Tubridge Flow Diverter Research Articles

Treatment of intracranial aneurysms using the Tubridge flow diverter.

The Tubridge flow diverter (TFD) was recently developed to treat intracranial aneurysm (IA). In this study, we aimed to assess the safety and efficacy of this novel device. A retrospective cohort of consecutive patients with IA was recruited between June 2017 and February 2022. The studied outcomes were perioperative complications, clinical quality of life, and angiographic IA occlusion. Multivariate logistic regression was performed to explore the potential predictors of perioperative stroke events and IA occlusion. A comprehensive literature review was conducted across five databases for evidence synthesis. Among the patients with IA in our cohort, 144 underwent successful TFD implantation. Postoperative stroke was observed in 11 (7.6%) patients, and 130 (90.3%) patients were discharged with modified Rankin scales (mRS) of ≤2. In the last clinical follow-up (mean, 16.9months), 96.6% of the patients reported a satisfactory quality of life (mRS ≤2). IA occlusion was observed in 84.6% of the patients at the last angiographic follow-up (mean, 10.4months). Aneurysmal subarachnoid hemorrhage [odds ratio (OR), 6.98; 95% confidence interval (CI), 1.11-43.91] and giant IA (OR, 5.63; 95% CI, 1.15-27.48) were associated with perioperative stroke events. The evidence synthesis found high rates of satisfactory quality of life (rate, 98.8%; 95% CI, 97.1-99.9%) and IA obliteration (rate, 78.5%; 95% CI, 74.0-82.7%) after TFD treatment. The pooled complication rate was 13.6% (95% CI, 10.9-16.5%). This study identified a high rate of IA occlusion in patients who received TFD treatment. These patients also reported a satisfactory quality of life. Further studies in larger prospective cohorts with longer follow-up periods are warranted to verify our findings. Key message What is already known on this topic Flow diverter (FD) devices are an optimal tool to modify hemodynamics and treat intracranial aneurysms (IAs). However, the safety and efficacy of a novel self-expanding FD, namely the Tubridge flow diverter (TFD), remain to be fully established owing to the short-term follow-up periods and limited sample size of existing studies. What this study adds In our cohort of patients who received TFD treatment, 96.6% of patients reported satisfactory quality of life at the last clinical follow-up (mean, 16.9months); and 84.6% of IAs were successfully occluded at the last angiographic follow-up (mean, 10.4months). Our comprehensive review and evidence synthesis of existing studies on TFD found high rates of satisfactory quality of life (98.8%; 97.1-99.9%) and IA obliteration (78.5%; 74.0-82.7%). How this study might affect research, practice or policy TFD demonstrated satisfactory performance in the treatment of IAs in our cohort. Studies with larger prospective cohorts and longer follow-up periods are warranted to further investigate this promising novel approach.

Erratum. Intracranial Aneurysms Managed by Parent Artery Reconstruction Using Tubridge Flow Diverter study: 1-year outcomes.

Erratum. Intracranial Aneurysms Managed by Parent Artery Reconstruction Using Tubridge Flow Diverter study: 1-year outcomes.

Intracranial Aneurysms Managed by Parent Artery Reconstruction Using Tubridge Flow Diverter study: 1-year outcomes.

Previous randomized controlled trials have reported a significantly higher occlusion rate of large and giant aneurysms when utilizing the Tubridge flow diverter (FD). In the present trial, the safety and efficacy of the Tubridge FD in treating unruptured internal carotid artery (ICA) or vertebral artery (VA) aneurysms were assessed in a real-world setting. The Intracranial Aneurysms Managed by Parent Artery Reconstruction Using Tubridge Flow Diverter (IMPACT) study is a prospective, multicenter, single-arm clinical trial assessing the efficacy of the Tubridge FD in the management of unruptured aneurysms located in the ICA or VA. The primary endpoint was the complete occlusion (Raymond-Roy class 1) rate at the 1-year follow-up. The secondary endpoints included the technical success rate, the successful occlusion rate of the aneurysm, which is the degree of aneurysm embolization scored as Raymond-Roy class 1 or 2, major (> 50%) in-stent stenosis, and incidence of disabling stroke or neurological death associated with the target aneurysms. This study included 14 interventional neuroradiology centers, with 200 patients and 240 aneurysms. According to angiographic core laboratory assessment, 205 (85.4%) aneurysms were located in the ICA, 34 (14.2%) in the VA, and 1 (0.4%) in the middle cerebral artery. Additionally, 189 (78.8%) aneurysms were small (< 10 mm). At the 12-month follow-up, the total occlusion rate was 79.0% (166/210, 95% CI 72.91%-84.34%). Additionally, the occurrence of disabling stroke or neurological death related to the specified aneurysms was 1% (2/200). The 1-year results from the IMPACT trial affirm the safety record of use of the Tubridge FD in the treatment of intracranial aneurysms in real-world scenarios. These results reveal low morbidity and mortality rates of 3.5% and 1.5%, respectively. Furthermore, they provide evidence of the effectiveness of the Tubridge FD, as demonstrated by the complete occlusion achieved in 166 of 210 (79%) cases.

Use of the Tubridge flow diverter in the treatment of intracranial aneurysms: a single center experience

To investigate the safety and effect of Tubridge flow diverter deployment for the treatment of intracranial aneurysms, 85 patients with intracranial aneurysms treated with the Tubridge flow diverter were retrospectively enrolled. The clinical data including the baseline data, aneurysm parameters before and after treatment, and follow-up outcomes were assessed. Among 85 patients, there were 35 (41.2%) males and 50 females (58.8%) aged 17–77 (mean 56.7 ± 11.1) years with 110 aneurysms. Five (5.9%) patients initially presented with subarachnoid hemorrhage from aneurysm rupture. The aneurysm size was 2–30 (mean 8.6) mm, and the aneurysm neck was 2–10.6 (mean 5.7 ± 2.3) mm. Ninety-three Tubridge stents were deployed. Twenty-five (29.4%) patients experienced adjunctive loose coiling. Blood flow was significantly reduced from entering the aneurysm after stent deployment. Periprocedural complications occurred in three (3.5%) patients, including in-stent thrombosis during embolization in one patient (1.2%), conjunctiva edema on the right in one patient (1.2%), and acute multiple cerebral infarctions in one patient (1.2%). Angiographic follow-up was conducted in 67 (78.8%) patients 3–36 (mean 15.3 ± 5.6) months later. In 11 (16.4% or 11/67) patients, blood flow still entered the aneurysm with the O’Kelly-Marotta (OKM) grade B in two (3.0%) patients and grade C in nine (13.4%), whereas complete occlusion (OKM grade D) was achieved in the other 56 (83.6% or 56/67) aneurysms. In-stent stenosis was present in five (7.5%) patients with approximately 25% stenosis in three (4.5%) patients and 50% in two (3.0%). In conclusion, the Tubridge flow diverter can be safely and efficiently applied in the treatment of small and large intracranial aneurysms, with a low periprocedural complication rate, a high occlusion degree, and a low in-stent stenosis rate at follow-up even though large aneurysms may necessitate a longer surgical time and adjunctive coiling.

Comparison of pipeline embolization device and tubridge flow diverter for posterior circulation aneurysms: A multicentre propensity score matched study

Rationale and objectivesThe off-label use of flow diverters (FDs) has broadened to include treating aneurysms in posterior circulation (PC). A novel flow diverter, the Tubridge flow diverter (TFD), has been created in China specifically for treating PC aneurysms. However, studies comparing between pipeline embolization device (PED) and TFD are rare. Thus, our study aimed to explore the effectiveness of PED and TFD in the treatment of PC aneurysms using a propensity score matched cohort design. MethodsRetrospective data collection was conducted on patients who underwent treatment with either PED or TFD over the period from 2015 through 2020. Propensity score matching (PSM) was employed to calibrate for patient age; history of ischemic stroke; aneurysm size; morphology; location and neck; number of FDs; parent vessel diameter; and the employment of assisted coiling and balloon techniques. Data on previously ruptured aneurysms was not included in the analysis. A comparison was conducted between the two devices to assess perioperative complications, aneurysm occlusion rates, and functional outcomes. ResultsA total of 252 PC aneurysms were treated in 248 patients. Clinical and imaging follow-ups were lost in 26 and 47 patients, respectively. Major perioperative complications occurred in 7.5% of the cases, with favorable clinical outcomes in 91.0% and complete occlusion in 79.1%. Eighty-two (32.5%) aneurysms were treated with TFD, while 170 (67.5%) aneurysms were treated with PED. PSM was used to account for these significant variations, producing 82 matched pairs of unruptured aneurysms treated with PED or TFD. In terms of functional and angiographic outcomes, no significant differences were found between PED and TFD (functional outcome, p = 0.594 and angiographic outcome, p = 0.415). However, more perioperative major complications were found in patients treated with TFD (p = 0.005) compared with those receiving PED. ConclusionThe comparative study of PED and TFD in the treatment of PC aneurysms resulted in positive clinical results and sustained occlusion rates, with acceptable perioperative complications. However, higher quality studies are needed to enhance our understanding of the use of FDs for treating of PC aneurysms.

Tubridge flow diverter for the treatment of recurrent cerebral aneurysms

Background &amp; Objective: The Tubridge flow diverter is a commonly used device in China for reconstructing the parental artery and occluding complex intracranial aneurysms. However, there is limited experience with the device in treating recurrent intracranial aneurysms. The purpose of this study is to assess the safety and effectiveness of the Tubridge flow diverter in treating recurrent single- coiling aneurysms. Methods: The clinical records of patients with recurrent intracranial aneurysms who were treated with a Tubridge flow diverter were reviewed to show the therapeutic process, occlusion rate, and clinical outcomes associated with this treatment method. Results: Five patients with recurrent aneurysms of the internal carotid artery after singe coiling were included in the study. The recurrent aneurysmal sac had a mean length and width of 8.34/4.30 mm. All five Tubridge flow diverters were implanted without any unfold failure. The last angiographic follow-up showed a complete occlusion rate of 100%. Five branch arteries were covered, and only one branch artery disappeared during follow-up. No cases of cerebral infarction or intracranial hemorrhage were found among the patients. Conclusions: Our initial findings indicate that the Tubridge flow diverter could be a reliable and successful method for treating recurring single-coil aneurysms. We observed that the branch arteries were well-preserved, and no patients experienced cerebral infarction or hemorrhage. However, further research is necessary to establish clear indications and potential complications through a multicenter randomized controlled trial with long-term follow-up.

Clinical Outcomes On Tubridge Flow Diverter in Treatmenting Intracranial Aneurysms: aRetrospective Multicenter Registry Study.

In China, the application of nitinol Tubridge flow diverter (TFD) has become popular for treating intracranial aneurysms (IAs). In this study, we investigated the safety outcomes of the application of TFD for treating IAs in real-world scenarios. We retrospectively analyzed aneurysms treated with TFD in 235 centers throughout China between April 2018 and April 2020. The primary endpoint was the event-free survival rate at 12months, defined as the occurrence of morbidity (spontaneous rupture, intraparenchymal hemorrhage (IPH), ischemic stroke, and permanent cranial neuropathy) or death. Univariate and multivariate analyses were performed to assess the risk factors. Agood outcome was defined as amodified Rankin Score (mRS) of 0-2. We included 1281 unruptured aneurysms treated with TFD. The overall neurological morbidity and death rates after 12months were 5.4 and 2.8%, respectively. Ischemic strokes were the most common complication (4.2%, P < 0.001). Cranial neuropathy, IPH, and spontaneous rupture occurred in 0.3%, 0.3%, and 0.5% of aneurysms, respectively. Univariate and multivariate analyses indicated that the male gender, older age, larger aneurysm diameter, and aneurysm located on BA were the independent risk factors for neurologic events. Aneurysm located on BA was the independent risk factor for ischemic strokes. Most patients (1222) had access to the mRS, and 93.2% of them achieved good outcomes. Treatment of IAs with TFD was associated with low morbidity and mortality, most of which were ischemic events. Large posterior aneurysms might be associated with ahigher complication rate. Retrospectively registered.

A novel flow diverter device (Tubridge) for the treatment of intracranial aneurysms: a systematic review and meta-analysis.

The flow diverter (FD) device has become a feasible and effective option for treating intracranial aneurysms. This study aimed to evaluate the efficacy and safety of Tubridge FD (TFD) in treating intracranial aneurysms and provide evidence for further research and clinical application. Electronic databases, including PubMed, Web of Science, Embase, and the Cochrane Library from inception to July 31, 2022, were searched. The eligible studies should include TFD investigations in treating intracranial aneurysms. Pooled technical success rate, complete occlusion rate, improvement rate, stable rate, symptom elimination rate, and adverse events rate were calculated with either the fixed-effects model or the random-effects model, depending on the results of tests for heterogeneity. Egger's tests were performed to assess the potential publication bias. A total of 7 studies (145 patients) were included in this study. The pooled technical success rate was 0.98, the complete occlusion rate was 0.79, the improvement rate was 0.21, and the stable rate was 0.05. One included study reported that the surgery-related mortality rate in the Tubridge group was higher than that in the control group (3.66% vs. 1.61%), while the surgery-related morbidity rate in the Tubridge group was 2.4% and that in the control group was 0. Findings of this meta-analysis indicate that TFD manifests promising and effective performance with acceptable adverse events in the treatment of intracranial aneurysms.

Pipeline versus Tubridge in the treatment of unruptured posterior circulation aneurysms

BackgroundTo compare the safety and efficacy of pipeline embolization device (PED) and Tubridge flow diverter (TFD) for unruptured posterior circulation aneurysms.MethodsPosterior aneurysm patients treated with PED or TFD between January, 2019, and December, 2021, were retrospectively reviewed. Patients’ demographics, aneurysm characteristics, treatment details, complications, and follow-up information were collected. The procedural-related complications and angiographic and clinical outcome were compared.ResultsA total of 107 patients were involved; PED was applied for 55 patients and TFD for 52 patients. A total of 9 (8.4%) procedural-related complications occurred, including 4 (7.3%) in PED group and 5 (9.6%) in TFD group. During a mean of 10.3-month angiographic follow-up for 81 patients, complete occlusion was achieved in 35 (85.4%) patients in PED group and 30 (75.0%) in TFD group. The occlusion rate of PED group is slightly higher than that of TFD group. A mean of 25.0-month clinical follow-up for 107 patients showed that favorable clinical outcome was achieved in 53 (96.4%) patients in PED group and 50 (96.2%) patients in TFD group, respectively. No statistical difference was found in terms of procedural-related complications (p = 0.737), occlusion rate (p = 0.241), and favorable clinical outcome (0.954) between groups.ConclusionsThe current study found no difference in complication, occlusion, and clinical outcome between PED and TFD for unruptured PCAs.

Tubridge flow diverter for the treatment of small and medium aneurysms.

Tubridge flow diverter is a widely used device aimed at reconstructing parent arteries and occluding complex aneurysms in China. The experience of Tubridge in treating small and medium aneurysms is still limited. In this study, we aimed to evaluate the safety and efficacy of the Tubridge flow diverter for the treatment of the two types of aneurysms. We reviewed the clinical records of aneurysms treated with a Tubridge flow diverter between 2018 and 2021 in a national cerebrovascular disease center. Cases were divided into small and medium aneurysms according to aneurysm size. The therapeutic process, occlusion rate, and clinical outcome were compared. In total, 57 patients and 77 aneurysms were identified. The patients were divided into two groups: small aneurysms (39 patients, 54 aneurysms) and medium aneurysms (18 patients, 23 aneurysms). There were 19 patients with tandem aneurysms (a total of 39 aneurysms) in the two groups, among which 15 patients (30 aneurysms) were in the small aneurysm group and four patients (nine aneurysms) were in the medium aneurysm group. The results show that the mean maximal diameter/neck in the small and medium aneurysms was 3.68/3.25 and 7.61/6.24 mm, respectively. In total, 57 Tubridge flow diverters were successfully implanted without unfolding failure, and there were six patients with new mild cerebral infarction in the small aneurysm group. The complete occlusion rate on the last angiographic follow-up was achieved in 88.46% of the small aneurysms group and 81.82% of the medium aneurysms group. The complete occlusion rate of patients with tandem aneurysms in the last angiographic follow-up was 86.67% (13/15) of the small aneurysms group and 50% (2/4) of the medium aneurysm group. Intracranial hemorrhage was nonencountered in the two groups. Our preliminary experience suggests that the Tubridge flow diverter might be a safe and effective treatment for small and medium aneurysms along the internal carotid artery. Long stents may increase the risk of cerebral infarction. Adequate evidence is required to clarify the definite indications and complications in a multicenter randomized controlled trial with a long-term follow-up.

Effect and safety of Tubridge flow diverter in the treatment of unruptured intracranial aneurysms

The effect and safety of the Tubridge flow diverting device are unknown in the treatment of intracranial aneurysms after optimization of the device, improvement in the deployment of the device, and accumulation of experience of using the device. This retrospective one-center study was performed to investigate the clinical effect and safety of the Tubridge flow diverting device in the treatment of unruptured intracranial aneurysms. Twenty-three patients with 33 unruptured intracranial aneurysms which were treated with the Tubridge device were retrospectively enrolled. The clinical data, endovascular procedure, complications, and follow-up were analyzed. Twenty-seven Tubridge devices were deployed to treat the 33 aneurysms, and the deployment was failed in 1 case, resulting in the success stenting rate of 96.3%. In 5 (15.2%) aneurysms, coils were loosely packed. Peri-procedural complications occurred in 2 patients (8.7%), including 1 procedure-related complication in which the distal end of a Tubridge device herniated into the aneurysm cavity. In another case, weakness of left upper limb occurred on the second day post procedure, with instent thrombosis being suspected, which was recovered after medication. No other complications occurred. Twenty-three (100%) patients had clinical follow-up 6 months later, with the mRS of 0 in 21 patients, 1 in 1, and 2 in 1. Five (21.7%) patients with 11 aneurysms underwent digital subtraction angiography at 6-month follow-up, with 8 aneurysms being completely occluded (Raymond grade I) and 3 aneurysms still visible (Raymond grade III). The Tubridge flow diverter may be safe and effective in the treatment of unruptured intracranial aneurysms with low perioperative complications and good follow-up outcomes even though multi-center and prospective clinical studies with a large size sample are still needed to validate these results.

Tubridge flow diverter alone vs. Tubridge flow diverter and coils for the treatment of intracranial aneurysms: A propensity score matching analysis.

The study was designed to assess the clinical performance of a tubridge flow diverter (TFD) in the treatment of intracranial aneurysms and to compare the efficacy and safety between intracranial aneurysms treated with TFD alone and TFD combined with coiling. In this retrospective study, patients treated with the TFD alone or TFD combined with coiling between June 2018 to November 2022 were included. The patient demographics, the characteristics of the aneurysm, and the treatment outcomes between the two groups were compared. Propensity score matching was performed to match the variables with a significant difference between groups. In the current study, data from 93 consecutive patients including 104 aneurysms treated with TFD were analyzed. In total, 43 patients with 49 aneurysms were treated with TFD alone, and 50 patients with 55 aneurysms were treated with TFD combined with coiling. Aneurysms in the TFD combined with the coiling group were larger (12.9 ± 8.6 vs. 8.7 ± 8.8 mm, P = 0.016) and more likely to be saccular (92.7% vs. 75.5%, P = 0.027) than in the TFD alone group. No significant difference was observed between the two groups in terms of perioperative complication rate. During the follow-up period, the complete occlusion rate in the TFD combined with the coiling group was higher (80.0% vs. 43.8%, P = 0.001) than in the TFD alone group. These results were further confirmed using a propensity score matching analysis. TFD combined with coiling can be a safe and effective alternative option for the treatment of complex aneurysms. Given the potential risks of these therapeutic modalities, thus very careful consideration is required on an individual patient basis.

Retreatment with a flow diverter for recurrent blood blister-like aneurysms after embolization: A single-center case series.

Background and purposeTreatment of blood blister-like aneurysms (BBAs) has been a significant challenge mainly due to their high recurrence rate even after stent-assisted coiling (SAC) embolization. This study aims to evaluate the safety and efficacy of treating recurrent BBAs after SAC with a flow diverter (FD).MethodsA retrospective series of patients with recurrent BBAs who underwent the retreatment with the FD from June 2018 to December 2021 was included to analyze perioperative safety and immediate postoperative and follow-up outcomes.ResultsThe study enrolled 13 patients with recurrent BBAs previously treated with SAC. Within previous stents, an FD was deployed for retreatment, including eight Tubridge FDs and five PEDs. The time interval between initial treatment and FD implantation was 14–90 days. A total of 11 cases were treated with a single FD alone; two cases were treated with further endovascular coiling embolization, followed by FD implantation. The angiographic follow-up (6–12 months) was available in 12 patients, and all 12 recurrent BBAs were completely occluded. No perioperative complication was detected, and no rebleeding was found during the clinical follow-up (6–36 months).ConclusionThe use of the FD to manage recurrent BBAs after SAC is technically feasible, safe, and effective. The key to the success of the procedure is to ensure that the FD stent is fully open and has good apposition with the previously implanted stent.

Modeling Flow Diverters Using a Porous Medium Approach: A Fast Alternative to Virtual Flow Diverter Deployment

The Tubridge flow diverter (FD) (MicroPort Medical Co. Ltd., Shanghai, China) is a novel device aimed at reconstructing the parent artery and eliminating the aneurysm. Numerical simulations based on virtual FD deployment allow the assessment of the complex nature of aneurismal flow changes before the actual intervention but are demanding on computational resources. Here, we evaluate an alternative strategy of modeling FD effects for the Tubridge system using a porous medium. The goal of this study is to reduce demands on time and complexity of the simulation procedure for applications in clinical research. Ten patient-specific aneurysm models were reconstructed from retrospectively collected diagnostic 3-dimensional digital subtraction angiographic images. Virtual FDs were deployed (SolidWorks, Dassault Systems, Concord, Massachusetts, USA; Meshmixer, Autodesk, San Rafael, California, USA) and corresponding porous medium patches were constructed at the ostium with a research computational fluid dynamics prototype (Siemens Healthineers, Forchheim, Germany). Hemodynamic conditions were simulated in 2 approaches. Hemodynamics inside the aneurysm based on these 2 approaches were compared. Both approaches yielded similar results. Mean wall shear stress and mean pressure of the aneurysmal wall correlated significantly (r= 0.8, r= 1.0, P < 0.05) as did mean velocity and mean pressure at a region inside the aneurysm, at the ostium and at a cross section containing the main vertex (for velocities r= 0.9; for pressures r= 1.0, P < 0.05). The use of porous medium patches reduced the preparation and simulation time together by approximately 50%. Using a porous medium approach yields comparable mean values for hemodynamic alterations compared to direct virtual FD simulations. Additionally, the porous medium approach greatly reduced the modeling complexity and computation time.

Endovascular treatment of complex middle cerebral artery aneurysms using TuBridge flow diverters.

The safety and efficacy of the TuBridge flow diverter in treating middle cerebral artery aneurysms remains unknown. In this study, we report our preliminary experience treating complex middle cerebral artery aneurysms using the TuBridge flow diverter. A prospectively maintained database of intracranial aneurysms treated with the TuBridge flow diverter was retrospectively reviewed, and patients with middle cerebral artery aneurysms were included in this study. Demographics, aneurysm features, complications, and clinical and angiographic outcomes were assessed. Evaluation of the angiographic results included occlusion grade of aneurysm (O'Kelly-Marotta grading scale), patency of jailed branch(es), and in-stent stenosis. Eight patients with eight middle cerebral artery aneurysms were included in this study. The mean aneurysm size was 11.8 ± 6.8 mm. There were no procedure-related complications and there was no morbidity or mortality at a mean follow-up of 11.3 ± 3.6 months. All patients had follow-up angiograms at a mean of 7.5 ± 4.0 months after surgery. Of the eight patients, there was 1 (12.5%) O'Kelly-Marotta grading scale A, 3 (37.5%) O'Kelly-Marotta grading scale B, 1 (12.5%) O'Kelly-Marotta grading scale C, and 3 (37.5%) O'Kelly-Marotta grading scale D. Of the seven patients with jailed branch, the blood flow of jailed branch was unchanged in 4 (57.1%), decreased in 2 (28.6%), and occluded in 1 (14.3%). In-stent stenosis was mild in 2 (25%) patients and moderate in 1 (12.5%) patient. Midterm results suggest that endovascular treatment of middle cerebral artery aneurysms using the TuBridge flow diverter is safe and associated with good outcomes. The TuBridge flow diverter may be an option for complex middle cerebral artery aneurysms that are difficult to treat with either clipping or coiling.

Giant serpentine aneurysm of the internal cerebral artery and mandibular aneurysm: a case report

BackgroundGiant serpentine aneurysms (GSA) originate from saccular or spindle aneurysm, dissimilar from dissected aneurysm, that are defined as partially thrombosed giant aneurysms with tortuous internal vascular channel. The clinical and neuroradiologic characteristics are clarified and the mechanism of formation and the efficacy of double stent implantation in GSA are discussed.Case presentationAn 18-year-old man presented himself with a GSA arising from the internal cerebral artery (ICA). In addition, a mandibular aneurysm (MA) arose from the external cerebral artery (ECA). Success was achieved in treating GSA through endovascular treatment with double stents implanted in the parent artery, which were LEO stent and Tubridge flow diverter. After 1 year of follow-up, three-dimensional reconstruction of blood vessels revealed the disappearance of the serpentine access of GSA, which was found to be replaced with a roughly normal vascular structure.ConclusionsDouble stent implantation has provided a feasible treatment option for giant serpentine internal carotid aneurysms and eliminated the possibility of causing collateral circulation occlusion. Therefore, it represents a simple and suitable treatment method for anatomical structure and operation.

Safety analysis of branch arteries covered by Tubridge flow diverters in treatment of intracra-nial aneurysms

Objective To evaluate the safety of branch arteries covered by Tubridge flow diverters (TFDs) in the treatment of intracranial aneurysms. Methods The clinical and angiographic data of 79 patients harboring 79 aneurysms treated with TFD from the Parent Artery Reconstruction for Large or Giant Cerebral Aneurysms Using Tubridge (PARAT) trials were retrospectively collected and analyzed, in which 12 nationwide centers participated from December 2012 to May 2014. Digital subtraction angiography (DSA) was performed to evaluate immediate treatment results and coverage of branch vessels. For aneurysms treated by TFDs and coils, immediate results were classified according to Raymond Grade System, and for aneurysms treated by TFDs only, immediate results were evaluated according to stagnation of contrast. Angiographic follow-up was preformed conventionally after treatment with TFDs at 3 months using magnetic resonance angiography (MRA)and 6 months using DSA. Results A total of 91 TFD were delivered and implanted successfully in the 79 lesions. Fifty-eight aneurysms were treated by TFDs and coils, and Raymond Ⅰwas achieved in 2 lesions (3.4%), Raymond Ⅱ in 5 lesions (8.6%) and Raymond Ⅲ in 51 lesions (87.9%). For 21 aneurysms treated by TFDs alone, stagnation of contrast was observed in 15 lesions (71.4%). One hundred and ten branch arteries were covered by TFDs. MRA was available in 52 patients at 3 months, and 31 lesions (59.6%) were completed cured, 16 lesions (30.8%) were improved and 5 lesions (9.6%) remained stable. DSA data were available in 73 patients at 6 months. Among them, 55 (75.3%) were completed cured, 14 (19.2%) were improved, 2 (2.7%) remained stable and 2 (2.7%) developed recurrence. The total rate of effective treatment (completely cured and improved) was 94.5% (69/73). Branch artery occlusion was observed in 3 cases, including 1 anterior choroidal artery, 1 anterior cerebral artery and 1 ophthalmic artery, without permanent neurologic deficits. The occlusion rate of branch arteries was 2.9% (3/104). Conclusion Branch arteries covered by Tubridge flow diverter in treatment of intracranial aneurysms seem relatively safe and further clinical follow-up is needed. Key words: Intracranial aneurysm; Flow diverter; Safety

Treatment of intracranial aneurysms with Tubridge flow diverter: A single-center experience

Objective To evaluate the safety and efficacy of Tubridge flow diverter (TFD) in the treatment of intracranial aneurysms at a single center. Methods The clinical and angiographic data of 139 patients harboring 143 aneurysms treated with TFD between August 2010 and December 2018 at Department of Neurosurgery, Changhai Hospital, Naval Medical University were retrospectively collected and analyzed. Among them, 127 lesions were located in anterior circulation and 16 in posterior circulation. The size of the aneurysms ranged from 2.8-50.0 mm, with the mean size of 16.4 ± 9.2 mm. Clinical and angiographic follow-up were preformed conventionally after treatment with TFD. The clinical outcomes of the patients were evaluated using modified Rankin Scale (mRS). Results Among the 139 patients with 143 intracranial aneurysms, a total of 163 TFD were delivered and implanted successfully. Three patients had acute ischemic stroke after TFD deploymnet.And there were no bleeding complications and no death. The median clinical follow-up time of 109 patients was 29.6 months (range: 5 to 82 months). The mRS of 0 was obtained in 97 patients, mRS of 1 in 10 and mRS of 2 in 2. Procedure-related complications occurred in 3 patients. Angiographic follow-up data were available in 103 patients. The median follow-up time was 13.0 months (range: 6 to 80 months). The complete occlusion rates at 6 months, 12 months, 24 months and last follow-up were 75.7% (78/103), 83.5% (66/79), 92.3%(48/52) and 82.5% (85/103), respectively. Conclusion Tubridge flow diverter seems safe and effective in the treatment of intracranial aneurysms with relatively high success rate and few complications. Key words: Intracranial aneurysm; Endovascular procedures; Flow diverter; Treatment outcome

Treatment of vertebral artery dissecting aneurysms with flow diverter: A single-center experience

Objective To evaluate the safety and efficacy of flow diverter (FD) in the treatment of vertebral artery dissecting aneurysms (VADA). Methods The clinical and imaging data of perioperative period and follow-up were retrospectively collected and analyzed from 22 patients with VADA treated with FD at Department of Neurosurgery, Changhai Hospital, Navy Medical University from August 2010 to March 2019. Of the 22 aneurysms, 4 were recurrent aneurysms, 1 was acute ruptured aneurysm and 17 were unruptured aneurysms. Modified Rankin scale (mRS) was used to comprehensively evaluate the patients after surgery, and O＇kelly-Marotta (OKM) grading scale was to evaluate aneurysm embolization. Results All 24 FDs were implanted successfully in 22 VADA (with 19 Tubridge FDs and 5 Pipeline FDs). The technical success rate was 100%. Ten aneurysms were treated with FD combined with coil embolization. The immediate results of embolization were classified according to Raymond′s classification, with 2 cases of grade Ⅱ and 8 cases of grade Ⅲ. Twelve aneurysms were treated with only FD and significant intra-aneurysmal contrast hemostasis was retained immediately after operation in all 12 cases. No procedure-related hemorrhagic or ischemic complications occurred during the perioperative period. As for clinical follow-up 13.0(8.3-67.9)months, 22 patients had the mRS score of 0. No novel neurological deficits were reported. The short-term imaging follow-up at 6.0(4.7-7.1)months involved 20 cases and the complete occlusion rate was 13/20. The complete occlusion rates were 17/20 for last follow-up at 7.7(6.0-24.4) months and 8/8 for long-term follow-up at 26.5(23.3-31.4) months, respectively. No recurrence was demonstrated. Eight PICAs covered by FD and 3 PICAs harboring aneurysms were all patent during follow-up. One case developed severe in-stent stenosis at 3.5-month follow-up post FD placement in which balloon dilatation and angioplasty with stenting was performed. Twenty-two months later, the stenosis of the lumen returned to normal and the aneurysm was completely occluded. Conclusion FD treatment of VADA seems to have high surgical safety and satisfactory results. Long-term efficacy needs to be further evaluated in large case series. Key words: Intracranial aneurysm; Aneurysm, dissecting; Vertebral artery; Flow diverter

Parent Artery Reconstruction for Large or Giant Cerebral Aneurysms Using the Tubridge Flow Diverter: A Multicenter, Randomized, Controlled Clinical Trial (PARAT).

Although flow diverters have been reported with favorable clinical and angiographic outcomes in various literatures, randomized trials determining their true effectiveness and safety are still in lack. The Parent Artery Reconstruction for Large or Giant Cerebral Aneurysms Using the Tubridge Flow Diverter (PARAT) trial was designed to evaluate the safety and efficacy of the Tubridge flow diverter in the treatment of large or giant aneurysms in comparison with Enterprise stent-assisted coiling. This prospective, multicenter, randomized trial was conducted at 12 hospitals throughout China. Enrolled adults with unruptured large/giant intracranial aneurysms were randomly assigned (1:1) to receive either Enterprise stent-assisted coiling or Tubridge flow diverter implantation. The primary end point was complete occlusion at 6-month follow-up, while secondary end points included technical success, mortality, target vessel-related stroke, aneurysm bleeding, in-stent stenosis, parent artery occlusion, and the frequency of all adverse events. Among 185 enrolled subjects, 41 withdrew before procedure initiation. Overall, 82 subjects underwent Tubridge implantation, and 62 subjects were primarily treated with stent-assisted coiling. The results of 6-month follow-up imaging included complete occlusion rates of 75.34% versus 24.53% for the Tubridge and stent-assisted coiling groups, respectively, with a calculated common odds ratio of 9.4 (95% confidence interval, 4.14-21.38; P < .001). There was a higher, nonsignificant frequency of complications for Tubridge subjects. Multivariate analysis showed a decreased stroke rate at the primary investigational site, with a marginal P value (P = .051). This trial showed an obviously higher rate of large and giant aneurysm obliteration with the Tubridge FD over Enterprise stent-assisted coiling. However, this higher obliteration rate came at the cost of a nonsignificantly higher rate of complications. Investigational site comparisons suggested that a learning curve for flow-diverter implantation should be recognized and factored into trial designs.