Today, Medtronic presented new positive data from two large registries aimed at evaluating 30-day clinical performance outcomes for its self-expanding, recapturable and repositionable CoreValve Evolut R transcatheter aortic valve implantation (TAVI) device in “real-world” severe aortic stenosis patient populations at the 2016 Transcatheter Cardiovascular Therapeutics (TCT) meeting (29 October-2 November, Washington, DC, USA).
Designed to confirm the results achieved in the Evolut R CE Study for patients with severe aortic stenosis, the FORWARD study demonstrated high survival (98%) and a low rate of all stroke (3%) at 30-days post-implant. Additionally, the real-world study also showed improved haemodynamic performance (by mean aortic valve gradient, a measure of blood flow through the valve) from 42.5 ± 17.7mmHg at baseline to 8.7 ±6.9mmHg at discharge. Furthermore, there was a low rate of major vascular complications (2.7%) and no reports of valve thrombosis at 30-days.
New data from the Society of Thoracic Surgeons and American College of Cardiology (STS/ACC) Transcatheter Valve Therapy (TVT) Registry also demonstrated successful real-world outcomes achieved with the Evolut R system. In the analysis of 9,616 patients implanted with Medtronic self-expanding TAVI systems, Evolut R demonstrated high survival (96.3%) and low rates of all stroke (3.1%) at 30 days, with successful valve implantation (99%). Patients in this analysis also experienced improved haemodynamic performance (mean gradient: 43.7 ± 15.4mmHg at baseline to 8.6 ± 5.5mmHg at discharge) and low rates of major vascular complications (1.5%). Additionally, post-procedure hospital stays were a median of four days for Evolut R and the majority of patients treated with Evolut R (75.7%) returned home following discharge, as opposed to a nursing home or other rehabilitation facility.
Eberhard Grube, director of the Structural Heart Program at University Hospital in Bonn, Germany, and co-principal investigator of the FORWARD study, comments: “We are encouraged by the initial 30-day outcomes of the FORWARD study, which further showcase the advantages of the recapturable and repositionable capabilities of the Evolut R system. As patient follow-up continues at one, two and three-years post-implant, we look forward to seeing how the features of the Evolut R system can address everyday clinical needs in various severe aortic stenosis patient scenarios worldwide.”