Evidence map›Paper›PMID 37334801›Full record

ArticleEuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology2023

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

Susheel K Kodali, Paul Sorajja, Christopher U Meduri, Kari Feldt, João L Cavalcante, Pankaj Garg, Nadira Hamid, Karl K Poon, Magnus R M Settergren, Marcus R Burns and 8 more

Open access · greenAbstract read
In one paragraph

Article in EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed
3.7field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 17 citations in OpenAlex.

  1. Review
  2. Innovation and Challenges in Materials for Transcatheter Aortic Valves.Journal of cardiovascular translational research · 2026
    Review
  3. Review
  4. Review
  5. DurAVR - a novel biomimetic balloon-expandable transcatheter valve for TAVI, valve-in-valve TAVI and redo-TAVI.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2025
    Article
  6. Innovations in TAVR: The Latest in Device Technology.Journal of clinical medicine · 2025
    Review
  7. Review
  8. Novel transcatheter aortic valve replacement devices.JTCVS structural and endovascular · 2025
    Article
  9. Review
  10. Review
  11. Article
  12. Durability of transcatheter aortic valve implantation.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2024
    Review
  13. Review
  14. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors at 10 institutions in 5 countries.

Susheel K KodaliColumbia University Irving Medical Center, New York, NY, USA.
Paul SorajjaMinneapolis Heart Institute, Abbott Northwestern Hospital, Minneapolis, MN, USA.
Christopher U MeduriDepartment of Cardiology, Karolinska University Hospital, Stockholm, Sweden.
Kari FeldtDepartment of Cardiology, Karolinska University Hospital, Stockholm, Sweden.
João L CavalcanteMinneapolis Heart Institute, Abbott Northwestern Hospital, Minneapolis, MN, USA.
Pankaj GargNorwich Medical School, University of East Anglia, Norwich, UK.
Nadira HamidMinneapolis Heart Institute, Abbott Northwestern Hospital, Minneapolis, MN, USA.
Karl K PoonSt. Andrew's War Memorial Hospital, Brisbane, QLD, Australia.
Magnus R M SettergrenDepartment of Cardiology, Karolinska University Hospital, Stockholm, Sweden.
Marcus R BurnsMinneapolis Heart Institute, Abbott Northwestern Hospital, Minneapolis, MN, USA.
Andreas RückDepartment of Cardiology, Karolinska University Hospital, Stockholm, Sweden.
Janarthanan SathananthanSt. Paul's Hospital, Vancouver, BC, Canada.
Alan ZajariasWashington University School of Medicine, St. Louis, MO, USA.
Tamaz ShaburishviliCardiovascular Clinic, Tbilisi Heart and Vascular Clinic, Tbilisi, Georgia.
Teona ZirakashviliCardiovascular Clinic, Tbilisi Heart and Vascular Clinic, Tbilisi, Georgia.
Maia ZhividzeCardiovascular Clinic, Tbilisi Heart and Vascular Clinic, Tbilisi, Georgia.
George KatchakhidzeAversi Clinic, Tbilisi, Georgia.
Vinayak N BapatMinneapolis Heart Institute, Abbott Northwestern Hospital, Minneapolis, MN, USA.
Abbott Northwestern Hospital · USKarolinska University Hospital · SEUnited Heart and Vascular Clinic · USColumbia University Irving Medical Center · USHarbin Clinic · USKarolinska Institutet · SENorfolk and Norwich University Hospitals NHS Foundation Trust · GBSt Andrew’s Hospital · AUSt. Paul's Hospital · CAWashington University in St. Louis · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTAVI 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.

aimsWe 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.

methodsThis 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.

resultsThirteen 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 cm

conclusionsPreliminary 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.

Indexed as

Aortic Valve StenosisHeart Valve ProsthesisTranscatheter Aortic Valve ReplacementAgedAged, 80 and overAortic ValveBiomimeticsFeasibility StudiesFemaleHumansMaleProspective StudiesProsthesis DesignTreatment Outcome

Identifiers

PMID37334801
PMCPMC10333917
OpenAlexW4381308912

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.