1Herzzentrum Leipzig - Universität Leipzig Universitätsklinik für Herzchirurgie Leipzig, Deutschland; 2Herzzentrum Leipzig - Universität Leipzig Klinik für Innere Medizin/Kardiologie Leipzig, Deutschland; 3Universitätsmedizin der Johannes Gutenberg-Universität Mainz Kardiologie 1, Zentrum für Kardiologie Mainz, Deutschland
Aims
Mitral valve transcatheter edge to edge repair is a common treatment in patients with functional mitral regurgitation and prohibitive surgical risk. There is a lack of knowledge regarding effectiveness and clinical outcomes comparing MitraClip G4 system with PASCAL system in patients with symptomatic functional mitral regurgitation used in the clinical routine.
Methods and results
In this monocentric retrospective observation study, patients with symptomatic severe functional mitral regurgitation were treated with MitraClip G4 system (MitraClip group) or PASCAL system (PASCAL group). The primary endpoints were 30-day mortality and estimated 1-year survival by Kaplan-Meier analysis. Procedural success and effectiveness in terms of reduction of mitral regurgitation were also reported.
A total of 285 consecutive patients underwent mitral valve transcatheter edge to edge repair for symptomatic functional mitral regurgitation with MitraClip G4 system (n=129, mean age 77 years) or PASCAL system (n=156, mean age 77 years) between 2021 and 2023. Aetiologies of functional mitral regurgitation in the MitraClip group were atrial functional mitral regurgitation in 63 patients (49%) and ventricular functional mitral regurgitation in 66 patients (51%). In the PASCAL group, 72 patients (46%) presented atrial functional mitral regurgitation and 84 patients (54%) ventricular functional mitral regurgitation. Left ventricular ejection fraction (LVEF) was comparable in both study groups (46% [IQR 31 – 60] vs. 45% [IQR 34 - 55], p=0.55). Pre-interventional grade of mitral regurgitation ≥ 2 was 97% (n=126) in the MitraClip group and 98% (n=154) in the PASCAL group (p=0.36). During mitral valve transcatheter edge to edge repair, mean procedure time was longer in the PASCAL group compared to MitraClip group (63 min [IQR 39 – 73] vs. 56 min min [IQR 48 - 85], p=0.035). Consequently, fluoroscopic time was shorter in MitraClip group (16 min [IQR 11 - 23]) than in PASCAL group (19 min [IQR 12 - 28], p=0.018) as well. No acute procedure- or device-related cardio-thoracic surgery was needed in both groups. Procedural success, defined as mitral regurgitation grade ≤ 2 at discharge was 96% (n=120) in the MitraClip group and 96% (n=144) in the PASCAL group (p=0.2). At 30 days, survival was 98% (n=118) in the MitraClip group and 98% (n=153) in the PASCAL group. Estimated 1-year survival was 78% (n=94) in the MitraClip group and 84% (n=131) in the PASCAL group (p=0.33).
Conclusions
In patients with functional mitral regurgitation, mitral valve transcatheter edge to edge repair with the MitraClip G4 system and PASCAL system are safe and effective with comparable clinical outcomes at 30 days and 1 year.