Arterial Closure Device Insertion 

Updated: Apr 18, 2018
Author: Venkat Rajaram, MD, MS; Chief Editor: Karlheinz Peter, MD, PhD 

Overview

Background

An increasing number of diagnostic and therapeutic procedures in the cardiovascular system are performed percutaneously because of greater safety and improvements in minimally invasive technology. More than 7 million such procedures are performed worldwide every year.

Despite the growing popularity of radial access, the vast majority of these procedures are still performed through the common femoral artery in the groin.[1]

Manual compression was once traditionally used to close the common femoral artery at the conclusion of the procedure. This method required that the patient avoid ambulation for at least 6 hours. Because of the increasing sophistication of the anticoagulant agents used in percutaneous interventions, prompt and successful hemostasis without complications became necessary.

Vascular closure devices were developed as a solution to this problem. Percutaneous left ventricular assist devices (LVADs) such as Impella[2] and the percutaneous aortic/mitral valve replacement procedures require large access sites. Manual compression is not an ideal option in these situations, and an appropriate closure device can obviate the need for surgical closure of the access site.

The use of closure devices is bound to increase, both because of increasing awareness and comfort levels among operators and because of improvements made to the devices themselves.

Many devices on the market are designed to achieve access closure and hemostasis.[3] This article discusses two of the most frequently used arterial active closure devices: Angio-Seal (a collagen plug–based device) and Perclose ProGlide (a suture-based device).

Indications

General indications for arterial closure devices include the following:

  • To close the common femoral artery puncture site in order to achieve complete hemostasis safely after a diagnostic or interventional angiographic procedure
  • To reduce time to hemostasis and time to ambulation
  • To improve patient comfort

A small retrospective study by Cuellar et al suggested that Angio-Seal might be usable on an off-label basis to achieve hemostasis for direct carotid puncture during endovascular procedures[4] ; however, larger studies with longer follow-up would be required to determine its safety in this setting.

Contraindications

Closure devices have no specific contraindications. However, there are several warnings and precautions, which may vary according to the particular device being used.

General warnings are as follows:

  • Do not use if the puncture site is at or distal to the common femoral bifurcation into the superficial femoral artery and the deep femoral artery (profunda femoris)
  • Do not use if access is obtained above the inguinal ligament
  • Do not use if bacterial contamination of the sheath is suspected
  • Do not use if there is a posterior-wall puncture or if multiple attempts were used to obtain arterial puncture
  • Do not use an expired or contaminated device

There are also a number of device-specific precautions (see Table 1 below).

Table 1. Precautions Specific to Angio-Seal or Perclose ProGlide Arterial Closure Devices (Open Table in a new window)

Clinical Condition

Angio-Seal

Perclose ProGlide

Concurrent warfarin therapy

Use caution

Data not available

Allergy to beef/collagen

Use caution

Data not available

Pregnancy/lactation

Use caution

Data not available

Thrombolysis

Use caution

Data not available

Vascular graft

Use caution

Data not available

Inflammatory/autoimmune

Use caution

Data not available

Uncontrolled hypertension (systolic BP >180 mm Hg)

Use caution

Data not available

Bleeding diathesis

Use caution

Data not available

Peripheral vascular disease

Use caution

Use caution

Calcified iliac artery

Use caution

Use caution

Angio-Seal should not be used in thin individuals; the collagen may become palpable, perhaps feeling like a knot.

Technical Considerations

Anatomy

The entry point of the sheath into the common femoral artery must be below the inguinal ligament, defined by the lower border of the inferior epigastric artery,[5]  and above the bifurcation of the common femoral artery into the profunda femoris and the superficial femoral artery. Ideally, the entry point of the sheath should be at or just below the middle of the femoral head. The proper placement of the entry point should then be verified by means of femoral angiography.

Procedural planning

Types of closure devices

Passive closure devices are used to assist in manual compression by enhancing or promoting coagulation (eg, Syvek Patch [Marine Polymer Technologies, Danvers, MA]), by fostering wire-stimulated track thrombosis (eg, Catalyst II and III [Cardiva Medical, Mountainview, CA]), or by enhancing manual compression (eg, FemoStop [St Jude Medical, St Paul, MN]). Although these devices do not afford immediate closure, they improve on manual compression.

Active closure devices include collagen-based devices such as Angio-Seal (St Jude Medical, St Paul, MN), suture-based devices such as Perclose ProGlide or Starclose (Abbott Vascular, Redwood City, CA), and polyethylene glycol (PEG)–based devices such as Mynx Cadence (AccessClosure, Mountain View, CA). These can achieve hemostasis within 5 minutes, with minimal or no manual compression.

The aforementioned devices do not constitute a comprehensive list; the number of arterial closure devices continues to grow.

An ideal closure device would have the following properties:

  • Capable of achieving early and complete hemostasis without discomfort to the patient
  • Safe to administer without any complications
  • Applicable to both diagnostic and interventional procedures
  • Easy to use, without a significant learning curve
  • Unlikely to fail
  • Widely applicable regardless of the type of stick or anatomy
  • Inexpensive

Outcomes

The potential beneficial outcomes of vascular closure devices include a reduced time to ambulation after angiography, reduced complication rates after femoral access closure, and cost-effectiveness.

Clearly, it stands to reason that the use of these devices would yield a reduced time to ambulation, and this benefit is established. Studies have validated a reduction in complication rates with the use of closure devices compared with manual compression in the setting of diagnostic angiography.[6] The complication rates of closure devices and manual compression in the setting of interventional procedures are comparable.

A systematic review of 34 randomized controlled trials (RCTs) by Cox et al showed that the use of vascular closure devices (VCDs) reduced time to hemostasis, ambulation, and discharge in comparison with the use of manual compression.[7]  Overall complication rates were comparable but varied somewhat from one device to another.

A Cochrane review of 52 RCTs by Robertson et al found that although collagen-based VCDs did not have a clear advantage over extrinsic compression with regard to time to hemostasis, both metal clip-based and suture-based VCDs were associated with reduced time to hemostasis compared with compression.[8]  Conclusions could not be reached regarding differences in time to mobilization. VCDs did not differ significantly from extrinsic compression with respect to vascular injury rate or mortality, nor did VCDs of different mechanisms of action differ from each other in terms of safety or efficacy.

A study by Jones et al that compared five different arterial closure devices (AngioSeal, Perclose, StarClose, ExoSeal, and Mynx) used for femoral artery access in an office-based setting found that Angio-Seal had the lowest rates of device failure and minor complications.[9]

The cost-effectiveness of vascular closure devices has not been formally studied. However, because closure devices allow earlier ambulation and the possibility of earlier discharge, the length of stay would therefore be reduced and turnaround time improved, leading to potential cost savings. In addition, if the practice of discharging patients home the same day they undergo percutaneous coronary intervention becomes the norm, it could lead to significant cost savings in the future, because closure devices would facilitate this process.

 

Periprocedural Care

Patient Education and Consent

During the consent process, discuss with the patient the possibility of using a closure device, including both the merits and the downsides. In addition, explain what to expect (eg, a temporary knot at the access site, usually after Angio-Seal is used).

Preprocedural Planning

Before obtaining access, make a clear track with a scalpel and the hemostat. This facilitates easy advancement of closure devices after the procedure. It also prevents accumulation of any blood in the soft tissue during the procedure.

Equipment

Equipment used for arterial closure device insertion includes the following:

  • Local anesthetic with syringe and needle
  • Gauze (4 × 4, dry and wet)
  • Chlorhexidine preparation kit
  • New pair of sterile gloves
  • Short and long J-wires (for Perclose ProGlide; Angio-Seal comes with its own wire)
  • Tegaderm dressing
  • Perclose ProGlide or Angio-Seal kit, with contents

Angio-Seal packet contents (see the video below) include the following:

  • Insertion sheath
  • Arteriotomy locator
  • 6-French Angio-Seal: 70-cm, 0.035-in./0.89-mm J-tip guide wire
  • 8-French Angio-Seal: 70-cm, 0.038-in./0.96-mm J-tip guide wire
  • Angio-Seal device
Arterial closure device insertion. Angio-Seal equipment.

Perclose ProGlide packet contents (see the video below) include the following:

  • Perclose ProGlide 6-French suture-mediated closure (SMC) device
  • Snared knot pusher
  • Suture trimmer
Arterial closure device insertion. Perclose ProGlide Suture-Mediated Closure equipment.

Patient Preparation

Clean the arteriotomy site and the sheath with chlorhexidine again before deploying the device.

Anesthesia

It is advisable to administer an additional dose of local anesthetic at the femoral access site before deploying a closure device in order to minimize discomfort. The local anesthetic administered before access is obtained may not be adequate.

Positioning

No specific position is required for access closure. As with any angiographic procedure performed from a femoral access site, the patient needs to stay in the supine position with lower limbs extended.

Monitoring & Follow-up

Before moving the patient out of the catheterization laboratory recovery area, ensure that any oozing of blood after closure device deployment is just track ooze and not failure of the device.

As a rule, the patient can ambulate normally in 2 hours after Perclose ProGlide placement. However, factors such as use of anticoagulants, access issues, and overall patient status (both general and cardiac) must be considered in deciding on the length of bedrest before ambulation.

 

Technique

Approach Considerations

A 6-French Angio-Seal can be used for sheath sizes of 6 French and smaller, and an 8-French Angio-Seal can be used for sheaths that are 8 French or smaller. A Perclose ProGlide can be used for sheath sizes in the range of 5-8 French.

Femoral Angiography Before Closure

Before using any arterial closure device, always confirm the position of the arteriotomy site with femoral angiography in the right anterior oblique view after securing the sheath. Pull the sheath medially during femoral angiography to clearly demonstrate the entry point of the sheath into the artery.

This routine step is used to assess the feasibility of using a closure device and, more important, to determine risk stratification for complications.[5, 10]  Look for the following:

  • Arteriotomy site below the inguinal ligament and above the bifurcation of the common femoral artery
  • Presence of calcium
  • Presence of disease such as stenosis or dissection
  • Posterior wall stick/continuing bleeding
  • Abnormalities such as arteriovenous fistula or pseudoaneurysms

It is prudent to clean the sheath and the surrounding skin with a chlorhexidine preparation kit and change to a new pair of sterile gloves.

Angio-Seal Closure

Device insertion

Angio-Seal arterial closure (see the video below) is carried out in the following steps.

Arterial closure device insertion. Angio-Seal technique.

Step 1

Open the contents under strict sterile conditions. Use the contents within 1 hour of opening the seal.

Step 2

Prepare the contents before proceeding with access closure. Insert the arteriotomy locator into the Angio-Seal sheath oriented in the correct direction. This can be ensured by pointing the green arrow on the hub of the sheath toward the green arrow on the arteriotomy locator. After ensuring proper orientation, snap the arteriotomy locator into the sheath. Open the packet that contains the Angio-Seal device, and keep it available for use. Keep the J-tip guide wire that comes in the packet available for use.

Step 3

Remove the femoral sheath that was used for the procedure over the Angio-Seal guide wire while maintaining pressure above the access site to ensure continued hemostasis. The Angio-Seal guide wire will maintain access to the arteriotomy once the sheath is removed.

Step 4

Insert the insertion sheath–arteriotomy locator assembly over the Angio-Seal wire with the side with markers and the green arrows facing up. If necessary, thread the wire back into the assembly until the wire is seen about 2.5 cm through the distal end. This will help secure the wire so that it is not threaded into the artery and lost. When the tip of the insertion sheath is about 1.5 cm into the artery, blood will begin to flow from the drip hole in the locator.

Step 5

Withdraw the insertion sheath–arteriotomy locator assembly until blood slows or stops flowing from the drip hole. This indicates that the distal locator holes of the insertion sheath have exited the artery.

Step 6

Reinsert the assembly again (no more than 2 cm) until the blood flows through the drip hole again. (The word Angio-Seal is printed on the sheath, and each letter is separated from the next by about 1 cm. This can be used as a guide to measure the depth of insertion and confirm the position of the sheath.) Deeper reinsertion may interfere with the anchor’s performance.

Step 7

Holding the insertion sheath steady, remove the arteriotomy locator and guide wire. The arteriotomy locator can be removed by twisting it down while holding the hub of the insertion sheath steady.

Step 8

Verify the position of the Angio-Seal sheath again. If the position has changed, repeat steps 4 through 8.

Step 9

Holding the hub of the sheath in position with the left hand, grasp the Angio-Seal device at the bypass tube with the other hand closer to the distal tip. Advance the device into the hole in the sheath hub with the reference indicator (green arrows) on the device and the hub of the sheath on the same side facing each other. In this position, the device will snap into the sheath when advanced.

If carrier tube advancement is met with resistance when insertion is almost complete, the anchor may be impinging on the posterior wall of the artery. Stop advancing. Reposition the sheath by reducing the angle of the sheath to the skin surface or by pulling the sheath back by 1-2 mm and redeploying.

Step 10

After snapping the Angio-Seal device in position, hold the hub of the sheath with one hand and pull the cap of the device away from the hub. Continue until resistance is felt, which results from the anchor catching the distal tip of the sheath. If deployed correctly, the edge of the device cap will fall within the colored bands on the device sleeve. After the anchor position is confirmed, pull the device cap into the full rear locked position.

Step 11

Pull the device sheath assembly in the direction of the track. This allows the anchor to position against the vessel wall.

Step 12

Continue to pull and maintain the tension on the device sheath assembly to expose the tamper, which should be advanced into the track to compact the collagen. Failure to maintain tension on the device sheath assembly may lead to advancement of collagen into the arterial lumen. This should be avoided.

Step 13

Maintain the tension on the assembly while simultaneously advancing the tamper until the clear stop is revealed distal to the sheath and the black compaction marker is revealed above the tamper. Once hemostasis is achieved and resistance is felt, stop advancing the tamper.

Step 14

Cut the suture below the clear stop, and remove the tamper tube. Cut the suture below the skin line by holding tension on the thread with the index finger and thumb of the left hand while pushing the skin and soft tissue with the other fingers. Alternatively, use a hemostat to push the skin and lock the thread while holding the thread with the other hand, then cut the suture. This ensures that the suture is cut below the level of the skin and below the black compaction marker.

Ambulation

The patient can ambulate normally within 2 hours after Angio-Seal placement. However, factors such as use of anticoagulants, access issues, and overall patient status, both general and cardiac, must be considered in deciding on the length of bedrest before ambulation.

Perclose ProGlide Suture-Mediated Closure

Device insertion

The Perclose ProGlide Suture-Mediated Closure (SMC) device is inserted in the following steps (see the video below).

Arterial closure device insertion. Perclose ProGlide Suture-Mediated Closure technique.

Step 1

Open the contents of the packet under sterile conditions, and flush the Perclose ProGlide device. Keep wet gauze handy to hold the hydrophilic ProGlide tube.

Step 2

Remove the arterial sheath over a short 0.038-in. J-tip wire while holding pressure over the groin to obtain hemostasis. The authors prefer to use the long (145-cm) J-tip wire for an additional margin of safety in preserving access.

Step 3

Backload the Perclose ProGlide device over the wire. With the wire acting as a rail, advance the SMC device into the arteriotomy until the wire exit port on the device is at the level of the skin. Next, remove the wire gently, holding the device body to prevent the device from being dislodged inadvertently.

Step 4

Advance the device further with a to-and-fro torque, holding the body until backflow of blood is seen through the marker lumen.

Step 5

With the device at a 45° angle, deploy the foot pedal by lifting the lever on top of the handle (marked as #1).

Step 6

Position the foot pedal against the wall of the artery by pulling the device. At this point, backflow of blood through the marker lumen will cease. If there is continued blood flow through the marker, the foot pedal must be repositioned.

Step 7

At this point, deploy the needle by pushing the plunger (in the direction marked #2) until the collar of the plunger comes in contact with the body.

Step 8

Pull the plunger back (in the direction marked #3) to disengage the needle. Completely remove the plunger with the needles from the body of the device. Note that the suture is attached to the anterior needle and the posterior needle is free. Pull the plunger until the suture is taut, and cut the suture from the anterior needle distal to the link with the optional Quickcut suture trimmer located on the handle.

Step 9

Relax the tension on the device, and return the foot pedal to the original position by turning the lever to the original position (marked #4).

Step 10

Gradually withdraw the SMC device until the guide wire port is visible. Through this port, pull both ends of the suture from the proximal metallic part of the device. Note that one suture limb is white (nonrail end) and the other is blue (rail end, through which the knot is railed distally).

Step 11

If the Perclose ProGlide device is deployed at the beginning, a guide wire could be inserted after pulling back the device and exposing the guide wire port before pushing the knot. The suture could be set aside, and intervention could be pursued.

Step 12

In the event of failure to deploy the suture or other forms of device failure, access to the arteriotomy can be gained by advancing a guide wire. The authors do not routinely insert a guide wire before proceeding further.

Step 13

The rail limb (blue) is wrapped around the left index finger, and the knot is advanced by applying tension to this wire while quickly removing the Perclose ProGlide device.

Step 14

Ensure hemostasis by inspecting and asking the patient to cough or raise his or her leg. If the guide wire had been reinserted, it can be removed at this point and the knot advanced by applying gentle tension to the rail limb. Do not use the knot pusher or suture trimmer to push the knot until the guide wire is removed if one has been reintroduced.

Step 15

The authors prefer using the suture trimmer for knot advancement because it gives good support and allows easy passage into the track. Wrap the rail (blue) limb in the left forefinger. Place the nonrail (white) limb securely between the left thumb and forefinger. Retract the black knob in the suture remover, and place both sutures into the window at the distal end of the suture trimmer. Ensure smooth play of the suture trimmer over the sutures.

With the rail limb wrapped in the left forefinger, drop the nonrail (white) limb and hold the suture trimmer with the tip of the left thumb. Advance the knot with the suture trimmer using a single-hand technique, pushing the suture trimmer into the tissue track with the left thumb while holding tension on the rail (blue) limb with the left forefinger. Gently tug the nonrail (white) limb to secure the knot. Check again for hemostasis, as described above. The above steps may be repeated to achieve hemostasis again.

Step 16

Once hemostasis has been achieved, advance the suture trimmer into the tissue track with both limbs of the suture still in place in the suture trimmer. Hold tension over both limbs, and cut the sutures deep in the track close to the arteriotomy by advancing the trimmer into the track and pulling back the red lever on the handle of the suture remover with the right thumb. To avoid any tissue damage, keep the red trimming lever pulled back while withdrawing the suture trimmer and the cut sutures from the track . The procedure may be repeated if only one limb of the suture is cut.

Suture breakage

Application of excessive tension to the suture limbs can lead to breakage and should be avoided. If this happens at any stage while access to arteriotomy is still available through a guide wire, the broken suture can be discarded and the closure repeated with another Perclose ProGlide SMC device. If the suture breaks after the device and guide wire are removed, hemostasis has to be ensured with manual compression.

Ambulation

The patient can ambulate normally in 2 hours after Perclose ProGlide placement. However, factors such as use of anticoagulants, access issues, and overall patient status, both general and cardiac, must be considered in deciding on the length of bedrest before ambulation.

Complications

Access-site complications were reported in 6% of cases in one series and are clearly the leading cause of morbidity after angiography.[11]

Potential complications of arterial closure devices include the following:

  • Failure of the device to achieve hemostasis
  • Hematoma
  • Pseudoaneurysm formation
  • Infection
  • Arteriovenous fistula
  • Collagen deposition and thrombosis in artery (Angio-Seal; diagnosis confirmed with duplex ultrasonography; treatment options include thrombolysis, percutaneous thrombectomy, surgery)
  • Anchor fracture or embolism (Angio-Seal; unlikely to produce ischemia)
  • Suture breakage (Perclose ProGlide)