Anteris Technologies Ltd (ASX:AVR, OTC:AMEUF) has presented promising updated data on its first-in-human DurAVR™ transcatheter heart valve (THV) study at the New York Valves Annual Conference held at the Jacob K. Javits Convention Center in New York City.
The structural heart company is developing a new class of Transcatheter Aortic Valve Implantation (TAVI), the world’s only balloon-expandable, single-piece biomimetic aortic replacement valve shaped to mimic the native human heart valve.
Dr João Cavalcante, section head, Cardiac Imaging, Allina Health Minneapolis Heart Institute and scientific director, Cardiovascular Imaging Core Lab and Research Center, presented new cardiac MRI data from the DurAVR™ THV First-in-Human (FIH) Study.
The findings showed the restoration of normal flow and hemodynamics (blood flow properties), leading to significant left ventricular mass regression in patients with symptomatic, severe aortic stenosis, which is a thickening and narrowing of the valve between the main pumping chamber of the heart and the body’s main artery.
Returning flow patterns to normal states
The DurAVR™ THV demonstrated excellent post-procedure hemodynamic results in 41 patients, with large effective orifice areas (2.20 cm2), single-digit mean gradients (8.5 mmHg) and a Doppler Velocity Index (DVI) of 0.62 – similar results to those seen in healthy subjects.
Dr Cavalcante commented that the current market-leading balloon-expandable valve would be unable to achieve these results in small annuli patients.
He also highlighted that aortic stenosis was not just a disease of the valve, it was also a disease of the arteries and the myocardium, as diseased heart valves disrupted healthy blood flow, causing flow displacement (FD) and flow reversal (FRR).
The DurAVR™ THV treatment restored laminar flow with near equivalence to a healthy aortic valve.
Studies performed on commercially available transcatheter valves, either balloon-expandable or self-expanding, do not appear to restore normal aortic flow:
- Normal Healthy Aortic Valve: FD = 10%, FRR = 1% (n=5);
- DurAVR™ THV: FD = 15%, FRR = 5% (n=11);
- Severe Aortic Stenosis: FD = 46%, FRR = 23%;
- Edwards Sapien 3: FD = 48%, FRR = 35%;
- Medtronic (NYSE:MDT) Evolut R: FD = 25%, FRR = 4%; and
- CEP Magna Ease: FD = 27%, FRR = 30%.
“When we look at commercially available surgical or TAVR valves, we are still seeing abnormal flow patterns on cardiac MRI,” Dr Cavalcante explained.
“The restoration of laminar flow, as we are seeing with this new DurAVRTM 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.”
Dr Cavalcante also reported that cardiac MRIs detected a significant left ventricular mass index regression at 6 months post-TAVR in patients treated with DurAVR™ THV.
A recent meta-analysis of other TAVR platforms demonstrated an average LV mass index regression of around 15 g/m2, in comparison to DurAVR™ THV, which demonstrated a difference of almost 20 g/m2.
AVR says 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.