UNMET MEDICAL NEED

WHAT IS AORTIC STENOSIS?

Aortic stenosis (AS) is one of the most common and serious valve disease problems. It is a life-threatening disease caused by the narrowing of the opening of the aortic valve. It is made up of three flexible leaflets that need to open completely to allow oxygened blood to exit from the heart towards the vital organs. AS restricts the blood flow from the left ventricle to the aorta.

In developed countries, AS is the third-most frequent cardiovascular disease (1) (2). AS affects 1,7% of the population aged 65 and over and 12,4% of people over 75 (1) (2) (3) : it has become a major public health concern because of the ageing Western population. The number of elderly patients with severe AS in North America is expected to increase from 540,000 patients in 2012 to 800,000 (+8.3%) in 2025 and 1.4 million (+11.8%) in 2050 driven by ageing population and better diagnosis(3). The average life expectancy of patients with severe, symptomatic AS is only 2.3 years without aortic valve replacement with a significant risk of sudden death (4). 65% of severe symptomatic AS patients remain untreated in the United States of America (5).

1 Durko AP, et al. Annual number of candidates for transcatheter aortic valve implantation per country: current estimates and future projections. European Heart Journal. July 01, 2018; 39(28):2635-2642. (DOI: 10.1093/eurheartj/ehy107)
2 Lindman B, et al. Calcific Aortic Stenosis. Nature Reviews Disease Primers 2, Article number: 16006. March 03, 2016. (DOI: 10.1038/nrdp.2016.6)
3 Osnabrugge R., et al. Aortic Stenosis in the Elderly: Disease Prevalence and Number of Candidates for Transcatheter Aortic Valve Replacement: A Meta-Analysis and Modeling Study. Journal of American College of Cardiology, Volume 62, Issue 11, Pages 1013-1014. September 2013. (DOI: 10.1016/j.jacc.2013.05.015)
4 Malaisrie S, et al. Transcatheter Aortic Valve Implantation Decreases the Rate of Unoperated Aortic Stenosis. European Journal of Cardio-thoracic Surgery, Volume 40, Issue 1, Pages 43-48. July 2011. (DOI: 10.1016/j.ejcts.2010.11.301)
5 Wood S. Vast Numbers of Severe Symptomatic AS Patients Untreated? A Plea and Some Pushback. TCTMD. June 14, 2019.
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Severe symptomatic, severe Calcific Aortic Stenosis (CAS) is associated with significant morbidity. Once symptoms appear, untreated patients have a poor prognosis; they will experience worsening symptoms, eventually leading to death. After the onset of symptoms, average survival is 50% at two years and 20% at five-years (1). The standard of care (SoC) for severe symptomatic CAS is currently invasive. Even after less-invasive treatment, mortality is still 2.27% after one month and 11.35% after 1 year (2).

1 Otto M, et al. 2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation; 143:e72–e227. Dec 17, 2020. (DOI: 10.1161/CIR.0000000000000923)
2 Mattke S, et al. Temporal trends in 30-day and 1-year mortality rates after transcatheter aortic valve replacement: A systematic review and meta-regression analysis. Journal of the American College of Cardiology, Volume 73, Issue 9 Supplement 1. March 12, 2019. (DOI: 10.1016/S0735-1097(19)31698-5).
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These procedures represent a significant cost to public health systems. Heart valve disease costs the U.S. US$23.4 billion each year in direct health care expenditures. Symptomatic aortic valve disease costs the U.S. at least US$5.6 billion in direct health care expenditures each year (1).

1 Moore M, et al. The direct health-care burden of valvular heart disease: evidence from US national survey data. Clinicoeconomics and Outcomes Research. October 18, 2016; 8:613-627 (DOI: 10.2147/CEOR.S112691)

AN UNMET MEDICAL NEED

Many patients untreated

In spite of the Transcatheter Aortic Valve Replacement (TAVR) revolution, Aortic Stenosis (AS) is still an unmet medical need. Most of the patients remain untreated.

International guidelines (1) (2) recommend nowadays to treat patients affected with severe symptomatic AS. 65% of severe symptomatic AS patients remain untreated in the United States of America (3) due to absence of diagnosis, lack of infrastructure, restrictions from payers or costs of aortic valve replacement.

All other patients evolving to a severe stenosis are not treated because they have no treatment options: huge unmet medical need.

1 Vahanian A, et al. Guidelines for the management of valvular heart disease. European Heart Journal. August 28, 2021; ehab395.(DOI: 10.1093/eurheartj/ehab395)
2 Otto CM, et al. Guideline for the Management of Patients with Valvular Heart Disease: A Report of the American College of Cardiology. American Heart Association. February 02, 2021. (DOI: 10.1161/CIR.0000000000000923)
3 Wood S. Vast Numbers of Severe Symptomatic AS Patients Untreated? A Plea and Some Pushback. TCTMD. June 14, 2019.
4 Durko AP, et al. Annual number of candidates for transcatheter aortic valve implantation per country: current estimates and future projections. European Heart Journal. July 01, 2018; 39(28):2635-2642. (DOI: 10.1093/eurheartj/ehy107)