CHICAGO — In this video, Nicolas Van Mieghem, MD, from Thoraxcenter, Erasmus Medical Center, Rotterdam, Netherlands, presents results of the RESPOND post-market study at the American College of Cardiology Scientific Sessions.
The RESPOND study enrolled up to 1,000 patients outside the United States who underwent TAVR with a transcatheter valve (Lotus, Boston Scientific) that allows precise device implantation and could reduce paravalvular leakage via a ceiling skirt.
Van Mieghem presented results from the first 750 patients, many of whom were at high risk (mean age, 81 years; Society of Thoracic Surgery Predicted Risk of Mortality score, 6.2%).
At 30 days, there were positive results in terms of mortality (intention-to-treat population, 2.3%; as-treated population, 1.9%). Stroke rate was 2.5% and more than 90% of patients had no paravalvular leakage or only a trace.
The pacemaker implantation rate of 29% is high, but the rate has decreased slightly over the course of the study, which may be due to modifications in the technique used for implantation, according to Van Mieghem.
“I think the Lotus results from the RESPOND trial seem to [show good performance],” Van Mieghem said. “We have low procedural risk, we have very good results at 30 days with almost no paravalvular leakage and I think as such, it is a very powerful device for the future.”
The study device is not yet approved in the U.S.