ECHO 2013 / Transcatheter Aortic and Mitral Valve Replacement The Future is Now 2
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Hospitalization Through 2 Years
Inoperable Cohort
TAVR |
Standard Tx p value |
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Repeat Hospitalizations (No.) |
78 |
151 |
<.0001 |
Repeat Hospitalizations (%) |
35.0% |
72.5% |
<.0001 |
Days Alive Out of Hospital |
699 [201-720] |
355 [116-712] |
.0003 |
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Median [IQR] |
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21
TAVR Admission Costs
$78,540
$80,000
$4,978
$60,000 |
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Mean (median) LOS |
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$30,756 |
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(days) |
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ICU |
4.0 (2.0) |
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$40,000 |
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Hospital Costs: |
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Non-ICU |
6.1 (5.0) |
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Total |
10.1 (7.0) |
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$73,563 |
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Post-Procedure |
8.6 (6.0) |
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$20,000 |
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$42,806 |
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(N=175) |
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$0
Index Admission Costs
Procedure |
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Non-Procedure |
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MD Fees |
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Published Cost Effectiveness
Estimates
Dollars per Life Year or QALY ($thousands)
$300
$250
$200
$150
$100
$50
$0
aspirin MI |
rosuvastatin |
ICD prim |
CRT-D v. |
dabigatran |
PARTNER |
AF ablation |
dialysis |
PCI stable |
LVAD |
prevention |
high-CRP |
prev |
medical Rx |
AF |
Cohort B |
vs. AAD |
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CAD |
destination |
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Rx |
TAVR Categories
(risk is a continuum)
Operable AS patients
Too Sick
Inoperable
High Risk
Low-Intermediate Risk
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90% |
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10% FDA Approval |
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November 2011
PARTNER Study Design
Symptomatic Severe Aortic Stenosis
ASSESSMENT: High-Risk AVR Candidate
3,105 Total Patients Screened
n = 699 High-Risk
Total = 1,057 patients
2 Parallel Trials:
Individually Powered
Inoperable n = 358
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ASSESSMENT: |
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ASSESSMENT: |
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Yes |
No |
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Transfemoral |
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Transfemoral |
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Access |
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Access |
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Transfemoral (TF) |
Transapical (TA) |
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1:1 Randomization |
1:1 Randomization |
1:1 Randomization |
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N = 244 |
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N = 248 |
N = 104 |
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N = 103 |
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TF TAVR |
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Standard |
TF TAVR |
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AVR |
TA TAVR |
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AVR |
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Therapy |
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n = 179 |
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n = 179 |
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VS |
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VS |
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VS |
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Primary Endpoint: All-Cause Mortality at 1 yr |
Primary Endpoint: All-Cause Mortality |
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(Non-inferiority) |
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Over Length of Trial (Superiority) |
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TAVR
Transfemoral and Transapical
Transfemoral |
Transapical |
All-Cause Mortality (ITT)
Landmark Analysis
100%
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TAVR |
Mortality starting at 1 yr |
Mortality |
80% |
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AVR |
HR [95% CI] = |
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1.02 [0.74, 1.40] |
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60% |
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p (log rank) = 0.922 |
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Cause-All |
40% |
26.8% |
26.3% |
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20% |
24.3% |
24.5% |
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12.4% |
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10.7% |
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0% |
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0 |
6 |
12 |
18 |
24 |
30 |
36 |
Numbers at Risk |
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Months |
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TAVR |
348 |
298 |
261 |
239 |
222 |
187 |
149 |
AVR |
351 |
252 |
236 |
223 |
202 |
174 |
142 |
Strokes (ITT)
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70% |
TAVR |
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HR [95% CI] = |
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60% |
AVR |
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1.09 [0.62, 1.91] |
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p (log rank) = 0.763 |
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50% |
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Strokes |
40% |
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30% |
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20% |
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7.7% |
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9.3% |
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6.0% |
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8.2% |
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10% |
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3.2% |
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4.9% |
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0% |
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0 |
6 |
12 |
18 |
24 |
30 |
36 |
Months Post Randomization
No. at Risk
TAVR |
348 |
287 |
250 |
228 |
211 |
176 |
139 |
AVR |
351 |
246 |
230 |
217 |
197 |
169 |
139 |