Masayuki Sato1, Yuji Matsumaru2, Nobuyuki Sakai3, Hirotoshi Imamura3, Masaru Hirohata4, Yasuharu Takeuchi4, Yasushi Matsumato5, Ichirou Suzuki5. 1. Department of Neuroendovascular, Therapy, Federation of National Public Service Personnel Mutual Aid Associations, Toranomon Hospital, 2-2-2 Toranomon Minatoku, Tokyo, 105-8470, Japan. 2. Department of Neuroendovascular, Therapy, Federation of National Public Service Personnel Mutual Aid Associations, Toranomon Hospital, 2-2-2 Toranomon Minatoku, Tokyo, 105-8470, Japan. yujimatsumaru@me.com. 3. Department of Neurosurgery, Kobe City Medical Center General Hospital, Kobe, Japan. 4. Department of Neurosurgery, Kurume University School of Medicine, Fukuoka, Japan. 5. Department of Neuroendovascular Therepy, Kohnan Hospital, Sendai, Japan.
Abstract
BACKGROUND: We examined the safety and efficacy of the access-site hemostasis device Angio-Seal™ STSPlus (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.
RCT Entities:
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 ASpatients and 38 MCpatients 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.
Entities:
Keywords:
Access site complication; Angio-Seal; Manual compression; Neuroendovascular therapy