Rate Of Complete Aneurysm Occlusion Research Articles

OUTCOME EVALUATION OF FLOW DIVERTER STENT PLACEMENT IN TREATMENT OF RUPTURED AND UNRUPTURED CEREBRAL ANEURYSMS

Background: Cerebral aneurysms affect about 5% of the population and are associated with high mortality rates and severe complications for families and society. Complex aneurysm types include giant aneurysms, wide - necked aneurysms, blister - like aneurysms, recurrent aneurysms, fusiform aneurysms, and multiple aneurysms, which are difficult to manage with conventional endovascular or surgical methods due to complications such as coil migration and high rates of re - rupture. The development of flow diverter stents has been a breakthrough in recent decades and has been demonstrated to be safe and effective in treating aneurysms. The aim of this study was to evaluate the outcomes of flow diverter stent placement in the treatment of ruptured and unruptured cerebral aneurysms. Methods: This was a descriptive prospective study that followed up on 23 patients diagnosed and treated for cerebral aneurysms with flow - diverter stent intervention at the Stroke Department of Hue Central Hospital from 6/2020 to 6/2022. The follow - up data after 6 months and 12 months were recorded. Results: There were 23 patients (9 males, 14 females) with 28 cerebral aneurysms, with a mean age of 51.7 ± 9.9 years. Aneurysms were predominantly located in the anterior circulation (85.7%) and 14.3% in the posterior circulation. The most common aneurysm type was fusiform (75%), followed by dissecting (17.9%) and blister - like (7.1%). Most aneurysms had wide necks, with a neck - to - dome ratio < 1.5, accounting for 82.1%. Flow diverter stent placement was successfully performed in 91.3% of patients, with 27 stents used. Stents were properly positioned, well - expanded in 88.9%. The complication rate after intervention was 4.3%. Complete aneurysm occlusion rates at 6 to 12 months were 92.9% and 96.4%, respectively. The rate of mild in - stent stenosis without clinical symptoms was 4.3%. The good outcome rate (mRS 0 - 2) was 91.3%. Conclusion: Flow diverter stent is effective and safe with high rate of successful and low procedural complications in the treatment of complex cerebral aneurysms.

LVIS-within-enterprise double-stent technique with coil embolization in the treatment of patients with acutely ruptured intracranial vertebrobasilar artery-dissecting aneurysms.

This study aimed to evaluate the feasibility of the low-profile visualized intraluminal support (LVIS)-within-enterprise double-stent technique for patients with acutely ruptured intracranial vertebrobasilar artery-dissecting aneurysms (ari-VBDAs). A total of 30 patients with ari-VBDAs who underwent reconstructive treatment using LVIS-within-enterprise double-stent technique with coil embolization between January 2014 and May 2022 were retrospectively enrolled. Patients' characteristics and clinical and imaging outcomes were reviewed. The functional outcomes were assessed using the modified Rankin scale (mRS). A total of 34 ari-VBDAs were identified, including seven (20.6%) basilar artery aneurysms and 27 (79.4%) vertebral artery aneurysms. All aneurysms were successfully treated in the acute phase. In total, six (20.0%) patients experienced in-hospital serious adverse events, including two deaths (6.7%). The median clinical follow-up time of the remaining 28 patients was 20.0 (IQR, 7.3-40.8) months. The incidences of dependency or death (mRS score of 3-6) at discharge and at the last follow-up were 16.7% and 14.3%, respectively. Aneurysm rebleeding occurred in one (3.3%) patient periprocedurally. In total, three (10.0%) patients had ischemic events, one of which occurred during the periprocedural period and two occurred during follow-up. A total of two patients (6.7%) underwent ventriculoperitoneal shunt. Imaging follow-up was available for 14 patients at the median of 12.0 (IQR, 7.0-12.3) months, with a complete occlusion rate of 93.3% (14/15). In total, one patient experienced parent artery occlusion, and no aneurysm was recanalized. LVIS-within-enterprise double-stent technique with coil embolization for the treatment of patients with ari-VBDAs could be performed with a good safety profile and high technical success rate. The rate of complete aneurysm occlusion during follow-up seemed to be satisfactory.

Abstract Number ‐ 142: Flow Diversion for Posterior Communicating Artery Aneurysms: Systematic Review and Meta‐Analysis

Introduction Posterior communicating artery (PComA) aneurysms are common and have a high risk of rupture. Flow diverters (FD) have demonstrated a safe and effective profile. However, the use of FD in PComA aneurysms has shown controversial results with high rates of recurrence and a high risk of potential ischemic complications. There, we aimed to evaluate the safety and efficacy of flow diversion for the treatment of PComA aneurysms with a meta‐analysis of the literature. Methods We performed a systematic search in Scopus, Embase, Medline, and Web of Science from inception until May 2022 for all the studies that reported the safety and effectiveness of FD for the treatment of intracranial aneurysms located in the posterior communicating artery. The primary effectiveness endpoint was a complete aneurysm occlusion rate at final follow‐up. The primary safety endpoint was a composite measure of cumulative events that occurred during and after the procedure. Events included death and ischemic/hemorrhagic complications. Random‐effects meta‐analysis was used to calculate proportions. Statistical heterogeneity across studies was assessed with I2 statistics. Results A total of 13 studies with 397 patients harboring 403 aneurysms were included in our analysis. Mean age was 48 years and mean aneurysm size was 5.3 mm. Complete aneurysm occlusion at final follow‐up was 74% (95% CI 66–81%; I2 = 54%). The primary safety composite outcome was 5% (95% CI 3–9%; I2 = 0%). The mortality rate was 1% (95% CI 0–2%; I2 = 0%). Subgroup analysis showed that patients with a non‐fetal PComA had a higher rate (76%; 95% CI 62%‐86%; I2 = 53%) of complete aneurysm occlusion compared to those with a fetal PComA (36%; 95% CI 21%‐54%; I2 = 0%). Conclusions Our findings show that flow diversion for the treatment of aneurysms located in the PComA is effective and safe. However, the same treatment for aneurysms located in a fetal‐type PComA did not show the same efficacy profile suggesting that these cases might require an alternative treatment to achieve permanent occlusion rates.

The off-label uses of pipeline embolization device for complex cerebral aneurysms: Mid-term follow-up in a single center.

To describe the off-label uses of pipeline embolization device for a variety of types of aneurysms including ruptured aneurysms, posterior circulation aneurysms, small aneurysms, distal aneurysms, and recurrent aneurysms. Clinical and angiographic data of patients who underwent pipeline embolization device treatment on off-label use at our center were retrospectively reviewed. For categorical variables, Fisher's exact test was used, and a two-sample Wilcoxon rank-sum test was used for patients' age to analyze the correlation with outcomes. In this study, 121 aneurysms in 107 patients received off-label pipeline embolization device treatments. The overall rate of complete aneurysm occlusion was 77.8% (28/36 in 35 patients) for posterior circulation aneurysms and 95.3% (81/85 in 72 patients) for anterior circulation aneurysms. The posterior circulation aneurysms have a lower rate of aneurysm occlusion (p = 0.0372). The small aneurysms have a higher rate of aneurysm occlusion (p = 0.0104). The patient's sex, age, and aneurismal size were associated with ischemic stroke complications (p = 0.0397, 0.0166, and 0.0178). In posterior circulation aneurysm patients, only two basilar apex aneurysms underwent pipeline embolization device treatment, both of whom died of thrombotic complications. There was no difference in mortality between posterior circulation aneurysm patients (8.6%, 3/35) and anterior circulation aneurysm patients (1.4%, 1/72) (p = 0.1015). Patients of older age have a higher risk of death rate (p = 0.0053). The off-label use of pipeline embolization device is often performed in clinical practice and can achieve efficacy in complex aneurysms. The off-label use of pipeline embolization device was found to carry an increased rate of mortality in older patients. Excluding basilar apex aneurysms, the pipeline embolization device is as safe as anterior circulation aneurysms in the treatment of posterior circulation aneurysms elsewhere.

LVIS EVO stent-through-balloon after hydrocoil embolization of intracranial aneurysms: One-year results.

To evaluate the durability and safety of complete intracranial aneurysm occlusion at one year using the low-profile braided intracranial LVIS EVO stent. This is a retrospective, monocentric, observational study of unruptured wide-necked intracranial aneurysms treated with the LVIS EVO stent-through-balloon technique after balloon-assisted hydrocoil embolization. Imaging and clinical data were assessed by two blinded independent neuroradiologists and neurologists, respectively. Primary endpoint was complete angiographic occlusion on day 0 and at 12 months. Secondary endpoints included clinical safety using the modified Rankin scale (mRS), ischemic and hemorrhagic adverse events, parent vessel stenosis > 50% or occlusion and retreatment rate. 103 aneurysms in 103 patients were included (53 years-old, 77% women). Mean aneurysm size and neck were 7 and 4 mm, respectively. Complete occlusion was 97% initially and 90% at 12 months, with pending follow up in 17.5% patients. Five patients (5%) with partially stented necks were retreated with a second stent in a T-configuration. Two stents failed to open initially and were immediately retrieved. Asymptomatic parent vessel occlusion and severe in-stent stenosis occurred in 1% and 3%, respectively. The 12-month procedure-related permanent neurological deficit and mortality rates (mRS 3-6) were 2% and 1%, respectively. There was one fatal bleeding but no large ischemic complications. Delivering the LVIS EVO stent through a dual lumen balloon after balloon-assisted hydrocoil embolization yields a high and stable rate of complete aneurysm occlusion at one year with a reasonable immediate and delayed complication rate.

A multicenter retrospective controlled study of the Pipeline™ and Tubridge™ Flow Diverter devices for intracranial wide-necked aneurysms.

PurposeTo compare the safety and efficacy of PipelineTM and TubridgeTM Flow Diverter devices (FDs) in the treatment of intracranial wide-necked aneurysms.MethodsWe retrospectively analyzed the clinical data of 92 patients with intracranial wide-necked aneurysms who were treated with those two flow-diverter devices (FDs) at four participating centers between July 2012 and December 2020.ResultsThis study included 92 patients who underwent endovascular therapy using either Pipeline™ (n = 39) or TubridgeTM (n = 53) for treating intracranial wide-necked aneurysms. The periprocedural complication developed in 2.56% (1/39) patients of Pipeline group and 3.77% (2/53) patients of the TubridgeTM group. During perioperative period, one patient in Pipeline™ group showed subarachnoid hemorrhage (2.56%, 1/39) and two ischemic complications in the Tubridge™ group (3.77%, 2/53). Follow-up assessments were conducted on 31 patients (79.49%) in the Pipeline™ group (the mean follow-up period was 9.7 ± 3.3 months). The rate of complete aneurysm occlusion at the final angiographic follow-up was 77.42%. Patients with a modified Rankin scale (mRS) score of 0.44 ± 0.31. Follow-up assessments were conducted on 42 patients (79.25%) in the TubridgeTM group (the mean follow-up period was 9.1 ± 4.4 months). The rate of complete aneurysm occlusion at the final angiographic follow-up was 85.71%. Patients with mRS score of 0.52 ± 0.28. Three patients showed parent artery stenosis, and one showed parent artery occlusion.ConclusionBoth the PipelineTM and TubridgeTM are safe and effective for the treatment of intracranial wide-necked aneurysms, with no significant difference in the rate of complete aneurysm occlusion and perioperative complications between the two FDs.

Aneurysm healing after endovascular treatment in the Helsinki sidewall aneurysm model: a systematic review

AimsIntracranial aneurysms are treated with a variety of endovascular devices including coils, stents, and flow diverters. The mechanisms by which these devices result in aneurysm occlusion and subsequent healing have...

Comparative study of on-label versus off-label treatment of intracranial aneurysms with the Pipeline embolization device.

The Pipeline embolization device (PED) is widely used for the treatment of intracranial aneurysms, including in off-label applications. In this work, the authors compared the real-world efficacy and safety of PED use in on-label and off-label aneurysm treatments. Clinical and angiographic data of patients who underwent PED placement at a high-volume academic medical center were retrospectively obtained. Treatments were classified as on-label if they fell within the applications approved by the United States Food and Drug Administration as of 2021. Recorded outcomes included aneurysm occlusion, procedural complications, ischemic events, in-stent stenosis, intracranial hemorrhage, postprocedural functional status, and death. In total, 416 aneurysms in 330 patients were treated with PED, comprising 256 aneurysms that received on-label treatments and 160 that received off-label treatments. The overall rate of complete aneurysm occlusion was 76.4% for on-label aneurysms and 75.6% for off-label aneurysms (p = 0.898). The risk of ischemic stroke in patients who underwent off-label treatments was 15.2%, which was higher than the 4.2% rate in patients who underwent on-label treatment (p = 0.003). All other clinical complications, procedural complications, and long-term functional status were comparable between the on-label and off-label groups. In real-world practice, off-label use of PED is common and can achieve similar efficacy as on-label use. However, in aggregate, off-label use was found to carry an increased rate of ischemic complications. With judicious attention to safety and individual patient characteristics, these results highlight the scale and general feasibility of off-label PED use by experts.

Y‐Stent–Assisted Coiling of Wide‐Necked Intracranial Aneurysms With the Neuroform Atlas Stent System

Background Endovascular management of wide‐necked bifurcation aneurysms poses a therapeutic challenge, as coiling often requires the use of multiple adjunctive stent constructs to achieve successful embolization without compromising parent vessel integrity. The Neuroform Atlas Stent System is a novel low‐profile, intraluminal remodeling device. The study aims to investigate the safety and efficacy of Y‐stent–assisted coiling configuration constructs using the next generation stent for aneurysm coil embolization. Methods Subjects undergoing Y‐stent–assisted coiling in the ATLAS IDE (Safety and Effectiveness of the Treatment of Wide Neck, Saccular Intracranial Aneurysms with the Neuroform Atlas Stent System Investigational Device Exception) trial were identified for subgroup analysis. Enrollment in the trial was not stratified on the basis of the procedural stenting technique used. The primary efficacy end point was complete aneurysm occlusion (Raymond–Roy class 1) on 12‐month angiography, in the absence of re‐treatment or parent artery stenosis (>50%) at the target location. The primary safety end point was any major stroke or ipsilateral stroke or neurological death within 12 months. Adjudication of the primary end points was performed by an independent imaging core laboratory and the clinical events committee. Results A total of 60 subjects were identified. The mean age was 59, and 28.3% were men. The median aneurysm size was 6.7 mm, with a median neck size of 4.3 mm. Frequently reported aneurysm locations included the basilar apex (56.7%), anterior communicating artery (20.0%), and middle cerebral artery bifurcation (11.7%). The composite primary efficacy end point was achieved in 81.1% of subjects. Overall, 1.7% of subjects experienced a primary safety endpoint of major ipsilateral stroke or neurological death. Conclusion In the ATLAS IDE aneurysm cohort premarket approval study, Y‐stent–assisted coiling with Neuroform demonstrated high rates of complete aneurysm occlusion at 12 months, with low rates of morbidity.

Intracranial aneurysm treatment with intrasaccular flow disruption: comparison of WEB-21 and WEB-17 systems

BackgroundNew generations of Woven EndoBridge (WEB) devices (WEB-21 and WEB-17) are available to treat aneurysms with a width <6.5 mm. Limited comparisons between both systems exist in the literature, but...

Treatment of Unruptured Cerebral Artery Aneurysm: A Meta-Analysis

Unruptured middle cerebral artery (MCA) aneurysms can be treated using two techniques or procedures, microsurgical clipping and endovascular coiling. The aim of this meta-analysis study is to compare the safety and efficacy of microsurgical clipping with the endovascular coiling in the treatment of unruptured MCA aneurysms. We searched electronic databases (PubMed, EMBASE and the Cochrane library) to identify studies published between 1991 and 2019. For clipping and coiling techniques, separate meta-analyses were conducted on efficacy and safety after the intervention and at follow-up by using random- and fixed-effects models. Forty-one articles were included in our meta-analyses: 23 case series using clipping and 25 case series using coiling procedures. The complete aneurysm occlusion rate was higher in the clipping procedure (96.1%, 95% CI: 92.8%-97.9%) as compared to the coiling procedure (57.6%, 95% CI: 49.4 – 65.4%). Clipping procedure has a slightly higher rate of favorable functional outcomes (96.4%, 95% CI: 94.8 – 97.5%) compared to coiling procedure (94.8%, 95% CI: 93.1 –96%). Interestingly, the rate of occlusion appears to decrease with time in the clipping group and increase with time in the coiling group, while the rate of favorable functional outcomes appears to increase with time in the clipping group and decrease with time in the coiling group. Publication bias was unlikely in all our analysis for studies assessing: coiling and occlusion rate, clipping and occlusion rate, coiling and functional outcomes, and clipping and functional outcomes. Microsurgical clipping yields a higher aneurysm occlusion rate, with slightly higher favorable functional outcomes in the treatment of unruptured MCA aneurysms than the endovascular coiling.

Retreatment of previously flow diverted intracranial aneurysms with the pipeline embolization device.

Flow diversion of intracranial aneurysms with the Pipeline Embolization Device (PED) is frequently performed, but the outcomes of retreatment for aneurysms that failed to occlude after prior treatment with PED have not been well studied. Here, we report the safety and efficacy of PED retreatment after initial failure to occlude. Clinical and angiographic data from eligible patients were retrospectively assessed for demographics, aneurysm occlusion status, and clinical outcomes. Patients were included in this study if they underwent PED retreatment to treat an aneurysm that had previously been treated with PED. Retreatment of previously flow-diverted aneurysms with PED was performed in 42 cases. At final angiographic follow-up, angiographic improvement was observed after 45% (19/42) of retreatments and complete aneurysm occlusion was observed following 26% (11/42). Significant clinical complications occurred in 10% (4/42) of PED retreatments. Retreatment of intracranial aneurysms with PED following initial failure to achieve aneurysm occlusion has a low rate of subsequent complete aneurysm occlusion.

Flow Diversion for ICA Aneurysms with Compressive Neuro-Ophthalmologic Symptoms: Predictors of Morbidity, Mortality, and Incomplete Aneurysm Occlusion.

Flow diversion is an effective treatment for aneurysms of the ICA with compression-related neuro-ophthalmologic symptoms, especially when treatment is initiated early after symptom onset and aneurysm occlusion is complete. However, non-negligible complication rates have been reported. Our aim was to identify risk factors for morbidity/mortality and incomplete aneurysm occlusion. We performed a secondary analysis of a previous publication, which included all patients treated with flow diversion for an unruptured aneurysm of the ICA with compression-related symptoms. Fifty-four patients with 54 aneurysms (48 women, 88.9%; mean age, 59.2 [SD, 15.9] years; range, 21-86 years) treated with flow diversion were included. We observed morbidity and mortality rates of 7.4% and 3.7%. Increasing age (OR per decade, 3.2; 95% CI, 1.23-8.49; P = .02) and dual-antiplatelet therapy with ticagrelor (OR, 13.9; 95% CI, 1.16-165.97; P = .04) were significantly associated with morbidity/mortality. After a median follow-up of 13.3 [SD, 10.5] months, the rates of complete aneurysm occlusion, neck remnant, and aneurysm remnant were 74%, 14%, and 12%. Incomplete occlusion at follow-up was less frequently observed in aneurysms treated with additional coil embolization (OR, 0.1; 95% CI, 0.01-0.86; P = .04). Although a promising treatment for compressive ICA aneurysms, flow diversion carries a relevant risk for complications and incomplete aneurysm occlusion. Our results may help identify patients in which flow diversion may not be the ideal treatment method. Additional coil embolization increased the likelihood of complete aneurysm occlusion at follow-up.

Endovascular treatments of intracranial vertebral and internal carotid arteries dissections: An interactive systematic review and meta-analysis.

Management of intracranial artery dissection (IAD) remains elusive in medical practice. Intracranially, vertebral artery dissection (VAD) is more commonly encountered than internal carotid artery dissection (ICAD). Deconstructive (EVT-d) and reconstructive (EVT-r) endovascular techniques have been utilized to treat VAD and ICAD. This meta-analysis investigates the safety and efficacy of EVT-r and EVT-d in the management of VAD and ICAD. The literature was searched for all studies with consecutive patient series evaluating EVT-d or EVT-r for VAD or ICAD management. Baseline characteristics and outcomes were compared between EVT-r and EVT-d groups using the random-effect model and meta-regression approaches. Overall, 1095 cases pooled from 56 studies were included. There was no statistically significant difference in baseline characteristics between VAD and ICAD. EVT-r was applied in 647 cases (59.1%) and EVT-d in the rest There was no statistical difference in the rate of procedural complications between EVT-r and EVT-d. Although EVT-d was significantly associated with higher rates of complete aneurysm occlusion (86.4%), lower rates of good clinical outcomes (72.1%) and higher mortality (15.1%) were achieved compared to EVT-r (70.2%, 83.3%, and 9.5%; respectively). The mortality rate was higher, and good clinical outcomes were less common in ruptured aneurysms. Ischemic presentation was statistically associated with poor outcomes (mRS 3-5) but low mortality. ICAD often tended to grow following treatment and resulted in poor neurological outcomes. IAD has favorable outcomes when treated appropriately. Novel reconstructive endovascular techniques are promising and should be integrated well in endovascular practice. Further studies are warranted.

Microsurgical clipping vs Woven EndoBridge (WEB) device for the management of unruptured wide-neck bifurcation aneurysms

The Woven EndoBridge device (WEB) was introduced in 2010 to treat wide-neck bifurcation aneurysms (WNBAs). Three landmark studies have been conducted to assess its safety and efficacy: WEBCAST, WEBCAST 2, and French Observatory Study. However, these studies have not compared its safety and efficacy to other treatment modalities. In this study, we compare WEB versus microsurgical clipping in the management of unruptured WNBA. We conducted a retrospective study of unruptured WNBA meeting the morphological criteria to be amenable for WEB treatment operated on at our institution. Surgical morbidity, mortality, and occlusion rates were assessed. We compared our results to those reported in the cumulative population of the three WEB landmark studies at 1 year. A total of 84 patients with 89 WNBA were included. The most common aneurysm location was the middle cerebral artery bifurcation (n = 67/89, 75%). No operative mortality was observed. Morbidity comprised small-vessel vasospasm (n = 1/89, 1%) resulting in hemiparesis vs. 3% morbidity for WEB (p = .324). All but one (n = 1/89, 1%) WNBA were completely occluded vs WEB occlusion rate of 53% at 1 year, statistically significantly worse (p < .001). In our analysis, we were not able to show superiority of WEB in terms of procedural morbidity in comparison to microsurgical clipping, defined as worsening in mRS. Microsurgical clipping achieves statistically significantly higher rates of complete aneurysm occlusion, thus posing the question of whether the WEB should be presented as a viable, comparable alternative to patients amenable to surgical treatment.

Single-Center Experience Using a 3D4K Digital Operating Scope System for Aneurysm Surgery.

In recent years, 3D4K exoscope systems (EXs) have been introduced to microneurosurgery and reported to be an alternative to conventional operating microscopes (OMs). This study reviews our single-center experience using an 3D4K EX in intracranial aneurysm surgery. To investigate the applicability of a novel 3D4K EX for intracranial aneurysm surgery. A retrospective analysis of patients who underwent microsurgical repair of incidentally or ruptured cerebral aneurysms between August 2018 and August 2020 was performed. Patient and aneurysm characteristics and technical features, including 3-dimensional indocyanine green fluorescence, were evaluated. Data on surgery duration were statically assessed for a time trend and comparability with the OM cohort. Overall, we collected 185 aneurysm cases in which the exoscope was used in 44 cases. The mean duration of surgery using the EX was in similar range to those using the OM (165.5 ± 45.8 minutes vs 160.5 ± 39.2 minutes, P > .05). Routine postoperative computed tomography angiography showed comparable rates of complete aneurysm occlusion (95.5% vs 92.2%, P > .05) and postoperative complications (9.1% vs 9.7%, P > .05). There was no necessity to revert to the OM from the EX. Three-dimensional indocyanine green fluorescence was used in all procedures without any malfunction. The 3D4K EX for vascular microsurgical cases proved to be as useful as the OM. Because of the ease of use and comparable surgical results, the EX has the potential to become an accepted and additional visualization tool in vascular microsurgery next to the OM.

Prospective study on embolization of intracranial aneurysms with the pipeline device (PREMIER study): 3-year results with the application of a flow diverter specific occlusion classification

BackgroundThe pipeline embolization device (PED; Medtronic) has presented as a safe and efficacious treatment for small- and medium-sized intracranial aneurysms. Independently adjudicated long-term results of the device in treating these...

First clinical multicenter experience with the new Pipeline Vantage flow diverter

BackgroundFlow diversion is an innovative and increasingly used technique for the treatment of intracranial aneurysms. New flow diverters (FDs) are being introduced to improve the safety and efficacy of this...

Abstract TMP3: Long-term Outcomes From The Pipeline Embolization Devices For The Treatment Of Intracranial Aneurysms (PEDESTRIAN) Registry With Ped Shield Sub-analysis

Background: Prospective studies have established the safety and efficacy of the Pipeline TM Embolization Device (PED) for treatment of intracranial aneurysms (IA). Objective: To investigate long-term outcomes from the Pipeline Embolization Devices for the Treatment of Intracranial Aneurysms (PEDESTRIAN) Registry. Methods: The PEDESTRIAN registry data was retrospectively reviewed, which included patients (March 2006-July2019) with complex IAs treated with PED. The primary angiographic endpoint was complete occlusion and long-term stability. Clinical and radiological follow-up was performed at 3-6 months, 12 months, and yearly thereafter. Results: A total of 835 patients (mean age 55.9±14.7 years; 80.0% female) with 1,000 aneurysms were included. Aneurysms varied in size: 64.6% were small (≤10mm), 25.6% were large (11-24mm), and 9.8% were giant (≥25mm). A total of 1,214 PEDs were deployed. Follow-up angiography was available for 85.1% of patients with 776 aneurysms at 24.6±25.0 months (mean). Complete occlusion was demonstrated in 75.8% of aneurysms at 12-months, 92.9% at 2-4 years, and 96.4% at &gt;5 years. During the post-procedural period, mRS remained stable or improved in 96.2% of patients, with stability or improvement in 99.1% of patients &gt;5 years. The overall major morbidity and neurological mortality rate was 5.8%. At multivariate analysis, age (HR 1.04; 95% CI 1.01-1.07, p=0.002) and non-saccular morphology (HR 2.91; 95% CI 1.06-7.97, p=0.038) were identified as independent predictors of mRs worsening. We found a trend towards lower rates of thromboembolic complications since the implementation of prasugrel, with 26 (4.4%) patients on clopidogrel developing stroke compared with 4 (1.6%) patients on prasugrel (OR 2.74; 95% CI 0.95-7.95, p=0.06). Trend towards less thromboembolic complications with PED Shield N= 3/213 (1,4%) OR 0.38 (95% CI o.12; 1.27), p value=0.11 Conclusion: This study demonstrated high rates of long-term complete aneurysm occlusion, stable or improved functional outcomes, and low rates of complications and mortality. Clinical and angiographic outcomes improved over long-term follow-up, demonstrating endovascular treatment of IA with PED is safe and effective.

Comaneci plus Balloon-assisted Embolization of Ruptured Wide-necked Cerebral Aneurysms.

Recently, avant-garde combinations of ancillary devices as an adjunct to coil embolization for acutely ruptured and wide-necked cerebral aneurysms have emerged. This study sought to investigate the feasibility, safety and durability of the simultaneous combination of temporary neck-bridging devices plus balloon-assisted coiling(BAC) to treat acutely ruptured and wide-necked cerebral aneurysms. Aretrospective review was performed of patients with ruptured and wide-necked intracranial bifurcation aneurysms treated with temporary stent plus balloon-assisted coiling. Anatomical features, technical details, intraprocedural complications, clinical and angiographic results were reviewed. Preprocedural and follow-up clinical statuses were evaluated using the modified Rankin scale(mRS). A total of 21 patients (mean age 54.5 years, range 37-72 years) were identified. The immediate postprocedural angiography revealed complete aneurysm occlusion in 85.7% (18/21) of the cases. Aperiprocedural complication developed in 9.5% of the cases. There was no mortality in this study. The permanent morbidity rate was 4.7%. Long-term follow-up angiography was performed in 18of 21patients (85.7%) (the mean follow-up period was 21months). The rate of complete aneurysm occlusion at final follow-up was 89.4%. The results of this study confirmed that temporary stent plus balloon-assisted coiling is adurable and relatively safe endovascular technique for the treatment of ruptured wide-necked bifurcation aneurysms located in both the posterior and anterior cerebral circulation.