Arrhythmias & electrophysiology
A Patch Wearable Cardioverter-Defibrillator for Patients at Risk of Sudden Cardiac Arrest
Authors' conclusion
The novel P-WCD is a safe and effective WCD with high patient compliance.
Study context
- Population
- Patients at sudden cardiac arrest (SCA) risk due to VT/VF who were not candidates for or refused an implantable defibrillator290 with device data
- Participants
- 305 patients
- Outcome
- Safety: <15% patients with clinically significant cutaneous adverse device effects; effectiveness: <2 inappropriate shocks/100 patient-months
Methodological details30 US sites
- 30 US sites
Main finding
As reported in the abstract
Clinically significant cutaneous adverse device effect rate
2.30%
upper 1-sided 98% CI: 4.80
Inappropriate shock rate
0.36/100 patient-months
upper 1-sided 98% CI: 1.53
Observational data: associations, not effects.
Secondary outcomes
Successful VT/VF conversion
- Shocks in 9 patients
- 11
- Shocks adjudicated appropriate
- 9
- Appropriate shocks successful with a single shock
- 8 of 9
Wear time compliance (target >14.1 h/d)
- Median wear time compliance
- 23.5 (20.7-23.9) h/d
Device-related deaths or serious adverse events
- Device-related deaths or serious adverse events
- 0
Safety
Clinically significant cutaneous adverse device effects
- Rate
- 2.30% (upper 1-sided 98% CI: 4.80)
- Severe
- 0
Original publication
A Patch Wearable Cardioverter-Defibrillator for Patients at Risk of Sudden Cardiac Arrest. J Am Coll Cardiol. Published 6 August 2024. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →