The TAVR platform showed superior haemodynamics and stable valve performance in intermediate risk aortic stenosis patients, at five years
CoreValve Evolut PRO TAVR System. (Credit: Medtronic.)
Medtronic has unveiled positive five-year clinical data for its CoreValve and Evolut transcatheter aortic valve implantation (TAVI) platforms from the Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI) trial.
The Evolut TAVR platform includes Evolut R, Evolut PRO, Evolut PRO+, and new-generation Evolut FX valves, and is indicated for severe aortic stenosis patients.
According to the study data, the platforms maintained hemodynamic benefits, safety profile and stable valve performance in severe aortic stenosis patients, for five years.
They showed similar rates of all-cause mortality and disabling stroke, to transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR).
The TAVR arm showed durable valve longevity, based on better mean aortic valve gradients, and valve thrombosis remained low for both TAVR and SAVR, for five years.
SURTAVI trial principal investigator Michael Reardon said: “TAVR has revolutionized the treatment of aortic stenosis with more TAVR cases now performed than surgical aortic valve replacement for this disease.
“With this shift in treatment, longer-term, randomized data is increasingly important as we strive to better understand the lifetime management of these patients.”
SURTAVI is a global, multi-centre, randomised clinical trial that evaluated CoreValve, Evolut R platforms.
The study used valves of various sizes, in 864 patients with intermediate-risk symptomatic severe aortic stenosis, in the TAVR arm.
Participants in the TAVR arm were compared to 796 intermediate-risk patients who were randomised to open-heart surgery.
Erasmus University Medical Centre department of cardiology professor Nicolas Van Mieghem said: “These longer-term outcomes are remarkably similar after TAVR and surgery in patients with severe aortic stenosis at intermediate operative risk.
“Additionally, results from this study are particularly impressive given the TAVR devices evaluated were first- and second-generation systems.”
In a separate development, Medtronic has unveiled early data for its self-expanding Intrepid transcatheter mitral valve replacement (TMVR) system in patients with severe, symptomatic mitral valve regurgitation (MR).
Intrepid TMVR system is currently being studied in Medtronic APOLLO trial in patients with severe MR, who are not eligible for mitral valve surgery or transcatheter edge-to-edge repair (TEER).