Evidence map›Paper›PMID 37462612›Full record

ArticleInterdisciplinary cardiovascular and thoracic surgery2023

Durability of bioprosthetic aortic valve replacement in patients under the age of 60 years - 1-year follow-up from the prospective INDURE registry.

Bart Meuris, Jean-Christian Roussel, Michael A Borger, Matthias Siepe, Pierluigi Stefano, Günther Laufer, Thierry Langanay, Alexis Theron, Martin Grabenwöger, Konrad Binder and 14 more

Registry-linked trialOpen access · diamondAbstract read
In one paragraph

Article in Interdisciplinary cardiovascular and thoracic surgery, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03666741 (Clinical Outcomes of Patients Under the Age of Sixty Undergoing INSPIRIS RESILIA Aortic Valve Replacement), which is not on this map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
1.3field-weighted citation impact, top 18% 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.

NCT03666741 active not recruitingnot on this map

Clinical Outcomes of Patients Under the Age of Sixty Undergoing INSPIRIS RESILIA Aortic Valve Replacement

Typeobservational_patient_registrySponsorInstitut für Pharmakologie und Präventive MedizinRan2019 to 2026Enrolled400ConditionsAortic Valve StenosisArmsAVR with or without CABG
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it, 6 citations in OpenAlex.

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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

24 authors at 20 institutions in 10 countries.

Bart MeurisCardiac Surgery, University Hospitals Leuven, Leuven, Belgium.ORCID 0000-0001-9176-293X
Jean-Christian RousselService de chirurgie thoracique et cardiovasculaire, CHU Nantes, Nantes, France.ORCID 0000-0003-3928-6977
Michael A BorgerDepartment for Cardiac Surgery, Leipzig Heart Center, University of Leipzig, Leipzig, Germany.ORCID 0000-0003-1046-1364
Matthias SiepeDepartment of Cardiovascular Surgery, University Heart Center, University Hospital Freiburg, Freiburg, Germany.
Pierluigi StefanoDivision of Cardiac Surgery, Careggi University Hospital, Florence, Italy.ORCID 0000-0001-8338-3016
Günther LauferDepartment of Cardiac Surgery, Medical University of Vienna, Vienna, Austria.
Thierry LanganayThoracic and Cardiovascular Surgery, Rennes University Hospital Center, Rennes, France.
Alexis TheronCardio-Thoracic Surgery Department, Hospital de la Timone, Marseille, France.ORCID 0000-0001-9453-9039
Martin GrabenwögerDepartment of Cardiovascular Surgery, HZH Heart Center Hietzing, Austria.
Konrad BinderHeart Center University St. Pölten, St. Pölten, Austria.
Philippe DemersDepartment of surgery, Montreal Heart Institute, University of Montreal, Montreal, Canada.
Renzo PessottoEdinburgh Heart Centre, Royal Infirmary of Edinburgh, Edinburgh, UK.
Wouter van LeeuwenCardio-Thoracic Surgery, Erasmus University Medical Center, Rotterdam, Netherlands.
Thierry BourguignonDepartment of Cardiology and Cardiac Surgery, Tours University Hospital, Tours, France.
Sergio CanovasCardiovascular Surgery Department, Hospital University Virgen de la Arrixaca, Murcia, Spain.
Giovanni MariscalcoNational Institute for Health Research Leicester Biomedical Research Centre, Glenfield Hospital, Leicester, England.
Enrico CoscioniDivision of Cardiac Surgery, University Hospital San Giovanni di Dio e Ruggi d'Aragona, Salerno, Italy.
Francois DagenaisInstitute University, Cardiology Center, Québec, Canada.
Olaf WendlerDepartment of Cardiothoracic Surgery, King's College Hospital NHS Foundation Trust, London, UK.ORCID 0000-0002-7494-5774
Gianluca PolvaniDepartment of Cardiovascular Surgery, Cardiology Center Monzino, Milan, Italy.
Matthias EdenDepartment for Internal Medicine III, Molecular Cardiology and Angiology, University Hospital Schleswig-Holstein, Kiel, Germany.
Beate BottaInstitute for Pharmacology and Preventive Medicine, Cloppenburg, Germany.
Peter BramlageInstitute for Pharmacology and Preventive Medicine, Cloppenburg, Germany.ORCID 0000-0003-4970-2110
Ruggero De Paulis25. Department of Cardiac Surgery, European Hospital, Rome, Italy.ORCID 0000-0002-3603-2202
IPPMed (Germany) · DEAzienda Ospedaliero-Universitaria Careggi · ITCentre Hospitalier Universitaire de Rennes · FRCentro Cardiologico Monzino · ITEdinburgh Royal Infirmary · GBErasmus MC · NLEuropean Hospital · ITGlenfield Hospital · GBHôpital de la Timone · FRHospital Universitario Virgen de la Arrixaca · ESKing's College Hospital NHS Foundation Trust · GBKlinik Hietzing · ATKU Leuven · BELeipzig Heart Institute · DEMedical University of Vienna · ATMontreal Heart Institute · CAOspedali Riuniti San Giovanni di Dio e Ruggi d'Aragona · ITUniversité de Tours · FRUniversity Hospital Schleswig-Holstein · DEUniversity of Applied Sciences St Pölten · AT

Funding

Edwards Lifesciences HVT-I18-331
6 · The paper itself

Abstract

objectivesWe report 1-year safety and clinical outcomes in patients <60 years undergoing bioprosthetic surgical aortic valve intervention.

methodsThe INSPIRIS RESILIA Durability Registry is a prospective, multicentre registry to assess clinical outcomes of patients <60 years. Patients with planned SAVR with or without concomitant replacement of the ascending aorta and/or coronary bypass surgery were included. Time-related valve safety, haemodynamic performance and quality of life (QoL) at 1 year were assessed.

resultsA total of 421 patients were documented with a mean age of 53.5 years, 76.5% being male and 27.2% in NYHA class III/IV. Outcomes within 30 days included cardiovascular-related mortality (0.7%), time-related valve safety (VARC-2; 5.8%), thromboembolic events (1.7%), valve-related life-threatening bleeding (VARC-2; 4.3%) and permanent pacemaker implantation (3.8%). QoL was significantly increased at 6 months and sustained at 1 year. Freedom from all-cause mortality at 1 year was 98.3% (95% confidence interval 97.1; 99.6) and 81.8% were NYHA I versus 21.9% at baseline. No patient developed structural valve deterioration stage 3 (VARC-3). The mean aortic pressure gradient was 12.6 mmHg at 1 year and the effective orifice area was 1.9 cm2.

conclusionsThe 1-year data from the INSPIRIS RESILIA valve demonstrate good safety and excellent haemodynamic performance as well as an early QoL improvement. CLINICAL

trial registrationclinicaltrials.gov: NCT03666741.

Indexed as

Structural valve degenerationSurgical aortic valve replacementValve durability

Identifiers

PMID37462612
PMCPMC10576637
OpenAlexW4384627166

What OpenQuestion holds

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LicenceCC BY
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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.