Sato Masayuki, Matsumaru Yuji, Sakai Nobuyuki, Imamura Hirotoshi, Hirohata Masaru, Takeuchi Yasuharu, Matsumato Yasushi, Suzuki Ichirou
Department of Neuroendovascular, Therapy, Federation of National Public Service Personnel Mutual Aid Associations, Toranomon Hospital, 2-2-2 Toranomon Minatoku, Tokyo, 105-8470, Japan.
Department of Neurosurgery, Kobe City Medical Center General Hospital, Kobe, Japan.
Acta Neurochir (Wien). 2017 Dec;159(12):2331-2335. doi: 10.1007/s00701-017-3299-5. Epub 2017 Aug 22.
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.
We conducted a prospective multicenter registration study enrolling 229 patients who were scheduled to undergo endovascular treatment.
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.
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.
我们比较了血管封堵装置Angio-Seal™ STS Plus（AS；美国明尼苏达州圣保罗市圣犹达医疗公司）与手动压迫止血法（MC）在神经血管内治疗中进行穿刺部位止血的安全性和有效性。
我们进行了一项前瞻性多中心注册研究，纳入229例计划接受血管内治疗的患者。
在分配至AS组和MC组的119例和110例病例中，分别有118例（99.2%）和105例（95.5%）实现了成功止血。6例AS组患者和38例MC组患者出现穿刺部位血肿（5% 对34.5%，P < 0.001）。AS组的止血时间显著短于MC组（4.4分钟对150.7分钟，P < 0.001）。AS组穿刺部位血肿明显大于MC组（5.5厘米对2.9厘米，P < 0.05）。AS组患者的住院时间显著短于MC组（8.7天对13.3天，P < 0.001）；他们开始行走前的时间也显著更短（23.9小时对52.2小时，P < 0.001）。两组均未观察到严重不良事件。轻微不良事件包括AS组4例和MC组2例。
在神经血管内治疗中，使用穿刺部位止血装置可实现快速可靠的穿刺部位止血。使用AS时，当有发生血肿的可能性时需谨慎，因为该组血肿虽比MC组明显少见，但明显更大。
