Adjustment of Malpositioned Woven EndoBridge Device Using Gooseneck Snare: Complication Management Technique.
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ABSTRACT:
SUBMITTER: Amuluru K
PROVIDER: S-EPMC8561038 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Selecting the appropriate Woven EndoBridge (WEB) device sizing for the treatment of wide-neck bifurcation aneurysms (WNBAs) remains challenging. The aim of this study was to evaluate different volumetric-based imaging methodologies to predict an accurate WEB device size selection to result in a successful implantation. All consecutive patients treated with WEB devices for intracranial aneurysms from January 2019 to June 2020 were included. Aneurysm dimensions to calculate aneurysm volumes were measured using three different modalities: automated three-dimensional (3D) digital subtraction angiography (DSA), manual 3D DSA, and two-dimensional (2D) DSA. The device-aneurysm volume (DAV) ratio was defined as device volume divided by the aneurysm volume. WEB volumes and the DAV ratios were used for assessing the device implantation success and follow-up angiographic outcomes at six months. Pearson correlation, Wilcoxon Rank Sum test, and density approximations were used for estimating the WEB volumes and the imaging modality volumes for successful implantation. A total of 41 patients with 43 aneurysms were included in the study. WEB device and aneurysm volume correlation coefficient was highest for 3D automatic (r = 0.943), followed by 3D manual (r = 0.919), and 2D DSA (r = 0.882) measurements. Measured median volumes were significantly different for 3D automatic and 2D DSA (p = 0.017). The highest rate of successful implantation (87.5%) was between 0.6 and 0.8 DAV ratio. Pre-procedural assessment of DAV ratios may increase WEB device implantation success. Our results suggest that volumetric measurements, especially using automated 3D volumes of the aneurysms, can assist in accurate WEB device size selection.
| S-EPMC8307121 | biostudies-literature
Project description:BackgroundThe 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.ObjectiveTo review early as-practiced clinical experience with the WEB device in the United States.MethodsRetrospective 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.ResultsThe 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.ConclusionImmediate 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.
| S-EPMC8660628 | biostudies-literature
Project description:BackgroundSurgical clipping of intracranial aneurysms is typically robust and durable. However, residual aneurysmal components may be seen after clipping. Furthermore, there may be occasional aneurysmal recurrence. These factors are both clinically relevant because subarachnoid hemorrhage after clipping is a rare but important event. The rationale for any treatment is to substantially decrease the future risk of hemorrhage. Small series have shown coiling as a retreatment strategy after unsuccessful clipping, but none has explored the feasibility of Woven Endobridge (WEB) implantation.Case descriptionWe examined the feasibility of WEB implantation as second-line treatment for wide-necked residual aneurysms after unsuccessful clipping. We also recorded the safety and efficacy in this small series of 6 patients. To determine safety, we measured the modified Rankin Scale score before and after the procedure, and at 2 later time points (mean follow-up, 5 months and 15 months). To determine efficacy, we obtained radiographic aneurysm occlusion outcomes (including WEB Occlusion Scale) at these 2 time points. Four middle cerebral artery and 2 anterior communicating artery complex aneurysms were treated with WEB implantation, showing feasibility in 6/6 cases (100%). Follow-up at 15 months showed no change from preprocedural modified Rankin Scale score and there were no other complications. There was adequate occlusion in 5/6 cases (83%).ConclusionsWEB implantation provided a feasible option in this challenging retreatment scenario. This is a small series and prospective data are required to make outcome inferences for this population. Nonetheless, we observed no complications and high adequate occlusion rates.
| S-EPMC7611019 | biostudies-literature
Project description:Background and purposeThe Woven EndoBridge has proved to be a safe and effective treatment, especially for wide-neck intracranial aneurysms. The recent fifth-generation Woven EndoBridge came with smaller devices. The purpose of this study was to assess the safety and efficiency of Woven EndoBridge treatment of small and very small aneurysms.Materials and methodsBetween September 2017 and March 2020, all consecutive patients treated with a 3- or 3.5 mm-width Woven EndoBridge device were included in this retrospective intention-to-treat study. Clinical and radiologic findings were evaluated at immediate and last-available follow-up. Angiographic outcome was assessed by an external expert reader.ResultsOne hundred twenty-eight aneurysms were treated with a fifth-generation Woven EndoBridge device including 29 with a width of ≤3.5 mm. Ten aneurysms were ruptured (34%). In 3 cases (10%), Woven EndoBridge treatment could not be performed because the aneurysm was still too small for the smallest available Woven EndoBridge device and another endovascular strategy was chosen. The median follow-up time was 11.2 months. Complete and adequate occlusion was obtained in 71% and 90% of the treated aneurysms, respectively. Retreatment was needed in 2 cases (10%). Symptomatic ischemic complications leading to transient neurologic deficits occurred in 2 cases (7%) (1 procedure-related and 1 device-related) but with full spontaneous recovery at discharge.ConclusionsThe fifth-generation Woven EndoBridge device seems to be a safe and technically feasible treatment for both ruptured and unruptured small and very small intracranial aneurysms, with satisfactory occlusion rates on midterm follow-up. However, further study is needed to evaluate longer-term efficiency.
| S-EPMC8324278 | biostudies-literature
Project description:Background and objectiveThe clinical outcome and angiographic outcome data of Woven EndoBridge (WEB) device for the treatment of ruptured intracranial aneurysms (IAs) are limited. We conducted a meta-analysis of the latest literature on the WEB device in the treatment of ruptured IAs.MethodsA comprehensive literature search of 4 databases (PubMed, Web of Science, Cochrane library, and Embase) was conducted for studies published from January 1, 2010 to December 31, 2020. Two reviewers independently extracted variables (aneurysm and patient characteristics) using a prespecified data-collection sheet. Outcomes studied included initial and latest follow-up angiographic outcomes, technical success rate, perioperative mortality, retreated rate, perioperative re-bleeding, complication, intraoperative rupture, favorable neurologic outcome at discharge. We used random-effects model to pool the data.ResultsWe finally presented the results of 7 articles including 276 patients with 283 aneurysms. Initial complete and adequate occlusion rate were 38% (95% CI, 25%-50%) and 98% (95% CI, 95%-100%), respectively. Latest follow-up complete and adequate occlusion rate were 61% (95% CI, 46%-75%) and 91% (95% CI, 84%-98%), respectively.Technical success rate was 99% (95% CI, 98%-100%). Perioperative mortality rates and perioperative re-bleeding rate were 9% (95% CI, 3%-15%) and 1% (95% CI, 0%-2%), respectively. Retreated rate was 6% (95% CI, 3%-10%). Overall and WEB treatment-related thromboembolic complication was 10% (95% CI, 6%-13%) and 7% (95% CI, 2%-12%), respectively. Intraoperative rupture rate was 3% (95% CI, 0%-6%).ConclusionEndovascular treatment of ruptured IAs with the WEB device has a good safety profile and an acceptable aneurysm occlusion rate.
| S-EPMC9131500 | biostudies-literature
Project description:Purpose The intrasaccular flow disruptor Woven EndoBridge (WEB) device is developed for the treatment of wide-necked aneurysms without supportive devices. We used the WEB as primary treatment for unruptured aneurysms suitable for the device, regardless of neck size. Methods Between February 2015 and June 2017, 59 aneurysms in 51 patients were selectively treated with the WEB. There were 15 men and 36 women with a mean age of 59 years. Mean aneurysm size was 7.0?mm (range 3-22?mm). Of 59 aneurysms, 45 (76%) had a wide neck defined as ?4?mm or dome-neck ratio ?1.5. No stents or supporting balloons were used. Results Initial WEB position was judged good in all 59 unruptured aneurysms. One patient with a basilar tip aneurysm had a late thrombotic posterior cerebral artery occlusion by protrusion of the WEB over the artery. There were no procedural ruptures. Overall complication rate was 2.0% (1 of 51, 95% CI 0.01-11.3%). Imaging follow-up was available in 55 of 59 aneurysms (93%). At 3 months, 41 of 57 aneurysms (72%) were completely occluded, 12 (21%) had a neck remnant and 4 (7%) were incompletely occluded. Conclusion WEB treatment is safe and effective in selected unruptured aneurysms suitable for the device, regardless of neck size or location. There was no need for supportive devices. Three-quarters of all unruptured small aneurysms could be treated with the WEB. In our opinion, the WEB is a valuable alternative to coils, especially in wide-necked aneurysms.
| S-EPMC6116134 | biostudies-literature
Project description:BackgroundEvaluating 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).MethodsAll 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.ResultsThe 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).ConclusionsThis 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 registrationWEBCAST and WEBCAST-2: Unique identifier: NCT01778322.
| S-EPMC10314010 | biostudies-literature
Project description: Not available
| S-EPMC7655346 | biostudies-literature
Project description:IntroductionAngiography is the standard follow-up modality for treated aneurysms with the Woven EndoBridge (WEB), and magnetic resonance angiography (MRA) is useful for extended follow-up. We present the results of WEB-treated aneurysms with angiographic follow-up at three months and at least 18 months' 3T MRA follow-up.Materials and methodsIncluded were 52 patients with 53 aneurysms treated with the WEB between February 2015 and July 2016. There were 29 women and 23 men with a mean age of 60 years (median 62, range 23-76). Mean aneurysm size was 6.2?mm (median 6, range 3-16?mm).Results3T MRA follow-up was mean 19.6 months (median 18, range 18-36 months). One patient had an aneurysm remnant at three-month angiography that was additionally coiled and with stable complete occlusion at 18 months' 3T MRA follow-up. At three-month follow-up angiography, 44 aneurysms were completely occluded and eight had a neck remnant. At latest 3T MRA, stable complete occlusion was present in 43 aneurysms and stable neck remnant in eight. One posterior cerebral artery (PCA) dissection aneurysm was stable at three and six months but was enlarged and reopened at 18 months, confirmed with angiography. Focal signal loss by the proximal marker of the WEB was apparent in four patients without compromising diagnostic evaluation.ConclusionWEB-treated aneurysms with adequate occlusion at three-month angiography remained stable during serial 3T MRA follow-up of 18-36 months. One PCA aneurysm reopened during the 6- to 18-month interval. Once the WEB-treated aneurysm is adequately occluded in the short term, later reopening is uncommon.
| S-EPMC6259330 | biostudies-literature
Project description:Background and purposeThe Woven EndoBridge is an intrasaccular device for the treatment of intracranial aneurysms. The first generation consisted of a high-profile double-layer braid. This review aims to evaluate the outcomes of the new generation low-profile Woven EndoBridge single layer device for intracranial aneurysm treatment.MethodsA systematic review was conducted with Medline, Embase, and Web of Science Conference Proceedings databases. The search strategy provided 589 articles, 15 articles were included.ResultsFifteen articles were identified reporting the use of Woven EndoBridge single-layer devices in 963 aneurysms, mostly wide-necked bifurcation aneurysms. Procedural aneurysm rupture was reported in 8 of 963 patients (0.83%; 95%CI 0.39-1.66%) and thromboembolic events in 54 of 963 patients (5.61%, 95CI 4.31-7.26%). Cumulative morbidity was 2.85% (27/949, 95%CI 1.95-4.12%) and mortality 0.93% (9/963, 95%CI 0.46-1.80%). The overall rate of adequate aneurysm occlusion at last follow-up was 83.3% (613/736; 95%CI 80.4-85.8%). Retreatment was reported in 38 aneurysms in eight studies with 450 aneurysms with follow-up (38/450; 8.4%, 95CI 6.2-11.4%). In 12 studies comprising 644 aneurysms with follow-up, rebleeds occurred in three patients in three studies with mean follow-up between 3.3 and 14.4 months (0.47%, 95%CI 0.09-1.43%).ConclusionWoven EndoBridge single-layer is a promising new low-profile device especially for wide-neck bifurcation aneurysms, both ruptured and unruptured. No antiplatelet medication is needed which is a great advantage, especially in ruptured aneurysms. Efficacy and safety compare favorably with (stent-assisted) coiling. However, no direct comparison with other treatments is available as yet.
| S-EPMC7446584 | biostudies-literature