Transcatheter Edge-to-Edge Repair in Patients With Anatomically Complex Degenerative Mitral Regurgitation
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Transcatheter Edge-to-Edge Repair in Patients With Anatomically Complex Degenerative Mitral Regurgitation. / Hausleiter, Jörg; Lim, D Scott; Gillam, Linda D; Zahr, Firas; Chadderdon, Scott; Rassi, Andrew N; Makkar, Raj; Goldman, Scott; Rudolph, Volker; Hermiller, James; Kipperman, Robert M; Dhoble, Abhijeet; Smalling, Richard; Latib, Azeem; Kodali, Susheel K; Lazkani, Mohamad; Choo, Joseph; Lurz, Philipp; O'Neill, William W; Laham, Roger; Rodés-Cabau, Josep; Kar, Saibal; Schofer, Niklas; Whisenant, Brian; Inglessis-Azuaje, Ignacio; Baldus, Stephan; Kapadia, Samir; Koulogiannis, Konstantinos; Marcoff, Leo; Smith, Robert L; PASCAL IID Registry Investigators.
in: J AM COLL CARDIOL, Jahrgang 81, Nr. 5, 07.02.2023, S. 431-442.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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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 -