Clin Res Cardiol (2022).

First experience with the new PASCAL Ace mitral valve repair-system regarding functional and hemodynamic outcome
C. Munoz-Perez1, S. Barth1, S. Kerber1, M. Zacher2, M. B. Hautmann1
1Klinik für Kardiologie I - Interventionelle Kardiologie und kardiale Bildgebung, RHÖN-KLINIKUM AG Campus Bad Neustadt, Bad Neustadt a. d. Saale; 2Abteilung für Medizinische Dokumentation, RHÖN-KLINIKUM Campus Bad Neustadt, Bad Neustadt a. d. Saale;

The new PASCAL Ace repair-system is an advanced version of the PASCAL device for transcatheter edge-to-edge treatment of MR. The aim of the study was to examine the functional and hemodynamic outcome after repair of mitral regurgitation (MR) with the PASCAL Ace device in a real-world cohort.

66 consecutive patients with symptomatic MR 3+/4+ were treated using exclusively the PASCAL Ace. Primary endpoints included procedural success, clinical success, and major adverse event rate at 30 days and 5 month.

75.6% had a functional etiology. Overall success rate was 98.5%. At follow-up, 89.4% of the patients had MR grade ≤ 1. MR reduction resulted in a relevant improvement of LV ejection fraction (45 ± 17% to 53 ± 8%, p=0.029) and LV diameters (LVEDD 57 ± 6 mm to 53 ± 7 mm, p=0.014). 94.7% were in NYHA class I or II. 6-minute-walking distance improved by 86m (p=0.001). Kansas City Cardiomyopathy Questionnaire (KCCQ) improved by 26 points (p=0.003) and European Quality of Life 5 Dimensions Questionnaire by 19 points (p=0.015). ProBNP levels decreased from 4350 to 1966 pg/dl (p=0.011). Mean pulmonary capillary wedge pressures improved from 21 to 16mmHg (p=0.006) and mean pulmonary artery pressure from 31 to 26mmHg (p=0.018). At 5 month, there was no cardiovascular death.

Severe MR can successfully and safely be treated with the new PASCAL Ace device, resulting in a sustained MR reduction, a reverse cardiac remodelling, improvement of exercise capacity, quality of life, proBNP levels and hemodynamics at follow-up.