Edwards SAPIEN 3 User Manual

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Table 15:
CEC Adjudicated Adverse Events at 1 Year
(S3OUS AT Population)
30 Day
1 Year
Outcomes
SAPIEN 3
Valve
Overall
SAPIEN 3
Valve
Transfemoral
Access
SAPIEN 3
Valve
Non-
Transfemoral
Access
SAPIEN 3
Valve
Overall
SAPIEN 3
Valve
Transfemoral
Access
SAPIEN 3 Valve
Non-
Transfemoral
Access
From any
death, n/N (%)
8/102
(7.8%)
2/57
(3.5%)
6/45
(13.3%)
20/102
(19.6%)
7/57
(12.3%)
13/45
(28.9%)
From
cardiovascular
cause, n/N (%)
7/102
(6.9%)
2/57
(3.5%)
5/45
(11.1%)
9/102
(8.8%)
2/57
(3.5%)
7/45
(15.6%)
Stroke, n/N (%)
3/102
(2.9%)
1/57
(1.8%)
2/45
(4.4%)
5/102
(4.9%)
2/57
(3.5%)
3/45
(6.7%)
Aortic
Insufficiency (AI)
≥ Moderate,
n/N (%)
3/81
(3.7%)
1/49
(2.0%)
2/32
(6.3%)
1/62
(1.6%)
1/40
(2.5%)
0/22
(0.0%)
Disabling Stroke,
n/N (%)
0/102
(0.0%)
0/57
(0.0%)
0/45
(0.0%)
1/102
(1.0%)
1/57
(1.8%)
0/45
(0.0%)
Myocardial
Infarction,
n/N (%)
2/102
(2.0%)
2/57
(3.5%)
0/45
(0.0%)
3/102
(2.9%)
2/57
(3.5%)
1/45
(2.2%)
Major Vascular
Complications,
n/N (%)
5/102
(4.9%)
1/57
(1.8%)
4/45
(8.9%)
N/A N/A N/A
Acute Kidney
Injury - Stage III,
n/N (%)
0/102
(0.0%)
0/57
(0.0%)
0/45
(0.0%)
N/A N/A N/A
Disabling
Bleeding Event,
n/N (%)
6/102
(5.9%)
3/57
(5.3%)
3/45
(6.7%)
N/A N/A N/A
Valve Dysfunction
Requiring
Intervention,
n/N (%)
0/102
(0.0%)
0/57
(0.0%)
0/45
(0.0%)
N/A N/A N/A
Prosthetic Valve
Endocarditis,
n/N (%)
0/102
(0.0%)
0/57
(0.0%)
0/45
(0.0%)
1/102
(1.0%)
0/57
(0.0%)
1/45
(2.2%)
Conduction
Abnormality
Requiring
Pacemaker,
n/N (%)
14/102
(13.7%)
7/57
(12.3%)
7/45
(15.6%)
14/102
(13.7%)
7/57
(12.3%)
7/45
(15.6%)
The composite adverse event rate involving all-cause mortality, all stroke, and AI ≥ moderate at 30 days
for all patients is higher in the S3OUS cohort than PIIS3HR cohort (14.8% vs. 6.8%). This disparity is due
to the composition of the study populations, specifically the S3OUS cohort comprises 44.1% TA/TAo
patients vs. 15.8% TA/TAo patients in the PIIS3HR cohort. Note, the composite adverse event rate at 30
days for TF patients was similar, specifically, 6.0% in the S3OUS cohort and 5.8% in the PIIS3HR cohort.
The K-M estimates for all-cause mortality for all patients, the TF patients, and the TA/TAo patients are
shown in Figure 11.

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)