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

被引:35
|
作者
Sawa, Yoshiki [1 ]
Saito, Shigeru [2 ]
Kobayashi, Junjiro [3 ]
Niinami, Hiroshi [4 ]
Kuratani, Toru [1 ]
Maeda, Koichi [1 ]
Kanzaki, Hideaki [3 ]
Komiyama, Nobuyuki [4 ]
Tanaka, Yutaka [2 ]
Boyle, Adam [5 ]
Zhang, Angie [5 ]
Moore, B. Jane [5 ]
de Medeiros, Ricardo [5 ]
机构
[1] Osaka Univ Hosp, Osaka, Japan
[2] Shonan Kamakura Gen Hosp, Kamakura, Kanagawa, Japan
[3] Natl Cerebral & Cardiovasc Ctr, Suita, Osaka, Japan
[4] Saitama Med Univ, Int Med Ctr, Saitama, Japan
[5] Medtronic Inc, Minneapolis, MN USA
关键词
Aortic stenosis; Elderly; Transcatheter aortic valve replacement/implantation; IMPLANTATION; VALVULOPLASTY; PREDICTORS; OUTCOMES; DISEASE;
D O I
10.1253/circj.CJ-14-0162
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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.
引用
收藏
页码:1083 / 1090
页数:8
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