Boston Scientific has initiated the RESPOND post market registry to assess real world performance of the Lotus valve system. The RESPOND registry will collect data on clinical outcomes and device performance in 1,000 patients implanted at 50 centres around the world.
Three patients enrolled in the RESPOND registry thus far have been successfully implanted with the Lotus valve system. Nicolas Van Mieghem and Peter De Jaegere led the first transcatheter aortic valve implantation (TAVI) procedure at Erasmus Medical Center in Rotterdam, the Netherlands, using the Boston Scientific Safari pre-shaped TAVI guidewire. The Safari guidewire, which received US Food and Drug Administration (FDA) clearance and CE mark approval in 2013, is compatible with the Lotus valve system and other TAVI devices and is designed to facilitate stable, atraumatic valve placement.
The RESPOND registry is a prospective, open label, single arm, multicentre, observational post market study. Clinical follow-up is at discharge, 30 days, 12 months and annually through five years. It features a primary endpoint of all-cause mortality compared to a performance goal, plus secondary endpoints using Valve Academic Research Consortium guidelines and definitions. An independent core laboratory will analyse the echocardiographic images and an independent clinical events committee will adjudicate key clinical events. These measures are designed to increase the quality of the collected data and address inconsistencies with site-reported data commonly observed in post market studies.
“It’s a great privilege to kick off the RESPOND registry with this first implant,” says Van Mieghem, co-lead principal investigator of the RESPOND registry. “The Lotus valve system truly is an elegant and novel transcatheter valve concept providing a high level of precision and control. It simplifies the TAVI procedure by having the ability to assess valve functionality fully before release, which helps ensure optimal valve placement and a positive clinical outcome.”
REPRISE II six-month outcomes were presented at EuroPCR 2014 (20–23 May; Paris, France). The clinical study demonstrated 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. REPRISE II is evaluating the Lotus valve system in symptomatic patients with severe aortic valve stenosis considered at high risk for surgical valve replacement.