Multicenter experience with a second- generation fully-retrievable and repositionable transcatheter aortic valve

Abstract

Introduction and objectives: The Lotus Valve device (Boston Scientific) is a second-generation fully-retrievable and repositionable transcatheter aortic valve. We report the initial multicenter experience with the Lotus valve in the management of patients with severe aortic stenosis. Methods: Observational study that described the short and long-term results of implanting the Lotus valve in 8 Spanish and Portuguese centers from March 2014 through April 2016. Results: The study included 102 patients (mean age 80.4 +/- 6.1 years; STS score 5.2% +/- 3.3%) with severe symptomatic aortic stenosis (mean aortic valve area 0.66 +/- 0.17 cm(2), aortic gradients 74.3 / 45.6 mmHg). The valve was successfully implanted in 100 patients (98%), with significant improvement in both the peak and mean aortic valve gradients and with only one patient showing moderate paravalvular regurgitation. Upon hospital discharge, mortality rate was 3.9% while the stroke rate was 2.9%. No cases of valve embolization, ectopic valve deployment or additional valve implantation (valve-in-valve) were seen. Thirty-three patients (32.3%) received a permanent pacemaker. Conclusions: The Lotus Valve System is effective and safe for the management of patients with severe symptomatic aortic stenosis. In particular, considering the low rate of periprosthetic regurgitation and lack of complications like embolization or ectopic valve deployment; however at the expense of a high pacemaker implantation rate.