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- Title
Perioperative Safety and Early Patient and Device Outcomes Among Subcutaneous Versus Transvenous Implantable Cardioverter Defibrillator Implantations : A Randomized, Multicenter Trial.
- 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
- Abstract
<bold>Background: </bold>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.<bold>Objective: </bold>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).<bold>Design: </bold>Randomized, multicenter trial. (ClinicalTrials.gov: NCT02881255).<bold>Setting: </bold>The ATLAS trial.<bold>Patients: </bold>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).<bold>Measurements: </bold>The primary outcome was perioperative major lead-related complications.<bold>Results: </bold>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; P = 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; P < 0.001) and 1 month later (1.3 ± 1.8 vs. 0.9 ± 1.5; P = 0.035).<bold>Limitation: </bold>At present, the ATLAS trial is underpowered to detect differences in clinical shock outcomes; however, extended follow-up is ongoing.<bold>Conclusion: </bold>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.<bold>Primary Funding Source: </bold>Boston Scientific.
- Subjects
IMPLANTABLE cardioverter-defibrillators; BOSTON Scientific Corp.; PATIENT safety; VENTRICULAR arrhythmia; POSTOPERATIVE pain; SECONDARY prevention; CARDIAC arrest
- Publication
Annals of Internal Medicine, 2022, Vol 175, Issue 12, p1658
- ISSN
0003-4819
- Publication type
Article
- DOI
10.7326/M22-1566