According to the latest Cardiac Surgery market study by iData Research, over 182,000 heart valve replacements are performed every year in the United States. These replacements are one of the most common procedures performed in the cardiac surgery market, and they make up nearly a quarter of the total procedure volume. Commonly, these procedures include Surgical Heart Valve Replacements, along with Transcatheter Aortic and Transcatheter Pulmonary Valve Replacements.
Heart Valve Replacement Procedure Trends
The primary method for treating heart valve conditions is through open surgery to place a replacement valve. Surgical heart valve replacement procedures can be performed using tissue or mechanical heart valves. Tissue valves have been gaining popularity over alternative mechanical valves because tissue valves are more biocompatible and do not require lifelong treatment with anticoagulant medication. However, both procedures are expected to continue declining in numbers due to the increased adoption of transcatheter heart valve replacements.
In recent years, there is a great deal of interest in the development of minimally invasive solutions, namely, transcatheter heart valve replacement (THVR) devices. In fact, the largest segment within the US cardiac surgery market in 2020 was the Transcatheter Aortic Valve Replacement (TAVR) market, accounting for over one-third of the total market value. Since the FDA Approval of TAVR in low-risk Patients in 2019, the TAVR market is projected to grow to over 130,000 procedures by 2026 and establish its dominance in the US market.
The trend towards minimally invasive procedures will drive growth in the TAVR market, cannibalizing the market for surgical aortic heart valves as a result. Edwards Lifesciences was the first company to develop a transcatheter aortic valve replacement device, followed by Medtronic. With the success of Edwards Lifesciences and Medtronic, other major competitors have taken steps to enter the market. Abbott and Boston Scientific have developed their own TAVR products, but only Boston Scientific’s LOTUS Edge™ device has been approved for patients at high risk of surgery to date.
As surgeon preferences shift towards the more minimally invasive procedures over traditional surgical methods, the growth in heart valve replacements will be primarily driven by the TAVR market in the United States. The surgical heart valve replacements are expected to continue losing patient favorability, with Tissue Heart Valve surgeries reaching an all-time low of around 80,000 procedures in 2026.
In 2026, the latest market study shows that the total number of heart valve replacements is expected to exceed 240,000 procedures within the US cardiac surgery market. However, the growth within this space will be partially limited by the lack of clinical data on long-term patient outcomes and valve durability, as well as the complexity and risk of the TAVR and transcatheter pulmonary valve replacement (TPVR) procedures.