Clinical Evidence
UNTOUCHED Acute Outcomes
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
Acute Outcomes
Conversion efficacy and complication-free rates remain high, consistent with historical S-ICD studies.
UNTOUCHED Chronic Outcomes
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
