Transcatheter Edge-to-Edge Repair in Patients With Anatomically Complex Degenerative Mitral Regurgitation.

Mitral valve transcatheter edge-to-edge repair is safe and effective in treating degenerative mitral regurgitation (DMR) patients at prohibitive surgical risk, but outcomes in complex mitral valve anatomy patients vary. The PASCAL IID registry assessed safety, echocardiographic, and clinical outcomes with the PASCAL system in prohibitive risk patients with significant symptomatic DMR and complex mitral valve anatomy. Patients in the prospective, multicenter, single-arm registry had 3+ or 4+ DMR, were at prohibitive surgical risk, presented with complex anatomic features based on the MitraClip instructions for use, and were deemed suitable for the PASCAL system by a central screening committee. Enrolled patients were treated with the PASCAL system. Safety, effectiveness, and functional and quality-of-life outcomes were assessed. Study oversight also included an echocardiographic core laboratory and clinical events committee. The study enrolled 98 patients (37.2% ≥2 independent significant jets, 15.0% severe bileaflet/multi scallop prolapse, 13.3% mitral valve orifice area <4.0 cm The outcomes of the PASCAL IID registry establish the PASCAL system as a useful therapy for prohibitive surgical risk DMR patients with complex mitral valve anatomy. (PASCAL IID Registry within the Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial [CLASP IID] NCT03706833).

Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Funding Support and Author Disclosures The PASCAL IID registry is funded by Edwards Lifesciences. Dr Hausleiter is a consultant and receives speaker honoraria and institutional research support from Edwards Lifesciences. Dr Lim is a consultant for Philips, Venus, and Valgen; and has received research grants from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr Gillam is a consultant for Philips, Bracco, and Edwards Lifesciences; and directs an echocardiography core laboratory for Abbott, Edwards Lifesciences, and Medtronic, for which she receives no direct compensation. Dr Zahr is a consultant for and receives research grants from Edwards Lifesciences. Dr Chadderdon is an educational consultant for Edwards Lifesciences and Medtronic. Dr Makkar is a consultant for and receives research grants from Edwards Lifesciences, Abbott, Medtronic, and Boston Scientific. Dr Goldman has provided minimally invasive mitral valve observation for Edwards Lifesciences. Dr Rudolph has received research grants from Edwards Lifesciences, Abbott, and Boston Scientific. Dr Hermiller is a consultant and proctor for Edwards Lifesciences. Dr Dhoble is a consultant and proctor for Edwards Lifesciences and Abbott. Dr Smalling receives clinical trial grant support from Edwards Lifesciences, Medtronic, and Abbott; and serves as a consultant for Abbott. Dr Latib is a consultant and serves on the advisory board for Boston Scientific, Edwards Lifesciences, Medtronic, Abbott, and Philips. Dr Kodali is a consultant for Admedus, Dura Biotech, TriCares, Phillips, and TriFlo; receives institutional research funding from Edwards Lifesciences, Medtronic, Abbott, Boston Scientific, and JenaValve; and serves on the scientific advisory for and has received equity from Dura Biotech, MicroInterventional Devices, Thubrikar Aortic Valve Inc, Supira, Admedus, TriFlo, Adona, Tioga, and X-Dot. Dr Lurz receives institutional grants from Edwards Lifesciences, Abbott, and ReCor. Dr O’Neill is a consultant for Abiomed, BSCI, and Abbott; and was previously a consultant (expired) for Edwards Lifesciences. Dr Laham is a speaker for Abbott, Edwards Lifesciences, and Medtronic. Dr Kar is a consultant for Abbott, Medtronic, Boston Scientific, WL Gore, Laminar, Intershunt, and V wave; receives institutional research grants from Abbott, Medtronic, Boston Scientific, Edwards Lifesciences, and Highlife; is the co-national principal investigator for the REPAIR MR trial and EXPAND registry; is the co-national principal investigator for the PINNACLE FLX trial and CHAMPION trial; serves on the steering committee for the Triluminate Trial; and is an executive committee member for the RELIEVE HF trial. Dr Schofer receives travel support from Edwards Lifesciences and Abbott/St Jude Medical; has received speaking honoraria from Edwards Lifesciences and Boston Scientific; and is a consultant for Edwards Lifesciences and Abbott. Dr Inglessis-Azuaje is a proctor and serves as a lecturer for Edwards Lifesciences; is a consultant and proctor for Medtronic; and is a lecturer for Boston Scientific. Dr Baldus receives research funding from Abbott; and has received lecturing fees from Edwards Lifesciences, Abbott and Medtronic. Dr Koulogiannis is a consultant and advisory board member for Edwards Lifesciences; and is a speaker for Abbott. Dr Marcoff serves as a member of the echocardiography core laboratory for Edwards Lifesciences and Abbott, for which he receives no direct compensation. Dr Smith is on the CLASP IID trial leadership team and receives institutional grant and travel support for device evaluation from Edwards Lifesciences; receives institutional grants from Artivion; and received honoraria for speaking from Artivion and Medtronic. Dr Rodés-Cabau receives institutional research grants and speaker fees from Edwards Lifesciences. Dr Whisenant is a consultant for Edwards Lifesciences and Abbott Vascular. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.