Echocardiographic Outcomes With Transcatheter Edge-to-Edge Repair for Degenerative Mitral Regurgitation in Prohibitive Surgical Risk Patients.

BACKGROUND

The CLASP IID randomized trial (Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial; NCT03706833) demonstrated the safety and effectiveness of the PASCAL system for mitral transcatheter edge-to-edge repair (M-TEER) in patients at prohibitive surgical risk with significant symptomatic degenerative mitral regurgitation (DMR).

OBJECTIVES

This study describes the echocardiographic methods and outcomes from the CLASP IID trial and analyzes baseline variables associated with residual mitral regurgitation (MR) ≤1+.

METHODS

An independent echocardiographic core laboratory assessed echocardiographic parameters based on American Society of Echocardiography guidelines focusing on MR mechanism, severity, and feasibility of M-TEER. Factors associated with residual MR ≤1+ were identified using logistic regression.

RESULTS

In 180 randomized patients, baseline echocardiographic parameters were well matched between the PASCAL (n = 117) and MitraClip (n = 63) groups, with flail leaflets present in 79.2% of patients. Baseline MR was 4+ in 76.4% and 3+ in 23.6% of patients. All patients achieved MR ≤2+ at discharge. The proportion of patients with MR ≤1+ was similar in both groups at discharge but diverged at 6 months, favoring PASCAL (83.7% vs 71.2%). Overall, patients with a smaller flail gap were significantly more likely to achieve MR ≤1+ at discharge (adjusted OR: 0.70; 95% CI: 0.50-0.99). Patients treated with PASCAL and those with a smaller flail gap were significantly more likely to sustain MR ≤1+ to 6 months (adjusted OR: 2.72 and 0.76; 95% CI: 1.08-6.89 and 0.60-0.98, respectively).

CONCLUSIONS

The study used DMR-specific echocardiographic methodology for M-TEER reflecting current guidelines and advances in 3-dimensional echocardiography. Treatment with PASCAL and a smaller flail gap were significant factors in sustaining MR ≤1+ to 6 months. Results demonstrate that MR ≤1+ is an achievable benchmark for successful M-TEER. (Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial [CLASP IID]; NCT03706833).

Informations de copyright

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

Déclaration de conflit d'intérêts

Funding Support and Author Disclosures The CLASP IID trial is funded by Edwards Lifesciences. Dr Marcoff has served as a member of the echocardiography core laboratory for Edwards Lifesciences, Abbott, and Medtronic, with no direct compensation. Dr Koulogiannis has served as a consultant and advisory board member for Edwards Lifesciences; has served as a speaker for Abbott; has served as a member of the echocardiography core laboratory for Edwards Lifesciences, Abbott, and Medtronic, with no direct compensation. Dr Lilian Aldaia has served as a member of the echocardiography core laboratory for Edwards Lifesciences, Abbott, and Medtronic, with no direct compensation. Dr Mediratta has served as a member of the echocardiography core laboratory for Edwards Lifesciences, Abbott, and Medtronic, with no direct compensation. Dr Chadderdon has served as a consultant for Edwards Lifesciences and Medtronic; and has received research grants from GE Healthcare. Dr Makar has served as a consultant for Boston Scientific and Abbott Vascular. Dr Ruf has received speaker, consulting, and proctoring fees from Abbott Laboratories and Edwards Lifesciences. Dr Nabauer has received speaker, consulting, and proctoring fees from Edwards Lifesciences. Dr Grayburn has received research grants from Abbott Vascular, Boston Scientific, Cardiovalve, Edwards Lifesciences, Medtronic, Neochord, W. L. Gore and Associates, and 4C Medical; and has also served as a consultant and advisory board member for Abbott Vascular, Cardiovalve, Edwards Lifesciences, Medtronic, W. L. Gore and Associates, and 4C Medical. Dr Vannan has received research grants and speaker honoraria from Piedmont Heart Institute for Abbott, Medtronic, Edwards Lifesciences, Philips, Siemens Healthineers, and GE Healthcare. Dr Ender has received institutional honoraria from Edwards Lifesciences, Abbott, and Medela, with no direct compensation. Dr Puthumana has served on the Speakers Bureau and as a training consultant for Abbott Structural and Edwards Lifesciences. Dr Mansoor has served as a consultant for Atricure. Dr Hahn has received speaker fees from Abbott Structural, Baylis Medical, Edwards Lifesciences, and Philips Healthcare; has stock options with Navigate; has held institutional consulting contracts with Abbott Structural, Boston Scientific, Edwards Lifesciences, Medtronic, and Novartis; and has served as a Chief Scientific Officer for the echocardiography core laboratory at the Cardiovascular Research Foundation for multiple industry-sponsored trials, with no direct industry compensation for either. Dr Mahmood has served as a consultant for education materials for Abbott Medical and GE Ultrasound. Dr Haeffele has served as a consultant to Edwards Lifesciences. Dr Ong has received speaker fees from Abbott. Dr Schneider has served as a speaker, proctor, and advisor for Edwards Lifesciences and Abbott; and has served as an advisor for Boehringer and Lilly. Dr D. Wang has served as a consultant to Edwards Lifesciences, Abbott Vascular, Materialise, and Boston Scientific. Dr Koss has served as an educational speaker for Abbott and Edwards Lifesciences. Dr Harb has served as a consultant for Abbott, Boston Scientific, and Mitria. Dr Miyasaka has served as a consultant for Abbott. Dr Ivannikova has received speaker fees from Edwards Lifesciences. Dr Mitchel has served on the Abbott Speakers Bureau. Dr Raissi has served as a consultant for Abbott. Dr Kalbacher has received proctor fees from Edwards Lifesciences and PiCardia Ltd; and has received lecture fees from Edwards Lifesciences and Abbott Medical. Dr Ho has served as an advisor for Neochord, Half Moon Medical, and Valgen; and has held institutional consulting contracts with GE Healthcare and Edwards Lifesciences. Dr Smith has served in clinical trial leadership and has received institutional grant and travel support for device evaluation from Edwards Lifesciences; has received institutional grants from Artivion; and has received speaker honoraria from Artivion and Medtronic. Dr Hausleiter has served as a consultant and has received speaker honoraria and institutional research support from Edwards Lifesciences. Dr Lim has served as a consultant for Ancora, LagunaTech, Nyra, Opus, Philips, Venus, and Valgen; and has received research grants from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr Gillam has served as a consultant for Philips, Bracco, Edwards Lifesciences, and Medtronic; and has institutional echocardiography core laboratory contracts from Abbott, Edwards Lifesciences, and Medtronic, with no direct compensation. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.