2024
Procedure Volume and Outcomes With WATCHMAN Left Atrial Appendage Occlusion
Friedman D, Du C, Zimmerman S, Tan Z, Lin Z, Vemulapalli S, Kosinski A, Piccini J, Pereira L, Minges K, Faridi K, Masoudi F, Curtis J, Freeman J. Procedure Volume and Outcomes With WATCHMAN Left Atrial Appendage Occlusion. Circulation Cardiovascular Interventions 2024, 17: e013466. PMID: 38889251, PMCID: PMC11189610, DOI: 10.1161/circinterventions.123.013466.Peer-Reviewed Original ResearchConceptsVolume-outcome relationshipLikelihood of procedural successLeft atrial appendage occlusionProcedural successProcedure volumeAppendage occlusionNational Cardiovascular Data Registry LAAO RegistryVolume quartilesLeft atrial appendage occlusion devicesThree-level hierarchical generalized linear modelsMinimum volume thresholdsWatchman FLX deviceProcedural success rateHierarchical generalized linear modelsAssociated with outcomePhysician volumeWATCHMAN procedureFLX deviceOcclusion deviceVolume thresholdCardiovascular proceduresPhysiciansHospitalNational analysisSuccess rate
2023
Watchman device migration and embolization: A report from the NCDR LAAO Registry
Friedman D, Freeman J, Zimmerman S, Tan Z, Pereira L, Faridi K, Curtis J. Watchman device migration and embolization: A report from the NCDR LAAO Registry. Journal Of Cardiovascular Electrophysiology 2023, 34: 1192-1195. PMID: 37078339, PMCID: PMC10290479, DOI: 10.1111/jce.15909.Peer-Reviewed Original ResearchConceptsWATCHMAN procedureSurgical retrievalDevice migrationMortality rateAtrial appendage closure deviceHospital mortality rateAnnual procedure volumeCardiac surgeryHospital eventsPostdischarge eventsOstial sizeDevice embolizationTaller patientsRetrospective analysisClosure deviceLAA ostiumPatientsProcedure volumeHigh mortalitySurgerySubstantial proportionEmbolizationRegistryGreater body massBody mass
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 ResearchMeSH KeywordsAtrial AppendageAtrial FibrillationCardiac CatheterizationHumansPericardial EffusionRegistriesStrokeTreatment OutcomeConceptsAtrial 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 complicationsDevelopment and validation of an automated algorithm for end point adjudication for a large U.S. national registry
Friedman DJ, Pierre D, Wang Y, Gambone L, Koutras C, Segawa C, Farb A, Vemulapalli S, Varosy PD, Masoudi FA, Lansky A, Curtis JP, Freeman JV. Development and validation of an automated algorithm for end point adjudication for a large U.S. national registry. American Heart Journal 2022, 254: 102-111. PMID: 36007567, DOI: 10.1016/j.ahj.2022.08.006.Peer-Reviewed Original ResearchMeSH KeywordsAftercareAtrial AppendageAtrial FibrillationHumansIschemic Attack, TransientPatient DischargeRegistriesStrokeTreatment OutcomeConceptsEnd point adjudicationCEC adjudicationEnd pointLarge registriesClinical trialsNational Cardiovascular Data RegistryMajor vascular complicationsU.S. National RegistryPost-discharge eventsAgreement rateMajor bleedingNeurologic eventsVascular complicationsNational registryEvent adjudicationData registryRegistryCommittee's evaluationsPercent agreementGold standardAgreement thresholdHospitalTrialsFurther confirmationBleedingAbnormal left atrial body stiffness is predicted by appendage size: impact of appendage occlusion on left atrial mechanics assessed by pressure-volume analysis
Bregasi A, Freeman JV, Curtis JP, Akar JG, Ortiz-Leon XA, Maia JH, Higgins AY, Matthews RV, Sinusas AJ, McNamara RL, Sugeng L, Lin BA. Abnormal left atrial body stiffness is predicted by appendage size: impact of appendage occlusion on left atrial mechanics assessed by pressure-volume analysis. AJP Heart And Circulatory Physiology 2022, 323: h559-h568. PMID: 35960632, PMCID: PMC9576173, DOI: 10.1152/ajpheart.00083.2022.Peer-Reviewed Original ResearchConceptsLeft atrial appendage occlusionLA stiffnessAppendage occlusionLA appendageLA mechanicsTransesophageal echocardiographyPressure-volume analysisPercutaneous left atrial appendage occlusionAdverse atrial remodelingAtrial appendage occlusionLeft atrial appendageLA volume measurementsAtrial cardiomyopathyBaseline characteristicsLA complianceAtrial remodelingClinical outcomesAtrial appendageAtrial mechanicsCardiac performancePathophysiological roleBaseline parametersMagnitude of increaseAppendage sizeOcclusionIndications 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 ResearchMeSH KeywordsAnticoagulantsAspirinAtrial AppendageAtrial FibrillationFibrinolytic AgentsFrailtyHumansStrokeTreatment OutcomeWarfarinConceptsLeft 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 strategiesPatient-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 riskClinical 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 ResearchMeSH KeywordsAtrial AppendageAtrial FibrillationHumansRegistriesThromboembolismTime FactorsTreatment OutcomeConceptsPeri-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 functionClinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States
Price MJ, Slotwiner D, Du C, Freeman JV, Turi Z, Rammohan C, Kusumoto FM, Kavinsky C, Akar J, Varosy PD, Koutras C, Curtis JP, Masoudi FA. Clinical Outcomes at 1 Year Following Transcatheter Left Atrial Appendage Occlusion in the United States. JACC Cardiovascular Interventions 2022, 15: 741-750. PMID: 35393108, PMCID: PMC9116488, DOI: 10.1016/j.jcin.2022.02.009.Peer-Reviewed Original ResearchMeSH KeywordsAgedAged, 80 and overAtrial AppendageAtrial FibrillationHemorrhageHumansIschemic StrokeMedicareStrokeTreatment OutcomeUnited StatesConceptsAtrial appendage occlusionIschemic strokeMajor bleedingClinical outcomesSystemic embolismAppendage occlusionMean HAS-BLED scoreHAS-BLED scoreKey secondary endpointKaplan-Meier methodCumulative event rateRate of mortalityMean CHAPrior strokeRelevant bleedingVASc scoreWATCHMAN procedurePrimary endpointSecondary endpointsThromboembolic eventsIntracranial bleedingBlood transfusionHemoglobin levelsHemorrhagic strokeKaplan-Meier
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 ResearchMeSH KeywordsAgedAged, 80 and overAtrial AppendageAtrial FibrillationEndovascular ProceduresFemaleHumansMaleRegistriesStrokeConceptsHospital 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