Arrhythmias & electrophysiology
Performance and Safety of the Extravascular Implantable Cardioverter Defibrillator Through Long-Term Follow-Up: Final Results From the Pivotal Study
Authors' conclusion
From implantation to study completion, the EV ICD Pivotal study demonstrated that a single integrated system with an extravascular lead placed in the substernal space maintains high ATP success, effective defibrillation, and a consistent safety profile.
Study context
- Population
- Individuals with a Class I or IIa indication for a single-chamber ICD per guidelines
- Participants
- 316 individuals299 successful implantations
- Outcome
- Freedom from major system- or procedure-related complications; appropriate and inappropriate therapy rates
- Follow-up
- Through 3 years
Methodological detailsglobal, Kaplan-Meier
- Global
- Kaplan-Meier
Main finding
As reported in the abstract
- Freedom from system- or procedure-related major complications at 1 year
- 91.9%
- Freedom from system- or procedure-related major complications at 3 years
- 89.0%
- First any appropriate therapy at 3 years (KM-estimated)
- 9.2%
- Inappropriate shock rate at 1 year
- 9.8%
- Inappropriate shock rate at 3 years (P-wave oversensing predominant cause)
- 17.5%
Observational data: associations, not effects.
Further findings
Anti-tachycardia pacing (ATP) success
- ATP successful in episodes (37/48)
- 77.1%
- ATP use significantly increased from discharge to last follow-up
- P < 0.0001
Shock success in discrete, spontaneous ventricular arrhythmias
- Shock therapy successful (27/27)
- 100%
Spontaneous arrhythmic episodes appropriately treated
- Patients with appropriately treated episodes
- 24
- Spontaneous arrhythmic episodes
- 82
- Treated with ATP only (38 episodes)
- 46.3%
- Treated with shock only (34 episodes)
- 41.5%
- Treated with both (10 episodes)
- 12.2%
- 299 patients with successful implantation
Safety
- Major intraprocedural complications
- 0
- Lead dislodgement (10 events; n=9 patients)
- 2.8%
- Postoperative wound or device pocket infection (n=8)
- 2.5%
- Device inappropriate shock delivery (n=4)
- 1.3%
- System revisions due to major complications
- 24
Original publication
Performance and Safety of the Extravascular Implantable Cardioverter Defibrillator Through Long-Term Follow-Up: Final Results From the Pivotal Study. Circulation. Published 26 September 2024. doi:10.
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