The Case of a Patient with Femoral Artery Stenosis Caused by Angio-Seal^® Use Treated with Endoarterectomy / 日本心臓血管外科学会雑誌

In cases of hemostasis of the femoral artery where the sheath is removed after percutaneous catheterization, there is greater improvement in patient condition and shorter duration of hospital stay when arterial puncture closing devices are used rather than standard manual compression because the use of these devices results in shorter hemostasis and rest times. However, some complications due to these devices have also been reported. Here, we report a case of femoral artery stenosis due to Angio-Seal^® use in a 67-year-old woman. Embolization of the basilar artery aneurysm by endovascular treatment was performed at another institution ; the percutaneous puncture site was the right femoral artery. When this treatment was provided, hemostasis of the artery was performed with the Angio-Seal^®. About one month after the embolization, right intermittent claudication occurred after a 300-m walk. Echography and computed tomography (CT) angiogram showed 75% stenosis of the right common femoral artery, and therefore endoarterectomy of the artery was performed. The postoperative course was favorable and the ankle brachial index score improved from 0.82 to 1.15. In addition, CT angiogram showed resolution of the stenosis of the right common femoral artery and right intermittent claudication ameliorated. Based on the intraoperative views, it was suggested that the arteriosclerotic lesion had existed at the common femoral artery before the endovascular treatment and it might be the cause of the complication mentioned above. In order to prevent complications due to Angio-Seal^® use, it is important to examine the indications of the use of this device by evaluating the puncture site of the artery with echography and other diagnostic techniques before the insertion of a sheath.

Fluoroscopic Guided Fogarty Embolectomy for an Angio-Seal Embolism in the Popliteal Artery

The Angio-Seal is a widely used arterial closure device that helps achieve faster hemostasis and provide early ambulation to patients. However, it can cause various complications in clinical practice. We present the uncommon complication of popliteal artery occlusion following Angio-Seal deployment, and describe an effective interventional approach to its treatment. Because fluoroscopy-guided Fogarty embolectomy has the advantages of complete removal of the embolus without fragmentation, and clear visualization of the exact location of the embolus during the procedure, it is a suitable method for treating this complication.

Angio-Seal(TM) Evolution(TM) versus Manual Compression for Common Femoral Artery Puncture in Neurovascular Diagnostic Angiography : A Prospective, Non-Randomized Study

OBJECTIVE: This prospective, non-randomized study compared the safety and efficacy of the Angio-Seal(TM) Evolution(TM) to that of manual compression for common femoral artery punctures in neurovascular diagnostic angiography. METHODS: From June 2009 to September 2009, we performed 169 diagnostic trans-femoral cerebral angiographies, using either the Angio-Seal(TM) Evolution(TM) or manual compression to achieve hemostasis. We included 60 patients in this study, 30 in each group. We defined minor complications as those requiring no further treatment such as hematoma size less than 6 cm and bruise size less than 25 cm. Major complications were those requiring surgery of the femoral artery pseudoaneurysm and/or the second line increase of hospital stay even without further treatment. RESULTS: Mean time to hemostasis was 0.42+/-0.04 minutes for the angioseal and 15.83+/-1.63 minutes for manual compression (p<0.001). Overall complication rate did not differ between the 2 groups. After the patients were fully mobile, at 24 hours, the rate of onset of new complication differed significantly between the 2 groups (p=0.032). In the angioseal group, 5 (16.7%) of the 30 patients experienced the onset of a new complication after 24 hours, including 3 (60.0%) of the 5 who experienced major complications. CONCLUSION: The Angio-Seal(TM) Evolution(TM) is effective at decreasing mean time to hemostasis, like other closing devices. However, it may not be effective at producing early ambulation and discharge, compared to manual compression, because delayed complications may occur significantly after 24 hours.

Prospective Comparison of Collagen Plug (Angio-SealTM) and Suture-Mediated (the Closer STM) Closure Devices at Femoral Access Sites

OBJECTIVE: Rapid and effective hemostasis at femoral puncture sites minimizes both the hospital stay and patient discomfort. Therefore, a variety of arterial closure devices have been developed to facilitate the closure of femoral arteriotomy. The objective of this prospective study was to compare the efficacy of two different closure devices; a collagen plug device (Angio-Seal) and a suture-mediated closure device (the Closer S). MATERIALS AND METHODS: From March 28, 2003 to August 31, 2004, we conducted a prospective study in which 1, 676 cases of 1, 180 patients were treated with two different types of closure device. Angio-Seal was used in 961 cases and the Closer S in 715 cases. The efficacy of the closure devices was assessed, as well as complications occurring at the puncture sites. RESULTS: Successful immediate hemostasis was achieved in 95.2% of the cases treated with Angio-Seal, and in 89.5% of the cases treated with the Closer S (p < 0.05). The rates of minor and major complications occurring between the two groups were not significantly different. In the Closer S group, we observed four major complications (0.6%), that consisted of one massive retroperitoneal hemorrhage (surgically explored) and three pseudoaneurysms. In the Angio-Seal group, we observed three major complications (0.3%) that consisted of one femoral artery occlusion, one case of infection treated with intravenous antibiotics and one pseudoaneurysm. CONCLUSION: The use of Angio-Seal was found to be more effective than that of the Closer S with regard to the immediate hemostasis of the femoral puncture sites. However, we detected no significant differences in the rate at which complications occurred.

Closure of femoral artery puncture site after CAG or PCI with the Angio-seal / 中国介入心脏病学杂志

Objective To estimate the value of the Angio seal (Vascular Cloure Device, St Jude Medical) in femoral artery closure after CAG (coronary angiography) or PCI (percutaneous coronary intervention). Methods From Oct 2002 to Oct 2003 316 patients received CAG or PCI at our hospital They were divided into group A (150 patients) and group B (166 patients) The Angio seal was useded in group A to close the puncturing spot of femoral artery, and the side of the body punctured was trigged for 4 hours Common hemostasis was adopted in group B Results As compared with group B, time to hemostasis and time to ambulation were notably decreased and groin hematoma and time to bleeding disposed at the puncture site were markedly reduced in group A Conclusion Safe and effective, the Angio seal may be widely adopted in clinical practice

Efficacy and Complications of Angio-Seal(r) Device in Patients Undergoing Coronary Angiography and Angioplasty

BACKGROUND AND OBJECTIVES: The Angio-Seal(r) (a St. Jude Medical Co., USA) hemostatic puncture closure device produces direct femoral arterial hemostasis, by anchoring a collagen plug to the anterior vascular wall, through a sheath delivery system. The rapid and effective hemostasis leads to earlier ambulation, minimized hospital stay, patient discomfort and vascular complications. This study was performed to evaluate the efficacy and complications of an Angio-Seal in patients undergoing coronary angiography and angioplasty. SUBJECTS AND MEHTODS: A total 228 consecutive patients, admitted to our hospital for percutaneous coronary intervention, between October 2001 and May 2002, were enrolled and randomized into 2 groups. 116 patients were treated with an Angio-Seal and the other 112 with manual compression only (control group). The clinical characteristics, procedure related factors, time to ambulation, times to outpatient discharge and complications were analyzed in each patient. All the clinical and procedure-related factors, leading to oozing and delayed bleeding, were also analyzed in the 113 patients who had a successfully completed Angio-Seal deployment. RESULTS: The times to ambulation (7.96+/-5.81 hours vs. 23.32+/-3.35 hours) and times to outpatient discharge (2.00+/-0.94 days vs. 3.47+/-3.61 days) were significantly shorter in the Angio-Seal compared to the control group (p=0.001 & p=0.001, respectively). There was oozing in 20 patients (17.7%) and delayed bleeding in 6 (5.3%) of the successful Angio-Seal deployment group. The occurrence of oozing was significantly higher in the heparin infusion cases (40%. 18.3%, p=0.034), and was correlated with a later hematoma formation rate and the size of the hematoma (30% vs. 9.7%, 0.68+/-1.26 cm vs. 0.17+/-0.70 cm, p=0.015 & p=0.001, respectively). Delayed bleeding was correlated to the hematoma occurrence rate (50% vs. 11.2%, p=0.006). CONCLUSION: The Angio-Seal resulted in earlier ambulation and shorten the patients' hospital stay. Oozing, delayed bleeding, hematomas were noted as complications. Oozing and delayed bleeding were correlated with a high hematoma occurrence rate. Careful inspection of the puncture sites, following an Angio-Seal deployment, should be performed.