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Transcatheter Aortic Valve Implantation: Insights on Prognostic - - PowerPoint PPT Presentation
Transcatheter Aortic Valve Implantation: Insights on Prognostic - - PowerPoint PPT Presentation
Long-Term Outcomes Following Transcatheter Aortic Valve Implantation: Insights on Prognostic Factors and Valve Durability from the Canadian Multicenter Experience Josep Rods-Cabau, M.D. Quebec Heart & Lung Institute, Laval University
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St Paul’s hospital, University of British Columbia, Vancouver, British Columbia, Canada John G Webb, Anson Cheung, Jian Ye, Samuel Lichenstein, Fabian Nietlispach, Ronen Gurvitch, Stefan Toggweiler, Chris Thompson, David Wood
Quebec Heart Lung Institute, Laval University, Quebec city, Quebec, Canada Josep Rodés-Cabau, Eric Dumont, Robert DeLarochellière, Daniel Doyle
Toronto General Hospital, University of Toronto, Toronto, Ontario, Canada Eric Horlick, Chris Feindel, Mark Osten
Hamilton General Hospital, McMaster University, Hamilton, Ontario, Canada Madhu Natarajan, James L Velianou, Kevin Teoh, Victor Chu, Kevin Bainey
Royal Victoria Hospital, McGuill University, Montreal, Quebec, Canada Giusssepe Martucci, Benoit DeVarennes, Adrian Dancea, Kevin Lachapelle
St Michael’s Hospital, University of Toronto, Toronto, Ontario, Canada Robert Chisholm, Mark Peterson, Asim Cheema, David Latter
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INTRODUCTION
Most data on TAVI are limited to acute and 1-year
follow-up, and very few data exist on clinical
- utcomes and prognostic factors at longer-term
follow-up
Very few data exist on the long-term durability of
transcatheter valves
Most echo data available to date in the TAVI field:
Single center studies or multicenter registries with
no central echo core lab evaluation
Variablity regarding the number of patients
evaluated over time: no real paired evaluation of the echocardiographic exams
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OBJECTIVE
To evaluate the long-term
- utcomes following TAVI in the
Multicenter Canadian Experience study, with special focus on the causes and predictors of late mortality and valve durability
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n=1 n=5 396 patients considered candidates for TAVI 5 turned down for TAVI (multicenter call conference) Transfemoral approach n=167 339 underwent TAVI under the Canadian compassionate clinical use TAVI program 52 included in the PARTNER trial Transapical approach n=172 Transfemoral Approach n=168 Transapical Approach n=177 Need for a second procedure n=6
Cribier-Edwards (n=57) Edwards SAPIEN (n=275) SAPIEN XT (n=7)
January 2005 – June 2009
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METHODS
Clinical Follow-Up
Clinical visits and/or phone contact at 30-
days, 1-year follow-up and annually thereafter
Follow-up available in all but 3 patients
(99% of the study population)
Median follow-up: 36 months (IQR: 26-44
months)
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METHODS
Valve Durability - Echo Data
Data analyzed at the Echo Core Lab of the Quebec Heart & Lung
Institute directed by Dr. Philippe Pibarot and Dr. Jean Dumesnil
Echo exams analyzed
Only echos performed at the participating centers Only patients with serial echos over time
Echo measures
Transvalvular gradient, valve effective orifice area Presence, location, and severity of aortic regurgitation:
multiparametric approach (ASE/EAE guidelines)
LVEF, ventricular diameters
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30-day death (n=36) 30-day to 1-year death (n=45) Unsuccessfull procedure, no valve implantation (n=9) Patient lost at follow-up (n=3) Echo at follow-up not performed at the participating site (n=88) 1- to 2-year death (n=23) Follow-up<2 years (n=29) Echo at follow-up not performed at the participating site (n=20) 2- to 3-year death (n=11) Follow-up<3 years (n=18) Echo at follow-up not performed at the participating site (n=23) Baseline 339 patients Follow-up<4 year (n=6) Echo at follow-up not performed at the participating site (n=17) 1-year follow-up 158 echocardiographic exams analyzed 2-year follow-up 86 echocardiographic exams analyzed 4-year follow-up 11 echocardiographic exams analyzed 3-year follow-up 34 echocardiographic exams analyzed
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Age (years) Male sex BMI (kg/m2) Diabetes Hypertension NYHA Functional Class I-II III-IV Chronic atrial fibrillation/flutter Coronary artery disease Previous myocardial infarction Previous PCI Prior coronary artery bypass grafting
Baseline Characteristics (1)
81 ± 8 152 (45) 26 ± 5 79 (23) 252 (74) 29 (9) 308 (91) 115 (34) 234 (69) 173 (51) 99 (29) 116 (34)
Variable P value Transapical (n=177) All patients (n=339)
80 ± 8 61 (35) 26 ± 5 42 (24) 150 (85) 18 (10) 158 (89) 49 (28) 124 (70) 91 (51) 52 (30) 67 (38) 0.009 <0.0001 0.93 0.89 <0.001 0.33 0.01 0.72 0.91 1.00 0.17
Transfemoral (n=162)
83 ± 8 91 (56) 26 ± 5 37 (23) 102 (63) 11 (7) 150 (93) 66 (41) 110 (68) 82 (51) 47 (29) 49 (30)
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Cerebrovascular disease Peripheral vascular disease COPD Creatinine (umol/l) eGFR<60ml/min STS score (%) Porcelain aorta Frailty Pulmonary hypertension Severe Mitral Regurgitation Mean Aortic Gradient (mmHg) Aortic Valve Area (cm2) LVEF (%) LVEF<40
Baseline Characteristics (2)
77 (23) 120 (35) 100 (30) 119 ± 83 191 (56) 9.8 ± 6.4 61 (18) 85 (25) 84 (25) 27 (8) 46 ± 17 0.63±0.17 55 ± 14 54 (16)
Variable P value Transapical (n=177) All patients (n=339)
50 (29) 89 (50) 55 (31) 113 ± 81 104 (59) 10.5 ± 6.9 33 (19) 43 (24) 49 (28) 9 (5) 44 ± 17 0.63±0.18 56 ± 14 28 (16) 0.01 <0.001 0.55 0.23 0.33 0.03 0.78 0.80 0.26 0.04 0.08 0.93 0.72 1.00
Transfemoral (n=162)
27 (17) 31 (19) 45 (28) 124 ± 85 86 (53) 9.0 ± 5.8 28 (17) 42 (26) 35 (22) 18 (11) 48 ± 18 0.63 ± 0.16 55 ± 14 26 (16)
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Procedural variables Succesful procedure Procedural death Valve embolization Need for a second valve Conversion to open heart surgery Need for hemodynamic support Major access site complications Life threatening arrythmias 30-day outcomes Myocardial infarction Stroke Sepsis Need for hemodialysis Need for pacemaker 30-day mortality
Procedural and 30-Day Outcomes
322 (93.3) 6 (1.7) 7 (2.0) 9 (2.6) 6 (1.7) 14 (4.1) 45 (13.0) 28 (8.1) 4 (1.2) 8 (2.3) 10 (2.9) 9 (2.6) 17 (4.9) 36 (10.4)
Variable P value Transapical (n=177) All Procedures (n=345)
170 (96.0) 3 (1.7) 2 (1.1) 5 (2.8) 4 (2.3) 7 (4.0) 23 (13.0) 16 (9.0) 3 (1.7) 3 (1.7) 5 (2.8) 6 (3.4) 11 (6.2) 20 (11.3) 0.051 1.00 0.27 1.00 0.69 1.00 1.00 0.56 0.62 0.49 1.00 0.50 0.32 0.73
Transfemoral (n=168)
152 (90.5) 3 (1.8) 5 (3.0) 4 (2.4) 2 (1.2) 7(4.2) 22 (13.1) 12 (7.1) 1 (0.6) 5 (3.0) 5 (3.0) 3 (1.8) 6 (3.6) 16 (9.5)
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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
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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100 90 80 70 60 50 40 30 20 10 6 12 18 24 30 36 42 48
Free of death (%)
76% 68% 52% 50%
All patients (n=339) Transapical (n=177) Transfemoral (n=162)
Months follow-up
75% 70% 53% 50% 77% 67% 52% 49%
48-month Follow-Up Survival Curves Canadian Multicenter Experience
339 271 248 221 190 141 92 59 31 All patients
Patients at risk:
177 139 131 114 94 69 42 26 14 Transapical 162 132 117 107 96 72 50 33 16 Transfemoral
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Non cardiac (n=74) Cardiac (n=29) Unknown (n=7)
CAUSES OF DEATH AT FOLLOW-UP Multicenter Canadian Experience
26% 67% 7%
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Pulmonary (n=36) Renal failure (n=11) Stroke (n=6) Major bleeding (n=6) Cancer (n=5) Other (n=10)
CAUSES OF NON-CARDIAC DEATH AT FOLLOW-UP
Multicenter Canadian Experience
8.1% 48.6% 6.8% 14.9% 8.1% 13.5%
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Predictive Factors of Late (>30 days) Mortality
Hazard Ratio 95%CI P value 1.34-2.95 1.09-2.41 1.24-2.67 1.17-2.64 1.99 1.62 1.82 1.76 0.0007 0.017 0.002 0.006 Chronic obstructive pulmonary disease Chronic kidney disease Chronic atrial fibrillation Frailty 42 (38.5%) 67 (60.9%) 47 (43.1%) 35 (31.8%) Yes (n=110)
Late Mortality
No (n=190) 44 (23.2%) 96 (50.5%) 54 (28.4%) 42 (22.1%)
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100 90 80 70 60 50 40 30 20 10 6 12 18 24 30 36 42 48
Free of cardiac death (%)
85% 83% 78% 76%
All patients (n=339) Transapical (n=177) Transfemoral (n=162)
Months follow-up
87% 86% 80% 78% 84% 80% 75% 75%
48-month Follow-Up Survival Curves / Freedom from Cardiac Death Canadian Multicenter Experience
339 271 248 221 190 141 92 59 31 All patients
Patients at risk:
177 140 134 113 93 68 41 25 14 Transapical 162 132 119 107 96 72 50 33 16 Transfemoral
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Cardiac failure (n=19) Sudden death (n=4) Myocardial infarction (n=4) Endocarditis (n=1) Post-mitral replacement (n=1)
CAUSES OF CARDIAC DEATH AT FOLLOW-UP Multicenter Canadian Experience
65.6% 13.8% 13.8% 3.4% 3.4%
No cases of structural valve failure during the follow-up period
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Hazard Ratio 95%CI P value 1.15-3.23 1.31-4.03 1.92 2.30 0.013 0.003 Pulmonary hypertension Chronic kidney disease 23 (35.4%) 47 (72.3%) Yes (n=65)
Cumulative Cardiac Mortality
No (n=274) 61 (22.3%) 143 (52.2%)
Predictive factors of cumulative cardiac mortality at follow-up
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48-month Follow-Up Survival Curves / Freedom from Stroke Canadian Multicenter Experience
100 90 80 70 60 50 40 30 20 10 6 12 18 24 30 36 42 48
Free of stroke (%)
95% 93% 92% 92%
All patients (n=339) Transapical (n=177) Transfemoral (n=162)
Months follow-up
94% 93% 92% 92% 95% 94% 92% 92%
339 260 236 211 177 122 78 50 26 All patients
Patients at risk:
177 133 124 108 84 54 32 20 11 Transapical 162 126 111 102 92 68 45 29 14 Transfemoral
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48-month Follow-Up Survival Curves / Freedom from Death and Stroke Canadian Multicenter Experience
100 90 80 70 60 50 40 30 20 10 6 12 18 24 30 36 42 48
Free of death and stroke (%)
73% 65% 48% 45%
All patients (n=339) Transapical (n=177) Transfemoral (n=162)
Months follow-up
72% 67% 49% 47% 74% 64% 47% 44%
339 262 238 211 177 122 78 50 26 All patients
Patients at risk:
177 135 125 108 84 54 32 20 11 Transapical 162 127 112 102 92 68 45 29 14 Transfemoral
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Functional status / NYHA CLASS
NYHA class 20 40 60 80 100 Baseline Last follow-up IV III II I 69.1 36.7 7.4 50.9 1.2 0.8 22.3 11.6 % of patients
p<0.0001
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Mean Gradient and Aortic Valve Area Over Time
n=158 n=86 n=34 n=11
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Mean Gradient and Aortic Valve Area Over Time
(Edwards SAPIEN valve)
n=137 n=76 n=31 n=7
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Aortic Regurgitation Over Time
n=158 n=86 n=34 n=11
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Aortic Regurgitation Over Time
(Edwards SAPIEN valve)
n=137 n=76 n=31 n=7
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0% 20% 40% 60% 80% 100% Discharge 1Y
Aortic Regurgitation Type: Paravalvular / Transvalvular
0% 20% 40% 60% 80% 100% Discharge 1Y 2Y 0% 20% 40% 60% 80% 100% Discharge 1Y 2Y 3Y 0% 20% 40% 60% 80% 100%
Discharge 1Y 2Y 3Y 4Y
Aortic Regurgitation Type Both Transvalvular Paravalvular n=158 n=86 n=34 n=11
p=0.429 p=0.391 p=0.144 p=0.278
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Mild Aortic Regurgitation and LV Changes Over Time
A B C D E F
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CONCLUSIONS
Canadian Multicenter Experience / Long-Term Results
A multicenter TAVI program with a balloon-expandable
valve including non-operable or very high risk patients was associated with a survival rate of 57% after a median follow-up of 3 years, with no differences between TF and TA approaches
Two thirds of late deaths were of non-cardiac origin and
were mostly determined by a history of COPD, CKD, chronic atrial fibrillation and frailty
About 1/3 of late deaths were of cardiac origin, mostly
secondary to cardiac failure. Pulmonary hypertension determined a higher rate of periprocedural death and remained a predictor of cardiac death at follow-up
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