Edwards SAPIEN 3 - Page 28

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The average mean gradient decreased from 44.8 ± 15.4 mmHg at baseline to 10.4 ± 4.1 mmHg at 30
days and maintained at 10.7 ± 4.1 mmHg at 1 year, as shown in Figure 14.
Figure 14:
Mean Gradient
(S3OUS VI Population)
The mean peak gradient decreased from 77.5 ± 24.9 mmHg at baseline to 21.0 ± 7.7 mmHg at 30 days,
and maintained at 21.5 ± 8.2 mmHg at 1 year, as shown in Figure 15.
Figure 15:
Peak Gradient
(S3OUS VI Population)
The proportion of patients with aortic insufficiency ≥ moderate was 9.8% at baseline, 3.7% at 30 days,
and 1.6% at 1 year, as shown in Figure 16.
Mean Gradient (mmHg)
0
10
20
30
40
50
60
70
80
90
100
110
Baseline 30 Day 1 Year
44.8 44.8 44.8
10.4 10.4 10.4
10.7 10.7 10.7
Peak Gradient (mmHg)
0
10
20
30
40
50
60
70
80
90
100
110
Baseline 30 Day 1 Year
77.5 77.5 77.5
21.0 21.0 21.0
21.5 21.5 21.5