Implant and Midterm Outcomes of the Subcutaneous Implantable Cardioverter-Defibrillator Registry
Why the study?
Does the subcutaneous implantable cardioverter-defibrillator (S-ICD) demonstrate acceptable safety and efficacy compared to transvenous ICDs?
Population
Patients enrolled in the EFFORTLESS S-ICD Registry
Comparison
Subcutaneous implantable cardioverter-defibrillat… vs Transvenous implantable cardioverter-defibrillato…
Design
Cohort
Follow-up
midterm
Authors
Discussion
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Member takes
Implication
May support S-ICD consideration in select patients; leaves open need for randomized confirmation versus transvenous ICDs.
Key Points
- Assess the midterm safety, complication rates, and shock conversion efficacy of the subcutaneous implantable cardioverter-defibrillator.
- Clinical trial evaluating patients receiving a subcutaneous implantable cardioverter-defibrillator (The EFFORTLESS S-ICD Registry; NCT01085435).
- Monitored midterm clinical performance endpoints, focusing on complications, inappropriate shock frequency, and successful arrhythmia conversion.
- The subcutaneous implantable cardioverter-defibrillator successfully met all predefined primary safety and efficacy performance criteria.
- Rates of complication, inappropriate shock delivery, and conversion efficacy aligned qualitatively with established benchmarks from transvenous implantable cardioverter-defibrillator studies.
Structured PICO
Does the subcutaneous implantable cardioverter-defibrillator (S-ICD) demonstrate acceptable safety and efficacy compared to transvenous ICDs?
P
Population
Patients enrolled in the EFFORTLESS S-ICD Registry
I
Intervention
Subcutaneous implantable cardioverter-defibrillator (S-ICD)
C
Comparator
Transvenous implantable cardioverter-defibrillator studies (historical comparison)
O
Outcome
Predefined endpoints for safety and efficacy (complications, inappropriate shocks, and conversion efficacy)safety
The EFFORTLESS S-ICD Registry demonstrates that the S-ICD has midterm safety and efficacy profiles comparable to traditional transvenous ICDs.
Cite This Study
Boersma et al. (2017) studied this question.