Direct aortic access for transcatheter aortic valve replacement with a fully repositionable and retrievable nonmetallic valve system.

OBJECTIVE: The standard procedure of transcatheter aortic valve implantation involves transfemoral access. Nevertheless, the use of this access route is limited by the vessel diameter, calcification, and tortuosity, making a subgroup of patients ineligible for peripheral access. We report the first use of direct aortic transcatheter aortic valve implantation with the Direct Flow Medical valve (Direct Flow Medical, Inc, Santa Rosa, Calif) in 15 patients at the Halle-Wittenberg University.

METHODS: Between January 2014 and May 2015, 55 patients with severe aortic valve disease underwent transcatheter aortic valve implantation with the Direct Flow Medical valve at the Halle-Wittenberg University. Subgroups of 15 patients were treated using direct aortic access because of small vessel diameter, excessive calcification, or extreme tortuosity of the iliofemoral vessels.

RESULTS: The mean patient age was 79.1 ± 6.72 years, and 10 patients (66%) were male. The mean logistic European System for Cardiac Operative Risk Evaluation was 23.4% ± 16.9%, and the mean Society of Thoracic Surgeons score was 7.8% ± 6.8%. Access related to redo-sternotomy during transcatheter aortic valve implantation was required in 4 patients (27%). Valve retrieval was performed in 2 patients (13%). There was no conversion to surgical aortic valve replacement and no incidence of major stroke. The postimplant mean gradient was 9.3 ± 2.5 mm Hg. No patient had moderate or severe paravalvular leakage. All patients survived the first 30 days.

CONCLUSIONS: Direct aortic access seems to be a feasible and safe endovascular alternative for implantation of the Direct Flow Medical valve. This access provides direct and accurate control of the entire implantation procedure.