Prospective Multicenter Evaluation of the Direct Flow Medical Transcatheter Aortic Valve

JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY

卷:63

Article

Schofer, Joachim¹  Colombo, Antonio²  Klugmann, Silvio³  Fajadet, Jean⁴  DeMarco, Federico³  Tchetche, Didier⁴  Maisano, Francesco²  Bruschi, Giuseppe³  Latib, Azeem²  Bijuklic, Klaudija¹  Weissman, Neil⁵  Low, Reginald^6,7  Thomas, Martyn⁸  Young, Christopher⁸  Redwood, Simon⁸  Mullen, Michael⁹  Yap, John⁹  Grube, Eberhard¹⁰  Nickenig, Georg¹⁰  Sinning, Jan-Malte¹⁰  Hauptmann, Karl Eugen¹¹  Friedrich, Ivar¹¹  Lauterbach, Michael¹¹  Schmoeckel, Michael¹²  Davidson, Charles¹³  Lefevre, Thierry¹⁴ 

[1] Univ Hamburg, Med Care Ctr Prof Mathey, Ctr Cardiovasc, D-22527 Hamburg, Germany

[2] Hosp San Raffaele, I-20132 Milan, Italy

[3] Azienda Osped Niguarda Ca Granda, Milan, Italy

[4] Clin Pasteur, Toulouse, France

[5] Georgetown Univ, MedStar Hlth Res Inst, Washington, DC USA

[6] Univ Calif Davis, Davis, CA 95616 USA

[7] St Thomas Hosp, London, England

[8] Heart Hosp, London, England

[9] Univ Hosp Bonn, Bonn, Germany

[10] Krankenhaus Barmherzigen, Trier, Germany

[11] Asklepios Klin St Georg, Hamburg, Germany

[12] NW Mem Hosp, Chicago, IL 60611 USA

[13] Inst Hosp Jacques Cartier, Inst Cardiovasc Paris Sud, Massy, France

[14] Clin Imaging Analyt, Guerneville, CA USA

关键词: aortic regurgitation;    aortic valve stenosis;    TAVR;    transfemoral;   

DOI  :  10.1016/j.jacc.2013.10.013

来源: Elsevier

【 摘 要 】

Objectives The study sought a prospective multicenter nonrandomized evaluation of the Direct Flow Medical ( DFM) system for the treatment of severe aortic stenosis. Background The DFM transcatheter aortic valve system is a nonmetallic design with a pressurized support structure that allows precise positioning, retrieval, and assessment of valve performance prior to permanent implantation. Methods One hundred high surgical risk patients with severe aortic stenosis were evaluated for the primary endpoint. There were 75 patients in the group evaluable for the secondary endpoints and 25 in the pre-specified roll-in training phase. Echocardiographic and angiographic data were evaluated by an independent core laboratory and adverse events adjudicated by clinical event committee and classified according to Valve Academic Research Consortium (VARC) criteria. Results There was 99% freedom from all cause mortality at 30 days (primary endpoint). VARC criteria defined 30 day combined freedom from patient safety event rate was 91% and overall device success was 93%. The postimplantation echocardiography results demonstrated mild or no aortic regurgitation in 99% (73 of 74) with a mean gradient of 12.6 +/- 7.1 mm Hg ( n 72) and effective orifice area of 1.50 +/- 0.56 cm(2) and New York Heart Association functional class was I or II in 92% of cases. Conclusions The present study demonstrates the safety and efficacy of the DFM system in surgical high risk patients with severe aortic stenosis and complex anatomy aortic regurgitation was less than moderate in 99% of patients. (c) 2014 by the American College of Cardiology Foundation

【 授权许可】

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