2023
Adding device identifiers to claims forms—a key step to advance medical device safety
Kadakia K, Dhruva S, Ross J, Krumholz H. Adding device identifiers to claims forms—a key step to advance medical device safety. The BMJ 2023, 380: p82. PMID: 36631149, DOI: 10.1136/bmj.p82.Commentaries, Editorials and Letters
2022
Clinical Presentation and Short- and Long-term Outcomes in Patients With Isolated Distal Deep Vein Thrombosis vs Proximal Deep Vein Thrombosis in the RIETE Registry
Bikdeli B, Caraballo C, Trujillo-Santos J, Galanaud JP, di Micco P, Rosa V, Cusidó GV, Schellong S, Mellado M, del Valle Morales M, Gavín-Sebastián O, Mazzolai L, Krumholz HM, Monreal M, Prandoni P, Brenner B, Farge-Bancel D, Barba R, Bertoletti L, Tzoran I, Reis A, Bosevski M, Bounameaux H, Malý R, Verhamme P, Caprini J, Adarraga M, Agudo de Blas P, Aibar J, Amado C, Arcelus J, Ballaz A, Barbagelata C, Barrón M, Barrón-Andrés B, Blanco-Molina Á, Beddar Chaib F, Botella E, Buño-Ramilo B, Castro J, Chasco L, Criado J, de Ancos C, de Miguel J, del Toro J, Demelo-Rodríguez P, Díaz-Brasero A, Díaz-Pedroche M, Díaz-Peromingo J, Díaz-Simón R, Domínguez I, Dubois-Silva Á, Escribano J, Espósito F, Farfán-Sedano A, Fernández-Capitán C, Fernández-Reyes J, Fidalgo Á, Font C, Francisco I, Gabara C, Galeano-Valle F, García M, García-Bragado F, García de Herreros M, García de la Garza R, García-Díaz C, Gil-Díaz A, Giménez-Suau M, Gómez-Cuervo C, Grau E, Guirado L, Gutiérrez J, Hernández-Blasco L, Jara-Palomares L, Jaras M, Jiménez D, Jiménez R, Jiménez-Alfaro C, Jou I, Joya M, Lainez-Justo S, Lalueza A, Latorre-Díez A, Lobo J, López-Jiménez L, López-Miguel P, López-Núñez J, López-Reyes R, López-Sáez J, Lorenzo A, Madridano O, Maestre A, Marchena P, Martín del Pozo M, Martín-Martos F, Martínez-Urbistondo D, Mella C, Mercado M, Muñoz-Blanco A, Nieto J, Núñez-Fernández M, Olid-Velilla M, Otalora S, Otero R, Paredes-Ruiz D, Parra P, Parra V, Pedrajas J, Peris M, Porras J, Portillo J, Ruiz-Artacho P, Ruiz-Giménez N, Ruiz-Ruiz J, Ruiz-Sada P, Salgueiro G, Sánchez-Martínez R, Sánchez-Muñoz-Torrero J, Sancho T, Soler S, Suárez-Rodríguez B, Suriñach J, Tolosa C, Torres M, Torres-Sánchez A, Uresandi F, Valero B, Valle R, Varona J, Vázquez-Friol C, Vela L, Vela J, Villalobos A, Villares P, Zamora C, Ay C, Nopp S, Pabinger I, Engelen M, Vanassche T, Yoo H, Hirmerova J, Accassat S, Ait Abdallah N, Bura-Riviere A, Catella J, Couturaud F, Crichi B, Debourdeau P, Espitia O, Falvo N, Grange C, Helfer H, Lacut K, Le Mao R, Mahé I, Morange P, Moustafa F, Poenou G, Sarlon-Bartoli G, Suchon P, Quere I, Nikandish R, Braester A, Kenet G, Basaglia M, Bilora F, Bortoluzzi C, Brandolin B, Ciammaichella M, Corgna C, de Angelis A, Imbalzano E, Mastroiacovo D, Merla S, Pesavento R, Pomero F, Siniscalchi C, Tufano A, Visonà A, Vo Hong N, Zalunardo B, Kigitovica D, Rusa E, Skride A, Fonseca S, Martins-Duarte F, Meireles J. Clinical Presentation and Short- and Long-term Outcomes in Patients With Isolated Distal Deep Vein Thrombosis vs Proximal Deep Vein Thrombosis in the RIETE Registry. JAMA Cardiology 2022, 7: 857-865. PMID: 35830171, PMCID: PMC9280612, DOI: 10.1001/jamacardio.2022.1988.Peer-Reviewed Original ResearchConceptsDeep vein thrombosisDistal deep vein thrombosisProximal DVTLong-term outcomesPulmonary embolismVein thrombosisPostthrombotic syndromeCohort studyClinical presentationLower riskIsolated Distal Deep Vein ThrombosisProximal deep vein thrombosisEnfermedad TromboEmbólica (RIETE) registryLower comorbidity burdenUpper extremity DVTInternational cohort studyMultivariable adjusted analysesOptimal long-term managementRandomized clinical trialsAnalysis of patientsCOVID-19 infectionLong-term managementAsymptomatic DVTComorbidity burdenInfrapopliteal veinsSex Differences in PrEsentation, Risk Factors, Drug and Interventional Therapies, and OUtcomes of Elderly PatientS with Pulmonary Embolism: Rationale and design of the SERIOUS-PE study
Bikdeli B, Piazza G, Jimenez D, Muriel A, Wang Y, Khairani CD, Rosovsky RP, Mehdipoor G, O'Donoghue ML, Spagnolo P, Dreyer RP, Bertoletti L, López-Jiménez L, Núñez MJ, Blanco-Molina Á, Bates SM, Gerhard-Herman M, Goldhaber SZ, Monreal M, Krumholz HM. Sex Differences in PrEsentation, Risk Factors, Drug and Interventional Therapies, and OUtcomes of Elderly PatientS with Pulmonary Embolism: Rationale and design of the SERIOUS-PE study. Thrombosis Research 2022, 214: 122-131. PMID: 35537232, DOI: 10.1016/j.thromres.2022.04.019.Peer-Reviewed Original ResearchConceptsRisk factorsElderly patientsUS Medicare feeInterventional therapyMedicare feeInternational registryService beneficiariesSex differencesNational US databasePrognostic prediction rulePulmonary embolism studyLarge international registryPrincipal discharge diagnosisSex-based disparitiesAssessment of outcomesPotential sex differencesSex-specific findingsPE presentationPulmonary embolismVenous thromboembolismTreatment patternsDischarge diagnosisAvailable therapiesDisease presentationTreatment-based differencesStudy protocol for the Innovative Support for Patients with SARS-COV-2 Infections Registry (INSPIRE): A longitudinal study of the medium and long-term sequelae of SARS-CoV-2 infection
O’Laughlin K, Thompson M, Hota B, Gottlieb M, Plumb ID, Chang AM, Wisk LE, Hall AJ, Wang RC, Spatz ES, Stephens KA, Huebinger RM, McDonald SA, Venkatesh A, Gentile N, Slovis BH, Hill M, Saydah S, Idris AH, Rodriguez R, Krumholz HM, Elmore JG, Weinstein RA, Nichol G, . Study protocol for the Innovative Support for Patients with SARS-COV-2 Infections Registry (INSPIRE): A longitudinal study of the medium and long-term sequelae of SARS-CoV-2 infection. PLOS ONE 2022, 17: e0264260. PMID: 35239680, PMCID: PMC8893622, DOI: 10.1371/journal.pone.0264260.Peer-Reviewed Original ResearchConceptsSARS-CoV-2 infectionLong-term sequelaePatient-reported outcomesRelative riskAcute SARS-CoV-2 infectionSARS-CoV-2 negative participantsHealth system encountersPredictors of sequelaeHealth recordsInstitutional review board approvalLongitudinal studyDigital health recordsReview board approvalSARS-CoV-2Secure online platformClinical outcomesStudy protocolNegative participantsViral testsSimilar symptomatologyNew diagnosisBoard approvalSequelaeSelf-administered surveyInfectionWomen's representation in venous thromboembolism randomized trials and registries: The illustrative example of direct oral anticoagulants for acute treatment
Bikdeli B, Khairani CD, Barns BM, Rosovsky RP, Jimenez D, Monreal M, Sylvester KW, Middeldorp S, Bates SM, Krumholz HM, Goldhaber SZ, Hunt BJ, Piazza G. Women's representation in venous thromboembolism randomized trials and registries: The illustrative example of direct oral anticoagulants for acute treatment. Contemporary Clinical Trials 2022, 115: 106714. PMID: 35202841, DOI: 10.1016/j.cct.2022.106714.Peer-Reviewed Original Research
2021
Changes in ST segment elevation myocardial infarction hospitalisations in China from 2011 to 2015
Zhou T, Li X, Lu Y, Murugiah K, Bai X, Hu S, Gao Y, Masoudi FA, Krumholz HM, Li J, . Changes in ST segment elevation myocardial infarction hospitalisations in China from 2011 to 2015. Open Heart 2021, 8: e001666. PMID: 34599073, PMCID: PMC8488733, DOI: 10.1136/openhrt-2021-001666.Peer-Reviewed Original ResearchConceptsST-segment elevation myocardial infarctionPrehospital delayMyocardial infarctionSegment elevation myocardial infarctionProportion of patientsElevation myocardial infarctionAcute cardiovascular careAcute myocardial infarctionWeighted national estimateHealth service capacityRisk-adjusted ratesAcute reperfusionEligible patientsHospital deathReperfusion therapyMedical chartsPatient characteristicsHospital treatmentPatient outcomesRandom cohortCardiovascular diseaseCardiovascular carePatientsNational estimatesStandardised definitionsAssociation of COVID-19 Hospitalization Volume and Case Growth at US Hospitals with Patient Outcomes
Khera R, Liu Y, de Lemos JA, Das SR, Pandey A, Omar W, Kumbhani DJ, Girotra S, Yeh RW, Rutan C, Walchok J, Lin Z, Bradley SM, Velazquez EJ, Churchwell KB, Nallamothu BK, Krumholz HM, Curtis JP. Association of COVID-19 Hospitalization Volume and Case Growth at US Hospitals with Patient Outcomes. The American Journal Of Medicine 2021, 134: 1380-1388.e3. PMID: 34343515, PMCID: PMC8325555, DOI: 10.1016/j.amjmed.2021.06.034.Peer-Reviewed Original ResearchConceptsCOVID-19 hospitalizationHospitalization volumeAmerican Heart Association COVID-19 Cardiovascular Disease RegistryCase volumeUS hospitalsCoronavirus disease 2019 (COVID-19) hospitalizationIntensive care unit therapyHospital case fatality ratePoor COVID-19 outcomesCardiovascular Disease RegistryHospital case volumeCase fatality rateCOVID-19 outcomesHospital bed capacityLowest quartilePatient outcomesHospital careHigher oddsTriage strategiesFuture health challengesDisease RegistryMedical treatmentEarly identificationHospitalSignificant associationUse of Machine Learning Models to Predict Death After Acute Myocardial Infarction
Khera R, Haimovich J, Hurley NC, McNamara R, Spertus JA, Desai N, Rumsfeld JS, Masoudi FA, Huang C, Normand SL, Mortazavi BJ, Krumholz HM. Use of Machine Learning Models to Predict Death After Acute Myocardial Infarction. JAMA Cardiology 2021, 6: 633-641. PMID: 33688915, PMCID: PMC7948114, DOI: 10.1001/jamacardio.2021.0122.Peer-Reviewed Original ResearchConceptsMachine learning modelsMeta-classifier modelLearning modelNeural networkGradient descent boostingAcute myocardial infarctionContemporary machineGradient descentXGBoost modelXGBoostHospital mortalityCohort studyLogistic regressionMyocardial infarctionNetworkChest Pain-MI RegistryPrecise classificationIndependent validation dataInitial laboratory valuesNovel methodLarge national registryHigh-risk individualsData analysisValidation dataResolution of riskPrevalence of Missing Data in the National Cancer Database and Association With Overall Survival
Yang DX, Khera R, Miccio JA, Jairam V, Chang E, Yu JB, Park HS, Krumholz HM, Aneja S. Prevalence of Missing Data in the National Cancer Database and Association With Overall Survival. JAMA Network Open 2021, 4: e211793. PMID: 33755165, PMCID: PMC7988369, DOI: 10.1001/jamanetworkopen.2021.1793.Peer-Reviewed Original ResearchConceptsNational Cancer DatabaseNon-small cell lung cancerOverall survivalCell lung cancerCancer DatabaseMedical recordsLung cancerProstate cancerBreast cancerPatient recordsComplete dataRetrospective cohort studyCohort studyCancer RegistryCommon cancerVariables of interestHigh prevalenceMAIN OUTCOMEPatientsClinical advancementReal-world data sourcesCancerPrevalenceSurvivalHeterogeneous differencesImpact of ST‐Segment–Elevation Myocardial Infarction Regionalization Programs on the Treatment and Outcomes of Patients Diagnosed With Non–ST‐Segment–Elevation Myocardial Infarction
Montoy JCC, Shen Y, Brindis RG, Krumholz HM, Hsia RY. Impact of ST‐Segment–Elevation Myocardial Infarction Regionalization Programs on the Treatment and Outcomes of Patients Diagnosed With Non–ST‐Segment–Elevation Myocardial Infarction. Journal Of The American Heart Association 2021, 10: e016932. PMID: 33470136, PMCID: PMC7955417, DOI: 10.1161/jaha.120.016932.Peer-Reviewed Original ResearchMeSH KeywordsAgedAged, 80 and overCaliforniaCoronary AngiographyEarly DiagnosisElectrocardiographyFemaleFollow-Up StudiesHospitalizationHumansMaleMiddle AgedNon-ST Elevated Myocardial InfarctionPercutaneous Coronary InterventionPrognosisProgram EvaluationRegistriesRetrospective StudiesRisk FactorsST Elevation Myocardial InfarctionSurvival RateTreatment OutcomeConceptsOutcomes of patientsEarly angiographyMyocardial infarctionST segmentST-segment elevation myocardial infarctionSegment elevation myocardial infarctionProportion of patientsElevation myocardial infarctionRisk of deathRisk of mortalityRegionalization programIndex admissionEmergency departmentRegionalized careNonfederal hospitalsMAIN OUTCOMETimely carePatientsAngiographyOverall populationNSTEMIInfarctionStudy periodMortalityCare
2020
Evaluation of a Risk Stratification Model Using Preoperative and Intraoperative Data for Major Morbidity or Mortality After Cardiac Surgical Treatment
Durant TJS, Jean RA, Huang C, Coppi A, Schulz WL, Geirsson A, Krumholz HM. Evaluation of a Risk Stratification Model Using Preoperative and Intraoperative Data for Major Morbidity or Mortality After Cardiac Surgical Treatment. JAMA Network Open 2020, 3: e2028361. PMID: 33284333, DOI: 10.1001/jamanetworkopen.2020.28361.Peer-Reviewed Original ResearchCharacteristics and Strength of Evidence of COVID-19 Studies Registered on ClinicalTrials.gov
Pundi K, Perino AC, Harrington RA, Krumholz HM, Turakhia MP. Characteristics and Strength of Evidence of COVID-19 Studies Registered on ClinicalTrials.gov. JAMA Internal Medicine 2020, 180: 1398-1400. PMID: 32730617, PMCID: PMC7385669, DOI: 10.1001/jamainternmed.2020.2904.Peer-Reviewed Original ResearchRates and Predictors of Patient Underreporting of Hospitalizations During Follow-Up After Acute Myocardial Infarction
Caraballo C, Khera R, Jones PG, Decker C, Schulz W, Spertus JA, Krumholz HM. Rates and Predictors of Patient Underreporting of Hospitalizations During Follow-Up After Acute Myocardial Infarction. Circulation Cardiovascular Quality And Outcomes 2020, 13: e006231. PMID: 32552061, PMCID: PMC9465954, DOI: 10.1161/circoutcomes.119.006231.Peer-Reviewed Original ResearchConceptsAcute myocardial infarctionMyocardial infarctionHospitalization eventsMedical recordsLongitudinal multicenter cohort studyMulticenter cohort studyMedical record abstractionDifferent patient characteristicsHealth care eventsPatients' underreportingTRIUMPH registryAccuracy of reportingCohort studyPatient characteristicsRecord abstractionProspective studyClinical studiesClinical investigationHospitalizationPatientsCare eventsInfarctionEvent ratesParticipantsPredictorsAssociation of Use of an Intravascular Microaxial Left Ventricular Assist Device vs Intra-aortic Balloon Pump With In-Hospital Mortality and Major Bleeding Among Patients With Acute Myocardial Infarction Complicated by Cardiogenic Shock
Dhruva SS, Ross JS, Mortazavi BJ, Hurley NC, Krumholz HM, Curtis JP, Berkowitz A, Masoudi FA, Messenger JC, Parzynski CS, Ngufor C, Girotra S, Amin AP, Shah ND, Desai NR. Association of Use of an Intravascular Microaxial Left Ventricular Assist Device vs Intra-aortic Balloon Pump With In-Hospital Mortality and Major Bleeding Among Patients With Acute Myocardial Infarction Complicated by Cardiogenic Shock. JAMA 2020, 323: 734-745. PMID: 32040163, PMCID: PMC7042879, DOI: 10.1001/jama.2020.0254.Peer-Reviewed Original ResearchMeSH KeywordsAgedCause of DeathExtracorporeal Membrane OxygenationFemaleHeart ArrestHeart-Assist DevicesHemorrhageHospital MortalityHumansIntra-Aortic Balloon PumpingMaleMatched-Pair AnalysisMiddle AgedMyocardial InfarctionPercutaneous Coronary InterventionPropensity ScoreRegistriesRetrospective StudiesShock, CardiogenicST Elevation Myocardial InfarctionConceptsMicroaxial left ventricular assist deviceIntra-aortic balloon pumpLeft ventricular assist deviceAcute myocardial infarctionPercutaneous coronary interventionNational Cardiovascular Data RegistryCardiogenic shockHemodynamic supportMyocardial infarctionRegistry-based retrospective cohort studyCardiology-National Cardiovascular Data RegistryChest Pain-MI RegistryST-elevation myocardial infarctionMechanical circulatory support devicesGreater hemodynamic supportHospital major bleedingRetrospective cohort studyPropensity-matched pairsCirculatory support devicesVentricular assist deviceClinical laboratory dataHospital mortalityMajor bleedingHospital deathCohort studyAttribution of Adverse Events Following Coronary Stent Placement Identified Using Administrative Claims Data
Dhruva SS, Parzynski CS, Gamble GM, Curtis JP, Desai NR, Yeh RW, Masoudi FA, Kuntz R, Shaw RE, Marinac‐Dabic D, Sedrakyan A, Normand S, Krumholz HM, Ross JS. Attribution of Adverse Events Following Coronary Stent Placement Identified Using Administrative Claims Data. Journal Of The American Heart Association 2020, 9: e013606. PMID: 32063087, PMCID: PMC7070203, DOI: 10.1161/jaha.119.013606.Peer-Reviewed Original ResearchMeSH KeywordsAdministrative Claims, HealthcareAgedAged, 80 and overCoronary RestenosisCoronary ThrombosisDatabases, FactualDrug-Eluting StentsFemaleHumansMaleMedicareMyocardial InfarctionPercutaneous Coronary InterventionProduct Surveillance, PostmarketingRegistriesRetreatmentRisk AssessmentRisk FactorsTime FactorsTreatment OutcomeUnited StatesConceptsIndex percutaneous coronary interventionPercutaneous coronary interventionSame coronary arteryDrug-eluting stentsNCDR CathPCI RegistrySubsequent percutaneous coronary interventionAcute myocardial infarctionCoronary arteryClaims dataCathPCI RegistryAdverse eventsIndex procedureMyocardial infarctionRepeat percutaneous coronary interventionReal-world registry dataTarget vessel revascularizationCoronary stent placementAdministrative claims dataLong-term safetyLongitudinal claims dataPotential safety eventsVessel revascularizationCoronary interventionDES placementStent thrombosisReal-Time Dissemination of Aggregate Data on Presentation and Outcomes of Patients With Venous Thromboembolism: The RIETE Infographics Project
Tafur A, Bikdeli B, Weinberg I, Jimenez D, Monreal A, Barba R, Mira E, Macrinici V, Krumholz HM, Hawkins M, Monreal M, . Real-Time Dissemination of Aggregate Data on Presentation and Outcomes of Patients With Venous Thromboembolism: The RIETE Infographics Project. Clinical And Applied Thrombosis/Hemostasis 2020, 26: 1076029620931200. PMID: 32936691, PMCID: PMC7498960, DOI: 10.1177/1076029620931200.Peer-Reviewed Original Research
2019
The relationship between off-hours admissions for primary percutaneous coronary intervention, door-to-balloon time and mortality for patients with ST-elevation myocardial infarction in England: a registry-based prospective national cohort study
Jayawardana S, Salas-Vega S, Cornehl F, Krumholz HM, Mossialos E. The relationship between off-hours admissions for primary percutaneous coronary intervention, door-to-balloon time and mortality for patients with ST-elevation myocardial infarction in England: a registry-based prospective national cohort study. BMJ Quality & Safety 2019, 29: 541-549. PMID: 31831635, PMCID: PMC7362773, DOI: 10.1136/bmjqs-2019-010067.Peer-Reviewed Original ResearchConceptsPrimary percutaneous coronary interventionOff-hours admissionPercutaneous coronary interventionDTB timeCoronary interventionBalloon timeST-elevation myocardial infarction (STEMI) patientsElevation myocardial infarction patientsProspective national cohort studyST-elevation myocardial infarctionCent of admissionsMedian DTB timeOff-hour effectPatient risk factorsProspective observational studyRecords of patientsPrimary outcome measureNational cohort studyTimeliness of careMyocardial infarction patientsHierarchical logistic regression modelsLogistic regression modelsHospital mortalityCohort studySecondary outcomesTapping Into Underutilized Healthcare Data in Clinical Research
Mori M, Schulz WL, Geirsson A, Krumholz HM. Tapping Into Underutilized Healthcare Data in Clinical Research. Annals Of Surgery 2019, Publish Ahead of Print: &na;. PMID: 30998537, DOI: 10.1097/sla.0000000000003329.Peer-Reviewed Original ResearchComparison of Machine Learning Methods With National Cardiovascular Data Registry Models for Prediction of Risk of Bleeding After Percutaneous Coronary Intervention
Mortazavi BJ, Bucholz EM, Desai NR, Huang C, Curtis JP, Masoudi FA, Shaw RE, Negahban SN, Krumholz HM. Comparison of Machine Learning Methods With National Cardiovascular Data Registry Models for Prediction of Risk of Bleeding After Percutaneous Coronary Intervention. JAMA Network Open 2019, 2: e196835. PMID: 31290991, PMCID: PMC6624806, DOI: 10.1001/jamanetworkopen.2019.6835.Peer-Reviewed Original ResearchConceptsPercutaneous coronary interventionMajor bleedingC-statisticCoronary interventionMAIN OUTCOMEIndex percutaneous coronary interventionSubsequent coronary artery bypassPercutaneous coronary intervention (PCI) proceduresHospital major bleedingMajor bleeding ratesNationwide clinical registryCoronary artery bypassCoronary intervention proceduresComparative effectiveness studiesRisk score modelComplexity of presentationMean c-statisticCoronary angiography dataRegistry modelNCDR modelsArtery bypassBleeding eventsPrediction of riskClinical variablesBleeding rateAssociation Between Hospital Recognition for Resuscitation Guideline Adherence and Rates of Survival for In-Hospital Cardiac Arrest
Khera R, Tang Y, Link MS, Krumholz HM, Girotra S, Chan PS. Association Between Hospital Recognition for Resuscitation Guideline Adherence and Rates of Survival for In-Hospital Cardiac Arrest. Circulation Cardiovascular Quality And Outcomes 2019, 12: e005429. PMID: 30871337, PMCID: PMC6592630, DOI: 10.1161/circoutcomes.118.005429.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdultAgedAged, 80 and overAwards and PrizesFemaleGuideline AdherenceHeart ArrestHospital MortalityHospitalsHumansInpatientsMaleMiddle AgedOutcome and Process Assessment, Health CarePatient DischargePractice Guidelines as TopicPractice Patterns, Physicians'Quality Indicators, Health CareRegistriesResuscitationTime FactorsTime-to-TreatmentTreatment OutcomeUnited StatesYoung AdultConceptsHospital cardiac arrestCardiac arrestRate of survivalSpontaneous circulationIn-Hospital Cardiac ArrestGuidelines-Resuscitation registryCardiac arrest survivalEndotracheal tube placementHigh rateHospital performanceBest tertileGuidelines-ResuscitationNational GetGuideline adherenceOverall survivalBackground HospitalTube placementNational registryChest compressionsResuscitation qualityHospitalHospital recognitionAward statusSurvivalWeak association