Medtronic (NYSE:MDT) today announced positive results from a study of its Evolut transcatheter aortic valve replacement (TAVR) system.
The Optimize PRO clinical study evaluated the self-expanding, supra-annular Evolut PRO and PRO+ TAVR platforms.
Medtronic’s CoreValve Evolut R, CorValve Evolut PRO and Evolut Pro+ systems are indicated for the relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis. Those patients are judged by a heart team to be appropriate for TAVR therapy.
A total of 400 patients were treated in the U.S. and Canada and evaluated the performance and procedural outcomes associated with the use of an “optimized” pre- and post-procedural TAVR care pathway, using the “cusp overlap” technique t deploy the valves, according to a news release. The cusp overlap method was designed to help implanters assess and achieve target implant depth to reduce the interaction with the conduction system.
Findings, which were presented as a featured Hotline Trial at EuroPCR 2022, showed that the cusp overlap technique led to more predictability and control, resulting in a single-digit pacemaker implantation rate (9.2%), a low 30-day mortality rate (0.8%), a median length of hospital stay totaling one day and, upon discharge, no cases of moderate/severe paravalvular leak (PVL).
In total, 78% of patients had none/trace PVL and the lowest pacemaker implantation rates were observed when all steps of the cusp overlap technique were followed.
The current interim analysis includes 400 main cohort patients and 104 roll-in patients across up to 46 sites in the U.S. and Canada, with the primary endpoint being the rate of all-cause mortality or all-stroke at 30 days.
Secondary endpoints include 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.
“We are committed to improving the TAVR care pathway with simple and repeatable techniques that implanting centers can use to help improve procedure efficiencies and success,” Medtronic VP and GM of Structural Heart Neil Yanke said in the release. “The findings presented today – coupled with our recent data presented at ACC 2022 establishing the CoreValve/Evolut TAVR systems as the first and only TAVR platform to demonstrate significantly lower rates of structural valve deterioration (SVD) vs. SAVR at five years – help to further establish the robust clinical evidence physicians need to make the best decisions for their patients.”