Vascular Closure Devices

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Abstract

Despite the recent introduction of vascular closure device (VCD) technology, vascular access site complications remain the leading source of morbidity and costs after the approximately eight to eight-and-a-half million percutaneous catheterbased procedures performed annually worldwide. VCD trials consistently demonstrate increased patient satisfaction, early ambulation, and decreased hospital resource utilisation compared with manual compression (MC). Unfortunately, these reports have not consistently demonstrated decreased complication rates, and current VCD technology has even created a new category of complications and treatments primarily involving infection and arterial thrombosis.

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In 1953, Seldinger classically reported the original description of percutaneous femoral artery (FA) access and, in so doing, first reported vascular access haemostasis (VAH). Since then, significant technological advances in the field of catheter-based cardiovascular (CV) therapy have rendered most early percutaneous technology obsolete. It is remarkable that, 50 years later, the gold standard of VAH remains MC, performed almost exactly as Seldinger originally described, ├óÔé¼┼ø20├óÔé¼ÔÇ£30 minutes hand-held pressure after catheter removal followed by overnight bed rest.├óÔé¼┼Ñ This gold standard remained largely unchallenged over the next four decades, until the widespread adoption of percutaneous CV interventions. These procedures require larger sheaths and more potent anticoagulation, increasing the clinical potential for complication.

The Problem Exposed
FA access complications (FAC) remain a significant source of mortality and are the leading cause of morbidity and costs after percutaneous coronary intervention (PCI). Remarkably, no standardisation exists with regard to reporting ├óÔé¼´åİmajor™ and/or ├óÔé¼´åİminor™ FAC rates, which vary widely from 0.4% to 27% depending on the definition of complications. Most reports site only ├óÔé¼´åİmajor™ FACs requiring surgery, and it is highly likely that many FACs go unreported or are accepted as ├óÔé¼´åİpart of the territory™.

Duffin et al. were among the first to identify FACs as a major problem, noting a 14% bleeding rate with PCI. In a randomised trial comparing MC with AngioSeal (St Jude Medical, St Paul, MN), Kussmall et al. reported a 27% overall ├óÔé¼´åİany complication™ rate in the MC group with heparin. In 2001, Danges et al. compared MC (n=4,596) with VCDs (n=497) after PCI and reported higher ├óÔé¼´åİoverall complication™ rates with VCDs versus MC (21.4% versus 12.1%, respectively), again confirming significant ├óÔé¼´åİoverall complications™ with MC and identifying that current VCD use may increase complications.

Pracyk et al. cited a 64% overall FAC rate with MC when patients were thoroughly scrutinised by physical examination and duplex ultrasound. A review of the literature reveals sparse data on MC with regard to a haemostatic mechanism, healing or scarring of the arteriotomy site, short- or long-term FA clinical sequelae, systemic effects of a groin haematoma, or a consensus recommendation on the safety, risks and timing of FA re-entry. After 50 years of truly remarkable CV technological achievements, it seems reasonable to ask whether MC should still be the gold standard, and why.

FAC├óÔé¼ÔÇ£Clinical and Economic Costs
Aguirre et al. found FAC increased the length of patient stay to an average of 3.5 days compared with <2 days in an uncomplicated PCI. Moscucci et al. suggested that FAC may indirectly increase ischaemic complications after PCI when they reported the incidence of death and myocardial infarction (MI) among patients with FAC as 2.4% and 13%, respectively, versus 0.2% and 3.0% in 4,090 PCI patients without FAC (p<0.0001). Extrapolating financial costs to FAC is difficult, but in tracking blood transfusions after PCI, Lauer et al. estimated a single unit of blood transfusion during PCI adds an additional US$8,000 to the overall cost of that hospitalisation. The Replace-2 study has now shown increased 30-day and oneyear mortalities in PCI patients who experience a bleeding complication and increased morbidities (MI, need for repeat PCI, etc.). />/>

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References
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