Longitudinal follow-up of implantable cardioverter defibrillator leads

Although implantable cardioverter defibrillator (ICD) leads are prone to failure and Food and Drug Administration recall, comprehensive longitudinal studies investigating contemporary ICD lead survival rate in the United States are lacking. All patients receiving Medtronic, Boston Scientific, or St. Jude Medical transvenous ICD leads at the hospitals of the University of Pittsburgh Medical Center from 2000 to 2012 were included. Leads were classified as (1) functional lead, patient deceased; (2) functional lead, replaced; (3) failed lead, replaced; or (4) functional lead, active. Kaplan-Meier survival curves were constructed for all lead models separately and in aggregate. We followed 5,288 patients (1,020 Quattro, 623 Fidelis, 627 Riata, 828 Durata, and 2,190 Reliance) over 3.7 ± 3.3 years. Functional leads that were replaced included 30 Quattro (3%), 99 Fidelis (16%), 24 Riata (4%), 24 Durata (3%), and 62 Reliance (3%). Leads replaced because of failure included 11 Quattro (1%), 47 Fidelis (8%), 38 Riata (6%), 18 Durata (2%), and 26 Reliance (1%; p <0.001 for Food and Drug Administration recalled vs nonrecalled leads). Overall survival rate of all leads was 89.3% at 5 years. Survival curves of Riata and Fidelis diverged from nonrecalled leads at approximately 2 years. In conclusion, the overall survival rate of ICD leads is nearly 90% at 5 years. Survival curves of recalled leads diverge from nonrecalled leads after 2 years of implantation. These data have important implications on postmarket release monitoring of ICD leads and physicians' choice of leads.