2025
Addressing Peri-Device Leaks in Next-Generation Transcatheter Left Atrial Appendage Occluders: An Open Question
Roshanfar M, Jang S, Sinusas A, Wong S, Mosadegh B. Addressing Peri-Device Leaks in Next-Generation Transcatheter Left Atrial Appendage Occluders: An Open Question. Surgeries 2025, 6: 15. DOI: 10.3390/surgeries6010015.Peer-Reviewed Original ResearchPeri-device leakLeft atrial appendageFDA-approved devicesRisk of thrombo-embolic eventsNon-valvular atrial fibrillationLeft atrial appendage anatomyLong-term anticoagulationPercutaneous LAA occlusionCHA2DS2-VASc scoreThrombo-embolic eventsIncreased risk of strokeRisk of strokeCircular cross-sectionLeft atrial appendage occluderSystemic embolismAnticoagulant therapyLAA occlusionObservational registryCHA2DS2-VAScNon-pharmacological alternativeAdverse eventsAtrial fibrillationAtrial appendageClinical dataIncreased risk
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 effectApproval, Evidence, and “Off-Label” Device Utilization: The Patent Foramen Ovale Closure Story
Goldsweig A, Deng Y, Yao X, Desai N, Cohen D, Aronow H, Messé S, Ross J, Lansky A, Savitz S. Approval, Evidence, and “Off-Label” Device Utilization: The Patent Foramen Ovale Closure Story. Circulation Cardiovascular Quality And Outcomes 2024, 17: e010200. PMID: 38189127, PMCID: PMC10844981, DOI: 10.1161/circoutcomes.123.010200.Peer-Reviewed Original ResearchStroke/systemic embolismTransient ischemia attackPFO closureSystemic embolismIschemia attackRetrospective cohort studyTransient ischemic attackHalf of patientsOptumLabs Data WarehouseCommercial insurance enrolleesRegulatory approvalClinical trial publicationsIschemic attackRecurrent strokeCohort studyPatent foramenUnderwent closureAtrial fibrillationClinical trialsInsurance enrolleesDecompression illnessTrial publicationsOff labelPatientsProcedure volume
2022
Body mass index from the RE-LY trial: further evidence of the obesity paradox
Jacobs M, Ezekowitz M, Nagarakanti R, Eikelboom J, Khan O, Reiss J, Liu H, McAndrew T, Francese D, Arce J, Brueckmann M, Connolly S, Yusuf S. Body mass index from the RE-LY trial: further evidence of the obesity paradox. European Heart Journal 2022, 43: ehac544.629. DOI: 10.1093/eurheartj/ehac544.629.Peer-Reviewed Original ResearchBody mass indexDirect oral anticoagulantsRE-LY trialObesity paradoxMajor bleedingIntracranial hemorrhageSystemic embolismIschemic strokeDrug assignmentMass indexResults Body mass indexHigher body mass indexWorld Health Organization criteriaCox proportional hazards modelIntracranial hemorrhage rateIschemic stroke rateRates of diabetesProportional hazards modelContinuous variablesLower ratesPrior strokeOral anticoagulantsRE-LYBaseline characteristicsCreatinine clearancePercutaneous Left Atrial Appendage Occlusion in Comparison to Non‐Vitamin K Antagonist Oral Anticoagulant Among Patients With Atrial Fibrillation
Noseworthy PA, Van Houten HK, Krumholz HM, Kent DM, Abraham NS, Graff‐Radford J, Alkhouli M, Henk HJ, Shah ND, Gersh BJ, Friedman PA, Holmes DR, Yao X. Percutaneous Left Atrial Appendage Occlusion in Comparison to Non‐Vitamin K Antagonist Oral Anticoagulant Among Patients With Atrial Fibrillation. Journal Of The American Heart Association 2022, 11: e027001. PMID: 36172961, PMCID: PMC9673739, DOI: 10.1161/jaha.121.027001.Peer-Reviewed Original ResearchConceptsComposite end pointAtrial appendage occlusionOral anticoagulantsAtrial fibrillationLower riskMajor bleedingSystemic embolismIntracranial bleedingAppendage occlusionNon-Vitamin K Antagonist Oral AnticoagulantsIschemic stroke/systemic embolismK Antagonist Oral AnticoagulantsPrimary composite end pointPropensity score overlap weightingStroke/systemic embolismEnd pointHigh bleeding riskSignificant differencesAntithrombotic regimensBleeding riskCause mortalityBaseline characteristicsComposite outcomeIschemic strokeSecondary outcomesResidual stroke risk despite oral anticoagulation in patients with atrial fibrillation
Carlisle M, Shrader P, Fudim M, Pieper K, Blanco R, Fonarow G, Naccarelli G, Gersh B, Reiffel J, Kowey P, Steinberg B, Freeman J, Ezekowitz M, Singer D, Allen L, Chan P, Pokorney S, Peterson E, Piccini J, Patients and Investigators O. Residual stroke risk despite oral anticoagulation in patients with atrial fibrillation. Heart Rhythm O2 2022, 3: 621-628. PMID: 36589908, PMCID: PMC9795305, DOI: 10.1016/j.hroo.2022.09.018.Peer-Reviewed Original ResearchTransient ischemic attackPermanent atrial fibrillationOral anticoagulationAtrial fibrillationVASc scoreIschemic attackThromboembolic eventsFemale sexPrevious stroke/transient ischemic attackStroke/transient ischemic attackTransient ischemic attack eventsCox proportional hazard modelingResidual riskResidual stroke riskBetter Informed TreatmentRisk of thromboembolismProportional hazard modelingSystemic embolismPrevious strokeStroke riskOutcomes RegistryMean ageRisk markersOutcome eventsThromboembolismPeriprocedural 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 ResearchConceptsAtrial 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
Personalizing the decision of dabigatran versus warfarin in atrial fibrillation: A secondary analysis of the Randomized Evaluation of Long-term anticoagulation therapY (RE-LY) trial
Reinhardt SW, Desai NR, Tang Y, Jones PG, Ader J, Spertus JA. Personalizing the decision of dabigatran versus warfarin in atrial fibrillation: A secondary analysis of the Randomized Evaluation of Long-term anticoagulation therapY (RE-LY) trial. PLOS ONE 2021, 16: e0256338. PMID: 34411158, PMCID: PMC8376053, DOI: 10.1371/journal.pone.0256338.Peer-Reviewed Original ResearchConceptsAbsolute risk reductionPrior stroke/TIAStroke/TIASystemic embolismAtrial fibrillationMajor bleedingRE-LYOlder patientsLong-Term Anticoagulation Therapy (RE-LY) trialStroke/systemic embolismGood renal functionHigh-risk patientsHistory of diabetesRE-LY trialPatient-level dataShared decision makingMedian followRenal functionHeart failureHeavier patientsMultivariable modelDabigatranIndividual patientsTreatment groupsIndividualized estimates
2020
Chapter 1 Embryology, Anatomy, and Physiology Anatomical Variations, Lipomatous Hypertrophy, Atrial Septal Aneurysm, Eustachian Valve, Chiari Network, Combination With Other Atrial Septal Defects
Kokkinidis D, Rios S, Avendano R, Zaidi A, Faillace R. Chapter 1 Embryology, Anatomy, and Physiology Anatomical Variations, Lipomatous Hypertrophy, Atrial Septal Aneurysm, Eustachian Valve, Chiari Network, Combination With Other Atrial Septal Defects. 2020, 3-12. DOI: 10.1016/b978-0-12-816966-7.00001-4.Peer-Reviewed Original ResearchPatent foramen ovaleAtrial septal aneurysmSeptal aneurysmPercutaneous closureEustachian valveInteratrial septumChiari networkSerious clinical syndromeAtrial septal defectCongenital cardiac malformationsParadoxical systemic embolismSystemic embolismIschemic strokeProfound hypoxemiaLipomatous hypertrophyForamen ovaleAnatomic anomaliesClinical syndromeInteratrial communicationMyocardial infarctionSeptal defectRisk factorsClinical impactMigraine headacheCardiac malformations
2019
Outcomes and Anticoagulation Use After Catheter Ablation for Atrial Fibrillation
Freeman JV, Shrader P, Pieper KS, Allen LA, Chan PS, Fonarow GC, Gersh BJ, Kowey PR, Mahaffey KW, Naccarelli G, Reiffel JA, Singer DE, Go AS, Hylek EM, Steinberg BA, Peterson ED, Piccini JP. Outcomes and Anticoagulation Use After Catheter Ablation for Atrial Fibrillation. Circulation Arrhythmia And Electrophysiology 2019, 12: e007612. PMID: 31830822, DOI: 10.1161/circep.119.007612.Peer-Reviewed Original ResearchConceptsAF catheter ablationOral anticoagulationRisk of strokeAF ablationCatheter ablationAntiarrhythmic medicationsDe novo AF ablationDiscontinuation of OACPropensity score-matched cohortAtrial fibrillation catheter ablationAF ablation patientsAnti-arrhythmic medicationsAtrial Fibrillation RegistryStroke prevention therapyBetter Informed TreatmentCohort of patientsPatterns of treatmentProportional hazards regressionUS national registryAnticoagulation useCause deathMajor bleedingSystemic embolismCardiovascular deathCause hospitalization
2018
Pharmacotherapy for Atrial Fibrillation in Patients With Chronic Kidney Disease: Insights From ORBIT‐AF
Washam JB, Holmes DN, Thomas LE, Pokorney SD, Hylek EM, Fonarow GC, Mahaffey KW, Gersh BJ, Kowey PR, Ansell JE, Go AS, Reiffel JA, Freeman JV, Singer DE, Naccarelli G, Blanco R, Peterson ED, Piccini JP. Pharmacotherapy for Atrial Fibrillation in Patients With Chronic Kidney Disease: Insights From ORBIT‐AF. Journal Of The American Heart Association 2018, 7: e008928. PMID: 30371218, PMCID: PMC6222961, DOI: 10.1161/jaha.118.008928.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, OralAgedAged, 80 and overAnti-Arrhythmia AgentsAnticoagulantsAtrial FibrillationDabigatranDrug Therapy, CombinationFemaleFollow-Up StudiesHumansMaleMiddle AgedProspective StudiesRegistriesRenal Insufficiency, ChronicRisk FactorsStrokeTime FactorsTreatment OutcomeWarfarinConceptsBackground Chronic kidney diseaseAntiarrhythmic drug useTransient ischemic attackChronic kidney diseaseAtrial fibrillationAdvanced CKDCKD statusIschemic attackSystemic embolismCause mortalityCreatinine clearanceRhythm controlKidney diseaseDrug useAtrial fibrillation scoreBaseline renal functionOral anticoagulant useRhythm control strategyCox proportional hazardsCKD patientsMajor bleedingOAC useCardiovascular deathCKD stageHigher CHAPrognostic Significance of Nuisance Bleeding in Anticoagulated Patients With Atrial Fibrillation
O'Brien EC, Holmes DN, Thomas LE, Fonarow GC, Allen LA, Gersh BJ, Kowey PR, Singer DE, Ezekowitz MD, Naccarelli GV, Ansell JE, Chan PS, Mahaffey KW, Go AS, Freeman JV, Reiffel JA, Peterson ED, Piccini JP, Hylek EM. Prognostic Significance of Nuisance Bleeding in Anticoagulated Patients With Atrial Fibrillation. Circulation 2018, 138: 889-897. PMID: 29678813, DOI: 10.1161/circulationaha.117.031354.Peer-Reviewed Original ResearchConceptsStroke/systemic embolismMajor bleedingOral anticoagulantsAtrial fibrillationMinor bleeding eventsSubset of patientsVASc risk scorePooled logistic regressionYears of ageBleeding eventsEligible followOAC discontinuationOAC therapyOutpatient registrySystemic embolismAnticoagulated patientsMinor bleedingMedian ageTreatment satisfactionPrognostic significanceNuisance bleedingMedical recordsORBIT-AFIncidence ratePatient visits
2017
Novel Oral Anticoagulants in Atrial Fibrillation: Update on Apixaban
Mezue K, Obiagwu C, John J, Sharma A, Yang F, Shani J. Novel Oral Anticoagulants in Atrial Fibrillation: Update on Apixaban. Current Cardiology Reviews 2017, 13: 41-46. PMID: 27450450, PMCID: PMC5324317, DOI: 10.2174/1573403x12666160720092024.Peer-Reviewed Original ResearchConceptsFood and Drug AdministrationAtrial fibrillationReversal agentsClinical trialsNon-valvular atrial fibrillationSignificant mitral stenosisNovel oral anticoagulantsUS Food and Drug AdministrationOnset of actionPrimary safety outcomeClinical trial dataPrevention of strokeRate of strokeInhibitors of factor XaProsthetic heart valvesClinical bleedingApixaban useSystemic embolismOral anticoagulantsINR monitoringMitral stenosisDose variabilityNOACsApixabanCardiac arrhythmias
2015
Randomized trial of atrial arrhythmia monitoring to guide anticoagulation in patients with implanted defibrillator and cardiac resynchronization devices
Martin DT, Bersohn MM, Waldo AL, Wathen MS, Choucair WK, Lip GY, Ip J, Holcomb R, Akar JG, Halperin JL. Randomized trial of atrial arrhythmia monitoring to guide anticoagulation in patients with implanted defibrillator and cardiac resynchronization devices. European Heart Journal 2015, 36: 1660-1668. PMID: 25908774, DOI: 10.1093/eurheartj/ehv115.Peer-Reviewed Original ResearchConceptsAtrial tachyarrhythmiasMajor bleedingImplanted defibrillatorsInterruption of anticoagulationRemote rhythm monitoringStandard clinical criteriaCardiac resynchronization devicesAT burdenSystemic embolismThromboembolism ratesPrimary endpointComposite endpointBiventricular defibrillatorMedian timeAtrial fibrillationClinical criteriaResynchronization devicesEarly initiationAnticoagulationRhythm monitoringBleedingPatientsPrimary analysisControl groupAtrial electrograms
2009
Multicenter randomized study of anticoagulation guided by remote rhythm monitoring in patients with implantable cardioverter-defibrillator and CRT-D devices: Rationale, design, and clinical characteristics of the initially enrolled cohort The IMPACT study
Ip J, Waldo AL, Lip GY, Rothwell PM, Martin DT, Bersohn MM, Choucair WK, Akar JG, Wathen MS, Rohani P, Halperin JL, Investigators F. Multicenter randomized study of anticoagulation guided by remote rhythm monitoring in patients with implantable cardioverter-defibrillator and CRT-D devices: Rationale, design, and clinical characteristics of the initially enrolled cohort The IMPACT study. American Heart Journal 2009, 158: 364-370.e1. PMID: 19699858, DOI: 10.1016/j.ahj.2009.07.002.Peer-Reviewed Original ResearchConceptsAtrial high-rate episodesRisk of strokeAnticoagulant therapyAtrial fibrillationAtrial flutterCardiac resynchronization therapy-defibrillator deviceConventional clinical managementRemote rhythm monitoringStudies of anticoagulationRate of strokeOral anticoagulant therapyHigh-rate episodesAdditional risk factorsCRT-D devicesStroke risk stratificationCommon cardiac arrhythmiaAHRE burdenElectrocardiographic documentationMajor bleedingSystemic embolismProphylactic therapyClinical characteristicsStroke riskAnticoagulation decisionsClinical features
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