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Implanted Heart Devices Have Real-World Benefits: Study
Date:1/4/2013

FRIDAY, Jan. 4 (HealthDay News) -- Implantable heart defibrillators aimed at preventing sudden cardiac death are as effective at ensuring patient survival during real-world use as they have proven to be in studies, researchers report.

The new finding goes some way toward addressing concerns that the carefully monitored care offered to patients participating in well-run defibrillator investigations may have oversold their related benefits by failing to account for how they might perform in the real-world.

The study is published in the Jan. 2 issue of the Journal of the American Medical Association.

"Many people question how the results of clinical trials apply to patients in routine practice," lead author Dr. Sana Al-Khatib, an electrophysiologist and member of the Duke Clinical Research Institute in Durham, N.C., acknowledged in a journal news release. "[But] we showed that patients in real-world practice who receive a defibrillator, but who are most likely not monitored at the same level provided in clinical trials, have similar survival outcomes compared to patients who received a defibrillator in the clinical trials."

The findings stem from a survival analysis (involving data collected since 2005 by a large national Medicare registry) following implantation with the small electrical devices known as implantable cardioverter-defibrillators (ICDs) that are connected by wire to the heart and designed to provide a life-saving electronic pulse if and when the heart stops beating.

The research team compared the performance of such devices among more than 5,300 real-world patients with the performance observed among more than 1,500 patients who had participated in clinical defibrillator studies. The authors stressed that the demographics of the two groups were comparable, with no particularly sick or elderly individuals included in the real-world pool.

But while the analysis revealed comparable r
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