2024
Modernizing Medical Device Regulation: Challenges and Opportunities for the 510(k) Clearance Process.
Kadakia K, Rathi V, Dhruva S, Ross J, Krumholz H. Modernizing Medical Device Regulation: Challenges and Opportunities for the 510(k) Clearance Process. Annals Of Internal Medicine 2024 PMID: 39374526, DOI: 10.7326/annals-24-00728.Peer-Reviewed Original ResearchCost-effectiveness of iptacopan in paroxysmal nocturnal hemoglobinuria
Ito S, Chetlapalli K, Wang D, Potnis K, Richmond R, Krumholz H, Lee A, Cuker A, Goshua G. Cost-effectiveness of iptacopan in paroxysmal nocturnal hemoglobinuria. Blood 2024 PMID: 39374533, DOI: 10.1182/blood.2024025176.Peer-Reviewed Original ResearchStandard-of-careParoxysmal nocturnal hemoglobinuriaIncremental net monetary benefitNocturnal hemoglobinuriaComplement-mediated hemolytic anemiaTreating paroxysmal nocturnal hemoglobinuriaComplement C5 inhibitor eculizumabPhase 3 studyQuality-adjusted life expectancyRare blood disorderComprehensive cost-effectiveness analysisProbabilistic sensitivity analysesCost-saving thresholdsC5 inhibitor eculizumabNet monetary benefitPersistent anemiaIptacopanExtravascular hemolysisIntravenous infusionMonotherapyHemolytic anemiaAnemia resolutionC5 inhibitionFDA approvalPrimary outcomeAdvancing 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 roundtableRiskLong-term exposure to wildland fire smoke PM2.5 and mortality in the contiguous United States
Ma Y, Zang E, Liu Y, Wei J, Lu Y, Krumholz H, Bell M, Chen K. Long-term exposure to wildland fire smoke PM2.5 and mortality in the contiguous United States. Proceedings Of The National Academy Of Sciences Of The United States Of America 2024, 121: e2403960121. PMID: 39316057, PMCID: PMC11459178, DOI: 10.1073/pnas.2403960121.Peer-Reviewed Original ResearchConceptsWildland firesContiguous United StatesNonaccidental mortalityExposure to ambient fine particlesSmoke PM<sWildland fire smokeMoving average concentrationsAmbient fine particlesLong-term exposureAverage concentrationSmoke PMHealth risksFine particlesFire smokeTemporal confoundingHealth effectsKidney disease mortalityChronic kidney disease mortalityPublic health actionFireMortality rateUnited StatesDisease mortalityHealth actionsMortality outcomesUse of electronic health records to characterize patients with uncontrolled hypertension in two large health system networks
Lu Y, Keeley E, Barrette E, Cooper-DeHoff R, Dhruva S, Gaffney J, Gamble G, Handke B, Huang C, Krumholz H, McDonough C, Schulz W, Shaw K, Smith M, Woodard J, Young P, Ervin K, Ross J. Use of electronic health records to characterize patients with uncontrolled hypertension in two large health system networks. BMC Cardiovascular Disorders 2024, 24: 497. PMID: 39289597, PMCID: PMC11409735, DOI: 10.1186/s12872-024-04161-x.Peer-Reviewed Original ResearchConceptsElectronic health recordsHealth recordsHealth systemUncontrolled hypertensionUse of electronic health recordsHypertension managementElectronic health record systemsOneFlorida Clinical Research ConsortiumElectronic health record dataYale New Haven Health SystemBP measurementsICD-10-CM codesHealth system networkPublic health priorityICD-10-CMIncidence rate of deathElevated BP measurementsElevated blood pressure measurementsHealthcare visitsAmbulatory careHealth priorityRetrospective cohort studyEHR dataOneFloridaBlood pressure measurementsClass 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 databaseRecallPatientsFDAPostmarketingCardiovascular Disease Risk Factor Control Following Release From Carceral Facilities: A Cross-Sectional Study.
Aminawung J, Puglisi L, Roy B, Horton N, Elumn J, Lin H, Bibbins-Domingo K, Krumholz H, Wang E. Cardiovascular Disease Risk Factor Control Following Release From Carceral Facilities: A Cross-Sectional Study. Journal Of The American Heart Association 2024, 13: ejaha2024035683t. PMID: 39248257, DOI: 10.1161/jaha.124.035683.Peer-Reviewed Original ResearchConceptsUncontrolled CVD risk factorsCardiovascular disease risk factor controlCVD risk factorsRisk factor controlFactor controlRisk factorsSocial determinant of cardiovascular healthCardiovascular diseaseProspective cohort study of individualsDeterminants of cardiovascular healthPublic health prevention effortsCardiovascular disease risk factorsCohort study of individualsHealth prevention effortsCross-sectional studyProspective cohort studyCarceral facilitiesCorrectional facilitiesSocial determinantsTailored interventionsTraditional risk factorsStudy of individualsAdversity scorePerceived stressCardiovascular healthCause-Specific Mortality Rates Among the US Black Population
Arun A, Caraballo C, Sawano M, Lu Y, Khera R, Yancy C, Krumholz H. Cause-Specific Mortality Rates Among the US Black Population. JAMA Network Open 2024, 7: e2436402. PMID: 39348122, PMCID: PMC11443349, DOI: 10.1001/jamanetworkopen.2024.36402.Peer-Reviewed Original ResearchArtificial Intelligence-Enhanced Risk Stratification of Cancer Therapeutics-Related Cardiac Dysfunction Using Electrocardiographic Images.
Oikonomou E, Sangha V, Dhingra L, Aminorroaya A, Coppi A, Krumholz H, Baldassarre L, Khera R. Artificial Intelligence-Enhanced Risk Stratification of Cancer Therapeutics-Related Cardiac Dysfunction Using Electrocardiographic Images. Circulation Cardiovascular Quality And Outcomes 2024 PMID: 39221857, DOI: 10.1161/circoutcomes.124.011504.Peer-Reviewed Original ResearchCancer therapeutics-related cardiac dysfunctionGlobal longitudinal strainLeft ventricular systolic dysfunctionCardiac dysfunctionBreast cancerNon-Hodgkin lymphoma therapyNon-Hodgkin's lymphomaVentricular systolic dysfunctionAssociated with worse global longitudinal strainRisk stratification strategiesHigh-risk groupMonths post-treatmentPost hoc analysisElectrocardiographic (ECGTrastuzumab exposureLymphoma therapySystolic dysfunctionAI-ECGBefore treatmentRisk biomarkersLongitudinal strainLow riskStratification strategiesHigher incidencePositive screenComparative Effectiveness of Second-Line Antihyperglycemic Agents for Cardiovascular Outcomes A Multinational, Federated Analysis of LEGEND-T2DM
Khera R, Aminorroaya A, Dhingra L, Thangaraj P, Pedroso Camargos A, Bu F, Ding X, Nishimura A, Anand T, Arshad F, Blacketer C, Chai Y, Chattopadhyay S, Cook M, Dorr D, Duarte-Salles T, DuVall S, Falconer T, French T, Hanchrow E, Kaur G, Lau W, Li J, Li K, Liu Y, Lu Y, Man K, Matheny M, Mathioudakis N, McLeggon J, McLemore M, Minty E, Morales D, Nagy P, Ostropolets A, Pistillo A, Phan T, Pratt N, Reyes C, Richter L, Ross J, Ruan E, Seager S, Simon K, Viernes B, Yang J, Yin C, You S, Zhou J, Ryan P, Schuemie M, Krumholz H, Hripcsak G, Suchard M. Comparative Effectiveness of Second-Line Antihyperglycemic Agents for Cardiovascular Outcomes A Multinational, Federated Analysis of LEGEND-T2DM. Journal Of The American College Of Cardiology 2024, 84: 904-917. PMID: 39197980, DOI: 10.1016/j.jacc.2024.05.069.Peer-Reviewed Original ResearchConceptsGLP-1 RAsSecond-line agentsGLP-1Antihyperglycemic agentsCardiovascular diseaseMACE riskGlucagon-like peptide-1 receptor agonistsSodium-glucose cotransporter 2 inhibitorsPeptide-1 receptor agonistsDipeptidyl peptidase-4 inhibitorsEffects of SGLT2isType 2 diabetes mellitusPeptidase-4 inhibitorsAdverse cardiovascular eventsCox proportional hazards modelsRandom-effects meta-analysisCardiovascular risk reductionTarget trial emulationProportional hazards modelThe Obesity Revolution Comes to Cardiology
Kadakia K, Pagidipati N, Krumholz H. The Obesity Revolution Comes to Cardiology. Journal Of The American College Of Cardiology 2024 PMID: 39218240, DOI: 10.1016/j.jacc.2024.08.042.Peer-Reviewed Original ResearchFloods and cause-specific mortality in the United States during 2001-2020
Chu L, Warren J, Spatz E, Lowe S, Lu Y, Ma X, Ross J, Krumholz H, Chen K. Floods and cause-specific mortality in the United States during 2001-2020. ISEE Conference Abstracts 2024, 2024 DOI: 10.1289/isee.2024.1705.Peer-Reviewed Original ResearchShort-term association between ambient ozone and onset of acute myocardial infarction of young patients: Results from the VIRGO study
Zhang S, Chu L, Lu Y, Krumholz H, Chen K. Short-term association between ambient ozone and onset of acute myocardial infarction of young patients: Results from the VIRGO study. ISEE Conference Abstracts 2024, 2024 DOI: 10.1289/isee.2024.0539.Peer-Reviewed Original ResearchLong-term exposure to wildfire smoke PM2.5 and mortality in the contiguous United States
Ma Y, Zang E, Liu Y, Wei J, Lu Y, Krumholz H, Bell M, Chen K. Long-term exposure to wildfire smoke PM2.5 and mortality in the contiguous United States. ISEE Conference Abstracts 2024, 2024 DOI: 10.1289/isee.2024.1154.Peer-Reviewed Original ResearchEffect of the COVID-19 Pandemic on Monitoring and Control of Cardiovascular Risk Factors and Disparities
Lu Y, Brush J, Liu Y, Li S, Asher J, Krumholz H. Effect of the COVID-19 Pandemic on Monitoring and Control of Cardiovascular Risk Factors and Disparities. JACC Advances 2024, 3: 101177. PMID: 39220712, PMCID: PMC11364117, DOI: 10.1016/j.jacadv.2024.101177.Peer-Reviewed Original ResearchTrends in use of intensive care during hospitalizations at the end‐of‐life among older adults with advanced cancer
Jain S, Long J, Rao V, Law A, Walkey A, Prsic E, Lindenauer P, Krumholz H, Gross C. Trends in use of intensive care during hospitalizations at the end‐of‐life among older adults with advanced cancer. Journal Of The American Geriatrics Society 2024 PMID: 39090970, DOI: 10.1111/jgs.19119.Peer-Reviewed Original ResearchEnd-of-life hospitalizationsLife-sustaining treatmentEnd-of-lifeIntensity of careIn-hospital deathOlder adultsIntensive care unitAdvanced cancerRisk-adjusted hospitalEvaluate trendsIncreased intensity of careIntensive care unit useSEER-Medicare dataIntensive care unit careMultinomial regression modelsYear of diagnosisIntensive careHospital categoryMedicare beneficiariesSEER-MedicareHospitalization ratesCareCancer characteristicsNoninvasive ventilationHospitalBarriers to Optimal Clinician Guideline Adherence in Management of Markedly Elevated Blood Pressure
Lu Y, Arowojolu O, Qiu X, Liu Y, Curry L, Krumholz H. Barriers to Optimal Clinician Guideline Adherence in Management of Markedly Elevated Blood Pressure. JAMA Network Open 2024, 7: e2426135. PMID: 39106065, PMCID: PMC11304113, DOI: 10.1001/jamanetworkopen.2024.26135.Peer-Reviewed Original ResearchConceptsBarriers to guideline adherenceElectronic health recordsGuideline adherenceClinician adherenceEHR dataElevated blood pressureHypertension managementAnalysis of EHR dataYale New Haven Health SystemSevere hypertensionClinical practice guidelinesAdherence scenariosQualitative content analysisPublic health challengeThematic saturationHealth recordsHealth systemBlood pressureThematic analysisTargeted interventionsManagement of severe hypertensionQualitative studyHealth challengesPractice guidelinesPatient outcomesTirzepatide and blood pressure reduction: stratified analyses of the SURMOUNT-1 randomised controlled trial
Krumholz H, de Lemos J, Sattar N, Linetzky B, Sharma P, Mast C, Ahmad N, Bunck M, Stefanski A. Tirzepatide and blood pressure reduction: stratified analyses of the SURMOUNT-1 randomised controlled trial. Heart 2024, 110: 1165-1171. PMID: 39084707, PMCID: PMC11420724, DOI: 10.1136/heartjnl-2024-324170.Peer-Reviewed Original ResearchBlood pressure reductionBlood pressure subgroupBlood pressurePost hoc analysisPressure reductionTirzepatide groupsAdverse eventsDiastolic blood pressure reductionHoc analysisAssociated with reduced blood pressureEffects of tirzepatideWeight-related complicationsOverall blood pressureLower blood pressure levelsWeight lossNormal blood pressureDiastolic blood pressureLower blood pressureBlood pressure levelsRandomised controlled trialsMediation analysisTirzepatideClinical subgroupsControlled hypertensionPlaceboInternal tremors and vibrations in long COVID: a cross-sectional study
Zhou T, Sawano M, Arun A, Caraballo C, Michelsen T, McAlpine L, Bhattacharjee B, Lu Y, Khera R, Huang C, Warner F, Herrin J, Iwasaki A, Krumholz H. Internal tremors and vibrations in long COVID: a cross-sectional study. The American Journal Of Medicine 2024 PMID: 39069199, DOI: 10.1016/j.amjmed.2024.07.008.Peer-Reviewed Original ResearchNew-onset conditionsInternal tremorLong COVID symptomsCOVID symptomsNon-Hispanic whitesCross-sectional studyQuality of lifeVisual analogue scaleWorse healthHealth statusStudy participantsDemographic characteristicsAnalogue scaleOutcome variablesNeurological conditionsLong COVIDMast cell disordersTreatment experienceHealthComorbiditiesSymptomsMedian agePeopleCell disordersLearning implementation of a guideline based decision support system to improve hypertension treatment in primary care in China: pragmatic cluster randomised controlled trial
Song J, Wang X, Wang B, Ge Y, Bi L, Jing F, Jin H, Li T, Gu B, Wang L, Hao J, Zhao Y, Liu J, Zhang H, Li X, Li J, Ma W, Wang J, Normand S, Herrin J, Armitage J, Krumholz H, Zheng X. Learning implementation of a guideline based decision support system to improve hypertension treatment in primary care in China: pragmatic cluster randomised controlled trial. The BMJ 2024, 386: e079143. PMID: 39043397, PMCID: PMC11265211, DOI: 10.1136/bmj-2023-079143.Peer-Reviewed Original ResearchConceptsClinical decision support systemsPrimary care practicesElectronic health recordsIntervention groupSystolic blood pressurePrimary careCare practicesBlood pressure <Health recordsPragmatic cluster randomised controlled trialCluster randomised controlled trialImproving hypertension treatmentPrimary care settingBlood pressure control ratesBlood pressureProportion of visitsProportion of participantsRandomised controlled trialsSystolic blood pressure <Control groupInjurious fallsRelated visitsCare settingsDiastolic blood pressure <Follow-up