Percutaneous endovascular management of Angio-Seal related vascular occlusion.

BACKGROUND: The use of vascular closure devices (VCDs) to achieve quick and safe hemostasis after femoral arterial access is widely accepted. Major complications include bleeding and occlusion of the femoral artery due to device failure, which often necessitates vascular intervention. This manuscript details our peripheral percutaneous endovascular interventional (PEI) approach for the management of femoral artery occlusion resulting from Angio-Seal (Terumo, Somerset, New Jersey, USA) VCD deployment. METHODS: Consecutive patients who developed occlusive complications after Angio-Seal deployment underwent PEI to overcome specific complications. Patients' clinical and procedural characteristics, along with their short- and long-term follow-up data, were analyzed. RESULTS: The study cohort included 40 patients who experienced Angio-Seal occlusive complications between July 2013 and September 2023. The mean age of the patients was 74 ± 10 years and 55% were female. All the patients were treated with PEI, with an overall procedural success rate of 100%. The primary approach for PEI was directional atherectomy, which was used in 35 cases (88%), followed by balloon, while a cutting balloon was used in 5 patients (13%). Stenting served as the definitive therapy in only 7 patients (18%). No procedural complications or conversions to surgery were observed. During a median follow-up of 244 (IQR = 100-707) days, none of the patients required re-intervention related to Angio-Seal occlusion and salvage intervention. CONCLUSION: In the management of Angi-Seal VCD-related femoral artery occlusion, the adjunctive use of directional atherectomy followed by balloon angioplasty was effective and safe, allowing re-establishment of flow with excellent long-term outcomes.

Single-Center Experience on the Elective Hybrid Combination of Single Perclose + Angio-Seal VIP 8F Compared With Standard Dual Perclose During Percutaneous Endovascular Aortic Aneurysm Repair.

PURPOSE: This single-center study aimed to assess patients who underwent intentional percutaneous endovascular aortic aneurysm repair (pEVAR) with Hybrid Technique combining a single Perclose (Abbott, Abbott Park, Illinois) Suture-Mediated Closure Device + single Angio-Seal VIP 8F (Terumo, Tokyo, Japan) and compare outcomes with the standard Dual Perclose technique. Materials and Methods: Consecutive elective pEVAR patients treated from November 2022 to November 2023, with healthy femoral accesses and introducer sheaths ≤20 French (F) outer diameter, were included. Coin-toss randomization determined whether a combination of single Perclose Device + single Angio-Seal VIP 8F (Hybrid Technique) or the standard double Perclose Devices (Dual Perclose) was used. In Hybrid Technique, a single Perclose device was positioned at 12 o'clock; a single Angio-Seal VIP 8F was placed after sheaths removal. Dual Perclose followed standard procedure. Primary endpoints included immediate hemostasis, sheath diameter differences, access conversion rate, technical success, and cost analysis. RESULTS: The study involved 60 pEVAR patients (median age=78, interquartile range [IQR]=72-85 years) within the inclusion criteria. In 14 (24%) cases, only 1 femoral access was studied. There were 106 pEVAR accesses, with 58 (54.7%) in the Hybrid Technique group and 48 (45.3%) in the Dual Perclose group. Both groups exhibited homogeneity in pre-operative characteristics and sheath diameter (Hybrid Technique-16F vs Dual Perclose-18F; p=0.202). Immediate hemostasis was achieved in 100% of the Hybrid Technique group vs 87.5% for the Dual Perclose group (p=0.006). Surgical access conversion was unnecessary. Technical success was 100%, with all 6 femoral bleeding cases after Dual Perclose resolved endovascularly, using additional devices. Cost analysis showed a median cost of 330 euros (IQR=0) for the Hybrid Technique group vs 384 euros (IQR=360-456) for the Dual Perclose group (p<0.001). Thirty-day mortality was 3%, in 2 fragile patients, without access-related complications. Multivariate analysis identified Dual Perclose access (odds ratio [OR]=35.6; 95% confidence interval [CI]=18.3-36.8; p<0.001) and obesity (OR=19.7; 95% CI=1.4-23.9.5; p<0.001) as independent risk factors for immediate hemostasis failure. Median follow-up was 134 days (IQR=41-227), with 1 Hybrid Technique case (2%) successfully treated with thrombin injection for a small femoral pseudoaneurysm after 62 days. CONCLUSIONS: The elective Hybrid Technique with combination of single Perclose Device + single Angio-Seal VIP 8F during pEVAR in selected patients appears to be non-inferior to the standard Dual Perclose procedure. It demonstrates a positive trend in reducing immediate hemostasis failure and costs. Both procedures achieved technical success and avoiding surgical access conversions. CLINICAL IMPACT: This study introduces a novel elective hybrid technique combining a single Perclose device with a single Angio-Seal VIP 8Fr for percutaneous endovascular abdominal aortic interventions. Results for hybrid technique showed 100% technical success and efficient immediate hemostasis, while costing less than standard dual Perclose procedure. Both procedures did not require surgical conversions. Despite being a single-center study, it demonstrates potential benefits of the intentional application of this hybrid technique towards minimally invasiveness. Obesity and dual Perclose technique were identified as independent risk factors for hemostasis failure, reaffirming the hybrid technique procedure's efficacy as well as and non-inferiority to standard procedure.

Real-World Experience With the Angio-Seal Closure Device: Insights From Manufacturer and User Facility Device Experience Database.

PURPOSE: Angio-Seal (Terumo Medical Corporations, Somerset, New Jersey) device is indicated for femoral arteriotomy closure. Real-world published data on complications are limited. We present 1 year of safety events involving Angio-Seal from the US Food and Drug Administration's post-market surveillance database of Manufacturer and User Facility Device Experience (MAUDE). Steps for managing frequent device-related problems are discussed. MATERIALS AND METHODS: Angio-Seal MAUDE data from November 2019 to December 2020 was classified according to (1) mode of device failure, (2) complication, (3) treatment, and (4) Cardiovascular and Interventional Radiological Society of Europe (CIRSE) adverse event classification system. RESULTS: There were 715 safety events, involving Angio-Seal VIP (93.1%), Evolution (5.7%), STS Plus (1.1%), and sizes 6F (62.5%) and 8F (37.5%). Failure mode involved unrecognized use of a damaged device (43.4%), failed deployment (20.1%), failed arterial advancement (6.3%), detachment of device component (4.9%), failed retraction (3.6%), operator error (1.1%), and indeterminate (20.6%). Of total, 44.8% of events were associated with patient harm. Complications involved minor blood loss (34.1%), hematoma (5.6%), significant blood loss (1.4%), and pseudoaneurysm (1.4%). Of total, 43.3% of cases required manual compression (MC), whereas 8.8% required more advanced intervention. Interventions included surgical repair (49.2%), thrombin injection (9.5%), balloon tamponade (6.3%), covered stent (4.8%), and unspecified (30.2%). Majority of safety events were CIRSE grade 1 (92.0%), followed by grades 2 (3.1%), 3 (4.6%), and 6 (deaths, 0.3%). Minority of devices were returned for manufacturer analysis (27.8%). CONCLUSIONS: The majority of safety events were associated with minor blood loss or local hematoma and could be addressed with MC alone. Most events were attributed to damaged device; however, very few devices were returned to manufacturer for analysis. This should be encouraged to allow for root cause analysis in order to improve safety profile of devices. System-level strategies for addressing barriers to under-reporting of safety events may also be considered. CLINICAL IMPACT: Our study highlights important safety events encountered in real-world practice with Angio-Seal closure device. The MAUDE database captures real-world device malfunctions not typically appreciated in conventional clinical trials. Our study provides valuable insight for clinician-users on anticipating and managing the most common device malfunctions. Additionally, our data provide feedback for manufactures to optimize product design and direct manufacturer user training to improve safety. Finally, we hope that the study promotes system-level strategies that foster reporting of safety events and undertaking of root cause analysis.

An update on the use of an arterial closure device following femoral arterial puncture in children.

BACKGROUND: The use of arterial closure devices in achieving femoral hemostasis has been well documented in adults but insufficiently studied in the pediatric population. An earlier study from our institution of 40 Angio-Seal devices in 38 patients concluded that the arterial closure device is safe in children with only a single minor complication. Ongoing experience with this device at our institution, however, suggests a higher rate of complication. OBJECTIVE: To retrospectively evaluate the safety and efficacy of the Angio-Seal in a pediatric population. MATERIALS AND METHODS: A retrospective analysis reviewed all cases in which the Angio-Seal was deployed from June 2011 to September 2017. Peri-procedural documentation was reviewed for pre-procedure labs, clinical effectiveness in achieving hemostasis and complications related to the use of this device. Logistic regression analysis was also used to evaluate the relationship between patient demographic, vessel size and indication for angiography, and the presence or absence of complications. RESULTS: During the study period, 48 additional Angio-Seal devices were deployed in 41 consecutive patients. Five patients were excluded for being older than 18 years. The mean age of the patients was 13.3 years (range: 4-18 years) with 18 patients female. The mean common femoral artery diameter was 5.98 mm in short axis diameter (range: 4-9 mm). Complications were present in 6/43 cases (14%) including 3 minor and 3 major complications that included additional procedures. No significant relationship was identified between vessel size, age and the indication for angiography, and the rate of complication on logistic regression analysis. CONCLUSION: While percutaneous arterial closure devices can be efficacious for achieving hemostasis, our experience demonstrates a higher rate of complications in children, contrary to a previous report. The deployment of such devices should be performed with prejudice in this population.

A systematic review of vascular closure devices for femoral artery puncture sites.

OBJECTIVE: The aim of this review was to provide an up-to-date summarization of available Food and Drug Administration-approved vascular closure devices (VCDs) and to analyze current evidence comparing individual devices with one another and with manual compression (MC). The review includes indications for use, advantages and disadvantages, safety and efficacy, and outcomes. METHODS: A review of literature available on VCDs was conducted using PubMed and MEDLINE. Only clinical trials published within the last 10 years evaluating the efficacy of different VCDs with access obtained through common femoral artery or vein were included. All literature included in this review was published in English and used human participants. RESULTS: The search strategy yielded 34 relevant articles. These studies included procedures ranging from diagnostic catheterizations to percutaneous endovascular aneurysm repair. There is considerable heterogeneity in the studies, with a wide variety of definitions and different outcome measures. The review demonstrated that VCDs provided improvement in the patients' comfort and satisfaction as well as in the time to hemostasis and ambulation. Most studies are underpowered to show differences, but even after meta-analysis or Cochrane review, complication rates as well as safety and efficacy between devices and MC remained comparable. CONCLUSIONS: VCDs have shown marked improvement in patients' comfort and satisfaction as well as in time to hemostasis and ambulation after percutaneous vascular procedures. According to multiple small randomized controlled trials, meta-analyses, and a Cochrane review, complication rates, safety and efficacy, and outcomes remain comparable between VCDs and MC (12% for VCDs vs 13% for MC). VCDs have a low incidence of major complications and high success rates, which provides convenience for the practitioner and facilitates turnover of patients. VCDs have a risk of infectious (0.6% with VCDs vs 0.2% with MC) and thrombotic complications (0.3% with VCDs vs none with MC) that is small but may be increased compared with MC. It is important to balance the goals of comfort of the patient, resources of the staff, and early ambulation against periprocedural and anatomic risk factors (ie, individualize use of VCDs to specific clinical scenarios). Users must be familiar with a device and its limitations to safely and effectively achieve hemostasis after femoral artery puncture.

Endovascular therapy for Angio-sealTM -related acute limb ischemia: Perioperative and long-term results.

OBJECTIVES: To investigate the perioperative and long-term outcomes of endovascular therapy for Angio-sealTM -related acute limb ischemia. BACKGROUND: Currently, limited data are available on the optimal treatment strategy for Angio-sealTM -related acute lower limb ischemia. METHODS: The prospectively maintained patient database of our institution was retrospectively searched to identify all patients who developed acute lower limb ischemia after use of the Angio-SealTM and received endovascular treatment from January 2010 to February 2016. The clinical and follow-up data were evaluated. RESULTS: Thirty-two patients with Angio-SealTM -related acute limb ischemia underwent endovascular therapy, resulting in an approximated incidence of 0.29% of all implanted devices. The overall procedural success rate was 96.9%. With regard to the patients who underwent successful endovascular treatment, the culprit lesion was located in the common femoral artery in 22 (71.0%) cases, the femoral artery bifurcation in 3 (9.7%) cases and the superficial femoral artery in 6 (19.4%) cases. Ten (31.3%) patients had thrombosis in other distal lower limb arteries ipsilateral to Angio-sealTM use. Eighteen (58.1%) patients underwent balloon angioplasty alone, while nine (29.0%) patients underwent balloon angioplasty and thrombolysis, and four (12.9%) patients underwent stent implantation. One patient suffered from minor bleeding at the site of application of the Angio-sealTM . During an average of 43.5 ± 22.9 months of follow-up, three patients with symptomatic restenosis underwent a second successful balloon angioplasty and remained asymptomatic until the last follow-up. CONCLUSIONS: Balloon angioplasty with selective thrombolysis or stent placement was safe and effective, with a low incidence of complication and restenosis. © 2017 Wiley Periodicals, Inc.

Usefulness of an access-site hemostasis device in neuroendovascular treatment.

BACKGROUND: We examined the safety and efficacy of the access-site hemostasis device Angio-Seal™ STS Plus (AS; St. Jude Medical,St. Paul, MN, USA) compared with the method of hemostasis by manual compression (MC) in neuroendovascular therapy. METHOD: We conducted a prospective multicenter registration study enrolling 229 patients who were scheduled to undergo endovascular treatment. RESULTS: Of the 119 and 110 cases assigned to the AS and MC groups, 118 (99.2%) and 105 (95.5%) achieved successful hemostasis, respectively. Six AS patients and 38 MC patients had access-site hematoma (5% vs 34.5%, P < 0.001). Hemostasis time was significantly shorter in the AS group than in the MC group (4.4 min vs 150.7 min, P < 0.001). Puncture-site hematoma was significantly larger in the AS group than the MC group (5.5 cm vs 2.9 cm, P < 0.05). Patients in the AS group had a significantly shorter hospital stay than those in the MC group (8.7 days vs 13.3 days, P < 0.001); they also had a significantly shorter time before they could start to walk (23.9 h vs 52.2 h, P < 0.001). No serious adverse events were noted in either group. Minor adverse events included four cases from the AS group and two cases from the MC group. CONCLUSIONS: Use of an access-site hemostatic device resulted in quick and reliable access-site hemostasis in neuroendovascular therapy. When using AS, it is necessary to be careful when there is a possibility of a hematoma, as the hematomas, though significantly less frequent than in MC, were significantly bigger in that group.

Percutaneous vascular closure using an anchored collagen plug provides effective haemostasis following both antegrade and retrograde femoral arterial punctures.

OBJECTIVES: Small published series suggest a higher failure rate for Angio-Seal vascular closure device (VCD) deployment after antegrade femoral puncture, despite the need for shorter haemostasis times, early discharge, and possibly higher turnover. We seek to compare the deployment efficacy and complications of the Angio-Seal VCD between antegrade and retrograde femoral arterial deployments. METHODS: Radiological data was retrospectively analysed from prospective databases from the hospitals' Computerised Radiology Information System (CRIS) over 2010-2012. Angio-Seal gauge, Rutherford class (as applicable), puncture mode (used to classify deployment as antegrade/retrograde), sheath sizes, and deployment success/failures were recorded. Numerical/statistical analyses were undertaken using Microsoft Excel 10/SISA software. RESULTS: A total of 519 Angio-Seal VIP VCDs were deployed in 470 patients over 2010-2012 (13 other patients could not be analysed due to incomplete data). Sheath sizes for antegrade/retrograde femoral puncture were 5F, n = 22/9; 6F, n = 244/223; 7F, n = 1/5; 9F, n = 4/0. 8F Angio-Seal VIPs were used for 9F punctures only, 6F for the remainder. The overall deployment success rate was 93.7%. In total, 247 (91.1%) successful antegrade deployments were undertaken with 24 (8.9%) failures, compared with 229 (96.6%) successful retrograde deployments with eight (3.4%) failures. Antegrade/retrograde failures were classed as failure to deploy, n = 15/5; bleeding despite successful deployment requiring supplementary compression, n = 6/1; haematoma formation, n = 2/1; groin pain, n = 0/1; vessel stenosis, n = 1/0. Higher deployment failures were noted with antegrade deployment (p < .02, chi-square test). CONCLUSIONS: Angio-Seal deployment is successful for both antegrade/retrograde femoral punctures albeit with a higher antegrade failure rate.

Collagen-Based Bailout Compared to Suture-Mediated Vascular Closure Alone During Transcatheter Aortic Valve Replacement.

Background: Hemostasis for transfemoral transcatheter aortic valve replacement (TAVR) is typically achieved using a suture-mediated vascular closure device (VCD) prior to large-bore sheath insertion (preclosure technique). Recently, the addition of a hybrid closure technique using a preclose technique with the addition of a collagen-plug VCD after sheath removal in cases of failed hemostasis has been utilized. Methods: Data were collected from the Northwell TAVR registry, including 3 high-volume TAVR centers. We evaluated a preclose strategy with suture-mediated vascular closure alone ("legacy strategy") and standard bailout techniques versus a contemporary hybrid strategy of suture-mediated closure with collagen-mediated closure bailout. The primary end point was major or minor vascular complications as defined by the VARC-3 criteria. Results: A total of 1327 patients were included, of which 791 patients underwent TAVR with suture-mediated closure alone and 536 with contemporary strategy. The primary end point (major or minor vascular complication) was lower in the contemporary strategy (5.44% vs 1.31%; P < .001). Both minor (3.92% vs 1.12%; P = .002) and major (1.14% vs 0.19%; P = .0196) vascular complications were reduced and the total length of stay was less in the contemporary strategy (median of 3 days vs 2 days; P < .0001). Using multivariable analysis, we observed that vascular management strategy significantly improved the composite primary outcome when adjusted for sheath size, peripheral artery disease, carotid disease, and site of procedure. In the contemporary group, bailout collagen-plug VCD with an Angio-Seal (Terumo Medical) was used in 68 patients (12.69%) and bailout MANTA (Teleflex) was required in 4 patients (0.75%). There were no major or minor vascular complications among the patients who received bailout collagen-plug VCD. Conclusions: A contemporary hybrid strategy of suture-mediated closure with collagen-mediated closure bailout reduces the risk of vascular complications among patients undergoing transfemoral TAVR.

A novel bailout technique using myocardial biopsy forceps to grasp a dislodged angio-seal collagen with footplate.

BACKGROUND: Hemostatic devices are now frequently used in femoral artery punctures, and the Angio-Seal (Terumo, Tokyo, Japan) is one of the most commonly used devices for closure of the femoral artery because it provides rapid hemostasis. Although device failure rarely occurs, if the collagen falls into the femoral artery, it may lead to severe limb ischemia. Herein, we describe a case of a novel endovascular technique for the treatment of Angio-Seal arterial closure device failure. CASE PRESENTATION: The patient in Case 1 was a 75-year-old man with severe left limb claudication. We used a contralateral antegrade approach and used the Angio-Seal for hemostasis. However, the Angio-Seal collagen and footplate dropped and stopped at the bifurcation of the superficial femoral artery and deep femoral artery. The collagen with the footplate was caught with myocardial biotome forceps (MBF) and pulled into the external iliac artery (EIA). The distal common femoral artery (CFA) was punctured, and we delivered a 10.0- × 80-mm stent (SMART®; Cordis, USA) to the EIA from the ipsilateral sheath. The stent was deployed at the EIA and crushed the collagen. The patient in Case 2 was an 88-year-old man with rest pain in the right limb. The right CFA was punctured using an ipsilateral approach and the Angio-Seal was used for hemostasis. The Angio-Seal collagen with the footplate dropped into the bifurcation of the deep femoral artery. The collagen and footplate were caught with MBF and pulled up to the EIA. The right CFA was punctured and a 10.0- × 60-mm stent (SMART®; Cordis) was delivered from the ipsilateral sheath. The stent was deployed at the EIA and crushed the collagen with the footplate. CONCLUSIONS: MBF were used to grasp the dislodged collagen with the anchor and cover it with a stent at the iliac artery. This may be a useful bailout technique for Angio-Seal dislodgement.

Procedure-Related Complication Rates With the Use of Vascular Closure Devices; Does Size Only Matter? A Large Single Centre Retrospective Study.

INTRODUCTION: Our retrospective study aimed at assessing safety of vascular closure devices (VCDs) used in a large single-centre Interventional Radiology (IR) department. Complication and deployment failure rates using collagen-based (Angio-seal) and suture-based (ProGlide) devices for common femoral artery haemostasis were compared. MATERIALS AND METHODS: Data from VCDs deployed over a 6-year period were retrospectively analysed for patient age, procedure indication, puncture mode (antegrade/retrograde), sheath size, deployment failure and complications (haematoma, pseudoaneurysm formation, limb occlusion). Numerical and statistical analysis was undertaken. RESULTS: Overall, 1321 common femoral artery punctures in 1217 patients were closed using VCDs. Failure rate using ProGlide was significantly higher when compared with Angio-seal (P=<0.001) in sheath sizes ≤8 Fr. Heparin was not administered in embolisation procedures compared with angioplasty with or without stenting. Therefore, haematoma tended to occur more frequently following angioplasty without stenting (P = 0.003) and angioplasty with stenting (P = 0.001), when compared with embolisation. Deployment failure occurred more frequently when heparin was used during the procedure (P = 0.005). CONCLUSION: Although complications relating to sheath size are well established in the literature, there remains a paucity of data assessing the impact of procedure specific factors when comparing VCDs. Our study challenges that size is the sole determinant of VCD success and invites a more holistic view of VCD deployment strategies. This study advocates continued research into the nuances of other potential confounding variables to optimise patient outcomes.

Protected high risk percutaneous coronary intervention-Impella 5.0 as a single-access technique: a case report.

Background: Patients requiring coronary intervention after acute myocardial infarction, with decompensated heart failure and multiple co-morbidities, present a challenging clinical scenario. Addressing such high-risk cases has been a marked increase in the simultaneous support using microaxial flow pump devices, providing a crucial haemodynamic support during procedures. Case summary: We report the case of a 58-year-old man, with a non-ST-segment elevation myocardial infarction in the context of a peripheral vascular surgery. Echocardiography revealed severely reduced left ventricular function and cardiac magnetic resonance imaging demonstrated transmural scars in all but left anterior descending artery area. The patient was of extreme high surgical risk due to the multiple co-morbidities, acute decompensation heart failure, and peripheral artery disease, and, therefore, the heart team preferred protected percutaneous coronary intervention (PCI) over coronary artery bypass graft for revascularization. The peripheral artery disease included severely calcified ascending aorta, occlusions of both femoral arteries, the left subclavian artery, and the right radial artery. Taken together, the heart team agreed on a hybrid approach with surgical implantation of Impella 5.0 via the left subclavian artery, by a single-access technique. Following the intervention procedure, haemostasis of the vascular prosthesis was achieved by an angio-seal technique without complications. The patient recovered satisfactorily, with improved left ventricular function, and discharged 10 days post-procedure. Discussion: The single-access high-risk PCI technique offers a standardized approach for microaxial flow pump devices such as Impella 5.0 and PCI. The subclavian artery as a single-access route for high-risk PCI has demonstrated safety and efficacy.

Complications with the use of Angio-Seal vascular closure device and their management.

Vascular closure devices (VCDs) are being increasingly used for achieving hemostasis after diagnostic and therapeutic endovascular procedures. Although uncommon, complications may be encountered which are associated with the use of these VCDs. We report four cases where the use of Angio-Seal (Terumo, Somerset, New Jersey, USA) was followed by complications. Three cases presented with acute limb ischemia, among them, two patients had arterial occlusion at the vascular access site and one patient had embolization of the footplate anchor of the closure device. One case presented with pseudoaneurysm at the common femoral artery access site along with occlusion at origin of the superficial femoral artery. We have described the mechanism in which these complications occur and the successful management of these cases preventing potential amputation and limb loss. The risk factors which increase the risk of complications with the use of Angio-Seal VCD were reviewed and the strategy to avoid these complications with particular emphasis on the utility of ultrasound when using Angio-Seal VCD is discussed. A strategy to manage these complications has been discussed while deciding on endovascular management or surgical management, especially in patients with challenging presentation and those with multiple comorbidities making them at very high risk for surgery.

Transaneurysmal Occlusion of Complicated Common Femoral Artery Pseudoaneurysms Using the Angio-Seal Closure Device-A Promising Technique.

PURPOSE: Pseudoaneurysm (PSA) developing after catheter examinations is one of the most frequent vascular complications and a nonsurgical technique with utmost low risk of complications is warranted. Our aim was to investigate the technical feasibility, success, and safety of transaneurysmal occlusion of complicated post-interventional common femoral artery (CFA) PSA using the Angio-Seal Closure Device (ASCD) and a technique that we describe as the transaneurysmal (TA) maneuver. MATERIAL AND METHODS: We used the Angio-Seal (Terumo, Tokyo, Japan) Closure System to manage complicated PSAs in patients who would otherwise have needed surgery after failure of all conservative therapies. The TA maneuver was performed in 14 consecutive patients from July 2021 to July 2022. After ultrasound-guided puncture of the PSA close to its neck, the CFA was entered radiographically with micro-guidewires, and the neck of the PSA was closed with the ASCD after changing the sheaths and wires. All patient had to wear a pressure dressing until the next day, when successful closure was verified by sonography. RESULTS: All procedures were performed with technical success and without any complications. No patient had to undergo surgery. All sonographies on the next day confirmed complete absence of perfusion within the PSA and normal flow conditions of the CFA and vessels below. CONCLUSION: The TA maneuver a promising minimally invasive procedure for closing complicated PSA of the CFA after catheter examination.

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.

Usefulness of duplex ultrasonography to detect collagen sponge misplacement into the arterial lumen during the use of Angio-Seal: A case report.

A 76-year-old man who had undergone percutaneous coronary intervention suffered intermittent claudication. Duplex ultrasonography revealed superficial femoral artery stenosis with an intraluminal heterogeneous echogenic mass. We suspected that stenosis was caused by the puncture procedure of the Angio-Seal. Open surgery revealed that a collagen sponge that should have been outside the arterial wall was misplaced in the wall with massive granulation, and atherectomy with patchplasty was performed. Vessel deterioration was considered due to several factors, including inappropriate access site, arterial wall calcification, and comorbidities like Behçet's disease. Ultrasonography is a convenient and useful method to evaluate arterial lesions.

Safety and efficacy of Angio-Seal device for transfemoral neuroendovascular procedures: A systematic review and meta-analysis.

INTRODUCTION: Angio-Seal is a commonly used device for femoral hemostasis in neuroendovascular procedures. This meta-analysis investigates of the safety and efficacy of Angio-Seal in patients undergoing endovascular neurointerventional procedures. METHODS: A systematic review and meta-analysis on all studies evaluating the Angio-Seal device in neurointerventional procedures from inception through 2020 were performed. We studied rates of groin hematoma, retroperitoneal hematoma, pseudoaneurysm, ipsilateral DVT, and ischemic complications. Meta-analysis was performed using the random-effects model. RESULTS: 13 studies were included in our analysis. 2250 patients with 104 complications were found {4.5% (95% CI, 2.7%-6.3%)}. Of these complications, groin hematoma was the most common with a rate of 2.4% (95% CI, 1.1%-3.6%). Retroperitoneal hematoma {0.3% (95% CI, 0%-0.5%)}, pseudo-aneurysm {0.5% (95% CI, 0.2%-0.8%), and ipsilateral DVT {0.3% (95% CI, 0.1%-0.7%) were also not in negligible rate. The rate of other complications were as follows: vessel occlusion/stenosis; 0.2% (95% CI, 0%-0.4%), vascular surgery; 0.2% (95% CI, 0%-0.5%), and infection; 0.2% (95% CI, 0%-0.5%). One patient died as result of hemorrhagic complications {0.1% (95% CI, 0%-0.3%)}. Use of anticoagulant/antiplatelet therapy was found to be positively correlated with high risk of any groin complication and groin hematoma (p ≤ .05). Female gender was associated with high risk of ipsilateral DVT (p ≤ .05). Interestingly, large sheath size was associated with low risk of groin hematoma (p ≤ .05). CONCLUSION: The safety and efficacy rate of Angio-Seal was approximately 95%. The most common complication was groin hematoma. Serious complications including retroperitoneal hematoma and femoral artery occlusion were rare.

Endovascular snare retrieval of an Angio-Seal causing acute limb ischemia.

Vascular complications (VCs) remain an important source of morbidity and mortality following percutaneous arterial catheterization. Vascular closure devices are popular and frequently used, but sometimes cause vessel occlusions that may require vascular surgery or complex endovascular procedures. In this case report, we describe the endovascular retrieval of an embolized Angio-Seal device causing acute limb ischemia in a severely diseased 75-year-old female patient. This case highlights the endovascular technique using a snare catheter and adds another example to the growing evidence of an endovascular approach to manage vascular access site complications in comorbid patients at risk.

Management of post-puncture bleeding after neurointerventional procedures performed with a large-bore sheath introducer.

Various adjunctive techniques for neurointerventional procedures require a large-bore sheath introducer, but there is concern that this could result in more puncture site hemorrhagic complications despite using a vascular closure device. The purpose of this study was to assess the relationship between use of large-bore sheath introducer and post-procedural complications. Between January 2016 and April 2018, 126 neurointerventional procedures were performed in our hospital using 8 or 9 Fr sheath introducer in size and the Angio-Seal STS PLUS (St. Jude Medical, Minnetonka, USA). Hemorrhagic complications were defined as obvious swelling or bleeding at the puncture site or as extravascular bleeding detected by ultrasonography or contrast-enhanced computed tomography. The procedures were divided into a group with post-puncture bleeding (group B, n = 21) and a group without bleeding (group N, n = 105). Risk factors were compared between the groups according to the incidence of post-puncture bleeding. In addition, we assessed the outcome and approach to hemostasis in the procedures with bleeding. In result, hemorrhagic complications occurred in 21 procedures (17%), and pseudoaneurysm was detected in 4 procedures (3.2%). In 20 of group B (16%), manual compression was performed for an average of 36.4 min. One patient (0.79%) required surgical angioplasty. Risk factors for bleeding were not significantly different between the two groups. None of the patients with bleeding showed a decrease on the modified Rankin Scale. In conclusion, use of a large-bore sheath introducer may increase the incidence of post-puncture bleeding, but the outcome of this complication is acceptable.

Risk Factors for Puncture Site Complications Using the Angio-Seal Closure Device in Endovascular Therapy: A Single-center Analysis.

Objective: To retrospectively analyze the complication rates and risk factors associated with the use of the Angio-Seal vascular closure device during neuroendovascular therapy. Methods: In this study, we enrolled 283 patients who underwent Angio-Seal hemostasis between December 2005 and June 2019 at our institute. We retrospectively analyzed the major and minor complication rates and risk factors between the complication and no-complication groups using the medical charts of patients for whom the device was used. Results: Of the 283 patients, 5 had major complications (1.8%) and 18 had minor complications (6.3%). There were no significant differences between the complication (n = 23) and no-complication (n = 260) groups regarding the baseline characteristics or operation procedures. Among the major complications, superficial femoral artery puncture, 8Fr device, Angio-Seal Evolution, post-carotid artery stenting, dual antiplatelet therapy, and delirium were considered risk factors. Conclusion: The Angio-Seal is a safe and useful hemostatic device. However, puncture site complications need to be considered when the device is used for contraindicated patients or for those with delirium who cannot rest following the procedure.