Safety and effectiveness analysis of Tubridge versus Surpass Streamline in the treatment of unruptured intracranial aneurysms
Objective To compare the safety and effectiveness of two different flow diverter devices between Tubridge flow diverter(TFD)and Surpass Streamline flow diverter(SFD)in the treatment of unruptured intracranial aneurysms.Methods A retrospective analysis from August 2020 to December 2023 was performed on the clinical data of 62 cases of unruptured aneurysms in the Department of Interventional Radiology(Shinan Branch),the Affiliated Hospital of Qingdao University treated with flow diverter.According to the type of implanted stents,they were divided into TFD group(32 cases)and SFD group(30 cases),general information about patients was collected,including age,sex,and past history(hypertension,diabetes,coronary heart disease),hospitalization time,surgical time(anesthesia start to anesthesia awakening time)and aneurysm location(anterior circulation,posterior circulation),type(giant aneurysm:maximum diameter ≥ 25 mm,large aneurysm:maximum diameter 15-＜25 mm,medium aneurysm:maximum diameter 5-＜15 mm,small aneurysm:maximum diameter＜5 mm),aneurysm morphology(saccular aneurysm,simple fusiform aneurysm,dissecting aneurysm),aneurysm maximum diameter,aneurysm neck,parent artery diameter,aneurysm wall enhancement in preoperative high-resolution MRI scan.Different types of flow diverters were selected according to the results of Surpass intracranial aneurysm embolization system pivotal trial to treat large or giant wide neck aneurysms(SCENT)and intracranial aneurysms managed by parent artery reconstruction using Tubridge flow diverter study(IMPACT).If"ejection sign"was found at the aneurysm neck on angiography immediately after the release of flow diverters,appropriate amount of coils were packed.Tamponade until there is no contrast filling in the aneurysm body on cerebral angiography,at which time the operation is terminated.If there is no"ejection sign"immediately after the release of the flow diverter,the procedure is terminated.Angiography was performed immediately after operation to evaluate the parent artery stenosis(patency[stenosis rate ≤50％],stenosis[stenosis rate＞50％]or occlusion[stenosis rate 100％])degree of aneurysm occlusion.O'Kelly-Marotta(OKM)classification was used to evaluate the degree of aneurysm occlusion.Effectiveness evaluation:DS A follow-up was performed≥1 month after operation,and the final angiographic result was taken as the final follow-up result to evaluate the postoperative aneurysm occlusion(OKM grade D:complete aneurysm occlusion,other grades:incomplete aneurysm occlusion),parent artery stenosis or occlusion.Safety evaluation:the clinical efficacy of patients at the last postoperative follow-up was evaluated by modified Rankin scale(mRS)score(mRS score 0-2:good clinical prognosis,mRS score 3-6:poor clinical prognosis),and perioperative(≤2 weeks after surgery)complications(ischemic complications,bleeding complications and other complications)were counted.The clinical effects and complications of the two groups were compared.Results A total of 62 aneurysms in 62 patients were included in the study.All patients were treated with a single flow diversion device.There were 28 males and 34females,aged 32 years to 76 years,with an average of(57±10)years.There were 39 anterior circulation aneurysms and 23 posterior circulation aneurysms.Among 62 patients,43 patients had saccular aneurysm,4 patients had simple fusiform aneurysm and 15 had dissecting aneurysm.Among them,38 saccular aneurysms were located in the anterior circulation and 5 in the posterior circulation;1 simple fusiform aneurysm was located in the anterior circulation and 3 in the posterior circulation;all dissecting aneurysms were located in the posterior circulation.The maximum diameter of the aneurysm ranged from 2.0 mm to 27.0 mm,with a median of 7.0(5.0,12.0)mm,and the aneurysm neck ranged from 2.0 mm to 18.5 mm,with a median of 5.0(4.0,6.7)mm.(1)There were statistically significant differences in aneurysm location and shape distribution between TFD group and SFD group(both P＜0.05),but there were no statistically significant differences in other general data(all P＞0.05).(2)The incidence of perioperative complications was 6.3％(2/32)in TFD group and 10.0％(3/30)in SFD group,and there was no significant difference between two groups(P=0.940).The good clinical outcome rate of both groups were 100.0％at the last follow-up.(3)All patients were followed up with DS A after operation.The follow-up time ranged from 55 d to 1 150 d,with a median follow-up time of 205.0(108.0,360.0)d.There was no significant difference in OKM classification distribution immediately after operation(P=0.607)and complete occlusion rate at the last follow-up(53.1％[17/32]vs.63.3％[19/30],P=0.416)between two groups.At the last follow-up,no parent artery stenosis or occlusion occurred in either group.Conclusions TFD has comparable efficacy and safety as SFD in the treatment of unruptured intracranial aneurysms.The results of this study need to be further verified by prospective large sample study.
万方数据
维普
