Many May Get Unneeded Implantable Defibrillators

TUESDAY Jan. 4, 2011 -- About 20 percent of U.S. patients who receive an implantable cardioverter-defibrillator (ICD) may not need it, a new study finds.

Patients who receive out-of-guideline ICDs are put at higher risk of death and serious complications than patients who meet the criteria for the life-saving device, the researchers say in the Jan. 5 issue of the Journal of the American Medical Association.

"Our findings highlight the importance of enhancing health-care practitioners' adherence to evidence-based practice," said lead researcher Dr. Sana M. Al-Khatib, an associate professor of medicine at the Duke Clinical Research Institute.

"There is a tremendous opportunity for improvement in site performance," she added.

For patients with advanced systolic heart failure, an ICD can prevent sudden cardiac death. However, guidelines recommend against its use in patients recovering from a heart attack or bypass surgery or those with severe heart failure symptoms or a recent diagnosis of heart failure, the researchers explained.

To determine how many ICDs are implanted outside the guidelines, Al-Khatib and colleagues analyzed records from the National Cardiovascular Data Registry's ICD Registry between January 2006 and June 2009.

During that time, 111,707 ICDs were implanted, of which 25,145 (22.5 percent) did not meet current criteria, the researchers found.

Among patients who received out-of-guideline implants, 36.8 percent had had a heart attack and 62.1 percent suffered from heart failure.

Slightly more in-hospital deaths occurred among the out-of-guideline group than among those whose ICD met the guidelines (0.57 percent versus 0.18 percent) and their risk for complications was also higher (3.23 percent versus 2.41 percent), the research team found.

Overall, most ICDs were implanted by electrophysiologists (66.6 percent), followed by nonelectrophysiologist cardiologists (24.8 percent), thoracic surgeons (2.6 percent) and other specialists (6.1 percent), the study authors noted.

But electrophysiologists prescribed the smallest proportion of the possibly unneeded ICDs, the researchers found. Most were implanted by thoracic surgeons and nonelectrophysiologist cardiologists.

Dr. Alan Kadish, president and chief executive officer of Touro College in New York City and author of an accompanying journal editorial, said some of the so-called unneeded ICDs were probably implanted for good reason.

"There are some people where the guidelines are gray, where implantation is probably appropriate," he said. "But there are still a significant number of people who receive ICDs who don't need them based on current criteria," he added.

Kadish suggested several reasons for the unnecessary ICD implants: lack of knowledge about the guidelines or gray areas of the guidelines where an ICD might improve patient outcome despite not being spelled out in the criteria.

"There may be some physicians who are just inappropriately putting them in," Kadish said, "but I think that's a minority of the out-of-guideline implantations."

Money is not really an incentive for doctors to implant ICDs, he said. The procedure can cost $50,000 or more, most of which covers the cost of the device and hospital fees. Only a small portion goes to the doctor, he said.

If your doctor wants to prescribe an ICD, Kadish advises asking if its use meets guidelines or if it is the right thing to do even though it doesn't meet guidelines.

Dr. Gregg Fonarow, an American Heart Association spokesman and professor of cardiology at the University of California, Los Angeles, said the findings point to "the need to enhance evidence-based care and quality feedback to health-care providers" regarding ICD use.

Feedback to hospitals can improve adherence to the guideline recommendations, which would eventually reduce unnecessary health costs and benefit patients' health, the authors stated.

More information

For more information on ICDs, visit the U.S. National Heart, Lung and Blood Institute.

Posted: January 2011


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