Key result
Recalled Sprint Fidelis leads show a ~19% failure rate versus Sprint Quattro leads.
Why the study?
The performance and failure rates of recalled implantable cardioverter defibrillator leads in Asian patients, particularly Japanese, were not well known.
Do recalled ICD leads (Sprint Fidelis, Riata) have a higher rate of failure compared to non-recalled leads (Sprint Quattro) in Japanese patients?
Cohort (n=214)
No
Do recalled ICD leads (Sprint Fidelis, Riata) have a higher rate of failure compared to non-recalled leads (Sprint Quattro) in Japanese patients?
Absolute Event Rate: 19% vs 0%
Absolute Risk Reduction: 19%
p-value: p=0.009
Recalled ICD leads (Sprint Fidelis and Riata) demonstrate a progressively increasing failure rate over time in Japanese patients, with previous device implantation being a significant risk factor.
May warrant closer monitoring of recalled Fidelis leads; confirms higher failure rates in Japanese patients but leaves broader implications open.
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.
No takes yet. Share an insight, caveat, or question.
Yanagisawa et al. (2013) conducted a cohort in Implantable cardioverter defibrillator (ICD) indication (n=214). Sprint Fidelis lead vs. Sprint Quattro lead was evaluated on Lead failure (p=0.009). The recalled Sprint Fidelis lead demonstrated a significantly higher failure rate of 19% compared to 0% for the non-recalled Sprint Quattro lead in Japanese patients.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: