title: Prospective Multicenter Evaluation of the Direct Flow Medical Transcatheter Aortic Valve System: 12-Month Outcomes of the Evaluation of the Direct Flow Medical Percutaneous Aortic Valve 18F System for the Treatment of Patients With Severe Aortic Stenosis (DISCOVER) Study.
abstract: OBJECTIVE
  The aim of this study was to assess the 1-year outcome after transcatheter aortic valve replacement (TAVR) of the Direct Flow Medical (DFM) valve in patients with severe symptomatic aortic stenosis who were contraindicated or high risk for surgery.
  
  
  BACKGROUND
  The DFM transcatheter heart valve is a new-generation, nonmetallic aortic valve with a pressurized support structure and conformable double-ring annular sealing delivered through an 18-F sheath. The device allows repositioning, retrieval, and assessment of valve performance before permanent implantation.
  
  
  METHODS
  A prospective multicenter European registry was set up to determine the safety and performance of the valve in 100 consecutive patients (10 centers). Echocardiographic and angiographic data were evaluated by an independent core laboratory, and adverse events were adjudicated by a clinical events committee using Valve Academic Research Consortium criteria.
  
  
  RESULTS
  Patients were 83.1 ± 5.9 years of age and had a logistic EuroSCORE of 22.5 ± 11.3% and a Society of Thoracic Surgeons score of 9.7 ± 8.7%. Correct valve positioning was obtained in 99% of cases with a combined 30-day safety endpoint at 10%, including major stroke in 5.0%, major vascular complications in 2.0%, and death in 1%. At 12 months, 95% of patients were in New York Heart Association functional class I or II. Freedom from any death was 90%, and freedom from any death or major stroke was 85%. Echocardiography demonstrated none/trace to mild aortic regurgitation in 100% of patients and an unchanged mean aortic gradient of 12.2 ± 6.6 mm Hg and effective orifice area of 1.6 ± 0.4 cm(2).
  
  
  CONCLUSIONS
  At 1 year, the DFM transcatheter heart valve had durable hemodynamics. This study demonstrates that the low rate of early complications and the low risk of significant aortic regurgitation translated into midterm clinical benefit.
authors.affiliation: Institut Cardiovasculaire Paris Sud, Hôpital Privé Jacques Cartier, Massy, France. Electronic address: t.lefevre@icps.com.fr.
authors.forename: Thierry
authors.initials: T
authors.lastname: Lefèvre
authors.affiliation: San Raffaele Hospital, Milan, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Colombo
authors.affiliation: Clinique Pasteur, Toulouse, France.
authors.forename: Didier
authors.initials: D
authors.lastname: Tchétché
authors.affiliation: San Raffaele Hospital, Milan, Italy.
authors.forename: Azeem
authors.initials: A
authors.lastname: Latib
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: De Marco
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: Medical Care Center Hamburg University Cardiovascular Center, Hamburg, Germany.
authors.forename: Klaudija
authors.initials: K
authors.lastname: Bijuklic
authors.affiliation: Azienda Ospedaliera Niguarda Ca Granda, Milan, Italy.
authors.forename: Stefano
authors.initials: S
authors.lastname: Nava
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.
authors.forename: Reginald
authors.initials: R
authors.lastname: Low
authors.affiliation: St. Thomas' Hospital, London, United Kingdom.
authors.forename: Martyn
authors.initials: M
authors.lastname: Thomas
authors.affiliation: St. Thomas' Hospital, London, United Kingdom.
authors.forename: Christopher
authors.initials: C
authors.lastname: Young
authors.affiliation: St. Thomas' Hospital, London, United Kingdom.
authors.forename: Simon
authors.initials: S
authors.lastname: Redwood
authors.affiliation: The Heart Hospital, London, United Kingdom.
authors.forename: Michael
authors.initials: M
authors.lastname: Mullen
authors.affiliation: The Heart Hospital, London, United Kingdom.
authors.forename: John
authors.initials: J
authors.lastname: Yap
authors.affiliation: University Hospital Bonn, Bonn, Germany.
authors.forename: Eberhard
authors.initials: E
authors.lastname: Grube
authors.affiliation: University Hospital Bonn, Bonn, Germany.
authors.forename: Georg
authors.initials: G
authors.lastname: Nickenig
authors.affiliation: University Hospital Bonn, Bonn, Germany.
authors.forename: Jan-Malte
authors.initials: JM
authors.lastname: Sinning
authors.affiliation: Krankenhaus der Barmherzigen, Trier, Germany.
authors.forename: Karl Eugen
authors.initials: KE
authors.lastname: Hauptmann
authors.affiliation: Krankenhaus der Barmherzigen, Trier, Germany.
authors.forename: Ivar
authors.initials: I
authors.lastname: Friedrich
authors.affiliation: Krankenhaus der Barmherzigen, Trier, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Lauterbach
authors.affiliation: Asklepios Klinik St Georg, Hamburg, Germany.
authors.forename: Michael
authors.initials: M
authors.lastname: Schmoeckel
authors.affiliation: Northwestern Memorial Hospital, Chicago, Illinois.
authors.forename: Charles
authors.initials: C
authors.lastname: Davidson
authors.affiliation: Medical Care Center Hamburg University Cardiovascular Center, Hamburg, Germany.
authors.forename: Joachim
authors.initials: J
authors.lastname: Schofer
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000000981:diagnostic imaging / Q000503:physiopathology*; D001022:Aortic Valve Insufficiency / Q000209:etiology / Q000503:physiopathology; D001024:Aortic Valve Stenosis / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D001705:Bioprosthesis; D006328:Cardiac Catheterization / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D018572:Disease-Free Survival; D005060:Europe; D005260:Female; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects / Q000295:instrumentation* / Q000401:mortality; D006439:Hemodynamics; D006801:Humans; D053208:Kaplan-Meier Estimate; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011474:Prosthesis Design; D011859:Radiography; D012042:Registries; D018570:Risk Assessment; D012307:Risk Factors; D012720:Severity of Illness Index; D020521:Stroke / Q000209:etiology; D013997:Time Factors; D016896:Treatment Outcome; D014463:Ultrasonography
keywords: aortic stenosids; transcatheter aortic valve replacement; transfemoral transcatheter aortic valve replacement