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.     

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.     

The use of arterial closure devices for incidental arterial injury

Incidental arterial injury is one of the main mechanical complications associated with central venous catheter placement. These injuries can result in significant morbidity and mortality. The use of arterial closure devices to repair these injuries offers a less invasive alternative than open repair and a safer approach than manual compression. We present 3 cases of critically ill patients treated with arterial closure devices when attempted central venous catheterization failed and inadvertent arterial cannulation occurred. A brief review of the various closure devices and there indications is discussed.     

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.     

经皮冠状动脉介入治疗后血管缝合器 应用的方法学探讨

目的探讨缝合器止血的合理使用方法，提高操作成功率。方法使用美国ABOTT公司生产的percloser血管缝合器，对80例冠脉介入治疗后患者血管穿刺部位进行缝合止血，观察股动脉不同穿刺部位、多次介入治疗的股动脉以及股动脉造影的投照角度选择对缝合效果的影响。结果80例患者中76例缝合成功，成功率97．37％，2例失败，2例放弃缝合术。两种造影角度中，选择后前位法造影血管分支重叠64例(重叠率80％)，右前斜30。投照角度血管重叠8例(重叠率10％)。腹股沟上位点穿刺法50例，成功缝合49例，1例失败；腹股沟下位点缝合法30例，成功缝合27例，1例失败，2例放弃缝合术。结论应用percloser缝合器止血是一种安全有效的方法。观察穿刺部位的血管解剖关系时，右前斜30。可作为常规投照角度，穿刺点可优先选择腹股沟韧带上穿刺位点，其次选择腹股沟韧带下穿刺位点，对多次进行过介入治疗的股动脉不宜在重复部位行缝合治疗。     

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.     

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.     

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 management of peripheral vascular complications associated with the use of percutaneous suture-mediated closure devices

PURPOSE: The purpose of this study is to identify the peripheral vascular complications associated with the use of percutaneous suture-mediated closure (PSMC) devices and compare them with postcatheterization femoral artery complications not associated with PSMC devices. METHODS: This is a retrospective review of all patients admitted to the vascular surgery service at the Chattanooga Unit of the University of Tennessee Department of Surgery with a peripheral vascular complication after percutaneous femoral arteriotomy between July 1, 1998, and December 1, 1999. The complications followed the use of PSMC devices (group I, n = 11) and traditional compression therapy (group II, n = 14) to achieve arterial hemostasis. Group II was subdivided into patients who required operative intervention (group IIA, n = 8), and those who were treated without operation (group IIB, n = 6). RESULTS: No significant difference was found between groups I and II with regard to age (P =.227), time to vascular surgery consultation (P =.987), or diagnostic versus therapeutic catheterization (P =.897). A significant difference was found with regard to mean pseudoaneurysm size (group I = 5.9 cm, group II 2.9 cm; P =.003). Ultrasound compression was successfully performed in 66.6% of group II patients, but no (0.0%) patient in group I responded to this therapy (P =.016). Groups I and IIA had a significant difference for mean estimated blood loss (group I = 377.2 mL, group II = 121.8 mL; P =.017) and requirement for transfusion (P =.013). More patients in group I required extensive surgical treatment (P =.007), with six of these patients requiring vein patch angioplasty during their treatment. More patients in group I also had infectious complications (n = 3) compared with group IIA (n = 1). CONCLUSION: In comparison with complications that follow percutaneous arteriotomy when PSMC devices are not used for hemostasis: (1) pseudoaneurysms after the use of PSMC devices are larger and do not respond to ultrasound compression, (2) complications associated with PSMC devices result in more blood loss and increased need for transfusion and are more likely to require extensive operative procedures, and (3) arterial infections after the use of PSMC devices are more common and require aggressive surgical management.     

Decreased ischemic complications after endovascular aortic aneurysm repair with newer devices

Ischemic complications after endovascular abdominal aortic aneurysm repair (EVAR) are well-recognized and have been reported to be as high as 9%. The goal of our study was to examine the incidence, management, and outcome of ischemic complications at our institution after EVAR and to compare complications according to graft type and time period. This is a retrospective review of all EVARs performed at our institution from 1993 through 2005 (n = 430). EVAR was performed in asymptomatic patients in most cases. Follow-up consisted of a computed tomography scan and office visit at 1, 6, and 12 months and yearly thereafter. Ischemic complications after EVAR have decreased significantly with the advent of lower-profile devices with easier delivery systems and supported limbs. Simultaneous coil embolization of internal iliac artery at the time of EVAR implant does not appear to increase the risk of pelvic or lower-extremity ischemia, can be done safely, and does not need to be staged.     

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.     

Improved limb salvage after arterial embolectomy.

Between January 1965 and August 1977, 122 patients with 135 arterial emboli were treated on the Peripheral Vascular Service at the Ohio State University Hospital. The heart was the source of the embolus in 94 patients (77%), one-third of whom had experienced a myocardial infarct. Thirteen patients died after the operation, which in 102 patients (84%) consisted of embolectomy only, making the hospital mortality 10.6%. Fourteen patients (11.5%) required subsequent amputations during the same hospitalization or on a later admission. The corrected limb salvage rate of 80.9% was unrelated to the length of delay in presentation. Although only 70 patients (57.4%) had palpable distal pulses following operation, 89 (73%) had a functional limb at the time of discharge or on later follow-up. An aggressive approach to the patient with an arterial embolus, regardless of the duration of symptoms, is urged. Embolectomy under local anesthesia is advocated in all cases after prompt correction of fluid and electrolyte imbalance and stabilization of the underlying cardiac disorder, except in patients with frank gangrene and irreversible rigor. In the absence of distal pulses or obvious revascularization, an intraoperative arteriogram is mandatory.     

Arteriovenous fistula in arterial reconstruction of the ischemic limb

The high flow associated with an arteriovenous fistula has been shown to help maintain patency in small arterial anastomoses. In 37 male patients we created common ostium arteriovenous fistula at the distal tibial or peroneal anastomosis as a part of their arterial reconstruction for threatened limb loss. Limb salvage was achieved in 28. Successful amputations at a lower level than would have been anticipated were performed in three. There was early graft failure in four patients resulting in below-the-knee amputations. This operative approach may be helpful in patients who have had previous revascularization procedures that have failed, who resist the idea of amputation, and who fulfill the angiographic criteria of extremely poor runoff with an absent or deficient pedal arch.     

Neonatal arterial occlusion with ischemic limb gangrene

Arterial occlusion in the extremity of a neonate is a rare event of obscure etiology. The diagnosis implies an urgent situation which may result in extremity gangrene and ultimate loss of limb. In contrast, early diagnosis and appropriate management should result in preservation of a normal limb. The key to successful management appears to be an awareness of this common clinical condition in an uncommon clinical setting.