[Percutaneous aortic valve replacement using the Direct Flow Medical system: results of the Luxembourg registry].

Abstract

Percutaneous aortic valve replacement (TAVI) is one of the most innovative procedure in interventional cardiology. The Direct Flow Medical transcatheter aortic valve (DFM) is a new nonmetallic valve which allows perfect repositioning and valve retrieval prior to the final deployment. This study is a prospective non-randomized evaluation of the DFM system in the Luxembourg registry. The study focused on 15 patients who received between March 2013 and October 2013 a percutaneous aortic valve replacement by DFM prosthesis. All clinical and echocardiographic data have been collected prospectively. Fifteen inoperable patients with severe aortic stenosis were evaluated. The average age of our population was 83 +/- 4.16 years, mean STS score was 16%. 46% of patients were in NYHA class III and 33.3% in NYHA class IV. Mean ejection fraction was 59% +/- 12.7, the average mean gradient was 52.86 +/- 18.5 mm Hg and mean aortic orifie was 0.63 +/- 0.15 cm2. Procedural success rate was 100%. The mean trans- valvular gradient decreased from 52.86 +/- 18.5 mm Hg to 12 +/- 4.2 mm Hg (p < 0.001). The average hospital stay was 14 +/- 7.6 days. The non-fatal major event rate at one month was 33.3%. The mortality rate at one month was limited to 6.6%. These results allow us to confirm the efficacy and safety of the DFM valve.