Safety and effectiveness assessment of the surpass evolve (SEASE): a post-market international multicenter study.

BACKGROUND: Flow diverters are the first-line treatment for specific intracranial aneurysms (iA). Surpass Evolve (SE) is a new-generation 64-wire flow diverter with a high braid angle. Current literature on the SE is limited. We aimed to report the first international real-world experience evaluating the safety and effectiveness of the SE. METHODS: The Safety and Effectiveness Assessment of the Surpass Evolve (SEASE) was a multicenter retrospective international post-marketing cohort study including consecutive patients treated with SE for iAs between 2020 and 2022. Demographic, clinical, and angiographic data were collected. Primary effectiveness was independent core lab adjudicated complete occlusion rates (Raymond-Roy Class 1) at last follow-up. Primary safety were major ischemic/hemorrhagic events and mortality. RESULTS: In total, 305 patients with 332 aneurysms underwent SE implantation. The patients had a median age of 59 [50-67] years, and 256 (83.9%) were female. The baseline modified Rankin scale score was 0-2 in 291 patients (96.7%). Most aneurysms were unruptured (285, 93.4%) and saccular (309, 93.1%). Previous treatment was present in 76 (22.9%) patients. The median aneurysm size was 5.1 [3.4-9.0] mm, and the median neck width was 3.6 [2.7-5.1] mm. Most aneurysms were in the internal carotid artery C6 ophthalmic segment (126, 38.0%), followed by the communicating segment (58, 17.5%). At median 10.2 [6.4-12.9] months follow-up, 233 (73.0%) aneurysms achieved complete occlusion. After adjusting for confounders, complete occlusion remained consistent. Major stroke and procedure-related mortality were reported in 6 (2%) and 2 (0.7%) cases, respectively. CONCLUSION: These results demonstrate that SE has a consistently high effectiveness and favorable safety for the treatment of iAs.

Early Outcomes of the Pipeline Vantage Flow Diverter : A Multicentre Study.

PURPOSE: The recently introduced Pipeline Vantage Embolization Device with Shield Technology is the fourth generation of Pipeline flow diverter devices. Due to the relatively high rate of intraprocedural technical complications, modifications were subsequently made to the device after a limited release of the device in 2020. This study aimed to evaluate the safety and efficacy of the modified version of this device. METHODS: This was a multicentre retrospective series. The primary efficacy endpoint was aneurysm occlusion in the absence of retreatment. The primary safety endpoint was any neurological morbidity or death. Ruptured and unruptured aneurysms were included in the study. RESULTS: A total of 52 procedures were performed for 60 target aneurysms. Treatment was performed on 5 patients with ruptured aneurysms. The technical success rate was 98%. The mean clinical follow-up time was 5.5 months. In patients presenting with unruptured aneurysms there were no deaths, 3 (6.4%) major complications and 7 (13%) minor complications. In the five patients presenting with subarachnoid haemorrhage there were 2 (40%) major complications with 1 (20%) of these resulting in death, and 1 (20%) minor complication. Of the patients 29 (56%) had undergone 6­monthly postprocedural angiographic imaging with a mean time of 6.6 months demonstrating that 83% of patients had achieved adequate occlusion (RROC1/2) of the aneurysm. CONCLUSIONS: In this non-industry-sponsored study, the occlusion rates and safety outcomes were similar to those seen in previously published studies with flow diverter devices and earlier generation Pipeline devices. Modifications to the device appear to have improved ease of deployment.

Utility of flow diverters in treatment of acutely ruptured uncoilable aneurysms of the posterior circulation of the brain.

PURPOSE: Aim of this study is to evaluate safety and efficacy of flow diverters (FDs) in treatment of acutely ruptured posterior circulation aneurysms MATERIALS AND METHODS: Databases of three participating institutions were retrospectively scanned for patients in whom FD placement was attempted for treatment of acutely ruptured vertebrobasilar aneurysms. An interval of 14 days or fewer between the latest ictus and treatment was used as inclusion criterion. Patients with dolichoectasia of vertebrobasilar arteries were excluded. If necessary, adjunctive techniques including coiling or stenting were utilized. Clinical outcomes were graded using mWFNS (modified World Federation of Neurosurgical Societies Scale) and mRS (modified Rankin Scale). Aneurysmal occlusion was defined as Raymond-Roy Class 1. Spearman's (ρ) test was used to assess the correlation between variables. Univariate and multivariate logistic regression were used to assess outcomes. RESULTS: 31 patients (25 women, mean age: 52.7 ± 15.2) harboring 32 aneurysms (16 non-saccular, mean size: 11.4 ± 7 mm) were included. Mean number of FDs used was 1.22 ± 0.42. In six cases, adjunctive coiling and in five cases, apposing stent placement were used. Overall mortality rate and procedure-related mortality rates were 22.5% (7/31) and 9.6% (3/31), respectively. At a mean imaging follow-up of 17.2 ± 12.6 months, total occlusion was achieved in 22 aneurysms (91.6%). Univariate analysis showed that mortality was positively correlated with vasospasm (ρ = 0.600, p < 0.05), higher mWFNS Scale (ρ = 0.685, p < 0.05), higher modified Fischer Score (ρ = 0.609, p < 0.05), higher mRS (ρ = 0.594, p < 0.05) on admission and negatively correlated with saccular morphology (ρ = -0.529, p < 0.05). Multivariate logistic regression identified mWFNS on admission as a significant predictor. (OR: 7.148, 95% CI 1.777-28.758, p: 0.01). Adjunctive coiling positively correlated with aneurysm occlusion. (ρ = 0.522, p < 0.05). CONCLUSION: The procedure-related morbidity and mortality is not negligible. However, the risks and efficacy associated with FDs are acceptable, especially when adjunctive coiling is possible, given the lack of treatment alternatives.

Treatment of carotid cavernous sinus fistulas with flow diverters. A case report and systematic review.

INTRODUCTION: Carotid cavernous fistulas (CCFs) are rare, usually follow head trauma or aneurysmal rupture. Recent treatment options include endovascular techniques such as flow diversion devices (FDDs). OBJECTIVE: To present our case treated with FDD application with transarterial cavernous-sinus coiling and present a systematic review on the use and effectiveness of FDDs in CCF treatment. MATERIALS AND METHODS: We present our case of CCF treatment with FDD. A search was also conducted in PubMed, EMBASE and Cochrane until November 2020. Reference lists were also cross-checked. RESULTS: Including our case, thirty-eight patients were identified with a CCF that was treated with FDDs in sixteen studies. Twenty-two patients were females, nine were males and the rest unidentified. The mean age was 52,6 years (range 17-86, SD± 19.28). Thirty-six patients suffered from direct and two from indirect CCFs. Single FDD was used in four cases, single FDD with embolic materials in eleven cases, multiple overlapping FDDs were used in six cases and multiple overlapping FDDs with embolic materials were used in seventeen cases. Thirty-five patients (92,1%) had clinical improvement, immediate angiographic occlusion was seen in 44,7% of the cases, while long-term occlusion rate was 100% but with variable follow-up periods. One patient (2,6%) presented with a neurological deficit related to FDD deployment. CONCLUSION: Targeted treatment of CCFs with single or overlapping FDDs with or without adjunct embolic agents offers a high success rate, both clinically and long-term angiographically compared to other endovascular methods alone. However, further research with multi-center prospective trials is warranted.

Safety and Efficacy of the Neuroform Atlas Stent for Treatment of Intracranial Aneurysms : A Systematic Review and Meta-Analysis.

OBJECTIVE: The Neuroform Atlas (Stryker Neurovascular, Fremont, CA, USA) is a low-profile laser cut self-expanding nitinol stent designed to provide coil support and wall apposition during aneurysm embolisation. In this study, we performed a meta-analysis of outcomes after treatment with the Neuroform Atlas stent for the purpose of coil embolisation. METHODS: The primary objectives of this meta-analysis were to define the safety (treatment-related complications, neurologic outcomes, mortality rate) and the efficacy (aneurysm occlusion rate) of the treatment of intracranial aneurysms with the Neuroform Atlas stent. A systematic review and meta-analysis was performed by searching PubMed, EMBASE, and the Cochrane CENTRAL Library for all published studies on the treatment of intracranial aneurysms with the Neuroform Atlas device up to 6 April 2020. The review was prepared in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. RESULTS: A total of 14 studies were analysed (577 patients with 593 intracranial aneurysms). The mean age was 58.2 years and 35.6% were male. Technical success of the procedure was 100%. RROC1/RROC2 (Raymond-Roy occlusion classification (RROC) 1/2) (total occlusion/neck remnant) at a mean follow-up of 8.9 months was achieved in 94.8%. RROC3 was 4.9%. All-cause mortality was 1.8% and permanent residual neurological deficit or disability was 2.7%. Overall complications at follow-up were 6.2%. CONCLUSION: Our analysis demonstrated good rates of occlusion at follow-up for aneurysms treated with the Atlas device at follow-up. The safety profile appears similar to other low-profile intracranial stents.

eCLIPs bifurcation remodeling system for treatment of wide neck bifurcation aneurysms with extremely low dome-to-neck and aspect ratios: a multicenter experience.

BACKGROUND: Wide necked bifurcation aneurysms (WNBA) are among the most difficult aneurysms to treat. Very low dome-to-neck (DTN) and aspect ratios provide an even greater challenge in the management of WNBAs. We present the safety and efficacy profile for endovascular clip system (eCLIPs) device in the treatment of this subset of WNBAs with very unfavorable morphologies. METHODS: In our case series, 24 patients treated at 12 international centers were taken from a larger prospective voluntary post-marketing registry of 65 patients treated with the eCLIPs device and coiling. Those who had WNBAs at either the carotid or basilar terminus with a DTN ratio <1.6 and aspect ratio <1.2 were included. Radiologic and clinical outcomes were assessed immediately after the procedure and at the latest follow-up. RESULTS: The eCLIPs device was successfully deployed in 23 cases (96%). One patient (4.2%) died due to guidewire perforation distal to the implant site. No other complications were documented. After a mean follow-up of 15.8 months (range 3-40 months), good radiologic outcomes (modified Raymond-Roy classification (MRRC) scores of 1 or 2) were documented in 20 of 21 patients (95%) with follow-up data. The lone patient with an MRRC score of 3 showed coiled compaction after incomplete neck coverage with the device. CONCLUSION: Our series of patients with aneurysms having adverse DTN and aspect ratios demonstrated that the eCLIPs device has a safety and efficacy profile comparable with currently available devices in the treatment of WNBAs.

Review of current intracranial aneurysm flow diversion technology and clinical use.

Endovascular treatment of intracranial aneurysms (IAs) has evolved considerably over the past decades. The technological advances have been driven by the experience that coils fail to completely exclude all IAs from the blood circulation, the need to treat the diseased parent vessel segment leading to the aneurysm formation, and expansion of endovascular therapy to treat more complex IAs. Stents were initially developed to support the placement of coils inside wide neck aneurysms. However, early work on stent-like tubular braided structure led to a more sophisticated construct that then later was coined as a flow diverter (FD) and found its way into clinical application. Although FDs were initially used to treat wide-neck large and giant internal carotid artery aneurysms only amenable to surgical trap with or without a bypass or endovascular vessel sacrifice, its use in other types of IAs and cerebrovascular pathology promptly followed. Lately, we have witnessed an explosion in the application of FDs and subsequently their modifications leading to their ubiquitous use in endovascular therapy. In this review we aim to compile the available FD technology, evaluate the devices' peculiarities from the authors' perspective, and analyze the current literature to support initial and expanded indications, recognizing that this may be outdated soon.

Delayed caroticocavernous fistula after stent-assisted coil embolization of intracavernous carotid aneurysm: should we manage conservatively?

Constructive endovascular techniques remain the mainstay for the treatment of cavernous carotid aneurysms due to their efficacy. However, they do harbor risks of complications, such as thromboembolic events, arterial injuries, and vessel occlusions. A 58-year-old lady presented with delayed caroticocavernous fistula (CCF) 1 month after stent-assisted coil embolization of a cavernous carotid aneurysm (CCA). Following this, her caroticocavernous fistula resolved spontaneously with no further intervention. Our case demonstrates a unique presentation of a CCF as a delayed complication of stent-assisted coil embolization of CCA and the spontaneous resolution of the CCF. Symptomatic CCFs are commonly treated as an emergency in many institutions and the question arises as to whether we should adopt a conservative policy in the light of this case report.