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 studiesStrokePatientsLesionsB-50 | Full-Body Embolic Protection During Transcatheter Aortic Valve Replacement: The Protect the Head-to-Head Study, a Pivotal, Randomized Study Comparing the Emboliner Embolic Protection Catheter to the Sentinel CPS
Lansky A. B-50 | Full-Body Embolic Protection During Transcatheter Aortic Valve Replacement: The Protect the Head-to-Head Study, a Pivotal, Randomized Study Comparing the Emboliner Embolic Protection Catheter to the Sentinel CPS. Journal Of The Society For Cardiovascular Angiography & Interventions 2023, 2: 100772. DOI: 10.1016/j.jscai.2023.100772.Peer-Reviewed Original ResearchCerebral 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
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