30
CARDIOVASCULAR
hamburger

Deployment & Suture Management

4 Key Steps to Suture Deployment

 

1. Advance device & lift Lever (Open Foot)

 

2. Maintain retraction and depress Plunger (Deploy Needles)

 

3. Pull back Plunger (Deploy Suture)

4. Lower Lever (Close Foot)

Suture Management

 

A. Capture blue (rail) suture limb in Suture Gate and advance Suture Knot

 

B. Lock Suture Knot by pulling white (non-rail) suture limb

 

C. Trim suture limbs by pulling Trimming Lever

Single and Multiple Device Deployment

View the animation library for full deployment steps for single and multiple devices.

 

Single Device Deployment

Multiple Device Deployment

Tips and Techniques

Refer to Instructions for Use for additional information.

Poor Flow

Arterial Poor Flow

CAUSES
  • Marker Port is against the vessel wall
  • Side wall stick
  • Low blood pressure
  • Clot or tissue plugging Marker Port
  • Device not in vessel lumen

Venous Poor Flow

RESOLUTION FOR POOR FLOW
  • If vessel is not ≥ 5 mm, do not deploy
  • Gently rotate device
  • Slow drip is acceptable
  • Retract device until Marker Port is above skin. Re-flush Marker Lumen and observe saline exit Marker Port
  • Continue inserting device until brisk pulsatile flow occurs in the artery and slow drip occurs in the vein

Suture Break

Causes/Prevention

 

  • Suture may look thin and elongated
  • Rail or non-rail limbs can break

 

  • Load Suture at mid-point of Suture Trimmer (Do not load at tip)
  • Keep Thumb Knob retracted until Suture limbs drop into Suture Gate (Do not close Suture Gate on the Suture)

 

  • Keep Thumb Knob toward ceiling (Do not rotate Suture Trimmer)
  • Keep suture limbs coaxial to Suture Trimmer and tissue tract at all times
  • Do not pull laterally or medially on Suture
  • Apply slow, consistent, increasing tension (Avoid quick, jerky movements)

Resolution

 

  • If the device is still in place
    Insert wire and exchange for another device
  • If closing over the wire
    Insert and deploy another device
  • If device is already removed and no wire access, assess hemostasis
    Manual compression may be necessary, depending on when and where the Suture broke

Cuff Miss

No suture or link present

Cuff and link present, no suture

  • Plunger is withdrawn and no Suture is present. The link may or may not be attached to Anterior Needle
  • Tip(s) of Needle(s) did not lock with Cuff(s)

Prevention

 

  • Proper patient selection
  • Deploy device at 45° stabilize device with left hand during Plunger deployment

 

  • Ensure black Collar on Plunger contacts purple Body

 

  • Maintain and stabilize the device at 45° throughout removal of Plunger/Needles and until Suture is fully retracted

Resolution

  • Insert wire and exchange for another device

Foot Break

Causes/Observations

Potential causes during Plunger deployment (Step 2)
  • Rotating/rocking the device or excessive force during Plunger deployment
  • Shallow (less than 45º) Plunger deployment angle

 

 

Potential observations after Plunger removal (Step 3) and/or device removal
  • No Suture or link present
  • Just a link and no Suture present
  • Missing part of Foot when the device is removed

Prevention

 

  1. Stable and position the device at 45º angle during Plunger deployment
    • The deployment angle may vary slightly depending on anatomy
  2. Maintain even and gentle tension over the Anterior and Posterior Foot against the vessel wall
    • The key is to raise the device until pressure is evenly distributed across the Anterior and Posterior Foot
  3. Press down on the Plunger with a gentle, increasing pressure to advance the Needles
    • The Needles are more susceptible to deflecting off calcification with higher Plunger force and higher Needle speed
Deployment Angle During plunger deployment (Step 2)

 

  Shallow Deployment Angle

  • Sub-optimal in any tissue conditions
  • Potential gap between Posterior Foot and vessel wall increases chance for foot break and cuff miss

 

  45º Deployment Angle

  • Ideal in healthy compliant tissue conditions
  • Posterior and Anterior Foot appose evenly to compliant vessel wall

 

  • Important in diseased non-compliant tissue conditions
  • Maintain even and gentle tension to position Posterior Foot close to non-compliant vessel wall

 

Exercise:

Use an actual device, observe the different foot deployment angles

Note: Best if protractor is viewed on a small screen or print out

Foot Break Prevention

 

  • Avoid challenging anatomical conditions such as heavily calcified arteries, scarred groins, etc
  • These conditions may make the Needles more susceptible to deflecting


Before attempting to remove the device:

  • Relax the device before pushing the Lever down
  • Push the Lever down to return Foot to the closed position

Lack of Hemostasis

Lack of hemostasis may be a result of incorrect order of knot advancement or tangled sutures.

Incorrect Order of Knot Advancement

 

  • Advance Sutures in the order of deployment

 

  • First Suture deployed is on the "bottom" or closest to the vessel. If Second Suture is tightened out of order, it may result in tangled Sutures and/or the inability to tighten the First Suture successfully

 

  • After initial knot advancement of all Sutures, continue to tighten and lock each knot in the order deployed
  • Tightening and locking the Second Suture before the First Suture is completely secure can result in an incomplete or "partial" close
Tangled Sutures

 

  • After Suture Deployment, a clamp is immediately placed on the Suture limbs. A gentle retraction is placed on the clamp until the Suture is taut. This removes all Suture slack from the tissue tract


  • If Suture slack is not removed, the Sutures can become tangled or pushed into the vessel during insertion of procedural sheaths and device exchanges

References

*As compared to Angio-Seal, ExoSeal, FemoSeal, InClosure, MANTA, Mynx, PerQseal, Vascade, Velox CD, X-Seal. Data on file at Abbott.

  1. Primary intention healing occurs where vessel wall edges are brought together, adjacent to each other. This can be achieved with suture, stitches, staples and clips.
  2. For arterial sheath sizes greater than 8F, at least two devices and the pre-close technique are required.
  3. For venous sheath sizes greater than 8F, at least one device and the pre-close technique are required.
  4. Max. OD 26F/0.340 inches/8.62 mm; Max. OD 29F/0.378 inches/9.59 mm. Tests performed by and data on file at Abbott.
  5. Time to hemostasis, ambulation and discharge applies to the arterial access.
  6. Bhatt, Deepak L. et al. Successful “Pre-Closure” of 7Fr and 8Fr Femoral Arteriotomies With a 6Fr Suture-Based Device (The Multicenter Interventional Closer Registry). American Journal of Cardiology Vol 89. March 2002.
  7. Mercandetti, Michael. Wound Healing and Repair. Medscape. WebMD, 02 April 2019. Web. January 15, 2020.
  8. Perclose ProGlide™ Versus Surgical Closure Outcomes – Real World Evidence. Schneider, Darren B; Krajcer, Zvonimir; et al. LINC 2018.
  9. The Use of the Perclose ProGlide™ Suture Mediated Closure (SMC) Device for Venous Access-Site Closure up to 24F Sheaths. Kar, Saibal; Hermiller, James; et al. CRT 2018.
  10. Applies to arterial access.

MAT-2002004 v2.0

DO YOU WISH TO CONTINUE AND EXIT CARDIOVASCULAR.ABBOTT?

CONTENTS OF THE SITE ARE NOT UNDER THE CONTROL OF ABBOTT.

False
accessibility
© 2016 Abbott. All Rights Reserved. Please read the Legal Notice for further details.

Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company.

accessibility

DO YOU WISH TO CONTINUE AND EXIT CARDIOVASCULAR.ABBOTT?

CONTENTS OF THE SITE ARE NOT UNDER THE CONTROL OF ABBOTT.