[Safety and feasibility of sheathless transfemoral aortic valve implantation]

Objective: To investigate the safety and feasibility of sheathless transfemoral aortic valve replacement (TAVR). Methods: In this prospective study, we enrolled 23 patients with severe aortic stenosis (AS) who were inoperable or at high-risk for surgical aortic valve replacement operation in Fuwai hospital From September 2012 to June 2015. Multislice spiral CT and angiography of femoral artery showed that all patients had minimal femoral artery diameters (<6.5 mm) and severe calcification which was not suitable for transfemoral TAVR through sheath. We attempted to apply the sheathless transfemoral TAVR using Venus-A prosthesis without sheath insertion, and procedure related complication during the procedure and hospital stay were observed. Results: The 6 mm×30 mm balloon was used for femoral artery predilation in 1 patient with iliofemoral artery stenosis before delivery system was transported. In the other 22 patients, the delivery system was transported directly. A total of 21 patients finished TAVR with transfemoral sheathless technique. In 2 patients, prosthesis was unable to fully expand after release due to severe valve calcification, and patients received urgent surgical aortic valve replacement. One patient had valve dislocation into the ascending aorta that was not related to the sheathless replacement technique, and delivery system and Venus-A valve were removed after femoral artery was opened surgically, and repeated sheathless TAVR implantation was performed and was successful. Moderate aortic regurgitation occurred in 2 patients immediately after procedure, and trace or mild aortic regurgitation was detected in rest of the patients. One patient had puncture site rupture and bleeding after procedure, and was successfully treated by balloon compression without blood transfusion. Complete atrioventricular block occurred in 3 patients within 24 hours after procedure and lasted after 48-72 hours, permanent pacemakers were implanted in these patients. Conclusion: The sheathless transfemoral technique in TAVR is safe and feasible in severe aortic stenosis patients with small access vessel diameter.