TAVI outcomes in the spotlight of current trials

June 7, 2024

Prof. Ralph von Bardeleben

Aortic Highlights, 2024

Dr. Thourani

Edwards Lifesciences at EACTS 2022: Aortic valve disease: Patient centric management in elderly population

Prof. Augusto D’Onofrio

MVT Aortic 2022, vol.2

– What’s less invasive than minimally-invasive surgery? Micro-invasive.

– The initial pros and cons of each approach are clear, but what about the outcomes?

– Don’t forget to implement Enhanced Recovery After cardiac Surgery (ERAS) protocols.

Prof. Marjan Jahangiri

MVT Aortic 2022, Vol.2

– Plan well, plan ahead, and keep the patient’s best interests in mind.

– Be sure you keep detailed notes during the first SAVR procedure.

– To avoid coronary artery obstruction, it may be worth avoiding SAVR valves where the leaflets are externally wrapped around the struts.

Prof. Gino Gerosa

MVT Aortic 2022, vol.1

– From small, to mini, to micro: it’s how technology evolves nowadays, and cardiac surgery is no exception

– When embracing technology, don’t forget to keep ethics in mind and be unbiased

– Keep an open mind and embrace new developments, but don’t forget to critically analyze the data and make your own logical conclusions

Prof. Marco Di Eusanio

MVT Aortic 2022, vol.1

– Minimally invasive: much more than just a small cut

– Already achieved a low mortality rate? Set new goals for new targets related to patient quality of life.

– Always consider… Do you need to be cautious with the sternum? Is the patient obese? Are you an experienced surgeon? Don’t forget to perform an Angio CT scan.

Dr. Vinod Thourani

Be courageous, be experienced, be ethical … according to the Guidelines!

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!

Prof. Hanneke Takkenberg

Be courageous, be experienced, be ethical … according to the Guidelines!

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!

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:

29SEPT21_Colaboration icon_0-1

Heart Team recommendations must be discussed with patient and family to allow informed treatment choice

29SEPT21_Medical centre_0-1

Heart Valve Centres are a key component of the Heart Team approach

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Early Heart Team referral encouraged if patient’s symptoms develop/worsen before next planned visit

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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.

27SEPT21_Heart team diagram_WEB_0-1

Class I recommendations for a collaborative Heart Team approach

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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.

29SEPT21_Recomendations_0-1


Interventions should be performed in Heart Valve Centres, using a structured and collaborative Heart Team approach.

29SEPT21_Recomendations_0-1

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:

You can also read more practical information about the 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

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.

  • SAVR is recommended in younger patients under 75 years, who are low surgical risk
  • TAVI is now recommended for all patients with severe aortic stenosis 75 years or older, who are suitable for transfemoral TAVI, based on clinical trial and registry data.
  • Further Heart Team evaluation is required for all remaining patients – such as those under 75 years with a risk score between 4% and 8%
  • 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

  • Order for free the 2021 ESC Pocket Guidelines: ESC/EACTS Guidelines on the management of valvular heart disease
  • Find a full summary of the EACTS congress, plus all you need to know from the guidelines
  • Follow us on Twitter and LinkedIn to be the first to know more

  • 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. NP–EU-0633 v1.0

    Edwards Lifesciences • Route de l’Etraz 70, 1260 Nyon, Switzerland • edwards.com

    Dr. Mark Hall

    MVT Aortic 2021

    Dr. Hendrik Treede, Germany

    MVT Fundamentals Course