Citation: Eurointervention. 12(11):e1413-e1419, 2016 Dec 10.Journal: EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology.Published: 2016ISSN: 1774-024X.Full author list: Naber CK; Pyxaras SA; Ince H; Frambach P; Colombo A; Butter C; Gatto F; Hink U; Nickenig G; Bruschi G; Brueren G; Tchetche D; Den Heijer P; Schillinger W; Scholtz S; Van der Heyden J; Lefevre T; Gilard M; Kuck KH; Schofer J; Divchev D; Baumgartner H; Asch F; Wagner D; Latib A; De Marco F; Kische S.UI/PMID: 27934611.Subject(s): Aged | Aged, 80 and over | *Aortic Valve/su [Surgery] | Aortic Valve Insufficiency/et [Etiology] | *Aortic Valve Stenosis/su [Surgery] | Cardiac Catheterization | Female | Heart Valve Prosthesis | Heart Valve Prosthesis Implantation/mt [Methods] | Humans | Male | Prospective Studies | Registries | Risk Factors | Transcatheter Aortic Valve Replacement/mt [Methods] | *Transcatheter Aortic Valve Replacement | Treatment OutcomeInstitution(s): MedStar Health Research InstituteActivity type: Journal Article.Medline article type(s): Clinical Trial | Journal Article | Multicenter StudyDigital Object Identifier: https://dx.doi.org/10.4244/EIJ-D-15-00511 (Click here)Abbreviated citation: EuroIntervention. 12(11):e1413-e1419, 2016 Dec 10.Abstract: AIMS: 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.Abstract: METHODS AND 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%).Abstract: 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).