2024
Clinical Significance of Diffusion-Weighted Brain MRI Lesions After TAVR Results of a Patient-Level Pooled Analysis
Lansky A, Grubman D, Dwyer M, Zivadinov R, Parise H, Moses J, Shah T, Pietras C, Tirziu D, Gambone L, Leon M, Nazif T, Messé S. Clinical Significance of Diffusion-Weighted Brain MRI Lesions After TAVR Results of a Patient-Level Pooled Analysis. Journal Of The American College Of Cardiology 2024, 84: 712-722. PMID: 39142725, DOI: 10.1016/j.jacc.2024.05.055.Peer-Reviewed Original ResearchConceptsTranscatheter aortic valve replacementClinical ischemic strokeAcute brain infarctionDW-MRIReceiver operating characteristicIschemic strokeTranscatheter aortic valve replacement resultBrain infarctionPatient-level pooled analysisC-statisticBrain MRI lesionsAcute ischemic brain injuryDiffusion-weighted magnetic resonance imagingAortic valve replacementIndividual lesion volumesCore laboratory analysisIschemic brain injuryPredicting ischemic strokeMagnetic resonance imagingStroke Prevention TrialMRI lesionsValve replacementDW-MRI acquisitionsPatient-level dataPooled analysis
2022
Safety and performance of a novel cerebral embolic protection device for transcatheter aortic valve implantation: the PROTEMBO C Trial.
Jagielak D, Targonski R, Frerker C, Abdel-Wahab M, Wilde J, Werner N, Lauterbach M, Leick J, Grygier M, Misterski M, Erglis A, Narbute I, Witkowski AR, Adam M, Frank D, Gatto F, Schmidt T, Lansky AJ. Safety and performance of a novel cerebral embolic protection device for transcatheter aortic valve implantation: the PROTEMBO C Trial. EuroIntervention 2022, 18: 590-597. PMID: 35608032, PMCID: PMC10241272, DOI: 10.4244/eij-d-22-00238.Peer-Reviewed Original ResearchConceptsTranscatheter aortic valve implantationAortic valve implantationLesion volumeValve implantationTechnical successC trialSingle lesionCerebral embolic protection devicesPerformance endpointBrain diffusion-weighted magnetic resonance imagingLarge single lesionsPrimary safety endpointBrain lesion volumeDiffusion-weighted magnetic resonance imagingCerebral protection systemSingle-arm studyEmbolic protection devicesPrimary performance endpointRate of deathMagnetic resonance imagingTAVI casesTAVI patientsVARC-2Cerebrovascular eventsPrimary endpoint
2016
Neurologic Complications of Unprotected Transcatheter Aortic Valve Implantation (from the Neuro-TAVI Trial)
Lansky AJ, Brown D, Pena C, Pietras CG, Parise H, Ng VG, Meller S, Abrams KJ, Cleman M, Margolis P, Petrossian G, Brickman AM, Voros S, Moses J, Forrest JK. Neurologic Complications of Unprotected Transcatheter Aortic Valve Implantation (from the Neuro-TAVI Trial). The American Journal Of Cardiology 2016, 118: 1519-1526. PMID: 27645761, DOI: 10.1016/j.amjcard.2016.08.013.Peer-Reviewed Original ResearchMeSH KeywordsAged, 80 and overAortic ValveAortic Valve StenosisBrainBrain IschemiaDiffusion Magnetic Resonance ImagingFemaleFollow-Up StudiesHumansIncidenceIntracranial EmbolismMalePostoperative ComplicationsPrognosisProspective StudiesRisk AssessmentRisk FactorsSurvival RateTranscatheter Aortic Valve ReplacementUnited StatesConceptsTranscatheter aortic valve implantationAortic valve implantationNeurologic injuryValve implantationNeurologic impairmentMagnetic resonance imaging lesionsCognitive AssessmentMontreal Cognitive Assessment scoreCerebral ischemic lesionsNew neurologic impairmentSubclinical cerebral infarctsDiffusion-weighted magnetic resonance imagingTotal lesion volumeCognitive Assessment scoreMontreal Cognitive AssessmentMagnetic resonance imagingCerebral embolizationCerebral infarctsNeurologic complicationsCerebral infarctionImaging lesionsMost patientsOvert strokeConsecutive patientsIschemic lesions
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