Valvular & structural heart diseaseCohort study
Outcomes and Impact of Device Iterations in Mitral Valve Transcatheter Edge-to-Edge Repair
- Registry study
- investigator-initiated
- multicentre
- consecutive patients
- Median follow-up 510 days (Q1-Q3: 369-874 days)
Authors' conclusion
Device iterations of the PASCAL system resulted in increasing rates of achieving MR reduction to ≤1+ at discharge, with stable and high technical success rates.
Study context
- Population
- Consecutive patients with mitral regurgitation (MR) treated with PASCAL mitral transcatheter edge-to-edge repair, 2019 to 2024
- Participants
- 2,165 patients
- Exposure
- PASCAL device iterations: P10only vs P10/AceGen1 vs P10/AcePrec
- P10onlyn = 660reference
- P10/AceGen1n = 945
- P10/AcePrecn = 560
- Outcome
- MR ≤1+
- Follow-up
- Discharge
Main finding
As reported in the abstract
P < 0.001
- Overall MR ≤1+ (n = 1,397 of 2,085)
- 72%
Observational data: associations, not effects.
Secondary outcomes
Technical success
- Overall technical success (n = 2,099 of 2,165), similar across device iterations
- 97.0%
- Across iterations
- P = 0.290
MR durability (30 days, 1 year, 2 years)
- MR ≤1+ and ≤2+ slightly worsened, primarily in primary MR, with no differences across iterations
Original publication
Outcomes and Impact of Device Iterations in Mitral Valve Transcatheter Edge-to-Edge Repair. JACC Cardiovasc Interv. Published 25 November 2024. doi:10.1016/j.jcin.2024.11.016
Summarised from the published abstract; every number is checked against it