Abstract 2497: Long-Term Rates of Device-Related Adverse Events and Repeat Procedures Among Patients With Primary-Prevention ICDs
Objective: Randomized trials show a survival benefit for ICDs implanted for primary prevention of sudden cardiac death in patients with low ejection fraction, but the burden of device-related untoward events and repeat invasive procedures is unknown. Such long-term data could inform patient expectations and risk-benefit assessment.
Methods: Comprehensive surveillance of a 543-patient, two-hospital captive subgroup of the ongoing prospective PROSE-ICD registry, using merged research, clinical and administrative data. Events included any departure from uncomplicated care, including peri-procedural events (major: pneumothorax, lead dislodgement, unplanned intubation, procedural stroke or death; minor: pocket hematoma, pericarditis, drug allergy or DVT), and any occurrences of inappropriate shock, device recall or failure, system infection, premature generator exchange, lead fracture/revision or pocket revision. Data were plotted with Kaplan-Meier curves and censored at death or loss to followup.
Results: Followup was complete for 98% of enrollees, with median followup for survivors of 922 days.
Overall survival was 96% at 1 year and 85% at 4 years. Within 60 days of implant 3.1% of patients had a significant event (1.5% (N=8) with lead dislodgement) and 1.3% had a minor event. Among survivors, 89% were event-free at 1 year, 83% at 3 years and 78% at 4 years. For patients without other events, the inappropriate-firing rate was 6% at 1 year and 12% at 4 years.
Conclusion: Along with a survival benefit, patients who undergo primary-prevention ICD implantation have about a 3% rate of significant peri-procedural events and a 22% untoward event rate at 4 years post-implant.