Transcatheter aortic valve implantation current patient selection - PowerPoint PPT Presentation

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 ACC Rockies velianj@mcmaster.ca

Potential Conflicts of Interest Proctor: Edwards Life Sciences

Aortic Stenosis The Problem

Dismal Prognosis of Untreated Patients Culmulative Survival : No AVR vs AVR Congestive Heart Failure Pts Cumulative Survival % 100% 80% 60% No AVR 40% AVR 20% 0% 1 5 10 Time in Years

Large Untreated Patient Population 31.8% did not undergo intervention, most frequently because of comorbidities!!!!!

Balloon Aortic Valvuloplasty

Positioning of TAVI

TAVI Deployment

Awesome!!!! !

TransApical Case with Small Thoracotomy for Vascular Issues

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

24-month Follow-Up Survival Curves – Success? 1.0 0.9 0.8 76% 0.7 75% 64% 78% % Survival 0.6 65% 64% 0.5 0.4 0.3 0.2 All patients Transfemoral 0.1 Transapical 0.0 0 6 12 18 24 Months of follow-up 339 166 95 53 39 205 129 34 26 Patients at risk 162 103 90 73 60 35 28 25 22 177 101 75 55 34 17 11 8 3

Predictive Factors of 30-day Mortality – Canadian Expeience Pulmonary Hypertension OR: 2.09, 95% CI: 1.02-4.43, P=0.048 Severe Mitral Regurgitation OR: 3.01, 95% CI: 1.09-8.24, P=0.033 Need for peri-procedural OR: 6.84, 95% CI: 2.04-22.93, P=0.002 hemodynamic support 0 0.1 1 10 100

Predictive Factors of Late Mortality – Canadian Experience OR: 2.63, 95% CI: 1.29-5.36 (P=0.008) COPD 0 2 4 6 8 OR: 1.07, 95% CI: 1.03-1.12 (P=0.002) STS-PROM score (for each increase of 1%) Cut-off: 10.5% 0.0 0.2 0.4 0.6 0.8 1.0 1.2

48-month Follow-Up Survival Curves Canadian Multicenter Experience 100 No Frailty (n=254) Frailty (n=85) 90 Frailty +STS<8 (n=36) 80 70 78% Free of death (%) 74% 80% 60 71% 59% 50 68% 58% 40 Log-Rank (Frailty vs. 41% No Frailty : 0.04 40% 30 58% Log-Rank (Frailty+STS<8% 37% vs. No Frailty: 0.31 20 30% 10 0 0 6 12 18 24 30 36 42 48 Months follow-up Patients at risk: 254 200 186 166 143 99 61 32 10 85 65 57 49 36 26 13 7 3 36 27 26 22 19 13 5 2 1

TIMING OF DEATH AT FOLLOW-UP – Time for Reboot? Number of patients 20 19 10 7 8 8 8 8 4 2 1 Months follow-up

Predictive factors of cumulative late mortality Cumulative Late Mortality Yes No Hazard Ratio 95%CI P value (n=136) (n=203) Chronic obstructive pulmonary disease 50 (37%) 50 (25%) 1.78 1.24-2.57 0.002 Chronic kidney disease 86 (63%) 104 (51%) 1.67 1.16-2.41 0.006 Chronic atrial fibrillation 58 (43%) 57 (28%) 1.58 1.12-2.24 0.009 Frailty 42 (31%) 43 (21%) 1.53 1.06-2.22 0.02

PARTNER Study Design Symptomatic Severe Aortic Stenosis ASSESSMENT: High-Risk AVR Candidate 3,105 Total Patients Screened Total = 1,057 patients N = 358 N = 699 Inoperable High Risk 2 Parallel Trials: Individually Powered ASSESSMENT: Transfemoral Access Yes No 1:1 Randomization Not In Study N = 179 N = 179 Standard TF TAVR VS Therapy Primary Endpoint: All-Cause Mortality Over Length of Trial (Superiority) Co-Primary Endpoint: Composite of All-Cause Mortality and Repeat Hospitalization (Superiority)

2 Year All Cause Mortality (ITT) Non-Surgical Patients HR [95% CI] = Standard Rx 100% 0.57 [0.44, 0.75] TAVR p (log rank) < 0.0001 All Cause Mortality (%) 80% 67.6% ∆ at 1 yr = 20.0% 60% 50.7% NNT = 5.0 pts 40% 43.3% 30.7% ∆ at 2 yr = 24.3% 20% NNT = 4.1 pts 0% 0 6 12 18 24 Months Numbers at Risk TAVR 179 138 124 110 83 Standard Rx 179 121 85 67 51 20

2 Year Mortality or Stroke (ITT) Non-Surgical Patients HR [95% CI] = Standard Rx 100% All Cause Mortality or Stroke (%) 0.64 [0.49, 0.84] TAVR p (log rank) = 0.0009 80% 68.0% ∆ at 1 yr = 16.1% NNT = 6.2 pts 60% 51.3% 40% 46.1% 35.2% ∆ at 2 yr = 21.9% 20% NNT = 4.6 pts 0% 0 6 12 18 24 Months Numbers at Risk TAVR 179 128 116 105 79 Standard Rx 179 118 84 62 42 21

PARTNER Study Design Symptomatic Severe Aortic Stenosis ASSESSMENT: High-Risk AVR Candidate 3,105 Total Patients Screened Total = 1,057 patients N = 358 N = 699 Inoperable High Risk 2 Parallel Trials: Individually Powered ASSESSMENT: ASSESSMENT: Yes No Transfemoral Access Transfemoral Access Transapical (TA) Transfemoral (TF) Yes No 1:1 Randomization 1:1 Randomization 1:1 Randomization Not In Study N = 244 N = 248 N = 104 N = 103 N = 179 N = 179 Standard TF TAVR AVR TF TAVR TA TAVR AVR VS VS VS Therapy Primary Endpoint: All-Cause Mortality Primary Endpoint: All-Cause Mortality at 1 yr Over Length of Trial (Superiority) (Non-inferiority) Co-Primary Endpoint: Composite of All-Cause Mortality and Repeat Hospitalization (Superiority)

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

Treatment Assignment of High-Risk Symptomatic Severe Aortic Stenosis Patients Referred for Transcatheter AorticValve Implantation Kevin R. Bainey MD a , Madhu K. Natarajan MD, MSc b , Mathew Mercuri MSc b , Tony Lai MD b , Kevin Teoh MD b , Victor Chu MD b , Richard P. Whitlock MD, PhD b , James L. Velianou MD b . a Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Alberta, Canada; b McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada Bainey et al. American Journal Cardiology In Press

Disposition of patients (n=170) 170 patients referred for TAVI assessment 17 patients died awaiting TAVI assessment: 10% 62 patients treated 33 patients accepted 58 patients conservatively: for conventional AVR: accepted for 37% 19% TAVI: 34% Bainey et al. American Journal Cardiology In Press

Treatment assignment of patients who survived until complete assessment (n=153) 38% 41% Conservative Conventional AVR TAVI 22% Bainey et al. American Journal Cardiology In Press

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/m 2 ) 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

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 0.30 0.09-0.98 <0.05 pulmonary disease Previous coronary 0.51 0.17-1.54 0.23 artery bypass grafting Porcelain aorta 0.00 0.00-0.00 0.998 Frailty 0.19 0.07-0.56 <0.01 Pulmonary 0.62 0.23-1.64 0.33 hypertension Bainey et al. American Journal Cardiology In Press

Reason for ineligibility (n=62) How about COPD? 3% 3% 3% Patient refusal Aortic valve area 7% >0.8cm2 34% 7% Life expectancy <1 yr Left ventricular ejection fraction <30% Mixed valve disease 27% Annulus 16% Asymptomatic severe AS Bainey et al. American Journal Cardiology In Press

“ 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

“ Of concern are 10% of patients who died awaiting complete assessment for TAVI ” . Bainey et al. American Journal Cardiology In Press

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!!!

5 A of Dr Rouleau ACC Rockies 2011 • Age (chronologic / physiologic) • Activity (prior normal activity) • Attitude / courage (includes realistic understanding) • Associated diseases • Ability to tolerate medical therapy

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?