TY  - BOOK
AU  - Asch, Federico M
TI  - A multicentre European registry to evaluate the Direct Flow Medical transcatheter aortic valve system for the treatment of patients with severe aortic stenosis
SN  - 1774-024X
PY  - 2016///
KW  - *Aortic Valve Stenosis/su [Surgery]
KW  - *Aortic Valve/su [Surgery]
KW  - *Transcatheter Aortic Valve Replacement
KW  - Aged
KW  - Aged, 80 and over
KW  - Aortic Valve Insufficiency/et [Etiology]
KW  - Cardiac Catheterization
KW  - Female
KW  - Heart Valve Prosthesis
KW  - Heart Valve Prosthesis Implantation/mt [Methods]
KW  - Humans
KW  - Male
KW  - Prospective Studies
KW  - Registries
KW  - Risk Factors
KW  - Transcatheter Aortic Valve Replacement/mt [Methods]
KW  - Treatment Outcome
KW  - MedStar Health Research Institute
KW  - Clinical Trial
KW  - Journal Article
KW  - Multicenter Study
N2  - 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; 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); 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%)
UR  - https://dx.doi.org/10.4244/EIJ-D-15-00511
ER  -