Challenges in cardiac device innovation: is neuroimaging an appropriate endpoint? Consensus from the 2013 Yale-UCL Cardiac Device Innovation Summit
Meller SM, Baumbach A, Voros S, Mullen M, Lansky AJ. Challenges in cardiac device innovation: is neuroimaging an appropriate endpoint? Consensus from the 2013 Yale-UCL Cardiac Device Innovation Summit. BMC Medicine 2013, 11: 257. PMID: 24330754, PMCID: PMC4029193, DOI: 10.1186/1741-7015-11-257.Peer-Reviewed Original ResearchConceptsTranscatheter aortic valve implantationAortic valve implantationLesion volumeCerebral eventsValve implantationNew lesionsClinical studiesSurrogate endpointsAppropriate endpointsPrimary efficacy endpointDiffusion-weighted magnetic resonance imagingCerebral protection devicesUseful surrogate endpointTotal lesion volumeMagnetic resonance imagingSample size limitationsEfficacy endpointClinical outcomesDevice successOngoing trialsNeurological protectionClinical eventsResonance imagingMRI valuesConsensus opinionClinical implications for diffusion‐weighted MRI brain lesions associated with transcatheter aortic valve replacement
Meller SM, Baumbach A, Brickman AM, Lansky AJ. Clinical implications for diffusion‐weighted MRI brain lesions associated with transcatheter aortic valve replacement. Catheterization And Cardiovascular Interventions 2013, 83: 502-508. PMID: 23460315, DOI: 10.1002/ccd.24904.Peer-Reviewed Original ResearchConceptsTranscatheter aortic valve replacementAortic valve replacementSilent strokeValve replacementCerebral embolic protection devicesDiffusion-weighted magnetic resonance imagingEmbolic protection devicesCerebral protection devicesMRI brain lesionsPotential therapeutic optionQuality of lifeLong-term cognitive consequencesMagnetic resonance imagingNeurological complicationsAortic stenosisImproved survivalNew lesionsEmbolic lesionsTherapeutic optionsBrain lesionsRisk candidatesCognitive declineResonance imagingClinical implicationsLesions