Six-year follow-up of the initial Dutch subcutaneous implantable cardioverter-defibrillator cohort: Long-term complications, replacements, and battery longevity
Six-year follow-up of the initial Dutch subcutaneous implantable cardioverter-defibrillator cohort: Long-term complications, replacements, and battery longevity
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DOI：
10.1111/jce.13498
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发表时间：
2018-07-01
影响因子：
2.7
通讯作者：
Knops, Reinoud E.
中科院分区：
文献类型：
--
作者：
Quast, Anne-Floor B. E.;van Dijk, Vincent F.;Knops, Reinoud E.
简介：皮下植入式心律转复除颤器（S-ICD）的经验正在迅速扩大。然而，数据的长期性能或并发症相关的择期发生器replacement.Methods：随访（FU）的所有患者之间植入2008年12月至2011年4月的数据收集。并发症定义为需要手术干预的并发症。KaplanMeier估计的并发症和休克率，相应的95%置信区间（CI），计算。中位随访时间为6.1年（IQR 5.66.5年）。短期并发症发生率（0-30天）为3%（CI 0-6%）。6年时的长期并发症发生率为19%（CI 12-26%），对应的年并发症发生率为3%。该队列中的1例患者需要使用经静脉ICD（TV-ICD）来提供心动过缓起搏（1%）。6名患者在发生SICD并发症后植入了TV-ICD，需要取出。总共取出了10个S-ICD;没有导致并发症。8例患者发生非全身性ICD相关感染，未观察到电极导线失效。大多数患者，68例（58%），接受了择期发生器更换。2例患者发生与发生器更换相关的并发症（3%）。电池寿命为5.6年（IQR 5.2-6.1）。适当和不适当的休克率6年的估计分别为17%（CI 9-25%）和21%（CI 15-27%），respectively：这个队列代表了最长的后续日期，并显示出较低的年度并发症发生率没有导致故障或全身感染。第一代S-ICD的电池寿命导致相对较早的发生器更换手术。
Introduction: Experience with the subcutaneous implantable cardioverter-defibrillator (S-ICD) is expanding rapidly. However, data on long-term performance or complications related to elective generator replacement are lacking.Methods: Follow-up (FU) data of all patients implanted between December 2008 and April 2011 were collected. Complications were defined as those requiring surgical intervention. KaplanMeier estimates for complication and shock rates, with corresponding 95% confidence intervals (CI), were calculated.Results: One hundred and eighteen patients were included. Median FU was 6.1 years (IQR 5.66.5 years). Short-term complication rate (0-30 days) was 3% (CI 0-6%). Long-term complication rate at 6 years was 19% (CI 12-26%), corresponding with an annual complication rate of 3%. One patient in this cohort developed a need for a transvenous ICD (TV-ICD) in order to provide pacing for bradycardia (1%). Six patients were implanted with a TV-ICD after experiencing an SICD complication for which extraction was necessary. In total, 10 S-ICDs were extracted; none resulted in a complication. Eight patients had a nonsystemic ICD-related infection and no lead failures were observed. Themajority, 68 (58%) patients, received an elective generator replacement. Two patients had a complication related to generator replacement (3%). Battery longevitywas 5.6 years (IQR 5.2-6.1). Appropriate and inappropriate shock rates of 6-year estimates were 17% (CI 9-25%) and 21% (CI 15-27%), respectively.Conclusions: This cohort represents the longest follow-up to date and shows a low annual complication rate without lead failures or systemic infections. Battery longevity of the first S-ICD generation results in relative early generator replacement procedures.