Aortic regurgitation after valve implantation has been shown to be a long -term mortality predictor. The aim of this study was to test the new Direct Flow Medical system, which is more flexible prosthesis with a lower profile that could result in minor aortic regurgitation and less need for post expansion. This multicenter study included 30 patients with symptomatic severe aortic stenosis and high surgical risk.

The all-cause mortality at 30 days was 3%, and only one patient required a permanent pacemaker. There were no cases of embolization or migration of the prosthesis. No patient had moderate or other level of aortic regurgitation during post procedure as well as at 30 days after implantation, only 15% shown mild regurgitation.

Conclusion

The system for percutaneous aortic valve replacement Direct Flow was safe and feasible with 97 % survival at 30 days and no patients with moderate aortic regurgitation over the same period.

M. Tuzcu
2014-05-22

Title: The SALUS trial: initial results of the US feasibility trial of the Direct Flow Medical transcatheter aortic valve