2023
Stroke reduction by cerebral embolic protection devices in transcatheter aortic valve implantation: a systematic review and Bayesian meta-analysis
Heuts S, Gabrio A, Veenstra L, Maesen B, Kats S, Maessen J, Walton A, Nanayakkara S, Lansky A, van 't Hof A, Vriesendorp P. Stroke reduction by cerebral embolic protection devices in transcatheter aortic valve implantation: a systematic review and Bayesian meta-analysis. Heart 2023, 110: 757-765. PMID: 37996242, DOI: 10.1136/heartjnl-2023-323359.Peer-Reviewed Original ResearchTranscatheter aortic valve implantationCerebral embolic protectionAbsolute risk differenceAortic valve implantationRelative riskTAVI patientsValve implantationSystematic reviewCerebral embolic protection devicesMedian relative riskEmbolic protection devicesMultiple sensitivity analysesEmbolic protectionPrimary outcomeFuture trialsStandard treatmentStroke reductionBaseline riskRisk differenceElectronic databasesExpert consensusNew-generation devicesSecondary analysisStrokeRelevant reduction
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
2021
A randomized evaluation of the TriGuard™ HDH cerebral embolic protection device to Reduce the Impact of Cerebral Embolic LEsions after TransCatheter Aortic Valve ImplanTation: the REFLECT I trial
Lansky AJ, Makkar R, Nazif T, Messé S, Forrest J, Sharma R, Schofer J, Linke A, Brown D, Dhoble A, Horwitz P, Zang M, DeMarco F, Rajagopal V, Dwyer MG, Zivadinov R, Stella P, Rovin J, Parise H, Kodali S, Baumbach A, Moses J. A randomized evaluation of the TriGuard™ HDH cerebral embolic protection device to Reduce the Impact of Cerebral Embolic LEsions after TransCatheter Aortic Valve ImplanTation: the REFLECT I trial. European Heart Journal 2021, 42: 2670-2679. PMID: 34000004, DOI: 10.1093/eurheartj/ehab213.Peer-Reviewed Original ResearchConceptsTranscatheter aortic valve replacementEfficacy endpointCerebral embolic protection devicesTranscatheter aortic valve implantationCentral nervous system injuryCerebral embolic lesionsCerebral ischemic lesionsHealth Stroke ScalePrimary efficacy endpointPrimary safety outcomeAortic valve replacementAortic valve implantationEmbolic protection devicesNervous system injuryDiffusion-weighted magnetic resonanceMontreal Cognitive AssessmentEffectiveness endpointCause mortalityCerebral protectionSafety endpointStroke ScaleValve implantationValve replacementI trialIschemic lesions
2020
Chapter 41 Embolic protection devices for stroke prevention during cardiac interventions
Ghare M, Zhou S, Tirziu D, Lansky A. Chapter 41 Embolic protection devices for stroke prevention during cardiac interventions. 2020, 941-960. DOI: 10.1016/b978-0-12-813704-8.00041-3.Peer-Reviewed Original ResearchTranscatheter aortic valve implantationAortic stenosisSevere symptomatic aortic stenosisSurgical aortic valve replacementSymptomatic aortic stenosisAortic valve replacementHigh-risk patientsPrevention of strokeAortic valve implantationEmbolic protection devicesNeurologic eventsStroke preventionDevastating complicationIntermediate riskNeurologic injuryValve implantationValve replacementAdjunctive pharmacotherapyStroke rateCurrent evidenceTranscatheter proceduresCardiac interventionsPatientsStrokePrevention
2019
Predictors of In-Hospital Mortality after Transcatheter Aortic Valve Implantation
Krittanawong C, Kumar A, Wang Z, Johnson KW, Rastogi U, Narasimhan B, Kaplin S, Virk HUH, Baber U, Tang W, Lansky AJ, Stone GW. Predictors of In-Hospital Mortality after Transcatheter Aortic Valve Implantation. The American Journal Of Cardiology 2019, 125: 251-257. PMID: 31759517, DOI: 10.1016/j.amjcard.2019.10.014.Peer-Reviewed Original ResearchConceptsTranscatheter aortic valve implantationBaseline heart failureAortic valve implantationHeart failureAdditional independent predictorsHospital mortalityEjection fractionIndependent predictorsValve implantationPresence of HFReduced ejection fractionSevere aortic stenosisIn-Hospital MortalityPredictors of mortalityPotential baseline confoundersAortic valve stenosisICD-9 codesAbsence of depressionTAVI patientsHF patientsAortic stenosisValve stenosisLiver diseaseMultivariable analysisPatient selection
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 ResearchConceptsTranscatheter 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 methodComplicationsStenosisInjuryStrokeIncidence
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 ResearchConceptsTranscatheter 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 circulationImplantationEmbolizationOstiumLesionsIncidenceA 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 imagingTriGuard
2014
Local versus general anesthesia for transcatheter aortic valve implantation (TAVR) – systematic review and meta-analysis
Fröhlich GM, Lansky AJ, Webb J, Roffi M, Toggweiler S, Reinthaler M, Wang D, Hutchinson N, Wendler O, Hildick-Smith D, Meier P. Local versus general anesthesia for transcatheter aortic valve implantation (TAVR) – systematic review and meta-analysis. BMC Medicine 2014, 12: 41. PMID: 24612945, PMCID: PMC4022332, DOI: 10.1186/1741-7015-12-41.Peer-Reviewed Original ResearchConceptsShorter hospital stayGeneral anesthesiaHospital stayRelative riskProcedure timeSevere aortic valve stenosisTranscatheter aortic valve implantationResultsSeven observational studiesAcute kidney injuryProcedure-related mortalityPooled relative riskAortic valve implantationAortic valve stenosisShort-term outcomesShorter procedure timeRandom-effects modelKidney injuryValve implantationOverall mortalityValve stenosisRandomized trialsTransfemoral TAVRLocal anesthesiaTreatment optionsMyocardial infarction
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 opinion