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Cardiac magnetic resonance imaging (MRI) data from the first-in-human study of the DurAVR transcatheter heart valve (THV, Anteris Technologies), shared at New York Valves (5–7 June, New York, USA), demonstrate that the valve was able to restore normal flow and haemodynamics, leading to significant left ventricular mass regression in patients with symptomatic, severe aortic stenosis.
DurAVR is a balloon-expandable, single-piece transcatheter aortic valve shaped to mimic the performance of a native human aortic valve.
Joao Cavalcante (Allina Health Minneapolis Heart Institute, Minneapolis, USA) presented the new MRI data, which showed excellent post-procedure haemodynamic results in 41 patients, with large effective orifice areas (2.2cm2), single-digit mean gradients (8.5mmHg) and a Doppler Velocity Index (DVI) of 0.62.
Cavalcante commented: “When we look at commercially available surgical or transcatheter aortic valve implantation (TAVI) valves, we are still seeing abnormal flow patterns on cardiac MRI. The restoration of laminar flow, as we are seeing with this new DurAVR THV, is a byproduct of the intrinsic valve design and novel technology, which might have positive downstream implications to the arteries and consequently to ventricle, and ultimately to the patients.”
Cavalcante also reported that in patients treated with DurAVR, cardiac MRI also detected a significant left ventricular mass index regression at six months post-TAVI.
The full downstream effect of restoring laminar flow will need to be further studied and validated in ongoing and future studies, including a larger pivotal imaging sub-study.