VitaFlow-Aortic-Valve.pptx

1.Product Introduction2.Case Report3.1-Year Clinical OutcomesVitaFlowTM Transcatheter Aortic Valve SystemVitaFlowTM Aortic ValveVitaFlowTM Delivery SystemBalloon CatheterIntroducer Set VitaFlowTM Aortic Valve3Size 21mm24mm27mm30mmAortic Annulus Diameter17-20mm20-23mm23-26mm26-29mmHeight H50mm50mm53mm53mmHSkirt12mmSize Low Density CellsFlexible design for better alignment during deploymentHigh Radial ForceDesigned for expanding calcified leafletsInner and outer skirtDesigned for better sealing and reducing PVLLarge CellsEnable coronary accesslSelf-expanding nitinol frame lBovine pericardial leaflets lPET skirt VitaFlowTM Delivery SystemMotorized HandleEasy to use,allow for easy wire manipulation during deploymentReinforced Inner/Outer ShaftDesigned for stable and accurate deploymentManual handle for back-upLow Delivery Profile16/18F valve capsuleBalloon CatheterIntroducer SetValve Accessories5Kink ResistanceLow Profile,for Vessel Complications ReductionBroad choice with 11 configurationsLow compliant balloon for accurate sizingFast inflation/deflationDiameter Availability:8mm to 28mm61.Product Introduction2.Case Report3.1-Year Clinical OutcomesStudy Design8ObjectiveDesignPrimary EndpointSecondary EndpointTo evaluate the safety and effectiveness of VitaFlowTM Valve and delivery system for(TAVI)in symptomatic patients with severe calcific aortic stenosis,who are considered unsuitable for Surgical Valve Replacement.lProspective,multi-center,single-arm trial lEnroll 110 patients lAll patients will be followed up at 30 days,6 months,12 months,and 2-5 years post TAVIAll cause mortality at 12 monthsDevice success,Procedure success,Major Stroke,Valve performance,Improvement of heart function,MACCE,Improvement of life quality,etc.Study Design9Key Inclusion Criteria lAge 70 years oldlDocumented severe calcified native aortic stenosis(by Echo)Either Mean pressure gradient 40 mmHg,or jet velocity 4.0 m/s,or aortic valve area(AVA)1.0 cm2(or AVA index 0.6 cm2/m2)lSymptomatic aortic valve stenosis with NYHA Class IIlLife expectancy 12months lPatients deemed to be suitable for TAVI anatomicallylUnsuitable for Surgical Valve Replacement as evaluated by the heart team lConsent from patientsStudy Administration&Cases Enrollment10BeijingPeking University First HospitalFuwai HospitalChinese PLA General HospitalShenyangThe Genral Hospital of Shenyang MilitaryShanghaiZhongshan Hospital,Fudan UniversityRenji HospitalRuijin Hospital HangzhouThe second Affiliated Hospital of Zhejiang Universtiy School of MedicineChengduWest China,Sichuan UniversityWuhanWuhan Asia Heart HospitalNanjing Nanjing Drum Tower HospitalPrincipal Investigator Ge Junbo,MDIndependent Clinical Events CommitteeCT Core LaboratoryDr.Nicolo PiazzaBaseline Characters11CharacteristicN=110CharacteristicN=110Age Year77.734.78COPD24/110Male Sex60/110Liver Disease3/110STS Score8.84Renal Insufficiency14/110Coronary Artery Disease62/110Diabetes Mellitus31/110Hypertension59/110Cerebral Vascular Disease22/110Previous Myocardial Infarction6/110Bicuspid Aortic ValveNon-bicuspid Aortic Valve42/11068/110Previous PCI14/110LVEF57.2212.00Peripheral Vascular Disease45/110Effective Orifice Area cm20.640.19Angina CCS Classes II-IV20/110Mean AV Gradient-mmHg60.4119.40Previous CABG 0/110Approach&Size12Procedural N=71;100%Device Success,Transfemoral,93.02Procedural N=71;100%Device Success,Asending Aorta,1.16Procedural N=71;100%Device Success,Carotid Artery,5.8194%1%5%ApproachTransfemoralAscending AortaCarotid ArteryImplanted Valve Size,21mm,7%Implanted Valve Size,24mm,58%Implanted Valve Size,27mm,31%Implanted Valve Size,30mm,4%Implanted Valve Size58%7%5%30%21mm24mm27mm30mmClinical Outcomes13Clinical OutcomesDischarge,%N=11030-Day,%N=1106-Month,%N=1101-Year,%N=110All-cause Mortality 0.9%(1)0.9%(1)2.7%(3)2.7%(3)Cardiovascular Mortality 1.8%(2)1.8%(2)1.8%(2)1.8%(2)All Stroke(Major&Minor)1.8%(2)2.7%(3)4.5%(5)4.5%(5)Major Vascular Complication1.8%(2)1.8%(2)1.8%(2)2.7%(3)Coronary Artery Obstruction 1.8%(2)1.8%(2)1.8%(2)1.8%(2)New Pacemaker Implantation15.5%(17)*16.4%(18)*19.1%(21)*19.1%(21)*5.5%(6)patients with IAVB Hemodynamic OutcomesMean Aortic Gradient(mmHg)Effective Orifice Area(cm）Mean Aortic Gradient(mmHg),Baseline N=110,60.41Mean Aortic Gradient(mmHg),Post-Procedural N=110,8.71Mean Aortic Gradient(mmHg),Discharge N=109,12.38Mean Aortic Gradient(mmHg),30Days N=108,11.17Mean Aortic Gradient(mmHg),6 Months N=102,10.56Mean Aortic Gradient(mmHg),12 Months N=105,9.8Effective Orifice Area(cm）,Baseline N=110,0.64Effective Orifice Area(cm）,Post-Procedural N=110,1.81Effective Orifice Area(cm）,Discharge N=109,1.81Effective Orifice Area(cm）,30Days N=108,1.75Effective Orifice Area(cm）,6 Months N=102,1.85Effective Orifice Area(cm）,12 Months N=105,1.83Mean Aortic Gradient(mmHg)Effective Orifice Area(cm）15Paravalvular LeakNone/Trace,Discharge N=110,71%None/Trace,30-Day N=108,72%None/Trace,6-Month N=102,71%None/Trace,12-Month N=105,71%Mild,Discharge N=110,27%Mild,30-Day N=108,26%Mild,6-Month N=102,29%Mild,12-Month N=105,29%Moderate,Discharge N=110,2%Moderate,30-Day N=108,2%Severe,Discharge N=110,0Severe,30-Day N=108,0Severe,6-Month N=102,0Severe,12-Month N=105,0None/TraceMildModerateSevereNo moderate or severe PVL at 12 months.NYHA CLASS6%27%47%71%19%44%56%48%26%59%42%16%4%2%22%8%1%1%1%Class IVClass IIIClass IIClass ISTS Score,Evolut R (CE Mark),7STS Score,Corevalve Pivotal Trial,10.3STS Score,Lotus RepriseII,7.1STS Score,PartnerII S3i Trial,5.2STS Score,VitaFlow,8.84All-cause Mortality,Evolut R (CE Mark),6.70%All-cause Mortality,Corevalve Pivotal Trial,24.30%All-cause Mortality,Lotus RepriseII,4.20%All-cause Mortality,PartnerII S3i Trial,7.40%All-cause Mortality,VitaFlow,2.70%Major Stroke,Evolut R (CE Mark),3.40%Major Stroke,Corevalve Pivotal Trial,4.30%Major Stroke,Lotus RepriseII,3.40%Major Stroke,PartnerII S3i Trial,2.30%Major Stroke,VitaFlow,0.00%STS ScoreAll-cause MortalityMajor Stroke1-Year Outcomes ComparisonRef:Popma JJ,M.D.,Adams HD,et al.Transcatherter Aortic Valve Replacement Using a Self-expanding Bio-prosthesis in Patients with Severe Aortic Stenosis at Extreme Risk for Surgery.JACC Vol.2014;63(19):1972-81,Leon MB,M.D.,Smith CR,et al.Transcatherter Aortic-Valve Implantation for Aortic Stenosis in Patients Who Cannot Undergo Surgery.N Engl J Med 2010;363(17):1598-607Meredith AM,MBBS,PhD,Darren L,et al.Transcatherter Aortic Valve Replacement for Severe Symptomatic Aortic Stenosis Using a Repositionable Valve System.JACC Vol.2014;64(13):1339-48CoreValve Evolut-R CE Study.Presented at the TCT Annual Meeting Oct.13,2015;Baseline Characters-Tricuspid Vs Bicuspid CharacteristicTricuspid N=68Bicuspid N=42P-ValueCharacteristicTricuspid N=68Bicuspid N=42P-ValueAge Year78.554.7676.414.560.0223COPD16(23.5%)8(19.0%)0.5778Male Sex41(60.3%)19(45.2%)0.1234Liver Disease2(2.9%)1(2.4%)1.0000STS Score9.726.287.423.870.0190Renal Insufficiency9(13.2%)5(11.9%)0.8382Coronary Artery Disease41(60.3%)21(50.0%)0.2907Diabetes Mellitus23(33.8%)8(19.0%)0.0883Hypertension41(60.3%)18(42.9%)0.0745Cerebral Vascular Disease14(20.6%)10(23.8%)0.6922Previous Myocardial Infarction4(5.9%)2(4.8%)1.0000LVEF56.0811.5559.0612.620.2060Previous PCI10(14.7%)4(9.5%)0.4201Effective Orifice Area cm20.650.180.610.210.3712Peripheral Vascular Disease29(42.6%)16(38.1%)0.6366Mean AV Gradient-mmHg57.9818.4564.3520.460.0945Angina CCS Classes II-IV14(20.6%)6(14.3%)0.7156Previous CABG0(0.0%)0(0.0%)NA1 year clinical outcomes-Tricuspid Vs Bicuspid Clinical Outcomes(1-year)Tricuspid N=68Bicuspid N=42P ValueAll-cause Mortality 3(4.4%)0(0.0%)0.2854 Cardiovascular Mortality 2(2.9%)0(0.0%)All Stroke(Major&Minor)3(4.6%)2(4.8%)1.0000Major Vascular Complication3(4.5%)0(0.0%)0.1579Moderate or Severe PVL0(0.0%)0(0.0%)New Pacemaker ImplantationTricuspid patients(N=68),Baseline N=67 N=40,0.65Tricuspid patients(N=68),Discharge N=63 N=40 ,1.85Tricuspid patients(N=68),30 Days N=59 N=39,1.81Tricuspid patients(N=68),6 Months N=59 N=39,1.86Tricuspid patients(N=68),12 Months N=61 N=41,1.82Bicuspid patients(N=42),Baseline N=67 N=40,0.61Bicuspid patients(N=42),Discharge N=63 N=40 ,1.76Bicuspid patients(N=42),30 Days N=59 N=39,1.67Bicuspid patients(N=42),6 Months N=59 N=39,1.84Bicuspid patients(N=42),12 Months N=61 N=41,1.84Tricuspid patients(N=68)Bicuspid patients(N=42)Tricuspid patients(N=68),Baseline N=68 N=42,57.98Tricuspid patients(N=68),Discharge N=67 N=42 ,11.84Tricuspid patients(N=68),30 Days N=65 N=41,10.69Tricuspid patients(N=68),6 Months N=62 N=40,10.38Tricuspid patients(N=68),12 Months N=62 N=42,9.92Bicuspid patients(N=42),Baseline N=68 N=42,64.35Bicuspid patients(N=42),Discharge N=67 N=42 ,13.24Bicuspid patients(N=42),30 Days N=65 N=41,11.92Bicuspid patients(N=42),6 Months N=62 N=40,10.83Bicuspid patients(N=42),12 Months N=62 N=42,9.62Mean Aortic Gradient(mmHg)Aortic Valve Area(cm2)Hemodynamic Outcomes-Tricuspid Vs Bicuspid 4.5%9.5%19.4%38.1%39.1%59.5%67.7%73.8%39.4%50%56.7%57.1%56.3%35.7%27.7%23.8%45.5%35.7%22.4%4.8%3.1%4.8%3.1%2.4%10.6%4.8%1.5%1.5%1.5%NYHA NYHA NYHA NYHA DischargeTricuspid Bicuspid N=66 N=4230 DaysTricuspid Bicuspid N=67 N=426 monthsTricuspid Bicuspid N=64 N=4212 monthsTricuspid Bicuspid N=65 N=42NYHA Class-Tricuspid Vs Bicuspid Summary22Low all-cause mortality 2.7%No Major StrokeNo moderate or severe PVLGood hemodynamic function up to 12-monthSignificant improvement in NYHA class -97%NYHA II at 12-monthPatients with bicuspid valves had similar outcomes,such as aortic gradient,EOA and PVL.