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Transcatheter Aortic Valve Therapies

Transcatheter Aortic Valve Therapies. Mark Russo Assistant Professor of Surgery Co-Director, Center for Aortic Diseases. SUMMARY POINTS. This is NOT experimental therapy 45,000 implants worldwide In Germany, 20-25% of isolated AVRs are TAVI Indications

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Transcatheter Aortic Valve Therapies

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  1. TranscatheterAortic 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 1951 - Cardiopulmonary Bypass 1977- Percutaneous Coronary Intervention 2011 - 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. Helping to Solve a Grave Problem Onset Severe Symptoms • Aortic stenosis is life threatening and progresses rapidly • Survival 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”1 • 1 Lester SJ, Heilbron B, Gin K, Dodek A, Jue J. The natural history and rate of progression of aortic stenosis. Chest. 1998;113:1109-1114. 100 80 Angina Latent Period (Increasing Obstruction, Myocardial Overload) Syncope Failure 60 Survival, % 40 0 2 4 6 Average Survival, y 20 0 40 50 60 70 80 Age, y

  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. Addressing a Serious Unmet Need At least 43-74% of patients with severe aortic stenosis (AS) do not have an AVR No AVR Aortic Valve Replacement (AVR) Patients, % 1999 2005 2006 2009 2009 2010 2006

  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. http://seer.cancer.gov/statfacts/. 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 Survival Survival, % * * * * * † * National Institutes of Health. National Cancer Institute. Surveillance Epidemiology and End Results. Cancer Stat Fact Sheets. http://seer.cancer.gov/statfacts/. Accessed November 16, 2010. † Using constant hazard ratio. Data on file, Edwards Lifesciences LLC. Analysis courtesy of Murat Tuczu.

  11. Onset Severe Symptoms • Survival after onset of symptoms is 50% at 2 years and 20% at 5 years1 • 1 Lester SJ, Heilbron B, Gin K, Dodek A, Jue J. The natural history and rate of progression of aortic stenosis. Chest. 1998;113:1109-1114. 100 80 Angina Latent Period (Increasing Obstruction, Myocardial Overload) Syncope Failure 60 Survival, % 40 0 2 4 6 Average Survival, y 20 0 40 50 60 70 80 Age, y

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

  15. PARTNER COHORT B Source: NEJM, 2001

  16. PARTNER COHORT B • 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 Source: NEJM, 2001

  17. PARTNER TRIAL – COHORT B20% Reduction in Mortality Edwards SAPIEN THV Standard Therapy • ∆ at 1 yr = 20.0%NNT = 5.0 pts 100 80 50.7% All-Cause Mortality, % 60 • HR [95% CI] =0.51 [0.38, 0.68] • P (log rank) < .0001 40 30.7% 20 Months 0 Source: NEJM, 2001

  18. PARTNER TRIAL – COHORT B20% Reduction in Mortality Edwards SAPIEN THV Standard Therapy • ∆ at 1 yr = 20.0%NNT = 5.0 pts 100 80 • 20% absolute reduction in mortality at 1 year 50.7% All-Cause Mortality, % 60 • HR [95% CI] =0.51 [0.38, 0.68] • P (log rank) < .0001 40 30.7% 20 Months 0 Source: NEJM, 2001

  19. Paravalvular Leaks Over Time

  20. PARTNER TRIAL – COHORT B Source: NEJM, 2001 NEJM, 2011

  21. PARTNER TRIAL– COHORT BQuality of Life Benefits 100 Standard Therapy 80 60 40 20 0 Edwards SAPIEN THV MCID = 5 points • Improvement in quality of life KCCQ Score (Mean) ∆ = 13.9P < .001 ∆ = 24.5P < .001 0 2 4 6 8 10 12 Months MCID, minimum clinically important difference.

  22. 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)

  23. 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

  24. FriedFrailty Index Fried LP, et al. J Gerontol A Biol Sci Med Sci. 2001;56:M146-M156.

  25. Approaches

  26. Approaches • Transfemoral • Illiac Conduit • Transapical • Subclavian • Transaortic

  27. TAVI - Transfemoral

  28. TAVI - Transapical Anterior Thoracotomy

  29. TAVI - Transapical Source: theheart.org

  30. TAVI – LEFT SUBCLAVIAN APPROACH

  31. TAVI-Transaortic

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