Transcatheter aortic valve replacement (TAVR) has revolutionised the management of aortic valve stenosis (AS), providing a less invasive alternative to traditional surgical aortic valve replacement (SAVR). Initially approved for high-risk surgical patients, TAVR’s indications have expanded to include intermediate and even low-risk patients. However, its application in patients with bicuspid aortic valve (BAV) disease presents unique challenges and considerations, according to GlobalData, leading data and analytics company.
Joselia Carlos, Senior Medical Device Analyst at GlobalData, states, “Unlike tricuspid aortic valves (TAVs), bicuspid aortic valve is a congenital heart defect where the aortic valve has only two flaps instead of the typical three. This condition affects approximately 1-2 per cent of the population and often leads to AS earlier in life than patients with TAV.”
Initially, populations with BAV were ineligible for receiving TAVR treatment since BAV was listed as a contraindication. However, this has been challenged by several clinical trials that have indicated favourable results for TAVR treatment in BAV patients. Due to these positive results, physicians have been implementing TAVR in BAV patients via off-label usage, bolstering a compound annual growth rate (CAGR) of 41 per cent between 2015 and 2020 in TAVR procedures in BAV patients.
“BAV was initially listed as a contraindication to TAVR due to the potential complications that may arise from having an atypical structural anatomy. As a result, SAVR has been the recommended treatment for BAV stenosis. However, data comparing the outcomes of TAVR and SAVR in BAV patients is becoming more available, and most studies have shown no difference in survival rates between BAV patients undergoing TAVR and SAVR,” adds Carlos.
In 2021, TAVR for low-risk patients regardless of aortic valve anatomy received both FDA and CE mark approval. Despite receiving approval, international guidelines still recommend open surgical replacement in populations with BAV. As a result, TAVR treatment for BAVs still remains relatively low in comparison to TAVR treatment for TAVs.
Carlos concludes, “According to physicians, TAVR is reserved for high surgical risk BAV stenosis patients, while SAVR remains the recommended option for low surgical risk BAV stenosis patients. Therefore, only about 20 per cent of low risk BAV patients receive TAVR, while 80 per cent receive SAVR. Continued research and innovation are essential to fully realise the potential of TAVR in this complex patient group and to ensure optimal long-term outcomes.”