2022
Development 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 confirmationBleeding
2015
Safety and performance of a novel embolic deflection device in patients undergoing transcatheter aortic valve replacement: results from the DEFLECT I study.
Baumbach A, Mullen M, Brickman AM, Aggarwal SK, Pietras CG, Forrest JK, Hildick-Smith D, Meller SM, Gambone L, den Heijer P, Margolis P, Voros S, Lansky AJ. Safety and performance of a novel embolic deflection device in patients undergoing transcatheter aortic valve replacement: results from the DEFLECT I study. EuroIntervention 2015, 11: 75-84. PMID: 25868876, DOI: 10.4244/eijy15m04_01.Peer-Reviewed Original ResearchMeSH KeywordsAgedAged, 80 and overAlloysAortic ValveAortic Valve StenosisBrain IschemiaBrazilCardiac CatheterizationCognitionCognition DisordersDiffusion Magnetic Resonance ImagingEmbolic Protection DevicesEuropeFemaleHeart Valve ProsthesisHeart Valve Prosthesis ImplantationHumansIntracranial EmbolismMalePredictive Value of TestsProspective StudiesProsthesis DesignRisk FactorsSeverity of Illness IndexStrokeTime FactorsTreatment OutcomeUltrasonography, Doppler, TranscranialConceptsTranscatheter aortic valve replacementAortic valve replacementValve replacementNew cerebral ischemic lesionsCerebral diffusion-weighted magnetic resonance imagingCerebral ischemic lesionsDays post procedurePrimary safety endpointDiffusion-weighted magnetic resonance imagingMajor cerebral arteriesTotal lesion volumeMagnetic resonance imagingSafety endpointIschemic lesionsTAVR proceduresCerebral arteryCerebral circulationConsecutive subjectsPost procedureAortic archHistorical controlsLesion volumeResonance imagingDW-MRIPatients
2009
Bivalirudin in patients undergoing primary angioplasty for acute myocardial infarction (HORIZONS-AMI): 1-year results of a randomised controlled trial
Mehran R, Lansky AJ, Witzenbichler B, Guagliumi G, Peruga JZ, Brodie BR, Dudek D, Kornowski R, Hartmann F, Gersh BJ, Pocock SJ, Wong SC, Nikolsky E, Gambone L, Vandertie L, Parise H, Dangas GD, Stone GW, Investigators F. Bivalirudin in patients undergoing primary angioplasty for acute myocardial infarction (HORIZONS-AMI): 1-year results of a randomised controlled trial. The Lancet 2009, 374: 1149-1159. PMID: 19717185, DOI: 10.1016/s0140-6736(09)61484-7.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAngioplasty, Balloon, CoronaryAnticoagulantsFemaleFollow-Up StudiesHemorrhageHeparinHirudinsHumansKaplan-Meier EstimateMaleMiddle AgedMyocardial InfarctionPeptide FragmentsPlatelet Aggregation InhibitorsPlatelet Glycoprotein GPIIb-IIIa ComplexProportional Hazards ModelsRecombinant ProteinsStentsSurvival RateThrombosisTreatment OutcomeConceptsGlycoprotein IIb/IIIa inhibitorsST-segment elevation myocardial infarctionNet adverse clinical eventsPercutaneous coronary interventionAdverse clinical eventsBivalirudin groupMajor bleedingClinical eventsControl groupMyocardial infarctionAcute ST-segment elevation myocardial infarctionIIb/IIIa inhibitorsPrimary percutaneous coronary interventionHORIZONS-AMI trialMajor haemorrhagic complicationsPrimary trial endpointRate of MACERate of NACEElevation myocardial infarctionOnset of symptomsAcute myocardial infarctionOptimum treatment strategyWithdrawal of consentThrombin inhibitor bivalirudinImportant clinical implications