The Incidence of Riata Defibrillator Lead Failure: a Single-Center Experience

Abstract

Riata defibrillator leads were recalled due to a high failure rate. This study measured the incidence of externalized conductor (EC) and electrical dysfunction (ED) and sought to determine the predictors of ED with Riata defibrillator leads. We enrolled patients who received Riata (R) or Riata (R) ST silicone defibrillator leads at our center between January 2003 and December 2010. The presence of EC was evaluated with chest radiography. The incidence rates were measured at < 3 years, 3-5 years, and > 5 years after lead implantation. We also investigated the rates of ED and other clinical events during the follow-up period. A total of 44 patients were analyzed. The total cumulative incidence of EC was 27.3%. During the median dwell time (80 months), the incidence of ED was 22.7%. Patients with ED were younger (46.5 vs. 56.5 years, P = 0.018) and had a higher prevalence of cardiomyopathy than those without ED (60.0% vs. 20.6%, P = 0.043). ECs were most frequently detected in patients who underwent X-ray analysis 3-5 years after lead implantation (44.4%). In contrast, ED had a bimodal incidence pattern, with peaks at 5 years (7.0%) and 9 years (5.3%). There was no difference in ED-free survival rate between patients with and without EC (P = 0.628). Given the delayed occurrence of EC and ED after implantation of Riata defibrillator leads, long-term close monitoring is critically important.