St. Antonius Ziekenhuis, Nieuwegein, the Netherlands; Academic Medical Center, Amsterdam, the Netherlands.
Russells Hall Hospital, Dudley, United Kingdom.
J Am Coll Cardiol. 2017 Aug 15;70(7):830-841. doi: 10.1016/j.jacc.2017.06.040.
The subcutaneous implantable cardioverter-defibrillator (S-ICD) was developed to defibrillate ventricular arrhythmias, avoiding drawbacks of transvenous leads. The global EFFORTLESS S-ICD (Evaluation oF FactORs ImpacTing CLinical Outcome and Cost EffectiveneSS of the S-ICD) registry is collecting outcomes in 985 patients during a 5-year follow-up.
The primary goal of the EFFORTLESS registry is to determine the safety of the S-ICD by evaluating complications and inappropriate shock rate.
This is the first report on the full patient cohort and study endpoints with follow-up ≥1 year. The predefined endpoints are 30- and 360-day complications, and shocks for atrial fibrillation or supraventricular tachycardia.
Patients were followed for 3.1 ± 1.5 years and 82 completed the study protocol 5-year visit. Average age was 48 years, 28% were women, ejection fraction was 43 ± 18%, and 65% had a primary prevention indication. The S-ICD system and procedure complication rate was 4.1% at 30 days and 8.4% at 360 days. The 1-year complication rate trended toward improvement from the first to last quartile of enrollment (11.3% [quartile 1]) to 7.8% [quartile 2], 6.6% [quartile 3], and 7.4% [quartile 4]; quartile 1 vs. quartiles 2 to 4; p = 0.06). Few device extractions occurred due to need for antitachycardia (n = 5), or biventricular (n = 4) or bradycardia pacing (n = 1). Inappropriate shocks occurred in 8.1% at 1 year and 11.7% after 3.1 years. At implant, 99.5% of patients had a successful conversion of induced ventricular tachycardia or ventricular fibrillation. The 1- and 5-year rates of appropriate shock were 5.8% and 13.5%, respectively. Conversion success for discrete spontaneous episodes was 97.4% overall.
This registry demonstrates that the S-ICD fulfills predefined endpoints for safety and efficacy. Midterm performance rates on complications, inappropriate shocks, and conversion efficacy were comparable to rates observed in transvenous implantable cardioverter-defibrillator studies. (Evaluation oF Factors ImpacTing CLinical Outcome and Cost EffectiveneSS of the S-ICD [The EFFORTLESS S-ICD Registry]; NCT01085435).
皮下植入式心律转复除颤器（S-ICD）的开发旨在除颤室性心律失常，避免了经静脉导联的缺点。全球 EFFORTLESS S-ICD（评估影响 S-ICD 临床结果和成本效益的因素）注册中心正在对 985 例患者进行 5 年随访，收集其结果。
EFFORTLESS 注册中心的主要目标是通过评估并发症和不适当的电击率来确定 S-ICD 的安全性。
这是第一个报告完整患者队列和研究终点随访时间≥1 年的报告。预先设定的终点是 30 天和 360 天的并发症，以及心房颤动或室上性心动过速的电击。
患者平均随访 3.1±1.5 年，82 例完成了研究方案 5 年的随访。平均年龄为 48 岁，28%为女性，射血分数为 43±18%，65%有一级预防指征。S-ICD 系统和程序的并发症发生率在 30 天为 4.1%，在 360 天为 8.4%。第 1 年的并发症发生率从入组的第 1 至第 4 四分位的趋势有所改善（11.3%[第 1 四分位]至 7.8%[第 2 四分位]、6.6%[第 3 四分位]和 7.4%[第 4 四分位]；第 1 四分位与第 2 至第 4 四分位比较；p=0.06）。少数因需要抗心动过速（n=5）、双心室（n=4）或心动过缓起搏（n=1）而进行了设备取出。第 1 年和第 3.1 年分别有 8.1%和 11.7%发生不适当的电击。植入时，99.5%的患者成功地转换了诱导的室性心动过速或室颤。第 1 年和第 5 年的适当电击率分别为 5.8%和 13.5%。总的来说，对离散性自发性发作的转换成功率为 97.4%。
该注册中心表明，S-ICD 满足了安全性和有效性的预设终点。中期并发症、不适当电击和转换效果的表现率与经静脉植入式心律转复除颤器研究中的观察结果相当。（评估影响 S-ICD 临床结果和成本效益的因素[EFFORTLESS S-ICD 注册研究]；NCT01085435）。
