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.     

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.     

Femoral endarteritis associated with percutaneous suture closure: new technology,challenging complications

OBJECTIVE: Use of percutaneous suture closure devices after catheter-based interventions is increasing. We recently have seen several severe femoral arterial wall infections after use of such devices. The purpose of this study was to examine the incidence, comorbid associations, and management of femoral arterial infections associated with percutaneous suture closure devices. METHODS: We retrospectively reviewed all infectious complications that occurred after 2223 consecutive cardiac catheterization procedures performed over 12 months in a university-affiliated community teaching hospital. Outcome variables included demographics, procedural details, infection, type of arterial reconstruction required, mortality, and limb loss. RESULTS: During this study, 822 patients received percutaneous suture devices. Infection developed in 6 patients (0.7%). The incidence of diabetes in the population undergoing percutaneous suture closure was 219 of 822 patients (26.6%). Three comorbid conditions, noted in multiple patients with infectious complications, included diabetes mellitus, obesity, and placement of a percutaneous suture closure device within the past 6 months. Invasive femoral endarteritis developed in 4 patients. Gram-positive cocci predominated in 4 patients. In 1 patient with polymicrobial infection catastrophic complications developed, including multiple anastomotic ruptures and hemorrhage. A new method of repair that incorporated double-thickness everted saphenous vein was used in 2 patients, and safe arterial closure was achieved. There was 1 late fatality on postoperative day 36. Limb salvage was achieved in all patients. CONCLUSIONS: Femoral endarteritis complicating percutaneous suture closure is a challenging new problem for vascular surgeons and can result in catastrophic complications. Customary techniques that use saphenous vein patch or interposition grafting are not adequate in all circumstances. Successful outcome requires operative exploration in patients with suspected infection. Removal of the percutaneous suture closure device and debridement to normal arterial wall is recommended in all patients with suspected femoral endarteritis, based on positive intraoperative Gram stains or abnormal appearance of the adjacent femoral artery. Early success with an autologous bolstered repair is reported. Caution is advised when considering the use of a percutaneous suture closure device in patients with comorbid conditions including diabetes, obesity, and previously implanted devices.     

Changing patterns of access site complications with the use of percutaneous closure devices.

The authors report their experience with 15 cases of groin complications associated with the use of percutaneous closure devices following femoral arterial catheterization over a 2-year period. The complication rate was 1.7% for catheterizations in which a closure device was used. The 15 cases included 7 uncomplicated pseudoaneurysms (PSA), 3 infected pseudoaneurysms, 4 nonarterial groin infections (infected hematomas and/or abscesses), and 1 case of femoral artery occlusion. These complications presented at an average of 5 +/- 4 days postcatheterization. One patient with an infected PSA required a below-the-knee amputation. During the same time interval, there were no infectious complications in patients not receiving closure devices. We conclude that groin complications associated with such devices tend to present late and include a higher percentage of infections as opposed to complications occurring in patients not receiving closure devices. An aggressive surgical approach to these problems appears warranted.     

Percutaneous Zenith endografting for abdominal aortic aneurysms

A completely percutaneous approach to infrarenal abdominal aortic aneurysm (AAA) endografting has the theoretic benefits of being minimally invasive and more expedient. Our goal was to demonstrate the utility of this approach using a suprarenal fixation device and a suture-mediated closure system. We conducted a single-institution, retrospective review of 14 patients who underwent percutaneous AAA repair with the Zenith device between August 2003 and March 2007. Immediate and delayed access-related outcomes were examined over a mean follow-up of 12.1+/-2.0 months. Mean AAA size was 5.6 cm. Immediate arterial closure and technical success rate was 96% (27/28 vessels). One immediate hemostatic failure required open surgical repair. Over follow-up, one vessel required operative repair for new-onset claudication. No other immediate or delayed complications (thrombosis, pseudoaneurysm, infection, or deep venous thrombosis) were detected. A percutaneous approach for the treatment of AAA has several advantages over femoral artery cutdown but also has its own unique set of risks in the immediate and late postoperative period. Ultimately, the "preclose technique" can be safely applied for the Zenith device despite its large-bore delivery system.     

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.     

Percutaneous closure devices for endovascular repair of infrarenal abdominal aortic aneurysms: a prospective, non-randomized comparative study.

PURPOSE: This study was designed to describe and evaluate our preliminary results with a percutaneous arterial closure device as compared to those obtained with conventional femoral surgical cut down during endovascular repair of abdominal aortic aneurysms (AAA). MATERIAL AND METHODS: Between January 2004 and December 2006, 40 of 86 AAA patients selected for endovascular repair met the criteria for inclusion in this study. Nineteen of these patients (Group A) received a bifurcated endograft placed by direct puncture of the femoral arteries (38 femoral triangles) with closure by a Prostar((R)) percutaneous arterial closure device (Abbott). The other 21 patients (control group B) were managed with a bifurcated endograft placed by conventional open surgery (42 femoral triangles). Data concerning all 40 patients were collected prospectively and analyzed. RESULTS: The technical success rate was 92% (group A) vs 90% (group B), P=0.79. The incidence of perioperative complications was 16% (3/19) in group A and 14% (3/21) in group B (P=0.89). The mean hospital stay was 5.8 days in group A and 7.8 days in group B (P=0.05). The difference in the length of hospitalisation was associated with reduced cost for the percutaneous group (5579.60 euros vs. 7503.60 euros; P=0.04), that counterbalanced the cost induced by the Prostar XL((R)) suture mediated device. Mean follow-up in both groups was 12 months. The overall incidence of locoregional complications after one year of follow-up was 11% (2/19) in group A and 19% (4/21) in group B (P=0.45). CONCLUSION: This study confirms the feasibility and safety of total percutaneous endovascular AAA repair. Our preliminary results suggest that the costs paid by healthcare providers for endovascular AAA repair might not be increased with the selective use of percutaneous closure 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、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。     

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.     

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.     

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 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.     

Iatrogenic vascular injuries from percutaneous vascular suturing devices

OBJECTIVE: The purpose of this study was to examine the patterns of injury and the strategies of surgical repair of iatrogenic vascular injuries from a percutaneous vascular suturing device after arterial cannulation. METHODS: We retrospectively reviewed the clinical experience from an academic vascular surgical practice over a 2-year period. The subjects were patients undergoing vascular repair of iatrogenic vascular injury after deployment of a percutaneous vascular suturing device. Interventions were direct repair of arterial injury (with or without device extraction) or arterial thrombectomy and repair. The main outcome variables included patterns of arterial injury, magnitude of arterial repair, limb salvage, hospital stay, and perioperative mortality and morbidity rates. RESULTS: From August 1998 through August 2000, eight patients (4 men, 4 women; median age, 55 years; range, 44-80 years) required vascular operations for complications of percutaneous suturing devices after diagnostic (2) or therapeutic (6) arteriograms through a transfemoral approach. Complications included four pseudoaneurysms (1 infected) due to arterial tear from suture pull through, two entrapped closure devices due to device malfunction, and two arterial thromboses due to narrowing/severe intimal dissection. All patients required operative intervention. Direct suture repair with or without device removal was performed in five patients, arterial debridement with vein patch angioplasty in one patient, and arterial thrombectomy and vein patch angioplasty in two patients. There were no perioperative deaths. The median hospital stay was 5 days (range, 2-33). Limbs were salvaged in all patients with a mean follow-up of 4.8 months (range, 1-13). CONCLUSIONS: Although abbreviated postangiography recovery periods and early ambulation have motivated the widespread use of percutaneous suturing devices, the infrequent occurrence of vascular injuries produced by these devices can be significantly more challenging than simple acute pseudoaneurysms or hemorrhage. In addition, thrombotic complications have a small but finite risk of limb loss.     

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.     

Ischemic complications of percutaneous femoral artery catheterization

Ischemic injuries following percutaneous femoral artery catheterization are uncommon but have been associated with vascular closure devices (VCDs). The purpose of this study was to retrospectively compare ischemic and hemorrhagic complications of femoral artery catheterization and to identify factors associated with ischemic injuries. The operative registries of the attending vascular surgeons at one academic and two community hospitals were retrospectively reviewed to identify all complications of femoral artery catheterization requiring operative intervention. Demographic, clinical, procedural, operative, and outcome data were compared between patients who sustained ischemic and hemorrhagic complications. From January 2001 to December 2006, 95 patients required operative management of complications related to femoral artery catheterization including 40 patients who experienced ischemic (group 1) and 55 patients who experienced hemorrhagic (group 2) complications. Compared to those sustaining hemorrhagic complications, ischemic complications were more frequently associated with younger age, smoking, VCD deployment, and, when controlling for VCD use, female gender. Time to presentation was also significantly longer in patients experiencing ischemic complications. Ischemic complications are increasingly recognized following femoral artery catheterization. Vascular surgeons should anticipate a new pattern of injury following femoral artery catheterization, one that often requires complex arterial reconstruction.     

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.     

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.     

Selective non-operative management of pseudoaneurysms and arteriovenous fistulae complicating femoral artery catheterization.

Femoral arterial pseudoaneurysms or arteriovenous fistulae may sometimes complicate percutaneous femoral artery catheterization procedures. Most surgeons recommend prompt operative repair because of the unfavorable natural history of pseudoaneurysms or arteriovenous fistulae secondary to violent or accidental arterial trauma. However, the natural history of catheterization-induced pseudoaneurysms and arteriovenous fistulae has not been well documented. Accordingly, we prospectively studied the natural history of 22 pseudoaneurysms, 8 arteriovenous fistulae, and 3 combined lesions, identified by duplex scan in 32 patients following trans-femoral cardiac, peripheral vascular, or vascular access arterial catheterization procedures. Angiographic procedures were performed with the use of 5-8F introducer sheaths. A femoral artery complication was significantly more likely to result from coronary balloon angioplasty (9/304; 3.0%) than from diagnostic cardiac catheterization (21/2476; 0.8%) (p less than 0.003; chi square). Fourteen patients (13 pseudoaneurysms, 1 combined pseudoaneurysm/fistulae) underwent surgical repair. Pain and/or enlarging hematoma resulted in repair within two days of the diagnosis in 8 patients. The need for chronic anticoagulation prompted elective repair in 2 patients. A pseudoaneurysm was repaired in one patient five days following catheterization when it became painful. In three stable patients, asymptomatic pseudoaneurysms were repaired electively during another surgical procedure. There were no operative deaths. One patients (7%) developed a wound infection postoperatively. Eighteen patients (19 arterial lesions: 9 pseudoaneurysms, 8 arteriovenous fistulae, 2 combined pseudoaneurysms/arteriovenous fistulae) with improving symptoms and stable physical signs were followed by serial clinical evaluation and duplex scans. Seventeen of 19 (89%) of these lesions resolved spontaneously within 5-90 days (mean 30.7 days).(ABSTRACT TRUNCATED AT 250 WORDS)     

Femoral artery infections associated with percutaneous arterial closure devices

Hemostasis obtained by manual compression after femoral artery catheterization results in consistently low rates of major complications. A rare complication of femoral artery catheterization is arterial infection. Its occurrence after diagnostic angiography using manual compression has not been reported. We report two cases of femoral arterial infection after uneventful diagnostic catheterization in nonimmunocompromised patients using the Perclose percutaneous arterial closure device. Our cases are representative of Perclose associated infections, with delayed presentation of a staphylococcal arterial infection requiring arterial debridement and reconstruction. This article indicates that Perclose use carries a risk of severe arterial infection. Surgeons should be aware of the potential infectious complications associated with Perclose use and the need for aggressive treatment.