Transfemoral aortic valve implantation with the repositionable Lotus valve for treatment of patients with symptomatic severe aortic stenosis: results from a single-centre experience.

AIMS: The aim of the study was to evaluate the procedural and 30-day results for the repositionable Lotus valve in patients undergoing transfemoral aortic valve implantation in a single-centre experience. METHODS AND
RESULTS: We prospectively enrolled 110 patients with severe symptomatic aortic stenosis (NCT02162069). All procedures were performed without general anaesthesia by the transfemoral approach. Patients were followed for 30 days. Patients received the 23 mm (n=20), 25 mm (n=43) or 27 mm (n=47) Lotus device. Mean oversizing in relation to annulus or left ventricular outflow tract (LVOT) did not differ among groups. There was no residual moderate or severe aortic regurgitation. The rate of mild aortic regurgitation was low at 9.1%. There was no valve embolisation, no need for a second valve and no conversion to surgery. The need for a new pacemaker implantation due to complete (third degree) or type II (Mobitz) second degree atrioventricular block was 24.1%, excluding patients with previously implanted devices. Within 30 days the rates of all-cause mortality and stroke were low.
CONCLUSIONS: In patients with severe aortic stenosis, transfemoral TAVI with the repositionable Lotus valve was associated with a high rate of device success, no moderate or severe residual aortic regurgitation, low rates of major vascular complications and mortality within 30 days.