Health Canada approves low-risk patients for minimally invasive treatment option

February 22, 2021

Aortic stenosis is the most common and serious form of heart valve disease and involves narrowing of the aortic valve opening. This means that the heart has to work harder to pump out the same amount of blood. Over time, this can cause serious complications. It is important for a patient with aortic valve stenosis to be identified and then followed by their medical team so that timely referral can be made for the correct treatment (surgical or percutaneous aortic valve replacement).

Health Canada has recently expanded indication and approval for two transcatheter heart valves for use in a TAVI procedure. This approval happened following the publication of two major clinical trials comparing TAVI and surgical aortic valve replacement in low-risk patients with 1 and 2 years follow-up. This is a method of treating aortic valve narrowing (stenosis) by delivering the new valve through a large artery and into the diseased aortic valve. This valve replaces the old diseased valve and allows the heart to pump much more efficiently and to improve the symptoms of aortic stenosis. The approval of these technologies means that many more patients will be eligible for TAVI.

To put this in perspective, patients with severe aortic stenosis who are at low risk for surgical aortic valve replacement who have a tricuspid aortic valve (the most common type), could be considered for a TAVI procedure. Previously, high and intermediate risk patients were approved by Health Canada to be considered to undergo a TAVI procedure. The indication for this has been expanded to the low risk group as well.  In addition, certain patients with a bicuspid valve are also approved to have a TAVI procedure. The heart team will look at many factors (health status and anatomical factors) in consultation with the patient to determine which is the best choice to make.

Expanding these approvals is significant as TAVI is done using minimally invasive techniques, and because of this, many patients can experience a faster recovery than they would from a traditional, open-heart valve replacement.

We commend Health Canada for these approvals which will give more patients an additional treatment option that may be more suitable and manageable for them. However, accessibility to this treatment remains an ongoing barrier for patients. The amount of these procedures performed each year is ultimately funded by Canada’s individual provinces, and pre-existing wait times for elective procedures in Canada continue to increase due to COVID-19 and concerns over healthcare system capacity.

It is important that developments in treating heart valve disease patients are not only made from a technology approvals standpoint, but also in how treatments are prioritized and funded within Canadian healthcare systems. We need to ensure that the entire patient journey is being considered when changes are made, rather than just one step of the many it takes for a heart valve disease patient to move from diagnosis to treatment.

Heart Valve Voice Canada remains committed to bringing attention to these important developments and calling for the continued advancement and access to treatments for Canadians with heart valve disease.

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