Perioperative Safety and Early Patient and Device Outcomes Among Subcutaneous Versus Transvenous Implantable Cardioverter Defibrillator Implantations : A Randomized, Multicenter Trial

Implantable cardioverter defibrillators (ICDs) improve survival in patients at risk for cardiac arrest, but are associated with intravascular lead-related complications. The subcutaneous ICD (S-ICD), with no intravascular components, was developed to minimize lead-related complications. To assess ke...

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Bibliographic Details
Published in:Annals of internal medicine Vol. 175; no. 12; p. 1658
Main Authors: Healey, Jeff S, Krahn, Andrew D, Bashir, Jamil, Amit, Guy, Philippon, François, McIntyre, William F, Tsang, Bernice, Joza, Jacqueline, Exner, Derek V, Birnie, David H, Sadek, Mouhannad, Leong, Darryl P, Sikkel, Markus, Korley, Victoria, Sapp, John L, Roux, Jean-Francois, Lee, Shun Fu, Wong, Gloria, Djuric, Angie, Spears, Danna, Carroll, Sandra, Crystal, Eugene, Hruczkowski, Tom, Connolly, Stuart J, Mondesert, Blandine
Format: Journal Article
Language:English
Published: United States 01.12.2022
Subjects:
Arrhythmias, Cardiac
Death, Sudden, Cardiac - etiology
Defibrillators, Implantable - adverse effects
Female
Heart Arrest
Humans
Risk Factors
Treatment Outcome
ISSN:1539-3704, 1539-3704
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Summary:Implantable cardioverter defibrillators (ICDs) improve survival in patients at risk for cardiac arrest, but are associated with intravascular lead-related complications. The subcutaneous ICD (S-ICD), with no intravascular components, was developed to minimize lead-related complications. To assess key ICD performance measures related to delivery of ICD therapy, including inappropriate ICD shocks (delivered in absence of life-threatening arrhythmia) and failed ICD shocks (which did not terminate ventricular arrhythmia). Randomized, multicenter trial. (ClinicalTrials.gov: NCT02881255). The ATLAS trial. 544 eligible patients (141 female) with a primary or secondary prevention indication for an ICD who were younger than age 60 years, had a cardiogenetic phenotype, or had prespecified risk factors for lead complications were electrocardiographically screened and 503 randomly assigned to S-ICD (251 patients) or transvenous ICD (TV-ICD) (252 patients). Mean follow-up was 2.5 years (SD, 1.1). Mean age was 49.0 years (SD, 11.5). The primary outcome was perioperative major lead-related complications. There was a statistically significant reduction in perioperative, lead-related complications, which occurred in 1 patient (0.4%) with an S-ICD and in 12 patients (4.8%) with TV-ICD (-4.4%; 95% CI, -6.9 to -1.9;  = 0.001). There was a trend for more inappropriate shocks with the S-ICD (hazard ratio [HR], 2.37; 95% CI, 0.98 to 5.77), but no increase in failed appropriate ICD shocks (HR, 0.61 (0.15 to 2.57). Patients in the S-ICD group had more ICD site pain, measured on a 10-point numeric rating scale, on the day of implant (4.2 ± 2.8 vs. 2.9 ± 2.2;  < 0.001) and 1 month later (1.3 ± 1.8 vs. 0.9 ± 1.5; = 0.035). At present, the ATLAS trial is underpowered to detect differences in clinical shock outcomes; however, extended follow-up is ongoing. The S-ICD reduces perioperative, lead-related complications without significantly compromising the effectiveness of ICD shocks, but with more early postoperative pain and a trend for more inappropriate shocks. Boston Scientific.
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ISSN:1539-3704
1539-3704
DOI:10.7326/M22-1566