Bicuspid Aortic Stenosis Treatment to Create Huge Market Potential for TAVR Devices

Despite preventative measures and a societal focus on healthy lifestyles, the incidence of valvular heart disease remains high, particularly among the elderly population. GlobalData, a worldwide data analytics firm, estimates valvular heart disease is rising about 1 percent annually in most countries. 

Aortic stenosis is one of the most common valvular heart diseases, with the moderate to severe form of the disease affecting nearly two million people in the US alone. While the majority of people have tricuspid aortic valve anatomy, a portion of the population has bicuspid aortic valve anatomy, and people with this variation of anatomy are more likely to develop calcification of the valve that leads to aortic stenosis. However, the highly popular treatment for severe aortic stenosis – that is, transcatheter aortic valve replacement (TAVR) – has historically only been used with caution in the bicuspid valve population.

Ashley Young, a senior medical devices analyst at GlobalData, said: “Physicians have previously been cautious about using TAVR in patients with bicuspid valve stenosis due to a number of factors. Perhaps most importantly, the long-term durability of TAVR valves has yet to be thoroughly proven in a robust clinical trial setting. This is of utmost importance to patients with bicuspid aortic valve anatomy, who typically present with stenosis at a younger age and depend on long-term durability of replacement valves.” 

GlobalData predicts that up to 53 percent of adult patients with diagnosed severe aortic stenosis have bicuspid valve anatomy, representing a huge potential for market expansion if TAVR devices are able to extend into this population. With the recent update to the precautionary labels of both the Edwards Lifesciences and Medtronic TAVR valves, this seems like a possibility for the near future.

“Once physicians become more comfortable with the recent clinical data supporting the use of TAVR devices in patients with bicuspid valve anatomy, GlobalData predicts that TAVR usage in this population will grow at a double-digit CAGR, mimicking the success of the procedure in the tricuspid valve population,” Young added.