Challenges in cardiac device innovation: is neuroimaging an appropriate endpoint? Consensus from the 2013 Yale-UCL Cardiac Device Innovation Summit

BMC Medicine
Stephanie M MellerAlexandra J Lansky

Abstract

Neurological events associated with transcatheter aortic valve implantation are major contributors to morbidity and mortality. Choosing an appropriate endpoint to determine neuroprotection device efficacy is a key difficulty inhibiting the translation of the innovation from the laboratory to the bedside. Cost and sample size limitations inhibit the feasibility of using the rate of clinical (such as stroke or other cerebral) events as the primary efficacy endpoint. This paper focuses on consensus opinions from the 2013 Yale-University College London (UCL) Device Innovation Summit. Neuroimaging, specifically diffusion-weighted magnetic resonance imaging (DW MRI), may serve as a surrogate endpoint for clinical studies detecting cerebral events in which cost and sample-size limitations prohibit the use of clinical outcomes. A major limitation of using imaging to prove efficacy in cardiac device studies is that no standardized endpoint exists. Ongoing trials investigating cerebral protection devices for transcatheter aortic valve implantation are utilizing and reporting various qualitative and quantitative DW MRI values; however, single lesion volume, number of new lesions, and total lesion volume have been found to be the most repr...Continue Reading

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Citations

Dec 10, 2015·Clinical Research in Cardiology : Official Journal of the German Cardiac Society·Omar Abdul-Jawad AltisentDavid Garcia-Dorado
Sep 28, 2015·The Journal of Thoracic and Cardiovascular Surgery·Lars G SvenssonBruce W Lytle
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Nov 17, 2016·Journal of the American Heart Association·Jonathon P FanningJohn F Fraser
Jan 13, 2021·The Journal of Thoracic and Cardiovascular Surgery·Mark D PetersonUNKNOWN ACE CardioLink-3 Trial Working Group

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