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.     

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.     

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.     

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.     

Angiographic access site complications in the era of arterial closure devices

Coronary and peripheral angiography is associated with a low but significant risk of access site complications. While percutaneous devices have been shown to permit more rapid puncture site closure, previous reports have suggested the incidence and severity of complications associated with these devices are greater than with manual compression. This study compares access site complications with and without closure devices in the current era. The authors conducted a retrospective review of patients with access site complications after coronary or peripheral angiography between 1998 and 2000. Forty-five complications requiring vascular surgical consultation were identified in the 4,800 procedures performed during this time period. Fourteen complications occurred in 1,536 procedures (0.9%) using suture-mediated or collagen devices and 31 occurred in 3,264 procedures without devices (0.9%). The types of procedures and catheter sizes (mean 7 Fr) used were not different in the 2 groups. Other than complications involving a retained device, there was no difference between device and manual compression with respect to incidence or types of complication,requirement for operation, type of operation, or outcome. Access site complications identified included pseudoaneurysm (n = 22; 49%), bleeding or hematoma (n = 8;18%), arteriovenous fistula (n=5;11%), arterial thrombosis (n = 4;9%), infection (n = 4;9%), and retained device (n = 2;4%). Twenty-four patients (71% vs 45%; p = NS) required operative intervention including pseudoaneurysm repair, hematoma drainage, and thrombectomy. Eleven patients (26%) underwent successful ultra-sound-guided pseudoaneurysm compression and 9 patients (21%) required no intervention. These data demonstrate that closure devices facilitate arterial puncture site repair without an increase in access site complications. These devices can be safely utilized when rapid hemostasis is desired after coronary or peripheral angiography.     

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。     

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 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.     

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.     

Arterial closure devices. A review

The use of arterial closure devices in achieving haemostasis following arterial puncture has become increasingly popular. This review aims to provide an overview of the currently available closure devices, with an up-to-date summary of the supporting literature. The various devices have their advantages and disadvantages as well as differing mechanisms of actions. Technical aspects of deployment affect the learning curve and ease of use of individual devices. Some complications that arise are device specific where others are related to arterial punctures in general. When choosing a device, all these factors should be taken into account as well as differing clinical requirements and priorities. Most studies of arterial closure devices that are currently in use conclude that the safety profile of closure devices is comparable to manual compression. The literature does not show superiority of any particular device. Caution is advised in extrapolating evidence based on differing patient groups, as many of the study populations are heterogeneous. As physicians become more familiar with the use of closure devices, off-label applications of some devices have emerged, some of which need further evaluation. The ideal closure device should reduce complication rates compared to manual compression, be easy to use with a short learning curve, and have a high rate of deployment success. It should also be usable across a wide range of sheath sizes, not leave any permanent foreign body behind, reduce time to haemostasis and ambulation, allow immediate repuncture, improve patient comfort and be cost effective. In spite of the wide range of devices currently available there remains room for improvement.     

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.     

Infectious complications resulting from use of hemostatic puncture closure devices

BACKGROUND: Femoral access site complications have increased as the fields of invasive cardiology, radiology, and endovascular surgery have emerged. In order to address one of these complications, hemorrhage, the hemostatic puncture closure devices were developed. METHODS: Retrospective review of cardiac catheterizations performed at a single institution to investigate infectious groin complications related to use of the Perclose Prostar and Techstar devices. RESULTS: Infectious groin complications were significantly higher in the Perclose group as compared with manual compression. Three patients had clinical and laboratory evidence of arterial infection whereas 2 had soft tissue infections. All 5 required operative intervention ranging from incision and drainage to arterial reconstruction. Hemorrhagic complications were not significantly different between the two groups. CONCLUSIONS: The Perclose devices provide hemostasis after femoral artery catheterization similar to manual compression. However, infectious groin complications appear to be more common with these devices.     

Closure of carotid artery puncture site with a percutaneous device

The surgical treatment of traumatic neck injuries in patients with hostile anatomy is associated with higher risk of complications, due to the technical challenge and associated clinical conditions. The use of a percutaneous closure device for removal of a 7.5 Fr sheath, nonintentionally implanted into the carotid artery, is reported. The right common carotid sheath was removed after introducing a 0.035-inch guidewire; the Angioseal 8 Fr device was then introduced over the wire, successfully sealing the puncture site. Duplex scan control showed patency of the carotids, sealing of the puncture, and adequate flow in the jugular vein and carotid arteries. This maneuver allowed the safe placement of a percutaneous arterial device (Angioseal) to close the puncture site.     

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.     

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.     

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.     

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.     

Surgical management of complications after transcatheter closure of an atrial septal defect or patent foramen ovale

OBJECTIVE: During recent years, transcatheter closure has become an alternative to operations for the treatment of atrial septal defects and patent foramen ovale. However, this procedure may be unsuccessful or complicated and requires surgical treatment. METHODS: We retrospectively analyzed the outcomes of patients who needed surgical treatment after failed or complicated transcatheter closure of an atrial septal defect or a patent foramen ovale. RESULTS: Between April 1994 and March 1999, 124 patients were treated with transcatheter closure of an atrial septal defect or a patent foramen ovale at our institution. We report the results of 10 (8%) patients of this series who required operations after transcatheter closure attempts. In 8 of these 10 patients a significant shunt caused by malposition or dislocation of the device persisted, leading to surgical closure of the defect. In 2 patients injury of the femoral artery at the puncture site required surgical repair. In one patient the device had to be removed surgically from the iliac vein after retraction. One patient died of left ventricular perforation after dislocation of the device and several surgical attempts to close the left ventricular rupture. All other patients recovered well. CONCLUSION: An operation was required after transcatheter closure of an atrial septal defect or a patent foramen ovale in 8% of patients. After device complications, the atrial septal defect and the patent foramen ovale can still successfully be closed surgically with good results and low morbidity. However, serious complications like cardiac perforation may have a fatal outcome. Residual shunt, dislocation, or vascular complications are the most frequent problems that require surgical interventions.