Boston Lotus Valve System

Results from the REPRISE II clinical trial demonstrated that the Lotus Valve System delivered sustained safety and effectiveness outcomes out to six months, with only 1.1 per cent of patients having moderate paravalvular aortic regurgitation (leaking).  No severe cases occurred.  The data were presented by Professor 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 System in symptomatic patients with severe aortic valve stenosis considered at high risk for surgical valve replacement.

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.

An impressive 79.8 per cent 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 per cent. The disabling stroke rate was 3.4 per cent.
No cases of non-study valve implantation, unplanned use of cardiopulmonary bypass, valve embolisation, valve-in-valve or ectopic valve placement occurred.