p48 血流导向装置：三个中心 25 个动脉瘤的初步临床结果。
The p48 flow diverter: First clinical results in 25 aneurysms in three centers.
机构信息
Department of Radiology, Algemeen Ziekenhuis St Lucas, Gent, Belgium.
Department of Radiology, Ziekenhuis Oost-Limburg, Genk, Belgium.
出版信息
Interv Neuroradiol. 2021 Jun;27(3):339-345. doi: 10.1177/1591019920972213. Epub 2020 Nov 8.
BACKGROUND
The novel low-profile p48 flow diverter has been designed to treat aneurysms on small vessels of 1.75-3mm. We report our first clinical experiences.
METHODS
Between March 2018-January 2020, 22 patients with 25 aneurysms were treated with the p48 in 3 centers. One patient had 3 aneurysms covered by one p48 and one patient had 2 aneurysms. There were 5 men, 17 women, with a mean age of 55 years (median 59, range 29-73 years).
RESULTS
In 25 aneurysms, 24 p48 flow diverters were placed. In 1 patient additional coils were placed in the aneurysm. Procedural vessel rupture by the micro guidewire occurred in 2 patients and vessel rupture during p48 balloon dilatation occurred in 1 patient. Overall, the permanent morbidity rate was 13.6% (3 of 22, 95%CI 3.9-34.2%) and mortality was 4.5% (1 of 22, 95%CI <0.01-23.5%). Most complications were procedure-related and not device-specific. Of 22 patients with 25 aneurysms treated with p48, 18 patients with 20 aneurysms had angiographic follow-up after 5-18 months. Of 19 aneurysms, 10 were occluded and 7 showed a remnant. Two aneurysms were open after 6 months. Three aneurysms were still not occluded after 12, 14, and 18 months and these 3 were retreated. Retreatment rate was 16% (3 of 19) and the adequate occlusion rate was 90% (17 of 19).
CONCLUSIONS
Treatment of aneurysms in small-caliber vessels with the p48 is feasible and effective but is not without complications. More data is needed to establish indications, safety, and efficacy more accurately.
背景
新型低剖面 p48 血流导向装置旨在治疗 1.75-3mm 小血管的动脉瘤。我们报告了我们的首次临床经验。
方法
2018 年 3 月至 2020 年 1 月，3 家中心的 22 名患者的 25 个动脉瘤接受了 p48 治疗。1 名患者的 3 个动脉瘤由 1 个 p48 覆盖，1 名患者有 2 个动脉瘤。5 名男性，17 名女性，平均年龄 55 岁（中位数 59 岁，范围 29-73 岁）。
结果
在 25 个动脉瘤中，共放置了 24 个 p48 血流导向装置。在 1 名患者中，动脉瘤内额外放置了线圈。2 名患者在微导丝操作过程中出现血管破裂，1 名患者在 p48 球囊扩张过程中出现血管破裂。总的来说，永久性发病率为 13.6%（22 例中的 3 例，95%CI 3.9-34.2%），死亡率为 4.5%（22 例中的 1 例，95%CI <0.01-23.5%）。大多数并发症与手术相关，与器械无关。在接受 p48 治疗的 22 名患者的 25 个动脉瘤中，18 名患者的 20 个动脉瘤在 5-18 个月后进行了血管造影随访。19 个动脉瘤中，10 个闭塞，7 个残留。6 个月后有 2 个动脉瘤开放。12、14 和 18 个月后，仍有 3 个动脉瘤未闭塞，这 3 个动脉瘤进行了再治疗。再治疗率为 16%（19 个中的 3 个），完全闭塞率为 90%（19 个中的 17 个）。
结论
使用 p48 治疗小血管动脉瘤是可行且有效的，但并非没有并发症。需要更多的数据来更准确地确定适应证、安全性和疗效。
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