Valvular & structural heart diseaseResearch article
One-Year Outcomes of M-TEER With the PASCAL System in Atrial and Ventricular FMR: Insights From the MiCLASP Postmarket Clinical Follow-Up Study
- multicenter European postmarket clinical follow-up study
Authors' conclusion
One-year MiCLASP results support the safety of mitral transcatheter edge-to-edge repair with the PASCAL system in both AFMR and VFMR, with comparable echocardiographic, functional, and quality-of-life changes, despite baseline differences in clinical presentation.
Study context
- Population
- Patients with functional mitral regurgitation (atrial functional mitral regurgitation (AFMR) or ventricular functional mitral regurgitation (VFMR)) undergoing mitral transcatheter edge-to-edge repair with the PASCAL systemfrom the first 600 enrolled in the MiCLASP study · AFMR 52 · VFMR 243
- Participants
- 295 patients
- Comparison
- AFMR vs VFMR
- AFMRn = 52
- VFMRn = 243
Main finding
As reported in the abstract
Further findings
Procedure duration
Freedom from all-cause mortality or heart failure hospitalizations (Kaplan-Meier estimate) · One-year
Echocardiographic, functional and quality-of-life outcomes · One-year
mitral regurgitation ≤1+
mean transmitral gradient AFMR 3.5 mm Hg · VFMR 3.1 mm Hg
left ventricular end-diastolic volume AFMR −12.9% · VFMR −16.4%
left atrial volume AFMR −9.6% · VFMR −10.9%
New York Heart Association class I/II
Kansas City Cardiomyopathy Questionnaire Overall Summary score AFMR +18.0 points · VFMR +11.6 points
Baseline characteristics
age AFMR 79.7±6.67 years · VFMR 74.6±10.30 years
female
hypertension
atrial fibrillation
NT-proBNP AFMR 1562.0 [790.0-2286.0] · VFMR 3350.0 [1720.0-6564.0]
mitral regurgitation ≥3+
- Procedure duration: P =0.044
- Freedom from all-cause mortality or heart failure hospitalizations (Kaplan-Meier estimate): P =0.267
- Echocardiographic, functional and quality-of-life outcomes: all P <0.05 from baseline
- Baseline characteristics: age, sex, hypertension, atrial fibrillation: all P <0.05
- Baseline characteristics: NT-proBNP P <0.001
- Baseline characteristics: mitral regurgitation ≥3+ P <0.001
Original publication
Summarised from the published abstract; every number is checked against it