2024
Association of Chronic Kidney Disease and Kidney Failure with Replacement Therapy with Procedural and Long-Term Outcomes after First Generation Watchman Device: Insights from the NCDR LAAO Registry
Munir M, Tan Z, Pun P, Wang Y, Tandar A, Darden D, Hsu J, Friedman D, Curtis J, Freeman J. Association of Chronic Kidney Disease and Kidney Failure with Replacement Therapy with Procedural and Long-Term Outcomes after First Generation Watchman Device: Insights from the NCDR LAAO Registry. Heart Rhythm 2024 PMID: 39515495, DOI: 10.1016/j.hrthm.2024.10.071.Peer-Reviewed Original ResearchChronic kidney diseaseLong-term outcomesLeft atrial appendage occlusionAssociation of chronic kidney diseaseNational Cardiovascular Data Registry LAAO RegistryReplacement therapyAdverse eventsAtrial fibrillationKidney diseaseKidney failureAssociated with higher ratesIn-hospital deathRisk of strokeRate of strokeBilling claimsAF patientsProcedural complicationsAppendage occlusionWatchman deviceMultivariate analysisKFRTHigh riskPatientsRegistryComplicationsAssociation of Physician Certification and Outcomes Among Patients Undergoing Left Atrial Appendage Occlusion
Vora A, Pereira L, Du C, Tan Z, Huang C, Friedman D, Wang Y, Faridi K, Lakkireddy D, Zimmerman S, Higgins A, Kapadia S, Curtis J, Freeman J. Association of Physician Certification and Outcomes Among Patients Undergoing Left Atrial Appendage Occlusion. JACC Cardiovascular Interventions 2024 PMID: 39474982, DOI: 10.1016/j.jcin.2024.10.020.Peer-Reviewed Original ResearchPhysician certificationAppendage occlusionAdverse eventsPercutaneous left atrial appendage occlusionLong-term oral anticoagulationDischarged patientsMultivariate Cox proportional hazards regression analysisRate of procedural complicationsLeft atrial appendage occlusionCox proportional hazards regression analysisProportional hazards regression analysisRisk of adverse eventsHazards regression analysisIn-hospital deathOral anticoagulantsWatchman FLXNo significant differenceLAAO devicesProcedural complicationsStratify patientsIntracardiac echocardiographyAtrial fibrillationEligible patientsIdentified patientsMultivariable adjustmentAnticoagulation Alone vs Anticoagulation Plus Aspirin or DAPT Following Left Atrial Appendage Occlusion
Reinhardt S, Gibson D, Hsu J, Kapadia S, Yeh R, Price M, Piccini J, Nair D, Christen T, Allocco D, Freeman J. Anticoagulation Alone vs Anticoagulation Plus Aspirin or DAPT Following Left Atrial Appendage Occlusion. Journal Of The American College Of Cardiology 2024, 84: 889-900. PMID: 39197978, DOI: 10.1016/j.jacc.2024.05.067.Peer-Reviewed Original ResearchConceptsLeft atrial appendage occlusionRate of adverse eventsAdverse eventsLAA closure deviceAppendage occlusionAntithrombotic strategiesP2Y<sub>12</sub> inhibitorsDays of follow-upMultivariable Cox proportional hazards regressionClosure deviceRisk of adverse eventsCox proportional hazards regressionWatchman FLX deviceDual antiplatelet therapyDevice-related thrombusProportional hazards regressionStroke/transient ischemic attackAntithrombotic regimensFLX deviceAntiplatelet therapyDOACsGroup patientsFollow-upMultivariate analysisHazards regressionOutcomes 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 thrombusStrokeProcedural Volume and Outcomes with Atrial Fibrillation Ablation: A Report from the NCDR AFib Ablation Registry
Kattel S, Tan Z, Lin Z, Mszar R, Sanders P, Zeitler E, Zei P, Bunch T, Mansour M, Akar J, Curtis J, Friedman D, Freeman J. Procedural Volume and Outcomes with Atrial Fibrillation Ablation: A Report from the NCDR AFib Ablation Registry. Heart Rhythm 2024 PMID: 38960302, DOI: 10.1016/j.hrthm.2024.06.056.Peer-Reviewed Original ResearchProcedure volumeProcedural successVolume outcome relationshipAblation RegistryPhysician procedure volumeAtrial fibrillationPhysician volumeFirst-time AF ablationU.S. hospitalsNational cohortLikelihood of procedural successHospital volumeAcute procedural successAtrial fibrillation ablationPhysiciansHospitalAF ablationCompare outcomesNCDRRegistryAdverse eventsOutcome relationshipAnnual volumeMAE rateOutcomesFeasibility of Amulet occluder implantation after failed left atrial appendage occlusion attempt: Insights from the EMERGE LAA postapproval study
Makkar A, Alkhouli M, Ellis C, Shah A, Coylewright M, Freeman J, Anderson J, Gage R, Lakkireddy D. Feasibility of Amulet occluder implantation after failed left atrial appendage occlusion attempt: Insights from the EMERGE LAA postapproval study. Heart Rhythm 2024, 21: 2126-2135. PMID: 38768843, DOI: 10.1016/j.hrthm.2024.05.004.Peer-Reviewed Original ResearchLeft atrial appendage occlusionAmulet occluderPost-approval studiesAdverse eventsImplant successOccluder implantationLow rate of adverse eventsRate of adverse eventsOutcomes of patientsSafety composite endpointImplantation attemptLAAO proceduresAppendage occlusionSafety endpointsPatient cohortComposite endpointFDA approvalPatientsHospital dischargeIntricate anatomyAnatomical scenariosOccluderImplantationEndpointLow ratePredicting 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
2023
Frailty and associated outcomes in patients undergoing percutaneous left atrial appendage occlusion: findings from the NCDR LAAO registry
Darden D, Bilal Munir M, Zimmerman S, Eskander M, Pothineni N, Gopinathannair R, Kabra R, Lakkireddy D, Duong T, Han F, Freeman J, Hsu J. Frailty and associated outcomes in patients undergoing percutaneous left atrial appendage occlusion: findings from the NCDR LAAO registry. Journal Of Interventional Cardiac Electrophysiology 2023, 67: 625-635. PMID: 37858000, DOI: 10.1007/s10840-023-01662-1.Peer-Reviewed Original ResearchAtrial appendage occlusionFrail patientsFrailty ScaleAdverse eventsAppendage occlusionHigh riskPercutaneous left atrial appendage occlusionLeft atrial appendage occlusionNon-frail patientsPre-frail patientsHospital adverse eventsModified Rankin ScaleHospital major complicationsRisk of complicationsBody mass indexRisk of fallsAdvanced age populationRankin ScaleMajor complicationsMass indexSignificant morbidityAtrial fibrillationMore disabilityWorse outcomesHigh burdenIn-hospital complications associated with pulmonary vein isolation with adjunctive lesions: the NCDR AFib Ablation Registry
Darden D, Aldaas O, Du C, Munir M, Feld G, Pothineni N, Gopinathannair R, Lakkireddy D, Curtis J, Freeman J, Akar J, Hsu J. In-hospital complications associated with pulmonary vein isolation with adjunctive lesions: the NCDR AFib Ablation Registry. EP Europace 2023, 25: euad124. PMID: 37184436, PMCID: PMC10228609, DOI: 10.1093/europace/euad124.Peer-Reviewed Original ResearchPulmonary vein isolationRisk of complicationsPersistent AFAblation RegistryHospital complicationsVein isolationAdjusted oddsHigher comorbidity burdenAtrial fibrillation ablationCavotricuspid isthmus ablationMultivariable logistic regressionComorbidity burdenMore comorbiditiesAdverse eventsFibrillation ablationIsthmus ablationMajor complicationsCTI ablationHigh heterogeneitySafety outcomesHigh riskComplicationsAblation lesionsLesion typeLesions
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 injuryIndications for Left Atrial Appendage Occlusion in the United States and Associated In-Hospital Outcomes: Results From the NCDR LAAO Registry
Daimee UA, Wang Y, Masoudi FA, Varosy PD, Friedman DJ, Du C, Koutras C, Reddy VY, Saw J, Price MJ, Kusumoto FM, Curtis JP, Freeman JV. Indications for Left Atrial Appendage Occlusion in the United States and Associated In-Hospital Outcomes: Results From the NCDR LAAO Registry. Circulation Cardiovascular Quality And Outcomes 2022, 15: e008418. PMID: 35959677, PMCID: PMC9388561, DOI: 10.1161/circoutcomes.121.008418.Peer-Reviewed Original ResearchConceptsHospital adverse eventsHigh fall riskNational Cardiovascular Data RegistryProcedural indicationsAtrial appendage occlusionAdverse eventsWatchman implantationFall riskMajor bleedsThromboembolic riskAppendage occlusionData registryAbnormal renal/liver functionLeft atrial appendage occlusionIn-Hospital OutcomesMean patient ageTransient ischemic attackMajority of patientsInternational normalized ratioIschemic attackMean CHAOral anticoagulationPrior strokeVASc scoreWATCHMAN procedureAntithrombotic Therapy After Left Atrial Appendage Occlusion in Patients With Atrial Fibrillation
Freeman JV, Higgins AY, Wang Y, Du C, Friedman DJ, Daimee UA, Minges KE, Pereira L, Goldsweig AM, Price MJ, Reddy VY, Gibson D, Doshi SK, Varosy PD, Masoudi FA, Curtis JP. Antithrombotic Therapy After Left Atrial Appendage Occlusion in Patients With Atrial Fibrillation. Journal Of The American College Of Cardiology 2022, 79: 1785-1798. PMID: 35512858, PMCID: PMC9097170, DOI: 10.1016/j.jacc.2022.02.047.Peer-Reviewed Original ResearchConceptsLeft atrial appendage occlusionAdverse eventsPivotal trialsWatchman deviceTreatment protocolAntithrombotic strategiesAppendage occlusionLower riskFrailty regressionPercutaneous left atrial appendage occlusionNational Cardiovascular Data RegistryContemporary U.S. practiceDual antiplatelet therapyAtrial appendage occlusionConcomitant aspirinPostprocedure careAdjusted riskAntiplatelet therapyAntithrombotic medicationAntithrombotic therapyAtrial fibrillationAdverse outcomesTrial protocolAntithrombotic agentsMedication strategiesClinical 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 proportionDaysAnticoagulationPeriprocedural 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
2019
Digoxin Use and Associated Adverse Events Among Older Adults
Angraal S, Nuti SV, Masoudi FA, Freeman JV, Murugiah K, Shah ND, Desai NR, Ranasinghe I, Wang Y, Krumholz HM. Digoxin Use and Associated Adverse Events Among Older Adults. The American Journal Of Medicine 2019, 132: 1191-1198. PMID: 31077654, DOI: 10.1016/j.amjmed.2019.04.022.Peer-Reviewed Original ResearchConceptsRate of hospitalizationDigoxin useDigoxin toxicityNational Prescription AuditMedicare feeService beneficiariesDigoxin prescriptionAssociated adverse eventsAdverse eventsCohort studyAdverse outcomesSecondary diagnosisNational cohortPrescription auditPrescription trendsClinical guidelinesHospitalizationMortality rateClinical practiceOlder adultsSubsequent outcomesOutcomesToxicityPrescriptionNational-level trends