The Boston Scientific Lotus valve system advanced transcatheter aortic valve implantation (TAVI) technology continued to demonstrate impressive performance at three months, according to new data presented at the American College of Cardiology conference 2014 in Washington, DC, USA.
The REPRISE II clinical trial, evaluating the Lotus valve system in symptomatic patients with severe aortic valve stenosis considered at high risk for surgical valve replacement, demonstrated favourable safety and efficacy outcomes out to three months with 85% of patients having no paravalvular aortic regurgitation. The data were presented by Ian Meredith, director of Monash Heart at Monash Medical Centre in Melbourne, Australia, and principal investigator of the REPRISE II trial.
REPRISE II is an ongoing prospective, single-arm study that has enrolled 120 patients at 14 sites in Australia, France, Germany and the UK. An additional 130 patients will be enrolled in an extension of REPRISE II at 16 sites in Australia and Europe, and enrolment in this extension of REPRISE II is expected to be complete in April 2014.
Key findings from the study include the following:
• At 90 days, an impressive 85.4% 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 90 days. There were two cases of moderate paravalvular aortic regurgitation (2.1%) and in 12.5% of patients, paravalvular regurgitation was considered mild.
• The primary device performance endpoint of 30-day mean aortic valve pressure gradient, as assessed by an independent core laboratory, was met as the 30-day mean aortic valve pressure gradient of 11.5±5.2mm Hg was significantly (P<0.001) less than the performance goal of 18mm Hg. At 90 days, the mean aortic valve pressure gradient remained low and stable at 11.5±5.4mm Hg.
• All-cause mortality at 90 days was 5%.
• No instances of non-study valve implantation, unplanned use of cardiopulmonary bypass, valve embolisation, valve-in-valve or ectopic valve placement occurred.
• The disabling stroke rate at 90 days was 2.5%.
One-year results from REPRISE I, a prospective, single-arm feasibility study of patients with severe symptomatic aortic stenosis conducted in Australia, were presented in May of 2013 at EuroPCR by Meredith and published online ahead of print by EuroIntervention. The data demonstrated sustained safety and performance of the Lotus valve system out to one year with no moderate or severe paravalvular aortic regurgitation in any patient.