The Lotus Valve system (Boston Scientific; Marlborough, MA) demonstrated excellent valve hemodynamics, minimal paravalvular regurgitation, and significant improvement in clinical outcomes for patients undergoing transcatheter aortic valve replacement (TAVR), according to results from the REPRISE II study.
REPRISE II (Repositionable Percutaneous Placement of Stenotic Aortic Valve Through Implantation of Lotus Valve System—Evaluation of Safety and Performance) investigators measured 1-year safety and performance outcomes of the Lotus Valve, a fully repositionable and retrievable valve designed to facilitate primary positioning, early valve function, and hemodynamic stability during deployment.
Researchers enrolled 120 patients 70 years of age or older (mean age: 84.4 ± 5.3 years) in the trial from 14 centers in Europe and Australia. All patients had severe calcific aortic stenosis and high or extreme risk of surgery.
At baseline, the mean aortic valve area was 0.7 ± 0.2 cm2, and the mean transvalvular pressure gradient was 46.4 ± 15.0 mm Hg. All patients in the study were successfully implanted with Lotus Valve and followed for 1 year.
“More than 88% of patients had no or trivial paravalvular regurgitation, and no patient had moderate or severe paravalvular regurgitation,” the authors wrote. “Additionally we observed significant and sustained improvement in NYHA [New York Heart Association] functional class, significantly improved quality of life measures from baseline, and adverse event rates consistent with those reported for other transcatheter valves.”
The mean 1-year transvalvular aortic pressure gradient was 12.6 ± 5.7 mm Hg and the mean 1-year valve area was 1.7 ± 0.5 cm2. In addition to the 88.6% of patients who had little or no paravalvular aortic regurgitation at 1 year, 97.1% were classified into NYHA functional class I or II.
At the 1-year end point, the all-cause mortality rate was 10.9%, the disabling stroke rate was 3.4%, the disabling bleeding rate was 5.9%, and there were no repeat procedures for valve-related dysfunction. However, 31.9% of patients did undergo new permanent pacemaker implantation at 1 year.
These 1-year results suggest that the Lotus Valve could be a valuable new addition for the minimally invasive treatment of aortic stenosis.
“Initial results with the Lotus Valve from this REPRISE II CE-mark study demonstrate very promising results for the improved treatment of aortic stenosis,” the authors concluded, “however, longer term follow-up and head-to-head comparisons with other available technologies will be needed to determine the wider clinical utility of the technological advancements of the Lotus Valve.”
Meredith IT, Walters DL, Dumonteil N, et al. 1-Year outcomes with the fully repositionable and retrievable lotus transcatheter aortic replacement valve in 120 high-risk surgical patients with severe aortic stenosis: results of the REPRISE II study. JACC Cardiovasc Interv. 2016;9(4):376-384. doi: 10.1016/j.jcin.2015.10.024.