Understanding structural valve deterioration and failure following AVR according to the VARC-3 consensus

August 18, 2022

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. 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. Kocher – EACTS 2021

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

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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Dr. Bart Meuris, Belgium

Keywords: aortic bioprostheses; aortic stenosis; aortic valve replacement

Surgical aortic valve replacement (SAVR) is still offered to elderly populations despite the potential for structural valve degeneration. Currently, however, there is limited comparative data on the long-term durability of different SAVR prostheses.

Reporting outcomes including repeat aortic valve replacement, prosthetic valve endocarditis and late all-cause mortality, Biancari et al. present key results from a retrospective, non-randomised, propensity-matched comparative analysis of the Trifecta and Carpentier-Edwards PERIMOUNT Magna Ease valves. The authors compared the outcomes of 2,216 patients who had undergone the procedure to implant one of the two SAVR prostheses.

Click the link below for an update on the latest research in aortic valve replacement.

Click here to access the full publication

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, Magna, Magna Ease, PERI, PERIMOUNT and PERIMOUNT Magna are trademarks of Edwards Lifesciences Corporation or its affiliates. All other trademarks or service marks are the property of their respective owners.

Keywords: aortic valve replacement; pericardial bioprostheses; reintervention

The use of pericardial bioprostheses in aortic valve replacement (AVR) is highly popular due to the lack of need for lifelong anticoagulation. Despite this, few studies have investigated the durability, rates of structural valve degeneration and valve-related events in newer bioprostheses. 

In this article Lam et al. present key results from a single-centre, retrospective study comparing three different aortic bioprosthetic valves . The authors assessed rates and causes of reinterventions in patients who underwent AVR with the Trifecta, Mitroflow and Carpentier-Edwards PERIMOUNT Magna Ease valves.

Follow the link below for the latest research in aortic valve replacement.

Click here to access the full publication

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, Magna, Magna Ease, PERI, PERIMOUNT, and PERIMOUNT Magna are trademarks or service marks of Edwards Lifesciences Corporation or its affiliates. All other trademarks are the property of their respective owners.

Keywords: bioprosthesis; aortic valve replacement; long-term outcomes; reintervention; mortality

Bioprostheses are the most common valve type used for aortic valve replacement (AVR) in the UK. Early structural valve degeneration of 19- to 21-mm Sorin Mitroflow LX valves led the UK Medicine and Healthcare products Regulatory Agency to issue a Medical Device Alert in 2017.

This summary presents key data from a single-centre, retrospective study comparing outcomes for the Mitroflow valve and the Carpentier-Edwards PERIMOUNT Magna valve. Theologou et al. analysed data from 2,608 patients, assessing aortic valve reintervention and mortality rates up to 10 years.

Download below to keep up to date with the latest research in AVR.

Click here to access the full publication

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 meet the requirements for bearing the CE marking of conformity.

Edwards, Edwards Lifesciences, the stylized E logo, Carpentier-Edwards, Magna, PERI, PERIMOUNT, and PERIMOUNT Magna are trademarks of Edwards Lifesciences Corporation or its affiliates. All other trademarks or service marks are the property of their respective owners.

Keywords: aortic bioprostheses; aortic valve replacement; structural valve degeneration

Long-term durability is a key concern for bioprosthetic valves, but measuring structural valve degeneration (SVD) has been complicated by different SVD definitions. The RESILIENCE trial is the first prospective study to use both clinical and imaging SVD definitions to assess long-term valve durability.

This summary describes the design of this multicentre, prospective trial. The trial will investigate predictors of durability and time to failure in RESILIA tissue valves, which are treated to minimise free aldehydes and preserve the tissue.

The trial will include up to 250 adults from up to 15 centres. The primary endpoint is time to valve failure due to SVD, while the secondary endpoints are valve leaflet calcification volume and SVD stage 2 or 3. Non‑contrast computed tomography and transthoracic echocardiography will be carried out at 5, 7, 9 and 11 years after valve implantation to assess valve morphology and haemodynamics.

Download below to keep up to date with the latest research in aortic valve replacement.

Click here to access the full publication

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 meet the requirements for bearing the CE marking of conformity.

Edwards, Edwards Lifesciences, the stylized E logo, Carpentier-Edwards, PERI, PERIMOUNT, and RESILIA are trademarks of Edwards Lifesciences Corporation or its affiliates. All other trademarks or service marks are the property of their respective owners.

EACTS Annual Meeting – Lisboa, October 2019