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Antegrade common femoral artery closure device use is associated with decreased complications.
ObjectiveAntegrade femoral artery access is often used for ipsilateral infrainguinal peripheral vascular intervention. However, the use of closure devices (CD) for antegrade access (AA) is still considered outside the instructions for use for most devices. We hypothesized that CD use for antegrade femoral access would not be associated with an increased odds of access site complications.MethodsThe Vascular Quality Initiative was queried from 2010 to 2019 for infrainguinal peripheral vascular interventions performed via femoral AA. Patients who had a cutdown or multiple access sites were excluded. Cases were then stratified into whether a CD was used or not. Hierarchical multivariable logistic regressions controlling for hospital-level variation were used to examine the independent association between CD use and access site complications. A sensitivity analysis using coarsened exact matching was performed using factors different between treatment groups to reduce imbalance between the groups.ResultsOverall, 11,562 cases were identified and 5693 (49.2%) used a CD. Patients treated with a CD were less likely to be white (74.1% vs 75.2%), have coronary artery disease (29.7% vs 33.4%), use aspirin (68.7% vs 72.4%), and have heparin reversal with protamine (15.5% vs 25.6%; all P < .05). CD patients were more likely to be obese (31.6% vs 27.0%), have an elective operation (82.6% vs 80.1%), ultrasound-guided access (75.5% vs 60.6%), and a larger access sheath (6.0 ± 1.0 F vs 5.5 ± 1.0 F; P < .05 for all). CD cases were less likely to develop any access site hematoma (2.55% vs 3.53%; P < .01) or a hematoma requiring reintervention (0.63% vs 1.26%; P < .01) and had no difference in access site stenosis or occlusion (0.30% vs 0.22%; P = .47) compared with no CD. On multivariable analysis, CD cases had significantly decreased odds of developing any access site hematoma (odds ratio, 0.75; 95% confidence interval, 0.59-0.95) and a hematoma requiring intervention (odds ratio, 0.56; 95% confidence interval, 0.38-0.81). A sensitivity analysis after coarsened exact matching confirmed these findings.ConclusionsIn this nationally representative sample, CD use for AA was associated with a lower odds of hematoma in selected patients. Extending the instructions for use indications for CDs to include femoral AA may decrease the incidence of access site complications, patient exposure to reintervention, and costs to the health care system
The Use of the "Preclosure” Technique for Antegrade Aspiration Thrombectomy with Large Catheters in Acute Limb Ischemia
Purpose: This study was designed to assess retrospectively short- and mid-term outcomes of the use of a suture-mediated closure device to close the antegrade access in patients undergoing percutaneous aspiration thrombectomy with large catheters for acute leg ischemia. Methods: Between November 2005 and February 2010, a suture-mediated active closure system (ProGlide® 6F, Abbott) was placed before arterial sheath (mean 9F, range 6-12F) introduction in 101 patients (74 men, 73%, mean age 70.1±12.6years standard deviation). Data regarding mortality, complications, and factors contributing to vascular complications at the access site was collected for 6month after the intervention to detect device-related problems. As a coincidence, 77 patients had follow-up visits for a duplex ultrasound. Results: There were a total of 19 vascular complications (19%) at the puncture site, all of which were of hemorrhagic nature and none of which consisted of vessel occlusion. Two major outcome complications (2%) occurred. A retroperitoneal hematoma and a serious inguinal bleeding required additive treatment and did not result in permanent sequelae. Nine cases involved death of which eight were not attributable to the closure and one remained unclear. Successful closure was achieved in 95 patients (94%); additional manual compression was sufficient in the majority of the remaining patients. Numerous factors contributing to vascular complications were encountered. Conclusions: With acceptable short- and mid-term outcomes, the "preclose” technique can be a reliable option for the closure of a large antegrade femoral access even for patients at a high risk of vascular complications, such as those undergoing aspiration thrombectom
Percutaneous ultrasound-guided carotid access and puncture closure with angio-seal in horses
Background: There are different indications for endovascular surgery in horses, mainly the treatment of guttural pouch mycosis. Traditionally, these procedures are carried out by open arteriotomy of the common carotid artery (CCA), although less invasive percutaneous ultrasound-guided carotid access (PUGCA) has been described in experimental horses. In human medicine, commercial closure systems are used to seal these arterial puncture sites and reduce complications. The aims of this study are to retrospectively describe our experience with PUGCA in clinical cases and to report, for the first time, the use of the commercial vascular closure device Angio-Seal after PUGCA in horses. Methods: Retrospective study of clinical case records. Collected parameters, including the feasibility of the PUGCA and variables related to the safety and efficacy of the use of the Angio-Seal. Results: Twelve PUGCA procedures in 11 horses were included. In all cases, the artery was effectively accessed, and the planned procedure could be performed. In two cases, haematoma/bleeding due to incorrect use of the Angio-Seal was recorded. This complication rate (16.66%) was lower than that obtained in other studies using PUGCA in horses, but where the puncture was sealed by manual compression only. Main limitations: A control group of clinical cases with PUGCA but without using Angio-Seal is not available. Conclusions: Clinical data confirm previous experimental results, which showed that PUGCA is safe and effective in horses. The Angio-Seal system, regardless of possible complications due to incorrect use, can be used safely and effectively in horses. Further studies comparing arterial access site management using manual compression or Angio-Seal would be necessary to state if its routine use in horses is advisable
A minimally invasive technique for closing an iatrogenic subclavian artery cannulation using the Angio-Seal closure device: two case reports
<p>Abstract</p> <p>Introduction</p> <p>In the two cases described here, the subclavian artery was inadvertently cannulated during unsuccessful access to the internal jugular vein. The puncture was successfully closed using a closure device based on a collagen plug (Angio-Seal, St Jude Medical, St Paul, MN, USA). This technique is relatively simple and inexpensive. It can provide clinicians, such as intensive care physicians and anesthesiologists, with a safe and straightforward alternative to major surgery and can be a life-saving procedure.</p> <p>Case presentation</p> <p>In the first case, an anesthetist attempted ultrasound-guided access to the right internal jugular vein during the preoperative preparation of a 66-year-old Caucasian man. A 7-French (Fr) triple-lumen catheter was inadvertently placed into his arterial system. In the second case, an emergency physician inadvertently placed a 7-Fr catheter into the subclavian artery of a 77-year-old Caucasian woman whilst attempting access to her right internal jugular vein. Both arterial punctures were successfully closed by means of a percutaneous closure device (Angio-Seal). No complications were observed.</p> <p>Conclusions</p> <p>Inadvertent subclavian arterial puncture can be successfully managed with no adverse clinical sequelae by using a percutaneous vascular closure device. This minimally invasive technique may be an option for patients with non-compressible arterial punctures. This report demonstrates two practical points that may help clinicians in decision-making during daily practice. First, it provides a practical solution to a well-known vascular complication. Second, it emphasizes a role for proper vascular ultrasound training for the non-radiologist.</p
Ease of Using a Dedicated Percutaneous Closure Device after Inadvertent Cannulation of the Subclavian Artery: Case Report
Inadvertent puncture of the subclavian artery is a relatively frequent and potentially disastrous complication of attempted central venous access. Due to its noncompressible location, accidental subclavian arterial cannulation may result in hemorrhage as the sheath is removed. We report a new case of successful percutaneous closure of the subclavian artery which had been inadvertently cannulated, using a closure device based on a collagen plug (Angio-Seal, St. Jude Medical). This was performed in a patient who had received maximal antiplatelet and anticoagulation therapies because of prior coronary stenting in the context of cardiogenic shock. There was no prior angiographic assessment, as arterial puncture was presumed to have been distal to the right common artery and vertebral arteries. No complications were observed in this high-risk patient, suggesting that this technique could be used once the procedure has been evaluated prospectively
Angio-Seal™ Embolization: A Rare Etiology of an Acute Distal Limb Ischemia
We herein report a serious vascular complication of diagnostic cardiac catheterization due to an embolization of an Angio-Seal closure device causing acute lower limb ischemia. The Angio-Seal was deployed via the right femoral artery following the catheterization which embolized several hours later to the right popliteal artery. Fogarty embolectomy restored perfusion to the right lower limb; however, compartment syndrome subsequently developed which required evacuation of a hematoma and repair of right popliteal artery
CIRSE Vascular Closure Device Registry
The conclusion of this registry of closure devices with an anchor and a plug is that the use of this device in interventional radiology procedures is safe, with a low incidence of serious access site complications. There seems to be no difference in complications between antegrade and retrograde access and other parameters
Thermic sealing in femoral catheterization: First experience with the Secure Device
Background: Devices currently used to achieve hemostasis of the femoral artery following percutaneous cardiac catheterization are associated with vascular complications and remnants of artificial materials are retained at the puncture site. The Secure arterial closure Device induces hemostasis by utilizing thermal energy, which causes collagen shrinking and swelling. In comparison to established devices, it has the advantage of leaving no foreign material in the body following closing. This study was designed to evaluate the efficacy and safety of the Secure Device to close the puncture site following percutaneous cardiac catheterization.
Methods: The Secure Device was evaluated in a prospective non-randomized single-center trial with patients undergoing 6 F invasive cardiac procedures. A total of 67 patients were enrolled and the device was utilized in 63 patients. Fifty diagnostic and 13 interventional cases were evaluated. Femoral artery puncture closure was performed immediately after completion of the procedure. Time to hemostasis (TTH), time to ambulation (TTA) and data regarding short-term and 30-day clinical follow-up were recorded.
Results: Mean TTH was 4:30 ± 2:15 min in the overall observational group. A subpopulation of patients receiving anticoagulants had a TTH of 4:53 ± 1:43 min. There were two access site complications (hematoma > 5 cm). No major adverse events were identified during hospitalization or at the 30 day follow-up.
Conclusions: The new Secure Device demonstrates that it is feasible in diagnostic and interventional cardiac catheterization. With respect to safety, the Secure Device was non-inferior to other closure devices as tested in the ISAR closure trial
Treatment of Infected Pseudoaneurysm of Femoral Artery after Vascular Closure Device Deployment: A Practical Solution
Like other invasive procedures, percutaneous coronary interventions are associated with complications. Most common access site for these procedures is common femoral artery. Complications such as groin and retroperitoneal hematoma can be encountered as well as pseudoaneurysms, arteriovenous fistulas, acute arterial occlusion, and infection. When infected pseudoaneurysm occurs, surgical treatment can be extremely difficult. We present a case of the patient in whom infected pseudoaneurysm of common femoral artery developed after percutaneous coronary intervention and was successfully treated by surgical excision and autoarterial graft insertion
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