Presentation on theme: "Transcatheter Aortic Valve Therapies"— Presentation transcript:
1 Transcatheter Aortic Valve Therapies Mark RussoAssistant Professor of SurgeryCo-Director, Center for Aortic Diseases
2 SUMMARY POINTS This is NOT experimental therapy 45,000 implants worldwideIn Germany, 20-25% of isolated AVRs are TAVIIndicationsSymptomatic, severe AS deemed inoperableShown to be clinically effective in a well-selected patientsRCT demonstrated an absolute 20% survival benefit40%+ of OMM pts are dead at 6 months
3 ADVANCES IN THE RX OF STRUCTURAL HEART DISEASE Cardiopulmonary Bypass1977- Percutaneous Coronary InterventionTranscatheter Valves
4 CHANGING TREATMENT PARADIGM Treatment options: Significant unmet needDelivery of care: “Heart team” conceptTools available: Catalyze other percutaneous technologies for treatment of structure heart disease
6 Helping to Solve a Grave Problem Aortic stenosis is life threatening and progresses rapidlySurvival after onset of symptoms is 50% at 2 years and 20% at 5 years1“Surgical intervention [for severe AS] should be performed promptly once even…minor symptoms occur”11 Lester SJ, Heilbron B, Gin K, Dodek A, Jue J. The natural history and rate of progression of aortic stenosis. Chest. 1998;113:Latent Period(Increasing Obstruction,Myocardial Overload)Survival, %100806040205070Age, yOnset Severe SymptomsAnginaSyncopeAverage Survival, yFailure246
7 THE BURDEN OF AORTIC STENOSIS In the US:AS: ,500,000Severe AS: 500,000Severe, symptomatic AS: 250,000AVRs performed annually: 85,000>150,000 untreated AS patients
8 Addressing a Serious Unmet Need At least 43-74% of patients with severe aortic stenosis (AS) do not have an AVR19992006200920052010Patients, %Aortic Valve Replacement (AVR)No AVR
9 Dismal Outcomes with Severe Inoperable AS 5-Year SurvivalSurvival, %*****†* National Institutes of Health. National Cancer Institute. Surveillance Epidemiology and End Results. Cancer Stat Fact Sheets. Accessed November 16, 2010.† Using constant hazard ratio. Data on file, Edwards Lifesciences LLC. Analysis courtesy of Murat Tuczu.
10 Dismal Outcomes with Severe Inoperable AS The predicted survival of inoperable patients with severe AS who are treated with standard non-surgical therapy is lower than with certain metastatic cancers.5-Year SurvivalSurvival, %*****†* National Institutes of Health. National Cancer Institute. Surveillance Epidemiology and End Results. Cancer Stat Fact Sheets. Accessed November 16, 2010.† Using constant hazard ratio. Data on file, Edwards Lifesciences LLC. Analysis courtesy of Murat Tuczu.
11 Survival after onset of symptoms is 50% at 2 years and 20% at 5 years1 Latent Period(Increasing Obstruction,Myocardial Overload)Survival, %100806040205070Age, yOnset Severe SymptomsAnginaSyncopeAverage Survival, yFailure246Survival after onset of symptoms is 50% at 2 years and 20% at 5 years11 Lester SJ, Heilbron B, Gin K, Dodek A, Jue J. The natural history and rate of progression of aortic stenosis. Chest. 1998;113:
13 INDICATIONS Severe Symptomatic AS Inoperable – determined by a surgeon Aortic Velocity > 40 m/secMean Gradient > 4 mmHgValve Area < 1.0 cm2Inoperable – determined by a surgeonMortality > 15%Death or serious, irreversible morbidity > 50%STS score > 8-10
14 The PARTNER Trial Protocol Not in StudyAssessmentTransfemoral AccessYesNoPrimary Endpoint: All-Cause Mortality Over Length of Trial (Superiority)Co-Primary Endpoint: Composite of All-Cause Mortality and Repeat Hospitalization (Superiority)TFTAVR(n = 179)Standard Therapy(Control)vs1:1 Randomization(n = 492)TA(n = 207)Primary Endpoint: All-Cause Mortality (1 yr) (Non-inferiority)(n = 244)AVR(n = 248)(n = 104)(n = 103)Cohort A(n = 699)Cohort B(n = 358)2 CohortsIndividually Powered(N = 1,057)TA, transapical; TF, transfemoral.OperabilitySevere Symptomatic Native Aortic Valve Stenosis
21 PARTNER TRIAL – COHORT B Source: NEJM, 2001NEJM, 2011
22 PARTNER TRIAL– COHORT B Quality of Life Benefits 6040208010046810122Standard TherapyEdwards SAPIEN THV∆ = 13.9 P < .001∆ = 24.5 P < .001KCCQ Score (Mean)MCID, minimum clinically important difference.MCID = 5 pointsMonthsImprovement in quality of life
23 CONCLUSIONS – PARTNER B Standard therapy (including BAV in 83.8% of pts) did not alter the dismal natural history of AS; all-cause and cardiovascular mortality at 1 year was 50.7% and 44.6% respectivelyTransfemoral balloon-expandable TAVI, despite limited operator experience and an early version of the system, was associated with acceptable 30-day survival (5% after randomization in the intention-to-treat population)
24 Inoperability Operative mortality > 15% Operative severe morbidity or death > 50%STS score > 8Previous cardiac surgery – multiple, s/p CABGHome O2PHTNRadiationPorcelain AortaFrailty
25 Fried Frailty Index Fried Phenotype of Frailty Weight Loss (unintentional)> 10 lb in previous yearGrip strengthLowest 20% by sex/BMIExhaustionSelf-report (CES-D depression scale)Walk time, 15 feetLowest 20% by sex/heightLow activityMales < 383 kcal/weekFemales < 270 kcal/weekFrailty: ≥ 3 criteria Intermediate/prefrail: 1 or 2 criteriaFried LP, et al. J Gerontol A Biol Sci Med Sci. 2001;56:M146-M156.25
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