OPTIMIZE PRO clinical study shows promising early outcomes for patients implanted with the Evolut PRO TAVR System.- Medtronic.

Medtronic plc announced results from an interim analysis of the first 171 patients (including 71 roll-ins) treated in the OPTIMIZE PRO clinical study The post-market, prospective, multi-center study is evaluating procedural outcomes (including pacemaker rate) associated with procedure-related techniques and post-procedure TAVR (transcatheter aortic valve replacement) care pathways when using the self-expanding, supra-annular Evolut PRO and PRO+ TAVR systems in patients with symptomatic severe aortic stenosis. The interim data was presented virtually at the Society for Cardiovascular Angiography and Interventions (SCAI) 2021 Scientific Sessions. Study investigators utilized several procedural approaches with the Evolut TAVR system in the study, including the "cusp overlap technique," which is designed to help implanters assess and achieve the target implant depth in an effort to reduce interaction with the conduction system. At 30 days, excellent safety outcomes were observed with zero death or disabling stroke and a low pacemaker rate (8.8%). Additionally, the Evolut platform showed excellent hemodynamic (blood flow) performance with low mean gradients (8.1 mm Hg) and low rates of residual total aortic regurgitation with the majority of subjects having none/trace (80.4%), and the rest mild (19.6%) at discharge. Patients also experienced an expedited discharge with a median hospital length of stay of one day. The OPTIMIZE PRO study utilizes a TAVR care pathway to evaluate common practices and shared experiences such as conscious sedation and early mobilization. A conduction disturbance pathway evaluates efficiencies and heart team considerations for monitoring and managing patients with conduction disturbance who might be considered for a pacemaker post TAVR. The OPTIMIZE PRO study is being conducted at 46 study sites in the U.S. and Canada and up to 15 sites in Europe. The primary endpoint includes the rate of all-cause mortality or all-stroke at 30 days with secondary endpoints of discharge time, percent of patients with more than moderate aortic regurgitation, and the rate of pacemaker implant for new-onset or worsening conduction disturbance at 30 days. The study will also evaluate rehospitalization rates and discharge time at 30 days and one year. The Evolut TAVR platform, including the Evolut R, Evolut PRO and Evolut PRO+ TAVR System, is indicated for symptomatic severe aortic stenosis patients across all risk categories (extreme, high, intermediate and low) in the U.S. The Evolut PRO and PRO+ valves feature an outer tissue wrap that adds surface area contact between the valve and the native aortic annulus to further advance valve sealing. The Evolut PRO system is the next-generation, self-expanding transcatheter aortic valve with exceptional design and advanced sealing capability. The Evolut PRO system features a unique valve design with an outer wrap that adds surface area contact between the valve and the native aortic annulus to further advance valve sealing performance.