Percutaneous Aortic Valves The Canadian Perspective Robert C. - - PowerPoint PPT Presentation

Percutaneous Aortic Valves The Canadian Perspective

Robert C. Welsh, MD, FRCPC

Associate Professor of Medicine Director, Adult Cardiac Catheterization and Interventional Cardiology Co-director, Mazankowski Alberta Heart Institute TAVI Team Co-Chair, Vital Heart Response Co-director, U of A Chest Pain Program

Disclosures Research funding:

‐ Abiomed, Astra Zeneca, Bayer, Boeringher Ingelheim, Bristol Myers-Squibb, Eli Lilly, Johnson and Johnson, Pfiser, Portola, Regado, Roche, sanofi aventis

Consultant/honorarium:

‐ Astra Zeneca, Bayer, Bristol Myers-Squibb, Eli Lilly, Medtronic, Roche, sanofi-aventis

Transcatheter Aortic Valve Implantation. A Canadian Cardiovascular Society Position Statement

John Webb, Josep Rodés-Cabau, Stephen Fremes , Philippe Pibarot, Marc Ruel, Reda Ibrahim, Robert Welsh, Christopher Feindel, Samuel Lichtenstein

• 1. Who should undergo TAVI?
• 2. Screening for TAVI.
• 3. TAVI program principles
• 1. The multidisciplinary team
• 2. TAVI procedure room
• 3. TAVI training
• 4. TAVI procedural volumes
• 5. Post procedural management

Symptomatic Severe Aortic Stenosis

ASSESSMENT: High Risk AVR Candidate 3105 Total Patients Screened

PARTNER A and B - Study Design

High Risk TA

ASSESSMENT: Transfemoral Access TAVI Trans femoral Surgical AVR

High Risk TF

Primary Endpoint: All Cause Mortality (1 yr) (Non-inferiority)

TAVI Trans femoral Surgical AVR

1:1 Randomization 1:1 Randomization

VS VS

Standard Therapy (usually BAV) ASSESSMENT: Transfemoral Access

Not In Study

TAVI Trans femoral

Primary Endpoint: All Cause Mortality over length

• f trial (Superiority)

1:1 Randomization

VS

Total = 1058 patients

2 Parallel Trials: Individually Powered

High Risk

n= 700

Inoperable

n=358

Study Devices

Retroflex 1 Edwards-SAPIEN THV 23mm and 26mm valve sizes 22F and 24F sheath sizes

PARTNER B Key Exclusion Criteria - 1

• Aortic valve is bicuspid or non-calcified
• Aortic dissection or iliac-femoral dimensions or disease

which precludes safe sheath insertion

• Severe LV dysfunction (LVEF < 20%)
• Untreated CAD requiring revascularization
• Severe AR or MR (> 3+) or prosthetic valve

(any location)

• Hemodynamic instability (e.g. requiring inotrope support)
• Life expectancy < 12 months (or little hope for meaningful

lifestyle recovery)

PARTNER B Key Exclusion Criteria - 2

• Serum Cr > 228 mmol/L or dialysis dependent
• Acute MI within 1 month
• Upper GI bleed within 3 months
• CVA or TIA within 6 months
• Any cardiac procedure, other than BAV, within 1 month or

within 6 months for DES

PARTNER B - Patient Characteristics - 1

Characteristic TAVI

n=179

Standard Rx

n=179

P value Age - yr 83.1 ± 8.6 83.2 ± 8.3 0.95 Male sex (%) 45.8 46.9 0.92 STS Score 11.2 ± 5.8 12.1 ± 6.1 0.14 Logistic EuroSCORE 26.4 ± 17.2 30.4 ± 19.1 0.04 NYHA I or II (%) III or IV (%) 7.8 92.2 6.1 93.9 0.68 0.68 CAD (%) 67.6 74.3 0.20 Prior MI (%) 18.6 26.4 0.10 Prior CABG (%) 37.4 45.6 0.17 Prior PCI (%) 30.5 24.8 0.31 Prior BAV (%) 16.2 24.4 0.09 CVD (%) 27.4 27.5 1.00

PARTNER B - Patient Characteristics - 2

Characteristic TAVI n=179 Standard Rx

n=179

P value PVD (%) 30.3 25.1 0.29 COPD Any (%) O2 dependent (%) 41.3 21.2 52.5 25.7 0.04 0.38 Creatinine >2mg/dL (%) 5.6 9.6 0.23 Atrial fibrillation (%) 32.9 48.8 0.04 Perm pacemaker (%) 22.9 19.5 0.49 Pulmonary HTN (%) 42.4 43.8 0.90 Frailty (%) 18.1 28.0 0.09 Porcelain aorta (%) 19.0 11.2 0.05 Chest wall radiation (%) 8.9 8.4 1.00 Chest wall deformity (%) 8.4 5.0 0.29 Liver disease (%) 3.4 3.4 1.00

Procedural Outcomes

TAVI (179 patients)

• 6 (3.4%) pts did not receive TAVI
• 2 died before scheduled implant
• 2 unsuccessful transfemoral access
• 2 intra-procedural annulus measurement too large and procedure

aborted

• After randomization, median time to TAVI was 6 days (inter-

quartile range 3 - 11 days)

• During TAVI (first 24 hours)
• 2 (1.1%) deaths
• 3 (1.7%) major strokes
• 1 (0.6%) valve embolization
• 2 (1.1%) pts with multiple (≥ 2) valve implants
• In the first 30 days, 11 (6.4%) pts receiving TAVI died

Procedural Outcomes

Standard Rx (179 patients)

• BAV performed in 114 (63.7%) pts ≤ 30 days and an additional 36

(20.1%) pts > 30 days after randomization (total BAV = 83.8% pts)

• Despite inoperable status:
• 12 (6.7%) pts received AVR
• 5 (2.8%) received LV - desc Ao conduit + AVR
• 4 (2.2%) received TAVI outside US
• 1-year mortality of pts receiving AVR, AVR-conduit, or TAVI

(outside US):

• AVR - 33%
• AVR + conduit - 80%
• TAVI (outside US) - 0%

0% 20% 40% 60% 80% 100% 6 12 18 24

All Cause Mortality (ITT)

Crossover Patients Followed

Numbers at Risk TAVR 179 138 124 110 83 Standard Rx 179 121 85 67 51

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%

12

Months HR [95% CI] = 0.57 [0.44, 0.75] p (log rank) < 0.0001

0% 20% 40% 60% 80% 100% 6 12 18 24

Cardiovascular Mortality (ITT)

Crossover Patients Censored

Numbers at Risk TAVR 179 138 124 110 83 Standard Rx 179 121 85 62 42

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%

13

Months HR [95% CI] = 0.44 [0.32, 0.60] p (log rank) < 0.0001

0% 20% 40% 60% 80% 100% 6 12 18 24

Repeat Hospitalization (ITT)

Numbers at Risk TAVR 179 115 100 89 64 Standard Rx 179 86 49 30 17

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%

14

Months HR [95% CI] = 0.41 [0.30, 0.58] p (log rank) < 0.0001

0% 20% 40% 60% 80% 100% 6 12 18 24

All Stroke (ITT)

Numbers at Risk TAVR 179 128 116 105 79 Standard Rx 179 118 84 62 42

Incidence (%) Months

Standard Rx TAVR

∆ at 2 yr = 8.3% 5.5% 13.8% ∆ at 1 yr = 5.7% 5.5% 11.2%

15

HR [95% CI] = 2.79 [1.25, 6.22] p (log rank) = 0.009

0% 20% 40% 60% 80% 100% 6 12 18 24

Numbers at Risk None to Mild 147 118 107 95 72 Moderate or Severe 17 12 11 10 8

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

16

p (log rank) = 0.891

NYHA Class Over Time

Survivors

P = 0.68 P < 0.0001 P < 0.0001 P < 0.0001

I II III IV

TAVI Standard Rx TAVI Standard Rx TAVI Standard Rx TAVI Standard Rx

Percent

Treatment Visit Baseline 30 Day 6 Month 1 Year

$50,000 per LY Cost = $79,837  LE = 1.59 years ICER = $50,212/LYG $100,000 per LY

Cost-Effectiveness of TAVR vs. Control

Lifetime Results

Reynolds MR et al, Circulation. 2012 Feb 3. [Epub ahead of print]

Transfemoral Transapical

TAVR vs. SAVR Transfemoral and Transapical

Characteristic TAVR (N = 348) AVR (N = 351) p-value Age (yr) 83.6 ± 6.8 84.5 ± 6.4 0.07 Male sex - % 57.8 56.7 0.82 STS Score 11.8 ± 3.3 11.7 ± 3.5 0.61 Logistic EuroSCORE 29.3 ± 16.5 29.2 ± 15.6 0.93 NYHA II - % III or IV - % 94.3 94.0 0.79 CAD - % 74.9 76.9 0.59 Previous MI - % 26.8 30.0 0.40 Prior CV Intervention - % 72.1 71.6 0.93 Prior CABG - % 42.6 44.2 0.70 Prior PCI - % 34.0 32.5 0.68 Prior BAV - % 13.4 10.2 0.24 29.3 27.4 0.60

Patient Characteristics (1)

Cerebrovascular disease - % 5.7 6.0

Characteristic TAVR (N = 348) AVR (N = 351) p-value Peripheral vascular disease - % 43.0 41.6 0.76 COPD Any 43.4 Oxygen dependent 9.2 7.1 0.34 Creatinine > 2mg/dL - % 11.1 7.0 0.06 Atrial fibrillation - % 40.8 42.7 0.75 Permanent pacemaker - % 20.0 21.9 0.58 Pulmonary hypertension - % 42.4 36.4 0.15 Frailty - % 15.6 17.6 0.58 Porcelain aorta - % 0.6 1.1 0.69 Chest wall radiation - % 0.9 0.9 1.00 Liver disease - % 2.0 2.6 0.80

Patient Characteristics (2)

43.0 0.94

0.1 0.2 0.3 0.4 0.5 6 12 18 24 TAVR AVR

Months

348 298 260 147 67 351 252 236 139 65

• No. at Risk

TAVR AVR

26.8 24.2

Transcatheter vs. Surgical Aortic Valve Replacement in High Risk Patients with Severe Aortic Stenosis: Results From The PARTNER Trial

Primary Endpoint: All-Cause Mortality at 1 Year

HR [95% CI] = 0.93 [0.71, 1.22] P (log rank) = 0.62

Smith CRet al, N Engl J Med. 2011 Jun 9;364(23):2187-98. Epub 2011 Jun 5.

NYHA Functional Class

Baseline 1 Year 6 Months 30 Days

Patients Surviving, %

I II III IV

P = 1.00 P < 0.001 P = 0.05 P = 0.75

20 40 60 80 100 TAVR AVR TAVR AVR TAVR AVR TAVR AVR

Transcatheter vs. Surgical Aortic Valve Replacement in High Risk Patients with Severe Aortic Stenosis: Results From The PARTNER Trial

All-Cause Mortality: Transfemoral (N=492)

Months

244 215 188 119 59 248 180 168 109 56

• No. at Risk

TAVR AVR

26.4 22.2 HR [95% CI] = 0.83 [0.60, 1.15] P (log rank) = 0.25

TAVR AVR 0.1 0.2 0.3 0.4 0.5 6 12 18 24 TAVR AVR 6 12 18 24 0.1 0.2 0.3 0.4 0.5

Smith CRet al, N Engl J Med. 2011 Jun 9;364(23):2187-98. Epub 2011 Jun 5.

104 83 72 28 8 103 72 68 30 9 TAVR AVR

Months

• No. at Risk

All-Cause Mortality Transapical (N=207)

0.1 0.2 0.3 0.4 0.5 6 12 18 24 TAVR AVR

29.0 HR [95% CI] = 1.22 [0.75, 1.98] P (log rank) = 0.41 27.9

Who should undergo TAVI?

• 1. Transfemoral TAVI is recommended if:

– The risk of open heart surgery is prohibitive and – A significant improvement in duration or quality of life is likely and – Life expectancy with treatment is likely to exceed 1 to 2 years (Strong Recommendation, High Quality Evidence)

• 2. Patients who are not candidates for open heart surgery
• r for TAVI using femoral artery access may be

considered for other alternative access procedures (eg. transapical, transaxillary, or transaortic).

(Conditional Recommendation, Low Quality Evidence)

Who should undergo TAVI?

• 3. TAVI is a reasonable alternative to SAVR for patients at

high risk of mortality or major morbidity* and

– duration and quality of life is likely to be significantly improved by treatment – life expectancy with treatment is likely to exceed 1 to 2 years with treatment – there is a consensus amongst a multidisciplinary Heart Team including cardiologists and surgeons (Strong Recommendation, High Quality Evidence)

* “High risk” can be defined as a risk of mortality of >8% or major morbidity of >50% within 30 days of surgery as determined by an experienced cardiac surgeon or by the STS risk calculator

Who should undergo TAVI?

• 4. SAVR is the treatment of choice for patients

diagnosed with severe symptomatic aortic stenosis considered at intermediate or low surgical risk

(Strong Recommendation, Moderate Quality Evidence)

• 5. TAVI may be offered to selected patients with severe

symptomatic aortic stenosis where there is a consensus

• f the Heart Team that they are at significantly

increased risk of either morbidity or mortality due to special circumstances (eg. frailty, very advanced age, patent bypass grafts, multivalvular disease, etc.)

(Conditional Recommendation, Low Quality Evidence)

Who should undergo TAVI?

• 6. Surgical valve replacement is the treatment of choice for non-high risk

patients with failure of bioprosthetic surgical valves. (Strong Recommendation, Low Quality Evidence)

• 7. Transcatheter valve-in-valve implants may be reasonable in patients with

failed surgical bioprosthetic valves in whom there is a Heart Team consensus that:

– the risk of open heart surgery is prohibitive and – a significant improvement in duration or quality of life is likely and – life expectancy with treatment is likely to exceed 1 to 2 years and – the dimensions and characteristics of the failed valve are understood and compatible with good transcatheter valve function (Conditional Recommendation, Low Quality Evidence)

• 8. Transcatheter valve implants is reasonable in carefully selected patients

with transcatheter valve failure

(Conditional Recommendation, Low Quality Evidence)

Webb et al, EHJ in press

Future TAVI vs SAVR Research

Clinical Assessment of the patient with symptomatic severe AS

TAVI TEAM

Key TAVI Team Membership Interventional Cardiologist(s) Cardiovascular Surgeon(s) Multimodality Imaging Cardiologist Clinical Nurse Specialist Clinical cardiologist Geriatric Assessment Team Social workers Secondary Interventionalist (transfemoral) Secondary CV Surgeon (transapical) Anaesthesiologist Cardiac Catheterization Nursing CV Surgery Nursing Perfusionist (stand by) Experienced Intensivist (post procedure management) Clinical cardiologist Cardiac Rehabilitation Exercise physiologist

Screening Peri-procedural Follow up

TAVI Procedural volumes

1. Primary operators should perform a minimum of 25 cases per year.

(Strong Recommendation, Low Quality Evidence)

2. Institutions should perform a minimum of 25-50 cases per year.

(Strong Recommendation, Low Quality Evidence)

3. TAVI should be performed in centers with:

– established clinical excellence – a large experience in high risk aortic valve surgery – a commitment to a comprehensive valve program – a strong, collaborative heart multidisciplinary Heart Team – the ability to provide ongoing quality improvement – the ability to participate in ongoing research (Strong Recommendation, Low Quality Evidence)

Conclusion

• TAVI is now standard of care for carefully

selected patients with symptomatic aortic stenosis who are not suitable for surgery

• The next generation of devices may help

reduce the frequency of procedural complications and expand current indications

• For the current time, this procedure should be

limited to dedicated teams with specific expertise