Arterial Closure Devices Research Articles

Distal Embolism of Percutaneous Arterial Closure Device Resulting in Critical Limb Ischemia

Distal Embolism of Percutaneous Arterial Closure Device Resulting in Critical Limb Ischemia

Predictors of Complications Following Sheath Removal With Percutaneous Coronary Intervention

Complex antiplatelet and antithrombotic regimens used in conjunction with percutaneous coronary intervention may increase the risk of vascular complications. The purpose of this study was to examine predictors of vascular complications following sheath removal for percutaneous coronary intervention. This prospective cohort study enrolled 413 patients during a 7-month period. Data elements were collected by chart abstraction. Practice variable included pharmacological agents and method and duration of sheath removal procedure. Patient outcomes included hematoma formation, bleeding occurrence, pseudoaneurysm prevalence, incidence of arteriovenous fistula formation, and thrombosis. Of the 413 patients, 68 (16.5%) had a complication. Sixty-four (15.5%) developed hematomas ranging in size from 1 to 5 cm (n = 35, 8.5%) to greater than 5 cm (n = 29, 7.0%), 6 experienced bleeding (1.5%), 4 (1%) had arteriovenous fistulas, and 3 (0.7%) developed pseudoaneurysms. There were no significant differences for complications using manual, C-clamp, or arterial vascular closure device. Patients with a higher systolic blood pressure (135 vs 129; df = 410, P = .025) and of older age (66 vs 63; df = 411, P = .016) were significantly more likely to have complications. Clinically significant major vascular complications were low. Arterial closure devices, mechanical C-clamp, and manual compression all provide low and comparable complication risks following sheath removal in the era of antiplatelet and antithrombotic therapies. Patients who are older and those with elevated blood pressure should have their femoral access site closely monitored and be observed for vascular complications.

The Cost of Closure

The article by McTaggart et al[1][1] in this issue of American Journal of Neuroradiology nicely highlights the use of arterial closure devices by neuroradiologists. Arterial closure devices are now a $500 million per year industry, with such devices being used in some 30%–40% of femoral artery

Hemostatic efficacy of chitosan-based bandage for closure of percutaneous arterial access sites: An experimental study in heparinized sheep model

BackgroundMost of the presently used percutaneous arterial closure devices (PACD) for hemostasis after interventional vascular procedures are effective, but carry risk of complications by deposition of a foreign body. A new promising externally applied PACD – chitosan-based HemCon Bandage (HCB) was explored in sheep. The HCB hemostatic efficacy and complications occurring with its use were compared to those with the standard manual compression (SMC).Material and methodsBoth superficial femoral arteries (SFA) of 9 heparinized sheep were catheterized with an 8F sheath for 5 minutes. After the sheath withdrawal, hemostasis with the HCB was compared with hemostasis achieved with SMC in the contralateral SFA. Iliac angiograms performed by carotid artery approach determined the hemostasis time.ResultsThe HCB use shortened time to hemostasis with a mean time of 6.9 ± 3.9 minutes versus 10.8 ± 2.8 minutes for the SMC (P-value 0.019). Seven SFAs in the HCB group and only 1 SFA in the SMC group exhibited hemostasis in 5 minutes. All nine SFAs using the HCB showed femoral artery patency and demonstrated less hematoma (2/9) than in the SMC group (8/9). No complications developed in the HCB group, one SFA occlusion was seen in the SMC group.ConclusionsThe externally applied HCB in heparinized sheep was safe and effective. It significantly shortened time to hemostasis at the SFA access sites following 8F sheath removal. Proper application of the HCB was necessary to shorten hemostasis and prevent hematoma formation. The HCB should be tested in a clinically controlled study to evaluate its efficacy in humans.

Surgical Treatment of Complications Associated with the Angio-Seal Vascular Closure Device: Report of Three Cases

The Angio-Seal arterial closure device consists of several bioabsorbable components and is used for hemostasis of arterial puncture sites. We report 3 cases of hemorrhagic and ischemic complications related to Angio-Seal use. Two cases were treated successfully by surgical removal of the device. In the third case surgical removal of the device failed and additional intervention was necessary. The unique structure of the Angio-Seal and the most likely cause of failure should be considered when treating device-related complications.

MRI after implantation of a novel femoral closure device following intra-arterial catheterisation: implications for subsequent contrast-enhanced MR angiography

To assess MRI safety aspects and artefacts of a novel femoral artery closure device during contrast-enhanced MR angiography in patients following intra-arterial catheterisation. Ten consecutive patients underwent MRI within 24 h of coronary angiography and placement of a femoral artery closure device. We used a T2-weighted gradient-echo MRI sequence to measure the device-related artefact size in comparison with a phantom image, phase-contrast flow measurement proximal to, at the level of and distal to the device to quantify potential differences in flow velocity and contrast-enhanced 3D gradient-echo MR angiography to differentiate potential femoral artery stenosis from device-related artefacts. The mean size of the oval-shaped artefact was 8.4 x 6.6 mm (+/-1.0 x 0.8 mm) and was almost identical to the maximum artefact size of the phantom measurement (8.3 x 5.7 mm). Device placement did not result in an increased peak velocity (proximal 69 +/- 23 cm/s, at the level of 64 +/- 11 cm/s and distal to the device 63 +/- 12 cm/s, p = 0.67). The mean artefact penetration into the vessel lumen was 0.5 +/- 0.5 mm (percentage vessel narrowing 7.0 +/- 6%; range 0-16%). The MR conditional StarClose femoral artery closure device was used safely within 24 h of deployment at 1.5 T. Despite clip-related artefacts MR angiography will allow for easy differentiation of clip-related artefacts from high-grade atherosclerotic stenosis.

TCT-220: Arterial Closure Devices and Major Bleeding In Percutaneous Coronary Interventions

TCT-220: Arterial Closure Devices and Major Bleeding In Percutaneous Coronary Interventions

TCT-215: Suture-Mediated Arterial Closure Devices Decrease ACC/NCDR Major Bleeding as Compared with a Collagen Based Device

TCT-215: Suture-Mediated Arterial Closure Devices Decrease ACC/NCDR Major Bleeding as Compared with a Collagen Based Device

Popliteal artery embolization with the Mynx closure device

Several different arterial puncture closure devices are available for use after cardiovascular procedures. The main advantages include decrease need of manual compression, reduce patient discomfort, and the time to ambulation. Access site complications are not rare after vascular closure device use. We report a case of popliteal artery embolization after using an extravascular water soluble plug-mediated vascular puncture closure device.

Roadmap Guidance for the Safer Deployment of an Arterial Closure Device

Arterial closure devices reduce the time to hemostasis, ambulation, and discharge after percutaneous arterial catheterization, but there is an increased risk of arterial occlusive complications compared with manual compression. As a step toward the elimination of this risk, the authors describe a technique where the movement of a balloon-tipped vessel locator and its final position at the site of closure mechanism deployment are monitored with roadmap fluoroscopic imaging.

Femoral Arterial Access Management for Endovascular Aortic Aneurysm Repair: Evolution and Outcome

Endovascular repair of abdominal and thoracic aortic aneurysms (AAAs and TAAs, respectively) has become the standard of care for anatomically appropriate patients. All the devices developed to date for endograft repair of AAAs and TAAs are deployed through relatively large (12F to 24F) sheaths. Traditionally, this access has required arterial exposure with open cut down, but with the development of suture-mediated arterial closure devices and decreasing profile of delivery sheaths of endografts, there is an increasing trend toward percutaneous endovascular repair of aortic aneurysms. This is an effective and safe approach in a select group of patients. Ultrasound guidance ensures that access is obtained proximal to the common femoral artery bifurcation. The procedure should be performed in a sterile operating room environment, and the physicians performing endovascular repair should be experienced in open arterial exposure, should the closure device fail to close the arteriotomy.

Complications of Modern Diagnostic Cerebral Angiography in an Academic Medical Center

Catheter cerebral angiography and noninvasive cerebral imaging have steadily improved in the past several decades. Now, catheter angiography is frequently reserved for treatment planning. To remain relevant as a diagnostic modality, catheter angiography must be safe, even in critically ill patients. The present report describes the complication rate of catheter cerebral angiography performed by neurointerventional specialists at an academic medical center. From July 2001 through June 2007, 3,636 diagnostic catheter cerebral angiograms were obtained at a large academic institution. Complication data were prospectively acquired according to institutional policy and New York Patient Occurrence Reporting and Tracking System criteria. Data collected included patient age, sex, indication for the procedure, operator, and nature of adverse event, including need for treatment. Clinical predictors of complications were evaluated with logistic regression. Among 3,636 diagnostic cerebral angiograms obtained in 6 years, there were 11 clinical complications (0.30%). One patient (0.03%) had magnetic resonance imaging-detected stroke with no apparent clinical deterioration. Iatrogenic dissections were seen in five arteries (0.14%). No patient developed neurologic symptoms. Nonneurologic complications occurred in five patients (0.14%) who had arteriotomy site-related complications: one femoral abscess, two occlusions of the femoral artery with leg ischemia requiring surgical revascularization, one dissection with pseudoaneurysm formation requiring percutaneous thrombin injection, and one retroperitoneal hemorrhage requiring transfusion. Three of these patients were treated with an arterial closure device. Age greater than 65 years was associated with development of complications (P = .03). Modern catheter cerebral angiography performed by neurointerventionalists is associated with a low complication rate of 0.30%, even in a highly complex patient population.

Femoral Artery Closure After Cardiac Catheterization

After diagnostic and interventional cardiac catheterization, femoral artery closure devices offer quicker time to hemostasis, ambulation, and discharge than does manual compression. Nurses should understand how femoral artery closure devices work, the potential vascular complications that may occur with their use, and the recommended time to ambulation and discharge.

Angio-Seal Use in Patients with Peripheral Arterial Disease (ASPIRE)

To investigate the incidence of complications after the use of an arterial closure device (Angio-Seal) in patients with peripheral arterial disease. In 105 consecutive patients after transfemoral catheterization, the puncture site was closed using a closure device (Angio-Seal). Colour-flow-duplexsonography studies were conducted 1 to 4 days before, within 3 days after and 3 month after the intervention. All patients had peripheral arterial disease, 34 had calcification at the puncture site. Detection of calcification did not prevent device deployment. Complications (2 minor bleedings, 1 pseudoaneurysm) were not associated with high risk groups (these were: 69 antegrade punctures, 22 obese and 32 hypertensive patients). Three-month postinterventional diameter and blood velocity changes were <1%. Patients with peripheral arterial disease in the region of the puncture site and patients at higher complication risk can safely and effectively be closed with an Angio-Seal device. At the puncture site, no lumen change can be observed 3 months postinterventional.

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.

The Angio-Seal™ Arterial Closure Device for Early Ambulation after Elective Percutaneous Coronary Intervention in Patients Receiving Low-Dose Enoxaparin

This study evaluated the efficacy and safety of use of the Angio-Seal vascular closure device deployment for early ambulation (2 h) after elective percutaneous coronary intervention in 143 consecutive patients receiving either intravenous low-dose enoxaparin (0.5 mg/kg) or unfractionated heparin (UFH). The initial success rate of Angio-Seal(trade mark) deployment was 98.6%, with no significant difference between the UFH group (98.9%) and the enoxaparin group (98.0%). In-hospital and clinic outcomes were evaluated in the 141 patients with successful Angio-Seal deployment. During hospitalization, there were no deaths, myocardial infarction, urgent target vessel revascularization or bleeding events in either group; three patients in the UFH group and none in the enoxaparin group had minor vascular complications (differences not significant). In clinic follow-up, two patients in the UFH group and none in the enoxaparin group had major vascular complications (differences not significant). Routine use of the Angio-Seal(trade mark) for early ambulation in patients receiving intravenous low-dose enoxaparin compared with UFH provides promising efficacy and safety for daily practice.

Femoral artery occlusion after using a suture‐mediated arterial puncture closure device

A femoral artery occlusion is a very rare complication after using a suture-mediated arterial puncture closing device (APCD). The mechanism of the femoral artery occlusion is unclear and its standard management has not been established. This case describes a mechanism of femoral artery occlusion by a suture-mediated APCD and suggests a method of prevention and treatment.

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.

Testing Percutaneous Arterial Closure Devices: An Animal Model

The ovine superficial femoral artery was used for testing the efficacy of percutaneous arterial closure devices (PACDs) in their developmental stage. Two topical devices containing chitostan, one staple-mediated PACD and a porcine small intestinal submucosa plug, were tested by follow-up angiography in 37 sheep. Absence or presence of bleeding and time to bleeding cessation were the main criteria for evaluation of PAVD efficacy. The results of these tests directed modification of individual PACDs and improved their efficacy.

Suture knot embolism—a rare complication of percutaneous arterial closure device

Percutaneous closure devices used after percutaneous endovascular procedures have become more popular over the past decade. Occlusive vascular complication of the device is rare but always leads to limb-threatening consequence. We report a case of arterial occlusion caused by distal embolization of the suture material in the percutaneous closure device.