Minneapolis Heart Institute Foundation, 920 E 28th St, Ste 300, Minneapolis, MN 55407, USA.
Circulation. 2011 Feb 1;123(4):358-63. doi: 10.1161/CIRCULATIONAHA.110.975219. Epub 2011 Jan 17.
Sprint Fidelis (Fidelis) implantable cardioverter-defibrillator leads are prone to fractures that have caused adverse events, primarily inappropriate shocks, and a few reported deaths. More than 100 000 patients have Fidelis leads. No independent multicenter long-term performance information exists for this lead, and single-center studies suggest that certain patients are at increased risk for Fidelis failure. Our aim was to assess the longevity of Fidelis leads and to evaluate clinical variables and adverse events associated with Fidelis failure. The results were compared with like data for Quattro Secure (Quattro) implantable cardioverter-defibrillator leads implanted at our centers.
This 3-center study included adults ≥18 years of age who received Fidelis or Quattro leads for the prevention of sudden cardiac death. From November 2001 to January 2009,1023 Fidelis and 1668 Quattro leads were implanted and followed up. The failure rate for Fidelis leads was 2.81%/y compared with 0.43%/y for Quattro leads (P<0.0001). No deaths or injuries occurred as a result of lead failure, but 42% of fractures caused inappropriate shocks. The survival of Fidelis leads at 4 years was 87.0% (95% confidence interval, 83.6 to 90.1) compared with 98.7% (95% confidence interval, 97.9 to 99.4) for Quattro leads (P<0.0001). Multivariate predictors of Fidelis failure were younger age (hazard ratio, 0.98; 95% confidence interval, 0.96 to 0.99), female gender (hazard ratio, 0.61; 95% confidence interval, 0.40 to 1.00), and cardiac disease (P=0.041).
Compared with Quattro leads, the survival of Fidelis leads continues to decline, and Fidelis failure is notably higher in younger patients, women, individuals with hypertrophic cardiomyopathy, and patients with arrhythmogenic right ventricular dysplasia or channelopathies. These findings have significant implications for the management of patients who have Fidelis leads, and they demonstrate the importance of weighing clinical variables in assessments of implantable cardioverter-defibrillator lead performance.
Sprint Fidelis（Fidelis）植入式心脏复律除颤器导线易发生导致不良事件的断裂，主要是不适当的电击，以及少数报告的死亡事件。超过 10 万名患者使用 Fidelis 导线。没有关于该导线的独立的多中心长期性能信息，而单中心研究表明某些患者的 Fidelis 故障风险增加。我们的目的是评估 Fidelis 导线的使用寿命，并评估与 Fidelis 故障相关的临床变量和不良事件。将结果与我们中心植入的 Quattro Secure（Quattro）植入式心脏复律除颤器导线的类似数据进行比较。
这项 3 中心研究包括年龄≥18 岁的成年人，他们接受 Fidelis 或 Quattro 导线预防心源性猝死。从 2001 年 11 月至 2009 年 1 月，植入了 1023 根 Fidelis 导线和 1668 根 Quattro 导线并进行了随访。Fidelis 导线的故障率为 2.81%/y，而 Quattro 导线的故障率为 0.43%/y（P<0.0001）。导线故障没有导致死亡或伤害，但 42%的断裂导致不适当的电击。4 年后 Fidelis 导线的存活率为 87.0%（95%置信区间，83.6 至 90.1），而 Quattro 导线的存活率为 98.7%（95%置信区间，97.9 至 99.4）（P<0.0001）。Fidelis 故障的多变量预测因素为年龄较小（风险比，0.98；95%置信区间，0.96 至 0.99）、女性（风险比，0.61；95%置信区间，0.40 至 1.00）和心脏病（P=0.041）。
与 Quattro 导线相比，Fidelis 导线的存活率继续下降，年轻患者、女性、肥厚型心肌病患者以及致心律失常性右室发育不良或通道病患者的 Fidelis 故障发生率明显更高。这些发现对 Fidelis 导线患者的管理具有重要意义，并证明在评估植入式心脏复律除颤器导线性能时，考虑临床变量非常重要。
