A new study in the Journal of the American Medical Association concludes that patients who have surgery to replace potentially faulty defibrillators recalled by Guidant and Medtronic last year may actually be at more risk than those who leave them in. Researchers looked at data on so-called "explant" surgeries at Canadian hospitals after the recalls and found that 5.9 percent of patients developed complications considered "serious." Three patients died. In contrast, the risk of defibrillator malfunction is believed to be one in 1,000 for most devices.
"This focus on device flaws is doing the field a great disservice," said David Cannom, chief of cardiology at Good Samaritan Hospital in Los Angeles. "The Canadian study is extremely well done and extremely significant. My bias all along has been that the fewer of these you remove, the better."
- read this Wall Street Journal article [1] (sub. req.)
PLUS: A separate JAMA study looks at mortality rates for patients who received defibrillators and other implantable cardiac devices (ICD) between 1990-2002 based on reported data. Pacemaker malfunctions declined. Defibrillator problems increased, particularly in the latter part of the study. Article [2]
Links:
[1] http://online.wsj.com/article/SB114598898548235507.html?mod=health_home_stories
[2] http://jama.ama-assn.org/