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.
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.
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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.
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Prof. Michele De Bonis
Be courageous, be experienced, be ethical … according to the Guidelines!
Prof. Gilles Dreyfus
Be courageous, be experienced, be ethical … according to the Guidelines!
Prof. Nikolaos Bonaros
Be courageous, be experienced, be ethical … according to the Guidelines!
Mr. Steve Livesey
Be courageous, be experienced, be ethical … according to the Guidelines!
Prof. Hanneke Takkenberg
Be courageous, be experienced, be ethical … according to the Guidelines!
Prof. Bart Meuris
Be courageous, be experienced, be ethical … according to the Guidelines!
Dr. Alison Duncan
Be courageous, be experienced, be ethical … according to the Guidelines!
Prof. Augusto D’Onofrio
Be courageous, be experienced, be ethical … according to the Guidelines
Prof. Gino Gerosa
Be courageous, be experienced, be ethical … according to the Guidelines!
The 2021 update of the ESC/EACTS Guidelines for the management of valvular heart disease, recommends treating patients with severe aortic stenosis younger than 75 years and low risk with surgical aortic valve replacement (SAVR), simplifying the initial patient treatment pathway and preferred mode of intervention. The implication is that valve durability is now even more important because of younger patients’ greater longevity.
Edwards Lifesciences has two ongoing trials, COMMENCE and EU Feasibility, that are evaluating the longevity of a bioprosthetic valve with novel RESILIA tissue. Both trials have demonstrated a favourable safety profile and good haemodynamic performance at 5 years, with additional follow-up to be conducted up to 10 years.1,2
The COMMENCE trial
Safety endpoints, probability event-free:
COMMENCE is an FDA pivotal trial designed to evaluate the safety and effectiveness of the INSPIRIS bioprosthetic aortic valve with the novel RESILIA tissue.1 The 5-year data are now available:
· All-cause mortality 89.2%
· Major paravalvular leak 99.5%
· Endocarditis 97.8%
Improved haemodynamic performance from baseline
The absence of structural valve deterioration through 5 years* and the presence of stable gradients, plus freedom from regurgitation support durability over the observational period.
*One case of structural valve deterioration was diagnosed at postoperative Day 1,848.
At 5 years, COMMENCE results indicate a favourable safety profile and stable haemodynamic performance of a bioprosthetic valve with RESILIA tissue. Ten-year data in an extended follow-up cohort and the RESILIENCE trial with 11-year follow-up are forthcoming.
The RESILIA EU Feasibility study
The RESILIA EU Feasibility study has investigated the safety and performance in aortic valve replacement patients of the bioprosthesis with the novel RESILIA tissue at 5 years.2 Here, we summarise the results at 5 years:
Stable haemodynamic performance:
Mean gradient was 14.8 ± 7.6 mmHg
Average effective orifice area was 1.4 ± 0.5 cm2
Zero structural valve deterioration events and stable transvalvular gradients were observed at 5 years.
At 5-years, results from the EU Feasibility study represent the longest follow-up of aortic valve replacement patients with RESILIA tissue and demonstrate excellent haemodynamic performance and safety outcomes.1
Recommended resources
https://edwardseducation.com/edwardsmasters/the-latest-tissue-valve-technology-responding-to-the-unmet-needs-in-avr/
References
1. Bavaria J, Griffith B, Heimansohn DA et al. Five-year outcomes of the COMMENCE trial investigating aortic valve replacement with a novel tissue bioprosthesis. Presented at the Society of Thoracic Surgeons (STS) Annual Meeting, January 29-31, 2021.
2. Bartus K, Litwinowicz R, Bilewska A et al. Final 5-year outcomes following aortic valve replacement with a RESILIA™ tissue bioprosthesis. Eur J Cardiothorac Surg 2020; 59: 434–41.
No clinical data are available that evaluate the long-term impact of RESILIA tissue in patients.
For professional use. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use (consult eifu.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, COMMENCE, INSPIRIS, INSPIRIS RESILIA, and RESILIA are trademarks or service marks of Edwards Lifesciences Corporation or its affiliates. All other trademarks are the property of their respective owners.
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Edwards Lifesciences • Route de l’Etraz 70, 1260 Nyon, Switzerland • edwards.com
Prosthetic valve choice and mode of intervention for aortic valve replacement in younger patients have been controversial because of concerns about long-term durability. The 2021 update to the ESC/EACTS guidelines for the management of valvular heart disease makes recommendations for patients with severe aortic stenosis, based on available evidence and
valve replacement innovation.1
In patients with severe aortic stenosis, age is now a key determining factor in the initial
choice between SAVR or TAVI. This change simplifies the initial patient treatment pathway
and preferred mode of intervention for patients with severe aortic stenosis.
The guidelines emphasise that while the durability of surgical bioprosthetic valves
beyond 10 years is well established, evidence supporting the durability of TAVI valves is
more limited.
As valve durability is a key consideration in younger patients (<75 years) at low surgical risk, SAVR (if feasible) is the preferred treatment option. SAVR is also recommended for patients who are unsuitable for transfemoral TAVI and operable.
The guidelines recommend TAVI for older patients (≥75 years) and those who are inoperable or high risk for surgery (particularly if feasible via the transfemoral approach).
SAVR or TAVI are recommended for remaining patients according to individual
clinical, anatomical and procedural characteristics.
Prosthesis selection: Tissue or mechanical valve?
If the Heart Team and patient agree that SAVR is the way forward, the choice between mechanical and biological valves comes to the fore. Key factors for the Heart Team to consider are:
- The patient’s life expectancy
- Lifestyle and environmental factors
- Bleeding and thromboembolic risk related to anticoagulation
- Potential for surgical or transcatheter reintervention
- Informed patient choice
The evidence continues to support the use of aortic bioprostheses for patients over 65 years of age, but just how durable are bioprostheses?
Latest recommendations are supported by real-world evidence and consistent clinical outcomes
Several large, long-term studies have demonstrated the excellent long-term durability of the Carpentier-Edwards PERIMOUNT aortic valve.2–9
Carpentier-Edwards PERIMOUNT valve
Overall expected valve durability of the PERIMOUNT aortic valve is 19.7 years.2-4
- Broken down by age, durability was
- 17.6 years for patients aged ≤60 years
- 19 years for patients aged 50–65 years
- 22.1 years for patients aged 60–70 years
- Twenty-year probability of explant due to SVD across all age groups is 5.4%7
- Younger age at implantation is associated with a higher risk of structural valve deterioration,2,6-9 but durability is good even in these younger patients2,6-9
Recommended resources
References
1. Vahanian A, Beyersdorf F, Praz F et al. 2021 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2021:
2. Bourguignon T, Bouquiaux-Stablo A-L, Candolfi P et al. Very long-term outcomes of the Carpentier-Edwards Perimount valve in aortic position. Ann Thorac Surg. 2015; 99: 831–7.
3. Bourguignon T, El Khoury R, Candolfi P et al. Very long-term outcomes of the Carpentier-Edwards Perimount aortic valve in patients aged 60 or younger. Ann Thorac Surg. 2015; 100: 853–9.
4. Bourguignon T, Lhommet P, El Khoury R et al. Very long-term outcomes of the Carpentier-Edwards Perimount aortic valve in patients aged 50–65 years. Eur J Cardio-Thorac Surg. 2016; 49: 1462–8.
5. Forcillo J, El Hamamsy I, Stevens LM et al. The Perimount valve in the aortic position: Twenty-year experience with patients under 60 years old. Ann Thorac Surg. 2014; 97: 1526–32.
6. Forcillo J, Pellerin M, Perrault LP et al. Carpentier-Edwards pericardial valve in the aortic position: 25-years experience. Ann Thorac Surg. 2013; 96: 486–93.
7. Johnston DR, Soltesz EG, Vakil N et al. Long-term durability of bioprosthetic aortic valves: Implications from 12,569 implants. Ann Thorac Surg. 2015; 99: 1239–47.
8. McClure RS, Narayanasamy N, Wiegerinck E et al. Late outcomes for aortic valve replacement with the Carpentier-Edwards pericardial bioprosthesis: up to 17-year follow-up in 1,000 patients. Ann Thorac Surg. 2010; 89: 1410–6.
9. Minakata K, Tanaka S, Okawa Y et al. Long-term outcome of the Carpentier-Edwards Pericardial valve in the aortic position in Japanese Patients. Circ J. 2014; 78: 882–9.
For professional use. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use (consult eifu.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, Carpentier-Edwards, Carpentier-Edwards PERIMOUNT, INSPIRIS, INSPIRIS RESILIA, Magna, Magna Ease, PERI, PERIMOUNT, RESILIA and SAPIEN are trademarks of Edwards Lifesciences Corporation. All other trademarks are the property of their respective owners.
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Edwards Lifesciences • Route de l’Etraz 70, 1260 Nyon, Switzerland • edwards.com
Prof. Michael Borger
Be courageous, be experienced, be ethical … according to the Guidelines!
A key focus of the new ESC/EACTS guidelines is the instrumental role of the Heart Team in decisions concerning intervention and treatment, and the importance of collaborative decision making, taking both the Heart Team’s expert guidance and the wishes of the patient into consideration.
Key points include:
Heart Team recommendations must be discussed with patient and family to allow informed treatment choice
Heart Valve Centres are a key component of the Heart Team approach
Early Heart Team referral encouraged if patient’s symptoms develop/worsen before next planned visit
All patients with severe aortic stenosis must be referred through the Heart Team
Joint decision making gets the right treatment to each patient
ESC/EACTS guidelines now recommend that an active and collaborative Heart Team make decisions about intervention and treatment.
Your expertise means you are best placed to recommend the optimal valve procedure for the patient, in collaboration with the other specialists and dedicated personnel of the Heart Team.
Class I recommendations for a collaborative Heart Team approach
The choice between a surgical or transcatheter approach will depend on evaluation of the clinical, anatomical and procedural factors by the Heart Team, considering the risks and benefits for each individual patient.
Interventions should be performed in Heart Valve Centres, using a structured and collaborative Heart Team approach.
All procedural decisions should be patient-centred, giving consideration to age, operative risk, the patient’s life expectancy, lifestyle and environmental factors, their potential for reintervention and any co-morbidities. The final recommendation should also consider the desires of the patient. Ensure you meet your patients’ high expectations by offering them the best valve technologies. Early referral is encouraged if a patient’s symptoms develop/worsen before the next planned visit.
All procedural decisions should be patient-centred, giving consideration to age, operative risk, the patient’s life expectancy, lifestyle and environmental factors, their potential for reintervention and any co-morbidities. The final recommendation should also consider the desires of the patient. Ensure you meet your patients’ high expectations by offering them the best valve technologies. Early referral is encouraged if a patient’s symptoms develop/worsen before the next planned visit.
Interested in finding out more
The upcoming EACTS Annual Meeting has several sessions relevant for these changes:
- Meet the people behind the guidelines in 2021 EACTS/ESC Guidelines for the management of valvular heart disease: Meet the task force members in room 111, at 12:30 on Saturday 16 October
- Join Drs Bonaros and Bourguignon for Problems and concerns related to the choice of an optimal aortic valve substitute in room 111 on Thursday 14 October at 14:15
- Challenging decisions and long-term outcomes in tricuspid and mitral disease with Professor Folliguet is one to attend in room 115 at 16:15 on Friday 15 October
Check out the Edwards congress hub for more information about their upcoming symposia, or meet them onsite at the booth.
You can also read more practical information about the ESC/EACTS guidelines
- Check out Professor Michael Borger’s recent presentation on what’s missing from the new ESC/EACTS guidelines
Edwards, Edwards Lifesciences, and the stylized E logo 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-2918 v1.0
Edwards Lifesciences • Route de l’Etraz 70, 1260 Nyon, Switzerland • edwards.com
Prof. Stephan Ensminger
MVT Aortic 2021
