Usefulness of an access-site hemostasis device in neuroendovascular treatment.

BACKGROUND: We examined the safety and efficacy of the access-site hemostasis device Angio-Seal™ STS Plus (AS; St. Jude Medical,St. Paul, MN, USA) compared with the method of hemostasis by manual compression (MC) in neuroendovascular therapy.

METHOD: We conducted a prospective multicenter registration study enrolling 229 patients who were scheduled to undergo endovascular treatment.

RESULTS: Of the 119 and 110 cases assigned to the AS and MC groups, 118 (99.2%) and 105 (95.5%) achieved successful hemostasis, respectively. Six AS patients and 38 MC patients had access-site hematoma (5% vs 34.5%, P < 0.001). Hemostasis time was significantly shorter in the AS group than in the MC group (4.4 min vs 150.7 min, P < 0.001). Puncture-site hematoma was significantly larger in the AS group than the MC group (5.5 cm vs 2.9 cm, P < 0.05). Patients in the AS group had a significantly shorter hospital stay than those in the MC group (8.7 days vs 13.3 days, P < 0.001); they also had a significantly shorter time before they could start to walk (23.9 h vs 52.2 h, P < 0.001). No serious adverse events were noted in either group. Minor adverse events included four cases from the AS group and two cases from the MC group.

CONCLUSIONS: Use of an access-site hemostatic device resulted in quick and reliable access-site hemostasis in neuroendovascular therapy. When using AS, it is necessary to be careful when there is a possibility of a hematoma, as the hematomas, though significantly less frequent than in MC, were significantly bigger in that group.