Safety and Efficacy of Medtronic’s Evolut Pro TAVR System Supported by FORWARD PRO Study

November 24, 2020—The prospective, multinational, multicenter, observational FORWARD PRO study evaluated the clinical performance and safety of the CoreValve Evolut Pro (Medtronic) in standard practice. The study was presented at the 2020 PCR Valves eCourse that was held as a virtual conference on November 22-24 and published by Ganesh Manoharan, MD, et al in EuroIntervention (2020;16:850-857).

The investigators concluded that the 30-day FORWARD PRO clinical outcomes confirmed the safety and efficacy of the Evolut Pro, a self-expanding transcatheter aortic valve with an external pericardial wrap to reduce paravalvular leak and facilitate tissue ingrowth.

In EuroIntervention, the investigators stated that transcatheter aortic valve replacement with the Evolut Pro valve (23, 26, or 29 mm) was attempted in 629 nonconsecutive patients from 39 centers from February 2018 to January 2019.

The primary endpoint was the rate of all-cause mortality at 30 days compared to a prespecified performance goal. An independent clinical events committee adjudicated safety endpoints based on Valve Academic Research Consortium-2 definitions. All echocardiograms were centrally assessed by an independent core laboratory at the Mayo Clinic in Rochester, Minnesota.

Baseline characteristics included mean age of 81.7 ± 6.1 years, 61.8% female, Society of Thoracic Surgeons score of 4.7% ± 3.3%, and 33.6% were frail.

All-cause mortality at 30 days was 3.2%, which was lower than the prespecified performance goal of 5.5% (P = .004). Aortic regurgitation that was greater than mild was present in 1.8% of patients at discharge, reported the investigators in EuroIntervention.