Lower limb ischemic complications after the use of arterial puncture closure devices.

We report three cases of lower limb ischemia occurring after the use of arterial puncture closure devices (APCDs). In two patients, who have undergone percutaneous angioplasty of lower limb arteries, the Angio-Seal APCD led to thrombosis of the common femoral artery. In another patient who has undergone coronary angiography, this device has led to dissection of the common femoral artery. Since these observations seem to not be merely sporadic, radiologists and cardiologists as well as vascular surgeons should be aware of their possible occurrence in order to avoid these complications and to provide promptly an adequate treatment.     

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.     

Surgical treatment of complications associated with the Angio-Seal vascular closure device

Vascular closure devices are used to provide quick hemostasis and early ambulation after percutaneous interventions. The Angio-Seal (AS) vascular closure device forms a mechanical seal by closing the puncture site located between a bioabsorbable anchor within the lumen and a collagen sponge on the adventitia. Although morbidities associated with AS are reportedly infrequent, even the slightest inaccuracy in device implantation may result in displacement of these device components, leading to sudden and severe complications. We report the surgical treatment of complications associated with the use of AS in four patients, including acute limb ischemia, pseudoaneurysm formation, significant hemorrhage, and hypovolemic shock. A common factor in all these cases was that the components of the AS device were displaced from their original site of implantation, stressing the importance of proper device placement. All patients underwent successful surgical vascular repair. Our report highlights the need for exercising extreme care during device implantation, and also the requirement for vigilant inspection for any associated vascular complications commencing immediately after device implantation. It is vital that these device components are actively looked for and removed during surgical exploration so as to prevent future complications.     

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.     

Infectious and Ischemic Complications from Percutaneous Closure Devices Used after Vascular Access

The introduction of percutaneous closure devices (PCDs) to seal arteriotomy sites following percutaneous vascular access (PVA) can lead to greater complications than those with manual compression. The aim of this study was to compare complications and outcome between patients requiring surgery after receiving a PCD and those undergoing standard manual compression. This retrospective study evaluated 56 patients (mean age, 63 years) requiring surgical intervention from January 1, 1998 to April 30, 2002, following complications of PVA. Operative indications were pseudoaneurysm, hemorrhage, infectious complications, and limb ischemia. Patients were divided into two groups for comparison: group I (n = 15, PCD) and group II (n = 41, no PCD). In group 1 patients there were 18 limbs in which 20 Perclose devices were used and 1 limb in which a Duett device was used. From the outcomes in these two groups we concluded that patients undergoing surgical intervention following complications of PVA are at a significantly increased risk for infectious and ischemic complications and require more complex vascular repair when percutaneous closure devices are used.     

股动脉穿刺介入治疗Angio-Seal血管闭合器应用并发症预测模型的构建与验证

目的 探讨股动脉穿刺后采用Angio-Seal血管闭合器发生并发症的危险因素并建立预测模型,为临床护理提供参考.方法 收集经股动脉入路行介入治疗、采用Angio-Seal血管闭合器的611例患者资料,行单因素和多因素Logistic回归分析并发症危险因素,建立风险预测模型进行验证.结果 体重指数、低分子肝素、鞘管尺寸、...     

Iatrogenic limb ischemia caused by angiography closure devices

Described are 2 cases of lower limb ischemia that resulted after deployment of 2 different arterial closure devices. One patient presented acutely with lower limb ischemia after an Angio-Seal (St Jude Medical, Minnetonka, Minn) device deployed at the conclusion of cerebral artery aneurysm embolization. The second patient, who underwent angioplasty for aortic recoarctation, presented with claudication 1 week after deployment of the Perclose (Perclose, Redwood City, Calif) device. The use of such devices can result in significant complications, and cardiologists, interventional radiologists, and vascular surgeons are advised to have a high index of suspicion for such complications and work in close conjunction to provide prompt and adequate treatment.     

Iatrogenic vascular injuries from percutaneous vascular suturing devices

OBJECTIVE: The purpose of this study was to examine the patterns of injury and the strategies of surgical repair of iatrogenic vascular injuries from a percutaneous vascular suturing device after arterial cannulation. METHODS: We retrospectively reviewed the clinical experience from an academic vascular surgical practice over a 2-year period. The subjects were patients undergoing vascular repair of iatrogenic vascular injury after deployment of a percutaneous vascular suturing device. Interventions were direct repair of arterial injury (with or without device extraction) or arterial thrombectomy and repair. The main outcome variables included patterns of arterial injury, magnitude of arterial repair, limb salvage, hospital stay, and perioperative mortality and morbidity rates. RESULTS: From August 1998 through August 2000, eight patients (4 men, 4 women; median age, 55 years; range, 44-80 years) required vascular operations for complications of percutaneous suturing devices after diagnostic (2) or therapeutic (6) arteriograms through a transfemoral approach. Complications included four pseudoaneurysms (1 infected) due to arterial tear from suture pull through, two entrapped closure devices due to device malfunction, and two arterial thromboses due to narrowing/severe intimal dissection. All patients required operative intervention. Direct suture repair with or without device removal was performed in five patients, arterial debridement with vein patch angioplasty in one patient, and arterial thrombectomy and vein patch angioplasty in two patients. There were no perioperative deaths. The median hospital stay was 5 days (range, 2-33). Limbs were salvaged in all patients with a mean follow-up of 4.8 months (range, 1-13). CONCLUSIONS: Although abbreviated postangiography recovery periods and early ambulation have motivated the widespread use of percutaneous suturing devices, the infrequent occurrence of vascular injuries produced by these devices can be significantly more challenging than simple acute pseudoaneurysms or hemorrhage. In addition, thrombotic complications have a small but finite risk of limb loss.     

The efficacy and safety of closure of brachial access using the AngioSeal closure device: experience with 161 interventions in diabetic patients with critical limb ischemia

PURPOSE: This study retrospectively evaluated the efficacy and safety of the 6F Angio-Seal (St. Jude Medical, St. Paul, Minn) as a closure device for transbrachial artery access for endovascular procedures in diabetic patients with critical limb ischemia. METHODS: From January 2005 and September 2007, 1887 diabetic patients underwent interventional procedures in the lower limbs at a two diabetic foot centers. Patients presented with rest pain (16%), ulcers (80%), or gangrene (4%). Systemic anticoagulation with sodium heparin (70 IU/kg) was obtained for all patients at the beginning of the endovascular treatment. A total of 249 brachial arteries (238 patients) were evaluated for possible Angio-Seal use after endovascular recanalization of the leg. Color Doppler ultrasound imaging of the artery was obtained before revascularization only in patients with previous Angio-Seal placement in the brachial artery. No further imaging studies were done in the remaining brachial arteries where the Angio-Seal was deployed at the operator's discretion. Impairment or disappearance of the radial pulse or onsets of hand ischemia or hand pain, or impairment of hand function during or at the end of the endovascular revascularization were all regarded as contraindications to Angio-Seal usage. Evidence of a highly calcified plaque of the brachial artery access site at the time of vessel puncture was regarded as an absolute contraindication to the Angio-Seal use. Patients were seen before discharge, at 1, 3, and 8 weeks after the procedure, and at 3-month intervals thereafter. Complications included hemorrhage, pseudoaneurysm, infection, and vessel occlusion. RESULTS: A total of 1947 Angio-Seal collagen plugs were deployed in 1709 diabetic patients (90.5%). The Angio-Seal was used for brachial artery closure in 159 patients (8.4%) in 161 procedures (159 in the left, 2 in the right brachial artery). In 79 patients (4.2%) in 88 procedures (87 in the left and 1 in the right brachial artery), the device was deemed contraindicated due to small vessel size in 73 patients (92.4%) or presence of calcium at the access site in five patients (6.3%). One patient (1.3%) refused the collagen plug closure after revascularization. The non-Angio-Seal group was evaluated for comparison. The success rate for achieving hemostasis in the Angio-Seal group was 96.9%. Five major complications (3.1%) at 30 days consisted of two puncture site hematomas >4 cm, two brachial artery occlusions, and one brachial artery pseudoaneurysm, with three patients requiring open surgery. Minor complications (7.50%) were three puncture site hematomas < 4 cm, three oozing of blood from the access site, and six patients had mild pain in the cubital fossa. No further complications were recorded in the 14-month follow-up (range 1-25 months) of a total of 140 patients. CONCLUSIONS: This retrospective study shows that the 6F Angio-Seal is a valuable and safe vascular closure device for transbrachial access in diabetic patients undergoing interventional procedures for critical limb ischemia.     

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.     

Can the Perclose suture-mediated closure system be used safely in patients undergoing diagnostic and therapeutic angiography to treat chronic lower extremity ischemia?

PURPOSE: Mechanical closure devices for arterial hemostasis after angiography, such as the Perclose suture-mediated closure system, are designed to decrease time to ambulation and improve patient comfort. Although these devices are safe and efficacious, to date there has been little reported about use of the Perclose device in a cohort consisting exclusively of patients with lower extremity peripheral vascular disease. The purpose of this study was to determine the safety and efficacy of routine use of the Perclose system in patients with documented peripheral vascular disease undergoing angiography to treat chronic lower extremity ischemia. METHODS: The Perclose device was placed for arterial closure after femoral artery access in 500 consecutive patients with documented peripheral vascular disease (ankle-brachial index, <0.8) who underwent diagnostic angiography or percutaneous intervention because of chronic lower extremity ischemia. These 500 patients composed 91% of all patients who underwent angiography because of chronic lower extremity ischemia between January 1, 2001, and April 1, 2002. All complications associated with the Perclose device were identified and reviewed. RESULTS: Of the 500 arteries, 54% were accessed for diagnostic angiography and 46% for intervention. Perclose device placement was successful in 475 attempts (95%). Overall major complication rate was 1.4% (7 of 500 arteries). Complications included one death from retroperitoneal hemorrhage; three episodes of limb ischemia, two requiring operation and one requiring lytic therapy; two pseudoaneurysms; and one hematoma, which prolonged hospitalization. The hematoma was the only complication in the 25 patients with failed Perclose device placement. There were no infections requiring admission or operation. CONCLUSION: The Perclose suture-mediated closure device is efficacious and can be used safely in selected patients with documented peripheral vascular disease. Complications associated with this device tend to be more severe than those historically reported for manual compression. Substantial experience with use of this device is required to achieve excellent results in patients with difficult anatomy.     

Complications associated with percutaneous closure devices.

BACKGROUND: In an effort to reduce time to hemostasis after angiography, several closure devices have been marketed. We report some of their complications. METHODS: A retrospective review was conducted. RESULTS: Over an 8-month study period, 2,181 diagnostic and interventional procedures were performed. Closure devices were used in 408 (19%) of these patients. The Angio-Seal closure device is composed of a collagen sponge and an absorbable polymer anchor that compresses the hole in the arteriotomy. The ProstarXL sealing device consists of a rotating barrel that deploys 4 needles through the arteriotomy, and then individual knots are extracorporeally tied. The Duett device consists of a balloon occluding catheter and injectable collagen and thrombin. Ten of the patients developed a complication from the closure device (2.5%). Four of these were subcutaneous abscesses. Two of these patients had expanding pseudaneurysms, 2 had lower extremity ischemia, and 1 patient had an acute bleed. These complications were all managed surgically. Another patient developed a retroperitoneal bleed that was managed nonoperatively. CONCLUSIONS: As the use of these devices increase, these complications will become more common.     

Complications associated with the Angio-Seal arterial puncture closing device: intra-arterial deployment and occlusion by dissected plaque

The Angio-Seal arterial closure device is widely used to prevent bleeding and facilitate early ambulation after arterial puncture. We had referred to us three female patients in whom this device had been used; its sponge had been unintentionally deployed in the arterial lumen. In a fourth female patient, a dissected plaque underneath the device occluded the femoral artery. Severe lower extremity ischemia occurred in each case. One intraluminal sponge was detected only after 20 days, when the patient had developed severe symptoms due to microembolization; in another patient, ischemia occurred 9 days after intraluminal deployment. In two, or possibly three, of the cases, the superficial femoral artery had been punctured. The device should not be used when the superficial femoral artery has been punctured, in which case complications are more likely to occur. Lower limb ischemia within several months after deployment of these devices should be investigated with duplex ultrasound scanning to examine the possibility that the ischemia may be caused by the device or by device-related thrombus. It is important to register the use of such devices in the procedural reports to make it possible to link their use to eventual later ischemic events.     

Incidence of Vascular Injuries after Use of the Angio-Seal Closure Device following Endovascular Procedures in a Single Center

Introduction Percutaneous closure devices have been used to obtain rapid hemostasis and early mobilization of the patient after arterial catheterization. However, we observed challenging problems with the sealing procedure that require further surgical intervention. The present report is a retrospective analysis of the patterns of injury and the final outcome of four cases of femoral artery injury following the use of Angio-Seal. Methods During the last 24 months, in a group of 175 patients (131 men, 44 women; median age 68.4 years, range 47–81 years) underwent percutaneous closure after diagnostic (n = 53) or therapeutic (n = 122) endovascular procedures. Among them we observed four patients (three men, one woman; median age 65.2 ± 10.8 years, range 47–75 years) who developed severe limiting claudication and required vascular repair of an iatrogenic vascular injury following deployment of the Angio-Seal. They had a femoral thrombosis due to narrowing/severe intimal dissection. Results All patients required operative intervention with removal of the device. We performed femoropopliteal thrombectomy and common femoral endarterectomy with patch angioplasty (n = 2), resection of the femoral bifurcation and reimplantation of the deep femoral artery (n = 1), and femoral bifurcation endarterectomy with direct arterial suture (n = 1). The median hospital stay was 6.5 ± 3.8 days (range 4–12 days). Limb salvage was achieved in all of the surviving patients at a mean follow-up of 7 months (range 1–12 months). Conclusions Vascular injuries are uncommon after use of the hemostasis closure device. When they occur, however, they are likely to require challenging surgical correction. This work was presented at the 4th International Central European Vascular Forum in Dubrovnijk, April–May 2004.     

Percutaneous closure devices for endovascular repair of infrarenal abdominal aortic aneurysms: a prospective, non-randomized comparative study.

PURPOSE: This study was designed to describe and evaluate our preliminary results with a percutaneous arterial closure device as compared to those obtained with conventional femoral surgical cut down during endovascular repair of abdominal aortic aneurysms (AAA). MATERIAL AND METHODS: Between January 2004 and December 2006, 40 of 86 AAA patients selected for endovascular repair met the criteria for inclusion in this study. Nineteen of these patients (Group A) received a bifurcated endograft placed by direct puncture of the femoral arteries (38 femoral triangles) with closure by a Prostar((R)) percutaneous arterial closure device (Abbott). The other 21 patients (control group B) were managed with a bifurcated endograft placed by conventional open surgery (42 femoral triangles). Data concerning all 40 patients were collected prospectively and analyzed. RESULTS: The technical success rate was 92% (group A) vs 90% (group B), P=0.79. The incidence of perioperative complications was 16% (3/19) in group A and 14% (3/21) in group B (P=0.89). The mean hospital stay was 5.8 days in group A and 7.8 days in group B (P=0.05). The difference in the length of hospitalisation was associated with reduced cost for the percutaneous group (5579.60 euros vs. 7503.60 euros; P=0.04), that counterbalanced the cost induced by the Prostar XL((R)) suture mediated device. Mean follow-up in both groups was 12 months. The overall incidence of locoregional complications after one year of follow-up was 11% (2/19) in group A and 19% (4/21) in group B (P=0.45). CONCLUSION: This study confirms the feasibility and safety of total percutaneous endovascular AAA repair. Our preliminary results suggest that the costs paid by healthcare providers for endovascular AAA repair might not be increased with the selective use of percutaneous closure devices.     

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.     

Acute Claudication caused by Angio-Seal Closure Devices: a Report of Four Cases

Femoral artery closure devices are increasingly used after percutaneous arterial interventions to obtain hemo-stasis at the puncture site. Their efficacy and advantages in patient comfort are established. Nevertheless they can cause their own specific complications. In a five month’s period we had to treat four patients with sudden onset invalidating claudication after the use of an Angio-Seal closure device. Malpositioning of the device led to the ischemic complications. We describe and illustrate the pre-and peroperative findings and the treatment. Interventionalists should monitor and register ischemic complications following the use of puncture site closure devices in order to try and minimize these. The occurrence of few serious complications can outweigh the relative small benefits these devices offer.     

Acute claudication caused by Angio-Seal closure devices: a report of four cases

Femoral artery closure devices are increasingly used after percutaneous arterial interventions to obtain hemostasis at the puncture site. Their efficacy and advantages in patient comfort are established. Nevertheless they can cause their own specific complications. In a five month's period we had to treat four patients with sudden onset invalidating claudication after the use of an Angio-Seal closure device. Malpositioning of the device led to the ischemic complications. We describe and illustrate the pre- and peroperative findings and the treatment. Interventionalists should monitor and register ischemic complications following the use of puncture site closure devices in order to try and minimize these. The occurrence of few serious complications can outweigh the relative small benefits these devices offer.     

Arterial thrombosis after using Angio-Seal

Percutaneous closure systems of arterial puncture sites are being used more and more in modern endovascular practice. In this article, we report five cases of thrombotic complications following Angio-Seal deployment which required to be treated in our department between June 2004 and January 2006. We carried out a computerized literature review using "vascular closure" as a keyword and elected 106 articles published between 1992 and 2007. The analysis of this literature review showed that the rate of percutaneous closure complications was similar to the rate of manual compression complications, which is still the reference method. The complications associated with the use of these systems were more complex and more often required surgical repair. The severity and frequency of these complications differ based on the type of closure systems. The vascular surgeon in charge must have a good knowledge of these systems and of the complications each of them entails to be able to treat them in the most appropriate way.     

Influence of failed arterial reconstruction on the outcome of major limb amputation.

BACKGROUND. Unsuccessful vascular repair may further preexisting limb ischemia and thus increase the risk of revascularization procedures. METHODS. The results of 94 primary major amputations (group A) have been analyzed and compared with 112 secondary ablations (group B) carried out after failed revascularization efforts. All patients suffered from chronic critical ischemia (grades III and IV) of the lower extremities. In group A the severity of ischemic symptoms was more pronounced (trophic changes in 80% vs 66% in group B), and a preponderance for older age, diabetes mellitus, and incidence of cardiac failure and cerebrovascular insufficiency was evident. RESULTS. In patients undergoing secondary amputation the final transection level was adversely affected by preceding unsuccessful reconstructive attempts. In spite of the better risk profile, 30% of patients in group B were subjected to above-knee amputation compared with 13% of patients in group A. The aggravated limb ischemia caused by graft failure is reflected by the decrease of the mean ankle systolic pressure index from 0.27 to 0.13 (before and after failed revascularization attempts). Although more amputations at the below-knee level were performed initially in group A, primary wound healing was obtained among these subjects in 68% of patients (compared with only 39% for patients in group B). CONCLUSIONS. In a substantial number of cases preexisting limb ischemia may be promoted by failed attempts at vascular reconstruction, thus leading to severe wound healing complications and a higher level of amputation.