Mitral Valve Transcatheter Edge-to-Edge Repair: 1-Year Outcomes From the MiCLASP Study.

Background: Mitral transcatheter edge-to-edge repair (M-TEER) is a guideline-recommended treatment option for patients with severe symptomatic mitral regurgitation (MR). Outcomes with the PASCAL system in a post-market setting have not been established.
Objectives: The authors report 30-day and 1-year outcomes from the MiCLASP (Transcatheter Repair of Mitral Regurgitation with Edwards PASCAL Transcatheter Valve Repair System) European post-market clinical follow-up study.
Methods: Patients with symptomatic, clinically significant MR were prospectively enrolled. The primary safety endpoint was clinical events committee-adjudicated 30-day composite major adverse event rate and the primary effectiveness endpoint was echocardiographic core laboratory-assessed MR severity at discharge compared with baseline. Clinical, echocardiographic, functional, and quality-of-life outcomes were assessed at 1 year.
Results: A total of 544 patients were enrolled (59% functional MR, 30% degenerative MR). The 30-day composite major adverse event rate was 6.8%. MR reduction was significant from baseline to discharge and sustained at 1 year with 98% of patients achieving MR ≤2+ and 82.6% MR ≤1+ (all P < 0.001 vs baseline). One-year Kaplan-Meier estimate for survival was 87.3%, and freedom from heart failure hospitalization was 84.3%. Significant functional and quality-of-life improvements were observed at 1 year, including 71.6% in NYHA functional class I/II, 14.4-point increase in Kansas City Cardiomyopathy Questionnaire score, and 24.2-m improvement in 6-minute walk distance (all P < 0.001 vs baseline).
Conclusions: One-year outcomes of this large cohort from the MiCLASP study demonstrate continued safety and effectiveness of M-TEER with the PASCAL system in a post-market setting. Results demonstrate high survival and freedom from heart failure hospitalization, significant and sustained MR reduction, and improvements in symptoms, functional capacity, and quality of life.
Competing Interests: Funding Support and Author Disclosures This work was supported by Edwards Lifesciences. Prof Lurz has received institutional fees and research grants from Abbott Vascular, Edwards Lifesciences, Medtronic, ReCor, and Occlutech. Dr Schmitz has received speaker fees and proctor honorarium from Edwards Lifesciences and Abbott. Dr Geisler has received personal fees (lecture honoraria) and institutional research grants from Edwards Lifesciences. Dr Hausleiter is a consultant and receives speaker fees and institutional research support from Edwards Lifesciences. Prof Eitel has received research grants from Abbott Vascular and speaker fees from Abbott, Edwards Lifesciences, and Boston Scientific. Dr Rudolph has received research grants from Edwards Lifesciences, Abbott, and Boston Scientific. Dr Lubos has received grants from Abbott and personal fees from Abbott, Abiomed, AstraZeneca, Bayer, Edwards Lifesciences, New Valve Technology, and Novartis. Dr von Bardeleben is a principal investigator for Abbott, DZHK, Edwards Lifesciences, JensCare, Medtronic, NeoChord, and the University of Göttingen IIT; and serves as an advisor, proctor, or speaker for Abbott, Edwards Lifesciences, JenaValve, JensCare, Medtronic, NeoChord, Philips, and Siemens. Dr Berti has received honoraria from and is a consultant for Proctor & Gamble, Abbott, and Boston Scientific. Dr De Marco has received honoraria and consultation fees from Edwards Lifesciences. Dr Linke has received grants from Novartis and Edwards Lifesciences; personal fees from Abbott, Abiomed, AstraZeneca, Bayer, Boehringer Ingelheim, Boston Scientific, Edwards Lifesciences, Medtronic, Novartis, Sanofi Genzyme, and Pfizer; and other fees from Picardia, Filterlex, and Transverse Medical outside the submitted work. Dr Hengstenberg has received institutional research grants from Edwards Lifesciences, Boston Scientific, Abbott, and Medtronic; and serves as a proctor for Edwards Lifesciences and Boston Scientific. Dr Baldus has received a research grant from Abbott; and lecture fees from Abbott and Edwards Lifesciences. Dr Spargias has received honoraria or consultation fees from Edwards Lifesciences, Abbott Vascular, and Medtronic. Dr Denti is a consultant for InnovHeart, Approxima, Picardia, and HRV; and receives speaker fees from Edwards Lifesciences and Abbott. Prof Nickenig has received research funding from the Deutsche Forschungsgemeinschaft, the German Federal Ministry of Education and Research, the EU, Abbott, AGA Medical, AstraZeneca, Bayer, Berlin Chemie, Biosensus, Biotronic, Bristol Myers Squibb, Boehringer Ingelheim, Daiichi-Sankyo, Edwards Lifesciences, Medtronic, Novartis, Pfizer, Sanofi, and St. Jude Medical; and has received honoraria for lectures or advisory boards from Abbott, AGA Medical, AstraZeneca, Bayer, Berlin, Cardiovalve, Berlin Chemie, Biosensus, Biotronic, Bristol Myers Squibb, Boehringer Ingelheim, Daiichi-Sankyo, Edwards Lifesciences, Medtronic, Novartis, Pfizer, Sanofi, and St. Jude Medical. Prof Möllmann has receives speaker/proctor fees from Abbott, Boston Scientific, Edwards Lifesciences, Medtronic, and SMT. Prof Rottbauer is a consultant for and receives speaker honoraria from Edwards Lifesciences. Dr Praz received travel expenses from Edwards Lifesciences, Abbott Vascular, Polares Medical, Medira, and Siemens Healthineers. Dr Butter has received lecture fees from Edwards Lifesciences and Abbott; and educational grants from Boston Scientific. Dr Van Mieghem has received research grants from Abbott Vascular, Boston Scientific, Medtronic, Edwards Lifesciences, Daiichi-Sankyo, AstraZeneca, and Teleflex; and scientific advisory fees from Anteris, JenaValve, Abbott Vascular, Boston Scientific, Medtronic, Amgen, Daiichi-Sankyo, Siemens, Pie Medical, and Teleflex. Dr Sherif is a consultant for and receives speaker honoraria from Edwards Lifesciences. Dr Swaans is a proctor/lecturer for Abbott Vascular, Boston Scientific, Bioventrix, Cardiac Dimensions, Edwards Lifesciences, GE Healthcare, Medtronic, and Philips Healthcare. Dr Witkowski is an advisory board member and has received honoraria from Abbott and Edwards Lifesciences. Dr Buch participates in the Abbott structural heart advisory group; and has received honoraria from Abbott. Prof Seidler has received honoraria for lectures, advisory boards, or travel grants from Abbott Vascular, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Corvia, Cytokinetics, Edwards Lifesciences, Medtronic, Myocardia, Novartis, Pfizer, and Teleflex. Dr Eißmann has received honoraria or consultation fees from Edwards Lifesciences and Abbott Vascular. Dr Marcoff serves as a member of the echocardiography core laboratory for Edwards Lifesciences and Abbott for which he receives no direct compensation. Dr Koulogiannis is a consultant and advisory board member for Edwards Lifesciences; and a speaker for Abbott. Dr Rassaf has received research funding from the Deutsche Forschungsgemeinschaft and Abbott; and receives honoraria for lectures or advisory boards from AstraZeneca, Bayer, Berlin Chemie, Bristol Myers Squibb, Boehringer Ingelheim, Daiichi-Sankyo, Medtronic, Novartis, and Pfizer. Dr Luedike received research grants and honoraria for consulting and lectures from Edwards Lifesciences, Novartis, and Pfizer. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
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