Challenges in treating patients with asymptomatic severe aortic stenosis (sAS)

Roughly 1/3 of patients with severe aortic stenosis (sAS) are asymptomatic and once symptoms develop their average survival declines^1,2
Symptom detection is difficult with many patients attributing them to other factors^3,4. Exercise testing is important for unmasking symptoms in patients with asymptomatic sAS⁵
Treatment is recommended in patients with asymptomatic severe aortic stenosis in the presence of one or more of these factors: adverse prognostic factors^*, LVEF<50%, positive exercise test† or symptom development⁶

Prompt symptom identification in patients with sAS can be challenging^3,4

Around 1/3 of patients with sAS aged 55 years or over are asymptomatic² with a proportion of them under ‘watchful waiting’.⁶ Once symptoms develop, patients with sAS have an average survival of only 50% at 2 years and 20% at 5 years.¹

However, identifying symptoms can be difficult as patients may:

Limit activities to avoid symptoms³
Attribute symptoms to comorbidities³
Think that symptoms e.g., breathlessness, are a normal part of ageing^3,4

Help your patients record and monitor their symptoms with the Aortic Stenosis Symptom Tracker

Exercise testing can unmask symptoms and help risk stratification^6,7

Exercise testing in patients with asymptomatic sAS and a normal LVEF is recommended to unmask symptoms,⁶ with roughly half of patients expected to test positive.^†5 Patients with limiting symptoms during exercise testing demonstrate 12-month-symptom-free survival of only 49% compared to 89% without.⁷

1 in 6 patients with symptomatic AS are unable to mobilise enough to perform an exercise stress test. Pharmacological stress testing with dobutamine alongside concomitant cardiac imaging is sometimes considered for these cases.^3,5

Ongoing trial comparing early TAVR intervention with ‘watchful waiting’ in patients with asymptomatic sAS⁸

The timing of treatment for asymptomatic sAS is an evolving area in patient management.^6,8-10 Unless patients with asymptomatic sAS develop symptoms, adverse prognostic features^*, an LVEF<50% or positive exercise test^† they undergo clinical surveillance through ‘watchful waiting’⁶
The EARLY TAVR trial is an ongoing randomised control study (N=901) evaluating the safety and effectiveness of the Edwards SAPIEN 3^TM/SAPIEN 3 Ultra^TM transcatheter valve compared with clinical surveillance in patients with asymptomatic, calcific sAS.⁸
The study started in July 2017 with an estimated primary completion date of March 2024⁸

Objectives of the EARLY TAVR trial⁸

Primary endpoint: composite of all cause death, all stroke, and unplanned cardiovascular admission at 2-year follow up
Secondary endpoints: composite of alive and quality of life, left ventricular health, LVEF change from baseline, new-onset atrial fibrillation and death or disabling stroke at 2-year follow up

EARLY TAVR trial study design^8,11

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References

AS, aortic stenosis; AVR, aortic valve replacement; LV, left ventricle; LVEF, left ventricular ejection fraction; sAS, severe aortic stenosis.

* Adverse features according to clinical, imaging (echocardiography or CT scanning), and/or assessment of biomarkers.⁶
† A positive result following exercise testing is the development of symptoms or a sustained blood pressure fall below the patient’s baseline.⁶

1Otto CM. Heart. 2000;84:211–218.
2Strange GA, et al. Open Heart. 2022;9:e001783.doi:10.1136/openhrt-2021-001783.
3Redfors B, et al. Circulation. 2017;135(20):1956—1976.
4Amato MCM, et al. Heart. 2001;86:381–386.
5Généreux P, et al. J Am Coll Cardiol. 2016;67:2263–2268.
6Vahanian A, et al. Eur Heart J. 2022;43(7):561-632.
7Das P, Rimington H and Chambers J. Eur Heart J. 2005;26(13):1309-1313.
8EARLY TAVR. Available at: https://clinicaltrials.gov/ct2/show/NCT03042104 (accessed April 2022)
9Baumgartner H, Iung B and Otto CM. Eur Heart J. 2020;41:4349-4356.
10Banovic M, et al. Circulation. 2022;45(1):648-658.
11Edwards. Early TAVR Clinical Protocol. Version 5.0. 2021.

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.

PP—EU-4175 v2.0

Challenges in treating patients with asymptomatic severe aortic stenosis (sAS)

Prompt symptom identification in patients with sAS can be challenging3,4

Exercise testing can unmask symptoms and help risk stratification6,7

Ongoing trial comparing early TAVR intervention with ‘watchful waiting’ in patients with asymptomatic sAS8