Details

Autor(en) / Beteiligte

• Sawa, Yoshiki
• Saito, Shigeru
• Kobayashi, Junjiro
• Niinami, Hiroshi
• Kuratani, Toru
• Maeda, Koichi
• Kanzaki, Hideaki
• Komiyama, Nobuyuki
• Tanaka, Yutaka
• Boyle, Adam
• Zhang, Angie
• Moore, B. Jane
• Medeiros, Ricardo de
• for the MDT-2111 Japan Investigators

Titel

First Clinical Trial of a Self-Expandable Transcatheter Heart Valve in Japan in Patients With Symptomatic Severe Aortic Stenosis

Ist Teil von

• Circulation Journal, 2014, Vol.78(5), pp.1083-1090

Ort / Verlag

Japan: The Japanese Circulation Society

Erscheinungsjahr

2014

Quelle

MEDLINE

Beschreibungen/Notizen

• 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 >1.2cm2 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.  (Circ J 2014; 78: 1083–1090)