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:

Related Content

Videos | Cath Lab| January 04, 2018
Bernadette Speiser, BSN, MSN, CCRN, RCIS, a cardiac cath/EP nurse at Palo Alto Veterans Hospital, Palo Alto, Calif.,
FDA Initiates Class I Recall of Sterilmed Reprocessed Agilis Steerable Introducer Sheath
News | Cath Lab| January 04, 2018
The U.S. Food and Drug Administration (FDA) announced a Class I recall of Sterilmed’s Agilis Steerable Introducer...
The California Heart & Vascular Clinic in El Centro, Calif., treated the first post-FDA clearance patient with a DABRA atherectomy system. Athar Ansari, M.D.

The California Heart & Vascular Clinic in El Centro, Calif., treated the first post-FDA clearance patient with a DABRA system. 

Feature | Cath Lab| November 24, 2017 | Athar Ansari, M.D., FACC
As debates about the current state and future of healthcare rage in Congress, the media and healthcare settings acros
Videos | Cath Lab| November 08, 2017
Juan Granada, M.D., Cardiovascular Research Foundation president and chief executive officer, shares his insights on
Results of the ORBITA study found no difference in exercise time after six weeks in patients with stable angina who received percutaneous coronary intervention (PCI) versus a placebo treatment. TCT 2017
Feature | Cath Lab| November 06, 2017
November 6, 2017 – Results from ORBITA, a prospective multi-center randomized blinded placebo-controlled study, found
Culprit Lesion-Only PCI Improves Outcomes for Cardiogenic Shock Patients Compared to Multivessel PCI
News | Cath Lab| November 01, 2017
November 1, 2017 — Results from the prospective, randomized, multicenter CULPRIT-SHOCK trial found an initial strateg
Three-Year Quality of Life Improvements Similar for PCI and CABG in Left Main Disease
News | Cath Lab| October 30, 2017
October 30, 2017 — New study results from the EXCEL trial comparing the quality of life (QoL) of patients with left m
Corindus Evaluates Incorporating HeartFlow Technology With CorPath GRX System
Technology | Cath Lab| October 26, 2017
Corindus Vascular Robotics Inc. announced that it will incorporate the HeartFlow FFRct (fractional flow reserve-...
Shockwave Medical Announces $35 Million in New Financing
News | Cath Lab| October 24, 2017
October 24, 2017 — Shockwave Medical reported $35 million in new financing, an extension of the company’s previously
Overlay Init