2015
A prospective randomized evaluation of the TriGuard™ HDH embolic DEFLECTion device during transcatheter aortic valve implantation: results from the DEFLECT III trial
Lansky AJ, Schofer J, Tchetche D, Stella P, Pietras CG, Parise H, Abrams K, Forrest JK, Cleman M, Reinöhl J, Cuisset T, Blackman D, Bolotin G, Spitzer S, Kappert U, Gilard M, Modine T, Hildick-Smith D, Haude M, Margolis P, Brickman AM, Voros S, Baumbach A. A prospective randomized evaluation of the TriGuard™ HDH embolic DEFLECTion device during transcatheter aortic valve implantation: results from the DEFLECT III trial. European Heart Journal 2015, 36: 2070-2078. PMID: 25990342, DOI: 10.1093/eurheartj/ehv191.Peer-Reviewed Original ResearchTranscatheter aortic valve implantationIschemic brain lesionsAortic valve implantationCerebral protectionNeurologic deficitsValve implantationBrain lesionsNew ischemic brain lesionsCerebral diffusion-weighted magnetic resonance imagingCognitive functionMontreal Cognitive Assessment scoreHealth Stroke ScaleNew neurologic deficitsDiffusion-weighted magnetic resonance imagingProspective Randomized EvaluationNormal cognitive functionCognitive Assessment scoreMagnetic resonance imagingSafety endpointStroke ScaleIII trialsControl subjectsTechnical successResonance imagingTriGuardSafety and performance of a novel embolic deflection device in patients undergoing transcatheter aortic valve replacement: results from the DEFLECT I study.
Baumbach A, Mullen M, Brickman AM, Aggarwal SK, Pietras CG, Forrest JK, Hildick-Smith D, Meller SM, Gambone L, den Heijer P, Margolis P, Voros S, Lansky AJ. Safety and performance of a novel embolic deflection device in patients undergoing transcatheter aortic valve replacement: results from the DEFLECT I study. EuroIntervention 2015, 11: 75-84. PMID: 25868876, DOI: 10.4244/eijy15m04_01.Peer-Reviewed Original ResearchMeSH KeywordsAgedAged, 80 and overAlloysAortic ValveAortic Valve StenosisBrain IschemiaBrazilCardiac CatheterizationCognitionCognition DisordersDiffusion Magnetic Resonance ImagingEmbolic Protection DevicesEuropeFemaleHeart Valve ProsthesisHeart Valve Prosthesis ImplantationHumansIntracranial EmbolismMalePredictive Value of TestsProspective StudiesProsthesis DesignRisk FactorsSeverity of Illness IndexStrokeTime FactorsTreatment OutcomeUltrasonography, Doppler, TranscranialConceptsTranscatheter aortic valve replacementAortic valve replacementValve replacementNew cerebral ischemic lesionsCerebral diffusion-weighted magnetic resonance imagingCerebral ischemic lesionsDays post procedurePrimary safety endpointDiffusion-weighted magnetic resonance imagingMajor cerebral arteriesTotal lesion volumeMagnetic resonance imagingSafety endpointIschemic lesionsTAVR proceduresCerebral arteryCerebral circulationConsecutive subjectsPost procedureAortic archHistorical controlsLesion volumeResonance imagingDW-MRIPatients
2013
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