Abstract 2438: Complications Increase Mortality Risk After De Novo Implantion of a Cardioverter Defibrillator: Initial Findings From the Ontario ICD Database
Background. Although implantable cardioverter defibrillators (ICDs) are widely used, the predictors and consequences of complications related to device implantation have not been determined.
Objectives. To determine the rates and predictors of complications after ICD implantation.
Methods. We examined complications occurring within 45 days of de novo (e.g., primary or secondary prevention) ICD implant in the Ontario ICD Database, a population-based clinical outcomes registry (Feb 2007–Mar 2009). Complications were determined at routine post-operative clinic visits and classified as implant-related or clinical. Deaths were determined by vital statistics database linkage.
Results. Among 3340 patients (64±13 yrs, 79% men), major complications occurred in 4.1% of de novo procedures at 45 days, and only 0.5% occurred in-hospital. The most frequent implant-related complications were lead replacement (2.1%) or repositioning (2.1%), pocket infection (1.0%), and lead extraction (0.7%). Pulmonary edema (0.7%) and electrical storm (0.6%) were the most frequent clinical complications. Use of cardiac resynchronization ICD (odds ratio [OR] 2.20; 95%CI, 1.38–3.50, p=0.001 vs. single), dual chamber device (OR 1.83; 95%CI, 1.19–2.81, p=0.006 vs. single), left ventricular end-systolic dimension ≥45 mm (OR 1.54; 95%CI, 1.07–2.22, p=0.02), and female sex (OR 1.51; 95%CI, 1.03–2.22, p=0.036) were associated with an increased risk of complications. Complications (excluding death) occurring early after ICD implant were associated with increased risk of subsequent death up to 45 days (OR 4.19; 95%CI, 1.18–14.85, p=0.026) and 180 days (OR 2.73; 95%CI; 1.21–6.16, p=0.016) adjusted for age, sex and ICD type. The association was significant for both implant-related and clinical complications (Table⇓).
Conclusions. Complications after de novo ICD implant were strongly associated with device type, and an increased risk of subsequent death.