Introduction: Options for Achieving Hemostasis
Arterial access was first described by Sven Ivar Seldinger in the 1950s and is increasingly being utilized as open surgeries are replaced by minimally invasive image-guided procedures. The common femoral artery (CFA) continues to be one of the preferred sites of access for both diagnostic angiography and percutaneous interventions ranging from coronary artery stenting to aortic aneurysm repair.
Vascular closure devices (VCD) were introduced in the 1990s to help achieve hemostasis in the common femoral artery after angiography. Prior to closure devices, manual compression (MC) of the CFA between the skin and the femoral head for at least 15 minutes, followed by a mandatory 6-hour bedrest, was used to achieve hemostasis after arterial access. This technique is still considered the gold standard and can be used if a VCD fails, is contraindicated, or when the operator does not wish to leave an implant behind. The advantages of manual compression include low complication rate, no significant learning curve, and no direct cost. However, increased physician time and pain at the compression site represent drawbacks. Furthermore, MC may not be safe in select populations. Application of MC in very obese patients may not deliver the necessary pressure to achieve hemostasis at the arteriotomy. Patients with lumbar disc herniation and other musculoskeletal or nerve derangements may not be able to tolerate the 6-hour period of bedrest required to consolidate the hemostasis achieved by manual compression. With the increased use of periprocedural anticoagulant and antiplatelet medications, risk of bleeding complications after initial hemostasis with MC has increased.
Advantages of vascular closure devices include immediate hemostasis, early ambulation, hemostasis despite anticoagulation/antiplatelet administration, hemostasis in high or low punctures that cannot be compressed against the femoral head, and improved comfort. Expense (which may be offset by improved workflow), clinical learning curve, and the possibility of complications during device deployment are considered drawbacks of VCD.
To date, there is little evidence that clearly dictates whether to use manual compression or a vascular closure device to achieve hemostasis. There are very few studies comparing different devices head to head in specific populations, such as coronary interventions, peripheral arterial disease interventions, interventional oncology, stroke, etc. Two meta analyses from the early 2000s looked at MC versus VCD in cardiac catheterization patients and found little if any benefit for using VCD ; however, the studies included in the analysis were heterogeneous and the MC patients usually had anticoagulation reversed, which was not the case for VCD patients. In the years since these initial meta-analyses were published, operator experience has increased while industry has produced newer generations of VCD, resulting in a decrease in VCD related complications. A prospective randomized controlled trial published in 2014, ISAR-CLOSURE, looked at 4524 patients undergoing diagnostic coronary angiography who were randomized to an intravascular VCD (FemoSeal), an extravascular VCD (ExoSeal), or manual compression. The primary endpoint was met indicating noninferiority of the VCDs compared with MC. A Cochrane review including 52 studies and 19,192 patients was published in 2016 and concluded that there was no difference in vascular injury or mortality when VCDs were compared with MC, and there was no difference in safety or efficacy when VCDs with different mechanisms of action were compared. Another systematic review published in 2015 included 34 randomized controlled trials and 14,401 patients showing overall success rate for achieving hemostasis with VCD was 95.7%. There are two basic types of closure devices: active and passive. The passive devices are placed externally to replace handheld compression. Active devices deploy a variety of methods to close the arterial puncture actively.
Complications Related to Active Vascular Closure Devices
Access-site complications can occasionally be life-threatening, but even minor complications may result in longer hospital stays and increased 1-year mortality. VCDs are essentially used to avoid complications related to incomplete hemostasis. Therefore, complications are often multifactorial with potential contributions from the initial access because of the location of the puncture and size of the access; anticoagulant, antiplatelet, and thrombolytic medications; and choice of closure device and technique used for deployment. These complications related to device implantation include arterial laceration, arterial thrombosis, device embolization, and infection. This chapter will discuss general steps to be taken prior to and during device deployment to protect against different types of complications followed by discussion of the nuances of several of the individual devices and how to troubleshoot them. There is no single best device; each VCD has its own unique benefits and drawbacks. Understanding how each device creates hemostasis will help the operator choose the appropriate device for a particular patient.
Access Site Considerations
Initially, rigid guidelines were used for evaluating the access vessel prior to deployment of a closure device. These guidelines included only retrograde CFA puncture below the inguinal ligament and above the take-off of the profunda femoris artery in vessels that were at least 5 mm in diameter without atherosclerotic plaque. More recently, however, the literature has been populated with reports of safe off-label use of VCDs in small and diseased arteries (and veins) all over the body, including high and low punctures in the groin as well as arterial access in the upper extremities. In fact, VCD deployment in the setting of unintended high puncture into the external iliac artery may prevent life-threatening hemorrhage in a situation where MC cannot be effective. Regardless of the circumstances and location of the arterial access, an angiogram should be performed through the sheath prior to its removal and deployment of the VCD. Typically, a 30-degree ipsilateral oblique projection is used so that the sheath does not directly overlap the entry vessel, helping to identify the exact site of entry ( Fig. 3.1A ). The angiogram helps the operator identify any potential obstacles that could interfere with successful device deployment such as calcified plaque at the arteriotomy, small vessel caliber, or nearby regions of focal stenosis or dissection.
General Steps to avoiding complications with Active Vascular Closure Devices
Ultrasound and Fluoroscopic Guidance for Arterial Access
Effective hemostasis starts with appropriate access technique. This topic was covered in detail in Chapter 1, Chapter 2 . However, studies show that using ultrasound guidance during initial femoral access results in decreased complication rates related to postprocedural hemostasis as seen in the FAUST Trial. Ultrasound should be used to identify the femoral bifurcation ( Fig. 3.1B ), with desired access being just above the bifurcation. Fluoroscopy should be used to confirm that this location is over or inferior to the femoral head. If the patient has a high femoral bifurcation, then more inferior access into the SFA may be preferred so that manual compression can be used if a VCD fails or is not appropriate because of the patient’s anatomy or vascular disease. Ultrasound should also be used to avoid puncturing directly into anterior wall CFA atherosclerotic plaque (and in particular calcified plaque) as this can lead to device failure for some VCDs. Additionally, if a patient has a recent history of VCD placement prior to the current arterial access, ultrasound should be used to identify the prior VCD placement site to avoid re-accessing the same location because this can lead to device failure and incomplete hemostasis or, rarely, embolization of VCD components.
Preparing the Tract from Skin to Vessel
A soft tissue tract is traversed for all patients receiving a VCD. In a thin patient who has never had an angiogram, this tract usually does not pose much resistance to successful VCD delivery. However, in obese patients and patients who have had prior arterial access, VCD placement, or surgery in the region of the percutaneous access, aggressive dissection of the tract may be necessary. A Kelly clamp should be passed along the sheath down to the anterior wall of the artery prior to VCD placement for scarred tissue. It is advisable to administer additional lidocaine prior to this dissection and VCD deployment to decrease patient discomfort. Effective soft tissue dissection can also help an operator understand if there is a failure in hemostasis prior to development of a large hematoma or pseudoaneurysm; pulsatile arterial blood is seen exiting the dermatotomy rather than pooling between the artery and the subcutaneous soft tissues. For obese patients, another concern is kinking of the sheath for the closure device. Consideration should be given to using stiffer sheaths, or maintaining stiff wires, when possible to facilitate delivery of the closure devices.
All of the devices discussed in this chapter involve implanting material at the arteriotomy, and steps should be taken in every case to ensure sterile technique. VCD infection is a rare complication, but it can require surgical resection of the device and debridement of the femoral artery, with rare instances requiring resection and extra-anatomic bypass, in addition to long courses of intravenous antibiotics. The skin around the percutaneous access site should be resterilized with chlorhexidine directly prior to VCD deployment. New sterile towels should be placed around the access site and along the leg where the device will be placed prior to deployment. Sterile gloves should be changed prior to handling the device. Prophylactic antibiotic administration can be considered prior to VCD deployment, particularly if the access was maintained overnight (such as during arterial thrombolysis), in diabetic patients who have demonstrated poor wound healing, and when closing access after synthetic graft puncture.
Optimizing Patient Parameters
A patient’s blood pressure and coagulation status can affect the ability to achieve hemostasis. Consider antihypertensive medications such as metoprolol or hydralazine to bring blood pressure into the normal range prior to VCD deployment or MC if the clinical situation allows. Similarly, when clinically feasible, consider reversing anticoagulation prior to attempting hemostasis.
Vascular Closure Device Selection
Several vascular closure devices are commercially available. There is no consensus as to which device is most effective. Each device has its own mechanism of action and learning curve. It is not necessary to become facile with all available VCDs; one or two options are sufficient for most practices. Select devices are described in detail here.
Angio-Seal (Terumo Medical, Somerset, New Jersey)
The mechanism of closure involves an intravascular footplate and an extravascular collagen plug that are cinched tight by an intervening suture ( Fig. 3.2A ). First the procedural sheath is exchanged for an Angio-Seal sheath over a wire. Pulsatile blood from the extravascular portion of the dilator indicates that the sheath tip is in appropriate intravascular position ( Fig. 3.2B ). The wire and dilator are removed. The Angio-Seal device is advanced through the sheath until the barrels meet the sheath as indicated by a click deploying the footplate. The footplate is centered into optimal alignment by pulling back on the barrel until another click is heard and a colored indicator is revealed between the sheath and barrel. The device and sheath are then retracted along the suture until the collagen plug and tamper are exposed ( Fig. 3.2C ). The tamper is advanced along the suture compressing the collagen onto the arterial wall until a black indicator is exposed on the suture ( Fig. 3.2D ). The suture is cut at the dermatotomy and the tamper is removed.
Angio-Seal is an extremely secure form of closure and is preferred in patients on anticoagulation/antiplatelet medications in many practices. Both the intravascular polymer footplate and extravascular plug are completely resorbed by 90 days. Prior to 90 days, a small lump can be palpated anterior to the vessel in thin patients, which may represent a reason to choose a different device. Re-access of the same vessel prior to 90 days after Angio-Seal deployment should occur at least one centimeter from the previous device deployment to avoid embolization of the anchor. The device is available in 6 and 8 French sizes.
Angio-Seal Deployment Tips and Troubleshooting
Avoiding intraarterial delivery of the collagen component of the Angio-Seal is paramount. The collagen is thrombogenic, and intraarterial delivery will likely result in thrombotic occlusion of the access vessel.
When initially inserting the Angio-Seal sheath, advance until pulsatile flow is seen, then retract until flow stops, then re-advance slowly until flow starts again. This prevents inserting the sheath too far into the vessel and deploying the anchor remote from the arteriotomy. If this happens, the footplate can catch on plaque away from the arteriotomy, and the collagen plug will be shuttled through into the arterial lumen.
Maintaining consistent back tension on the device and suture as the tamper is used to compact the collagen plug onto the external portion of the arterial wall is also important. This ensures that the anchor remains pulled up against the arterial wall. If there is slack in the suture during the tamping process, the anchor can drift away from the arteriotomy, allowing the plug to be driven into the lumen.
Since the footplate represents an implanted intraarterial component of the device, the device is not recommended for small CFAs (less than 5 mm) or CFAs with significant atherosclerotic plaque as the luminal diameter of the vessel could be slightly diminished postdeployment. Additionally, the device should not be used near an indwelling stent where the footplate can catch on stent interstices, potentially leading to intraarterial collagen deposition.
StarClose (Abbott Vascular, Abbott Park, Illinois)
The mechanism of closure involves a circular nitinol clip with barbs that cinch the arteriotomy closed ( Fig. 3.3A ). First, the procedural sheath is exchanged for a StarClose sheath over a wire. The wire and dilator are removed. The device is inserted into the sheath until a click is heard (step 1). A plunger in the back of the device is depressed which deploys intravascular locator wings (step 2) ( Fig. 3.3B ). The device and sheath are retracted until resistance is felt, indicating the locator wings are in proper position at the arteriotomy. A thumb advancer is slid down the device toward the access site delivering the clip to the vessel wall (and splitting the sheath) (step 3). The device is tilted up at 60–75 degrees, slight downward force is applied, and the clip is deployed by pressing a button (step 4). The intravascular locator wings are simultaneously collapsed and retracted during clip deployment. Each step has a corresponding labeled number on the device.