Abstract 20158: Long-Term Device-Related Adverse Events After Implantable Cardioverter-Defibrillator Therapy
Background: Long-term implantable cardioverter-defibrillator (ICD) adverse events are poorly documented. In the NCDR ICD Registry™, a nationally representative cohort, we calculated the rate of long-term post-discharge device related adverse events.
Methods: We included first-time ICD implants from 2006-2010 that could be matched with Medicare fee-for-service claims data to identify outcomes. We excluded patients if they had a previous ICD or pacemaker, CABG during their procedure, or were not discharged alive. The primary outcome was device reoperation (involving the generator, leads, pocket, or a combination) for device malfunction, infection, other complications (wound disruption, cardiac perforation, etc.), or reoperation for battery end-of-life and/or device upgrade. Analysis was performed using unadjusted cumulative incidence functions taking into consideration the competing risk of death.
Results: We identified 185,263 ICD implants of which 114,649 (19.7% single-chamber, 41.3% dual-chamber, 38.8% CRT-D) could be matched to Medicare data (mean age 74.8±6.2 years, 72.5% male).Of these, 83.5% were for primary prevention of sudden cardiac death. The median follow up was 2.7 yrs (max follow-up 6 yrs). At least 1 reoperation occurred in 15.5% of patients by 6 yrs and more than 80% of these reoperations occurred after the early (>90 days) post-implantation period (Figure). Reoperation rates for specific complications (per 1000 patient yrs) were device malfunction (14.3), infection (5.1), other device related complications (18.4) and reoperation for generator battery end-of-life and/or device upgrade (12.9). The crude reoperation rate (for any cause) was similar among device types (P=0.19).
Conclusion: Patients continue to have adverse outcomes in the years post ICD implantation, predominately from device malfunction. Our next steps are to identify patient, device, and provider factors associated with these long-term adverse events.
Author Disclosures: I. Ranasinghe: None. C. Parzynski: None. J.V. Freeman: None. R.P. Dreyer: None. J.S. Ross: None. J.G. Akar: None. H.M. Krumholz: Research Grant; Significant; Medtronic, Johnson and Johnson. Consultant/Advisory Board; Significant; United Health Care. J.P. Curtis: None.
- © 2014 by American Heart Association, Inc.