2024
Class 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 databaseRecallPatientsFDAPostmarketingOptimizing 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 societies
2022
Renewing the Call for Reforms to Medical Device Safety—The Case of Penumbra
Kadakia KT, Beckman AL, Ross JS, Krumholz HM. Renewing the Call for Reforms to Medical Device Safety—The Case of Penumbra. JAMA Internal Medicine 2022, 182: 59-65. PMID: 34842892, DOI: 10.1001/jamainternmed.2021.6626.Commentaries, Editorials and LettersConceptsReperfusion catheterClinical evidenceClass IPenumbra reperfusion catheterSingle-arm trialUser Facility Device Experience (MAUDE) databaseAdverse event reportsPostmarket surveillanceHealth policy makersMedical device reportsPenumbra deviceClinical evaluationPatient deathDevice safetyMedicine recommendationsAnimal dataCatheterFDA databaseFDA medical device regulationsClinical literatureSmall sample sizeDevice reportsEvent reportsPublic healthExperience database
2020
Postmarket Clinical Evidence for High-Risk Therapeutic Medical Devices Receiving Food and Drug Administration Premarket Approval in 2010 and 2011
Rathi VK, Krumholz HM, Masoudi FA, Ross JS. Postmarket Clinical Evidence for High-Risk Therapeutic Medical Devices Receiving Food and Drug Administration Premarket Approval in 2010 and 2011. JAMA Network Open 2020, 3: e2014496. PMID: 32857145, PMCID: PMC7455850, DOI: 10.1001/jamanetworkopen.2020.14496.Peer-Reviewed Original Research
2017
Postapproval studies of drugs initially approved by the FDA on the basis of limited evidence: systematic review
Pease AM, Krumholz HM, Downing NS, Aminawung JA, Shah ND, Ross JS. Postapproval studies of drugs initially approved by the FDA on the basis of limited evidence: systematic review. The BMJ 2017, 357: j1680. PMID: 28468750, PMCID: PMC5421452, DOI: 10.1136/bmj.j1680.Peer-Reviewed Original ResearchConceptsSingle pivotal trialPivotal trialsPostapproval studiesSurrogate markerPrimary endpointNovel drugsClinical outcomesClinical studiesLimited evidenceSystematic reviewDouble-blind studyMedian total numberClinical evidenceSuperior efficacyBlind studyDrug AdministrationOriginal FDATrial approvalDiseaseTrialsDrugsFDAEndpointEfficacyMarkers
2016
Fibrinolytic therapy in hospitals without percutaneous coronary intervention capabilities in China from 2001 to 2011: China PEACE-retrospective AMI study
Li J, Li X, Ross JS, Wang Q, Wang Y, Desai NR, Xu X, Nuti SV, Masoudi FA, Spertus JA, Krumholz HM, Jiang L, Group F. Fibrinolytic therapy in hospitals without percutaneous coronary intervention capabilities in China from 2001 to 2011: China PEACE-retrospective AMI study. European Heart Journal Acute Cardiovascular Care 2016, 6: 232-243. PMID: 26787648, DOI: 10.1177/2048872615626656.Peer-Reviewed Original ResearchConceptsST-segment elevation myocardial infarctionElevation myocardial infarctionFibrinolytic therapyMyocardial infarctionPercutaneous coronary intervention capabilitySequential cross-sectional studiesChina PEACE-Retrospective AMI StudyPrimary reperfusion strategyPercutaneous coronary interventionLittle clinical evidenceCross-sectional studyQuality of careTwo-stage random samplingCoronary interventionHospital delayNeedle timeReperfusion strategySymptom onsetTherapy useClinical evidenceEmergency departmentMedian admissionIdeal patientPatientsWeighted proportion
2015
Characteristics of Clinical Studies Conducted Over the Total Product Life Cycle of High-Risk Therapeutic Medical Devices Receiving FDA Premarket Approval in 2010 and 2011
Rathi VK, Krumholz HM, Masoudi FA, Ross JS. Characteristics of Clinical Studies Conducted Over the Total Product Life Cycle of High-Risk Therapeutic Medical Devices Receiving FDA Premarket Approval in 2010 and 2011. JAMA 2015, 314: 604-612. PMID: 26262798, DOI: 10.1001/jama.2015.8761.Peer-Reviewed Original ResearchConceptsPrimary effectiveness end pointEffectiveness end pointPostmarket studiesClinical studiesClinical evidencePMA pathwayPremarket studiesEnd pointAvailable FDA documentsInitial marketing approvalPremarket approval pathwayTherapeutic devicesMedian durationMedian enrollmentHigh-risk medical devicesMAIN OUTCOMEPatientsDrug AdministrationUS FoodFDA approvalMarketing approvalLonger durationFDA documentsMonthsPostmarket
2012
Hospital Patterns of Use of Positive Inotropic Agents in Patients With Heart Failure
Partovian C, Gleim SR, Mody PS, Li SX, Wang H, Strait KM, Allen LA, Lagu T, Normand SL, Krumholz HM. Hospital Patterns of Use of Positive Inotropic Agents in Patients With Heart Failure. Journal Of The American College Of Cardiology 2012, 60: 1402-1409. PMID: 22981548, PMCID: PMC3636773, DOI: 10.1016/j.jacc.2012.07.011.Peer-Reviewed Original ResearchConceptsPositive inotropic agentsRisk-standardized ratesInotropic agentsHeart failureInotrope useHospital patternsMortality rateRisk-standardized mortality ratesHospital mortality rateHeart failure patientsLittle clinical evidenceLength of stayPatient case mixHierarchical logistic regression modelsLogistic regression modelsIntraclass correlation coefficientFailure patientsHospital variationClinical evidenceInterhospital variationClinical guidelinesIndividual hospital effectsHospital ratesHospital effectsPatterns of use