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FDA advisories on ICDs not linked to increased mortality
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Implantable cardioverter defibrillators under FDA safety advisories were not associated with increased mortality based on a conservative management strategy and over a background of significant disease-related mortality, according to research published in Heart Rhythm.
Researchers at the Heart & Vascular Institute, Cleveland Clinic, examined the association between FDA advisory status of ICDs and long-term mortality.
For the retrospective, single-center review, researchers identified 1,644 patients who had an ICD first implanted at the Cleveland Clinic between August 1996 and May 2004, and who became subject to FDA advisories on ICD generators. Clinical outcomes examined included device malfunctions from implantation to explant or death. Researchers used the Social Security Death Index for data on mortality.
Overall, 43% of patients became subject to an FDA advisory. Of those, 10.5% were class I advisories and 32.3% were class II advisories. ICDs were explanted before advisories in the case of 14.1% of class I advisories and 10.1% of class II advisories.
When researchers examined ICDs under advisories specifically, they found that 28 were related to the advisory and 15 were not.
During an average 70 months of follow-up, 814 patients died. The overall 5-year survival rate was 65.6%. The 5-year survival rate was 64.2% for patients subject to no advisories, 61.1% for patients subject to class I advisories and 69.3% for patients subject to class II advisories (P=.17).
“Despite this high incidence [of ICD FDA advisories], having an ICD under a safety advisory was not associated with higher all-cause mortality,” the researchers wrote. “Further analysis censoring at explant date and controlling for independent predictors of mortality also did not show increased mortality in the combined advisory, class I or class II advisory groups when compared with the no-advisory group.”
Disclosure: All members of the Cleveland Clinic Cardiac Electrophysiology staff participate in industry-sponsored research (Biotronik, Boston Scientific, Medtronic, St. Jude Medical). See the full study for specific disclosure information.
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