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 massInitial 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 ResearchMeSH KeywordsAgedAtrial FibrillationCardiovascular SystemFemaleHospital MortalityHumansMaleMiddle AgedProspective StudiesRegistriesConceptsAtrial 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 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 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 ResearchMeSH KeywordsAdultAtrial FibrillationCatheter AblationCohort StudiesFemaleHumansLungMaleQuality of LifeTreatment OutcomeConceptsAcute 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 injuryDevelopment 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 confirmationBleedingIndications 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 procedureAbnormal 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 ResearchMeSH KeywordsAtrial AppendageAtrial FibrillationCardiac CatheterizationEchocardiography, TransesophagealHumansStrokeTreatment OutcomeVascular DiseasesConceptsLeft 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 sizeOcclusionPatient-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 ResearchMeSH KeywordsAnticoagulantsAtrial AppendageAtrial FibrillationClinical Trials as TopicEmbolismHemorrhagic StrokeHumansIschemic StrokeTreatment OutcomeWarfarinConceptsRegistry 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 riskAntithrombotic 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 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 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-MeierTrends in Use of Single- vs Dual-Chamber Implantable Cardioverter-Defibrillators Among Patients Without a Pacing Indication, 2010-2018
Borne RT, Varosy P, Lan Z, Masoudi FA, Curtis JP, Matlock DD, Peterson PN. Trends in Use of Single- vs Dual-Chamber Implantable Cardioverter-Defibrillators Among Patients Without a Pacing Indication, 2010-2018. JAMA Network Open 2022, 5: e223429. PMID: 35315917, PMCID: PMC8941353, DOI: 10.1001/jamanetworkopen.2022.3429.Peer-Reviewed Original ResearchMeSH KeywordsAtrial FibrillationCardiac Resynchronization TherapyCross-Sectional StudiesDefibrillators, ImplantableHumansMaleMiddle AgedRegistriesConceptsDual-chamber ICDFirst-time ICD implantationPacing indicationICD implantationMedian odds ratioPatient characteristicsOdds ratioAtrial leadNational Cardiovascular Data Registry ICD RegistryCardiac resynchronization therapy indicationDual-chamber ICD implantationMulticenter cross-sectional studyBradycardia pacing indicationSingle-chamber ICDHospital-level variationHigh procedural riskCross-sectional studyLow-value practicesImplantable cardioverter defibrillatorLow-value careCochran-Armitage trend testImplantable cardioverter-defibrillator systemsDual-chamber devicesCardioverter-defibrillator systemsReal-world practice
2021
Risk and predictors of mortality after implantable cardioverter-defibrillator implantation in patients with sarcoid cardiomyopathy
Higgins AY, Annapureddy AR, Wang Y, Minges KE, Bellumkonda L, Lampert R, Rosenfeld LE, Jacoby DL, Curtis JP, Miller EJ, Freeman JV. Risk and predictors of mortality after implantable cardioverter-defibrillator implantation in patients with sarcoid cardiomyopathy. American Heart Journal 2021, 246: 21-31. PMID: 34968442, DOI: 10.1016/j.ahj.2021.12.011.Peer-Reviewed Original ResearchConceptsNon-ischemic cardiomyopathyAtrial fibrillation/flutterChronic lung diseaseCardiac sarcoidosisHeart failureCS patientsNICM patientsICD implantationLung diseaseNew York Heart Association class III heart failureNational Cardiovascular Data Registry ICD RegistryNYHA class IV heart failureClass III heart failureClass IV heart failureImplantable cardioverter defibrillator implantationKaplan-Meier survival curvesCox proportional hazards modelPredictors of mortalityCardioverter-defibrillator implantationVentricular ejection fractionMultivariable logistic regressionPrior ventricular arrhythmiasProportional hazards modelRate of deathTime of implantationSex 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
2017
Use of Cardiac Resynchronization Therapy Among Eligible Patients Receiving an Implantable Cardioverter Defibrillator: Insights From the National Cardiovascular Data Registry Implantable Cardioverter Defibrillator Registry
Marzec LN, Peterson PN, Bao H, Curtis JP, Masoudi FA, Varosy PD, Bradley SM. Use of Cardiac Resynchronization Therapy Among Eligible Patients Receiving an Implantable Cardioverter Defibrillator: Insights From the National Cardiovascular Data Registry Implantable Cardioverter Defibrillator Registry. JAMA Cardiology 2017, 2: 561-565. PMID: 28122073, PMCID: PMC5814986, DOI: 10.1001/jamacardio.2016.5388.Peer-Reviewed Original ResearchMeSH KeywordsAgedAged, 80 and overAtrial FibrillationBlack or African AmericanBundle-Branch BlockCardiac Resynchronization TherapyCardiac Resynchronization Therapy DevicesCerebrovascular DisordersCohort StudiesComorbidityDefibrillators, ImplantableDiabetes MellitusEthnicityFemaleHealth Facility SizeHeart FailureHospitalsHospitals, TeachingHumansHypertensionInsurance, HealthLung DiseasesMaleMedicaidMedicareMiddle AgedMortalityMyocardial IschemiaPractice Patterns, Physicians'RegistriesRegression AnalysisRetrospective StudiesUnited StatesWhite PeopleConceptsUse of CRTCardiac resynchronization therapyCRT-D useImplantable cardioverter defibrillatorGuideline-eligible patientsDevice implantationEligible patientsResynchronization therapyCardioverter defibrillatorNational Cardiovascular Data Registry Implantable Cardioverter Defibrillator RegistryNational Cardiovascular Data Registry ICD RegistryHeart failure-related eventsImplantable Cardioverter-Defibrillator RegistryCRT-D groupMulticenter retrospective cohortRisk-standardized ratesHospital-level variationCRT-D devicesHierarchical multivariable modelNonprivate insuranceRetrospective cohortSelect patientsICD RegistryGuideline recommendationsICD placement
2016
Trends and In-Hospital Outcomes Associated With Adoption of the Subcutaneous Implantable Cardioverter Defibrillator in the United States
Friedman DJ, Parzynski CS, Varosy PD, Prutkin JM, Patton KK, Mithani A, Russo AM, Curtis JP, Al-Khatib SM. Trends and In-Hospital Outcomes Associated With Adoption of the Subcutaneous Implantable Cardioverter Defibrillator in the United States. JAMA Cardiology 2016, 1: 900-911. PMID: 27603935, PMCID: PMC5112106, DOI: 10.1001/jamacardio.2016.2782.Peer-Reviewed Original ResearchConceptsSubcutaneous implantable cardioverter defibrillatorPropensity-matched analysisS-ICDHospital outcomesImplantable cardioverter defibrillatorICD implantsComplication rateICD RegistryDFT testingS-ICDsCardioverter defibrillatorNational Cardiovascular Data Registry ICD RegistryHospital complication ratesIn-Hospital OutcomesPrior cardiac arrestLow complication rateS-ICD implantationUse of ICDsSC-ICDICD implantationCardiac arrestMean ageRetrospective analysisMAIN OUTCOMEPatients