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/eight and a half million percutaneous catheter-based procedures performed annually worldwide. VCD trials consistently demonstrate increased patient satisfaction, early ambulation, and decreased hospital resource utilization as 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.
In 1953, Seldinger classically reported the original description of percutaneous femoral artery access and, in so doing, first reported vascular access hemostasis (VAH). Since then, significant technological advances in the field of catheter-based cardiovascular 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.ÔÇØThis gold standard remained largely unchallenged over the next four decades, until the widespread adoption of percutaneous cardiovascular interventions. These procedures require larger sheaths and more potent anticoagulation, therefore increasing the clinical potential for complication.
The Problem Exposed
Femoral artery 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 standardization exists with regard to reporting 'majorÔÇÖ and/or 'minorÔÇÖ FAC rates, which vary widely from 0.4% to 27% depending upon the definition of complications. 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. Duffin et al. were among the first to identify FACs as a major problem noting a 14% bleeding rate with PCI. In a randomized trial comparing MC with AngioSeal (St Jude Medical, St Paul, MN),Kussmall et al. reported a 27% overall ÔÇ£any complicationÔÇØ 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 ÔÇ£overall complicationÔÇØ rates with VCDs versus MC (21.4% versus 12.1%, respectively), again confirming significant ÔÇ£overall complicationsÔÇØ with MC and identifying that current VCD use may increase complications.