2024
Moving Beyond Devices to Patient Selection A New Frontier in Stroke Prevention After TAVR
Ahmad Y, Lansky A. Moving Beyond Devices to Patient Selection A New Frontier in Stroke Prevention After TAVR. JACC Cardiovascular Interventions 2024, 17: 1691-1692. PMID: 39048256, DOI: 10.1016/j.jcin.2024.06.017.Peer-Reviewed Original Research
2023
Sex Differences in pLVAD-Assisted High-Risk Percutaneous Coronary Intervention Insights From the PROTECT III Study
Shah T, Abu-Much A, Batchelor W, Grines C, Baron S, Zhou Z, Li Y, Maini A, Redfors B, Hussain Y, Wollmuth J, Basir M, O'Neill W, Lansky A. Sex Differences in pLVAD-Assisted High-Risk Percutaneous Coronary Intervention Insights From the PROTECT III Study. JACC Cardiovascular Interventions 2023, 16: 1721-1729. PMID: 37409991, DOI: 10.1016/j.jcin.2023.04.036.Peer-Reviewed Original ResearchConceptsHigh-risk percutaneous coronary interventionFemale patientsIII studySex-based differencesImmediate PCISYNTAX scoreClinical outcomesMyocardial infarctionStroke/transient ischemic attackWorse renal functionAcute limb ischemiaTransient ischemic attackSex differencesPercutaneous coronary interventionAcute myocardial infarctionHigher ejection fractionCause deathCoronary complicationsIschemic attackMajor bleedingNonfemoral accessPercutaneous CoronaryPrior strokeCerebrovascular eventsVascular complicationsColchicine and high-intensity rosuvastatin in the treatment of non-critically ill patients hospitalised with COVID-19: a randomised clinical trial
Shah T, McCarthy M, Nasir I, Archer H, Ragheb E, Kluger J, Kashyap N, Paredes C, Patel P, Lu J, Kandel P, Song C, Khan M, Huang H, Haq F, Ahmad R, Howes C, Cambi B, Lancaster G, Cleman M, Dela Cruz C, Parise H, Lansky A. Colchicine and high-intensity rosuvastatin in the treatment of non-critically ill patients hospitalised with COVID-19: a randomised clinical trial. BMJ Open 2023, 13: e067910. PMID: 36828654, PMCID: PMC9971831, DOI: 10.1136/bmjopen-2022-067910.Peer-Reviewed Original ResearchConceptsStandard of careHigh-intensity rosuvastatinElectronic medical recordsCOVID-19 diseaseMedical recordsPrimary endpointThromboembolic eventsYale New Haven Health SystemSevere COVID-19 diseaseCOVID-19Prespecified primary endpointVenous thromboembolic eventsRisk of progressionCombination of colchicineSafety monitoring boardCare armHispanics/LatinosTherapeutic anticoagulationIndex hospitalisationIll patientsMedian ageFuture trialsEffect of colchicineClinical trialsMonitoring boardPublic Reporting of Stroke After Transcatheter Aortic Valve Replacement A Cautionary Tale ∗
Lansky A, Ahmad Y. Public Reporting of Stroke After Transcatheter Aortic Valve Replacement A Cautionary Tale ∗. JACC Cardiovascular Interventions 2023, 16: 177-178. PMID: 36697153, DOI: 10.1016/j.jcin.2022.11.010.Peer-Reviewed Original Research
2022
Impella Versus Intra-Aortic Balloon Pump for High-Risk PCI: A Propensity-Adjusted Large-Scale Claims Dataset Analysis
Lansky AJ, Tirziu D, Moses JW, Pietras C, Ohman EM, O'Neill WW, Ekono MM, Grines CL, Parise H. Impella Versus Intra-Aortic Balloon Pump for High-Risk PCI: A Propensity-Adjusted Large-Scale Claims Dataset Analysis. The American Journal Of Cardiology 2022, 185: 29-36. PMID: 36210212, DOI: 10.1016/j.amjcard.2022.08.032.Peer-Reviewed Original ResearchConceptsHigh-risk percutaneous coronary interventionIntra-aortic balloon pumpPercutaneous coronary interventionAcute kidney injuryCardiogenic shockMyocardial infarctionIABP supportKidney injuryBalloon pumpImproved survivalPropensity adjustmentAcute ST-elevation myocardial infarctionST-elevation myocardial infarctionIndex hospitalization lengthLess myocardial infarctionPremier Healthcare DatabaseHospital myocardial infarctionPropensity-adjusted analysisMechanical circulatory supportMechanical support devicesImpella useHospital survivalIndex hospitalizationCoronary interventionReal-world practiceSelf-expanding Transcatheter vs Surgical Aortic Valve Replacement in Intermediate-Risk Patients
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Neumann F, Büttner H, Comberg T, Diab N, Gick M, Günkel L, Pingpoh C, Rothe H, Siepe M, Thoma M, Winker T, Hager C, Sänger U, Stader M, Biaggi P, Gruner C, Stämpfli S, Binder R, Corti R, Falk V, Holy E, Maisano F, Grünenfelder J, Holubec T, Maier W, Nietlispach F, Wegener S, Atkinson R, Davis A, Hall S, Mangene S, Mazzurco S, Hoit B, Musarra R, Costa M, Markowitz A, Asi K, Attizzani G, Chuang D, Elgudin Y, Garcia C, Jadhav V, Le S, Miller B, Serkin Z, Shams T, Sila C, Simon D, Bezerra H, Deo S, Anderson J, Greening K, Karson J, Page S, Shawgo T, Freeman J, Mulhern K, Nath J, Tadros P, Zorn G, Hockstad E, Lechtenberg C, Muehlebach G, Rippee M, Rosterman L, Sundararajan J, Wang Y, Wiley M, Atapattu S, Marin y Kall C, Lowery M, de Marchena E, Salerno T, Alfonso C, Carillo R, Ferreira A, Panos A, Romano J, Williams D, Bhatt S, Migda E, Oakley J, Warshal W, Wilcock S, Booher A, LaBounty T, Chetcuti S, Deeb G, Adelman E, Boyle M, Geml R, Grossman P, Guerin D, Hodges K, Kim K, Lammers D, McDermott M, Menees D, Pace R, Patel H, Prager R, Ramchandren S, Romano M, Stamper A, Wang M, Zahuranec D, Ziarkiewicz M, Charlebois C, Chilton C, Labinaz M, Ruel M, Glover C, Lam K, Masters R, Steffenhagen N, Enlow-Germovsek M, Konopka K, McGargle R, Travis M, Anderson K, Cavalcante J, Crock F, Edelman K, Katz W, Gleason T, Lee J, Sultan I, Aghaebrahim A, Al-Bayai A, Bonaccorsi C, Campbell D, Giurgiutiu D, Gulati D, Hawkes C, Henry L, Jadhav A, Kenmuir C, Klein B, Kliner D, Limaye K, Nanduri S, Navid F, Patel P, Rangaraju S, Rocha M, Schindler J, Shoirah H, Streib C, Tadi P, Tememe D, Totoraitis R, Walker G, Ziayee H, Caufield L, Yeager C, Forbes J, Schwart K, Knight P, Ling F, Benesch C, Bogachan S, Hicks G, Kelly A, Narins C, Stuver T, Adams K, Blair-Anton L, Haynes M, Watts C, Baker M, Mendes L, Ball S, Goel K, Kaiser C, Robbins M, Zhao D, Ahmad R, Crenshaw M, Fredi J, Hermann L, Hoff S, Kirshner H, Levack M, Mittal S, O'Duffy A, Petracek M, Baer J, Liang G, Nguyen S, Heidenreich P, Nguyen P, Burdon T, Giacomini J, Yong C, Buchbinder M, Fann J, Kilgore S, Mitchell R, McDaniel S, Pack A, White W, Young T, Burgess P, Pu M, Upadhya B, Applegate R, Kon N, Arnan M, Baghshomali S, Bishop L, Bradbury E, Gandhi S, Kincaid E, Lefkowitz D, Lisle B, Batteria M, Rerisi E, Stepinowski K, Senicola T, Goncalves J, Schubach S, Schwartz R, Antaky K, Christiansen C, Marzo K, Michel K, Misra A, Varghese P, Wirkowski E, Levesque L, Sugeng L, Cleman M, Forrest J, Hashim S, Mangi A, Amin H, Darr U, Dewar M, Faheem O, Geirsson A, Greer D, Kaleel A, Kaple R, Lansky A, MacGrory B, Pfau S, Schindler J, Thompson C, Youn T, Yuh D, Yun J. Self-expanding Transcatheter vs Surgical Aortic Valve Replacement in Intermediate-Risk Patients. JAMA Cardiology 2022, 7: 1000-1008. PMID: 36001335, PMCID: PMC9403849, DOI: 10.1001/jamacardio.2022.2695.Peer-Reviewed Original ResearchConceptsTranscatheter aortic valve replacementAortic valve replacementSevere aortic valve stenosisIntermediate-risk patientsAortic valve stenosisValve replacementAdverse eventsAortic stenosisValve stenosisParavalvular leakClinical trialsIndependent echocardiographic core laboratorySurgical aortic valve replacementSymptomatic severe aortic stenosisIndependent clinical events committeePrespecified secondary end pointsEchocardiographic core laboratoryIntermediate surgical riskIntermediate-risk subjectsLocal heart teamSecondary end pointsSerious adverse eventsSevere aortic stenosisSymptomatic aortic stenosisAortic valve areaSafety and performance of a novel cerebral embolic protection device for transcatheter aortic valve implantation: the PROTEMBO C Trial.
Jagielak D, Targonski R, Frerker C, Abdel-Wahab M, Wilde J, Werner N, Lauterbach M, Leick J, Grygier M, Misterski M, Erglis A, Narbute I, Witkowski AR, Adam M, Frank D, Gatto F, Schmidt T, Lansky AJ. Safety and performance of a novel cerebral embolic protection device for transcatheter aortic valve implantation: the PROTEMBO C Trial. EuroIntervention 2022, 18: 590-597. PMID: 35608032, PMCID: PMC10241272, DOI: 10.4244/eij-d-22-00238.Peer-Reviewed Original ResearchConceptsTranscatheter aortic valve implantationAortic valve implantationLesion volumeValve implantationTechnical successC trialSingle lesionCerebral embolic protection devicesPerformance endpointBrain diffusion-weighted magnetic resonance imagingLarge single lesionsPrimary safety endpointBrain lesion volumeDiffusion-weighted magnetic resonance imagingCerebral protection systemSingle-arm studyEmbolic protection devicesPrimary performance endpointRate of deathMagnetic resonance imagingTAVI casesTAVI patientsVARC-2Cerebrovascular eventsPrimary endpointDevelopment 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
2021
Randomized Evaluation of TriGuard 3 Cerebral Embolic Protection After Transcatheter Aortic Valve Replacement REFLECT II
Nazif TM, Moses J, Sharma R, Dhoble A, Rovin J, Brown D, Horwitz P, Makkar R, Stoler R, Forrest J, Messé S, Dickerman S, Brennan J, Zivadinov R, Dwyer MG, Lansky AJ, Investigators R. Randomized Evaluation of TriGuard 3 Cerebral Embolic Protection After Transcatheter Aortic Valve Replacement REFLECT II. JACC Cardiovascular Interventions 2021, 14: 515-527. PMID: 33663779, DOI: 10.1016/j.jcin.2020.11.011.Peer-Reviewed Original ResearchConceptsTranscatheter aortic valve replacementAortic valve replacementSafety endpointValve replacementProcedure-related ischemic strokeCerebral embolic protectionComposite efficacy endpointPrimary safety endpointCerebral embolizationCerebral protectionEfficacy endpointII trialCerebral injuryIschemic strokeEmbolic protectionPatientsDrug AdministrationUS sitesU.S. FoodEndpointData reviewTrialsMulticenterEmbolizationInjury
2020
Cerebral Embolic Protection Burden of Proof ∗
Lansky A, Pietras C, Shah T. Cerebral Embolic Protection Burden of Proof ∗. JACC Cardiovascular Interventions 2020, 13: 2156-2158. PMID: 32972579, DOI: 10.1016/j.jcin.2020.06.030.Peer-Reviewed Original ResearchAdjunctive Antithrombotic Therapy for Patients With Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement
Saito Y, Nazif T, Baumbach A, Tchétché D, Latib A, Kaple R, Forrest J, Prendergast B, Lansky A. Adjunctive Antithrombotic Therapy for Patients With Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement. JAMA Cardiology 2020, 5: 92-101. PMID: 31721980, DOI: 10.1001/jamacardio.2019.4367.Peer-Reviewed Original ResearchConceptsTranscatheter aortic valve replacementAortic valve replacementAdjunctive antithrombotic therapyDual antiplatelet therapyAntithrombotic therapyAntiplatelet therapyValve replacementAortic stenosisAortic stenosis (AS) undergoing transcatheter aortic valve replacementSevere symptomatic aortic stenosisSurgical aortic valve replacementGuideline-recommended regimenOral anticoagulant useSevere aortic stenosisSingle antiplatelet therapySymptomatic aortic stenosisPatient risk factorsOngoing clinical trialsRisk prediction modelMajor bleedingOral anticoagulationAnticoagulant useStroke riskTAVR proceduresThrombotic risk
2018
Carotid Disease and Stroke After Transcatheter Aortic Valve Replacement
Lansky AJ, Ghare MI, Pietras C. Carotid Disease and Stroke After Transcatheter Aortic Valve Replacement. Circulation Cardiovascular Interventions 2018, 11: e006826. PMID: 29895605, DOI: 10.1161/circinterventions.118.006826.Peer-Reviewed Original Research2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials
Hicks KA, Mahaffey KW, Mehran R, Nissen SE, Wiviott SD, Dunn B, Solomon SD, Marler JR, Teerlink JR, Farb A, Morrow DA, Targum SL, Sila CA, Hai M, Jaff MR, Joffe HV, Cutlip DE, Desai AS, Lewis EF, Gibson CM, Landray MJ, Lincoff AM, White CJ, Brooks SS, Rosenfield K, Domanski MJ, Lansky AJ, McMurray JJV, Tcheng JE, Steinhubl SR, Burton P, Mauri L, O’Connor C, Pfeffer MA, Hung HMJ, Stockbridge NL, Chaitman BR, Temple RJ, Initiative S, Fitter H, Illoh K, Cavanaugh K, Scirica B, Irony I, Kichline R, Levine J, Park A, Sacks L, Szarfman A, Unger E, Wachter L, Zuckerman B, Mitchel Y, Peddicord D, Shook T, Kisler B, Jaffe C, Bartley R, DeMets D, Mencini M, Janning C, Bai S, Lawrence J, D’Agostino R, Pocock S. 2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials. Journal Of The American College Of Cardiology 2018, 71: 1021-1034. PMID: 29495982, DOI: 10.1016/j.jacc.2017.12.048.Peer-Reviewed Original ResearchConceptsClinical trialsStandardized data collectionTrials InitiativeProspective data collectionEffectiveness of drugsClinical care processesCardiovascular safetyStroke outcomeEndpoint definitionsWriting committeeDrug AdministrationCare processesU.S. FoodTrialsFurther studiesUniform definitionMedical product development programsMultiple trialsFDAData collectionCardiovascularAdministration2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials
Hicks KA, Mahaffey KW, Mehran R, Nissen SE, Wiviott SD, Dunn B, Solomon SD, Marler JR, Teerlink JR, Farb A, Morrow DA, Targum SL, Sila CA, Hai MTT, Jaff MR, Joffe HV, Cutlip DE, Desai AS, Lewis EF, Gibson CM, Landray MJ, Lincoff AM, White CJ, Brooks SS, Rosenfield K, Domanski MJ, Lansky AJ, McMurray JJV, Tcheng JE, Steinhubl SR, Burton P, Mauri L, O'Connor CM, Pfeffer MA, Hung HMJ, Stockbridge NL, Chaitman BR, Temple RJ. 2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials. Circulation 2018, 137: 961-972. PMID: 29483172, DOI: 10.1161/circulationaha.117.033502.Peer-Reviewed Original ResearchConceptsClinical trialsStandardized data collectionTrials InitiativeProspective data collectionEffectiveness of drugsClinical care processesCardiovascular safetyStroke outcomeEndpoint definitionsWriting committeeUS FoodDrug AdministrationCare processesTrialsFurther studiesUniform definitionMedical product development programsMultiple trialsFDAData collectionCardiovascularAdministration
2016
Transcatheter Aortic Valve Replacement in Women Versus Men (from the US CoreValve Trials)
Forrest JK, Adams DH, Popma JJ, Reardon MJ, Deeb GM, Yakubov SJ, Hermiller JB, Huang J, Skelding KA, Lansky A. Transcatheter Aortic Valve Replacement in Women Versus Men (from the US CoreValve Trials). The American Journal Of Cardiology 2016, 118: 396-402. PMID: 27346591, DOI: 10.1016/j.amjcard.2016.05.013.Peer-Reviewed Original ResearchMeSH KeywordsAgedAged, 80 and overAortic Valve StenosisCause of DeathComorbidityFemaleFrail ElderlyHumansIncidenceMaleMortalityPostoperative ComplicationsPostoperative HemorrhageSeverity of Illness IndexSex FactorsStrokeTranscatheter Aortic Valve ReplacementTreatment OutcomeVentricular Dysfunction, LeftConceptsTranscatheter aortic valve replacementAortic valve replacementCoreValve prosthesisValve replacementSevere symptomatic aortic stenosisSurgical aortic valve replacementLeft ventricular systolic functionWomen Versus MenMajor vascular complicationsSymptomatic aortic stenosisIncidence of strokeProcedure-related complicationsVentricular systolic functionCoronary artery diseaseLife-threatening bleedsSignificant baseline differencesGender-related differencesCause mortalityVascular complicationsBaseline characteristicsPatient characteristicsPrevious strokeSystolic functionAortic stenosisArtery disease
2015
The TriGuard embolic deflection device for prevention of stroke and cerebral embolization during transcatheter aortic valve replacement
Baumbach A, Pietras C, Lansky A. The TriGuard embolic deflection device for prevention of stroke and cerebral embolization during transcatheter aortic valve replacement. Expert Review Of Medical Devices 2015, 12: 649-651. PMID: 26364995, DOI: 10.1586/17434440.2015.1086642.Peer-Reviewed Original ResearchConceptsTranscatheter aortic valve implantationAortic valve implantationValve implantationTranscatheter aortic valve replacementIschemic cerebral eventsAortic valve replacementPrevention of strokeCerebral embolizationEmbolic strokeCerebral eventsEmbolic eventsValve replacementEmbolic lesionsClinical studiesNeurocognitive impairmentNeurocognitive functionMemory lossVessel ostiumStrokeBrain circulationImplantationEmbolizationOstiumLesionsIncidenceSafety 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
2014
Will this trial change my practice? TASTE - a randomised registry on thrombus aspiration in primary PCI with a 30-day endpoint.
Behan MW, Lansky AJ, Jolly S, Baumbach A. Will this trial change my practice? TASTE - a randomised registry on thrombus aspiration in primary PCI with a 30-day endpoint. EuroIntervention 2014, 10: 406-7. PMID: 25042270, DOI: 10.4244/eijv10i3a68.Peer-Reviewed Original ResearchLocal versus general anesthesia for transcatheter aortic valve implantation (TAVR) – systematic review and meta-analysis
Fröhlich GM, Lansky AJ, Webb J, Roffi M, Toggweiler S, Reinthaler M, Wang D, Hutchinson N, Wendler O, Hildick-Smith D, Meier P. Local versus general anesthesia for transcatheter aortic valve implantation (TAVR) – systematic review and meta-analysis. BMC Medicine 2014, 12: 41. PMID: 24612945, PMCID: PMC4022332, DOI: 10.1186/1741-7015-12-41.Peer-Reviewed Original ResearchConceptsShorter hospital stayGeneral anesthesiaHospital stayRelative riskProcedure timeSevere aortic valve stenosisTranscatheter aortic valve implantationResultsSeven observational studiesAcute kidney injuryProcedure-related mortalityPooled relative riskAortic valve implantationAortic valve stenosisShort-term outcomesShorter procedure timeRandom-effects modelKidney injuryValve implantationOverall mortalityValve stenosisRandomized trialsTransfemoral TAVRLocal anesthesiaTreatment optionsMyocardial infarction
2013
Almanac 2013: novel non-coronary cardiac interventions
Meier P, Franzen O, Lansky AJ. Almanac 2013: novel non-coronary cardiac interventions. Wiener Klinische Wochenschrift 2013, 125: 766-775. PMID: 24337591, DOI: 10.1007/s00508-013-0481-5.Peer-Reviewed Original ResearchConceptsHigh riskPercutaneous left atrial appendage closureImportant new treatment optionInterventional cardiologyLeft atrial appendage closureNon-pharmacologic therapiesAtrial appendage closureAortic valve stenosisCoronary artery diseaseAortic valve diseaseSurgical valve repairNew treatment optionsImportant clinical evidenceRecent clinical dataRenal denervationResistant hypertensionStroke preventionAppendage closureElderly patientsArtery diseasePercutaneous treatmentValve stenosisValvular diseaseValve diseaseClinical evidence