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Sizing recommendations for implanting the Edwards SAPIEN 3 transcatheter
heart valve in a failing bioprosthesis are provided in the table below:
Surgical Valve True
THV-in-THV (Native
Inner Diameter
Valve Annulus
(ID) [ 1 ]
16.5-19.0 mm
18.6 – 21.0 mm
18.5-22.0 mm
20.7 – 23.4 mm
22.0-25.0 mm
23.4 – 26.4 mm
25.0-28.5 mm
26.2 – 29.5 mm
Note: Surgical valve 'True ID' may be smaller than the labeled valve
size. For THV-in-THV, the native valve annulus size should be
considered to determine the appropriate THV size to implant.
For a failing stentless bioprosthesis, consider sizing
recommendations for a native annulus. The dimensions of the
failed bioprosthesis should be determined so that the appropriate
THV size can be implanted; and is best determined by using
computed tomography, magnetic resonance imaging, and/or
transesophageal echocardiography.
Sizing recommendations for implanting the Edwards SAPIEN 3 transcatheter
heart valves in a failing INSPIRIS RESILIA aortic surgical bioprosthesis in sizes
19 - 25 mm, based on bench testing, are provided in the table below:
INSPIRIS RESILIA Aortic Valve
(model 11500A)* Labeled Size
19 mm
21 mm
23 mm
25 mm
*INSPIRIS RESILIA aortic valve model 11500A sizes 19 - 25 mm incorporate
VFit technology which consists of expandable bands and fluoroscopically
visible size markers designed for potential future valve-in-valve procedures.
Clinical data are not currently available on the INSPIRIS RESILIA aortic valve
Model 11500A valve-in-valve procedure or expansion feature. The impact of
tissue ingrowth on the expansion feature of the INSPIRIS RESILIA aortic valve
has not been assessed.
WARNING: Do not perform stand-alone balloon aortic valvuloplasty
procedures in the INSPIRIS RESILIA aortic valve for the sizes
19-25 mm. This may expand the valve causing aortic incompetence,
coronary embolism or annular rupture.
Note: INSPIRIS RESILIA aortic valve model 11500A sizes 27-29 mm
do not incorporate VFit technology and therefore follow the
surgical valve True ID sizing provided in Table 2.
Note: Exact volume required to deploy the THV may vary depending
on the bioprosthesis inner diameter. Factors such as calcification
and pannus tissue growth may not be accurately visualized in
imaging and may reduce the effective inner diameter of the failing
bioprosthesis to a size smaller than the 'True ID' .
Table 2
SAPIEN 3
Size)
Valve Size
20 mm
23 mm
26 mm
29 mm
Table 3
THV Size
20 mm or 23 mm
23 mm or 26 mm
26 mm
29 mm
These factors should be considered and assessed in order to
determine the most appropriate THV size to achieve nominal THV
deployment and sufficient anchoring. Do not exceed the rated burst
pressure. See Table 4 for inflation parameters.
• Edwards Commander Delivery System (Figure 2)
The Edwards Commander delivery system facilitates the placement of the
bioprosthesis.
It consists of a Flex Catheter to aid in valve alignment to the balloon,
tracking, and positioning of the THV. The delivery system includes a tapered
tip to facilitate crossing of the valve. The handle contains a Flex Wheel to
control flexing of the Flex Catheter, and a Balloon Lock and Fine Adjustment
Wheel to facilitate valve alignment and positioning of the valve within the
target location. A stylet is included within the guidewire lumen of the
delivery system. The Balloon Catheter has radiopaque Valve Alignment
Markers defining the working length of the balloon. A radiopaque Center
Marker in the balloon is provided to help with valve positioning.
A radiopaque Triple Marker proximal to the balloon indicates the Flex
Catheter position during deployment.
The inflation parameters for valve deployment are:
Nominal
Balloon
Model
Diameter
9610TF20
20 mm
9610TF23
23 mm
9610TF26
26 mm
9610TF29
29 mm
• Qualcrimp Crimping Accessory (Figure 3)
The Qualcrimp crimping accessory is used during THV crimping.
• Loader (Figure 4)
The loader is used to aid insertion of the delivery system into the sheath.
• Edwards Crimper and Crimp Stopper (Figure 5)
The Edwards crimper reduces the diameter of the valve to mount it onto the
delivery system. The crimper is comprised of a housing and a compression
mechanism that is closed with a handle located on the housing. A 2-piece
crimp stopper is used to crimp the valve to its intended diameter.
• Edwards Sheath
Refer to the Edwards sheath instructions for use for device description.
• Inflation Device
An inflation device with locking mechanism is used during valve
deployment.
Note: For proper volume sizing, the delivery system must be used
with the inflation device provided by Edwards Lifesciences.
2
Table 4
Nominal
Rated Burst
Inflation
Pressure
Volume
(RBP)
11 ml
7 atm
17 ml
7 atm
23 ml
7 atm
33 ml
7 atm
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