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, 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 rateOutcomesProcedure 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 rateFEASIBILITY OF AMULET OCCLUDER IMPLANTATION AFTER FAILED LEFT ATRIAL APPENDAGE OCCLUSION ATTEMPT: INSIGHTS FROM THE EMERGE LAA POST-APPROVAL 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 POST-APPROVAL STUDY. Heart Rhythm 2024 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 rateMP-470550-005 FEASIBILITY OF AMULET IMPLANTATION AFTER FAILED LAAO ATTEMPT: INSIGHTS FROM THE EMERGE LAA POST-APPROVAL STUDY
Makkar A, Alkhouli M, Ellis C, Shah A, coylewright M, Freeman J, Lakkireddy D. MP-470550-005 FEASIBILITY OF AMULET IMPLANTATION AFTER FAILED LAAO ATTEMPT: INSIGHTS FROM THE EMERGE LAA POST-APPROVAL STUDY. Heart Rhythm 2024, 21: s97. DOI: 10.1016/j.hrthm.2024.03.457.Peer-Reviewed Original ResearchB-40 | Safety and Efficacy of Combining Left Atrial Appendage Occlusion With Another Cardiac Procedure
Ismayl M, Ahmed H, Freeman J, Alkhouli M, Lakkireddy D, Goldsweig A. B-40 | Safety and Efficacy of Combining Left Atrial Appendage Occlusion With Another Cardiac Procedure. Journal Of The Society For Cardiovascular Angiography & Interventions 2024, 3: 101607. DOI: 10.1016/j.jscai.2024.101607.Peer-Reviewed Original ResearchPredicting 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 proceduresIn-hospital safety outcomes of left atrial appendage occlusion in octogenarians and nonagenarians
Ismayl M, Ahmed H, Goldsweig A, Freeman J, Alkhouli M. In-hospital safety outcomes of left atrial appendage occlusion in octogenarians and nonagenarians. EP Europace 2024, 26: euae055. PMID: 38391186, PMCID: PMC10927254, DOI: 10.1093/europace/euae055.Peer-Reviewed Original ResearchConceptsOutcomes of left atrial appendage occlusionLeft atrial appendage occlusionIn-hospital all-cause mortalityOdds of vascular complicationsLength of stayAll-cause mortalityYounger patientsAppendage occlusionComposite of in-hospital all-cause mortalityOdds of in-hospital all-cause mortalityVascular complicationsSafety outcomesAcute kidney injuryNational Inpatient Sample databaseRetrospective cohort studyInpatient Sample databaseYears of ageCardiac tamponadeBlood transfusionProcedural complicationsSafety profileKidney injuryLogistic regression modelsElderly patientsCohort studyAmulet Occluder Implantation in Patients With Failed Prior Left Atrial Appendage Occlusion EMERGE LAA Insights
Alkhouli M, Makkar A, Freeman J, Ellis C, Shah A, Gada H, Coylewright M, Lo M, Agarwal H, Lakkireddy D. Amulet Occluder Implantation in Patients With Failed Prior Left Atrial Appendage Occlusion EMERGE LAA Insights. JACC Cardiovascular Interventions 2024, 17: 457-459. PMID: 38355277, DOI: 10.1016/j.jcin.2023.12.012.Peer-Reviewed Original ResearchFirst 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 effectSafety and Efficacy of Combining Left Atrial Appendage Occlusion With Another Cardiac Procedure
Ismayl M, Ahmed H, Freeman J, Alkhouli M, Lakkireddy D, Goldsweig A. Safety and Efficacy of Combining Left Atrial Appendage Occlusion With Another Cardiac Procedure. JACC Cardiovascular Interventions 2024, 17: 262-273. PMID: 38267141, DOI: 10.1016/j.jcin.2023.10.017.Peer-Reviewed Original ResearchConceptsLeft atrial appendage occlusionLength of stayCardiac proceduresIn-hospital mortalityAppendage occlusionOutcomes of left atrial appendage occlusionConcomitant transcatheter aortic valve replacementVascular injuryTranscatheter aortic valve replacementConcomitant procedure groupConcomitant cardiac proceduresAortic valve replacementOdds of MACEAcute kidney injuryNational Inpatient Sample databaseRetrospective cohort studyRetrospective observational studyAdverse cardiovascular eventsInpatient Sample databaseOdds of strokeFlutter ablationValve replacementBlood transfusionClinical outcomesHeart block
2023
Correction: 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. Correction: 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: 637-637. PMID: 38019421, DOI: 10.1007/s10840-023-01704-8.Peer-Reviewed Original ResearchDAPT Is Comparable to OAC Following LAAC With WATCHMAN FLX A National Registry Analysis
Coylewright M, Holmes D, Kapadia S, Hsu J, Gibson D, Freeman J, Yeh R, Piccini J, Price M, Allocco D, Nair D. DAPT Is Comparable to OAC Following LAAC With WATCHMAN FLX A National Registry Analysis. JACC Cardiovascular Interventions 2023, 16: 2708-2718. PMID: 37943200, DOI: 10.1016/j.jcin.2023.08.013.Peer-Reviewed Original ResearchConceptsDual antiplatelet therapyDevice-related thrombusOral anticoagulationWatchman FLXStroke preventionLong-term oral anticoagulationComposite endpoint rateMedical therapy optionsNational registry analysisSimilar safety profilePropensity-matched analysisAtrial appendage occlusionAspirin patientsDAPT patientsMajor bleedingAntiplatelet therapyComposite endpointDrug regimensMedication regimensAppendage occlusionComorbid conditionsAtrial fibrillationRegistry analysisSafety profileMean ageFrailty 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 burdenIntracardiac 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 ratesEchocardiographyTCT-33 Racial Disparities in the Utilization and Outcomes of LAA Occlusion Using Watchman FLX: A SURPASS analysis of the NCDR LAAO Registry
Alli S, Garg J, Kapadia S, Yeh R, Price M, Piccini J, Nair D, Hsu J, Christen T, Allocco D, Freeman J. TCT-33 Racial Disparities in the Utilization and Outcomes of LAA Occlusion Using Watchman FLX: A SURPASS analysis of the NCDR LAAO Registry. Journal Of The American College Of Cardiology 2023, 82: b14. DOI: 10.1016/j.jacc.2023.09.038.Peer-Reviewed Original ResearchLeft ventricular lead implantation failure in an unselected nationwide cohort
Friedman D, Qin L, Freeman J, Singh J, Curtis J, Piccini J, Al-Khatib S, Jackson K. Left ventricular lead implantation failure in an unselected nationwide cohort. Heart Rhythm 2023, 20: 1420-1428. PMID: 37406870, DOI: 10.1016/j.hrthm.2023.06.023.Peer-Reviewed Original ResearchImplant failureIndependent predictorsSleep apneaBlack raceFemale sexQRS durationHispanic ethnicityNational Cardiovascular Data Registry ICD RegistryYounger ageLeft bundle branch blockCoronary sinus dissectionPredictors of LVUnselected nationwide cohortVentricular lead implantationCardiac resynchronization therapy (CRT) proceduresObstructive sleep apneaImplant failure rateSignificant independent predictorsBundle branch blockCoronary sinus accessCRT implantationDiaphragmatic stimulationNationwide cohortEjection fractionICD RegistryImpact of Preprocedure Imaging for Left Atrial Appendage Occlusion Insights From the NCDR LAAO Registry
Clarke J, Higgins A, Wang Y, Faridi K, Curtis J, Freeman J, Friedman D. Impact of Preprocedure Imaging for Left Atrial Appendage Occlusion Insights From the NCDR LAAO Registry. JACC Cardiovascular Interventions 2023, 16: 1317-1328. PMID: 37316143, DOI: 10.1016/j.jcin.2023.05.008.Peer-Reviewed Original ResearchConceptsDevice successImplantation successPreprocedure imagingProcedure successLAAO proceduresAbnormal renal functionAtrial appendage occlusionMultivariable logistic regressionOutcomes of interestMagnitude of benefitLAAO implantationPrior thromboembolismUncontrolled hypertensionRate of useRenal functionAppendage occlusionProcedural successUniversity HospitalLogistic regressionCMR useOverall rateCMRPatientsPreprocedureRegistryIn-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 typeLesionsSCAI/HRS Expert Consensus Statement on Transcatheter Left Atrial Appendage Closure
Saw J, Holmes D, Cavalcante J, Freeman J, Goldsweig A, Kavinsky C, Moussa I, Munger T, Price M, Reisman M, Sherwood M, Turi Z, Wang D, Whisenant B. SCAI/HRS Expert Consensus Statement on Transcatheter Left Atrial Appendage Closure. Journal Of The Society For Cardiovascular Angiography & Interventions 2023, 2: 100577. DOI: 10.1016/j.jscai.2022.100577.Peer-Reviewed Original ResearchAtrial appendage closureAppendage closureConsensus statementTranscatheter Left Atrial Appendage ClosureLeft atrial appendage closureImportant clinical trialsExpert consensus statementLeft atrial appendageCardiovascular Computed TomographyDrug Administration approvalEvidence-based best practicesThromboembolic riskWatchman deviceLAAC procedureAtrial fibrillationAtrial appendageAdministration approvalClinical trialsCardiovascular AngiographyAmerican CollegeComputed tomographyClinical developmentClinical practiceEndovascular devices