https://doi.org/10.1007/s00392-025-02625-4
1Herzzentrum der Universität zu Köln Klinik III für Innere Medizin Köln, Deutschland; 2Herzzentrum der Universität zu Köln Klinik für Kardiologie, Angiologie, Pneumologie und Internistische Intensivmedizin Köln, Deutschland; 3LMU Klinikum der Universität München Medizinische Klinik und Poliklinik I München, Deutschland; 4Universitätsklinikum Düsseldorf Klinik für Kardiologie, Pneumologie und Angiologie Düsseldorf, Deutschland; 5Universitätsklinikum Ulm Klinik für Innere Medizin II Ulm, Deutschland; 6Herz- und Diabeteszentrum NRW Allgemeine und Interventionelle Kardiologie/Angiologie Bad Oeynhausen, Deutschland; 7Universitätsklinikum Gießen und Marburg GmbH Medizinische Klinik I - Kardiologie und Angiologie Gießen, Deutschland; 8Kath. St. Paulus Gesellschaft Klinik für Innere Medizin I Dortmund, Deutschland; 9Universitätsklinikum Essen Klinik für Kardiologie und Angiologie Essen, Deutschland; 10Universitätsklinikum Heidelberg Klinik für Innere Med. III, Kardiologie, Angiologie u. Pneumologie Heidelberg, Deutschland; 11Universitäres Herz- und Gefäßzentrum Hamburg Hamburg, Deutschland; 12Universitätsklinikum Bonn Medizinische Klinik und Poliklinik II Bonn, Deutschland; 13Universitätsmedizin der Johannes Gutenberg-Universität Mainz Kardiologie 1, Zentrum für Kardiologie Mainz, Deutschland; 14Städtische Kliniken Mönchengladbach GmbH Kardiologie & Angiologie Mönchengladbach, Deutschland; 15Herzzentrum Leipzig - Universität Leipzig Klinik für Innere Medizin/Kardiologie Leipzig, Deutschland; 16Universitäres Herz- und Gefäßzentrum Hamburg Allgemeine und Interventionelle Kardiologie Hamburg, Deutschland
Residual mitral regurgitation (MR) ≥2+ and mean transmitral valve gradient (MVG) >5 mmHg have been associated with adverse outcomes following mitral valve transcatheter edge-to-edge repair (M-TEER). Recently, MR reduction to ≤1+ has been shown to be associated with clinical benefits, regardless of MVG following M-TEER with the MitraClip (Abbott Structural). We aimed to validate these findings with the PASCAL system (Edwards Lifesciences).
Methods
The REPAIR study (REgistry of PAscal for mItral Regurgitation) is an ongoing, investigator-initiated, retrospective, multicenter registry including all-comers treated with the PASCAL for MR across 14 centers in Germany from 02/2019 to 06/2024. Subjects were categorized into 4 groups based on MR grade and MVG at discharge: 1) MR ≤1+/MVG <5 mmHg; 2) MR ≤1+/MVG ≥5mmHg; 3) MR ≥2+/MVG <5 mmHg; and 4) MR ≥2+/MVG ≥5 mmHg.
Results
A total of 2,000 patients (age 80 [74-84], 44% female, 85% NYHA class III/IV, EuroScore II 4.9% [3.0-8.2]) with available discharge echocardiograms were included: 1,187 (59.4%) with MR ≤1+/<5 mmHg, 248 (12.4%) with MR ≤1+/MVG ≥5 mmHg, 423 (21.1%) with MR ≥2+/MVG <5 mmHg, and 142 (7.1%) with MR ≥2+/MVG ≥5 mmHg. MR etiology differed significantly across groups, with secondary MR (SMR) most prevalent in the MR ≤1+/MVG <5 mmHg group (56%) and least frequent in MR ≥2+/MVG ≥5 mmHg (39%), p<0.001 across groups. Overall, significant 1-year survival differences across these groups were observed (log-rank p=0.005) (Figure 1). These findings were confirmed for both patients with primary MR (PMR, log-rank p=0.043) and SMR (log-rank p=0.034). After Bonferroni correction, patients with MR ≤1+/MVG <5 mmHg had superior survival (91% [95% CI: 89-93]) compared to those with MR ≥2+/MVG ≥5 mmHg (79% [95% CI: 72-88], log-rank p=0.007). No significant difference was found for MVG ≥5 mmHg vs <5 mmHg (log-rank p=0.13) (Figure 2), consistent in both PMR (log-rank p=0.17) and SMR (log-rank p=0.29). In contrast, MR ≤1+ vs ≥2+ showed a significant difference (log-rank p<0.001) (Figure 3), confirmed for both PMR (log-rank p=0.014) and SMR (log-rank p<0.001).
Conclusions
Our analysis confirms that achieving an MR reduction to ≤1+ is associated with a survival benefit, independent of MVG. This underscores minimal residual MR as a key target in optimizing outcomes following M-TEER across different devices.
Figure 1. Kaplan-Meier survival analysis by combined residual MR grade and MVG at discharge, showing significant differences in 1-year survival across the four groups (log-rank p=0.005).
Figure 2. Kaplan-Meier survival analysis by MVG (≥5 mmHg vs. <5 mmHg) at discharge, indicating no significant difference in 1-year survival based on MVG alone (log-rank p=0.13).
Figure 3. Kaplan-Meier survival analysis by residual MR grade (≤1+ vs. ≥2+) at discharge, demonstrating significantly improved 1-year survival in patients achieving MR ≤1+ (log-rank p<0.001).