Clinical Evidence

Graph 2002 - 2017
 

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

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 ​

Results from the UNTOUCHED Trial ​
Download or latest Clinical Update

 

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 
Download the Spanish, German and Italian EFFORTLESS mid-term outcome report. 

 
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