The objective was to evaluate the safety and efficacy of the Lotus Valve System to treat patients with severe aortic stenosis and high surgical risk. The study included 60 patients who received the device and were followed during 30 days. Mortality from all causes was 1.7% and the incidence of stroke was 8.6%, with half of these being of disabling nature. According to the VARC criteria, the successful implantation rate of the device was 100%.
Conclusion: This device was successfully implanted in all patients, with a low 30-day mortality rate. No valve embolization or inadequate implantation was observed. The rate of clinical events is similar to the one showed by other valves.
Ian T. Meredith, MBBS, PHD
2013-05-22
Original title: Repositionable percutaneous replacement of a stenotic aortic valve throughimplantation of the Lotus Valve System: 30-day outcomes for the first60 patients in the REPRISE II study
