More than five million diagnostic and interventional cardiac catheterizations are performed each year in the United States. (Kalapatapu, et al.) Cardiac catheterization is considered the gold standard for the diagnosis, evaluation, and treatment of cardiac diseases. Although it has reduced morbidity and mortality for cardiovascular disease, this invasive procedure is not free of complications. Nurses on the front line caring for patients before, during and after cardiac catheterization play a vital role in the prevention of complications. With the growing number of cardiac catheterizations performed, evolving technology, and advances in pharmaceutical therapy comes an increased risk of vascular complications. Nurses play a critical role in the management of patients after cardiac catheterization. Early detection and management of vascular complications are vital to minimizing complications.
Transfemoral percutaneous coronary procedures have evolved in the past several years as a standard in both diagnostic and interventional cardiology. On the other hand, safe management of vascular access sites after removal of percutaneous catheters remains a serious concern. Manual compression of the site, the traditional method for closure of the femoral artery, is associated with a complication rate of up to 5 percent, marked discomfort and immobility for patients, and prolonged hospitalization. (Muller, et al.) Nowadays, new methods for management of vascular access sites have been introduced to increase patients’ comfort and promote a safe recovery.
The femoral artery is the second most cannulated artery for hemodynamics monitoring because of its accessibility and large size. The blood pressure waveform provides a more accurate estimation of aortic pressure than the radial artery even in hypovolemic, vasoconstricted and central shunting states. Femoral artery catheter complications are infrequent but are more complicated than that of the radial artery. It is recommended that lower extremity insertion sites be avoided due to the density of microbes. The femoral artery lies in a neurovascular bundle lateral to the femoral vein and median to the femoral nerve. (Cousins & O’Donnell)
The femoral artery begins right behind the inguinal ligament, midway between the anterior superior spine of the ilium and the symphysis pubis. The femoral artery passes down the front and medial side of the thigh and ends as the popliteal artery in the lower third of the thigh. In the upper third of the thigh the femoral artery is contained in the femoral triangle which is bound laterally by the Sartorius, Adductor longus and Inguinal ligament. Collateral circulation exists via several anastomoses. Just below the inguinal ligament, the artery is closest to the surface of the skin and easily accessible and is the optimal location of cannulation. (Hopkins, J.)
This technique requires locating the femoral artery and inguinal ligament that runs from the anterior superior iliac spine to the pubic tubercle; the true position of the inguinal ligament is 1-2 cm below that line. 97 percent of patients have the femoral artery lying on the medial third of the femoral head. Only 3 percent have the artery totally medial to the femoral head. (Grier & Hatnell)
• Directing the Needle: Once the needle tip is near the artery, it tends to pulsate except in patients with severe local scarring. If the hub inclines to the right, the needle should be withdrawn by 1 or 2 cm and the tip redirected to the right before advancing forward. If the hub inclines to the left side, the tip is redirected to the left before pushing in. If the needle pulsates on the vertical axis, it just needs to be inserted deeper. (Grier & Hatnell)
• Wire cannot be inserted: Usually, this happens because the needle hit the contra-lateral wall. Just move the needle by a slight pull or rotate it a little, the wire may be able to be inserted. If there is a problem, it is better to withdraw the needle and re-puncture the artery rather than dissect the artery with a slippery wire. (Fajadet J, et al.) After the sheath has been inserted where there is strong arterial back flow and the wire is not able to negotiate the tortuous iliac artery, then pull the sheath a little and a gentle injection of contrast may help to delineate the anatomy and determine the reason why the wire could not be advanced. If there is no strong backflow, then the sheath is not in the arterial lumen. In a very tortuous iliac artery, a diagnostic ‘Judkins Right’ catheter can be inserted with caution and advanced to help steer the wire tip. Injection through the Judkins Right would also help in finding out the problem in advancing the wire.
• Order Sequence for Arterial and Venous Puncture: The order of arterial and venous access is often a matter of personal preference. Many favor to puncture the vein first and insert a wire inside the vein to secure the access. Then, a few seconds later after puncturing the artery, insert the sheath into the artery and the vein. Since there is only a wire in the vein, there is minimal distortion of the arterial puncture site, which may be caused by the placement of the venous sheath. If inadvertently the artery is punctured first, cannulate the artery, then puncture the vein under fluoroscopy, with the needle medial and parallel to the arterial sheath.
• Kinked Wire: It is not unusual that the wire will pass into the lumen easily but attempts to advance any dilator over the wire will result in kinking of the wire at the point of entry. Instead of exchanging the wire, if the wire is not too crooked, the best maneuver is to advance the wire further, so the dilator can be advanced to dilate the entry site on a straight and stiff segment of the wire. If the wire is too soft, then the second-best maneuver is to exchange the softer wire with a stiffer wire over the needle at the straight portion or over a smallest size 4F dilator. (Chisholm, R.J.)
• Puncture of Pulseless Femoral Artery: Often, the artery should be punctured over the middle of the medial third of the femoral head. Localize the skin puncture site by fluoroscopy just below the inferior border of the femoral head in order to prevent high punctures that may lead to uncontrollable bleeding. On the other hand, these proportions are valid only in the anterior posterior, neutral position. Internal or external rotation of the femur can considerably change the relationship of the femoral artery to the femoral head. (Gerlock & Mirfakhraee) Another way to puncture the femoral artery is to use Doppler guidance with the ‘Smart Needle’ (Escalon Medical), which is an arteriotomy needle that incorporates a continuous Doppler probe, and enable the identification of arterial or venous vessels by means of continuous auditory feedback. This method is very helpful in puncturing an artery with very weak pulse or a pulse-less artery, particularly when the standard anatomy is disturbed by a large hematoma, or thick scar after surgery for artificial femoral head replacement. (Biondi-Zoccai, et al.)
• Insertion of Intra-Aortic Balloon Pump through Diseased Iliac Artery: When an Intra-Aortic Balloon Pump needs to be inserted and an iliac lesion is found, the lesion should be dilated first. Insert the balloon pump, and then perform stenting of the lesion later after the Intra-Aortic Balloon Pump is removed. When a balloon pump is to be inserted through a previously stented iliac artery, do it under fluoroscopy to be sure the balloon does not get stuck on the stent struts. To remove the Intra-Aortic Balloon Pump deflated balloon, insert a large femoral sheath and withdraw the winged balloon into the sheath so the folds of the winged balloon are not caught by struts at the stent edges. Chronic reendothelializations of the stent struts should lessen the problem.
• Two Catheters Inserted with One Puncture Technique: Used in situations such as angioplasty for chronic total occlusion when there is a need for contralateral injection. Another puncture higher or lower than the puncture site of the first site of vascular access, or in the contralateral artery, is suggested. On the other hand, if there is no need for another puncture, then change the sheath to an 8F introducer. There two 4-Fr diagnostic catheters can be inserted and attached to separate injection manifolds for diagnostic purposes. (Nicholson & Rab)
• Puncture of Femoral Bypass Graft: The problems involving puncture of an old vascular graft in the femoral area include: uncontrollable bleeding and hematoma formation because of the nonvascular nature of the punctured graft; disruption of the anastomotic suture line with subsequent false aneurysm formation; infection of the graft site; and catheter damage, kinking, and separation due to scar tissue in the inguinal area and firmness of the healed graft material. (Chisholm, R.J.) Unintentional entry to the native arterial system may lead to the dead-end stump in the common femoral or iliac artery.
Closure device can be used after any procedure such as valvuloplasty, Intra-Aortic Balloon Pump, or due to inadvertent arterial puncture such as after cannulation of a subclavian artery instead of a jugular vein. The choice between collagen plugs and suture closure is largely a matter of personal preference and experience. The time needed to deploy the various devices is unique to each system. When physicians’ time to utilize the device and staff time for adjunctive compression or puncture site management are considered together, sealing devices do not provide an advantage over manual pressure in decreasing complications. (Feldman T.) In deploying an ‘Angio Seal’ device (St Jude Medical Devices), an iliac angiogram needs to show the artery diameter is at least 4 mm and there is no bifurcation within 2 cm of the arterial entry site.
• Pre-closure of Large Arterial Access: In situations wherein, a large sized sheath is needed, pre-placement of untied sutures using the Per close percutaneous suture delivery system prior to placement of a large intended sheath can be done. A 5Fr to 6Fr sheath may be used for arterial angiography to identify appropriate anatomy for suture delivery; a suture device is then used to place untied sutures. At the end of the procedure, the existing string is closed around the arteriotomy. (Feldman T.)
• Pre-closure of Large Venous Access: The technique of pre-closure entails preloading a 6Fr Perclose suture closure device into the femoral vein after access with a 6Fr or 8Fr dilator before insertion of a 14Fr venous introducer sheath used for antegrade aortic valvuloplasty. Intravenous placement of the Per close device within the venous system is then verified by either back-bleeding from the marker port, or contrast injection through the marker port. Then the needles are pulled and the sutures clipped, and after the sutures are deployed, a wire is placed into the femoral vein through the Per close device, and an exchange is made over the wire for a 14Fr sheath while the sutures are laid alongside of the puncture and covered with betadine-soaked gauze. After completing the valvuloplasty procedure, a wire is passed through the 14Fr sheath to secure the vessel in case the suture closure fails. The sheath is then removed through the existing sutures, and the sutures are tied around the wire. If hemostasis is successfully achieved with the suture, the wire is carefully removed, and the knot pushed further to complete the closure.
• Intra-Arterial Deployment of Collagen Plug: During deployment of an Angio Seal device, intra-arterial deployment of the collagen plug can be due to inadequate tension on the suture, vigorous tamping, too deep insertion of device into the artery then the anchor is caught in the posterior wall, etc. Suspicion of a problem is aroused when there is a long travel distance of the tamper tube or continued bleeding. (Stein & Terstein)
• Removal of Intra-arterial Collagen Plug by Atherectomy: One of the complications of using the AngioSeal device is the partial protrusion of the collagen sponge into the artery, likely due to insufficient tension on the suture while the collagen is deployed. It has been complicated to treat this problem with balloon angioplasty alone due to the highly eccentric nature of the lesion in an otherwise relatively healthy common femoral artery. Suboptimal results of balloon angioplasty in markedly eccentric lesions have been attributed to the compliance and elastic recoil of healthier portions of the arterial wall. Stenting of the common femoral artery should be avoided if possible since it can result in deformation and strut fracture secondary to hip flexion and could compromise future arterial access and surgical repair. The unique design of the ‘Silver Hawk’ catherectomy catheter allows clear visualization of the cutter position during the procedure and enables preferential excision in the direction of the lesion, hence sparing the normal portions of the arterial wall. While the technical success of this device in femoro-popliteal lesions is high, distal embolization may complicate the procedure, particularly in patients with poor distal runoff. (Lee, J.H., et al.)
Femoral artery access remains the most widely used for diagnostic and therapeutic cardiac catheterization. On the other hand, it may require manual compression at the vascular access site with or without the use of adjunctive compression tools. Also, patients need prolonged bed rest, which results in discomfort, longer hospital stay and additional costs. The risk of morbidity and even mortality as a result of vascular complications after percutaneous coronary intervention (PCI) remains a major concern for interventional cardiologists. In emergency procedures, this is exacerbated by the use of dual antiplatelet therapy, glycoprotein IIb/IIIa receptor antagonists and, in some cases, thrombolytic agents. The radial approach may be safer from this point of view, but it is not yet the preferred option in all centers or in complex cases. Following the transfemoral approach, the use of arteriotomy closure devices as alternatives to mechanical compression facilitates early patient mobilization and improves patient satisfaction. (Lee, W.A., et al.) On the other hand, few data have convincingly demonstrated a reduction in vascular complications.
The incidence of major vascular complication in a practice using predominantly femoral artery access and a default strategy of arterial closure was found to be substantially lower than rates quoted in most published data. The past years witnessed the effect of the recession in endovascular procedures trickle down to vascular closure devices: fewer catheterizations and fewer interventions led to at least a slowing, if not a reversal, of the persistent growth seen in vascular closure devices in the past decade. Despite the economic realities of a maturing market, diminishing growth, and increased competition, a number of new devices made their appearance. Several devices had significant changes in platform, and at least one important new technological concept was introduced.
• Angio-Seal: A belts-and-suspenders device because it incorporates active approximation of the arteriotomy along with a thrombosing agent in the tissue track, continues to dominate the vascular closure market. It is favored with a short learning curve, a high success rate even in the setting of full anticoagulation, and a modest complication rate. It is handicapped by two properties inherent to the technology. The anchor placed inside the vessel produces a transiently visible filling defect in the arterial lumen and is occasionally obstructive, either at the puncture site or with embolization. Also, it leaves a mass of collagen inside the tissue track and a suture that extends from the arteriotomy to near the skin surface, providing both a nidus and a wick for potential infection. Repuncture should be done with caution during the first three months. (Applegate, et al.)
• Perclose: popular among those who prefer the well-established surgical approach of suturing arteriotomies. It leaves less foreign body inside either the artery or tissue track, but unlike Angio Seal, does not resorb.
• StarClose: simpler to use than Perclose, deploys a nitinol clip rather than suture and is designed not to leave behind any intraluminal foreign body. In general classification terms, it is similar to Perclose, featuring active approximation, a permanent foreign body, and no thrombosing agent; thus, it has less of a nidus for infection but more of a predisposition to oozing after the procedure in fully anticoagulated patients.
Both Perclose and StarClose lend themselves well to immediate repuncture. There is no restriction on reaccess after Perclose; the evidence base for repuncture after StarClose is modest.
• The Boomerang Closure Wire: Unlike Angio-Seal, Perclose, or StarClose, it is a passive approximator, relying on a nitinol disk inside the artery, with a spring mechanism to maintain traction at the arteriotomy inside the vessel until hemostasis occurs. A theoretical drawback is the need to withdraw the relatively low-profile collapsed assembly through the freshly formed plug, requiring additional compression. Its appeal includes the lack of any foreign body left behind, ability to repuncture with the same considerations as if manual compression had been used, and deployment through the original procedural sheath. A new version, the Boomerang Catalyst (Cardiva Medical), is designed to provide facilitated thrombosis in the tissue track by exposing two agents on the shaft of the device to stimulate coagulation, platelet adhesion, and platelet aggregation when tension is applied to the disk inside the vessel.
An innovative method for percutaneous vascular access was laid out by Seldinger in 1953, along with his report on how a new method to achieve hemostasis at the entry site, “20 to 30 minutes of hand-held pressure after catheter removal followed by overnight bedrest.” (Seldinger, S.I.) From there on, manual application of pressure has persisted as a standard for access site management, which is still uses the same method reported more than half a century ago. Amid succeeding developments in percutaneous arterial procedures, access site management stayed for the most part unaltered until the introduction of interventional cardiovascular procedures between the 1980s and 1990s. The utilization of bigger sheaths and many anticoagulants resulted to higher risk of bleeding complications, showing the need for better hemostatic techniques.
Other issues, such as patient comfort and catheterization lab throughput, have also boosted innovation. Vascular closure devices were created as a reaction to the limitations of traditional manual compression. A wide array of devices, like sutures, plugs, clips, gels, and patches have afterwards been designed and approved in response to access site management. These innovations bore significant increase on the options available for the practitioner. On the other hand, several deficiencies remain especially on issues such as cost, device complexity, and complication rates have restricted compact discs from displacing manual compression as the standard for access management. It is noteworthy that no single access management scheme, either manual compression or vascular closure devices, is ideal for the entire spectrum of patients and anatomy. With the recent focus in peripheral interventional procedures, the would-be-close challenge in vascular access management will be the broader application of closure in complex situations and nontraditional access sites.
Manual compression is usually underappreciated task performed at the conclusion of a percutaneous arterial procedure. It has been described as problematic, time-consuming, and potentially lethal; yet it remains the standard means of achieving hemostasis after catheterization. (Hoffer & Bloch) Procedures are often performed in a busy outpatient setting, with speed and efficiency being primary concerns. Patients are commonly held supine for 4 to 6 hours after manual sheath removal, straining staff and slowing workflow. The compression and bed rest can be uncomfortable for elderly patients and those with orthopedic problems. Manual compression is also challenging for those with obesity or peripheral arterial disease, which can make it difficult to achieve hemostasis manually. Caregivers who perform many these procedures are at risk of repetitive stress injury, particularly if proper ergonomic technique is not done.
Despite the importance of proper manual compression technique to procedural outcomes and patient comfort, it is typically learned through an apprenticeship process: see one, do one, teach one. A wide variety of healthcare workers perform compression, leading to significant variation in technique and skill level. Protocols for manual compression method, hold times, and time to ambulation vary widely across institutions. There has been little literature to establish a widely accepted standard for practice. Although it has been known that vascular closure devices can cause some degree of local injury, recent concern has been raised about a similar phenomenon occurring with manual compression. Inflammation and scarring of the arteriotomy and surrounding soft tissue may lead to vessel stenosis and limit ability for recess. In a porcine model of arterial closure, thirty days after percutaneous arterial sheath insertion, mononuclear infiltrate and fibrous deposition were seen in the arterial wall and subcutaneous tissues consistent with fat necrosis. (Silver & Quintero) Although vascular closure devices were associated with significant scarring and inflammation, it was notable that those closed with manual compression showed these changes to a similar degree.
Even though vascular closure devices have been shown to reduce time to ambulation and improve catheterization lab efficiency; there are several reasons why manual compression remains a fundamental component of sheath management. The initial cost is lower, although the benefit might be reduced by increased staffing requirements. Certain patients probably do not require prolonged bed rest after achieving hemostasis. (Baim, et al.) In one study, low-risk patients had excellent outcomes with 10 to 15 minutes of manual compression and 1 hour of bed rest followed by 1 hour of observation after ambulation. (Doyle, et al.) Despite the large number of devices and techniques available, vascular closure devices have not clearly been shown to reduce the incidence of bleeding and vascular complications when compared with traditional compression. (Carey, et al.) Also, many patients are not good candidates for closure for anatomical reasons. Angiography is recommended before deployment of vascular closure devices to ensure a single front-wall common femoral arterial puncture.
These devices are not indicated for use in patients with an arteriotomy above the inguinal ligament or below the femoral bifurcation. Occasionally, vascular closure devices will fail due to improper deployment or inability to obtain hemostasis. Traditional, vascular closure devices do not deal well with these complex situations, leaving manual compression as the default option.
In addition, vascular closure devices use is often precluded due to the presence of atherosclerotic plaque or a bypass graft. Given the recent increase in the number and type of cardiac and endovascular procedures being performed, many patients are having repeat procedures via the same access point. Furthermore, these patients are likely to have complicating factors such as peripheral arterial disease and scarring of the surrounding soft tissue. Techniques that allow for immediate re-entry and preserve the site for future access should be favored. For these reasons, manual compression continues to be a mainstay of arterial access management.
Despite the initial promise of vascular closure devices, complication rates compared with manual compression have dampened enthuse enthusiasm about their widespread use. Even more concerning are the rare but catastrophic complications that are unique to vascular closure devices use. There are many examples in the literature of vascular closure device-related complications, such as device entrapment, perforation, and infection. (Sohail, et al.) The consequences of these events are considerable and include neurologic injury, limb loss, and even death. Since the main benefit of vascular closure is one of convenience due to early ambulation, the expectation of safety should be quite high. Improving safety is a critical feature for the next generation of closure devices.
There are numerous technical reasons why vascular closure devices have yet to meet their promise of rapid, safe, and reliable hemostasis. Despite several successive generations of these devices, they remain somewhat complex to use. Failure to apply proper techniques or use in high-risk patient and anatomical subsets increases the likelihood of complications. In the event of deployment failure, many devices do not have a bailout mechanism that allows reattempt at closure. By depositing foreign material in the vessel and soft tissue, there is a risk of infection and thrombosis. These devices can be improved by the development of an atraumatic mechanism of closure and avoidance of retained material.
The objectives for ideal access management include minimizing patient discomfort, reducing bleeding and other vascular complications, facilitating early ambulation, and preserving the entry site for future procedures. Accomplishing these goals requires a comprehensive approach, starting with proper placement of the arterial puncture and ending with the correct choice and implementation of the access management method. Many options are available, and decisions should be tailored to the individual patient and situation. Factors such as patient gender, size, and anticoagulation status play a role, as do their anatomical features. Manual compression has long been considered the standard of care, having changed little despite five decades of technological advancement. Vascular closure devices have been developed to improve the process of hemostasis.
On the other hand, barriers remain to widespread adoption. Vascular closure devices have been successful in decreasing time to ambulation but have not reduced the rate of serious complications. Their use is contraindicated in many patient subsets. The retained foreign material used in these devices may paradoxically increase the severity of complications due to the risk of vessel thrombosis and infection. There is still a need for a vascular access management system that provides rapid and robust hemostasis while addressing the shortcomings of indwelling vascular closure devices.