Echocardiographic Outcomes With Transcatheter Edge-to-Edge Repair for Degenerative Mitral Regurgitation in Prohibitive Surgical Risk Patients.
Document Type
Article
Publication Date
12-1-2023
Publication Title
JACC Cardiovasc Imaging
Keywords
washington; swedish
Abstract
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).
Clinical Institute
Cardiovascular (Heart)
Department
Cardiology
Department
Surgery
Recommended Citation
Marcoff, Leo; Koulogiannis, Konstantinos; Aldaia, Lilian; Mediratta, Anuj; Chadderdon, Scott M; Makar, Moody M; Ruf, Tobias Friedrich; Gößler, Theresa; Zaroff, Jonathan G; Leung, Gordon K; Ku, Ivy A; Nabauer, Michael; Grayburn, Paul A; Wang, Zuyue; Hawthorne, Katie M; Fowler, Dale E; Dal-Bianco, Jacob P; Vannan, Mani A; Bevilacqua, Carmine; Meineri, Massimiliano; Ender, Joerg; Forner, Anna Flo; Puthumana, Jyothy J; Mansoor, Atizazul Hassan; Lloyd, Dustin J; Voskanian, Steven J; Ghobrial, Andrew; Hahn, Rebecca T; Mahmood, Feroze; Haeffele, Christiane; Ong, Geraldine; Schneider, Leonhard Moritz; Wang, Dee Dee; Sekaran, Nishant K; Koss, Elana; Mehla, Priti; Harb, Serge; Miyasaka, Rhonda; Ivannikova, Maria; Stewart-Dehner, Terri; Mitchel, Lucas; Raissi, Sasan R; Kalbacher, Daniel; Biswas, Santanu; Ho, Edwin C; Goldberg, Ythan; Smith, Robert L; Hausleiter, Jörg; Lim, D Scott; Gillam, Linda D; and CLASP IID Pivotal Trial Investigators, "Echocardiographic Outcomes With Transcatheter Edge-to-Edge Repair for Degenerative Mitral Regurgitation in Prohibitive Surgical Risk Patients." (2023). Articles, Abstracts, and Reports. 8180.
https://digitalcommons.providence.org/publications/8180
