ECHO 2013 / Transcatheter Aortic and Mitral Valve Replacement The Future is Now 2
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Intra-procedural: Valve Deployment
Rapid pacing : 220/min
TAVR - The Future
Surgery – The “PAST”
TAVR – The “Future”
Transfemoral Approach Not Always
Feasible
Transfemoral TAVR – 2013
Access Alternatives
subclavian/ direct 
axillary aortic
transapical
Iliac-aortic conduits
transfemoral
fully percutaneous (access and closure)
TAVR
Clinical Outcomes
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
ASSESSMENT:
Transfemoral
Access
1:1 Randomization
TF TAVR |
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Standard |
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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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Primary Endpoint: All-Cause Mortality
Over Length of Trial (Superiority)
16
Baseline Patient Characteristics
Demographics (ITT) - Inoperable
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TAVR |
Standard |
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Therapy |
p-value |
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(n = 179) |
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Characteristic |
(n = 179) |
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Age – years (Mean ± SD) |
83.1 ± 8.6 |
83.2 ± 8.3 |
0.95 |
Male |
45.8% |
46.9% |
0.92 |
STS Score (Mean ± SD) |
11.2 ± 5.8 |
12.1 ± 6.1 |
0.14 |
NYHA Class III or IV |
92.2% |
93.9% |
0.68 |
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Baseline Patient Characteristics
Vasculopathy (ITT) - Inoperable
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Standard |
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TAVR |
Therapy |
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Characteristic |
(%) |
(%) |
P value |
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CAD |
67.6 |
74.3 |
0.20 |
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Previous MI |
18.6 |
26.4 |
0.10 |
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Previous CABG |
37.4 |
45.6 |
0.17 |
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Previous PCI |
30.5 |
24.8 |
0.31 |
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Cerebrovascular disease |
27.4 |
27.5 |
1.00 |
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Peripheral vascular disease |
30.3 |
25.1 |
0.29 |
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Baseline Patient Characteristics
Other Co-morbidities (ITT) - Inoperable
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Standard |
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TAVR |
Therapy |
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Characteristic |
(%) |
(%) |
P Value |
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COPD – Any |
41.3 |
52.5 |
0.04 |
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COPD – O2 dependent |
21.2 |
25.7 |
0.38 |
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Creatinine >2mg/dL |
5.6 |
9.6 |
0.23 |
Atrial fibrillation |
32.9 |
48.8 |
0.04 |
Pacemaker implant |
22.9 |
19.5 |
0.49 |
Pulmonary hypertension |
42.4 |
43.8 |
0.90 |
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All Cause Mortality (ITT)
Crossover Patients Censored at Crossover
All Cause Mortality (%)
100% |
Standard Rx |
HR [95% CI] = 0.53 [0.41, 0.68] |
|
TAVR |
p (log rank) < 0.0001 |
|
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80.9% |
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80% |
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68.0% |
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26.8% |
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60% |
50.8% |
25.0% |
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20.1% |
54.1% |
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40% |
NNT = 3.7 pts |
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43.0% |
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30.7% |
NNT = 4.0 pts |
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20% |
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NNT = 5.0 pts |
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0%
0 |
6 |
12 |
18 |
24 |
30 |
36 |
Months
Numbers at Risk
Standard Rx |
179 |
121 |
85 |
62 |
46 |
27 |
17 |
TAVR |
179 |
138 |
124 |
110 |
101 |
88 |
70 |
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