Understanding Outcomes with the EMBLEM S-ICD in Primary Prevention Patients with Low EF Study (UNTOUCHED): Clinical characteristics and perioperative results
Lucas V Boersma, Mikhael F El-Chami, Maria Grazia Bongiorni, Martin C Burke, Reinoud E Knops, Johan D Aasbo, Pier D Lambiase, Jean Claude Deharo, Andrea M Russo, Jay Dinerman, Naushad Shaik, Craig S Barr, Nathan Carter, Ursula Appl, Amy J Brisben, Kenneth M Stein, Michael R Gold, Lucas V Boersma, Mikhael F El-Chami, Maria Grazia Bongiorni, Martin C Burke, Reinoud E Knops, Johan D Aasbo, Pier D Lambiase, Jean Claude Deharo, Andrea M Russo, Jay Dinerman, Naushad Shaik, Craig S Barr, Nathan Carter, Ursula Appl, Amy J Brisben, Kenneth M Stein, Michael R Gold
Abstract
Background: The subcutaneous implantable cardioverter-defibrillator (S-ICD) has shown favorable outcomes in large registries with broad inclusion criteria. The cohorts reported had less heart disease and fewer comorbidities than standard ICD populations.
Objective: The purpose of this study is to characterize acute performance for primary prevention patients with a left ventricular ejection fraction (LVEF) ≤35% (primary prevention ≤35%).
Methods: Primary prevention ≤35% patients with no prior documented sustained ventricular tachycardia (VT), pacing indication, end-stage heart failure, or advanced renal failure were prospectively enrolled. Analyses included descriptive statistics, Kaplan-Meier time to event, and multivariable linear and logistic regression.
Results: In 1112 of 1116 patients, an S-ICD was successfully implanted (99.6%). Predictors for longer procedure time included 3-incision technique, higher body mass index (BMI), performing defibrillation testing (DFT), imaging, younger age, black race, and European vs North American centers. Patients undergoing DFT (82%) were successfully converted (99.2%; 93.5% converting at ≤65 J). Higher BMI was predictive of failing DFT at ≤65 J. The rate of 30-day freedom from complications was 95.8%. Most complications involved postoperative healing (45%) or interventions after DFT or impedance check (19%).
Conclusion: The procedural outcome data of UNTOUCHED reinforce that S-ICD therapy has low perioperative complication rates and high conversion efficacy of induced ventricular fibrillation, even in a higher-risk cohort with low LVEF and more comorbidities than previous S-ICD studies. Higher BMI warrants more careful attention to implant technique.
Trial registration: ClinicalTrials.gov NCT02433379.
Keywords: Arrhythmia; Heart failure; Implantable cardioverter-defibrillator; Primary prevention; Subcutaneous ICD; Sudden cardiac death; Ventricular arrhythmia.
Copyright © 2019 The Authors. Published by Elsevier Inc. All rights reserved.
Source: PubMed