Medtronic has completed an interim analysis of the first 171 patients treated with the Evolut Pro and Pro+ transcatheter aortic valve replacement (TAVR) systems, unveiling the data at the Society for Cardiovascular Angiography & Interventions 2021 Scientific Sessions.
After 30 days, Medtronic announced, patient outcomes for participants enrolled in the OPTIMIZE PRO clinical study have been “excellent.” This includes mortality and stroke rates of 0% and a pacemaker rate of 8.8%. In addition, more than 80% of patients have had presented with either trace residual total aortic regurgitation or none at all. The median hospital length of stay, meanwhile, is one day.
“The evolution of TAVR requires that we refine aspects of the procedure and post-procedure care pathways to improve patient outcomes,” Kendra Grubb, MD, co-principal investigator and surgical director of the Structural Heart and Valve Center at Emory Healthcare in Atlanta, said in a prepared statement. “Interim results from this study demonstrate improvements, like low pacemaker rates and next-day discharge, and are supportive of the hypothesis that the cusp overlap technique can improve patient care.”
“As a leader in transcatheter valves therapies, we are committed to helping implanting centers standardize and further refine their TAVR care pathways to improve patient outcomes,” added Nina Goodheart, president of Medtronic’s Structural Heart & Aortic business. “In addition to helping us better understand the site-driven dynamics around conduction disturbance post-TAVR, the study also allows us to generate additional evidence around the Evolut PRO and PRO+ system's advanced sealing skirt and its impact on paravalvular leak.”
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