-- Alan Mozes
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 results among both
groups, the authors stressed that their findings clearly could not
speak to how older and sicker patients might fare outside the
confines of a study situation, which itself often favors the
inclusion of younger/healthier patients.
"That is an issue, and the only way to get at that is to randomly assign such patients to either receive an ICD or not in a clinical trial," Al-Khatib said in the news release. "Even without those data, however, our study gives patients and their health care providers reassurance that what we have been doing in clinical practice has been helpful, and is improving patient outcomes. Our findings support the continued use of this life-saving therapy in clinical practice," she added.
For more on ICDs, visit the
U.S. National Heart, Lung, and Blood
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