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 Risk in Coronary and Structural Heart Interventions: Clinical Evidence
Tirziu D, Huang H, Parise H, Pietras C, Moses J, Messé S, Lansky A. Cerebral Embolic Risk in Coronary and Structural Heart Interventions: Clinical Evidence. Journal Of The Society For Cardiovascular Angiography & Interventions 2023, 2: 100631. PMID: 39130705, PMCID: PMC11307836, DOI: 10.1016/j.jscai.2023.100631.Peer-Reviewed Original ResearchStructural heart interventionsHeart interventionsCardiac proceduresBrain injuryLong-term neurocognitive sequelaeTranscatheter aortic valve replacement (TAVR) proceduresAortic valve replacement proceduresCerebral embolic riskIatrogenic brain injuryIschemic brain injuryRisk of thromboembolismCoronary artery diseaseEmbolic protection devicesNumber of patientsValve replacement proceduresPercutaneous transcatheter interventionsLikelihood of disabilitySymptomatic strokeCerebral embolismCerebral embolizationEmbolic riskAcute strokeNeurologic injuryArtery diseaseIschemic infarction
2021
Randomized Evaluation of TriGuard 3 Cerebral Embolic Protection After Transcatheter Aortic Valve Replacement REFLECT II
Nazif TM, Moses J, Sharma R, Dhoble A, Rovin J, Brown D, Horwitz P, Makkar R, Stoler R, Forrest J, Messé S, Dickerman S, Brennan J, Zivadinov R, Dwyer MG, Lansky AJ, Investigators R. Randomized Evaluation of TriGuard 3 Cerebral Embolic Protection After Transcatheter Aortic Valve Replacement REFLECT II. JACC Cardiovascular Interventions 2021, 14: 515-527. PMID: 33663779, DOI: 10.1016/j.jcin.2020.11.011.Peer-Reviewed Original ResearchConceptsTranscatheter aortic valve replacementAortic valve replacementSafety endpointValve replacementProcedure-related ischemic strokeCerebral embolic protectionComposite efficacy endpointPrimary safety endpointCerebral embolizationCerebral protectionEfficacy endpointII trialCerebral injuryIschemic strokeEmbolic protectionPatientsDrug AdministrationUS sitesU.S. FoodEndpointData reviewTrialsMulticenterEmbolizationInjury
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
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 circulationImplantationEmbolizationOstiumLesionsIncidence