Estimates of Implantable Cardioverter-Defibrillator Complications

Abstract

Appropriate selection of patients for implantable cardioverter-defibrillator (ICD) therapy requires knowledge of the beneficial effects and adverse consequences of such therapy. Although the randomized clinical trial is the sine qua non for establishing the benefits and exposing the adverse effects of interventions, subjects recruited for ICD trials may not represent the eligible population.1 Moreover, improved treatments of the underlying disorders and comorbid conditions and advances in equipment and implantation techniques could alter the balance of benefits and risks so that information from older clinical trials cannot be assumed to reflect current practice. In this issue of Circulation , Peterson and colleagues provide one of the first peer-reviewed studies using the National ICD Registry (NICDR) to examine gender-related differences in ICD implantation complication rates.2 Two preliminary reports have shown that patients in the NICDR differ significantly from those recruited into 2 of the primary prevention ICD trials that provided the evidence base for current practice guidelines and reimbursement policies of the Center for Medicaid and Medicare Services.3,4 Article p 1078 Participation is voluntary for most registries. Registries that include hospitals that agree to time- and labor-intensive data recording requirements and external scrutiny cannot be expected to represent hospitals that do not. The NICDR is part compulsory and part voluntary. Participation in the NICDR is required to receive reimbursement for primary prevention ICDs in Center for Medicaid and Medicare Services beneficiaries; however, about 75% of hospitals have elected to enroll all ICD patients in the NICDR.5 As of June 2008, data from 1448 hospitals totaling >270 373 implants had been entered in the NICDR. The report by Peterson et al2 is based on 204 700 unique patients accrued between January 2006 and December 2007 from 1224 hospitals. After exclusion of patients with a previous ICD implantation, the …