2024
Thirty-Day Outcomes from the Disrupt PAD BTK II Study of the Shockwave Intravascular Lithotripsy System for Treatment of Calcified Below-the-Knee Peripheral Arterial Disease
Chandra V, Lansky A, Sayfo S, Shammas N, Soukas P, Park J, Siah M, Babaev A, Shields R, West N, Armstrong E. Thirty-Day Outcomes from the Disrupt PAD BTK II Study of the Shockwave Intravascular Lithotripsy System for Treatment of Calcified Below-the-Knee Peripheral Arterial Disease. Journal Of Vascular Surgery 2024 PMID: 39536842, DOI: 10.1016/j.jvs.2024.11.003.Peer-Reviewed Original ResearchPost-operative deathsII studyPercutaneous transluminal angioplastyProcedural successBTK lesionsResidual stenosisFollow-upIntravascular lithotripsyIndex limbCore labRutherford category 3Treated target lesionsUltrasound core laboratoryInterventional clinical studyAngiographic core labThirty-day outcomesMinimal adverse eventsTarget lesion lengthSevere lesion calcificationIVL systemAdverse limb eventsOptimal standard of careStandard of carePeripheral arterial diseaseVascuQol scoresEquity in Modifying Plaque of Women With Undertreated Calcified Coronary Artery Disease: Design and Rationale of EMPOWER CAD study
McEntegart M, Gonzalo N, Fendelander L, West N, Lansky A. Equity in Modifying Plaque of Women With Undertreated Calcified Coronary Artery Disease: Design and Rationale of EMPOWER CAD study. Journal Of The Society For Cardiovascular Angiography & Interventions 2024, 3: 102289. DOI: 10.1016/j.jscai.2024.102289.Peer-Reviewed Original ResearchCoronary artery diseaseCalcified coronary artery diseasePercutaneous coronary interventionTarget lesion failureCoronary intravascular lithotripsyArtery diseaseFemale patientsIntravascular lithotripsySubcohort analysis of patientsPrevalence of coronary artery calcificationEnd pointsOptical coherence tomography imagesComposite of cardiac deathClinical events committeeSafety end pointAnalysis of patientsIndependent core laboratoryIncreased risk of mortalityIschemia-driven target lesion revascularizationTarget vessel myocardial infarctionTarget lesion revascularizationCoronary artery calcificationEffectiveness end pointCAD studiesCardiology clinical trials
2023
Coronary Intravascular Lithotripsy for Treatment of Severely Calcified Lesions: Long-Term Sex-Specific Outcomes
Frampton J, Kearney K, Abbott J, Kereiakes D, Di Mario C, Saito S, Cristea E, Riley R, Fajadet J, Shlofmitz R, Ali Z, Klein A, Price M, Hill J, Stone G, Lansky A. Coronary Intravascular Lithotripsy for Treatment of Severely Calcified Lesions: Long-Term Sex-Specific Outcomes. Journal Of The Society For Cardiovascular Angiography & Interventions 2023, 2: 101069. PMID: 39129889, PMCID: PMC11307843, DOI: 10.1016/j.jscai.2023.101069.Peer-Reviewed Original ResearchIntravascular lithotripsyLesion failureIschemia-driven target lesion revascularizationMajor adverse cardiac event ratesAdverse cardiac event ratesDrug-eluting stent placementMajor adverse cardiac eventsSmaller reference vessel diameterTarget vessel myocardial infarctionCoronary intravascular lithotripsyAdverse cardiac eventsCardiac event ratePrimary end pointTarget lesion failureTarget lesion revascularizationVessel myocardial infarctionReference vessel diameterAdverse clinical eventsHigh procedural successSex-based outcomesSex-specific outcomesLesion revascularizationAngiographic outcomesCardiac eventsCardiac deathSex-specific analysis of intravascular lithotripsy for peripheral artery disease from the Disrupt PAD III observational study
Nagpal S, Altin S, McGinigle K, Mangalmurti S, Adams G, Shammas N, Mehrle A, Soukas P, Bertolet B, Lansky A. Sex-specific analysis of intravascular lithotripsy for peripheral artery disease from the Disrupt PAD III observational study. Journal Of Vascular Surgery 2023, 79: 358-365. PMID: 37925039, DOI: 10.1016/j.jvs.2023.10.058.Peer-Reviewed Original ResearchPeripheral artery diseaseLower extremity peripheral artery diseaseIntravascular lithotripsyResidual stenosisArtery diseaseAcute safetyObservational studyLow ankle-brachial indexUse of IVLChronic limb-threatening ischemiaFinal residual stenosisPeripheral intravascular lithotripsySevere lesion calcificationAnkle-brachial indexLimb-threatening ischemiaReference vessel sizeAbrupt vessel closureHigh complication rateRates of diabetesFisher's exact testSex-specific analysesAngiographic complicationsAtherectomy useIVL treatmentEfficacy outcomes
2022
TCT-207 Intravascular Lithotripsy for Calcified Peripheral Artery Disease (PAD) in Female vs Male Patients: Sex-Specific Analysis From the Disrupt PAD III Observational Study
Nagpal S, McGinigle K, Mangalmurti S, Adams G, Shammas N, Soukas P, Bertolet B, Lansky A. TCT-207 Intravascular Lithotripsy for Calcified Peripheral Artery Disease (PAD) in Female vs Male Patients: Sex-Specific Analysis From the Disrupt PAD III Observational Study. Journal Of The American College Of Cardiology 2022, 80: b83-b84. DOI: 10.1016/j.jacc.2022.08.244.Peer-Reviewed Original ResearchPeripheral artery diseaseIntravascular lithotripsyArtery diseaseMale patientsObservational studyPatientsDiseaseLithotripsyE-19 | Sex-Specific 1-Year Outcomes in Coronary Intravascular Lithotripsy for Treatment of Severely Calcified Coronary Lesions: A Patient-Level Pooled Analysis of the Disrupt CAD III and CAD IV Studies
Lansky A, Kearney K, Abbott J, Saito S, Hill J, Kereiakes D. E-19 | Sex-Specific 1-Year Outcomes in Coronary Intravascular Lithotripsy for Treatment of Severely Calcified Coronary Lesions: A Patient-Level Pooled Analysis of the Disrupt CAD III and CAD IV Studies. Journal Of The Society For Cardiovascular Angiography & Interventions 2022, 1: 100279. DOI: 10.1016/j.jscai.2022.100279.Peer-Reviewed Original ResearchSex-Specific Outcomes After Coronary Intravascular Lithotripsy: A Patient-Level Analysis of the Disrupt CAD Studies
Hussain Y, Kearney K, Abbott J, Kereiakes D, Di Mario C, Saito S, Cristea E, Riley R, Fajadet J, Shlofmitz R, Ali Z, Klein A, Price M, Hill J, Stone G, Lansky A. Sex-Specific Outcomes After Coronary Intravascular Lithotripsy: A Patient-Level Analysis of the Disrupt CAD Studies. Journal Of The Society For Cardiovascular Angiography & Interventions 2022, 1: 100011. PMID: 39130137, PMCID: PMC11307712, DOI: 10.1016/j.jscai.2021.100011.Peer-Reviewed Original ResearchPrimary efficacy end pointPrimary safety end pointMajor adverse cardiovascular eventsAdverse cardiovascular eventsEfficacy end pointSafety end pointIntravascular lithotripsyEnd pointCardiovascular eventsMyocardial infarctionHospital major adverse cardiovascular eventsMean reference vessel diameterCoronary intravascular lithotripsySevere coronary calcificationCoronary artery calcificationReference vessel diameterPercutaneous coronary interventionPrior myocardial infarctionSex-based outcomesSex-specific outcomesSide branch involvementPatient-level analysisSmall vessel sizeAngiographic complicationsLesion predilatation
2021
TCT-122 Sex-Specific Characteristics and Outcomes in Coronary Intravascular Lithotripsy: A Patient-Level Analysis of the Disrupt CAD Studies
Hussain Y, Kereiakes D, Di Mario C, Saito S, Kearney K, Abbott J, Cristea E, Lansky A. TCT-122 Sex-Specific Characteristics and Outcomes in Coronary Intravascular Lithotripsy: A Patient-Level Analysis of the Disrupt CAD Studies. Journal Of The American College Of Cardiology 2021, 78: b51-b52. DOI: 10.1016/j.jacc.2021.09.972.Peer-Reviewed Original Research
2020
Safety and effectiveness of coronary intravascular lithotripsy in eccentric calcified coronary lesions: a patient-level pooled analysis from the Disrupt CAD I and CAD II Studies
Blachutzik F, Honton B, Escaned J, Hill JM, Werner N, Banning AP, Lansky AJ, Schlattner S, De Bruyne B, Di Mario C, Dörr O, Hamm C, Nef HM. Safety and effectiveness of coronary intravascular lithotripsy in eccentric calcified coronary lesions: a patient-level pooled analysis from the Disrupt CAD I and CAD II Studies. Clinical Research In Cardiology 2020, 110: 228-236. PMID: 32948882, PMCID: PMC7862504, DOI: 10.1007/s00392-020-01737-3.Peer-Reviewed Original ResearchConceptsCoronary intravascular lithotripsyIntravascular lithotripsyCalcified coronary lesionsII studyResidual stenosisCoronary lesionsCAD IPooled patient-level analysisFinal residual stenosisPercent residual stenosisFlow-limiting dissectionPatient-level analysisPatient-level dataHospital MACEIVL useAcute gainClinical outcomesConcentric lesionsEccentric lesionsCalcified lesionsAbrupt closureReflow eventsResultsClinical successStenosisConcentric stenosisIntravascular Lithotripsy for Treatment of Calcified Lower Extremity Arterial Stenosis: Initial Analysis of the Disrupt PAD III Study
Adams G, Shammas N, Mangalmurti S, Bernardo NL, Miller WE, Soukas PA, Parikh SA, Armstrong EJ, Tepe G, Lansky A, Gray WA. Intravascular Lithotripsy for Treatment of Calcified Lower Extremity Arterial Stenosis: Initial Analysis of the Disrupt PAD III Study. Journal Of Endovascular Therapy 2020, 27: 473-480. PMID: 32242768, PMCID: PMC7288854, DOI: 10.1177/1526602820914598.Peer-Reviewed Original ResearchConceptsPeripheral artery diseasePeripheral intravascular lithotripsyIntravascular lithotripsyResidual stenosisAcute gainObservational studyChronic limb-threatening ischemiaSingle-arm observational studyBalloon-based technologiesHigher acute gainMean residual stenosisLimb-threatening ischemiaLower limb arteriesEnd of procedureSevere arterial calcificationLow residual stenosisReal-world studyAngiographic complicationsDistal embolizationHospital dischargeIII studyArtery diseaseThrombotic eventsEndovascular treatmentLimb arteries
2019
TCT-27 Safety and Effectiveness of Coronary Intravascular Lithotripsy for Treatment of Severely Calcified Coronary Stenoses: The Disrupt CAD II Study
Ali Z, Nef H, Escaned J, Werner N, Banning A, Hill J, Montorfano M, Lefevre T, Stone G, Lansky A. TCT-27 Safety and Effectiveness of Coronary Intravascular Lithotripsy for Treatment of Severely Calcified Coronary Stenoses: The Disrupt CAD II Study. Journal Of The American College Of Cardiology 2019, 74: b27. DOI: 10.1016/j.jacc.2019.08.054.Peer-Reviewed Original ResearchCoronary intravascular lithotripsyII studyIntravascular lithotripsyCoronary stenosisStenosisLithotripsySafety and Effectiveness of Coronary Intravascular Lithotripsy for Treatment of Severely Calcified Coronary Stenoses
Ali ZA, Nef H, Escaned J, Werner N, Banning AP, Hill JM, De Bruyne B, Montorfano M, Lefevre T, Stone GW, Crowley A, Matsumura M, Maehara A, Lansky AJ, Fajadet J, Di Mario C. Safety and Effectiveness of Coronary Intravascular Lithotripsy for Treatment of Severely Calcified Coronary Stenoses. Circulation Cardiovascular Interventions 2019, 12: e008434. PMID: 31553205, DOI: 10.1161/circinterventions.119.008434.Peer-Reviewed Original ResearchMeSH KeywordsAgedAged, 80 and overCardiac CatheterizationCoronary AngiographyCoronary StenosisEuropeFemaleHumansLithotripsyMaleMiddle AgedPatient SafetyPercutaneous Coronary InterventionProspective StudiesRisk FactorsSeverity of Illness IndexStentsTime FactorsTomography, Optical CoherenceTreatment OutcomeUnited StatesVascular CalcificationConceptsSevere coronary artery calcificationCoronary artery calcificationMajor adverse cardiac eventsAdverse cardiac eventsPrimary end pointIntravascular lithotripsyOptical coherence tomographyCardiac eventsStent implantationPlaque fractureHospital major adverse cardiac eventsNon-Q-wave myocardial infarctionOptical coherence tomography substudyIndependent clinical events committeeCoherence tomographyDrug-eluting stent implantationEnd pointCoronary intravascular lithotripsyClinical events committeeHigh procedural successIndependent core laboratoryAcute luminal gainPost-approval studiesMechanism of actionCalcium fractureFeasibility of Shockwave Coronary Intravascular Lithotripsy for the Treatment of Calcified Coronary Stenoses
Brinton TJ, Ali ZA, Hill JM, Meredith IT, Maehara A, Illindala U, Lansky A, Götberg M, Van Mieghem NM, Whitbourn R, Fajadet J, Di Mario C. Feasibility of Shockwave Coronary Intravascular Lithotripsy for the Treatment of Calcified Coronary Stenoses. Circulation 2019, 139: 834-836. PMID: 30715944, DOI: 10.1161/circulationaha.118.036531.Peer-Reviewed Original Research
2018
Primary outcomes and mechanism of action of intravascular lithotripsy in calcified, femoropopliteal lesions: Results of Disrupt PAD II
Brodmann M, Werner M, Holden A, Tepe G, Scheinert D, Schwindt A, Wolf F, Jaff M, Lansky A, Zeller T. Primary outcomes and mechanism of action of intravascular lithotripsy in calcified, femoropopliteal lesions: Results of Disrupt PAD II. Catheterization And Cardiovascular Interventions 2018, 93: 335-342. PMID: 30474206, DOI: 10.1002/ccd.27943.Peer-Reviewed Original ResearchMeSH KeywordsAgedAged, 80 and overEuropeFemaleFemoral ArteryHumansLithotripsyMaleMiddle AgedNew ZealandPeripheral Arterial DiseasePopliteal ArteryProgression-Free SurvivalProspective StudiesRetreatmentRisk FactorsSeverity of Illness IndexTime FactorsUltrasonic TherapyVascular CalcificationVascular PatencyConceptsMajor adverse eventsIntravascular lithotripsyPrimary patencyDuplex ultrasonographyPAD IIAcute procedure successFinal residual stenosisPrimary effectiveness endpointPrimary safety endpointKey secondary endpointPeripheral arterial stenosisMulti-center studySonic pressure wavesMechanism of actionCompelling safetyEffectiveness endpointAnti-proliferative therapiesSafety endpointSecondary endpointsVascular complicationsAdverse eventsFemoropopliteal lesionsResidual stenosisPrimary outcomeAcute gain