1-Year Outcomes of Fourth-Generation Mitral Transcatheter Edge-to-Edge Repair in Japan From the EXPAND G4 Study

• Published in: JACC. Asia Vol. 4; no. 11; pp. 810 - 821
• Main Authors: Morikawa, Takao, Enta, Yusuke, Sakamoto, Tomohiro, Yamamoto, Masanori, Ueno, Hiroshi, Yagasaki, Hiroto, Asch, Federico M., Dong, Melody, Peterman, Kelli, Rodriguez, Evelio, von Bardeleben, Ralph Stephen, Asami, Masahiko
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.11.2024; Elsevier
• Subjects: Cardiovascular; MitraClip G4 System; mitral valve repair; mitral regurgitation; Original Research; transcatheter edge-to-edge repair; APS; KCCQ; MR; mitral valve repair; LVESV; MV; LV; MitraClip G4 System; HFH; ECL; transcatheter edge-to-edge repair; PMR; mitral regurgitation; M-TEER; MVA; SMR; LVEDV; Kansas City Cardiomyopathy Questionnaire; secondary (functional) mitral regurgitation; acute procedural success; left ventricular end-diastolic volume; mitral valve; left ventricular; left ventricular end-systolic volume; mitral regurgitation; primary (degenerative) mitral regurgitation; mitral valve area; heart failure hospitalization; mitral transcatheter edge-to-edge repair; echocardiographic core laboratory
• ISSN: 2772-3747; 2772-3747
• DOI: 10.1016/j.jacasi.2024.08.003

The MitraClip (Abbott), a percutaneous edge-to-edge mitral valve (MV) repair device, is the only approved device in Japan for mitral transcatheter edge-to-edge repair (M-TEER) therapy to treat primary and secondary mitral regurgitation (MR). Outcomes of the fourth-generation M-TEER system, featuring independent grasping, improved clip deployment, and 4 clip sizes with wider and longer clip arms, have not been reported in Japan. This study evaluates the 1-year safety and effectiveness of the fourth-generation M-TEER system in Japan to treat MR in a contemporary, real-world setting. EXPAND G4 is a prospective, single-arm, international, postmarket study. One-year outcomes from subjects treated in Japan include MR severity (assessed by an echocardiography core laboratory), all-cause mortality, heart failure hospitalization, NYHA functional class, and quality of life. A total of 95 subjects were treated with the fourth-generation M-TEER system at 7 centers in Japan. Subjects in Japan had a higher surgical risk with smaller cardiac dimensions and MV areas. A 100% implant rate was achieved with a large proportion of standard clips (NT/XT). At 1 year, there was significant and sustained MR reduction (99%, 77/78 MR ≤1+), with low MV mean gradients (2.9 ± 1.8 mm Hg) and improved functional capacity (96.2%, 75/78 NYHA functional class I/II). The 1-year rates of all-cause mortality and heart failure hospitalizations were 9.5% and 18.9%, respectively, with low major and device-related adverse event rates. This first report of echocardiography core laboratory–assessed outcomes with the fourth-generation M-TEER system in Japan shows that excellent and durable technical and clinical outcomes can be achieved with M-TEER in Japan. (MitraClip EXPAND G4 Study; NCT04177394) [Display omitted]