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 ratesEchocardiographyInitial Findings From the National Cardiovascular Data Registry of Atrial Fibrillation Ablation Procedures
Hsu J, Darden D, Du C, Marine J, Nichols S, Marcus G, Natale A, Noseworthy P, Selzman K, Varosy P, Masoudi F, Freeman J, Curtis J, Akar J, Kowey P. Initial Findings From the National Cardiovascular Data Registry of Atrial Fibrillation Ablation Procedures. Journal Of The American College Of Cardiology 2023, 81: 867-878. PMID: 36858707, DOI: 10.1016/j.jacc.2022.11.060.Peer-Reviewed Original ResearchConceptsAtrial fibrillation ablation proceduresAblation RegistryHospital outcomesAblation proceduresSuccessful pulmonary vein isolationNational Cardiovascular Data RegistryOutcomes of patientsProspective cohort studyMajority of patientsPulmonary vein isolationEvidence-based guidelinesDifferent patient outcomesReal-world prevalenceProcedural admissionsHospital deathAF ablationCohort studyPericardial effusionVein isolationHeart failureLarge multicenterMajor complicationsCatheter ablationTreatment patternsPatient population
2022
Device-Sizing and Associated Complications With Left Atrial Appendage Occlusion: Findings From the NCDR LAAO Registry
Sandhu A, Varosy P, Du C, Aleong R, Tumolo A, West J, Tzou W, Curtis J, Freeman J, Friedman D, Hess P. Device-Sizing and Associated Complications With Left Atrial Appendage Occlusion: Findings From the NCDR LAAO Registry. Circulation Cardiovascular Interventions 2022, 15: e012183. PMID: 36472194, DOI: 10.1161/circinterventions.122.012183.Peer-Reviewed Original ResearchConceptsAtrial appendage occlusionAppendage occlusionPericardial effusionLower oddsOversized deviceComposite adverse outcomeNonvalvular atrial fibrillationShort-term complicationsShort-term outcomesSignificant leakDevice embolismSelect patientsAdverse eventsWatchman deviceAssociated complicationsPeridevice leakAtrial fibrillationAdverse outcomesDevice embolizationHigh prevalenceDevice migrationManufacturer's recommendationsPatientsStudy periodUndersized devicesComparative 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 injuryPatient-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 riskPeriprocedural Pericardial Effusion Complicating Transcatheter Left Atrial Appendage Occlusion: A Report From the NCDR LAAO Registry
Price MJ, Valderrábano M, Zimmerman S, Friedman DJ, Kar S, Curtis JP, Masoudi FA, Freeman JV. Periprocedural Pericardial Effusion Complicating Transcatheter Left Atrial Appendage Occlusion: A Report From the NCDR LAAO Registry. Circulation Cardiovascular Interventions 2022, 15: e011718. PMID: 35369701, PMCID: PMC9132377, DOI: 10.1161/circinterventions.121.011718.Peer-Reviewed Original ResearchConceptsAtrial appendage occlusionComposite of deathPericardial effusionAppendage occlusionSystemic embolismOdds ratioEarly postdischarge mortalityDual antiplatelet therapyLow serum albuminMean patient ageAdverse event ratesParoxysmal atrial fibrillationRisk of deathRisk-benefit ratioHospital strokeMean CHAPostdischarge mortalityVASc scoreWATCHMAN procedureAntiplatelet therapyIndex hospitalizationAdverse eventsPatient agePrimary outcomeVentricular function
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
2020
The NCDR Left Atrial Appendage Occlusion Registry
Freeman JV, Varosy P, Price MJ, Slotwiner D, Kusumoto FM, Rammohan C, Kavinsky CJ, Turi ZG, Akar J, Koutras C, Curtis JP, Masoudi FA. The NCDR Left Atrial Appendage Occlusion Registry. Journal Of The American College Of Cardiology 2020, 75: 1503-1518. PMID: 32238316, PMCID: PMC7205034, DOI: 10.1016/j.jacc.2019.12.040.Peer-Reviewed Original ResearchConceptsHospital adverse event ratesAdverse event ratesEvent ratesMean HAS-BLED scoreHAS-BLED scoreHospital adverse eventsMean patient ageAtrial appendage occlusionMedian annual numberMajor bleedingMean CHAMore comorbiditiesVASc scoreWATCHMAN procedureAdverse eventsCommon complicationPatient agePericardial effusionPivotal trialsAppendage occlusionRandomized trialsAtrial fibrillationPatient populationPresent patientPhysician characteristics