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

TY - JOUR

T1 - Transcatheter Edge-to-Edge Repair in Patients With Anatomically Complex Degenerative Mitral Regurgitation

AU - Hausleiter, Jörg

AU - Lim, D Scott

AU - Gillam, Linda D

AU - Zahr, Firas

AU - Chadderdon, Scott

AU - Rassi, Andrew N

AU - Makkar, Raj

AU - Goldman, Scott

AU - Rudolph, Volker

AU - Hermiller, James

AU - Kipperman, Robert M

AU - Dhoble, Abhijeet

AU - Smalling, Richard

AU - Latib, Azeem

AU - Kodali, Susheel K

AU - Lazkani, Mohamad

AU - Choo, Joseph

AU - Lurz, Philipp

AU - O'Neill, William W

AU - Laham, Roger

AU - Rodés-Cabau, Josep

AU - Kar, Saibal

AU - Schofer, Niklas

AU - Whisenant, Brian

AU - Inglessis-Azuaje, Ignacio

AU - Baldus, Stephan

AU - Kapadia, Samir

AU - Koulogiannis, Konstantinos

AU - Marcoff, Leo

AU - Smith, Robert L

AU - PASCAL IID Registry Investigators

N1 - Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

PY - 2023/2/7

Y1 - 2023/2/7

N2 - BACKGROUND: 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.OBJECTIVES: 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.METHODS: 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.RESULTS: 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 cm2, and 10.6% large flail gap and/or large flail width). The implant success rate was 92.9%. The 30-day composite major adverse event rate was 11.2%. At 6 months, 92.4% patients achieved MR ≤2+ and 56.1% achieved MR ≤1+ (P < 0.001 vs baseline). The Kaplan-Meier estimates for survival, freedom from major adverse events, and heart failure hospitalization at 6 months were 93.7%, 85.6%, and 92.6%, respectively. Patients experienced significant symptomatic improvement compared with baseline (P < 0.001).CONCLUSIONS: 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).

AB - BACKGROUND: 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.OBJECTIVES: 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.METHODS: 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.RESULTS: 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 cm2, and 10.6% large flail gap and/or large flail width). The implant success rate was 92.9%. The 30-day composite major adverse event rate was 11.2%. At 6 months, 92.4% patients achieved MR ≤2+ and 56.1% achieved MR ≤1+ (P < 0.001 vs baseline). The Kaplan-Meier estimates for survival, freedom from major adverse events, and heart failure hospitalization at 6 months were 93.7%, 85.6%, and 92.6%, respectively. Patients experienced significant symptomatic improvement compared with baseline (P < 0.001).CONCLUSIONS: 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).

KW - Humans

KW - Mitral Valve Insufficiency/diagnostic imaging

KW - Prospective Studies

KW - Treatment Outcome

KW - Heart Valve Prosthesis Implantation/adverse effects

KW - Mitral Valve/diagnostic imaging

KW - Cardiac Catheterization/adverse effects

U2 - 10.1016/j.jacc.2022.11.034

DO - 10.1016/j.jacc.2022.11.034

M3 - SCORING: Journal article

C2 - 36725171

VL - 81

SP - 431

EP - 442

JO - J AM COLL CARDIOL

JF - J AM COLL CARDIOL

SN - 0735-1097

IS - 5

ER -