Valvular & structural heart diseaseCohort study
Mitral Valve Transcatheter Edge-to-Edge Repair
- Prospective single-arm post-market clinical follow-up study
- European
- core laboratory-assessed
- clinical events committee-adjudicated
Authors' conclusion
One-year outcomes of this large cohort from the MiCLASP study demonstrate continued safety and effectiveness of M-TEER with the PASCAL system in a post-market setting.
Study context
- Population
- Patients with symptomatic, clinically significant mitral regurgitation (MR)59% functional MR, 30% degenerative MR
- Participants
- 544 patients
- Outcome
- Safety: 30-day composite major adverse event rate (clinical events committee-adjudicated); effectiveness: MR severity at discharge vs baseline (echocardiographic core laboratory)
- Follow-up
- 30 days; discharge
Main finding
As reported in the abstract
Primary safety (30-day composite MAE) and primary effectiveness (MR severity at discharge vs baseline)
30-day composite major adverse event rate
6.8%
Observational data: associations, not effects.
Further findings
MR severity, sustained · 1 year
- MR ≤2+
- 98%
- MR ≤1+
- 82.6%
- all P < 0.001 vs baseline
Survival and freedom from HF hospitalization (Kaplan-Meier) · 1 year
- Survival
- 87.3%
- Freedom from HF hospitalization
- 84.3%
Functional and quality-of-life outcomes · 1 year
- NYHA class I/II
- 71.6%
- Increase in KCCQ score
- 14.4-point
- Improvement in 6-minute walk distance
- 24.2-m
- all P < 0.001 vs baseline
Safety
30-day composite major adverse events (CEC-adjudicated)
- Composite major adverse event rate
- 6.8%
Original publication
Mitral Valve Transcatheter Edge-to-Edge Repair. JACC Cardiovasc Interv. Published 8 April 2024. doi:10.1016/j.jcin.2024.02.022
Summarised from the published abstract; every number is checked against it