Six-month outcomes for the first 60 patients in a clinical study of a repositionable second generation device for transcatheter aortic valve implantation.

Aims: The repositionable and fully retrievable Lotus Aortic Valve Replacement System is designed to facilitate controlled, precise positioning and minimise paravalvular leakage. The REPRISE II study is evaluating safety and performance of Lotus for TAVI. Methods and Results: In the prospective, single arm, multicentre REPRISE II study, symptomatic patients at high risk for surgical intervention received the transfemoral Lotus Valve for the treatment of calcified aortic valve stenosis. Eligible patients had a Society of Thoracic Surgeons (STS) score greater than or equal to 8% and/or documented Heart Team agreement of high risk due to frailty or other comorbidities, and an aortic annulus of 19-27 mm (23 mm and 27 mm valve sizes used). The primary device performance endpoint is the mean aortic valve pressure gradient at 30 days post implant as measured by core-lab echocardiography and compared to a prespecified performance goal. The primary safety endpoint is all-cause mortality at 30 days. Secondary endpoints include effective orifice area at 30 days, device performance endpoints peri-procedure and post-procedure, and device success assessed according to the most recent Valve Academic Research Consortium criteria (VARC-2). A prespecified interim analysis was conducted on the first 60 enrolled patients (7 centres); mean age was 85.5 years and 63% were female. The mean STS score was 6.4+/-3.0%. Most (85%) had hypertension, 27% had diabetes, 12% had moderate/severe chronic obstructive pulmonary disease, 60% had a history of coronary artery disease, 75% were classified as NYHA Class III or IV, and 5% had a history of cerebrovascular accident. Conclusion(s): Six-month data from the first 60 REPRISE II patients will be available for presentation for the first time at PCR London Valves 2013.