New evidence suggests wider use of valve procedure

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A major change appears likely for the treatment of Aortic Stenosis based on results from recent clinical trials.

Aortic Stenosis (AS) is the most common heart valve disease. Approximately one-in-eight senior Australians is diagnosed with AS - up to 50 per cent die within two years if left untreated.

Transcatheter Aortic Valve Implantation (TAVI) is a minimally invasive surgical procedure that repairs rather than replaces an old and damaged valve. It scraps the need for open-heart surgery for the majority of patients.

While the incidence of AS in Australia is expected to increase given the ageing population, only patients considered to be at high-risk or inoperable are eligible for the TAVI procedure under Medicare. 

At the same time, emerging evidence suggests the benefit of the procedure could now extend to more patients.

Edwards Lifesciences recently secured FDA approval of its SAPIEN 3 and SAPIEN 3 Ultra transcatheter heart valve systems for the treatment of severe, symptomatic AS patients who are determined to be at low risk of open-heart surgery.

The trial result, along with a similar outcome in a trial for Medtronic, has according to the Australian and New Zealand Society of Cardiac and Thoracic Surgeons, "...led to some clinicians to advocate that TAVI should be the treatment modality of choice in most patients, including low risk younger patients."

In a recently released position statement on TAVI in low-risk patients, the Society acknowledged "promising outcomes" but said limitations in the data mean they need to be "considered carefully".

"As always, the appropriate treatment of patients requires a tailored approach considering clinical trials, patient factors and the local healthcare environment," it said.

According to Dr Martin Leon, director of the Center for Interventional Vascular Therapy at New York-Presbyterian/Columbia University Medical Center and professor of medicine at the Columbia University College of Physicians and Surgeons, the outcome of the Edwards Lifesciences TAVI study in low-risk patients shows it "should be considered the preferred treatment for the majority of low-risk severe AS patients."