Low-risk patient management: EACTS and STS position

June 7, 2024

Prof. Patrick Myers

Aortic Highlights 2024

Prof. De Paulis

Aortic Highlights course, 2023

Prof. Borger

Aortic Highlights course, 2023

Prof. Michael Borger

MVT Intermediate 2022 Course

Prof. Siepe

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

Prof. Doenst

Edwards Lifesciences at EACTS 2022: State of the art in the treatment of aortic valve regurgitation in young patients

Prof. Jeroen Bax

MVT Aortic 2022, vol.2

– Valve Academic Research Consortium: created in 2010, updated in 2012, and updated again in 2021

– Get up to date regarding clinical endpoints.

– It’s not necessary to memorize it all, but to at least be familiar with all parts of the VARC-3 consensus.

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.

Alexey Dashkevich

MVT Aortic 2022, Vol.2

– Is the patient 50-65 years old? Be sure to think about re-intervention, keep the guidelines in mind, and fully inform the patient.

– Which type of anticoagulation therapy should be used?

– Don’t forget, a Ross procedure may be an option.

Prof. Marjan Jahangiri

MVT Aortic 2022, vol.2

– How do we decide between a Ross procedure or a modified Ross procedure? Who are the candidates, and what is their anatomy like?

– Perhaps most interesting, hear what she has to say about how and why we should be cautious when interpreting long-term results, even from large studies and meta-analyses.

– Advantages, disadvantages, complications, autograft failure predictors, and more!

Prof. Ruggero De Paulis

MVT Aortic 2022, vol.2

– Pros and cons of valve-sparing versus the pros and cons of biological or mechanical Bentall procedures

– Plenty of data with plenty of insights, get ready to take notes

– Experience and confidence reign supreme

– If relevant, don’t forget to plan for future valve-in-valve

Prof. Alessandro Della Corte

MVT Aortic 2022, vol.1

– New classification system and nomenclature of bicuspid aortic valve (and bicuspid aortic valve disease)

– Genes are important, but a single gene may contribute to fewer than 1% of cases

– Different valve repair techniques according to valve phenotype

Prof. Marjan Jahangiri

MVT Aortic 2022, vol.1

– Shorter time to extubation, shorter length of stay, shorter hospital stays

– Pre-operative strategies to enhance post-operative and follow-up outcomes

– Don’t forget to pay attention to the intra-operative details and work with the entire Heart Team for optimal patient outcomes

Prof. Marjan Jahangiri

MVT Aortic 2022, vol.1

– Pay attention to comorbidities, the anticoagulation choice may not as simple as it seems

– Be aware of the limitations of the currently available studies, question them in a logical manner

Prof. Joseph Bavaria

MVT Aortic 2022, vol.1

Prof. Michael Borger

MVT Aortic 2022, vol.1

-The “aortic size paradox”: an interesting paradox, indeed

-Length? Diameter? Which should we pay more attention to?

-Be sure to pay attention to genetics, biomarkers, abnormal flow, other risk factors, and more

Prof. Friedhelm Beyersdorf

MVT Aortic 2022, vol.1

Guidelines: based on scientific data, not an individual hospital’s, country’s, or region’s practices.

It’s important to truly understand the recommendations and evidence classifications.

Pay attention to the details in phrasing.

Prof. Benussi – MVT Intermediate 2021

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.

© 2021 Edwards Lifesciences Corporation. All rights reserved. PP–EU-3060 v1.0

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

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 referralregular 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.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

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.

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-3061 v1.0

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