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

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.

Clinical implications for diffusion-weighted MRI brain lesions associated with transcatheter aortic valve replacement.

Transcatheter aortic valve replacement (TAVR) is increasingly used to treat patients with aortic stenosis deemed high or extreme surgical risk candidates. Despite improved survival and quality of life following the procedure, TAVR is not without its complications. Stroke is a major source of morbidity and mortality in patients undergoing the procedure, with rates similar to and often higher than those associated with surgery.