Vascular and Endovascular Surgery Volume 40, Number 5, 2006
Techniques for Managing Complications of Arterial Closure Devices
Venkat R. Kalapatapu, MD, Ahsan T. Ali, MD, Farzad Masroor, BS, Mohammed M. Moursi, MD, and John F. Eidt, MD, Little Rock, AR
According to data reported by the American Heart Association, more than 5 million diagnostic and therapeutic catheterizations are performed each year in the United States. The number of catheterizations has tripled since 1979. It has been estimated that complications related to the access site result in more than 75,000 surgical procedures annually. Thus, improved management of the access site itself is essential to achieve the greater goals of improved care and reduced cost. Manual compression directly over the site of arterial puncture usually results in adequate hemostasis but has several significant drawbacks. Manual compression is uncomfortable for the patient, is fatiguing and time-consuming for staff, and necessitates several hours of costly in-hospital observation. In addition, it may be ineffective in achieving hemostasis, especially in the setting of systemic anticoagulation or following the use of large-bore devices. Based on the perceived need for an improved method of managing the arterial access site following catheterization, various vascular sealing devices have been developed. There are at least 8 (and the number is increasing) hemostatic vascular closure devices that are currently approved by the FDA for access site closure after femoral arterial catheterization. The chief advantage attributed to vascular sealing devices is accelerated access site hemostasis, even in the setting of anticoagulation, leading to earlier ambulation and hospital discharge following arterial catheterization. The most important drawbacks related to vascular sealing devices include the cost of the devices and the possibility of increased access site complications. Despite the paucity of properly designed studies supporting their use, it is estimated that over one million vascular sealing devices are used annually in the United States, a number that has increased dramatically in the past 5 years. In this review, we present a brief description of the design and function of the most widely used devices, describe the most common mechanisms of failure, and recommend strategies for management of access site complications including hemorrhage, arterial obstruction, and infection.
Vasc Endovasc Surg 40:399–408, 2006
From the University of Arkansas for Medical Sciences, Little Rock, AR Correspondence: John F. Eidt, MD, Professor of Surgery and Radiology, University of Arkansas for Medical Sciences, 4301 W Markham St, Slot 520-2, Little Rock, AR 72205
Copyright © 2006 Sage Publications
According to data reported by the American Heart Association, more than 5 million diagnostic and therapeutic catheterizations are performed each year in the United States.1 The number of catheterizations has tripled since 1979. It has been estimated that complications related to the access site result in more than 75,000 surgical procedures annually.2 Thus, improved management of
Vascular and Endovascular Surgery Volume 40, Number 5, 2006
the access site itself is essential to achieve the greater goals of improved care and reduced cost.
Manual compression directly over the site of arterial puncture usually results in adequate hemostasis but has several significant drawbacks. Manual compression is uncomfortable for the patient, is fatiguing and time-consuming for staff, and necessitates several hours of costly in-hospital observation. In addition, it may be ineffective in achieving hemostasis, especially in the setting of systemic anticoagulation or following the use of large-bore devices.
Based on the perceived need for an improved method of managing the arterial access site following catheterization, various vascular sealing devices have been developed. There are at least 8 (and the number is increasing) hemostatic vascular closure devices that are currently approved by the FDA for access site closure after femoral arterial catheterization. The chief advantage attributed to vascular sealing devices is accelerated access site hemostasis, even in the setting of anticoagulation, leading to earlier ambulation and hospital discharge following arterial catheterization. The most important drawbacks related to vascular sealing devices include the cost of the devices and the possibility of increased access site complications. Despite the paucity of properly designed studies supporting their use, it is estimated that more than 1 million vascular sealing devices are used annually in the United States, a number that has increased dramatically in the past 5 years.3
In this review, we present a brief description of the design and function of the most widely used devices, describe the most common mechanisms of failure, and recommend strategies for management of access site complications including hemorrhage, arterial obstruction, and infection
Device Design and Function
The Vasoseal® devices (a family of 4 devices including Vasoseal Vascular Hemostasis Device (VHD), Vasoseal ES (Extravascular Security), Vasoseal Low Profile, and Vasoseal Elite) (Datascope Corp., Mahwah, NJ) consist of 1 or 2 entirely extravascular purified bovine collagen plugs that are inserted adjacent to the arterial puncture site. Vasoseal VHD was originally approved
approved by the FDA in September 1995 and is indicated for reducing time to hemostasis and time to ambulation in patients who have undergone diagnostic angiography, balloon angioplasty, or stent procedures via retrograde femoral puncture. The Vasoseal devices are contraindicated in obese patients. The design of the device is based on the well-established efficacy of collagen as a surgical topical hemostatic agent.4 The deployment of Vasoseal requires 2 operators. Calcification in the femoral artery is not a contraindication to Vasoseal because it is an extravascular device.4-10 There is no recommendation for angiography of the femoral artery before placement.
The most common problem reported with this device is the formation of an irritated lump under the skin owing to the inflammation associated with resorption of the collagen plug. This problem was addressed by reducing the amount of collagen inserted in later versions of the device. Rare cases of intraarterial placement of the collagen plug have been reported. In most cases, failure to achieve hemostasis with the device can be remedied with direct manual compression.
The Angio-Seal vascular closure devices (STS and STS Plus) (St Jude Medical Company, Minnetonka, MN) consist of an absorbable, Tshaped anchor (a 2 x 10 mm copolymer of polylactic and polyglycolic acids), a small (24–28 mg) bovine collagen plug, and an absorbable traction suture in a 6 or 8 Fr delivery system.11,12 It was first approved by the FDA in September 1996 and more than 5 million devices have been distributed. At the completion of the percutaneous catheterization, the anchor and collagen plug are inserted into the artery through a specially designed sheath and then pulled up snugly against the arterial wall to seal the puncture site. Femoral arteriography is recommended before device insertion since heavy calcification may interfere with proper deployment of the device. The device should not be used if the arterial puncture is in the superficial femoral, profunda femoris, or external iliac arteries. Time to hemostasis was more rapid with Angio-Seal than manual compression: Diagnostic 2 vs 15 minutes, percutaneous transluminal coronary angioplasty (PTCA) 6 vs 17 minutes.13-16 The collagen is resorbed in 60–90 days. Ipsilateral repuncture is not contraindicated.
Various arterial obstructive complications have been reported with this device, including em-
bolization of various components, occlusion of the femoral artery, and laceration of the puncture site.
The Duett sealing device (Vascular Solutions, Minneapolis, MN) combines the procoagulant effect of thrombin with the platelet activation of collagen. A small balloon catheter is deployed through the existing introducer sheath to create a temporary seal of the arteriotomy. The procoagulant, a suspension of thrombin (2,000 units/mL) and collagen (50 mg/mL) is mixed by utilizing 2 syringes connected by a single mixing port. The procoagulant is then delivered by the syringe to the outside of the artery through the side port of the sheath. The balloon is then deflated and the sheath and balloon are retracted through the collagen/ thrombin gel in the tissue tract. Light pressure is held for a short period of time. The device is indicated for sealing femoral arterial puncture sites and reducing time to hemostasis and ambulation in patients who have undergone diagnostic or interventional endovascular procedures using a 5-9 Fr introducer sheath with an overall length not exceeding 15.2 cm. The device should not be used in small femoral arteries (<6 mm), with punctures distal to the common femoral artery, with posterior wall punctures, or in patients with severe peripheral vascular disease. Arteriography of the femoral artery is recommended before deployment. This device has been shown to be effective in achieving earlier hemostasis and ambulation compared to manual compression.17-20 There is no contraindication to repuncture.
The most worrisome complication with this device is injection of the procoagulant directly into the artery, causing thrombosis. This may require surgical thrombectomy, but a variety of catheter-based thrombolytic techniques may be effective in restoring flow.
The Perclose devices (ProGlide, Perclose A-T, Closer S, Prostar XL [8 or 10 Fr]) (Abbott laboratories, Abbott Park, IL) first received approval from the FDA in April 1997. The devices are designed to insert 1 or 2 nonabsorbable sutures directly into the arterial wall adjacent to the arteriotomy. This device relies on direct suture closure of the arteriotomy rather than augmentation of hemostasis. The Prostar device was the first generation and relies on a relatively complex mechanism that involves the delivery of either 2 or 4
needles from inside-out the artery. These needles are captured by the barrel of the delivery system. An inability to capture the needles in the barrel may result in the entrapment of the device in the arterial wall, necessitating surgical removal. Once engaged in the arterial wall, the sutures are tied in a conventional surgical manner with a slipknot after removal of the device. Although indicated for the closure of 10 French or smaller arterial punctures, this device owes its popularity to the ability to “preclose” access punctures up to 24 French.
The next generation of Perclose (ProGlide, Closer and A-T) devices is based on a completely different design that eliminates the intraarterial location of needles. These devices place the suture through the arterial wall in a fashion similar to a sewing machine, ie, from “outside in.” In the absence of device failure, hemostasis is achieved in > 95% of patients.21,22 There is no restriction on repuncture of the same groin, but some angiographers prefer to avoid repuncture for several weeks, particularly in the presence of significant hematoma.
A number of arterial infections have been reported with the Perclose devices.23 Monofilament polypropylene suture has replaced the braided suture in the ProGlide model, at least in part, to reduce this risk.
There are a number of devices, either in development or recently approved by the FDA, with insufficient published data from which to make firm judgments regarding their efficacy or complication rates. The Boomerang (Cardiva Medical Inc., Mountain View, CA) received 510 K approval in October 2004). It consists of a conformable, nitinol- wire mesh disk on a tether that is placed inside the artery to obtain immediate temporary access site hemostasis while the arteriotomy recoils (the “boomerang” effect). After a few minutes, the disk is removed and a few minutes of manual compression are required to achieve complete hemostasis. The EVS vascular stapling system (Medtronic, Inc., Minneapolis, MN) places a single titanium staple in the arterial puncture site. It was approved by the FDA in 2004. X-Press (Xsite Medical, Blue Bell, PA) and Sutura (Sutura Inc., Fountain Valley, CA) are suture-mediated closure devices with little published clinical data. Soundseal (Therus/Boston Scientific Corporation, Natick, MA) uses external application of ultrasound to effect thermal closure of the arterioto-
my. QuikSeal (Sub-Q, Inc., San Clemente, CA) is similar to Vasoseal but uses Gelfoam rather than collagen. Autoclose (Rex Medical, Conshohocken, PA) uses an intraarterial nitinol clip. Matrix VSG (AccessClosure Inc., Mountain View, CA) uses a polyethylene glycol extravascular sealant. The apparent size of the closure market, estimated to be up to $1 billion, will undoubtedly lead to further development of novel products.
Access Site Complications
Complications related to arterial closure devices may be broadly classified into 3 categories: Hemorrhagic, obstructive, and infective. The management of these complications is now reviewed.
Hemorrhage Including Pseudoaneurysm and Arteriovenous Fistula
Bleeding from the access site is the most common complication following arterial access. If the puncture site is below the inguinal ligament, bleeding is confined to the groin. External hemorrhage or expanding groin hematoma can usually be controlled with manual compression. If attempts at manual compression are unsuccessful, direct surgical cutdown under local anesthesia is simple and effective and should be elected earlier, rather than later, in the course of treatment. At the time of surgical exploration, finger pressure over the puncture site will usually suffice while adequate exposure is achieved, and extensive incisions to obtain formal proximal control are usually unnecessary and lead to excessive morbidity. An appropriate-sized Garrett dilator or small balloon catheter may be inserted into the arteriotomy to obtain temporary control while nonabsorbable, monofilament sutures are placed in the arterial wall. Perioperative antibiotics should be given but systemic anticoagulation is unnecessary. We do not recommend the use of endovascular techniques in the management of groin bleeding from the femoral artery because open surgical treatment is definitive and cost-effective.
If the arterial puncture is above the inguinal ligament, bleeding into the retroperitoneum may occur. Retroperitoneal bleeding should be suspected in patients with unexplained hypotension after angiographic procedures. Immediate fluid resuscitation, including appropriate blood transfusion, is mandatory. In hemodynamically stable
patients, a computed tomography (CT) scan without contrast will delineate the extent of the hematoma. In most cases, retroperitoneal hematoma can be managed nonoperatively. Surgery should be considered in patients with ongoing bleeding despite transfusion and correction of hemostatic parameters. In rare cases, expanding retroperitoneal hemorrhage can compromise the circulation to the bowel, particularly the left colon, and lead to pressure necrosis. Patients with persistent retroperitoneal bleeding should be taken to an operating room for definitive control.
In the operating room, the patient should be prepped for all likely interventions including retroperitoneal exploration. In selected patients, contralateral femoral access may be obtained and arteriography performed. Bleeding from the puncture site can be temporarily controlled with balloon occlusion. If the puncture site is above the inguinal ligament, a covered stent such as the iCast balloon expandable stent (Atrium Medical, Hudson, NH) or the Fluency stent-graft (Bard Vascular) can be used to achieve permanent hemostasis. If percutaneous techniques are not an option, then direct surgical cutdown should be undertaken. A “transplant” incision in the appropriate lower quadrant usually provides appropriate access for control and repair of most injuries.
When evaluating hemorrhage from the groin following the use of closure devices, the surgeon should take into account the unique design features of each hemostatic device. Details of the angiographic procedure should be obtained from the angiographer (if other than the surgeon) or cath lab record including the name and model of the closure device and any history of difficulty with insertion. Manual compression may be effective in achieving hemostasis in many cases. Given the large number of available devices and their frequent design modifications, it is often useful to consult the instructions for use (IFU) or manufacturer’s website of the specific closure device before surgical exploration. The threshold for surgery should probably be lower than after manual compression since the likelihood of complex arterial injury is higher with a closure device than with manual compression. If surgical exploration is necessary, all foreign bodies, such as remnants of hemostatic devices, catheters, sheaths, and sutures should be removed completely. The Vasoseal device consists of a prominent subcutaneous collagen plug that should be removed. The T-shaped anchor, collagen plug, and retention suture of the Angio-Seal device may have to be extracted from the arterial wall. Because of their intravascular
mechanisms of action, the Perclose devices and the Angioseal device have been reported to cause arterial lacerations that may require more complex vascular repair.
A pseudoaneurysm is a partially thrombosed hematoma. Clinically significant pseudoaneurysms of the femoral access site occur in 0.05–1.0% of diagnostic studies and up to 5.5% of angioplasties using 8 Fr sheaths.24 Most femoral access site pseudoaneurysms are not due to infection. An access site pseudoaneurysm may thrombose spontaneously, may remain stable in size, may enlarge, or may become infected. In general, active treatment of a pseudoaneurysm should be initiated for 1 of the following indications: (1) persistent or severe local pain; (2) signs of compromise to the circulation of the skin including blisters, discoloration, or pressure necrosis; (3) signs of compression of adjacent structures, including the femoral nerve or common femoral vein; (4) interference with distal perfusion; (5) enlargement; or (6) signs of infection.
Small (<2 cm), stable, minimally symptomatic pseudoaneurysms may undergo spontaneous thrombosis within 2–3 weeks and usually do not warrant specific therapy. Small pseudoaneurysms that persist more than 7–14 days may be injected with bovine thrombin under ultrasound guidance.25 The small risk of allergic reactions with thrombin injection should be recognized, especially in patients who have been previously exposed to bovine products.26 Care must be taken to avoid injection directly into the arterial blood stream. Note that bovine collagen is not approved for intravascular injection.
Larger pseudoaneurysms (>5 cm) may become symptomatic by compressing the adjacent femoral vein (inducing deep vein thrombosis [DVT]), femoral nerve (causing neuropathy), or, rarely, nearby muscles, resulting in myonecrosis. Direct surgical repair is indicated for large (>5 cm), enlarging, or symptomatic pseudoaneurysms. Unlike the approach to acute postprocedural bleeding, it is usually wise to obtain proximal arterial control before entering a large pseudoaneurysm that has been present for several weeks because the arteriotomy may enlarge during the interval. Internal vascular control with occluding balloons, placed either percutaneously or directly into the open pseudoaneurysm, is a good alternative. Primary repair, patch closure, or interposition grafting is undertaken at the discretion of the operating surgeon. All foreign bodies, including hemostatic devices, should be removed at the time of pseudoaneurysm repair.
Occasionally, cultures obtained at the time of repair of an apparently uninfected pseudoaneurysm eventually grow specific pathogens. In most cases, these positive cultures represent irrelevant skin contaminants. In rare cases, positive intraoperative cultures may indicate true arterial infection and should be treated with prolonged systemic antibiotics. We have elected to not remove synthetic patches in this setting, preferring to maintain a heightened awareness for possible signs of infection. There is no definitive guidance in the available surgical literature regarding this perplexing situation.
In general, postcatheterization arteriovenous fistulas (AVF) should be treated. In selected small AVFs not directly involving the common femoral artery, coil embolization may be the least cumbersome treatment alternative. Open surgical repair may be needed for larger AVFs, particularly involving the common femoral artery.
Arterial Obstructive Complications
Arterial obstruction following peripheral artery access may be due to local injury, embolization, or, rarely, spasm. If there is any uncertainly regarding the diagnosis, duplex ultrasound may be beneficial in defining the specific injury. Arteriography from the contralateral groin may be appropriate to evaluate the ipsilateral extremity. Once the diagnosis is confirmed, treatment should be customized to fit the scenario. In the setting of complete occlusion of the femoral artery following manual compression, femoral exploration under local anesthesia is usually the most judicious course of action. If a closure device has resulted in arterial obstruction, it is important to identify the specific device and direct therapy to the likely injury.
Various obstructive problems have been reported with Angioseal. In some cases, the Tshaped anchor has been trapped under a posterior plaque, resulting in femoral occlusion when the anchor is retracted against the arterial wall. Another mechanism of failure is due to inadequate traction on the anchor, leaving a thrombotic foreign body in the lumen. Inadequate fixation may allow the anchor to embolize distally. While distal embolization of the anchor may occasionally be asymptomatic, we have observed complete occlusion of the popliteal artery necessitating surgical embolectomy. If there is complete arterial
occlusion following Angioseal, we prefer direct surgical cutdown, retrieval of the device, and definitive arterial repair. In cases of arterial stenosis following Angioseal, successful balloon angioplasty has been reported.
The most serious obstructive complication related to Vasoseal is due to direct insertion of the collagen plug into the femoral artery. The plug is so large that distal embolization is unusual. Removal of the plug and primary repair of the artery is usually sufficient.
The Perclose devices can cause arterial obstruction in rare cases. The Prostar device inserts the needles from inside the artery to outside. If the needles are not properly recaptured by the barrel of the device, it is sometimes necessary to surgically remove the device. In heavily diseased femoral arteries, the suture may ensnare the plaque, resulting in occlusion. In early versions, the J-tip of the device can be ensnared by the suture if excessive tension is placed on the suture before removal of the device. The latest version of the device (Closer, A-T and ProGlide) are infrequently associated with arterial obstruction.
The Duett device is unique in that arterial occlusion may result from inadvertent injection of the procoagulant into the artery. This can usually be remedied by simple balloon thrombectomy.
In general, we do not recommend endovascular treatment of most arterial obstructive complications following angiography. While snares and other gadgets may be used to retrieve a variety of foreign materials, there is a significant risk of simply making matters worse. All foreign bodies should be removed, including collagen plugs, sutures, and hemostatic gels.27,28 The wound should be irrigated with antibiotic solution.
The management of infections following arterial access is one of the most challenging situations encountered by a vascular surgeon. Infection is usually suspected owing to classic physical findings: rubor, dolor, calor, and tumor. Ultrasound is an accurate, nontoxic, relatively inexpensive method to detect the presence of more sinister findings including abscess, hematoma, or pseudoaneurysm. Simple subcutaneous cellulitis in the absence of pseudoaneurysm or abscess usually responds to antibiotic treatment of typical
skin flora. The optimum duration of antibiotic treatment is not clearly defined, but it is certain that antibiotics should be continued until complete resolution of the physical signs of infection. With appropriate management, most soft tissue infections of the groin are rapidly responsive to antibiotics and rarely progress to endanger either limb or life.
Infection of the arterial wall is a much more complex problem. Undoubtedly, some infections that appear confined to the skin and subcutaneous tissues actually involve the arterial wall. Some early cases of bacterial arteritis may respond to antibiotic therapy, albeit unbeknownst to the treating physicians. If an apparent soft tissue infection is resistant to conservative management, consideration should be given to the removal of sutures, old graft material, catheters, and hemostatic agents such as microcrystalline collagen and cellulose products. The most effective management strategy is “prevention.” Many vascular surgeons prefer to delay elective vascular surgery involving the ipsilateral femoral artery for at least a week after angiography, even in the absence of closure devices, owing to the fear of graft contamination. The evidence for this practice is anecdotal, but the potential for catastrophic outcome accompanying bacterial graft infection mandates that every effort be taken to avoid this outcome.
Bacterial arteritis following angiography and routine manual compression is extremely uncommon and occurs with an estimated frequency of 1 per 100,000 cases.29 Owing to the extremely low incidence, most clinicians will never encounter this problem. During the past 20 years at a university hospital, the authors have not encountered a single episode of infective arteritis requiring vascular reconstruction following manual compression of femoral access after peripheral or coronary angiography. Bacterial arteritis more commonly occurs in association with (1) illicit use of injectable drugs or (2) infection of synthetic vascular grafts. In these patients, the consequences of arterial infection may be catastrophic. For example, the risk of limb loss following ligation of the femoral artery for drug-related femoral arteritis approaches 25%.30 Thus, despite the infrequent occurrence of arterial access-site infections, the consequences clearly mandate every effort to, first, avoid vascular infection, and second, to provide aggressive treatment when it is identified.
Endarteritis Without Hemorrhage or Pseudoaneurysm
Bacterial endarteritis, in the absence of structural deterioration of the arterial wall as evidenced by bleeding or pseudoaneurysm, may sometimes be treated with systemic antibiotics. The likelihood of successful treatment is difficult to estimate since some true arterial infections respond to treatment for overlying soft tissue infection and thereby go undetected. Surgical intervention should be considered in 4 cases: (1) persistent bacteremia despite appropriate antibiotic coverage, (2) symptomatic relapse after appropriate antibiotic course, (3) abscess formation, or (4) hemorrhage ± pseudoaneurysm formation
Endarteritis with Hemorrhage/ Pseudoaneurysm
The surgical treatment of arterial infection associated with sudden hemorrhage or pseudoaneurysm is complex, poorly standardized, and prone to catastrophic failure. Conventional management includes broad-spectrum antibiotics; operative debridement of all infected material, including the affected arterial wall; and control of the inflow and outflow vessels. If the extremity is in jeopardy with vascular control, either in situ or extraanatomic revascularization may be undertaken.
Operative Approach to Arterial Access Site Infection
Urgent surgery is indicated for patients with groin infection with use of a closure device and for those with manual compression and suspected endarteritis with hemorrhage/pseudoaneurysm.
The simplest surgical treatment involves debridement of the infected arterial wall and in situ reconstruction. This technique is particularly appealing if the arterial infection appears to involve only a limited portion of the arterial wall. A simple vein patch may be effective, but note that vein may be susceptible to degradation by certain gram-negative strains, in particular Pseudomonas. Some surgeons prefer to use synthetic patches made of polytetrafluoroethylene (PTFE), based on limited data from the trauma literature that PTFE may be resistant to bacterial degradation. Hollis et al31 described a technique for repairing minor
arterial infections using a Bolstered, Everted, double- layer Saphenous vein patch Technique, the socalled BEST procedure (Figure 1).
Revascularization may not be necessary in all cases, particularly if the communication between the deep and superficial femoral artery can be preserved. Revascularization is undertaken as a secondary procedure if distal ischemia is present. If revascularization must be undertaken, the obturator bypass has proven to be a useful technique that avoids exposure of the new bypass graft to groin sepsis. If the diagnosis of infected pseudoaneurysm can be made preoperatively with certainty, extraanatomic reconstruction should be considered before opening the septic area. In situ reconstruction with autogenous material (eg, contralateral saphenous vein) may be
Figure 1. Bolstered Everted doublelayered Saphenous vein patch Technique (BEST), as described by Hollis et al,31 maybe used in treating minor arterial infection involving the femoral artery.
appropriate in selected cases with minimal signs of infections. Vein grafts may be susceptible to digestion by some aggressive gram-negative bacteria. Reconstruction of the femoral artery using an arterial allograft has been described.32 A recent study demonstrates use of superficial femoral vein in the reconstruction of infected femoral artery.33 Despite reports heralding the benefits of in situ reconstruction with synthetic grafts (± various adherent antimicrobials), the authors remain skeptical and reserve this option as a last resort. The reported amputation rate following excisionligation and selective or delayed revascularization ranges from 11% to 33%.30 Suffice it to say that treatment of groin sepsis involving the femoral vessels is a complex challenge for even the most experienced vascular surgeons. While limb salvage can usually be achieved in the majority of patients, claudication is common and multiple surgical procedures may be necessary to maintain limb viability.
Guidelines for Vascular Surgeons
The following recommendations are based on our understanding of the current state of practice. Maintain meticulous sterile technique during catheterizations. In reality, sterility during
Figure 2. A simplified algorithm showing management of the major complications arising from percutaneous femoral access.
catheterization procedures is rarely maintained with the diligence practiced during open surgical procedures.
Change gloves before use of hemostatic devices. Routine performance of femoral angiography is advisable before a closure device is used in order to delineate the femoral anatomy.
Avoid the use of hemostatic devices after prolonged sheath dwell times, especially greater than 24 hours.
Prophylactic antibiotics such as Cefazolin 1 g for typical skin flora should probably be administered before deployment of vascular closure devices, especially in immunocompromised patients (eg, diabetes).
Repuncture of the ipsilateral groin should be avoided if possible during the resorption of collagen products. Hemostatic devices should probably be avoided if puncture of the ipsilateral femoral artery has occurred within the previous 1–2 weeks owing to the risk of contaminated hematoma.
If signs of infection are present, cultures should be obtained and broad-spectrum antibiotics should be started.
Ultrasound should be obtained to identify abscess, hematoma, or pseudoaneurysm. Abscesses should be surgically drained. The decision to drain hematomas must be individualized. Consideration should be given to the evacuation of hematoma
unquestionably if there is associated pain or skin ischemia. Symptomatic, enlarging, and persistent pseudoaneurysms should be treated.
If an infected pseudoaneurysm is detected, most vascular surgeons recommend extraanatomic bypass followed by surgical excision/ligation of the infected pseudoaneurysm. Reconstruction with autogenous material may be appropriate in selected cases with less severe arterial destruction. Excision/ligation of the common femoral artery without revascularization carries a risk of amputation of up to 20–30%.
If vascular surgery involving the access site is planned shortly after angiography, closure devices should probably be avoided at the time of angiography. Communication with the angiographer is essential to avoid undesirable inflammatory reactions.
If a closure device has been used in the recent past, the vascular surgeon should be prepared to encounter inflammation or scarring during groin dissection. This is particularly true 2–4 weeks after insertion of Vasoseal.24
Infections following angiography are extremely unusual. Most infections are relatively minor soft tissue infections that respond to antibiotics, but occasionally, more severe infection involving the artery wall develops. The management of bacterial arteritis is technically challenging and the results are not uniformly satisfactory. Adherence to strict sterile technique and liberal use of prophylactic antibiotics are recommended. Avoidance of vascular closure devices immediately before planned ipsilateral vascular surgery is probably prudent in order to avoid even the slightest risk of graft contamination.
Hemostasis following percutaneous arterial procedures is the final, but not the least important, stage in a complex task. Vascular closure devices appear to have decreased the time to hemostasis and to ambulation. More rapid hemostasis may result in cost savings by allowing earlier discharge, though this claim appears poorly substantiated at present. Significant complications continue to occur with all methods of hemostasis, including manual compression. The overall incidence of surgical complications does not appear to be different with use of vascular closure devices. Infection is a rare but potentially devastating
devastating complication following angiography. The potential relationship between hemostatic devices and arterial infection should be considered in the decision to use them. Reasonable efforts to avoid infection should always be employed if hemostatic devices are selected.
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