Valvular & structural heart disease
First-in-human study of the CAPTIS embolic protection system during transcatheter aortic valve replacement
Authors' conclusion
The use of the CAPTIS full-body embolic protection system during TAVR was safe, and it captured a substantial number of debris particles. No patient suffered from a cerebrovascular event.
Study context
- Population
- Patients undergoing transcatheter aortic valve replacement (TAVR) with balloon-expandable or self-expanding valves30-day follow-up
- Participants
- 20 patients
- Outcome
- Device safety and cerebrovascular events
- Follow-up
- 72 hours
Methodological detailssingle-arm, Patients followed for 30 days
- Single-arm
- Patients followed for 30 days
Main finding
As reported in the abstract
Device-related complications
0
Cerebrovascular events
0
Further findings
Device delivery, positioning, deployment and retrieval
- Successful in all cases; TAVR completed in all
Debris capture
- High numbers of debris particles captured in all patients
Safety
Device-related complications and cerebrovascular events · 72 hours
- No device-related complications
- No cerebrovascular events
Original publication
First-in-human study of the CAPTIS embolic protection system during transcatheter aortic valve replacement. EuroIntervention. Published 18 December 2023. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →