Navigation Links
Study looks at off-label use of biliary stents

BOSTON Although approved by the U.S. Food and Drug Administration as a palliative treatment for cancer patients who have developed bile-duct obstructions, biliary stents are sometimes used off-label for the treatment of peripheral vascular disease (PVD). A study in todays issue of the American Journal of Therapeutics finds that off-label use of biliary stents is increasing, and that the majority of adverse events and device malfunctions associated with the use of these stents occurs during off-label usage.

Our study found that more than 1 million patients received biliary stents for off-label treatments between 2003 and 2006, explains cardiologist William Maisel, MD, MPH, Director of the Medical Device Safety Institute at Beth Israel Deaconess Medical Center (BIDMC) and senior author of the study. We also found that more than 80 percent of the reported adverse events and device malfunctions associated with these products have occurred during off-label use.

The most common off-label use for biliary stents is treatment of peripheral arterial disease (PAD), which develops when leg arteries become narrowed by cholesterol plaques. Patients who suffer from PAD can develop pain, skin ulcers, reduced exercise tolerance and even loss of limb. The condition affects millions of patients throughout the U.S. and is a significant cause of morbidity and mortality.

Clinical management of peripheral artery disease can be challenging, explains Maisel. Although noninvasive treatment strategies such as exercise training can help some patients, for many others, pain and discomfort persist. In an effort to unblock the vessels, many physicians have turned to stents, flexible tubular devices which can keep the vessels propped open.

Because there is little data supporting the clinical utility and safety of biliary stents for treatment of vascular disorders, Maisel and colleague Jonathan Bridges, MD, of BIDMCs Cardiovascular Institute decided to take a closer look.

The authors determined that biliary stent implants among PVD patients increased 21.4 percent, from 227,145 in 2003 to 275,795 in 2006; approximately 1 million biliary stents were implanted off-label in the peripheral vasculature in total. Additionally, using the publicly available MAUDE (Manufacturer and User Facility Device Experience) database -- a compilation of serious adverse events and malfunctions associated with medical devices that have been reported to the FDA -- the authors reviewed all reports involving biliary stents between 2003 and 2006. During this time period, 1,036 confirmed biliary-stent malfunctions were reported, 81.2 percent of which occurred during off-label use. Malfunctions were most often due to premature stent dislodgement, premature deployment or failure of the catheter/delivery system.

In addition, notes Maisel, 87.9 percent of the 561 adverse events associated with biliary stent use during the study period occurred during off-label use, with retained product, additional catheter procedures or surgery being the most common adverse events. Thirteen patient deaths were reported during off-label use. Like the malfunctions, we found that many more adverse events occurring during the use of biliary stents in peripheral blood vessels than when they were used in a biliary or gastrointestinal location, he adds.

Our analysis raises several important issues, says Maisel. The frequent off-label use of biliary stents for treatment of peripheral vascular disease implies an unmet clinical need in the management of these patients. With the aging of the U.S. population, the number of patients with vascular disease can be expected to grow. Efforts should be directed at improving the evaluation of devices used to treat peripheral vascular disease in order to better identify those patients that will most benefit from this promising therapy.


Contact: Bonnie Prescott
Beth Israel Deaconess Medical Center

Related medicine news :

1. Penn study finds pro-death proteins required to regulate healthy immune function
2. New study shows promise in reducing surgical risks associated with surgical bleeding
3. Study, meta-analysis examine factors associated with death from heatstroke
4. Study suggests loss of 2 types of neurons -- not just 1 -- triggers Parkinsons symptoms
5. Study says COPD testing is not measuring up
6. Preclinical study suggests organ-transplant drug may aid in lupus fight
7. Ability to cope with stress can increase good cholesterol in older white men, study finds
8. High alcohol consumption increases stroke risk, Tulane study says
9. Mailman School of Public Health study examines link between racial discrimination and substance use
10. Pitt study finds inequality in tobacco advertising
11. Stanford study highlights cost-effective method of lowering heart disease risks
Post Your Comments:
(Date:6/27/2016)... Overland Park, KS (PRWEB) , ... June 27, 2016 , ... ... leader in retailers of Eyeglasses . , Millions of individuals in the United ... life, eyeglasses have become a way to both correct vision and make a fashion ...
(Date:6/26/2016)... ... June 26, 2016 , ... Brent Kasmer, a legally blind and certified personal trainer ... through a fitness app. The fitness app plans to fix the two major problems leading ... a one size fits all type program , They don’t eliminate all the ...
(Date:6/25/2016)... ... June 25, 2016 , ... "With 30 hand-drawn hand gesture animations, FCPX ... Austin - CEO of Pixel Film Studios. , ProHand Cartoon’s package transforms over ... Cut Pro X . Simply select a ProHand generator and drag it above media ...
(Date:6/25/2016)... Canada (PRWEB) , ... June 25, 2016 , ... Conventional ... pursuit of success. In terms of the latter, setting the bar too high can ... risk more than just slow progress toward their goal. , Research from ...
(Date:6/24/2016)... ... June 24, 2016 , ... The Pulmonary Hypertension Association ... it will receive two significant new grants to support its work to advance ... 25th anniversary by recognizing patients, medical professionals and scientists for their work in ...
Breaking Medicine News(10 mins):
(Date:6/26/2016)... 2016 Story Highlights: ... within the health care industry is causing providers to ... , Deloitte offers a suite of solutions for health ... efficient cost optimization: labor resource analysis, revenue cycle optimization ... better outcomes and better economics ...
(Date:6/24/2016)... 2016   Bay Area Lyme Foundation , ... Center for Tick Borne Illness , Harvard Medical ... Hacking Medicine, University of California, Berkeley, and the ... five finalists of Lyme Innovation , the ... 100 scientists, clinicians, researchers, entrepreneurs, and investors from ...
(Date:6/24/2016)... -- Dehaier Medical Systems Ltd. (NASDAQ: DHRM ... sells medical devices and wearable sleep respiratory products in ... agreement with Hongyuan Supply Chain Management Co., Ltd. (hereinafter ... 2016, to develop Dehaier,s new Internet medical technology business. ... leverage Hongyuan Supply Chain,s sales platform to reach Dehaier,s ...
Breaking Medicine Technology: