2018
TAVI and the brain: update on definitions, evidence of neuroprotection and adjunctive pharmacotherapy.
Lansky A, Ghare MI, Tchétché D, Baumbach A. TAVI and the brain: update on definitions, evidence of neuroprotection and adjunctive pharmacotherapy. EuroIntervention 2018, 14: ab53-ab63. PMID: 30158096, DOI: 10.4244/eij-d-18-00454.Peer-Reviewed Original ResearchMeSH KeywordsAortic ValveAortic Valve StenosisBrainHeart Valve Prosthesis ImplantationHumansNeuroprotectionRisk FactorsTranscatheter Aortic Valve ReplacementTreatment OutcomeConceptsTranscatheter aortic valve implantationAortic stenosisAdjunctive pharmacotherapySevere symptomatic aortic stenosisIntermediate-risk patientsSymptomatic aortic stenosisHigh-risk patientsAortic valve implantationSurgical valve replacementEvidence of neuroprotectionNeurologic eventsDevastating complicationNeurologic injuryValve implantationValve replacementCurrent evidenceNeuroprotectionPharmacotherapyPatientsPreferred methodComplicationsStenosisInjuryStrokeIncidence2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials
Hicks KA, Mahaffey KW, Mehran R, Nissen SE, Wiviott SD, Dunn B, Solomon SD, Marler JR, Teerlink JR, Farb A, Morrow DA, Targum SL, Sila CA, Hai M, Jaff MR, Joffe HV, Cutlip DE, Desai AS, Lewis EF, Gibson CM, Landray MJ, Lincoff AM, White CJ, Brooks SS, Rosenfield K, Domanski MJ, Lansky AJ, McMurray JJV, Tcheng JE, Steinhubl SR, Burton P, Mauri L, O’Connor C, Pfeffer MA, Hung HMJ, Stockbridge NL, Chaitman BR, Temple RJ, Initiative S, Fitter H, Illoh K, Cavanaugh K, Scirica B, Irony I, Kichline R, Levine J, Park A, Sacks L, Szarfman A, Unger E, Wachter L, Zuckerman B, Mitchel Y, Peddicord D, Shook T, Kisler B, Jaffe C, Bartley R, DeMets D, Mencini M, Janning C, Bai S, Lawrence J, D’Agostino R, Pocock S. 2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials. Journal Of The American College Of Cardiology 2018, 71: 1021-1034. PMID: 29495982, DOI: 10.1016/j.jacc.2017.12.048.Peer-Reviewed Original ResearchMeSH KeywordsCardiac CatheterizationCardiovascular DiseasesClinical Trials as TopicEndpoint DeterminationHeart Valve Prosthesis ImplantationHospitalizationHumansProspective StudiesRisk AssessmentStrokeConceptsClinical trialsStandardized data collectionTrials InitiativeProspective data collectionEffectiveness of drugsClinical care processesCardiovascular safetyStroke outcomeEndpoint definitionsWriting committeeDrug AdministrationCare processesU.S. FoodTrialsFurther studiesUniform definitionMedical product development programsMultiple trialsFDAData collectionCardiovascularAdministrationCerebral Embolic Risk During Transcatheter Mitral Valve Interventions An Unaddressed and Unmet Clinical Need?
Pagnesi M, Regazzoli D, Ancona MB, Mangieri A, Lanzillo G, Giannini F, Buzzatti N, Prendergast BD, Kodali S, Lansky AJ, Colombo A, Latib A. Cerebral Embolic Risk During Transcatheter Mitral Valve Interventions An Unaddressed and Unmet Clinical Need? JACC Cardiovascular Interventions 2018, 11: 517-528. PMID: 29566796, DOI: 10.1016/j.jcin.2017.12.018.Peer-Reviewed Original ResearchMeSH KeywordsAgedAged, 80 and overCardiac CatheterizationFemaleHeart Valve Prosthesis ImplantationHumansIntracranial EmbolismMaleMiddle AgedMitral ValveMitral Valve InsufficiencyRisk AssessmentRisk FactorsTreatment OutcomeConceptsTranscatheter mitral valve interventionsCerebral embolic riskMitral valve interventionMV proceduresEmbolic riskValve interventionHeart interventionsProcedure-related adverse eventsPatient-related factorsStructural heart interventionsReal clinical issueMV interventionAdverse eventsEmbolic injuryMV diseaseUnmet ClinicalMV anatomyClinical issuesAvailable evidenceInterventionRiskSystematic assessmentClinicalInjuryAvailable data
2017
The SURTAVI study: TAVI for patients with intermediate risk.
Jones DA, Tchétché D, Forrest J, Hellig F, Lansky A, Moat N. The SURTAVI study: TAVI for patients with intermediate risk. EuroIntervention 2017, 13: e617-e620. PMID: 28781252, DOI: 10.4244/eijv13i5a97.Peer-Reviewed Original ResearchAortic ValveAortic Valve StenosisHeart Valve Prosthesis ImplantationHumansRisk FactorsTranscatheter Aortic Valve ReplacementTreatment Outcome
2015
The TriGuard embolic deflection device for prevention of stroke and cerebral embolization during transcatheter aortic valve replacement
Baumbach A, Pietras C, Lansky A. The TriGuard embolic deflection device for prevention of stroke and cerebral embolization during transcatheter aortic valve replacement. Expert Review Of Medical Devices 2015, 12: 649-651. PMID: 26364995, DOI: 10.1586/17434440.2015.1086642.Peer-Reviewed Original ResearchMeSH KeywordsClinical Trials as TopicHeart Valve Prosthesis ImplantationHumansIntracranial EmbolismStrokeTranscatheter Aortic Valve ReplacementConceptsTranscatheter aortic valve implantationAortic valve implantationValve implantationTranscatheter aortic valve replacementIschemic cerebral eventsAortic valve replacementPrevention of strokeCerebral embolizationEmbolic strokeCerebral eventsEmbolic eventsValve replacementEmbolic lesionsClinical studiesNeurocognitive impairmentNeurocognitive functionMemory lossVessel ostiumStrokeBrain circulationImplantationEmbolizationOstiumLesionsIncidenceSafety 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 ResearchMeSH KeywordsAged, 80 and overAortic ValveBrainCardiac CatheterizationDiffusion Magnetic Resonance ImagingEmbolic Protection DevicesHeart Valve Prosthesis ImplantationHumansIntracranial EmbolismMaleNeuroimagingTreatment OutcomeConceptsTranscatheter 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 opinionAlmanac 2013: Novel non-coronary cardiac interventions
Meier P, Franzen O, Lansky AJ. Almanac 2013: Novel non-coronary cardiac interventions. Heart 2013, 99: 1309. PMID: 23899781, DOI: 10.1136/heartjnl-2013-304430.Peer-Reviewed Original ResearchMeSH KeywordsAortic Valve StenosisAtrial AppendageAtrial FibrillationCardiologyDenervationEmbolic Protection DevicesEquipment DesignHeart DiseasesHeart Valve DiseasesHeart Valve Prosthesis ImplantationHumansKidneyMitral Valve InsufficiencyPercutaneous Coronary InterventionSeptal Occluder DeviceTreatment OutcomeConceptsHigh riskPercutaneous left atrial appendage closureImportant new treatment optionInterventional cardiologyLeft atrial appendage closureNon-pharmacologic therapiesAtrial appendage closureAortic valve stenosisCoronary artery diseaseAortic valve diseaseSurgical valve repairNew treatment optionsImportant clinical evidenceRecent clinical dataRenal denervationResistant hypertensionStroke preventionAppendage closureElderly patientsArtery diseasePercutaneous treatmentValve stenosisValvular diseaseValve diseaseClinical evidenceClinical 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