Vascular Closure Devices

General description of procedure, equipment, technique

Femoral Artery Closure Devices: Introduction

Vascular closure devices (VCD) have emerged as an effective alternative to traditional mechanical compression for femoral artery closure and is being widely used in patients undergoing catheterization via the femoral route. These devices have the potential to reduce the time to hemostasis, facilitate early patient mobilization, reduce patient discomfort associated with prolonged bed rest, improve patient satisfaction, decrease hospital length of stay (by early mobilization and reduction of complications), and potentially reduce femoral artery complications (though this is controversial with few studies showing a similar or higher complication rate when compared with manual compression alone).

While a variety of VCDs are currently available, we will discuss the three commonly used VCDs—the collagen plug-based (Angio-Seal), the suture based (Perclose), and the nitinol clip-based (StarClose) devices.

Indications and patient selection

Femoral Artery Closure Devices

Indications

• To achieve hemostasis after femoral arterial sheath removal in situations where early ambulation is desirable (patients who cannot tolerate prolonged bed rest, same day discharge after percutaneous coronary intervention)
• To achieve hemostasis in patients undergoing cardiac catheterization early after thrombolytic therapy (rescue PCI, facilitated PCI)
• To achieve hemostasis in patients who require prolonged infusion of anticoagulant therapy postprocedure
• As a routine practice to achieve hemostasis after femoral arterial sheath removal after diagnostic or therapeutic procedures via the femoral route to improve patient throughput in a busy catheterization laboratory, for early ambulation and discharge of patients, for improved patient satisfaction, and for potentially reducing bleeding complications
• To achieve hemostasis for femoral vein punctures, especially when large bore catheters are used and when the patient is fully anticoagulated (this is an off-label indication for a vascular closure device)

Contraindications

Femoral Artery Closure Devices

There are no absolute contraindications for VCDs. The below are relative contraindications where caution is advised for the use of VCDs.

• Low femoral artery cannulation—Bifurcation or superficial femoral artery or profunda femoris arterial sheath insertion (increased risk of ischemic complications with VCD use)
• High femoral artery cannulation—above the level of inferior epigastric artery (increased risk of retroperitoneal hemorrhage in case of device failure, although VCD use is preferred to manual compression as the compression has to be done without the solid support of the femoral head)
• Patients with moderate to severe peripheral artery disease at the site of sheath entry (increased risk of ischemic complications with VCD use due to the intravascular component of the VCD or VCD footplate causing femoral artery dissection in the region of the plaque or plaque embolization)
• Patients with small (<4 to 5 mm) femoral artery caliber (increased risk of ischemic complications, especially with VCD with intravascular components such as Angio-Seal)
• Patients with diabetes, HIV, immunodeficiency from prolonged steroid use, patients undergoing major surgical procedures (consider antibiotic prophylaxis though there are no robust data to support this; increased risk of infection with VCD with foreign body–anchor, suture, or clip)
• Patients with history of allergies to beef products, collagen and/or collagen products, or polyglycolic or polylactic acid polymers (for Angio-Seal)
• For others, please refer to product instructions for use (IFU) for each individual VCD

Details of how the procedure is performed

Vascular Closure Devices

Angio-Seal device

The Angio-Seal device consists of the following:

• A delivery device—The device contains an anchor that is biodegradable and a collagen plug tethered together by a suture
• An insertion sheath
• Arteriotomy locator, which is also a modified dilator
• A 70-cm, J-tipped guide wire (0.035-inch for 6 Fr and 0.038-inch for 8 Fr) (although a regular 0.035-inch, J-tipped guide wire 150 cm/200 cm or 300 cm can also be used).

The device works on the principle of active approximator where the device actively approximates the arteriotomy site by the use of the anchor and the collagen plug, which are tethered with the help of suture. The collagen plug facilitates coagulation, thereby speeding up the process of hemostasis and it also reduces oozing from the site. Of note, the anchor and suture are fully biodegradable.

Insertion technique (Please refer to the device information for use for more details)

• Obtain femoral angiogram prior to procedure as described above making certain to retain the J-tipped guidewire during contrast injection to prevent femoral artery dissection (ipsilateral oblique projection).
• Ensure no contraindications for the procedure (listed above).
• Reglove and prepare the area with antiseptic solution (not based on evidence).
• Dry the area with a dry gauge.
• Use a 6 Fr or 8 Fr device corresponding to the size of the femoral arterial sheath.
• Insert the arteriotomy locator into the insertion sheath until the two pieces snap together and keep this ready.
• Administer local anesthesia at the site for patient comfort.
• Flush the femoral artery sheath to ensure that it is free of thrombi.
• Remove the sheath over the guidewire making sure that an adequate length of wire is intraarterial.
• Load the arteriotomy locator with the sheath on to the guidewire with the reference indicator facing upward and advance this until a pulsatile flow is observed from the arteriotomy locator.
• Withdraw the assembly until blood stops from the drip hole (this is optional).
• Readvance the assembly until pulsatile flow is again noticed. This will ensure that the distal tip is just distal to the arteriotomy site.
• Stabilize the insertion sheath with one hand and remove the arteriotomy locator and guidewire as a unit.
• Holding the insertion sheath steady, insert the delivery device into it by holding the bypass tube ensuring the reference indicators of the insertion sheath and the delivery device are facing upward.
• Advance the delivery device until it snaps fit with the insertion device. This deploys the anchor.
• Holding the insertion sheath steady, pull the device cap back until it assumes a fully rear locked position. This sets the anchor.
• Slowly, withdraw this assembly at a 45-degree angle to the skin surface until the anchor is up against the arterial wall (you will feel some resistance). Collagen is also deployed and a tamper tube is now visible.
• Holding the assembly back at a 45-degree angle, push the tamper tube down while pulling back on the assembly at the same time. Avoid excessive pressure while pulling the assembly back.
• A clear stop is exposed on the suture and in most cases a black compaction marker is also seen beyond it.
• Cut the suture below the clear stop and remove the tamper tube.
• Observe for hemostasis.
• Cut the suture below skin level making sure to leave only a minimal length of the suture behind.
• Hold gentle pressure on the site for a minute to ensure hemostasis (this is optional).

Postprocedure

• Apply a sterile dressing to the site. Ensure that the dressing is transparent so as to easily visualize any oozing from the site.
• Check for femoral artery and distal pulses to ensure no complications of the procedure. Compare with preintervention vascular exam and record this in the patient’s chart.
• Re-access at the site of the Angio-Seal deployment, which should be done >90 days postprocedure (to allow for resorption of the anchor and the suture). However, a procedure to re-access within 90 days can be performed 1 cm proximal/distal to the prior arteriotomy site if absolutely necessary.
• The dressing can be removed by the patient the next day but should be kept dry for at least 3 to 5 days until the site heals.

Perclose Device (Please refer to the device information for use for more details)

The Perclose device consists of the following:

• Delivery device consisting of a biodegradable, pretied suture
• A snared knot pusher
• A suture trimmer

The device works on the principle of an active approximator with the use of a pretied suture. There is no intravascular foreign body left behind and the suture is absorbed over a period of weeks.

Insertion technique

• Obtain femoral angiogram in the ipsilateral oblique view to ensure no contraindications for the procedure (described above). Ensure that the J-tipped guidewire is within the artery prior to obtaining the angiogram to prevent femoral artery dissection.
• Obtain additional views (contralateral oblique or posterior-anterior view) for additional clarification as needed.
• Reglove and prepare the area with antiseptic solution (optional and not based on evidence).
• Dry the area with a dry gauge.
• Perclose can be used for femoral sheath size 5 to 8 Fr. For a larger size sheath, a “preclose” technique is recommended.
• Prepare the Perclose by flushing the delivery sheath and the side port/marker with saline.
• Administer local anesthetic at the site for patient comfort.
• Flush the femoral artery sheath to ensure that it is free of thrombi.
• Remove the sheath over the guidewire making sure that an adequate length of wire is intraarterial.
• Insert the Perclose device until the guidewire exit port is at skin level.
• Remove the guidewire and advance the Perclose until pulsatile blood flow is seen at the side port/marker. This indicates that the device is intraarterial.
• Lift the lever to deploy the footplate and withdraw the device as a unit until resistance is felt. The footplate is now up against the artery. The pulsatile flow from the side port/marker will cease. Take care not to exert too much back tension on the device to avoid damage to the artery.
• Hold the device steady and depress the plunger to deploy the needles.
• Holding the device steady, carefully retract the plunger until the suture is retrieved and is taut. Relieve the suture by cutting it using a quick cut or a sterile scissor.
• Decrease back tension on the device, depress the level to return the footplate to undeployed position.
• Carefully retract the Perclose device until the guidewire exit port is seen. Carefully free the sutures taking care not to pull on the sutures. Tension on the white limb of the suture can tighten the knot.
• Load the blue rail suture limb onto the snare knot pusher; wetting the sutures can help them go down more smoothly.
• Wrap this limb onto the index finger of the left hand and apply careful tension to keep the limb taut
• Advance the knot pusher until it is up against the Perclose device.
• Hold the knot pusher with the left hand and remove the Perclose device with the right hand.
• As the device exists, advance the knot pusher simultaneously to the surface of the artery.
• Push the knot all the way down to the surface of the artery and parallel to the artery.
• Release tension on the knot pusher and observe for hemostasis.
• If there is no hemostasis, repeat the above steps with the knot pusher.
• Pull the white limb of the suture to tighten the knot.
• Remove the knot pusher and observe for hemostasis.
• Load both the suture limbs onto the suture trimmer. Advance all the way down to the artery and lift the red lever to cut the sutures, leaving behind only a small part of the suture.
• Remove the suture trimmer. Apply pressure for a minute to ensure hemostasis (optional).

Postprocedure

• Apply a sterile dressing to the site.
• Check for femoral artery and distal pulses to ensure no complications from the procedure. Compare with preintervention vascular exam and record this in the patient’s chart.
• There is no re-access restriction after using this device.
• The dressing can be removed by the patient the next day but should be kept dry for at least 3 to 5 days until the site heals.

StarClose device (Please refer to the device information for use for more details)

The StarClose device consists of the following:

• Clip applicator
• Delivery sheath
• Dilator
• A 0.035-inch, J-tipped guidewire

The device works on the principle of an active approximator with the use of a clip. There is no intravascular foreign body left behind.

Insertion technique

• Obtain femoral angiogram in the ipsilateral oblique view to ensure no contraindications for the procedure (described above). Ensure that the J-tipped guidewire is within the artery prior to obtaining the angiogram to prevent femoral artery dissection.
• Obtain additional views (contralateral oblique or posterior-anterior view) for additional clarification as needed.
• Reglove and prepare the area with antiseptic solution (optional and not based on evidence).
• Dry the area with a dry gauge.
• StarClose can be used for femoral sheath size 5 to 6 Fr. For a larger size sheath, a “preclose” technique using a Perclose device is recommended.
• Prior to the procedure, given that the StarClose is bulky, ensure adequate skin tract by enlarging the track using an artery forcep.
• Administer local anesthetic at the site for patient comfort.
• Insert the dilator into the StarClose delivery sheath.
• Flush the femoral artery sheath to ensure that it is free of thrombi
• Remove the femoral artery sheath over the guidewire and exchange it for the StarClose delivery sheath.
• Remove the guidewire and the dilator leaving behind the delivery sheath.
• Insert the clip applicator into the sheath until a click is heard.
• Retract the unit in a 45-degree angle for about 3 to 5 cm.
• Depress the plunger to deploy the locator wings.
• Split the sheath partially down and move the assembly to ensure that it can go down the arteriotomy track.
• Retract the device at a 45-degree angle until resistance is felt. The locator wings are up against the wall of the artery.
• Hold the sheath steady with the left hand, split the sheath all the way down to the artery until a click is heard.
• Raise the device to a 60- to 70-degree angle to the artery, hold steady with the left hand, press down until arterial pulsations are felt; deploy the clip maintaining downward pressure for 2 to 3 seconds.
• Depress the tissue around the clip applier with the left hand, and remove the clip applier and hold pressure for several seconds to ensure hemostasis.

Postprocedure

• Apply a sterile dressing to the site.
• Check for femoral artery and distal pulses to ensure no complications of the procedure. Compare with preintervention vascular exam and record this in the patient’s chart.
• There is no re-access restriction after using this device.
• The dressing can be removed by the patient the next day but should be kept dry for at least 3 to 5 days until the site heals.

What’s the evidence?

Bangalore, S, Bhatt, DL. “Femoral arterial access and closure”. Circulation. vol. 124. 2011. pp. e147-56.

Bangalore, S, Arora, N, Resnic, FS. “Vascular closure device failure: frequency and implications: a propensity-matched analysis”. Circ Cardiovasc Interv. vol. 2. 2009. pp. 549-56.

Arora, N, Matheny, ME, Sepke, C, Resnic, FS. “A propensity analysis of the risk of vascular complications after cardiac catheterization procedures with the use of vascular closure devices”. Am Heart J. vol. 153. 2007. pp. 606-11.

Slaughter, PM, Chetty, R, Flintoft, VF. “A single center randomized trial assessing use of a vascular hemostasis device vs. conventional manual compression following PTCA: what are the potential resource savings?”. Cathet Cardiovasc Diagn. vol. 34. 1995. pp. 210-4.

Applegate, RJ, Grabarczyk, MA, Little, WC. “Vascular closure devices in patients treated with anticoagulation and IIb/IIIa receptor inhibitors during percutaneous revascularization”. J Am Coll Cardiol. vol. 40. 2002. pp. 78-83.

Kussmaul, WG, Buchbinder, M, Whitlow, PL. “Rapid arterial hemostasis and decreased access site complications after cardiac catheterization and angioplasty: results of a randomized trial of a novel hemostatic device”. J Am Coll Cardiol. vol. 25. 1995. pp. 1685-92.

Applegate, RJ, Rankin, KM, Little, WC, Kahl, FR, Kutcher, MA. “Restick following initial Angioseal use”. Catheter Cardiovasc Interv. vol. 58. 2003. pp. 181-4.

Baim, DS, Knopf, WD, Hinohara, T. “Suture-mediated closure of the femoral access site after cardiac catheterization: results of the suture to ambulate aNd discharge (STAND I and STAND II) trials”. Am J Cardiol. vol. 85. 2000. pp. 864-9.

Kahn, ZM, Kumar, M, Hollander, G, Frankel, R. “Safety and efficacy of the Perclose suture-mediated closure device after diagnostic and interventional catheterizations in a large consecutive population”. Catheter Cardiovasc Interv. vol. 55. 2002. pp. 8-13.

Martin, JL, Pratsos, A, Magargee, E. “A randomized trial comparing compression, Perclose Proglide and Angio-Seal VIP for arterial closure following percutaneous coronary intervention: the CAP trial”. Catheter Cardiovasc Interv. vol. 71. 2008. pp. 1-5.

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