ArticleJournal of cardiothoracic surgery2020
Durability of bioprosthetic aortic valves in patients under the age of 60 years - rationale and design of the international INDURE registry.
Article in Journal of cardiothoracic surgery, 2020. 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 11 papers, 1 of them a synthesis that pooled it.
What it found
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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.
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.
Clinical Outcomes of Patients Under the Age of Sixty Undergoing INSPIRIS RESILIA Aortic Valve Replacement
Who cites it
11 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Early and late clinical outcomes and cost-effectiveness of aortic valve replacement using the Inspiris Resilia bioprosthesis : A systematic review and meta-analysis.Journal of cardiothoracic surgery · 2025Pooled it
- Aortic Valve Interventions in Asymptomatic Severe Aortic Stenosis: Who, Why, and When?Journal of clinical medicine · 2026Review
- Could the age threshold for TAVI be relaxed to below 65 years? Pros and cons.EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2025Article
- Sutureless Bioprostheses for Aortic Valve Replacement: An Updated Systematic Review with Long-Term Results.Journal of clinical medicine · 2024Review
- Sex-related differences among patients undergoing surgical aortic valve replacement-a propensity score matched study.Interdisciplinary cardiovascular and thoracic surgery · 2024Article
- Case Series of First Microinvasive Fully Endoscopic Use of a New Mitral Prosthesis.Journal of clinical medicine · 2024Article
- Durability of bioprosthetic aortic valve replacement in patients under the age of 60 years - 1-year follow-up from the prospective INDURE registry.Interdisciplinary cardiovascular and thoracic surgery · 2023Article
- The Longest Known Survival of a Patient With Bioprosthetic Aortic Valve Replacement: A 42-Year Follow-Up.Cureus · 2023Article
- Mid-term clinical and echocardiographic results of the INSPIRIS RESILIA aortic valve: a retrospective comparison to the Magna Ease.Interdisciplinary cardiovascular and thoracic surgery · 2023Article
- Perimount MAGNA Ease vs. INSPIRIS Resilia Valve: A PS-Matched Analysis of the Hemodynamic Performances in Patients below 70 Years of Age.Journal of clinical medicine · 2023Article
- Impact of pre-existing comorbidities on outcomes of patients undergoing surgical aortic valve replacement - rationale and design of the international IMPACT registry.Journal of cardiothoracic surgery · 2021Article
Corrections and comments
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Authors and funding
23 authors.
Funding
Abstract
backgroundThere is an ever-growing number of patients requiring aortic valve replacement (AVR). Limited data is available on the long-term outcomes and structural integrity of bioprosthetic valves in younger patients undergoing surgical AVR.
methodsThe INSPIRIS RESILIA Durability Registry (INDURE) is a prospective, open-label, multicentre, international registry with a follow-up of 5 years to assess clinical outcomes of patients younger than 60 years who undergo surgical AVR using the INSPIRIS RESILIA aortic valve. INDURE will be conducted across 20-22 sites in Europe and Canada and intends to enrol minimum of 400 patients. Patients will be included if they are scheduled to undergo AVR with or without concomitant root replacement and/or coronary bypass surgery. The primary objectives are to 1) determine VARC-2 defined time-related valve safety at one-year (depicted as freedom from events) and 2) determine freedom from stage 3 structural valve degeneration (SVD) presenting as morphological abnormalities and severe haemodynamic valve degeneration at 5 years. Secondary objectives include the assessment of the haemodynamic performance of the valve, all stages of SVD, potential valve-in-valve procedures, clinical outcomes (in terms of New York Heart Association [NYHA] function class and freedom from valve-related rehospitalisation) and change in patient quality-of-life. DISCUSSION: INDURE is a prospective, multicentre registry in Europe and Canada, which will provide much needed data on the long-term performance of bioprosthetic valves in general and the INSPIRIS RESILIA valve in particular. The data may help to gather a deeper understanding of the longevity of bioprosthetic valves and may expand the use of bioprosthetic valves in patients under the age of 60 years.
trial registrationClinicalTrials.gov identifier: NCT03666741 (registration received September, 12th, 2018).
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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.