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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.

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Presentation on theme: "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."— 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 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 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

6 At least 40% of patients with severe aortic stenosis (AS) do not have an AVR 2-8 Addressing a Serious Unmet Need Patients, % Aortic Valve Replacement (AVR) No AVR Bouma Pellikka Charlson Varadarajan Jan Bach Freed

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

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 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

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

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

12 Edwards SAPIEN THV Delivered QOL Benefits MCID, minimum clinically important difference Standard Therapy Edwards SAPIEN THV = 13.9 P <.001 = 24.5 P <.001 KCCQ Score (Mean) MCID = 5 points Months Improvement in quality of life

13 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 Peri-procedural Hazards

14 Sobering Perspective * National Institutes of Health. National Cancer Institute. Surveillance Epidemiology and End Results. Cancer Stat Fact Sheets.http://seer.cancer.gov/statfacts/. Accessed November 16, Using constant hazard ratio. Data on file, Edwards Lifesciences LLC. Analysis courtesy of Murat Tuczu. 5-Year Survival Survival, % * * *** Breast Cancer Lung CancerColorectal Cancer Prostate Cancer Ovarian Cancer Severe Inoperable AS

15 Advancing the Science of TAVR

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

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 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 All cause mortality Cardiac mortality Cardiac mortality Rehospitalization Rehospitalization Stroke Stroke NYHA functional class NYHA functional class Days alive and out of hospital Days alive and out of hospital Echo-derived valve areas, transvalvular gradients, paravalvular aortic regurgitation Echo-derived valve areas, transvalvular gradients, paravalvular aortic regurgitation Mortality outcomes stratified by STS score Mortality outcomes stratified by STS score

21 n = 358 Randomized Inoperable n = 358 Randomized Inoperable n = 179 TAVR n = 179 TAVR n = 179 Standard therapy n = 179 Standard therapy 124/124 patients 100% followed at 1 Yr 124/124 patients 100% followed at 1 Yr 85/85 patients 100% followed at 1 Yr 85/85 patients 100% followed at 1 Yr 99/102 patients* 97.1% followed at 2 Yr 99/102 patients* 97.1% followed at 2 Yr 56/56 patients 100% followed at 2 Yr 56/56 patients 100% followed at 2 Yr Study Flow - Inoperable Cohort 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) CharacteristicTAVR n = 179 Standard Rx n = 179 p value Age – yr 83.1 ± ± Male sex (%) STS Score 11.2 ± ± NYHA I or II (%) I or II (%) III or IV (%) III or IV (%) CAD (%) Prior MI (%) Prior CABG (%) Prior PCI (%) Prior BAV (%) CVD (%)

23 Patient Characteristics (2) Characteristic TAVR n = 179 Standard Rx n = 179 p value PVD (%) COPD Any (%) Any (%) O 2 dependent (%) O 2 dependent (%) Creatinine > 2 mg/dL (%) Atrial fibrillation (%) Perm. pacemaker (%) Pulmonary HTN (%) Frailty (%) Porcelain aorta (%) Chest wall radiation (%) Chest wall deformity (%) Liver disease (%)

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

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

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

27 Cardiovascular Mortality (ITT) Landmark Analysis Cardiovascular Mortality (%) Months Cardiovascular Mortality 0-1 yr Cardiovascular Mortality 1-2 yr Standard Rx TAVR HR [95% CI] = 0.44 [0.32, 0.60] p (log rank) < HR [95% CI] = 0.48 [0.29, 0.81] p (log rank) = % 20.5% 32.1% 13.2% Numbers at Risk TAVR TAVR Standard Rx Standard Rx

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

29 Hospitalization Through 2 Years TAVR Standard Tx p value Repeat Hospitalizations (No.) 78151<.0001 Repeat Hospitalizations (%) 35.0%72.5%<.0001 Days Alive Out of Hospital Median [IQR] 699 [ ] 355 [ ].0003

30 Percent Treatment Visit Baseline1 Year2 Year p = 0.61p < % 57.5% 16.9% 23.7% 60.8% 93.9% NYHA Class Over Time Survivors

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

32 All Cerebrovascular Events (%) 30 Days 30 Days 31 Days – 1 Year 1 Year – 2 Years All CVAp = 0.010p = 0.387p = Ischemic Strokep = 0.017p = 0.155p = Hemorrhagic Strokep = 0.316p = 0.121p = Events Note: Percents are of patients in the trial (n/179).

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

34 1 Year n = 179 OutcomeTAVR Standard Rx P value 2 Year 2 Year n = 179 TAVR Standard Rx P value Acute kidney injury Creatinine > 3 mg/dL, % (n) 1.1 (2) 2.8 (5) (2) 2.8 (5) Renal failure (CEC), % (n) Renal failure (CEC), % (n) 2.3 (4) 4.7 (7) (5) 7.6 (9) Cardiac re-intervention BAV, % (n) 1.1 (2) 82.3 (138) < (4) 85.3 (140) <.0001 Re-TAVR, % (n) Re-TAVR, % (n) 1.7* (3) NA- NA- AVR, % (n) AVR, % (n) 0 (0) 7.6 (10) (1) 8.9 (11) Endocarditis, % (n) 1.4 (2) 0.8 (1) (3) 0.8 (1) Bleeding – major, % (n) 24.2 (42) 14.9 (21) (48) 20.1 (25) New pacemaker, % (n) 4.7 (8) 8.6 (14) (10) 8.6 (14) Myocardial infarction All, % (n) All, % (n) 0.8 (1) 0.7 (1) (2) 2.5 (2) Clinical Outcomes 1 Year and 2 Year (ITT)

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

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

37 Death Incidence (%) Months STS <5 STS STS Months STS 15 STS 15 p value (log rank) = p value (log rank) = Mortality Stratified by STS Score (ITT) TAVR Standard Rx Numbers at Risk

38 Conclusions (1) At 2 years, in patients with symptomatic severe AS who 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).

39 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.

40 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. 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. 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.

41 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.

42 QUESTIONS?


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