The Novel Angiolink Staple-mediated Vascular Closure Device

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Citation
US Cardiology 2004;2004:1(1):1-5

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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 catheter-based procedures performed annually worldwide.1 VCD trials consistently demonstrate increased patient satisfaction, early ambulation, and decreased hospital resource utilisation compared with manual compression (MC).2,3 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.4-9

In 1953, Seldinger classically reported the original description of percutaneous femoral artery (FA) access and, in so doing, first reported vascular access haemostasis (VAH).10 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, ÔÇ£20-30 minutes hand-held pressure after catheter removal followed by overnight bed rest.ÔÇØ10 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).10-12 Remarkably, no standardisation exists with regard to reporting 'majorÔÇÖ and/or 'minorÔÇÖ FAC rates, which vary widely from 0.4% to 27% depending on the definition of complications.7-9,12 Most reports site only 'majorÔÇÖ FACs requiring surgery, and it is highly likely that many FACs go unreported or are accepted as 'part of the territoryÔÇÖ (see Figure 1). Duffin et al.3 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.11 reported a 27% overall 'any complicationÔÇÖ rate in the MC group with heparin. In 2001, Danges et al.5 compared MC (n=4,596) with VCDs (n=497) after PCI and reported higher 'overall complicationÔÇÖ rates with VCDs versus MC (21.4% versus 12.1%, respectively), again confirming significant 'overall complicationsÔÇÖ with MC and identifying that current VCD use may increase complications.

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References
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