1 Cardiology, Department of Clinical Research, Det Sundhedsvidenskabelige Fakultet, SDU2 Cardiology Department, The Heart Hospital, Institute of Cardiovascular Science, University College London, 16-18 Westmoreland Street, W1G 8PH London, UK email@example.com Cardiology Department, Russells Hall Hospital, Dudley, UK.4 Erasmus Medical Center5 Academic Medical Center6 Department of Cardiology, Homnolka Hospital, Prague, Czech Republic.7 Auckland City Hospital8 Department of Psychology, Det Sundhedsvidenskabelige Fakultet, SDU9 University of Munich10 King's College London11 Boston Scientific Corporation, St Paul MN, USA.12 St Antonius Ziekenhuis, Nieuwegein, The Netherlands.13 unknown14 Cardiology, Department of Clinical Research, Det Sundhedsvidenskabelige Fakultet, SDU15 Department of Psychology, Det Sundhedsvidenskabelige Fakultet, SDU
early results from the EFFORTLESS S-ICD Registry
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.
European Heart Journal, 2014, Vol 35, Issue 25, p. 1657-65