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.

Flow Diverter Performance in Aneurysms Arising From the Posterior Communicating Artery: A Systematic Review and Meta-Analysis.

BACKGROUND: Flow diverters (FDs) have demonstrated a safe and effective profile. However, the use of FDs for posterior communicating artery (PComA) aneurysms remains controversial. OBJECTIVE: To evaluate the safety and effectiveness of FDs for PComA aneurysms using a systematic review and meta-analysis of the literature. METHODS: We performed a systematic search from inception until June 2022 for flow diversion in PComA aneurysms. Primary effectiveness was the rate of complete aneurysm occlusion defined by Raymond-Roy class 1. Primary safety outcomes were treatment-related ischemic/hemorrhagic (composite) events causing morbidity and mortality. Secondary safety was PComA patency at follow-up. Random-effects meta-analyses were used to calculate proportions, and statistical heterogeneity was assessed. RESULTS: A total of 13 studies with 397 patients harboring 403 aneurysms were included. Mean age was 48 years, and the mean aneurysm size was 5.3 mm. Most aneurysms were unruptured (65%). Complete occlusion at final follow-up was 73% (CI 66%-79%), and adjunctive coils were used in 10% of aneurysms. Retreatment rate was 2% (CI 0%-9%). The primary safety composite outcome was 4% (CI 3%-7%), and mortality was 1%. PComA patency at final follow-up was 76% (CI 57%-89%). Subgroup analysis, patients with fetal PComAs had a lower complete occlusion rate (42% fetal PComA vs 77%, psubgroupdifference = <.01). CONCLUSION: The performance of FDs in PComA aneurysms is comparable with outcomes found in other subtypes of supraclinoid aneurysms. Effectiveness was acceptable and safety favorable. However, effectiveness was suboptimal in patients with fetal-type PComAs; alternative treatments should be considered in these cases.

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.

BACKGROUND: The 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 lesions are still indeterminate. We present 3-year results, with additional application of a flow diverter specific occlusion scale. METHODS: PREMIER (prospective study on embolization of intracranial aneurysms with pipeline embolization device) is a prospective, single-arm trial. Inclusion criteria were patients with unruptured wide-necked intracranial aneurysms ≤12 mm. Primary effectiveness (complete aneurysm occlusion) and safety (major neurologic event) endpoints were independently monitored and adjudicated. RESULTS: As per the protocol, of 141 patients treated with a PED, 25 (17.7%) required angiographic follow-up after the first year due to incomplete aneurysm occlusion. According to the Core Radiology Laboratory review, three (12%) of these patients progressed to complete occlusion, with an overall rate of complete aneurysm occlusion at 3 years of 83.3% (115/138). Further angiographic evaluation using the modified Cekirge-Saatci classification demonstrated that complete occlusion, neck residual, or aneurysm size reduction occurred in 97.1%. The overall combined safety endpoint at 3 years was 2.8% (4/141), with only one non-debilitating major event occurring after the first year. There was one case of aneurysm recurrence but no cases of delayed rupture in this series. CONCLUSIONS: The PED device presents as a safe and effective modality in treating small- and medium-sized intracranial aneurysms. The application of a flow diverter specific occlusion classification attested the long-term durability with higher rate of successful aneurysm occlusion and no documented aneurysm rupture. TRIAL REGISTRATION: NCT02186561.

Pivotal trial of the Neuroform Atlas stent for treatment of posterior circulation aneurysms: one-year outcomes.

BACKGROUND: Stent-assisted coiling of wide-necked intracranial aneurysms (IAs) using the Neuroform Atlas Stent System (Atlas) has shown promising results. OBJECTIVE: To present the primary efficacy and safety results of the ATLAS Investigational Device Exemption (IDE) trial in a cohort of patients with posterior circulation IAs. METHODS: The ATLAS trial is a prospective, multicenter, single-arm, open-label study of unruptured, wide-necked, IAs treated with the Atlas stent and adjunctive coiling. This study reports the results of patients with posterior circulation IAs. The primary efficacy endpoint was complete aneurysm occlusion (Raymond-Roy (RR) class I) on 12-month angiography, in the absence of re-treatment or parent artery stenosis >50%. The primary safety endpoint was any major ipsilateral stroke or neurological death within 12 months. Adjudication of the primary endpoints was performed by an imaging core laboratory and a Clinical Events Committee. RESULTS: The ATLAS trial enrolled and treated 116 patients at 25 medical centers with unruptured, wide-necked, posterior circulation IAs (mean age 60.2±10.5 years, 81.0% (94/116) female). Stents were placed in all patients with 100% technical success rate. A total of 95/116 (81.9%) patients had complete angiographic follow-up at 12 months, of whom 81 (85.3%) had complete aneurysm occlusion (RR class I). The primary effectiveness outcome was achieved in 76.7% (95% CI 67.0% to 86.5%) of patients. Overall, major ipsilateral stroke and secondary persistent neurological deficit occurred in 4.3% (5/116) and 1.7% (2/116) of patients, respectively. CONCLUSIONS: In the ATLAS IDE posterior circulation cohort, the Neuroform Atlas Stent System with adjunctive coiling demonstrated high rates of technical and safety performance. Trial registration number https://clinicaltrials.gov/ct2/show/NCT02340585.

Prospective study on embolization of intracranial aneurysms with the pipeline device: the PREMIER study 1 year results.

BACKGROUND: Preliminary clinical studies on the safety and efficacy of the pipeline embolization device (PED) for the treatment of small/medium aneurysms have demonstrated high occlusion rates with low complications. OBJECTIVE: To evaluate the safety and effectiveness of the PED for treatment of wide necked small and medium intracranial aneurysms. METHODS: PREMIER is a prospective, multicenter, single arm trial. Patients were treated with the PED for unruptured wide necked aneurysms, measuring ≤12 mm along the internal carotid artery or vertebral artery, between July 2014 and November 2015. At 1 year post-procedure, the primary effectiveness endpoint was complete occlusion (Raymond grade 1) without major parent vessel stenosis (≤50%) or retreatment, and the primary safety endpoint was major stroke in the territory supplied by the treated artery or neurologic death. RESULTS: A total of 141 patients were treated with PEDs (mean age 54.6±11.3 years, 87.9% (124/141) women). Mean aneurysm size was 5.0±1.92 mm, and 84.4% (119/141) measured <7 mm. PED placement was successful in 99.3% (140/141) of patients. Mean number of PEDs implanted per patient was 1.1±0.26; a single PED was used in 92.9% (131/141) of patients. At 1 year, 97.9% (138/141) of patients underwent follow-up angiography with 76.8% (106/138) of patients having met the study's primary effectiveness endpoint. The combined major morbidity and mortality rate was 2.1% (3/140). CONCLUSIONS: Treatment of wide necked small/medium aneurysms with the PED results in high rates of complete occlusion without significant parent vessel stenosis and low rates of permanent neurologic complications. TRIAL REGISTRATION: NCT02186561.

Transvenous arteriovenous malformation embolization.

Transvenous embolization of arteriovenous malformations has emerged as a safe and effective intervention. In carefully selected patients the transvenous approach has shown efficacy similar to that of conventional transarterial routes. The optimal lesions amenable to the transvenous approach have not been robustly delineated; however, the approach is reserved for small, deep seeded, single venous drainage lesions with poorly amenable arterial vascular supply. In this video we demonstrate a case of transvernous Onyx embolization of a Spetzler-Martin grade 3 (SM3) left hemispheric, ruptured arteriovenous malformation. The patient underwent successful, single session, complete embolization of the arteriovenous malformation through a venous route without further complications or repeat treatment.

Treatment of blood blister aneurysms of the internal carotid artery with flow diversion.

BACKGROUND: Blood blister aneurysms (BBA) are a rare subset of intracranial aneurysms that represent a therapeutic challenge from both a surgical and endovascular perspective. OBJECTIVE: To report multicenter experience with flow diversion exclusively for BBA, located at non-branching segments along the anteromedial wall of the supraclinoidal internal carotid artery (ICA). METHODS: Consecutive cases of BBA located at non-branching segments along the anteromedial wall of the supraclinoidal ICA treated with flow diversion were included in the final analysis. RESULTS: 49 patients with 51 BBA of the ICA treated with devices to achieve the flow diversion effect were identified. 43 patients with 45 BBA of the ICA were treated with the pipeline embolization device and were included in the final analysis. Angiographic follow-up data were available for 30 patients (32 aneurysms in total); 87.5% of aneurysms (28/32) showed complete obliteration, 9.4% (3/32) showed reduced filling, and 3.1% (1/32) persistent filling. There was no difference between the size of aneurysm (≤2 mm vs >2 mm) or the use of adjunct coiling and complete occlusion of the aneurysm on follow-up (P=0.354 and P=0.865, respectively). Clinical follow-up data were available for 38 of 43 patients. 68% of patients (26/38) had a good clinical outcome (modified Rankin scale score of 0-2) at 3 months. There were 7 (16%) immediate procedural and 2 (5%) delayed complications, with 1 case of fatal delayed re-rupture after the initial treatment. CONCLUSIONS: Our data support the use of a flow diversion technique as a safe and effective therapeutic modality for BBA of the supraclinoid ICA.

Complication analysis in nitinol stent-assisted embolization of 486 intracranial aneurysms.

OBJECT: Stent-assisted embolization (SAE) has broadened the scope of endovascular cerebral aneurysm treatment. The risks associated with stent selection and configuration are poorly defined. In this study, the authors aimed to characterize the risk factors that contribute to complications in SAE of intracranial aneurysms. METHODS: Over a 10-year period, a single surgeon treated 486 aneurysms with SAE in which open-cell Neuroform or closed-cell Enterprise stents were used. Single stents were used in 386 cases, overlapping stents were deployed in 80 cases, and Y-configuration stents were used in the remaining 20 cases. All neurological complications, which included transient deficits, were analyzed; disabling strokes and death were considered major complications. The chi-square test and multivariate logistic regression were used to evaluate the influence of aneurysm size and morphology, aneurysm location, stent selection, and stent configuration on complication rates. RESULTS: There were 7 deaths (1.4%), 9 major strokes (1.9%), and 18 minor neurological complications (3.7%). For all complications, multivariate analysis revealed that large aneurysm size (10-25 mm; p = 0.01), giant aneurysm size (> 25 mm; p = 0.04), fusiform aneurysm morphology (p = 0.03), and using a Y-configuration stent (p = 0.048) were independent risk factors. For the major complications, independent risk factors included an aneurysm in the posterior circulation (p = 0.02), using an overlapping stent configuration (p = 0.03), and using a Y-configuration stent (p < 0.01). CONCLUSIONS: In this series, SAE for cerebral aneurysm treatment carried an acceptable complication rate. With continued innovations in techniques and devices and with increased experience, the complication rates associated with SAE may be even lower in the future.

Long-term radiographic results of stent-assisted embolization of cerebral aneurysms.

BACKGROUND: Aneurysmal subarachnoid hemorrhage is a disabling disease. Endovascular coiling provides minimally invasive, effective, and safe treatment of both ruptured and unruptured intracranial aneurysms. Intracranial stents have improved the endovascular treatment of complex aneurysms, but the long-term durability of this treatment modality needs clarification. OBJECTIVE: To elucidate the long-term success of intracranial stent use in the treatment of aneurysms. METHODS: Four hundred ten patients were treated with stent-assisted endovascular management of 464 aneurysms. Treatment of 363 small aneurysms, 88 large aneurysms, and 13 giant aneurysms was analyzed with respect to both long-term anatomic results with digital subtraction angiography and magnetic resonance angiography over the follow-up period. RESULTS: The 6-month angiographic results of 387 aneurysm treatments revealed complete aneurysm occlusion in 282 (72.9%), residual aneurysm neck in 50 (12.9%), and residual aneurysm filling in 55 (14.2%). Long-term radiographic follow-up, performed in 262 patients (mean, 3.63 years), showed significant recurrence of only 3 aneurysms after 6-month follow-up imaging. Forty-eight aneurysms (11.9%) were considered radiographic failures during the follow-up period. CONCLUSION: The aneurysm recurrence rate after stent-assisted embolization in this series was similar to published data using only coil embolization for the period between treatment and the initial follow-up imaging. For aneurysms that do not initially recur, the presented data suggest improved durability in the subsequent long-term follow-up period. ABBREVIATIONS: DSA, digital subtraction angiographyMRA, magnetic resonance angiography.

Endovascular repair of a double-lumen dissecting aneurysm.

Treating dissections and dissecting aneurysms requires maintenance of flow through the true lumen and exclusion of the false lumen from the circulation. A dissecting aneurysm of the vertebral artery presented with both a true and false lumen within the aneurysmal sac. Stenting of the true lumen followed by coil embolization of both lumens was performed. Management options and decision-making are discussed for this unique situation.

Endovascular repair of a double-lumen dissecting aneurysm.

Treating dissections and dissecting aneurysms requires maintenance of flow through the true lumen and exclusion of the false lumen from the circulation. A dissecting aneurysm of the vertebral artery presented with both a true and false lumen within the aneurysmal sac. Stenting of the true lumen followed by coil embolization of both lumens was performed. Management options and decision-making are discussed for this unique situation.

Stent assisted embolization of 64 anterior communicating artery aneurysms.

INTRODUCTION: Anterior communicating artery (ACoA) aneurysms comprised over half of the ruptured aneurysms in the International Subarachnoid Trial. Endovascular treatment of ACoA aneurysms has provided good results, but until the introduction of intracranial stents, many ACoA aneurysms could not be treated without craniotomy. The current study analyzes the results of ACoA aneurysm treatment using stent assisted embolization. METHODS: 64 patients with ACoA aneurysms underwent stent assisted aneurysm repair. Four were treated in the acute rupture phase and a fifth ruptured aneurysm was stented in a second procedure after initial coiling. Five aneurysms were 10 mm or more in greatest diameter. Follow-up angiography was performed 6 months after treatment; then, patients were followed with annual MR angiography. Technical, clinical, and long term radiographic results were analyzed. RESULTS: Stents were successfully deployed in each case. One patient was eventually treated with a three stent construct and died of perioperative hemorrhage. One major stroke occurred during a separate procedure when a patient was taken off antiplatelet medications. These cases were the only aneurysm related morbidity (1.6%) and mortality (1.6%) events during the entire follow-up period. After stent assisted embolization, 32 (50.0%) ACoA aneurysms were completely occluded, 15 (23.4%) had residual neck, and 17 (26.6%) had residual filling. At first radiographic follow-up, 39 of 55 (70.9%) showed complete occlusion. Three (5.5%) total aneurysms required retreatment. CONCLUSIONS: Stent assisted aneurysm treatment was a safe and effective option in this series of ACoA aneurysms with maximum diameter less than 15 mm. ACoA aneurysms may be more likely to recur regardless of treatment option, but stent assisted embolization may be durable after stable initial radiographic follow-up.

Venous sinus manometry and intervention using the PrimeWire Prestige pressure guidewire: technique and initial experience.

BACKGROUND: Cerebral venography and manometry are used for the diagnosis of hemodynamically significant venous sinus stenosis in patients with the syndrome of idiopathic intracranial hypertension. Intravenous pressure measurements using the traditional microcatheter technique can be cumbersome, time consuming and potentially unreliable. The PrimeWire Prestige pressure guidewire conducts pressure electrically and can be used as a guidewire for intervention. It has been validated in interventional cardiology procedures. OBJECTIVE: We describe our initial clinical experience with the PrimeWire Prestige pressure guidewire system for cerebral venous manometry and intervention. METHOD: Cerebral venous pressure gradient was directly measured by advancing the pressure wire across a region of stenosis. The pressure wire was also used as a guidewire for intravascular ultrasound, angioplasty and stenting. RESULTS: The PrimeWire Prestige pressure guidewire successfully navigated the intracranial venous sinus anatomy. Transfer of devices over the guidewire in a monorail fashion was uncomplicated, and measurement of sinus pressure between the steps of the intervention was efficiently performed. CONCLUSION: The PrimeWire Prestige pressure guidewire system provided a safe, fast and effective method for intracranial venous sinus manometry and intervention. It has several potential advantages over the traditional microcatheter method, including efficiency, accuracy and cost.

Initial Experience with Neuroform EZ in the Treatment of Wide-neck Cerebral Aneurysms.

PURPOSE: Stent-assisted coiling allows embolization and parent vessel reconstruction of wide-necked intracranial aneurysms. The Neuroform EZ (Boston Scientific, Fremont, CA, U.S.A.) stent delivery system offers deployment of a Neuroform stent with fewer steps and improved operator control. Initial experience, technical considerations, and treatment outcomes using the Neuroform EZ stent delivery system in combination with coil embolization are reported. MATERIALS AND METHODS: Seventeen consecutive patients harboring 21 wide-necked saccular cerebral aneurysms were treated with stent reconstruction. Twenty aneurysms were unruptured; one was treated within 24 hours of diagnosis of rupture. Twenty aneurysms were located in the anterior circulation; one was in the posterior circulation. Immediate and six-month post-treatment angiography and clinical assessment were performed. RESULTS: In all cases, the stents were delivered and positioned without difficulty in deployment. Technical complications occurred in 4 patients, but none were directly related to the stent delivery system. On immediate post-treatment angiography, 5 of 21 aneurysms showed complete occlusion, 5 of 21 showed residual neck, and 11 of 21 showed residual contrast filling of the aneurysm sac. At six month follow-up, all 17 patients were clinically stable. Angiography of 18 of the aneurysms showed total occlusion in 12, residual neck in 3, and residual aneurysm filling in 3. Retreatment was performed in the three with residual aneurysm. CONCLUSION: The Neuroform EZ stent system offers improved anchoring and support in stent delivery, which is particularly useful when multiple stents are overlapped to further protect the parent vessel and increase flow diversion away from the aneurysm sac. The only significant problem encountered was coil prolapse, which could be treated with a second stent when necessary. The ease of deployment improves upon the already clinically successful Neuroform design.

Evaluation of cerebral artery perforators and the pipeline embolization device using optical coherence tomography.

INTRODUCTION: Optical coherence tomography (OCT) provides high resolution imaging of tissue; this technology has been validated using intra-arterial catheters in the evaluation of arterial anatomy, pathology and treatments. The perforating cerebral arteries and intracranial stents have not been previously visualized with an OCT catheter. METHODS: Using a standard transfemoral endovascular technique, a LightLab C7 Dragonfly catheter was inserted in the middle and posterior cerebral arteries of a fresh frozen cadaver. OCT images of the cerebral vessels and a deployed Pipeline Embolization Device were acquired using the LightLab C7-XR OCT Intravascular Imaging System. RESULTS: Distal cerebral artery access with the imaging catheter was feasible via the femoral artery using a distal access catheter instead of the standard monorail system used in coronary investigations. Imaging of perforators and stent struts had exceptional resolution. CONCLUSION: The first use of a commercial OCT catheter in the evaluation of intracranial vessels using transfemoral endovascular techniques is described. Challenges of intracranial OCT include blood clearance and vessel tortuosity. This technology may aid in the diagnosis and treatment of cerebrovascular disease in the future.

Double wire technique for stenting tortuous cerebral vessels.

The failure to catheterize distal vessels may preclude optimal endovascular intervention. We present a double wire technique to facilitate the selective placement of catheters into tortuous vasculature when a single wire and catheter technique does not suffice. A wide necked middle cerebral artery (MCA) aneurysm incorporated the origin of the inferior MCA trunk, and despite successful passage of a wire into the distal MCA, the catheter could not be advanced beyond 2 sharp turns at the inferior trunk origin. A second wire was passed through the catheter into the inferior trunk providing adequate stability for advancement of the catheter into the vessel. The distal vessel was successfully catheterized and a stent was placed without complication. The double wire technique may allow the passage of catheters into vessels that are otherwise inaccessible because of tortuosity.

Treatment of a middle cerebral artery bifurcation aneurysm using a double neuroform stent "Y" configuration and coil embolization: technical case report.

OBJECTIVE AND IMPORTANCE: Wide-necked cerebral aneurysms have been particularly difficult to treat using coil embolization. The introduction of the first intracranial flexible stent (Neuroform stent; Boston Scientific/Target, Fremont, CA) has provided a great advantage to this dilemma by forming a bridge across the aneurysm neck and allowing the packing of coils. Despite this advancement, some parent vessel bifurcation aneurysms can still remain elusive to single stent and coiling technique. CLINICAL PRESENTATION: A 55-year-old woman presented for a routine follow-up angiogram. Her past history was significant for a subarachnoid hemorrhage and clipping of an anterior communicating aneurysm with full recovery. An incidental new right middle cerebral artery aneurysm was found on the angiogram. We report here a case of an unruptured asymptomatic wide-neck middle cerebral artery bifurcation aneurysm that was treated with a novel endovascular repair. INTERVENTION: The aneurysm was successfully treated using a double stent "Y" configuration and coil embolization technique using the Neuroform stent. Technical aspects are discussed. Perioperative management issues and potential pitfalls are also considered. CONCLUSION: Double stenting in "Y" configuration and coiling is feasible. This technique should increase the ability to endovascularly treat wide-necked aneurysms.