Prospective Multicenter Evaluation of the Direct Flow Medical Transcatheter Aortic Valve

Abstract

The present study demonstrates the safety and efficacy of the DFM system in surgical high risk patients with severe aortic stenosis and complex anatomy aortic regurgitation was less than moderate in 99% of patients.

Transcatheter Aortic Valve Replacement Indications Should be Expanded to Lower-Risk and Younger Patients

“…69 Data from the multicenter prospective trial of the direct flow medical transcatheter aortic valve (DISCoVER CE) trial evaluating this valve reported 2.7% with major strokes, 16% with permanent pacemaker implantation, with 99% with absent or only mild aortic regurgitation. 69 These data are in line with the recent experience from the ACURATE TF study, 70 investigating the performance of the Symetis ACURATE valve (Symetis, Ecublens, Switzerland). The procedural success was high; 13% required a permanent pacemaker; and 95% had mild or absent perivalvular leak at 30 days after implantation.…”

Aortic Regurgitation After Transcatheter Aortic Valve Replacement

“…The multicenter non-randomized DISCOVER trial in 100 patients with logistic EuroSCORE ≥20 or other high surgical risk features not reflected by the log EuroSCORE showed a 30-day survival rate of 99% and mild or no AR in 99% (73/74 patients). 45 Initially observed higher residual gradients after valve implantation were not significant in the DISCOVER trial because of a clear strategy that included repositioning of the valve in cases of significant residual stenosis. The mean echocardiographic gradient decreased from an average of 45.9±9.6 mmHg (n=72) to an average of 12.6±7.1 mmHg (n=72) post-procedure over 30 days.…”

Advances in Transcatheter Aortic Valve Replacement

“…In the first study performed, aortic regurgitation was mild or less in 98.6% of patients. 20 Both the Lotus and Direct Flow Medical valves are commercially available in Europe but remain investigational in local and national U.S. research centers.…”