Clinical Evidence
UNTOUCHED Study
Hypothesis
The incidence of inappropriate shocks in primary prevention, LVEF ≤ 35% patients will be non-inferior to the rate in transvenous ICD patients with similar programming observed in MADIT-RIT Arms B and C.
Study Design
- Follow-up for 18 months
- Device programming with a conditional zone of 200 bpm and a shock zone of 250 bpm
- Primary endpoint of inappropriate shock-free rate at 18 months
- Secondary endpoints of all cause shock-free rate at 18 months and system and procedure complications at 30 days
Despite enrolling a sicker patient population, replacement of S-ICD for pacing indications occurred in less than 0.5% with almost 90% having symptomatic heart failure.
Only 4 patients out of 1,111 (less than 0.5%) were explanted due to need for pacing:
- 2 for ATP (0.2%)
- 2 for CRT (0.2%)
- 0 for bradycardia
The IAS Rate of 2.4% at 1 Year for EMBLEM™ MRI S-ICDs in UNTOUCHED is Lower than IAS Rate in TV-ICD Studies
Results from the UNTOUCHED Trial
Presented by Dr Michael Gold, Medical University of South Carolina
Moderated by Dr Ulrika Birgersdotter-Green, University of California, San Diego
EFFORTLESS S-ICD 3-Yr Summary
- Almost all (97.4%) spontaneous ventricular tachycardia/ventricular fibrillation (VT/VF) episodes were successfully converted, showing that S-ICD is effective in treating spontaneous arrhythmias
- Results also showed that development of a new need for pacing or ATP was low, respectively 0.1% and 0.5%
- The data shows that 99.7% of patients experienced freedom from complications in the first 30 days after implant, and 98.0% were complication-free
- After the first year during the mean follow-up period, there were ZERO endovascular infections, systemic infections or electrode failures
