ECHO 2013 / Transcatheter Aortic and Mitral Valve Replacement The Future is Now 2
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Clinical Outcomes at 1, 2, and 3 Years (ITT)
All Patients (N=699)
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1 Year |
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2 Years |
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3 Years |
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Outcome |
AVR |
TAVR |
p-value |
AVR |
TAVR |
p-value |
AVR |
TAVR |
p-value |
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(N = 351) |
(N = 348) |
(N = 351) |
(N = 348) |
(N = 351) |
(N = 348) |
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Major Vasc. Comp. – no. (%) |
13 (3.8) |
42 (12.1) |
<0.001 |
13 (3.8) |
43 (12.5) |
<0.001 |
13 (3.8) |
43 (12.5) |
<0.001 |
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Major Bleeding – no. (%) |
88 |
(26.7) |
52 (15.7) |
<0.001 |
95 |
(29.5) |
61 (19.3) |
0.003 |
99 |
(31.5) |
64 |
(20.8) |
0.003 |
New PM – no. (%) |
16 (5.0) |
21 (6.4) |
0.44 |
19 (6.3) |
24 (7.6) |
0.54 |
20 (6.8) |
25 (8.1) |
0.56 |
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Endocarditis – no. (%) |
3 |
(1.0) |
2 (0.6) |
0.63 |
3 |
(1.0) |
4 (1.5) |
0.62 |
6 |
(2.6) |
4 |
(1.5) |
0.37 |
SVD§ Requiring AVR |
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0 |
0 |
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0 |
0 |
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0 |
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0 |
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MI – no. (%) |
2 |
(0.6) |
0 |
0.16 |
4 |
(1.5) |
0 |
0.05 |
6 |
(2.7) |
2 |
(1.1) |
0.23 |
Acute Kidney Inj.* – no. (%) |
20 (6.5) |
18 (5.4) |
0.57 |
22 (7.3) |
20 (6.2) |
0.59 |
23 (7.9) |
22 (7.2) |
0.76 |
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§ SVD = Structural Valve Deterioration
* Renal replacement therapy
Echocardiographic Findings (AT)
Mean & Peak Gradients
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80 |
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70 |
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Peak Gradient - AVR |
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60 |
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Peak Gradient - TAVR |
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(mmHg) |
50 |
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Mean Gradient - AVR |
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40 |
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Mean Gradient - TAVR |
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Gradient |
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30 |
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20 |
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10 |
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0 |
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Baseline |
30 Days |
6 Months |
1 Year |
2 Years |
3 Years |
No. of Echos
TAVR |
310 |
277 |
233 |
219 |
155 |
88 |
AVR |
299 |
230 |
169 |
158 |
123 |
72 |
Echocardiographic Findings (AT)
Aortic Valve Area
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2.5 |
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p = NS |
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TAVR |
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2 |
AVR |
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Area (cm2) |
1.5 |
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Valve |
1 |
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p = 0.0005 |
p = 0.0017 |
p = 0.0019 |
p = NS |
p = NS |
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0.5 |
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p = NS |
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p = NS |
Error bars at 1 |
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standard deviation |
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0 |
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Baseline |
30 Days |
6 Months |
1 Year |
2 Years |
3 Years |
No. of Echos
TAVR |
304 |
271 |
223 |
211 |
150 |
88 |
AVR |
294 |
226 |
163 |
154 |
121 |
70 |
Aortic Regurgitation
A Round Peg in a not so Round Hole
Paravalvular Aortic Regurgitation (AT)
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None |
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Trace |
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Mild |
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Moderate |
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Severe |
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p < 0.0001 |
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p < 0.0001 |
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p < 0.0001 |
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p < 0.0001 |
p < 0.0001 |
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100%
echos |
80% |
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evaluableof |
40% |
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Percent |
60% |
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20% |
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0% |
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TAVR |
AVR |
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TAVR |
AVR |
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TAVR |
AVR |
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TAVR |
AVR |
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TAVR |
AVR |
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30 Days |
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6 Months |
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1 Year |
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2 Years |
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3 Years |
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No. of Echos 279 228 |
230 173 |
217 158 |
156 122 |
88 72 |
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Impact of Total AR on Mortality (AT)
TAVR Patients
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70% |
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60% |
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50% |
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Mortality |
40% |
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30% |
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20% |
10%
0%
0
No. at Risk
None-Tr 131
Mild 171
Mod-Sev 34
None - Trace
Mild
53.7%
Moderate - Severe
38.2% 
32.5%
26.0%
25.6% |
60.8%
44.6%
35.3% |
12.3%
6 |
12 |
18 |
24 |
30 |
36 |
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Months post Procedure |
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121 |
114 |
102 |
93 |
80 |
63 |
146 |
125 |
117 |
110 |
94 |
62 |
24 |
21 |
18 |
15 |
12 |
9 |
Impact of Mild PVL on Mortality (AT)
TAVR Patients
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70% |
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60% |
Mortality |
50% |
30% |
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40% |
20%
10%
0%
0
No. at Risk
None-Tr 168
Mild 139
Mod-Sev 24
None - Trace |
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Mild |
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51.0% |
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Moderate - Severe |
45.8% |
50.4% |
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33.3% |
37.7% |
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33.9% |
28.9% |
24.3% |
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14.4% |
6 |
12 |
18 |
24 |
30 |
36 |
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Months post Procedure |
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150 |
142 |
130 |
120 |
106 |
81 |
119 |
98 |
91 |
83 |
67 |
42 |
18 |
16 |
14 |
13 |
11 |
9 |
Index Admission Costs
Transfemoral
= ($2,496) P = 0.53
$80,000
$60,000
$40,000
$20,000
$0
$71,955 |
$74,452 |
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$5,773 |
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$4,742 |
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$31,192
$54,228
$34,863
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$14,451 |
TF-TAVR |
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AVR |
Procedure |
Non-Procedure |
Total MD Fees |
Reynolds et al, TCT 2011
Clinical
Reality
TAVR vs. AVR in EU (est. 2011)
TAVR 16.9% of all AVR procedures
TAVR
Surgical AVR
100,000
90,000
80,000
70,000
60,000
50,000
40,000
30,000
20,000
10,000
0
85,800
17,500
AVR Procedures