2020
Three-Year Outcomes With a Contemporary Self-Expanding Transcatheter Valve From the Evolut PRO US Clinical Study
Wyler von Ballmoos MC, Reardon MJ, Williams MR, Mangi AA, Kleiman NS, Yakubov SJ, Watson D, Kodali S, George I, Tadros P, Zorn GL, Brown J, Kipperman R, Oh JK, Qiao H, Forrest JK. Three-Year Outcomes With a Contemporary Self-Expanding Transcatheter Valve From the Evolut PRO US Clinical Study. Cardiovascular Revascularization Medicine 2020, 26: 12-16. PMID: 33199247, DOI: 10.1016/j.carrev.2020.11.007.Peer-Reviewed Original ResearchConceptsTranscatheter aortic valve replacementEvolut PRO valveParavalvular regurgitationUS clinical studiesCause mortalityClinical studiesNew York Heart Association class ISelf-expanding transcatheter valveValve Academic Research ConsortiumExtreme surgical riskMild paravalvular regurgitationAcademic Research ConsortiumAortic valve replacementIndependent core laboratoryThree-Year OutcomesSelf-expanding prosthesisLong-term resultsEffective orifice areaValve thrombosisCardiovascular mortalityExcellent hemodynamicsValve replacementEchocardiographic measuresSurgical riskTranscatheter valve
2017
Proposed Standardized Neurological Endpoints for Cardiovascular Clinical Trials
Lansky AJ, Messé SR, Brickman AM, Dwyer M, van der Worp H, Lazar RM, Pietras CG, Abrams KJ, McFadden E, Petersen NH, Browndyke J, Prendergast B, Ng VG, Cutlip DE, Kapadia S, Krucoff MW, Linke A, Moy C, Schofer J, van Es GA, Virmani R, Popma J, Parides MK, Kodali S, Bilello M, Zivadinov R, Akar J, Furie KL, Gress D, Voros S, Moses J, Greer D, Forrest JK, Holmes D, Kappetein AP, Mack M, Baumbach A. Proposed Standardized Neurological Endpoints for Cardiovascular Clinical Trials. European Heart Journal 2017, 39: 1687-1697. PMID: 28171522, PMCID: PMC6251670, DOI: 10.1093/eurheartj/ehx037.Peer-Reviewed Original ResearchConceptsCardiovascular proceduresClinical trialsNeurological endpointsAcademic Research ConsortiumBenefit-risk assessmentAdjunctive pharmacologyNeurological complicationsNeurological outcomePreventive therapyClinical effectsNeurovascular injuryNeurological injuryNeurological riskEndpoint definitionsCardiovascular interventionsAscertainment methodsTherapyInjuryResearch ConsortiumRiskTrialsEndpointInherent risksSuch proceduresComplicationsProposed Standardized Neurological Endpoints for Cardiovascular Clinical Trials An Academic Research Consortium Initiative
Lansky AJ, Messé SR, Brickman AM, Dwyer M, van der Worp HB, Lazar RM, Pietras CG, Abrams KJ, McFadden E, Petersen NH, Browndyke J, Prendergast B, Ng VG, Cutlip DE, Kapadia S, Krucoff MW, Linke A, Moy CS, Schofer J, van Es GA, Virmani R, Popma J, Parides MK, Kodali S, Bilello M, Zivadinov R, Akar J, Furie KL, Gress D, Voros S, Moses J, Greer D, Forrest JK, Holmes D, Kappetein AP, Mack M, Baumbach A. Proposed Standardized Neurological Endpoints for Cardiovascular Clinical Trials An Academic Research Consortium Initiative. Journal Of The American College Of Cardiology 2017, 69: 679-691. PMID: 28183511, DOI: 10.1016/j.jacc.2016.11.045.Peer-Reviewed Original ResearchConceptsCardiovascular proceduresClinical trialsNeurological endpointsAcademic Research ConsortiumBenefit-risk assessmentAdjunctive pharmacologyNeurological complicationsNeurological outcomePreventive therapyClinical effectsNeurovascular injuryNeurological injuryNeurological riskEndpoint definitionsCardiovascular interventionsAscertainment methodsTherapyInjuryResearch ConsortiumRiskTrialsEndpointInherent risksSuch proceduresComplications