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BACKGROUND: Cerebral aneurysms, especially large and giant aneurysms, pose challenges in neurointerventional surgery. Treatment choices involve clinical presentation, aneurysm details, and global resource variations. Neurointerventional methods, while innovative, may be cost restrictive in certain regions. In public healthcare, cost is crucial, notably in countries like Brazil. This study examines the device specific cost estimation of flow diverters (FD) and traditional stent assisted coiling (SAC) for large and giant cerebral aneurysms, providing insights into optimizing neurosurgical interventions within the Brazilian public health system's unique challenges. METHODS: A comprehensive retrospective analysis was conducted at our medical center of cases of large and giant aneurysms treated between 2013 and 2023. Determination of the estimated number of coils for aneurysms previously treated with FDs at our center was made, with the cost of each case, and the difference between both treatments was calculated. RESULTS: We investigated the profiles of 77 patients: 40 had large aneurysms (51.9%) and 37 had giant aneurysms (48.1%). Large aneurysms had a mean cost difference of US$274 (standard deviation (SD) $2071), underscoring the device specific cost estimation of FDs over SAC in their treatment. For giant aneurysms, the mean cost difference increased to $6396 (SD $2694), indicating FDs as the more economically sound choice. CONCLUSION: Our study indicated that, for the treatment of giant aneurysms and some large aneurysms, the FD intervention was more economical than SAC.
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BACKGROUND: A new generation of modified surface flow diverters (FDs) and monotherapy using new antiplatelets may reduce both ischemic and hemorrhagic complications during the treatment of intracranial aneurysms. Previous preliminary safety analysis of distal unruptured intracranial aneurysms treated with the FD p48 MW HPC (phenox-Wallaby, Bochum, Germany) under antiplatelet monotherapy with prasugrel showed promising results. However, the long term outcomes of distal intracranial aneurysms treated with FDs under antiplatelet monotherapy are not known. METHODS: This was a single center, prospective, pivotal, open single arm study. The primary (safety) endpoint was absence of any new neurological deficits after treatment until the 24 month follow-up. The primary (efficacy) endpoint was the incidence of complete aneurysm occlusion 24 months after treatment. The secondary (efficacy) endpoints were any incidence of aneurysm dome reduction 24 months after treatment. RESULTS: 21 patients harboring 27 distal aneurysms of the anterior circulation were included. No patient had neurologic deficits in the time from treatment to the 24 month follow-up. Complete aneurysm occlusion occurred in 20 (74%) of 27 aneurysms at the 24 month follow-up. Four aneurysms (14.8%) had dome reduction, and three aneurysms (11.1%) remained unchanged. CONCLUSIONS: In this pilot trial, treatment of distal unruptured intracranial aneurysms with an FD under monotherapy with prasugrel, followed by monotherapy with aspirin, appeared to be safe and effective. Randomized studies with long term follow-up are needed to confirm these results.
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Background: The silk + flow-diverter stent is increasingly used to treat complex intracranial aneurysms including wide-neck and fusiform aneurysms. Balloon angioplasty has been used to better appose the flow diverter (FD) to the vessel wall and, thus, improve aneurysm occlusion rates and decrease periprocedural complications. Sparse data are available concerning the results of this technique. We report our experience with silk + FD associated with balloon angioplasty for the treatment of intracranial aneurysms. Methods: A retrospective study was conducted on all patients treated by the silk + FD. Clinical charts, procedural data, and angiographic results were reviewed and compared between those treated with balloon angioplasty. A multivariate analysis was conducted to identify predictors of complications, occlusion, and outcome. Results: Between July 2014 and May 2016, we identified 209 patients with 223 intracranial aneurysms. There were 176 (84.2%) women and 33 (15.8%) men. The most common stent size used was 4.5 mm in 101 patients (46.1%), followed by 4 mm in 57 patients (26%). Univariate analysis observed that stent diameter was significantly related to aneurysm occlusion (P < 0.05). Patients with more than 1 aneurysm treated with silk + stent have a 9.07 times greater chance of having complications in the procedure than patients with only 01 aneurysm (OR = 9.07; P = 0.0008). Patients who had angioplasty without the use of a balloon have a 13.69-times-higher risk of complications (OR = 13.69; P = 0.0003). Older age, larger aneurysms, and the use of more than 1 FD device were predictors of recanalization. Conclusion: Endovascular treatment of intracranial aneurysms with the silk + FD associated with balloon angioplasty is a safe and effective therapeutic option. Balloon angioplasty in combination with FD lowers the risk of complications. Higher complication rates and worse outcomes are associated with older age and large aneurysms.
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RESUMEN Antecedentes : los aneurismas de arterias viscerales (AAV) tienen una frecuencia baja (0,1 a 2%). Hasta un 25% puede presentarse como rotura, con una alta mortalidad (hasta 70%). La terapia endovascular ha ganado terreno y se recomienda como primera opción según las últimas guías. Hoy en día, es posible adaptarse a casi cualquier anatomía utilizando tecnología cerebral. Objetivo : describir la experiencia y enfoque en el manejo endovascular de AAV, con resultados a corto, mediano y largo plazo. Material y métodos : llevamos a cabo una evaluación retrospectiva de pacientes tratados por AAV verdaderos por vía endovascular en un solo centro entre 2010 y 2020, con un seguimiento mínimo de 6 meses. Resultados : analizamos 19 procedimientos en 18 pacientes (9 hombres y 9 mujeres). La edad promedio fue 61,9 años; el promedio de tiempo de internación fue 1,94 días y el promedio de seguimiento de 40 meses. La arteria más involucrada fue la esplénica (n = 9, 50%). El tamaño aneurismático promedio fue 30,1 mm. La estrategia terapéutica más utilizada fue colocación de diversor de flujo (n = 8, 42,1%). Dos pacientes fueron reintervenidos (11,1%). Las tasas de exclusión completa fueron del 47,4%, 68,4% y 94,7% a los 3, 6 y 12 meses, respectivamente. No hubo casos de mortalidad a 30 días ni mortalidad relacionada con el aneurisma durante el seguimiento. Conclusión : el tratamiento endovascular de los AAV es seguro y eficaz. Sin embargo, se debe contar con la tecnología adecuada, para la planificación preoperatoria y el tratamiento.
ABSTRACT Background : the prevalence of visceral artery aneurysms (VAAs) is low (0.1 to 2%). Up to 25% may present as rupture which is associated with high mortality (up to 70%). Endovascular treatment has gained ground and is even considered the first option according to the most recent recommendations. Nowadays, almost any anatomy can be approached with endovascular techniques used to treat intracranial aneurysms. Objective : the aim of our study was to describe the experience and approach for the endovascular management of VAAs with short-, mid-, and long-term results. Material and methods : we conducted a retrospective evaluation of patients with true VAAs undergoing endovascular treatment in a single center between 2010 and 2020 who were followed up for a minimum of 6 months. Results : we analyzed 19 procedures in 18 patients (9 men and 9 women). Mean age was 61.9 years; mean length of hospital stay was 1.94 days and mean follow-up was 40 months. The splenic artery was the vessel most affected (n = 9, 50%). Mean aneurysm size was 30.1 mm. Flow diversion was the strategy most used (n = 8, 42.1%). Two patients required reintervention (11%). Complete exclusion rate was 38.4%, 47.4%, 68.4% and 94.7% at 3, 6 and 12 months, respectively. There were no cases of mortality within the first 30 days and no aneurysm-related mortality during the follow-up period. Conclusion : endovascular treatment of VAAs is a safe and efficient strategy but requires adequate technology for preoperative planning and treatment.
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INTRODUCTION: The Woven EndoBridge device (WEB) was developed as an alternative to treat Wide-Necked bifurcation aneurysms. It has proven to be effective and safe, however, cases of recanalization have been reported. The purpose of this study was to evaluate and quantify hemodynamic parameters and indexes with CFD of the intracranial aneurysms before and after WEB simulation and to establish their relationship to complete occlusion. MATERIALS AND METHODS: Using the heterogeneous model based on the marching cubes algorithm, we created 3D representations of 27 bifurcated intracranial aneurysms treated with the single-layer WEB device to evaluate hemodynamics parameters with CFD, calculated with and without the WEB. RESULTS: We observed a lower treatment entry concentration indices (ICI) (2.12 ± 1.31 versus 3.14 ± 0.93, p-value: 0.029) previous to placement of WEB and higher pre-treatment FN (7.56 ± 5.92 versus 3.35 ± 1.51, p-value: 0.018) and post-treatment FN (5.34 ± 5.89 versus 1.99 ± 0.83, p-value: 0.021) for cases with successful occlusions. Lower post-treatment SRa (197.81 ± 221.29 versus 80.02 ± 45.25, p-value: 0.044) and higher pre (0.11 ± 0.07 versus 0.25 ± 0.19, p-value: 0.011) and post-treatment MATT (0.69 ± 1.23 versus 1.02 ± 0.46, p-value: 0.006) were observed in non-occluded cases. CONCLUSIONS: In our CFD analysis of the hemodynamic parameters of IA, we found lower ICI before the placement of the WEB device and higher FN pre- and post-treatment for cases with successful occlusions. Non-occluded cases had lower post-treatment SRa and higher pre-treatment and post-treatment MATT.
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INTRODUCTION: The Woven EndoBridge device (WEB) is used to treat wide-neck bifurcation aneurysms. These devices are deployed inside the sac. Therefore, the mesh structure provides apposition with the aneurysm wall and induces aneurysmal thrombosis. The objective of our study was to evaluate the anatomic and device-related parameters and indexes with Computational Fluid Dynamics (CFD) of the intracranial aneurysms before and after WEB simulation and find their relationship to complete occlusion. MATERIALS AND METHODS: Using the heterogeneous model based on the marching cubes algorithm, we created 3D representations of 27 bifurcated intracranial aneurysms treated with the single-layer WEB device to evaluate anatomic and device-related parameters with CFD. RESULTS: In our CFD analysis, we observed higher large volumes (Va) (0.25 ± 0.18 versus 0.39 ± 0.09, p-value= 0.025) and higher volume to neck surface ratio (Ra) (1.32 ± 0.17 versus 1.54 ± 0.14, p-value= 0.021) in cases with occlusion failure. CONCLUSIONS: Large aneurysm volumes (Va) and higher volume to neck surface ratio (Ra) could be associated with occlusion failure in aneurysms treated with the WEB device.
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BACKGROUND: Flow diversion is the first-line treatment for several types of intracranial aneurysms. We report on a large series of patients treated with the Derivo Embolization Device who underwent a 1-year angiographic control follow-up. METHODS: We performed a multicenter retrospective analysis of prospectively collected data, designed to evaluate the clinical and angiographic results of treatment of intracranial aneurysms with the Derivo Flow Diverter. The primary endpoint was complete occlusion of the aneurysm within 12 months, which was evaluated using DSA. The secondary endpoint was the absence of any serious adverse events. Univariate and multivariate logistic regression analyses were performed to analyze the data. RESULTS: The study was conducted from December 2016 to September 2019 and enrolled 127 patients with 177 intracranial aneurysms, treated at three different centers. Efficacy at 6 months was 70.1% (122/174) for total occlusion and 87.3% (152/174) for favorable occlusion and, at 12 months, it was 83.3% (145/174) for total occlusion and 97.7% (170/174) for favorable occlusion. Regarding safety concerns, 97.6% (124/127) of patients did not experience severe adverse effects during the follow-up period of 12 months, and there was no procedure-related mortality. CONCLUSIONS: The Derivo Embolization Device, achieving a total occlusion rate of 83.3% and a favorable occlusion rate of 97.7% in a 1-year angiographic control study of 174 aneurysms with minor morbidity and no intervention-related mortality, is a safe and effective treatment for intracranial aneurysms.
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Embolização Terapêutica , Procedimentos Endovasculares , Aneurisma Intracraniano , Humanos , Aneurisma Intracraniano/diagnóstico por imagem , Aneurisma Intracraniano/terapia , Aneurisma Intracraniano/complicações , Estudos Retrospectivos , Angiografia Cerebral/métodos , Resultado do Tratamento , Embolização Terapêutica/métodos , Stents , SeguimentosRESUMO
Background: Pediatric intracranial aneurysms (PIAs) are uncommon. Flow diverters (FDs) have shown to be effective on treatment of selected aneurysms. Methods: We describe 10 cases of PIAs treated with FDs at one medical center in Mexico, from April 2015 to April 2020. Results: Out of 230 patients treated with FDs, 10 (4.3%) were pediatric. Average age was 9.4 years old (R: 6-15). Two patients (20%) had subarachnoid hemorrhage, 3 had epilepsy (30%), 3 (30%) had clinical signs of cranial nerve compression, and 4 (40%) had only headache. Two patients were in 1a grade of Hunt and Kosnik scale. Out of the nonruptured aneurysms, 7 (70%) were in 15 points of Glasgow Coma Scale and 1 patient (10%) was in 13 points. Treatment was performed without complications; nevertheless, appropriate distal deployment was not achieved in one case. At discharge, nine patients had 5 points of Glasgow Outcome Scale. All patients underwent computed tomography angiography or digital subtraction angiography at 1, 3, 6, and 12 months, 2 patients (20%) had a 2-year follow-up, and 3 patients (30%) had a 3-year follow-up. According to Kamran grading scale, 9 patients (90%) were classified as Grade 4 and 1 patient (10%) as Grade 3. Conclusion: Even though it is a small series, as this is an uncommon disease, we may suggest that FDs are useful to treat properly selected PIAs. Our study has consecutive imaging assessment at least a year of follow-up in which aneurysm stable occlusion was observed in 90% of patients.
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BACKGROUND: Prospective studies have established the safety and efficacy of the PipelineTM Embolization Device (PED; Medtronic) for treatment of intracranial aneurysms (IA). OBJECTIVE: To investigate long-term outcomes from the Pipeline Embolization Devices for the Treatment of Intracranial Aneurysms (PEDESTRIAN) Registry. METHODS: The PEDESTRIAN Registry data were retrospectively reviewed, which included patients (March 2006 to July 2019) with complex IAs treated with PED. Patients with unfavorable anatomy and/or recurrence following previous treatment were included and excluded those with acute subarachnoid hemorrhage. The primary angiographic endpoint was complete occlusion and long-term stability. Clinical and radiological follow-up was performed at 3 to 6 mo, 12 mo, and yearly thereafter. RESULTS: A total of 835 patients (mean age 55.9 ± 14.7 yr; 80.0% female) with 1000 aneurysms were included. Aneurysms varied in size: 64.6% were small (≤10 mm), 25.6% were large (11-24 mm), and 9.8% were giant (≥25 mm). A total of 1214 PEDs were deployed. Follow-up angiography was available for 85.1% of patients with 776 aneurysms at 24.6 ± 25.0 mo (mean). Complete occlusion was demonstrated in 75.8% of aneurysms at 12 mo, 92.9% at 2 to 4 yr, and 96.4% at >5 yr. During the postprocedural period, modified Rankin Scale scores remained stable or improved in 96.2% of patients, with stability or improvement in 99.1% of patients >5 yr. The overall major morbidity and neurological mortality rate was 5.8%. CONCLUSION: This study demonstrated high rates of long-term complete aneurysm occlusion, stable or improved functional outcomes, and low rates of complications and mortality. Clinical and angiographic outcomes improved over long-term follow-up, demonstrating that endovascular treatment of IA with PED is safe and effective.
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Embolização Terapêutica , Aneurisma Intracraniano , Adulto , Idoso , Angiografia , Angiografia Cerebral , Embolização Terapêutica/efeitos adversos , Feminino , Seguimentos , Humanos , Aneurisma Intracraniano/diagnóstico por imagem , Aneurisma Intracraniano/terapia , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Sistema de Registros , Estudos Retrospectivos , Resultado do TratamentoRESUMO
BACKGROUND: Flow diverters (FDs) are effective in the treatment of carotid aneurysms. Compared with carotid aneurysms, the treatment of distal intracranial aneurysms with FDs has been associated with a relatively high incidence of complications. Low thrombogenic modified-surface FDs may reduce ischemic complications and allow for the use of a single antiplatelet medication. The aim of this study was to assess the safety and efficacy of the p48 MW HPC Flow Modulation Device (Phenox GmbH, Bochum, Germany) to treat distal intracranial aneurysms used in combination with prasugrel monotherapy. METHODS: This was a single-center, prospective, pivotal, open, single-arm study. Patients were included in this study from December 2019 to September 2020. The primary endpoints were the incidence of any neurologic deficit after treatment until 1 month of follow-up, defined as National Institutes of Health Stroke Scale (NIHSS) ≥1, and the incidence of acute ischemic lesions in magnetic resonance imagin (MRI) images 48 hours after treatment. The secondary endpoint was the rate of complete occlusion of the aneurysms at the 1-month follow-up. RESULTS: Twenty-one patients harboring 27 distal aneurysms of the anterior circulation were included. Mean age was 57.8 (SD 9.7) years, and 16 patients were female (80%). No patient had neurologic symptoms at the 1-month follow-up. Four patients (20%) had asymptomatic acute brain ischemic lesions on MRI. Complete aneurysm occlusion occurred in 9/27 (33.3%) aneurysms at the 1-month follow-up. CONCLUSION: In this pilot safety trial, treatment of distal intracranial aneurysms with p48 MW HPC under monotherapy with prasugrel appeared to be safe.