BACKGROUND: Transcatheter aortic valve implantation (TAVI) may be a viable solution for inoperable or high-risk patients with aortic stenosis (AS), providing the benefit of valve replacement without the associated risks of surgery. METHODS AND RESULTS: The prospective, multicenter MDT-2111 Japan Trial evaluated the efficacy and safety of a self-expandable TAV in patients with severe AS. A total of 55 patients were enrolled (October 2011 to October 2012). Mean age was 82.5±5.5 years; 30.9% male, 100% NYHA III/IV, and STS 8.0±4.2%. At 6 months, 91.7% of the iliofemoral patients had met the primary endpoint (an improvement of at least 1 NYHA class and an effective orifice area >1.2 cm(2) for iliofemoral patients). For all patients, freedom from all-cause mortality at 6 months was 90.8%. At 30 days, the Kaplan-Meier rate of major vascular complications was 10.9%, the rate of permanent pacemaker implantation was 22.2% and the rate of major stroke was 3.7%. The incidences of paravalvular regurgitation for all implanted patients at 6 months were: 38.3% (none), 25.5% (trace), 31.9% (mild), 4.3% (moderate), and 0.0% (severe). CONCLUSIONS: This is the first study to evaluate a self-expandable TAV in a Japanese patient population. The data show successful achievement of the study's primary objective and demonstrate the functional and anatomical effectiveness of the MDT-2111 TAV system.
BACKGROUND: Transcatheter aortic valve implantation (TAVI) may be a viable solution for inoperable or high-risk patients with aortic stenosis (AS), providing the benefit of valve replacement without the associated risks of surgery. METHODS AND RESULTS: The prospective, multicenter MDT-2111 Japan Trial evaluated the efficacy and safety of a self-expandable TAV in patients with severe AS. A total of 55 patients were enrolled (October 2011 to October 2012). Mean age was 82.5±5.5 years; 30.9% male, 100% NYHA III/IV, and STS 8.0±4.2%. At 6 months, 91.7% of the iliofemoral patients had met the primary endpoint (an improvement of at least 1 NYHA class and an effective orifice area >1.2 cm(2) for iliofemoral patients). For all patients, freedom from all-cause mortality at 6 months was 90.8%. At 30 days, the Kaplan-Meier rate of major vascular complications was 10.9%, the rate of permanent pacemaker implantation was 22.2% and the rate of major stroke was 3.7%. The incidences of paravalvular regurgitation for all implanted patients at 6 months were: 38.3% (none), 25.5% (trace), 31.9% (mild), 4.3% (moderate), and 0.0% (severe). CONCLUSIONS: This is the first study to evaluate a self-expandable TAV in a Japanese patient population. The data show successful achievement of the study's primary objective and demonstrate the functional and anatomical effectiveness of the MDT-2111 TAV system.
Authors: Tsuyoshi Kaneko; Sreekanth Vemulapalli; Shun Kohsaka; Kazuo Shimamura; Amanda Stebbins; Hiraku Kumamaru; Adam J Nelson; Andrzej Kosinski; Koichi Maeda; Joseph E Bavaria; Shigeru Saito; Michael J Reardon; Toru Kuratani; Jeffrey J Popma; Taku Inohara; Vinod H Thourani; John D Carroll; Hideyuki Shimizu; Morimasa Takayama; Martin B Leon; Michael J Mack; Yoshiki Sawa Journal: J Am Heart Assoc Date: 2022-03-04 Impact factor: 6.106
Authors: Cheol Woong Yu; Won Jang Kim; Jung Min Ahn; Hyungdon Kook; Se Hun Kang; Jung Kyu Han; Young Guk Ko; Seung Hyuk Choi; Bon Kwon Koo; Kiyuk Chang; Hyo Soo Kim Journal: Korean Circ J Date: 2018-04-17 Impact factor: 3.243