Journal
EXPERT REVIEW OF MEDICAL DEVICES
Volume 15, Issue 11, Pages 771-791Publisher
TAYLOR & FRANCIS LTD
DOI: 10.1080/17434440.2018.1536427
Keywords
TAVI; aortic stenosis; calcific aortic valve disease; prosthetic heart valve; valve hydrodynamics; thrombogenicity; medical device; ISO 5840
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Funding
- NATIONAL HEART, LUNG, AND BLOOD INSTITUTE [R41HL134418] Funding Source: NIH RePORTER
- NHLBI NIH HHS [R41 HL134418] Funding Source: Medline
- NIBIB NIH HHS [U01 EB012487, R01 EB008004] Funding Source: Medline
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Introduction: Transcatheter aortic valve replacement (TAVR) has emerged as an effective minimally-invasive alternative to surgical valve replacement in medium- to high-risk, elderly patients with calcific aortic valve disease and severe aortic stenosis. The rapid growth of the TAVR devices market has led to a high variety of designs, each aiming to address persistent complications associated with TAVR valves that may hamper the anticipated expansion of TAVR utility. Areas covered: Here we outline the challenges and the technical demands that TAVR devices need to address for achieving the desired expansion, and review design aspects of selected, latest generation, TAVR valves of both clinically-used and investigational devices. We further review in detail some of the up-to-date modeling and testing approaches for TAVR, both computationally and experimentally, and additionally discuss those as complementary approaches to the ISO 5840-3 standard. A comprehensive survey of the prior and up-to-date literature was conducted to cover the most pertaining issues and challenges that TAVR technology faces. Expert commentary: The expansion of TAVR over SAVR and to new indications seems more promising than ever. With new challenges to come, new TAV design approaches, and materials used, are expected to emerge, and novel testing/modeling methods to be developed.
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