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Primary results from the Understanding Outcomes with the S-ICD in Primary Prevention Patients with Low Ejection Fraction (UNTOUCHED) trial

Circulation Nov 02, 2020

Gold MR, Lambiase PD, El-Chami MF, et al. - Researchers assessed the inappropriate shocks (IAS) rate in a more typical, contemporary ICD patient population implanted with the Subcutaneous ICD (S-ICD), employing standardized programming and enhanced discrimination algorithms, in the UNTOUCHED trial. Participants were primary prevention patients exhibiting left ventricular ejection fraction ≤ 35% and no pacing indications. In 1,116 patients, an S-ICD implant was performed. A post-implant follow-up analysis with 1,111 patients was performed. The estimated 18-month freedom from IAS was 95.9%. Although there was a relatively high incidence of co-morbidities vs earlier S-ICD trials, findings revealed that contemporary S-ICD devices and programming had a high efficacy and safety. The inappropriate shock rate (3.1% at one year) was found to be the lowest for the S-ICD and was lower in comparison with many TV (transvenous) ICD studies employing contemporary programming to decrease IAS.

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