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.     

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.     

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。     

����������ǻ���޸�����Ѫ�ܷ�����������п�����ٴ�Ӧ�öԱ��о�

??Comparation between blood vessel suture instrument and traditional surgical suture in EVAR surgery for abdominal aortic aneurysm: An analysis of 130 cases ZHANG Zheng, CHEN Zhong, TANG Xiao-bin, et al. Beijing Anzhen Hospital ??Capital Medical University, Beijing 100029, China
Corresponding author??CHEN Zhong, E-mail??chenzhong8658@vip.sina.com
Abstract Objective To investigate the application of the Perclose Proglide vascular closure devices in the endovascular abdominal aortic aneurysm repairing operation and its significance. Methods The clinical data of 130 cases of endovascular abdominal aortic aneurysm repairing operation performed between March 2013 and February 2015 in Department of Vascular Surgery??Beijing Anzhen Hospital of Capital Medical University were analyzed retrospectively. Among them, 69 cases were treated with Perclose Proglide vascular closure devices to suture the puncture site of the femoral arteries and 61 cases were treated with the traditional surgical suture to close the puncture site of the femoral arteries. The relationship between the two groups and various clinicopathological factors of patients with abdominal aortic aneurysm were analyzed by Chi-square using statistical software SPSS17.0. The clinicopathological factors include operation successful rate??operation time??intraoperative blood loss??hospital stay??cost of operation??wound healing??lower limb ischemia and so on. Results Analysis using chi-square showed that Perclose Proglide vascular closure devices group was obviously better than the other group in operative time, intraoperative blood loss and hospital stay (P<0.05). Conclusion Comparing with the traditional surgical suture method??Perclose Proglide vascular closure devices are safe and effective. The patients have less injury and can recover more quickly??The Perclose Proglide vascular closure devices are worthy of clinical popularization??     

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.     

Management of infected femoral closure devices

An increase in infectious complications has been noted with the introduction of percutaneous femoral artery closure devices. We report five cases of infected groins and/or femoral arteries following angiographic procedures that were completed using the Perclose Suture Mediated Closure Device (Perclose). Each patient required drainage of the abscess and removal of the Perclose suture. Most patients required more extensive vascular reconstructive procedures. When these complications arise, we recommend expeditious drainage of the abscess, removal of the suture, and adequate exposure of the femoral artery to facilitate repair of the vessel.     

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.     

Management of acute lower limb ischemia associated with the Angio-Seal arterial puncture closing device

Arterial percutaneous closure devices (APCD) could lead to severe vascular complications, like acute lower limb ischemia. The aim of this study was to evaluate retrospectively our personal series of acute lower limb ischemia following the use of APCD. From January 2004 to June 2009 the Angio-Seal percutaneous closure devices was deployed in 198 patients. Eight (4%) acute lower limb ischemia required urgent surgical repair. The device was removed in all cases. A thromboembolectomy was performed in five patients (62.5%) and in three (37.5%) an endarterectomy with patch closure was carried out (two saphenous vein and one Dacron). Limb salvage rate was 87.5%. We compared Angio-Seal complications group (A) with the 190 patients in which the Angio-Seal was successfully used without complications (group B) by means of Student's t-test. At 36-month follow-up with color-coded duplex ultrasounds, no chronic limb ischemia or other complications requiring surgical repair occurred. Diabetes, obesity, severe femoral atherosclerotic involvement, use of sheath size >7 Fr and time-consuming procedures were significant risk factors for ischemic APCD complications. Despite vascular injuries being uncommon after APCD deployment, generally a complex surgical repair is necessary. A more careful patient selection would be advisable.     

腹主动脉瘤腔内修复术中血管缝合器与手术切开缝合临床应用对比研究

目的 探讨Perclose Proglide血管缝合器在腹主动脉瘤腔内修复手术中的应用及意义。方法 回顾性分析2013年3月至2015年2月,首都医科大学附属安贞医院血管外科临床确诊腹主动脉瘤并实施腔内修复术的130例病人资料。术中采用穿刺股动脉方法建立入路并使用Perclose Proglide 血管缝合器缝合69例（A组）,手术切开股动脉并缝合61例（B组）。分析两组在缝合成功率、手术时间、术中出血量、住院时间、手术费用、伤口愈合情况、有无下肢缺血等因素,探讨Perclose Proglide 血管缝合器在腹主动脉瘤腔内修复手术中的应用效果。结果 在130例病人中,与手术切开组（B组）相比,使用缝合器组（A组）手术时间更短、术中出血量少、且住院时间较短,且差异均有统计学意义（P<0.05）。结论 在腹主动脉瘤腔内修复手术中,经皮穿刺建立股动脉入路并使用Perclose Proglide 血管缝合器处理穿刺点,该方法安全有效,且创伤小,病人术后恢复更快,值得推广使用。     

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 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.     

Midterm outcomes of femoral arteries after percutaneous endovascular aortic repair using the Preclose technique

OBJECTIVE: Percutaneous access during endovascular aortic repair has been shown to be feasible and safe using a suture-mediated closure device ("Preclose" technique) for closure of up to 24F introducer sheaths. The purpose of this study is to examine the late outcomes of those femoral arteries repaired in this manner. METHODS: The Preclose technique has been previously described. Briefly, the technique involves two Perclose Proglide devices deployed in the femoral artery prior to insertion of the large diameter introducer sheath and then closure of the arteriotomy by tying down knots of the Proglide following removal of the sheath. The medical records of all patients who underwent endovascular aortic repairs using the Preclose technique between December 2004 and August 2007 were reviewed. Follow-up protocol consisted of computed tomography (CT) angiograms performed at 1, 6, and 12 months, and annually thereafter. All Preclose patients who had at least a 6-month postoperative scan were included in the study. For each patient, the most recent postoperative scan was compared with the preoperative scan for evidence of any new anatomic abnormalities of the femoral artery such as dissection, stenosis, or pseudoaneurysm. Three-dimensional post processing with multiplanar reconstructions was also performed as necessary to confirm axial scan findings. RESULTS: A total of 292 patients underwent percutaneous endovascular aortic repairs (TEVAR-125, EVAR-167). Four hundred thirty-two femoral arteries were closed with 870 devices. Four hundred eighteen vessels were approximated with two devices, while 30 arteries required three devices for hemostasis and an additional four vessels only required a single device. Two hundred seventy-eight (64.3%) vessels were accessed with sheaths 18 to 24F. Four hundred eight femoral arteries (94.4%) were closed successfully with the Preclose technique. There were 100 patients (TEVAR-35, EVAR-65) who had adequate postoperative CT scan at 6-months or later. The mean follow up was 11.6 +/- 5.0 months. Of the 156 femoral arteries in these 100 patients repaired using the Preclose technique, there were 3 late complications in 3 patients, 1 asymptomatic femoral artery dissection, and 2 femoral artery pseudoaneurysms requiring surgical repair, resulting in a late complication rate of 1.92% (3/156). CONCLUSION: Percutaneous closure of femoral arteries after large diameter introducer sheaths using the Preclose technique has a low incidence of early and late complications related to the closure site.     

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、活化凝血时间、制动时间是Angio-Seal血管闭合器相关并发症的独立危险因素(OR值为2.087~14.005;P<0.05,P<0.01)。ROC曲线下面积为0.864,敏感性72.7%,特异性88.2%。决策曲线分析显示预测出血风险0.02~0.81区间进行决策干预具有临床获益。结论股动脉穿刺后采用Angio-Seal血管闭合器发生并发症的独立危险因素为高体重指数、较短制动时间等5项,构建的风险预测模型效能较好,可作为相应护理的参考。     

A rat femoral artery model for vasospasm

A new animal model for vasospasm using rat femoral artery has been developed. Whole blood, washed erythrocytes, or leukocytes in platelet-rich plasma were selectively applied to the adventitial surface of the femoral artery for 7 days in 15 rats, after which the vessels were perfusion-fixed and examined by light and transmission electron microscopy and immunohistochemistry. As compared with matched control arteries, there was a prominent reduction in luminal cross-sectional area after 7 days in vessels exposed to whole blood or washed erythrocytes, but not in those exposed to leukocytes in platelet-rich plasma. In arteries with luminal narrowing, light and transmission electron microscopy demonstrated marked morphological changes throughout the vessel wall similar to those seen in cerebral vasospasm after subarachnoid hemorrhage. Immunohistochemistry disclosed a prominent loss of immunoreactive actin in smooth muscle cells of arteries exposed to whole blood or erythrocytes. To assess the time course of arterial narrowing in this model, whole blood was selectively applied to the adventitial surface of femoral arteries in 23 rats for periods from 2 to 20 days. As compared with control arteries, arterial narrowing was variably present at 2 days, progressively increased by 5 days, was maximal at 7 to 10 days, and returned to near control levels by 20 days. The presence and severity of ultrastructural changes in vessel wall corresponded to the degree of arterial narrowing over time. These results suggest that chronic narrowing in rat femoral artery exposed to periadventitial blood is analogous to that observed in cerebral arterial vasospasm after subarachnoid hemorrhage. This new model represents a simple and reliable means to investigate pathogenic mechanisms and potential therapies for vasospasm.     

主动脉腔内修复术双Perclose ProGlide交叉缝合与传统缝合穿刺点的疗效比较

目的通过与传统缝合比较,探讨主动脉腔内修复术采用双Perclose ProGlide交叉缝合修复20F或22F穿刺点的优缺点,为临床穿刺点修复方法选择提供参考。方法 2007年6月-2011年5月,103例115侧采用外径为20F或22F输送鞘行主动脉腔内修复术,其中采用双Perclose ProGlide交叉缝合修复穿刺点57例64侧(双Perclose组),传统缝合修复46例51侧(传统缝合组)。两组患者年龄、性别、病程等一般资料比较,差异均无统计学意义(P>0.05),具有可比性。结果双Perclose组不同病种患者的手术时间、术中出血量、住院时间均明显优于传统缝合组(P<0.05)。术后双Perclose组5例(5侧)、传统缝合组2例(2侧)出现不同程度腹股沟区皮下瘀血;双Perclose组2例(2侧)皮肤穿刺点处淋巴漏,传统缝合组6例(8侧)切口发生淋巴漏。双Perclose组术后早期并发症发生率为7.8%(5/64),传统缝合组为15.7%(8/51),比较差异无统计学意义(χ2=1.76,P=0.19)。双Perclose组技术成功率为96.9%(62/64),传统缝合组为100%(51/51),差异无统计学意义(χ2=0.31,P=0.50)。两组患者术后均获随访,双Perclose组随访时间2～19个月,平均15个月;传统缝合组随访时间2～18个月,平均14个月。双Perclose组1例(1侧)术后3个月出现原穿刺点处假性动脉瘤,给予切开缝合;其余患者无缝合动脉狭窄、假性动脉瘤形成等中期并发症发生。双Perclose组中期并发症发生率为1.6%(1/64),传统缝合组为0,两组比较差异无统计学意义(P=1.000)。结论与传统缝合技术相比,双PercloseProGlide交叉缝合技术修复主动脉腔内修复术中20F或22F穿刺点疗效相似,但在控制手术时间、术中出血量及住院时间方面具有明显优势。     

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.     

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.     

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.     

完全穿刺技术在腹主动脉瘤腔内修复术中的应用

目的 探讨应用Perclose ProGlide缝合器完全穿刺技术行腹主动脉瘤腔内修复术的安全性和有效性.方法 2008年5月至2010年4月,36例腹主动脉瘤患者完全穿刺下行腔内修复术治疗.其中男性30例,女性6例;平均年龄68岁.所应用的支架型血管包括:3例Endurant,13例Talent,20例Zenith.18～24 F的鞘管预置两把ProGlide,14～16 F的鞘管预置单把ProGlide.缝合动脉切口时取出鞘管并将线结下滑收紧.统计技术成功率、相关并发症及手术操作时间.术后3、6、9、12个月及其后每年进行CT血管造影随访.结果 20例局部麻醉,16例全身麻醉.68条股动脉共应用128把ProGlide,其中38条股动脉各应用2把,8条各应用3把,2条各应用4把,20条各应用1把.63条股动脉(63/68,92.6%)技术操作成功,2条中转切开缝合,3条出现血肿,无需手术处理.平均随访时间(12±3)个月.1例于术后3个月出现无症状的动脉夹层.结论 完全穿刺技术在腹主动脉瘤腔内修复术中的应用是安全和有效的.由于可能需要切开缝合,建议在杂交手术室中操作.     

The use of the Angioseal device for femoral artery closure

BACKGROUND: As vascular surgeons perform increasing numbers of percutaneous catheter-based procedures, they will need to become familiar with varying methods of femoral artery closure. Few studies on closure devices have included significant numbers of patients with peripheral arterial disease. It is the purpose of this study to determine whether the Angioseal device (St. Jude Medical) is a satisfactory method of achieving femoral artery puncture site hemostasis in these patients. METHODS: The records of all patients undergoing Angioseal closure of femoral artery puncture by a single vascular surgeon were reviewed. Indication, type of intervention, and size of the vascular sheath employed were recorded. Times to mobilization and discharge were determined. Patients were seen before discharge and 1, 4, and 12 weeks after the procedure, and at 3- month intervals thereafter. Complications including hemorrhage, pseudoaneurysm, infection, and vessel occlusion were noted. RESULTS: Between February 1, 2002, and August 31, 2003, 220 Angioseal collagen plugs were deployed in 188 patients. Attempts were made to deploy Angioseal devices in 92% of patients undergoing percutaneous procedures during this time period. One hundred forty-four procedures were diagnostic and 74 procedures included 76 therapeutic interventions. One hundred forty-four 5F sheaths, 47 6F sheaths, and 29 7F sheaths were employed during the procedures. Time to mobilization and discharge was 58 +/- 19 minutes and 102 +/- 31 minutes in patients undergoing diagnostic studies, 68 +/- 22 minutes and 146 +/- 42 minutes following interventions using 6F sheaths, and 127 +/- 18 minutes and 219 +/- 37 minutes when interventions were performed using 7F sheaths. No patient developed a major hematoma or infection following the use of an Angioseal. There were 2 complications related to device deployment. One patient developed a 1.4-cm false aneurysm at the femoral artery puncture site that resolved spontaneously. A second patient required operation for vessel occlusion when an Angioseal was deployed in a markedly diseased femoral artery. These adverse events occurred early in our experience. CONCLUSIONS: The Angioseal provides a secure method of achieving hemostasis following femoral artery puncture. It is easy to deploy, has a high level of patient satisfaction, and allows for early ambulation and hospital discharge. When simple guidelines are observed, the device can be safely used in the great majority of patients with peripheral vascular disease. It offers considerable advantages over the traditional method of manual compression.