A Boston Scientific press release reports that new data for its Lotus transcatheter aortic valve implantation (TAVI) device indicate that the valve is associated with sustained safety and effectiveness at six months. The data were presented at EuroPCR (20-23 May; Paris, France).
Results from the REPRISE II clinical trial demonstrate that the Lotus valve system delivered sustained safety and effectiveness outcomes out to six months, with only 1.1% of patients having moderate paravalvular aortic regurgitation. No severe cases occurred. The data were presented by Ian Meredith, director of MonashHeart, at Monash Medical Centre in Melbourne, Australia, and principal investigator of the REPRISE II trial. The study is evaluating the Lotus valve in symptomatic patients with severe aortic valve stenosis considered at high risk for surgical valve replacement.
In REPRISE II, the key six-month findings include the following:
- The primary device performance endpoint of 30-day mean aortic valve pressure gradient, as assessed by an independent core lab, was met as the 30-day mean aortic valve pressure gradient of 11.5 +/- 5.2mmHg was significantly less than the performance goal of 18 mmHg (P<0.001). At six months, the mean aortic valve pressure gradient remained low and stable at 11.4 +/- 4.6 mmHg.
- 79.8% of patients had no paravalvular aortic regurgitation by independent core lab assessment. In addition, no cases of severe paravalvular aortic regurgitation occurred in any patient at six months.
- The all-cause mortality rate was 8.4%.
- The disabling stroke rate was 3.4%.
- No cases of non-study valve implantation, unplanned use of cardiopulmonary bypass, valve embolization, valve-in-valve or ectopic valve placement occurred.
“These new results from the REPRISE II clinical trial programe underscore the unique technology behind the Lotus valve system,” says Keith Dawkins, global chief medical officer, Boston Scientific. “These features are designed to provide a predictable implantation procedure and may result in improved clinical outcomes. The Lotus valve offers a novel TAVI option for patients with severe aortic valve disease considered at high risk for surgical valve replacement.”
REPRISE II is an ongoing prospective, single-arm study that enrolled 120 patients at 14 sites in Australia, France, Germany and the UK. The trial was extended to an additional 130 patients at 16 sites in Australia and Europe. Enrolment in this extension of REPRISE II is now complete.