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.     

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.     

Management of Vascular Complications following Femoral Artery Catheterization with and without Percutaneous Arterial Closure Devices

Percutaneous arterial closure devices allow earlier mobilization and discharge of patients after arterial catheterization than with manual compression for puncture site hemostasis. We reviewed our recent experience managing the complications of femoral artery catheterization with and without these devices on the vascular surgery service at a tertiary hospital. Thirty-one patients presenting over an 18-month period with complications after femoral artery catheterization with manual compression (n = 21) or percutaneous arterial closure devices (n = 10) were retrospectively reviewed.     

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.     

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 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.     

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.     

Histologic and duplex comparison of the perclose and angio-seal percutaneous closure devices

The intravascular and extravascular effects of percutaneous closure devices have not been well studied. We assessed the performance and healing characteristics in dogs of two devices approved by the US Food and Drug Administration. Nine adult male dogs were anesthesized prior to percutaneous access of both femoral arteries with a 6F sheath. All dogs were systemically heparinized to an activated clotting time (ACT) > 250 seconds. Duplex sonography was performed preoperatively to measure vessel diameter and flow velocity. In each dog, one of two devices (Perclose, Abbot Laboratories, Abbott Park, IL or Angio-Seal, St. Jude Medical, St. Paul, MN) was randomly deployed into one of the two femoral arteries. The other device was deployed on the opposite side. Duplex sonography was repeated immediately after deployment and 28 days later to measure changes in vessel diameter and flow velocity. At 28 days, angiography was performed on both femoral arteries before they were removed for histologic evaluation. The time required to excise each vessel reflected the degree of scarring. Hemostasis time for the Angio-Seal device far surpassed the Perclose device (39 +/- 7 vs 0 minutes; p < .05). Vessel narrowing was observed only at 28 days after deployment of the Angio-Seal device (p < .05). Extensive extravascular scarring was observed with the Angio-Seal device, which resulted in a longer femoral artery dissection time and greater periadventitial scar thickness compared with the Perclose device (p < .05). When compared with the Perclose suture closure device, the Angio-Seal collagen plug closure device prolonged hemostasis time and produced greater vessel narrowing and periadventitial inflammation (extravascular scarring) in a canine model at 4 weeks.     

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.     

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、...     

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。     

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.     

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.     

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.     

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.     

模拟器训练在实施股动脉穿刺点ExoSealTM封堵止血系统操作的多中心对照研究

背景与目的：介入手术已成为血管外科的主要治疗手段,对于手术直接相关的股动脉穿刺点封堵处理是手术操作收尾的一个重要环节。鉴于国内外目前尚缺乏关于封堵止血系统模拟器训练应用效果的高级别证据,本研究旨在评估模拟器训练在实施股动脉穿刺点ExoSealTM封堵止血系统操作的临床应用效果以及在血管介入操作基础教学培训中的应用价值。 方法：采用前瞻性对照设计,选择2020年5月—2020年10月7个中心的8名血管介入医师分别用两种不同方式进行封堵操作培训。4名血管介入医师通过阅读ExoSealTM说明书和观看视频进行培训（对照组）,另4名血管介入医师的培训方式为在前者基础上增加专业人员指导下的模拟器使用（研究组）。培训结束后,在主诊医师监管下,每名医师对接受血管介入手术,并在股总动脉使用6 F鞘管的患者,采用ExoSealTM封堵止血系统对穿刺点进行封堵。两组医师各操作50例患者,比较两组的操作时间、出血量、器械成功率、股动脉栓塞发生率、二次干预率、24 h内发生血肿率。 结果：研究组在ExoSealTM封堵止血系统操作中,所需的操作时间和出血量均少于对照组（24.50 s vs. 30.00 s,P=0.003;8.60 mL vs. 11.22 mL,P=0.019）。研究组的器械成功率（98.0%）高于对照组（96.0%）,但差异无统计学意义（P=0.558）。两组均无动脉栓塞、二次干预和24 h内发生血肿情况。 结论：ExoSealTM封堵止血系统模拟器的训练能够提高股动脉封堵的安全性和有效性。该模拟器的训练应常规用于血管介入操作的基础教学培训中。     

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.     

The use of a percutaneous closure device for closure of an accidental puncture of the aortic arch; a simple solution for a difficult problem.

Percutaneous closure devices are now often used for closure of the femoral puncture site after percutaneous vascular interventions. We describe a case were an accidental puncture in the aortic arch during placement of a central venous catheter is successfully closed with a closure device.     

血管闭合器研究进展

血管闭合器是用于经皮穿刺动脉后穿刺点止血的医疗器械,按照其原理主要分为主动血管闭合器和被动血管闭合器。本文针对常用血管闭合器的原理、适用范围及优缺点等进行综述。