Failure-free survival of the Durata defibrillator lead.

AIMS Given design similarities and a common manufacturer, there have been suspicions regarding the Durata™ defibrillator (ICD) lead, in the aftermath of the Riata™ class I recall. We therefore examined the failure-free survival rates of the Durata™ compared with the Riata™ and Sprint Quattro™ ICD leads. METHODS AND RESULTS All patients (n = 2475) implanted with a Durata (n = 828), Riata [n = 627; 8 Fr. (n = 472) and 7 Fr. (n = 155)], or Sprint Quattro (n = 1020) leads at our institution were included and Kaplan-Meier failure-free survival curves were constructed for all leads. Lead failure was defined as electrical malfunction resulting in lead replacement, excluding dislodgements or perforations. Annual electrical failure rates were 0.3%, 1.7, and 0.3% for the Durata, Riata, and Sprint Quattro leads, respectively (P < 0.0001 for the comparison of Durata to Riata and P = 0.1.0 for the comparison of Durata to Sprint Quattro). The failure-free survival of the Durata lead was significantly better than that of the Riata lead (P < 0.0001) and similar to that of the Sprint Quattro (P = 0.94). The 7 Fr. Riata ST lead had better survival compared with the 8 Fr. Riata lead (P = 0.050) and comparable survival with the Durata lead (P = 0.12). CONCLUSION The Durata lead failure-free survival is significantly better than the 8 Fr. Riata, albeit at a shorter follow-up time. Riata and comparable with that of the 7 Fr. Riata ST and the Sprint Quattro ICD leads. These data provide an insight into the mechanism of electrical failure of Riata leads and have implications for patient management.