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Observational Study
. 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

Pier D Lambiase  1 , Craig Barr  2 , Dominic A M J Theuns  3 , Reinoud Knops  4 , Petr Neuzil  5 , Jens Brock Johansen  6 , Margaret Hood  7 , Susanne Pedersen  8 , Stefan Kääb  9 , Francis Murgatroyd  10 , Helen L Reeve  11 , Nathan Carter  11 , Lucas Boersma  12 ; EFFORTLESS Investigators
Collaborators, Affiliations
Observational Study

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

Pier D Lambiase et al. Eur Heart J. .

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.

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Figures

Figure 1
Figure 1
EFFORTLESS Subcutaneous Implantable Defibrillator Registry enrolment by country in Europe and Australasia (inset).
Figure 2
Figure 2
Patient flow chart for EFFORTLESS Subcutaneous Implantable Defibrillator Registry.
Figure 3
Figure 3
Proportion of appropriate and inappropriate therapies and their aetiologies (three other unclassified treated episodes are excluded in the figure as they that could not be classified as either treated or untreated episodes). Numbers in brackets represent number of patients.
Figure 4
Figure 4
Kaplan–Meier analysis for freedom from subcutaneous implantable defibrillator system-related complications for the first 360-day post-implant.
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