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Supra-annular sizing and implantation:
Using supra-annular technique, the sewing ring of the valve
is placed above the annulus, maximizing valve orifice area.
A larger valve size can often be implanted using a supra-
annular technique compared to an intra-annular technique.
This increase in prosthetic valve size provides improved
hemodynamic performance. For optimal implantation of the
valve in the supra-annular position, the sizer should be
parallel with the plane of the annulus and the following
sizing technique should be used:
Step 1: Using the Model 1130 sizer, select the cylindrical end
of the largest diameter sizer that comfortably fits in the
patient’s annulus (Figure 5a).
Step 2: Once you have verified the appropriate cylindrical end,
use the replica end of the same sizer to verify that the sewing
ring will fit comfortably on top of the annulus (Figure 5b).
Step 3: Determine if upsizing of the valve is possible by using
the replica end of the
next largest sizer
(Figure 5c). Ensure
that the coronary ostia are not obstructed and that the valve
stent posts do not interfere with the aortic wall at the
sinotubular junction (Figure 5d). If this larger size replica end
fits comfortably, implant this size of the PERIMOUNT Magna
valve. If this larger size replica end does not fit comfortably,
implant the valve size identified by Step 2.
A suture technique resulting in supra-annular placement of
the valve, such as a horizontal mattress technique, should
be employed.
Intra-annular sizing and implantation:
Using intra-annular technique, the entire valve including the
sewing ring is placed inside the annulus. Either the
cylindrical or valve replica end of the Model 1130 sizer can
be used for intra-annular sizing.
For proper sizing, the sizer should be parallel with the plane
of the annulus and the entire sizer, including the simulated
sewing ring portion, should pass through the annulus.
(Figure 6a-6c). A suture technique resulting in intra-annular
placement of the valve, such as an everting mattress
technique, should be employed.
4. Suture the valve in place using an appropriate suture technique
that avoids the potential problems noted under
5. Precautions
.
Caution: Because of the intense temperature and lighting
conditions in the operating field, the bioprosthesis should be
irrigated frequently (every 1 to 2 minutes is recommended)
on both sides with sterile physiological saline to keep the
valve moist during the implant procedure.
Handle/Holder Removal
The integral holder and attached handle are removed as a unit
at the completion of the suturing procedure in the following
manner (see Figure 3):
1. Using a scalpel or scissors as shown, cut each of the three
exposed sutures that are on the surface of the holder.
Caution: Avoid cutting or damaging the stent or delicate
leaflet tissue when cutting the sutures.
2. When all three attaching sutures have been properly cut,
remove the handle/holder assembly, along with the
attaching sutures, from the valve as a unit.
3. Following surgery, remove the holder from the handle and
discard the holder. If using Model 1111 handle clean and
sterilize the handle before each use.
11.4 Accessories
Sizers
The use of a sizing instrument facilitates selection of the
correct size valve for implantation. Model 1130 sizers are
fabricated from translucent polysulfone plastic to permit direct
observation of their fit within the annulus. The Model 1130
sizer was developed to facilitate accurate sizing of the
Carpentier-Edwards PERIMOUNT Magna model 3000TFX valve
in a wide range of patients. Each sizer consists of a handle with
a different sizer configuration at each end (Figure 4a). On one
side of the handle is a cylindrical end with an integrated lip that
accurately reflects the valve sewing ring geometry (Figure 4b).
On the other side of the handle is a valve replica end that
reflects the valve sewing ring geometry as well as the height
and location of the stent posts (Figure 4c). A sizer is available
for each size of the PERIMOUNT Magna model 3000TFX valve
(19, 21, 23, 25, 27 and 29 mm). The limits of accuracy for the
Model 1130 sizer are ±0.127 mm.
Valve Holder and Handle
The handle/holder assembly consists of two components: an
integral disposable part that is physically mounted to the valve
by the manufacturer, and a
malleable
handle (reusable Model
1111 or disposable Model 1126 for single use) that is attached
to the holder at the time of surgery.
Caution: The Model 1126 disposable handle is supplied
sterile for single use and must not be resterilized.
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