Long-term complications, reoperations and survival following cardioverter-defibrillator implant.

OBJECTIVE: Implantable cardioverter-defibrillators (ICDs) reduce risk of death in select populations, but are also associated with harms. We aimed to characterise long-term complications and reoperation rate.

METHODS: We assessed the rate, cumulative incidence and predictors of long-term reoperation and survival using a prospective, multicentre registry serving British Columbia in Canada, a universal single payer healthcare system with 4.5 million residents. 3410 patients (mean 63.3 years, 81.7% male) with new primary (n=1854) or secondary prevention (n=1556) ICD implant from 2003 to 2012 were followed for a median of 34 months (single chamber n=1069, dual chamber n=1905, biventricular n=436). Independent predictors of adverse outcomes were defined using Cox regression models.

RESULTS: The overall reoperation rate was 12.0% per patient-year, and less for single vs dual vs biventricular ICDs (9.1% vs 12.5% vs 17.8% per patient-year, respectively). The Kaplan-Meier complication estimates (excluding generator end of life) at 1, 3 and 5 years were respectively: single chamber 10.2%, 16.2% and 21.6%; dual 11.7%, 19.1% and 27.4% and biventricular 15.9%, 22.2% and 24.7%. Cardiac resynchronisation therapy had the highest rate of early lead complications, but lower long-term need for upgrade. Device complexity, age and atrial fibrillation were key determinants of complications. Overall mortality at 1, 3 and 5 years was 5.4%, 17.4% and 32.7%, respectively. In younger patients, observed 5-year survival approached the expected survival in the general population (relative survival ratio=0.96 (0.90-0.98)). With increasing age, observed survival steadily declined relative to expected.

CONCLUSIONS: In a prospective registry capturing all procedures, complication and reoperation rates following de novo ICD implantation were high. Shared decision making must carefully consider these factors.