Email updates

Keep up to date with the latest news and content from BMC Medicine and BioMed Central.

Journal App

google play app store
Open Access Debate

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

Stephanie M Meller1, Andreas Baumbach2, Szilard Voros3, Michael Mullen4 and Alexandra J Lansky1*

Author Affiliations

1 Yale University School of Medicine and Yale Cardiovascular Research Group, 1 Church Street Suite #330, PO Box 208017, New Haven, CT 06510, USA

2 The Bristol Heart Institute, University Hospitals Bristol NHS Foundation Trust, Bristol, UK

3 Stony Brook University Medical Center, Stony Brook, NY, USA

4 The Heart Hospital, University College London, London, UK

For all author emails, please log on.

BMC Medicine 2013, 11:257  doi:10.1186/1741-7015-11-257

Published: 11 December 2013

Abstract

Background

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.

Discussion

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 reproducible and prognostically important imaging measures.

Summary

DW MRI may be a useful surrogate endpoint for clinical studies detecting cerebral events to determine the device’s success in neurological protection. Consensus from the 2013 Yale-UCL Device Innovation Summit specifically recommends the reporting of mean single lesion volume, number of new lesions, and total volume, and encourages European Union (EU)-US regulatory consensus in the guidance of implementing this endpoint.