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. 2024 Jul 17;13(14):4187.
doi: 10.3390/jcm13144187.

Early Outcomes of Two Large Mitral Valve Transcatheter Edge-to-Edge Repair Devices-A Propensity Score Matched Multicenter Comparison

Philipp von Stein  1 , Hendrik Wienemann  1 , Jennifer von Stein  1 , Atsushi Sugiura  2 , Tetsu Tanaka  2 , Refik Kavsur  2 , Can Öztürk  2 , Marcel Weber  2 , Jean Marc Haurand  3 , Patrick Horn  3 , Tobias Kister  4 , Amir Abbas Mahabadi  5 , Niklas Boeder  6 , Tobias Ruf  7 , Muhammed Gerçek  8 , Christoph Mues  9 , Christina Grothusen  9   10 , Julia Novotny  11 , Ludwig Weckbach  11 , Henning Guthoff  1 , Felix Rudolph  8 , Amin Polzin  3 , Stephan Baldus  1 , Tienush Rassaf  5 , Holger Thiele  4 , Helge Möllmann  9 , Malte Kelm  3 , Volker Rudolph  8 , Ralph Stephan von Bardeleben  7 , Holger Nef  6 , Peter Luedike  5 , Philipp Lurz  4 , Jörg Hausleiter  11 , Roman Pfister  1 , Victor Mauri  1
Affiliations

Early Outcomes of Two Large Mitral Valve Transcatheter Edge-to-Edge Repair Devices-A Propensity Score Matched Multicenter Comparison

Philipp von Stein et al. J Clin Med. .

Abstract

Background/Objectives: Previous trials reported comparable results with PASCAL and earlier MitraClip generations. Limited comparative data exist for more contemporary MitraClip generations, particularly the large MitraClip XT(R/W). We aimed to evaluate acute and 30-day outcomes in patients undergoing mitral valve transcatheter edge-to-edge repair (M-TEER) with one of the large devices, either PASCAL P10 or MitraClip XT(R/W) (3rd/4th generation). Methods: A total of 309 PASCAL-treated patients were matched by propensity score to 253 MitraClip-treated patients, resulting in 200 adequately balanced pairs. Procedural, clinical, and echocardiographic outcomes were collected for up to 30 days, including subgroup analysis for mitral regurgitation (MR) etiologies. Results: PASCAL and MitraClip patients were comparable regarding age (80 vs. 79 years), sex (female: 45.5% vs. 50.5%), and MR etiology (degenerative MR: n = 94, functional MR [FMR]: n = 96, mixed MR: n = 10 in each group). Technical success rates were comparable (96.5% vs. 96.0%; p > 0.999). At discharge, the mean gradient was higher (3.3 mmHg vs. 3.0 mmHg; p = 0.038), and the residual mitral valve orifice area was smaller in MitraClip patients (3.0 cm2 vs. 2.3 cm2; p < 0.001). At discharge, the reduction to MR ≤ 2+ was comparable (92.4% vs. 87.8%; p = 0.132). However, reduction to MR ≤ 1+ was more frequently observed in PASCAL patients (67.7% vs. 56.6%; p = 0.029), driven by the FMR subgroup (74.0% vs. 60.0%; p = 0.046). No difference was observed in 30-day mortality (p = 0.204) or reduction in NYHA-FC to ≤II (p > 0.999). Conclusions: Both M-TEER devices exhibited high and comparable rates of technical success and MR reduction to ≤2+. PASCAL may be advantageous in achieving MR reduction to ≤1+ in patients with FMR.

Keywords: MitraClip; PASCAL; mitral regurgitation; mitral valve transcatheter edge-to-edge repair.

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Conflict of interest statement

H Wienemann received travel support from JenaValve. J von Stein received lecture honoraria from Edwards Lifesciences. P Horn received honoraria for consulting and lectures from Abbott Vascular and received research grants and honoraria for lectures from Edwards Lifesciences. M Gerçek received funding from the Ruhr University Bochum (Advanced Clinician Scientist). S Baldus received honorarium for consultation from Abbott and Edwards Lifescience. T Rassaf received speaker/consulting honoraria from Astra Zeneca, Bayer, Pfizer, and Daiichi Sankyo. J Hausleiter received research grants and speaker honoraria from Abbott Cardiovascular and Edwards Lifesciences. H Moellmann received speaker honoraria from Abbott Cardiovascular and Edwards Lifesciences. V Rudolph received research grants and honoraria for consultation from Edwards Lifescience. RS von Bardeleben received consultancy/lecture honoraria from Abbott Cardiovascular, Boehringer Ingelheim, Edwards Lifesciences, Neochord, and Medtronic. H Nef received speaker and consultant honoraria from Abbott Vascular and Edwards Lifesciences. P Luedike received speaker honoraria and consulting fees from Astra Zeneca, Bayer, Pfizer, and Edwards Lifesciences, and research honoraria from Edwards Lifesciences. P Lurz received institutional fees and research grants from Abbott Cardiovascular, Edwards Lifescience, and Medtronic. R Pfister received honorarium for consultation from Edwards Lifescience. The other authors report no potential conflicts of interest.

Figures

Figure 1
Figure 1
Reduction to MR ≤ 2+ and MR ≤ 1+ at discharge and 30 days. (A) The degree of MR ≤ 2+ at discharge was similar in both groups, although there were more patients with MR ≤ 1+ in the PASCAL group. (B) At 30-days, MR ≤ 2+ and ≤ 1+ were more frequently achieved in the PASCAL group. Patients with functional mitral regurgitation were the primary driver of the between-group differences. Abbreviations: FMR: Functional Mitral Regurgitation; MR: Mitral Regurgitation.
Figure 2
Figure 2
Reduction in MR severity according to MR etiology. (A) MR severity in the DMR subgroups. At discharge and 30 days, MR reduction to ≤ 2+ (p = 0.833 and p = 0.547) and ≤ 1+ (p = 0.553 and p = 0.191) was equally frequently achieved. (B) MR severity in the FMR subgroups. At discharge and 30-days, MR reduction to ≤ 2+ (p = 0.133 and p = 0.031) and ≤ 1+ (p = 0.046 and p = 0.076) tended to be achieved more frequently in patients treated with the PASCAL. The patients with mixed mitral regurgitation showed comparable results (Please refer to Supplemental Table S10). Abbreviations: DMR: Degenerative Mitral Regurgitation; FMR: Functional Mitral Regurgitation; MR: Mitral Regurgitation.
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