Clinical outcome of implantable cardioverter defibrillators with recalled and non-recalled leads in Japanese patients. Increased failure rate of the Sprint Fidelis lead.

ABSTRACT

BACKGROUND: In recent years, there has been a series of recalls of popular implantable cardioverter defibrillators leads, and several reports have demonstrated an increasing rate of failure of such leads over time in Caucasian patients. However, little is known about the performance of these leads in Asian patients. The aim of this study was to investigate the rate of failure of the recalled leads and the characteristics as compared with non-recalled leads in Japanese patients. METHODS AND RESULTS: A retrospective chart review was conducted in 214 patients (75 Sprint Fidelis, 8 Riata, and 131 Sprint Quattro leads) who underwent implantation and follow-up at Nagoya University Hospital. During the follow-up period, 14 Sprint Fidelis leads (19%) and 1 Riata lead (13%) failed, but no abnormality was found in the Sprint Quattro, non-recalled leads. Five patients (4 Sprint Fidelis and 1 Riata, 33% of lead failure patients) received inappropriate shocks. The 3-, 4-, and 5-year lead survival rates in Sprint Fidelis leads were 95.1% (95% confidence interval [CI] 89.6%-100%), 89.8% (95% CI 82.1%-97.6%), and 88.0% (95% CI 79.6%-96.4%), respectively. A previous device implantation before Sprint Fidelis lead was the only significant predictor for lead fracture (hazard ratio, 5.33; 95% CI 1.55-18.4; P=0.008). CONCLUSIONS: The rate of Sprint Fidelis lead failure continues to increase over time in Japanese patients.