2020
Validation of Administrative Claims to Ascertain Outcomes in Pivotal Trials of Transcatheter Aortic Valve Replacement
Butala NM, Strom JB, Faridi KF, Kazi DS, Zhao Y, Brennan JM, Popma JJ, Shen C, Yeh RW. Validation of Administrative Claims to Ascertain Outcomes in Pivotal Trials of Transcatheter Aortic Valve Replacement. JACC Cardiovascular Interventions 2020, 13: 1777-1785. PMID: 32682677, PMCID: PMC7444647, DOI: 10.1016/j.jcin.2020.03.049.Peer-Reviewed Original ResearchMeSH KeywordsAdministrative Claims, HealthcareAgedAged, 80 and overAortic Valve StenosisBioprosthesisClinical Trials as TopicData AccuracyData MiningDatabases, FactualFemaleHealth Services ResearchHeart Valve ProsthesisHumansInternational Classification of DiseasesMaleMedicarePostoperative ComplicationsReproducibility of ResultsTranscatheter Aortic Valve ReplacementTreatment OutcomeUnited StatesConceptsTranscatheter aortic valve replacementAortic valve replacementNegative predictive valuePositive predictive valueValve replacementPivotal trialsAdministrative claimsPredictive valueAortic valve reinterventionProcedural billing codesAcute kidney injuryPermanent pacemaker implantationKappa agreement statisticsBleeding eventsValve reinterventionKidney injuryTrial patientsPacemaker implantationProcedural complicationsOutcome ascertainmentTrial endpointsClinical endpointsMyocardial infarctionInpatient claimsClinical trialsUse of Administrative Claims to Assess Outcomes and Treatment Effect in Randomized Clinical Trials for Transcatheter Aortic Valve Replacement
Strom JB, Faridi KF, Butala NM, Zhao Y, Tamez H, Valsdottir LR, Brennan JM, Shen C, Popma JJ, Kazi DS, Yeh RW. Use of Administrative Claims to Assess Outcomes and Treatment Effect in Randomized Clinical Trials for Transcatheter Aortic Valve Replacement. Circulation 2020, 142: 203-213. PMID: 32436390, PMCID: PMC7672506, DOI: 10.1161/circulationaha.120.046159.Peer-Reviewed Original ResearchConceptsTrial primary end pointPrimary end pointEnd pointSURTAVI trialCause mortalitySecondary outcomesAdjudicated outcomesClinical trialsTrial dataSecondary trial end pointsTranscatheter aortic valve replacementTreatment effectsClaims-based outcomesAortic valve replacementTrial end pointsRandomized clinical trialsMedicare inpatient claimsCardiovascular clinical trialsYears of ageSAVR patientsValve replacementTreatment armsInpatient claimsProcedural outcomesAdministrative claims
2019
Comparison of Clinical Trials and Administrative Claims to Identify Stroke Among Patients Undergoing Aortic Valve Replacement
Strom JB, Zhao Y, Faridi KF, Tamez H, Butala NM, Valsdottir LR, Curtis J, Brennan JM, Shen C, Boulware M, Popma JJ, Yeh RW. Comparison of Clinical Trials and Administrative Claims to Identify Stroke Among Patients Undergoing Aortic Valve Replacement. Circulation Cardiovascular Interventions 2019, 12: e008231. PMID: 31694411, PMCID: PMC7212938, DOI: 10.1161/circinterventions.119.008231.Peer-Reviewed Original ResearchMeSH KeywordsAdministrative Claims, HealthcareAgedAged, 80 and overAortic ValveAortic Valve StenosisBrain IschemiaClinical Trials as TopicDatabases, FactualFemaleHeart Valve Prosthesis ImplantationHumansIschemic Attack, TransientMaleMedicareRisk AssessmentRisk FactorsStrokeTime FactorsTranscatheter Aortic Valve ReplacementTreatment OutcomeUnited StatesConceptsNegative predictive valueAortic valve replacementCerebrovascular eventsInternational ClassificationPositive predictive valuePredictive valueValve replacementNinth RevisionClinical trialsTenth RevisionBilling codesKaplan-Meier estimatesMedicare inpatient claimsSURTAVI trialClinical event adjudicationDevastating complicationIschemic strokeNeurological eventsCerebrovascular diseaseBilling claimsInpatient claimsEvent adjudicationAdministrative claimsHigh riskTrial participants