Aims: To examine the functional and hemodynamic mid-term outcome at 5 months of mitral regurgitation (MR) reduction using the PASCAL repair system.
Methods and results: Between July 2019 and February 2020 31 consecutive patients with MR 3 +/4 + (mean age 77.5 years, 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 5 months, 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 145 m (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 ± 9 mmHg to 17.3 ± 8 mmHg (p = 0.041) and right atrial pressure from 10.3 ± 6 mmHg to 8.0 ± 6 mmHg (p = 0.013) from baseline to 5 months. In addition, propensity score matching showed that PASCAL and MitraClip procedures resulted in equally hemodynamic and functional improvement.
Conclusion: MR reduction of severe MR with the PASCAL device is feasible and safe regardless of etiologies. Mid-term follow-up at 5 months 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.
Keywords: Mitral regurgitation; PASCAL-system; Transcatheter mitral; Valve repair.