The life-saving benefit of implantable cardioverter defibrillators (ICD) has been well demonstrated, and therefore their utilization has considerably grown in the last 10 years. At the same time, complications have become an increasingly important concern.

This study aimed to assess the prevalence and impact on outcomes (late complications and overall mortality) of early complications after ICD implantation for primary prevention in a large French population.

From a multicentric French registry (DAI-PP Registry, 2002-2012), 5547 consecutive patients, with coronary artery disease or dilated cardiomyopathy, were implanted with an ICD in the setting of primary prevention. From 5338 (96%) patients with full information, we determined prevalence, independent associated factors and prognosis of the occurrence of early (within 30 days post implantation) complications.

Early complications occurred in 709 patients (13.5%), mainly related to lead dysfunction or hematoma (56%). Independent associated factors to early complications were renla impairment (clearance <30ml/min, OR=1.69, 95% CI 1.19-2.41, P<0.001), cardiac resynchronization therapy (OR=1.61, 95% CI 1.17-2.21, P=0.004), anticoagulant therapy (OR=1.30, 95% CI 1.04-1.63, P=0.02) and older age (OR=1.02, 95% CI 1.01-1.02, P=0.03). During a mean follow-up of 3.1±2.3 years, 834 patients experienced ≥1 complication (15.6%), mainly inappropriate therapies and/or lead dysfunction (75%). After consideration of potential confounding factors, early complications were significantly associated with the occurrence of late complications (OR=2.15, 95% CI 1.73-2.66, P<0.0001) and a higher risk of overall mortality (OR=1.48, 95% CI 1.17-1.88, P=0.001).

Early complication is a frequent event after ICD implantation occurring in one out of six patients. These events are associated with a significant increase of late complications and overall mortality.