Medtronic Reports Midterm Results of OPTIMIZE PRO Study of Evolut TAVR System With Cusp Overlap Technique

May 17, 2022—Medtronic announced results of 400 patients treated in the United States and Canada from the main cohort of the OPTIMIZE PRO clinical study evaluating valve performance and procedural outcomes associated with an “optimized” pre- and postprocedural transcatheter aortic valve replacement (TAVR) care pathway, utilizing the cusp overlap technique to deploy the company’s Evolut valves.

According to Medtronic, 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 cusp overlap technique is designed to help interventionalists assess and achieve the target implantation depth to reduce interaction with the conduction system.

The postmarket, prospective, multicenter OPTIMIZE PRO study is evaluating outcomes associated with procedure-related techniques and postprocedure TAVR when using the self-expanding, supra-annular Evolut Pro and Pro+ TAVR systems in patients with symptomatic severe aortic stenosis.

The current interim analysis includes 400 main cohort patients and 104 roll-in patients at up to 46 sites in the United States and Canada. 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 implantation 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.

OPTIMIZE PRO Coprincipal Investigator Kendra Grubb, MD, presented the findings as a featured Hotline Trial at the EuroPCR 2022 conference held May 17-20 in Paris, France. Dr. Grubb is Surgical Director of the Structural Heart and Valve Center at Emory University in Atlanta, Georgia.

Medtronic reported that the study results showed that the cusp overlap technique led to more predictability and control resulting in a pacemaker implantation rate of 9.2%; a 30-day mortality rate of 0.8%; median length of hospital stay of 1 day; and no cases of moderate/severe paravalvular leak (PVL) on discharge with 78% of patients having none/trace PVL. The lowest pacemaker implantation rates were observed when all steps of the cusp overlap technique were followed, noted the company’s press release.

“The results demonstrate significant improvement for TAVR with the Evolut valve, some of the best results in an Evolut trial we have ever seen,” commented Dr. Grubb in Medtronic’s press release. “Adopting the cusp overlap technique and clinical pathways resulted in single-digit pacemaker rates out to 30 days, next-day discharge in the majority of the patients, and remarkably low rates of PVL.”