Perclose ProGlide - Il Club del Percutaneo

Perclose ProGlide
Suture-Mediated Closure System
Large Hole (8.5F – 21F) Closure
In-Service Presentation
Perclose ProGlide
Suture-Mediated Closure System
Device Components
Needle Plunger
Handle
Collar
SUTURE TRIMMER
Lever
Marker Lumen
Body
Foot
QuickCut
Link
Foot (Deployed)
Guide Wire
Exit Port
Sheath
©2013 Abbott. All rights reserved. AP2937461-OUS Rev. B 01/13
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Proximal
Guide
Distal
Guide
Marker
Port
posterior side of device
Perclose ProGlide
Suture-Mediated Closure System
Pre-Close Technique
• The pre-close technique using at least 2 devices must be used when closing sheath sizes from 8.5F to 21F.
– The pre-close technique is when 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.
©2013 Abbott. All rights reserved. AP2937461-OUS Rev. B 01/13
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Perclose ProGlide
Suture-Mediated Closure System
Pre-Procedural
Prep device
• Flush the Marker Lumen with heparinized saline.
• Must observe saline dripping out the Marker Port.
©2013 Abbott. All rights reserved. AP2937461-OUS Rev. B 01/13
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Perclose ProGlide
Suture-Mediated Closure System
Deployment
• Place a 0.038" (or smaller) guide wire through the introducer sheath.
• Remove the introducer sheath while applying pressure on the groin to maintain hemostasis.
• Backload first of two ProGlide devices and advance until Guide Wire Exit Port is at skin level.
• Remove the guide wire before the exit port crosses the skin line.
©2013 Abbott. All rights reserved. AP2937461-OUS Rev. B 01/13
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Perclose ProGlide
Suture-Mediated Closure System
Positioning First Device
1. With the device lever and logo
facing upwards (12 o’clock),
advance the device into the
artery until brisk pulsatile flow
is observed exiting the Marker
Lumen.
2. Rotate the device approximately
30 degrees towards the patient’s
right side (approximately 10
o’clock).
©2013 Abbott. All rights reserved. AP2937461-OUS Rev. B 01/13
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Perclose ProGlide
Suture-Mediated Closure System
Needle Deployment
1. Keeping device at 45° angle,
lift the Lever to deploy the Foot
(NOTE: Foot Plate should NOT
be opened before rotating the
device).
2. Retract the device until a tactile
sensation of the Foot is felt
against the anterior wall of the
artery and cessation of mark
occurs.
3. Depress the Plunger until the
black Collar meets the purple
Body.
©2013 Abbott. All rights reserved. AP2937461-OUS Rev. B 01/13
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Lever
Perclose ProGlide
Suture-Mediated Closure System
Suture Retrieval
1. Remove the Plunger using the thumb as a fulcrum.
2. Pull the suture taut.
3. Use the QuickCut or sterile scissors to cut the suture.
©2013 Abbott. All rights reserved. AP2937461-OUS Rev. B 01/13
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Perclose ProGlide
Suture-Mediated Closure System
Foot Parking
1. Relax device and return the
lever to its original position to
park the Foot.
©2013 Abbott. All rights reserved. AP2937461-OUS Rev. B 01/13
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Perclose ProGlide
Suture-Mediated Closure System
First Device Suture Retrieval
1. Withdraw device until the guidewire port exits the skin line.
2. Remove the two suture limbs.
3. 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 limb with white tip). Placing hemostat on suture limbs prevents the knot from advancing.
©2013 Abbott. All rights reserved. AP2937461-OUS Rev. B 01/13
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Perclose ProGlide
Suture-Mediated Closure System
First Device Suture Management
1. Gently pull on the clamp until the suture is taut.
2. Place the clamped 10 o’clock suture on the right side of the patient under a sterile towel.
©2013 Abbott. All rights reserved. AP2937461-OUS Rev. B 01/13
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Perclose ProGlide
Suture-Mediated Closure System
Device Removal
1. Reinsert the guide wire.
2. Remove device, while holding compression above the puncture site and maintaining an adequate length of guide wire
inside the artery.
©2013 Abbott. All rights reserved. AP2937461-OUS Rev. B 01/13
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Perclose ProGlide
Suture-Mediated Closure System
Positioning Second Device
1. Rotate the device approximately
30 degrees towards the patient’s
left side (approximately 2 o’clock).
2. Repeat device deployment and
suture retrieval steps for the
second device (see pages 6-8).
©2013 Abbott. All rights reserved. AP2937461-OUS Rev. B 01/13
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Perclose ProGlide
Suture-Mediated Closure System
Second Device Suture Retrieval
1. Withdraw device until the
guidewire port exits the skin
line.
2. Remove the two suture limbs.
3. 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 limb with
white tip). Placing hemostat on
suture limbs prevents the knot
from advancing.
©2013 Abbott. All rights reserved. AP2937461-OUS Rev. B 01/13
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Perclose ProGlide
Suture-Mediated Closure System
Second Device Suture Management
1. Gently pull on the clamp until
the suture is taut.
2. Place the clamped suture on
the left side of the patient under
a sterile towel.
3. Knot advancement will be
placed on hold at this point
and the sutures set aside
under sterile towels while the
operator proceeds with the
procedure.
4. Device is exchanged for an
appropriately sized introducer
sheath.
©2013 Abbott. All rights reserved. AP2937461-OUS Rev. B 01/13
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Perclose ProGlide
Suture-Mediated Closure System
After the Procedure
1. After completing the procedure, a guide wire should be advanced into the artery.
2. Heavily irrigate the secured ProGlide sutures with heparinized saline.
©2013 Abbott. All rights reserved. AP2937461-OUS Rev. B 01/13
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Perclose ProGlide
Suture-Mediated Closure System
Sheath Removal
1. Remove the clamp from the first
suture placed at 10 o’clock.
2. Wrap the rail suture limb around
your left forefinger.
3. While maintaining guide wire
access, remove the entire sheath
system and simultaneously pull
the rail limb with slow, consistent
increasing tension.
©2013 Abbott. All rights reserved. AP2937461-OUS Rev. B 01/13
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Perclose ProGlide
Suture-Mediated Closure System
Sheath Removal
1. Remove the clamp from the
2 o’clock suture and advance the
knot using the same technique
and maintaining guide wire access.
2. DO NOT lock or excessively
tighten the knot while the guide
wire is still in the vessel.
©2013 Abbott. All rights reserved. AP2937461-OUS Rev. B 01/13
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Perclose ProGlide
Suture-Mediated Closure System
Assess Hemostasis
1. Assess the site for adequate
hemostasis.
2. Due to the size of the arteriotomy it is usually requires knot
advancement multiple times
and the Suture Trimmer may be
needed to obtain hemostasis.
DO NOT lock or excessively
tighten the knot while the
guide wire is still in the vessel.
3. Once bleeding is controlled, the
operator should then remove the
guide wire.
IMPORTANT: DO NOT remove
wire if there is not adequate
hemostasis. By maintaining
wire access you can place
additional ProGlide devices.
©2013 Abbott. All rights reserved. AP2937461-OUS Rev. B 01/13
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Perclose ProGlide
Suture-Mediated Closure System
Assess Hemostasis
1. If acceptable hemostasis is not
observed, additional Perclose
ProGlide SMC devices may be
deployed at this point. Repeat
deployment steps.
– Third device should not be
rotated. The device will be
deployed in a straight cranial/
caudad position (logo facing
the ceiling / 12 o’clock).
2. After deployment of this device,
advance the knot in the same
fashion. DO NOT lock the knot
or excessively tighten the knot
while the guide wire remains in
the vessel.
3. Assess the site for adequate
hemostasis. If bleeding is controlled, the operator should then
remove the guide wire.
©2013 Abbott. All rights reserved. AP2937461-OUS Rev. B 01/13
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Perclose ProGlide
Suture-Mediated Closure System
Knot Advancement with Suture Trimmer
Advance the first suture placed at 10 o’clock
1. Wrap the rail suture limb around your left forefinger.
2. Retract Thumb Knob with right hand. Place the Suture Trimmer under the suture limb making an “x” or a “cross”.
3. Slide the Suture Trimmer back to load the suture into the Suture Gate.
4. Keeping the Thumb Knob retracted, turn the Suture Trimmer coaxial to the suture and then release the Thumb Knob to capture
the suture.
5. Keeping the taut rail suture limb and Suture Trimmer coaxial to tissue tract, 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.
©2013 Abbott. All rights reserved. AP2937461-OUS Rev. B 01/13
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Perclose ProGlide
Suture-Mediated Closure System
Locking the Knot
Lock the knot of the first suture placed at 10 o’clock first
1. With the Suture Trimmer in place
and the suture taut, tighten the
knot by gently pulling the non-rail
(shorter, white tipped) suture limb,
keeping it coaxial to the tissue tract.
2. To ensure hemostasis is achieved
the knot must be locked.
3. Test for hemostasis by having the
patient cough or bend his/her
leg. If hemostasis has not been
achieved, assume the singlehanded position for 20 seconds,
or until hemostasis is achieved.
4. Secure the knot again by gently
pulling on the white tipped nonrail suture limb.
Repeat the knot advancement
and locking steps for second
suture placed at 2 o’clock.
©2013 Abbott. All rights reserved. AP2937461-OUS Rev. B 01/13
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Perclose ProGlide
Suture-Mediated Closure System
Suture Trimming
Trim first suture placed at 10 o’clock first
1. While holding both suture limbs
together and pulled taut, load
both suture limbs into the Suture
Trimmer.
2. Keeping the thumb knob at
12 o’clock, advance the Suture
Trimmer to the arterial surface.
3. Keeping the sutures taut, pull
back on the red Trimming Lever
to cut the sutures.
4. Keep the red lever pulled back
while removing the Suture Trimmer
to avoid capturing subcutaneous
tissue.
Repeat these steps for second
suture placed at 2 o’clock.
NOTE: A Suture Trimmer is packaged with each device.
It is recommended to use a new Suture Trimmer to trim each set of suture limbs.
©2013 Abbott. All rights reserved. AP2937461-OUS Rev. B 01/13
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Abbott Vascular International BVBA
Park Lane, Culliganlaan 2B, 1831 Diegem, Belgium, Tel: 32.2.714.14.11
Caution: This product is intended for use by or under the direction of a physician. Prior to use, it is important to read the package insert thoroughly for
Instructions for Use, Warnings and Potential Complications associated with use of this device. Information contained herein for distribution outside
the U.S. and Japan only. Please check the regulatory status of the device before distribution in areas where CE marking is not the regulation in force.
Tests performed by and data on file at Abbott Vascular. All drawings are artist’s representations only and should not be considered as an engineering
drawing or photograph. Photo(s) on file at Abbott Vascular. Perclose ProGlide is a trademark of the Abbott Group of Companies.
www.AbbottVascular.com
©2013 Abbott. All rights reserved. AP2937461-OUS Rev. B 01/13