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Eur Heart J. 2014 Jul 1;35(25):1657-65. doi: 10.1093/eurheartj/ehu112. Epub 2014 Mar 26.

Worldwide experience with a totally subcutaneous implantable defibrillator: early results from the EFFORTLESS S-ICD Registry.

Author information

  • 1Cardiology Department, The Heart Hospital, Institute of Cardiovascular Science, University College London, 16-18 Westmoreland Street, W1G 8PH London, UK pier.lambiase@uclh.nhs.uk.
  • 2Cardiology Department, Russells Hall Hospital, Dudley, UK.
  • 3Department of Clinical Electrophysiology, Erasmus Medical Center, Rotterdam, The Netherlands.
  • 4Department of Cardiology and Electrophysiology, Academic Medical Center, Amsterdam, The Netherlands.
  • 5Department of Cardiology, Homnolka Hospital, Prague, Czech Republic.
  • 6Department of Cardiology, Electrophysiology Section, Odense University Hospital, Odense, Denmark.
  • 7Auckland City Hospital, Auckland, New Zealand.
  • 8Center of Research on Psychology in Somatic Diseases, Department of Medical and Clinical Psychology, Tilburg University, Tilburg, The Netherlands Department of Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands.
  • 9Division of Electrophysiology, Campus Grosshadern, University of Munich, Munich, Germany.
  • 10King's College Hospital, London, UK.
  • 11Boston Scientific Corporation, St Paul MN, USA.
  • 12St Antonius Ziekenhuis, Nieuwegein, The Netherlands.

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.

© The Author 2014. Published by Oxford University Press on behalf of the European Society of Cardiology.

KEYWORDS:

Cardiac arrest; Primary prevention; Secondary prevention; Subcutaneous ICD; Ventricular arrhythmias

PMID:
24670710
[PubMed - indexed for MEDLINE]
PMCID:
PMC4076663
Free PMC Article
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