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Understanding Outcomes with the EMBLEM S-ICD in Primary Prevention Patients with Low EF Study (UNTOUCHED): Clinical characteristics and perioperative results

Boersma, LV; El-Chami, MF; Bongiorni, MG; Burke, MC; Knops, RE; Aasbo, JD; Lambiase, PD; ... Gold, MR; + view all (2019) Understanding Outcomes with the EMBLEM S-ICD in Primary Prevention Patients with Low EF Study (UNTOUCHED): Clinical characteristics and perioperative results. Heart Rhythm , 16 (11) pp. 1636-1644. 10.1016/j.hrthm.2019.04.048. Green open access

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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 co-morbidities than standard ICD populations. OBJECTIVE: The purpose of this study is to characterize acute performance for primary prevention patients with an 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, and/or advanced renal failure were prospectively enrolled. Analyses included descriptive statistics, Kaplan-Meier time to event, and multivariable logistic regression. RESULTS: In 1112 of 1116 patients, an S-ICD was successfully implanted (99.6%). Predictors for longer procedure time included three-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% (94.3% converting at ≤65J). Higher BMI was predictive of failing DFT at ≤65J. The rate of 30-day freedom from complications was 95.8%. Most complications involved post-op healing (45%) or interventions after DFT or impedance check (19%). CONCLUSIONS: 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 co-morbidities than previous S-ICD studies. Higher BMI warrants more careful attention to implant technique.

Type: Article
Title: Understanding Outcomes with the EMBLEM S-ICD in Primary Prevention Patients with Low EF Study (UNTOUCHED): Clinical characteristics and perioperative results
Location: United States
Open access status: An open access version is available from UCL Discovery
DOI: 10.1016/j.hrthm.2019.04.048
Publisher version: https://doi.org/10.1016/j.hrthm.2019.04.048
Language: English
Additional information: Copyright © 2019 The Authors. Published by Elsevier Inc. on behalf of Heart Rhythm Society. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
Keywords: Arrhythmia, Heart failure, Implantable cardioverter-defibrillator, Primary prevention, Subcutaneous ICD, Sudden cardiac death, Ventricular arrhythmia
UCL classification: UCL
UCL > Provost and Vice Provost Offices
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Institute of Cardiovascular Science
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Institute of Cardiovascular Science > Clinical Science
URI: https://discovery.ucl.ac.uk/id/eprint/10074851
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