Propensity Score-matched Comparison of WEB 17 and WEB 21 with 4-7 mm Device Sizes for the Treatment of Unruptured Intracranial Aneurysms.

PURPOSE: The WEB 17 system represents the fifth generation of Woven Endobridge (WEB) flow disruptors and features a low profile with fewer wires than its predecessor, the WEB 21. The present study compares the safety and efficacy of the WEB 17 and WEB 21 for the treatment of unruptured cerebral aneurysms with 4-7 mm device sizes, which were available for both systems. METHODS: Patient and aneurysm characteristics, complications, clinical outcome and angiographic results were retrospectively analysed. 1:1 propensity score matching was performed to adjust for minor baseline differences between the groups. RESULTS: Sixty aneurysms treated with WEB 21 and 90 with WEB 17 were included. The overall failure rate (deployment failure and adjunctive stent) was significantly higher with WEB 21 (16.7%) than with WEB 17 (3.3%, p < 0.01). The rates of neurological events between WEB 21 (6.7%) and WEB 17 treatment (1.1%) were not significantly different (p = 0.08). Also, procedural morbidity was comparably low in both groups (WEB 21: 3.3%, WEB 17: 0%, p = 0.16). The rates of complete/adequate occlusion at follow up were 69.7%/86.4% for WEB 17 vs. 80.4%/91.3% for WEB 21 at short-term (p = 0.27), and 64.5%/83.9% vs. 75.9%/86.2% at mid-term (p = 0.41), respectively. Propensity score matching confirmed the results of the unmatched series. CONCLUSION: WEB 17 and WEB 21 had a similar safety and efficacy profile, but WEB 17 was associated with an improved feasibility. Prospective studies with long-term follow-up will define the full potential of the WEB 17 system.

Outcome after Neuro-interventional Treatment of Intracranial Aneurysm (as a First Treatment Modality).

Endovascular treatment is widely applied as the first-line treatment for intracranial aneurysms and includes simple coiling (SC), stent-assisted coiling (SAC), flow diversion stent, and flow disruption stent. The present study is a retrospective cohort study performed in Imam Khomeini Hospital, Department of Neurovascular Intervention, between March 2016 and March 2021. A total number of 229 patients with intracranial aneurysms who underwent therapeutic intravascular interventions were enrolled, of which 89 were treated with SC, 111 with SAC, 25 with flow diversion stent, and 4 with flow disruption stent. The mean age of the subjects was 51.8±12.6 years, and 51.1% were male. Modified Raymond-Roy classification (MRRC) was used to define the occlusion outcome. The success rate, considered as Class I and Class II of MRRC at treatment time was 89% (94.4% in SC, and 84.7% in SAC), which was increased to 90.9% (94% in SC, 93% in SAC, 69.6% in flow diversion stenting, 100% in flow disruption) at 6-month follow-up, and 84.6% (80.8% in SC, 87.8% in SAC, 78.3% in flow diversion stenting, and 100% in flow disruption) at 12-month follow-up. The mean modified Rankin Scale (mRS) before the procedure was 0.05±0.26 which was increased to 0.22±0.76 after the procedure, 0.22±0.76 at 6 months, and 0.30±0.95 at 12 months (P<0.001). Similar to previous studies, the present study demonstrates that neurovascular intervention can treat ruptured aneurysms as the first therapeutic modality with favourable outcomes. A double-blind, randomized clinical trial is needed to eliminate the confounding factors and better demonstrate the outcome.

Oversizing of the Woven EndoBridge for Treatment of Intracranial Aneurysms Improves Angiographic Results (WEBINAR).

OBJECTIVE: Several studies have demonstrated a high safety and efficacy profile of the Woven EndoBridge (WEB) for endovascular aneurysm treatment. However, contemporary large-scale studies of the WEB are rare. This multicenter study attempts to set a benchmark for state-of-the-art WEB treatment with consistent application of the WEB oversizing technique. METHODS: This is a retrospective, multicenter study of aneurysms (dome width 2-10 mm) treated with the WEB between 2015 and 2023. Patient and aneurysm characteristics, complications, and clinical and angiographic outcomes were analyzed. RESULTS: The study consisted of 247 patients treated for 251 aneurysms (25.5% ruptured, 5.6% recurrent). WEB implantation was feasible in 98.8%, achieving a mean WEB/dome ratio of 1.2 ± 0.1. The thromboembolic complication rate was 7.2%, which was higher in ruptured versus unruptured aneurysms (hazard ratio: 2.8, 95%CI: 1.0-7.6, P = 0.04), but lower in cases where WEB 17 was used (hazard ratio: 4.0, 95%CI: 1.4-11.2, P = 0.01). Neurological complications occurred in 8 procedures (3.2%), including 3 (1.2%) major, and 5 (2.0%) minor events. Procedural morbidity and mortality were 0.8% and 0%, respectively. Mid-term complete and adequate occlusion rates were 66.3% and 88.4%, respectively. The retreatment rate was 5.2%. Feasibility, complication, and occlusion rates were comparable between typical and atypical aneurysm locations. CONCLUSIONS: Oversizing the WEB and using currently available WEB types in this series resulted in slightly better treatment outcomes compared to early WEB studies, confirming the high safety, feasibility, and efficacy of this technique.

Contour device implantation for treatment of intracranial aneurysms in the basilar tip.

INTRODUCTION: Treatment of basilar apex aneurysms will remain challenging regarding the nobility of the parent vessel and their often wide-necked configuration. With endovascular techniques being the treatment approach of choice, novel intrasaccular flow-disruption devices constitute an endovascular embolization option. In this research, we report our experiences in embolizing basilar tip aneurysms with the novel Contour device. MATERIAL AND METHODS: Retrospective analysis of eight patients after Contour implantation into a basilar apex aneurysm. Periprocedural data on intervention times, radiation dose, procedural success and complications were gathered. All patients received follow-up digital subtraction angiography after six months. Further follow-up examination results were analysed given their availability. RESULTS: Contour implantation was successful in all patients. The mean device instrumentation time was 18.8 ± 7.7 min with a mean full intervention time of 100 ± 65.8 min. The mean full procedure radiation dose was 1917 (421-5107) cGy/cm2. After six months, six aneurysms were occluded (Raymond Roy Scale (RRS) 1/2), one showed perfusion inside the device (RRS 3a) and one patient had undergone reintervention due to progression. The aneurysm with constant perfusion at six months was seen to be occluded after 24 months. CONCLUSION: Contour device implantation is a promising feasible alternative endovascular method for embolization of intracranial aneurysms located in the basilar tip with short intervention times and low radiation dosages. Short- and medium-term follow-ups show promising results concerning aneurysm occlusion and reinterventions, however further research is needed to show long-term stability.

Persistent flow inside the Woven EndoBridge at angiographic follow-up: A multicenter study.

BACKGROUND: The occurrence of persistent intra-device filling (BOSS 1, using the Bicêtre Occlusion Scale Score (BOSS)) in aneurysms treated with a Woven Endobridge (WEB) device is infrequent based on angiographic follow-up. To date, three monocentric case series were published studying BOSS 1 cases. Through a multicenter retrospective study, we aimed to report the incidence, and risk factors of intra-WEB persistent filling. METHODS: We reached out to European academic centers that treat patients using WEB devices and requested de-identified data of patients treated with a WEB device and underwent angiographic follow-up, at least 3 months after embolization, to assess the BOSS 1 occlusion score. We compared baseline characteristics, treatment modalities, and aneurysm data of the included BOSS 1 patients with those of a control group consisting of non-BOSS 1 patients (n = 116) who had an available angiographic follow-up. Univariable and multivariable models were employed for analysis. RESULTS: Among the pooled sample of 591 aneurysms treated with WEB, the rate of persistent flow (BOSS 1) at angiographic follow-up was 5.2% (n = 31 out of 591), performed after an average of 8.7 ± 6.3 months. In the multivariable-adjusted analysis, dual antiplatelet therapy in the postoperative period (adjusted odds ratio [aOR] 4.3 [95% CI 1.3-14.2]), and WEB undersizing (aOR 10.8 [95% CI 2.9-40]) were independently associated with a BOSS 1 persistent flow result. CONCLUSION: Persistent blood flow within the WEB device during angiographic follow-up (BOSS 1) is an uncommon occurrence. Our findings indicate that post-procedural dual antiplatelet therapy and undersizing of the WEB device are independently associated with the presence of BOSS 1 at follow-up.

Intra-cranial aneurysm treatment with contour or WEB - a single center comparison of intervention times and learning curves.

BACKGROUND AND PURPOSE: Treating aneurysms with intra-saccular flow disruption is a feasible alternative to coil-embolization. Besides the established WEB device, the novel Contour Neurovascular System has emerged as a potentially easier alternative regarding sizing and deployment. We report the learning curve experienced at our center from the first 48 patients treated with Contour and compared it with 48 consecutive WEB cases. METHODS: Both groups were compared concerning intervention time, sizing failures leading to device changes and radiation dose. Additionally, we analyzed potential learning effects by comparing the first 24 Contour cases with our last 24 Contour cases and WEB cases respectively. RESULTS: Patient demographics, acute vs. incidental cases and aneurysm localization were comparable in both groups. The deployment time was faster in our 48 Contour cases (median: 22.0 ± 17.0 min), than in the WEB group (median: 27.5 ± 24.0 min). Total intervention time was similar for Contour (median: 68.0 ± 46.9 min) and WEB cases (median: 69.0 ± 38.0 min). Device implantation times in our WEB cases were slightly shorter in the later cases (median: 25.5 ± 24.1 min) than in the earlier (median: 28.0 ± 24.4 min) cases. In the Contour cohort, deployment times were similar for the first 24 cases (median: 22.0 ± 14.5 min) and the final 24 (median: 22.0 ± 19.4 min). Radiation dose was lower in the Contour group (1469.0 ± 1718 mGy*cm2 vs. 1788.0 ± 1506 mGy*cm2 using the WEB device). Less intra-procedural device changes were performed in the Contour cohort (6 of 48 cases, 12.5%), than in the WEB group (8 of 48 cases, 16.7%). CONCLUSION: Aneurysm occlusion times and consequently radiation doses, as well as the amount of device changes were lower in the Contour group. Occlusion times did not differ in the first and last 24 Contour cases, leading to the assumption that the handling of Contour does not require extended training. A short training effect in occlusion times was noted, however, between the first and last WEB cases as shorter procedure times were seen in the latter cases.

Identifying Workflow Disruptions in Robotic-Assisted Bariatric Surgery: Elucidating Challenges Experienced by Surgical Teams.

PURPOSE: Bariatric surgery is an effective and durable treatment for weight loss for patients with extreme obesity. Although traditionally approached laparoscopically, robotic bariatric surgery (RBS) has unique benefits for both surgeons and patients. Nonetheless, the technological complexity of robotic surgery presents new challenges for OR teams and the wider clinical system. Further assessment of the role of RBS in delivering quality care for patients with obesity is necessary and can be done through a human factors approach. This observational study sought to investigate the impact of RBS on the surgical work system via the study of flow disruptions (FDs), or deviations from the natural workflow progression. MATERIALS AND METHODS: RBS procedures were observed between October 2019 and March 2022. FDs were recorded in real time and subsequently classified into one of nine work system categories. Coordination FDs were further classified into additional sub-categories. RESULTS: Twenty-nine RBS procedures were observed at three sites. An average FD rate of 25.05 (CI = ± 2.77) was observed overall. FDs were highest between insufflation and robot docking (M = 29.37, CI = ± 4.01) and between patient closing and wheels out (M = 30.00, CI = ± 6.03). FD rates due to coordination issues were highest overall, occurring once every 4 min during docking (M = 14.28, CI = ± 3.11). CONCLUSION: FDs occur roughly once every 2.4 min and happen most frequently during the final patient transfer and robot docking phases of RBS. Coordination challenges associated with waiting for staff/instruments not readily available and readjusting equipment contributed most to these disruptions.

Endosaccular flow disruption with the Contour Neurovascular System: angiographic and clinical results in a single-center study of 60 unruptured intracranial aneurysms.

BACKGROUND: The Contour Neurovascular System is a novel device designed to treat intracranial aneurysms by intrasaccular flow disruption. We report our experience and mid-term follow-up in a series of patients treated with the Contour. METHODS: The patients were divided into an intention to treat and a per protocol population, the latter defined by the successful implantation of the Contour device. The intention to treat population included 53 patients (30 women, mean age 56 years) with 60 unruptured intracranial aneurysms (53 in the anterior circulation and seven in the posterior circulation). There was clinical and angiographic follow-up immediate postoperatively and at 24 hours, 3 months and 1 year using the Raymond-Roy classification and the O'Kelly-Marotta grading scale. RESULTS: The Contour was successfully implanted in 54/60 (90%) aneurysms. With regard to the angiographic follow-up, there was adequate occlusion (defined as complete occlusion or presence of a neck remnant) in 31.5% of 54 aneurysms immediately postoperatively, 62.3% (in 53/54 aneurysms) at 24 hours, 81.4% (in 43/54 aneurysms) at 3 months, and 89.3% (in 28/54 aneurysms) at 1 year. Technical complications in 60 aneurysms of the intention to treat population included two (3.3%) inadvertent detachments of the device. Thromboembolic events were observed in four of the 60 aneurysms (6.7%), with no clinical symptoms in three patients and transient morbidity in one (1.7%). No aneurysm bleeding was observed and no patient was retreated during the 1-year follow-up period. There was no permanent morbidity or mortality. CONCLUSIONS: The Contour device is effective and safe in the treatment of intracranial aneurysms. However, more experience and long-term follow-up are needed.

The safety and effectiveness of the Contour Neurovascular System for the treatment of wide-necked aneurysms: A systematic review and meta-analysis of early experience.

BACKGROUND: The Contour is a new generation intrasaccular flow disruption tool that aims to cover the aneurysm neck and is sized according to the neck diameter. While several case series have been published, no literature review has been performed on this promising device. OBJECTIVE: To assess the safety and effectiveness profile of the Contour Neurovascular System for wide-necked aneurysms. METHODS: We followed the recommendations of the PRISMA checklist Four databases were searched with a supplemental manual search. All data were analyzed using R software version 4.2.1. RESULTS: We finally included six studies with 131 treated aneurysms. The overall procedural time was 97.27 (95% CI = 70.07-124.47) minutes, ranging from 78.9 to 136.0 min. The pooled adequate occlusion rate was 84.21% (95% CI = 75.45-90.25), and the overall functional independence rate was 94.74% (87.97-97.79). The overall adverse event rate was 4.70 (95% CI = 3.24-6.76), varying among different events from 0.78 to 8.53%. Thromboembolic events were the most commonly encountered in 8.53% of the patients (95% CI = 4.78-14.74), followed by headache and minor stroke with incidence rates of 5.88 (95% CI = 2.83-11.83) and 4.35 (95% CI = 1.41-12.63), respectively. The overall procedural time in studies using the Contour system only was 86.17 (95% CI = 68.70-10.64) minutes, while it was 136 (95% CI = 90.96-181.04) in the Contour-assisted coiling procedures. However, both techniques were comparable regarding adequate occlusion rates and functional independence. CONCLUSION: With the anticipation of future studies, the Contour Neurovascular System is a safe and effective treatment option for wide-necked intracranial aneurysms.

WEB embolization of very broad-based intracranial aneurysms with a dome-to-neck ratio ≤ 1.1.

OBJECTIVE: The Woven EndoBridge (WEB) is a well-studied intrasaccular device for endovascular treatment of wide-necked bifurcation aneurysms. We evaluated the feasibility, safety and efficacy of the WEB for the treatment of very broad-based aneurysms with a dome-to-neck ratio ≤ 1.1. METHODS: Thirty-four aneurysms treated at three neurovascular centers were retrospectively identified. The mean aneurysm size was 5.5 ± 1.6 mm with a mean neck width of 4.7 ± 1.5 and a mean dome-to-neck ratio of 1.0 ± 0.1. The primary outcome measures were immediate technical treatment success by WEB only, complete or near-complete occlusion at 6-month follow-up and ischemic stroke. RESULTS: Aneurysm embolization by WEB only was technically feasible in 79.4%. Additional stenting was required in 14.7%. In two aneurysms (5.9%), WEB implantation failed, and the aneurysm was treated by stent- and balloon-assisted coiling, respectively. Thromboembolic events occurred during 5 interventions (14.7%), all of these performed in ruptured aneurysms. One patient (2.9%) remained asymptomatic (follow-up modified Rankin scale [mRS] score: 0), 2 patients (5.9%) had a transient deficit (mRS 0 and 1, respectively), and 2 (5.9%) had a disabling ischemic stroke (mRS 3, respectively). Mid-term angiographic follow-up of 29 patients (4.0 ± 2.6 months, range: 2-9 months) showed complete occlusion (WEB occlusion scale [WOS] A) in 41.4%, near-complete occlusion (WOS B) in 34.5%, a neck remnant (WOS C) in 10.3%, and aneurysm remnants (WOS D) in 13.8%. CONCLUSIONS: WEB embolization of very broad-necked aneurysms was technically feasible and could be achieved by WEB only in the majority of cases. Considering the challenging anatomy of very broad-based aneurysms, the WEB procedure was reasonably safe and efficient.

Flow Diverter Devices for Treatment of Intracranial Aneurysms in Small Parent Vessels-A Systematic Review of Literature.

BACKGROUND: The overall safety and efficacy of flow diverting stents (FDSs) deployed in small caliber parent arteries (≤2.5 mm) for the treatment of intracranial aneurysms remains unclear. Recent studies have provided additional outcomes data to assess the use of FDSs for such arteries. In the present review, we have summarized the reported clinical and angiographic outcomes of FDS-treated brain aneurysms in small parent arteries. METHODS: A systematic literature review was performed for outcomes data related to FDS-treated intracranial aneurysms using PubMed, Ovid Medline, and Web of Science. Procedural data, angiographic outcomes, and clinical outcomes at various time points were collected and summarized. RESULTS: The 19 studies included 580 patients with 604 aneurysms, of which 6.1% had been acutely ruptured and 28.3% had been previously treated. The procedural complication rate and symptomatic stroke rate was 9.8% and 7.5%. The complete occlusion rate at the last radiographic follow-up (mean, 12.1 months) was 73.6%. At the last clinical follow-up (mean, 10.6 months), the FDS-associated mortality was 2.5%. CONCLUSIONS: FDSs for the treatment of intracranial aneurysms located in small caliber arteries was associated with rates of long-term complete aneurysm occlusion, mortality, and permanent neurologic deficit comparable to the rates with FDS-treated aneurysms in larger parent arteries. However, the relatively increased risk of symptomatic stroke of these FDS-treated aneurysms should not be ignored. Direct comparisons with alternative endovascular approaches are necessary to further define the optimal use of FDS for these aneurysms.

Intrasaccular flow disruption for brain aneurysms: a systematic review of long-term outcomes.

OBJECTIVE: The long-term safety and efficacy of intrasaccular flow disruption (IFD) for the treatment of brain aneurysms remain unclear. With accumulating experience and increasing use of IFD devices, recent studies have provided additional data regarding their outcomes. This review summarizes the long-term outcomes of IFD-treated brain aneurysms. METHODS: A systematic literature review was performed on May 23, 2021, in PubMed, Web of Science, and Ovid MEDLINE for aneurysm treatment outcomes with IFD devices. Procedural details, including use of adjunctive devices and complications, were collected. The quality of studies was assessed using the Downs and Black checklist. Angiographic outcomes were classified as complete occlusion, residual neck, and residual aneurysm. Other outcomes included need for retreatment, permanent neurological deficit, and mortality. Pooled analyses were performed. RESULTS: The final analysis comprised 1217 patients with 1249 aneurysms from 22 studies. The mean aneurysm diameter and neck width were 6.9 and 4.5 mm, respectively, and 27.6% of aneurysms were ruptured. The complete occlusion rates at 12 months and final follow-up (pooled mean duration 15.7 months) were 50.1% and 58.2%, respectively. Adjunctive devices were used in 6.4% of cases. The rates of hemorrhage, symptomatic infarction, permanent neurological deficit, and mortality were 1.2%, 2.8%, 1.0%, and 2.6%, respectively. CONCLUSIONS: IFD is a very safe treatment for appropriately selected brain aneurysms with low complication and neurological deterioration rates. However, complete occlusion is achieved in only half of IFD-treated aneurysms at 1 year with a modest increase beyond this time point. As the majority of the studies were single arm, the pooled data are subject to selection and reporting biases. Future device developments, increased operator experience, and direct comparisons with alternative endovascular strategies and surgical clipping may clarify the role of IFD in aneurysm management.

Postmarket American Experience With Woven EndoBridge Device: Adjudicated Multicenter Case Series.

BACKGROUND: The Woven EndoBridge (WEB) device was granted premarket approval in the United States following results of the Woven EndoBridge Intrasaccular Therapy (WEB-IT) study. WEB-IT reported excellent adequate angiographic occlusion of treated aneurysms with a high safety profile. These results were achieved, however, in the context of a prospective study with strict inclusion criteria and rigorous training support. OBJECTIVE: To review early as-practiced clinical experience with the WEB device in the United States. METHODS: Retrospective review across 6 institutions identified 91 patients undergoing 92 treatment sessions for WEB device placement in treatment of 91 intracranial aneurysms. Details regarding demographics, aneurysm characteristics, treatment considerations, clinical outcomes, and aneurysm occlusion were obtained and analyzed in a multicenter database. Angiograms from the index procedure and follow-up studies were reviewed by a blinded and independent adjudicator. RESULTS: The middle cerebral, anterior communicating, and basilar artery complexes were the commonly treated locations. Eight patients presented with ruptured aneurysms. A mean of 1.2 devices were introduced per case. Technical failure without deployment of a WEB device occurred in 2% (2/92) of sessions. Complete aneurysm occlusion for patients with imaging follow-up was 49% (mean follow-up of 8 mo). Four aneurysms were retreated. 90% of patients had modified Rankin Scale ≤ 2 at last clinical follow-up with no mortalities. CONCLUSION: Immediate postmarket experience with the WEB device, newly introduced at American centers, confirms safe procedural use, but long-term efficacy remains unclear. Early challenges include accurate sizing and device selection.

Intrasaccular flow disruption (WEB) of a large wide-necked basilar apex aneurysm using PulseRider-assistance.

Large, wide-necked basilar apex aneurysms are difficult to treat. Microsurgical clipping can result in neurologic morbidity and mortality. Endovascular treatment often leaves remnants that need retreatment and/or stent placement with dual antiplatelet therapy. The Woven EndoBridge (WEB) is an intrasaccular flow disruption device that can be used without dual antiplatelet therapy. However, the WEB cannot typically be used in large or giant aneurysms > 10 mm because the largest diameter device is the 11 × 9.6 mm single layer sphere (SLS). We present a case in which we use a PulseRider aneurysm neck reconstruction device in the basilar artery to assist in WEB deployment within a 22 mm basilar apex aneurysm with 14 mm neck, thereby permitting aspirin monotherapy postoperatively.

Endovascular Treatment of Intracranial Aneurysms.

Traditionally, surgical clipping was the only available treatment modality for intracranial aneurysms. However, in the last few decades, the endovascular therapy of intracranial aneurysms (IAs) has seen a tremendous evolution and development. From coiling to flow diversion and flow disruptor devices, endovascular treatment modalities have increased in number and received broader indications throughout the years. In this review article, the treatment modalities for the endovascular management of IAs are presented, emphasizing newer devices and technologies.

The Woven EndoBridge embolization device for the treatment of intracranial wide-necked bifurcation aneurysms.

Wide-necked bifurcation aneurysms are common when evaluating both ruptured and unruptured intracranial aneurysms and can pose unique challenges. The Woven EndoBridge device (recently approved in the US) is specifically designed for the treatment of these aneurysms. This article serves to introduce the device to a wider audience with a thorough review of the literature, device design, indications, pre-operative evaluation, procedural usage and potential pitfalls.

Lay abstract The Woven EndoBridge device recently received approval by the US FDA for use in certain types of difficult to treat brain aneurysms. This article is primarily a descriptive and technical article aimed at doctors who use catheter-based techniques to treat problems of the blood vessels. Initial studies show that the device is at least as effective as previously existing methods, though more research needs to be done regarding long-term outcomes.

Technical aspects of web device in aneurysm treatment.

Wide-neck bifurcation aneurysms (WNBAs) make up 26-36% of all brain aneurysms. Intrasaccular flow disruption is an innovative technique for the treatment of WNBAs. The Woven EndoBridge (WEB) device (Sequent Medical, Aliso Viejo, California USA) is the only United States Food and Drug Administration approved intrasaccular flow disruption device. In this video article, a few cases of intracranial aneurysms treated with the WEB device are presented and various aspects of treating WNBAs with the WEB device, including aneurysm/device selection strategies, and procedural technique, are discussed (video 1).

Aneurysm Treatment With Woven EndoBridge in the Cumulative Population of 3 Prospective, Multicenter Series: 2-Year Follow-Up.

BACKGROUND: Woven EndoBridge (WEB; Sequent Medical) treatment is an innovative endovascular approach for treatment of wide-neck bifurcation aneurysms. Initial studies have shown high safety with good efficacy at short term confirmed by trials conducted in United States (WEB-Intrasaccular Therapy) and in Europe (WEB Clinical Assessment of Intrasaccular Aneurysm Therapy [WEBCAST], French Observatory, and WEBCAST-2). OBJECTIVE: To report the 2-yr clinical and anatomical results of WEB treatment in the combined population of 3 European trials. METHODS: In a French Observatory, 2-yr clinical and anatomical data were collected. In WEBCAST and WEBCAST-2, 2-yr follow-up was optional, and data were collected when follow-up was performed. Aneurysm occlusion was evaluated using a 3-grade scale: complete occlusion, neck remnant, and aneurysm remnant. RESULTS: The population for safety was 138/168 patients (82.1%), including 89 females (64.5%), with mean age of 55.5 ± 10.2 yr. The population for efficacy was 121/169 aneurysms (71.6%). Aneurysm locations were middle cerebral artery in 65/121 aneurysms (53.7%), anterior-communicating artery in 25/121 (20.7%), basilar artery in 17/121 (14.0%), and internal carotid artery terminus in 14/121 (11.6%). No clinically relevant adverse events occurred between years 1 and 2. At 2 yr, complete occlusion was observed in 62/121 (51.2%) aneurysms, neck remnant in 36/121 (29.8%) aneurysms, and aneurysm remnant in 23/121 (19.0%) aneurysms. The global retreatment rate at 2 yr was 9.3%. CONCLUSION: This analysis confirms the high safety profile of WEB treatment at 2 yr. Aneurysm occlusion is generally stable at 2 yr, and the retreatment rate between 1 yr and 2 yr is low (2.0%).

Endosaccular Flow Disruption: A New Frontier in Endovascular Aneurysm Management.

Flow modification has caused a paradigm shift in the management of intracranial aneurysms. Since the FDA approval of the Pipeline Embolization Device (Medtronic, Dublin, Ireland) in 2011, it has grown to become the modality of choice for a range of carefully selected lesions, previously not amenable to conventional endovascular techniques. While the vast majority of flow-diverting stents operate from within the parent artery (ie, endoluminal stents), providing a scaffold for endothelial cells growth at the aneurysmal neck while inducing intra-aneurysmal thrombosis, a smaller subset of endosaccular flow disruptors act from within the lesions themselves. To date, these devices have been used mostly in Europe, while only utilized on a trial basis in North America. To the best of our knowledge, there has been no dedicated review of these devices. We therefore sought to present a comprehensive review of currently available endosaccular flow disruptors along with high-resolution schematics, presented with up-to-date available literature discussing their technical indications, procedural safety, and reported outcomes.

Endosaccular flow disruption: where are we now?

Endosaccular flow disruption is an innovative method of treating wide-necked complex aneurysms. Currently four types of devices have obtained the CE mark for use within Europe. These are the Woven EndoBridge device (WEB), the Luna Aneurysm Embolization System, the Medina Embolic Device (Medtronic), and the Contour Neurovascular System. The aim of this article is to provide an overview of these devices and to summarize the evidence in the literature pertaining to the treatment of intracranial aneurysms with them.