Mid-term hemodynamic and functional results after transcatheter mitral valve leaflet repair with the new PASCAL device.

Abstract

To examine the functional and hemodynamic mid-term outcome at 5months of mitral regurgitation (MR) reduction using the PASCAL repair system. Between July 2019 and February 2020 31 consecutive patients with MR 3 +/4 + (mean age 77.5years, all in New York Heart Association (NYHA) class III-IV, STS score 9.1 ± 7.4) underwent MR reduction in our institute using the PASCAL device. 61.3% had a functional, 29.0% a degenerative, and 9.7% a mixed etiology. Successful implantation was achieved in 30/31 (96.8%) patients. 27/31 patients (87.1%) completed 5-month follow-up with clinical, echocardiographic, laboratory and hemodynamic assessment. At 5months, 70.4% of the patients had MR grade ≤ 1 (p < 0.001). 85.2% were in NYHA class I or II (p < 0.001). Six-minute walk distance improved by 145m (p = 0.010), Kansas City cardiomyopathy questionnaire and European quality of life 5 dimensions questionnaire (EQ5D) improved by 31 (p < 0.001) and 9 points (p = 0.001), respectively. Mean pulmonary capillary wedge pressure decreased significantly from 22.1 ± 9mmHg to 17.3 ± 8mmHg (p = 0.041) and right atrial pressure from 10.3 ± 6mmHg to 8.0 ± 6mmHg (p = 0.013) from baseline to 5months. In addition, propensity score matching showed that PASCAL and MitraClip procedures resulted in equally hemodynamic and functional improvement. MR reduction of severe MR with the PASCAL device is feasible and safe regardless of etiologies. Mid-term follow-up at 5months showed a sustained MR reduction, improvement of exercise capacity, quality of life, proBNP levels and hemodynamics regarding pulmonary capillary wedge pressure and right atrial pressure.