1 / 41

Types of AVR

Types of AVR. Examples of replacement aortic valves: a) shows an aortic homograft, b) and c) show a xenograft, d) shows a ball and cage valve, e) shows a tilting-disk valve, f) shows a bi-leaflet valve. Elderly Patients. Pts >80years, operative mortality as high as 30%.

wood
Download Presentation

Types of AVR

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Types of AVR Examples of replacement aortic valves: a) shows an aortic homograft, b) and c) show a xenograft, d) shows a ball and cage valve, e) shows a tilting-disk valve, f) shows a bi-leaflet valve

  2. Elderly Patients • Pts >80years, operative mortality as high as 30%. • Percutaneous aortic balloon valvuloplasty is an alternative to valve replacement introduced in ‘80s. • Inflating one or more large balloons across the aortic valve from a percutaneous route, a modest decrease in gradient and improvement in symptoms

  3. Balloon Valvuloplasty • Follow-up has demonstrated a high rate of re-stenosis (>60% at 6 months and nearly 100% at 2 years), with no decrease in mortality rate after procedure • Therefore, now only has a role in critically ill elderly pts who are not candidates for surgery or as a “bridge” in critically ill pts before AV replacement

  4. Building on 50 Years of Proven Valve Expertise

  5. 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”1 100 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

  6. Addressing a Serious Unmet Need No AVR Aortic Valve Replacement (AVR) 54 60 61 74 69 100 43 52 80 60 57 Patients, % 40 48 46 40 39 31 20 26 0 Jan Bach Freed Bouma Pellikka Charlson Varadarajan 1999 2005 2006 2009 2009 2010 2006 • At least 40% of patients with severe aortic stenosis (AS) do not have an AVR2-8

  7. Edwards SAPIEN Transcatheter Heart Valve With the RetroFlex 3 Transfemoral System • For inoperable patients with severe symptomatic native aortic valve stenosis

  8. Patient-Focused Multidisciplinary Heart Team Approach • Multidisciplinary in all aspects: • Patient selection • Procedure planning • Patient treatment • Post-operative care

  9. 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.

  10. A Seminal Date in Cardiovascular Medicine September 22, 2010 on NEJM.org

  11. Absolute Reduction in Mortality Continues to Diverge at 2 Years Edwards SAPIEN THV Standard Therapy • HR [95% CI] = 0.57 [0.44, 0.75] • P (log rank) < .0001 100 • ∆ at 1 yr = 20.0%NNT = 5.0 pts 67.6% 80 50.7% All-Cause Mortality, % 60 43.3% 40 30.7% • ∆ at 2 yr = 24.3%NNT = 4.1 pts 20 0 Months

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

  13. Peri-procedural Hazards • At 30 days, TAVR resulted in more frequent strokes, major vascular complications, and bleeding events than standard therapy • All strokes, 7.3% vs 1.7%, P = .02 • Major vascular complications, 16.8% vs 1.1%, P < .0001 • Bleeding events, 16.2% vs 2.2%, P < .0001

  14. Sobering Perspective 5-Year Survival 35 30 30 28 25 23 20 Survival, % 15 12 10 5 4 3 0 Breast Lung Cancer Colorectal Prostate Ovarian Severe * Cancer Cancer Cancer Cancer Inoperable * * * * † AS * 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.

  15. Advancing the Science of TAVR

  16. Two-Year Outcomes of Transcatheter Aortic Valve Replacement (TAVR) in “Inoperable” Patients With Severe Aortic Stenosis: The PARTNER Trial Raj R. Makkar, MDOn behalf of The PARTNER Trial Investigators • TCT 2011 | San Francisco, CA | November 10, 2011

  17. Background (1) • Transcatheter aortic valve replacement (TAVR) is the recommended treatment for “inoperable” patients with severe aortic stenosis (AS), based upon 1-year results of The PARTNER Trial which demonstrated reduced mortality and improved quality of life. • However, whether clinical benefit and valve performance are sustained beyond one year is unknown and longer term outcomes will importantly alter clinical practice decisions.

  18. Objectives • To evaluate the clinical outcomes of TAVR compared to standard therapy at 2 years in “inoperable” aortic stenosis patients. • To assess valve hemodynamics and durability using echocardiography. • To perform subgroup analyses to better define the impact of co-morbidities on outcomes.

  19. Inclusion Criteria • Severe calcific aortic stenosis defined as echo derived valve area of < 0.8 cm2 (EOA index < 0.5 cm2), and mean gradient > 40 mmHg or jet velocity > 4.0 m/s. • NYHA functional class II or greater. • Risk of death or serious irreversible morbidity of AVR as assessed by cardiologist and two surgeons must exceed 50%. • Surgeons must agree and attest that before PARTNER these patients would not have received AVR treatment!

  20. Key End-Points for 2 Year Analysis • All cause mortality • Cardiac mortality • Rehospitalization • Stroke • NYHA functional class • Days alive and out of hospital • Echo-derived valve areas, transvalvular gradients, paravalvular aortic regurgitation • Mortality outcomes stratified by STS score

  21. Study Flow - Inoperable Cohort n = 358 Randomized Inoperable n = 179 Standard therapy n = 179 TAVR 85/85 patients 100% followed at 1 Yr 124/124 patients 100% followed at 1 Yr 56/56 patients 100% followed at 2 Yr 99/102 patients* 97.1% followed at 2 Yr • 5 withdrawals in the first year in Standard Rx arm • *3 patients followed outside of protocol window in TAVR group • No patients were lost to follow-up

  22. Patient Characteristics (1)

  23. Patient Characteristics (2)

  24. Standard Rx TAVR All Cause Mortality (ITT)Crossover Patients Followed • HR [95% CI] =0.57 [0.44, 0.75] • p (log rank) < 0.0001 67.6% • ∆ at 1 yr = 20.0%NNT = 5.0 pts 50.7% All Cause Mortality (%) 43.3% 30.7% • ∆ at 2 yr = 24.3%NNT = 4.1 pts Months

  25. Standard Rx TAVR All Cause Mortality (ITT)Landmark Analysis Mortality 0-1 yr Mortality 1-2yr • HR [95% CI] =0.58 [0.37, 0.92] • p (log rank) = 0.0194 • HR [95% CI] =0.57 [0.44, 0.75] • p (log rank) < 0.0001 50.7% All Cause Mortality (%) 35.1% 30.7% 18.2% Months

  26. Standard Rx TAVR Cardiovascular Mortality (ITT)Crossover Patients Censored • HR [95% CI] =0.44 [0.32, 0.60] • p (log rank) < 0.0001 • ∆ at 1 yr = 24.1%NNT = 4.1 pts 62.4% 44.6% Cardiovascular Mortality (%) 31.0% 20.5% • ∆ at 2 yr = 31.4%NNT = 3.2 pts Months

  27. Standard Rx TAVR Repeat Hospitalization (ITT) • HR [95% CI] =0.41 [0.30, 0.58] • p (log rank) < 0.0001 72.5% • ∆ at 1 yr = 26.9%NNT = 3.7 pts 53.9% Repeat Hospitalization (%) 35.0% 27.0% • ∆ at 2 yr = 37.5%NNT = 2.7 pts Months

  28. Hospitalization Through 2 Years

  29. NYHA Class Over TimeSurvivors • p = 0.61 • p < 0.0001 • p < 0.0001 16.9% 23.7% 57.5% 60.8% 93.9% 92.2% Percent Baseline 1 Year 2 Year Treatment Visit

  30. TAVR All Stroke (ITT) Standard Rx • HR [95% CI] =2.79 [1.25, 6.22] • p (log rank) = 0.009 Incidence (%) • ∆ at 1 yr = 5.7% • ∆ at 2 yr = 8.3% 11.2% 5.5% 13.8% Months 5.5%

  31. All Cerebrovascular Events (%) Events Note: Percents are of patients in the trial (n/179).

  32. TAVR Mortality or Stroke (ITT) • HR [95% CI] =0.64 [0.49, 0.84] • p (log rank) = 0.0009 Standard Rx • ∆ at 1 yr = 16.1%NNT = 6.2 pts 68.0% 51.3% All Cause Mortality or Stroke (%) 46.1% 35.2% • ∆ at 2 yr = 21.9%NNT = 4.6 pts Months

  33. Clinical Outcomes1 Year and 2 Year (ITT)

  34. EOA Mean Gradient Mean Gradient & Valve Area Mean Gradient (mm Hg) AVA (cm²) N = 84 N = 89 N = 158 N = 162 N = 137 N = 143 N = 65 N = 65 N = 9 N = 9 • Error bars = ± 1 Std Dev

  35. Moderate or Severe None to Mild Mortality Stratified by Paravalvular Leak (ITT)Starting at Discharge • p (log rank) = 0.891 Death Incidence (%) 35.3% 41.2% 40.5% 27.2% Months

  36. STS <5 STS 5-14.9 STS ≥15 Mortality Stratified by STS Score (ITT) TAVR Standard Rx • p value (log rank) = 0.676 • p value (log rank) = 0.012 Death Incidence (%) Months Months Numbers at Risk

  37. Conclusions (1) At 2 years, in patients with symptomatic severe ASwho are not suitable candidates for surgery… • TAVR remained superior to standard therapy with incremental benefit from 1 to 2 years, markedly reducing the rates of… • All cause mortality • Cardiovascular mortality • Repeat hospitalization • TAVR improved NYHA functional status and decreased Class III/IV symptoms compared to standard therapy (17% vs 64%; p < 0.001).

  38. Conclusions (2) At 2 years, in patients with symptomatic severe AS who are not suitable candidates for surgery… • There were more neurologic events in TAVR patients vs Standard Rx (16.2% vs 5.5%; p = 0.003) with 5 new events (3 strokes and 2 TIAs) between 1-2 years in TAVR patients. • After 30 days, differences in stroke frequency were largely due to increased hemorrhagic strokes in TAVR patients. • A subgroup analysis according to surgical risk score suggests that the most pronounced benefit of TAVR is in patients without extreme clinical co-morbidities.

  39. Conclusions (3) At 2 years, in patients with symptomatic severe AS who are not suitable candidates for surgery… • TAVR hemodynamics by echo showed durable improvements in AVA and mean gradients up to 3 years after implantation. • Moderate or severe paravalvular AR in the TAVR patients did not influence 2-year survival and there was a trend towards reduced paravalvular AR between 1 and 2 years.

  40. Clinical Implications • Two year data continues to support the role of TAVR as the standard-of-care for symptomatic patients with aortic stenosis who are not surgical candidates. • The ultimate value of TAVR in “inoperable” patients will depend on careful selection of patients who are not surgical candidates, and yet do not have extreme co-morbidities that overwhelm the benefits of TAVR and render the intervention futile.

  41. QUESTIONS?

More Related