2023
Predictors of Cerebral Embolic Debris During Transcatheter Aortic Valve Replacement: The SafePass 2 First-in-Human Study
Grubman D, Ahmad Y, Leipsic J, Blanke P, Pasupati S, Webster M, Nazif T, Parise H, Lansky A. Predictors of Cerebral Embolic Debris During Transcatheter Aortic Valve Replacement: The SafePass 2 First-in-Human Study. The American Journal Of Cardiology 2023, 207: 28-34. PMID: 37722198, DOI: 10.1016/j.amjcard.2023.08.137.Peer-Reviewed Original ResearchConceptsTranscatheter aortic valve replacementAortic valve replacementValve replacementAtrial fibrillationHuman studiesEmbolic protection device useHigh embolic riskPrimary end pointHigh-risk patientsIndependent core laboratorySelf-expanding valvesComputed tomography angiographyProtection device useCerebral embolizationCerebrovascular eventsEmbolic riskAcute thrombusEmbolic burdenAngiography featuresTechnical successTomography angiographyEmbolic debrisValve useCore laboratoryEnd pointCerebral embolic protection during transcatheter heart interventions.
Jimenez Diaz V, Kapadia S, Linke A, Mylotte D, Lansky A, Grube E, Settergren M, Puri R. Cerebral embolic protection during transcatheter heart interventions. EuroIntervention 2023, 19: 549-570. PMID: 37720969, PMCID: PMC10495748, DOI: 10.4244/eij-d-23-00166.Peer-Reviewed Original ResearchConceptsCerebral embolic protection devicesTranscatheter aortic valve replacementNew cerebral lesionsMajority of patientsCerebral lesionsTransfemoral transcatheter aortic valve replacementHeart interventionsCerebral embolic protectionAortic valve replacementEmbolic protection devicesBrain imaging studiesPrimary endpointDevastating complicationPeriprocedural strokeValve replacementEmbolic protectionEmbolic showerApparent strokeCerebral embolisationTranscatheter proceduresSpecific trialsImaging studiesStrokePatientsLesions
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 ResearchMeSH KeywordsDiffusion Magnetic Resonance ImagingEmbolic Protection DevicesHumansIntracranial EmbolismStrokeTranscatheter Aortic Valve ReplacementTreatment OutcomeConceptsTranscatheter 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
2020
Cerebral Embolic Protection Burden of Proof ∗
Lansky A, Pietras C, Shah T. Cerebral Embolic Protection Burden of Proof ∗. JACC Cardiovascular Interventions 2020, 13: 2156-2158. PMID: 32972579, DOI: 10.1016/j.jcin.2020.06.030.Peer-Reviewed Original ResearchA pilot study with the TriGUARD 3 cerebral embolic protection device.
Magalhaes PG, Kooistra NHM, Leenders GEH, Margolis PM, Lansky AJ, Kraaijeveld AO, Voskuil M, Stella PR. A pilot study with the TriGUARD 3 cerebral embolic protection device. EuroIntervention 2020, 16: e507-e509. PMID: 32091398, DOI: 10.4244/eij-d-19-00741.Peer-Reviewed Original ResearchAortic Valve StenosisEmbolic Protection DevicesHumansIntracranial EmbolismPilot ProjectsTreatment OutcomeCerebral Embolic Protection Finding a Black Cat in a Coal Cellar ∗
Lansky A, Saito Y, Kaple R. Cerebral Embolic Protection Finding a Black Cat in a Coal Cellar ∗. JACC Cardiovascular Interventions 2020, 13: 869-871. PMID: 32273099, DOI: 10.1016/j.jcin.2019.12.013.Peer-Reviewed Original Research
2018
Cerebral 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 ResearchConceptsTranscatheter 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
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
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 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