Format

Send to

Choose Destination
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

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

KEYWORDS:

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

PMID:
24670710
PMCID:
PMC4076663
DOI:
10.1093/eurheartj/ehu112
[Indexed for MEDLINE]
Free PMC Article

Supplemental Content

Full text links

Icon for Silverchair Information Systems Icon for PubMed Central
Loading ...
Support Center