Article
作者: Aldaia, Lilian ; Ruf, Tobias Friedrich ; Haeffele, Christiane ; Biswas, Santanu ; Koss, Elana ; Ivannikova, Maria ; Ong, Geraldine ; Makar, Moody M ; Smith, Robert L ; Gößler, Theresa ; Stewart-Dehner, Terri ; Grayburn, Paul A ; Vannan, Mani A ; Raissi, Sasan R ; Hahn, Rebecca T ; Mediratta, Anuj ; Goldberg, Ythan ; Ho, Edwin C ; Koulogiannis, Konstantinos ; Lim, D Scott ; Ender, Joerg ; Dal-Bianco, Jacob P ; Ku, Ivy A ; Mansoor, Atizazul Hassan ; Lloyd, Dustin J ; Chadderdon, Scott M ; Hawthorne, Katie M ; Fowler, Dale E ; Marcoff, Leo ; Nabauer, Michael ; Kalbacher, Daniel ; Wang, Dee Dee ; Sekaran, Nishant K ; Bevilacqua, Carmine ; Ghobrial, Andrew ; Harb, Serge ; Schneider, Leonhard Moritz ; Forner, Anna Flo ; Leung, Gordon K ; Mahmood, Feroze ; Puthumana, Jyothy J ; Mitchel, Lucas ; Mehla, Priti ; Meineri, Massimiliano ; Wang, Zuyue ; Hausleiter, Jörg ; Gillam, Linda D ; Zaroff, Jonathan G ; Voskanian, Steven J ; Miyasaka, Rhonda
BACKGROUND:The CLASP IID randomized trial (Edwards PASCAL TrAnScatheter Valve RePair System Pivotal Clinical Trial) 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).