A multicentre European registry to evaluate the Direct Flow Medical transcatheter aortic valve system for the treatment of patients with severe aortic stenosis

被引:8
作者
Naber, Christoph K. [1 ]
Pyxaras, Stylianos A. [1 ]
Ince, Hueseyin [2 ,3 ]
Frambach, Peter [4 ]
Colombo, Antonio [5 ]
Butter, Christian [6 ]
Gatto, Fernando [7 ]
Hink, Ulrich [8 ]
Nickenig, Georg [9 ]
Bruschi, Giuseppe [10 ]
Brueren, Guus [11 ]
Tchetche, Didier [12 ]
Den Heijer, Peter [13 ]
Schillinger, Wolfgang [14 ]
Scholtz, Smita [15 ]
Van der Heyden, Jan [16 ]
Lefevre, Thierry [17 ]
Gilard, Martine [18 ]
Kuck, Karl-Heinz [19 ]
Schofer, Joachim [20 ]
Divchev, Dimitar [21 ]
Baumgartner, Helmut [22 ]
Asch, Federico [23 ]
Wagner, Daniel [4 ]
Latib, Azeem [5 ]
De Marco, Federico [10 ]
Kische, Stephan [2 ,3 ]
机构
[1] Elisabeth Krankenhaus Essen, Contilia Heart & Vasc Ctr, Klara Kopp Weg 1, D-45138 Essen, Germany
[2] Vivantes Klinikum Friedrichshain & Urban, Berlin, Germany
[3] Univ Klinikum Rostock, Rostock, Germany
[4] Inst Chirurg Cardiaque & Cardiol Intervent, Luxembourg, Luxembourg
[5] Ist Sci San Raffaele, Intervent Cardiol Unit, Milan, Italy
[6] Immanuel Klinikum Bernau, Herzzentrum Brandenburg, Bernau, Germany
[7] Herzzentrum Saar, Volklingen, Germany
[8] Univ Klinikum Mainz, Mainz, Germany
[9] Univ Klinikum Bonn, Bonn, Germany
[10] Osped Niguarda Ca Granda, Milan, Italy
[11] Catharina Hosp, Eindhoven, Netherlands
[12] Clin Pasteur, Toulouse, France
[13] Amphia Ziekenhuis Hartctr, Cardiol, Breda, Netherlands
[14] Univ Klinikum Gottingen, Gottingen, Germany
[15] Ruhr Univ Bochum, Klin Kardiol Herz & Diabet Zentrum NRW, Bad Oeynhausen, Germany
[16] St Antonius Hosp, Nieuwegein, Netherlands
[17] Hop Prive Jacques Cartier, Massy, France
[18] CHU Brest, Brest, France
[19] Asklepios Klin St Georg, Hamburg, Germany
[20] Albertinen Herzzentrum, Hamburg, Germany
[21] Univ Klinikum Rostock, Rostock, Germany
[22] Univ Klinikum Munster, Munster, Germany
[23] MedStar Hlth Res Inst, Washington, DC USA
关键词
repositionability; retrievability; severe aortic valve stenosis; transcatheter aortic valve implantation; IMPLANTATION; REGURGITATION; DEFINITIONS; REPLACEMENT; PROSTHESIS; EXPERIENCE; COREVALVE;
D O I
10.4244/EIJ-D-15-00511
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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).
引用
收藏
页码:E1413 / E1419
页数:7
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