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
2015
A prospective randomized evaluation of the TriGuard™ HDH embolic DEFLECTion device during transcatheter aortic valve implantation: results from the DEFLECT III trial
Lansky AJ, Schofer J, Tchetche D, Stella P, Pietras CG, Parise H, Abrams K, Forrest JK, Cleman M, Reinöhl J, Cuisset T, Blackman D, Bolotin G, Spitzer S, Kappert U, Gilard M, Modine T, Hildick-Smith D, Haude M, Margolis P, Brickman AM, Voros S, Baumbach A. A prospective randomized evaluation of the TriGuard™ HDH embolic DEFLECTion device during transcatheter aortic valve implantation: results from the DEFLECT III trial. European Heart Journal 2015, 36: 2070-2078. PMID: 25990342, DOI: 10.1093/eurheartj/ehv191.Peer-Reviewed Original ResearchTranscatheter aortic valve implantationIschemic brain lesionsAortic valve implantationCerebral protectionNeurologic deficitsValve implantationBrain lesionsNew ischemic brain lesionsCerebral diffusion-weighted magnetic resonance imagingCognitive functionMontreal Cognitive Assessment scoreHealth Stroke ScaleNew neurologic deficitsDiffusion-weighted magnetic resonance imagingProspective Randomized EvaluationNormal cognitive functionCognitive Assessment scoreMagnetic resonance imagingSafety endpointStroke ScaleIII trialsControl subjectsTechnical successResonance imagingTriGuard