Dataset Information

Early safety and feasibility of a first-in-class biomimetic transcatheter aortic valve - DurAVR.

ABSTRACT:

Background

TAVI is a widely accepted treatment for patients with severe aortic stenosis (AS). Despite the adoption of diverse therapies, opportunities remain to develop technologies tailored to provide optimal acute and potential long-term benefits, particularly around haemodynamics, flow and durability.

Aims

We aimed to evaluate the safety and feasibility of the DurAVR transcatheter heart valve (THV), a first-in-class biomimetic valve, in the treatment of patients with symptomatic severe AS.

Methods

This was a first-in-human (FIH), prospective, non-randomised, single-arm, single-centre study. Patients with severe, symptomatic AS of any surgical risk and who were eligible for the DurAVR THV prosthesis were recruited; they were assessed at baseline, 30 days, 6 months, and 1 year post-procedure for implant success, haemodynamic performance, and safety.

Results

Thirteen patients (73.9±6.4 years old, 77% female) were enrolled. The DurAVR THV was successfully implanted in 100% of cases with no device-related complications. One access site complication, one permanent pacemaker implantation, and one case of moderate aortic regurgitation occurred. Otherwise, no deaths, stroke, bleeding, reinterventions, or myocardial infarction were reported during any of the follow-up visits. Despite a mean annulus size of 22.95±1.09 mm, favourable haemodynamic results were observed at 30 days (effective orifice area [EOA] 2.00±0.17 cm², and mean pressure gradient [MPG] 9.02±2.68 mmHg) and were sustained at 1 year (EOA 1.96±0.11 cm², MPG 8.82±1.38 mmHg), resulting in zero patients with any degree of prosthesis-patient mismatch. Additionally, new valve performance measures derived from cardiovascular magnetic resonance displayed restoration of laminar flow, consistent with a predisease state, in conjunction with a mean coaptation length of 8.3±1.7 mm.

Conclusions

Preliminary results from the FIH study with DurAVR THV demonstrate a good safety profile with promising haemodynamic performance sustained at 1 year and restoration of near-normal flow dynamics. Further clinical investigation is warranted to evaluate how DurAVR THV may play a role in addressing the challenge of lifetime management in AS patients.

SUBMITTER: Kodali SK

PROVIDER: S-EPMC10333917 | biostudies-literature | 2023 Jul

REPOSITORIES: biostudies-literature

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Publications

Early safety and feasibility of a first-in-class biomimetic transcatheter aortic valve - DurAVR.

Kodali Susheel K SK Sorajja Paul P Meduri Christopher U CU Feldt Kari K Cavalcante João L JL Garg Pankaj P Hamid Nadira N Poon Karl K KK Settergren Magnus R M MRM Burns Marcus R MR Rück Andreas A Sathananthan Janarthanan J Zajarias Alan A Shaburishvili Tamaz T Zirakashvili Teona T Zhividze Maia M Katchakhidze George G Bapat Vinayak N VN

EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology 20230717 4

<h4>Background</h4>TAVI is a widely accepted treatment for patients with severe aortic stenosis (AS). Despite the adoption of diverse therapies, opportunities remain to develop technologies tailored to provide optimal acute and potential long-term benefits, particularly around haemodynamics, flow and durability.<h4>Aims</h4>We aimed to evaluate the safety and feasibility of the DurAVR transcatheter heart valve (THV), a first-in-class biomimetic valve, in the treatment of patients with symptomati ...[more]

PMID: 37334801

Similar Datasets

Project description:BackgroundThere is an increasing trend towards shorter hospital stays after transcatheter aortic valve implantation (TAVI), in particular for patients undergoing the procedure via transfemoral (TF) access. Preliminary data suggest that there exists a population of patients that can be discharged safely very early after TF-TAVI. However, current evidence is limited to few retrospective studies, encompassing relatively small sample sizes.MethodsThe Feasibility And Safety of early discharge after Transfemoral TAVI (FAST-TAVI) registry is a prospective observational registry that will be conducted at 10 sites across Italy, the Netherlands and the UK. Patients will be included if they have been scheduled to undergo TF-TAVI with the balloon-expandable SAPIEN 3 transcatheter heart valve (THV; Edwards Lifesciences, Irvine, CA). The primary endpoint is a composite of all-cause mortality, vascular-access-related complications, permanent pacemaker implantation, stroke, re-hospitalisation due to cardiac reasons, kidney failure and major bleeding, occurring during the first 30 days after hospital discharge. Patients will be stratified according to whether they were high or low risk for early discharge (≤3 days) (following pre-specified criteria), and according to whether or not they were discharged early. Secondary endpoints will include time-to-event (Kaplan-Meier) analysis for the primary outcome and its individual components, analysis of the relative costs of early and late discharge, and changes in short- and long-term quality of life. Multivariate logistic regression will be used to identify factors that indicate that a patient may be suitable for early discharge.DiscussionThe data gathered in the FAST-TAVI registry should help to clarify the safety of early discharge after TF-TAVI and to identify patient and procedural characteristics that make early discharge from hospital a safe and cost-effective strategy.Trial registrationClinicalTrials.gov Identifier: NCT02404467 (registration first received March 23rd 2015).

Dataset Information

Early safety and feasibility of a first-in-class biomimetic transcatheter aortic valve - DurAVR.

Background

Aims

Methods

Results

Conclusions

Publications

Early safety and feasibility of a first-in-class biomimetic transcatheter aortic valve - DurAVR.

Similar Datasets

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