Novel radiopaque ethanol injection: physicochemical properties, animal experiments, and clinical application in vascular malformations.

BACKGROUND: Despite the efficacy of absolute ethanol (EtOH), its radiolucency introduces several risks in interventional therapy for treating vascular malformations. This study aims to develop a novel radiopaque ethanol injection (REI) to address this issue. METHODS: Iopromide is mixed with ethanol to achieve radiopacity and improve the physicochemical properties of the solution. Overall, 82 male New Zealand white rabbits are selected for in vivo radiopacity testing, peripheral vein sclerosis [animals were divided into the following 5 groups (n = 6): negative control (NC, saline, 0.250 ml/kg), positive control (EtOH, 0.250 ml/kg), low-dose REI (L-D REI, 0.125 ml/kg), moderate-dose REI (M-D REI, 0.250 ml/kg), and high-dose REI (H-D REI 0.375 ml/kg)], pharmacokinetic analyses (the blood sample was harvested before injection, 5 min, 10 min, 20 min, 40 min, 1 h, 2 h, 4 h, and 8 h after injection in peripheral vein sclerosis experiment), peripheral artery embolization [animals were divided into the following 5 groups (n = 3): NC (saline, 0.250 ml/kg), positive control (EtOH, 0.250 ml/kg), L-D REI (0.125 ml/kg), M-D REI (0.250 ml/kg), and H-D REI (0.375 ml/kg)], kidney transcatheter arterial embolization [animals were divided into the following 4 groups (n = 3): positive control (EtOH, 0.250 ml/kg), L-D REI (0.125 ml/kg), M-D REI (0.250 ml/kg), and H-D REI (0.375 ml/kg); each healthy kidney was injected with saline as negative control], and biosafety evaluations [animals were divided into the following 5 groups (n = 3): NC (0.250 ml/kg), high-dose EtOH (0.375 ml/kg), L-D REI (0.125 ml/kg), M-D REI (0.250 ml/kg), and H-D REI (0.375 ml/kg)]. Then, a prospective cohort study involving 6 patients with peripheral venous malformations (VMs) is performed to explore the clinical safety and effectiveness of REI. From Jun 1, 2023 to August 31, 2023, 6 patients [age: (33.3 ± 17.2) years] with lingual VMs received sclerotherapy of REI and 2-month follow-up. Adverse events and serious adverse events were evaluated, whereas the efficacy of REI was determined by both the traceability of the REI under DSA throughout the entire injection and the therapeutic effect 2 months after a single injection. RESULTS: The REI contains 81.4% ethanol (v/v) and 111.3 mg/ml iodine, which can be traced throughout the injection in the animals and patients. The REI also exerts a similar effect as EtOH on peripheral venous sclerosis, peripheral arterial embolization, and renal embolization. Furthermore, the REI can be metabolized at a similar rate compared to EtOH and Ultravist® and did not cause injury to the animals' heart, liver, spleen, lungs, kidneys and brain. No REI-related adverse effects have occurred during sclerotherapy of VMs, and 4/6 patients (66.7%) have achieved complete response at follow-up. CONCLUSION: In conclusion, REI is safe, exerts therapeutic effects, and compensates for the radiolucency of EtOH in treating VMs. TRIAL REGISTRATION: The clinical trial was registered as No. ChiCTR2300071751 on May 24 2023.

Coil-assisted ethanol embolotherapy for refractory head and neck arteriovenous malformations with Onyx recrudescence: 10-Year experiences.

OBJECTIVE: This study aimed to evaluate the outcomes of coil-assisted ethanol embolotherapy in recanalized head and neck arteriovenous malformations (HNAVMs) with dilated outflowing veins after Onyx treatment. METHODS: Thirty-six patients with HNAVMs (18 females and 18 males with a mean age of 26.83 years) who experienced recurrence after Onyx embolization from October 2007 to October 2017 were included in this study. All patients underwent complete clinical and angiographic examinations. Further, each patient was classified based on the Schobinger stage before undergoing staged ethanol embolization. All patients were followed up for 5 years in-person at an interval of 3 months after discharge. The Kaplan-Meier method was used to perform the recurrence-free survival analysis. RESULTS: Sixteen patients (44.4%) had Schobinger stage II HNAVMs, and the remaining patients had Schobinger stage III or IV (20/36 patients [55.6%]) HNAVMs. A total of 116 embolization procedures were performed, coils were applied in 107 procedures (92.2%) among patients with dilated outflowing veins. The dose of absolute ethanol was 16.39 mL per procedure in patients with Schobinger II HNAVMs, and 22.45 mL per procedure in patients with Schobinger III and IV HNAVMs (P = .024, 95% confidence interval, 1.128-5.009). During the 3-month evaluation, complete response was observed in 13 of 36 patients (36.1%), and partial response was observed in 23 of 36 patients (63.9%). The 5-year recurrence-free survival rate for patients who underwent Onyx treatment had improved 58.3% after ethanol embolization (95% confidence interval, 2.853-9.595; P < .0001). CONCLUSIONS: Coil-assisted ethanol embolotherapy could treat refractory HNAVMs with Onyx recrudescence effectively.

A coarse-to-fine cascade deep learning neural network for segmenting cerebral aneurysms in time-of-flight magnetic resonance angiography.

BACKGROUND: Accurate segmentation of unruptured cerebral aneurysms (UCAs) is essential to treatment planning and rupture risk assessment. Currently, three-dimensional time-of-flight magnetic resonance angiography (3D TOF-MRA) has been the most commonly used method for screening aneurysms due to its noninvasiveness. The methods based on deep learning technologies can assist radiologists in achieving accurate and reliable analysis of the size and shape of aneurysms, which may be helpful in rupture risk prediction models. However, the existing methods did not accomplish accurate segmentation of cerebral aneurysms in 3D TOF-MRA. METHODS: This paper proposed a CCDU-Net for segmenting UCAs of 3D TOF-MRA images. The CCDU-Net was a cascade of a convolutional neural network for coarse segmentation and the proposed DU-Net for fine segmentation. Especially, the dual-channel inputs of DU-Net were composed of the vessel image and its contour image which can augment the vascular morphological information. Furthermore, a newly designed weighted loss function was used in the training process of DU-Net to promote the segmentation performance. RESULTS: A total of 270 patients with UCAs were enrolled in this study. The images were divided into the training (N = 174), validation (N = 43), and testing (N = 53) cohorts. The CCDU-Net achieved a dice similarity coefficient (DSC) of 0.616 ± 0.167, Hausdorff distance (HD) of 5.686 ± 7.020 mm, and volumetric similarity (VS) of 0.752 ± 0.226 in the testing cohort. Compared with the existing best method, the DSC and VS increased by 18% and 5%, respectively, while the HD decreased by one-tenth. CONCLUSIONS: We proposed a CCDU-Net for segmenting UCAs in 3D TOF-MRA, and the obtained results show that the proposed method outperformed other existing methods.

Long-Term Outcomes of Stenting on Non-Acute Phase Extracranial Supra-Aortic Dissections.

OBJECTIVE: Extracranial supra-aortic dissections (ESADs) with severe stenosis, occlusion and/or pseudoaneurysm presents potential risk of stroke. Endovascular stenting to reconstruct non acute phase ESADs (NAP-ESADs) is an alternative to anticoagulant or antiplatelet therapy. However, its feasibility, safety and efficacy of stenting in NAP-ESADs is unclear. This study aims to investigate the long-term outcomes of the feasibility, safety and efficacy of stenting in NAP-ESADs. METHODS: Seventy-four patients with 91 NAP-ESAD vessels with severe stenosis, occlusion and/or pseudoaneurysm presents potential risk of stroke who underwent stent remodeling were enrolled into this respective study from December 2008 to March 2020. Technical success rate, complications, clinical and angiographic results were harvested and analyzed. RESULTS: Success rate of stent deployment was 99% (90/91) with no procedural mortality or morbidity. Transient ischemic attack occurred in three patients during operation (4.1%, 3/74). Asymptomatic embolisms of distal intracranial vessels were found in two patients (2.7%, 2/74). One hundred and forty-two stents deployed at 85 carotid (135 stents) and six vertebral (seven stents) vessels. Six stent types (Wingspan, 28/135, 20.7%; Solitaire, 10/135, 7.4%; Neuroform, 8/135, 5.9%; LVIS, 2/135, 1.5%; Precise, 75/135, 55.6%; Acculink, 12/135, 8.9%) were deployed at carotid arterial dissection while two types (Wingspan, 5/7, 71.4%; Solitaire 2/7, 28.6%) at vertebral arterial dissection. Digital subtracted angiography (56%, 51/91), computational tomography angiography (41.8%, 38/91) and high resolution magnetic resonance imaging (2.2%, 2/91) were adopted for follow up, with a mean time of 17.2±15.4 months (5-77). All patient modified Rankin Scale scores showed no increase at discharge or follow-up. Angiographically, dissections in 86 vessels in 69 patients (94.5%, 86/91) were completely reconstructed with only minor remnant dissections in four vessels in four patients (4.4%, 4/91). Severe re-stenosis in the stented segment required re-stenting in one patient (1.1%, 1/91). CONCLUSION: Stent remodeling technique provides feasible, safe and efficacious treatment of ESADs patients with severe stenosis, occlusion and/or pseudoaneurysm.

Clinical and angiographic outcomes of stent-assisted coiling of paraclinoid aneurysms: Comparison of LVIS and Neuroform stents.

Paraclinoid aneurysms are mainly intradural, and are associated with a potential risk of subarachnoid hemorrhage (SAH). The application of stent-assisted coiling has been widely used in endovascular treatment of intracranial aneurysms. Here we aimed to compare clinical outcomes between low-profile visualized intraluminal support stents (LVIS) and Neuroform (NU) stents. Between January 2013 and December 2017, a total of 101 patients with 118 unruptured paraclinoid aneurysms were embolized by LVIS or NU stents. Procedure-related complications, angiography, and follow-up results were retrospectively analyzed. A total of 45 patients with 54 aneurysms received LVIS stents, and 56 patients with 64 aneurysms received NU stents. Procedure-related complication rate was 6.7% in the LVIS group and 5.4% in the NU group, with no statistical differences between groups (P = 0.511). Compared with the NU group, greater initial complete or near-complete aneurysm obliteration was achieved in the LVIS group (79.6% vs 59.4%, P = 0.0192). DSA angiography follow-up imaging of the 118 aneurysms showed that the LVIS group increased in Raymond-Roy Grade Scale I (RRGS I), however there is no statistical difference (P = 0.32). Compared with NU stents, LVIS stents may achieve greater complete or near-complete occlusion rate immediately post-operation. However, there was no difference in procedural-related complications and follow-up outcomes between LVIS and NU stent groups.

Differences in hemodynamic characteristics under high packing density between the porous media model and finite element analysis in computational fluid dynamics of intracranial aneurysm virtual treatment.

OBJECTIVE: This study aimed to compare the hemodynamic differences among no sac (NOS), porous media (POM) and finite element analysis (FEA) models to investigate the recurrence-related risks for coiled intracranial aneurysms (IAs). METHODS: The study enrolled 10 patients with 11 IAs who received simple coiling treatment and hemodynamic simulations were performed for all IAs using the above three models. Velocity, wall shear stress (WSS) and residual flow volume (RFV) were calculated and compared in order to assess the model differences for both aneurysm sac and parent vessel regions. RESULTS: For parent artery regions, all three models produced similar flow patterns and quantification analysis did not indicate differences in velocity and WSS (p>0.05). For aneurysm sac regions, the FEA model resulted in higher sac-maximized (0.18 m/s vs 0.06 m/s) and sac-averaged velocity (0.013 m/s vs 0.007 m/s), and higher sac-averaged (0.55 Pa vs 0.36 Pa, p=0.006) and sac-maximized WSS (12.1 Pa vs 6.6 Pa) than the POM model. The differences in RFV between the POM and FEA models under 11 different isovelocity thresholds (0.0001 m/s, 0.001 m/s, 0.002 m/s, 0.005 m/s, 0.01 m/s, 0.02 m/s, 0.05 m/s, 0.1 m/s, 0.2 m/s, 0.5 m/s, and 1 m/s) showed that the POM RFV was generally larger than those of the FEA model. CONCLUSIONS: Compared with the FEA model, the POM model provides a lower velocity and WSS and higher RFV for the aneurysm sac, which could lead to incorrect estimates of the recurrent risk of coiled IAs under high packing density.

Midterm outcomes of intracranial aneurysms with bleb formation with densely coiling of the aneurismal neck or entire aneurysm.

To evaluate whether the efficacy and safety of embolization of the aneurysmal neck were better than those of embolization of the entire aneurysm. Previous studies found that embolization of the aneurysmal neck can be used for treating ruptured intracranial aneurysm with bleb formation.In all, 163 patients with ruptured aneurysms with bleb formation who underwent endovascular embolization at the Shanghai Municipal Jing'an District Central Hospital from January 2014 to August 2015 were divided into the embolization of aneurysmal neck group (neck group; 87 cases) and embolization of entire aneurysm group (aneurysm group; 76 cases). A retrospective analysis of clinical data, follow-up Glasgow Outcome Scale (GOS) score, and occurrence of complications was performed. The impacts of different embolisms on the prognosis were compared.The median follow-up time in the neck and aneurysm groups was 17 months (9.62) and 16.5 months (9.54), respectively (P = .799). No differences were found in recurrence, postoperative GOS score, and GOS score at the last follow-up between the 2 groups. The numbers of coils and surgical complications in the neck group were smaller than those in the aneurysm group (P < .001 and P < .030, respectively). After adjusting for age and sex, the embolization method was found to be an independent predictor for surgery-related complications (odds ratio 2.419, 95% confidence interval 1.111-5.269, P = .026).The numbers of coils and surgery-related complications were smaller when embolizing the aneurysmal neck than the entire aneurysm, showing potential advantages of embolization of the aneurysmal neck.