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.

Middle cerebral artery bifurcation aneurysms are associated with patient age, sex, bifurcation angle, and vascular diameters.

To investigate the relationship of the middle cerebral artery (MCA) bifurcation aneurysms with patients' age and sex, vascular angles at the bifurcation, and diameters of the M1 and two M2 arteries, patients with and without MCA aneurysms were retrospectively enrolled. The lateral angles, MCA bifurcation angle and arterial diameter were measured and analyzed. Totally, 121 (19.0%) patients with and 517 (81.0%) without MCA aneurysms were enrolled. Most (n = 88 or 72.7%) aneurysms were present in the age range of 40-70 years, and significantly (P = 0.01) more women than men had the bifurcation aneurysms. The MCA bifurcation angle was significantly greater (149.2° ± 32.6° vs. 107.2° ± 26.3°; P < 0.0001) while both the smaller and larger lateral (M1/M2) angles were significantly smaller in patients with than without aneurysms (82.0° ± 23.7° vs. 109.1° ± 22.7° with P < 0.001 for the smaller and 123.2° ± 25.2° vs. 139.5° ± 16.9° with P < 0.001 for the larger lateral angle). 109 (90.1%) bifurcation aneurysms deviated towards the smaller lateral angle, and 103 (85.1%) aneurysms deviated towards the thinner M2 branch. The maximal aneurysm diameter ranged 1.6-13.8 (mean 5.4 ± 2.4) mm and was significantly (P < 0.05) positively correlated with the diameter of both M2 arterial branches (R = 0.57 and P = 0.01 for the smaller M2, and R = 0.69 and P = 0.002 for the larger M2) or the MCA bifurcation angle. A significant (P < 0.0001) negative correlation was detected between age and the smaller lateral angle but a significant (P < 0.0001) positive correlation between age and the MCA bifurcation angle in patients without MCA bifurcation aneurysms or in the total patients. MCA bifurcation angle was the only significant (P = 0.0001, odds ratio 2.7, 95% confidence interval 1.6-3.8) independent risk factor for MCA bifurcation aneurysm presence, with the bifurcation angle threshold of 124.1° and an area under the ROC curve of 0.86. In conclusion, significantly more MCA bifurcation aneurysms are present in older patients, females, and patients with a wider MCA bifurcation angle, and deviate towards the smaller lateral angle and the thinner M2 segment. MCA bifurcation angle is the only independent risk factor for presence of MCA bifurcation aneurysms with the threshold of 124.1°.

Use of the Neuroform Atlas stent for wide-necked cerebral aneurysms.

To investigate the effect and safety of the Neuroform Atlas (NFA) stent in stent-assisted coiling of wide-necked intracranial aneurysms, patients with wide-necked intracranial aneurysms were retrospectively enrolled and treated with the NFA stent-assisted coiling. The modified Rankin scale (mRS) grades and Raymond grades were used to assess the clinical outcomes and aneurysm occlusion degrees, respectively, after embolization and at follow-up. Totally, 122 patients were enrolled with 129 wide-necked aneurysms, and forty-nine (40.2%) patients experienced subarachnoid hemorrhage. A total of 134 NFA stents were deployed in all patients. Immediately after endovascular embolization, the Raymond grade was I in 112 (86.8%), II in 8 (6.2%), and III in 9 (7.0%). Complications occurred in 7 (5.7%) patients, including stent displacement in 2 (1.6%) patients, thrombosis and cerebral infarction in 4 (3.3%), and death in 1 (0.8%). Clinical follow-up was performed in 113 (92.6%) patients 6-30 (mean 21) months after embolization, with the mRS grade 0 in 99 (87.6%) patients, 1 in 7 (6.2%), 2 in 5 (4.4%), and 3 in 2 (1.8%). Good prognosis (mRS ≤ 2) was achieved in 111 (98.2%) patients while poor prognosis (mRS > 2) in two (1.8%). Digital subtraction angiography was conducted in 98 (80.3%) patients with 104 (80.6%) aneurysms 6-30 (mean 21) months after embolization. The Raymond grade was grade I in 94 (90.4%) aneurysms, II in 4 (3.8%), and III in 6 (5.8%). Compared with the Raymond grades immediately after embolization, 93 (89.4%) aneurysms disappeared, 9 (8.7%) remained unchanged in the occlusion status, and 2 (1.9%) were recurrent. In conclusion, the NFA stent may have a high aneurysm occlusion rate and a low complication rate in assisting coiling of wide-necked intracranial aneurysms even though further studies are necessary to prove this.

Comparison of pipeline classic and flex embolization devices in endovascular performance for intracranial aneurysms.

To investigate the endovascular performance of the Pipeline Classic embolization device (PED Classic) and PED Flex device (PED Flex) in the treatment of intracranial aneurysms. Fifty-three patients with intracranial aneurysms treated with the PED Classic were retrospectively enrolled into the PED Classic group, and 118 patients with intracranial aneurysms treated with the PED Flex were enrolled into the PED Flex group. The Procedure time, contrast dosage, fluoroscopy time, and perioperative complications were analyzed. The success rate of the stenting procedure was 100% in both groups. In the PED Classic group, 58 PED Classic devices were implanted, and 26 aneurysms underwent coil embolization. In the PED Flex group, 126 PED Flex devices were implanted, and 35 aneurysms underwent concomitant coil embolization. The procedure time was significantly (P < .001) greater in the PED Classic (159.0 ±â€…42.0 minutes) than in the PED Flex (121.9 ±â€…4.0 minutes) group. The dosage of contrast agent (156.4 ±â€…39.4 vs 110.1 ±â€…38.5 mL) and the total fluoroscopic time (34.7 ±â€…5.7 minutes vs 22.8 ±â€…7.6 minutes) were significantly (P < .001) greater in the PED Classic than in the PED Flex group. Peri-procedural complications occurred in 5 (9.4%) patients in the PED Classic group and in 3 (2.5%) patients in the Flex group, without a statistically significant (P = .11) difference. The performance of the PED Flex device may be safer and easier than that of the PED Classic device in the treatment of intracranial aneurysms despite some serious complications which remain to be prevented.

Safety and effect of pipeline flex embolization device for complex unruptured intracranial aneurysms.

To investigate the safety and short-term effect of Pipeline Flex devices in the treatment of complex unruptured intracranial aneurysms, a retrospective study was performed for patients with complex unruptured intracranial aneurysms who were treated with the Pipeline Flex embolization device (PED Flex device) combined with or without coiling. The clinical, endovascular, and follow-up data were analyzed. One hundred and thirty-one patients with 159 complex unruptured cerebral aneurysms were treated with the PED Flex device, with 144 Flex devices deployed. Periprocedural complications occurred in four patients, resulting in the complication rate of 3.1%, including ischemic complications in three patients (2.3%) and hemorrhagic complication in one (0.8%). At discharge, the mRS was 0 in 101 (77.1%) patients, 1 in 25 (19.1%), 2 in four (3.1%), and 4 in one (0.8%), with the good prognosis rate (mRS 0-2) of 99.2%. Clinical follow-up was carried out in 87 (66.4%) patients 3-42 months after the procedure, with the mRS of 0 in 78 (89.7%), 1 in five (5.7%), 2 in three (3.4%), and 4 in one (1.1%). No significant (P = 0.16) difference existed in the mRS at discharge compared with that at clinical follow-up. Angiographic follow-up was performed in 61 (46.7%) patients with 80 (50.3%) aneurysms at 3-40 months, with the OKM grade of D in 57 (71.3%) aneurysms, C in eight (10%), and B in 15 (18.8%). Asymptomatic instent stenosis occurred in four patients (6.6%). In conclusion: The treatment of complex intracranial aneurysms with the Pipeline Flex embolization device may be safe and effective, with a high complete occlusion rate, a decreased complication rate, and a good prognosis rate at medium follow-up.

Pipeline Embolization Device for Small and Medium Vertebral Artery Aneurysms: A Multicenter Study.

BACKGROUND: Pipeline embolization devices (PEDs) have been increasingly used for the treatment of posterior circulation aneurysms. OBJECTIVE: To investigate the safety and efficacy of PED in the treatment of small to medium unruptured vertebral artery intracranial aneurysms (VAIAs). METHODS: Data from 76 patients with 78 unruptured small and medium (≤12 mm) VAIAs were analyzed. Data for this study come from the PLUS study, which was conducted at 14 centers in China from 2014 to 2019. Univariate analyses were performed to evaluate predictors of the occlusion and complication. RESULTS: Seventy-eight aneurysms in 76 patients were treated with PED. The mean aneurysm size was 8.28 ± 2.13 mm, and all PEDs were successfully placed. The median follow-up was 7 months and available for 67 (85.9%) aneurysms. Complete occlusion was seen in 60 (89.6%) aneurysms, which 86.6% met the primary efficacy outcome. All patients received clinical follow-up, the combined major morbidity and mortality was 2.6%, and 98.7% of patients had a good prognosis. Ischemic stroke occurred in 10.5% of patients, and adjuvant coil and successful after adjustment were predictors of ischemic stroke in the early postoperative and follow-up, respectively. There was no significant difference in the occlusion rate of aneurysm involving posterior inferior cerebellar artery ( P = .78). In cases where posterior inferior cerebellar artery was covered by PED, there was no significant difference in ischemic stroke. CONCLUSION: In the treatment of unruptured ≤12 mm VAIAs, PED has a high surgical success rate, a high degree of occlusion, and low morbidity and mortality. PED may be a promising endovascular technique.

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.

Spontaneous healing and complete disappearance of an intracranial vertebral artery dissecting aneurysm: A case report.

RATIONALE: Intracranial vertebrobasilar dissecting aneurysms (VBDAs) are associated with a greater tendency to rupture and a greater risk of worse outcomes than anterior circulation aneurysms. Spontaneous healing of a VBDA is very rare, and there have been very few case reports of spontaneous healing of an aneurysm. We describe a case of intracranial vertebral artery dissecting aneurysm that healed spontaneously and disappeared completely on follow-up images. PATIENT CONCERNS: A 40-years-old woman was referred to the neurology department because of a persistent headache, especially in the left occiput. DIAGNOSES: Magnetic resonance angiography and computed tomography angiography showed a left vertebral artery dissection-like aneurysm (4.5 × 2.0 × 2.5 mm in size) with proximal parent artery mild stenosis (40%). INTERVENTIONS: Flunarizine hydrochloride was administered for symptomatic treatment and follow-up angiography was performed. OUTCOMES: Digital subtraction angiography and magnetic resonance angiography showed that the aneurysm had completely disappeared at 3 months follow-up. High-resolution magnetic resonance vessel wall imaging revealed intimal thickening and mild stenosis in the left intracranial vertebral artery without an aneurysm signal. In addition, enhancement scanning revealed that the aneurysm area was moderately enhanced. MR-vessel wall imaging at 7 months follow-up showed that the enhancement was slightly reduced compared with the previous time. LESSONS: This case illustrates the relatively plastic nature of a vertebral dissecting aneurysm, indicating that spontaneous healing remains possible.

Small Unruptured Intracranial Aneurysms Can Be Effectively Treated With Flow-Diverting Devices.

Purpose: To investigate the effect and safety of flow diverters in the management of small (<10 mm in diameter) unruptured intracranial aneurysms. Materials and Methods: One hundred and ten patients with 145 small intracranial aneurysms treated with flow diverters were retrospectively enrolled. The clinical, endovascular, and follow-up data were analyzed. Results: One hundred twenty-one flow diverters were deployed for the treatment of 145 small intracranial aneurysms in 110 patients, and the stenting success rate was 99.1%. In 133 (91.7%) aneurysms, only flow-diverting devices were deployed, and in the rest 12 (8.3%) of aneurysms, coils were used to loosely pack the aneurysm after deployment of a flow-diverting device. Five patients (4.5%) experienced ischemic complications, but no hemorrhagic complications were occurred. All patients had clinical follow-up 6-18 (median 12) after the procedure, with the modified Rankin scale score (mRS) 0 in 101 patients, 1 in four patients, 2 in three patients, 4 in one patient, and 5 in one patient. Digital subtraction angiography was performed at follow-up in 90 (81.8%) patients with 118 (81.4%) aneurysms 6-18 months (median 12) after the procedure, with the Raymond grade I in 90 (76.2%) aneurysms and Raymond grade III in 28 (23.7%). Eighteen patients with 22 partially occluded aneurysms at the first angiographic follow-up experienced the second digital subtraction angiography 12-36 months (median 26) after the procedure, and 21 (95.5%) aneurysms were completely occluded. Two patients had asymptomatic in-stent stenosis. Conclusion: Treatment of small unruptured intracranial aneurysms with flow diverters can be performed safely and effectively with satisfactory outcomes.

Small and Medium-Sized Aneurysm Outcomes Following Intracranial Aneurysm Treatment Using the Pipeline Embolization Device: A Subgroup Analysis of the PLUS Registry.

Objective: The purpose of this work was to summarize the real-world safety and efficacy of Pipeline Embolization Device (PED) therapy for small and medium-sized intracranial aneurysms in China. Methods: Patients from the PED in China post-market multi-center registry study (PLUS) with aneurysms smaller than 12 mm were selected. Radiographic outcomes were assessed using digital subtraction angiography. Clinical outcomes included functional outcomes (modified Rankin Scale, MRS) in the early postoperative period ( ≤ 30 days) and early postoperative complications associated with PED therapy. Results: A total of 652 patients with a combined 754 aneurysms were included in this study (mean age of 53.9 ± 10.3 years, 68.7% women). Mean aneurysm diameter was 6.78 ± 2.67 mm. Of the 687 stents deployed, 99.7% (685/689) were successfully deployed. In this study, 64.7% (488/754) of aneurysms were treated with only the PED, whereas 35.3% (266/754) were subjected to PED-assisted therapy. Radiographic outcome at the last follow-up (median time: seven months) was available for 64.3% (485/754) of the aneurysms. 82.5% (400/485) of aneurysms demonstrated complete occlusion (Raymond Roy Grade I). 81.4% (395/485) of aneurysms were found to meet the study's primary effectiveness outcome. At the early postoperative period, the mRS score was determined to be 0-2 vs. 3-6 in 98.2% (640/652) vs. 1.8% (12/652) of the cases, respectively. The combined major morbidity and mortality rate was 3.2% (21/652). Conclusion: In the largest study of PED therapy for small and medium-sized intracranial aneurysms to date, pipeline-assisted coil embolization was chosen more often than multiple stent implantation for aneurysm treatment, demonstrating good results, high surgical success rates, high occlusion rates, and low morbidity and mortality. Clinical Trial Registration: www.ClinicalTrials.gov, identifier: NCT03831672.

Pipeline flex embolization device for the treatment of large unruptured posterior circulation aneurysms: Single-center experience.

PURPOSE: To investigate the safety and effect of the Pipeline Embolization Device (PED) Flex device in the treatment of large unruptured posterior circulation aneurysms in a single center. MATERIALS AND METHODS: Patients with large unruptured posterior circulation aneurysms which were treated with the PED Flex device were enrolled. The clinical, endovascular and follow-up data were analyzed, and the O'Kelly-Marotta (OKM) grading system was used to assess the aneurysm occlusion status. RESULTS: Fourteen patients with 14 large posterior circulation aneurysms who were treated with the PED Flex device were enrolled. The maximal diameter of aneurysm was 17.0 ± 3.9 mm. Fourteen PED Flex devices were deployed in 14 patients, with a technical success rate of 100%. All stents covered the aneurysm neck with good wall adherence and patent parent artery. Ten (71.4%) aneurysms were treated with a single PED Flex device each, and four (28.6%) patients experienced additional coiling. No neurological complications occurred in the periprocedural period. The mRS was 0 in eleven (78.6%) patients, 1 in two (14.3%), and 2 in one (7.1%) at discharge. All patients were followed up at 6-28 months (median 18), with an mRS score of 0 in all patients. Twelve (85.7%) patients experienced digital subtraction angiography 6-28 (median 18) months after the embolization procedure, and the OKM grade was D in nine (75%), C in two (16.7%), and B in one (8.3%). CONCLUSION: The Pipeline Flex Embolization Device can be safely applied to treat large unruptured posterior circulation aneurysms with a high complete aneurysm occlusion rate at follow-up.

Safety and Efficacy of Coils in Conjunction With the Pipeline Flex Embolization Device for the Treatment of Cerebral Aneurysms.

Background: Flow diverters (FD) have shown promising results in the treatment of intracranial aneurysms (IAs). However, there is still controversy whether pipeline flex embolization device (PED flex)-assisted coils can facilitate the curing of aneurysms. Our aim was to assess the safety and effectiveness of PED flex adjunctive with coils (PED flex + coil) in the treatment of IAs. Method: Patients who underwent PED flex treatment in combination with coiling between January 2018 and June 2020 were included in this study. The clinical and radiographic characteristics before and after treatments were retrospectively evaluated. The study cohort comprised of 125 patients with 140 IAs, which was subdivided into two subgroups: one group included patients treated only through PED alone, and the other group included patients treated through PED flex adjunctive with coil. Patient baseline characteristics, aneurysm characteristics, treatment-related factors, and outcomes were analyzed to determine the effectiveness of both techniques. Results: Aneurysms in the PED flex + coil group were larger (10.0 ± 5.8 mm, P < 0.001) and wider (7.2 ± 4.6 mm, P = 0.002) compared with those in the PED flex group. There was no statistical difference in the perioperative complication rate between the two groups. The overall complete occlusion rate was 75.7% at 6.2 months, with 71.7% at 6.2 ± 1.7 months in the PED flex group and 85.4% at 6.2 ± 1.8 months in the PED flex + coil group, respectively. A higher percentage of satisfactory angiography results was found in the PED flex + coil group during follow-up (92.7 vs. 78.8%, P = 0.047). Conclusion: PED flex placement with adjunctive coil embolization represents a safe alternative option for the treatment of IAs. In these cases, coil embolization increases the occlusion rate in PED flex-treated patients without increasing the periprocedural complications.

Application of 3D T1-SPACE combined with 3D-TOF sequence for follow-up evaluation of stent-assisted coil embolization for intracranial aneurysm.

OBJECTIVES: To assess 3D T1-SPACE combined with 3D-TOF sequence for follow-up evaluation of stent-assisted coil embolization for intracranial aneurysm. MATERIALS AND METHODS: Between Oct 2018 and May 2019, we enrolled 25 patients with intracranial aneurysm who underwent stent-assisted coil embolization. All patients were followed up for 6 to10 months after endovascular treatment (EVT) using 3D-TOF MRA, 3D T1-SPACE and DSA to evaluate aneurysm occlusion and parent artery patency. RESULTS: With regards to aneurysm occlusion, the specificity of 3D-TOF MRA was 86.9% (20/23) and the accuracy was 84% (21/25). There was no statistical significance (P â€‹= â€‹0.409) compared with the DSA. The parent artery by 3D-TOF MRA showed that there were 14 patients with grade 3, 8 patients with grade 2 and 3 patients with grade 1. However, 3D T1-SPACE showed that all 25 patients were grade 4, and were clearly displayed without metal artifacts. The comparison of the two MR techniques demonstrated that 3D T1-SPACE was superior to 3D-TOF MRA in the evaluation of parent artery (P<0.001). CONCLUSIONS: 3D T1-SPACE sequence provides better image quality and higher accuracy for evaluating stented parent arteries compared to TOF-MRA. This study also shows that 3D-TOF MRA has a merit to evaluate aneurysm occlusion. The combination of these two modalities can be used as an optional follow-up evaluation after EVT of intracranial aneurysms.

Comparison of 3D T1-SPACE and DSA in evaluation of intracranial in-stent restenosis.

OBJECTIVE: In-stent restenosis (ISR) after stenting for intracranial stenosis is a significant issue. This study aimed to evaluate the usefulness of the 3D T1-SPACE technique in the follow-up of patients after stent implantation. METHODS: Fifteen patients with intracranial arterial stenosis were prospectively enrolled 6-8 months after stenting. Digital subtraction angiography (DSA) and 3D T1-SPACE imaging were performed to evaluate the degree of stenosis and the enhancement of the vessel wall. Bland-Altman plots were used to assess the agreement between the two imaging methods, and the Pearson correlation coefficient was calculated as a measure of the linear correlation. RESULTS: Eight Enterprise stents and seven Wingspan stents were used in 15 patients. The follow-up DSA after 6-8 months showed that the degree of stenosis was 40% (range, 30-72%), and ISR occurred in 4 of 15 (26.7%) lesions. The degree of stenosis assessed using the 3D T1-SPACE imaging technique was 35% (range, 30-75%). All four patients with ISR demonstrated significant enhancement. The Pearson correlation coefficient between the two methods was 0.959 (p < 0.05), and the Bland-Altman plot showed that all data points were within the consistency limits ([Formula: see text] ± 1.96 s). CONCLUSION: As a non-invasive imaging modality, 3D T1-SPACE showed great consistency with DSA in measuring the degree of stenosis after intracranial stenting. It may be used as an optional method for detecting ISR. ADVANCES IN KNOWLEDGE: This study evaluated the usefulness of 3D T1-SPACE technique in the follow-up of patients after stent implantation, which could be used as an optional and non-invasive method in detection of in-stent restenosis.

Intracranial aneurysms managed by parent artery reconstruction using Tubridge: Study protocol for a prospective, multicenter, post-market clinical trial.

BACKGROUND: As a new endovascular reconstruction technique, flow diverter (FD) shows excellent efficacy and safety for treatment of intracranial aneurysms. In a previous multicenter, randomized, controlled, pre-market study, Tubridge FD showed remarkably higher complete occlusion rate compared with traditional stent-assisted coiling. However, a nonsignificant higher complication rate in the Tubridge group was noted. Considering the learning curve, the safety, and long-term outcomes of Tubridge FD should be verified in new prospective, real world, multicenter, post-market trials. METHODS: This study is a prospective, multicenter, single-arm, post-market clinical trial that evaluates the safety and efficacy of Tubridge in the treatment of patients with intracranial aneurysms by reconstructing parent artery. We expect 200 participants who meet the inclusion and exclusion criteria to be included. Clinical information and angiographic results (Raymond-Roy grading scale, RRGS) will be recorded objectively. The primary endpoint will be the complete occlusion rate of the target aneurysm (RRGS 1) at 12-month follow-up. Secondary endpoints will include the adequate occlusion rate (RRGS 1 & 2) and the rate of major in-stent stenosis (>50%) at 12-month follow-up, technique success rate, changes of modified Rankin Scale before and after the procedure, the rate of aneurysm related disability, neurological mortality, and all-cause mortality within follow-up period. DISCUSSION: This post-market, prospective trial may offer more information on the safety and long-term outcomes of Tubridge FD. When the study is complete, the results may provide us a new strategy for the treatment of intracranial aneurysms.Trial registration: WHO-Chinese Clinical Trial Registry: ChiCTR2000032282.

Prophylactic administration of tirofiban for preventing thromboembolic events in flow diversion treatment of intracranial aneurysms.

BACKGROUND: Flow diverter (FD) is widely used in the treatment of intracranial aneurysms. However, thromboembolic events (TEs) continue to be the major complications during the periprocedural phase. To evaluate the safety and efficacy of the prophylactic use of tirofiban, combined with the conventional dual antiplatelet therapy (DAT), as a new antiplatelet protocol in patients with intracranial aneurysms treated with FDs. METHODS: At least 3-5 days before the procedure, daily DAT were administrated to the patients. Tirofiban was administered as an intravenous bolus (5 µg/kg) over a 3 min period during or immediately after FD deployment, followed by a 0.05 µg/kg/min maintenance infusion for 24-48 hours. Periprocedural TEs and hemorrhagic events (HEs) were recorded. RESULTS: A total of 331 patients were included, including 229 (69.2%) who received tirofiban administration (tirofiban group) and 102 (30.8%) who received only DAT (non-tirofiban group). Periprocedural TEs occurred in 12 (3.6%) patients, including eight (7.8%) in the non-tirofiban group and four (1.7%) in the tirofiban group. In multivariate analysis, patients receiving tirofiban administration had significantly lower TEs as compared with those who received only DAT (P=0.004). Balloon angioplasty and longer procedure time (>137 min) were also risk factors for TEs. Also, no increase was observed in the rate of HEs related to tirofiban administration. CONCLUSIONS: The current study suggested that prophylactic administration of tirofiban combined with conventional oral DAT seems safe and efficient for preventing TEs during FD treatment of unruptured intracranial aneurysms. Balloon angioplasty and prolonged procedure are associated with a high risk of TEs.

Usefulness of 3D T1-SPACE in Combination With 3D-TOF MRA for Follow-Up Evaluation of Intracranial Aneurysms Treated With Pipeline Embolization Devices.

Object: Follow-up evaluation of intracranial aneurysms treated by flow-diverting stents using MRI is challenging due to the presence of imaging artifacts. This study evaluated 3D T1-SPACE in combination with 3D-TOF sequence for follow-up evaluation of intracranial aneurysms treated with Pipeline embolization devices. Methods: Forty patients with 53 intracranial aneurysms who were treated with Pipeline Embolization Devices from October 2018 to July 2019 were enrolled in this study. All patients were evaluated for aneurysm occlusion and stent patency 4 to 7 months post-treatment using 3D T1-SPACE sequence, 3D-TOF MRA, and DSA examinations. Results: With regards to aneurysm occlusion, the intermodality (DSA and 3D-TOF MRA) agreement was good (κ = 0.755). The specificity of 3D-TOF MRA was 94.4% (34/36), the sensitivity was 76.5% (13/17), the total coincidence rate was 88.7% (47/53). With regards to the patency of the stented arteries after PED treatment, 3D T1-SPACE sequence was more accurate compared to 3D-TOF MRA (Z = -6.283, P < 0.001), with a no-artifact rate of 95.7% (44/46). Conclusions: 3D T1-SPACE sequence provides better image quality and higher accuracy for evaluating stented parent arteries compared to TOF-MRA. 3D-TOF MRA may be valuable in the evaluation of aneurysm occlusion. The combination of these two modalities may be used for long-term follow-up of intracranial aneurysms treated with Pipeline Embolization Devices.

Intracranial Stenting as a Rescue Therapy for Acute Ischemic Stroke After Stentriever Thrombectomy Failure.

OBJECTIVE: To evaluate the efficacy and safety of intracranial stenting as a rescue therapy for acute ischemic stroke (AIS) after stentriever thrombectomy failure. METHODS: Patients who received intracranial stenting as a rescue therapy for AIS after failure of stent retrieval with or without concomitant treatment between January 2014 and December 2016 were retrospectively analyzed. Recanalization results and outcome at 3 months were assessed, and perioperative complications related to the procedure were recorded. RESULTS: A total of 193 patients with AIS received stent retriever thrombectomy. Initial successful recanalization with stent retriever was achieved in 125 patients. Among the 68 patients with stent retrieval failure, 47 patients received stent placement as rescue therapy, and successful recanalization was achieved in 38 patients. The rate of successful recanalization, favorable outcome at 90 days, mortality, and symptomatic intracerebral hemorrhage were comparable between the stenting group and no-stenting group; however, the time from groin puncture to recanalization was significantly longer in the stenting group (P = 0.03). Compared with anterior circulation stroke, the rate of stent placement was significantly greater (P = 0.041) and the intracerebral hemorrhage rate was lower in the patients with posterior circulation stroke who received stent placement. CONCLUSIONS: Intracranial stenting as a rescue therapy for AIS after failure of Solitaire retrieval stent is feasible and safe. AIS of posterior circulation showed greater intracranial stent placement than anterior circulation.

Mechanical Recanalization Using Solitaire AB Device for Severe Thromboembolic Events in Endovascular Treatment of Intracranial Aneurysms.

INTRODUCTION: Severe thromboembolism with complete occlusion of the proximal arteries during or after coil embolization can cause serious neurologic deficits. The study aimed to assess the effectiveness and safety of Solitaire AB device as a rescue therapy for severe thromboembolic complications in the endovascular treatment of intracranial aneurysms. MATERIALS AND METHODS: Between February 2013 and April 2016, 1047 intracranial aneurysms treated with endovascular procedures were retrospectively reviewed in our center. Severe thromboembolisms occurred in ten patients and were treated by Solitaire AB device including clot retriever and permanent stent deployment. RESULTS: The location of arterial occlusion was distal to the aneurysm rather than the coil/parent artery interface or in-stent area. Four patients had distal thromboembolic events before coil embolization, and six patients had it after coiling. The complete arterial recanalization (TICI 3) was achieved in all patients, and no cerebral hemorrhage was related to the procedure after the rescue therapy. Among these patients with the aforementioned neurovascular procedures, the mean Glasgow Outcome Scale (GOS) score was 4.5 (ranging 3-5) and eight cases had good outcome with a score of GOS 4-5 at discharge, while eight patients presented mRS ≤2 at 3-month follow-up. CONCLUSIONS: These results demonstrate that mechanical recanalization using Solitaire AB device seems to be effective and safe as a rescue therapy for severe thromboembolic events during cerebral aneurysm embolization.

Management of tandem internal carotid and middle cerebral arterial occlusions with endovascular multimodal reperfusion therapy.

The aim of this study was to evaluate the safety and efficacy of multimodal reperfusion therapy (MMRT) for tandem internal carotid artery and middle cerebral arterial (TIM) occlusions. Cases of TIM occlusion were collected and retrospectively reviewed. The analyzed objects included etiology, sites of tandem occlusion, collateral flow, location and size of infarcts. Combined with mechanical recanalization techniques and its complications, the National Institute of Health Stroke Scale (NIHSS) score and imaging data that was derived pre- and post-procedure were further contrasted. The study enrolled six patients with TIM occlusions. The mean NIHSS score on admission was 17 (range 13-20) and the median time from puncture to recanalization was 141 min (range 60-230). The substantial recanalization rate (Thrombolysis in Cerebral Infarction 2b or 3) was 83.3% and no symptomatic intracerebral hemorrhage was observed. The mean NIHSS score after three days was 14 (range 10-19) and 9 (range 3-17) following discharge. However, one patient died of pulmonary infection one month after discharge. For the five patients who survived, the modified Rankin Scale was evaluated at three months, with scores of 3, 1, 3, 5 and 3, respectively. It is concluded that endovascular therapy for acute TIM occlusions are complex, MMRT may be relatively safe and effective.