Clin Res Cardiol (2022). https://doi.org/10.1007/s00392-022-02002-5

MitraClip versus PASCAL for mitral valve transcatheter edge-to-edge repair: A quasi-randomised controlled study
J. Haschemi1, J. Haurand1, M. Kelm1, R. Westenfeld1, P. Horn1
1Klinik für Kardiologie, Pneumologie und Angiologie, Universitätsklinikum Düsseldorf, Düsseldorf;

Background
Transcatheter edge-to-edge repair (TEER) of the mitral valve has emerged as standard treatment in selected patients with clinically relevant mitral regurgitation (MR) and increased surgical risk. We aimed to compare the current two available TEER systems, the MitraClip with the PASCAL repair system in terms of their effectiveness and safety.

Methods
This pseudo-randomised prospective study enrolled 214 patients who were treated with TEER at the University Hospital Düsseldorf between June 2019 and August 2021. The type of device system used was not randomized but was determined by the operational structuring of our mitral valve program such that patients were scheduled for the next available implantation date with weekly alternating time slots for MitraClip and PASCAL

Results
From June 2019 to August 2021, 112 patients were treated using the MitraClip system and 102 patients were treated using the PASCAL repair system. Both groups were comparable in baseline characteristics and comorbidities. Functional MR was more common than degenerative MR (72% in the MitraClip group, 71% in the PASCAL group (p= 0.9501). The procedural safety and efficacy were high and comparable in both groups. Successful device implantation was established in 98 out of 102 patients (96%) in the MitraClip group, and in 110 out of 112 patients (98%) in the MitraClip group (p= 0.3445). One month after TEER, 84 out of 112 patients in the MitraClip group (75%), and 78 out of 101 patients in the PASCAL group (77%) had mild MR or less (each p< 0.0001 compared to baseline and p = 0.5964 between groups). In both groups, New York Heart Association (NYHA) functional class improved in the vast majority of patients. NYHA functional Class III or worse was present in 15 out of 111 patients (14%) in the MitraClip group, and in 22 out of 101 patients (22%) in the PASCAL group (each p< 0.0001 compared with baseline, p= 0.369 between the groups).

Conclusion
Both systems, the MitraClip and the Pascal repair system were comparable safe and effective for the treatment of severe MR.


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