Angio-Seal Device Research Articles

Transaneurysmal Suturing of Pseudoaneurysm Neck: Novel and Not a Pseudo-Technique for Treatment of Complicated Femoral Pseudoaneurysm

Abstract Introduction Femoral pseudoaneurysm is one of the common complications following femoral artery catheterization. It poses a significant morbidity and a nonsurgical technique with the utmost low complication risk is warranted. Various methods have been used to treat these pseudoaneurysms including manual compression, ultrasound-guided compression, and percutaneous injection of thrombin or glue. Various novel methods are also being used to treat the pseudoaneurysms, including angioseal closure device, vascular plugs, etc. Cirrhosis poses a separate challenge with deranged coagulation and hyperfibrinolysis, making traditional methods, which are dependent on patients' coagulation cascade, less effective. Materials and Methods We used a novel technique to treat the complicated femoral pseudoaneurysm using a suture-mediated closure device, Perclose ProGlide system (Abbott Vascular, California, United States). The transaneurysmal approach was used in seven patients. All the patients had acute or chronic liver disease with deranged coagulation. Six patients had femoral arterial access for angiographic procedure while one had a femoral line for intensive care unit monitoring. Compression was done in all the patients, but failed. Percutaneous injection of thrombin was done in two patients. Results Technical success was achieved in 7/7 (100%) patients. There was instantaneous thrombosis of the pseudoaneurysm, which was confirmed the next day by ultrasound. There were no procedure-related complications. Conclusion Transaneurysmal closure of the femoral pseudoaneurysm using suture-mediated closure device is a novel and effective, minimally invasive bedside technique that can be used in patients with deranged coagulation.

Feasibility and safety of endovascular interventions via percutaneous access to the axillary artery

Endovascular treatment of peripheral arterial disease requires safe and reliable arterial access. This study evaluates the feasibility and safety of percutaneous axillary artery access for endovascular therapy. A variety of anatomic and logistic obstacles can be overcome with upper extremity access. In this retrospective case review, we describe our experience with percutaneous trans-axillary access for lower extremity peripheral arterial disease intervention. Medical records of all patients undergoing axillary artery percutaneous access from December 2021 to August 2024 were reviewed. Demographic data, procedural details, and complications such as pseudoaneurysm, hematoma, nerve injury, and closure device success were analyzed. Technical success and perioperative complications-including bruising, edema, hematoma, nerve injury, infection, thrombosis, and pseudoaneurysm-were assessed. Clinical outcomes were analyzed via follow-up clinic records. During the study period, 79 axillary artery accesses were performed on 64 patients. The patients were 55% male and had typical vascular comorbidities: hypertension (87%), hyperlipidemia (68%), coronary artery disease (27%), stroke (19%), and diabetes (16%); 58% were active tobacco users, and 80% were former tobacco users. Axillary access facilitated peripheral endovascular procedures, including iliac intervention (55), femoral (44), mesenteric (16), tibial (11), and embolization or visceral aneurysm treatments. A 6F sheath and ultrasound-guided Angio-Seal closure device were uniformly employed, with no major complications, perioperative deaths, or reoperations required. Minor complications of bruising and edema were present in 11 patients (14%). Other minor complications such as hematoma, nerve injury, thrombosis, dissection, pseudoaneurysm, or limb ischemia were absent. Percutaneous axillary artery access demonstrates promise for complex endovascular interventions with a favorable safety profile. Advantages include avoidance of unfavorable femoral anatomy, improved working length compared with radial access, and enhanced control of visceral therapy. Bilateral iliac and lower extremity therapy is feasible in a single treatment as well. Percutaneous axillary artery access is a safe, reliable adjunct for enhancing endovascular arterial intervention capabilities.

Acute lower limb ischemia caused by repeat deployment of vascular closure device.

Vascular closure devices are used to facilitate faster hemostasis and earlier ambulation, improve patient comfort, and reduce length of hospital stay after percutaneous endovascular procedures. However, their use may rarely be associated with limb ischemia due to endothelial damage and arterial thrombosis. This report illustrates the case of a patient who experienced acute lower limb ischemia due to superficial femoral artery occlusion caused by repeat closure with Angio-Seal vascular closure device within 30 days in a small-caliber superficial femoral artery. The patient was surgically treated by vascular repair with a synthetic graft, and remains symptom-free in 3-year follow-up. Repeat deployment of vascular closure devices in the same access site within a period of 30 days may cause acute limb ischemia due to arterial thrombosis, especially in patients with small-caliber arteries, even in the absence of evident risk factors.

Mechanical marvels: robots in carotid artery stenting - a systematic review of effectiveness in neuroendovascular interventions

Aim: Carotid artery disease, or carotid stenosis, is a critical medical condition carrying the risk of stroke and fatality. The underlying pathology involves the accumulation of atheromatous plaques, leading to luminal constriction and disrupted blood flow. Endovascular interventions, such as carotid artery stenting (CAS), aim to restore vessel patency. Robotic assistance in CAS surgeries is rapidly evolving globally, offering precision and fatigue-free capabilities. Despite growing interest, a dedicated systematic review on robotic applications in CAS is notably absent. Methods: Adhering to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, a comprehensive search strategy involving five databases. Data extraction encompassed study origin, patient demographics, procedural details, procedure times, complications, fluoroscopy, and radiation parameters. Results: Over 199 articles were identified from five databases. Seven studies meeting inclusion criteria were analyzed. The predominant robotic system, CorPath GRX, demonstrated advantages such as remote operation, precision, and compatibility with various catheter sizes. Magellan Robotic System, employed in one study, showcased remote-controlled capabilities. These studies involved a total of 44 patients undergoing carotid artery stenosis procedures with robotic assistance. Reported complications included access site conversion, Angio-Seal device failure, and residual stenosis. Mean operation time varied from 34 to 85 min. Conclusions: The integration of robotic assistance in carotid interventions, as demonstrated by the CorPath GRX and Magellan Robotic System, holds significant promise in improving the precision and safety of CAS procedures. However, the limited number of studies, the high risk of bias, and the need for further research and standardization highlight the evolving nature of this technology.

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

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. 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. 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%). 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. 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.

The Utility of Ultrasound Guidance to Improve the Safety of Closure of Antegrade Common Femoral Artery Access after Lower Limb Revascularization

This study aimed to investigate the feasibility of ultrasound (US)-guidance in reducing adverse event (AE) rates when using Angioseal device during antegrade lower limb angioplasty via common femoral artery access. From December 2016 to November 2022, 1,322 patients were identified, including 1,131 (85.6%) patients who underwent US-guided closure and 191 (14.4%) who underwent non–US-guided closure. Moderate AEs were encountered in 10 (5.2%) patients in the non–US-guided closure group compared to 38 (3.4%) patients in the US-guided closure group (P = .208). Severe AEs were encountered in 4 (2.1%) patients in the non–US-guided closure group compared to 3 (0.3%) patients in the US-guided closure group (P = .010). Overall AEs occurred in 14 (7.3%) patients in the non–US-guided closure group compared to 41 (3.6%) patients in the US-guided closure group (P = .029). Binary logistic regression showed that only non-US guidance was an independent risk factor for the occurrence of severe AEs (P = .008).

Limb Ischemia Secondary to Inadvertent Intravascular Angio-Seal Closure Device Deployment

AbstractVascular closure devices (VCD) are frequently used after endovascular interventions to attain faster hemostasis, earlier mobilization, and patient comfort compared to manual compression. VCDs are safe. However, rare complications have been reported. We report a case of an inadvertent intravascular deployment of an Angio-Seal VCD causing limb ischemia and discussing management options from our experience and the previously published cases.

Impact of hemodynamic support in high-risk VT ablation procedures

Abstract Funding Acknowledgements Type of funding sources: None. Introduction It is an ongoing debate whether VT ablation is better performed in SR or during VT. During SR patients are in stable conditions, however, VT mechanisms can only be visualized during VT. Hemodynamic stability during VT is critical and is shorter in patients with structural heart disease and severely reduced left ventricular ejection fraction (LVEF). In unstable VT with need for cardioversion, the risk of map anatomy shifts is increased, but a precise anatomical reconstruction is crucial for successful ablation. Considering hemodynamic support during VT ablation, handling must be easy and as little disruptive to the ablation procedure as possible. Percutaneous left ventricular support systems with appropriate access size seem to be the most suitable, but are limited in their support capacity. The aim of this study was to evaluate, whether a hemodynamic support of a maximum of 3,5 L/min is sufficient to ensure hemodynamic stability even in faster VT. Methods The study enrolled patients with a history of one or more sustaining VTs and severely reduced LVEF. Procedure was performed under deep sedation. Transseptal and transaortal access was prepared to access the LV. In epicardial cases an additional subxiphoidal access was used. Impella CP with SmartAssist was introduced via the opposite groin. Hemodynamic support was started immediately after placement. VTs were induced via programmed RV and burst pacing. VT was mapped and ablated with the Carto 3 Mapping system. The need to frequently adjust pump setting, duration of hemodynamic stability during VT, identification of VT mechanism and ablation success were evaluated. Results 8 patients with a total of 21 VTs have been mapped, analyzed and ablated. 4/8 patients received epi-/endocardial ablation. With hemodynamic support, all VTs could be mapped under stable conditions (CLmedian VT = 360ms). 87,5% could be terminated during catheter ablation, in 50% no VT was reinducible after ablation. The median time for Impella placement was 20min. The Smart Assist Mode enabled an easy handling without the necessity of manual adjustments during the course of the case. The Impella could be explanted at the end of the procedure in 7 out of 8 cases. Femoral closure was done with either Proglide or AngioSeal closure device. Post procedural, one patient developed a segmental stenosis of the A. femoralis superficialis, most likely due to the Proglide device. This case was treated conservatively and recovered after a few months. Conclusion Hemodynamic support of a maximum of 3,5L/min provides adequate and effective support for mapping of sustained VTs. No manual adjustment was required and patients could in general be weaned directly at the end of the procedure. Broader benefits of this concept need to be evaluated in further studies.

Difficult Percutaneous Closure of Axillary Access.

This case illustrates step-by-step troubleshooting in difficult axillary access closure. A standard balloon-assisted dry closure technique; escalation of wire support; trial of different closure devices with understanding in their mechanisms of failure; meticulous deployment of closure devices under fluoroscopy; a novel approach in deliverance of Angio-Seal device in a hydrophilic braided sheath all contributed to successful hemostasis.

The “Pro-Seal” Large-Bore Arterial Access Closure Technique: Making the Best of What Is Available

The number of patients undergoing transcatheter aortic valve replacement (TAVR) and other percutaneous procedures for structural heart disease has risen in recent years and will likely continue to increase. Despite iterative improvements in delivery systems resulting in smaller sizes and entry profiles, large-bore vascular access will continue to be needed. Cardiovascular interventionalists are tasked with performing TAVR procedures as safely as possible while maintaining a low incidence of bleeding and ischemic access site complications—all while using commercially available vascular closure equipment.Multiple large-bore vascular closure devices are currently used in clinical practice; one of the most commonly employed is the suture-based Perclose ProGlide system (Abbott Vascular, Inc). Even though its versatility and effectiveness are acceptable, the Perclose ProGlide device does occasionally fail. How best to achieve complete hemostasis when a failure occurs remains to be determined.In this issue of the Journal, Cakal et al1 report their experience using an ANGIOSEAL device (Terumo Medical Corporation) in patients for whom Perclose ProGlide device deployment did not result in complete hemostasis. The authors performed a retrospective review of 185 patients who underwent TAVR in their center. In all individuals, vascular closure was performed using 2 Perclose ProGlide devices; in 46 of these patients, an 8F ANGIO-SEAL device was added as a “bailout” when the Per-close ProGlide device failed and persistent vascular bleeding was noted. The auxiliary ANGIO-SEAL device was deemed successful in all cases. No statistically significant differences in vascular complications were noted, although a higher incidence of hematoma formation was found in the ANGIO-SEAL bailout group.The findings from Cakal et al1 support the safety and feasibility of using an ANGIO-SEAL device as bailout when use of 2 Perclose ProGlide devices fails to achieve hemostasis in large-bore arterial closure—an approach that has come to be referred to as the “Pro-Seal” technique. These are welcome data because they inform current practice and broaden the operators' options in complex patients. Nonetheless, it is worth noting a particular limitation of this study and its proposed approach (beyond its limited number of patients and retrospective nature). Deciding when hemostasis is suboptimal remains a significantly subjective endeavor. It is unclear whether manual compression after Perclose ProGlide closure might have successfully controlled bleeding in some of these patients, thereby avoiding the use of an additional device that could cause further complications. Clarifying this point is especially important because the operators suggest a Perclose ProGlide failure rate exceeding 20%, which is significantly higher than expected. Fortunately, given the authors' experience, the downside of adding an ANGIO-SEAL device appears to be minimal.Even though a surgeon with experience in open vascular repair may be profoundly dissatisfied with the macroscopic and microscopic appearance of 2 Perclose ProGlide devices and 1 ANGIO-SEAL device in the arteriotomy site, the Pro-Seal technique appears to be an acceptable solution for completing the procedure safely and efficiently. This strategy is effective not only as bailout in case of bleeding but also as a planned strategy from the outset, as demonstrated in a large retrospective study.2 As expected, additional data confirming the utility, safety, and effectiveness of the Pro-Seal approach are needed, as is the development of newer and better closure devices designed from inception to be used specifically for large-bore access closure.

Angio-Seal Used as a Bailout for Incomplete Hemostasis After Dual Perclose ProGlide Deployment in Transcatheter Aortic Valve Implantation

The failure rate of vascular closure devices remains a significant cause of major vascular complications in contemporary transcatheter aortic valve implantation practice. This research aimed to evaluate use of the Angio-Seal device in a bailout context in the setting of incomplete hemostasis following use of dual Perclose ProGlide devices in patients undergoing transfemoral transcatheter aortic valve implantation. A total of 185 patients undergoing transfemoral transcatheter aortic valve implantation with either dual Per-close ProGlide (n = 139) or a combination of dual Perclose ProGlide and Angio-Seal (n = 46) were retrospectively analyzed. The baseline, procedural characteristics, and all outcomes (defined according to Valve Academic Research Consortium-2 criteria) were compared. No significant differences were seen between the dual Perclose ProGlide vs dual Perclose ProGlide+Angio-Seal groups with regard to the in-hospital Valve Academic Research Consortium-2 primary end points of major vascular complications (n = 13 [9.4%] vs n = 2 [4.3%]; P = .36), minor vascular complications (n = 13 [9.4%] vs n = 8 [14.7%]; P = .14), major bleeding (n = 16 [11.5%] vs n = 2 [4.3%]; P = .25), and minor bleeding (n = 9 [6.5%] vs n = 5 [10.9%]; P = .34), with higher rates of hematoma in the dual Perclose ProGlide+Angio-Seal group (n = 4 [2.9%] vs n = 5 [10.9%]; P = .044). Finding from the current study suggest that adjunctive Angio-Seal deployment may be feasible and safe, especially in patients with incomplete hemostasis following dual Perclose ProGlide use, and can be an optimal "bailout" procedure.

Abstract No. 519 Using the Angio-Seal closure device to treat iatrogenic common femoral artery pseudoaneurysms

The rate of femoral artery access complication ranges from 0.2% to 4.6% and includes hematoma, arteriovenous fistula, arterial occlusion, and pseudoaneurysm. This case series evaluates off-label use of the Angio-Seal closure device (St. Jude Medical, St. Paul, MN) to treat patients with PSA after common femoral access that were either not responsive or not amenable to more traditional methods.

The modified interventional method of antegrade common femoral artery access closure using the Angio-Seal device: modified Angio-Seal haemostasis technique: Modified Angio-Seal haemostasis technique.

Antegrade femoral puncture is frequently performed in endovascular therapy, with haemostasis achieved through manual compression. The aim of this paper is to report the novel method of achieving haemostasis using the Angio-Seal device for antegrade punctures of the femoral artery. Between September 2017 and March 2018, a total of 50 consecutive patients who underwent endovascular therapies (EVT) through the common femoral artery with an antegrade puncture using a 6 Fr introducer sheath were retrospectively analysed. After EVT, all patients received a 6 Fr Angio-Seal STS Plus Vascular Closure Device. All procedures were performed using the following new technique. First, we inserted the Angio-Seal guidewire from the inserted EVT sheath into the artery. Second, we removed the EVT sheath and inserted the Angio-Seal sheath and then removed the dilator and Angio-Seal guidewire. Under angiography using an 18 G needle sheath, we pulled back the Angio-Seal sheath as near to the insertion site of the vessel as possible. Finally, a collagen sponge and plug were inserted as per the standard technique. In all patients, the Angio-Seal was successfully deployed, and haemostasis was achieved within several minutes. No major complications occurred. We demonstrated the feasibility and efficacy of achieving haemostasis using the Angio-Seal device in an antegrade femoral puncture using the novel method.

Late Access Site Complications Following Transfemoral Aortic Valve Implantation

Few data exist on late vascular complications (VCs) after transfemoral (TF) transcatheter aortic valve implantation (TAVI). The objective of this study was to evaluate the incidence and predictors of late access site VC after TF TAVI. A total of 128 patients (mean age: 80 ± 8 years, women: 52%) who underwent TF TAVI without major VC were included. A femoral US-Doppler evaluation was performed in all patients at a median of 5 (3 to 15) months after the procedure, and 76 patients (59.4%) also had a preprocedural ultrasound (US)-Doppler examination. The impact of baseline and procedural factors (including the use of simple 2 Proglides or complex additional Proglide or Angioseal device on top of the 2 Proglide technique, hemostasis techniques, and the use of balloon dilation for optimizing femoral hemostasis) were evaluated. The follow-up US-Doppler evaluation detected 2 asymptomatic VCs (1.6%), and 5 (3.9%) patients exhibited significant femoral stenosis (peak systolic velocity [PSV] ≥300 cm/s). Female gender (p <0.001) and smaller femoral diameter (p=0.045) were associated with higher femoral PSV values. In those patients who underwent a pre-TAVI femoral US-Doppler, the median PSV values after TAVI were higher compared with those obtained pre-TAVI (p <0.001), but similar results were found for the contralateral femoral arteries. A complex hemostasis technique or the use of balloon optimization at the puncture site was not associated with any increase in PSV values. In conclusion, percutaneous femoral hemostasis after TAVI was associated with a low rate of late VC. The results were similar irrespective of the hemostasis technique and the use of balloon dilation at the puncture site, but women and a smaller femoral size were associated with increased PSV values. Further studies are needed to determine the optimal femoral hemostasis technique in TAVI procedures.

Analysis ofpredictiveandpreventivefactorsfor access complications associated with vascular closure devices in complicated endovascular procedures.

The main goal is to evaluate the effectiveness of angioseal and starclose vascular closure devices (VCDs) in high-risk patients under intensive anticoagulation who require therapeutic angiographic procedures and to discuss which factors are important in complications associated with VCDs. Medical records of the patients who underwent therapeutic complex interventional vascular procedures were reviewed retrospectively. One hundred sixty-six patients were divided into two groups regarding VCDs used for access-site closure after the procedure: group 1, (angioseal); group 2, (starclose). Data including patients' demographics and comorbidity information, procedural characteristics, and complications were analyzed. The device deployment success rate was 100%. For the procedural characteristics, there was no significant difference between the groups except access site (P = 0.016) and sheath size > 6F (P = 0.0001). No major complications had occurred in none of the patients. Minor complications including hematoma, access-site pain, and access-site infection, except prolonged hemostasis did not differ significantly between groups. The patients' demographic and periprocedural factors were not significantly correlated with the development of complications. Contrary to published reports, our study showed that demographic and periprocedural factors may not be responsible for the vascular access-site complications associated with VCDs.

Abstract No. 492 Comparison of complication rates associated with Celt and Angio-Seal vascular closure devices: a single-center retrospective review

Celt and Angio-Seal are prominent vascular closure devices (VCD) used for achieving hemostasis at the access site after endovascular procedures. The Celt uses a stainless-steel plug and the Angio-Seal uses a collagen-based plug. Complications of VCD placement include pseudoaneurysm, arteriovenous fistula formation, hematoma, and limb ischemia. To date, there is a paucity of published studies comparing the safety of these devices in interventional radiology (IR). We investigated the rates of complications between Celt and Angio-Seal in patients within interventional radiology.

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

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. 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. 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). 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.

Iatrogenous puncture of the aortic arch closed with ProGlide.

An 89-year-old woman was referred to our hospital owing to syncope caused by an atrioventricular conduction disease. She presented with a past medical history of hypertension, dyslipidemia, and depression. A temporary balloon-tipped pacemaker electrode was inserted in the emergency department through the right jugular vein. Jugular catheter placement is a routine procedure. Several authors recommend the use of ultrasound guidance to avoid complications, such as arterial injury. Saugle et al1Saugle B. Scheeren T.W.L. Teboul J.L. Ultrasound-guided central venous catheter placement: a structured review and recommendations for clinical practice.Crit Care. 2017; 21: 225Crossref PubMed Scopus (135) Google Scholar reviewed the literature and described six steps to perform ultrasound-guided jugular catheter placement: identify the anatomy of the insertion site and localize the vessels, confirm the patency of the jugular vein with a compression test, use real-time ultrasound guidance for puncture of the vein, confirm needle position in the vein, confirm the wire position, and confirm the catheter position in the vein. In our case, a percutaneous echocardiography-guided puncture of the jugular vein was made; however, once the 6F sheath was placed inside, an arterial flow was obtained from the sheath; therefore, the on-call cardiologist considered it to be placed in the carotid artery. Upon examination, an abnormally oblique position of the sheath was observed in the patient's neck (A). Doppler ultrasound examination revealed no contact between the sheath and the supra-aortic trunks. Arteriography was performed through the sheath, revealing an introducer placed in the aortic arch (B and C/Cover). After a multidisciplinary consensus, owing to the patient's age and the difficulty of open sheath withdrawal, a percutaneous artery closure device was used. Under general anesthesia and controlled hypotension, the 6F sheath was removed and the aortic arch was closed with a ProGlide (Abbott Laboratories, Chicago, Ill). A computed tomography scan after the procedure revealed a hematoma at the superior mediastinum close to supra-aortic trunks without signs of bleeding (D). The patient was admitted to the coronary unit with strict control of the blood pressure. After 48 hours, a permanent pacemaker was inserted. One week later, the patient was discharged home. The patient provided consent for the publication of her case details and imaging. Inadvertent arterial puncture during central venous catheter placement is a well-known complication.2Bowdle A. Vascular complications of central venous catheter placement: evidence-based methods for prevention and treatment.J Cardiothorac Vasc Anesth. 2014; 28: 358-368Abstract Full Text Full Text PDF PubMed Scopus (70) Google Scholar In the majority of cases of misplaced jugular catheters, the carotid artery is punctured. Accidental aortic arch puncture is a rare complication and its treatment includes open surgery with median sternotomy.3Sellem M.I. Al-Hashemy A.A. Al-Naemi A. Ectopic intra-aortic insertion of a subclavian central venous catheter: case report and review of the literature.J Thorac Cardiovasc Surg. 2004; 127: 1515-1516Abstract Full Text Full Text PDF PubMed Scopus (5) Google Scholar Since the advent of percutaneous closures, some authors have described their use in the management of accidental artery puncture.4Pikwer A. Acosta S. Kölbel T. Malina M. Sonesson B. Akeson J. Management of inadvertent arterial catheterisation associated with central venous access procedures.Eur J Vasc Endovasc Surg. 2009; 38: 707-714Abstract Full Text Full Text PDF PubMed Scopus (53) Google Scholar We found one case in the literature where an aortic arch puncture was treated with a percutaneous closure. In this case, the puncture of the aorta was done during subclavian catheter placement and they used Angio-Seal Vascular Closure Device (St Jude Medical, Saint Paul, Minn).5Leijdekkers V.J. Go H.L.S. Legemate D.A. Reekers J.A. The use of percutaneous closure device for closure of an accidental puncture of the aortic arch; a simple solution for a difficult problem.Eur J Vasc Endovasc Surg. 2006; 32: 94-96Abstract Full Text Full Text PDF PubMed Scopus (7) Google Scholar In our case, there was no option for open repair owing to patients comorbidities. We preferred to use a suture-mediated closure system (ProGlide) because we have experience using this system in peripheral arteries. This case highlights that complications may occur and, even though there is no indication for the use of the ProGlide system in aortic puncture, we have to be able to individualize the treatment plan for this patients without other available options. The authors thank Dr Bernat Lloret Villas for his expertise and assistance with patient management.

Single Angio-Seal vascular closure device for transfemoral access exceeding 8F

BackgroundThis was a retrospective single-center evaluation for off-label use of a single Angio-Seal-VIP 8F vascular closure device (VCD) (Terumo Interventional Systems, Somerset, NJ, USA) for retrograde transfemoral arterial access exceeding 8F. MethodsBetween 2010 and 2018, in 32 consecutive patients (3 females; mean age 67±9; range 46–86 years) retrograde femoral access was performed in 48 groins for aortoiliac stent or stent graft implantations using 9-14F sheaths. For vascular closure, one single Angio-Seal™-VIP 8F was used. Procedural success, closure-related complications, and risk factors were retrospectively evaluated using patient characteristics, duplex-ultrasound, and contrast-enhanced computed tomography angiography (CTA). Receiver-operating-characteristics were used for statistical analysis. ResultsTechnical success for deployment of VCD was 100%. Visual inspection and duplex-ultrasound confirmed immediate hemostasis in 100%. Postinterventional CTA depicted major vascular access site complications in 6.3% (3/48 groins) requiring surgical treatment. A subgroup of 13 patients underwent surgical cut-down one day after VCD deployment as part of a two-staged complex endovascular aortic aneurysm repair procedure, allowing for visual assessment of prior used undersized Angio-SealTM. Patient's height (p=0.028) and severe access site calcifications (p=0.028) proved as predictors for one vessel occlusion and two pseudoaneurysms. Low body-mass-index (BMI) showed a non-significant trend. Sheath-size, common femoral artery depth, or body weight were not indicative for occurrence of complications. ConclusionsIn selected cases, without availability of appropriate VCDs, a single Angio-SealTM-VIP 8F served as a feasible option to achieve sufficient hemostasis of transfemoral access exceeding 8F without relevant bleeding complications. Very low BMI, tall body-height, and severe atherosclerosis were identified to predispose to access site complications.

4:21 PM Abstract No. 51 Safety and efficacy of arterial closure devices following antegrade femoral access: a case-control study

Vascular closure device (VCD) use following antegrade femoral access is not indicated by the Food and Drug Administration, and may present unique anatomic challenges relative to retrograde access. We compared safety and efficacy of three devices between antegrade and retrograde access cohorts undergoing percutaneous intervention. A consecutive series of 107 limbs in 84 patients underwent VCD arteriotomy closure following percutaneous revascularization using an antegrade approach (VCD-A). These were compared with a contemporaneous control group of 402 limbs in 306 patients who underwent closure following retrograde access (VCD-R) (n = 509) during revascularization and/or embolization procedures. Device deployment success, patient time to ambulation, and major/minor complications were compared between the two groups. Antegrade closure was attempted in the VCD-A cohort using 53 StarClose (Abbott, Santa Clara, CA), 35 Perclose (Abbott), and 19 Angio-Seal (Terumo, Somerset, NJ) devices. Hemostasis (without supplemental manual compression) was achieved in 86/107 (80.4%) limbs. In the VCD-R group, closure was attempted using 215 StarClose, 120 Perclose, and 67 Angio-Seal devices, with hemostasis achieved in 357/402 (88.8%) limbs without supplemental manual compression. Device deployment failure occurred in 7/107 (6.5%) of VCD-A patients and 20/402 (5.0%) of VCD-R patients (P = 0.48). Femoral pseudoaneurysm developed in 1/107 and 1/402 of VCD-A and VCD-R patients (P = 0.38). Major hematoma requiring further intervention developed in 1/107 and 1/402 of VCD-A and VCD-R patients (P = 0.38), and minor hematoma not requiring further intervention developed in 3/107 and 8/402 of the VCD-A and VCD-R (P = 0.71). Mean time to ambulation was 204.1 minutes in the VCD-A group and 204.8 minutes in VCD-R (P = 0.97). In both VCD-R and VCD-A groups, the StarClose, Perclose, and Angio-Seal devices were associated with similar rates of deployment failure (P = 0.080; P = 0.67). Antegrade femoral closure among the studied devices was associated with high rates of technical success and low complications, similar to retrograde closure. Time to ambulation was similar among VCD-A and VCD-R groups.Tabled 1ComplicationVCD-R (n = 402)VCD-A (n = 107)PDevice failure2070.48Pseudoaneurysm110.38Major hematoma110.38Minor hematoma830.71Supplemental manual compression25140.030 Open table in a new tab