Quantifying the utilization of medical devices necessary to detect postmarket safety differences: A case study of implantable cardioverter defibrillators
Bates J, Parzynski CS, Dhruva SS, Coppi A, Kuntz R, Li S, Marinac‐Dabic D, Masoudi FA, Shaw RE, Warner F, Krumholz HM, Ross JS. Quantifying the utilization of medical devices necessary to detect postmarket safety differences: A case study of implantable cardioverter defibrillators. Pharmacoepidemiology And Drug Safety 2018, 27: 848-856. PMID: 29896873, PMCID: PMC6436550, DOI: 10.1002/pds.4565.Peer-Reviewed Original ResearchConceptsAdverse event ratesSafety differencesEvent ratesMedical device utilizationICD utilizationRate ratioNational Cardiovascular Data RegistryICD modelsImplantable cardioverter defibrillatorEvent rate ratioMost patientsCardioverter defibrillatorProportion of individualsAmerican CollegeData registryRoutine surveillanceSample size estimatesAverage event rateDevice utilizationSignificance levelDifferencesPatientsRegistryDefibrillatorICDStatewide Inferior Vena Cava Filter Placement, Complications, and Retrievals
Charalel RA, Durack JC, Mao J, Ross JS, Meltzer AJ, Sedrakyan A. Statewide Inferior Vena Cava Filter Placement, Complications, and Retrievals. Medical Care 2018, 56: 260-265. PMID: 29356721, DOI: 10.1097/mlr.0000000000000867.Peer-Reviewed Original ResearchConceptsIVC filter placementFilter placementIVC filtersFilter retrievalIVC filter-related complicationsProphylactic IVC filter placementInferior vena cava filter placementVena cava filter placementFilter-related complicationsPulmonary embolism riskAverage patient ageDrug Administration (FDA) safety communicationRetrospective cohort studyCava filter placementKaplan-Meier analysisAge-adjusted ratesIVC filter retrievalCohort studyPatient agePE occurrencePE ratePE eventsCumulative riskPopulation-level trendsClinical practice