Edwards SAPIEN 3 - Page 29

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Figure 16:
Aortic Insufficiency
(S3OUS VI Population)
The proportion of patients with aortic PVL ≥ moderate was 3.7% at 30 days, and 1.6% at 1 year, as
shown in Figure 17.
Figure 17:
Aortic Paravalvular Leak
(S3OUS VI Population)
NYHA
The NYHA class by visit is shown in Figure 18. For all patients, the mean NYHA class decreased from 3.0
± 0.5 at baseline to 1.6 ± 0.7 at 30 days and 1.8 ± 0.6 at 1 year.
None
Trace
Mild
Mild-Moderate
Moderate
Moderate-Severe
Severe
Percentage
0
20
40
60
80
100
Baseline
30 Day 1 Year
13%
37%
55%
37%
44%
32%
35%
12%
8%
5%
9%
None Trace Mild
Mild-Moderate Moderate Moderate-Severe
Severe
Percentage
0
20
40
60
80
100
30 Day 1 Year
40%
56%
42%
31%
12%
6%
5%