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Background: The PASCAL P10 system for mitral valve transcatheter edge-to-edge repair has undergone iterations, including introduction of the narrower Ace implant and the Precision delivery system., Objectives: The study sought to evaluate outcomes and the impact of PASCAL mitral valve transcatheter edge-to-edge repair device iterations., Methods: The REPAIR (REgistry of PAscal for mltral Regurgitation) study is an investigator-initiated, multicenter registry including consecutive patients with mitral regurgitation (MR) treated from 2019 to 2024. Patients were stratified by device iteration: P10 only , P10/Ace Gen1 (introduction of Ace), and P10/Ace Prec (introduction of Precision). The primary endpoint was MR ≤1+ at discharge; secondary endpoints included technical success and MR durability (discharge vs 30 days, 1 year, and 2 years)., Results: A total of 2,165 patients (mean age 78 ± 10 years, 44% female, 85% in NYHA functional class ≥III, EuroSCORE II [European System for Cardiac Operative Risk Evaluation II] 4.9% [Q1-Q3: 3.0% to 8.1%]) were included: 660 P10 only , 945 P10/Ace Gen1 , and 560 P10/Ace Prec . Median follow-up was 510 days (Q1-Q3: 369-874 days). Primary (47% [n = 1,019 of 2,142]) and secondary (52% [n = 1,123 of 2,142]) MR etiology did not change across device iterations (P = 0.547). Technical success was achieved in 97.0% (n = 2,099 of 2,165) with similar rates across device iterations (P = 0.290). MR ≤1+ was achieved in 72% (n = 1,397 of 2,085), improving with device iterations (P10 only : 66% [n = 422 of 638], P10/Ace Gen1 : 73% [n = 661 of 906], P10/Ace Prec : 77% [n = 414 of 541]; P < 0.001). MR grades of ≤1+ and ≤2+ slightly worsened at 30 days, 1 year, and 2 years, primarily in patients with primary MR, with no differences across iterations., Conclusions: Device iterations of the PASCAL system resulted in increasing rates of achieving MR reduction to ≤1+ at discharge, with stable and high technical success rates. A slight deterioration of the initial result warrants further investigation., Competing Interests: Funding Support and Author Disclosures Dr Stolz has received speaker honoraria from Edwards Lifesciences. Dr Mahabadi has received honoraria, lecture fees, and/or grant support from Amgen, Daiichi-Sankyo, Edwards Lifesciences, Novartis, and Sanofi, all unrelated to this work; and is co-founder of Mycor GmbH, a company focusing on artificial intelligence–based electrocardiography algorithms. Dr Gerçek has served as consultant for Edwards Lifesciences; and received a research grant from the Ruhr-University Bochum as Advanced Clinician Scientist. Dr Rassaf has received honoraria, lecture fees, and grant support from Edwards Lifesciences, AstraZeneca, Bayer, Novartis, Berlin Chemie, Daiichi-Sankyo, Boehringer Ingelheim, Novo Nordisk, Cardiac Dimensions, and Pfizer, all unrelated to this work; is co-founder of Bimyo GmbH, a company that develops cardioprotective peptides; is co-founder of Mycor GmbH, a company focusing on artificial intelligence–based electrocardiography algorithms; and is co-founder of Yes2NO, developing nitric oxide–based treatments. Dr Lurz has received institutional fees and research grants from Abbott Cardiovascular, Edwards Lifesciences, and Medtronic. Dr Horn has received an unrestricted research grant from Edwards Lifesciences; and speaking honoraria from Abbott Cardiovascular. Dr Möllmann has received speaker honoraria from Abbott Cardiovascular and Edwards Lifesciences. Dr Baldus has received honorarium for consultation by Edwards Lifesciences and was supported by the Deutsche Forschungsgemeinschaft, Bonn, Germany (397484323). Dr Rudolph has received research grants and honoraria for consultation from Edwards Lifesciences. Dr Hausleiter has received speaker honoraria from and served as consultant for Edwards Lifesciences. Dr Pfister has received honorarium for consultation by Edwards Lifesciences. Dr Mauri has received speaker honoraria and travel compensation by Edwards Lifesciences and was supported by the Deutsche Forschungsgemeinschaft, Bonn, Germany (397484323). All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2025 The Authors. Published by Elsevier Inc. All rights reserved.)

Background: In addition to the edge-to-edge MitraClip repair system, the edge-to-spacer PASCAL repair system was approved for percutaneous treatment of severe mitral regurgitation (MR). Comparative data are lacking., Objectives: The aim of this study was to compare procedural and short-term safety and efficacy of 2 leaflet-based transcatheter mitral valve repair systems., Methods: Procedural and 30-day outcomes were investigated in a propensity score-matched cohort of 307 PASCAL and 307 MitraClip patients at 10 sites. Matching criteria included sex, age, left ventricular ejection fraction, New York Heart Association functional class, MR etiology, left ventricular end-diastolic diameter, left atrial volume index, and vena contracta width. The primary efficacy endpoints were technical success and degree of residual MR at discharge. The primary safety endpoint was the rate of major adverse events (MAE)., Results: Technical success was 97.0% in the PASCAL group and 98.0% in the MitraClip group (P = 0.624). MR ≤2+ at discharge was comparable in both groups (PASCAL: 93.8% vs MitraClip: 92.4%; P = 0.527), with more patients exhibiting MR ≤1+ in the PASCAL group (70.5% vs 56.6%; P < 0.001). The postprocedural mean gradient was significantly higher in the MitraClip group (3.3 ± 1.5 mm Hg vs 3.9 ± 1.7 mm Hg; P < 0.001). At 30 days, all-cause mortality and MAE rates were similar (mortality: 1.7% vs 3.3%; P = 0.299; MAE: 3.9% vs 5.2%; P = 0.562)., Conclusions: In this first large propensity score-matched comparison, procedural success rates and MAE did not differ significantly between patients treated with the PASCAL or MitraClip valve repair system. Procedural results with less than moderate MR and no elevated transmitral gradient were more common in the PASCAL group, which might have an impact on long-term outcome., Competing Interests: Funding Support and Author Disclosures Dr Iliadis has received travel support from Abbott; and has received consultant honoraria from Abbott and Edwards Lifesciences. Dr Hausleiter has received research grants and speaker honoraria from Abbott Cardiovascular and Edwards Lifesciences. Dr Lurz has received institutional fees and research grants from Abbott Cardiovascular, Edwards Lifesciences, and Medtronic. Dr Möllmann has received speaker honoraria from Abbott Cardiovascular and Edwards Lifesciences. Dr Rudolph has received research grants and consulting honoraria from Edwards Lifesciences. Dr von Bardeleben has received consulting and lecture honoraria from Abbott Cardiovascular, Boehringer Ingelheim, Edwards Lifesciences, NeoChord, and Medtronic. Dr Nef has received speaker and consulting honoraria from Abbott Vascular and Edwards Lifesciences. Dr Luedike has received consulting and lecture honoraria from Edwards Lifesciences. Drs Pfister and Baldus have received consulting honoraria from Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2022 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to investigate the procedural and short-term safety and efficacy of a new leaflet-based transcatheter mitral valve repair system., Background: The PASCAL repair system has been recently approved for percutaneous treatment of mitral regurgitation (MR). Novel characteristics are broad paddles positioned around a central spacer and the ability for independent leaflet capture., Methods: Procedural and 30-day outcomes were investigated in the first 309 patients with symptomatic MR 3+/4+ treated with the PASCAL repair system at 10 sites. Primary efficacy endpoints were technical success and degree of residual MR at discharge. The primary safety endpoint was the rate of major adverse events (MAE)., Results: Among the 309 patients (mean age 77 ± 10 years, 42% women, mean European System for Cardiac Operative Risk Evaluation II score 5.8 ± 4.5%) included in this study, MR etiology was degenerative in 33%, functional in 52%, and mixed in 16%. Eighty-six percent of patients were in New York Heart Association functional class III or IV. The technical success rate was 96%. Of 308 patients discharged alive, MR was ≤2+ in 93.5%. At 30 days, the MAE rate was 4.1%, with an estimated all-cause mortality rate of 2.0%, and 72% of patients were in New York Heart Association functional class ≤II (p < 0.001). Rates of device success and CLASP (Edwards PASCAL Transcatheter Mitral Valve Repair System Study) trial-defined clinical success were 81.9% and 86.9%, respectively. Single-leaflet device attachment occurred in 7 patients (2.3%)., Conclusions: Mitral valve repair with the PASCAL system in the early post-approval phase was effective and safe, with high procedural success rates and low rates of MAE. MR was significantly reduced, accompanied by significant improvement in functional status., Competing Interests: Author Disclosures Drs. Pfister and Baldus have received honoraria for consulting from Edwards Lifesciences. Dr. Luedike has received honoraria for consulting and lectures from Edwards Lifesciences. Dr. Rudolph has received research grants and honoraria for consulting from Edwards Lifesciences. Dr. Hausleiter has received research grants and speaking honoraria from Abbott Cardiovascular and Edwards Lifesciences. Dr. Lurz has received institutional fees and research grants from Abbott Cardiovascular, Edwards Lifesciences, and Medtronic. Dr. Nef has received speaking and consulting honoraria from Abbott Vascular and Edwards Lifesciences. Dr. Möllmann has received speaking honoraria from Abbott Cardiovascular and Edwards Lifesciences. Dr. von Bardeleben has received consulting and lecture honoraria from Abbott Cardiovascular, Boehringer Ingelheim, Cardiac Dimensions, and Edwards Lifesciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2020 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)