Edwards SAPIEN 3 User Manual

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Table 14:
Patient Demographics and Baseline Characteristics
(S3OUS AT Population)
Demographics and Baseline
Characteristics
SAPIEN 3
Valve
Overall
(N = 102)
SAPIEN 3 Valve
Transfemoral
Access
(N = 57)
SAPIEN 3 Valve
Non-Transfemoral
Access
(N = 45)
Coronary-artery bypass grafting
(CABG)
24 (23.5%)
10 (17.5%)
14 (31.1%)
Percutaneous coronary intervention
(PCI)
34 (33.3%)
16 (28.1%)
18 (40.0%)
Prior aortic valvuloplasty
10 (9.8%)
8 (14.0%)
2 (4.4%)
Stroke, no.(%)
7 (6.9%)
4 (7.0%)
3 (6.7%)
Peripheral vascular disease, no.(%)
27 (26.5%)
10 (17.5%)
17 (37.8%)
Chronic obstructive pulmonary disease
(COPD), no.(%):
Any
25 (24.5%)
13 (22.8%)
12 (26.7%)
Oxygen-dependent
1 (1.0%)
1 (1.8%)
0 (0%)
Atrial fibrillation, no.(%)
48 (47.1%)
22 (38.6%)
26 (57.8%)
Permanent pacemaker, no.(%)
15 (14.7%)
7 (12.3%)
8 (17.8%)
Severe pulmonary hypertension, no.(%)
10 (9.8%)
6 (10.5%)
4 (8.9%)
Severe liver disease / Cirrhosis, no.(%)
1 (1.0%)
1 (1.8%)
0 (0%)
Echocardiographic findings
Effective Orifice Area (EOA), cm
2
0.6 ± 0.2
0.6 ± 0.2
0.6 ± 0.1
Mean aortic-valve gradient, mmHg
44.8 ± 15.3
45.2 ± 14.7
44.2 ± 16.1
Mean left ventricular ejection
fraction (LVEF), %
56.7 ± 9.1
57.7 ± 9.3
55.3 ± 8.7
Moderate or severe mitral
regurgitation, no./total no. (%)
23/85
(27.1%)
9/48
(18.8%)
14/37
(37.8%)
Plus–minus values are means ± SD.
Safety and Effectiveness Results
Key Adverse Events
Key adverse events as adjudicated by the CEC are presented in Table 15.
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
Composite Event
Rate of Death, All
Stroke and AI ≥
Moderate,
n/N (%)
13/88
(14.8%)
3/50
(6.0%)
10/38
(26.3%)
25/82
(30.5%)
9/47
(19.1%)
16/35
(45.7%)
Death

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)