Edwards SAPIEN 3 User Manual

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Table 11:
Secondary Endpoints for Labeling –
SAPIEN 3 Valve vs. SAPIEN Valve (VI Population)
Endpoints
Original
p-value
Inference
Major Vascular
Complications at 30
Days
0.0578
> 0.05; reject the alternative
hypothesis. Proceed to the rest of
testing
AI at 30 Days
0.0051
< 0.025; claim superiority
Adverse Events
The key CEC adjudicated adverse events at 30 days are presented in Table 12.
Table 12:
CEC Adjudicated Adverse Events at 30 Days
(PIIS3HR VI Population)
30 Day Adverse Events
SAPIEN 3 Valve
Overall
SAPIEN 3 Valve
Transfemoral
Access
TF
SAPIEN 3
Valve
Non-
Transfemoral
Access
Composite Event Rate of Death, All Stroke and
AI ≥ Moderate, n/N (%)
37/545 (6.8 %) 27/463 (5.8 %) 10/82 (12.2 %)
Death
From Any cause, n/N (%) 13/583 (2.2%) 8/491 (1.6%) 5/92 (5.4%)
From cardiovascular cause, n/N (%) 8/583 (1.4%) 5/491 (1.0%) 3/92 (3.3%)
Stroke, n/N (%) 9/583 (1.5%) 8/491 (1.6%) 1/92 (1.1%)
AI ≥ moderate, n/N (%) 16/532 (3.0%) 12/455 (2.6%) 4 /77 (5.2%)
Myocardial Infarction, n/N (%) 3/583 (0.5%) 2/491 (0.4%) 1/92 (1.1%)
Major Vascular Complications, n/N (%) 29/583 (5.0%) 26/491 (5.3%) 3/92 (3.3%)
Acute Kidney Injury, Stage III, n/N (%) 6/583 (1.0%) 4/491 (0.8%) 2/92 (2.2%)
Disabling Bleeding Event, n/N (%) 37/583 (6.3%) 27/491 (5.5%) 10/92 (10.9%)
Aortic Valve Re-Intervention, n/N (%) 6/583 (1.0%) 4/491 (0.8%) 2/92 (2.2%)
Endocarditis, n/N (%) 1/583 (0.2%) 1/491 (0.2%) 0/92 (0.0%)
Conduction Disturbance Requiring Permanent
Pacemaker,
n/N (%)
76/583 (13.0%) 65/ 491 (13.2%) 11/ 92 (12.0%)
Other Results
Procedural Information
Overall, the mean duration in the catheterization laboratory/hybrid suite was 192.8 ± 59.3 min, the mean
total procedure time was 86.3 ± 44.2 min, and the mean total anesthesia time was 193.7 ± 62.9 min.
These duration times were slightly shorter in the TF patients. General anesthesia was used in the vast
majority of cases; 15.9% of the TF patients had conscious sedation. Correct positioning of the valve was
achieved in 99.1% of the patients. Five patients (0.9%; including 3 TF patients) were implanted with a
second valve. One patient (0.2%) experienced valve embolization following rupture of the delivery balloon
on annular calcium. This patient was converted to surgical aortic valve replacement and later died from
aortic dissection.

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)