2024
Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry
Kapadia S, Yeh R, Price M, Piccini J, Nair D, Bansal A, Hsu J, Freeman J, Christen T, Allocco D, Gibson D. Outcomes With the WATCHMAN FLX in Everyday Clinical Practice From the NCDR Left Atrial Appendage Occlusion Registry. Circulation Cardiovascular Interventions 2024, 17: e013750. PMID: 39056187, DOI: 10.1161/circinterventions.123.013750.Peer-Reviewed Original ResearchClinical practiceHospital dischargeSafety end pointIschemic strokeWatchman FLX deviceWatchman FLXEveryday clinical practiceFLX deviceAll-cause deathRegistryAdverse eventsAnalysis planRate of implant successEnd pointsImprove outcomesLow incidence of adverse eventsIncidence of adverse eventsCohort of patientsOpen cardiac surgeryPeri-device leakProcedure-related eventsDays post-procedureMajor adverse eventsDevice-related thrombusStrokePredicting Major Adverse Events in Patients Undergoing Transcatheter Left Atrial Appendage Occlusion
Faridi K, Ong E, Zimmerman S, Varosy P, Friedman D, Hsu J, Kusumoto F, Mortazavi B, Minges K, Pereira L, Lakkireddy D, Koutras C, Denton B, Mobayed J, Curtis J, Freeman J. Predicting Major Adverse Events in Patients Undergoing Transcatheter Left Atrial Appendage Occlusion. Circulation Arrhythmia And Electrophysiology 2024, 17: e012424. PMID: 38390713, PMCID: PMC11021146, DOI: 10.1161/circep.123.012424.Peer-Reviewed Original ResearchNational Cardiovascular Data RegistryLeft atrial appendage occlusionIn-hospital major adverse eventsMajor adverse eventsBedside risk scoreRisk scoreData RegistryIncreased fall riskAdverse eventsQuality improvement effortsWatchman FLXAppendage occlusionFall riskLeft atrial appendage occlusion procedureRegistry dataImprovement effortsRisk of in-hospital major adverse eventsPredicting major adverse eventsLogistic regressionAdverse event ratesModerate discriminationClinically relevant variablesFemale sexAtrial fibrillation terminationLAAO proceduresFirst 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
2022
Comparative Safety of Transcatheter LAAO With the First-Generation Watchman and Next-Generation Watchman FLX Devices
Price M, Friedman D, Du C, Wang Y, Lin Z, Curtis J, Freeman J. Comparative Safety of Transcatheter LAAO With the First-Generation Watchman and Next-Generation Watchman FLX Devices. JACC Cardiovascular Interventions 2022, 15: 2115-2123. PMID: 36357014, DOI: 10.1016/j.jcin.2022.09.002.Peer-Reviewed Original ResearchConceptsHospital major adverse eventsMajor adverse eventsWatchman FLXMajor vascular complicationsMajor bleedingPericardial effusionCardiac arrestDevice embolizationVascular complicationsMyocardial infarctionLower ratesSystemic arterial embolismComposite of deathTransient ischemic attackAtrial appendage occlusionSignificant lower rateBalance of risksHospital mortalityIschemic attackArterial embolismHospital outcomesPrimary endpointStroke preventionAdverse eventsProcedural complicationsSex-based differences in atrial fibrillation ablation adverse events
Mszar R, Friedman D, Ong E, Du C, Wang Y, Zeitler E, Cunningham S, Akar J, Curtis J, Freeman J. Sex-based differences in atrial fibrillation ablation adverse events. Heart 2022, 109: 595-605. PMID: 36104219, DOI: 10.1136/heartjnl-2022-321192.Peer-Reviewed Original ResearchConceptsAcute pulmonary vein isolationAdverse eventsPulmonary vein isolationAtrial fibrillationHigh riskSex-based differencesVein isolationCatheter ablationFemale sexLarge prospective registryHospital adverse eventsMajor adverse eventsObservational cohort studyPhrenic nerve damageAF ablation proceduresQuality of lifeAblation RegistryMore comorbiditiesProspective registryAF ablationCohort studyPericardial effusionNerve damagePatient sexVascular injuryClinical Impact of Residual Leaks Following Left Atrial Appendage Occlusion Insights From the NCDR LAAO Registry
Alkhouli M, Du C, Killu A, Simard T, Noseworthy PA, Friedman PA, Curtis JP, Freeman JV, Holmes DR. Clinical Impact of Residual Leaks Following Left Atrial Appendage Occlusion Insights From the NCDR LAAO Registry. JACC Clinical Electrophysiology 2022, 8: 766-778. PMID: 35387751, PMCID: PMC9233062, DOI: 10.1016/j.jacep.2022.03.001.Peer-Reviewed Original ResearchConceptsPeri-device leakAdverse eventsResidual leakMajor adverse eventsProportion of patientsAdverse clinical eventsAtrial appendage occlusionAnticoagulant utilizationMajor bleedingSystemic embolizationAppendage occlusionClinical eventsClinical impactHigher oddsHigh incidencePatientsThromboembolicSignificant differencesRegistryLarge leaksLAAOLeakHigher proportionDaysAnticoagulation
2021
Sex Differences in Procedural Outcomes Among Patients Undergoing Left Atrial Appendage Occlusion
Darden D, Duong T, Du C, Munir MB, Han FT, Reeves R, Saw J, Zeitler EP, Al-Khatib SM, Russo AM, Minges KE, Curtis JP, Freeman JV, Hsu JC. Sex Differences in Procedural Outcomes Among Patients Undergoing Left Atrial Appendage Occlusion. JAMA Cardiology 2021, 6: 1275-1284. PMID: 34379072, PMCID: PMC8358791, DOI: 10.1001/jamacardio.2021.3021.Peer-Reviewed Original ResearchConceptsHospital adverse eventsMajor adverse eventsAdverse eventsAtrial appendage occlusionMajor bleedingPericardial effusionAppendage occlusionAtrial fibrillationSex differencesCongestive heart failureCoronary artery diseaseAdjusted logistic regression analysisParoxysmal atrial fibrillationLogistic regression analysisMultivariable adjusted logistic regression analysesPrior strokeUncontrolled hypertensionHospital outcomesHospital stayMultivariable adjustmentProlonged hospitalBaseline characteristicsCohort studySelect patientsArtery disease
2016
Cost-Effectiveness of Percutaneous Closure of the Left Atrial Appendage in Atrial Fibrillation Based on Results From PROTECT AF Versus PREVAIL
Freeman JV, Hutton DW, Barnes GD, Zhu RP, Owens DK, Garber AM, Go AS, Hlatky MA, Heidenreich PA, Wang PJ, Al-Ahmad A, Turakhia MP. Cost-Effectiveness of Percutaneous Closure of the Left Atrial Appendage in Atrial Fibrillation Based on Results From PROTECT AF Versus PREVAIL. Circulation Arrhythmia And Electrophysiology 2016, 9: e003407. PMID: 27307517, PMCID: PMC4911813, DOI: 10.1161/circep.115.003407.Peer-Reviewed Original ResearchConceptsLAA closureLeft atrial appendageQuality-adjusted life yearsPROTECT AFAtrial fibrillationPercutaneous closureWatchman deviceAtrial appendageLife yearsTrial dataWATCHMAN LAA closure devicePROTECT AF trialIncremental cost-effectiveness ratioMajor adverse eventsPrevention of strokeAtrial appendage closureProspective Randomized EvaluationLAA closure deviceLong-term trial resultsQuality-adjusted survivalCost-effectiveness ratioCost-effectiveness resultsMedical anticoagulationAF trialAdverse events
2015
Association Between Atrial Fibrillation Symptoms, Quality of Life, and Patient Outcomes
Freeman JV, Simon DN, Go AS, Spertus J, Fonarow GC, Gersh BJ, Hylek EM, Kowey PR, Mahaffey KW, Thomas LE, Chang P, Peterson ED, Piccini JP. Association Between Atrial Fibrillation Symptoms, Quality of Life, and Patient Outcomes. Circulation Cardiovascular Quality And Outcomes 2015, 8: 393-402. PMID: 26058720, DOI: 10.1161/circoutcomes.114.001303.Peer-Reviewed Original ResearchConceptsQuality of lifeAtrial fibrillationHigh riskAF patientsAF symptomsPatient outcomesSymptom severityAtrial Fibrillation EffectBorderline higher riskMajor adverse eventsBetter Informed TreatmentAtrial fibrillation symptomsCommunity-based studyAFEQT scoreEHRA classMajor bleedingMost patientsSymptom burdenAdverse eventsOutcomes RegistryCox regressionLife QuestionnaireFibrillation EffectInformed TreatmentPatients