title: Prospective multicenter evaluation of the direct flow medical transcatheter aortic valve.
abstract: OBJECTIVE
  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 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.
  
  
  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.
authors.affiliation: Medical Care Center Prof. Mathey, Prof. Schofer, Hamburg University Cardiovascular Center, Hamburg, Germany. Electronic address: schofer@herz-hh.de.
authors.forename: Joachim
authors.initials: J
authors.lastname: Schofer
authors.affiliation: San Raffaele Hospital, Milan, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Colombo
authors.affiliation: Azienda Ospedaliera Niguarda Ca Granda, Milan, Italy.
authors.forename: Silvio
authors.initials: S
authors.lastname: Klugmann
authors.affiliation: Clinique Pasteur, Toulouse, France.
authors.forename: Jean
authors.initials: J
authors.lastname: Fajadet
authors.affiliation: Azienda Ospedaliera Niguarda Ca Granda, Milan, Italy.
authors.forename: Federico
authors.initials: F
authors.lastname: DeMarco
authors.affiliation: Clinique Pasteur, Toulouse, France.
authors.forename: Didier
authors.initials: D
authors.lastname: Tchétché
authors.affiliation: San Raffaele Hospital, Milan, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Maisano
authors.affiliation: Azienda Ospedaliera Niguarda Ca Granda, Milan, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Bruschi
authors.affiliation: San Raffaele Hospital, Milan, Italy.
authors.forename: Azeem
authors.initials: A
authors.lastname: Latib
authors.affiliation: Medical Care Center Prof. Mathey, Prof. Schofer, Hamburg University Cardiovascular Center, Hamburg, Germany.
authors.forename: Klaudija
authors.initials: K
authors.lastname: Bijuklic
authors.affiliation: MedStar Health Research Institute, Georgetown University, Washington, DC.
authors.forename: Neil
authors.initials: N
authors.lastname: Weissman
authors.affiliation: University of California Davis, Davis, California; St. Thomas' Hospital, London, England.
authors.forename: Reginald
authors.initials: R
authors.lastname: Low
authors.affiliation: The Heart Hospital, London, England.
authors.forename: Martyn
authors.initials: M
authors.lastname: Thomas
authors.affiliation: The Heart Hospital, London, England.
authors.forename: Christopher
authors.initials: C
authors.lastname: Young
authors.affiliation: The Heart Hospital, London, England.
authors.forename: Simon
authors.initials: S
authors.lastname: Redwood
authors.affiliation: University Hospital Bonn, Bonn, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Mullen
authors.affiliation: University Hospital Bonn, Bonn, Germany.
authors.forename: John
authors.initials: J
authors.lastname: Yap
authors.affiliation: Krankenhaus der Barmherzigen, Trier, Germany.
authors.forename: Eberhard
authors.initials: E
authors.lastname: Grube
authors.affiliation: Krankenhaus der Barmherzigen, Trier, Germany.
authors.forename: Georg
authors.initials: G
authors.lastname: Nickenig
authors.affiliation: Krankenhaus der Barmherzigen, Trier, Germany.
authors.forename: Jan-Malte
authors.initials: JM
authors.lastname: Sinning
authors.affiliation: Asklepios Klinik St Georg, Hamburg, Germany.
authors.forename: Karl Eugen
authors.initials: KE
authors.lastname: Hauptmann
authors.affiliation: Asklepios Klinik St Georg, Hamburg, Germany.
authors.forename: Ivar
authors.initials: I
authors.lastname: Friedrich
authors.affiliation: Asklepios Klinik St Georg, Hamburg, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Lauterbach
authors.affiliation: Northwestern Memorial Hospital, Chicago, Illinois.
authors.forename: Michael
authors.initials: M
authors.lastname: Schmoeckel
authors.affiliation: L'Institut Cardiovasculaire Paris Sud, L'Institut Hospitalier Jacques Cartier, Massy, France.
authors.forename: Charles
authors.initials: C
authors.lastname: Davidson
authors.affiliation: Clinical Imaging Analytics, Guerneville, California.
authors.forename: Thierry
authors.initials: T
authors.lastname: Lefevre
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000818:Animals; D001021:Aortic Valve / Q000473:pathology / Q000601:surgery; D001024:Aortic Valve Stenosis / Q000175:diagnosis / Q000601:surgery*; D006328:Cardiac Catheterization / Q000295:instrumentation / Q000379:methods*; D002417:Cattle; D015331:Cohort Studies; D005260:Female; D005500:Follow-Up Studies; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000295:instrumentation / Q000379:methods*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies
keywords: TAVR; aortic regurgitation; aortic valve stenosis; transfemoral