Medtronic Presents Data on Evolut Pro TAVR System
November 6, 2017—Medtronic announced that new data for the company's CoreValve Evolut transcatheter aortic valve replacement (TAVR) platform were presented at TCT 2017, the 29th annual Transcatheter Cardiovascular Therapeutics scientific symposium held October 30 to November 2 in Denver, Colorado.
Six-months follow-up in 60 patients treated with the Evolut Pro continued to demonstrate low rates of paravalvular leak (PVL) with 88% of patients showing no or trace PVL. Additionally, rates of all-cause mortality and disabling stroke were low with no instances of coronary obstruction or valve thrombosis, and the permanent pacemaker implantation rate remained low at 11.7%.
In the company's announcement, John Forrest, MD, commented, "These latest 6-month results suggest that the Evolut Pro valve, with its self-expanding nitinol frame and outer pericardial tissue wrap, maintains a very low incidence of PVL. It is encouraging to observe the sustained low rates of PVL over time combined with exceptional hemodynamics, while maintaining a low rate of new pacemaker implants."
Separate clinical evidence was unveiled from the Society of Thoracic Surgeons and American College of Cardiology Transcatheter Valve Therapy registry that compared patients at high surgical risk with bicuspid aortic valve disease (n = 191) to those with severe tricuspid aortic valve disease (n = 6,526) in real-world clinical practice. At 30 days, clinical outcomes were similar for the bicuspid group compared to the tricuspid group with lower rates of all-cause mortality (2.2% vs 3.2%), stroke (2.6% vs 3.4%), and major vascular complications (0.5% vs 1.6%). Additionally, hemodynamic outcomes were similar between the groups with both patient populations showing a symptomatic improvement over time.
Jeffrey J. Popma, MD, stated in Medtronic's press release, "The results from this large, real-world analysis are promising indicators for new patient populations in the future. We look forward to further study and evaluation."
Also at TCT, Medtronic announced plans to conduct a new study utilizing the Evolut Pro system in a bicuspid patient population to further support TAVR clinical evidence for the treatment of these patients.