Insights from the first-in-human study of the DurAVR (Anteris Technologies) biomimetic transcatheter heart valve system provide “encouraging” evidence of improved haemodynamics and normalised flow characteristic associated with the device’s single-piece, molded leaflet design.
An update from the study was presented at the Society for Cardiovascular Angiography & Interventions (SCAI) 2024 scientific sessions (2–4 May, Long Beach, USA) by Azeem Latib (Montefiore Health System, New York, USA).
Design features of the device include a single-piece, molded leaflet geometry, intended for optimal haemodynamics and flow characteristics, an anti-calcification treatment to reduce structural valve deterioration, and a balloon-expandable platform with a large open-cell structure to facilitate coronary access.
The prospective, non-randomised, single-arm, single-centre, first-in-human study, designed to evaluate safety and feasibility in patients with severe symptomatic aortic stenosis included clinical, echo, computed tomography (CT), and cardiac magnetic resonance imaging (MRI) assessments up to one year.
A total of 28 patients were enrolled in the study, with a mean age of 73 years, and 75% of the study cohort was female. Latib reported a 100% success rate across all of the cases, and all patients showed excellent post-procedural haemodynamic results, despite a small mean annulus size. No moderate or severe paravalvular leak or central aortic regurgitation were observed.
One year transthoracic echocardiogram (TTE) completed for the first 12 patients confirmed sustained haemodynamics, while laminar flow was consistently displayed on transesophageal echocardiography (TEE) and TTE.
DurAVR showed a favourable safety profile in all patients at the latest follow-up, Latib reported, and there were no valve-related complications, strokes, bleeding, or reoperations. One patient died as a result of a car accident (non-cardiac death) on postoperative day (POD) 343, three had access site complications, and a pacemaker was implanted in a patient with pre-existing conduction disturbances. No cases of moderate or severe prosthesis-patient mismatch were observed.
Latib is the national principal investigator in the early feasibility study (EFS) of the device in the USA, having enrolled the first patient in summer 2023.
“In the field of TAVI, the understanding of haemodynamics has become increasingly important, especially as TAVI is now being performed on younger patients,” Latib tells Cardiovascular News. “The recent SMART trial [see page 3] has shed light on the fact that not all TAVI valves are created equal. The data from the trial suggests that by using an intra-annular balloon-expandable valve, we may be able to achieve supra-annular haemodynamics.”
Latib adds that the data for DurAVR appear to be positive, particularly in terms of haemodynamics, though he cautions that further studies will need to confirm whether, as these initial results suggest, the valve holds potential for improving patient outcomes in the future.
“As for specific scenarios or patients in whom this device may have a particular advantage, I believe that this device could be a workhorse TAVI that could be used in all patients, having the reproducibility and ease of use of balloon-expandable valves with the haemodynamics of supra-annular valves.
“However, further research and clinical experience are necessary to fully understand the potential benefits and limitations of the DurAVR.”
*Updated 14/05/2024 to describe device as having a “single-piece, molded leaflet geometry”.
