title: A multicentre European registry to evaluate the Direct Flow Medical transcatheter aortic valve system for the treatment of patients with severe aortic stenosis.
abstract: OBJECTIVE
  Our aim was to assess the clinical outcomes of the Direct Flow Medical Transcatheter Aortic Valve System (DFM-TAVS), when used in routine clinical practice.
  
  
  RESULTS
  This is a prospective, open-label, multicentre, post-market registry of patients treated with DFM-TAVS according to approved commercial indications. Echocardiographic and angiographic data were evaluated by an independent core laboratory and adverse events were adjudicated and classified according to VARC-2 criteria by an independent clinical events committee. The primary endpoint was freedom from all-cause mortality at 30 days post procedure. Secondary endpoints included procedural, early safety and efficacy endpoints at 30 days. Two hundred and fifty patients with severe aortic stenosis undergoing transcatheter aortic valve implantation (TAVI) with the DFM-TAVS were enrolled in 21 European centres. The primary endpoint, freedom from all-cause mortality at 30 days, was met in 98% (245/250) of patients. Device success was 83.8%. Moderate or severe aortic regurgitation was reported in 3% of patients, and none/trace regurgitation in 73% of patients. Post-procedural permanent pacemaker implantation was performed in 30 patients (12.0%).
  
  
  CONCLUSIONS
  The DFM-TAVS was associated with good short-term outcomes in this real-world registry. The low pacemaker and aortic regurgitation rates confirm the advantages of this next-generation transcatheter heart valve (THV).
authors.affiliation: Contilia Heart and Vascular Centre, Elisabeth-Krankenhaus Essen, Essen, Germany.
authors.forename: Christoph K
authors.initials: CK
authors.lastname: Naber
authors.forename: Stylianos A
authors.initials: SA
authors.lastname: Pyxaras
authors.forename: Hüseyin
authors.initials: H
authors.lastname: Ince
authors.forename: Peter
authors.initials: P
authors.lastname: Frambach
authors.forename: Antonio
authors.initials: A
authors.lastname: Colombo
authors.forename: Christian
authors.initials: C
authors.lastname: Butter
authors.forename: Fernando
authors.initials: F
authors.lastname: Gatto
authors.forename: Ulrich
authors.initials: U
authors.lastname: Hink
authors.forename: Georg
authors.initials: G
authors.lastname: Nickenig
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Bruschi
authors.forename: Guus
authors.initials: G
authors.lastname: Brueren
authors.forename: Didier
authors.initials: D
authors.lastname: Tchétché
authors.forename: Peter
authors.initials: P
authors.lastname: Den Heijer
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Schillinger
authors.forename: Smita
authors.initials: S
authors.lastname: Scholtz
authors.forename: Jan
authors.initials: J
authors.lastname: Van der Heyden
authors.forename: Thierry
authors.initials: T
authors.lastname: Lefèvre
authors.forename: Martine
authors.initials: M
authors.lastname: Gilard
authors.forename: Karl-Heinz
authors.initials: KH
authors.lastname: Kuck
authors.forename: Joachim
authors.initials: J
authors.lastname: Schofer
authors.forename: Dimitar
authors.initials: D
authors.lastname: Divchev
authors.forename: Helmut
authors.initials: H
authors.lastname: Baumgartner
authors.forename: Federico
authors.initials: F
authors.lastname: Asch
authors.forename: Daniel
authors.initials: D
authors.lastname: Wagner
authors.forename: Azeem
authors.initials: A
authors.lastname: Latib
authors.forename: Federico
authors.initials: F
authors.lastname: De Marco
authors.forename: Stephan
authors.initials: S
authors.lastname: Kische
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001021:Aortic Valve / Q000601:surgery*; D001022:Aortic Valve Insufficiency / Q000209:etiology; D001024:Aortic Valve Stenosis / Q000601:surgery*; D006328:Cardiac Catheterization; D005260:Female; D006350:Heart Valve Prosthesis; D019918:Heart Valve Prosthesis Implantation / Q000379:methods; D006801:Humans; D008297:Male; D011446:Prospective Studies; D012042:Registries; D012307:Risk Factors; D065467:Transcatheter Aortic Valve Replacement / Q000379:methods; D016896:Treatment Outcome