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

Christoph K. Naber, Stylianos A. Pyxaras, Hüseyin Ince, Peter Frambach, Antonio Colombo, Christian Butter, Fernando Gatto, Ulrich Hink, Georg Nickenig, Giuseppe Bruschi, Guus Brueren, Didier Tchétché, Peter Den Heijer, Wolfgang Schillinger, Smita Scholtz, Jan Van Der Heyden, Thierry Lefèvre, Martine Gilard, Karl Heinz Kuck, Joachim SchoferDimitar Divchev, Helmut Baumgartner, Federico Asch, Daniel Wagner, Azeem Latib, Federico De Marco, Stephan Kische

Research output: Contribution to journalArticlepeer-review

5 Scopus citations

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. 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).

Original languageEnglish (US)
Pages (from-to)e1413-e1419
JournalEuroIntervention
Volume12
Issue number11
DOIs
StatePublished - Dec 2016
Externally publishedYes

Keywords

  • Repositionability
  • Retrievability
  • Severe aortic valve stenosis
  • Transcatheter aortic valve implantation

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Fingerprint Dive into the research topics of 'A multicentre European registry to evaluate the Direct Flow Medical transcatheter aortic valve system for the treatment of patients with severe aortic stenosis'. Together they form a unique fingerprint.

Cite this