Subcutaneous implantable cardioverter-defibrillators: long-term results of the EFFORTLESS study

• Verfasst von: Lambiase, Pier D. [VerfasserIn]
• Verfasst von: Theuns, Dominic A [VerfasserIn]
• Verfasst von: Murgatroyd, Francis [VerfasserIn]
• Verfasst von: Barr, Craig [VerfasserIn]
• Verfasst von: Eckardt, Lars [VerfasserIn]
• Verfasst von: Neuzil, Petr [VerfasserIn]
• Verfasst von: Scholten, Marcoen [VerfasserIn]
• Verfasst von: Hood, Margaret [VerfasserIn]
• Verfasst von: Kuschyk, Jürgen [VerfasserIn]
• Verfasst von: Brisben, Amy J [VerfasserIn]
• Verfasst von: Carter, Nathan [VerfasserIn]
• Verfasst von: Stivland, Timothy M [VerfasserIn]
• Verfasst von: Knops, Reinoud [VerfasserIn]
• Verfasst von: Boersma, Lucas V A [VerfasserIn]
• Titel: Subcutaneous implantable cardioverter-defibrillators: long-term results of the EFFORTLESS study
• Titelzusatz: clinical research : clinical trials
• Verf.angabe: Pier D. Lambiase, Dominic A. Theuns, Francis Murgatroyd, Craig Barr, Lars Eckardt, Petr Neuzil, Marcoen Scholten, Margaret Hood, Jȕrgen Kuschyk, Amy J. Brisben, Nathan Carter, Timothy M. Stivland, Reinoud Knops, Lucas V.A. Boersma, and on behalf of the EFFORTLESS Investigators
• E-Jahr: 2022
• Jahr: 1 June 2022
• Umfang: 14 S.
• Fussnoten: Online veröffentlicht: 28 January 2022 ; Gesehen am 23.01.2024
• Titel Quelle: Enthalten in: European heart journal
• Ort Quelle: Oxford : Oxford University Press, 1980
• Jahr Quelle: 2022
• Band/Heft Quelle: 43(2022), 21 vom: Juni, Seite 2037-2050
• ISSN Quelle: 1522-9645
• DOI: doi:10.1093/eurheartj/ehab921
• Datenträger: Online-Ressource
• Sprache: eng
• K10plus-PPN: 1878695495

Abstract

To report 5-year outcomes of EFFORTLESS registry patients with early generation subcutaneous implantable cardioverter-defibrillator (S-ICD) devices.Kaplan-Meier, trend and multivariable analyses were performed for mortality and late (years 2-5) complications, appropriate shock (AS) and inappropriate shock (IAS) rates. Nine hundred and eighty-four of 994 enrolled patients with diverse diagnoses (28% female, 48 ± 17 years, body mass index 27 ± 6 kg/m2, ejection fraction 43 ± 18%) underwent S-ICD implantation. Median follow-up was 5.1 years (interquartile range 4.7-5.5 years). All-cause mortality was 9.3% (95% confidence interval 7.2-11.3%) at 5 years; 703 patients remained in follow-up on study completion, 171 withdrew including 87 (8.8%) with device explanted, and 65 (6.6%) lost to follow-up. Of the explants, only 20 (2.0%) patients needed a transvenous device for pacing indications. First and final shock efficacy for discrete ventricular arrhythmias was consistent at 90% and 98%, respectively, with storm episode final shock efficacy at 95.2%. Time to therapy remained unaltered. Overall 1- and 5-year complication rates were 8.9% and 15.2%, respectively. Early complications did not predict later complications. There were no structural lead failures. Inappropriate shock rates at 1 and 5 years were 8.7% and 16.9%, respectively. Self-terminating inappropriately sensed episodes predicted late IAS. Predictors of late AS included self-terminating appropriately sensed episodes and earlier AS.In this diverse S-ICD registry population, spontaneous shock efficacy was consistently high over 5 years. Very few patients underwent S-ICD replacement with a transvenous device for pacing indications. Treated and self-terminating arrhythmic episodes predict future shock events, which should encourage more personalized device optimization.