Cohort study
Real-World Outcomes of Fourth-Generation Mitral Transcatheter Repair
- Prospective postapproval study
- multicentre
- international
- single-arm
- 60 centres
- echocardiography core laboratory
Authors' conclusion
This study demonstrates for the first time the effectiveness and safety of MitraClip G4 System at 30 days in a cohort of >1,000 patients with MR in a contemporary, real-world setting.
Study context
- Population
- Patients with primary (degenerative) or secondary (functional) mitral regurgitation (MR) treated with MitraClip G4, March 2021 to February 2022
- Participants
- 1,141 patients
- Outcome
- Safety and performance of the MitraClip G4 System in a contemporary real-world setting
Main finding
As reported in the abstract
Procedural results and MR reduction · 30 days
- Implantation success
- 98.0%
- Acute procedural success
- 96.2%
- Clips implanted per subject, mean ± SD
- 1.4 ± 0.6
- MR ≤ 2+ at 30 days
- 98%
- MR ≤ 1+ at 30 days (vs baseline P < 0.0001)
- 91%
Observational data: associations, not effects.
Safety
Composite major adverse events and all-cause death · 30 days
- Composite major adverse event rate
- 2.7%
- All-cause death rate
- 1.3%
Original publication
Real-World Outcomes of Fourth-Generation Mitral Transcatheter Repair. JACC Cardiovasc Interv. Published 26 June 2023. doi:10.1016/j.jcin.2023.05.013
Summarised from the published abstract; every number is checked against it