Evidence map›Paper›PMID 37565470›Full record

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

Clinical outcomes of TAVI with the Myval balloon-expandable valve for non-calcified aortic regurgitation.

Juan Pablo Sanchez-Luna, Pedro Martín, Antonio E Dager, Pablo D Charry, Javier R Beltrán, Ángel Sánchez-Recalde, Francesco Giannini, Antonio Gómez-Menchero, Manuel Pan, Alfonso Ielasi and 18 more

Registry-linked trialAbstract readObservational Study
In one paragraph

Observational study 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. It is linked to trial NCT07751965 (Prospective, Multicenter, Single-arm, Open-label Study Evaluating the Safety and Effectiveness of the Myval Transcatheter Heart Valve), which is not on this map. Cited by 15 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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.

NCT07751965 nanot yet recruitingnot on this mapstarted 2026, after this paper: background citation

Prospective, Multicenter, Single-arm, Open-label Study Evaluating the Safety and Effectiveness of the Myval Transcatheter Heart Valve (THV) System in High-risk Patients With Severe Symptomatic Non- or Mildly Calcified Aortic Regurgitation.

TypeinterventionalSponsorCeric SàrlRan2026 to 2032Enrolled164ConditionsAortic Regurgitation, Aortic Disease, Calcified Aortic ValveArmsMyval THV series
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Myval Octacor and Octapro TInternational journal of cardiology. Heart & vasculature · 2026
    Article
  5. Review
  6. Article
  7. Article
  8. Article
  9. Review
  10. Transcatheter Aortic Valve Replacement for Aortic Insufficiency.Interventional cardiology (London, England) · 2025
    Review
  11. Review
  12. Aortic regurgitation: from mechanisms to management.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2024
    Review
  13. Article
  14. Transcatheter aortic valve implantation: the shape matters.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2023
    Article
  15. Article
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

28 authors.

Juan Pablo Sanchez-LunaCardiology Department, Hospital Clinico Universitario de Valladolid, Valladolid, Spain.
Pedro MartínCardiology Department, Hospital Universitario de Gran Canaria Dr Negrin, Las Palmas, Gran Canaria, Spain.
Antonio E DagerCardiology Department, Angiografía de Occidente Hospital, Cali, Colombia.
Pablo D CharryCardiology Department, Clínica Medilaser, Neiva, Colombia.
Javier R BeltránCardiology Department, Los Comuneros Hospital Universitario de Bucaramanga, Bucaramanga, Colombia.
Ángel Sánchez-RecaldeCardiology Department, Hospital Universitario Ramón y Cajal, Madrid, Spain.
Francesco GianniniCardiology Department, San Raffaele Scientific Institute, Milan, Italy.
Antonio Gómez-MencheroCardiology Department, Hospital Juan Ramón Jimenez, Huelva, Spain.
Manuel PanCardiology Department, Hospital Reina Sofía, Cordoba, Spain and University of Cordoba (IMIBIC), Cordoba, Spain.
Alfonso IelasiCardiology Department, IRCCS Ospedale Galeazzi Sant'Ambrogio, Milan, Italy.
Andrea MonastyrskiCardiology Department, Hospital Universitario Val d'Hebron, Barcelona, Spain.
Marco BarbantiCardiology Department, Policlinico-Vittorio Emanuele Hospital, Catania, Italy.
Francisco Fernandez-AvilésCardiology Department, Hospital General Universitario Gregorio Marañón, Madrid, Spain.
Marco Bruno AnconaCardiology Department, San Raffaele Scientific Institute, Milan, Italy.
Abdurashid MussayevCardiology Department, National Research Cardiac Surgery Center, Astana, Kazakhstan.
Juan Pablo De BrahiCardiology Department, Sanatorio de La Trinidad Mitre, Buenos Aires, Argentina.
Pablo LamelasCardiology Department, Instituto Cardiovascular, Buenos Aires, Argentina.
Andrés Sánchez-PérezCardiology Department, Hospital Universitario de Gran Canaria Dr Negrin, Las Palmas, Gran Canaria, Spain.
Melissa García PuertaCardiology Department, Angiografía de Occidente Hospital, Cali, Colombia.
Miguel OrtizCardiology Department, Angiografía de Occidente Hospital, Cali, Colombia.
Jose Carlos Gonzalez-GutiérrezCardiology Department, Hospital Clinico Universitario de Valladolid, Valladolid, Spain.
Giorgio MarengoCardiology Department, Hospital Clinico Universitario de Valladolid, Valladolid, Spain.
Javier GómezCardiology Department, Hospital Clinico Universitario de Valladolid, Valladolid, Spain.
Esther Gonzalez-BartolCardiology Department, Hospital Clinico Universitario de Valladolid, Valladolid, Spain.
Alexander StepanenkoCardiology Department, Hospital Clinico Universitario de Valladolid, Valladolid, Spain.
Itziar Gomez-SalvadorCentro de Investigación Biomédica en Red, Enfermedades Cardiovasculares, Madrid, Spain.
J Alberto San RománCardiology Department, Hospital Clinico Universitario de Valladolid, Valladolid, Spain.
Ignacio J Amat-SantosCardiology Department, Hospital Clinico Universitario de Valladolid, Valladolid, Spain.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTranscatheter aortic valve replacement (TAVR) in non-calcified aortic regurgitation (NCAR) is an off-label procedure. The balloon-expandable Myval includes extra-large sizes (30.5 mm and 32 mm) of interest in this setting.

aimsWe aimed to evaluate the safety and feasibility of Myval in NCAR.

methodsThis was an international, multicentre, observational study that enrolled all consecutive patients with symptomatic severe NCAR undergoing TAVR with the Myval device. The images were centrally analysed.

resultsA total of 113 patients were recruited, 64.6% were men, the mean age was 78.4±7.5 years, and the Society of Thoracic Surgeons score was 2.7±1.7%. Aortic root dilatation was present in 59.3% of patients, 7.1% were bicuspid, and the mean annular area was 638.6±106.0 mm

conclusionsMyval is a feasible and safe option for selected non-operable patients with NCAR and demonstrated good midterm outcomes and lack of impact of oversizing on device durability.

Indexed as

Aortic Valve InsufficiencyAortic Valve StenosisHeart Valve ProsthesisTranscatheter Aortic Valve ReplacementAgedAged, 80 and overAortic ValveFemaleHumansMaleProsthesis DesignTreatment Outcome

Identifiers

PMID37565470
PMCPMC10500190

What OpenQuestion holds

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Registered trials

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.