Management of acute lower limb ischemia associated with the Angio-Seal arterial puncture closing device (original) (raw)
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Il Giornale di chirurgia, 2006
The Authors report their experience in the management of acute lower limb ischemia following percutaneous arterial closure device application. Five patients required an emergency vascular operations for acute lower limb ischemia. The symptoms onset was < 1 hour in 1 case, 4-12 hours in 2 cases and > 24-36 hours in 2 cases. A preoperative angiography was performed in all the cases. A transfemoral embolectomy was carried out. Direct suture repair were performed in three cases, vein patch angioplasty was carried out in two cases. In one case, a common femoral artery endarterectomy was performed. No post-operative mortality and limb loss occurred. Acute lower limb ischemia due to closure devices required an extensive approach with reconstruction in high risk septic area. Angiography is mandatory for surgical strategies. We prefer direct suture repair and vein path angioplasty for vascular reconstruction.
World Journal of Surgery, 2006
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.
Journal of Vascular Surgery, 2003
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. (J Vasc Surg 2003;38:1305-8.)
Journal of the American College of Cardiology, 2004
This review investigated the safety of arteriotomy closure devices (ACDs) versus mechanical compression in patients undergoing percutaneous transfemoral coronary procedures. The vascular complication rates were similar in diagnostic settings. In intervention settings, two ACDs had similar complication rates to mechanical compression, whereas one had higher rates. The lack of a validity assessment of the included studies limits the results. Authors' objectives To assess the safety of arteriotomy closure devices (ACDs) versus mechanical compression in patients undergoing percutaneous transfemoral coronary surgery. Searching The Cochrane Library, MEDLINE, CINAHL and EMBASE were searched from 1991 to April 2003 for published studies; the keywords were listed. The reference lists of identified articles were also checked. Study selection Study designs of evaluations included in the review Randomised controlled trials (RCTs), cohort and case-control studies were eligible for inclusion. Some studies were excluded because they used historical controls or because there was a risk of bias in patient selection. Specific interventions included in the review Studies comparing ACD with mechanical compression (manual, by means of hand compression, sandbag, C-clamp, or Femostop) were eligible for inclusion. The authors stated that the included studies had to have a well-described protocol of intervention, but this was not defined further. The included studies assessed Angio-Seal, VasoSeal and Perclose ACDs. Participants included in the review Studies of patients undergoing percutaneous coronary intervention (PCI) with transfemoral access were eligible for inclusion. The authors stated that the included studies had to have a precise report on each of the major vascular complications, but this was not defined further. The included studies were conducted in diagnostic settings and/or PCI settings. In the included studies the proportion of men ranged from 56 to 94% and the proportion of patients with diabetes from 8 to 43%. Seventy-three per cent of studies used a >=8-F device sheath. Outcomes assessed in the review Studies that compared access-related complications were eligible for inclusion. The primary outcome measure was the cumulative incidence of major vascular complications. This was defined as: pseudo-aneurysm requiring ultrasoundguided compression or surgical repair; arterio-venous fistula; retro-peritoneal haematoma causing haemodynamic compromise, surgery, blood transfusion, prolonged hospitalisation and/or death; femoral artery thrombosis (vessel occlusion requiring surgery or thrombolysis); surgical vascular repair; access-site infection necessitating treatment with antibiotics and/or surgical drainage; and blood transfusion. How were decisions on the relevance of primary studies made? Two authors independently searched the literature and assessed the relevance of studies. Any disagreements were resolved by consensus, with arbitration by a third reviewer.
Journal of Vascular Surgery, 2003
Background: Patients with peripheral vascular disease have been excluded from initial studies of percutaneous suturemediated 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.
Vascular Closure Device-related Complications After Percutaneous Coronary Intervention
We describe a case of a 56-year-old female patient who presented with acute onset claudication after percutaneous coronary intervention (PCI), in whom the femoral arterial puncture site was closed with an Angio-Seal. The femoral artery occlusion was diagnosed by vascular ultrasound, that showed the presence of a thrombus with a grape-like morphology at the bifurcation of the common femoral artery. The thrombus was surgically removed, and a pathologic study demonstrated that it contained an anchor and collagen, which were parts of the Angio-Seal.