Transcatheter aortic valve implantation current patient selection - - PowerPoint PPT Presentation

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Transcatheter aortic valve implantation current patient selection - - PowerPoint PPT Presentation

May 31, 2023 215 likes •579 views

Transcatheter aortic valve implantation current patient selection and approaches to care James L Velianou MD, FRCPC Director, Cardiac Care Unit Co-Director, Catheterization Laboratory Interventional Cardiology Hamilton Health Sciences

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Transcatheter aortic valve implantation – current patient selection and approaches to care

James L Velianou MD, FRCPC Director, Cardiac Care Unit Co-Director, Catheterization Laboratory Interventional Cardiology Hamilton Health Sciences Associate Professor of Medicine McMaster University velianj@mcmaster.ca

ACC Rockies

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Potential Conflicts of Interest

Proctor: Edwards Life Sciences

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Aortic Stenosis

The Problem

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Dismal Prognosis of Untreated Patients

Culmulative Survival : No AVR vs AVR

Congestive Heart Failure Pts

0% 20% 40% 60% 80% 100%

1 5 10 Time in Years Cumulative Survival % No AVR AVR

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Large Untreated Patient Population

31.8% did not undergo intervention, most frequently because of comorbidities!!!!!

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Balloon Aortic Valvuloplasty

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Positioning of TAVI

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TAVI Deployment

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!

Awesome!!!!

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TransApical Case with Small Thoracotomy

for Vascular Issues

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JACC 2010; 55:00 Cribier-Edwards, Edwards-SAPIEN, SAPIEN XT Valve 26 and 23 Fr

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24-month Follow-Up Survival Curves – Success?

Months of follow-up

6 12 18 24

% Survival

0.0 0.1 0.2 0.3 0.4 0.5 0.6 0.7 0.8 0.9 1.0 All patients Transfemoral Transapical 76% 64% 78% 64% 75% 65% Patients at risk 339 166 95 39 26 205 129 53 34 162 90 60 28 22 103 73 35 25 177 75 34 11 3 101 55 17 8

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0.1 1 10 100

Pulmonary Hypertension Severe Mitral Regurgitation Need for peri-procedural hemodynamic support

Predictive Factors of 30-day Mortality – Canadian Expeience

OR: 2.09, 95% CI: 1.02-4.43, P=0.048 OR: 3.01, 95% CI: 1.09-8.24, P=0.033 OR: 6.84, 95% CI: 2.04-22.93, P=0.002

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Predictive Factors of Late Mortality – Canadian Experience

COPD 2 4 6 8 0.0 0.2 0.4 0.6 0.8 1.0 1.2 STS-PROM score OR: 2.63, 95% CI: 1.29-5.36 (P=0.008) OR: 1.07, 95% CI: 1.03-1.12 (P=0.002) (for each increase of 1%) Cut-off: 10.5%

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100 90 80 70 60 50 40 30 20 10 6 12 18 24 30 36 42 48

Free of death (%)

78% 71% 58% 58%

Months follow-up

74% 59% 41% 37% 80% 68% 40% 30%

48-month Follow-Up Survival Curves Canadian Multicenter Experience

254 200 186 166 143 99 61 32 10

Patients at risk:

36 27 26 22 19 13 5 2 1 85 65 57 49 36 26 13 7 3

Log-Rank (Frailty+STS<8%

  • vs. No Frailty: 0.31

Log-Rank (Frailty vs. No Frailty : 0.04 No Frailty (n=254) Frailty +STS<8 (n=36) Frailty (n=85)

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TIMING OF DEATH AT FOLLOW-UP – Time for Reboot?

Months follow-up Number of patients

8 19 2 10 8 20 4 1 8 7 8

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Predictive factors of cumulative late mortality

Hazard Ratio 95%CI P value 1.24-2.57 1.16-2.41 1.12-2.24 1.06-2.22 1.78 1.67 1.58 1.53 0.002 0.006 0.009 0.02 Chronic obstructive pulmonary disease Chronic kidney disease Chronic atrial fibrillation Frailty 50 (37%) 86 (63%) 58 (43%) 42 (31%) Yes (n=136)

Cumulative Late Mortality

No (n=203) 50 (25%) 104 (51%) 57 (28%) 43 (21%)

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N = 699 N = 358 High Risk Inoperable

PARTNER Study Design

Symptomatic Severe Aortic Stenosis

ASSESSMENT: High-Risk AVR Candidate 3,105 Total Patients Screened

Total = 1,057 patients 2 Parallel Trials: Individually Powered

Standard Therapy

ASSESSMENT:

Transfemoral Access

Not In Study TF TAVR Primary Endpoint: All-Cause Mortality Over Length of Trial (Superiority) Co-Primary Endpoint: Composite of All-Cause Mortality and Repeat Hospitalization (Superiority) 1:1 Randomization

VS

Yes No

N = 179 N = 179

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

2 Year All Cause Mortality (ITT) Non-Surgical Patients

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%

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

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

2 Year Mortality or Stroke (ITT) Non-Surgical Patients

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

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%

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HR [95% CI] = 0.64 [0.49, 0.84] p (log rank) = 0.0009

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N = 179

N = 358 Inoperable

Standard Therapy

ASSESSMENT:

Transfemoral Access

Not In Study TF TAVR Primary Endpoint: All-Cause Mortality Over Length of Trial (Superiority) Co-Primary Endpoint: Composite of All-Cause Mortality and Repeat Hospitalization (Superiority) 1:1 Randomization

VS

Yes No

N = 179

TF TAVR AVR Primary Endpoint: All-Cause Mortality at 1 yr (Non-inferiority) TA TAVR AVR

VS VS N = 248 N = 104 N = 103 N = 244

PARTNER Study Design

Symptomatic Severe Aortic Stenosis

ASSESSMENT: High-Risk AVR Candidate 3,105 Total Patients Screened

Total = 1,057 patients 2 Parallel Trials: Individually Powered

N = 699 High Risk

ASSESSMENT:

Transfemoral Access Transapical (TA) Transfemoral (TF)

1:1 Randomization 1:1 Randomization Yes No

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TAVI vs SAVR 3 Year PARTNER Can we do Better?

  • Mortality - SAVR 44.8% vs TAVI 44.2%
  • Stroke - SAVR 9.3% vs TAVI 8.2%
  • Combined – SAVR 45.9% vs. TAVI 47.1%
  • Predictors in SAVR – Prev CABG, PPM, MR, STS
  • Predictors in TAVI – BMI, AF, Gradient, Renal, Paravalvular
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Treatment Assignment of High-Risk Symptomatic Severe Aortic Stenosis Patients Referred for Transcatheter AorticValve Implantation

Kevin R. Bainey MDa, Madhu K. Natarajan MD, MScb, Mathew Mercuri MScb, Tony Lai MDb, Kevin Teoh MDb, Victor Chu MDb, Richard P. Whitlock MD, PhDb, James L. Velianou MDb.

aMazankowski Alberta Heart Institute, University of Alberta, Edmonton,

Alberta, Canada; bMcMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada Bainey et al. American Journal Cardiology In Press

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Disposition of patients (n=170)

170 patients referred for TAVI assessment 62 patients treated conservatively: 37% 33 patients accepted for conventional AVR: 19% 58 patients accepted for TAVI: 34% 17 patients died awaiting TAVI assessment: 10%

Bainey et al. American Journal Cardiology In Press

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Treatment assignment of patients who survived until complete assessment (n=153)

41% 22% 38%

Conservative Conventional AVR TAVI

Bainey et al. American Journal Cardiology In Press

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Descriptive Characteristics

Variable Conservative (n=62) AVR (n=33) TAVI (n=58) Age (year) 82.5(5.5) 82.7(6.4) 81.3(7.6) Male 53% 61% 47% Body mass index (kg/m2) 25.8(5.4) 26.5(4.8) 25.8(5.6) Diabetes mellitus 26% 36% 31% Hypercholesterolemia 58% 67% 81% Hypertension 79% 67% 88% Current smoker 8% 6% 0% New York Heart Association IV 18% 6% 24% Atrial fibrillation 36% 46% 36% Angiographic coronary disease

  • 64%

67% Previous myocardial infarction 18% 24% 33% Chronic obstructive pulmonary disease 29% 9% 36% Cerebrovascular disease 16% 27% 24% Peripheral artery disease 13% 6% 14% Creatinine (umol/l) 130(106) 102(53.5) 115(95.3) Porcelain aorta 10% 0% 14% Frail 48% 18% 55%

Bainey et al. American Journal Cardiology In Press

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Correlates for Conventional Aortic Valve Replacement

Surgeons are actually Smart!!

Variable Multivariable Cox Analysis HR 95% CI P-value Age 1.02 0.95 -1.11 0.56 Chronic obstructive pulmonary disease 0.30 0.09-0.98 <0.05 Previous coronary artery bypass grafting 0.51 0.17-1.54 0.23 Porcelain aorta 0.00 0.00-0.00 0.998 Frailty 0.19 0.07-0.56 <0.01 Pulmonary hypertension 0.62 0.23-1.64 0.33

Bainey et al. American Journal Cardiology In Press

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Reason for ineligibility (n=62) How about COPD?

34% 16% 27% 7% 7% 3% 3% 3% Patient refusal Aortic valve area >0.8cm2 Life expectancy <1 yr Left ventricular ejection fraction <30% Mixed valve disease Annulus Asymptomatic severe AS Bainey et al. American Journal Cardiology In Press

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“In conclusion, of the high-risk severe AS patients referred for TAVI in a large single center, approximately one-half were accepted for intervention (conventional AVR/TAVI) and roughly one-third were treated conservatively”.

Bainey et al. American Journal Cardiology In Press

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“Of concern are 10% of patients who died awaiting complete assessment for TAVI”.

Bainey et al. American Journal Cardiology In Press

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How Do we Improve Selection of Patients?

Heart Team – Check Egos at Door! Involve other Specialties – Neuro, Geriatrics, Resp , OT/PT Frailty Assessment (Formalized) Efficient, Rapid Assessment to ensure SAVR if Appropriate Courage to Decline Patients More Research to Facilitate the Above!!!

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  • Age (chronologic / physiologic)
  • Activity (prior normal activity)
  • Attitude / courage (includes realistic understanding)
  • Associated diseases
  • Ability to tolerate medical therapy

5 A of Dr Rouleau ACC Rockies 2011

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Points to Consider in Selection of Patients for TAVI

Will patient be better off with TAVI or SAVR? Can Patient Benefit from TAVI or Medical? Does Patient want TAVI? Family Pressure? Does Patient and family Understand Intervention? Does TAVI Team Understand Patient Wishes? Does End Result justify Emotional, Economic Costs?