Implantable cardioverter-defibrillator FDA safety advisories: Impact on patient mortality and morbidity.

ABSTRACT:

Background

A significant proportion of implantable cardioverter-defibrillators (ICDs) have been subject to Food and Drug Administration (FDA) advisories. The impact of device advisories on mortality or patient care is poorly understood. Although estimated risks of ICD generators under advisory are low, dependency on ICD therapies to prevent sudden death justifies the assessment of long-term mortality.

Objective

To test the association of FDA advisory status with long-term mortality.

Methods

The study was a retrospective, single-center review of clinical outcomes, including device malfunctions, in patients from implantation to either explant or death. Patients with ICDs first implanted at Cleveland Clinic between August 1996 and May 2004 who became subject to FDA advis

SUBMITTER: Sengupta J 

PROVIDER: S-EPMC3459308 | biostudies-literature | 2012 Oct

REPOSITORIES: biostudies-literature