Aortic stenosis is stated to be a widespread valvular heart condition. Credit: sasirin pamai / Shutterstock.
Medtronic has announced the Small Annuli Randomized To Evolut or SAPIEN (SMART) head-to-head comparative trial’s two-year outcomes of the Evolut transfemoral transcatheter aortic valve replacement (TAVR) for aortic stenosis (AS) and small aortic annulus.
In the international, multi-centre trial, the Evolut TAVR demonstrated “continued superior” valve performance, according to bioprosthetic valve dysfunction (BVD) measurements.
In addition, the findings demonstrated “comparable” composite results of death, disabling stroke, and heart failure hospitalisation in individuals with AS and a small aortic annulus.
The prospective, randomised post-market trial has also indicated that the Evolut TAVR is associated with lower instances of BVD against SAPIEN TAVR.
It is designed to compare the performance and safety of Evolut self-expanding TAVR and SAPIEN balloon-expandable TAVR in individuals with symptomatic severe AS, and small aortic annulus.
According to further trial findings, the Evolut TAVR showed a fivefold reduction in prosthetic valve thrombosis and a ninefold decrease in haemodynamic structural valve dysfunction when compared to the SAPIEN TAVR.
Medtronic noted that the trial enrolled 716 subjects, 87% of whom were women, in more than 80 sites worldwide.
Those who were eligible, had an aortic valve annulus area of ≤430mm as per the computed tomography measurements, and “suitable” anatomy for transfemoral TAVR with either an Evolut PRO/PRO+/FX or a SAPIEN 3/3 Ultra valve.
Subjects will continue to be monitored for five years.
Medtronic structural heart chief medical officer and vice-president Kendra Grubb said: “The SMART Trial is a groundbreaking, head-to-head comparison that, for the first time, highlights how a patient with a small annulus can benefit from Evolut’s differentiated valve design.”
AS is stated to be a widespread valvular heart condition, affecting an estimated 1.5 million individuals in the US.
Last month, the company expanded its lumbar fixation offerings with the launch of the CD Horizon ModuLeX spinal system [for deformity procedures](https://www.medicaldevice-network.com/news/medtronic-spinal-system-deformity/).