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 point
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 ResearchMeSH KeywordsDiffusion Magnetic Resonance ImagingEmbolic Protection DevicesHumansIntracranial EmbolismStrokeTranscatheter Aortic Valve ReplacementTreatment OutcomeConceptsTranscatheter 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 lesionsRandomized 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
A pilot study with the TriGUARD 3 cerebral embolic protection device.
Magalhaes PG, Kooistra NHM, Leenders GEH, Margolis PM, Lansky AJ, Kraaijeveld AO, Voskuil M, Stella PR. A pilot study with the TriGUARD 3 cerebral embolic protection device. EuroIntervention 2020, 16: e507-e509. PMID: 32091398, DOI: 10.4244/eij-d-19-00741.Peer-Reviewed Original ResearchAortic Valve StenosisEmbolic Protection DevicesHumansIntracranial EmbolismPilot ProjectsTreatment Outcome
2015
Tools and Techniques - Clinical: Embolic protection devices in transcatheter aortic valve implantation.
Van Gils L, Baumbach A, Himbert D, Lansky AJ, Vahanian A, Van Mieghem NM. Tools and Techniques - Clinical: Embolic protection devices in transcatheter aortic valve implantation. EuroIntervention 2015, 11: 247-8. PMID: 26093841, DOI: 10.4244/eijv11i2a45.Peer-Reviewed Original ResearchAortic Valve StenosisEmbolic Protection DevicesHumansTranscatheter Aortic Valve ReplacementVascular Surgical ProceduresSafety and performance of a novel embolic deflection device in patients undergoing transcatheter aortic valve replacement: results from the DEFLECT I study.
Baumbach A, Mullen M, Brickman AM, Aggarwal SK, Pietras CG, Forrest JK, Hildick-Smith D, Meller SM, Gambone L, den Heijer P, Margolis P, Voros S, Lansky AJ. Safety and performance of a novel embolic deflection device in patients undergoing transcatheter aortic valve replacement: results from the DEFLECT I study. EuroIntervention 2015, 11: 75-84. PMID: 25868876, DOI: 10.4244/eijy15m04_01.Peer-Reviewed Original ResearchMeSH KeywordsAgedAged, 80 and overAlloysAortic ValveAortic Valve StenosisBrain IschemiaBrazilCardiac CatheterizationCognitionCognition DisordersDiffusion Magnetic Resonance ImagingEmbolic Protection DevicesEuropeFemaleHeart Valve ProsthesisHeart Valve Prosthesis ImplantationHumansIntracranial EmbolismMalePredictive Value of TestsProspective StudiesProsthesis DesignRisk FactorsSeverity of Illness IndexStrokeTime FactorsTreatment OutcomeUltrasonography, Doppler, TranscranialConceptsTranscatheter aortic valve replacementAortic valve replacementValve replacementNew cerebral ischemic lesionsCerebral diffusion-weighted magnetic resonance imagingCerebral ischemic lesionsDays post procedurePrimary safety endpointDiffusion-weighted magnetic resonance imagingMajor cerebral arteriesTotal lesion volumeMagnetic resonance imagingSafety endpointIschemic lesionsTAVR proceduresCerebral arteryCerebral circulationConsecutive subjectsPost procedureAortic archHistorical controlsLesion volumeResonance imagingDW-MRIPatients
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 opinionAlmanac 2013: Novel non-coronary cardiac interventions
Meier P, Franzen O, Lansky AJ. Almanac 2013: Novel non-coronary cardiac interventions. Heart 2013, 99: 1309. PMID: 23899781, DOI: 10.1136/heartjnl-2013-304430.Peer-Reviewed Original ResearchMeSH KeywordsAortic Valve StenosisAtrial AppendageAtrial FibrillationCardiologyDenervationEmbolic Protection DevicesEquipment DesignHeart DiseasesHeart Valve DiseasesHeart Valve Prosthesis ImplantationHumansKidneyMitral Valve InsufficiencyPercutaneous Coronary InterventionSeptal Occluder DeviceTreatment OutcomeConceptsHigh riskPercutaneous left atrial appendage closureImportant new treatment optionInterventional cardiologyLeft atrial appendage closureNon-pharmacologic therapiesAtrial appendage closureAortic valve stenosisCoronary artery diseaseAortic valve diseaseSurgical valve repairNew treatment optionsImportant clinical evidenceRecent clinical dataRenal denervationResistant hypertensionStroke preventionAppendage closureElderly patientsArtery diseasePercutaneous treatmentValve stenosisValvular diseaseValve diseaseClinical evidence