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Reducing complications of femoral access

In this issue of the journal, Deuling et al. review two closure devices in comparison to manual compression regarding safety and efficacy [1]. In the prospective trial, 450 patients were randomized to AngioSeal, StarClose, or manual compression. Although there was no difference in safety between the three methods of arterial closure, StarClose was more often not successfully deployed. In addition, StarClose patients had more continued oozing. The authors concluded that AngioSeal would be the preferred device for closure. The authors should be commended for their reasonable trial size and design. Multiple studies have reported differences between the effectiveness of closure devices in comparison to manual compression. Over the years, closure devices have varied in their performance in comparison to manual compression. In our study in 2001, we found that manual compression had a lower incidence of complication than closure devices [2]. However, in a recent national review for the National Cardiovascular Data Registry presented at the American Heart Association meeting in 2007, closure devices had a lower complication rate than manual compression. Variations in outcomes between devices in individual smaller trials are difficult to interpret, since there are countless numbers of factors involved with successful vascular closure (Fig. 1); smaller trials may be difficult to adequately balance many of the factors associated with a higher incidence of complications including elevated systolic blood pressure, low body weights, percentage of elderly females, concomitant coagulopathies, level of anticoagulation, and preexisting peripheral vascular disease. From a practice standpoint, the common theme of reducing complications and shortening time to ambulation should constantly be reviewed by all interventionalists in their daily practice because many of the complications associated with closure devices will be related to the operator and the patient (Fig. 2). Continuous meticuFig. 2. Reducing bleeding risk: prevention. Fig. 1. Risk factors for vascular complications.