First clinical trial of a self-expandable transcatheter heart valve in Japan in patients with symptomatic severe aortic stenosis.
Circ J
; 78(5): 1083-90, 2014.
Article
en En
| MEDLINE
| ID: mdl-24662399
ABSTRACT
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 ANDRESULTS:
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.
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Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
Estenosis de la Válvula Aórtica
/
Prótesis Valvulares Cardíacas
/
Reemplazo de la Válvula Aórtica Transcatéter
Tipo de estudio:
Clinical_trials
/
Diagnostic_studies
/
Observational_studies
/
Risk_factors_studies
Límite:
Aged
/
Aged80
/
Female
/
Humans
/
Male
País/Región como asunto:
Asia
Idioma:
En
Revista:
Circ J
Asunto de la revista:
ANGIOLOGIA
/
CARDIOLOGIA
Año:
2014
Tipo del documento:
Article