176-51: Performance of the St.Jude Durata ICD lead: long-term results of a multicenter study

Background: the inacceptable high rate of ICD lead failure related to the Sprint Fidelis’ and Riata's design flaws raised serious concerns about the reliability of ICD leads. The St. Jude Medical Durata® family of ICD leads replaced the preceding Riata® line following increased rates of lead failure, (1.17% per year). The latest St.Jude Durata lead has design similarities to Riata although assembled with a different insulation material and with a specific design of the lead to reduce the risk of insulation defect. The aim of our study was to evaluate the long term performance of the Durata ICD lead.

Methods: Between June 2008 and September 2013, 811 Durata ICD leads (models: 7120, 7122, 7170, 7171, 7120Q, 7122Q,7170Q, 7172Q) were implanted. The incidence of lead failure, defined as a sudden rise in long-term pacing or defibrillation impedance and/or a sudden change in R wave amplitude and capture threshold was assessed. The incidence of lead dislodgment and lead perforation was also evaluated.

Results: During a median follow-up of 41 months (=3.3 years) (25th–75th IQ range 22–57 months) lead failure occurred in 13/811 leads (0.48%/year).

Lead failure was due to impedance out of range (2 cases), rise in capture threshold (7 cases), insulation defect (2 cases) and significant reduction of R wave amplitude (5 cases). The overall survival free of lead failure was 99.1% at 3 years and 98.3% at 4 years. Mean time to failure was 44 (=3.6 years) ± 19 months. Lead dislodgment occurred in 15/811 leads with an incidence of 0.55%/year and a median time of 6 months. No cases of cardiac perforation were reported. No major adverse clinical events were reported except for 2 cases of inappropriate shocks as a consequence of lead failure or lead dislodgment. Potential cofactors like active or passive fixation, presence of single or double coil, lead position didn't influence the incidence of failure or dislodgment.

Conclusions: Our study suggests that the Durata ICD lead does not engender a higher risk of failure. Overall survival free from lead failure at 3 and 4 years was found to be within normal range and higher than previously reported for Riata ICD leads.