Surgical complications from hemostatic puncture closure devices

BACKGROUND: For securing immediate hemostasis following percutaneous arterial catheterization, the Food and Drug Administration has approved three hemostatic puncture closure devices. We reviewed our institutional experience with one device (Angio-Seal). METHODS: A retrospective, single-center, nonrandomized observational study was made of all vascular complications following femoral cardiac catheterization. RESULTS: An immediate mechanical failure of the device was experienced in 34 (8%) patients. Surgical repair was required in 1.6% (7 of 425) of patients following Angio-Seal versus 0.3% (5 of 1662) following routine manual compression (P = 0.004). In 5 patients, the device caused either complete occlusion or stenosis of the femoral artery. The polymer anchor embolized in 1 patient and was retrieved with a balloon catheter at surgery. CONCLUSION: During the first year of utilization of a percutaneous hemostatic closure device following cardiac catheterization, we observed a marked increase in arterial occlusive complications requiring surgical repair. Surgeons must be familiar with the design of these devices to achieve precise repair of surgical complications.     

Femoral artery infections associated with percutaneous arterial closure devices

Hemostasis obtained by manual compression after femoral artery catheterization results in consistently low rates of major complications. A rare complication of femoral artery catheterization is arterial infection. Its occurrence after diagnostic angiography using manual compression has not been reported. We report two cases of femoral arterial infection after uneventful diagnostic catheterization in nonimmunocompromised patients using the Perclose percutaneous arterial closure device. Our cases are representative of Perclose associated infections, with delayed presentation of a staphylococcal arterial infection requiring arterial debridement and reconstruction. This article indicates that Perclose use carries a risk of severe arterial infection. Surgeons should be aware of the potential infectious complications associated with Perclose use and the need for aggressive treatment.     

Infectious complications resulting from use of hemostatic puncture closure devices

BACKGROUND: Femoral access site complications have increased as the fields of invasive cardiology, radiology, and endovascular surgery have emerged. In order to address one of these complications, hemorrhage, the hemostatic puncture closure devices were developed. METHODS: Retrospective review of cardiac catheterizations performed at a single institution to investigate infectious groin complications related to use of the Perclose Prostar and Techstar devices. RESULTS: Infectious groin complications were significantly higher in the Perclose group as compared with manual compression. Three patients had clinical and laboratory evidence of arterial infection whereas 2 had soft tissue infections. All 5 required operative intervention ranging from incision and drainage to arterial reconstruction. Hemorrhagic complications were not significantly different between the two groups. CONCLUSIONS: The Perclose devices provide hemostasis after femoral artery catheterization similar to manual compression. However, infectious groin complications appear to be more common with these devices.     

The use of closure devices

The use of arterial closure devices offers significant benefits over manual compression in achieving groin hemostasis following catheter-based procedures. Several currently available devices provide rapid puncture site closure with complication rates similar to that of manual compression. Closure devices allow for early times to ambulation and hospital discharge, and have a high degree of patient satisfaction. Their use may be of particular benefit inpatients that are anticoagulated. We believe that their use should be strongly considered in all patients following femoral artery catheterization.     

Ischemic complications of percutaneous femoral artery catheterization

Ischemic injuries following percutaneous femoral artery catheterization are uncommon but have been associated with vascular closure devices (VCDs). The purpose of this study was to retrospectively compare ischemic and hemorrhagic complications of femoral artery catheterization and to identify factors associated with ischemic injuries. The operative registries of the attending vascular surgeons at one academic and two community hospitals were retrospectively reviewed to identify all complications of femoral artery catheterization requiring operative intervention. Demographic, clinical, procedural, operative, and outcome data were compared between patients who sustained ischemic and hemorrhagic complications. From January 2001 to December 2006, 95 patients required operative management of complications related to femoral artery catheterization including 40 patients who experienced ischemic (group 1) and 55 patients who experienced hemorrhagic (group 2) complications. Compared to those sustaining hemorrhagic complications, ischemic complications were more frequently associated with younger age, smoking, VCD deployment, and, when controlling for VCD use, female gender. Time to presentation was also significantly longer in patients experiencing ischemic complications. Ischemic complications are increasingly recognized following femoral artery catheterization. Vascular surgeons should anticipate a new pattern of injury following femoral artery catheterization, one that often requires complex arterial reconstruction.     

The management of peripheral vascular complications associated with the use of percutaneous suture-mediated closure devices

PURPOSE: The purpose of this study is to identify the peripheral vascular complications associated with the use of percutaneous suture-mediated closure (PSMC) devices and compare them with postcatheterization femoral artery complications not associated with PSMC devices. METHODS: This is a retrospective review of all patients admitted to the vascular surgery service at the Chattanooga Unit of the University of Tennessee Department of Surgery with a peripheral vascular complication after percutaneous femoral arteriotomy between July 1, 1998, and December 1, 1999. The complications followed the use of PSMC devices (group I, n = 11) and traditional compression therapy (group II, n = 14) to achieve arterial hemostasis. Group II was subdivided into patients who required operative intervention (group IIA, n = 8), and those who were treated without operation (group IIB, n = 6). RESULTS: No significant difference was found between groups I and II with regard to age (P =.227), time to vascular surgery consultation (P =.987), or diagnostic versus therapeutic catheterization (P =.897). A significant difference was found with regard to mean pseudoaneurysm size (group I = 5.9 cm, group II 2.9 cm; P =.003). Ultrasound compression was successfully performed in 66.6% of group II patients, but no (0.0%) patient in group I responded to this therapy (P =.016). Groups I and IIA had a significant difference for mean estimated blood loss (group I = 377.2 mL, group II = 121.8 mL; P =.017) and requirement for transfusion (P =.013). More patients in group I required extensive surgical treatment (P =.007), with six of these patients requiring vein patch angioplasty during their treatment. More patients in group I also had infectious complications (n = 3) compared with group IIA (n = 1). CONCLUSION: In comparison with complications that follow percutaneous arteriotomy when PSMC devices are not used for hemostasis: (1) pseudoaneurysms after the use of PSMC devices are larger and do not respond to ultrasound compression, (2) complications associated with PSMC devices result in more blood loss and increased need for transfusion and are more likely to require extensive operative procedures, and (3) arterial infections after the use of PSMC devices are more common and require aggressive surgical management.     

Angiographic access site complications in the era of arterial closure devices

Coronary and peripheral angiography is associated with a low but significant risk of access site complications. While percutaneous devices have been shown to permit more rapid puncture site closure, previous reports have suggested the incidence and severity of complications associated with these devices are greater than with manual compression. This study compares access site complications with and without closure devices in the current era. The authors conducted a retrospective review of patients with access site complications after coronary or peripheral angiography between 1998 and 2000. Forty-five complications requiring vascular surgical consultation were identified in the 4,800 procedures performed during this time period. Fourteen complications occurred in 1,536 procedures (0.9%) using suture-mediated or collagen devices and 31 occurred in 3,264 procedures without devices (0.9%). The types of procedures and catheter sizes (mean 7 Fr) used were not different in the 2 groups. Other than complications involving a retained device, there was no difference between device and manual compression with respect to incidence or types of complication,requirement for operation, type of operation, or outcome. Access site complications identified included pseudoaneurysm (n = 22; 49%), bleeding or hematoma (n = 8;18%), arteriovenous fistula (n=5;11%), arterial thrombosis (n = 4;9%), infection (n = 4;9%), and retained device (n = 2;4%). Twenty-four patients (71% vs 45%; p = NS) required operative intervention including pseudoaneurysm repair, hematoma drainage, and thrombectomy. Eleven patients (26%) underwent successful ultra-sound-guided pseudoaneurysm compression and 9 patients (21%) required no intervention. These data demonstrate that closure devices facilitate arterial puncture site repair without an increase in access site complications. These devices can be safely utilized when rapid hemostasis is desired after coronary or peripheral angiography.     

Infection is an unusual but serious complication of a femoral artery catheterization site closure device

Percutaneous devices have been developed to close the femoral artery puncture site after catheterization. Because direct compression is not needed, the devices save time for the treating health-care provider, reduce patient discomfort, and obviate the need for post-catheterization bed rest. Reported complications with use of these devices are similar in nature and frequency to those accompanying direct compression. Complications of infection requiring surgical treatment are exceedingly rare with use of these devices. We describe a series of five catheterization site infections occurring among 1807 patients (0.3%) whose femoral artery puncture was closed with a percutaneous suture closure device. All patients required operative intervention and there was one late death. Physicians should be aware of this uncommon but serious complication to expedite evaluation and treatment of patients with suspected infections from these devices.     

The use of arterial closure devices for incidental arterial injury

Incidental arterial injury is one of the main mechanical complications associated with central venous catheter placement. These injuries can result in significant morbidity and mortality. The use of arterial closure devices to repair these injuries offers a less invasive alternative than open repair and a safer approach than manual compression. We present 3 cases of critically ill patients treated with arterial closure devices when attempted central venous catheterization failed and inadvertent arterial cannulation occurred. A brief review of the various closure devices and there indications is discussed.     

Groin Infection Caused by a Percutaneous Femoral Artery Closure Device: Report of a Case

Hemostasis after femoral artery catheterization is generally achieved by manual compression, which results in a low incidence of infection at the puncture site. Percutaneous femoral artery closure devices have recently been used to prevent bleeding complications, shorten the hospital stay, and reduce the patient's discomfort. However, they have been associated with infectious complications, necessitating surgical intervention, such as patch angioplasty or arterial bypass; the treatment depending on the damage to the artery and the type of device used. Thus, the possibility of infection should be kept in mind when employing these devices. We report a case of groin infection associated with one such device, known as The Closer, which was successfully treated by drainage and removal of the suture material.     

Surgical intervention for complications caused by femoral artery catheterization in pediatric patients

PURPOSE: This study evaluated the risk factors and surgical management of complications caused by femoral artery catheterization in pediatric patients. METHODS: From January 1986 to March 2001, the hospital records of all children who underwent operative repairs for complications caused by femoral artery catheterization were reviewed. A prospective cardiac data bank containing 1674 catheterization procedures during the study period was used as a means of determining risk factors associated with iatrogenic femoral artery injury. RESULTS: Thirty-six operations were performed in 34 patients (age range, 1 week-17.4 years) in whom iatrogenic complications developed after either diagnostic or therapeutic femoral artery catheterizations during the study period. Non-ischemic complications included femoral artery pseudoaneurysms (n = 4), arteriovenous fistulae (n = 5), uncontrollable bleeding, and expanding hematoma (n = 4). Operative repairs were performed successfully in all patients with non-ischemic iatrogenic femoral artery injuries. In contrast, ischemic complications occurred in 21 patients. Among them, 14 patients had acute femoral ischemia and underwent surgical interventions including femoral artery thrombectomy with primary closure (n = 6), saphenous vein patch angioplasty (n = 6), and resection with primary anastomosis (n = 2). Chronic femoral artery occlusion (> 30 days) occurred in seven patients, with symptoms including either severe claudication (n = 4) or gait disturbance or limb growth impairment (n = 3). Operative treatments in these patients included ileofemoral bypass grafting (n = 5), femorofemoral bypass grafting (n = 1), and femoral artery patch angioplasty (n = 1). During a mean follow-up period of 38 months, no instances of limb loss occurred, and 84% of children with ischemic complications eventually gained normal circulation. Factors that correlated with an increased risk of iatrogenic groin complications that necessitated surgical intervention included age younger than 3 years, therapeutic intervention, number of catheterizations (>or= 3), and use of 6F or larger guiding catheter. CONCLUSION: Although excellent operative results can be achieved in cases of non-ischemic complications, acute femoral occlusion in children younger than 2 years often leads to less satisfactory outcomes. Operative intervention can provide successful outcome in children with claudication caused by chronic limb ischemia. Variables that correlated with significant iatrogenic groin complications included a young age, therapeutic intervention, earlier catheterization, and the use of a large guiding catheter.     

Femoral endarteritis associated with percutaneous suture closure: new technology,challenging complications

OBJECTIVE: Use of percutaneous suture closure devices after catheter-based interventions is increasing. We recently have seen several severe femoral arterial wall infections after use of such devices. The purpose of this study was to examine the incidence, comorbid associations, and management of femoral arterial infections associated with percutaneous suture closure devices. METHODS: We retrospectively reviewed all infectious complications that occurred after 2223 consecutive cardiac catheterization procedures performed over 12 months in a university-affiliated community teaching hospital. Outcome variables included demographics, procedural details, infection, type of arterial reconstruction required, mortality, and limb loss. RESULTS: During this study, 822 patients received percutaneous suture devices. Infection developed in 6 patients (0.7%). The incidence of diabetes in the population undergoing percutaneous suture closure was 219 of 822 patients (26.6%). Three comorbid conditions, noted in multiple patients with infectious complications, included diabetes mellitus, obesity, and placement of a percutaneous suture closure device within the past 6 months. Invasive femoral endarteritis developed in 4 patients. Gram-positive cocci predominated in 4 patients. In 1 patient with polymicrobial infection catastrophic complications developed, including multiple anastomotic ruptures and hemorrhage. A new method of repair that incorporated double-thickness everted saphenous vein was used in 2 patients, and safe arterial closure was achieved. There was 1 late fatality on postoperative day 36. Limb salvage was achieved in all patients. CONCLUSIONS: Femoral endarteritis complicating percutaneous suture closure is a challenging new problem for vascular surgeons and can result in catastrophic complications. Customary techniques that use saphenous vein patch or interposition grafting are not adequate in all circumstances. Successful outcome requires operative exploration in patients with suspected infection. Removal of the percutaneous suture closure device and debridement to normal arterial wall is recommended in all patients with suspected femoral endarteritis, based on positive intraoperative Gram stains or abnormal appearance of the adjacent femoral artery. Early success with an autologous bolstered repair is reported. Caution is advised when considering the use of a percutaneous suture closure device in patients with comorbid conditions including diabetes, obesity, and previously implanted devices.     

The utility of the StarClose arterial closure device in patients with peripheral arterial disease

The StarClose (Abbott Vascular, Redwood City, CA) arterial closure device utilizes an extraluminal nitinol clip to establish hemostasis. The purpose of this study was to determine the safety and efficacy of StarClose from a prospective peripheral arterial disease (PAD) registry. Over an 18-month time interval, 500 StarClose devices were used in 378 consecutive patients with symptomatic PAD after diagnostic and/or therapeutic endovascular cases. Patient demographics along with objective criteria including duplex ultrasound images, common femoral artery flow velocities, and ankle-brachial indexes (ABIs) were analyzed before and after StarClose placement. All outpatients received prophylactic antibiotic (one dose), periprocedural heparin (without protamine reversal), and antiplatelet therapy. Aspirin and clopidogrel (Plavix) was used for all patients undergoing therapeutic intervention. There were 378 patients who underwent procedures for aortoiliac or infrainguinal PAD, 99 of which were bilateral. Of the 500 arteriotomy closures, 296 were therapeutic interventions with sheath sizes of 6-8 F in the common femoral artery. The diagnostic studies (n = 204 arteriotomies) were performed with a 5F sheath. The technical success in achieving hemostasis was 97.2%; only 14 devices had a deployment problem requiring prolonged manual compression. Median length of stay was 157 min for patients done on an outpatient basis. Eleven of 260 (4.2%) on duplex follow-up had a doubling of the peak systolic velocity, only one of which was symptomatic. Late follow-up showed 42 of 360 (11.7%) with a drop in ABI >0.10. Nine major complications (2.0%) were identified in follow-up. The StarClose closure device has a low major complication rate and is safe and efficacious in patients with PAD, although stenosis at the arteriotomy site may occur. The device has achieved rapid hemostasis without need for anticoagulant reversal and requires significantly less time to ambulation than manual compression.     

Percutaneous arterial closure in peripheral vascular disease: a prospective randomized evaluation of the Perclose device

BACKGROUND: Patients with peripheral vascular disease have been excluded from initial studies of percutaneous suture-mediated closure devices (SMCD) despite representing a significant proportion of those requiring endovascular intervention. We sought to determine whether these devices could be safely used in patients with peripheral vascular disease. METHODS: Patients were stratified into two groups and five subgroups on the basis of indication for arteriography, and they were prospectively randomized at the end of the procedure to receive either the SMCD or manual compression. Ankle-brachial index was determined and duplex ultrasound scanning of the accessed femoral artery was performed, before and after the procedure. Ultrasound data included peak systolic velocity, minimum intraluminal vessel diameter, and presence or absence of calcified plaque. Time to hemostasis, ambulation, and discharge were recorded, and major or minor complications were noted. RESULTS: Of 102 patients included in the study, 52 patients were randomized to receive the SMCD. There was no difference in ankle-brachial index, minimum intraluminal vessel diameter, or peak systolic velocity in the accessed vessel after closure with SMCD or manual compression. Time to hemostasis, ambulation, and discharge was significantly less in the SMCD group (P =.001). Presence of calcified plaque was not associated with complications (P =.146). In the SMCD group, hemostasis was achieved with 49 of 52 devices (94.2%). There were six complications (5.9%), two of which were major and required operative intervention. All complications were hemorrhagic and not occlusive. There was no difference in overall complication rate between SMCD (7.7%) and manual compression (4.0%) groups (P =.678). No infection was noted in any of the 102 patients. CONCLUSIONS: Suture-mediated percutaneous arterial closure can be safely performed in patients with peripheral vascular disease, even in the presence of calcified plaque. This closure technique enables shorter time to hemostasis, ambulation, and hospital discharge. There are observed differences in minor, but not major, complication rates for MC versus percutaneous arterial closure in patients with peripheral vascular disease, but these differences did not achieve statistical significance in this small series.     

Changing patterns of access site complications with the use of percutaneous closure devices.

The authors report their experience with 15 cases of groin complications associated with the use of percutaneous closure devices following femoral arterial catheterization over a 2-year period. The complication rate was 1.7% for catheterizations in which a closure device was used. The 15 cases included 7 uncomplicated pseudoaneurysms (PSA), 3 infected pseudoaneurysms, 4 nonarterial groin infections (infected hematomas and/or abscesses), and 1 case of femoral artery occlusion. These complications presented at an average of 5 +/- 4 days postcatheterization. One patient with an infected PSA required a below-the-knee amputation. During the same time interval, there were no infectious complications in patients not receiving closure devices. We conclude that groin complications associated with such devices tend to present late and include a higher percentage of infections as opposed to complications occurring in patients not receiving closure devices. An aggressive surgical approach to these problems appears warranted.     

Influence of arterial access sites and interventional procedures on vascular complications after cardiac catheterizations.

The purpose of this study is to define the incidence of complications at the arterial access site after cardiac catheterization. The influence of the arterial access site on these complications was identified, as were the clinical characteristics of these problems. A total of 8,797 cardiac catheterizations were performed over the 3-year period of this study. Diagnostic catheterizations and percutaneous transluminal coronary angioplasties (PTCAs) were included, and the arterial access site was identified. Diagnostic catheterizations were performed via the brachial artery (group I, n = 3,137) or the femoral artery (group II, n = 4,055). PTCAs were also performed via the brachial artery (group III, n = 32) or the femoral route (group IV, n = 1,573). Ninety-five major vascular complications occurred during the course of this study. The frequency of complications was higher with brachial artery catheterization when compared with the femoral route. PTCA was associated with a higher complication rate than diagnostic studies. Brachial artery complications were primarily arterial thromboses, which were easily diagnosed and treated. Femoral artery complications were more complicated, difficult to identify, and associated with significant morbidity.     

Complications associated with the arterial puncture closure device--Angio-Seal

BACKGROUND: Arterial puncture closure devices (APCD) are frequently used after cardiac catheterization. Here, the diagnosis and therapy of femoral artery complications after the use of the Angio-Seal APCD is reported. PATIENTS AND METHODS: The Angio-Seal APCD was deployed in 1600 patients undergoing transfemoral catheterization. RESULTS: In 7 of 1600 cases (0.4%) vascular complications occurred following Angio-Seal deployment. Diagnosis was made by duplex sonography. Intraoperative findings consisted of a complete occlusion with dissection of the femoral artery in all patients. In 6 cases, the femoral bifurcation had to be reconstructed after endarterectomy. Follow-up is complete with a mean of 6 months. CONCLUSION: The Angio-Seal device should not be used for closure of the superficial femoral artery and in patients with severe arteriosclerosis. The application of arteriography as well as the use of ultrasound-guided puncture is advisable. In all cases, surgical intervention was successful and an adequate therapy for management of complications.     

Early experience with infectious complications of percutaneous femoral artery closure devices

Percutaneous femoral artery closure devices are being used routinely after cardiac catheterizations. The use of these devices has been advocated to decrease length of stay, promote early ambulation, and prevent bleeding. We reviewed the use of these devices in our institution and report three cases of infectious complications (two pseudoaneurysms and one infected hematoma). Reports of infected pseudoaneurysms after cardiac catheterization before the implementation of these devices are rare. The use of these devices may be associated with an increased incidence of infected femoral pseudo-aneurysms.     

Femoral artery occlusion with a percutaneous arterial closure device after a routine coronary angiogram: a case report and literature review

Groin vessels are most commonly used to obtain vascular access for angiography because of their size and accessibility. Haemostasis at the puncture site can be achieved with manual compression alone or by using a vascular closure device. We highlight the case of a 68-year-old woman who developed acute claudication in the right leg after a routine diagnostic coronary angiogram when an Angio-Seal(?) device had been employed to close a relatively low arterial puncture. On exploring the common femoral artery, fragments of the device were found occluding the bifurcation. A patch angioplasty was carried out and the patient's claudicant symptoms improved. The Angio-Seal(?) device has a polylactide and polyglycolide polymer anchor, a collagen plug and a suture contained within a carrier system. Haemostasis is achieved by compressing the arterial puncture site between the anchor and the collagen plug. The manufacturer's recommended criterion for using the device safely permits its use only for common femoral artery punctures with an internal vessel diameter of 4mm. Anatomical confirmation of the puncture site and evidence of any arterial disease or stenosis in the artery is detected on fluoroscopy during the procedure. Recent meta-analyses have cast doubt on the assumption that vascular closure devices are superior to mechanical compression alone and serious complications do occur occasionally but are under-reported. Clinicians should be aware of the potentially serious problems that may occur when deciding to employ vascular closure devices, especially with an anatomically low puncture site.     

血管闭合器在老年经皮冠状动脉介入治疗患者中应用的安全性和有效性评价

目的评价Angio—Seal及Perclose止血器在老年冠脉介入治疗患者应用的效果及安全性。方法选取984例老年择期冠脉介入患者，分为3组，A组使用Angio—Seal血管闭合器（390例），B组使用Perclose血管闭合器（312例），C组采用徒手压迫法止血（282例），观察三组患者止血时间、卧床制动时间以及并发症的情况。结果A组，B组及C组的止血成功率为98．97％，97．76％，100．00％，差异无统计学显著性意义（P〉0．1）；止血时间分别为（1．2±0．4）min，（2．0±1．2）min和（21．5±5．6）min，卧床制动时间分别为（5．4±1．5）h，（6．5±2．3）h和（20．3±4．2）h，A组和B组明显短于C组（P〈0．05）；血管并发症发生率各组分别为3．60％、5．45％和10．28％，A组和B组亦明显少于C组（P〈0．05）。结论对于70岁以上的老年冠脉介入患者，术后应用Angio-Seal和Perclose血管闭合装置同样安全有效，优于徒手压迫止血法。