Exploring the relationship between case volume and intracranial aneurysm treatments with flow-diverters and flow-disruptors: Insights from the 2020 to 2021 Database of the German Society for Interventional Radiology National Registry in Germany.

BACKGROUND AND PURPOSE: Intracranial aneurysm treatment using flow-diverters and flow-disruptors requires a higher level of expertise when compared to more traditional methods. Our hypothesis was that the procedural success and the rate of complications are dependent on the annual case load of a center. MATERIALS AND METHODS: Conducting a retrospective analysis on the Database of the German Society for Interventional Radiology for the years 2020 to 2021, we examined flow-diverter and flow-disruptor procedures. We categorized centers into four groups according to their annual case load and proceeded to analyze success rates, complication rates, and fluoroscopy times across these centers. RESULTS: No statistically significant differences were observed among the groups in both flow-diverter and flow-disruptor cases concerning fluoroscopy time and the incidence of technical complications. However, within the subgroup of flow-disruptor cases, centers with lower case load exhibited significantly higher rates of hemorrhagic and clinically relevant complications. Additionally, it was noted that the rate of therapeutic success in the flow-diverter group significantly increased in centers with higher case volumes. CONCLUSION: Our findings support the intention towards centralization of medical care especially for complex neuroendovascular procedures. Furthermore, our findings are an argument to further develop a standardized educational and procedural algorithm based on defined case numbers and training modules for complex neurovascular procedures as already implemented by the Database of the German Society for Interventional Radiology.

Evaluation of DeGIR registry data on endovascular treatment of cerebral vasospasm in Germany 2018-2021: an overview of the current care situation. / Auswertung der DeGIR-Registerdaten zur endovaskulären Therapie von zerebralen Vasospasmen in Deutschland 2018­2021: Ein Überblick über die aktuelle Versorgungssituation.

BACKGROUND: Evaluation of endovascular therapies for cerebral vasospasm (CVS) documented in the DeGIR registry from 2018-2021 to analyse the current clinical care situation in Germany. METHODS: Retrospective analysis of the clinical and procedural data on endovascular spasm therapies (EST) documented anonymously in the DeGIR registry. We analysed: pre-interventional findings of CTP and consciousness; radiation dose applied, interventional-technical parameters (local medication, devices, angiographic result), post-interventional symptoms, complications and mortality. RESULTS: 3584 patients received a total of 7628 EST (median age/patient: 53 [range: 13-100, IQR: 44-60], 68.2 % women) in 91 (2018), 92 (2019), 100 (2020) and 98 (2021) centres; 5388 (70.6 %) anterior circulation and 378 (5 %) posterior circulation (both involved in 1862 cases [24.4 %]). EST was performed once in 2125 cases (27.9 %), with a mean of 2.1 EST/patient. In 7476 times, purely medicated EST were carried out (nimodipine: 6835, papaverine: 401, nitroglycerin: 62, other drug not specified: 239; combinations: 90). Microcatheter infusions were documented in 1132 times (14.8 %). Balloon angioplasty (BA) (additional) was performed in 756 EST (9.9 %), other mechanical recanalisations in 154 cases (2 %) and stenting in 176 of the EST (2.3 %). The median dose area product during ET was 4069 cGycm² (drug: 4002/[+]BA: 8003 [p < 0.001]). At least 1 complication occurred in 95 of all procedures (1.2 %) (drug: 1.1 %/[+]BA: 4.2 % [p < 0.001]). Mortality associated with EST was 0.2 % (n = 18). After EST, overall improvement or elimination of CVS was found in 94.2 % of cases (drug: 93.8 %/[+]BA: 98.1 % [p < 0.001]). In a comparison of the locally applied drugs, papaverine eliminated CVS more frequently than nimodipine (p = 0.001). CONCLUSION: EST have a moderate radiation exposure and can be performed with few complications. Purely medicated EST are predominantly performed, especially with nimodipine. With (additional) BA, radiation exposure, complication rates and angiographic results are higher or better. When considering drug EST alone, there is evidence for an advantage of papaverine over nimodipine, but a different group size has to be taken into account. In the analysis of EST, the DeGIR registry data are suitable for answering more specific questions, especially due to the large number of cases; for this purpose, further subgroupings should be sought in the data documentation. KEY POINTS: · In Germany, there are currently no guidelines for the endovascular treatment of cerebral vasospasm following spontaneous subarachnoid hemorrhage.. · In addition to oral nimodipine administration endovascular therapy is used to treat cerebral vasospasm in most hospitals.. · This is the first systematic evaluation of nationwide registry data on endovascular treatment of cerebral vasopasm in Germany.. · This real-world data shows that endovascular treatment for cerebral vasospasm has a moderate radiation exposure and can be performed with few complications overall. With (additional) balloon angioplasty, radiation exposure, complication rates and angiographic therapy results are higher or better.. CITATION FORMAT: · Neumann A, Weber W, Küchler J et al. Evaluation of DeGIR registry data on endovascular treatment of cerebral vasospasm in Germany 2018-2021: an overview of the current care situation. Fortschr Röntgenstr 2023; 195: 1018 - 1026.

Treatment of broad-based intracranial aneurysms with the LVIS EVO stent: a retrospective observational study at two centers with short- and medium-term follow-up.

The use of stents is well established in the treatment of broad-based intracranial aneurysms. The aim of this study is to report on safety, feasibility and midterm follow-up of the new LVIS EVO braided stent for the treatment of cerebral aneurysms. All consecutive patients with intracranial aneurysms who were treated with the LVIS EVO stent in two high volume neurovascular centers were retrospectively enrolled in this observational study. Clinical and technical complications, angiographic outcome and clinical short-term and midterm results were evaluated. The study included 112 patients with 118 aneurysms. 94 patients presented with incidental aneurysms, 13 patients with acute SAH and 2 patients with acute cranial nerve palsy. For 100 aneurysms a jailing technique was used, re-crossing of the stent was performed in 3 cases. For the residual 15 cases the stent was placed as a bail-out or as a second step. Immediate complete occlusion was observed in 85 aneurysms (72%). Midterm follow-up was available for 84 patients with 86 aneurysms (72.9%). One stent showed asymptomatic complete occlusion on follow-up imaging, in all other cases no in-stent stenosis was observed. The rate of complete occlusion was 79.1% at 6 months and 82.2% at 12-18 months. Midterm follow-up data of this retrospective observational cohort of two neurovascular centers corroborates the safety profile of the LVIS EVO device for treatment of ruptured and unruptured intracranial aneurysms.

LIQUID - Treatment of high-grade dural arteriovenous fistulas with Squid liquid embolic agent: a prospective, observational multicenter study.

BACKGROUND: Endovascular embolization is a feasible treatment for cranial dural arteriovenous fistulas (DAVFs). New embolic agents aim to improve the success of DAVF embolization. OBJECTIVE: To assess the safety, efficacy, and short-term outcome of the treatment of DAVFs using the new liquid embolic agent Squid. METHODS: The LIQUID study is a prospective, observational multicenter study on the treatment of high-grade (Cognard type ≥3) DAVFs with the embolic agent Squid. The primary outcome measures were safety (ie, morbidity and mortality), as well as the occlusion rate 90 to 180 days after treatment. RESULTS: In eight centers, 53 patients (mean age 59.8 years, 22.6% female) were treated in 55 treatment sessions. Of the DAVFs, 56.6% were Cognard type III, 41.5% type IV, and 18.9% were ruptured. Squid 18 was used in 83.6% and Squid 12 in 32.7% of the treatments. The overall rate of intraprocedural or postprocedural adverse events (AEs) was 18.2%. Procedure-related AEs resulting in permanent morbidity were observed in 3.6%. One patient (1.8%) died unrelated to the procedure due to pulmonary embolism. The final complete occlusion rate at 90 to 180 days was 93.2%. After a mean follow-up of 5.5 months, the modified Rankin Scale (mRS) score was stable or improved in 93.0%. In one of the patients, worsening of the mRS score was related to the procedure (1.8%). CONCLUSION: Squid is a safe and effective liquid embolic agent for the treatment of high-grade DAVFs.

CLinical Assessment of WEB device in Ruptured aneurYSms (CLARYS): 12-month angiographic results of a multicenter study.

BACKGROUND: The CLinical Assessment of WEB device in Ruptured aneurYSms (CLARYS) study has shown that the endovascular treatment of ruptured bifurcation aneurysms with the Woven EndoBridge (WEB) is safe and effective and provides protection against rebleeding at 1 month and 1 year. The 12-month angiographic follow-up is an important endpoint of the study. METHODS: The CLARYS study is a prospective multicenter study conducted in 13 European centers. The study enrolled 60 patients with 60 ruptured aneurysms of the anterior and posterior circulation. The study was conducted with an independent assessment of safety outcomes and imaging. RESULTS: Sixty patients with 60 ruptured bifurcation aneurysms to be treated with the WEB were included. Fifty-three aneurysms (88.3%) had a broad base with a dome to neck ratio <2 (mean 1.6). Of these, 46 patients were evaluated by an independent core laboratory with follow-up imaging performed at 12 months or before eventual retreatment. At 1 year, 19/46 aneurysms (41.3%) were completely occluded (Raymond-Roy grade I), 21/46 (45.7%) had a residual neck and 6/46 (13.0%) had residual aneurysm filling. Adequate occlusion was reported in 40/46 (87%) aneurysms. Six patients underwent target aneurysm retreatment. CONCLUSIONS: The CLARYS study has previously shown that the use of the WEB in the endovascular treatment of ruptured bifurcation aneurysms provides effective protection against rebleeding with a good safety profile. The angiographic occlusion rates at 1 year reported here are comparable to those already seen in previous multicenter studies which primarily included unruptured aneurysms.

Aneurysm treatment with the Woven EndoBridge (WEB) device in the combined population of two prospective, multicenter series: 5-year follow-up.

BACKGROUND: Evaluating a new endovascular treatment for intracranial aneurysms must not only demonstrate short-term safety and efficacy, but also evaluate longer-term outcomes (eg, delayed complications, anatomical results, retreatment). The current analysis reports the 5-year clinical and anatomical results of Woven EndoBridge (WEB) treatment in two European combined trial populations (WEBCAST (WEB Clinical Assessment of Intrasaccular Aneurysm Therapy) and WEBCAST-2). METHODS: All adverse events occurring between the procedure and 5-year follow-up were independently evaluated by an expert. Aneurysm occlusion was evaluated by an independent core laboratory using a three-grade scale: complete occlusion, neck remnant, and aneurysm remnant. In cases where data were not available at 5-year follow-up, the last observation carry forward (LOCF) method was used. RESULTS: The safety and efficacy populations comprised 100 patients and 95 aneurysms, respectively. No adverse event related to the device occurred after the procedure during the 5-year follow-up period. Mortality at 5 years was 7.0% (7/100 patients) including mortality related to the WEB (0/100, 0.0%), the procedure (1/100, 1.0%), and another condition (6/100, 6.0%). At 5 years, complete aneurysm occlusion was observed in 49/95 (51.6%) aneurysms, neck remnant in 25/95 (26.3%), and aneurysm remnant in 21/95 (22.1%). Retreatment rate at 5 years was 11.6% (11/95 aneurysms). CONCLUSIONS: This analysis conducted in a population of patients with wide-neck bifurcation aneurysms confirms WEB's safety profile. Additional evidence demonstrates good stability of aneurysm occlusion with adequate occlusion (complete occlusion or neck remnant) at 5 years in 77.9% of aneurysms with a low retreatment rate (11.6%). CLINICAL TRIAL REGISTRATION: WEBCAST and WEBCAST-2: Unique identifier: NCT01778322.

The Tigertriever 13 for mechanical thrombectomy in distal and medium intracranial vessel occlusions.

PURPOSE: To report our two-center initial experience using the Tigertriever 13 in the treatment of acute stroke of distal, medium vessel occlusions (DMVO). METHODS: We performed a retrospective analysis of all patients treated by mechanical thrombectomy using the Tigertriever 13 device (a manually expandable low profile stent retriever) due to an acute DMVO. Locations included the anterior, middle, and posterior cerebral artery in the A2 and A3, the M3 and M4, and the P2 or P3 segment and the superior cerebellar artery. RESULTS: Forty-three patients with 45 DMVOs underwent MTE using the Tigertriever 13 with the intention-to-treat approach between May 2019 and December 2020. After a median of two thrombectomy maneuvers, the successful recanalization rate (mTICI 2b-3) was 84.4% (38/45) with a first pass effect of 26.7% (12/45). The rate of symptomatic intracranial hemorrhages (sICH) and subarachnoid hemorrhages (SAH) was 7.0% (3/43) and 14.0% (6/43), respectively. At discharge, 53.5% (23/43) of the patients had a favorable clinical outcome (mRS 0-2). CONCLUSION: Mechanical thrombectomy in DMVOs using the Tigertriever 13 leads to high recanalization rates. The incidence of mostly asymptomatic hemorrhagic events appears higher compared to MTE procedures in LVOs. Further studies will help to identify anatomic and clinical criteria to define a guideline for MTE in DMVOs.

CLinical Assessment of WEB device in Ruptured aneurYSms (CLARYS): results of 1-month and 1-year assessment of rebleeding protection and clinical safety in a multicenter study.

BACKGROUND: The primary goal of the CLARYS study is to assess the protection against rebleeding when treating ruptured bifurcation aneurysms with the Woven EndoBridge (WEB) device. METHODS: The CLARYS study is a prospective, multicenter study conducted in 13 European centers. Patients with ruptured bifurcation aneurysms were consecutively included between February 2016 and September 2017. The primary endpoint was defined as the rebleeding rate of the target aneurysm treated with the WEB within 30 days postprocedure. Secondary endpoints included periprocedural and postprocedural adverse events, total procedure and fluoroscopy times, and modified Rankin Scale score at 1 month and 1 year. RESULTS: Sixty patients with 60 ruptured bifurcation aneurysms to be treated with the WEB were included. A WEB device was successfully implanted in 93.3%. The rebleeding rate at 1 month and 1 year was 0%. The mean fluoroscopy time was 27.0 min. Twenty-three periprocedural complications were observed in 18 patients and resolved without sequelae in 16 patients. Two of these complications were attributed to the procedure and/or the use of the WEB, leading to a procedure/device-related intraoperative complication rate of 3.3%. Overall mortality at 1 month and 1 year was 1.7% and 3.8%, respectively and overall morbidity at 1 month and 1 year was 15% and 9.6%, respectively. WEB-related 1-month and 1-year morbidity and mortality was 0%. CONCLUSIONS: The interim results of CLARYS show that the endovascular treatment of ruptured bifurcation aneurysms with the WEB is safe and effective and, in particular, provides effective protection against rebleeding. It may induce profound change in the endovascular management of ruptured bifurcation aneurysms.

Thrombectomy of symptomatic isolated occlusions of posterior cerebral arteries in segment P1 and P2 in acute stroke treatment.

BACKGROUND: Interventional stroke treatments for occlusions of the posterior circulation are established procedures. However, there are limited data on the treatment of isolated symptomatic P1 and P2 occlusions, which we have examined in this study. PURPOSE: To investigate the mechanical thrombectomy of distal posterior occlusions. MATERIAL AND METHODS: Retrospectively, data from patients with isolated P1 and P2 occlusions treated with MT were evaluated. Successful reperfusions have been defined as modified thrombolysis in cerebral infarct (mTICI) Grade 2b-3. A good clinical outcome was defined as a 90-day modified Rankin score 0-2. RESULTS: All 79 treated patients were primarily aspirated. Stent retrievers were used secondarily in nine patients. Successful reperfusion was achieved in 95% of patients. Of the patients, 57% had a favorable clinical outcome after 90 days. CONCLUSION: Mechanical thrombectomy with first line aspiration of symptomatic P1 and P2 occlusions is a safe and effective procedure.

Mechanical Thrombectomy in Acute Terminal Internal Carotid Artery Occlusions Using a Large Manually Expandable Stentretriever (Tiger XL Device): Multicenter Initial Experience.

BACKGROUND: The recently introduced Tigertriever XL Device for treatment of cerebral vessel occlusions combines manual adjustability and maximum length in one device. In this study, we report our initial experience with the Tigertriever XL in terminal ICA occlusions. METHODS: Retrospective multicenter analysis of acute terminal ICA occlusions treated by mechanical thrombectomy using the Tigertriever XL Device. RESULTS: 23 patients were treated using the Tigetriever XL due to an acute occlusion of the terminal ICA. The overall successful reperfusion rate after a median of two maneuvers using the Tigertriever XL Device was 78.3% (mTICI 2b-3). In 43.5% (10/23) additional smaller devices were applied to treat remaining occlusions in downstream territories, which resulted in a final successful reperfusion rate of 95.7%. Device related complications did not occur. Two symptomatic intracerebral hemorrhages (sICH) were observed. CONCLUSIONS: The Tigertriever XL Device might be a helpful tool in the treatment of ICA terminus occlusions with large clot burden resulting in high reperfusion rates. This is mainly related to the manual adjustability of the device combined with the maximum length.

"Shelf" Technique Using a Novel Braided Self-Expandable Stent for the Treatment of Wide-Necked Bifurcation Aneurysms.

BACKGROUND: Different endovascular techniques exist for treatment of cerebral wide-necked bifurcation aneurysms (WNBA). We present the "shelf" technique with the novel woven LVIS EVO stent, which enables forming a buttress at the level of the aneurysm neck to prevent coil prolapse and additional stenting. METHODS: Single-center retrospective analysis of patients treated with the "shelf" technique by using LVIS EVO stent in incidental WNBAs between January 2020 and March 2021. Inclusion criteria were saccular aneurysms with neck width ≥4 mm or a dome/neck ratio ≤2. Primary endpoint was a favorable navigation to the target vessel and successful deployment of the LVIS EVO stent with forming a buttress that enables aneurysm occlusion by subsequent coiling. Secondary endpoints were aneurysm occlusion on follow-up, procedure-related complications and clinical outcome. RESULTS: A total of 15 patients were included. The primary end point was reached in 100% of cases. A complete aneurysm occlusion at the end of the procedure was achieved in 14/15 patients (93%). No intraprocedural complications occurred. All patients except one were discharged with an modified Rankin Scale (mRS) of 0. Procedure-related morbidity was 7%. Median follow-up imaging was 115 days (7-419 days) and available for 11/15 (73%) of the patients. Of those, 10 (91%) individuals had a complete aneurysm occlusion and 1 showed a residual neck. In all patients, the covered branch was patent and no ischemic complications occurred during follow-up. CONCLUSION: This study demonstrates the "shelf" technique with LVIS EVO stents as a feasible and safe treatment option for WNBAs with very good short-term occlusion rates.

Two-center experience with Neuroform Atlas stent-assisted coil occlusion of broad-based intracranial aneurysms.

PURPOSE: Stent-assisted coiling (SAC) represents an established treatment option for broad-based intracranial aneurysms. Here we report our initial and follow-up experience with the Neuroform Atlas Stent, a hybrid open- and closed-cell low-profile stent in the treatment of broad-based aneurysms. METHODS: All intracranial aneurysms treated by SAC with the intention to apply the Neuroform Atlas Stent between July 2015 and December 2019 were included. Angiographic and clinical results were analyzed including all follow-up examinations. RESULTS: A total of 119 aneurysms (8 acutely ruptured) in 112 patients were included. In 19 cases (16.0%) re-catheterization of the aneurysm was performed in a second procedure after failure to re-cross the stent initially. Of all aneurysms, 83.2% (99/119) were completely occluded following the procedure. In 75.6% of all cases (90/119), a single microcatheter was used for both, implantation of the stent and coil occlusion of the aneurysm. At 3-6 and 12 months follow-up, the complete occlusion rates were 75.2 (79/105) and 81.3% (74/91). The thromboembolic (stent thrombosis) and hemorrhagic complication rate was 1.7 (2/119) and 0.8% (1/119), respectively, resulting in a procedure-related morbidity and mortality rate of 0.9 and 0.9% (1/112 patients). CONCLUSION: SAC using the Neuroform Atlas Stent offers a safe and effective option to treat broad-based intracranial aneurysms with a high angiographic and clinical success rate. In the majority of procedures, the application of two mircocatheters is not required. Prospective comparative studies might help to identify the value of SAC using the Neuroform Atlas Stent among the growing treatment options for broad-based aneurysms.

Aneurysm treatment with WEB in the cumulative population of two prospective, multicenter series: 3-year follow-up.

BACKGROUND: WEB treatment is an endovascular approach for wide-neck bifurcation aneurysms that has demonstrated high safety and good efficacy in mid-term follow-up. While evaluating safety in the long term is important to determine if delayed adverse events occur affecting late morbidity and mortality, the most important point to evaluate is the long-term stability of aneurysm occlusion. The current analysis reports the 3-year clinical and anatomical results of WEB treatment in the combined population of two European trials (WEBCAST (WEB Clinical Assessment of Intrasaccular Aneurysm Therapy) and WEBCAST-2). METHODS: Aneurysm occlusion was evaluated using a 3-grade scale: complete occlusion, neck remnant, and aneurysm remnant. RESULTS: The safety population comprised 79 patients. The efficacy population comprised 61 aneurysms. Aneurysm locations were middle cerebral artery in 32/61 aneurysms (52.5%), anterior communicating artery in 13/61 (21.3%), basilar artery in 9/61 (14.8%), and internal carotid artery terminus in 7/61 (11.5%). No adverse events related to the device or procedure occurred between 2 and 3 years. At 3 years, complete occlusion was observed in 31/61 (50.8%) aneurysms, neck remnant in 20/61 (32.8%), and aneurysm remnant in 10/61 (16.4%). Between 1 year and 3 years, aneurysm occlusion was improved or stable in 53/61 (86.9%) aneurysms and worsened in 8/61 (13.1%). Worsening was mostly from complete occlusion to neck remnant in 6/61 (9.8%) aneurysms. The retreatment rate at 3 years was 11.4%. CONCLUSIONS: This analysis confirms the high safety profile of WEB. Moreover, evidence demonstrates the great stability of aneurysm occlusion with adequate occlusion (complete occlusion or neck remnant) in 83.6% of aneurysms. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. WEBCAST and WEBCAST-2: Unique identifier: NCT01778322.

Endovascular Treatment of Intracranial Dural Arteriovenous Fistulas: A German Single-Center Experience.

BACKGROUND AND PURPOSE: Intracranial dural arteriovenous fistulas (DAVFs) are abnormal shunts between dural arteries and dural venous sinus or cortical veins. We report our experience with endovascular therapy of primary complex DAVFs using modern embolic agents. METHODS: This is a retrospective analysis of patients with DAVFs treated between 2015 and 2019. Patient demographics and technical aspects including the use of embolic agent, access to the fistula, number of treatments, occlusion rates, and complications were addressed. Angiographic treatment success was defined as complete occlusion (CO) of the DAVF. RESULTS: Fifty patients were treated endovascularly. Median age was 61 years and 66% were men. The most common symptom was pulsatile tinnitus in 17 patients (34%). The most frequent location of the DAVF was the transverse-sigmoid sinus (40%). Thirty-six fistulas (72%) had cortical venous reflux. Nonadhesive and adhesive liquid agents were used in 92% as a single material or in combination. CO was achieved in 48 patients (96%). In 28 individuals (56%), only 1 procedure was necessary. Nonadhesive liquid agents were exclusively used in 14 patients (28%) with CO attained in every case. For CO of tentorial DAVFs, multiple sessions were more often required than at the other locations (55 vs. 14%, p = 0.0051). Among 93 procedures, the overall complication rate was 3%. The procedure-related mortality rate was 0%. CONCLUSION: Endovascular treatment of intracranial DAVFs is feasible, safe, and effective with high rates of CO. In more than half of the patients, the DAVF was completely occluded after a single procedure. However, in tentorial DAVFs, multiple sessions were more often required.

[Acute Neurointerventions, Covid-19 and Chest-CT: SOP and Literature Review]. / Notfällige Neurointerventionen, Covid-19 und Thorax-CT: SOP und Literaturübersicht.

BACKGROUND AND PURPOSE: To analyze standard operating procedures (SOP) of acute stroke imaging and interventions during COVID-19 pandemic with special emphasis on chest CT within a multimodal stroke protocol. METHODS: A questionnaire was distributed via email to members of the Professional Organization of German Neuroradiologists (Berufsverband Deutscher Neuroradiologen e.V.). RESULTS: Answers were received from 25 units: eleven of them acquire chest CT, three in any patient and eight, when COVID-19 is suspected due to body temperature increase, patient's history or when the latter cannot be sufficiently obtained. Preliminary data indicate a high sensitivity and moderate negative predictive value. CONCLUSION: Different SOP reflect an uncertainty whether chest CT should be acquired as part of a multimodal stroke protocol. Accuracy of low dose chest CT cannot be determined yet. The strengths and limitations of chest CT are discussed.

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%).