Arterial Closure Device Insertion

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 (VCDs) were developed as a solution to this problem. ^[2] Percutaneous left ventricular assist devices (LVADs) such as Impella ^[3] 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. ^[4] This article focuses on two commonly used arterial active closure devices: Angio-Seal (a collagen plug–based device) and Perclose ProGlide (a suture-based device).

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 ^[5] ; however, larger studies with longer follow-up would be required to determine its safety in this setting.

A study using data from the multicenter international PAXA registry indicated that in selected patients, a suture-mediated VCD could safely and effectively be employed to achieve hemostasis after axillary artery access during endovascular procedures on the aortic valve, the aorta and its side branches. ^[6]

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)

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

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, ^[7]  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) or MANTA ^[8] (Teleflex, Morrisville, NC), 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

The potential beneficial outcomes of VCDs 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. ^[9] 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 VCDs reduced time to hemostasis, ambulation, and discharge in comparison with the use of manual compression. ^[10]  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. ^[11]  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. ^[12]

In a randomized trial comparing polymer-based (FemoSeal; Terumo Europe, Leuven, Belgium) and suture-based (ProGlide) VCDs for arterial closure after lower-limb arterial endovascular revascularization, the polymer-based device was found to be superior in terms of technical success. ^[13]

The cost-effectiveness of VCDs 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 on which 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.