Thirty-day clinical outcomes for the DurAVR (Anteris Technologies) transcatheter heart valve (THV) in 100 severe aortic stenosis patients with small aortic annuli (404±37mm2) have been presented PCR London Valves (16–18 November, London, UK).
The DurAVR THV demonstrated single digit mean gradients, large effective orifice areas (EOAs), no moderate or severe paravalvular leak (PVL) and no valve related mortality, with 97% freedom from moderate or severe prosthesis-patient mismatch (PPM) in a cohort of small annuli patients similar to those reported in the SMART trial, Anteris Technologies states in a press release.
Ole De Backer (Rigshospitalet, Copenhagen, Denmark) presented the data a PCR London Valves, with simultaneous publication online in EuroIntervention.
At 30 days, DurAVR THV delivered a favourable haemodynamic profile with a large EOA of 2.2±0.3cm2 and a single digit mean pressure gradient (MPG) of 8.2±3.1mmHg.
At 30-days, clinical safety outcomes were positive with no valve related mortality and no moderate or severe PVL. Prosthesis-patient mismatch was 3% compared with 11.2% to 35.3% for current commercial devices, highlighting a meaningful reduction in a key predictor of valve failure and disease progression, according to the company.
“The DurAVR THV demonstrated high rates of technical and device success with encouraging 30-day haemodynamic outcomes, including very low PPM in small annuli patients. These results reflect a unique balance of balloon-expandable benefits characterised by high device success and low pacemaker rates, combined with a hemodynamic profile typically associated with self-expanding platforms,” said De Backer.
“When PPM occurs, patients essentially exchange one obstruction for another. Moderate to severe PPM is independently associated with reduced survival and increased risk of structural valve deterioration. Achieving 97% freedom from moderate or severe PPM is clinically relevant, particularly in small annuli patients where the risk of PPM is amplified,” said Chris Meduri, Anteris chief medical officer.
This pooled analysis of 100 patients derived from the ongoing EMBARK study and early feasibility studies (EFS) conducted in the USA and Europe, consists of patients with small aortic annuli (SAA) treated with the small size DurAVR THV.
“When we look at the strength of the 30-day outcomes together with the one-year results presented at TCT, we see a consistent clinical profile that serves as a potential proxy for the recently initiated PARADIGM trial. This pooled analysis of 100 patients represents approximately 20% of the planned DurAVR enrolment for the all comers randomised cohort of PARADIGM. This consistency across earlier and longer-term patient outcomes reinforces our confidence in DurAVR’s potential as we advance this life-saving technology toward anticipated commercialisation,” said Anteris vice chairman and chief executive officer, Wayne Paterson.
The global PARADIGM trial is a prospective, randomised controlled trial (RCT) which will evaluate the safety and effectiveness of the DurAVR THV compared to commercially available transcatheter aortic valve implantation (TAVI) devices in the treatment of severe aortic stenosis.
