Pierot Laurent, Leclerc Xavier, Bonafé Alain, Bracard Serge
Department of Neuroradiology, University of Reims, Reims, France.
Neurosurgery. 2008 Nov;63(5):850-7; discussion 857-8. doi: 10.1227/01.NEU.0000327694.13261.DF.
A prospective multicenter registry was conducted in France to evaluate the safety and efficacy of Matrix coils (Boston Scientific Neurovascular, Fremont, CA). The short- and mid-term results are presented.
From January to October 2004, 236 patients harboring ruptured (Group I) or unruptured (Group II) aneurysms were treated via an endovascular approach with Matrix coils and were included in this registry. In-hospital morbidity and mortality was determined. One-year clinical follow-up data were obtained in 218 patients (92.4%). One-year angiographic follow-up data were obtained in 165 patients (171 aneurysms, 70.1%).
In Group I, in-hospital morbidity and mortality rates were 5.8 and 6.5%, respectively, with a procedure-related morbidity and mortality of 3.6 and 1.4%, respectively. At 1 year, the morbidity and mortality rates were 2.4 and 11.0%, respectively. In Group II, procedure-related morbidity and mortality rates were 1.0 and 0.0%, respectively. At 1 year, the morbidity and mortality rates were 1.1 and 0%, respectively. For both groups, no bleeding or rebleeding was observed during the follow-up period. The only factor associated with an increased rate of complications was delay before treatment of more than 2 days after bleeding. Aneurysm recanalization was observed in 44 aneurysms (25.7%).
In-hospital and 1-year morbidity and mortality rates in patients harboring ruptured or unruptured aneurysms treated with Matrix coils were similar to those previously reported with the use of bare coils. The efficacy of Matrix coils to prevent aneurysm recanalization was not demonstrated, despite a high percentage of progressive thrombosis that suggests biological activity resulting from Matrix coils.
在法国开展了一项前瞻性多中心注册研究,以评估Matrix线圈(波士顿科学神经血管公司,弗里蒙特,加利福尼亚州)的安全性和有效性。本文展示了短期和中期结果。
2004年1月至10月,236例患有破裂(I组)或未破裂(II组)动脉瘤的患者通过血管内途径使用Matrix线圈进行治疗,并纳入该注册研究。确定了住院期间的发病率和死亡率。218例患者(92.4%)获得了1年的临床随访数据。165例患者(171个动脉瘤,70.1%)获得了1年的血管造影随访数据。
在I组中,住院期间的发病率和死亡率分别为5.8%和6.5%,与手术相关的发病率和死亡率分别为3.6%和1.4%。1年时,发病率和死亡率分别为2.4%和11.0%。在II组中,与手术相关的发病率和死亡率分别为1.0%和0.0%。1年时,发病率和死亡率分别为1.1%和0%。两组在随访期间均未观察到出血或再出血。与并发症发生率增加相关的唯一因素是出血后治疗延迟超过2天。44个动脉瘤(25.7%)观察到动脉瘤再通。
使用Matrix线圈治疗的破裂或未破裂动脉瘤患者的住院期间及1年发病率和死亡率与先前使用裸线圈报道的相似。尽管Matrix线圈导致的进展性血栓形成比例较高,提示其具有生物活性,但未证实Matrix线圈预防动脉瘤再通的有效性。