Flow Diverter Combined with Coil Embolization for Acutely Ruptured Intracranial Aneurysms: A Single Center Experience.

BACKGROUND: Extensive research has confirmed the safety and effectiveness of flow diverters in the treatment of unruptured intracranial aneurysms. However, their use in cases of acute rupture remains a subject of debate. METHODS: This study was conducted as a single-center retrospective investigation from January 2018 to January 2022 and included patients with acutely ruptured intracranial aneurysms (within three days of rupture) who were treated using the Pipeline Embolization Device with adjunctive coil embolization. Patient demographics, operative procedures, and outcomes were analyzed. Antiplatelet therapy included intra-arterial tirofiban and postoperative dual therapy with clopidogrel and aspirin. RESULTS: A total of 21 patients (5 males, 16 females) diagnosed with acutely ruptured intracranial aneurysms were included in this study. The aneurysm types included 7 blood blister-like aneurysms (30.0%), 3 dissecting (14.3%), and 1 fusiform aneurysm (4.8%). Perioperative complications occurred in 2 patients (9.5%), and both cases involved thrombogenesis. Nineteen patients completed digital subtraction angiography during follow-up, with an average follow-up time of 8.7 months (5 - 18 months). Results showed a complete embolization rate of 94.7% (18/19), with a partial aneurysm still present in 1 patient. A total of 90.4% (19/21) of patients had a favorable prognosis (modified Rankin Scale score = 0 - 2). CONCLUSIONS: The Pipeline Embolization Device with adjunctive coil embolization proved to be a viable option for managing acutely ruptured intracranial aneurysms, notwithstanding the potential for ischemic complications.

Systematic Review of Treatment for Unruptured Intracranial Aneurysms: Clipping Versus Coiling.

AIM: To compare endovascular coiling and surgical clipping for the evaluation of clinical outcomes in patients with unruptured intracranial aneurysms. MATERIAL AND METHODS: We searched MEDLINE, EMBASE, the Cochrane Library and three Chinese domestic electronic databases, namely, Wanfang, CNKI and VIP for studies published between January 1990 and January 2018. We included controlled clinical studies comparing clinical outcomes between surgical clipping and endovascular coiling treatments. Two researchers extracted the data and assessed the quality of the studies, and a meta-analysis was performed using RevMan 5 software. RESULTS: We analysed a total of 23 controlled clinical studies including 117,796 cases. Meta-analysis demonstrated similar ischaemia rates between clipping and coiling with an odds ratio [OR] of 1.36 (95% CI: 0.77?2.40). The occlusion rate and bleeding risk were higher with clipping than coiling; the pooled ORs were 5.31 (95% CI: 3.07?9.19) and 2.39 (95% CI: 1.82?3.13), respectively. In addition, clipping resulted in a longer hospital stay (OR = 2.90, 95% CI: 2.14?3.65) than coiling did. Patients who underwent clipping had a higher short-term mortality (OR = 1.99, 95% CI: 1.70?2.33) and neurological deficit rate (OR = 2.05, 95% CI: 1.73? 2.44) compared with those who underwent coiling. However, 1 year mortality and deficit rate were similar for both clipping and coiling, with pooled ORs of 0.75 (95% CI: 0.41?1.38) and 0.94 (95% CI: 0.53?1.67), respectively. Funnel plots did not demonstrate a publication bias, with the exception of ischaemic outcome, and sensitivity analysis showed consistent results. CONCLUSION: Our study demonstrates that coiling is associated with a lower rate of occlusion, shorter hospital stay, lower bleeding risk and lower short-term mortality and morbidity compared with clipping. In terms of ischaemic risk, 1 year mortality and morbidity, coiling and clipping bear a similar risk. In addition, we speculate that surgical clipping may have a better outcome than endovascular coiling in the long term especially in young patients. Further research is needed to confirm our conclusion.

Endovascular Coiling of Ruptured Tiny Saccular Intracranial Aneurysms: A Systematic Review and Meta-Analysis.

BACKGROUND: The safety and efficacy of endovascular coiling of ruptured tiny saccular intracranial aneurysms (IAs) (≤3 mm) remain unknown. METHODS: A comprehensive search of PubMed, Embase, Web of Science, and Scorpus databases up to November 15, 2023 was performed. Pooled prevalence was calculated for occlusion rates, recanalization, retreatment, long-term favorable outcome, and procedure-related complications and mortality. Pooled odds ratios were calculated to compare these outcomes between coiling and stent-assisted coiling (SAC). RESULTS: Forty-two studies with 2166 ruptured tiny saccular IAs treated with coiling were included. The follow-up complete aneurysm occlusion rate was 83.9% (95% CI: 77.2-88.9%). The rates of recanalization and retreatment were 7.7% (95% CI: 5.7-10.2%) and 5.8% (95% CI: 4.5-7.5%). The range of median Hunt and Hess grades was 1.4-2.9 and the favorable outcome rate was 85.6% (95% CI: 81.1-89.2%). The rates of thromboembolism, intraprocedural rupture, and mortality were 4.6% (95% CI: 3.6-5.8%), 5.4% (95% CI: 4.1-7.0%), and 5.6% (95% CI: 4.4-7.2%), respectively. Comparison of coiling and SAC revealed no significant difference, except for a higher likelihood of follow-up complete aneurysm occlusion in SAC (odds ratio [OR] 0.37, 95% CI: 0.17-0.80) and recanalization in the coiling (OR, 3.21 [95% CI, 1.37-7.51]). CONCLUSIONS: Our meta-analysis demonstrates that coiling for ruptured tiny saccular IA is a feasible, effective, and safe approach that is associated with favorable clinical outcomes in both the short and long term for patients with mild to moderate Hunt and Hess grades.

Low-Profile Visualized Intraluminal Support Device for Y-Stent-Assisted Coiling of Wide-Neck Intracranial Aneurysms: A Single-Center Experience.

BACKGROUND: The Low-Profile Visualized Intraluminal Support (LVIS) device has been frequently used as an intracranial stent for treating intracranial aneurysms. However, the feasibility and efficacy of LVIS devices in Y-stent-assisted coiling (Y-SAC) have remained contentious. This study aimed to evaluate long-term angiographic and clinical outcomes of Y-SAC using LVIS devices. METHODS: We retrospectively reviewed the clinical presentation and angiography data of patients treated with Y-SAC using LVIS stents. The vascular angle geometry between the parent and the 2 branch vessels, before and after stent deployment and after coiling, were analyzed. Based on the Raymond-Roy Occlusion Classification (RROC), aneurysm occlusion status was classified. Clinical outcomes were assessed using the modified Rankin Scale. RESULTS: Forty patients with 40 aneurysms were included in this study. Immediate postprocedural angiograms showed complete/near-complete occlusion (RROC 1 and 2) in 31 aneurysms (77.5%). The long-term follow-up angiographic studies were available in 32 patients and showed RROC class 1 and 2 in 93.8% of patients. Y-SAC with LVIS devices significantly decreased the angle between the bifurcation branches from 171.90° ± 48.0° (standard deviation) to 130.21° ± 46.3° (standard deviation) (P < 0.0001). Periprocedural complications occurred in 5 patients (12.5%) including 4 in-stent thromboses (10.5%). Thirty-six patients (90.0%) had favorable clinical outcomes at the final follow-up. Univariate analysis showed that World Federation of Neurological Societies grade 3-5, thickness of subarachnoid hemorrhage on head computed tomography, intraprocedural complications, and in-stent thrombosis were predictors of poor outcome. CONCLUSIONS: Y-SAC using the LVIS device for intracranial bifurcation aneurysms is a feasible and relatively safe procedure with favorable long-term angiographic and clinical outcomes.

Midterm follow-up after embolization of intracranial aneurysms proximal to the circle of Willis with the Silk Vista flow diverter: the I-MAMA registry.

PURPOSE: The aim of this registry was to assess technical success, procedural safety and mid- to long-term follow-up results of the Silk Vista "Mama" (SVM) flow diverter (BALT, Montmorency, France) for the treatment of proximal intracranial aneurysms. METHODS: Between August 2020 and March 2022, data from nine Italian neurovascular centres were collected. Data included patients' clinical presentation, aneurysms' size, location and status, technical details, overall complications and mid- to long-term angiographic follow-up. RESULTS: Forty-eight aneurysms in 48 patients were treated using the SVM. Most aneurysms were small (≤ 10 mm: no. 29, 60%) and unruptured (no. 31, 65%); 13 aneurysms were recurrent after coiling or clipping. 37/48 aneurysms involved the internal carotid artery (77%). Optimal opening and complete wall apposition of the device were achieved in 46 out of 48 cases (96%). Four intra- or periprocedural complications occurred (two thrombotic complications successfully resolved, one cerebellar ischemia, one perirenal hematoma), without new neurological deficit. No significant intra-stent stenosis or stent displacement was observed during follow-up. No FD-related morbidity nor mortality was reported. At midterm (6-12 months) to long-term (> 12 months) follow-up, complete aneurysm occlusion (OKM D) was achieved in 76% of cases. Eighty-eight percent of patients had complete aneurysm occlusion or entry remnant (OKM D + C). CONCLUSIONS: Our experience suggests that the new generation of low-profile SVM flow diverter for the treatment of proximal intracranial aneurysms is safe and effective, with low rates of intraprocedural complications and acceptable mid- to long-term occlusion rate.

Safety and Outcomes of the Off-Label Treatment of Intracranial Aneurysms with Pipeline Embolization Device: A Systematic Review and Meta-analysis.

BACKGROUND: Off-label use of pipeline embolization devices (PEDs) has been increasingly used for endovascular treatment of intracranial aneurysms. Numerous articles have highlighted the safety and effectiveness of PED placement from independent centers for both on- and off-label indications. There remains a paucity of information that considers overall safety and efficacy of off-label PED placement across the existing literature. Our objective is to systematically review the safety and occlusion outcomes of PED off-label use in intracranial aneurysm embolization. METHODS: A systematic search of PubMed and Embase was performed to identify studies on off-label use of PED. The selected studies provided relevant information, including study characteristics, patient demographics, clinical outcomes, peri-procedural complications, and long-term outcomes, which were subjected to meta-analysis. RESULTS: Twelve studies met the inclusion and exclusion criteria. There were 747 patients and 791 aneurysms included for analysis. Among the patient, 69.2% were female, with an age range of 16 to 80 years. The overall incidence rates for ischemic and hemorrhagic complications were 7% (95% CI: 4%-10%) and 2% (95% CI: 0%-4%), respectively. The mortality rate was 1% (95% CI: 0%-4%). The occlusion rates of aneurysm at initial follow up and 1 year follow-up were 82% (95% CI: 72%-91%) and 81% (95%CI: 75%-86%), respectively. Meta-regression analysis indicated no correlation between occlusion rate and factors such as age, sex, aneurysm size, location, morphology, rupture, or history of treatment. CONCLUSIONS: Despite variations in results observed in single-center studies, this meta-analysis provides evidence supporting the safety and efficacy of PED off-label use.

Large Single-Center Experience with Short-Term Follow-up of Neqstent-Assisted Coiling.

BACKGROUND AND PURPOSE: Endovascular treatment of wide-neck bifurcation aneurysms has historically proved difficult with variable outcomes. Different endovascular techniques such as balloon-assisted coiling, stent-assisted coiling, or intrasaccular devices provide a varied range of efficacy and safety. Neqstent-assisted coiling is a new device and technique that aim to provide a maximum of both. We analyzed the early clinical and radiologic outcomes after the use of this new technique and device in our practice. MATERIALS AND METHODS: This study was a retrospective analysis of ruptured and unruptured intracranial aneurysms treated with the Neqstent. The primary radiologic outcomes were quantified on DSA, CTA, or MRA using the modified Raymond-Roy criteria. The outcomes were defined as immediate complete occlusion (modified Raymond-Roy criteria 1) and complete (modified Raymond-Roy criteria 1) and adequate occlusion (modified Raymond-Roy criteria 1 and modified Raymond-Roy criteria 2) at 6 months posttreatment. The primary safety outcome was the rate of device-related adverse events. Secondary safety outcomes included time to discharge and change in the mRS score at 6-month follow-up. RESULTS: Twenty patients were treated with the Neqstent from November 2020 to January 2023. Nine had unruptured aneurysms, and 11 were patients with subarachnoid haemorrhage due to ruptured aneurysms. Eighteen of 20 aneurysms (90%) treated demonstrated complete occlusion (modified Raymond-Roy criteria 1) on immediate postembolization angiograms. Sixteen of 17 aneurysms treated (94.1%) remained adequately occluded on 6-month follow-up (modified Raymond-Roy criteria 1 and modified Raymond-Roy criteria 2). Immediate postoperative complications occurred in 2 patients; only 1 patient had residual neurologic deficits at 6 months (mRS = 2). CONCLUSIONS: Management of large, wide-neck aneurysms remains difficult, with high rates of recurrence and complications. The use of the Neqstent shows promising short-term results for the treatment of complex wide-neck aneurysms. Initial complication rates for our cohort were relatively high. However, this result is likely related to the initial learning experience of device deployment and the use of antiplatelets.

Optimizing Patient Care: A Multicentric Study on the Clinical Impact of Sim&Size™ Simulation Software in Intracranial Aneurysm Treatment With Pipeline Embolization Devices.

BACKGROUND: To determine the clinical effects (stent size, and number of stents used) of the Sim&Size™ simulation software on the endovascular treatment of unruptured saccular intracranial aneurysms with Pipeline Embolization Devices (PED). METHODS: This study is a retrospective analytical multicenter study of patients treated with PED (Flex and Flex with SHIELD) for intracranial aneurysm in FOSCAL clinic and CHU de Montpellier. RESULTS: The study included 253 patients, of which 75 were treated in Colombia and 178 were treated in France. The majority of patients were women (83.8%), with a median age of 57.48 years, and had large vessel location (88.1%), with most aneurysms located in the ICA paraclinoid segment (56.8%). Patients in the group with Sim&Size™ simulation had shorter stents than those without simulation (15.62 mm versus 17.36 mm, P-value = 0.001). Also, a lower proportion of these patients required more than one stent (1.4% versus 7.3%, P-value = 0.022). There were 7 complications reported in the group that used the Sim&Size™ simulation software, compared to 9 complications in the group that did not use the software. CONCLUSIONS: Using Sim&Size™ simulation software for endovascular treatment of patients with intracranial aneurysms using PED reduces the stent length and decreasing the number of devices needed per treatment.

Pre-emptive Aortic Side Branch Embolization during Endovascular Aneurysm Repair Using the Excluder Stent-Graft System: A Prospective Multicenter study.

PURPOSE: To evaluate the effectiveness and safety of pre-emptive transcatheter arterial embolization (P-TAE) for aortic side branches (ASBs) to prevent Type 2 endoleaks (EL2) before endovascular aneurysm repair (EVAR) using the Excluder stent-graft system (Excluder). MATERIALS AND METHODS: In this prospective, multicenter study, 80 patients (mean age, 79.1 years [SD ± 6.7]; 85.0% were men; mean aneurysmal sac diameter, 48.4 mm [SD ± 7.4]) meeting the eligibility criteria were prospectively enrolled from 9 hospitals. Before EVAR, P-TAE was performed to embolize the patent ASBs originating from the abdominal aortic aneurysm. Contrast-enhanced computed tomography (CT) was performed at 1 month and 6 months after EVAR. The primary endpoint was EL2 incidence at 6 months, and the secondary endpoints were aneurysmal sac diameter changes at 6 and 12 months, P-TAE outcomes, adverse events related to P-TAE, reintervention, and aneurysm-related mortality. RESULTS: All patients successfully underwent P-TAE without serious. Coil embolization was successful in 81.6% of ASBs. EL2 incidence at 6 months was identified in 18 of 70 (25.7%) patients. Aneurysmal sac diameter shrinkage (≥5 mm) was observed in 30.0% of patients at 6 months and in 40.9% at 12 months. Only 1 patient required reintervention for EL2 within 1 year of EVAR; aneurysm-related deaths were not observed. CONCLUSIONS: P-TAE for ASBs before EVAR using Excluder is a safe and effective strategy. It aids in achieving early aneurysmal sac shrinkage and reduces EL2 reintervention at 1 year after EVAR.

Long-Term Safety and Efficacy of Pipeline Embolization Device in Anterior and Posterior Circulation Aneurysms: A Systematic Review and Meta-Analysis.

BACKGROUND: Flow diversion using the pipeline embolization device (PED) has been a paradigm shift for anterior circulation (AC) aneurysms. However, only a few studies report the long-term (≥1 year) angiographic and clinical outcomes for posterior circulation (PC) aneurysms. This study aims to compare the long-term safety and efficacy of treatment of AC and PC aneurysms with PED. METHODS: The databases included Ovid MEDLINE, Ovid EMBASE, Ovid Cochrane, and Scopus. Studies with at least 10 patients and 1-year follow-up were included. Twenty-four studies met our inclusion criteria. A random effect meta-analysis was performed to estimate the ischemic and hemorrhagic complications. A meta-analysis of proportions was performed to estimate the pooled rates of long-term complete aneurysmal occlusion, symptomatic stroke, aneurysmal rupture, and intracranial hemorrhage. RESULTS: There were 1952 aneurysms, of which 1547 (79.25%) were in the AC and 405 (20.75%) in the PC. The 1-year occlusion rate was 78% in AC compared to 73% in PC aneurysms (P < 0.01). The symptomatic infarct rate was 5% in AC compared to 13% in PC (P < 0.01). While the rupture rate was 1% in AC compared to 4% in PC (P = 0.01), the rate of intracranial hemorrhage was 2% for both (P = 0.99). CONCLUSIONS: The long-term occlusion rate after PED was higher in AC aneurysms, and the cumulative incidence of stroke and aneurysm rupture was higher in PC aneurysms.

Predictors of occlusion, long-term outcomes, and safety in a cohort of 674 aneurysms treated with the Pipeline embolization device.

OBJECTIVE: By providing a more physiological approach to the treatment of intracranial aneurysms, the Pipeline embolization device (PED) has revolutionized the endovascular treatment of aneurysms. Although there are many flow diverters on the market, the authors report their experience with the PED, the first flow diverter to be approved by the Food and Drug Administration. They aimed to assess the efficacy and safety of PED flow diversion for the treatment of a wide range of aneurysms, as well as to look at factors affecting occlusion. METHODS: This is a retrospective study of a prospectively maintained database of patients treated with the PED between January 2011 and December 2019. Charts were reviewed for patient, aneurysm, and procedure characteristics. The primary outcomes of interest were complication rates, occlusion outcomes (O'Kelly-Marotta grading scale), and functional outcomes (modified Rankin Scale [mRS]). Secondary outcomes included predictors of incomplete occlusion at 6 and 24 months of follow-up. RESULTS: The study cohort included 581 patients with 674 aneurysms. Most aneurysms (90.5%) were in the anterior circulation and had a saccular morphology (85.6%). Additionally, 638 aneurysms (94.7%) were unruptured, whereas 36 (5.3%) were acutely ruptured. The largest mean aneurysm diameter was 8.3 ± 6.1 mm. Complications occurred at a rate of 5.5% (n = 32). The complete occlusion rate was 89.3% at 24 months' follow-up, and 94.8% of patients had a favorable neurological outcome (mRS score 0-2) at the last follow-up. On multivariate analysis, predictors of incomplete aneurysm occlusion at 6 months were hypertension (OR 1.7, p = 0.03), previous aneurysm treatment (OR 2.4, p = 0.001), and increasing aneurysm neck diameter (OR 1.2, p = 0.02), whereas a saccular morphology was protective (OR 0.5, p = 0.05). Predictors of incomplete occlusion at 24 months were increasing aneurysm neck diameter (OR 1.2, p = 0.01) and previous aneurysm treatment (OR 2.3, p = 0.01). CONCLUSIONS: The study findings are corroborated by those of previous studies and trials. The complete occlusion rate was 89.3% at 24 months' follow-up, with 94.8% of patients having favorable functional outcomes (mRS score 0-2). Aneurysm treatment before PED deployment and an increasing aneurysm neck diameter increase the risk of incomplete occlusion at 6 and 24 months.

Lateral Compression Manipulation: A Simple Approach for Sizing Taller-Than-Wide Intracranial Aneurysms with the Woven EndoBridge Device.

BACKGROUND AND PURPOSE: The Woven EndoBridge (WEB) system has established itself as a safe and effective option for managing wide-neck bifurcation aneurysms. Addressing aneurysms with a greater height than width using conventional WEB-sizing methods has proved ineffective due to the inherent configuration of the devices. To overcome this limitation, we propose an intuitive approach that involves swapping the width and height dimensions of the aneurysm to determine the appropriate WEB size. MATERIALS AND METHODS: A retrospective analysis was conducted on patients undergoing WEB embolization at a single neuroscience center from March 2013 to February 2023. RESULTS: Twenty-five eligible aneurysms were identified, with the height dimension exceeding the width by an average of 2.33 mm (ranging from 1.4 to 4.5 mm). Of these, 20 cases adhered to the recommended sizing technique, resulting in a 100% success rate of adequate occlusion (14/20 complete occlusion, 6/20 proximal recess filling). In contrast, the outcomes for the remaining 5 cases that did not follow the proposed sizing method were less favorable (P < .05). Among these, 4 cases treated with undersized WEBs showed neck remnants during follow-up, and 1 patient who received an oversized WEB required device replacement during the same procedure. CONCLUSIONS: The simple sizing method we proposed for treating taller-than-wide aneurysms has demonstrated promising results, allowing the WEB system to address twice the original size range of treatable aneurysms. Further research with a larger sample size is recommended.

Gekko Coil System for Intracranial Aneurysms Treatment in China (GREAT-China): A Prospective Randomized Controlled Open-Label Noninferiority Trial.

OBJECTIVE: This study aimed to evaluate the safety and efficacy of the Gekko coil system in treating intracranial aneurysms (IAs) in clinical practice. METHODS: A prospective multicenter randomized open-label parallel positive control noninferiority trial was conducted by 11 centers in China. Patients with a target IA were randomized 1:1 to coiling with either Gekko or Axium coils. The primary outcome was successful aneurysm occlusion at 6 months postoperative follow-up, whereas the secondary outcomes included the successful occlusion aneurysm rate in the immediate postoperative period, recanalization rate at the 6 months follow-up, and technical success and security. RESULTS: Between May 2018 and September 2020, 256 patients were enrolled and randomized. Per-protocol analysis showed that the successful aneurysm occlusion rate at 6 months was 96.08% for the Gekko coil group compared with 96.12% in the Axium coil group, with a difference of -0.04% (P = 0.877). The successful immediate aneurysm occlusion rates were 86.00% and 77.45% in the Gekko coil group and the Axium coil group, respectively, showing no significant difference between the 2 groups (P = 0.116), whereas the recanalization rates during the 6 months follow-up were 2.02% and 1.96% in the Gekko and Axium coil groups, respectively, which was not statistically significant (P = 1.000). CONCLUSIONS: This trial showed that the Gekko coil system was noninferior to the Axium coil system in terms of efficacy and safety for IA embolization. In clinical practice, the Gekko coil system can be considered safe and effective for treating patients with IA.