Decision making in primary MR: which patient for which therapy
Dr. Dahle
Mitral Highlights course, 2023
Prof. Michael Borger
MVT Intermediate 2022 Course
Herzklinik Hirslanden
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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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!
Mr. Steve Livesey
Be courageous, be experienced, be ethical … according to the Guidelines!
Prof. Bart Meuris
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.
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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
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The highly anticipated 2021 European Society of Cardiology (ESC) and European Association for Cardio-Thoracic Surgery (EACTS) guidelines for the management of valvular heart disease have finally landed.
We are excited to bring you a summary of the main updates, plus the new materials coming soon to support you and your teams in understanding and implementing the changes.
Key points include:
Treatment recommendations for all patients with severe aortic stenosis to be made by the Heart Team
Intervention options for patients with asymptomatic aortic stenosis
Bioprosthetic valves now recommended for those with life expectancy shorter than valve durability
Intervention recommended for patients with secondary mitral regurgitation, who remain symptomatic despite guideline-directed medical therapy
Use your experience of severe aortic stenosis to ensure the best patient outcomes
The choice between surgical aortic valve replacement (SAVR) and transcatheter aortic valve implantation (TAVI) must be made following evaluation of all factors – clinical, anatomical and procedural – weighing the risks and benefits of each approach for all patients with severe aortic stenosis, and after discussion with the patient.
Treatment options have broadened for patients with asymptomatic aortic stenosis, including those with systolic left ventricular (LV) dysfunction (LV ejection fraction <55%) without another cause.
Enable more of your patients to live the active lifestyle they desire
Bioprosthetic valves now have a Class I recommendation for patients with life expectancy lower than the durability of the valve. Now, more of your patients can live a life free from anticoagulation. In addition, bioprosthetic valves may be considered for patients already on long-term novel oral anticoagulants.
Ensure you meet your patients’ high expectations by offering them the best valve technologies.
Be courageous, be experienced, be ethical… according to the guidelines!
Join us from the comfort of your office for a virtual symposium discussing the changes and what they mean for your practice. Eleven speakers from across Europe will cover the implications for the aortic, mitral and tricuspid valves. Click here for the full programme.
Tuesday 21 September 2021
3.00–7.45 pm CET
REGISTER NOW
Coming soon from Edwards
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Dr. Hendrik Treede, Germany
