2024
Advancing patient-centric care: integrating patient reported outcomes for tolerability assessment in early phase clinical trials – insights from an expert virtual roundtable
Yap C, Aiyegbusi O, Alger E, Basch E, Bell J, Bhatnagar V, Cella D, Collis P, Dueck A, Gilbert A, Gnanasakthy A, Greystoke A, Hansen A, Kamudoni P, Kholmanskikh O, King-Kallimanis B, Krumholz H, Minchom A, O'Connor D, Petrie J, Piccinin C, Rantell K, Rauz S, Retzer A, Rizk S, Wagner L, Sasseville M, Seymour L, Weber H, Wilson R, Calvert M, Peipert J. Advancing patient-centric care: integrating patient reported outcomes for tolerability assessment in early phase clinical trials – insights from an expert virtual roundtable. EClinicalMedicine 2024, 76: 102838. PMID: 39386161, PMCID: PMC11462221, DOI: 10.1016/j.eclinm.2024.102838.Peer-Reviewed Original ResearchEarly phase trialsPatient-reported outcomesPhase trialsInvestigator-reported adverse eventsEarly phase clinical trialsTolerability assessmentsPhase clinical trialsIntegration of patient-reported outcomesAdverse eventsClinical trialsPatient-centred careDosing decisionsDiverse clinical areasTherapy risksLaboratory assessmentPatientsTrialsPatient advocatesClinical areasOutcomesSafety alertsPharmaceutical representativesVirtual roundtableRiskClass I Recalls of Cardiovascular Devices Between 2013 and 2022 : A Cross-Sectional Analysis.
See C, Mooghali M, Dhruva S, Ross J, Krumholz H, Kadakia K. Class I Recalls of Cardiovascular Devices Between 2013 and 2022 : A Cross-Sectional Analysis. Annals Of Internal Medicine 2024 PMID: 39284187, DOI: 10.7326/annals-24-00724.Peer-Reviewed Original ResearchCross-sectional studyCross-sectional analysisAdverse health consequencesPatient safetyClinical testingClass IHealth consequencesClinical evidenceFDA summariesPostapproval studiesDecision summariesFood and Drug AdministrationU.S. Food and Drug AdministrationEnd-point selectionPremarket approvalMultiple class IClinical studiesPostmarketing surveillanceSummaryDrug AdministrationMedical device recall databaseRecallPatientsFDAPostmarketingCost-effectiveness of rapid vs in-house vs send-out ADAMTS13 testing for immune thrombotic thrombocytopenic purpura
Allen C, Ito S, Butt A, Purcell A, Richmond R, Tormey C, Krumholz H, Cuker A, Goshua G. Cost-effectiveness of rapid vs in-house vs send-out ADAMTS13 testing for immune thrombotic thrombocytopenic purpura. Blood Advances 2024, 8: 2279-2289. PMID: 38502197, PMCID: PMC11116991, DOI: 10.1182/bloodadvances.2024012608.Peer-Reviewed Original ResearchImmune thrombotic thrombocytopenic purpuraPLASMIC scoreThrombotic thrombocytopenic purpuraThrombocytopenic purpuraADAMTS13 testingIncremental net monetary benefitPer-patient cost savingsTherapeutic plasma exchangeBase-case analysisMarkov cohort simulationProbabilistic sensitivity analysesAmount of QALYEmpirical therapyADAMTS13 assaysPlasma exchangeEmpirical treatmentCaplacizumabFRET-based assayPrimary outcomePatientsNet monetary benefitCohort simulationCost-effectiveness evaluationPurpuraTesting strategiesOptimizing antithrombotic therapy in patients with coexisting cardiovascular and gastrointestinal disease
Talasaz A, Sadeghipour P, Ortega-Paz L, Kakavand H, Aghakouchakzadeh M, Beavers C, Fanikos J, Eikelboom J, Siegal D, Monreal M, Jimenez D, Vaduganathan M, Castellucci L, Cuker A, Barnes G, Connors J, Secemsky E, Van Tassell B, De Caterina R, Kurlander J, Aminian A, Piazza G, Goldhaber S, Moores L, Middeldorp S, Kirtane A, Elkind M, Angiolillo D, Konstantinides S, Lip G, Stone G, Cushman M, Krumholz H, Mehran R, Bhatt D, Bikdeli B. Optimizing antithrombotic therapy in patients with coexisting cardiovascular and gastrointestinal disease. Nature Reviews Cardiology 2024, 21: 574-592. PMID: 38509244, DOI: 10.1038/s41569-024-01003-3.Peer-Reviewed Original ResearchRisk of gastrointestinal bleedingGastrointestinal bleedingAntithrombotic therapyHigh risk of gastrointestinal bleedingIncreased risk of bleedingRisk of bleedingGastrointestinal diseasesEfficacy of antithrombotic agentsAntithrombotic regimensConcomitant medicationsRisk stratificationClinical evidenceGastrointestinal comorbiditiesMultidisciplinary discussionAntithrombotic drugsAntithrombotic agentsIncreased riskHigh riskPatientsGastrointestinal disordersCardiovascular diseaseTherapyBleedingDiseaseMedical societiesRacial/Ethnic Disparities in Aortic Valve Replacement Among Medicare Beneficiaries in the United States, 2012-2019
Gupta A, Mori M, Wang Y, Pawar S, Vahl T, Nazif T, Onuma O, Yong C, Sharma R, Kirtane A, Forrest J, George I, Kodali S, Chikwe J, Geirsson A, Makkar R, Leon M, Krumholz H. Racial/Ethnic Disparities in Aortic Valve Replacement Among Medicare Beneficiaries in the United States, 2012-2019. The American Journal Of Medicine 2024, 137: 321-330.e7. PMID: 38190959, PMCID: PMC11019903, DOI: 10.1016/j.amjmed.2023.12.026.Peer-Reviewed Original ResearchAortic valve replacementRace/ethnicityValve replacementAortic stenosisWhite patientsMedicare beneficiariesSurgical aortic valve replacement (SAVR) proceduresCross-sectional cohort studyAortic valve replacement proceduresAortic stenosis treatmentRacial/Ethnic DisparitiesValve replacement proceduresSelf-reported race/ethnicityRace-related differencesIndex admissionIndex hospitalizationCohort studyAsian patientsPrincipal diagnosisProcedural outcomesStenosis treatmentCare spectrumPatientsEthnic disparitiesStenosis
2023
PB0014 Do Antiphospholipid Antibodies Inform the Choice of Anticoagulant Agents in Patients with Atrial Fibrillation?
Bikdeli B, Bejjani A, Khairani C, Jimenez D, Monreal M, Siegal D, Kanthi Y, Barnes G, O’Donoghue M, Ruff C, Middeldorp S, Lopes R, Goldhaber S, Weitz J, Cushman M, Krumholz H, Lip G, Piazza G. PB0014 Do Antiphospholipid Antibodies Inform the Choice of Anticoagulant Agents in Patients with Atrial Fibrillation? Research And Practice In Thrombosis And Haemostasis 2023, 7: 100697. DOI: 10.1016/j.rpth.2023.100697.Peer-Reviewed Original ResearchClinical Phenotyping with an Outcomes-driven Mixture of Experts for Patient Matching and Risk Estimation
Hurley N, Dhruva S, Desai N, Ross J, Ngufor C, Masoudi F, Krumholz H, Mortazavi B. Clinical Phenotyping with an Outcomes-driven Mixture of Experts for Patient Matching and Risk Estimation. ACM Transactions On Computing For Healthcare 2023, 4: 1-18. PMID: 37908872, PMCID: PMC10613929, DOI: 10.1145/3616021.Peer-Reviewed Original ResearchSafety and Efficacy of Inferior Vena Cava Filters in Patients at Risk of Pulmonary Embolism: A Systematic Review and Meta-Analysis
Rashedi S, Bejjani A, Khairani C, Lou J, Chatterjee S, Jiménez D, Gerhard-Herman M, Mena-Hurtado C, Goldhaber S, Piazza G, Krumholz H, Sadeghipour P, Bikdeli B. Safety and Efficacy of Inferior Vena Cava Filters in Patients at Risk of Pulmonary Embolism: A Systematic Review and Meta-Analysis. Cardiovascular Revascularization Medicine 2023, 53: s66-s67. DOI: 10.1016/j.carrev.2023.05.150.Peer-Reviewed Original ResearchRelationship Between In-Hospital Adverse Events and Hospital Performance on 30-Day All-cause Mortality and Readmission for Patients With Heart Failure
Wang Y, Eldridge N, Metersky M, Rodrick D, Eckenrode S, Mathew J, Galusha D, Peterson A, Hunt D, Normand S, Krumholz H. Relationship Between In-Hospital Adverse Events and Hospital Performance on 30-Day All-cause Mortality and Readmission for Patients With Heart Failure. Circulation Cardiovascular Quality And Outcomes 2023, 16: e009573. PMID: 37463255, PMCID: PMC10351904, DOI: 10.1161/circoutcomes.122.009573.Peer-Reviewed Original ResearchConceptsMore adverse eventsAdverse eventsHeart failureCause mortalityReadmission ratesHigh riskMedicare Patient Safety Monitoring SystemHospital-acquired adverse eventsIn-Hospital Adverse EventsHospital adverse eventsRate of patientsPatient Safety DatabasePerformance categoriesAdverse event dataCross-sectional studyUnited States CentersHospital performanceHospital characteristicsReadmission dataPatient riskMAIN OUTCOMEPatientsWorst hospitalsHospitalHigh mortalityOpportunities and Achievement of Medication Initiation Among Inpatients With Heart Failure With Reduced Ejection Fraction
Swat S, Xu H, Allen L, Greene S, DeVore A, Matsouaka R, Goyal P, Peterson P, Hernandez A, Krumholz H, Yancy C, Fonarow G, Hess P, Program A. Opportunities and Achievement of Medication Initiation Among Inpatients With Heart Failure With Reduced Ejection Fraction. JACC Heart Failure 2023, 11: 918-929. PMID: 37318420, DOI: 10.1016/j.jchf.2023.04.015.Peer-Reviewed Original ResearchConceptsEvidence-based medicationsMedication initiationReduced ejection fractionNumber of medicationsMultivariable logistic regressionNumber of patientsPre-existing conditionsReduced ejectionEjection fractionHeart failureMultivariable analysisFemale sexLower oddsMedicationsMean net gainPatientsRural hospitalsAdmissionOlder ageLogistic regressionStudy periodMean numberOddsInitiationRural locationsAtorvastatin versus Placebo in ICU Patients with COVID-19: Ninety-day Results of the INSPIRATION-S Trial
Talasaz A, Sadeghipour P, Bakhshandeh H, Sharif-Kashani B, Rashidi F, Beigmohammadi M, Moghadam K, Rezaian S, Dabbagh A, Sezavar S, Farrokhpour M, Abedini A, Aliannejad R, Riahi T, Yadollahzadeh M, Lookzadeh S, Rezaeifar P, Matin S, Tahamtan O, Mohammadi K, Zoghi E, Rahmani H, Hosseini S, Mousavian S, Abri H, Sadeghipour P, Baghizadeh E, Rafiee F, Jamalkhani S, Amin A, Mohebbi B, Parhizgar S, Soleimanzadeh M, Aghakouchakzadeh M, Eslami V, Payandemehr P, Khalili H, Talakoob H, Tojari T, Shafaghi S, Tabrizi S, Kakavand H, Kashefizadeh A, Najafi A, Jimenez D, Gupta A, Madhavan M, Sethi S, Parikh S, Monreal M, Hadavand N, Hajighasemi A, Ansarin K, Maleki M, Sadeghian S, Barco S, Siegerink B, Spatz E, Piazza G, Kirtane A, Tassell B, Lip G, Klok F, Goldhaber S, Stone G, Krumholz H, Bikdeli B. Atorvastatin versus Placebo in ICU Patients with COVID-19: Ninety-day Results of the INSPIRATION-S Trial. Thrombosis And Haemostasis 2023, 123: 723-733. PMID: 36944357, DOI: 10.1055/a-2059-4844.Peer-Reviewed Original ResearchConceptsExtracorporeal membrane oxygenationArterial thrombosisMAIN OUTCOMEAtorvastatin 20Symptom onsetICU patientsFunctional statusIntensive care unit patientsCOVID-19Double-blind multicenterAdult ICU patientsCare unit patientsThrombo-inflammatory responseCoronavirus disease 2019Meaningful treatment effectPrespecified studyCause mortalityAtorvastatin useUnit patientsMembrane oxygenationFunctional outcomeDisease 2019Functional scalesPlaceboPatientsDo PCI Facility Openings and Closures Affect AMI Outcomes Differently in High- vs Average-Capacity Markets?
Shen Y, Krumholz H, Hsia R. Do PCI Facility Openings and Closures Affect AMI Outcomes Differently in High- vs Average-Capacity Markets? JACC Cardiovascular Interventions 2023, 16: 1129-1140. PMID: 37225284, PMCID: PMC10229059, DOI: 10.1016/j.jcin.2023.02.010.Peer-Reviewed Original ResearchConceptsPercutaneous coronary interventionPCI hospitalsSame-day percutaneous coronary interventionHealth outcomesHigh-volume PCI hospitalsHospital PCI volumeRetrospective cohort studyAcute myocardial infarctionPercentage point decreasePatient health outcomesHospital revascularizationCohort studyCoronary interventionAMI outcomesPCI volumePoint decreasePoor outcomePCI facilitiesMyocardial infarctionRelative increaseHospital openingPatientsHospital availabilityHospitalHospital closuresSex Difference in Outcomes of Acute Myocardial Infarction in Young Patients
Sawano M, Lu Y, Caraballo C, Mahajan S, Dreyer R, Lichtman J, D'Onofrio G, Spatz E, Khera R, Onuma O, Murugiah K, Spertus J, Krumholz H. Sex Difference in Outcomes of Acute Myocardial Infarction in Young Patients. Journal Of The American College Of Cardiology 2023, 81: 1797-1806. PMID: 37137590, DOI: 10.1016/j.jacc.2023.03.383.Peer-Reviewed Original ResearchConceptsAcute myocardial infarctionNoncardiac hospitalizationsSubdistribution HRYounger patientsMyocardial infarctionSex differencesYoung womenCause-specific hospitalizationsCause of hospitalizationWorse health statusSignificant sex disparityNoncardiovascular hospitalizationsVIRGO StudyIndex episodeAdverse outcomesIncidence rateHospitalizationHigh riskSex disparitiesHealth statusPatientsU.S. hospitalsWomenInfarctionOutcomesReclassification of moderate aortic stenosis based on data-driven phenotyping of hemodynamic progression
Cho I, Kim W, Kim S, Ko K, Seong Y, Kim D, Seo J, Shim C, Ha J, Mori M, Gupta A, You S, Hong G, Krumholz H. Reclassification of moderate aortic stenosis based on data-driven phenotyping of hemodynamic progression. Scientific Reports 2023, 13: 6694. PMID: 37095171, PMCID: PMC10125992, DOI: 10.1038/s41598-023-33683-1.Peer-Reviewed Original ResearchConceptsRapid progression groupModerate aortic stenosisAortic valve replacementSlow progression groupAortic stenosisProgression groupHemodynamic progressionRapid progressionMore rapid progressionLatent class trajectory modelingTransthoracic echocardiography studyBetween-group differencesData-driven phenotypingPressure gradient measurementAVR ratesModerate ASCause mortalityValve replacementEchocardiography studyAtrial fibrillationTTE studiesEchocardiographic dataRisk factorsPredictive valuePatientsSex Differences in Symptom Complexity and Door-to-Balloon Time in Patients With ST-Elevation Myocardial Infarction
Brush J, Chaudhry S, Dreyer R, D'Onofrio G, Greene E, Hajduk A, Lu Y, Krumholz H. Sex Differences in Symptom Complexity and Door-to-Balloon Time in Patients With ST-Elevation Myocardial Infarction. The American Journal Of Cardiology 2023, 197: 101-107. PMID: 37062667, PMCID: PMC10198892, DOI: 10.1016/j.amjcard.2023.03.009.Peer-Reviewed Original ResearchConceptsPercutaneous coronary interventionD2B timeSymptom complexityYoung womenChest painBalloon timeST-elevation myocardial infarctionSILVER-AMI StudySymptom phenotypeSex differencesPain symptomsCoronary interventionOlder patientsMyocardial infarctionOlder womenSTEMIOlder menSymptom patternsPresentation delayPatientsSymptom clustersLogistic regressionSymptomsWomenMean numberIn-Hospital Observation on Oral Diuretics After Treatment for Acute Decompensated Heart Failure: Evaluating the Utility
Ivey-Miranda J, Rao V, Cox Z, Moreno-Villagomez J, Mahoney D, Maulion C, Bellumkonda L, Turner J, Collins S, Wilson F, Krumholz H, Testani J. In-Hospital Observation on Oral Diuretics After Treatment for Acute Decompensated Heart Failure: Evaluating the Utility. Circulation Heart Failure 2023, 16: e010206. PMID: 36896716, PMCID: PMC10186250, DOI: 10.1161/circheartfailure.122.010206.Peer-Reviewed Original ResearchConceptsAcute decompensated heart failureDecompensated heart failureDiuretic responseDiuretic dosingOral diureticsHeart failureMulticenter cohortHospital observationLower readmission ratesNet fluid balanceDays postdischargeReadmission ratesHospital readmissionUrine outputReadmission riskFluid statusFluid balanceHospital measuresDose selectionCohortProvider decisionsWeight changeReadmissionDiureticsPatientsASSOCIATION OF NEIGHBORHOOD-LEVEL MATERIAL DEPRIVATION WITH ADVERSE OUTCOMES AND PROCESSES OF CARE AMONG PATIENTS WITH HEART FAILURE IN A SINGLE-PAYER HEALTHCARE SYSTEM: A POPULATION-BASED COHORT STUDY
Dorovenis A, Bobrowski D, Abdel-Qadir H, McNaughton C, Alonzo R, Fang J, Austin P, Udell J, Jackevicius C, Alter D, Bhatia R, Atzema C, Ha A, Johnston S, Dhalla I, Kapral M, Krumholz H, Wijeysundera H, Ko D, Tu K, Ross H, Schull M, Lee D. ASSOCIATION OF NEIGHBORHOOD-LEVEL MATERIAL DEPRIVATION WITH ADVERSE OUTCOMES AND PROCESSES OF CARE AMONG PATIENTS WITH HEART FAILURE IN A SINGLE-PAYER HEALTHCARE SYSTEM: A POPULATION-BASED COHORT STUDY. Journal Of The American College Of Cardiology 2023, 81: 361. DOI: 10.1016/s0735-1097(23)00805-7.Peer-Reviewed Original ResearchCRT-300.15 Safety and Efficacy of Inferior Vena Cava Filters in Patients at Risk of Pulmonary Embolism: A Systematic Review and Meta-Analysis
Rashedi S, Bejjani A, Khairani C, Lou J, Chatterjee S, Jiménez D, Gerhard-Herman M, Mena-Hurtado C, Goldhaber S, Piazza G, Krumholz H, Sadeghipour P, Bikdeli B. CRT-300.15 Safety and Efficacy of Inferior Vena Cava Filters in Patients at Risk of Pulmonary Embolism: A Systematic Review and Meta-Analysis. JACC Cardiovascular Interventions 2023, 16: s53. DOI: 10.1016/j.jcin.2023.01.172.Peer-Reviewed Original ResearchTiming of Blood Draws Among Patients Hospitalized in a Large Academic Medical Center
Caraballo C, Mahajan S, Murugiah K, Mortazavi B, Lu Y, Khera R, Krumholz H. Timing of Blood Draws Among Patients Hospitalized in a Large Academic Medical Center. JAMA 2023, 329: 255-257. PMID: 36648476, PMCID: PMC9856620, DOI: 10.1001/jama.2022.21509.Peer-Reviewed Original Research
2022
Characterization of multi-domain postoperative recovery trajectories after cardiac surgery using a digital platform
Mori M, Dhruva S, Geirsson A, Krumholz H. Characterization of multi-domain postoperative recovery trajectories after cardiac surgery using a digital platform. Npj Digital Medicine 2022, 5: 192. PMID: 36564550, PMCID: PMC9789027, DOI: 10.1038/s41746-022-00736-0.Peer-Reviewed Original ResearchPatient-reported outcome measuresCardiac surgeryProspective cohort studyPROM data collectionPostoperative complicationsCohort studyPostoperative recoveryTertiary centerPatients' perceptionsOutcome measuresClinical practicePatientsSurgeryRecovery progressionRecovery trajectoriesTrajectory membershipComplicationsOverall recoveryDaysAnxiety trajectoriesRecoveryProgressionCare