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Principles of TAVR valve design, modelling, and testing
Oren M Rotman1, Matteo Bianchi1, Ram P Ghosh1
1a Department of Biomedical Engineering , Stony Brook University , Stony Brook , NY , USA.
Expert Review of Medical Devices
|October 16, 2018
Summary
Transcatheter aortic valve replacement (TAVR) offers a minimally invasive option for severe aortic stenosis. Ongoing advancements in TAVR device design and testing are crucial for expanding its clinical use and improving patient outcomes.
Area of Science:
- Cardiovascular Surgery
- Biomedical Engineering
- Medical Devices
Background:
- Transcatheter aortic valve replacement (TAVR) is a key alternative to surgical valve replacement for elderly, high-risk patients with severe aortic stenosis.
- The expanding TAVR market features diverse device designs addressing complications and aiming for broader utility.
Purpose of the Study:
- To review the challenges and technical demands for TAVR device expansion.
- To examine design aspects of current and investigational TAVR valves.
- To discuss advanced computational and experimental modeling/testing approaches for TAVR devices.
Main Methods:
- Comprehensive literature survey of TAVR technology, challenges, and solutions.
- Review of latest-generation TAVR valve designs.
- Analysis of computational and experimental modeling and testing methodologies.
Main Results:
- Identified key challenges and technical requirements for TAVR device advancement.
- Highlighted design innovations in current and investigational TAVR valves.
- Detailed current and emerging modeling and testing strategies, including ISO 5840-3 compliance.
Conclusions:
- TAVR's expansion over surgical aortic valve replacement (SAVR) and into new indications is promising.
- Future TAVR development will likely involve novel designs, materials, and advanced testing/modeling methods to overcome emerging challenges.
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