Arrhythmias & electrophysiologyCohort study
Postapproval Study of a Subcutaneous Implantable Cardioverter-Defibrillator System
- Prospective multicentre registry (post-approval study)
- real-world
- prespecified performance goals
- 86 US centres
Authors' conclusion
In the largest prospective study of the S-ICD to date, all study endpoints were met, despite a cohort with more comorbidities than in most previous trials. Complication rates were low and shock efficacy was high. These results demonstrate the 5-year S-ICD safety and efficacy for a large, diverse cohort of S-ICD recipients.
Study context
- Population
- Patients with standard subcutaneous implantable cardioverter-defibrillator (S-ICD) indications at US centresmedian follow-up 4.2 years
- Participants
- 1,643 patients
- Outcome
- Efficacy: first and final shock efficacy; safety: complications directly related to the S-ICD system or implantation procedure (assessed vs prespecified performance goals)
- Follow-up
- Up to 5 years
Main finding
As reported in the abstract
Shock efficacy for discrete VT or VF episodes
98.4%
Shock efficacy did not differ across follow-up years
P = 0.68
S-ICD-related complication-free rate
93.4%
Electrode-related complication-free rate
99.3%
Observational data: associations, not effects.
Further findings
Cumulative all-cause mortality
- Cumulative all-cause mortality
- 21.7%
Safety
Device replaced by transvenous implantable cardioverter-defibrillator (TV-ICD) for pacing need
- Patients with S-ICD replaced by TV-ICD for pacing need
- 1.6%
Original publication
Summarised from the published abstract; every number is checked against it