TY - JOUR
T1 - A multicentre European registry to evaluate the Direct Flow Medical transcatheter aortic valve system for the treatment of patients with severe aortic stenosis
AU - Naber, Christoph K.
AU - Pyxaras, Stylianos A.
AU - Ince, Hüseyin
AU - Frambach, Peter
AU - Colombo, Antonio
AU - Butter, Christian
AU - Gatto, Fernando
AU - Hink, Ulrich
AU - Nickenig, Georg
AU - Bruschi, Giuseppe
AU - Brueren, Guus
AU - Tchétché, Didier
AU - Den Heijer, Peter
AU - Schillinger, Wolfgang
AU - Scholtz, Smita
AU - Van Der Heyden, Jan
AU - Lefèvre, Thierry
AU - Gilard, Martine
AU - Kuck, Karl-Heinz
AU - Schofer, Joachim
AU - Divchev, Dimitar
AU - Baumgartner, Helmut
AU - Asch, Federico
AU - Wagner, Daniel
AU - Latib, Azeem
AU - De Marco, Federico
AU - Kische, Stephan
PY - 2016/12/1
Y1 - 2016/12/1
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. 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%). 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).
AB - 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. 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%). 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).
KW - Repositionability
KW - Retrievability
KW - Severe aortic valve stenosis
KW - Transcatheter aortic valve implantation
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U2 - 10.4244/EIJ-D-15-00511
DO - 10.4244/EIJ-D-15-00511
M3 - Article
VL - 12
SP - e1413 - e1419
JO - EuroIntervention
JF - EuroIntervention
SN - 1774-024X
IS - 11
ER -