Arrhythmias & electrophysiology
Extravascular Implantable Cardioverter-Defibrillator Sensing and Detection in a Large Global Population
Authors' conclusion
In a global population, EV-ICD detected induced and spontaneous VT/VF accurately. Although discriminators withheld detection from most non-VT/VF episodes, inappropriate shocks were common.
Study context
- Population
- Patients discharged with an EV-ICD in the global pivotal study
- Participants
- 299 patients
- Primary endpoint
- Sensing and detection performance (induced VF and spontaneous episodes in a programmed VT/VF therapy zone)
Methodological detailsglobal, adjudicated episodes
- Global
- Adjudicated episodes
Primary result
As reported in the abstract
VT/VF detection
- Induced ventricular fibrillation (VF) detected at programmed sensitivity at implantation
- all
- Induced VF detected with 3× safety margin
- 95.9%
- Sustained spontaneous ventricular tachycardia (VT)/VF episodes detected in follow-up
- 59
Further findings
Non-VT/VF episodes (n = 1,034)
- Caused by oversensing
- 87.9%
- Caused by SVT
- 12.1%
- Therapy withheld
- 80.9%
- Therapy aborted
- 10.6%
- Therapy delivered
- 8.5%
- Oversensing from myopotentials
- 61.2%
- Oversensing from P-wave oversensing (PWOS)
- 19.9%
Predictors of oversensing
- Myopotential oversensing more common with Ring-Can sensing
- P < 0.0001
- Myopotential oversensing correlated with low R-wave amplitude
- P < 0.0001
- PWOS almost exclusively with Ring1-Ring2 sensing
- P = 0.0001
- PWOS began with transient decrease in R-wave or increase in P-wave amplitude
- P < 0.0001
- New PWOS discriminator significantly reduced total inappropriate detections (software emulation)
Safety
Inappropriate shocks
- Myopotential episodes
- 3.2%
- PWOS episodes
- 21.8%
Original publication
Extravascular Implantable Cardioverter-Defibrillator Sensing and Detection in a Large Global Population. JACC Clin Electrophysiol. Published 15 May 2024. doi:10.
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