2021
The Impact of Depression on Outcomes in Patients With Heart Failure and Reduced Ejection Fraction Treated in the GUIDE-IT Trial
Chouairi F, Fuery MA, Mullan CW, Caraballo C, Sen S, Maulion C, Wilkinson ST, Surti T, McCullough M, Miller PE, Pacor J, Leifer ES, Felker GM, Velazquez EJ, Fiuzat M, O'Connor CM, Januzzi JL, Desai NR, Ahmad T. The Impact of Depression on Outcomes in Patients With Heart Failure and Reduced Ejection Fraction Treated in the GUIDE-IT Trial. Journal Of Cardiac Failure 2021, 27: 1359-1366. PMID: 34166799, DOI: 10.1016/j.cardfail.2021.06.008.Peer-Reviewed Original ResearchConceptsGuideline-directed medical therapyReduced ejection fractionAmino-terminal pro-B-type natriuretic peptide levelsPro-B-type natriuretic peptide levelsGUIDE-IT trialNatriuretic peptide levelsHeart failureEjection fractionClinical outcomesPeptide levelsOptimal guideline-directed medical therapyCox proportional hazards regression modelingProportional hazards regression modelingImpact of depressionHistory of depressionCardiovascular deathCause hospitalizationCause mortalityOverall cohortMedical therapyAdverse outcomesTarget dosesPatientsMental healthTime pointsIntercountry Differences in Guideline-Directed Medical Therapy and Outcomes Among Patients With Heart Failure
Fuery MA, Chouairi F, Januzzi JL, Moe GW, Caraballo C, McCullough M, Miller PE, Reinhardt SW, Clark K, Oseran A, Milner A, Pacor J, Kahn PA, Singh A, Ravindra N, Guha A, Vadlamani L, Kulkarni NS, Fiuzat M, Felker GM, O'Connor CM, Ahmad T, Ezekowitz J, Desai NR. Intercountry Differences in Guideline-Directed Medical Therapy and Outcomes Among Patients With Heart Failure. JACC Heart Failure 2021, 9: 497-505. PMID: 33992564, DOI: 10.1016/j.jchf.2021.02.011.Peer-Reviewed Original ResearchConceptsGuideline-directed medical therapyGDMT useCountry of enrollmentHeart failureMedical therapyHigher body mass indexKaplan-Meier survival estimatesGUIDE-IT trialHeart failure hospitalizationReduced ejection fractionLog-rank testingMineralocorticoid receptor antagonistsPrimary study endpointBody mass indexPatterns of careCare delivery structuresGUIDE-ITHF hospitalizationFailure hospitalizationUsual careEjection fractionStudy endpointBlack patientsClinical outcomesMass index
2020
Clinical implications of differences between real world and clinical trial usage of left ventricular assist devices for end stage heart failure
Mezzacappa C, Ravindra NG, Caraballo C, Chouairi F, Miller PE, Clarke JD, Gruen J, Mori M, McCullough M, Mullan C, Geirsson A, Rogers JG, Anwer M, Desai N, Ahmad T. Clinical implications of differences between real world and clinical trial usage of left ventricular assist devices for end stage heart failure. PLOS ONE 2020, 15: e0242928. PMID: 33270648, PMCID: PMC7714148, DOI: 10.1371/journal.pone.0242928.Peer-Reviewed Original ResearchConceptsClinical trialsVentricular assist deviceExclusion criteriaLVAD recipientsAssist deviceReal-world settingClinical implicationsClinical trial exclusion criteriaHeart failure clinical trialsEnd-stage renal diseaseEnd-stage heart failureReal-world registryRetrospective cohort studyLandmark clinical trialsStage renal diseaseTrial exclusion criteriaRisk of deathStage heart failureRespiratory failureCohort studyPatient characteristicsHeart failurePatient factorsRenal diseaseClinical outcomesNon-inferiority trials using a surrogate marker as the primary endpoint: An increasing phenotype in cardiovascular trials
Bikdeli B, Caraballo C, Welsh J, Ross JS, Kaul S, Stone GW, Krumholz HM. Non-inferiority trials using a surrogate marker as the primary endpoint: An increasing phenotype in cardiovascular trials. Clinical Trials 2020, 17: 723-728. PMID: 32838556, PMCID: PMC8088773, DOI: 10.1177/1740774520949157.Peer-Reviewed Original ResearchConceptsNon-inferiority trialPrimary endpointClinical outcome trialsNon-inferiority marginSurrogate markerNon-inferiority designCardiovascular trialsOutcome trialsClinical outcomesDefinitive clinical outcome trialsNon-inferiority criteriaStudy protocolSurrogate outcomesBACKGROUND/Median numberSurrogate endpointsPrimary analysisCardiovascular interventionsCardiovascular medicineTrialsEndpointClinical interpretationOutcomesMarkersInterventionSex Differences in Patients Receiving Left Ventricular Assist Devices for End-Stage Heart Failure
Gruen J, Caraballo C, Miller PE, McCullough M, Mezzacappa C, Ravindra N, Mullan CW, Reinhardt SW, Mori M, Velazquez E, Geirsson A, Ahmad T, Desai NR. Sex Differences in Patients Receiving Left Ventricular Assist Devices for End-Stage Heart Failure. JACC Heart Failure 2020, 8: 770-779. PMID: 32653446, DOI: 10.1016/j.jchf.2020.04.015.Peer-Reviewed Original ResearchConceptsAdverse eventsVentricular assist deviceClinical outcomesPotential underuseHigh riskAssist deviceEnd-stage heartWomen 65 yearsRisk of deathContinuous-flow LVADYears of ageAdvanced treatment optionsSex differencesHeart transplantationMultivariable adjustmentHeart failureHeart transplantSimilar incidenceTreatment optionsSimilar riskSurvival analysisLVADPatientsDevice malfunctionWomenPsychiatric Comorbidity and Outcomes After Left Ventricular Assist Device Implantation for End-Stage Heart Failure
Mullan C, Caraballo C, Ravindra NG, Miller PE, McCullough M, Brown K, Aw TW, Gruen J, Clarke JD, Velazquez EJ, Geirsson A, Mori M, Desai NR, Ahmad T. Psychiatric Comorbidity and Outcomes After Left Ventricular Assist Device Implantation for End-Stage Heart Failure. JACC Heart Failure 2020, 8: 569-577. PMID: 32535119, DOI: 10.1016/j.jchf.2020.03.011.Peer-Reviewed Original ResearchConceptsPsychiatric comorbidityMajor psychiatric illnessNarcotic dependencePsychiatric illnessAdverse eventsHeart failureAlcohol abuseKansas City Cardiomyopathy Questionnaire scoreDrug useVentricular assist device implantationEnd-stage heart failureMechanically Assisted Circulatory SupportAssist device implantationEnd-stage heartRisk of rehospitalizationContinuous-flow LVADRisk of mortalityVulnerable patient populationVentricular assist deviceDevice-related infectionsInteragency RegistryLVAD recipientsSpecific psychiatric conditionsClinical outcomesPatient selectionClinical impact of concomitant tricuspid valve procedures during left ventricular assist device implantation
Mullan C, Caraballo C, Ravindra NG, Miller PE, Mori M, McCullough M, Clarke JD, Anwer M, Velazquez EJ, Geirsson A, Desai NR, Ahmad T. Clinical impact of concomitant tricuspid valve procedures during left ventricular assist device implantation. The Journal Of Heart And Lung Transplantation 2020, 39: 926-933. PMID: 32593561, DOI: 10.1016/j.healun.2020.05.007.Peer-Reviewed Original ResearchConceptsConcomitant tricuspid valve proceduresTricuspid valve proceduresSevere tricuspid regurgitationTricuspid regurgitationLVAD implantationValve proceduresLeft ventricular assist device implantationVentricular assist device implantationDegree of TREnd-stage heart failureAssist device implantationRisk of bleedingCases of mildContinuous-flow LVADVentricular assist deviceInteragency RegistryAdult patientsAdverse eventsSurvival benefitHeart failureClinical outcomesDevice implantationTR severityQOL outcomesClinical impact