Medtronic Announces Early OPTIMIZE PRO Data for Evolut Pro TAVR Systems

April 28, 2021—Medtronic announced results from an interim analysis of the first 171 patients (including 71 roll-ins) treated in the OPTIMIZE PRO clinical study of the company’s self-expanding, supra-Evolut Pro and Pro+ transcatheter aortic valve replacement (TAVR) systems.

The findings were presented by the study’s Coprincipal Investigator, Kendra Grubb, MD, at the Society for Cardiovascular Angiography and Interventions’ SCAI 2021 Virtual Scientific Sessions.

According to Medtronic, the postmarket, prospective, multicenter OPTIMIZE PRO study is evaluating procedural outcomes (including pacemaker rate) associated with procedure-related techniques and post-procedure TAVR care pathways when using the annular Evolut Pro and Pro+ devices in patients with symptomatic severe aortic stenosis.

The OPTIMIZE PRO study is being conducted at 46 study sites in the United States 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 1 year.


Several procedural approaches with the Evolut TAVR system were utilized in the study, including the cusp overlap technique, which is designed to help physicians assess and achieve the target implant depth to reduce interaction with the conduction system.


Medtronic reported that the 30-day safety outcomes included zero deaths or disabling strokes and a low pacemaker rate (8.8%). Additionally, the Evolut platform’s hemodynamic performance demonstrated low mean gradients (8.1 mm Hg) and low rates of residual total aortic regurgitation with the majority of patients 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 1 day.


The company noted that the OPTIMIZE PRO study uses 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 evolution of TAVR requires that we refine aspects of the procedure and post-procedure care pathways to improve patient outcomes,” commented Dr. Grubb in Medtronic’s press release. “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.” Dr. Grubb is Surgical Director of the Structural Heart and Valve Center at Emory Healthcare in Atlanta, Georgia.


The Evolut TAVR platform, including the Evolut R, Evolut Pro and Evolut Pro+ system, is indicated for symptomatic severe aortic stenosis patients across all risk categories (extreme, high, intermediate, and low) in the United States, advised Medtronic.