Klinische und hämodynamische Effekte nach interventioneller Mitralklappenrekonstruktion mit dem PASCAL Ace™ Transcatheter Valve Repair System bei Patienten mit hochgradiger Mitralklappeninsuffizienz

Background: Edge-to-edge catheter-based therapy for MR has become a valuable and well-established treatment option in patients with severe MR who are at high surgical risk. In addition to the MitraClip®, the PASCAL® transcatheter valve repair system is approved for the interventional treatment of MR. Since September 2020 the PASCAL Ace® Implantation System, an newer version of the PASCAL® system, is also available. However, evidence is scarce regarding MR reduction and concomitant improvement in functional and hemodynamic outcome using the PASCAL Ace® repair system. The aim of the study was to assess the hemodynamic effects as well as the procedural and clinical outcome after transcatheter mitral valve repair using the PASCAL Ace® mitral valve repair system in a retrospective manner. Methods: The present study was a retrospective single-center study that consecutively included 66 patients between September 2020 and August 2021 with symptomatic severe MR. The patients underwent edge-to-edge treatment with the PASCAL Ace® repair system at the Rhön-Klinikum Bad Neustadt. The endpoints of our study followed the definitions of the Mitral Valve Academic Research Consortium. Device success at 30 days and 5 months was defined as persistent mitral valve regurgitation ≤ 2, lack of mitral valve stenosis, absence of death, stroke, and freedom of unplanned surgical or interventional procedures related to the device. The primary safety endpoint was defined as a composite of the following major adverse events (MAE) at 30 days and 5 months: all-cause mortality, stroke, myocardial infarction, and new need for renal replacement therapy or major bleeding. Results: Successful implantation of the PASCAL Ace® repair system was achieved in 65/66 (98.5%) patients. Device success for PASCAL Ace® was high (97%). The majority of patients were treated with one device (66.7%). Two devices were implanted in 21/66 (31.8%) patients. The mean total procedure time was 67 ± 32 min. On-site-follow-up was performed in 59/66 (89.4%) patients. 3 patients died before follow-up. In 59 patients, a significant reduction in PCWPmean (22 ± 9 mmHg vs. 15 ± 9 mmHg, p=0.001), PAPsys (49 ± 13 mmHg vs. 40 ± 14 mmHg, p=0.005), PAPmean (31 ± 10 mmHg vs. 25 ± 10 mmHg, p=0.010) and PAPdias (18 ± 8 mmHg vs. 14 ± 8 mmHg, p=0.006) could be achieved. The cardiac index showed no difference (2.0 ± 0.5 vs. 2.1 ± 0.5, p=0.290). Postprocedural MR was ≤ 1 in 82.2% and at 5 months follow-up in 84.7% of patients. The reduction in MR resulted in a relevant improvement in LVEF (45± 17% vs. 51 ± 12%, p=0.048). The LV diameter showed no difference (LVEDD 55 ± 7 mm vs. 52 ± 8 mm, p=0.053). The creation of a double mitral valve opening area after device implantation did not result in a relevant mitral valve stenosis (mean transmitral pressure gradient 2.8 ± 0.7 mmHg) at the follow-up examination. After successful TEER with PASCAL Ace® a significant improvement of functional capacity could be observed after 5 month (86.5% of the patients were in NYHA functional class I or II, p<0.001). The mean 6-minute walk test increased significantly by 79m (p=0.009). The KCCQ and EQ-5D-5L improved by 19 and 18 points, respectively (p=0.012; p=0.025). Mean proBNP levels decreased significantly from 4832 to 2137 pg/mL (p=0.003). The primary safety endpoints at 30 days and 5 months were 4.5% and 4.8%, respectively. One patient experienced pericardial effusion after the procedure. Major bleeding occurred in 2 patients at the access site. No patient died within the first 30 days. After 5 months, 3 patients (4.8%) died, none of them due to device malfunction. Conclusions: This study demonstrates promising results with the new PASCAL Ace® mitral valve repair system a newer version of the PASCAL® device in the treatment of patients with at least MR grade 3+ in a real-world setting. MR reduction can be performed successfully and safely resulting in a sustained and efficient MR reduction, improvement of exercise capacity, quality of life, NT- proBNP levels and hemodynamics at 5 month follow-up.