A calcified polymeric valve for valve-in-valve applications

Area of Science:

• Biomaterials Science
• Cardiovascular Research
• Medical Device Engineering

Background:

• Aortic valve stenosis (AS) prevalence is rising due to aging populations.
• Current transcatheter aortic valve replacement (TAVR) research lacks suitable animal models mimicking native calcific aortic valve pathology.
• Existing models with normal aortic valves do not accurately replicate the disease state for device testing.

Purpose of the Study:

• To develop and characterize a novel polymeric valve model that accurately mimics calcific aortic valve stenosis (AS).
• To assess the feasibility of using this model for in vitro testing of transcatheter aortic valve replacement (TAVR) devices.
• To provide a cost-effective and realistic simulation for TAVR research and development.

Main Methods:

• Development of two types of polymeric valves with calcium hydroxyapatite inclusions to simulate moderate and severe AS.
• Deployment of transcatheter valves within the polymeric models in a heart flow simulator.
• Assessment of valve performance using echocardiography and measurement of hemodynamic parameters, including aortic valve area.

Main Results:

• The developed polymeric valves exhibited high echogenicity, correlating with simulated calcification severity.
• Aortic valve area measurements allowed for classification of stenosis severity according to clinical guidelines.
• The novel valves effectively mimicked key pathological features of AS, demonstrating their utility in simulated conditions.

Conclusions:

• The novel polymeric valves serve as a viable and cost-effective in vitro model for aortic valve stenosis (AS).
• These models closely replicate the native calcific valve pathology, addressing a critical limitation in current TAVR research.
• The developed model facilitates the performance testing of transcatheter aortic valve systems in a controlled, simulated environment.