Abbott lounge: Closure Devices Prostar X for large hole closure

Abbott lounge:
Closure Devices
Chairman and speaker:
Luigi Inglese, M.D.
Prostar X for large hole closure
The Prostar XL 10 Fr Device
• The Prostar XL 10 Fr device
is a suture mediated device
capable of closing different
sizes of arteriotomy, based
on how it’s used:
– Post-procedure closing: the
Prostar is used at the end of
the procedure to close up to
14-16 Fr
– Pre-close tecnique: the
Prostar is used at the
beginning of the procedure
on a 8-10 Fr introducer to
deploy the suture; at the end
the suture is used to close an
arteriotomy up to 22-24 Fr
Deployment – Post-procedure (I)
• Insert and position device
• Insert the device over the guide
wire
• Remove the guide wire
• Position the device until blood
back-flow is seen through the
marker lumen
• Help the Prostar to pass through
the subcutis rotating the barrel
Deployment – Post-procedure (II)
• Deploy needles and sutures
• While mantaining the Prostar
stable at 45°, rotate and pull back
the handle
• 4 needles will appear out of the
white hub
• Remove the needles: sutures are
attached to the needles
• Cut the needles away
Deployment – Post-procedure (III)
• Handle the sutures
• Pull the sutures back from the
hub
• Partially retract the device, until
suture exiting from the barrel are
visible
• Harvest the sutures out of the
barrel
Deployment – Post-procedure (IV)
• Tie knots and achieve hemostasis
• Tie a surgical knot on the white
suture
• Tie a surgical knot on the green
suture
• Remove the device
• Push down the white knot on the
arteriotomy with the knot pusher
• Push down the green knot on the
arteriotomy with the knot pusher
• Cut the sutures under skin
How to tie a surgical sliding knot
Deployment – Pre-close tecnique (I)
• Puncture the artery and insert a
8-10 Fr introducer
• Insert and position the device
• Deploy needles and sutures
• Handle the sutures
• Firmly block the sutures in a
cross-shape with Steri-strips or
Klammers
• Re-insert guide wire
• Remove Prostar and Re-insert
introducer
• Complete the procedure
Deployment – Pre-close tecnique (II)
• Tie knots and achieve hemostasis
• Tie a surgical knot on the white
suture
• Tie a surgical knot on the green
suture
• Remove the introducer
• Push down the white knot on the
arteriotomy with the knot pusher
• Push down the green knot on the
arteriotomy with the knot pusher
• Cut the sutures under skin
Prostaring a 18 Fr
Totally DRY!
Troubleshooting
• 1 or more needles do not
appear in the hub:
– Under fluoroscopy reinsert the
needles and try to pull them back
out again
• One suture detached from
needles:
– Reinsert guide wire in the Prostar
– Remove Prostar
– Insert a Perclose, rotated to
simulate the detached Prostar
suture or
– Insert another Prostar (removing
the previous suture)
• Unable to push down the knot:
– Saturate sutures with saline
solution and push knots down
again
– Apply manual compression
• Unable to achieve hemostasis:
– Check AC Time
– If guide wire has been kept during
closing procedure, use another
closing device
– Revert to manual compression
• Rescue procedure with
elastomeric baloon clamping
ipsi- or controlateral
Advices
• Make an echo color doppler to
the femoral artery to evaluate if
it’s idoneous to be closed with
Prostar:
• Skin incision at least 1.5 cm wide
– No plaques in the anterior wall
• Keep Prostar very stable (and
pushed on the arteriotomy) at 45°
while retracting the needles
– No heavy calcification
– At least 5 mm in diameter
• Make an ultrasound guided
puncture to be sure to access in
front of the Common Femoral
Artery
• Generously enlarge the
subcutaneous tissue before
inserting the Prostar
• Keep sutures wet during
procedure and saturate them
before tying the knots
• Firstly, tye the knot on the white
suture and then on the green one
(white suture is nearest to the
arterial wall)
The Peclose Proglide Device
• The Perclose Proglide device is a
prolene 3.0 suture mediated
device capable of closing
different sizes of arteriotomies,
based on how it’s used:
– Post-procedure closing: the
Perclose is used at the end of the
procedure to close up to 10 Fr
– Pre-close tecnique: the Perclose is
used at the beginning of the
procedure on a 8 Fr introducer to
deploy the suture; at the end the
suture is used to close an
arteriotomy up to 12-13 Fr
– Double Pre-close tecnique:
simulating a Prostar, 2 Perclose are
used to close up to 18 Fr
Deployment – Post-procedure (I)
• Insert device over a guide wire
• Remove guide wire
• Advance Perclose until pulsatile
blood back-flow is seen through
the marker lumen
• Open the foot inside the artery
• Retract the device until
resistance of the foot over the
arterial wall is felt
Deployment – Post-procedure (II)
• Keeping the device stable at 45°,
push the plunger to release the
needles
• Needles will hook the suture
• Retract the plunger
• Cut the suture under the white
mark
Deployment – Post-procedure (III)
• Advance the device 1-2 mm and
close the foot
• Retract the device until suture is
exposed
• Harvest the suture out of the
Perclose
Deployment – Post-procedure (IV)
• Remove the device while
tensioning the blue limb of the
suture
• Use the Knot-Pusher to advance
the knot over the arteriotomy
• Block the knot pulling the white
limb of the suture
Deployment – Post-procedure (V)
• Test for hemostasis
• Cut the suture with suturetrimmer 4 mm over the
arteriotomy
Color Doppler post-closure
Perclose Proglide 4 weeks later
Troubleshooting
• Needles do not hook the suture:
– Reinsert guide wire in the Perclose and Remove Perclose
– Insert another Perclose or Reinsert introducer
• Unable to push down the knot:
– Saturate suture (if Perclose AT) with saline solution and push knot
down again
– Apply manual compression
• Unable to achieve hemostasis:
– Check AC Time
– If guide wire has been kept during closing procedure, use another
closing device
– Revert to manual compression
Advices
• If pulsatile blood back-flow cannot be seen, exit and re-enter
with Perclose in the artery and flush the marker lumen
• Keep Perclose very stable at 45° while deploying and retracting
the needles
• In case of a double pre-close tecnique:
– make an echo color doppler to the femoral artery to evaluate if it’s
idoneous to be closed with a double Perclose:
• No plaques in the anterior wall
• No heavy calcification
• At least 5 mm in diameter
– Make an ultrasound guided puncture to be sure to access in front of
the Common Femoral Artery
– Keep sutures wet during procedure and saturate them before tying
the knots