Edwards SAPIEN 3 User Manual

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Figure 3:
Aortic Insufficiency by Visit –
SAPIEN 3 Valve (PIIS3HR VI Population) vs. SAPIEN Valve
The proportion of patients with AI ≥ moderate at 30 days was 3.0% in the SAPIEN 3 cohort and 14.3% in
the SAPIEN cohort, which were found to be statistically significantly different (p=0.0051; Table 9).
Table 9:
Aortic Insufficiency at 30 Days
(SAPIEN 3 Valve vs. SAPIEN Valve VI Population)
Event at 30 Days
SAPIEN 3
Valve
(N = 583)
SAPIEN Valve
(N = 326 )
Weighted Proportion
Difference in Average
Treatment Effect on the
Treated (ATT)
P-value
AI ≥Moderate, n/Total
no. (%) [95% CI]
16/532
(3.0%)
[1.7%, 4.8%]
1
40/280
(14.3%)
[10.4%,
18.9%]
1
-13.1%
[-22.2%, -3.9%]
2
0.0051
1
95% Clopper-Pearson Exact confidence interval.
2
The Wald-type two-sided 90% confidence interval using weighted mean and SD is provided
The rate of major vascular complications at 30 days post implantation is shown in Figure 4. The rate was
5.0% for the SAPIEN 3 cohort and 10.1% for the SAPIEN cohort, which were found to be not statistically
significantly different (p=0.0578; Table 10).

Edwards SAPIEN 3 Specifications

General

Product Name	Edwards SAPIEN 3
Category	Transcatheter Heart Valve
Valve Type	Balloon-expandable
Material	Bovine pericardial tissue
Frame Material	Cobalt-Chromium Alloy
Sizes	20 mm, 23 mm, 26 mm, 29 mm
Delivery System	Commander Delivery System
Regulatory Status	FDA Approved, CE Marked
Indication	Severe symptomatic aortic stenosis
Sheath Size	14F (20-23mm), 16F (26-29mm)