Promising results for bioprosthetic SAVR in patients under 60 years old
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.
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Patients are at the core of the new ESC/EACTS guidelines. The recommendation for patient-focused decision making covers all therapeutic areas.
Key points include:
Informed patient choice is crucial
Patient life expectancy and quality of life should be considered
Patient-centred evaluation is at the heart of ensuring informed treatment choice is offered to patients
Prosthetic valve selection should be made during Heart Team evaluation, and with consideration of the patient’s preferences
The patient-centred approach
Patient-centred decision making should be made by a fully collaborative Heart Team, right from clinical evaluation, imaging assessment through to intervention selection. Learn more about the importance of the Heart Team here.
All pieces of the puzzle need to fit together, to understand patient preferences and robustly diagnose and evaluate each patient, in order to come to a joint decision on treatment choice.
Prosthetic valve selection
To ensure the right treatment for each patient, every time, your patient should be given the opportunity to make an informed choice, and any decisions should be made in close collaboration with the Heart Team.
Involve your patients when it comes to:
- Understanding their lifestyle, any impact of anti-coagulation or the possibility of future re-do surgical, or transcatheter surgery
- Informing them of the influence of age in valve selection, particularly where life expectancy is less than bioprosthesis durability
- How valve selection will impact quality of life, whether this is an impact on diet or return to active lifestyle
- Understanding the potential risks and benefits of any potential intervention
The guidelines give a clear recommendation on when tissue valves should be selected, find out more here.
Edwards, Edwards Lifesciences, and the stylized E logo are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.
© 2021 Edwards Lifesciences Corporation. All rights reserved. PP–EU-3125 v1.0
Edwards Lifesciences • Route de l’Etraz 70, 1260 Nyon, Switzerland • edwards.com
Prof. Hanneke Takkenberg
Be courageous, be experienced, be ethical … according to the Guidelines!
EACTS Annual Meeting – Lisboa, October 2019
