public health problem. One study revealed an “alarming” rate of HCC related to NAFLD, even among

Gastroenterologists are the fourth most highly compensated physicians compared with doctors in 24 other medical specialties, according to an online survey conducted by Medscape in February 2013. Average annual income for gastroenterologists was up 13% in 2012 compared with 2011, coming in at $342,000. The three specialties that beat out gastroenterology in average yearly compensation were orthopedists at $405,000, cardiologists at $357,000 and radiologists at $349,000 (see Figure 1, page 28).

But despite robust earnings, less than half (48%) of the gastroenterologists surveyed said they felt fairly compensated, the same percentage as that of physicians of all specialties who said they felt fairly compensated.

The findings were based on responses collected in a third-party online survey of 21,878 U.S. physicians, 2% of whom were gastroenterologists. Most gastroenterologists who responded were men (84%) and board certified (96%), and 62% were aged 45 years or older.

see NAFLD, page 14

see Income, page 28

BY CHRISTINA FRANGOU Hepatologists have added their voices to the debate over screening for hepatitis C virus (HCV) infection and are urging the U.S. Preventive Services Task Force (USPSTF) to upgrade its current recommendation see HCV Screening, page 18

What this really represents is the ambiguous attitude toward obesity from both the general public and health care professionals. The hidden meaning of their objection for bariatric surgery is that obesity does not justify a potentially dangerous surgical procedure. Despite the dangers of severe and morbid obesity, despite its effects on life expectancy and on emotional health, the perception for many remains that surgical treatment is not mandatory.

The two most commonly performed general surgical procedures are cholecystectomy and hernia repair. Few patients resist surgical intervention when it is suggested, as it is presented as the proper treatment. My take is that to succeed, we need to move the discussion to areas where treatment is already mandatory.

It is my impression that many patients would consent to have diabetes surgery if the consensus opinion was that surgical intervention was the best treatment.

Similarly, those with sleep apnea, heart disease and severe degenerative joint disease are more likely to proceed with surgical intervention for these conditions than obesity alone. Again, the difference may be semantics, but today we mainly perform bariatric surgery that improves comorbidities. We need to change the discussion and demonstrate that the procedures we offer provide better

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H E PAT O L O G Y

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Investigational Device Prolongs Survival of Livers For Transplantation .................................................page 8 Effect of Preexisting Cardiovascular Disease On Outcomes After Liver Transplantation May Be Underestimated..........................................page 9

Patients with private insurance will no longer be responsible for any cost sharing in the event that a polyp is removed during a screening colonoscopy, according to a recent clarification, issued by the federal government, on preventive screening benefits under the Affordable Care Act (ACA).

“This is very good news,” said Durado Brooks, MD, MPH, direcof Prostate and Colorectal Cancers at the American Cancer Society in

Retreatment of Hepatitis C With Interferon Alone May Increase Mortality ..........................................«>}iÊ£È Statins Linked to Reduction in Mortality From Liver Cancer .................................................«>}iÊÓ{

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approach to the treatment of IBD using 5-aminosalicylic

Assistant Attending Physiciana Assistant Professor of Medicineb Anne and Ken Estabrook Clinical Scholar in Gastroenterologyb

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OPINION

GASTROENTEROLOGY & ENDOSCOPY NEWS • JUNE 2014

Bariatric Surgery continued from page 23

and Bariatric Surgery (ASMBS). The formation of BSQIP, or the bariatric surgery quality improvement program, signals a closer collaboration with the American College of Surgeons. Hopefully, this relationship will allow us to have greater influence with national decision makers.

An additional benefit will be mandatory data contribution from all centers participating. Hopefully, data will be available to

allow us the information to carve out these core areas where bariatric and metabolic surgery become the standard treatment.

Frequently, I have heard that the key to growth will be improved quality.

Although it would be nice if this were true, recent data do not support this position. According to most reports, the mortality of bariatric surgery has been reduced fivefold in the past several years. A similar increase in cases has not

It is essential that procedure growth be a major objective for the ASMBS. … We need our insurance arms to work to get codes for surgery for diabetes and other core areas.

coincided with these encouraging results.

It is essential that procedure growth be a major objective for the ASMBS. Coordination between all committees

is vital. For us to truly be a metabolic surgical society, we need our insurance arms to work to get codes for surgery for diabetes and other core areas. Public education materials need to be developed that deliver the proper message. Funding for pivotal studies must be obtained and dedicated to areas that can push us across the goal line in key areas.

Conclusions

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The absence of growth in the past several years is multifactorial, but should be extremely concerning. Increasing competition for health care dollars will exacerbate the present condition and will make certification even more difficult in the future. The economy is a significant factor, but we cannot accept that it is the only cause. Stated differently, unless we do our part, there will be no growth even if the economy improves.

Whereas the number of individuals afflicted with severe obesity and diabetes has dramatically increased, the volume of bariatric surgical procedures has plateaued and now declined. This has happened as procedures have become safer and outcomes have improved.

This indicates that obesity and its treatment remain in somewhat of a state of limbo in the minds of the public, insurers and employers. Success with a national coverage decision by Medicare as well as with the majority of insurers has not made the process easier for patients or our practices. Obstacles for coverage such as six-month treatment programs and exclusions for coverage are common.

Until there is a mandatory treatment threshold for obesity, it is best to concentrate on core areas where bariatric surgery becomes the standard. We need to accept that it is not practical for every obese or diabetic individual to have surgery. Thus, we need to identify subgroups that can most benefit from surgery; subgroups for which we can convince the majority of physicians and the public that surgery is the treatment of choice.

Returning to my Intuitive Surgical analogy from Part 1 of this article (“Bariatric Procedures Decline Despite Rise in Rates of Obesity, Diabetes,” Gastroenterology & Endoscopy Newss May 2014;46:34,36-38), Intuitive’s robot da Vinci was originally designed for cardiac surgery. The robot was floundering, and see Bariatric Surgery, page 31

EXPERT ROUNDTABLE

GASTROENTEROLOGY & ENDOSCOPY NEWS • JUNE 2014

Phillip Fleshner, MD Shierley, Jesslyne and Emmeline Widjaja Chair in Colorectal ctal Surgery Su Cedars-Sinai Medical al Ce Center Clinical Professo essor of Surgery University sity of o California, Los Angeles Sch School of Medicine Lo Angeles, California Los

Uma Mahadevan, MD Co-Medical Director, Center for Colitis and Crohn’s Disease University of California, San Francisco San Francisco, California

25

Bo Shen, MD Section Head Department of Gastroenterology and a Hepatology He Cleveland and Clinic Foundation Cleveland, Ohio hio

IBD Roundtable continued from page 1

(CTE). Should that patient be tried on the latest biologic treatment, treated with endoscopic dilation or referred for ileocolonic resection?

For their take on this question, Gastroenterology & Endoscopy News (GEN) interviewed three experts, who debated this question at the Crohn’s & Colitis Foundation’s 2013 Advances in Inflammatory Bowel Diseases conference. Arguing in favor of endoscopic therapy was Bo Shen, MD; making the case for medical treatment was Uma Mahadevan, MD; and asserting the strengths of surgery was Phillip Fleshner, MD.

consequences, such as fistula development. Therefore, if it is a fibrotic stricture, then it is a mechanical problem that calls for a mechanical solution: endoscopy or surgery. If the stricture is short and straight, I would give endoscopic dilatation a chance; if it is a long stricture or if it is angulated or associated with an abscess or fistula, go with surgery. For anastomotic strictures, again, you can try endoscopic dilatation.

‘Even if the stricture does not

GEN: This is a complex case. What clinical factors should one take into account when choosing a treatment approach for this patient?

reverse completely, if a patient

Dr. Shen: At the Cleveland Clinic, we’ve been developing an algorithm for treating CD-related strictures. We begin by delineating the treatment roadmap by performing abdominal imaging studies before endoscopy and determining the number of strictures, the degree and length of the stricture or strictures, and then deciding on a next step. High-quality CTE or magnetic resonance enterography may show whether there is an inflammatory component to the stricture or strictures.

If there is concurrent inflammation, you can try medical therapy to see whether it reduces the inflammatory component of stenosis, but medication has largely been found not to affect the fibrotic component of a stricture or reduce the likelihood for related adverse

to remove less small bowel

does indeed require surgery, reducing the inflammation around the stricture may allow the surgeon than if there had been no antiinflammatory treatment.’

—Uma Mahadevan, MD

Dr. Mahadevan: With this patient, I would ask whether he or she previously received biologics. If the patient is naive to biologic therapy and has inflammation in addition to a stricture, I would consider trying biologic therapy first.

If the patient has not received biologics before but the stricture has responded to prior corticosteroid treatment,

that suggests the stricture has an inflammatory component that is reversible and can be addressed to some extent with medication.

If the patient had failed prior biologic therapy, it would be appropriate to send the individual to a surgeon.

I would say that endoscopic dilatation in the context of a nonanastomotic stricture is unlikely to be durable, so I would not choose that as an option.

I also would consider the extent of small bowel involvement and inflammation, as well as how much of the disease is accounted for by the stricture. If there is a long segment of inflammation and not all of it is strictured, I would try biologic therapy because it could provide an opportunity to heal whatever inflammation there is, in both the nonstenotic and stenotic areas. Even if the stricture does not reverse completely, if a patient does indeed require surgery, reducing the inflammation around the stricture may allow the surgeon to remove less small bowel than if there had been no anti-inflammatory treatment.

However, if the patient has a short stenotic stricture with minimal inflammation, the patient is unlikely to respond to anti-inflammatory treatment and is probably better off with surgical resection. The outcomes with surgical treatment of short stricture segments are favorable.

Dr. Fleshner: First of all, is there the local expertise to perform a laparoscopic ileocolonic resection well? The surgery is associated with excellent outcomes, given the right patient selection and if the surgeon is experienced in performing CD surgery. see IBD Roundtable, page 26

26

EXPERT ROUNDTABLE

GASTROENTEROLOGY & ENDOSCOPY NEWS • JUNE 2014

IBD Roundtable continued from page 25

I would also want to know if the patient has multisegment stricturing disease. In that case, endoscopic dilatation might be preferable.

‘Surgery would be an undesirable option in patients with loss of a large amount of small bowel from prior surgery, where there is a chance to lose even more bowel.’

—Phillip Fleshner, MD

Also, if the patient has had multiple prior resections, surgery would probably not be an ideal option. The presence of adhesions could make this surgery difficult. And surgery would be an undesirable option in patients with loss of a large amount of small bowel from prior surgery, where there is a chance to lose even more bowel.

Additionally, some patients may not be psychologically prepared to have surgery.

GEN: What makes the treatment you are arguing in favor of a good choice?

Dr. Shen: First of all, the response rate with medical treatment of strictures is fairly low. Our pediatric colleagues published a case series of 36 pediatric patients and found that slightly more than 50% achieved a complete response at six months with steroids, azathioprine and/ or biologics, and this fell to 35% at two years (Aloi M et al. Dig Liver Dis 2013;45:464-468). Keep in mind, these researchers measured response using Pediatric Crohn’s Disease Activity Index scores rather than objective criteria, like the need for surgery or endoscopic therapy.

Another 53-patient case series in adults also confirmed that medical therapy for stricturing disease typically does not work well (Samimi R et al.

Inflamm Bowel Dis 2010;16:1187-1194). The patients had ileal or ileocolonic stricturing, penetrating, or combined stricturing and penetrating disease; they received biologics or nonbiologic drugs. At 30 days, 75% of those with ileal disease responded to therapy compared with 38% of patients with ileocolonic disease (P=0.026). Overall, 64% of patients ended up requiring surgery. Patients with ileocolonic disease required surgery after an average of 0.55 years compared with 1.07 years in patients with ileal disease (P=0.023). And 24% of patients, most of whom had penetrating disease, experienced an anastomotic leak, fistula or abscess (P=0.047). Thirty-two percent of patients on biologic therapy had these complications compared with none of those not on biologics (P=0.059).

It also is worth noting that in almost all the large clinical medical drug trials for CD, the presence of obvious stricture was an exclusion criteria, which

suggests that medical treatment plays a very small role in stricture management.

As far as surgery goes, it is not a cure. Almost all patients have a postoperative recurrence, and there is the additional concern of postsurgical complications.

Although endoscopy also is not a cure, it delays the need for surgery, and over the life of the patient it can reduce the overall number of surgeries, therefore having a bowel-sparing effect.

At the 2014 Digestive Diseases Week meeting, we presented data on the endoscopic and surgical treatment of anastomotic strictures (Lian L et al). This study included patients with CD treated endoscopically (n=176) or surgically (n=130), and we found that endoscopic treatment delayed surgery by an average of 6.45 years.

Endoscopic dilatation is effective in the presence of a variety of patient disease factors: It does not matter whether the stricture is CD-related and surgery ischemia-related, whether there is mucosal inflammation, the type of medical therapy being used or whether the stricture is anastomotic or nonanastomotic. However, the presence of proximal luminal dilatation does reduce the efficacy somewhat.

Dr. Mahadevan: Treatment goals with this type of CD patient are to achieve both symptomatic and endoscopic remission, to avoid surgery and to spare the small bowel: Medical therapy has the potential to achieve all three of these goals.

Admittedly, there is a weak body of data on the effect of anti-tumor necrosis factor (TNF) agents on stricture behavior. One retrospective study included 11 patients with CD with inflammatory stenoses who were treated with infliximab. Nine of these patients responded well and became completely asymptomatic (Holtmann et al.

Z Gastroenterol 2003;41:11-17). Infliximab was well tolerated, except in one patient who developed an intraabdominal abscess.

Another study looked at a group of six patients with CD with small bowel stricturing who had been refractory to treatment with corticosteroids and/or immu-

‘It also is worth noting that in almost all the large clinical medical drug trials for CD, the presence of obvious stricture was an exclusion criteria, which suggests that medical treatment plays a very small role in stricture management.’

—Bo Shen, MD

nosuppressants (Louis et al. Acta Gastroenterol Belg 2007;70:15-19). Patients received a single infusion of infliximab. Four patients required surgery in the first month after the infliximab infusion. Only two patients, both of whom did not undergo surgery, were reexamined

eight weeks after infliximab infusion and both demonstrated reduced inflammation documented by C-reactive protein levels and CT scans.

There are some better data from a retrospective study of 18 symptomatic patients with strictures treated with infliximab after failing conventional treatment (Pelletier et al. Aliment Pharmacol Ther 2009;29:279-283). Eight weeks after a single infusion, 10 patients had a complete response, seven had a partial response and one had failed treatment. After 18 months, eight patients were receiving maintenance therapy and eight were receiving prednisone. Five patients had achieved and maintained complete clinical response, 10 were partial responders and three had failed infliximab treatment.

‘At the Cleveland Clinic, Dr. Shen and his team developed a modified stricture severity score that takes into consideration factors that might impact the need for stricture resection.’

—Uma Mahadevan, MD

And at the Cleveland Clinic, Dr. Shen and his team developed a modified stricture severity score that takes into consideration factors that might impact the need for stricture resection (Wild D. Gastroenterology & Endoscopy Newss July 2012). They found that biologics can reduce the risk for surgery by up to 44% in CD patients with stricturing disease.

Dr. Fleshner: I have always thought the best defense is a good offense, and ileocolonic resection falls into that category. Remember that the ileocolonic resection we know today is not the ileocolonic resection that we knew 10 years ago. With laparoscopy, there is minimal scarring, enhanced cosmesis, rapid recovery, fast restoration of bowel function, a very low rate of complications and often medications can be stopped or decreased postoperatively. Most often, small bowel loss is limited to between 20 and 25 cm, or eight to 10 inches.

In terms of long-term complications, in addition to not having a large scar as was seen with open surgery, laparoscopic ileocolonic resection may be associated with fewer incisional hernias and fewer adhesions. Although not proven yet, there is the possibly of a lower future incidence of small bowel obstruction when ileocolonic resection is performed laparoscopically.

The most profound point in terms of the benefit of ileocolonic resection is the technical and clinical success rate: With laparoscopic surgery, since you are removing the stricture, the technical success rate is 100% and the clinical success rate is more than 95% (Maartense S et al. Ann Surgg 2006;243:143-149). On the other hand, endoscopic dilatation has a technical success rate of 90% but the clinical success rate is only about 50%.

The other thing is that we take care of 99% of our see IBD Roundtable, page 28

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EXPERT ROUNDTABLE

IBD Roundtable continued from page 26

patients only once. Although patients who undergo laparoscopic ileocolonic surgery almost never require repeat surgeries on the whole, 70% of those who are endoscopically dilated need more than one dilatation. In fact, they need a mean of four dilatations to achieve clinical success.

In terms of quality of life, surgical patients feel great as soon as one month postoperatively; they have very little scarring; they are beginning to discuss what they will do for prophylaxis; and they are feeling well. In contrast, there are no data on quality of life after endoscopic dilatation.

‘The overall rate of complications is comparable between endoscopic dilatation and laparoscopic ileocolonic resection;

strictures and prestenotic dilation. In a study examining the utility of magnetic resonance imaging findings for identifying patients with CD who are most likely to respond to medical therapy, 75% of patients with no stenosis had a clinical response to medical therapy, 61% with a stenosis but no prestenotic dilation had clinical improvement, but only 28% of those with stenosis and proximal dilatation actually got better (Lawrance IC et al.

World J Gastroenterol 2009;15:3367–3375).

So, there is a fairly low chance that medical therapy is going to work in these patients.

GASTROENTEROLOGY & ENDOSCOPY NEWS • JUNE 2014

Given the low likelihood of response, one needs to consider the cost of treatment. Although the cost of surgery is significant, we know it works. But the cost of medical therapy, and in particular biologics, also is significant and the duration of treatment is indefinite. And, as the data above show, it is not clear whether the patient will actually get better. Even if they do get better, if they only have a partial clinical response, that means their quality of life is still impaired.

Aggressive medical therapy also can affect surgical outcomes. For example, a

patient with CD who receives steroids or biologics but ends up requiring surgery is at increased risk for postoperative morbidity. So, consider that if the patient is on his or her way to the operating room, you are not doing them a service by placing them on steroids or anti-TNF agents.

Probably the most profound argument against using medication to treat this type of patient is from a consensus panel opinion from a group of gastroenterologists.

The European Panel on the Appropriateness of Crohn’s Disease Therapy II looked at data on the treatment of patients with

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complications that require surgery, in contrast to less than 1% of patients who undergo laparoscopic ileocolonic surgery.’

—Phillip Fleshner, MD

Again, the safety profile of ileocolonic resection is good. The overall rate of complications is comparable between endoscopic dilatation and laparoscopic ileocolonic resection; roughly 10% of patients in either group experience complications. But with endoscopic dilatation, about 5% of patients have complications that require surgery, in contrast to less than 1% of patients who undergo laparoscopic ileocolonic surgery. This is assuming that surgery is performed by experienced hands.

Additionally, although no gastroenterologist would knowingly dilate a cancer, these strictures uncommonly have a cancer within them. Dilation would obviously lead to a poorer outcome than resection of the cancerous stricture.

There is very little use for medical therapy in the treatment of patients with

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small bowel stenosis and concluded that strictures shorter than 7 cm should be treated with endoscopic balloon dilation,

For longer segments, the panel said that strictureplasty and bowel resection are the only appropriate treatments. So,

GEN: What are the limitations and disadvantages of the modality you prefer?

Dr. Shen:

‘If you look at major complications, it is roughly 1% with endoscopy compared with 8% with surgery.’

—Bo Shen, MD

strictureplasty or bowel resection (www. epact.ch/EPACT_ADM/start2.html).

medical treatment is largely inappropriate in these patients.

There is no free lunch. If you want an effective therapy, you have to pay. There is an overall complication rate of between 3% and 5%. However, if you look at major complications, it is roughly 1% with endoscopy compared with 8% with surgery (Lian L et al. DDW 2014). Colonoscopy-related perforations occur in 19

29

of every 10,000 patients with inflammatory bowel disease (IBD) compared with about 2.5 per 10,000 non-IBD patients, according to unpublished data from Cleveland Clinic Health System.

In patients with IBD, severe IBD and corticosteroid use are both significant risk factors for endoscopy-related perforations (Navaneethan U et al. J Crohns Colitis 2011;5:189-195). Corticosteroids further complicate things because if a perforation occurs in a patient receiving corticosteroids, there is the problem of see IBD Roundtable, page 31

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IBD Roundtable continued from page 29

impaired healing. These patients will likely require a temporary stoma, whereas perforations in patients not receiving steroids may be treated surgically by creating a primary anastomosis.

Another limitation is the presence of a skilled endoscopist with experience doing dilatation. In experienced hands, balloon dilatation is not a complicated procedure, and the immediate technical success of dilating a Crohn’s stricture ranges from 73% to 100%.

Other technical limitations include a stricture that is too long or angulated, or one that is deep inside the small bowel, making it difficult to reach with an endoscope.

‘If the patient has a prestenotic fistula, there is a worry that if you administer a biologic that closes the fistula vent, you can cause an obstruction. So, you have to be careful to select the right patient population and to rule out the presence of prestenotic fistula.’

—Uma Mahadevan, MD

Dr. Mahadevan: If the patient has a prestenotic fistula, there is a worry that if you administer a biologic that closes the fistula vent, you can cause an obstruction. So, you have to be careful to select the right patient population and to rule out the presence of prestenotic fistula.

There have been theoretical concerns that rapid luminal healing in patients with CD that is achieved with biologics can increase the risk for intestinal stenosis, stricture or obstruction. However, Lichtenstein et al found this is not the case ((Am J Gastroenterol 2006;101:1030-1038). Their analysis looked at data from the observational TREAT (the Crohn’s Therapy, Resource, Evaluation and Assessment Tool) Registry

and ACCENT 1 (A Crohn’s Disease Clinical Trial Evaluating Infliximab in a New Long-Term Treatment Regimen) study and found that although a univariate analysis from TREAT showed that infliximab recipients were 1.95 times more likely than non-infliximab recipients to experience strictures and related complications, a multivariate analysis showed that only disease duration, disease severity, the presence of ileal disease and new corticosteroid use were significantly associated with stenosis, stricture or obstruction. Additionally, there was no increased risk for stricturing disease in ACCENT 1, even in the presence of rapid mucosal healing at week 10. So, I would say this theoretical concern is unfounded.

Dr. Fleshner: As stated above, there are patients who are not good candidates for ileocolonic stricture resection. Then there is the cost issue.

Additionally, an ileocolonic resection is an approximately a 120-minute procedure. Most endoscopic dilatations are fairly quick because most strictures are in the terminal ileum. However, in cases where the stricture is in the middle of the small bowel, general anesthesia is required for dilatation and it can be very difficult to get to the stricture, in which case the procedure durations would be similar.

GEN: Now that you have presented your somewhat one-sided case, can you share a more integrated and balanced approach to treating this patient?

Dr. Shen: I would try balloon dilatation first along with concurrent medical therapy, and I would reassess the patient in two to three months. I typically redilate every three to six months, but I also go by the patient’s reported symptoms. If the patient is feeling blocked, or prefers not to wait until symptoms recur, I dilate. If dilatation is ineffective, I would send the patient for surgery.

Dr. Mahadevan: I believe biologic-naive patients should receive medical therapy first to prevent unnecessary surgery. If they do

require surgery, medical treatment can potentially minimize the loss of small bowel by addressing the inflammatory component of the stricture.

‘If the patient has already had multiple surgeries, you can try endoscopic dilatation first. I think medication has a very small role in treating these patients.’

—Phillip Fleshner, MD

Dr. Fleshner: If there is an isolated stricture and it is the patient’s first surgery and the patient is otherwise healthy, surgery is without question the way to go. If the patient has already had multiple surgeries, you can try endoscopic dilatation first. I think medication has a very small role in treating these patients.

In general, laparoscopic ileocolonic resection is a very straightforward procedure with very good outcomes, and patients will end up thanking you.

■ Dr. Shen has served as a speaker for AbbVie and Aptalis; he has consulted for Prometheus and Janssen; and he has received a research grant from Aptalis.

Dr. Mahadevan has consulted for AbbVie, Janssen and UCB.

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Bariatric Surgery continued from page 24

many stated that it was a technology in search of an application. Few urologists were capable of performing the urethral anastomosis of a prostatectomy with standard laparoscopic equipment. Therefore, for the minimally invasive application for prostate removal, the robot became a must-have. If this must-have were not found, Intuitive would probably not have survived as an independent company.

Now that there is much greater acceptance, the growth in robotic procedures is

in the nice-to-have areas, not the musthaves. The growth areas are general, thoracic, bariatric and gynecologic surgeries.

The fastest growing procedure is hysterectomy. Is a robot required for extirpative surgery such as a hysterectomy? Certainly, our laparoscopic results in bariatric surgery demonstrate that it is not a must-have in our field. However, after entering the market as a must-have for urologists, growth has occurred as other fields have realized its advantages. The message is clear: you

need your core and then you can expand to the periphery. If you have no core, you have no sustainable business model. In our field, many believe that refractive morbid obesity has been and should be that core.

Bariatric surgery has been the focus of my surgical practice for nearly 20 years.

Although I have witnessed far greater acceptance, certification remains a hassle. Each year brings new restrictions.

Furthermore, despite our efforts, there is no clear consensus regarding obesity

treatment.

In bariatric and metabolic surgery, we need to find our must-haves. Our goal over the next few years is to find several core areas. If we are successful, I am certain that our numbers will improve and we can make the certification system more efficient for our patients and our practices. Most importantly, patients who can benefit the most will have a greater chance of gaining access to our procedures.

■

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Here is a review of the winners of the 2013 employee awards: MANAGEMENT/SUPPORT/IT/FINANCE/PRODUCTION

MANAGEMENT/SUPPORT/IT/FINANCE/PRODUCTION

Employees are asked to select two outstandding members from these diverse departments. The first winner was ROSA DIMICCO, whose challenging work in Finance includes overseeing accounts payyable.

The seconnd winner was YUMI VELIZ, who as part of the IT Department manages requests for IT assistance and maintains all servers and the infrastructture of the McMahon network.

MOST IMPROVED SALESPERSON OF THE YEAR

SALES ACHIEVEMENT AWARD OF THE YEAR

MATTHEW SPOTO,, whose work on Gastroenterology & Endoscopy News has brrought in new clients and maintained steady relationships with existinng clients, clients resulting in a record year.

DAVID KA APLAN, publication director of Pharmacy Practice Newss as well as Speciallty Pharmacy Continuum, received this award for, among other accomplisshments, hments spearheading new pharmacy publications. publications

ASSOCIATE/SENIOR/PROJECTS EDITOR OF THE YEAR

MANAGING EDITOR/COPYEDITOR OF THE YEAR

This award was given to Associate Projects Editor CARLOS PERKINS JR., whose job includes working closely with sponsoring companies to create great medical education programs that are delivered on time.

This year, Copy Editor ELIZABETH ZHONG won the award for her efforts in fine-tuning all the editorial material that is assigned to her. Her work helps ensure acccuracy in all of our publications, medical education programs and sponsoredd custom media.

MAX GRAPHICS PERSON OF THE YEAR

SALESPERSON OF THE YEAR

Longtime staffer FRANK TAGARELLO, who manages the Graphics Department, received the award for his inveentive design work on such publications as Clinical Oncology News and Pharmacy Practice News and a variety of medical education projects.

For the eigghth year in a row, RICHARD TUORTO, the senior group publicatioon director of both Anesthesiology News and Pain Medicine News, won the award for bringing in the most revenue in the calendar year.

MCMAHON GROUP PERSON OF THE YEAR

PARTNERS’ AWARD

The winner of this year’s award was HYONG KWON, manager of the company’s IT development team, who oversaw innumerable projects, including updating our websites, creating tablet and digital versions of our publications, and managing the IT staff, to name just a few. There is a constant stream of IT requests that land on his desk and, somehow, Hyongg is able to continually perfect our digital presence.

From time to time, CEO and Managing Partner Ray McMahon extends a special award to an individual whose efforts over many years have madee a fundamental difference in the well-being of the company. This year that award went to his son, MATTHEW MCMAHON, whose position as thhe company’s general manager puts him front and center for major decisioons involving policy, finance and overall governance.

F D A U P D AT E & P R O D U C T N E W S

GASTROENTEROLOGY & ENDOSCOPY NEWS • JUNE 2014

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Shire Launches Online Educational Resource Center for Patients With Ulcerative Colitis Shire recently launched www.ShireUCentral.com, an online disease information and resource center for U.S. patients with ulcerative colitis (UC).

At Shire UCentral, patients and their caregivers will find educational information and a variety of other resources that offer support.

“Patient education and support are essential components to empowering patients and encouraging shared decision making,” said Laura D. Wingate, vice president of Patient and Professional Services, Crohn’s & Colitis Foundation of America. “Shire UCentral is another resource for patients

with UC and caregivers in the spectrum of support and information.”

Shire UCentral offers the following resources for patients with UC: • an interactive and customizable “Doctor Discussion Guide” to help prepare patients for their next appointment; • tips and advice from medical experts, including the “Experts Speak” video series featuring key opinion experts in UC;

• connections to patient advocacy communities; • general information about nutrition and planning a healthy diet; and • access to an on-call nurse representative who can answer general questions about UC. “The Doctor Discussion Guide on Shire UCentral is an excellent tool that can help patients prepare for more productive interactions with their health care providers,” said Charles

—Based on a press release from Shire

2014 Advances in

New ‘My Healthy’ Campaign Encourages Individuals To Think About Weight Loss as Health Gained

Eisai Inc. recently launched “My Healthy,” an online interactive, motivational campaign designed to shift the focus of obesity from pounds lost to health gained. The initiative emphasizes that obese or overweight individuals with a related health condition can benefit from small positive changes, including modest weight loss.

The cornerstone of the campaign is the “My Healthy Promise,” a commitment to set realistic goals and recognize that every positive step counts, including talking openly with your doctor about your weight and health, making healthy food choices and being more active.

“When you make the ‘My Healthy Promise,’ it all starts with your doctor,” said Steven Lamm, MD, director of men’s health at NYU Langone Medical Center in New York City. “He or she can advise you on what may work best for you and create a tailored plan because there is no ‘onesize-fits-all’ approach when it comes to weight loss. Together you can determine the health milestones you want to achieve.” To learn more, visit www.myhealthy.com.

Sninsky, MD, a gastroenterologist based in Gainesville, Fla. “Patients may help control their UC better when they have open communications with their doctor.”

The on-call nurse hotline service, “Shire UCentral LIVE,” is available Monday through Friday, from 8 a.m. to 8 p.m. ET. To access Shire UCentral, visit www.ShireUCentral.com.

Improve Your Knowledge, Improve Your Practice Welcoming, accessible, and extremely comprehensive, the 2014 “can’t miss” event for you and your colleagues will feature more content, special events, and attendees than ever before.

DECEMBER 4-6, 2014 ORLANDO, FLORIDA CHAIRS Richard P. MacDermott, MD, MACG, FACP, AGAF Albany Medical College Albany, New York Stephen B. Hanauer, MD, FACG, AGAF Northwestern University Chicago, Illinois

We Asked.

You Answered.

Our focus is to continually improve your meeting experience from the scientific content to the meeting logistics. To accommodate the growing needs of this event, we’re moving to Orlando, FL. Improvements will include larger conference space and meeting rooms, more hotel room availability, more dining options, more nonstop, daily flights, enhanced technological capabilities, and more networking opportunities.

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Call for Abstracts Deadline: September 1, 2014

W W W . A D V A N C E S I N I B D . C O M

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F D A U P D AT E & P R O D U C T N E W S

GASTROENTEROLOGY & ENDOSCOPY NEWS • JUNE 2014

Boston Scientific Introduces Expect Slimline Needle for EUS-FNA Procedures Boston Scientific recently received FDA clearance to market the Expect Slimline (SL) Needle, which is now globally available for endoscopic ultrasound fine-needle aspiration (EUS-FNA) procedures. The company introduced the Expect Endoscopic Ultrasound Aspiration Needle in 2011, which was followed by the introduction of the Expect 19 gauge Flex Endoscopic Ultrasound Aspiration Needle, a more flexible needle

made of nitinol. The new Expect Slimline Needle offers a smaller handle profile and a smooth gliding mechanism used during tissue sampling.

“I’m passionate about EUS-FNA because it’s a great way to biopsy tissue and get a diagnosis very quickly and minimally invasively,” said Ann M. Chen, MD, director of endoscopic ultrasound, Stanford University School of Medicine, Stanford, Calif. “Boston Scientific approached

me during the development process for the Expect Slimline Needle and was very receptive to my comments.

It’s been very gratifying to see that the company cares about physician feedback and acts on it very quickly.”

The control zone on the handle of the Expect SL Needle has two ergonomically defined areas designed to optimize control during the actuation motion and to accommodate different hand sizes and techniques. All

Advances in Probiotic Therapy For Diarrhea-Associated Illness To participate in this FREE CME activity, log on to

www.CMEZone.com

Release Date: February 10, 2014

Statement of Need

Intended Audience

William D. Chey, MD

Probiotics can be powerful tools in managing a number of medical conditions. However, effi fficacy may be suboptimal if these agents are not used appropriately. As public interest in the benefi fits of probiotics increases, so does the need for clinical education.

Many physicians and patients are unfamiliar with the nuances of probiotic pharmacology, or—with many probiotics available for over-the-counter purchase— may not be aware that their patients are selecting ineff ffective therapies. Thus, it is important for health care professionals to familiarize themselves with the latest research data on probiotic use.

Gastroenterologists, primary care physicians, nurse practitioners, nurses, physician assistants, pharmacists, and other health care professionals involved in the care of patients who may benefit fi from the use of probiotic therapy.

Faculty Brooks Cash, MD Professor of Medicine Division of Gastroenterology University of South Alabama Mobile, Alabama

Shanti Eswaran, MD Clinical Assistant Professor Division of Gastroenterology University of Michigan Health System Ann Arbor, Michigan

Photo courtesy of Boston Scientific

Expiration Date: February 10, 2015

Chair Professor of Internal Medicine Director, Gastrointestinal Physiology Laboratory Co-Director, Michigan Bowel Control Program H. Marvin Pollard Institute Scholar Division of Gastroenterology University of Michigan Health System Ann Arbor, Michigan

The innovative handle design of the Expect Slimline (SL) Needle offers a smaller handle profile and a smooth gliding mechanism.

Goal The goal of this educational activity is to provide clinicians with current evidence and strategies for effecff tive probiotic therapy in a variety of disease states.

Learning Objectives Upon completion of this activity, the participant will be better prepared to do the following: 1 Review key differentiating ff characteristics of various probiotic therapies, including mechanism of action.

2 Describe the importance of strain specificity fi in the clinical applicability of probiotic therapies.

Estimated Time for Completion 1 hour

Course Format Monograph

Accreditation Statement This activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of AKH Inc., Advancing Knowledge in Healthcare, and Applied Clinical Education. AKH Inc. is accredited by the ACCME to provide continuing medical education for physicians.

Expect Needles have a sharp needle grind and a highly visible echogenic pattern, providing precise guidance and helping to maintain tip visibility.

“Expect Slimline is a high-quality device that marries what you feel in the handle to what’s happening at the device’s tip,” said Anand Sahai, MD, MSc (Epid), professor of medicine, chief, Division of Gastroenterology at Centre Hospitalier de l’Université de Montreal, Ontario, Canada. “This translates into excellent precision and control, which is what you strive for in a device.”

—Based on a press release from Boston Scientific

Credit Designation AKH Inc. designates this activity for a maximum of 1.0 AMA PRA Category 1 Credit™. t Physicians should claim only the credit commensurate with the extent of their participation in the activity.

3 Discuss the role of probiotic therapy in clinical digestive ailments.

4 Review strategies for appropriate patient selection and education in the use of probiotic therapies.

Gastroenterology & Endoscopy News’

FDA Update & Product News column is compiled by the editors based on press releases from manufacturers and the U.S. Food and Drug Administration.

Jointly sponsored by AKH Inc. and Applied Clinical Education

Supported via an educational grant from Procter & Gamble

Distributed via CMEZone and Gastroenterology and Endoscopy News

Please send product news to:

amarcus@mcmahonmed.com

GASTROENTEROLOGY & ENDOSCOPY NEWS • JUNE 2014

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AbbVie Submits New Drug Application for All-Oral, IFN-Free HCV Therapy In late April, AbbVie submitted a New Drug Application (NDA) to the FDA seeking approval for an investigational, all-oral, interferon (IFN)-free regimen for the treatment of adult patients with chronic genotype 1 hepatitis C virus (HCV) infection. The NDA is supported by data from the largest all-oral, IFN-free clinical program in HCV genotype 1 patients conducted to date, comprising six Phase III studies that included more than 2,300

patients in more than 25 countries.

“This NDA submission is a significant advancement for AbbVie’s HCV development program,” said Scott Brun, MD, vice president of Pharmaceutical Development at AbbVie. “Based on the robust data that have been generated in our international Phase III HCV program, we believe our all-oral, interferon-free regimen holds the potential to be a promising new therapy for patients living

with this chronic infection.”

In May 2013, AbbVie’s investigational direct-acting antiviral regimen—with or without ribavirin—for HCV genotype 1 was designated as a “breakthrough therapy” by the FDA. This designation is intended to help expedite the development of drugs for serious or life-threatening conditions and is based in part on preliminary clinical evidence demonstrating that a drug or regimen

may offer substantial improvement on at least one clinically significant end point compared with available therapy. The AbbVie investigational regimen consists of a fixed-dose combination of ABT-450/ritonavir (150/100 mg) coformulated with ombitasvir (ABT-267) 25 mg, dosed once daily, and dasabuvir (ABT-333) 250 mg, with or without weightbased ribavirin, dosed twice daily.

—Based on a press release from AbbVie

Janssen Submits Supplemental NDA For Olysio for Once-Daily Use In Combination With Sofosbuvir

with the best-read gastroenterology publication.

Olysio (simeprevir) is an HCV NS3/4A protease inhibitor approved for the treatment of chronic hepatitis C. Photo courtesy of Janssen Therapeutics

On May 7, Janssen announced the submission of a Supplemental New Drug Application (sNDA) to the FDA for simeprevir (Olysio), an NS3/4A hepatitis C virus (HCV) protease inhibitor, in combination with the NS5B HCV polymerase inhibitor, sofosbuvir (Sovaldi, Gilead Sciences). Janssen is seeking regulatory approval of the combination for the treatment of HCV genotype 1 infection in treatmentnaive patients with advanced liver fibrosis and in null responders with all stages of liver fibrosis.

Simeprevir was approved in November 2013 for use as part of a treatment regimen that includes peginterferon alfa and ribavirin for the treatment of patients with chronic HCV genotype 1 infection with compensated liver disease, including cirrhosis.

The sNDA is supported by data from the Phase II COSMOS (Combination of Simeprevir and Sofosbuvir in HCV Genotype 1–Infected Patients) study, which included treatment-naive patients with advanced fibrosis and null-responder patients with all stages of liver fibrosis.

—Based on a press release from Janssen

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