The S-Nitrosylation of Septin2 (SNO-Septin2) axis: A novel potential therapeutic target for treating aneurysms and dissection.

Aortic aneurysm and aortic dissection (AAD) are severe life-threatening cardiovascular disorders for which no approved pharmaceutical therapies are currently available. Protein S-nitrosylation (SNO) is a typical redox-dependent posttranslational modification whose role in AAD has yet to be described. Recently, Zhang et al. revealed for the first time that SNO modification of macrophage cytoskeletal protein septin2 promotes vascular inflammation and extracellular matrix degradation in aortic aneurysm. Mechanically, the TIAM1-RAC1(T lymphoma invasion and metastasis-inducing protein 1-Ras-related C3 botulinum toxin substrate 1) axis participates in the progression of AAD induced with S-nitrosylated septin2. More importantly, developing R-ketorolac and NSC23766 compounds that specifically target the TIAM1-RAC1 pathway may be new a potential strategy for alleviating AAD.

A simple and effective machine learning model for predicting the stability of intracranial aneurysms using CT angiography.

Background: It is vital to accurately and promptly distinguish unstable from stable intracranial aneurysms (IAs) to facilitate treatment optimization and avoid unnecessary treatment. The aim of this study is to develop a simple and effective predictive model for the clinical evaluation of the stability of IAs. Methods: In total, 1,053 patients with 1,239 IAs were randomly divided the dataset into training (70%) and internal validation (30%) datasets. One hundred and ninety seven patients with 229 IAs from another hospital were evaluated as an external validation dataset. The prediction models were developed using machine learning based on clinical information, manual parameters, and radiomic features. In addition, a simple model for predicting the stability of IAs was developed, and a nomogram was drawn for clinical use. Results: Fourteen machine learning models exhibited excellent classification performance. Logistic regression Model E (clinical information, manual parameters, and radiomic shape features) had the highest AUC of 0.963 (95% CI 0.943-0.980). Compared to manual parameters, radiomic features did not significantly improve the identification of unstable IAs. In the external validation dataset, the simplified model demonstrated excellent performance (AUC = 0.950) using only five manual parameters. Conclusion: Machine learning models have excellent potential in the classification of unstable IAs. The manual parameters from CTA images are sufficient for developing a simple and effective model for identifying unstable IAs.

Vasa vasorum: The role in intracranial physiology and pathophysiology.

Background: Vasa vasorum (VVs) is a Latin word representing vessels of vessels. VVs are usually found on the adventitia of the parent vessel and infrequently reach the media and intima, depending on the size and type of the parent vessels and physiological and pathological conditions. The VVs include arteries, capillaries, veins, and lymphatic vessels, involving the oxygenation and nourishment of the vessel's wall to sustain its healthy state. Accumulated studies have revealed that VVs are involved in various intracranial lesions, including atherosclerotic diseases, aneurysms, and shunt diseases. The current review aims to review and integrate past and recent findings and knowledge on VVs and to facilitate our understanding of VVs and intracranial pathology involving VVs. Methods: A literature review was carried out with a focus on the role of VVs by searching the Pubmed database. Results: We identified 71 articles that discuss the role of VVs. We discussed the anatomical structure, physiological significance, and pathological significance of the VV. Conclusion: VV is not only involved in the nutrition and metabolism of the vascular wall but is also deeply involved in the pathogenesis of inflammation, ischemia, and thrombosis of the vascular wall. In addition, in the central nervous system, intracranial vascular wall nutrient particularities and VVs are closely related to the pathogenesis of cerebral aneurysms, subarachnoid hemorrhage, arteriovenous shunt disease, atherosclerotic lesions, and other conditions.

Intracranial aneurysms and abducent nerve palsy.

Background: Cranial nerve (CN) palsy may manifest as an initial presentation of intracranial aneurysms or due to the treatment. The literature reveals a paucity of studies addressing the involvement of the 6th CN in the presentation of cerebral aneurysms. Methods: Clinical patient data, aneurysmal characteristics, and CN 6th palsy outcome were retrospectively reviewed and analyzed. Results: Out of 1311 cases analyzed, a total of 12 cases were identified as having CN 6th palsy at the presentation. Eight out of the 12 were found in the unruptured aneurysm in the cavernous segment of the internal carotid artery (ICA). The other four cases of CN 6th palsy were found in association with ruptured aneurysms located exclusively at the posterior inferior cerebellar artery (PICA). For the full functional recovery of the CN 6th palsy, there was 50% documented full recovery in the eight cases of the unruptured cavernous ICA aneurysm. On the other hand, all four patients with ruptured PICA aneurysms have a full recovery of CN 6th palsy. The duration for recovery for CN palsy ranges from 1 to 5 months. Conclusion: The association between intracranial aneurysms and CN 6th palsy at presentation may suggest distinct patterns related to aneurysmal location and size. The abducent nerve palsy can be linked to unruptured cavernous ICA and ruptured PICA aneurysms. The recovery of CN 6th palsy may be influenced by aneurysm size, rupture status, location, and treatment modality.

Natural History of Cavernous Carotid Artery Aneurysms: A Systematic Review and Meta-Analysis.

BACKGROUND: Cavernous carotid artery aneurysms (CCAAs) represent a common condition seen in clinical practice with significant practice variability. The aim of this systematic review and meta-analysis was to aggregate current evidence on the natural history of CCAAs. METHODS: MEDLINE/PubMed, EMBASE, and Cochrane Library were queried from inception until December 2023. The primary outcome of this study was CCAA-related mortality. The secondary outcomes of this study were aneurysm growth, intracranial ischemic and hemorrhagic events, improved non-cerebrovascular symptoms, and new or worsened non-cerebrovascular symptoms during follow-up. RESULTS: Ten studies met our inclusion criteria, involving 835 patients and 975 CCAAs. CCAA-related mortality had an incidence rate of 0.28 (95% confidence interval 0.12-0.64) per 100 person-years (PYs) of follow-up. The incidence rate of CCAA growth was 2.91 (1.05-8.07) per 100 PYs of follow-up. The incidence rate of CCAA-related intracranial ischemic events was 0.4 (0.16-1.01) per 100 PYs of follow-up. The incidence rate of CCAA-related intracranial hemorrhagic events was 0.54 (0.33-0.87) per 100 PYs of follow-up. The incidence rate of improved non-cerebrovascular symptoms was 2.51 (1.18-5.33) per 100 PYs of follow-up. The incidence rate of new or worsened non-cerebrovascular symptoms was 3.41 (2.03-5.73) per 100 PYs of follow-up. CONCLUSIONS: CCAAs are typically benign lesions with a low risk of rupture and life-threatening complications. CCAAs tend to follow an indolent course regarding non-cerebrovascular outcomes, and new or worsening symptoms are infrequent during the clinical course. However, spontaneous resolution of non-cerebrovascular symptoms and cranial nerve deficits at presentation is uncommon.

Coronary Artery Outcomes in Kawasaki Disease by Treatment Day Within 10 Days of Fever Onset.

Background: Kawasaki disease (KD) is an acute febrile illness of childhood that can lead to coronary artery aneurysms (CAAs) and myocardial infarction. Intravenous immunoglobulin reduces the prevalence of CAA when given to patients with KD within 10 days of fever onset. Children with KD may undergo evaluation for other diagnoses before treatment, particularly those with incomplete KD criteria. If KD outcomes are improved with early treatment, a delay in treatment while evaluating for other causes might place these patients at risk. Methods: We performed a retrospective cohort study of children treated for KD within the first 10 days of illness at our KD center from 2014 to 2021 to determine the prevalence of CAA by day of treatment. Results: A total of 290 patients met the study criteria. No statistically significant difference was found in the odds of developing a maximum z score ≥2.5 for each day of delayed treatment within 10 days of fever onset (adjusted odds ratio, 0.87; 95% CI, .72-1.05; P = .13). Subgroup analyses by age, sex, and year of treatment did not reveal a significant association between treatment day and maximum z score ≥2.5, although the number of patients <6 months of age was small. Conclusions: Our study supports current recommendations. We found similar odds of developing adverse coronary outcomes regardless of treatment day within 10 days from fever onset.

Long-term cardiovascular inflammation and fibrosis in a murine model of vasculitis induced by Lactobacillus casei cell wall extract.

Background: Kawasaki disease (KD), an acute febrile illness and systemic vasculitis, is the leading cause of acquired heart disease in children in industrialized countries. KD leads to the development of coronary artery aneurysms (CAA) in affected children, which may persist for months and even years after the acute phase of the disease. There is an unmet need to characterize the immune and pathological mechanisms of the long-term complications of KD. Methods: We examined cardiovascular complications in the Lactobacillus casei cell wall extract (LCWE) mouse model of KD-like vasculitis over 4 months. The long-term immune, pathological, and functional changes occurring in cardiovascular lesions were characterized by histological examination, flow cytometric analysis, immunofluorescent staining of cardiovascular tissues, and transthoracic echocardiogram. Results: CAA and abdominal aorta dilations were detected up to 16 weeks following LCWE injection and initiation of acute vasculitis. We observed alterations in the composition of circulating immune cell profiles, such as increased monocyte frequencies in the acute phase of the disease and higher counts of neutrophils. We determined a positive correlation between circulating neutrophil and inflammatory monocyte counts and the severity of cardiovascular lesions early after LCWE injection. LCWE-induced KD-like vasculitis was associated with myocarditis and myocardial dysfunction, characterized by diminished ejection fraction and left ventricular remodeling, which worsened over time. We observed extensive fibrosis within the inflamed cardiac tissue early in the disease and myocardial fibrosis in later stages. Conclusion: Our findings indicate that increased circulating neutrophil counts in the acute phase are a reliable predictor of cardiovascular inflammation severity in LCWE-injected mice. Furthermore, long-term cardiac complications stemming from inflammatory cell infiltrations in the aortic root and coronary arteries, myocardial dysfunction, and myocardial fibrosis persist over long periods and are still detected up to 16 weeks after LCWE injection.

T Cells Immune Imbalance Present in Patients With Multiple Intracranial Aneurysms.

Growing evidence suggests that systemic immune and inflammatory responses may play a critical role in the formation and development of aneurysms. Exploring the differences between single intracranial aneurysm (SIA) and multiple IAs (MIAs) could provide insights for targeted therapies. However, there is a lack of comprehensive and detailed characterization of changes in circulating immune cells in MIAs. Peripheral blood mononuclear cell (PBMC) samples from patients with SIA (n = 16) or MIAs (n = 6) were analyzed using high-dimensional mass cytometry to evaluate the frequency and phenotype of immune cell subtypes. A total of 25 cell clusters were identified, revealing that the immune signature of MIAs included cluster changes. Compared to patients with SIA, patients with MIAs exhibited immune dysfunction and regulatory imbalance in T-cell clusters. They also had reduced numbers of CD8+ T cells and their subgroups CD8+ Te and CD8+ Tem cells, as well as reduced numbers of the CD4+ T-cell subgroup CD27-CD4+ Tem cells. Furthermore, compared to SIA, MIAs were associated with enhanced T-cell immune activation, with elevated expression levels of CD3, CD25, CD27, CCR7, GP130, and interleukin 10. This study provides insights into the circulating immune cell profiles in patients with MIAs, highlighting the similarities and differences between patients with SIA and those with MIAs. Furthermore, the study suggests that circulating immune dysfunction may contribute to development of MIAs.

Late Open Abdominal Aneurysm Reconstruction and Graft Salvage in a Patient With Persistent Endoleak Type II Following Endovascular Aneurysm Repair.

This study highlights a case of late open conversion repair (OCR) for persistent Type II endoleak after endovascular aneurysm repair (EVAR), presenting a 78-year-old male with a history of EVAR for an infrarenal abdominal aortic aneurysm. Despite conservative management of the initial endoleak, the aneurysm sac's progressive growth necessitated open reconstruction to salvage the graft. Successful postoperative outcomes emphasize the critical need for meticulous intervention strategies and surveillance in managing persistent Type II endoleaks. This case underlines the importance of a tailored approach, leveraging both endovascular and open surgical techniques, to optimize long-term outcomes and prevent aneurysm rupture in complex cases.

Radiomics-Based Predictive Nomogram for Assessing the Risk of Intracranial Aneurysms.

Aneurysm wall enhancement (AWE) has the potential to be used as an imaging biomarker for the risk stratification of intracranial aneurysms (IAs). Radiomics provides a refined approach to quantify and further characterize AWE's textural features. This study examines the performance of AWE quantification combined with clinical information in detecting symptomatic IAs. Ninety patients harboring 104 IAs (29 symptomatic and 75 asymptomatic) underwent high-resolution magnetic resonance imaging (HR-MRI). The assessment of AWE was performed using two different methods: 3D-AWE mapping and composite radiomics-based score (RadScore). The dataset was split into training and testing subsets. The testing set was used to build two different nomograms using each modality of AWE assessment combined with patients' clinical information and aneurysm morphological data. Finally, each nomogram was evaluated on an independent testing set. A total of 22 radiomic features were significantly different between symptomatic and asymptomatic IAs. The 3D-AWE mapping nomogram achieved an area under the curve (AUC) of 0.77 (63% accuracy, 78% sensitivity, and 58% specificity). The RadScore nomogram exhibited a better performance, achieving an AUC of 0.83 (77% accuracy, 89% sensitivity, and 73% specificity). The comprehensive analysis of IAs with the quantification of AWE data through radiomic analysis, patient clinical information, and morphological aneurysm metrics achieves a high accuracy in detecting symptomatic IA status.

A Case of Multiple Intracranial Hemorrhages due to a Ruptured Neoplastic Cerebral Aneurysm Secondary to Metastasis of Poorly Differentiated Parotid Gland Carcinoma.

Neoplastic cerebral aneurysms (NCAs) are rare. This study reported a case of an NCA secondary to a poorly differentiated carcinoma of the parotid gland. An 84-year-old Japanese woman undergoing treatment for parotid gland cancer was admitted to our hospital with headache and progressive loss of consciousness. Based on computed tomography (CT) and CT angiography (CTA), a diagnosis of subarachnoid hemorrhage due to rupture of a left posterior inferior cerebellar artery aneurysm was made, and emergency aneurysmectomy was performed. Pathological examination of the resected aneurysm showed an NCA secondary to parotid carcinoma. After the aneurysmectomy, her condition stabilized; however, 33 days later, the patient developed an intracerebral hemorrhage, and a new aneurysm was confirmed in the right middle cerebral artery. To the best of our knowledge, there have been no previous reports on cases of NCAs secondary to parotid carcinoma. The pathology and clinical course strongly suggest that NCAs derived from malignant tumors may have an aggressive course.

"Pediatric Spontaneous Intracranial Dissecting Aneurysms: Impact of Ischemic and Hemorrhagic Manifestations on Endovascular Treatment Strategies - Insights from a Developing World Setting".

BACKGROUND: Pediatric spontaneous intracranial dissecting aneurysms (IDA) are rare, but systematic studies comparing hemorrhagic and ischemic presentations are lacking. This study addresses gaps in understanding their epidemiology, clinical presentation, management, and outcome. METHODS: A retrospective analysis of 23 pediatric patients with nontraumatic IDA treated between July 2018 and December 2023 was conducted. Patients were divided into two groups based on presentation: hemorrhagic (n=16) and ischemic (n=7). Clinical data were analyzed, including demographics, radiological findings, treatment modalities, and outcomes. RESULTS: Clinical presentations varied, with limb weakness being more prevalent in hemorrhagic cases (p=0.014), while headache and seizures were more common in ischemic cases. Angiographic analysis revealed distinct patterns, with hemorrhagic cases showing more distal involvement on vessel segments with stenosis and dilatation (pearl string sign). At the same time, the ischemic group exhibited the double-lumen sign. Various treatments, including microsurgery and endovascular techniques, were utilized, with perioperative complications observed, including one mortality in a hemorrhagic case. Multiple regression analysis identified significant risk factors for perioperative complications, namely, the configuration of the dissecting aneurysm (p=0.016) and the type of presentation (p=0.0006). Long-term Glasgow Outcome Scores were comparable, but patients with hemorrhagic manifestations experienced prolonged hospital and ICU stays (p=0.001). CONCLUSION: Pediatric intracranial dissecting aneurysms, particularly hemorrhagic cases, are associated with severe neurological deficits and higher perioperative complications. Despite similar long-term outcomes, hemorrhagic cases require prolonged hospitalization, increasing treatment costs. Optimizing management strategies for pediatric ICDAs, especially those with hemorrhagic features, is essential to improve outcomes and reduce healthcare expenditures.

First multicenter study evaluating the utility of the BENCHMARKTM BMXTM 81 large-bore access catheter in neurovascular interventions.

INTRODUCTION: This study is the first multicentric report on the safety, efficacy, and technical performance of utilizing a large bore (0.081″ inner diameter) access catheter in neurovascular interventions. METHODS: Data were retrospectively collected from seven sites in the United States for neurovascular procedures via large bore 0.081″ inner diameter access catheter (Benchmark BMX81, Penumbra, Inc.). The primary outcome was technical success, defined as the access catheter reaching its target vessel. Safety outcomes included periprocedural device-related and access site complications. RESULTS: There were 90 consecutive patients included. The median age of the patients was 63 years (IQR: 53, 68); 53% were female. The most common interventions were aneurysm embolization (33.3%), carotid stenting (12.2%), and arteriovenous malformation embolization (11.1%). The transradial approach was most used (56.7%), followed by transfemoral (41.1%). Challenging anatomic variations included severe vessel tortuosity (8/90, 8.9%), type 2 aortic arch (7/90, 7.8%), type 3 aortic arch (2/90, 2.2%), bovine arch (2/90, 2.2%), and severe angle (<30°) between the subclavian artery and target vessel (1/90, 1.1%). Technical success was achieved in 98.9% of the cases (89/90), with six cases requiring a switch from radial to femoral (6.7%) and one case from femoral to radial (1.1%). There were no access site complications or complications related to the 0.081″ catheter. Two postprocedural complications occurred (2.2%), unrelated to the access catheter. CONCLUSION: The BMX™ 81 large-bore access catheters was safe and effective in both radial and femoral access across a wide range of neurovascular procedures, achieving high technical success without any access site or device-related complications.

Endothelial Progenitor Cells: A Review of Molecular Mechanisms in the Pathogenesis and Endovascular Treatment of Intracranial Aneurysms.

This comprehensive review explores the multifaceted role of endothelial progenitor cells (EPCs) in vascular diseases, focusing on their involvement in the pathogenesis and their contributions to enhancing the efficacy of endovascular treatments for intracranial aneurysms (IAs). Initially discovered as CD34+ bone marrow-derived cells implicated in angiogenesis, EPCs have been linked to vascular repair, vasculogenesis, and angiogenic microenvironments. The origin and differentiation of EPCs have been subject to debate, challenging the conventional notion of bone marrow origin. Quantification methods, including CD34+ , CD133+ , and various assays, reveal the influence of factors, like age, gender, and comorbidities on EPC levels. Cellular mechanisms highlight the interplay between bone marrow and angiogenic microenvironments, involving growth factors, matrix metalloproteinases, and signaling pathways, such as phosphatidylinositol-3-kinase (PI3K) and mitogen-activated protein kinase (MAPK). In the context of the pathogenesis of IAs, EPCs play a role in maintaining vascular integrity by replacing injured and dysfunctional endothelial cells. Recent research has also suggested the therapeutic potential of EPCs after coil embolization and flow diversion, and this has led the development of device surface modifications aimed to enhance endothelialization. The comprehensive insights underscore the importance of further research on EPCs as both therapeutic targets and biomarkers in IAs.

Cavernous Sinus Syndrome in a Polio-Afflicted Patient With Multiple Aneurysms.

Cavernous sinus syndrome (CSS) is a complex, multifactorial condition that presents with a myriad of signs and symptoms including ptosis, double vision, and headache. We present the case of a 65-year-old woman with a chief concern of left-eye pain, including polio syndrome and hip replacement surgery. Unlike typical CSS cases often linked to tumors, this patient's condition involved a carotid-cavernous fistula (CCF), multiple internal carotid artery aneurysms, and a pericallosal aneurysm, without any associated tumor. She presented with severe left eye pain, ptosis, double vision, vomiting, headache, and other neurological symptoms since she woke up. Her treatment at a tertiary care center included diagnostic imaging, a cerebral angiogram, and embolization procedures, and she was discharged in stable condition. This case adds significant value to the medical literature by documenting the successful management of CSS with multiple aneurysms and a CCF, highlighting the importance of personalized treatment strategies and the effectiveness of modern embolization techniques in complex neurological conditions.

Systematic Review and Meta-Analysis of Endovascular Therapy Effectiveness for Unruptured Saccular Intracranial Aneurysms.

Background: Currently, endovascular treatment of intracranial aneurysms (ICAs) is limited by low complete occlusion rates. The advent of novel endovascular technology has expanded the applicability of endovascular therapy; however, the superiority of novel embolic devices over the traditional Guglielmi detachable coils (GDCs) is still debated. We performed a systematic review of literature that reported Raymond-Roy occlusion classification (RROC) rates of modern endovascular devices to determine their immediate and follow-up occlusion effectiveness for the treatment of unruptured saccular ICAs. Methods: A search was conducted using electronic databases (PUBMED, Cochrane, ClinicalTrials.gov, Web of Science). We retrieved studies published between 2000-2022 reporting immediate and follow-up RROC rates of subjects treated with different endovascular ICA therapies. We extracted demographic information of the treated patients and their reported angiographic RROC rates. Results: A total of 80 studies from 15 countries were included for data extraction. RROC rates determined from angiogram were obtained for 21,331 patients (72.5% females, pooled mean age: 58.2 (95% CI: 56.8-59.6), harboring 22,791 aneurysms. The most frequent aneurysm locations were the internal carotid artery (46.4%, 95% CI: 41.9%-50.9%), the anterior communicating artery (26.4%, 95% CI: 22.5%-30.8%), the middle cerebral artery (24.5%, 95% CI:19.2%-30.8%) and the basilar tip (14.4%, 95% CI:11.3%-18.3%). The complete occlusion probability (RROC-I) was analyzed for GDCs, the Woven EndoBridge (WEB), and flow diverters. The RROC-I rate was the highest in balloon-assisted coiling (73.9%, 95% CI: 65.0%-81.2%) and the lowest in the WEB (27.8%, 95% CI:13.2%-49.2%). The follow-up RROC-I probability was homogenous in all analyzed devices. Conclusions: We observed that the coil-based endovascular therapy provides acceptable rates of complete occlusion, and these rates are improved in balloon-assisted coils. Out of the analyzed devices, the WEB exhibited the shortest time to achieve >90% probability of follow-up complete occlusion (~18 months). Overall, the GDCs remain the gold standard for endovascular treatment of unruptured saccular aneurysms.

Multiple Intracranial Aneurysms Associated With Brain Arteriovenous Malformation: A Case Report and Treatment Strategies.

In the field of cerebrovascular neurosurgery, intracranial aneurysms (IAs) have been occasionally associated with brain arteriovenous malformations (BAVMs), indicating a more aggressive clinical course, and increased rates of hemorrhage and rehemorrhage. Treatment of flow-related IAs in BAVMs remains debatable, with considerations for preventive intervention versus concurrent BAVM treatment. Managing such situations might be challenging, especially in determining which of the IAs or BAVMs should be treated first, and which treatment strategy would be most appropriate for each situation. A precise identification of the rupture site is required, whether it is the AVM nidus or the IA, for choosing the best treatment plans. We present a case of a 29-year-old male patient diagnosed with several intracranial vascular conditions: a ruptured anterior communicating artery (ACoA) aneurysm and an unruptured ophthalmic artery aneurysm, associated with a frontal BAVM. Moreover, we discussed the possible scenarios regarding the association of these conditions, highlighting their manifestations and the most suitable therapeutic approach for each. Thus, our exploration of the challenges and considerations involved in treating these intricate neurovascular conditions underscores the need for a customized approach for each patient's situation.

Subacute Multivalvular Bacterial Endocarditis Complicated by Ruptured Mycotic Aneurysm and the Impact of Gender on Early Surgical Intervention.

Subacute bacterial endocarditis (SBE) evolves over weeks to months, often without typical features of acute endocarditis. Its presentation progresses gradually until possibly complicated by sentinel events, such as a cerebrovascular accident from embolization or a ruptured vessel. This is a case of SBE presenting as symptomatic anemia in a female patient with severe aortic regurgitation (AR) and mitral regurgitation (MR) due to bi-valvular vegetations in the absence of typical acute endocarditis and congestive heart failure (CHF) features.

Intracranial Aneurysms Managed by Parent Artery Reconstruction Using Tubridge Flow Diverter study: 1-year outcomes.

OBJECTIVE: Previous randomized controlled trials have reported a significantly higher occlusion rate of large and giant aneurysms when utilizing the Tubridge flow diverter (FD). In the present trial, the safety and efficacy of the Tubridge FD in treating unruptured internal carotid artery (ICA) or vertebral artery (VA) aneurysms were assessed in a real-world setting. METHODS: The Intracranial Aneurysms Managed by Parent Artery Reconstruction Using Tubridge Flow Diverter (IMPACT) study is a prospective, multicenter, single-arm clinical trial assessing the efficacy of the Tubridge FD in the management of unruptured aneurysms located in the ICA or VA. The primary endpoint was the complete occlusion (Raymond-Roy class 1) rate at the 1-year follow-up. The secondary endpoints included the technical success rate, the successful occlusion rate of the aneurysm, which is the degree of aneurysm embolization scored as Raymond-Roy class 1 or 2, major (> 50%) in-stent stenosis, and incidence of disabling stroke or neurological death associated with the target aneurysms. RESULTS: This study included 14 interventional neuroradiology centers, with 200 patients and 240 aneurysms. According to angiographic core laboratory assessment, 205 (85.4%) aneurysms were located in the ICA, 34 (14.2%) in the VA, and 1 (0.4%) in the middle cerebral artery. Additionally, 189 (78.8%) aneurysms were small (< 10 mm). At the 12-month follow-up, the total occlusion rate was 79.0% (166/210, 95% CI 72.91%-84.34%). Additionally, the occurrence of disabling stroke or neurological death related to the specified aneurysms was 1% (2/200). CONCLUSIONS: The 1-year results from the IMPACT trial affirm the safety record of use of the Tubridge FD in the treatment of intracranial aneurysms in real-world scenarios. These results reveal low morbidity and mortality rates of 3.5% and 1.5%, respectively. Furthermore, they provide evidence of the effectiveness of the Tubridge FD, as demonstrated by the complete occlusion achieved in 166 of 210 (79%) cases.

Assessing the Impact of an Artificial Intelligence-Based Model for Intracranial Aneurysm Detection in CT Angiography on Patient Diagnosis and Outcomes (IDEAL Study)-a protocol for a multicenter, double-blinded randomized controlled trial.

BACKGROUND: This multicenter, double-blinded, randomized controlled trial (RCT) aims to assess the impact of an artificial intelligence (AI)-based model on the efficacy of intracranial aneurysm detection in CT angiography (CTA) and its influence on patients' short-term and long-term outcomes. METHODS: Study design: Prospective, multicenter, double-blinded RCT. SETTINGS: The model was designed for the automatic detection of intracranial aneurysms from original CTA images. PARTICIPANTS: Adult inpatients and outpatients who are scheduled for head CTA scanning. Randomization groups: (1) Experimental Group: Head CTA interpreted by radiologists with the assistance of the True-AI-integrated intracranial aneurysm diagnosis strategy (True-AI arm). (2) Control Group: Head CTA interpreted by radiologists with the assistance of the Sham-AI-integrated intracranial aneurysm diagnosis strategy (Sham-AI arm). RANDOMIZATION: Block randomization, stratified by center, gender, and age group. PRIMARY OUTCOMES: Coprimary outcomes of superiority in patient-level sensitivity and noninferiority in specificity for the True-AI arm to the Sham-AI arm in intracranial aneurysms. SECONDARY OUTCOMES: Diagnostic performance for other intracranial lesions, detection rates, workload of CTA interpretation, resource utilization, treatment-related clinical events, aneurysm-related events, quality of life, and cost-effectiveness analysis. BLINDING: Study participants and participating radiologists will be blinded to the intervention. SAMPLE SIZE: Based on our pilot study, the patient-level sensitivity is assumed to be 0.65 for the Sham-AI arm and 0.75 for the True-AI arm, with specificities of 0.90 and 0.88, respectively. The prevalence of intracranial aneurysms for patients undergoing head CTA in the hospital is approximately 12%. To establish superiority in sensitivity and noninferiority in specificity with a margin of 5% using a one-sided α = 0.025 to ensure that the power of coprimary endpoint testing reached 0.80 and a 5% attrition rate, the sample size was determined to be 6450 in a 1:1 allocation to True-AI or Sham-AI arm. DISCUSSION: The study will determine the precise impact of the AI system on the detection performance for intracranial aneurysms in a double-blinded design and following the real-world effects on patients' short-term and long-term outcomes. TRIAL REGISTRATION: This trial has been registered with the NIH, U.S. National Library of Medicine at ClinicalTrials.gov, ID: NCT06118840 . Registered 11 November 2023.