2024
First Experience With Amulet in the United States Early Insights From EMERGE LAA Postapproval Study
Alkhouli M, Freeman J, Ellis C, Shah A, Gada H, Coylewright M, Lo M, Makkar A, Agarwal H, Lakkireddy D. First Experience With Amulet in the United States Early Insights From EMERGE LAA Postapproval Study. JACC Cardiovascular Interventions 2024, 17: 422-434. PMID: 38310499, DOI: 10.1016/j.jcin.2023.11.027.Peer-Reviewed Original ResearchPericardial effusionAmulet occluderImplant successAdverse eventsIn-hospitalFood and Drug Administration approvalOpen cardiac surgeryMajor adverse eventsDrug Administration approvalComposite endpoint eventsFood and Drug AdministrationSafety composite endpointPatients in-hospitalImplantation attemptSystemic embolismCardiac surgeryAppendage occlusionOccluder implantationAdministration approvalComposite endpointDevice implantationEndpoint eventsPostapproval studiesEndovascular interventionLearning curve effect
2023
Intracardiac vs Transesophageal Echocardiography for Left Atrial Appendage Occlusion With Watchman FLX in the U.S.
Ferro E, Alkhouli M, Nair D, Kapadia S, Hsu J, Gibson D, Freeman J, Price M, Roy K, Allocco D, Yeh R, Piccini J. Intracardiac vs Transesophageal Echocardiography for Left Atrial Appendage Occlusion With Watchman FLX in the U.S. JACC Clinical Electrophysiology 2023, 9: 2587-2599. PMID: 37831030, DOI: 10.1016/j.jacep.2023.08.004.Peer-Reviewed Original ResearchConceptsAtrial appendage occlusionTransesophageal echocardiographyIntracardiac echocardiographyBaseline characteristicsAppendage occlusionLeft atrial appendage occlusionPericardial effusion rateSuccessful device implantationAdverse event ratesSimilar baseline characteristicsUnadjusted mortality ratesHigh rateICE patientsTEE patientsPericardial effusionPivotal trialsDevice implantationGeneral anesthesiaAdjusted comparisonsProcedural timeLAAO devicesDevice deliveryMortality rateEvent ratesEchocardiography
2022
Patient-Level Analysis of Watchman Left Atrial Appendage Occlusion in Practice Versus Clinical Trials
Friedman DJ, Du C, Wang Y, Agarwal V, Varosy PD, Masoudi FA, Holmes DR, Reddy VY, Price MJ, Curtis JP, Freeman JV. Patient-Level Analysis of Watchman Left Atrial Appendage Occlusion in Practice Versus Clinical Trials. JACC Cardiovascular Interventions 2022, 15: 950-961. PMID: 35512918, PMCID: PMC9370831, DOI: 10.1016/j.jcin.2022.02.029.Peer-Reviewed Original ResearchConceptsRegistry patientsHemorrhagic stroke riskIschemic strokeWarfarin patientsTrial patientsStroke riskLAAO patientsClinical practiceMore pericardial effusionsPeriprocedural ischemic strokePropensity-matched analysisAtrial appendage occlusionCox proportional hazardsPatient-level dataFine-Gray modelMore comorbiditiesPROTECT AFNoncardiovascular deathPericardial effusionHemorrhagic strokeAppendage occlusionDevice implantationTrial criteriaClinical trialsSimilar risk
2018
Association of Atrial Fibrillation Clinical Phenotypes with Treatment Patterns and Outcomes: A Multicenter Registry Study
Inohara T, Shrader P, Pieper K, Blanco RG, Thomas L, Singer DE, Freeman JV, Allen LA, Fonarow GC, Gersh B, Ezekowitz MD, Kowey PR, Reiffel JA, Naccarelli GV, Chan PS, Steinberg BA, Peterson ED, Piccini JP. Association of Atrial Fibrillation Clinical Phenotypes with Treatment Patterns and Outcomes: A Multicenter Registry Study. JAMA Cardiology 2018, 3: 54-63. PMID: 29128866, PMCID: PMC5833527, DOI: 10.1001/jamacardio.2017.4665.Peer-Reviewed Original ResearchConceptsAtrial fibrillationAtherosclerotic comorbiditiesMajor bleedingComorbidity clustersNeurological eventsClinical outcomesDevice implantationORBIT-AF II registryPrior coronary artery diseaseAtrial Fibrillation RegistryComorbid behavioral disordersMulticenter registry studyBaseline clinical characteristicsImportance of comorbiditiesBetter Informed TreatmentSinus node dysfunctionCoronary artery diseaseData-driven cluster analysisHemostasis criteriaClinical characteristicsObservational cohortRegistry studyTotal patientsArtery diseaseAtrial size
2017
Oral anticoagulation management in patients with atrial fibrillation undergoing cardiac implantable electronic device implantation
Black‐Maier E, Kim S, Steinberg BA, Fonarow GC, Freeman JV, Kowey PR, Ansell J, Gersh BJ, Mahaffey KW, Naccarelli G, Hylek EM, Go AS, Peterson ED, Piccini JP, Investigators F. Oral anticoagulation management in patients with atrial fibrillation undergoing cardiac implantable electronic device implantation. Clinical Cardiology 2017, 40: 746-751. PMID: 28543401, PMCID: PMC5638096, DOI: 10.1002/clc.22726.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, OralAgedAged, 80 and overAnticoagulantsAtrial FibrillationCardiac Pacing, ArtificialCardiac Resynchronization TherapyCardiac Resynchronization Therapy DevicesDefibrillators, ImplantableDrug Administration ScheduleDrug SubstitutionElectric CountershockFemaleHemorrhageHumansMaleMiddle AgedPacemaker, ArtificialRegistriesRisk FactorsStrokeTime FactorsTreatment OutcomeConceptsCardiac implantable electronic device implantationCIED implantationNOAC patientsAnticoagulation managementAF patientsAtrial fibrillationDevice implantationOral anticoagulation managementHigher creatinine clearanceManagement of anticoagulationOral anticoagulation therapyBetter Informed TreatmentOral anticoagulant therapyAtrial fibrillation patientsValvular heart diseaseBridging anticoagulationConcomitant aspirinInterrupted warfarinOAC therapyAnticoagulation strategiesAnticoagulation therapyOral anticoagulantsPeriprocedural riskAdverse eventsAnticoagulant therapy