Abstract 13932: Implantable Cardioverter-Defibrillator FDA Safety Advisories Impact Patient Morbidity but Not Mortality
Background: A significant proportion of implantable cardioverter-defibrillators (ICDs) have been subject to FDA advisories. Dependency to prevent sudden death justifies an assessment of patient care and long-term outcomes.
Hypothesis: Management of patients with ICDs under advisory may be associated with increased surveillance, procedures, and mortality. Design and Setting: Single center, observational study.
Patients: First ICD implants at the Cleveland Clinic between 8/96-5/04.
Measurements: After identifying ICDs subject to FDA advisories, survival analyses were performed to test association of FDA advisory status with mortality (via Social Security Death Index). Clinical events were documented in patients with at-risk ICDs from implantation to either explant or death.
Results: In 1644 1st ICD implants, 704 (43%) became subject to an FDA advisory; 172 (10.5%) were Class I and 532 (32.3%) Class II advisories. ICDs were explanted before advisory notification in 24 (14.0%) of Class I and 53 (10.1%) of Class II advisories, 11/77 (14.3%) due to potential advisory-related malfunctions. After notification, excluding patients who had died or were explanted, at least 6/96 and 71/406 patients had additional visits, and 1/96 (1.0%) and 41/406 (10.1%) advisory-related explants occurred in Class I and II ICDs, respectively. Among advisory-associated ICDs, 28 (4.0%) advisory related and 13 non-advisory related malfunctions were documented (5.8% overall). Over follow-up (median 70 mos), 814 patients died. Kaplan-Meier 5-year survival was 65.6% overall, and 64.2%, 61.1%, and 69.3% in patients with no, Class I, and Class II advisories, respectively, p=0.17.
Conclusions: ICD advisories impacted 43% of patients. Patients with devices under advisory experienced more malfunctions. Advisories contributed to additional non-invasive monitoring but were not associated with increased explants or higher mortality over the background of disease-related mortality.
- © 2011 by American Heart Association, Inc.