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Abstract
Background The Woven EndoBridge (WEB) device is approved in the USA for treatment of unruptured wide-neck bifurcation aneurysms. However, the safety and effectiveness of the WEB device in the treatment of ruptured intracranial aneurysms is not clear. We aim to evaluate the perioperative safety and effectiveness of the WEB device in patients with ruptured intracranial aneurysms.
Methods This retrospective study, conducted at eight centers in the USA, included patients with ruptured intracranial aneurysms treated with the WEB device in the setting of subarachnoid hemorrhage (SAH). Safety outcomes included intraoperative complications such as vessel perforation, thromboembolic events, and postoperative hemorrhagic or thromboembolic complications based on radiologic imaging. The primary effectiveness outcome was adequate (complete and neck remnant) aneurysm occlusion, according to the Raymond–Roy classification.
Results A total of 91 patients with 94 ruptured intracranial aneurysms were included (mean age 57.7±15.2 years; 68.1% women; 82.9% wide-necked). Aneurysms were located in the anterior communicating artery (42/94, 44.6%), middle cerebral artery (16/94, 17%), and basilar artery (15/94, 16%). Adequate occlusion was achieved in 48.8% (41/84) and 80.0% (40/50) at discharge and last follow-up (mean of 3.4 months), respectively. At discharge, procedural-related morbidity was 3.3% (3/91) and there was no procedure-related mortality. No re-rupture or delayed aneurysm rupture was observed.
Conclusions This study demonstrates the perioperative safety and effectiveness of the WEB device for the treatment of patients with ruptured intracranial aneurysms in the setting of SAH, with low periprocedural morbidity and mortality. Long-term follow-up is warranted.
- aneurysm
- angiography
- device
- stroke
- subarachnoid
Data availability statement
Data are available upon reasonable request.
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INTRODUCTION
The Woven EndoBridge (Sequent Medical, Aliso Viejo, California, USA) device offers an alternative to traditional endovascular approaches for the treatment of wide-necked bifurcation aneurysms as demonstrated by prospective studies showing low rates of complications and high rates of adequate occlusion.1 2 However, these studies included a small fraction (6–8.3%) of ruptured aneurysms and excluded patients with subarachnoid hemorrhage (SAH) with a poor grade (Hunt and Hess 4–5) at presentation, thus preventing open-label use of the WEB device for the treatment of ruptured aneurysms in patients with SAH.1–6 High thrombogenicity of the nitinol mesh and the flow disruption following device implantation make the WEB device a potential option for the management of intracranial aneurysms in the setting of SAH. Additionally, this device is deployed within the aneurysm sac, offering the possibility to obviate the need for potent antiplatelet therapy, which has been associated with up to 18% complication rates in cases of ruptured aneurysms.7–9
The WEB device has been available for clinical use since 2011, but was approved by the US Food and Drug Administration (FDA) in December 2018 for the treatment of unruptured aneurysms.1 6 However, data regarding the safety and effectiveness of this device in the setting of ruptured aneurysms are sparse.10–16 CLinical Assessment of WEB device in Ruptured aneurysms (CLARYS) is an ongoing European trial assessing the clinical utility of the WEB in the presence of subarachnoid hemorrhage (NCT02687607).17 The objective of our study was to evaluate the periprocedural safety and early effectiveness of the WEB device in the management of ruptured intracranial aneurysms in the setting of SAH in the USA.
Methods
A retrospective review was performed at eight centers within the USA. Local ethics committees and/or the Institutional Review Board at each institution approved the retrospective analysis of deidentified patient data, which did not require informed consent. The cohort consisted of all consecutive patients who presented with ruptured intracranial aneurysms and were treated with the WEB device in the setting of SAH. The data collected at each center were entered into a standardized data form. Patient demographics, clinical and radiologic presentation, Hunt and Hess grade and modified Fisher score at presentation, procedural details, perioperative antiplatelet medications, intraoperative/postoperative complications, functional and angiographic outcomes were collected. Angiographic outcomes were collected as-read by the treating physician.
Procedure details
The use of the WEB device to treat ruptured intracranial aneurysms was based on clinical presentation and aneurysm characteristics and was at the discretion of the interventionalists. The procedure was performed through a biplane angiographic system under general anesthesia in the majority of patients. The sizes of the catheter delivery system and WEB devices were chosen according to the dimensions of the aneurysm. Additional coils or stents were used at the operators’ discretion. Control angiography was performed before final detachment of the device by the electrothermal system. In case of unsatisfactory positioning, the device was recaptured, repositioned, or exchanged for a device with different dimensions. Intraprocedural information regarding vessel perforation, thromboembolic event, and device deployment failure were retrieved.
Perioperative use of intravenous heparin, aspirin or any other antiplatelet agent was done per treating site protocol.
Outcomes
Safety outcomes included periprocedural complications such as vessel perforation, thromboembolic events, and in-hospital hemorrhagic or thromboembolic complications (defined based on radiologic imaging associated with the presence of new-onset symptoms or acute symptoms), along with procedure-related mortality. All complications and outcomes were collected from chart review and defined by each site's treating physician with a specific question asked about the relationship of the complication to the treating device. WEB effectiveness was evaluated by the Raymond–Roy classification (1, complete occlusion; 2, residual neck; 3, residual aneurysm).18 Adequate occlusion included complete occlusion and neck remnant. Patency of the adjacent vessel, the requirement of a concomitant stent, and device deployment failure were also used to adjudicate overall procedure effectiveness.
Given the recent approval of the device in the USA, only short-term imaging follow-up was available at the present time for this cohort. Mean follow-up imaging data at 3.4 months (range 2–6 months) was assessed via DSA, MR angiography, or CT angiography. The clinical outcome at discharge and at 90 days was assessed using the modified Rankin Scale (mRS). An mRS 0–2 was considered a favorable functional outcome and an mRS 0–3 an acceptable functional outcome.
Statistical analysis
Mean and SD values are presented for continuous variables and frequency is presented for categorical variables. Univariate comparisons were performed using a Fisher exact test or χ2 test. The confidence intervals (CI) around proportions were calculated using the Clopper–Pearson method. The statistical analysis was conducted using SPSS (IBM, Armonk, New York, USA).
Results
Patient demographics, presentation, and aneurysm characteristics
A total of 91 patients with 94 aneurysms treated with the WEB device in the setting of SAH were included. The patient population included 62 (68.1%) women, with a mean age of 57.3±15.4 years (median 59, IQR 47–67). The majority of patients (94.5%, 86/91) had mRS 0 before the occurrence of SAH. The most common comorbidities were hypertension (72.4%, 66/91) and tobacco use (55.2%, 50/91). Clinical presentation of SAH according to the Hunt and Hess scale was 1–2 in 48.3% (44/91) of patients, 3 in 22.0% (20/91) of patients, and 4–5 in 29.7% (27/91) of patients. The timing of treatment after SAH was less than 3 days in 95.6% (87/91) of the patients.
Aneurysm characteristics are shown in table 1. The most common aneurysm locations were the anterior communicating artery (44.6%, 42/94), middle cerebral artery (17%, 16/94), and basilar artery (16%, 15/94). The mean aneurysm dome size was 5.7±1.9 mm (range 2.4–11), and the maximum aneurysm diameter was 6.9±2.6 mm (range 3.3–16). The mean dome-to-neck ratio was 1.6±0.5 mm and the mean neck size was 3.7±1.5 mm. Seventy-eight (82.9%) aneurysms were considered wide-necked, with either a neck ≥4 mm or a dome-to-neck ratio ≤2.0. The target aneurysm was previously treated with coiling in two patients.
Aneurysms: baseline characteristics
Procedural details, morbidity, and mortality
During the procedure, 13.1% (12/91) of patients received single antiplatelet therapy and 2.2% (2/91) received dual antiplatelet therapy (DAPT); for the remaining (79/91), no antiplatelets were used. Treatment was performed successfully in 97.8% (89/91) of patients. Device dislodgment occurred in 2.2% (2/91) of patients. Clipping and coiling were used to treat lesions in 1.1% (1/91) and 2.2% (2/91) of patients, respectively. The WEB SL was the device of choice in the majority of cases (71/94, 75.5%), followed by the WEB SLS (23/94, 24.5%). In one patient (1/91, 1.1%) the WEB device failed to open and was replaced with another device.
The dimensions and distribution of the devices used are shown in figure 1. In three patients (3/91, 3.2%) more than one aneurysm was treated with the implantation of the WEB because the origin of the bleeding could not be accurately determined. Additionally, adjuvant stenting was required in 3.2% (3/91) of patients and adjuvant coiling in 9.9% (9/91) (mean of 3.6 coils per patient). Immediate post-procedure angiography showed complete occlusion in 28.6% (24/84) of the patients, residual neck in 20.2% (17/84), and residual aneurysm in 51.2% (43/84).
Dimensions and distribution of the WEB-SL and WEB-SLS devices used in the study. VIA indicates the delivery microcatheter used and its dimension.
Table 2 summarizes periprocedural symptomatic complications. Overall, procedure-related symptomatic complications occurred in 4.5% (4/91) of patients (cases 1–4), of which 75.0% (3/4) were associated with ischemic events and 25.0% (1/4) with intraoperative aneurysm rupture. Neurologic sequelae at discharge were seen in three patients, resulting in procedure-related morbidity of 3.3% (3/91, 95% CI 0.6% to 9.3%). There was no procedure-related mortality at discharge (0/91). However, 12 patients (12/91, 13.9%) were dead at discharge as a result of the SAH, 9 had poor grade (Hunt and Hess 4–5) at presentation, and 11 with Fisher score of 4; none of these fatal outcome cases had intraoperative or postoperative complications.
Periprocedural symptomatic events
After WEB deployment, 4.5% (4/91) of patients had flow limitation in the parent vessel. In one of these patients (1/4, 25.0%) the procedure was aborted and clipping was used to treat the aneurysm. In the remaining three cases (3/4, 75.0%), a Neuroform Atlas stent (Stryker Neurovascular, Fremont, California, USA) was placed to preserve parent vessel patency.
Intraoperative thrombus formation occurred in 6.7% (6/91) of patients; two were managed with eptifibatide and aspirin, one with abciximab, one with intra-arterial tissue plasminogen activator (IA-tPA), one with aspirin and vessel angioplasty, and one with aspiration only. Of these six patients, one patient with an ACA aneurysm progressed with right-sided weakness despite optimal intraoperative management with aspirin and eptifibatide (case 1) and two patients developed symptomatic ischemic events despite no evidence of thrombus during the intervention (cases 2 and 3).
Intraoperative aneurysm rupture occurred in three patients (3.2%, 9/91). One of these patients had a posterior inferior cerebellar artery (PICA) aneurysm and had device dislodgment into the vertebrobasilar junction with contrast extravasation, and rescue coiling used to treat the aneurysm. Further deconstruction of the vertebral artery distal to the PICA origin was achieved with Onyx (Medtronic, Dublin, Ireland) and coiling without any neurological sequelae. The other two patients had anterior communicating artery aneurysms where extravasation abated spontaneously after device deployment, although external ventricular drain (EVD) placement was required in one of these patients (case 4). Additionally, there were four symptomatic intracranial hemorrhages not related to the endovascular procedure following the intervention. Three of these cases were related to EVD tract hematomas (cases 5–7) and one was an MCA aneurysm that required decompressive hemicraniectomy due to the previous enlargement of a Sylvian fissure hemorrhage (case 8).
Hospital course and clinical and angiographic outcome at early follow-up
The median length of stay was 16 days (IQR 11–22). Favorable functional outcome at discharge was achieved in 54.9% (50/91) of patients and acceptable outcome in 67.0% (61/91). Seventeen (17/91, 18.7%) patients were discharged on DAPT.
Among 41 patients (41/79, 51.9%) with 90-day mRS follow-up, 87.8% (36/41) had a favorable outcome and 95.1% (39/41) had an acceptable functional outcome. Angiographic follow-up was available for 50 patients, with a median follow-up of 3.4 months (IQR 2–6). Complete aneurysm occlusion was observed in 48.0% (24/50) of patients, residual neck in 32.0% (16/50), and residual aneurysm in 20% (10/50). There was no difference in the rate of symptomatic thromboembolic events and ICH among patients, regardless of DAPT status (p=1). However, those who were discharged on DAPT were more likely to have residual aneurysm at follow-up (46.7% vs 8.6%, p=0.002). Four patients (4/50, 8.0%) had target aneurysm retreatment during the follow-up period. There was neither delayed mortality nor delayed aneurysm re-rupture. An illustrative case is presented in figure 2.
A middle-aged patient presented with subarachnoid hemorrhage (A) and Hunt and Hess grade 3. A cerebral angiogram revealed an irregular anterior communicating artery aneurysm (B, C). After proper measures were obtained (D), the lesion was treated with WEB device deployment (E). Immediate angiographic results demonstrated a good position of the device with residual aneurysm filling and contrast stasis within the device (F, unsubtracted; G, subtracted). Three-month CT angiography follow-up confirmed complete occlusion of the aneurysm and patency of the adjacent vessels (H, I).
Discussion
This large multicenter retrospective study in the USA demonstrated low procedure-related morbidity, no procedure-related mortality, and no rebleeding at short-term follow-up. The perioperative safety and effectiveness of the WEB device for the treatment of patients with ruptured intracranial aneurysms in the setting of SAH was demonstrated.
Several single-center and multicenter retrospective studies have reported their experience using the WEB device for the management of ruptured intracranial aneurysms with procedure-related complication rates of 3–6% and procedure-related mortality rates of up to 12%.10–16 In a large single-center study of 100 patients, van Rooji et al 13 reported a treatment-related permanent morbidity-mortality of 4% (4/100; 95% CI 1.2% to 10.2%).13 In a systematic review and meta-analysis of 588 intracranial aneurysms, of which 78.4% were unruptured aneurysms, all the aneurysms were treated with the WEB device and perioperative morbidity (mRS score >1) and mortality rates of 4% (95% CI 1% to 8%) and 1% (95% CI 0% to 2%), respectively, were reported.19 The complication rate in our study is low and similar to that reported in these studies.10–16 19 Moreover, there was no early aneurysm rebleeding after WEB device deployment in our study, similar to that reported by van Rooji et al. 13
The rate of intraoperative ruptures in our study was similar to the average risk of 2.5% (6/234, 95% CI 0.9% to 5.5%) in patients when combining data from previous studies with ruptured aneurysms exclusively.10–16 A similar risk of intraoperative rupture was observed in the Analysis of Treatment by Endovascular approach of Non ruptured Aneurysms (ATENA) (2.6%) and Clinical and Anatomical Results in the Treatment of Ruptured Intracranial Aneurysms (CLARITY) (3.7%) studies involving patients treated with coiling.20 21 Furthermore, there appears to be no significant difference in intraoperative rupture risk associated with the WEB devices for treating ruptured (6%; 95% CI 0% to 11%) versus unruptured aneurysms (1%; 95% CI 0% to 3%) (p=0.08).19 An intact aneurysm wall does not seem to be enough to prevent perforation, so special attention during aneurysm catheterization and initial device deployment is necessary to avoid vessel damage and to allow optimal device positioning, regardless of rupture status. Thus, it is necessary to understand the technical caveats intrinsic to the WEB device to achieve satisfactory and reliable outcomes. A standardized approach must be warranted including (1) comprehension of aneurysm morphology, comprising its dimensions and adjacent vessels anatomy; (2) selection of the ideal device and accurate preparation; (3) optimized supporting system; and (4) perspicuity during catheterization and device positioning to ensure good apposition to lateral walls before detachment.22
Endovascular treatment of ruptured intracranial aneurysms has been demonstrated to have improved outcomes when compared with clipping.21 23 24 However, wide-necked aneurysms remain a challenge and were likely under-represented in these studies due to their associated treatment difficulties, often preventing successful coiling.25 26 A systematic review and meta-analysis of the existing treatments for wide-necked aneurysms reported relatively low rates of complete occlusion in both endovascular (39.8%) and surgical clipping groups (52.2%), with overall augmented rates of safety events at 12 months, reasserting the complexity of treating wide-neck aneurysms and the necessity for newer technologies.27 In our study, the WEB device achieved progressive adequate occlusion rates between immediate post-procedure and at an early follow-up of 3.4 months. Long-term follow-up is planned to be reported for the current series.
A retrospective experience of matched patients with large-neck intracranial aneurysms demonstrated similar safety and efficacy between the WEB device and stent-assisted coiling.28 However, the majority of analyzed cases were composed of unruptured aneurysms (63.6%). Additionally, owing to an increased risk for thromboembolic events, endoluminal devices most often necessitate DAPT.8 9 The use of a dual regimen in patients with SAH, however, may lead to catastrophic consequences, and the rate of complications associated with stenting in acutely ruptured aneurysms tends to be higher than that in unruptured aneurysms.29 Patients with ruptured lesions treated with the WEB device also showed a trend for increased thromboembolism, likely related to a prothrombotic environment triggered by the SAH but with no added morbidity from these events.19
Similar to our results, the WEBCAST sample did not show increased rates of thromboembolic events between patients using DAPT.3 Additionally, early follow-up of our cohort showed a higher rate of residual aneurysm in patients discharged on DAPT. Therefore, in the absence of other indications, our findings reinforce the potentialities of waiving the use of potent antiplatelet therapies in patients with ruptured intracranial aneurysms treated with the WEB device.
Limitations
This study was limited by its retrospective design, lack of randomization, and risk of selection bias. The lack of a control group and the absence of independent adjudicators limit the study’s external validity. Although it has a small sample size which limits the interpretation of the complications and their relationship with the procedure and drug regimen, it remains one of the largest series in the literature. While the scope of the study was to report periprocedural complications, it is evident that long-term follow-up is required to determine the efficacy of the WEB device. Some of the included cases may have been previously published.16 30
Conclusion
The use of the WEB device for treatment of ruptured aneurysms showed low rates of procedure-related morbidity and mortality with no documented rebleeding, making the WEB device a safe and effective option for the treatment of this population. Prospective independently adjudicated studies involving the WEB device with long-term follow-up are needed to better evaluate the occlusion rate and durability of the procedure.
Data availability statement
Data are available upon reasonable request.
Ethics statements
Patient consent for publication
Acknowledgments
This study aligns with the STROBE statement for observational studies.
References
Footnotes
Twitter @AdamArthurMD, @PascalJabbourMD, @AhmadSweidMD, @Ansaar_Rai, @drnimajax
Correction notice This article has been corrected since it first published. The provenance and peer review statement has been included.
Contributors All authors have substantially contributed to the conception and design of the study and/or data acquisition. GMC was responsible for the initial draft, and RAH for its critical revision. All the authors revised the manuscript and approved the final version of the manuscript.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests ASA is a consultant for Balt, Johnson and Johnson, Leica, Medtronic, Microvention, Penumbra, Scientia, Siemens, and Stryker; receives research support from Microvention, Penumbra, and Siemens; and is a shareholder in Bendit, Cerebrotech, Endostream, Magneto, Marblehead, Neurogami, Serenity, Synchron, Triad Medical and Vascular Simulations outside the submitted work. PJ is a consultant for Medtronic, Microvention, Balt, and Cerus. MRG and SITs are consultants to Stryker. JEDA is a consultant to Medtronic, Penumbra, and Sequent. YK is a consultant for Penumbra and for Medtronic Neurovascular. ATR is a consultant to Stryker and Cerenovus. SB is a consultant to Stryker Neurovascular and MicroVention. DF is a consultant to Balt, Marblehead, Medtronic, Stryker, Microvention, Penumbra, and Cerenovus; receives research support from Cerenovus, Medtronic, Stryker, Siemens, Microvention, and Penumbra, and royalties from Codman; and is a stockholder for Marblehead, Neurogami, and Vascular Simulations outside of the submitted work. JV is a proctor for Microvention for the WEB device. MC is a consultant to Cerenovus. AHS reports grants from Coinvestigator: NIH/NINDS 1R01NS091075 Virtual Intervention of Intracranial Aneurysms; personal fees from Adona Medical, Amnis Therapeutics, BlinkTBI, Boston Scientific Corp (for purchase of Claret Medical), Buffalo Technology Partners, Cardinal Consultants, Cerebrotech Medical Systems, Cognition Medical, Endostream Medical, Imperative Care, International Medical Distribution Partners, Neurovascular Diagnostics, Q’Apel Medical, Rebound Therapeutics Corp (purchased 2019 by Integra Lifesciences), Rist Neurovascular, Sense Diagnostics, Serenity Medical, Silk Road Medical, Spinnaker Medical, StimMed, Synchron, Three Rivers Medical, Vastrax, VICIS, Viseon; additional personal fees from Amnis Therapeutics, Canon Medical Systems USA, Cerenovus, Corindus, Integra LifeSciences, Medtronic, MicroVention, Minnetronix Neuro, Northwest University, Penumbra, Rapid Medical, Stryker, VasSol, WL Gore & Associates; consultant fees for opinion on the design of clinical trials. RAH reports conflict of interest with Medtronic, Stryker, Cerenovous, Microvention, Balt, Phenox, MiVI, and Codman and is a stockholder for Neurvana, Elum, Endostream, Three Rivers Medical, Synchron, RisT, Cerebrotech, Deinde, BendIT, and InNeurCo. All the other authors have no competing interests to report.
Provenance and peer review Not commissioned; externally peer reviewed.