Valvular & structural heart diseaseCohort study
1-Year Outcomes With Fourth-Generation Mitral Valve Transcatheter Edge-to-Edge Repair From the EXPAND G4 Study
- Prospective single-arm study
- multicentre
- international
- ongoing
Authors' conclusion
M-TEER with the fourth-generation M-TEER device was safe and effective at 1 year, with durable reductions in MR severity to ≤1+ in more than 90% of patients and concomitant improvements in functional status and quality of life.
Study context
- Population
- Subjects with primary and secondary mitral regurgitation (MR) treated with mitral transcatheter edge-to-edge repair (M-TEER), 2020–2022
- Participants
- 1,164 subjects
- Outcome
- 1-year outcomes: MR severity (core laboratory), HF hospitalization, all-cause mortality, NYHA class, KCCQ quality of life
- Follow-up
- 1 year
Main finding
As reported in the abstract
- MR reduced to mild or less
- 92.6%
- MR reduced to none or trace (vs baseline P < 0.0001)
- 44.2%
- All-cause mortality (Kaplan-Meier)
- 12.3%
- HF hospitalization (Kaplan-Meier)
- 16.9%
- NYHA class I or II (vs baseline P < 0.0001)
- 82%
- KCCQ overall summary score improvement (P < 0.0001)
- 18.5-point
Observational data: associations, not effects.
Safety
Major adverse events (MI, surgical reintervention, single-leaflet device attachment) · 1 year
- Each of MI, surgical reintervention, single-leaflet device attachment
- <2%
Original publication
1-Year Outcomes With Fourth-Generation Mitral Valve Transcatheter Edge-to-Edge Repair From the EXPAND G4 Study. JACC Cardiovasc Interv. Published 24 October 2023. doi:10.1016/j.jcin.2023.09.029
Summarised from the published abstract; every number is checked against it