作者
Leo Marcoff,Konstantinos Koulogiannis,Lillian Aldaia,Anuj Mediratta,Scott Chadderdon,Moody Makar,T. Ruf,Theresa Ann Maria Gößler,Jonathan G. Zaroff,Gordon Leung,Ivy A. Ku,Michael Näbauer,Paul Grayburn,Zuyue Wang,Katie Hawthorne,Dale Fowler,Jacob P. Dal‐Bianco,Mani A. Vannan,Carmine Bevilacqua,Massimiliano Meineri,Joerg Ender,Anna Flo Forner,Jyothy Puthumana,Atizazul Hassan Mansoor,D. M. Lloyd,Steven J. Voskanian,Andrew Ghobrial,Rebecca T. Hahn,Feroze Mahmood,Christiane Haeffele,Géraldine Ong,L. Schneider,Dee Dee Wang,Nishant K. Sekaran,Elisabeth Koss,Priti Mehla,Serge C. Harb,Rhonda Miyasaka,Maria Ivannikova,Terri L. Stewart-Dehner,Lucas Mitchel,Sasan R. Raissi,Daniel Kalbacher,Santanu Biswas,Edwin Ho,Ythan Goldberg,Robert L. Smith,Jörg Hausleiter,D. Scott Lim,Linda D. Gillam
摘要
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). This study describes the echocardiographic methods and outcomes from the CLASP IID trial and analyzes baseline variables associated with residual mitral regurgitation (MR) ≤1+. 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. 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). 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)