A Randomized Comparison of a Novel Bioabsorbable Vascular Closure Device Versus Manual Compression in the Achievement of Hemostasis After Percutaneous Femoral Procedures

Wong, S. Chiu; Bachinsky, William; Cambier, Patrick A.; Stoler, Robert C.; Aji, Janah; Rogers, Jason H.; Hermiller, James; Nair, Ravi; Hutman, Herbert; Wang, Hong; Investigators, Eclipse Trial

doi:10.1016/j.jcin.2009.06.006

Cited by 89 publications

(69 citation statements)

References 15 publications

(12 reference statements)

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“…A similar finding was reported by a relatively more recent study, involving 401 patients, which noted a statistically significant reduction in the time to haemostasis and ambulation in the VCD group. The 30 days access-site related complication rates were remarkably low in both the groups in this study [4]. However, most of the pivotal studies comparing vascular closure devices and standard manual pressure comprised of small numbers and were underpowered [5].…”

Section: Discussionmentioning

confidence: 61%

Vascular Closure Device: To Close or Not To Close?

George¹,

John²,

Chattopadhyay³

2011

J Clinic Experiment Cardiol

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Angio-Seal is a femoral arterial closure device that is commonly used following coronary angiography and angioplasty, to achieve haemostasis at the access site. It is reasonably well tolerated and is proven to improve the time to ambulation. Nonetheless they are associated with certain complications which can cause significant morbidity to the patients unless intervened in time. Here we describe details of complications that we have encountered over the last year, and discuss the evidence base with regard to the use of these devices.RIGHT

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Section: Discussionmentioning

confidence: 61%

Vascular Closure Device: To Close or Not To Close?

George¹,

John²,

Chattopadhyay³

2011

J Clinic Experiment Cardiol

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“…The ECLIPSE trial was a multi-centre RCT of 401 patients undergoing diagnostic or interventional cardiovascular procedures randomised to closure with Exoseal or MC [34]. Mean time to haemostasis and time to ambulation were significantly shorter in the Exoseal arm of the study (4.4 vs 20.1 min and 2.5 vs 6.2 h, respectively), and there were no major complications reported in this study [34].…”

Section: Exosealmentioning

confidence: 77%

Vascular Closure Devices in Interventional Radiology Practice

Patel

Müller‐Hülsbeck

Morgan

et al. 2015

Cardiovasc Intervent Radiol

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Manual compression (MC) is a well-established technique for haemostasis following percutaneous arterial intervention. However, MC is labour and time intensive with potential limitations, particularly for patients who are coagulopathic, unable to comply with bed rest or obese and when large sheaths or anti-coagulants are used. There are a variety of vascular closure devices (VCDs) available to overcome these limitations. This review gives an overview of current VCDs, their mechanism of action, individual strengths and weaknesses, evidence base and utility in interventional radiology (IR) practice. The majority of the published evidence on VCDs is derived from patients undergoing cardiac interventions, which should be borne in mind when considering the applicability and transfer of this data for general IR practice. Overall, the evidence suggests that most VCDs are effective in achieving haemostasis with a similar rate of complications to MC although the complication profile associated with VCDs is distinct to that of MC. There is insufficient evidence to comparatively analyse the different types of VCDs currently available or reliably judge their cost-effectiveness. The interventional radiologist should have a thorough understanding of the available techniques for haemostasis and be able to identify and utilise the most appropriate strategy and closure technique for the individual patient.

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“…Unfortunately, these studies differed in classification of major and minor adverse events. Schmelter et al (3) used the ECLIPSE classification as published by Wong et al (7). Successful device application was accomplished in 96% of their patients, and no major adverse event was observed.…”

Section: Discussionmentioning

confidence: 99%