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
2018
Primary outcomes and mechanism of action of intravascular lithotripsy in calcified, femoropopliteal lesions: Results of Disrupt PAD II
Brodmann M, Werner M, Holden A, Tepe G, Scheinert D, Schwindt A, Wolf F, Jaff M, Lansky A, Zeller T. Primary outcomes and mechanism of action of intravascular lithotripsy in calcified, femoropopliteal lesions: Results of Disrupt PAD II. Catheterization And Cardiovascular Interventions 2018, 93: 335-342. PMID: 30474206, DOI: 10.1002/ccd.27943.Peer-Reviewed Original ResearchMeSH KeywordsAgedAged, 80 and overEuropeFemaleFemoral ArteryHumansLithotripsyMaleMiddle AgedNew ZealandPeripheral Arterial DiseasePopliteal ArteryProgression-Free SurvivalProspective StudiesRetreatmentRisk FactorsSeverity of Illness IndexTime FactorsUltrasonic TherapyVascular CalcificationVascular PatencyConceptsMajor adverse eventsIntravascular lithotripsyPrimary patencyDuplex ultrasonographyPAD IIAcute procedure successFinal residual stenosisPrimary effectiveness endpointPrimary safety endpointKey secondary endpointPeripheral arterial stenosisMulti-center studySonic pressure wavesMechanism of actionCompelling safetyEffectiveness endpointAnti-proliferative therapiesSafety endpointSecondary endpointsVascular complicationsAdverse eventsFemoropopliteal lesionsResidual stenosisPrimary outcomeAcute gain