2022
Clinical Research on Transcatheter Aortic Valve Replacement for Bicuspid Aortic Valve Disease: Principles, Challenges, and an Agenda for the Future
Ahmad Y, Madhavan M, Baron S, Forrest J, Borger M, Leipsic J, Cavalcante J, Wang D, McCarthy P, Szerlip M, Kapadia S, Makkar R, Mack M, Leon M, Cohen D. Clinical Research on Transcatheter Aortic Valve Replacement for Bicuspid Aortic Valve Disease: Principles, Challenges, and an Agenda for the Future. Structural Heart 2022, 7: 100102. PMID: 37275317, PMCID: PMC10236801, DOI: 10.1016/j.shj.2022.100102.Peer-Reviewed Original ResearchTranscatheter aortic valve replacementBicuspid aortic valve diseaseSurgical aortic valve replacementAortic valve replacementAortic valve diseaseValve replacementClinical researchValve diseaseValvular heart diseaseDesign of RCTsProcedural therapiesProspective registryHeart diseaseExclusion criteriaRisk scorePatientsRCTsDiseaseCardiovascular communityMultidisciplinary workshopSelection biasTrialsInternational expertsPotential studiesRegistryTHE ROLE OF TRANSCATHETER AORTIC VALVE REPLACEMENT IN LOW-FLOW, LOW-GRADIENT AORTIC STENOSIS: INSIGHTS FROM THE EVOLUT LOW RISK TRIAL
Anwaruddin S, Forrest J, Gada H, Mumtaz M, Huang J, Maini B, Oh J, Ito S, Kleiman N, Reardon M. THE ROLE OF TRANSCATHETER AORTIC VALVE REPLACEMENT IN LOW-FLOW, LOW-GRADIENT AORTIC STENOSIS: INSIGHTS FROM THE EVOLUT LOW RISK TRIAL. Journal Of The American College Of Cardiology 2022, 79: 653. DOI: 10.1016/s0735-1097(22)01644-8.Peer-Reviewed Original Research
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
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
2015
TCT-623 Transcatheter Aortic Valve Replacement In Women Versus Men: An Analysis of the CoreValve US Pivotal and Continued Access Trials
Forrest J, Lansky A, Maini B, Skelding K, Casale A, Fail P, Popma J. TCT-623 Transcatheter Aortic Valve Replacement In Women Versus Men: An Analysis of the CoreValve US Pivotal and Continued Access Trials. Journal Of The American College Of Cardiology 2015, 66: b254-b255. DOI: 10.1016/j.jacc.2015.08.642.Peer-Reviewed Original Research