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 reductionCerebral 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 studiesStrokePatientsLesionsCerebral Embolic Protection in Transcatheter Aortic Valve Replacement
Iskander M, Jamil Y, Forrest J, Madhavan M, Makkar R, Leon M, Lansky A, Ahmad Y. Cerebral Embolic Protection in Transcatheter Aortic Valve Replacement. Structural Heart 2023, 7: 100169. PMID: 37520138, PMCID: PMC10382985, DOI: 10.1016/j.shj.2023.100169.Peer-Reviewed Original ResearchTranscatheter aortic valve replacementCerebral embolic protection devicesCerebral embolic protectionAortic valve replacementEmbolic protection devicesValve replacementEmbolic protectionSymptomatic severe aortic stenosisSevere aortic stenosisLow-risk patientsPredictors of strokeOccurrence of complicationsRisk of strokeRecent trial dataRelevant clinical studiesOverall evidence baseExpansion of TAVRFeared complicationAortic stenosisSurgical riskTreatment optionsWorse outcomesClinical studiesPatientsTrial data
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
Reduction of Cerebral Emboli: In vitro Study with a Novel Cerebral Embolic Protection Device
Haiman G, Nazif T, Moses JW, Ashkenazi A, Margolis P, Lansky AJ. Reduction of Cerebral Emboli: In vitro Study with a Novel Cerebral Embolic Protection Device. Medical Devices Evidence And Research 2020, 13: 67-73. PMID: 32210643, PMCID: PMC7075333, DOI: 10.2147/mder.s234961.Peer-Reviewed Original ResearchCerebral embolic protection devicesEmbolic protection devicesMajor cerebral arteriesCerebral arteryCerebral embolizationCerebral circulationEmbolic debrisCerebral embolic protectionUnprotected controlsCerebral protectionEmbolic protectionCerebral emboliAortic archPulsatile flow patternLeft ventricleArteryPhysiologic flow conditionsCustom-made simulatorTriGuardEmbolizationEfficacyAortaAortic arch modelProtection devicesPercent of particles
2013
Clinical 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