The Design of the Understanding Outcomes with the S‐ICD in Primary Prevention Patients with Low EF Study (UNTOUCHED)
Why the study?
Does the S-ICD provide an acceptable inappropriate shock-free rate compared to historical transvenous ICD controls in primary prevention patients with LVEF ≤35%?
Population
Minimum 1,100 patients undergoing de novo S-ICD implantation for primary prevention of sudden cardiac death…
Comparison
Subcutaneous implantable cardioverter… vs Historical control of transvenous ICD patients…
Design
Cohort
Follow-up
18 months
Authors
Discussion
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Member takes
Implication
May inform S-ICD use in primary prevention LVEF ≤35% patients; leaves open whether shock-free rates meet historical transvenous thresholds.
Structured PICO
Does the S-ICD provide an acceptable inappropriate shock-free rate compared to historical transvenous ICD controls in primary prevention patients with LVEF ≤35%?
P
Population
Minimum 1,100 patients undergoing de novo S-ICD implantation for primary prevention of sudden cardiac death with a left ventricular EF ≤35%.
I
Intervention
Subcutaneous implantable cardioverter defibrillator (S-ICD)
C
Comparator
Historical control of transvenous ICD patients with similar programming (performance goal of 91.6% derived from MADIT-RIT)
O
Outcome
Freedom from inappropriate shock (IAS) at 18 monthssafety
The UNTOUCHED study is designed to prospectively evaluate the safety and efficacy of the S-ICD in primary prevention patients with LVEF ≤35%.
Cite This Study
Gold et al. (2016) studied this question.