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
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