BACKGROUND The subcutaneous implantable cardioverterdefibrillator (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.
RESULTSIn 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 Disclosures: Drs Lambiase, Dinerman, and Barr report no disclosures. Dr Boersma serves as a consultant and receives research grants from Boston Scientific and Medtronic. Dr El-Chami receives honoraria for Boston Scientific and Medtronic. Dr Bongiorni receives honoraria from Abbott Medical Italia S.p.a., Biotronik, Boston Scientific, and Medtronic. Dr Burke is a consultant and receives honoraria from Boston Scientific; receives research grants from Boston Scientific; and has equity in AtaCor Medical. Dr Knops reports honoraria for consulting and speaking, and research grants from Boston Scientific. Dr Aasbo reports Boston Scientific and Biotronik consulting fees. Dr Deharo receives research grants, travel grants, and honoraria for lectures/consulting from Medtronic, Boston Scientific, Abbott, Microport, and Biotronik. Dr Russo reports research grants from Boston Scientific, serves on steering Committees for Boston Scientific and Apple, and receives royalties from Up-to-Date. Dr Shaik receives honoraria for consulting, research, and speaking from Boston Scientific, Abbott, Biotronik, and Biosense Webster. Ms Appl, Mr Carter, Dr Brisben, and Dr Stein are all employees and shareholders of Boston Scientific. Dr Gold receives honoraria and research grants from Boston Scientific and Medtronic. Funding: The UNTOUCHED study was funded entirely by Boston Scientific Corporation.
