New data from the Boston Scientific clinical trial programme of the Lotus transcatheter aortic valve implantation (TAVI) system continue to demonstrate strong performance with the device as a less invasive treatment for patients with severe aortic stenosis who are considered high risk for surgical valve replacement.
According to a press release, data from the REPRISE II clinical trial confirmed safety and effectiveness out to one year, with more than 86% of patients exhibiting a complete absence of paravalvular aortic regurgitation and no patients demonstrating moderate or severe paravalvular aortic regurgitation. New data from the REPRISE I and REPRISE II clinical trials were presented at the 26th Transcatheter Cardiovascular Therapeutics (TCT) meeting (13–17 September, Washington, USA).
REPRISE II is an ongoing prospective, single-arm, multicentre study designed to evaluate safety and performance of the Lotus valve system for symptomatic patients with severe calcific aortic stenosis who are considered high risk for surgical valve replacement. The study enrolled 120 patients at 14 sites in Australia, France, Germany and the UK. Key one-year results include the following:
Mean aortic valve pressure gradient remained low and stable at 12.6 + 5.7mmHg
More than 86% of patients had no paravalvular aortic regurgitation by independent core lab assessment. In addition, no cases of moderate or severe paravalvular aortic regurgitation occurred. Mild and trace paravalvular aortic regurgitation rates were low at 11.4% and 2.3%, respectively.
Cardiovascular mortality rate was 6.7%
Disabling stroke rate was 3.4%
No cases of non-study valve implantation, unplanned use of cardiopulmonary bypass, valve embolisation, valve-in-valve or ectopic valve placement occurred.
“The one-year REPRISE II data show strong and sustained clinical benefits, excellent valve haemodynamics and remarkably low rates of paravalvular regurgitation and cardiovascular mortality,” says Ian Meredith, director of MonashHeart at Monash Medical Centre in Melbourne, Australia, and principal investigator of the REPRISE II trial. “These positive data reinforce the benefits and features of the Lotus valve system including the ability to achieve precise primary valve placement, reposition or fully retrieve if needed, and minimise if not obliterate paravalvular regurgitation with an effective adaptive seal.”