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Transcatheter Aortic Valve Therapies Mark Russo Assistant Professor of Surgery Co-Director, Center for Aortic Diseases.

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Presentation on theme: "Transcatheter Aortic Valve Therapies Mark Russo Assistant Professor of Surgery Co-Director, Center for Aortic Diseases."— Presentation transcript:

1 Transcatheter Aortic Valve Therapies Mark Russo Assistant Professor of Surgery Co-Director, Center for Aortic Diseases

2 SUMMARY POINTS This is NOT experimental therapy – 45,000 implants worldwide – In Germany, 20-25% of isolated AVRs are TAVI Indications – Symptomatic, severe AS deemed inoperable Shown to be clinically effective in a well-selected patients – RCT demonstrated an absolute 20% survival benefit – 40%+ of OMM pts are dead at 6 months

3 ADVANCES IN THE RX OF STRUCTURAL HEART DISEASE Cardiopulmonary Bypass Percutaneous Coronary Intervention Transcatheter Valves

4 CHANGING TREATMENT PARADIGM Treatment options: Significant unmet need Delivery of care: “Heart team” concept Tools available: Catalyze other percutaneous technologies for treatment of structure heart disease

5 The Problem of Aortic Stenosis

6 Aortic stenosis is life threatening and progresses rapidly – Survival after onset of symptoms is 50% at 2 years and 20% at 5 years 1 – “Surgical intervention [for severe AS] should be performed promptly once even…minor symptoms occur” 1 1 Lester SJ, Heilbron B, Gin K, Dodek A, Jue J. The natural history and rate of progression of aortic stenosis. Chest. 1998;113: Helping to Solve a Grave Problem Latent Period (Increasing Obstruction, Myocardial Overload) Survival, % Age, y Onset Severe Symptoms Angina Syncope Average Survival, y Failure 0246

7 THE BURDEN OF AORTIC STENOSIS In the US: – AS: 1,500,000 – Severe AS:500,000 – Severe, symptomatic AS: 250,000 – AVRs performed annually: 85,000 >150,000 untreated AS patients

8 At least 43-74% of patients with severe aortic stenosis (AS) do not have an AVR Addressing a Serious Unmet Need Patients, % Aortic Valve Replacement (AVR) No AVR 2009

9 Dismal Outcomes with Severe Inoperable AS 5-Year Survival Survival, % * National Institutes of Health. National Cancer Institute. Surveillance Epidemiology and End Results. Cancer Stat Fact Sheets. Accessed November 16, † Using constant hazard ratio. Data on file, Edwards Lifesciences LLC. Analysis courtesy of Murat Tuczu. † * * ***

10 Dismal Outcomes with Severe Inoperable AS 5-Year Survival Survival, % * National Institutes of Health. National Cancer Institute. Surveillance Epidemiology and End Results. Cancer Stat Fact Sheets. Accessed November 16, † Using constant hazard ratio. Data on file, Edwards Lifesciences LLC. Analysis courtesy of Murat Tuczu. † * * *** The predicted survival of inoperable patients with severe AS who are treated with standard non-surgical therapy is lower than with certain metastatic cancers.

11 – Survival after onset of symptoms is 50% at 2 years and 20% at 5 years 1 1 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, % Age, y Onset Severe Symptoms Angina Syncope Average Survival, y Failure 0246

12 TAVI for Who? What is the Data to Support Use?

13 INDICATIONS Severe Symptomatic AS – Aortic Velocity> 40 m/sec – Mean Gradient> 4 mmHg – Valve Area < 1.0 cm2 Inoperable – determined by a surgeon – Mortality > 15% – Death or serious, irreversible morbidity > 50% – STS score > 8-10

14 The PARTNER Trial Protocol Not in Study Assessment Transfemoral Access Assessment Transfemoral Access Yes No Primary Endpoint: All-Cause Mortality Over Length of Trial (Superiority) Co-Primary Endpoint: Composite of All-Cause Mortality and Repeat Hospitalization (Superiority) Primary Endpoint: All-Cause Mortality Over Length of Trial (Superiority) Co-Primary Endpoint: Composite of All-Cause Mortality and Repeat Hospitalization (Superiority) TF TAVR (n = 179) TF TAVR (n = 179) Standard Therapy (Control) (n = 179) Standard Therapy (Control) (n = 179) vs 1:1 Randomization Assessment Transfemoral Access Assessment Transfemoral Access TF (n = 492) TF (n = 492) TA (n = 207) TA (n = 207) Yes No Primary Endpoint: All-Cause Mortality (1 yr) (Non-inferiority) TF TAVR (n = 244) TF TAVR (n = 244) AVR (Control) (n = 248) AVR (Control) (n = 248) vs 1:1 Randomization TA TAVR (n = 104) TA TAVR (n = 104) AVR (Control) (n = 103) AVR (Control) (n = 103) vs 1:1 Randomization Cohort A (n = 699) Cohort B (n = 358) 2 Cohorts Individually Powered (N = 1,057) 2 Cohorts Individually Powered (N = 1,057) TA, transapical; TF, transfemoral. Assessment Operability Assessment Operability No Yes Severe Symptomatic Native Aortic Valve Stenosis

15 PARTNER COHORT B Source: NEJM, 2001

16 Mean Age: early 80s Mean STS Score: 11 Mean EuroScore: 12 NYSA III/IV - 90% s/p CABG - 40% COPD - 45% – O2 - 20% PHTN - 40% Radiation - 10% Porcelain Aorta PARTNER COHORT B Source: NEJM, 2001

17 PARTNER TRIAL – COHORT B 20% Reduction in Mortality ∆ at 1 yr = 20.0% NNT = 5.0 pts All-Cause Mortality, % 50.7% 30.7% HR [95% CI] = 0.51 [0.38, 0.68] P (log rank) <.0001 Numbers at Risk Edwards SAPIEN THV Standard Therapy Months Edwards SAPIEN THV Standard Therapy Source: NEJM, 2001

18 PARTNER TRIAL – COHORT B 20% Reduction in Mortality ∆ at 1 yr = 20.0% NNT = 5.0 pts All-Cause Mortality, % 50.7% 30.7% HR [95% CI] = 0.51 [0.38, 0.68] P (log rank) <.0001 Numbers at Risk Edwards SAPIEN THV Standard Therapy Months Edwards SAPIEN THV Standard Therapy 20% absolute reduction in mortality at 1 year Source: NEJM, 2001

19

20 Paravalvular Leaks Over Time

21 PARTNER TRIAL – COHORT B NEJM, 2011 Source: NEJM, 2001

22 PARTNER TRIAL– COHORT B Quality of Life Benefits Standard Therapy Edwards SAPIEN THV ∆ = 13.9 P <.001 ∆ = 24.5 P <.001 KCCQ Score (Mean) MCID, minimum clinically important difference. MCID = 5 points Months Improvement 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% respectively Transfemoral 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 > 8 Previous cardiac surgery – multiple, s/p CABG Home O2 PHTN Radiation Porcelain Aorta Frailty

25 Fried Frailty Index Fried Phenotype of Frailty Weight Loss (unintentional) > 10 lb in previous year Grip strengthLowest 20% by sex/BMI ExhaustionSelf-report (CES-D depression scale) Walk time, 15 feetLowest 20% by sex/height Low activity Males < 383 kcal/week Females < 270 kcal/week Frailty: ≥ 3 criteria Intermediate/prefrail: 1 or 2 criteria Fried LP, et al. J Gerontol A Biol Sci Med Sci. 2001;56:M146-M156.

26 Approaches

27 Transfemoral Illiac Conduit Transapical Subclavian Transaortic

28 TAVI - Transfemoral

29 TAVI - Transapical Anterior Thoracotomy

30 TAVI - Transapical Source: theheart.org

31 TAVI – LEFT SUBCLAVIAN APPROACH

32 TAVI-Transaortic


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