Primary Results From the EvolutLow Risk Bicuspid StudyBasel Ramlawi M - PDF document

Primary Results From the EvolutLow Risk Bicuspid StudyBasel Ramlawi, MD, FACCValley Health System, Winchester, VirginiaFor the EvolutLow Risk Bicuspid Investigators 1 Disclosure Statement of Financial InterestsWithin the past 12 months, I have had a financial interest/arrangement or affiliation with the organiz

ation(s) listed below.Financial RelationshipCompanyResearch grants, consulting feesAtriCure, LivaNova, MedtronicMedtronic personnel performed all statistical analyses and assisted with the graphical display of the data presented. 2 BackgroundTAVR with Evolutsupraannular selfexpanding valves has demonstrated ex

cellent outcomes in tricuspid aortic stenosis and is currently approved in the US for patients across all risk classes.Patients with bicuspid aortic stenosis have been generally excluded from prior TAVR trials, due to concerns of: Asymmetric calcification, elliptical shape, potential incomplete valve expansion,

procedural technical concerns etc.Annular vs. supraannular measurementsThere have been no prospective studies assessing TAVR in low risk patients with bicuspid aortic stenosis. 3 To assess the safety and efficacy of TAVR in patients with bicuspid aortic valve stenosis and low surgical riskObjective 4 The Mou

nt Sinai Medical CenterNew York, NYSt. Francis Hospital, Roslyn, NY Abbott Northwestern Minneapolis, MN Beth Israel DeaconessMass GeneralBoston, MA Northwell Health, Manhasset, NY Mercy Medical CenterIowa HeartDes Moines, IA Morton PlantClearwater, FL Baylor Heart & VascularDallas, TX Houston Methodist DeBakey

Heart & Vascular CenterHouston, TX St. Lukes/AuroraMilwaukee, WI Piedmont Heart InstituteAtlanta, GA Case Medical Center Cleveland, OH OhioHealth/Riverside MethodistColumbus, OH Valley HealthWinchester, VA University of MichiganAnn Arbor, MI Yale New Haven Hospital, New Haven, CT Oregon Health & Science Univers

ityPortland, OR Tallahassee Research InstituteTallahassee, FLAbrazo Arizona Heart HospitalPhoenix, AZ Lee Memorial Health SystemFt. Myers, FL Los Robles HospitalThousand Oaks, CA Spectrum HealthGrand Rapids, MIParticipating SitesUniversity Pittsburg Pinnacle HealthHarrisburg, PAScripps MemorialLa Jolla, CA 5

Study AdministrationPrincipal InvestigatorJohn Forrest, Basel RamlawiExecutive CommitteeJohn Forrest, Jeffrey Popma, Basel Ramlawi, Michael ReardonScreening Committee:G. Michael Deeb(Chair), John Forrest, Jeffrey Popma, Basel Ramlawi, Michael Reardon, Steven YakubovEcho Core Laboratory: Jae Oh, Mayo Clinic, Ro

chester, MNData & Safety Monitoring Board: David Faxon (Chair), William Holman, John Lopez, Scott Kasner, John OravClinical Events Committee: Cliff Berger, Scott Bortman, Manish Chauhan, Donald Cutlip, TorinFitton, Eli Gelfand, David Grossman, Claudia Hochberg (Chair), Carey Kimmelstiel, Daniel Kramer, Megan Le

ary, Robert Rodriguez, Sanjay Samy, Jonathan Silver, Gregory Smaroff, David Thaler, Jonathan Waks, Sergio Waxman, David Weiss, Jeffrey VeluzSponsor: Medtronic, Minneapolis, MN Multicenter, prospective, interventional, singlearm studyBaseline MSCT to confirm bicuspid morphologyPatient eligibility reviewed by loc

al Heart Team & Screening Committee Implant ProcedureAnnular sizing recommended for all patientsPreTAVR balloon valvuloplasty strongly encouragedCEC adjudicated all endpointrelated adverse eventsHemodynamics centrally assessed by echocardiographic core laboratory Patient followup planned for 10 yearsStudy Metho

ds 7 Valves Studied EvolutR Valve [43%]EvolutPRO Valve [57%]23, 26, 29 and 34 mm23, 26 and 29 mm 8 Bicuspid aortic valve anatomy confirmed by MSCTSymptomatic and asymptomatic severe ASA predicted risk of 30day mortality 3% per multidisciplinary local Heart Team assessmentNishimura RA, et al. Circulation. 2014;1

29:244092. Key Inclusion Criteria 9 Age 0 yearsMultivessel coronary artery disease (SYNTAX scor&#x 60.; 00;e 22)Ascending aorta diameter&#x 60.; 00; 4.5 cmAortopathyrequiring surgical interventionProhibitive LVOT calcificationAnatomic dimensions outside recommended rangeSOV (≥ 25 mm)Annulus (18 to 30

mm)Trileafletaortic valve on MSCTKey Exclusion Criteria 10 Primary Safety EndpointAllcause mortality or disabling stroke at 30 daysStudy Endpoints Primary Efficacy EndpointDevice Success Absence of procedural mortality ANDCorrect position of 1 valve in the proper anatomical location ANDAbsence of � mild

aortic valve regurgitation 10 11 Patient Flow Patients screened (n=222) Excluded (n=72):Exclusion criteria met (n=60)Patient withdrawal (n=2)Physician withdrawal (n=3)Other (n=7) Attempted procedure (n=150) Aborted procedure (n=1) Implanted TAV (n=149) Day followup (n=147) Death (n=1) Discharged with TAV (n=1

48) Conversion to surgery (n=1) 12 ReasonAnatomical reasonsTricuspid aortic valveAortic root dimensions: annular perimeter/diameterMean ascending aorta � 45 mmAortic root dimensions: SOV diameterProhibitive LVOT calcificationRisk of mortality outside protocol(� low risk)Contraindication for placem

ent of bioprosthetic valveAllergiesDid not meet severe AS criteriaAge less than 60 yearsOther condition excluding from study per investigatorReasons for Study Exclusion RESULTS 14 Mean SD or no. (Age, years70.3 5.5Male sex78 (52.0)Body surface area, m1.9 0.2STS PROM, %1.4 0.6NYHA Class III or IV41 (27.3)Periphe

ral arterial disease14 (9.3)Chronic lung disease/ COPD26 (17.7)Prior coronary artery bypass grafting2 (1.3)Mean gradient, mm Hg48.0 16.1Aortic valve area, cm0.8 0.2Baseline Clinical Characteristics 15 Bicuspid Valve Sievers Subtypes Type 0N = 14Type ILeftRightN = 107Type IRightN=27Type I LeftN= 2No patients ha

d Sievers Type 2. 9.3%71.3%18.0%1.3% 16 No. (%)N = 149*General anesthesia95 (63.3)Iliofemoral access147 (98.7)Embolic protection45 (30.0)PreTAVR balloon dilation137 (91.3)PostTAVR balloon dilation55 (36.9)� 1 valve implanted5 (3.3)Procedural Characteristics No. (%)N = 149*Resheathor recapture49 (32.9)Im

planted valve size23 mm0 (0.0)26 mm32 (22.4)29 mm55 (36.9)34 mm62 (41.6)*For 1 patient, the procedure was aborted. Only Evolut 17 Primary Endpoint 0%2%4%6%8%10%10152025301.3% Death or Disabling Stroke No. at RiskDays Post Procedure 18 No. of patients (KM estimates as %)N = 150causemortality or disabling stroke2

(1.3)cause mortality1 (0.7)Disabling stroke1 (0.7)Nondisabling stroke5 (3.3)Major vascular complication2 (1.3)Aortic dissection0 (0.0)Annular rupture 0 (0.0)Permanent pacemaker*22 (14.7)Permanent pacemaker†22 (15.1)Coronary artery obstruction1 (0.7)Outcomes at 30 Days*Includes patients with baseline perma

nent pacemaker. †Excludes patients with baseline permanent pacemaker. 19 No. of patients (%)Device success141/148 (95.3) Patientprosthesis mismatch*None115 (87.1)Moderate10 (7.6)Severe7 (5.3)Mean gradient � 20 mm Hg2/146 (1.4)Additional Outcomes at 30 Days*N=132 patients per VARC 20 0.82.22.348.09.

07.60.010.020.030.040.050.060.0BaselinePost Procedure30 Days0.00.51.01.52.02.53.0 EOA Mean Gradient Effective Orifice Area, cm 2 AV Mean Gradient, mm HgValve HemodynamicsEOAAVG No. of Echos 21 0.010.020.030.040.050.060.0BaselinePost Procedure30 Days0.00.51.01.52.02.53.0 Effective Orifice Area, cm 2

AV Mean Gradient, mm HgValve Hemodynamics by SubtypesType 0Type 1 21 22 Patients w/Echo (%)Total Aortic Valve RegurgitationImplant population. Core lab assessments. 59.684.657.140.415.442.9All PatientsN = 146Type 0N = 13Type IN = 133 Severe Moderate Mild None/Trace 23 75.370.721.926.7N=150N=146Baseline30 Days

NYHA IV NYHA III NYHA II NYHA I Proportion of Patients w/Echo (%) New York Heart Association 24 Study performed at high volume expert centersNonrandomized study designStandardized implant techniqueAnnular sizingPreTAVR balloon dilationRigorous adherence to patient selection parameters Discussion 25 TAVR with Ev

olutsupraannular selfexpanding valve in lowrisk bicuspid patients achieved excellent early results:Annular sizing achieved 95.3% device successLow mortality and stroke at 30 days (1.3%)Low rates of PVL (no moderate/severe)Consistent hemodynamics across Sievers ClassificationPatients will be followed for 10 year

s Summary 26 In lowrisk AS patients with bicuspid morphology, TAVR with Evolut can be considered a viable alternative to SAVR… after considering anatomic, clinical and patient social factors.Data is based on shortterm results and needs to be confirmed longterm in this lowrisk cohort. Clinical Implications