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Introduction: Embolisation of type II internal iliac artery endoleaks is challenging given limited options for obtaining transarterial access and for achieving access site haemostasis. Report: An 86 year old woman who had undergone endovascular repair for an aorto-iliac aneurysm was found to have serial enlargement of the left common iliac artery portion of the aneurysm observed over a period of two years. At the time of the initial repair, the left internal iliac artery was embolised using coils, and then was covered by extending the iliac limb endoprosthesis into the external iliac artery. However, computed tomography angiography showed recanalisation of the previously coiled left internal iliac artery, thus allowing contrast to flow into the left common iliac aneurysm sac. Given that the internal iliac artery origin was covered and there was no visible collateral pathway, direct puncture of the superior gluteal artery was selected to access the left internal iliac artery in a retrograde fashion. This presented a challenge in terms of achieving haemostasis given the deep position of the arterial access site, which was unlikely to be amenable to manual compression. Off label StarClose was chosen for closure of the superior gluteal arterial access, with successful haemostasis and preserved patency of the vessel. Discussion: Off label StarClose was used successfully to obtain haemostasis after obtaining percutaneous transgluteal access to the superior gluteal artery in order to embolise a type II endoleak arising from the internal iliac artery. Keywords: StarClose; Iliac artery type II endoleak; Arterial closure device; Haemostasis; Superiorgluteal artery

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. [ABSTRACT FROM AUTHOR]

Objective: To assess the safety and efficacy of the StarClose device following intra-aortic balloon pump (IABP) counterpulsation using 8-Fr femoral sheaths. Subjects and Methods: From June 2008 to August 2012, 42 consecutive patients who received IABP implantation via common femoral artery (CFA) punctures with an 8-Fr sheath (which were then sealed with the StarClose Vascular Closure System at the bedside) were included in this retrospective single-arm study. All the patients underwent duplex control of the puncture site 24 h after deployment of the device, in order to determine the presence or absence of vascular complications including hematoma, pseudoaneurysm, arteriovenous fistula and arterial/venous thrombosis or stenosis. The safety end points were the vascular complications during the hospital stay, and the efficacy end points included device and procedure success. Results: The procedure success rate was 92.9% (39/42) and the device success rate was 88.1% (37/42). Major vascular complications occurred in 3 (7.1%) patients; 1 developed a massive hematoma >10 cm which was managed by blood transfusion and surgical reconstruction, and the other 2 developed pseudoaneurysm which was cured by ultrasound-guided thrombin injection or manual compression. Minor vascular complications occurred in 5 (11.9%) patients, including blood oozing in 2, hematoma <5 cm in 2 and severe pain in the remaining patient. Conclusion: CFA closure with the StarClose device was safe, feasible and effective in patients undergoing IABP support using 8-Fr sheath sizes. © 2014 S. Karger AG, Basel [ABSTRACT FROM AUTHOR]

Coronary angiography is often performed via the femoral artery. Following removal of the arterial sheath, there are various methods of closing the arteriotomy. The traditional method is to use manual compression. Vascular closure devices emerged in the 1990s to promote more rapid haemostasis. This article reviews the various vascular closure devices on the market today, examining their mechanisms of action, as well as their individual advantages and disadvantages. [ABSTRACT FROM AUTHOR]

Objectives: The goal of this study was to assess the frequency and predictors of vascular closure device (VCD) deployment failure, and its association with vascular complications of 3 commonly used VCDs. Background: VCDs are commonly used following percutaneous coronary intervention on the basis of studies demonstrating reduced time to ambulation, increased patient comfort, and possible reduction in vascular complications as compared with manual compression. However, limited data are available on the frequency and predictors of VCD failure, and the association of deployment failure with vascular complications. Methods: From a de-identified dataset provided by Massachusetts Department of Health, 23,813 consecutive interventional coronary procedures that used either a collagen plug–based (n = 18,533), a nitinol clip–based (n = 2,284), or a suture-based (n = 2,996) VCD between June 2005 and December 2007 were identified. The authors defined VCD failure as unsuccessful deployment or failure to achieve immediate access site hemostasis. Results: Among 23,813 procedures, the VCD failed in 781 (3.3%) procedures (2.1% of collagen plug–based, 6.1% of suture-based, 9.5% of nitinol clip–based VCDs). Patients with VCD failure had an excess risk of “any” (7.7% vs. 2.8%; p < 0.001), major (3.3% vs. 0.8%; p < 0.001), or minor (5.8% vs. 2.1%; p < 0.001) vascular complications compared with successful VCD deployment. In a propensity score–adjusted analysis, when compared with collagen plug–based VCD (reference odds ratio [OR] = 1.0), nitinol clip–based VCD had 2-fold increased risk (OR: 2.0, 95% confidence interval [CI]: 1.8 to 2.3, p < 0.001) and suture-based VCD had 1.25-fold increased risk (OR: 1.25, 95% CI: 1.2 to 1.3, p < 0.001) for VCD failure. VCD failure was a significant predictor of subsequent vascular complications for both collagen plug–based VCD and nitinol clip–based VCD, but not for suture-based VCD. Conclusions: VCD failure rates vary depending upon the type of VCD used and are associated with significantly higher vascular complications as compared with deployment successes. [Copyright &y& Elsevier]

Background: Following percutaneous intervention, obtaining femoral artery hemostasis quickly and reliably with few complications is of considerable importance. While the StarClose device has been studied in patients undergoing cardiac catheterization, its use in patients undergoing treatment for peripheral vascular disease has rarely been reported. It is the purpose of this report to determine whether the Starclose is able to deliver safe and effective femoral artery closure in this group of patients. Methods: The records of all patients undergoing StarClose closure of the femoral artery by or under the supervision of a single vascular surgeon were reviewed. Indication, type of intervention, and size of the vascular sheath employed were noted. Times to mobilization and discharge were tabulated. Complications including hemorrhage, pseudoaneurysm, infection, and vessel occlusion were recorded. Results: Between February 2006 and September 2009, 603 StarClose nitinol clip closure devices were deployed in 478 patients. In all, 97 procedures were diagnostic and 506 included therapeutic interventions. A total of 97 5F sheaths, 465 6F sheaths, and 41 7F sheaths were employed. Time to ambulation and discharge was 44.2 ± 13.2 minutes and 119.3 ± 22.6 minutes in patients in whom a 5F sheath was used, 112.5 ± 13.5 minutes and 157.5 ± 20.6 minutes when a 6F sheath was used, and 121.9+/-38.8 minutes and 160.2+/-43.2 minutes when a 7F sheath was employed. The clip could not be successfully deployed in 21 arteries (3.5%) and manual compression was successful in achieving hemostasis in 17 patients without complication. Three patients (0.5%) developed major hematomas requiring transfusion; 1 patient developed a pseudoaneurysm (0.17%) requiring thrombin injection. A single patient (0.17%) occluded his common femoral artery following StarClose deployment and 1 patient (0.17%) developed a femoral artery stenosis requiring balloon dilatation. No patient developed a groin infection. Conclusions: The StarClose provides a safe and reliable method of achieving femoral artery closure following percutaneous intervention for peripheral arterial disease. When successfully deployed, it allows for early ambulation and discharge. Since it remains entirely extraluminal, it offers advantages over other closure devices and can be safely used in the vast majority of patients with peripheral vascular disease. [ABSTRACT FROM PUBLISHER]

Abstract: Background: Transradial access (RA) is associated with less complications and is preferred by patients. Vascular closure devices (VCDs) may improve discomfort and may reduce complications associated with transfemoral access. Aim was to evaluate complications and discomfort associated with percutaneous coronary procedures employing RA or VCDs. Methods: We enrolled 1492 consecutive patients who underwent percutaneous coronary procedures with RA (604 procedures), femoral approach with manual compression (MC) (276 procedures), or with either Angioseal™ (311 procedures) or Starclose™ (301 procedures) closure device. Discomfort was assessed using procedure-specific questions. Major vascular complications were evaluated during hospitalization. Results: RA significantly reduced major complications (0.7%) compared to either the MC (2.9%, p =0.03) or the VCDs (Starclose™ 2.7%, Angioseal™ 3.9%, p =0.003). There were no significant differences in major complications between MC and either the Angioseal™ or the Starclose™. At multivariate analysis the RA was predictor of reduced complications (OR 0.26, 95% CI 0.08–0.85, p =0.03 vs MC, and OR 0.19, 95% CI 0.07–0.57, p =0.003 vs VCDs). The RA was associated with a significant reduction in procedural discomfort with 44.2% of patients referring no discomfort (p <0.0001). Starclose™ and Angioseal™ were better tolerated than MC (27.8%, 29.3% and 8.9% patients respectively without discomfort, p <0.0001). Conclusions: RA is associated with a significant reduction in major vascular complications compared to femoral approach even if two different VCDs are employed. VCDs are better tolerated than MC but the RA was associated with the lowest discomfort. [Copyright &y& Elsevier]

StarClose is a novel arterial closure device which achieves hemostasis, following arteriotomy, via a nitinol clip deployed on the outer arterial wall. Since its introduction to the market, several studies have shown StarClose to be both safe and effective, with few major complications encountered. We report a case of common femoral artery laceration following deployment of the StarClose vascular closure system. We conclude that the injury occurred secondary to intravascular misplacement of the nitinol clip. [ABSTRACT FROM AUTHOR]

The StarClose device (Abbott Vascular Devices; Abbott Laboratories, Redwood City, CA) utilizes an externally placed Nitinol clip to achieve arterial closure following femoral artery puncture. The objectives of this study were to assess the efficacy and complications of the StarClose device in patients undergoing interventional radiological procedures. Preprocedural clotting status, pulse and blood pressure, severity of vessel calcification, sheath size, and time to deployment were recorded. Postdeployment complications immediately postprocedure, at 1 h, at 2 h, and at 1 week were recorded. A duplex scan was performed in the first 10 patients to assess any immediate vascular complications. Deployments were successful in 96% achieving immediate hemostasis. Mean deployment time was 48 s. There were no major complications. The StarClose device was found to have a high technical and clinical efficacy. [ABSTRACT FROM AUTHOR]

We compared the use of manual compression and Angio-Seal and Starclose arterial closure devices to achieve hemostasis following common femoral artery (CFA) punctures in order to evaluate safety and efficacy. A prospective nonrandomized, single-center study was carried out on all patients undergoing CFA punctures over 1 year. Hemostasis was achieved using manual compression in 108 cases, Angio-Seal in 167 cases, and Starclose in 151 cases. Device-failure rates were low and not significantly different in the two groups (manual compression and closure devices; p = 0.8). There were significantly more Starclose (11.9%) patients compared to Angio-Seal (2.4%), with successful initial deployment subsequently requiring additional manual compression to achieve hemostasis ( p < 0.0001). A significant number of very thin patients failed to achieve hemostasis ( p = 0.014). Major complications were seen in 2.9% of Angio-Seal, 1.9% of Starclose, and 3.7% of manual compression patients, with no significant difference demonstrated; 4.7% of the major complications were seen in female patients compared to 1.3% in males ( p = 0.0415). All three methods showed comparable safety and efficacy. Very thin patients are more likely to have failed hemostasis with the Starclose device, although this did not translate into an increased complication rate. There is a significant increased risk of major puncture-site complications in women with peripheral vascular disease. [ABSTRACT FROM AUTHOR]

Abstract: Access site complication rates remain relatively high following interventional procedures and have not been shown to be reduced by the use of vascular closure devices. This report describes an ultrasound-assisted technique of deploying one type of vascular closure device, the StarClose (Abbott Vascular, Illinois, USA). This technique has significantly reduced failure rates and complication rates since its introduction. The technique is relatively simple but requires familiarity with the use of ultrasound and the StarClose device. [Copyright &y& Elsevier]

Objectives: This study is the first head-to-head analysis of StarClose vs. ProGlide in patients undergoing 5F or 6F percutaneous coronary catheterization or peripheral artery interventions., Background: The clip based StarClose and the suture mediated ProGlide vascular closure device are well established for femoral hemostasis in endovascular therapy. However, until now no prospective randomized study compared the safety and efficacy of the two devices., Methods: This prospective, randomized, single-center study enrolled 505 patients (69.6 ± 11.2 years) resulting in 538 procedures due to more than one intervention in several patients: We analyzed 422 cardiac catheterization and 116 peripheral artery interventions via a common femoral artery access. Patients were randomized to StarClose or ProGlide (1:1). In-hospital complications (major bleeding, hematoma, pseudoaneurysm, vessel occlusion, and arteriovenous fistula) and device failure were recorded. The puncture site was assessed by ultrasound in all patients prior to discharge., Results: Overall complication rate was 3.9%. There were more complications after utilization of StarClose compared to ProGlide (5.6 vs. 2.2%, P = 0.064), which was significant in adjusted logistic regression analysis with a 2.9-fold increased risk of complications for StarClose (P < 0.05). In the subgroup of coronary catheterizations there were significantly more complications for StarClose compared to ProGlide (1.4 vs. 5.2%, P < 0.05) with a 4.7-fold increased risk. Device failure rate was not significantly different between the two devices., Conclusion: In this first randomized trial comparing the two closure systems complication rate was higher for StarClose with equal efficacy compared to ProGlide. © 2017 Wiley Periodicals, Inc., (© 2017 Wiley Periodicals, Inc.)

Background: In the past two decades vascular closure devices (VCD) have been increasingly utilized as an alternative to manual compression after percutaneous femoral artery access. However, there is a lack of data confirming a significant reduction of vascular complication in a routine interventional setting. Systematic assessment of puncture sites with ultrasound was hardly performed., Methods: 620 consecutive patients undergoing elective or urgent percutaneous coronary intervention were randomly allocated to either Angioseal (AS; n = 210), or Starclose (SC; n = 196) or manual compression (MC; n = 214). As an adjunct to clinical evaluation vascular ultrasonography was used to assess the safety of each hemostatic method in terms of major and minor vascular complications. The efficacy of VCDs was assessed by achievement of puncture site hemostasis., Results: No major complications needing transfusion or vascular surgery were observed. Furthermore, the overall incidence of clinical and subclinical minor complications was similar among the three groups. There was no differences in the occurrence of pseudoaneurysmata (AS = 10; SC = 6; MC = 10), arteriovenous fistula (AS = 1; SC = 4; MC = 2) and large hematoma (AS = 11; SC = 10; MC = 14). The choice of access site treatment had no impact in the duration of hospital stay (AS = 6.7; SC = 7.4; MS = 6.4 days)., Conclusions: In the setting of routine coronary intervention AS and SC provide a similar efficacy and safety as manual compression. Subclinical vascular injuries are rare and not related to VCD use.