2024
Inter-Rater Reliability for the Amputation Endpoint in the National Vascular Quality Initiative
Smolderen K, Romain G, Scierka L, Cleman J, Rahman M, Siddiqui W, Lau F, Mao J, Akhlaghi N, Higaki A, Fowler X, Carroll M, Telma K, Alvermann T, Baribeau V, Goodney P, Mena-Hurtado C. Inter-Rater Reliability for the Amputation Endpoint in the National Vascular Quality Initiative. JACC Cardiovascular Interventions 2024, 17: 622-631. PMID: 38479964, DOI: 10.1016/j.jcin.2024.01.003.Peer-Reviewed Original ResearchConceptsElectronic health recordsElectronic health record reviewAmputation dataPeripheral arterial diseaseInterrater reliabilityVQI registryAcademic health systemTrained data collectorsNational quality registryInter-rater reliabilityEvaluate interrater reliabilityNational reporting systemHealth recordsQuality registryHealth systemCurrent Procedural Terminology codesInter-raterVascular Quality Initiative registryVascular Quality InitiativeProcedural Terminology codesNational Vascular Quality InitiativeRegistryQuality InitiativeAmputationSpearman's rPsychosocial and socioeconomic factors are most predictive of health status in patients with claudication
Scierka L, Peri-Okonny P, Romain G, Cleman J, Spertus J, Fitridge R, Secemsky E, Patel M, Gosch K, Mena-Hurtado C, Smolderen K. Psychosocial and socioeconomic factors are most predictive of health status in patients with claudication. Journal Of Vascular Surgery 2024, 79: 1473-1482.e5. PMID: 38266885, DOI: 10.1016/j.jvs.2024.01.021.Peer-Reviewed Original ResearchPeripheral Artery QuestionnairePeripheral Artery Questionnaire summary scoresPeripheral arterial diseaseHealth statusSummary scoreSymptomatic peripheral arterial diseaseSocial supportInsurance statusPAD-specific health statusHierarchical multivariable linear regression modelSocioeconomic patient characteristicsLow social supportPeripheral artery disease cohortPeripheral artery questionnaire scoresImprove health statusComparative effectiveness researchDiagnosis of depressionPatient characteristicsMultivariate linear regression modelPrediction of health statusDepression scoresLinear regression modelsAge of patientsDuration of symptomsAnxiety scoresLack of diversity in patients undergoing carotid artery stenting: Implications for the Distressed Community Index
Pajarillo C, Romain G, Cleman J, Scierka L, Grubman S, Schenck C, Kluger J, Smolderen K, Mena-Hurtado C. Lack of diversity in patients undergoing carotid artery stenting: Implications for the Distressed Community Index. Vascular Medicine 2024, 30: 27-37. PMID: 39526556, DOI: 10.1177/1358863x241292545.Peer-Reviewed Original ResearchDistressed Communities IndexCommunity distressDistress groupCarotid artery stentingDistressed Communities Index scoreHierarchical Cox regressionCumulative incidence function curvesSocial determinantsNon-Hispanic/LatinoStroke incidenceAccess barriersFine-Gray modelArtery stentingDistressKaplan-Meier survival curvesVascular Quality Initiative databaseZip-codeFine-GrayMortality incidenceCox regressionAssociationAnalyzed patientsNo significant differenceMortalityLack of diversityPrediction of Health Status in Patients Undergoing Lower Extremity Intervention for Claudication
Peri-Okonny P, Romain G, Callegari S, Cleman J, Vashist A, Smolderen K, Mena-Hurtado C. Prediction of Health Status in Patients Undergoing Lower Extremity Intervention for Claudication. Annals Of Vascular Surgery 2024, 110: 314-322. PMID: 39395588, DOI: 10.1016/j.avsg.2024.08.016.Peer-Reviewed Original ResearchHealth statusPeripheral arterial diseaseEQ-5D VASPeripheral vascular interventionsPredictor of future health statusPredictor of health statusDrug-coated balloonLower extremity peripheral arterial diseaseHealth status outcomesFuture health statusEQ-5D-3LHistory of deep venous thrombosisImprove patient outcomesStatus outcomesPrediction of health statusChronic lung diseaseDeep venous thrombosisPlain balloon angioplastyPatient outcomesDisease managementExtremity interventionsApproach to treatmentSD ageVenous thrombosisBaseline characteristicsAssociation of health status and hospitalization risk for peripheral artery disease in the PORTRAIT registry
Cleman J, Romain G, Scierka L, Labrosciano C, Bradley B, Fitridge R, Beltrame J, Shishehbor M, Spertus J, Mena-Hurtado C, Smolderen K. Association of health status and hospitalization risk for peripheral artery disease in the PORTRAIT registry. Vascular Medicine 2024, 29: 664-674. PMID: 39319857, DOI: 10.1177/1358863x241274758.Peer-Reviewed Original ResearchPeripheral Artery QuestionnairePeripheral arterial diseaseED visitsHealth statusHospital admissionHealthcare utilizationPAD-specific health statusEmergency departmentCause-specific hospital admissionsAssociation of health statusPatient-reported outcome measuresPatient's risk of hospitalizationBaseline health statusAll-cause hospital admissionsCox proportional hazards modelsRisk of hospitalizationOverall summary scorePAQ scoresProportional hazards modelSummary scoreOutcome measuresHospitalization riskArtery diseaseVisitsHazards modelCompeting risk analysis to estimate amputation incidence and risk in lower-extremity peripheral artery disease
Callegari S, Smolderen K, Cleman J, Mena-Hurtado C, Romain G. Competing risk analysis to estimate amputation incidence and risk in lower-extremity peripheral artery disease. Vascular Medicine 2024, 29: 496-506. PMID: 39219174, PMCID: PMC11575932, DOI: 10.1177/1358863x241268727.Peer-Reviewed Original ResearchChronic limb-threatening ischemiaAmputation riskTime-to-event analysisPeripheral arterial diseaseLower-extremity peripheral arterial diseaseCumulative incidence functionCompeting risk analysisAmputation incidenceAmputation dataMedicare claimsLimb-threatening ischemiaVascular Quality Initiative registryMortality riskOutcomes researchPeripheral vascular interventionsArtery diseaseAmputationVascular outcomesCox regressionRiskMortalityCohortVascular interventionsTime-to-event methodsPatientsTwelve-month health status response after peripheral vascular intervention for femoropopliteal lesions using Zilver PTX databases focusing on the role of preprocedural health status, comorbid risks, and global setting
Smolderen K, Romain G, Cleman J, Callegari S, Peri-Okonny P, Mena-Hurtado C. Twelve-month health status response after peripheral vascular intervention for femoropopliteal lesions using Zilver PTX databases focusing on the role of preprocedural health status, comorbid risks, and global setting. Journal Of Vascular Surgery 2024, 81: 210-220.e7. PMID: 39214426, DOI: 10.1016/j.jvs.2024.08.035.Peer-Reviewed Original ResearchMinimal clinically important differenceEQ-5D indexHealth statusPeripheral vascular interventionsPeripheral arterial diseaseEQ-5DNon-respondersValue-based careEuroQol-5D-3LClinically important differenceSecondary data analysisFemoropopliteal peripheral vascular interventionsStable health statusLogistic regression modelsArtery diseaseSymptomatic peripheral arterial diseaseStatus responseTailored resourcesVascular interventionsSingle-arm studyImportant differenceCarotid artery diseaseComorbidity riskEnrolling centersPatient characteristicsAssociation of social support and health status outcomes in peripheral artery disease
Callegari S, Romain G, Cleman J, Scierka L, Peri-Okonny P, Spertus J, Labrosciano C, Beltrame J, Abbott J, Fitridge R, Mena-Hurtado C, Smolderen K. Association of social support and health status outcomes in peripheral artery disease. Journal Of Vascular Surgery 2024, 80: 1824-1835.e7. PMID: 39151740, PMCID: PMC11585422, DOI: 10.1016/j.jvs.2024.08.010.Peer-Reviewed Original ResearchENRICHD Social Support InventoryLow social supportLow perceived social supportGeneric health statusHealth status outcomesPeripheral arterial diseaseSocial supportHealth statusBiopsychosocial variablesStatus outcomesAssociation with health status outcomesAssociated with lower health statusDisease-specific health statusBaseline perceived social supportImprove social supportLower health statusSocial Support InventoryImprove health statusPerceived social supportDisease-specificEQ-5D-3LCare of patientsQuality of lifeEQ-5D-3L indexBiopsychosocial factorsFactors associated with sustained improvement after peripheral vascular intervention in patients with claudication
Peri-Okonny P, Romain G, Rambhujun V, Callegari S, Vashist A, Cleman J, Smolderen K, Mena-Hurtado C. Factors associated with sustained improvement after peripheral vascular intervention in patients with claudication. Vascular Medicine 2024, 29: 718-719. PMID: 39087625, DOI: 10.1177/1358863x241261369.Peer-Reviewed Original ResearchAddressing Psychosocial Care Needs in Women with Peripheral Artery Disease
Mubarak E, Cleman J, Romain G, Mena-Hurtado C, Smolderen K. Addressing Psychosocial Care Needs in Women with Peripheral Artery Disease. Current Cardiology Reports 2024, 26: 1085-1095. PMID: 39073508, DOI: 10.1007/s11886-024-02106-6.Peer-Reviewed Original ResearchVascular careIncreased psychosocial riskPsychosocial care needsIntegration of careMental health comorbiditiesBehavioral health careReviewPeripheral artery diseaseManagement of individualsCare integrationIllness perceptionsGender-based factorsCare needsHealthcare accessHealth behaviorsHealth comorbiditiesSubstance use disordersCare strategiesHealth carePeripheral arterial diseasePsychosocial comorbiditiesReimbursement structuresClinician educationCare paradigmUnique sexPsychosocial risksVariability and Factors Associated With the Use of Embolic Protection Devices in Carotid Artery Stenting
Callegari S, Romain G, Pajarillo C, Cleman J, Scierka L, Smolderen K, Mena-Hurtado C. Variability and Factors Associated With the Use of Embolic Protection Devices in Carotid Artery Stenting. Journal Of The Society For Cardiovascular Angiography & Interventions 2024, 3: 102170. PMID: 39575211, PMCID: PMC11576362, DOI: 10.1016/j.jscai.2024.102170.Peer-Reviewed Original ResearchReply Errors and Misinterpretation of Society for Vascular Surgery’s Vascular Quality Initiative Registry Data
Smolderen K, Romain G, Mao J, Goodney P, Mena-Hurtado C. Reply Errors and Misinterpretation of Society for Vascular Surgery’s Vascular Quality Initiative Registry Data. JACC Cardiovascular Interventions 2024, 17: 1513. PMID: 38925757, DOI: 10.1016/j.jcin.2024.05.006.Peer-Reviewed Original ResearchLong‐Term Mortality Predictors Using a Machine‐Learning Approach in Patients With Chronic Limb‐Threatening Ischemia After Peripheral Vascular Intervention
Callegari S, Romain G, Cleman J, Scierka L, Jacque F, Smolderen K, Mena‐Hurtado C. Long‐Term Mortality Predictors Using a Machine‐Learning Approach in Patients With Chronic Limb‐Threatening Ischemia After Peripheral Vascular Intervention. Journal Of The American Heart Association 2024, 13: e034477. PMID: 38761075, PMCID: PMC11179837, DOI: 10.1161/jaha.124.034477.Peer-Reviewed Original ResearchConceptsChronic limb-threatening ischemiaPeripheral vascular interventionsHealth careLimb-threatening ischemiaMortality predictorsLong-term mortality riskMultidimensional risk factorsBody mass indexLong-term mortality predictorsImprove individualized careVascular interventionsIndividualized careAssisted careBiopsychosocial modelMortality riskCareMass indexRisk factorsMedical comorbiditiesRisk profileInterventionMortality rateChronic kidney diseaseMortalityPredictive variablesImpact of early intervention on health status outcomes in peripheral artery disease patients with chronic total occlusion lesions using the PORTRAIT registry
Cerrud-Rodriguez R, Romain G, Hussain Y, Cleman J, Callegari S, Scierka L, Smolderen K, Mena-Hurtado C. Impact of early intervention on health status outcomes in peripheral artery disease patients with chronic total occlusion lesions using the PORTRAIT registry. Journal Of Vascular Surgery 2024, 80: 780-790.e10. PMID: 38735596, DOI: 10.1016/j.jvs.2024.04.061.Peer-Reviewed Original ResearchPeripheral Artery QuestionnairePeripheral arterial diseaseHealth statusChronic total occlusionChronic total occlusion lesionsPAD-specific health statusEarly invasive treatmentMultilevel generalized linear regression modelsPeripheral arterial disease symptomsLower extremity peripheral arterial diseaseBaseline health statusHealth status outcomesInvasive treatmentHealth status trajectoriesNon-invasive treatmentPatients' health statusImpact of early interventionHigh health statusFollow-upPeripheral arterial disease patientsSymptomatic peripheral arterial diseaseMonths of follow-upPresence of chronic total occlusionNon-invasive treatment strategyStatus outcomes
2023
Longitudinal Pathways Between Physical Activity, Depression, and Perceived Stress in Peripheral Artery Disease.
Yazgan I, Bartlett V, Romain G, Cleman J, Petersen-Crair P, Spertus J, Hardt M, Mena-Hurtado C, Smolderen K. Longitudinal Pathways Between Physical Activity, Depression, and Perceived Stress in Peripheral Artery Disease. Circulation Cardiovascular Quality And Outcomes 2023, 16: 544-553. PMID: 37470195, PMCID: PMC10561081, DOI: 10.1161/circoutcomes.122.009840.Peer-Reviewed Original ResearchConceptsPhysical activityPAD diagnosisDepressive symptomsLower physical activity scoresPerceived stressVascular specialty clinicsPeripheral artery diseasePhysical activity scoreSignificant depressive symptomsPatient Health QuestionnaireBehavioral health approachesSubsequent depressive symptomsINTERHEART studySymptomatic PADCardiovascular eventsPAD symptomsArtery diseaseInitial presentationActivity scoreSpecialty clinicHealth QuestionnairePatient's abilityTreatment goalsPAD managementPerceived Stress ScaleGuideline-Directed Medical Therapy and Long-Term Mortality and Amputation Outcomes in Patients Undergoing Peripheral Vascular Interventions
Smolderen K, Romain G, Provance J, Scierka L, Mao J, Goodney P, Henke P, Sedrakyan A, Mena-Hurtado C. Guideline-Directed Medical Therapy and Long-Term Mortality and Amputation Outcomes in Patients Undergoing Peripheral Vascular Interventions. JACC Cardiovascular Interventions 2023, 16: 332-343. PMID: 36792257, PMCID: PMC10359106, DOI: 10.1016/j.jcin.2022.09.022.Peer-Reviewed Original ResearchConceptsGuideline-directed medical therapyPeripheral vascular interventionsMedical therapyVascular interventionsEnzyme inhibitors/angiotensin receptor blockersVascular Quality Initiative registryAngiotensin receptor blockersLong-term mortalityRisk of amputationRisk of mortalityNational quality registryQuality improvement effortsAmputation outcomesAmputation riskMajor amputationAntiplatelet therapyCause mortalityReceptor blockersMean ageVascular careQuality registryObservational studyMortality riskHigh riskAmputation data
2022
The shifting care and outcomes for patients with endangered limbs – Critical limb ischemia (SCOPE-CLI) registry overview of study design and rationale
Scierka LE, Mena-Hurtado C, Shishehbor MH, Spertus JA, Nagpal S, Babrowski T, Bunte MC, Politano A, Humphries M, Chung J, Kirksey L, Alabi O, Soukas P, Parikh S, Faizer R, Fitridge R, Provance J, Romain G, McMillan N, Stone N, Scott K, Fuss C, Pacheco CM, Gosch K, Harper-Brooks A, Smolderen KG, Consortium O. The shifting care and outcomes for patients with endangered limbs – Critical limb ischemia (SCOPE-CLI) registry overview of study design and rationale. IJC Heart & Vasculature 2022, 39: 100971. PMID: 35198727, PMCID: PMC8850321, DOI: 10.1016/j.ijcha.2022.100971.Peer-Reviewed Original ResearchCritical limb ischemiaTreatment preferencesPeripheral artery diseaseProspective observational registryPatient-centered outcomesPatterns of carePoor wound healingHealth status outcomesProcess of careCLI careObservational registryLimb ischemiaPatient characteristicsArtery diseaseVascular centersVital statusMean agePatient preferencesPatient's perspectiveSevere formPatientsPsychosocial factorsStatus outcomesHealth statusCare experiences
2025
Association between guideline-directed medical therapy and reintervention risk following peripheral vascular interventions in patients with peripheral artery disease.
Callegari S, Romain G, Capuano I, Cleman J, Scierka L, Smolderen K, Mena-Hurtado C. Association between guideline-directed medical therapy and reintervention risk following peripheral vascular interventions in patients with peripheral artery disease. Vascular Medicine 2025, 1358863x251320347. PMID: 39992181, DOI: 10.1177/1358863x251320347.Peer-Reviewed Original ResearchGuideline-directed medical therapyGuideline-directed medical therapy ratesPeripheral vascular interventionsPeripheral arterial diseaseReintervention outcomesReintervention riskMedical therapyArtery diseaseVascular interventionsAngiotensin receptor blockersCompeting risk analysisScore-matched cohortReceipt of statinsPost-PVIAngiotensin-converting enzymeReceptor blockersReinterventionMedicare outcomesMedication adherencePatientsRegistry dataTherapyOutcomesReceiptRiskDefining Thresholds for Meaningful Health Status Changes Following Transfemoral Carotid Artery Stenting
Kluger J, Romain G, Mena‐Hurtado C, Grubman S, Pajarillo C, Cleman J, Scierka L, Smolderen K. Defining Thresholds for Meaningful Health Status Changes Following Transfemoral Carotid Artery Stenting. Catheterization And Cardiovascular Interventions 2025, 105: 927-937. PMID: 39789704, DOI: 10.1002/ccd.31410.Peer-Reviewed Original ResearchConceptsMinimal clinically important differenceHealth status changesHealth statusSF-36Visual analog scaleEQ-5DDistribution-based MCIDPhysical component scoreCarotid artery stentingDisease-specific instrumentHealth status improvementTransfemoral carotid artery stentingSymptom statusClinically important differenceTF-CASStatus changesGeneric instrumentsArtery stentingRegistry dataComponent scoresImportant differencePatients no changeStatus improvementAsymptomatic carotid stenosisHealthInteraction of anxiety symptoms with peripheral artery disease treatment strategies and health status outcomes.
Odu T, Romain G, Scierka L, Cleman J, Callegari S, Jacque F, Mena-Hurtado C, Smolderen K. Interaction of anxiety symptoms with peripheral artery disease treatment strategies and health status outcomes. Vascular Medicine 2025, 1358863x241306406. PMID: 39760470, DOI: 10.1177/1358863x241306406.Peer-Reviewed Original Research
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