Edwards SAPIEN 3 User Manual

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In the PIIA-SAVR EP population, the mean duration in the operating room was 333.2 ± 96.4 min, the
mean total procedure time was 237.5 ± 86.58 min, and the mean anesthesia time was
333.5 ± 108.42 min. General anesthesia was used in all patients.
Valve Performance
The measurements of EOA, mean gradient, peak gradient, total aortic regurgitation (AR), and aortic
paravalvular leak (PVL) are presented in Figures
24-28. The increase in EOA and decrease in
gradient were sustained at 1 year.
In PIIS3i, the proportion of patients with total AR ≥ moderate was
6.2% at baseline, 3.9% at 30 days, and 1.6% at 1 year,
while in PIIA-SAVR, the proportion of patients
with tot
al AR ≥ moderate was 12.0% at baseline, 0.7% at 30 days, and 0.3% at 1 year. The proportion
of patients with aortic PVL ≥ moderate was 3.8% at 30 days and 1.5% at 1 year
in PIIS3i, as compared
to
0.5% at 30 days and 0.3% at 1 year in PIIA-SAVR.
Figure 24: Effective Orifice Area (VI Population)
Figure 25: Mean Gradient (VI Population)

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)