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

Tay, Edgar; Co, Melissa; Tai, Bee–Choo; Lee, Yian Ping; Low, Adrian; Lim, Yu Liang; Tan, Huay‐Cheem; Lee, Chi‐Hang

doi:10.1111/j.1540-8183.2007.00291.x

Cited by 16 publications

(15 citation statements)

References 18 publications

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“…The 7.1% major vascular complication rate attributable to StarClose in this study was higher than previously reported 0–4.1% [2,3,4,5,6,9,18,19,20,21,22,23,24], but the minor 11.9% complication rate was within the range of 2.1–27%, even though the device was used for closing larger puncture holes.…”

Section: Discussioncontrasting

confidence: 71%

“…The 88.1% device success rate of this study was within the range of the 87–94% device success rate [3,9,18,19,20,21], but the 92.9% was slightly lower than the 96–100% procedural success rate [2,3,19,20,21,22,23] reported for the same device in 5-, 6- or 7-Fr punctures. The 7.1% major vascular complication rate attributable to StarClose in this study was higher than previously reported 0–4.1% [2,3,4,5,6,9,18,19,20,21,22,23,24], but the minor 11.9% complication rate was within the range of 2.1–27%, even though the device was used for closing larger puncture holes.…”

Section: Discussionsupporting

confidence: 60%

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Safety and Efficacy of the StarClose Vascular Closure System following 8-Fr Sheath Placement for Intra-Aortic Balloon Pump: A Single-Center Analysis of 42 Consecutive Patients

Chu¹,

Yang²,

Zhang³

et al. 2014

Med Princ Pract

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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.

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Section: Discussioncontrasting

confidence: 71%

Section: Discussionsupporting

confidence: 60%

Safety and Efficacy of the StarClose Vascular Closure System following 8-Fr Sheath Placement for Intra-Aortic Balloon Pump: A Single-Center Analysis of 42 Consecutive Patients

Chu¹,

Yang²,

Zhang³

et al. 2014

Med Princ Pract

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“…Tay et al reported their experience with repeat closure in 25 patients undergoing coronary interventions. 7 The device success (96%) and low complication rates (8%) were encouraging.…”

Section: Discussionmentioning

confidence: 79%

“…Procedural success was 95.7% and complication rates are in keeping with those reported in studies of patients undergoing cardiac and peripheral vascular procedures. [1][2][3][4][5][6][7][8] Rates of groin hematomas in both the manual closure (4.2%) and StarClose (1.4%) groups were similar.…”

Section: Discussionmentioning

confidence: 99%

StarClose Vascular Closure Device: Safety and Efficacy of Deployment and Reaccess in a Neurointerventional Radiology Service

McTaggart¹,

Raghavan²,

Haas³

et al. 2010

AJNR Am J Neuroradiol

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BACKGROUND AND PURPOSE:Obtaining safe and effective closure of the femoral access site following neurointerventional procedures can sometimes be challenging, especially in patients on anticoagulation or anti-platelet therapy. The purpose of this study was to evaluate the safety and efficacy of a novel percutaneous closure device that employs a nitinol clip-mediated extravascular closure strategy following neurointerventional procedures.

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“…1). The sheath is a 6 F sheath with a sidearm that is introduced into the target vessel and then used as a passageway for the insertion of diagnostic, guide, or other interventional catheters [9][10][11]. The angiography of femoral arteries was not executed before the implantation of the StarClose clip.…”

Section: Procedures (Protocol) Description In Group IImentioning

confidence: 99%

The utility of duplex ultrasound scanning in reporting the vascular complications after heart catheterization performed from new arterial approaches – radial or femoral artery access with StarClose usage – a substudy of the RADIAMI II trial

Kowalczuk¹,

Chodór²,

Streb³

et al. 2010

pwki

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A b s t r a c tBackground: RADIAMI II -Radial versus Femoral Approach for Percutaneous Intervention with StarClose Device Using in Patients with Acute Myocardial Infarction was a single center, randomized prospective trial. A substudy of this trial was to evaluate the to utility of duplex ultrasound scanning (DUS) in the patency assessment of the radial or femoral arteries as well as the to evaluate the occurrence of local iatrogenic complications.Aim: To choose the safest method of arterial access in primary coronary angioplasty in ST elevation myocardial infarction (STEMI) by the comparison of both studied groups.Material and methods: The 108 consecutive patients hospitalized from September 2006 to March 2008 with STEMI and qualified to percutaneous coronary intervention (PCI) were randomly assigned to transradial (group I, n = 49) or transfemoral (group II, n = 59) approaches. The DUS protocol was devised and implemented by vascular ultrasound core laboratory with extensive experience in vascular device trials in 5 days after PCI. DUS inguinal region from 6 cm proximal to 6 cm distal to the arteriotomy puncture was performed. A qualitative examination was performed to determine the presence StarClose localization and iatrogenic vascular injuries: major haematoma ≥ 5 cm, pseudoaneurysm (PSA), arteriovenous fistula (AVF), and arterial thrombosis or stenosis, using 2-dimensional gray scale, color and focused Doppler images.Results: Duplex ultrasonography of 108 subjects randomized to either group I (n = 49) or group II (n = 59) were performed and evaluated. In both groups there were no evidence of PSA, AVF, stenosis or arterial thrombosis. The hematoma ≥ 5 cm was observed in 4 patients of group I whereas in group II such a complication was affirmed in 10 patients (8.16% vs. 16.95%, p = 0.287). Pseudoaneurysm was observed only in patient from the group II (1.69%, p = 0.926). Both groups maintained vessel patency without stenosis, thrombosis, pseudoaneurysm, or AV fistula in follow-up.Conclusions: Duplex ultrasonography is a reliable, safe and accurate method for the assessment the vascular access site complications after invasivly treated patients with STEMI. The study showed that both radial and femoral access followed by StarClose implantation are safe metods of arterial access during PCI.

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

Abstract: 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.

Cited by 16 publications

References 18 publications

Safety and Efficacy of the StarClose Vascular Closure System following 8-Fr Sheath Placement for Intra-Aortic Balloon Pump: A Single-Center Analysis of 42 Consecutive Patients

Safety and Efficacy of the StarClose Vascular Closure System following 8-Fr Sheath Placement for Intra-Aortic Balloon Pump: A Single-Center Analysis of 42 Consecutive Patients

StarClose Vascular Closure Device: Safety and Efficacy of Deployment and Reaccess in a Neurointerventional Radiology Service

The utility of duplex ultrasound scanning in reporting the vascular complications after heart catheterization performed from new arterial approaches – radial or femoral artery access with StarClose usage – a substudy of the RADIAMI II trial

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