StarClose Device Research Articles

Use of the Starclose Device for Closure of Inadvertent Subclavian Artery Punctures

The placement of central catheters is a common procedure. It is also associated with multiple known complications. One of the potential complications that carry high morbidity and morality is arterial puncture and cannulation. Herein, we describe five case reports of a central line that was inadvertently placed in the subclavian artery and successfully removed using a StarClose device (Abbott Laboratories, Redwood CA). A retrospective chart review of a prospectively maintained database was performed. We identified five cases of inadvertent subclavian artery cannulation during central venous catheter placement. All catheters were removed successfully either in the operating room under fluoroscopic guidance or at the bedside with closure of the arteriotomy using the StarClose device. No cases required conversion to an open procedure for repair. No postremoval hematomas, bleeding episodes, myocardial infarctions, arrhythmias, or adverse clinical sequelae were identified. Based on our limited experience, we feel that this method can be performed safely and expeditiously not only in the operating room but also at the bedside.

Safety and Efficacy of the StarClose Vascular Closure System Using 7-F and 8-F Sheath Sizes:A Consecutive Single-Center Analysis

To assess the safety and efficacy of the StarClose device following peripheral vascular interventions employing 7-F and 8-F femoral sheaths. From May 2006 to December 2007, 226 consecutive patients (143 men; mean age 69 years, range 36-92) underwent 231 groin punctures (150 with a 7-F sheath and 81 with an 8-F sheath) that were sealed with the StarClose Vascular Closure System. All the patients underwent duplex control of the puncture site 24 hours after deployment of the device to determine the presence of vascular complications (hematoma, pseudoaneurysm, arteriovenous fistula, and arterial/venous thrombosis or stenosis). Endpoints were major vascular complications during the hospital stay, device success (hemostasis using the StarClose device alone or with <5 minutes of adjunctive compression and freedom from major vascular complications), and procedure success (hemostasis established using any method and freedom from major vascular complications). Procedural success was 96.0% (144/150) for the 7-F group and 97.5% (79/81) in the 8-F group. Device success was achieved in 91.3% (137/150) of the 7-F group and 90.1% (73/81) the 8-F group. Major vascular complications occurred in 4.1% (6/150) of the 7-F group: 1 patient developed massive retroperitoneal hematoma that required blood transfusion and surgical evacuation, 2 patients presented new ipsilateral lower extremity ischemia requiring revascularization, and 3 other patients developed pseudoaneurysm treated by ultrasound-guided compression or thrombin injection. In the 8-F group, only 2 (2.5%) patients had a major complication: 1 developed a high-grade stenosis of the punctured femoral artery that required angioplasty and the other developed massive retroperitoneal hematoma followed by blood transfusion and surgical evacuation. Minor complications occurred at a rate of 11.3% (17/150) in the 7-F group and 9.9% (8/81) in the 8-F group. Common femoral artery closure with the StarClose device following peripheral vascular procedures utilizing 7-F and 8-F sheath sizes is feasible, with few device-specific complications. A randomized trial of a larger number of patients comparing standard compression methods and StarClose is warranted.

Re‐access complication with a starclose device

Diagnostic cardiac catheterizations are predominantly performed using access through the femoral artery. To improve patient comfort and early mobilization, a number of percutaneous closure devices have been developed. One such device using the nitinol clip was developed by Abbott Vascular Devices and was approved for use on the basis of the results of the Clip Closure In Percutaneous Procedures (CLIP) study. The safety of repuncture through a previously deployed device has not been established in humans. We present the case of a patient who had an arterial line placed for post-operative monitoring after cardiac surgery at the site of a previous arteriotomy closed with the Starclose device. The catheter traversed through the central portion, tethered to the periphery of the ninitol clip, and required surgery for extraction.

VS14P THE USE OF ULTRASOUND TO ASSIST DEPLOYMENT OF THE STARCLOSE(TM) VASCULAR CLOSURE DEVICE

Purpose: Arterial access site complications have not been reduced by the introduction of vascular closure devices. An ultrasound guided technique for the StarClose(tm) device was introduced in an attempt to reduce complications.Methodology: A prospectively collected series of 197 consecutive StarClose deployments using standard and ultrasound guided techniques of deployment were studied from the Repatriation General Hospital. Outcomes with regards to complication and failure rates were collected and analysed.Results: 39.6% were deployed using an ultrasound guided technique and 60.1% with standard deployment. There was a significant reduction in failure rates (p &lt; 0.05) with use of ultrasound guidance and a reduction in complications that did not reach significance (p = 0.23).Conclusion: The introduction of an ultrasound guided technique of deployment can significantly reduce failure rates with the StarClose device and may reduce complications.

The Use of Ultrasound to Assist Deployment of the StarClose Vascular Closure Device in Arterial Access Sites

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.

A randomized controlled trial comparing StarClose and AngioSeal vascular closure devices in a district general hospital

A randomized controlled trial comparing StarClose and AngioSeal vascular closure devices in a district general hospital.

The Utility of the StarClose Arterial Closure Device in Patients with Peripheral Arterial Disease

The StarClose (Abbott Vascular, Redwood City, CA) arterial closure device utilizes an extraluminal nitinol clip to establish hemostasis. The purpose of this study was to determine the safety and efficacy of StarClose from a prospective peripheral arterial disease (PAD) registry. Over an 18-month time interval, 500 StarClose devices were used in 378 consecutive patients with symptomatic PAD after diagnostic and/or therapeutic endovascular cases. Patient demographics along with objective criteria including duplex ultrasound images, common femoral artery flow velocities, and ankle-brachial indexes (ABIs) were analyzed before and after StarClose placement. All outpatients received prophylactic antibiotic (one dose), periprocedural heparin (without protamine reversal), and antiplatelet therapy. Aspirin and clopidogrel (Plavix) was used for all patients undergoing therapeutic intervention. There were 378 patients who underwent procedures for aortoiliac or infrainguinal PAD, 99 of which were bilateral. Of the 500 arteriotomy closures, 296 were therapeutic interventions with sheath sizes of 6-8 F in the common femoral artery. The diagnostic studies (n = 204 arteriotomies) were performed with a 5F sheath. The technical success in achieving hemostasis was 97.2%; only 14 devices had a deployment problem requiring prolonged manual compression. Median length of stay was 157 min for patients done on an outpatient basis. Eleven of 260 (4.2%) on duplex follow-up had a doubling of the peak systolic velocity, only one of which was symptomatic. Late follow-up showed 42 of 360 (11.7%) with a drop in ABI >0.10. Nine major complications (2.0%) were identified in follow-up. The StarClose closure device has a low major complication rate and is safe and efficacious in patients with PAD, although stenosis at the arteriotomy site may occur. The device has achieved rapid hemostasis without need for anticoagulant reversal and requires significantly less time to ambulation than manual compression.

Posterior wall capture and resultant common femoral occlusion complicating StarClose access closure

Vascular closure devices have been shown to decrease hemostasis and ambulation time after percutaneous transcatheter procedures. The StarClose Vascular Closure System (Abbott Vascular, Redwood City, Calif) is a shape memory clip-mediated device that is designed to provide extraluminal mechanical closure without compromising the arterial lumen. We report a case of iatrogenic arterial occlusion secondary to mechanical closure of the anterior and posterior walls of the common femoral artery with a StarClose device. We provide objective observations from the rescue surgical intervention and discuss potential mechanisms of device failure.

A clinical evaluation of the StarClose device in patients who are ambulated early post-diagnostic catheterization procedure

A clinical evaluation of the StarClose device in patients who are ambulated early post-diagnostic catheterization procedure

A randomised controlled trial comparing StarClose and AngioSeal vascular closure devices in a district general hospital - the SCOAST study

AngioSeal and StarClose are vascular closure devices (VCDs) that can be used following cardiac catheterisation via the femoral artery to achieve haemostasis. Both devices have been demonstrated to be superior to conventional manual pressure, which reduce time to haemostasis and time to patient ambulation. We sought to compare these devices in a prospective, randomised trial. Patients undergoing elective coronary angiography were randomised to receive either AngioSeal VIP or StarClose VCD with immediate postprocedure mobilisation. Bruising was recorded at 30 min, 60 min and at 1 week postprocedure. Patient satisfaction surveys were taken at 1 h and 1 week postprocedure. Complications for both groups were compared. Four hundred and one patients were included. Arteriotomy closure was achieved in 144 of 208 (69.2%) patients randomised to AngioSeal and 134 of 193 (69.3%) patients randomised to StarClose (p = ns). There was no significant bruising in either group at either 30 or 60 min postprocedure. However, at 1 week, there was significantly more bruising in the AngioSeal group than the StarClose group (63.1 vs. 38.5cm2, p = 0.02). Patient satisfaction and pain perception with the procedure at closure were not significantly different between the groups. Deployment success and instant mobilisation rates were significantly lower for junior, as compared with senior, operators. Achievement of haemostasis is similar with both AngioSeal and StarClose. The StarClose vascular closure device results in significantly less bruising at 1 week postprocedure as compared with AngioSeal, with no significant differences in complication rates. Patients' pain perception and satisfaction are similar with both VCDs.

Arterial Puncture Closure Using a Clip Device After Transpopliteal Retrograde Approach for Recanalization of the Superficial Femoral Artery

To report the safety and efficacy of a clip device to close retrograde popliteal artery puncture sites used in recanalization of the superficial femoral artery (SFA). From January 2005 to March 2007, 28 patients (20 men; mean age 66+/-10 years) with stable chronic peripheral artery disease were treated for chronic total SFA occlusion. All patients received aspirin and clopidogrel and were heparinized during the procedure. After failed antegrade recanalization, the SFA was revascularized via a retrograde transpopliteal access. The StarClose Vascular System was used to seal the popliteal artery puncture site. All (100%) interventions were finished successfully, and hemostasis was secured with the StarClose device in all cases. There was 1 (3.6%) major complication with the StarClose system: a transient popliteal artery occlusion induced by plaque shift during sheath removal, which was corrected with balloon angioplasty via the femoral access. Three (10.8%) small hematomas (<5 cm) occurred at the puncture site without causing significant patient discomfort. In this small experience, the StarClose Vascular Closure System appeared to be an effective and safe sealing device after percutaneous transpopliteal interventions. Plaque shifting leading to stenosis or occlusion at the puncture site can occur.

Clinical Experience of StarClose Vascular Closure Device in Patients with First and Recurrent Femoral Punctures

We present our clinical experience of StarClose in patients undergoing coronary interventions, including its use in patients after repeated puncture of the same femoral access site. The StarClose is a novel vascular closure device that deploys a small, flexible, circumferential nitinol clip onto the femoral artery surface. In this study, 103 consecutive patients (24% with repeated punctures) who underwent percutaneous coronary intervention and received a StarClose were followed up prospectively. The patients were assessed for vascular complications prior to hospital discharge. Device success, based on time-to-hemostasis, was divided into (1) immediate success: hemostasis achieved immediately after StarClose deployment without the need for adjunctive manual compression, (2) partial success: occurrence of minor oozing after StarClose deployment and hemostasis achieved after <3 minutes of manual compression, and (3) device failure: need for adjunctive manual compression for >3 minutes. Immediate success, partial success, and device failure rates were 74% (n = 68), 16% (n = 15), and 10% (n = 9), respectively. There were no major complications attributable to the StarClose device. There were 10 (9.7%) cases of minor complications; all were recurrent wound bleeding requiring manual compression in the wards. Among these 10 cases of recurrent bleeding, 5 (50%) had initial device success (immediate success, n = 2, partial success, n = 3) in the catheterization laboratory. The risk for recurrent bleeding was 2.9% after immediate device success and 20.0% after partial device success. Our study found no major complications but a 10% failure rate and a 9.7% rate of minor complications. Close surveillance is important as there is a risk for recurrent bleeding, especially in patients with partial device success as defined in this report.

Multicenter Safety and Efficacy Analysis of Assisted Closure after Antegrade Arterial Punctures Using the StarClose Device

To evaluate the safety and efficacy of the StarClose device for closure of antegrade punctures following infrainguinal endovascular interventions. A retrospective review was conducted of 221 consecutive patients treated with the StarClose device in a 12-month period at 5 centers (4 French and 1 British). Of these, 107 patients (69 men; median age 75 years, range 44-93) were from the UK cohort (111 closures), and 94 patients (75 men; median age 67 years, range 32-95) were from the French cohort (111 closures). Technical success, complication rates, demographic data, medical history, and procedural details were gathered for all patients. Residual bleeding and the requirement for additional manual compression were recorded when the device failed. Clinical evaluation was performed at discharge; color-coded duplex ultrasonography was done in a subset of French patients. The overall technical success rate was 94.6% (210/222; 95% CI 3.1%-9.2%). The results were similar in the 2 cohorts: 95.5% (106/111; 95% CI 1.9%-10.1%) in the UK and 93.7% (104/111; 95% CI 3.1%-12.4%) in France. The 12 failures (5 UK and 7 France) were due to several mechanisms: device failure (n=5), obesity (n=1), groin scarring (n=2), and unexplained (n=4). In 2 failed cases, open surgical closure of the arteriotomy was performed because pressure hemostasis failed. Two pseudoaneurysms were observed: one after immediate failure was successfully treated by prolonged pressure; the other, after apparent success of the device, required surgical therapy. The incidence of serious vascular complication was 1.8% (4/222; 95% CI 0.7%-4.5%); 2 patients from each cohort. The StarClose device safely and effectively closes antegrade punctures after infrainguinal endovascular intervention, even in patients who would be considered to be at high risk for puncture-site bleeding. However, a randomized trial would be required to support any definitive recommendations.

Multicenter Safety and Efficacy Analysis of Assisted Closure After Antegrade Arterial Punctures Using the Starclose Device

Multicenter Safety and Efficacy Analysis of Assisted Closure After Antegrade Arterial Punctures Using the Starclose Device

StarClose Vascular Closure Device: Prospective Study on 222 Deployments in an Interventional Radiology Practice

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.

Prospective Nonrandomized Trial of Manual Compression and Angio-Seal and Starclose Arterial Closure Devices in Common Femoral Punctures

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.

The StarClose® vascular closure system: Interventional results from the CLIP study

The StarClose Vascular Closure System is a femoral access site closure technology that uses a flexible nitinol clip to complete a circumferential, extravascular arteriotomy close. The Clip CLosure In Percutaneous Procedures study was initiated to study the safety and efficacy of the StarClose device in subjects undergoing diagnostic and interventional catheterization procedures. A total of 17 U.S. sites enrolled 596 subjects, with 483 subjects randomized at a 2:1 ratio to receive StarClose or standard compression of the arteriotomy after the percutaneous procedure. The study included roll-in (n = 113), diagnostic (n = 208), and interventional (n = 275) arms with a primary safety endpoint of major vascular complications through 30 days and a primary efficacy endpoint of postprocedure time to hemostasis. The results of the diagnostic StarClose cohort have been reported separately. Results for the interventional arm revealed major vascular complications occurring in 1.1% of StarClose subjects (2/184) and 1.1% in manual compression subjects (1/91; P = 1.00). No infections were seen in either cohort. Minor complications in the StarClose interventional group occurred at a rate of 4.3% (8/184) and with compression at 9.9% (9/91; P = 0.107). Pseudoaneurysm or arteriovenous fistula was not seen with StarClose. With StarClose, procedural success was 100% (136/136) for the diagnostic group and 98.9% (181/183) in the interventional group. Device success for the treatment group was 86.8%. In the interventional cohort, 87.3% (158/181) of StarClose subjects reported a pain scale of 0-3 compared with 93.3% (84/90) in the compression group, which was not statistically different. The clinical results of this study demonstrate that the StarClose Vascular Closure System is noninferior to manual compression with respect to the primary safety endpoint of major vascular events in subjects who undergo percutaneous interventional procedures. StarClose significantly reduced time to hemostasis, ambulation, and dischargeability when compared with compression.

Use of the Profunda Femoris to Facilitate Closure of an Antegrade Puncture With the StarClose Device After Proximal SFA Angioplasty

To report a novel technique for safely closing antegrade common femoral artery (CFA) punctures using the StarClose device after proximal superficial femoral artery (SFA) angioplasty. The vessel locator of the StarClose device should not be deployed within a recently dilated vessel, so after proximal SFA angioplasty, the sheath is withdrawn into the CFA. A second guidewire is inserted into the profunda femoris artery followed by insertion of the StarClose sheath. The vessel locator is deployed in the profunda main stem and withdrawn into the CFA until resistance is felt, indicating apposition to the luminal aspect of the vessel wall. The device is subsequently deployed according to the manufacturer's instructions. Use of profunda femoris artery allows safe closure of the CFA using the StarClose device following antegrade puncture for proximal SFA angioplasty.

Initial experience with a new femoral artery closure device following percutaneous coronary intervention with glycoprotein IIb/IIIa inhibition

The aim of the study was to determine the safety and efficacy of a novel femoral artery closure device (StarClose, Abbott Vascular Devices, Redwood City, CA) following percutaneous coronary intervention employing aspirin, heparin, and glycoprotein (GP) IIb/IIIa inhibition. A prospective nonrandomized single-center pilot study of the StarClose device included a subset of patients undergoing percutaneous coronary intervention utilizing GP IIb/IIIa inhibitors. Those that fulfilled the inclusion criteria (age < 80, no periprocedural haematoma, puncture above the superficial femoral and profunda femoralis artery bifurcation, no significant femoral artery disease) underwent closure of the femoral artery puncture site with a StarClose device immediately on completion of the procedure. Time to hemostasis (TTH), bleeding, mobilization, and short-term clinical follow-up data were collected, and an ultrasound scan of the femoral artery was performed 2 weeks later. Twenty-five patients were recruited, of whom 23 underwent percutaneous coronary intervention (PCI). Their mean age was 58 +/- 12 years, 84% were male, and 63% had unstable angina. All were on aspirin 100-150 mg daily and all PCI patients received i.v. heparin 4-10,000 units at commencement of the procedure and clopidogrel 600 mg on completion. Two patients were on a tirofiban infusion and 23 received a double bolus of eptifibatide, each 0.18 mg/kg, separated by 10 min. The procedural success was 100% and device success 23/25 (92%), with 1 failure due to technical error. The median device delivery time was 36 sec (range, 11-178) and median TTH 37 sec (range, 10-509 sec). There were no major adverse events. In 10 patients, a moderate amount of tract ooze required a short period of adjunctive manual compression. Follow-up ultrasound femoral artery scans revealed no compromise of the vessel lumen. Femoral artery closure with the device following coronary angiography and intervention using glycoprotein IIb/IIIa receptor inhibitors is safe and effective. A randomized trial of a larger number of patients is warranted.