A RAPIDLY INCREASING AND UNMET MEDICAL NEED: AORTIC STENOSIS

WHAT IS AORTIC STENOSIS?

Aortic stenosis is a life-threatening disease caused by the narrowing of the opening of the aortic valve which is the “gateway” from the heart to the body. 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.

With age, the aortic valve calcifies and stiffens, it is less elastic. It fails to open fully, leading to poor blood perfusion of the body and sudden death.

Aortic stenosis affects 3% of the population aged 65 and over and 12% of people over 75: it has become a major public health concern because of the ageing Western population. 1 person out of 10 could be affected in the near future. There are currently 10 million patients affected in Western countries.

A patient affected with a severe symptomatic Aortic Stenosis has a survival rate of 2 to 5 years.

The overall cost to treat aortic valve disease exceeds $50bn in Europe and in the US.

The standard treatment consists in replacing the aortic valve with an artificial valve during an open-heart surgery or, since 2007, by transcatheter aortic valve replacement (TAVR).

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A major public health concern

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Huge costs for public health systems

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AN UNMET MEDICAL NEED

Many patients untreated

In spite of the TAVR revolution, Aortic Stenosis is still an unmet medical need. Most of the patients remain untreated.

International guidelines recommend nowadays to treat patients affected with severe symptomatic Aortic Stenosis. Only 30% of these patients are treated 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 (3 million patients in Europe). These patients are being told to wait until they are sick enough to receive a TAVR, often too late.

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CURRENT MEDICAL RESPONSE

The only medical response to severe symptomatic Aortic Stenosis is currently a valve replacement surgery, either by open-heart surgery or by a less-invasive procedure called TAV. Unfortunately about 10 to 15% of affected patients at a severe stage are ineligible or refuse the surgery because they are too weak, there are contraindications or the risks outweigh the benefits.

Open heart surgery

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The standard treatment consists in replacing the aortic valve with an artificial tissue or mechanical valve during an open-heart surgery, with extracorporeal circulation and the heart stopped – the patient is clinically dead. This surgery is a serious, expensive and risky operation. There are about 350,000 surgeries performed every year worldwide.

TAVR (endovascular surgery)

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Since 2007, a new technique for minimally invasive endovascular surgery called TAVR (Trans Aortic Valve Replacement) has been used with spectacular results. This surgery consists in replacing the aortic valve via a percutaneous route passing through either the aorta or the femoral artery. It allows almost all patients for whom open-heart surgery is contraindicated to be treated, but it has an incidence of vascular and hemorrhagic complications and causes cerebrovascular accidents and kidney injury.

TODAY WITH THE CURRENT MEDICAL RESPONSE

Patients with no medical response
Invasive treatment
Valve replacement
20% morbidity at 1 year – risks and complications
Overall actual cost: from €50 to €80k
WITH THE CURRENT MEDICAL RESPONSE

TOMORROW THANKS TO CARDIAWAVE

New eligible patients – preventive treatment foreseeable
Non-invasive treatment
Repair of native valves
Expected morbidity ~0% – quality of life improvement
Decrease of cost per procedure
THANKS TO CARDIAWAVE

The morbidity associated with both surgeries remains high: 2-5% of patients die during or 30-days following surgery, 20% die within 1 year, 40% within 3 years.
These surgeries also cause numerous complications (CVA, infections and infarctions).
These procedures represent a significant cost to public health systems, for reference US$100,000 per patient in the United States.
Overall costs associated with aortic valve disease exceeds $50 billion in Western countries.