A randomised controlled trial comparing the routine use of an Angio-Seal STS device strategy with conventional femoral haemostasis methods in a district general hospital.

Femoral artery closure devices reduce the time to haemostasis and ambulation. Most district general hospitals (DGHs) now perform day case angiography on site. The purpose of this study was to assess the Angio-Seal self-tightening suture (STS) device in comparison with manual compression in this environment. A prospective randomised controlled trial was undertaken comparing the Angio-Seal STS device with manual pressure recording complications, time from end of procedure and patient satisfaction in a DGH setting. Angiography lists of 206 patients undergoing day case diagnostic cardiac catheterisation with a five French sheath at a DGH were randomised by intention to treat to receive either manual compression or a six French Angio-Seal STS device. Time from sheath removal to mobilisation, complication rate and patient satisfaction were compared. There were no significant differences between the two groups in terms of demographics (manual compression: Angio-Seal; male (%) 58 vs. 57, age (years) 65.4 vs. 66.3, body mass index (kg/m(2)) 27.7 vs. 27.5). Despite randomisation, only 74 of 107 patients in the Angio-Seal group actually had a device deployed. Angio-Seal use was associated with significantly shorter times to mobilisation (87.6 vs. 144.1 min; p < 0.001), significantly less bruising (bruise size at 1 week (28.5 vs. 82.5 cm(3); p < 0.01) and no increase in vascular complications. In addition, patients were more satisfied with Angio-Seal devices in terms of length of immobility. The routine use of Angio-Seal closure devices result in earlier mobilisation, less bruising, increased patient satisfaction with no increase in other complications in comparison to manual pressure.