Impact of duration of dual anti-platelet therapy on risk of complications after stent-assisted coiling of unruptured aneurysms.

BACKGROUND: The optimal duration for dual antiplatelet therapy (DAPT) after stent-assisted coiling (SAC) of intracranial aneurysms is unclear. Longer-term therapy may reduce thrombotic complications but increase the risk of bleeding complications. METHODS: A retrospective review of prospectively maintained data at 12 institutions was conducted on patients with unruptured intracranial aneurysms who underwent SAC between January 1, 2016 and December 31, 2020, and were followed ≥6 months postprocedure. The type and duration of DAPT, stent(s) used, outcome, length of follow-up, complication rates, and incidence of significant in-stent stenosis (ISS) were collected. RESULTS: Of 556 patients reviewed, 450 met all inclusion criteria. Nine patients treated with DAPT <29 days after SAC and 11 treated for 43-89 days were excluded from the final analysis as none completed their prescribed duration of treatment. Eighty patients received short-term DAPT. There were no significant differences in the rate of thrombotic complications during predefined periods of risk in the short, medium, or long-term treatment groups (1/80, 1.3%; 2/188, 1.1%; and 0/162, 0%, respectively). Similarly, no differences were found in the rate of hemorrhagic complications during period of risk in any group (0/80, 0%; 3/188, 1.6%; and 1/162, 0.6%, respectively). Longer duration DAPT did not reduce ISS risk in any group. CONCLUSIONS: Continuing DAPT >42 days after SAC did not reduce the risk of thrombotic complications or in-stent stenosis, although the risk of additional hemorrhagic complications remained low. It may be reasonable to discontinue DAPT after 42 days following non-flow diverting SAC of unruptured intracranial aneurysms.

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.

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.

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.

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.

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.

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.

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.

Consideraçäes éticas e legais sobre a utilizaçäo de animais em experimentaçäo científica / Ethical and legal considerations about the utilization of animals in cientific experimentation

Säo feitas consideraçöes sobre a discussäo a respeito da utilizaçäo de animais em laboratório