Many Defibrillator Patients Don't Meet Guidelines

A study of nearly 112,000 implantable-defibrillator patients indicated more than one in five people didn't meet medical guidelines for getting the expensive devices, and in some cases may not have needed one.

The findings suggest that if doctors better stick to guidelines, it could lead to lower health-care costs, which could dampen a roughly $4.3 billion U.S. defibrillator market led by Medtronic Inc. (MDT), Boston Scientific Corp. (BSX) and St. Jude Medical Inc. (STJ). The companies are already dealing with sluggish growth and pressure on product prices; the devices can cost upwards of $25,000 each.

Defibrillator patients who fell outside guidelines were often sicker, leading to a higher rate of complications--including death--at hospitals, according to the study, which is being published in the Journal of the American Medical Association. This increase in complications was modest but still problematic, study authors said.

"While a small risk of complications is acceptable when a procedure has been shown to improve outcomes, no risk is acceptable if a procedure has no demonstrated benefit," they wrote. They were led by Sana M. Al-Khatib, a cardiologist at Duke University Medical Center in North Carolina.

The study was embargoed for release at 4:00 p.m. EST Tuesday by JAMA, but leaked early and appeared to pressure device-makers' shares. Among them, St. Jude recently traded down 2.2% to $41.36 while Boston Scientific declined 2.2% to $7.43.

The study was funded by the National Heart Lung and Blood Institute. Al-Khatib and other study authors reported various ties to Medtronic and other drug and device firms.

The study reviewed data from a large national registry that collects information on heart patients, which has some limitations. For example, medical records may not precisely identify when heart failure began for some patients, but giving defibrillators too soon after a heart-failure diagnosis was the main way doctors didn't follow medical guidelines, two doctors noted in a JAMA editorial.

The study doesn't discern why doctors weren't sticking to guidelines. Al-Khatib suggested that doctors' lack of awareness and knowledge were the culprits and indicated manufacturers didn't play a role.

-By Jon Kamp, Dow Jones Newswires; 617-654-6728; Jon.Kamp@dowjones.com

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