J Cerebrovasc Endovasc Neurosurg > Epub ahead of print
Ghanaati, Rahmatian, Torkaman, Dashtkoohi, and Ohadi: Comparison of Woven EndoBridge and stent-assisted coiling for treatment of acutely ruptured wide-neck bifurcation aneurysms: Single-center experience

Abstract

Objective

Treating wide-necked bifurcation aneurysms (WNBA) is challenging. Nevertheless, recent progress in endovascular techniques is promising. Woven EndoBridge devices (WEB) have exhibited outcomes comparable to conventional treatments like stent-assisted coiling (SAC) in treating aneurysms. However, their safety and efficacy in managing acutely ruptured aneurysms remain a topic of interest. This study focuses on this issue.

Methods

We searched our database from 2020 to 2023 and found 38 patients with acutely (< a week) ruptured WNBA. We extracted radiologic and clinical data from the available medical reports. Favorable functional and radiologic outcomes were assessed using the modified Rankin scale (mRS) and modified Raymond-Roy occlusion classification (MRRC).

Results

Our study population comprised 15 aneurysms treated with WEB and 25 treated with SAC. Operational time was significantly lower in the WEB compared to the SAC group (39.3 vs 66.2 minutes, p value: < 0.001). Immediate (p value=0.64) and the 18th-month (p value=0.42) occlusion rates were comparable between the two groups. Favorable mRS scores in the 3rd month were seen in 100% of SAC patients and 93.3% of WEB patients (p value=0.79). Retreatment (p value=1.0) and complication (p value=0.39) rates were comparable. Vasospasms after the procedure were the most common complication.

Conclusions

WEB demonstrated comparable safety and efficacy to SAC in patients with acutely ruptured WNBA. Notably, WEB had a shorter procedure duration. Additional studies with extended follow-up periods are necessary for comprehensive evaluation.

INTRODUCTION

Spontaneous subarachnoid hemorrhage (SAH) is mostly due to intracranial aneurysm ruptures [15]. The mortality rate is up to 40-60%. However, New endovascular treatments (EVT) have revolutionized the approach to vascular diseases leading to new treatment indications and improved outcomes [15,25]. The results of the International subarachnoid aneurysm trial showed that patients who underwent EVT had a better disability-free survival rate than patients who underwent neurosurgical clipping. These findings have increased the EVT preference for ruptured and unruptured aneurysms [16].
Wide-necked bifurcation aneurysms (WNBA) are among the most critical types of intracranial aneurysms. These aneurysms have large necks (>4 mm) or a small dome-to-neck ratio (<2) and are at major bifurcations [10,24]. Treatment of WNBA aneurysms is challenging because the branches originate from the neck. The risk of coil protrusion, thromboembolic complications, and recanalization is higher in WNBA [13]. Various EVTs are available for this condition, including balloon-assisted coiling, stent-assisted coiling (SAC), and the Woven EndoBridge (WEB) [13].
Neurosergones mainly deploy SAC for WNBA, in which a stent is inserted into the vessel wall to support coil placement into the aneurysm sac [2]. However, the new WEB embolization, which uses a self-expandable titanium device has shown promising results. Unlike the SAC embolization, the WEB embolization works with the flow disruption theory, and the device is placed only in the aneurysm sac, needless for antiplatelet agents [4]. The FDA approved this method after the successful WEB IT trial [1].
Several studies have investigated the safety and efficacy of this device [12,18]. However, there is still a need to adapt indications for EVT to the subtype of ruptured WNBA [13]. Only a few studies with small study populations have compared these embolization methods in acute ruptured WNBA [8,23]. In this study, we compare the clinical and imaging outcomes immediately and at the 18th-month follow-up in patients with ruptured WNBA.

MATERIALS AND METHODS

Study population

Between 2020 to 2023 a total of 307 patients were treated for intracranial aneurysms in our center. Among them, 94 were wide neck aneurysms located on the bifurcation sites. We included patients with ruptured WNB aneurysms who were treated by WEB or SAC alone within a week from the initial symptom. Patients with an 18th-month DSA follow-up were included in the study. Details of patient selection are provided in Fig. 1.
Age, gender, and other epidemiologic variables were obtained from electronic medical records. The initial status of subarachnoid hemorrhage (SAH) was assessed using the Hunt and Hess (H&H) scale. Aneurysms were described based on angiographic attributes such as dome-to-neck ratio and neck size. The duration of the procedure was defined as the time from arterial sheath placement to removal. This research adhered to the principles outlined in the Declaration of Helsinki. The institutional review boards approved our study with a waiver of written informed consent as deemed appropriate.

Endovascular procedure and follow-up

WEB and SAC were deployed in patients based on the treatment guidelines and under general anesthesia. Before the surgery, digital subtraction angiography (DSA) was conducted for all patients to ascertain the appropriate size of the devices. All the patients treated with SAC were administered peri procedural 5,000 IU heparin. Transfemoral access was obtained for all the patients. Guide sheath 7F (CATAPULTTM, Boston Scientific, USA) and Intermediate Catheter SOFIA 6 F (MicroVention, Aliso Viejo, CA) were employed for WEB embedding. The device was implanted with a suitable VIA microcatheter (Sequent Medical, Aliso Viejo, California, USA) for the size of the WEB device (MicroVention—Terumo, Tustin, CA, USA). In the SAC group, an intermediate catheter appropriate for SAC (MicroVention—Terumo, Tustin, CA, USA) was used, and the coiling catheter was either jailed or coiled with the deployed stents. The WEB group did not receive any antiplatelet medication, while the SAC group was given dual antiplatelet therapy with oral aspirin (80 mg/day) and clopidogrel (75 mg/day) after the procedure.
DSA was conducted immediately after device placement to evaluate immediate occlusion and in the 6th and 18th months. Radiological assessments during follow-up were classified according to the modified Raymond classification system (MRRC). Patients demonstrating major recanalization underwent reassessment for potential repeat endovascular interventions. Two experienced neurointerventionists were tasked with independently reviewing the initial and all subsequent DSA studies. Any discrepancies in interpretation were resolved through consensus, with consultation from a third neurointerventionist when necessary. The clinical status of patients was assessed using the modified Rankin scale (mRS) at the 3-month follow-up evaluation. A favorable mRS score was defined as 0-2.

Statistical analysis

All the statistical analyses were conducted by R-Studio 4.1.2. using TableOne package. Categorical variables are presented as counts and percentages and analyzed using the χ2 or Fisher exact test. Shapiro-Wilk test was used to check the normality assumption. Continues variables presented by means±standard deviation (SD) and tested using independent t-test or Mann-Whitney U test. Significant results are defined as p value <0.05.

RESULTS

Clinical characteristics

A total of 38 patients with 40 aneurysms were identified through searching our database. All patients had one aneurysm except for two patients with two aneurysms. SAC was used to treat 25 aneurysms (62.5%) in 23 patients, while WEB was utilized for 15 (37.5%) aneurysms in 15 patients (Table 1). The mean age was 58.62 and females comprised 40% of patients. Hypertension was reported in 65% of patients. Aneurysms were located in the middle cerebellar artery (35%), anterior communicating artery (32.5%), Basilar tip (12.5%), terminal part of the internal carotid (17.5%), and posterior inferior cerebellar artery (2.5%). All the patients presented with SAH and high-grade H&H scores (III and IV) were found in 40% without a significant difference between the two groups (p value=0.34). Aneurysm’s dome height (5.68±0.91 vs 6.96±1.43, p value: 0.002), width (4.58±0.77 vs 6.18±1.38, p value: <0.001), and neck (3.18±0.52 vs 4.35±0.98, p value: <0.001) were significantly higher in WEB. However, the aneurysmal dome-to-neck ratio did not differ significantly between the two groups (1.45±0.19 vs 1.43±0.17, p value: 0.79). Operational time was significantly lower in the WEB group (39.3 vs 66.2 minutes, p value: <0.001).

Follow-up outcome and complications

Immediate complete occlusion was recorded in 72% and 60% of SAC and WEB respectively without significant difference in occlusion rate (p value=0.64). DSA findings on the 18th month revealed similar occlusion rates between the two groups (p value=0.42). Favorable mRS score at 3 months reached 100% and 93.3% of SAC and WEB patients respectively which was comparable between the two groups (p value=0.79). In addition, we did not find a significant difference in retreatment rate between the two groups (p value=1.0). Three patients in the SAC group retreated with additional flow diversion and SAC embolization was used in two primarily treated with WEB intervention. Comparable complication rate was found between the two groups (p value=0.39). Seven cases in each group showed post-operational vasospasm on magnetic resonance imaging (MRI) which was treated by intravascular injection of nimodipine and did not result in long-term sequel. The compressive effect of the device on the near branches occurred in one patient in each group which was solved by the device replacement (Table 2).

DISCUSSION

This study included 38 patients with 40 aneurysms. We showed that WEB and SAC had similar occlusion expectancy immediately after the procedure and in the 18th-month follow-up. The immediate occlusion rate in WEB was 60%, and in SAC was 72%. In addition, occlusion rates in follow-up improved by 80% and 88% in SAC and WEB. Treatment complication rates were similar. The most common postoperative complication was vasospasm, which in all cases resolved by medical treatment without sequel. Both groups didn’t have treatment-related mortality. The operational time in the WEB cohort was significantly shorter than SAC.
Our results for WEB efficiency in WNBA are consistent with a single-arm systematic review by Lv et al. Their study included 925 patients with WNBA. They showed that regardless of whether WNBA was ruptured or unruptured, the rates of complete occlusion and adequate occlusion in short and mid-term follow-ups were 55% and 81% [14]. Regarding the long-term efficiency of WEB, the three-year follow-up of the WEBCAST and WEBCAST 2 clinical trials showed improvement compared to the first-year follow-up. The 5-year follow-up also showed 51.6% complete aneurysm occlusion, 26.3% neck remnant, and 22.1% aneurysm remnant [20].
A study evaluating SAC found that 21.4% of treated patients’ anatomic outcomes during follow-up deteriorated, while 45.7% had improved occlusion [11]. Recanalization is estimated to occur for up to 9.2% of WNBA treated with SAC. Also, up to 11.4 of re-treatments have been reported in studies of WEB [7,26]. Most recanalizations occur within the first 6-12 months [8]. In this study, the only recanalization during the follow-up in SAC did not require additional treatment.
Studies have shown that the likelihood of associated complications with EVT in WNBA is higher than in other intracranial aneurysms [3,5]. A comparative analysis of complications in WEB and SAC procedures revealed that thrombosis is the most common complication. Despite the widely held belief that thrombotic complications occur more frequently in SAC patients, the results of WEB-IT failed to demonstrate a statistically significant difference in the incidence of thrombosis between SAC and WEB [1,3]. Due to the high possibility of thrombotic complications during and after the SAC procedure, antiplatelet therapy is compulsory. Patients treated with the WEB do not require antiplatelet during or after the procedure [7]. Furthermore, this study found no discernible difference in the likelihood of complications between SAC and WEB. The available literature also emphasizes that late complications in WEB are rare [6,21].
Monteiro et al. conducted a systematic study to evaluate the effectiveness and safety of deploying WEB in patients with ruptured intracranial aneurysms. Their study, which included 377 cases with 82.7% ruptured aneurysms, concluded with a 1% postoperative and 8.4% intraoperative complication rate. Like Monteiro et al., we did not meet any intraoperative complications. However, following the surgery, 35% of our patients showed signs of vasospasm and were treated with nifedipine [17]. One reason for this discrepancy may be that their study focused only on thromboembolies and hemorrhages, without considering vasospasm. If we only consider these complications, our study shows similar low postoperation complications.
Studies have compared the duration of medical procedures, which is crucial because it can increase treatment efficiency in areas with limited equipment and reduce patient’s exposure to radiation [19,22]. We found that the operational time in the WEB cohort was significantly shorter. The WEB device usually does not require an additional device, which makes the process more efficient. These results are consistent with previous research in this area [3,9,23].
This study has limitations that need to be considered for future studies. First, WNBA is a relatively heterogeneous entity that includes aneurysms of varying sizes, anatomic locations, and morphologies, but this study assumes all aneurysms are homogenous [13]. Second, this study was retrospective and is susceptible to patient selection bias. However, our institute has no established criteria for deciding when to use WEB or SAC in ruptured WBA. There might be a neurosurgeon’s preference in cases. Therefore, future clinical trials are necessary to eradicate this bias. Third, the sample size of this study was relatively small, which means that the lack of complications in both the SAC and WEB groups could be due to the small sample size. Fourth, the follow-up was relatively short, which may have affected the conclusions drawn from the results. Nevertheless, it is worth noting that this study is a prominent contribution to our knowledge of EVT in acutely ruptured WNBA.

CONCLUSIONS

The Clinical and angiographic outcomes of WEB and SAC embolization in patients with acutely ruptured WNBA were comparable. In addition, none of the patients experienced long-term adverse effects or death as a result of the procedure. This result indicates that the performance of these two methods is comparable and very efficient in treating ruptured WNBA.

NOTES

Disclosure

The authors report no conflict of interest concerning the materials or methods used in this study or the findings specified in this paper.

Fig. 1.
Schematic of study design. EVT, endovascular treatment; WNB, wide-necked bifurcation
jcen-2024-e2024-11-002f1.jpg
Table 1.
Patients and aneurysms characteristics
Total (n=40) SAC (n=25) WEB (n=15) p value
Age (Year, mean (SD)) 58.62 (10.25) 59.88 (10.16) 56.53 (10.41) 0.324
Female (%) 16 (40.0) 11 (44.0) 5 (33.3) 0.739
Hypertension (%) 26 (65.0) 17 (68.0) 9 (60.0) 0.864
Posterior circulation (%) 6 (15.0) 3 (12.0) 3 (20.0) 0.819
H&H (%) 0.337
    I 12 (30.0) 9 (36.0) 3 (20.0)
    II 12 (30.0) 6 (24.0) 6 (40.0)
    III 15 (37.5) 10 (40.0) 5 (33.3)
    IV 1 (2.5) 0 (0.0) 1 (6.7)
Dome-to-neck ratio (mean (SD)) 1.44 (0.18) 1.45 (0.19) 1.43 (0.17) 0.795
Procedure duration (Minute, mean (SD)) 56.12 (18.38) 66.20 (14.81) 39.33 (9.04) <0.001
Location 0.05
MCA 14 10 4
ACA 13 5 8
Basilar tip 5 2 3
PICA 1 1 0
ICA 7 7 0
Category Anterior 34 22 12 0.49
Posterior 6 3 3

SAC, stent-assisted coiling; WEB, Woven EndoBridge; H&H: Hunt and Hess grade; SD, standard deviation; MCA, middle cerebral artery; ACA, anterior cerebral artery; PICA, posterior inferior cerebellar artery; ICA, internal carotid artery.

Table 2.
Treatment outcome
Total (n=40) SAC (n=25) WEB (n=15) p value
Immediate occlusion, MRRC (%) 0.641
    I 27 (67.5) 18 (72.0) 9 (60.0)
    II 10 (25.0) 5 (20.0) 5 (33.3)
    IIIa 3 (7.5) 2 (8.0) 1 (6.7)
    IIIb 0 (0.0) 0 (0.0) 0 (0.0)
18th-month occlusion, MRRC (%) 0.417
    I 34 (85.0) 22 (88.0) 12 (80.0)
    II 5 (12.5) 2 (8.0) 3 (20.0)
    IIIa 0 (0.0) 0 (0.0) 0 (0.0)
    IIIb 1 (2.5) 1 (4.0) 0 (0.0)
Favorable mRS score* (%) 39 (97.5) 25 (100.0) 14 (93.3) 0.794
Retreatment rate (%) 5 (12.5) 3 (12.0) 2 (13.3) 1
Complication rate (%) 14 (35.0) 7 (28.0) 7 (46.7) 0.392

MRRC, modified Raymond-Roy occlusion classification; mRS, modified Rankin scale; SAC, stent-assisted coiling; WEB, Woven EndoBridge

* Favorable mRS score: 0-2

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