9
8. Use the QuickCut suture-trimming mechanism located on the handle to cut
the suture from the anterior needle distal of the link. Use of a new, sterile
scalpel or scissors is optional.
9. Relax the device and then return the foot to its original position by pushing the
lever
(marked #4)
down to the body of the device. Do not attempt to remove
the device without closing the lever.
10. Withdraw the Perclose ProGlide SMC device until the guide wire port exits
the skin line.
11. Grasp the suture adjacent to the device sheath and pull the suture ends
through the distal end of the proximal guide. The rail suture limb is blue and
is the longer of the two suture limbs. This rail suture limb will be used to
advance the knot. The shorter, non-rail limb is white tipped and will be used
to lock the knot.
12. Continue with Knot Advancement (Step 13). If closing over the wire, continue
with section 10.3.1.
10.3.1 Optional: Maintaining Wire Access During Knot Advancement
(Closing over the wire)
If the operator chooses to maintain wire access, reinsert the guide
wire after exposing the guide wire port at skin level AND after the
sutures have been harvested from the distal guide but before removing
the device for knot advancement. Steps A–H are necessary when
closing over the wire.
A. There should be sufficient guide wire exposed out of the guide wire
exit port before removing the device.
B. Wrap the rail limb (long blue limb) of suture around your left index
finger, low, close to skin level.
C. Remove the Perclose ProGlide SMC device with the right hand, while
maintaining an adequate length of guide wire inside the artery. This
allows placement of another Perclose ProGlide SMC device or a sheath
in the event that hemostasis is not obtained.
D. While removing the device with the right hand, simultaneously advance
the knot to the arteriotomy by applying slow, consistent increasing
tension to the rail suture limb, keeping the suture coaxial to the tissue
tract. (Do not advance the knot with the Suture Trimmer until the wire
has been completely removed from the patient.)
E. Assess the site for adequate hemostasis. If bleeding is controlled,
the operator should then remove the guide wire. Next, use the Suture
Trimmer, as described in step 13, to advance and tighten the knot
until complete closure is achieved. Confirm the security of the knot
by having the patient cough and / or bend his / her leg. Additionally,
patients may be able to move freely in bed without head of bed or leg
restrictions if the close is successful.
F. If the wire is still in place and suture breakage occurs during knot
advancement, or if hemostasis is not achieved, another Perclose
ProGlide SMC device can be used to complete the procedure or a
sheath can be inserted. Either remove the broken suture limbs or cut
the suture limbs close to the knot (using the Suture Trimmer in step 13
or a new, sterile scalpel or scissor).
G. Care should be taken to avoid excessive force if the insertion of another
Perclose ProGlide SMC device or introducer sheath is required. To avoid
resistance, use an introducer sheath small enough to avoid undue force.
H. If hemostasis cannot be achieved after the wire is removed, apply
manual compression.
10.3.2 Optional: Pre-Close Technique
The Perclose ProGlide suture can be placed around the arteriotomy at
the beginning of the procedure and knot advancement can be placed
on hold until the procedure is complete. Steps A–D are necessary
when using a pre-close technique.
A. After completing steps 1
–
10 of Device Placement as described in
section 10.3, slightly rotate the device until you can see the two suture
limbs in the bend of the distal guide. Grasp the sutures adjacent to the
sheath. While holding the two suture limbs together, gently pull both
suture ends through the distal end of the proximal guide.
B. Immediately place a shodded hemostat or clamp to hold the two suture
limbs together at the distal end of the non-rail suture limb (shortest
blue limb with white tip). To prevent knot advancement or locking of the
knot, care must be taken not to pull on the individual suture limbs until
the clamp is securely holding the two limbs together.
C. After securing the suture limbs and before inserting the procedural
sheath, gently pull on the clamp until the suture is taut to remove any
suture slack from the tissue tract.
D. Place the clamped suture under a sterile towel during the procedure.
NOTE:
The monofilament suture can be damaged by opening and
closing the clamp. If you want to attach the suture to the drape, it is
recommended that you use a second clamp with the tip placed through
the handle of the first clamp and attach the second clamp to the drape.
E. At the end of the catheterization, reinsert the guide wire into the
procedural sheath.
F. Knot advancement to close the arteriotomy will resume starting with
section 10.3.1 (In step C, the procedural sheath will be removed instead
of a Perclose ProGlide device).
13. Knot Advancement Using the Suture Trimmer
A. Securely wrap the rail (longer, blue) limb of the suture around your left
forefinger, low, close to the skin.
B. Do not tighten the suture around the sheath. Completely remove
the device or the arterial sheath (if the device was deployed at the
beginning of the catheterization procedure) from the artery, while
simultaneously pulling gently on the rail limb. Always keep the suture
coaxial to the tissue tract.
C. With the rail (longer, blue) suture limb securely wrapped around your
left forefinger, place the rail limb into the Suture Trimmer utilizing the
following steps: Retract the Thumb Knob on the Suture Trimmer with
the right hand. Place the Suture Trimmer under the suture limb making
an “x” or a “cross” between the suture limb and the mid-point of the
Suture Trimmer. Slide the Suture Trimmer back to load the suture into
the Suture Gate located at the distal end of the Suture Trimmer. Keeping
the Thumb Knob retracted, turn the Suture Trimmer coaxial to the suture
and then release the Thumb Knob to capture the suture in the Suture
Gate. Releasing the Thumb Knob before the suture is coaxial to the
Suture Trimmer can cause the suture to be caught within the sliding
mechanism at the distal tip and damage the suture. Once the suture is
loaded correctly, the Suture Trimmer should slide easily.
D. With the suture limb and Suture Trimmer coaxial to the tissue tract,
move the knot to the arterial surface by advancing the Suture Trimmer
with the right hand while placing slow, consistent increasing tension
on the rail suture with the left forefinger. Avoid quick or jerking type
movements with the suture limbs. The Suture Trimmer and suture limbs
should always remain coaxial to the tissue tract. The Thumb Knob
should be at 12 o’clock (facing the ceiling) and the Suture Trimmer
should not be rotated.
E. With the rail (longer, blue) suture limb securely wrapped around the left
forefinger, place the Suture Trimmer under the left thumb to assume
a single-handed position and complete knot advancement with slow,
consistent increasing tension until the suture is taut (guitar string
tightness).
F. With the Suture Trimmer in place and suture taut, tighten the knot by
gently pulling the non-rail (shorter, white tipped) suture limb, keeping it
coaxial to the tissue tract.
G. Hemostasis of the access site is achieved when the knot is fully
advanced to the arterial surface, the slack is gently pulled from the knot
with the non-rail limb while the Suture Trimmer holds tension on the rail
limb of the suture, and the tissue is in complete apposition.
H. Remove the Suture Trimmer from the tissue tract, relax tension on
the suture, and test for hemostasis by having the patient cough or
bend his / her leg. If hemostasis has not been achieved, assume the
single-handed position for 20 seconds, or until hemostasis is achieved.
Secure the knot again by gently pulling on the white tipped non-rail
suture limb. Do not apply excessive pressure to the suture.
I. Confirm the security of the knot by having the patient cough and / or
bend his / her leg. Additionally, patients may be able to move freely in
bed without head of bed or leg restrictions if the close is successful.
J. Once hemostasis is achieved, use the Suture Trimmer to trim the
sutures below the skin. While holding both suture limbs together
and pulled taut, load both suture limbs into the Suture Trimmer (as
described above in step 13 C) and advance the Suture Trimmer to the
arterial surface. Trim the sutures by pulling back on the red Trimming
Lever. Keep the Trimming Lever pulled back while removing the Suture
Trimmer and trimmed suture limbs from the tissue tract. If only one
suture limb has been loaded and trimmed, repeat the same technique
on the other suture limb.
K. If hemostasis cannot be achieved, apply manual compression until
hemostasis is achieved.
10.4
SMC Device Placement 8.5F–21F Sheath, Utilizing Pre-Close and
Maintaining Wire Access Techniques
The following introductions detail the deployment sequence for closing
the access site of an interventional catheterization procedure performed
through 8.5F to 21F sheath size. The pre-close technique using at least two
devices must be used when closing sheath sizes from 8.5F to 21F.
1. Place a 0.038” (0.97 mm) (or smaller) guide wire through the introducer
sheath. Remove the introducer sheath while applying pressure on the groin
to maintain hemostasis.
2. Backload the SMC device over the guide wire until the guide wire exit port of
the device sheath is just above the skin line. Remove the guide wire before
the exit port crosses the skin line.
3. Place the first of two Perclose ProGlide SMC devices over the guide wire.
Continue to advance the device just until brisk pulsatile flow of blood is
evident from the marker lumen. The device lever
(marked #1)
and logo
should be facing the ceiling (12 o’clock).
4. Rotate the device approximately 30 degrees towards the patient’s right side
(approximately 10 o’clock). Position the device at a 45-degree angle. Deploy
the foot by lifting the lever
(marked #1)
on top of the handle.
Do not deploy
the foot unless brisk pulsatile flow of blood (“mark”) is evident from the
marker lumen.
5. Gently pull the device back to position the foot against the arterial wall. If
proper position of the foot has been achieved, tactile sensation will be felt
AND
blood marking will cease or be significantly reduced to a slight drip. If
marking does not stop or significantly change, evaluate the angiogram for
femoral artery size, calcium deposits, tortuosity, disease and for location of
the puncture (ensure footplate is not in bifurcation or any side branch vessel).
Reposition the device to stop blood marking (maintain the 30 degree rotation)
or reinsert the wire and evaluate the situation before continuing the procedure.
6. While maintaining the device position, stabilize the device with your free hand
(the one not used to deploy the device) to maintain the gentle retraction and
to ensure the device doesn’t twist or move forward during deployment. Use
your other hand to deploy needles by pushing on the plunger assembly
(in the
direction marked #2)
until you visually confirm that the collar of the plunger
makes contact with the proximal end of the body. Do not use excessive force
or repeatedly push the plunger assembly. After visually confirming contact with
the body of the device only
one time,
this step is complete.
RELEASED
RELEASED
