Chronic performance of Riata 1580 and Endotak 0158 ICD leads: A single center 10‐year experience

BACKGROUND: The long-term performance of the Riata family of leads has recently come under increasing scrutiny. We aimed to determine the long-term performance of the Riata 1580 leads compared with Endotak 0158 leads. METHODS: All patients with Riata 1580 or Endotak 0158 leads implanted from 2003 to 2008 at the Heart Hospital, UCLH were analyzed. Significant electrical changes were as follows: threshold increase >1 V at a set pulse width between pacing checks, persistent R wave fall to <2 mV or reduction in R wave >50%, noise, pacing impedance change to <300 Ω or >1500 Ω, high voltage (HV) change to <20 Ω or >200 Ω, HV change ± 15 Ω, pacing impedance change >400 Ω over 12 months. RESULTS: 333 Riata and 356 Endotak leads were implanted. Median follow-up time + interquartile range were calculated, after exclusion of censored events including loss to follow-up: Riata 3652 + 655 days, Endotak 3730 + 810 days. A total of 51 (15.9%) Riata leads and 21 (6.3%) Endotak leads were affected. A greater risk of failure was found for the Riata lead compared with the Endotak lead (P = .0001). An additional time-dependent effect was found, with the Riata lead 1.9 times more likely to fail in the first 6 years following lead implantation and 5.3 times more likely to fail after 6 years. CONCLUSIONS: Riata leads have a higher risk of failure compared to Endotak leads over time. The importance of careful ongoing performance surveillance late in the leads' lifetime is reflected in this 10-year follow-up study.