INDURE registry: Clinical and quality of life outcomes of surgical aortic valve replacement in 421 patients under 60 years of age
December 8, 2022
Meuris B, Senage T, Borger M, Siepe M, Stefano P, Laufer G, Langanay T and De Paulis R, on behalf of the INDURE investigators
Presented at 36th European Association for Cardio-Thoracic Surgery Annual Meeting, 2022.
Key points:
- One-year clinical outcomes of patients aged ≤60 years within the INDURE registry were excellent, with few cardiovascular events and satisfactory valve performance
- Patients achieved a general population standard quality of life (QoL) within 3–6 months post surgery
Background information
- The treatment of comparatively young patients with implantation of surgical aortic bioprosthetic valves has raised questions about valve durability and longetivity.1
- The INSPIRIS RESILIA Durability Registry (INDURE) was designed to assess the performance of the INSPIRIS RESILIA bioprosthetic valve in patients aged 60 years or younger.1
Aims
- To evaluate the clinical and QoL outcomes of the INSPIRIS RESILIA valve in patients aged ≤60 years 1 year after surgical aortic valve replacement (SAVR).
Type of study
- A prospective, open-label, multicentre registry study.
Endpoints
Endpoints included time-related valve safety according to VARC-2 guidelines and haemodynamic performance at 1 year and changes in QoL from baseline to 1 year.
- Follow-up included Clinical Events Committee adjudication and CoreLab echocardiography adjudication at 1, 3 and 5 years.
Methods
- The study included patients aged 18–60 years undergoing SAVR.
- Patients were followed-up with echocardiography after 1 year.
- QoL was assessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ) and the Short Form 12 item (version 2) Health Survey (SF12v2).
Results
Patients
- The 1-year analysis included 421 patients from 21 centres across Europe and Canada, with a mean age of 53.5 ± 6.9 years, of whom 23.5% were female. Mean body surface area was 2.00 ± 0.23 m2. Mean EuroSCORE II was 1.5 ± 1.6% and 27.2% of patients were in NYHA class III/IV.
- The mean follow-up was 7 ± 2.3 months.
- Despite being of similar age to males, female patients had reduced body surface area (p<0.001), increased EuroSCORE II (p<0.001), as well as increased incidence of NYHA class III or IV (p<0.001) and chronic obstructive pulmonary disease (p=0.005).
Clinical outcomes
- Clinical outcomes were excellent (Table 1), with a hospital mortality that was better than predicted (0.7% vs 1.5%).
- Haemodynamic performance was satisfactory and stable throughout follow-up (mean pressure gradient at discharge was 7 ± 4.3 mmHg, and 12.6 ± 5.3 mmHg at one year).
- No cases of structural valve deterioration (SVD) were recorded.
Table 1. Safety outcomes early and between 31 days and 1 year after surgery

QoL
- Within 3–6 months, QoL was restored to good-to-excellent on the KCCQ scale (score between 75–100) and approximately matching the QoL of the general US population according to the SF12v2 scoring system (approximate score of 50).
- Female patients had generally significantly lower scores than men.
Conclusion
One-year clinical outcomes of patients aged ≤60 years within the INDURE registry were excellent, with stable performance, better-than-predicted hospital mortality, low incidence of cardiovascular events, only four incidences of valve thrombosis (which did not require intervention), and no SVD events. Patients returned to expected QoL within 3–6 months after surgery. Notably, female patients tended to have a higher NYHA functional class at the time of surgery and had consistently lower QoL scores than males. Longer follow-up is underway.
References
- Meuris B, Borger MA, Bourguignon T et al. Durability of bioprosthetic aortic valves in patients under the age of 60 years – rationale and design of the international INDURE registry. J Cardiothorac Surg. 2020; 15: 119.
This document is a summary of the Meuris B et al. presentation and covers key information including aim, type of study, methods, results and conclusions.
The full publication is available at:
Abbreviations:

No clinical data are available that evaluate the long-term impact of RESILIA tissue in patients.
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Insights from INDURE registry
Prof. Ruggero De Paulis
Prof. Kocher – EACTS 2021
The recently updated ESC/EACTS Guidelines contain two key changes in the recommendations for prosthetic valve selection:1
- A new Class IIb recommendation for bioprostheses in patients already on long-term NOACs
- An upgraded Class I recommendation for bioprostheses in patients for whom good-quality anticoagulation is unlikely or contraindicated, and in patients whose life-expectancy is lower than the presumed durability of the valve
Importantly, the desire of the informed patient remains central to prosthetic valve selection. Valve durability in young patients is an important consideration, but long-term data on bioprosthetic SAVR have been limited.
INDURE registry
INDURE is a prospective, open-label, multicentre registry that is tackling this issue head-on. INDURE has enrolled over 400 patients aged up to 60 years who are undergoing SAVR with the INSPIRIS RESILIA valve in 21 sites across Europe and Canada. Patients are being followed up for five years, with echocardiograms analysed by Echo Core Laboratory at years one and five.2,3
One-year results from the first 435 patients were reported at the 2021 EACTS Annual Meeting. Younger patients (up to 50 years old) in the registry were more likely to have a bicuspid aortic valve or aortic valve regurgitation at baseline than patients aged 51–60 years, but were less likely to have aortic stenosis, hypertension or diabetes.3

Excellent haemodynamic outcomes at 1 year
The excellent haemodynamic outcomes were comparable in the younger and older patient groups.
Plus, preliminary safety outcomes demonstrated low all-cause mortality and no confirmed cases of valve-related mortality up to one year. Rates of endocarditis and stroke were low (<1%). There were no cases of stage 3 SVD.
The INDURE registry will continue to provide clinical evidence on the use of the INSPIRIS RESILIA valve in young patients for the next 5 years.

References
1. Vahanian A, Beyersdorf F, Praz F et al. 2021 ESC/EACTS Guidelines for the management of valvular heart disease. Eur J Cardiothorac Surg. 2021.
2. Meuris B, Borger MA, Bourguignon T et al. Durability of bioprosthetic aortic valves in patients under the age of 60 years – rationale and design of the international INDURE registry. J Cardiothorac Surg. 2020; 15: 119.
3. De Paulis R. Surgical aortic valve replacement in patients under 60 years old: A prospective, multicentre real-world registry in Europe and Canada. EACTS 2021.
For professional use. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the instructions for Use (consult eifi.edwards.com where applicable)
Edwards devices placed on the European market meeting the essential requirements referred to in Article 3 of the Medical Device Directive 93/42/EEC bear the CE marking of conformity.
Edwards, Edwards Lifesciences, the stylized E logo, INSPIRIS, and RESILIA are trademarks or service marks of Edwards Lifesciences Corporation or its affiliates. All other trademarks are the property of their respective owners.
© 2021 Edwards Lifesciences Corporation. All rights reserved. PP–EU-3060 v1.0
Edwards Lifesciences • Route de l’Etraz 70, 1260 Nyon, Switzerland • edwards.com