What is the added value for the patient?
Herzklinik Hirslanden
Herzklinik Hirslanden
Historically, survival data on patients with mild-to-moderate aortic stenosis (AS) have been limited. This situation was addressed in 2019, however, when Strange et al. published their analysis of the relationship between AS severity and mortality in a cohort of 241,303 adult patients in an observational registry. The mean age of patients at baseline was 61 years and median follow up was 1,208 days. Mild and moderate AS were found in 6.7% (n=16,129) and 1.4% (n=3,315) of patients, respectively.1
While it has been observed that severe AS is associated with poor survival, this study also suggests poor survival rates in patients with moderate AS. The five-year mortality rate for these patients was 56% (mean gradient 20.0–39.9 mmHg and/or peak velocity 3.0–3.9 m/s and/or aortic valve area greater than 1 cm²).
Mortality rates according to AS severity
The importance of early referral, regular clinical and echocardiographic surveillance and early intervention were emphasised in the recent update to the ESC/EACTS Guidelines for the management of valvular heart disease.2 In addition to recommendations for an active collaboration among Heart Team members and the inclusion of the informed patient’s preferences when determining optimal treatment, specific recommendations relevant to patients with moderate AS include:2
- Regular clinical and echocardiographic surveillance where prognosis of patients with normal-flow,
low-gradient AS and preserved ejection fraction is similar to that of moderate AS - Earlier referral if patient’s symptoms advance or worsen
- Earlier intervention to be considered in asymptomatic patients with:
- severe AS and left ventricular ejection fraction (LVEF) <55% without another cause (IIa)
- severe AS and a sustained fall in blood pressure (>20 mmHg) during exercise testing (IIa)
- LVEF >55% and a normal exercise test if the procedural risk is low and one of the following is present: very severe AS, severe valve calcification plus Vmax progression >0.3 m/s/year, or markedly elevated B-type natriuretic peptide levels without other explanation is present (IIa)2
The ESC/EACTS guidelines also support consideration of earlier intervention in select patients with asymptomatic aortic regurgitation.2
References
1. Strange G, Stewart S, Celermajer D et al. Poor long-term survival in patients with moderate aortic stenosis. JACC. 2019; 74: 1851–63.
2. Vahanian A, Beyersdorf F, Praz F et al. 2021 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 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.
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Edwards Lifesciences • Route de l’Etraz 70, 1260 Nyon, Switzerland • edwards.com
Prof. Gino Gerosa
Be courageous, be experienced, be ethical … according to the Guidelines!
With the publication of the 2021 update to ESC/EACTS guidelines for the management of valvular heart disease, new guidance should be considered when caring for patients with severe aortic stenosis.1
Three key recommendations stand out:
Early intervention is recommended for asymptomatic patients with a LVEF below 55% without another cause
An emphasis on Heart Team collaboration to provide the optimal treatment while informing and involving patients in their decision-making
A clear age delineation that patients younger than 75 years of age with severe aortic stenosis receive SAVR, and patients older receive TAVI
It is established that the durability of modern surgical bioprosthetic valves is over 10 years,2 and in recent years there has been a trend towards a greater use of bioprosthetic valves.3 On the other hand, mechanical valves continue to be associated with bleeding risks because of the need for lifelong anticoagulation therapy, leading to lifestyle changes.4-6
Several large, long-term studies have demonstrated up to 20-year durability for the bioprosthetic Carpentier-Edwards PERIMOUNT
aortic valve.2,7,8
Carpentier-Edwards PERIMOUNT valve
Two ongoing trials, COMMENCE and EU Feasibility, are evaluating the longevity of bioprosthetic aortic valves with novel RESILIA tissue after five-year implantation. Five-year results from these studies have demonstrated a favourable safety profile and good haemodynamic performance.9,10
INSPIRIS RESILIA aortic valve
Another study found that the INSPIRIS RESILIA valve reduced the length of hospital stay compared with mechanical valves (6.6 days versus 10.3 days).11 Selecting the right treatment for the patient requires many considerations, most importantly the desire of the informed patient.
Additionally, the Heart Team needs to consider the age, estimated life expectancy, comorbidities, and anatomical and procedural characteristics of the patient; relative risks and long-term outcomes associated with SAVR or TAVI; prosthetic heart valve durability; feasibility of transfemoral TAVI; and local experience and outcome data to achieve optimal outcomes for patients.1
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: doi:10.1093/eurheartj/ehab395.
2. 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
3. Bartus K, Sadowski J, Litwinowicz R et al. Changing trends in aortic valve procedures over the past ten years—from mechanical prosthesis via stented bioprosthesis to TAVI procedures—analysis of 50,846 aortic valve cases based on a Polish National Cardiac Surgery Database. J Thorac Dis. 2019; 11: 2340–9.
4. Head SJ, Çelik M, Kappetein AP. Mechanical versus bioprosthetic aortic valve replacement. Eur Heart J. 2017; 38: 2183–91.
5. Reul RM, Ramchandani MK, Reardon MJ. Transcatheter aortic valve-in-valve procedure in patients with bioprosthetic structural valve deterioration. Methodist DeBakey Cardiovasc J. 2017; 13: 132.
6. Swinkels B, Ten Berg J, Kelder J et al. What can we learn from the past by means of very long-term follow-up after aortic valve replacement? J Clin Med. 2021; 10: 3925.
7. 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.
8. 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.
9. Bartus K, Litwinowicz R, Bilewska A et al. Final 5-year outcomes following aortic valve replacement with a RESILIA™ tissue bioprosthesis. Eur J Cardio-Thorac Surg. 2021; 59: 434–41.
10. 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 2021.
11. Meuris B. Innovation in anticalcification technology in heart valves leads to lower hospital stay in adults undergoing aortic valve replacement. Oral Presentation at HTAi 2021 virtual congress.
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, Carpentier-Edwards, Carpentier-Edwards PERIMOUNT, COMMENCE, INSPIRIS, INSPIRIS RESILIA, PERIMOUNT, 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-2950 v1.0
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.
© 2021 Edwards Lifesciences Corporation. All rights reserved. PP–EU-2949 v1.0
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!
