European Pivotal Trial Results Published for Medtronic's CoreValve Evolut R TAVR Device

August 27, 2015—In the Journal of American College of Cardiology (JACC): Cardiovascular Interventions, Ganesh Manoharan, MD, et al published findings from a prospective evaluation of the safety and clinical performance of the CoreValve Evolut R transcatheter aortic valve replacement (TAVR) system (Medtronic, plc) in the single-arm, multicenter CE Mark pivotal study for the device in high- or extreme-risk patients with symptomatic aortic valve stenosis (2015;8:1359–1367).

According to the investigators, the repositionable 14-F–equivalent CoreValve Evolut R TAVR system was developed to mitigate some of the challenges that still exist (such as death, stroke, paravalvular leak, and the need for permanent pacing), although TAVR outcomes are improving.

The study concluded that the repositionable 14-F–equivalent Evolut R TAVR system is safe and effective at treating patients with high-risk symptomatic aortic stenosis. Additionally, repositioning was successful when required in all patients, with low rates of moderate or severe paravalvular aortic regurgitation and low permanent pacemaker implantation. Larger studies are required to evaluate and confirm the findings of this small pivotal study, advised the investigators.

As summarized in JACC: Cardiovascular Interventions, suitable patients (n = 60) underwent TAVR with a 26- or 29-mm Evolut R device. The primary safety endpoints were mortality and stroke at 30 days. The primary clinical performance endpoints were device success per the Valve Academic Research Consortium-2 (VARC-2) and the percent of patients with mild or less aortic regurgitation at 24 hours to 7 days postprocedure.

In the study, patients (66.7% female; mean age 82.8 ± 6.1 years; Society of Thoracic Surgeons Score 7.0 ± 3.7%) underwent TAVR via the transfemoral route in 98.3%, using a 29-mm valve in 68.3% of patients. All attempts at repositioning were successful. No death or stroke was observed up to 30 days.

The VARC-2 overall device success rate was 78.6%. Paravalvular regurgitation after TAVR was mild or less in 96.6%, moderate in 3.4%, and severe in 0% of patients at 30 days. Major vascular complications occurred in 8.3%, and permanent pacemaker implantation was required in 11.7% of patients, reported the investigators in JACC: Cardiovascular Interventions.