According to a new study nearly 20% of American patients who receive an implantable cardioverter-defibrillator (ICD) may not need it. These ICDs when unnecessary could put the patients at higher risk of death and serious complications than patients who meet the criteria for the life-saving device say authors of the study published in the Jan. 5 issue of the Journal of the American Medical Association.
According to lead researcher Dr. Sana M. Al-Khatib, an associate professor of medicine at the Duke Clinical Research Institute, “Our findings highlight the importance of enhancing health-care practitioners’ adherence to evidence-based practice… There is a tremendous opportunity for improvement in site performance.” She explained that in patients with advanced systolic heart failure, an ICD can prevent sudden cardiac death. However this move is not necessary in patients recovering from a heart attack or bypass surgery or those with severe heart failure symptoms or a recent diagnosis of heart failure as per guidelines.
The team analyzed records from the National Cardiovascular Data Registry’s ICD Registry between January 2006 and June 2009. Within this time frame a total of 111,707 ICDs were implanted, of which 25,145 (22.5 percent) did not meet current criteria. Among these out-of-guideline patients 36.8 percent had had a heart attack and 62.1 percent suffered from heart failure. In-hospital deaths were 0.57 percent among non guidelines patients compared to 0.18 percent among those whose ICD met the guidelines. Risk of complications was higher with out-of-guideline group (3.23 percent) compared to within guideline (2.41 percent). Most of these 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. The electrophysiologists were the smallest prescriber of ICDs. Most were implanted by thoracic surgeons and nonelectrophysiologist cardiologists.
According to Dr. Alan Kadish, president and chief executive officer of Touro College in New York City and author of an accompanying journal editorial, there may be good reason for implanting the unnecessary ICDs. He said, “There are some people where the guidelines are gray, where implantation is probably appropriate… But there are still a significant number of people who receive ICDs who don’t need them based on current criteria.” He said some reasons for unnecessary ICD implants could be 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. He said, “There may be some physicians who are just inappropriately putting them in… but I think that’s a minority of the out-of-guideline implantations.”
According to Dr. Gregg Fonarow, an American Heart Association spokesman and professor of cardiology at the University of California, Los Angeles the study shows that there is a “need to enhance evidence-based care and quality feedback to health-care providers” regarding ICD use.
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