Study Data Reinforce Procedural, Performance Benefits of Medtronic’s Evolut TAVR

Medtronic plc is touting new clinical data supporting favorable outcomes for the Evolut Transcatheter Aortic Valve Replacement System (TAVR).

New findings from the Optimize PRO clinical study demonstrated positive procedural outcomes after using an optimized care pathway and the cusp overlap technique (COT) to deploy Evolut valves when treating patients with symptomatic severe aortic stenosis (SASS). Additionally, a pooled analysis of Evolut PRO patients showed improved rates of paravalvular leak (PVL) in TAVR patients over time after patients were discharged from the hospital.

“With the Evolut TAVR system, we are committed to improving outcomes for patients while maintaining exceptional safety and efficiency” said Nina Goodheart, senior vice president and president of the Structural Heart & Aortic business, which is part of the Cardiovascular Portfolio at Medtronic. “The data further establishes Medtronic and Evolut as leaders in the supporting and sharing the clinical evidence physicians need to make the best decisions for their patients when choosing and performing TAVR.”

Full 30-day findings from the Optimize PRO global study show utilization of the cusp overlap technique with the Evolut PRO and PRO+ devices led to favorable procedural and clinical outcomes. Findings of the multi-center, post-market, prospective study conducted in 50 centers globally demonstrated low rates of new 30-day permanent pacemaker implantation (6.4% with cusp overlap technique compliance) and no moderate or severe aortic regurgitation at discharge.

The Optimize PRO clinical study evaluated valve performance and procedural outcomes associated with an “optimized” pre- and post-procedural TAVR care pathway, utilizing the cusp overlap technique to deploy the Evolut valves. The cusp overlap technique is designed to help physicians assess and achieve the optimal implant depth to reduce interaction with the conduction system. At 30 days, the primary endpoint of all-cause mortality or all stroke was 5.1%, all-cause mortality 0.8%, disabling stroke 1.7%, and cardiovascular rehospitalization was 5.7%.

“We are encouraged by this data as it demonstrates significant positive outcomes when leveraging the cusp overlap technique with the Evolut valve,” said Steven J. Yakubov, M.D., OhioHealth Riverside Methodist Hospital and co-principal investigator. “The new results support a standardized protocol that will help support early hospital discharge and lower rates of complications for our patients, improving their quality of life.”

A second analysis assessed improvement in PVL over time post-TAVR with the Evolut PRO valve in patients with SSAS. The study analyzed core lab echocardiographic data from 620 patients treated with Evolut PRO from the prospective Evolut Low Risk Trial, FORWARD PRO Study, and Evolut PRO US Study. The analysis demonstrated improvements in severity of PVL—a leak that occurs when blood flows backward between the heart’s natural tissue and a replacement valve—after 30 days post-hospital discharge to three-year follow-up.

From the paired analysis of patients with available data at all follow-up visits, the PVL severity for 30 days post-hospital discharge was 60.8% none/trace, 36.0% mild, 2.9% moderate, and 0.3% severe. At three-year follow-up, the PVL severity was 79.8% none/trace, 19.6% mild, 0.6% moderate and 0.0% severe. The occurrence of worsened PVL from discharge/30 days to 3-year follow-up was uncommon.

“This analysis expands upon previous studies and found a majority of patients classified with mild or greater PVL improved in their PVL severity at 3 years,” said Nicolas Van Mieghem, M.D., Ph.D., Thoraxcenter, Erasmus University Medical Center in Rotterdam, The Netherlands, and lead investigator “This study will help inform physicians on the treatment of this complication post-TAVR.”

Headquartered in Galway, Ireland, Medtronic is a global healthcare technology company whose technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. The company employs more than 95,000 people across 150 countries.