Arrhythmias & electrophysiologyCohort study
Real-World Experience With the Extravascular Implantable Cardioverter Defibrillator Through 1 Year: The Enlighten Post Approval Registry Study
- Prospective registry study
- global
- post-approval registry
Authors' conclusion
In the largest prospective worldwide cohort of patients with an EV-ICD to date, both antitachycardia pacing and shock therapy were effective, while the rate of major complications agreed with the premarket experience through 1 year.
Study context
- Population
- Patients undergoing an extravascular implantable cardioverter defibrillator (EV-ICD) implantation attempt in real-world practice168 implanters
- Participants
- 787 patients
- Outcome
- Freedom from all system- or procedure-related major complications
- Follow-up
- 1 year
Main finding
As reported in the abstract
Freedom from major system- or procedure-related complications at 1 year
89.1% (95% CI 86.3%-91.3%)
Observational data: associations, not effects.
Further findings
Substernal tunneling and lead placement achieved
- Achieved in 781 of 787
- 99.2%
Remaining implanted after defibrillation and electrical testing
- 758 patients
- 96.3%
First appropriate therapy (shock, antitachycardia pacing or both) · 1 year
- 1-year rate
- 7.3% (95% CI 5.5-9.6)
Shock success for discrete spontaneous episodes
- 61 of 61
- 100%
Antitachycardia pacing success for monomorphic VT
- Generalized estimating equations success rate
- 74.2%
- accounts for multiple episodes per patient
Safety
First inappropriate shock · 1 year
- 1-year rate
- 7.1% (95% CI 5.4-9.4)
- Noncardiac oversensing as main cause (share of inappropriately shocked episodes)
- 40.5%
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
Summarised from the published abstract; every number is checked against it