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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

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Title: Understanding Outcomes with the EMBLEM S-ICD in Primary Prevention Patients with Low EF Study (UNTOUCHED): Clinical characteristics and perioperative results
Authors: Boersma, LV, El-Chami, MF, Bongiorni, MG, Burke, MC, Knops, RE, Aasbo, JD, Lambiase, PD, Deharo, JC, Russo, AM, Dinerman, J, Shaik, N, Barr, CS, Carter, N, Appl, U, Brisben, AJ, Stein, KM, Gold, MR
Source: Heart Rhythm , 16 (11) pp. 1636-1644. (2019)
Publication Year: 2019
Collection: University College London: UCL Discovery
Subject Terms: Arrhythmia, Heart failure, Implantable cardioverter-defibrillator, Primary prevention, Subcutaneous ICD, Sudden cardiac death, Ventricular arrhythmia
Description: 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.
Document Type: article in journal/newspaper
File Description: text
Language: English
Relation: https://discovery.ucl.ac.uk/id/eprint/10074851/
Availability: https://discovery.ucl.ac.uk/id/eprint/10074851/14/Lambiase_1-s2.0-S154752711930431X-main.pdf
https://discovery.ucl.ac.uk/id/eprint/10074851/
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  Data: Understanding Outcomes with the EMBLEM S-ICD in Primary Prevention Patients with Low EF Study (UNTOUCHED): Clinical characteristics and perioperative results
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  Data: Heart Rhythm , 16 (11) pp. 1636-1644. (2019)
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  Data: 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.
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  Data: https://discovery.ucl.ac.uk/id/eprint/10074851/14/Lambiase_1-s2.0-S154752711930431X-main.pdf<br />https://discovery.ucl.ac.uk/id/eprint/10074851/
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      – SubjectFull: Heart failure
        Type: general
      – SubjectFull: Implantable cardioverter-defibrillator
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