Observation Study Of Mid-Term Efficacy Of Tubridge Flow Diverter For Small And Medium-Sized Unruptured Intracranial Aneurysms

Objective: To investigate the mid-term occlusion rate and safety of Tubridge flow diverter for small and medium-sized unruptured intracranial aneurysms,and to explore the influencing factors of mid-term occlusion rate.Methods: Data on patients with small and medium-sized unruptured intracranial aneurysms who underwent Tubridge flow diverter and traditional interventional therapy at the department of neurosurgery of the affiliated hospital of Southwest Medical University from January 2018 to December2021 were collected.The clinical and imaging follow-up was up to December2022.According to different treatment methods,Tubridge flow diverter treatment group and traditional interventional treatment group were divided.The demographic characteristics,aneurysm characteristics,perioperative conditions and follow-up data of the two groups were analyzed.Results: A total of 158 patients with 191 small and medium-sized unruptured intracranial aneurysms were included,including 64 males(40.51%)and 94(59.49%)females,with the mean age of 57.38±9.85 years and median diameter of 4.58 mm(3.49,7.10).There were 40 patients with 54 aneurysms in the Tubridge flow diverter treatment group,with the mean age of 56.80±9.11 years,including 17(42.50%)males and 23(57.50%)females,and the median diameter was 6.06 mm(3.30,9.72).And there were 118 patients with 137 aneurysms in the traditional interventional treatment group,with the mean age of 57.58±10.11 years,of which 47(39.83%)were males and 71(60.17%)were females,and the median diameter was 4.40 mm(3.50,6.06).In the comparison of clinical baseline data between the two groups,there were no significant statistical differences in age,sex,comorbidities,smoking history,alcohol history,and m RS scores at admission(P>0.05).There were no significant statistical differences in the location(anterior circulation,posterior circulation),morphology(regular,irregular)aneurysmal height and body/neck ratio in the two groups(P>0.05),but there were significant differences in aneurysmal neck and aneurysmal body(P<0.05).A comparison of the two treatment modalities in the perioperative conditions showed no statistically significant difference in the overall incidence of perioperative complications between the two groups(P>0.05).Neither group of patients treated with two different modalities suffered from hemorrhagic complications.Three(7.50%)patients suffered from ischemic stroke in the Tubridge flow diverter treatment group and 6(5.08%)patients in the traditional interventional treatment group.However,there was no significant statistically difference in ischemic complications between the two groups(P>0.05).The two groups showed significant differences in operation time and postoperative hospital stay(P<0.05).The median operation time of Tubridge flow diverter treatment group was 92.50 min(75.00,118.75)and the median operation time of traditional interventional treatment group was 122.50 min(90.00,170.00).The median postoperative hospital stay of Tubridge flow diverter treatment group was 3.00d(3.00,4.75)and the median postoperative hospital stay of traditional interventional treatment group was 4.00 d(4.00,6.00).The operation time and postoperative hospital stay of the Tubridge flow diverter treatment group were lower than those of the traditional interventional treatment group.The results of immediate angiographic in two groups showed a significant statistically difference(P<0.001).In the Tubridge flow diverter group,the complete occlusion rate,aneurysmal neck visualization rate and aneurysmal body visualization rate were 0,18.52%(10/54)and 81.48%(44/54),respectively,while those in traditional interventional treatment group were 89.05%(122/137),9.49%(13/137)and 1.46%(2/137).The rate of complete occlusion was higher in the traditional interventional treatment group.There was no statistically significant difference in the m RS scores at 3,6 and 12 months of two groups(P>0.05).The rate of complete occlusion was 88.89%(48/54)at 12 months in the Tubridge group compared with 94.16%(129/137)in the traditional interventional treatment group,however,no statistically significant difference(P>0.05)in two groups.Univariate analysis showed that age was associated with the mid-term complete occlusion rate in the Tubridge flow diverter group,with a statistically higher mean age in the complete occlusion group than in the incomplete occlusion group(P=0.043).Conclusion: 1.Treatment of small and medium-sized unruptured intracranial aneurysms with the Tubridge was safe and effective,with no statistically significant difference in mid-term complete occlusion rate between the Tubridge group and traditional interventional treatment group.2.The use of Tubridge flow diverter for small and medium-sized unruptured intracranial aneurysms showed a shorter operation time and shorter postoperative hospital stay than traditional interventional treatment.3.Age may be one of the factors affecting the mid-term complete occlusion rate of small and medium-sized unruptured intracranial aneurysms treated by the Tubridge flow diverter.