Prospective multicenter evaluation of the direct flow medical transcatheter aortic valve.

MedStar author(s):
Citation: Journal of the American College of Cardiology. 63(8):763-8, 2014 Mar 4.PMID: 24211506Institution: MedStar Heart & Vascular InstituteForm of publication: Journal ArticleMedline article type(s): Journal Article | Multicenter Study | Research Support, Non-U.S. Gov'tSubject headings: *Aortic Valve Stenosis/su [Surgery] | *Cardiac Catheterization/mt [Methods] | *Heart Valve Prosthesis | *Heart Valve Prosthesis Implantation/mt [Methods] | Aged | Aged, 80 and over | Animals | Aortic Valve Stenosis/di [Diagnosis] | Aortic Valve/pa [Pathology] | Aortic Valve/su [Surgery] | Cardiac Catheterization/is [Instrumentation] | Cattle | Cohort Studies | Female | Follow-Up Studies | Heart Valve Prosthesis Implantation/is [Instrumentation] | Humans | Male | Middle Aged | Prospective StudiesYear: 2014Local holdings: Available online from MWHC library: 1995 - present, Available in print through MWHC library:1999-2007ISSN:
  • 0735-1097
Name of journal: Journal of the American College of CardiologyAbstract: 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.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. Copyright 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.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.OBJECTIVES: The study sought a prospective multicenter nonrandomized evaluation of the Direct Flow Medical (DFM) system for the treatment of severe aortic stenosis.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 post-implantation 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.All authors: Bijuklic K, Bruschi G, Colombo A, Davidson C, DeMarco F, Fajadet J, Friedrich I, Grube E, Hauptmann KE, Klugmann S, Latib A, Lauterbach M, Lefevre T, Low R, Maisano F, Mullen M, Nickenig G, Redwood S, Schmoeckel M, Schofer J, Sinning JM, Tchetche D, Thomas M, Weissman N, Yap J, Young CFiscal year: FY2014Digital Object Identifier: Date added to catalog: 2014-08-21
Holdings
Item type Current library Collection Call number Status Date due Barcode
Journal Article MedStar Authors Catalog Article 24211506 Available 24211506

Available online from MWHC library: 1995 - present, Available in print through MWHC library:1999-2007

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.

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. Copyright 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

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.

OBJECTIVES: The study sought a prospective multicenter nonrandomized evaluation of the Direct Flow Medical (DFM) system for the treatment of severe aortic stenosis.

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 post-implantation 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.

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