2024
Clinical Significance of Diffusion-Weighted Brain MRI Lesions After TAVR Results of a Patient-Level Pooled Analysis
Lansky A, Grubman D, Dwyer M, Zivadinov R, Parise H, Moses J, Shah T, Pietras C, Tirziu D, Gambone L, Leon M, Nazif T, Messé S. Clinical Significance of Diffusion-Weighted Brain MRI Lesions After TAVR Results of a Patient-Level Pooled Analysis. Journal Of The American College Of Cardiology 2024, 84: 712-722. PMID: 39142725, DOI: 10.1016/j.jacc.2024.05.055.Peer-Reviewed Original ResearchConceptsTranscatheter aortic valve replacementClinical ischemic strokeAcute brain infarctionDW-MRIReceiver operating characteristicIschemic strokeTranscatheter aortic valve replacement resultBrain infarctionPatient-level pooled analysisC-statisticBrain MRI lesionsAcute ischemic brain injuryDiffusion-weighted magnetic resonance imagingAortic valve replacementIndividual lesion volumesCore laboratory analysisIschemic brain injuryPredicting ischemic strokeMagnetic resonance imagingStroke Prevention TrialMRI lesionsValve replacementDW-MRI acquisitionsPatient-level dataPooled analysis
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 ResearchConceptsEnd 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
2007
Cobalt chromium stent with antiproliferative for restenosis trial in India (COSTAR I).
Kaul U, Gupta RK, Mathur A, Dani S, Sapra R, Nayak PR, Lansky A, Cristea E, Carlier S, Gambone L, Litvack F. Cobalt chromium stent with antiproliferative for restenosis trial in India (COSTAR I). Indian Heart Journal 2007, 59: 165-72. PMID: 19122251.Peer-Reviewed Original ResearchConceptsStent late lossGroup 2Group 1Late lossI trialCoronary lesionsGroup 3De novo coronary lesionsSegment late lossBinary restenosis rateNative coronary lesionsNovo coronary lesionsMulti-center registryCoronary stent systemRelease formulationExtended-release formulationSmall-caliber vesselsCobalt-chromium stentNovo lesionsPrimary endpointRestenosis TrialRestenosis rateClinical outcomesFeasibility trialClinical results
2005
The Effect of Variable Dose and Release Kinetics on Neointimal Hyperplasia Using a Novel Paclitaxel-Eluting Stent Platform The Paclitaxel In-Stent Controlled Elution Study (PISCES)
Serruys P, Sianos G, Abizaid A, Aoki J, Heijer P, Bonnier H, Smits P, McClean D, Verheye S, Belardi J, Condado J, Pieper M, Gambone L, Bressers M, Symons J, Sousa E, Litvack F. The Effect of Variable Dose and Release Kinetics on Neointimal Hyperplasia Using a Novel Paclitaxel-Eluting Stent Platform The Paclitaxel In-Stent Controlled Elution Study (PISCES). Journal Of The American College Of Cardiology 2005, 46: 253-260. PMID: 16022951, DOI: 10.1016/j.jacc.2005.03.069.Peer-Reviewed Original ResearchConceptsMajor adverse cardiac eventsStent late lossLate lossNeointimal hyperplasiaRelease kineticsVolume obstructionStent groupErodable polymerStent platformsVariable dosePolymer coatingAdverse cardiac eventsSingle-vessel diseasePaclitaxel-eluting stentsAngiographic late lossBare stent groupStent neointimal hyperplasiaDurable polymer coatingDrug deliverySub-acute thrombosisTLR rateCardiac eventsRestenosis rateVessel diseaseIntravascular ultrasound