Featured Publications
2-Year Outcomes After Transcatheter Versus Surgical Aortic Valve Replacement in Low-Risk Patients
Forrest JK, Deeb GM, Yakubov SJ, Rovin JD, Mumtaz M, Gada H, O'Hair D, Bajwa T, Sorajja P, Heiser JC, Merhi W, Mangi A, Spriggs DJ, Kleiman NS, Chetcuti SJ, Teirstein PS, Zorn GL, Tadros P, Tchétché D, Resar JR, Walton A, Gleason TG, Ramlawi B, Iskander A, Caputo R, Oh JK, Huang J, Reardon MJ. 2-Year Outcomes After Transcatheter Versus Surgical Aortic Valve Replacement in Low-Risk Patients. Journal Of The American College Of Cardiology 2022, 79: 882-896. PMID: 35241222, DOI: 10.1016/j.jacc.2021.11.062.Peer-Reviewed Original ResearchConceptsTranscatheter aortic valve replacementEvolut Low Risk trialLow-risk trialsAortic valve replacementPrimary endpointRisk trialsCause mortalityValve replacementTranscatheter Versus Surgical Aortic Valve ReplacementLow surgical risk patientsSurgical aortic valve replacementIndependent clinical events committeeEchocardiographic core laboratoryKaplan-Meier ratesSevere aortic stenosisClinical events committeeLow-risk patientsCause mortality ratesSelf-expanding valvesDisabling strokeEchocardiographic outcomesSurgical AVRTAVR groupSurgery groupAdverse eventsEarly Outcomes With the Evolut PRO Repositionable Self-Expanding Transcatheter Aortic Valve With Pericardial Wrap
Forrest JK, Mangi AA, Popma JJ, Khabbaz K, Reardon MJ, Kleiman NS, Yakubov SJ, Watson D, Kodali S, George I, Tadros P, Zorn GL, Brown J, Kipperman R, Saul S, Qiao H, Oh JK, Williams MR. Early Outcomes With the Evolut PRO Repositionable Self-Expanding Transcatheter Aortic Valve With Pericardial Wrap. JACC Cardiovascular Interventions 2018, 11: 160-168. PMID: 29348010, DOI: 10.1016/j.jcin.2017.10.014.Peer-Reviewed Original ResearchMeSH KeywordsAgedAged, 80 and overAortic ValveAortic Valve StenosisCause of DeathEchocardiographyFemaleHeart Valve ProsthesisHemodynamicsHumansMaleMitral Valve InsufficiencyPericardiumProspective StudiesProsthesis DesignRisk FactorsSeverity of Illness IndexStrokeTime FactorsTranscatheter Aortic Valve ReplacementTreatment OutcomeUnited StatesConceptsSelf-expanding transcatheter aortic valveSevere symptomatic aortic stenosisEvolut PRO valveSymptomatic aortic stenosisTranscatheter aortic valveAortic stenosisParavalvular leakAortic valveValve Academic Research Consortium-2 criteriaIndependent echocardiographic core laboratoryTranscatheter aortic valve replacementTranscatheter aortic valve systemEchocardiographic core laboratoryPrimary safety endpointPrimary efficacy endpointRemainder of patientsAortic valve replacementProportion of patientsProsthetic valve regurgitationSupra-annular valveEffective orifice areaDisabling strokeCause mortalityEfficacy endpointSafety endpoint3-Year Outcomes After Transcatheter or Surgical Aortic Valve Replacement in Low-Risk Patients With Aortic Stenosis
Forrest J, Deeb G, Yakubov S, Gada H, Mumtaz M, Ramlawi B, Bajwa T, Teirstein P, DeFrain M, Muppala M, Rutkin B, Chawla A, Jenson B, Chetcuti S, Stoler R, Poulin M, Khabbaz K, Levack M, Goel K, Tchétché D, Lam K, Tonino P, Ito S, Oh J, Huang J, Popma J, Kleiman N, Reardon M, Investigators L, Sorajja P, Byrne T, Kirshner M, Bajwa T, Crouch J, Coselli J, Silva G, Hebeler R, Stoler R, Islam A, Rousou A, Poulin M, Khabbaz K, Bladergroen M, Fail P, Netherland D, Lam K, Tonino W, Sudre A, Berthoumieu P, Tchétché D, Khalili H, Hughes G, Harrison J, De A, Tsau P, van Mieghem N, Larbalestier R, Yong G, Agarwal S, Martin W, Park S, Kleiman N, Reardon M, Mohammadi S, Rodes-Cabau J, Sparling J, Elkins C, Ganzel B, Matthews R, Starnes V, Ando K, Chevalier B, Farge A, DeFrain M, Muppala M, Combs W, Bagur R, Chu M, Fontana G, Dev V, Leya F, Tuchek J, Inglessis I, Jassar A, Piazza N, Lacappelle K, Steinberg D, Katz M, Wang J, Kozina J, Slachman F, Merritt R, Chawla A, Jensen B, Alvarez J, Gooley R, Smith J, Ibrahim R, Cartier R, Rovin J, Fujita T, Rutkin B, Yakubov S, Song H, Zahr F, Miyagawa S, Rajagopal V, Kauten J, Gada H, Mumtaz M, Bhindi R, Brady P, Batra S, Davis T, Iskander A, Heimansohn D, Hermiller J, Takamisawa I, Haldis T, Yamazaki S, Teirstein P, Tada N, Saito S, Merhi W, Leung S, Muller D, Heijmen R, Petrossian G, Robinson N, Knight P, Ling F, Radhakrishnan S, Fremes S, Lehr E, Gafoor S, Noel T, Walton A, Resar J, Adams D, Sharma S, Lilly S, Tadros P, Zorn G, Dauerman H, Ittleman F, Horlick E, Feindel C, Welt F, Sharma V, Markowitz A, Carroll J, Fullerton D, Griffith B, Gupta A, de Marchena E, Salerno T, Chetcuti S, Deeb G, Sultan I, Goel K, Pasupati S, Kon N, Zhao D, Ramlawi B, Forrest J. 3-Year Outcomes After Transcatheter or Surgical Aortic Valve Replacement in Low-Risk Patients With Aortic Stenosis. Journal Of The American College Of Cardiology 2023, 81: 1663-1674. PMID: 36882136, DOI: 10.1016/j.jacc.2023.02.017.Peer-Reviewed Original ResearchConceptsTranscatheter aortic valve replacementAortic valve replacementLow-risk patientsCause mortalityPrimary endpointParavalvular regurgitationValve replacementEvolut Low Risk trialLow surgical risk patientsSurgical aortic valve replacementGreater paravalvular regurgitationLow-risk trialsData comparing outcomesLow-risk studiesSupra-annular valveEchocardiographic outcomesSecondary endpointsSurgery groupTAVR patientsRisk patientsSurgery patientsAortic stenosisPacemaker placementTreatment armsMean age
2024
Reinterventions After CoreValve/Evolut Transcatheter or Surgical Aortic Valve Replacement for Treatment of Severe Aortic Stenosis
Grubb K, Lisko J, O'Hair D, Merhi W, Forrest J, Mahoney P, Van Mieghem N, Windecker S, Yakubov S, Williams M, Chetcuti S, Deeb G, Kleiman N, Althouse A, Reardon M. Reinterventions After CoreValve/Evolut Transcatheter or Surgical Aortic Valve Replacement for Treatment of Severe Aortic Stenosis. JACC Cardiovascular Interventions 2024, 17: 1007-1016. PMID: 38573257, DOI: 10.1016/j.jcin.2024.01.292.Peer-Reviewed Original ResearchMeSH KeywordsAgedAged, 80 and overAortic ValveAortic Valve StenosisFemaleHeart Valve ProsthesisHeart Valve Prosthesis ImplantationHumansIncidenceMalePostoperative ComplicationsProsthesis DesignRandomized Controlled Trials as TopicRetreatmentRisk AssessmentRisk FactorsSeverity of Illness IndexTime FactorsTranscatheter Aortic Valve ReplacementTreatment OutcomeConceptsSurgical aortic valve replacementTranscatheter aortic valve replacementIncidence of reinterventionAortic valve replacementCumulative incidence of reinterventionValve replacementValve reinterventionCumulative incidenceCoreValve transcatheter aortic valve replacementLow incidence of reinterventionSurgical aortic valve replacement patientsSingle-arm studyFirst-generation CoreValveEvolut R/ProParavalvular regurgitationReinterventionRandomized trialsLow incidenceCoreValvePooled dataTranscatheterIncidenceTreatmentYearsEndocarditis
2023
Feasibility of Coronary Access Following Redo-TAVR for Evolut Failure: A Computed Tomography Simulation Study
Tang G, Spencer J, Rogers T, Grubb K, Gleason P, Gada H, Mahoney P, Dauerman H, Forrest J, Reardon M, Blanke P, Leipsic J, Abdel-Wahab M, Attizzani G, Puri R, Caskey M, Chung C, Chen Y, Dudek D, Allen K, Chhatriwalla A, Htun W, Blackman D, Tarantini G, Sanchez J, Schwartz G, Popma J, Sathananthan J. Feasibility of Coronary Access Following Redo-TAVR for Evolut Failure: A Computed Tomography Simulation Study. Circulation Cardiovascular Interventions 2023, 16: e013238. PMID: 37988439, PMCID: PMC10653288, DOI: 10.1161/circinterventions.123.013238.Peer-Reviewed Original ResearchConceptsRedo-TAVRSAPIEN 3Coronary accessRedo transcatheter aortic valve replacementYounger low-risk patientsFuture coronary accessSAPIEN 3 valveAortic valve replacementLow-risk patientsSelf-expanding valvesPre-TAVR CTValve replacementValve implantationCT planningEvolutImplant positionTomography imagingPatientsCTNodes 4Implant depthTAVRSubstudyNodes 5Valve4-Year Outcomes of Patients With Aortic Stenosis in the Evolut Low Risk Trial
Forrest J, Deeb G, Yakubov S, Gada H, Mumtaz M, Ramlawi B, Bajwa T, Teirstein P, Tchétché D, Huang J, Reardon M, Investigators E. 4-Year Outcomes of Patients With Aortic Stenosis in the Evolut Low Risk Trial. Journal Of The American College Of Cardiology 2023, 82: 2163-2165. PMID: 37877907, DOI: 10.1016/j.jacc.2023.09.813.Peer-Reviewed Original ResearchSevere aortic stenosis detection by deep learning applied to echocardiography
Holste G, Oikonomou E, Mortazavi B, Coppi A, Faridi K, Miller E, Forrest J, McNamara R, Ohno-Machado L, Yuan N, Gupta A, Ouyang D, Krumholz H, Wang Z, Khera R. Severe aortic stenosis detection by deep learning applied to echocardiography. European Heart Journal 2023, 44: 4592-4604. PMID: 37611002, PMCID: PMC11004929, DOI: 10.1093/eurheartj/ehad456.Peer-Reviewed Original ResearchConceptsSevere aortic stenosisEffect of antecedent statin usage on conduction disturbances and arrhythmias after transcatheter aortic valve replacement
Shah T, Maarek R, See C, Huang H, Wang Y, Parise H, Forrest J, Lansky A. Effect of antecedent statin usage on conduction disturbances and arrhythmias after transcatheter aortic valve replacement. Cardiovascular Revascularization Medicine 2023, 59: 3-8. PMID: 37573173, DOI: 10.1016/j.carrev.2023.07.022.Peer-Reviewed Original ResearchConceptsAtrial fibrillationConduction disturbancesPrimary endpointStatin usersPacemaker placementRate of AFTranscatheter aortic valve replacementNew atrial fibrillationNew conduction disturbancesPersistent conduction disturbancesAortic valve replacementLong-term prognosisSmall retrospective studiesSignificant differencesPrior pacemakerIndex hospitalizationIntensity statinsValve replacementConsecutive patientsPropensity matchingProcedural complicationsStatin regimenRetrospective studyStatin usageCardiac proceduresFeasibility of redo-TAVI in self-expanding Evolut valves: a CT analysis from the Evolut Low Risk Trial substudy.
Grubb K, Shekiladze N, Spencer J, Perdoncin E, Tang G, Xie J, Lisko J, Sanchez J, Lucas L, Sathananthan J, Rogers T, Deeb G, Fukuhara S, Blanke P, Leipsic J, Forrest J, Reardon M, Gleason P. Feasibility of redo-TAVI in self-expanding Evolut valves: a CT analysis from the Evolut Low Risk Trial substudy. EuroIntervention 2023, 19: e330-e339. PMID: 37067193, PMCID: PMC10333920, DOI: 10.4244/eij-d-22-01125.Peer-Reviewed Original ResearchConceptsRedo-TAVIFlow compromiseEvolut valvesBalloon-expandable SAPIEN 3Transcatheter aortic valve implantationHigher body mass indexAortic valve implantationAortic root dimensionsBody mass indexSinotubular junction diameterSmaller annulus diameterSAPIEN 3Clinical characteristicsValve implantationTranscatheter valveMass indexAnatomical feasibilityCoronary accessFemale sexCoronary heightsAnnulus diameterHigh riskEvolutLower sinusProcedural variablesImpact of New-Onset Conduction Disturbances following Transcatheter Aortic Valve Replacement on Outcomes: A Single-Center Study
See C, Wang Y, Huang H, Parise H, Yang Y, Tirziu D, Francese D, Papoutsidakis N, Bader E, Kaple R, Cleman M, Lansky A, Forrest J. Impact of New-Onset Conduction Disturbances following Transcatheter Aortic Valve Replacement on Outcomes: A Single-Center Study. Journal Of Interventional Cardiology 2023, 2023: 5390338. PMID: 37292113, PMCID: PMC10247319, DOI: 10.1155/2023/5390338.Peer-Reviewed Original ResearchConceptsTranscatheter aortic valve replacementNew-onset conduction disturbancesAortic valve replacementPersistent conduction disturbancesConduction disturbancesValve replacementSurgical aortic valve replacementSingle-center retrospective analysisYale-New Haven HospitalSingle-center studyCause mortality ratesCause mortality riskLong-term outcomesNew Haven HospitalPeriprocedural factorsAortic stenosisConsecutive patientsTAVR proceduresTerm outcomesRetrospective analysisMortality riskMortality ratePatientsOutcomesPatient's ECGImpact of aortic valve replacement in symptomatic low-risk patients with less than severe aortic stenosis
Ito S, Laham R, Nkomo V, Forrest J, Reardon M, Little S, Mumtaz M, Gada H, Bajwa T, Langholz D, Heiser J, Chawla A, Jenson B, Attizanni G, Markowitz A, Huang J, Oh J. Impact of aortic valve replacement in symptomatic low-risk patients with less than severe aortic stenosis. Open Heart 2023, 10: e002297. PMID: 37173100, PMCID: PMC10186477, DOI: 10.1136/openhrt-2023-002297.Peer-Reviewed Original ResearchMeSH KeywordsAortic ValveAortic Valve StenosisHeart Valve Prosthesis ImplantationHumansQuality of LifeTreatment OutcomeConceptsSevere aortic stenosisAortic valve replacementAortic stenosisSymptomatic patientsValve replacementKansas City Cardiomyopathy Questionnaire overall summary scoreEvolut Low Risk trialSurgical aortic valve replacementLow-risk trialsLow-risk patientsOverall summary scoreRate of deathQuality of lifeDisabling strokeEchocardiographic evidenceIsolated AVRHaemodynamic profileClinical outcomesHaemodynamic outcomesRisk trialsClinical trialsCalcium volumeSummary scoresPatientsCore laboratory measurementsTranscatheter Aortic Valve Replacement in Large Annuli Valves With the Supra-Annular, Self-Expandable Evolut Platform in a Real-World Registry
Dallan L, Tang G, Forrest J, Reardon M, Szeto W, Kodali S, Baeza C, Eisenberg R, Attizzani G. Transcatheter Aortic Valve Replacement in Large Annuli Valves With the Supra-Annular, Self-Expandable Evolut Platform in a Real-World Registry. Circulation Cardiovascular Interventions 2023, 16: e012623. PMID: 36943929, PMCID: PMC10022658, DOI: 10.1161/circinterventions.122.012623.Peer-Reviewed Original ResearchConceptsTranscatheter aortic valve replacementAortic valve replacementCardiology Transcatheter Valve Therapy RegistryThoracic Surgeons/American CollegeTranscatheter Valve Therapy RegistryValve replacementAortic stenosisAmerican CollegeMultivariable Cox proportional hazards regression modelsAnnulus sizeCox proportional hazards regression modelProportional hazards regression modelsAortic valve reinterventionTricuspid aortic stenosisReal-world registrySevere aortic stenosisBetter clinical outcomesTreatment of patientsHazards regression modelsComputed tomography angiographyLarge annulusValve reinterventionCause mortalityReadmission ratesValve proceduresTranscatheter versus surgical aortic valve replacement in lower-risk and higher-risk patients: a meta-analysis of randomized trials
Ahmad Y, Howard J, Arnold A, Madhavan M, Cook C, Alu M, Mack M, Reardon M, Thourani V, Kapadia S, Thyregod H, Sondergaard L, Jørgensen T, Toff W, Van Mieghem N, Makkar R, Forrest J, Leon M. Transcatheter versus surgical aortic valve replacement in lower-risk and higher-risk patients: a meta-analysis of randomized trials. European Heart Journal 2023, 44: 836-852. PMID: 36660821, DOI: 10.1093/eurheartj/ehac642.Peer-Reviewed Original ResearchConceptsSurgical aortic valve replacementTranscatheter aortic valve implantationHigh-risk patientsLow-risk patientsComposite of deathAortic valve replacementValve replacementMAIN OUTCOMENew-onset atrial fibrillationSignificant differencesRandomized clinical trial dataAcute kidney injuryAortic valve implantationMain clinical outcomesRisk of deathClinical trial dataMajor bleedingKidney injurySecondary endpointsVascular complicationsValve implantationClinical outcomesParavalvular leakRandomized trialsAtrial fibrillation
2022
Risk factors and mortality associated with permanent pacemaker after surgical or transcatheter aortic valve replacement: Early versus late implantation
Bin Mahmood SU, Mori M, Amabile A, Prescher L, Forrest J, Kaple R, Geirsson A, Mangi AA. Risk factors and mortality associated with permanent pacemaker after surgical or transcatheter aortic valve replacement: Early versus late implantation. Journal Of Cardiac Surgery 2022, 37: 4295-4300. PMID: 36131523, DOI: 10.1111/jocs.16938.Peer-Reviewed Original ResearchConceptsMid-term mortalityAortic valve replacementRisk factorsPPM implantationTAVR proceduresValve replacementPermanent pacemakerCox proportional hazards analysisTranscatheter aortic valve replacementTranscatheter aortic valve replacement (TAVR) proceduresAortic valve replacement proceduresRight bundle branch blockYale-New Haven HospitalNon-PPM groupProportional hazards analysisSingle-center evaluationNumber of patientsBundle branch blockValve replacement proceduresFurther subgroup analysisNew Haven HospitalPPM placementTAVR cohortKaplan-MeierPatient populationReadmission and In-Hospital Outcomes After Transcatheter Aortic Valve Replacement in Patients With Dementia
Park DY, Sana MK, Shoura S, Hammo H, Hu JR, Forrest JK, Lowenstern A, Cleman M, Ahmad Y, Nanna MG. Readmission and In-Hospital Outcomes After Transcatheter Aortic Valve Replacement in Patients With Dementia. Cardiovascular Revascularization Medicine 2022, 46: 70-77. PMID: 35973922, PMCID: PMC10940024, DOI: 10.1016/j.carrev.2022.08.016.Peer-Reviewed Original ResearchConceptsTranscatheter aortic valve replacementAortic valve replacementAortic stenosisValve replacementSecondary diagnosisHospital adverse outcomesAcute kidney injuryIn-Hospital OutcomesNational Readmission DatabasePresence of dementiaPrevalence of dementiaProportional hazards modelDecade of ageHigher hazardIndex hospitalizationInpatient outcomesKidney injuryDefinitive treatmentPacemaker placementReadmission riskAdverse outcomesReadmissionHigher oddsDecision-making discussionsHigh riskPropensity-Matched 1-Year Outcomes Following Transcatheter Aortic Valve Replacement in Low-Risk Bicuspid and Tricuspid Patients
Deeb GM, Reardon MJ, Ramlawi B, Yakubov SJ, Chetcuti SJ, Kleiman NS, Mangi AA, Zahr F, Song HK, Gada H, Mumtaz M, Heiser J, Merhi W, Murrah CP, Noel T, Kirshner M, Byrne T, Ito S, Huang J, Forrest JK. Propensity-Matched 1-Year Outcomes Following Transcatheter Aortic Valve Replacement in Low-Risk Bicuspid and Tricuspid Patients. JACC Cardiovascular Interventions 2022, 15: 511-522. PMID: 35272776, DOI: 10.1016/j.jcin.2021.10.027.Peer-Reviewed Original ResearchConceptsTranscatheter aortic valve replacementAortic valve replacementValve replacementAortic stenosisTricuspid patientsOutcomes Following Transcatheter Aortic Valve ReplacementEvolut Low Risk trialLow surgical risk patientsIndependent clinical events committeeBicuspid aortic stenosisLow-risk trialsSurgical risk patientsTricuspid aortic stenosisPropensity-matched groupsSerious adverse eventsClinical events committeeIndependent core laboratoryBicuspid aortic valveEffective orifice areaTricuspid groupCause mortalityPrimary endpointTAVR patientsAdverse eventsRisk patients
2021
Coronary Revascularization in Patients Undergoing Aortic Valve Replacement for Severe Aortic Stenosis
Patel KP, Michail M, Treibel TA, Rathod K, Jones DA, Ozkor M, Kennon S, Forrest JK, Mathur A, Mullen MJ, Lansky A, Baumbach A. Coronary Revascularization in Patients Undergoing Aortic Valve Replacement for Severe Aortic Stenosis. JACC Cardiovascular Interventions 2021, 14: 2083-2096. PMID: 34620388, DOI: 10.1016/j.jcin.2021.07.058.Peer-Reviewed Original ResearchConceptsAortic valve replacementCoronary artery diseaseAortic stenosisHemodynamic statusCoronary revascularizationValve replacementAssessment of CADPatients Undergoing Aortic Valve ReplacementConcomitant coronary artery diseaseImpact of ASSignificant coronary artery diseaseConcomitant aortic stenosisRole of revascularizationSevere aortic stenosisThird of patientsCohort of patientsDual pathologyArtery diseaseTherapeutic challengeCertain patientsMyocardial ischemiaCoronary assessmentPatientsRevascularizationMultidisciplinary teamRedo‐transcatheter aortic valve replacement with the supra‐annular, self‐expandable Evolut platform: Insights from the Transcatheter valve Therapy Registry
Attizzani GF, Dallan LAP, Forrest JK, Reardon MJ, Szeto WY, Liu F, Pelletier M. Redo‐transcatheter aortic valve replacement with the supra‐annular, self‐expandable Evolut platform: Insights from the Transcatheter valve Therapy Registry. Catheterization And Cardiovascular Interventions 2021, 99: 869-876. PMID: 34533891, DOI: 10.1002/ccd.29941.Peer-Reviewed Original ResearchConceptsTranscatheter Valve Therapy RegistryTranscatheter aortic valveRedo-TAVRTVT RegistryRedo transcatheter aortic valve replacementBetter short-term outcomesTotal aortic regurgitationAortic valve replacementLow-risk patientsShort-term outcomesHospital mortalityIndex hospitalizationAortic regurgitationValve replacementDevice successEvolut RSafety profileMyocardial infarctionAortic valveEvolut PROPatientsRegistryMean gradientOutcomesEvolutAlternate accesses for transcatheter aortic valve replacement: A network meta‐analysis
Hameed I, Oakley CT, Hameed NUF, Ahmed A, Naeem N, Singh S, Rizwana K, Brackett A, Forrest JK, Kaple R, Mangi A, Salemi A, Geirsson A, Gaudino M, Vallabhajosyula P. Alternate accesses for transcatheter aortic valve replacement: A network meta‐analysis. Journal Of Cardiac Surgery 2021, 36: 4308-4319. PMID: 34494307, DOI: 10.1111/jocs.15961.Peer-Reviewed Original ResearchConceptsTranscatheter aortic valve replacementAortic valve replacementTF accessValve replacementHigher long-term mortalityLong-term strokeSuperior postoperative outcomesLong-term mortalityRandom-effects networkComprehensive literature searchDifferent treatment groupsPostoperative outcomesTransfemoral accessRandomized trialsTA accessTranscarotidTreatment groupsTransapicalLiterature searchTC accessCombination of TFSignificant differencesStrokeProbability rankMortalityA randomized evaluation of the TriGuard™ HDH cerebral embolic protection device to Reduce the Impact of Cerebral Embolic LEsions after TransCatheter Aortic Valve ImplanTation: the REFLECT I trial
Lansky AJ, Makkar R, Nazif T, Messé S, Forrest J, Sharma R, Schofer J, Linke A, Brown D, Dhoble A, Horwitz P, Zang M, DeMarco F, Rajagopal V, Dwyer MG, Zivadinov R, Stella P, Rovin J, Parise H, Kodali S, Baumbach A, Moses J. A randomized evaluation of the TriGuard™ HDH cerebral embolic protection device to Reduce the Impact of Cerebral Embolic LEsions after TransCatheter Aortic Valve ImplanTation: the REFLECT I trial. European Heart Journal 2021, 42: 2670-2679. PMID: 34000004, DOI: 10.1093/eurheartj/ehab213.Peer-Reviewed Original ResearchConceptsTranscatheter aortic valve replacementEfficacy endpointCerebral embolic protection devicesTranscatheter aortic valve implantationCentral nervous system injuryCerebral embolic lesionsCerebral ischemic lesionsHealth Stroke ScalePrimary efficacy endpointPrimary safety outcomeAortic valve replacementAortic valve implantationEmbolic protection devicesNervous system injuryDiffusion-weighted magnetic resonanceMontreal Cognitive AssessmentEffectiveness endpointCause mortalityCerebral protectionSafety endpointStroke ScaleValve implantationValve replacementI trialIschemic lesions