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.
- implantable cardioverter defibrillator
- cardiac resynchronisation therapy
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Contributors JB, MG and LD designed the analysis. JB obtained funding for the study. LD provided data and statistical guidance. All authors participated in interpreting results. MG performed the statistical analysis, supervised by MG, with input from NMH. NMH, JGA, FH and MG drafted the manuscript. FH performed a background literature review to guide manuscript preparation. All authors critically revised the manuscript for important intellectual content. All authors read and approved the final manuscript and take responsibility for all aspects of the work.
Funding The study was funded by a St Paul's Hospital research grant.
Competing interests None declared.
Ethics approval Providence Health Care Research Institute.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement There is no additional unpublished data from the study.