| Objective(s):Endovascular treatment has now become the recommended treatment of choice for unruptured intracranial aneurysms,but for complex intracranial aneurysms such as wide neck,dissection,and fusiform aneurysms,techniques such as stenting and balloon-assisted embolization are required.Flow Diverters(FDs)have gradually been applied to treat intracranial complex aneurysms(ICCAs)as a new endovascular treatment based on the concept of repairing the pathological vessel.The Tubridge flow diverter(TFD),as the first independently developed and marketed flow-directed device in China,still needs more studies to confirm its safety and efficacy in the treatment of unruptured ICCAs.The purpose of this study was to assess the efficacy and safety of the TFD in the treatment of ICCAs.Methods:Cases of patients who met the ICCAs staging criteria and were treated with TFD at our hospital from October 2019 to December 2022 were consecutively included by retrospective analysis.we collected general clinical data,surgical methods,imaging data,and follow-up data of all included patients,and analyzed the immediate and follow-up aneurysm embolization rates after different types of intracranial ICCAs(assessed using the O’Kelly-Marotta grading system),the perioperative and medium and long-term complications,and clinical outcomes(assessed using the mRS scale,with mRS scores 0-2 being good outcomes)to assess the efficiency and safety of TFD for unruptured ICCAs.Statistical methods of this study:IBM SPSS statistics 26.0 was used for statistical analysis and processing.Measures that conformed to a normal distribution were expressed uniformly using the mean standard deviation((?)±s);measures that did not conform to a normal distribution were expressed using the median.Categorical variables were expressed as frequencies and percentages(n,%).Appropriate statistical methods were used for analysis and comparison according to the variables,and P<0.05 was used to indicate that the differences were statistically significant.Results:A total of 72 patients with 89 aneurysms were enrolled in the study,of which 80 aneurysms received treatment using TFD,with a total of 73 TFDs.There were58 saccular aneurysms,10 entrapment aneurysms,8 fusiform aneurysms,and 4 blood blister-like aneurysms;70 aneurysms were located in the anterior circulation and 10aneurysms in the posterior circulation.There were 69 aneurysms of medium size(<10mm)and below,with 11 aneurysms of large size(≥10 mm)and above.The immediate postoperative successful embolization rate of 80 aneurysms was 16.25%(13/80),of which 52 aneurysms were treated with TFD alone and 28 aneurysms were treated with a combination of TFD+coils,and The difference in the immediate postoperative angiographic aneurysm embolization rate between the two groups was statistically significant(P<0.001).A total of 54 patients received at least one imaging follow-up(53 DSA follow-up and 1 CTA follow-up),and a total of 61 treated aneurysms received at least one DSA imaging follow-up in 53 patients,with a median follow-up time of 109 days.A total of67 patients were followed up clinically(including telephone and outpatient follow-up)and the median follow-up time was 405 days.5 patients were missed.53 patients had43 aneurysms completely occluded by the last DSA follow-up,and the cumulative rate of complete occlusion of aneurysms was 70.49%(43/61);the successful occlusion rate was 80.33%(49/61),and the median time to complete occlusion of aneurysms was 127days.The complete occlusion rate of aneurysm in the TFD alone group was 60.53%(23/38)and the successful occlusion rate was 68.42%(26/38);the complete occlusion rate in the TFD+coil group was 86.96%(20/23)and the successful occlusion rate was100%(23/23),and the difference between the two groups was statistically significant(P=0.016).There was no statistically significant difference in the rate of complete occlusion of aneurysms between the two groups for aneurysms of different sizes(P>0.05).The rate of complete occlusion of non-saccular aneurysms was 94.12%(16/17)than that of complete occlusion of saccular aneurysms 61.36%(27/44),and the difference was statistically significant(P=0.013).The level of aneurysm healing was positively correlated with the use of spring coils(r_s=0.379,P=0.003),but there was no correlation between the follow-up interval and embolic grade difference.A total of 64branches were covered during the follow-up TFD procedure,and 6 penetrating vessels were asymptomatically occluded at the time of follow-up,with a penetrating occlusion rate of 9.38%(6/64).54 patients(55 stents)with imaging follow-up had a total of 2 in-stent vessel occlusions;16 vessels in the TFD had different stenosis degrees(29.09%,16/55),of which 11 had mild stenosis(20.00%.11/55)and 5 cases of moderate-to-severe stenosis(9.09%,5/55).A total of 6 patients had perioperative complications(8.33%,6/72).A total of 83branch vessels were covered by intraoperative stents during the TFD procedure,and no ischemic symptoms related to the involved penetrating branches occurred until the last follow-up.67 patients had 4 total ischemic complications(5.97%,4/67)and 8hemorrhagic complications(11.94,8/67)from postoperative to final clinical follow-up,with no fatal cases.The overall good outcome was 97.01%(65/67).Conclusion(s):1.Domestic TFD has a high rate of complete occlusion of unruptured ICCAs,and is not limited to treating large and giant aneurysms,but also has good efficacy for small and medium-sized aneurysms,and can simplify the surgical procedure and enhance surgical safety.2.For large aneurysms or larger,TFD combined with spring coils is preferred to provide more complete occlusion of the aneurysm.TFD has advantages in the treatment of non-cystic aneurysms.3.TFD is safe and effective in the treatment of unruptured intracranial aneurysms,with less impact on the penetrating vessels and a low overall complication rate,but it should not be neglected.Appropriate individualized surgical strategies and antiplatelet therapy to ensure adequate stent apposition to the wall can reduce the occurrence of associated hemorrhagic and ischemic complications. |
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