News | Heart Valve Technology | October 31, 2016

New Data on Medtronic Evolut R TAVR System Show Positive Real-World Outcomes

Results from FORWARD and STS/ACC TVT Registry demonstrate high survival and low rate of all stroke for next-generation TAVR device in everyday clinical practice

Medtronic, CoreValve Evolut R TAVR system, TCT 2016, FORWARD Study, STS/ACC TVT Registry

October 31, 2016 — Medtronic plc presented new positive data from two large registries aimed at evaluating 30-day clinical performance outcomes for the self-expanding, recapturable and repositionable CoreValve Evolut R System in “real-world” severe aortic stenosis patient populations at the Transcatheter Cardiovascular Therapeutics (TCT) Annual Meeting.

Evolut R FORWARD Study

Positive early clinical results from the first 300 patients enrolled in the FORWARD study—a global, single-arm, prospective study at 60 centers across Europe, Australia, the Middle East, Africa, Latin America and Canada— marks the first time that the self-expanding Evolut R System was evaluated in routine clinical practice on a global scale. Designed to confirm the results achieved in the Evolut R CE Study for patients with severe aortic stenosis, the FORWARD study demonstrated an exceptionally high survival (98 percent) and a low rate of all stroke (3 percent) at 30-days post-implant.

The Evolut R FORWARD study also showed improved hemodynamic performance (by mean aortic valve gradient, a measure of blood flow through the valve) from 42.5 ± 17.7 mm Hg at baseline to 8.7 ±6.9 mm Hg at discharge. Additionally, there was a low rate of major vascular complications (2.7 percent) and no reports of valve thrombosis at 30-days.

“We’re 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,” said Prof. Eberhard Grube, M.D., director of the Structural Heart Program at University Hospital in Bonn, Germany, and co-principal investigator of the FORWARD Study. “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.”

STS/ACC TVT Registry Data

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 transcatheter aortic valve replacement (TAVR) systems, Evolut R demonstrated high survival (96.3 percent) and low rates of all stroke (3.1 percent) at 30 days, with successful valve implantation (99 percent). Patients in this analysis also experienced improved hemodynamic performance (mean gradient: 43.7 ± 15.4 mm Hg at baseline to 8.6 ± 5.5 mm Hg at discharge) and low rates of major vascular complications (1.5 percent). 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 percent) returned home following discharge, as opposed to a nursing home or other rehabilitation facility.

The CoreValve Evolut R System is available in Europe and other countries that recognize the CE Mark and was approved for commercial use in the United States in 2015.

For more information: www.medtronic.com

Related Content

Shockwave Announces Collaboration With Abiomed on Physician Training
News | Cath Lab | December 14, 2018
Shockwave Medical announced a new investment and collaboration agreement with Abiomed Inc. As outlined by the agreement...
Sponsored Content | Videos | Cath Lab | October 24, 2018
Michael Flaherty, M.D., discusses a study published in Circulation Research which finds that use of hemodynamic suppo
Philips Showcases Integrated Solutions for Cardiovascular Care at TCT 2018
News | Cath Lab | September 20, 2018
At the Transcatheter Cardiovascular Therapeutics (TCT) annual meeting, Sept. 21–25 in San Diego, Philips is showcasing...
Sponsored Content | Videos | Cath Lab | September 19, 2018
William O’Neill, M.D., outlines his recent clinical publication of AMICS patients from the Impella Quality (IQ) datab
A complex PCI case to revascularize a chronic total occlusion (CTO) at Henry Ford Hospital in Detroit. Complex PCI and CHIP cases are increasing patient volumes in the cath lab and using a minimally invasive approach in patients who otherwise would have been sent for CABG. Pictured is Khaldoon Alaswad, M.D. DAIC staff photo by Dave Fornell

A complex PCI case to revascularize a chronic total occlusion (CTO) at Henry Ford Hospital in Detroit. Complex PCI and CHIP cases are increasing patient volumes in the cath lab and using a minimally invasive approach in patients who otherwise would have been sent for CABG. Pictured is Khaldoon Alaswad, M.D. (right) who is proctoring a fellow in treating CTOs.

Feature | Cath Lab | September 13, 2018 | Artur Kim, Kamran Zamanian
Coronary artery disease (CAD) is a multifaceted disease that demands various approaches in terms of diagnosis and tre
Videos | Cath Lab | August 13, 2018
Jeffrey Schussler, M.D., FACC, FSCAI, FSCCT, FACP, interventional cardiologist at Baylor Scott White Heart and Vascul
Shockwave Launches Coronary Intravascular Lithotripsy in Europe
News | Cath Lab | May 30, 2018
Shockwave Medical recently announced the European commercial availability of Intravascular Lithotripsy (IVL) for...
Overlay Init