Lambiase Pier D, Barr Craig, Theuns Dominic A M J, Knops Reinoud, Neuzil Petr, Johansen Jens Brock, Hood Margaret, Pedersen Susanne, Kääb Stefan, Murgatroyd Francis, Reeve Helen L, Carter Nathan, Boersma Lucas
Cardiology Department, The Heart Hospital, Institute of Cardiovascular Science, University College London, 16-18 Westmoreland Street, W1G 8PH London, UK
Cardiology Department, Russells Hall Hospital, Dudley, UK.
Eur Heart J. 2014 Jul 1;35(25):1657-65. doi: 10.1093/eurheartj/ehu112. Epub 2014 Mar 26.
The totally subcutaneous implantable-defibrillator (S-ICD) is a new alternative to the conventional transvenous ICD system to minimize intravascular lead complications. There are limited data describing the long-term performance of the S-ICD. This paper presents the first large international patient population collected as part of the EFFORTLESS S-ICD Registry.
The EFFORTLESS S-ICD Registry is a non-randomized, standard of care, multicentre Registry designed to collect long-term, system-related, clinical, and patient reported outcome data from S-ICD implanted patients since June 2009. Follow-up data are systematically collected over 60-month post-implant including Quality of Life. The study population of 472 patients of which 241 (51%) were enrolled prospectively has a mean follow-up duration of 558 days (range 13-1342 days, median 498 days), 72% male, mean age of 49 ± 18 years (range 9-88 years), 42% mean left ventricular ejection fraction. Complication-free rates were 97 and 94%, at 30 and 360 days, respectively. Three hundred and seventeen spontaneous episodes were recorded in 85 patients during the follow-up period. Of these episodes, 169 (53%) received therapy, 93 being for Ventricular Tachycardia/Fibrillation (VT/VF). One patient died of recurrent VF and severe bradycardia. Regarding discrete VT/VF episodes, first shock conversion efficacy was 88% with 100% overall successful clinical conversion after a maximum of five shocks. The 360-day inappropriate shock rate was 7% with the vast majority occurring for oversensing (62/73 episodes), primarily of cardiac signals (94% of oversensed episodes).
The first large cohort of real-world data from an International patient S-ICD population demonstrates appropriate system performance with clinical event rates and inappropriate shock rates comparable with those reported for conventional ICDs. Clinical trial registration URL: http://www.clinicaltrials.gov. Unique identifier NCT01085435.
完全皮下植入式除颤器（S-ICD）是传统经静脉ICD系统的一种新的替代方案，可将血管内导线并发症降至最低。描述S-ICD长期性能的数据有限。本文介绍了作为EFFORTLESS S-ICD注册研究一部分收集的首个大型国际患者群体。
EFFORTLESS S-ICD注册研究是一项非随机、标准治疗、多中心注册研究，旨在收集自2009年6月以来植入S-ICD患者的长期、系统相关、临床和患者报告的结局数据。随访数据在植入后60个月内系统收集，包括生活质量。472例研究人群中，241例（51%）为前瞻性入组，平均随访时间为558天（范围13 - 1342天，中位数498天），男性占72%，平均年龄49±18岁（范围9 - 88岁），平均左心室射血分数为42%。30天和360天的无并发症率分别为97%和94%。随访期间85例患者记录到317次自发事件。其中，169次（53%）接受了治疗，93次是针对室性心动过速/心室颤动（VT/VF）。1例患者死于复发性VF和严重心动过缓。对于离散的VT/VF事件，首次电击转复成功率为88%，最多5次电击后总体临床转复成功率为100%。360天不适当电击率为7%，绝大多数发生在感知过度（62/73次事件），主要是心脏信号（94%的感知过度事件）。
来自国际患者S-ICD人群的首个大型真实世界数据队列显示系统性能良好，临床事件发生率和不适当电击率与传统ICD报告的相当。临床试验注册网址：http://www.clinicaltrials.gov。唯一标识符NCT01085435。
