Use of a Repositionable and Fully Retrievable Aortic Valve in Routine Clinical Practice
The RESPOND Study and RESPOND Extension Cohort
Nicolas M. Van Mieghem, Jochen Wöhrle, David Hildick-Smith, Sabine Bleiziffer, Daniel J. Blackman, Mohamed Abdel-Wahab, Ulrich Gerckens, Axel Linke, Hüseyin Ince, Peter Wenaweser, Dominic J. Allocco, Ian T. Meredith and Volkmar Falk
(A) The RESPOND study enrolled 1,014 patients in the main cohort (intent-to-treat population), 996 of whom were implanted with a Lotus valve (as-treated population). At 1 year, 995 patients had sufficient follow-up or had a clinical event (116 patients had died). Echocardiographic data at 1 year were available for core laboratory evaluation in 551 of the 880 surviving patients (62.6%). (B) The RESPOND Extension cohort comprised 50 patients treated with the Lotus valve with Depth Guard, all of whom had 30-day clinical follow-up available (there were no deaths at 30 days). Echocardiographic data at hospital discharge were available for 37 of the 50 Extension cohort patients (74.0%). RESPOND = Repositionable Lotus Valve System—Post-Market Evaluation of Real World Clinical Outcomes trial; TEE = transesophageal echocardiography; TTE = transthoracic echocardiography.