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.     

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.     

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.     

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.     

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.     

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.     

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.     

Arterial access site closure with a novel sealing device: Duett.

Management of arterial access sites following percutaneous endovascular procedures is associated with patient discomfort and local complications. A new vascular sealing device, comprised of a balloon delivery catheter and a flowable procoagulant consisting of thrombin and collagen, was tested. Immediately following catheterization 200 patients (age, 66.1 +/- 11.2 years) were treated with the sealing device (Duett). Of these 200 patients, 132 underwent diagnostic catheterization, 67 underwent percutaneous transluminal coronary angioplasty, and one underwent percutaneous transluminal angioplasty. The sheath sizes included 2-5 Fr, 166-6 Fr, 25-7 Fr and 7-8 Fr. All patients undergoing diagnostic procedures received at least 5,000 U of intravenous heparin during the procedure. The Duett was used successfully in 198/200 (99%) patients immediately following completion of the endovascular procedure. In two patients a device malfunction resulted in uncomplicated crossover to manual compression. The time to hemostasis ranged from 3 to 5 minutes. All patients were walking 2 to 5 hours following the procedure unless a complication had occurred. No patient experienced leg ischemia, required surgical repair of the arterial access site, or had an infection at the site. In three patients (1.5%), a pseudoaneurysm occurred and was successfully treated with ultrasound-guided compression and three patients received a blood transfusion. No late complications were observed following hospital discharge. This novel vascular sealing device successfully achieves rapid hemostasis and allows early ambulation following percutaneous endovascular procedures with a low incidence of complications.     

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 utility of the StarClose arterial closure device in patients with peripheral arterial disease

The StarClose (Abbott Vascular, Redwood City, CA) arterial closure device utilizes an extraluminal nitinol clip to establish hemostasis. The purpose of this study was to determine the safety and efficacy of StarClose from a prospective peripheral arterial disease (PAD) registry. Over an 18-month time interval, 500 StarClose devices were used in 378 consecutive patients with symptomatic PAD after diagnostic and/or therapeutic endovascular cases. Patient demographics along with objective criteria including duplex ultrasound images, common femoral artery flow velocities, and ankle-brachial indexes (ABIs) were analyzed before and after StarClose placement. All outpatients received prophylactic antibiotic (one dose), periprocedural heparin (without protamine reversal), and antiplatelet therapy. Aspirin and clopidogrel (Plavix) was used for all patients undergoing therapeutic intervention. There were 378 patients who underwent procedures for aortoiliac or infrainguinal PAD, 99 of which were bilateral. Of the 500 arteriotomy closures, 296 were therapeutic interventions with sheath sizes of 6-8 F in the common femoral artery. The diagnostic studies (n = 204 arteriotomies) were performed with a 5F sheath. The technical success in achieving hemostasis was 97.2%; only 14 devices had a deployment problem requiring prolonged manual compression. Median length of stay was 157 min for patients done on an outpatient basis. Eleven of 260 (4.2%) on duplex follow-up had a doubling of the peak systolic velocity, only one of which was symptomatic. Late follow-up showed 42 of 360 (11.7%) with a drop in ABI >0.10. Nine major complications (2.0%) were identified in follow-up. The StarClose closure device has a low major complication rate and is safe and efficacious in patients with PAD, although stenosis at the arteriotomy site may occur. The device has achieved rapid hemostasis without need for anticoagulant reversal and requires significantly less time to ambulation than manual compression.     

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.     

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。     

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.     

Acute Leg Ischemia: The Dark Side of a Percutaneous Femoral Artery Closure Device

The use of femoral artery closure devices to obtain hemostasis after percutaneous catheterization has become widespread because of their proven feasibility in combination with patient-related advantages. Since 2002 more than 6,500 patients have undergone either diagnostic angiography or therapeutic intervention via the femoral route with an Angioseal closure device in our hospital. We were faced with six cases of limb-threatening complications, which are described here. Most (5/6) complications were of obstructive origin due to traumatic dissection or occlusion of the artery mainly caused by malpositioning of the device. Recommendations are made in order to prevent or successfully overcome this certainly increasing problem in the vascular field.     

Posterior wall capture and resultant common femoral occlusion complicating StarClose access closure

Vascular closure devices have been shown to decrease hemostasis and ambulation time after percutaneous transcatheter procedures. The StarClose Vascular Closure System (Abbott Vascular, Redwood City, Calif) is a shape memory clip-mediated device that is designed to provide extraluminal mechanical closure without compromising the arterial lumen. We report a case of iatrogenic arterial occlusion secondary to mechanical closure of the anterior and posterior walls of the common femoral artery with a StarClose device. We provide objective observations from the rescue surgical intervention and discuss potential mechanisms of device failure.     

Gamma radiation induces positive vascular remodeling after balloon angioplasty: a prospective,randomized intravascular ultrasound scan study

BACKGROUND: Endovascular brachytherapy (EBT) has been shown to prevent restenosis after percutaneous transluminal coronary angioplasty (PTA) in both animal and clinical studies. However, as yet, the effect of EBT on peripheral arteries is unknown. OBJECTIVE: This intravascular ultrasound scan (IVUS) study evaluates the effect of EBT on the extent of plaque growth and vascular remodeling after PTA of the femoropopliteal artery. METHODS: Twenty-four patients with obstructive disease of the femoropopliteal artery underwent standard PTA. Patients were randomized to receive no additional therapy or additional EBT (192-Iridium) after PTA. IVUS investigation was performed after PTA and at 6-month follow-up. A comparison was made between patients without EBT (n = 16) and with EBT (n = 8) in the change in lumen, vessel, and plaque area and plaque dissections seen with IVUS at 6-month follow-up. RESULTS: At follow-up, IVUS revealed a significant difference in lumen area change between patients without and with EBT (-9% and +23%, respectively; P =.03). This difference was the result of a significant difference in vessel area change (+2% and +19%, respectively; P =.05). In both groups of patients, a similar increase in plaque area (+12% and +16%, respectively; P =.80) was encountered. Plaque dissections encountered immediately after PTA were absent at follow-up in patients without EBT, whereas in four of the eight patients with EBT, a persistent dissection was encountered. CONCLUSION: This randomized IVUS study showed that gamma-radiation after PTA has a positive effect on lumen dimensions at 6-month follow-up by inducing positive vascular remodeling (ie, vascular dilatation); gamma-radiation seemed not to affect plaque growth. In addition, gamma-radiation has an effect on the healing process of dissections after PTA.     

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。     

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.     

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.