Medtronic have announced new one-year data revealing exceptional clinical outcomes for transcatheter aortic valve replacement (TAVR) with their CoreValve Evolut R System. This system is the first and only next-generation recapturable, self-expanding valve available in the US market.
The Evolut R CE study – a prospective, single-arm, multi-centre study which enrolled 60 extreme and high risk patients at six centres in Australia, New Zealand and the United Kingdom – reported the lowest rate of all-cause mortality (6.7%) of any TAVR study in extreme and high risk patients to date at one-year follow-up. These data were presented at the Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium.
“These data show that, even in a high and extreme risk patient population, the exceptional procedural outcomes experienced with Evolut R were maintained through one year, which indicates that this next-generation, recapturable technology delivers on its promise to advance TAVR outcomes for patients,” says Ganesh Manoharan, M.D., consultant cardiologist at the Royal Victoria Hospital in Belfast, Northern Ireland and study investigator for the Evolut R CE Study who presented the data. “The low rate of paravalvular leak and new pacemaker implantation suggest that the ability to recapture and reposition during deployment will play an important role in the evolution of TAVR technology.”
In the data, Evolut R showed strong hemodynamic performance, which may be attributed to the valve’s supra-annular design. Mean aortic gradients (a common method for measuring the restriction of blood flow through the aortic valve) remained low in the single digits at 7.5mm±2.7mmHg at one year. With optimised valve positioning accuracy due to the device’s 1:1 response and controlled deployment, rates of moderate or severe paravalvular leak remained low (3.4% at 30 days and 4.3% at one year). The permanent pacemaker implantation rate was similarly low at 30 days (11.7%) and at one year (15.2%).
These data showed no incidents of valve dysfunction, procedural death, annular rupture, coronary occlusion, valve thrombosis, embolization, or conversion to surgery. Transfemoral access was possible in all but one patient in a population that included patients with smaller vessels (down to 5.0mm).
The Evolut R valve is delivered through the EnVeo R Delivery Catheter System, which features an InLine Sheath that significantly reduces the profile to the lowest on the market (14Fr equivalent, less than 1/5 inch). A smaller profile size provides a greater opportunity to treat patients with smaller vessels through the preferred transfemoral access route, and may minimise the risk of major vascular complications in some patients.
The 23mm, 26mm and 29mm sizes of the CoreValve Evolut R transcatheter valve and the CoreValve EnVeo R Delivery Catheter System are available in Europe and other countries that recognise the CE mark. The CoreValve Evolut R System was FDA-approved for commercial use in the United States in June 2015.