Worldwide experience with a totally subcutaneous implantable defibrillator: early results from the EFFORTLESS S-ICD Registry. (26th March 2014)

• Record Type: Journal Article
• Authors: 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
• Other Names: Adragão P. author non-byline.; Agarwal S. author non-byline.; Barr C. author non-byline.; Boersma L. author non-byline.; Brock-Johanssen J. author non-byline.; Butter C. author non-byline.; Calò L. author non-byline.; Eckhardt L. author non-byline.; Gulizia M. author non-byline.; Scholten M. author non-byline.; Dekker L. author non-byline.; Khiani R. author non-byline.; Hjortshot S. author non-byline.; Høgh Petersen H. author non-byline.; Hood M. author non-byline.; Kääb S. author non-byline.; Knops R. author non-byline.; Kuschyk J. author non-byline.; Lambiase P. author non-byline.; Maass K. A. author non-byline.; McLeod K. author non-byline.; Molon G. author non-byline.; Morgan J. author non-byline.; Mortensen P. author non-byline.; Murgatroyd F. author non-byline.; Neuzil P. author non-byline.; Pepper C. author non-byline.; Sheridan P. author non-byline.; Stellbrink C. author non-byline.; Stuart G. author non-byline.; Theuns D. author non-byline.; Vernooy K. author non-byline.; Veltmann C. author non-byline.; Wende C. author non-byline.;
• Is Part Of: European heart journal. Volume 35:Number 25(2014:Jul.)
• Page Start: 1657
• Page End: 1665
• Publication Date: 2014-03-26
• Subjects: Subcutaneous ICD -- Ventricular arrhythmias -- Cardiac arrest -- Primary prevention -- Secondary prevention; Cardiology -- Periodicals; Heart -- Diseases -- Periodicals; 616.12005
• DOI: 10.1093/eurheartj/ehu112
• Languages: English
• ISSNs: 0195-668X

Abstract

Abstract : Aims: 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. Methods and results: 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). Conclusion: 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.