Arrhythmias & electrophysiology
Periprocedural outcomes from the postmarket study of the extravascular implantable cardioverter-defibrillator: Preliminary Enlighten study results and meta-analysis
Authors' conclusion
In a global, real-world cohort, the EV-ICD system demonstrated a high success rate for terminating induced ventricular arrhythmia episodes at implant and a low rate of periprocedural major complications at discharge, comparable with the premarket experience.
Study context
- Population
- Patients guideline indicated for an ICD with a planned implantation of the Aurora extravascular implantable cardioverter-defibrillator (EV-ICD) systemunderwent an Aurora EV-ICD implant attempt
- Participants
- 228 participants
- Exposure
- Postmarket Enlighten Study data vs meta-analysis of premarket EV-ICD studies
- Aurora EV-ICDn = 228
- Outcome
- Tunneling and substernal lead placement success
Methodological detailsmeta-analysis of premarket EV-ICD studies in Supplemental Material
- Meta-analysis of premarket EV-ICD studies in Supplemental Material
Main finding
As reported in the abstract
Aurora EV-ICD
99.6%
227 of 228 of 228
Observational data: associations, not effects.
Further findings
| Outcome | Values |
|---|---|
| Remained implanted after electrical testing and proceeded to follow-up | Aurora EV-ICD 96.9% |
| Defibrillation testing success, if performed | Aurora EV-ICD 99.0% |
Baseline characteristics
- Age (years)
- 49.4 ± 15.4
- Female
- 27.9%
- Mean left ventricular ejection fraction
- 43.5 ± 16.1
Electrical measurements · discharge
- Electrical measurements were stable at discharge
Safety
| Outcome | Values |
|---|---|
| System- or procedure-related major complications · discharge | Aurora EV-ICD 3.9% |
Original publication
Periprocedural outcomes from the postmarket study of the extravascular implantable cardioverter-defibrillator: Preliminary Enlighten study results and meta-analysis. Heart Rhythm. Published 2 April 2025. doi:10.
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