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1.
J Neuroradiol ; 50(5): 518-522, 2023 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-36868371

RESUMEN

BACKGROUND: Safety and efficacy of the WEB (Woven EndoBridge) device have been extensively evaluated in several good clinical practice studies. Nonetheless, the WEB had several structural evolutions overtime up to the fifth generation WEB device (WEB17). Here, we tried to understand how this may have modified our practices and enlarged our indications for its use. METHODS: We retrospectively analyzed data from all patients with aneurysms treated (or intended to be treated) with a WEB at our institution between July 2012 and February 2022. The time frame was split in two periods: before and after the arrival of the WEB17 in our center (February 2017). RESULTS: 252 patients with 276 wide-necked aneurysms were included; 78 aneurysms (28.2%) were ruptured. Successful embolization with a WEB device was achieved in 263/276 aneurysms (95.3%). With the availability of WEB17, treated aneurysms were significantly smaller (8.2 mm versus 5.9 mm, p<0.001) and off-label location significantly increased (4.4% versus 17.3%, p = 0.02) with an increase of sidewall aneurysm (4.4% versus 11.6%, p = 0.06). Also, WEB were more significantly oversized (1.05 versus 1.11, p<0.01). Adequate and complete occlusion rates increased constantly during the two periods (54.8% versus 67.5%, p = 0.08 and 74.2% versus 83.7%, p = 0.10, respectively). The proportion of ruptured aneurysms slightly increased between the two periods (24.6% versus 29.5%, p = 0.44). CONCLUSIONS: Over the first decade of its availability, the WEB device usage shifted towards smaller aneurysms and broader indications, including ruptured aneurysms. The oversizing strategy also became the standard of practice for WEB deployment in our institution.


Asunto(s)
Aneurisma Roto , Embolización Terapéutica , Procedimientos Endovasculares , Aneurisma Intracraneal , Humanos , Resultado del Tratamiento , Aneurisma Intracraneal/diagnóstico por imagen , Aneurisma Intracraneal/terapia , Estudios Retrospectivos , Aneurisma Roto/diagnóstico por imagen , Aneurisma Roto/terapia
2.
Pediatr Neurosurg ; 57(4): 270-278, 2022.
Artículo en Inglés | MEDLINE | ID: mdl-35398842

RESUMEN

PURPOSE: Pediatric intracranial aneurysms (PIA) are rarer and more complex when compared to adult aneurysms. In general, the clinical presentation of PIA is due to a mass effect, but the presenting symptoms can be also related to ischemia, subarachnoid hemorrhage (SAH), or in a combination of different symptoms. This paper aimed to report a single-center experience with clinical and angiographic aspects of brain aneurysm in children. METHODS: We retrospectively reviewed our prospectively maintained database for patients with intracranial aneurysms in our institution from July 2015 to February 2021. Among these, all patients under 18 years of age submitted to a diagnostic or therapeutic procedure for an intracranial aneurysm were included. RESULTS: Twelve patients were submitted to diagnostic or therapeutic procedures in our department. Three of them had multiple aneurysms, and in total, 17 intracranial aneurysms were assessed in this study. The most frequent location was in the middle cerebral artery (7 cases/41%). Five out of twelve children (42%) presented SAH due to ruptured aneurysm. Three patients (25%) had symptoms due to the mass effect from large aneurysms, with compression of cranial nerves or brainstem. Aneurysms diameters ranged from 1.5 mm to 34 mm (mean 14.2 mm), with six aneurysms being giant and eight being nonsaccular/fusiform. Twelve aneurysms were submitted to endovascular treatment, with one treatment-related clinical complication and later death. CONCLUSION: PIAs are rare diseases that can arise from a variety of different underlying pathological mechanisms. The management of these conditions requires a detailed understanding of the pathology and a multidisciplinary approach. Despite the availability of new technologies, parent vessel occlusion remains a valid option for aneurysms in the pediatric population.


Asunto(s)
Aneurisma Roto , Embolización Terapéutica , Procedimientos Endovasculares , Aneurisma Intracraneal , Hemorragia Subaracnoidea , Adolescente , Adulto , Aneurisma Roto/complicaciones , Aneurisma Roto/diagnóstico por imagen , Aneurisma Roto/cirugía , Angiografía Cerebral/efectos adversos , Niño , Procedimientos Endovasculares/métodos , Humanos , Aneurisma Intracraneal/diagnóstico por imagen , Aneurisma Intracraneal/cirugía , Estudios Retrospectivos , Hemorragia Subaracnoidea/diagnóstico por imagen , Hemorragia Subaracnoidea/cirugía , Resultado del Tratamiento
3.
Stroke ; 51(10): 3147-3155, 2020 10.
Artículo en Inglés | MEDLINE | ID: mdl-32933417

RESUMEN

Endovascular treatment is a highly effective therapy for acute ischemic stroke due to large vessel occlusion and has recently revolutionized stroke care. Oftentimes, ischemic core extent on baseline imaging is used to determine endovascular treatment-eligibility. There are, however, 3 fundamental issues with the core concept: First, computed tomography and magnetic resonance imaging, which are mostly used in the acute stroke setting, are not able to precisely determine whether and to what extent brain tissue is infarcted (core) or still viable, due to variability in tissue vulnerability, the phenomenon of selective neuronal loss and lack of a reliable gold standard. Second, treatment decision-making in acute stroke is multifactorial, and as such, the relative importance of single variables, including imaging factors, is reduced. Third, there are often discrepancies between core volume and clinical outcome. This review will address the uncertainty in terminology and proposes a direction towards more clarity. This theoretical exercise needs empirical data that clarify the definitions further and prove its value.


Asunto(s)
Isquemia Encefálica/diagnóstico por imagen , Encéfalo/diagnóstico por imagen , Accidente Cerebrovascular/diagnóstico por imagen , Isquemia Encefálica/tratamiento farmacológico , Fibrinolíticos/uso terapéutico , Humanos , Imagen por Resonancia Magnética , Accidente Cerebrovascular/tratamiento farmacológico , Terapia Trombolítica , Tomografía Computarizada por Rayos X
4.
J Neuroradiol ; 47(3): 227-232, 2020 May.
Artículo en Inglés | MEDLINE | ID: mdl-30658137

RESUMEN

INTRODUCTION: The treatment of wide-neck bifurcation aneurysms is still challenging despite the use of new techniques, such as Y-stenting, the waffle-cone technique and intrasaccular flow disrupters, in recent years. Moreover, the use of flow diverter stents in bifurcation aneurysms has been proposed by several teams, although the results remain controversial. This study aims to evaluate the feasibility and efficacy of Y-stent assisted coiling of bifurcation aneurysms with braided stents. METHODS: We retrospectively reviewed all patients in whom Y-stenting with braided stents had been performed in our center. Six patients were identified and analyzed. Technical success, complications, angiographic outcomes, procedural data, and follow-up controls are reported here. This study was approved by our local ethical committee. RESULTS: Technical success was achieved in all procedures. Overall procedure-related morbidity and mortality was 0%. In the immediate post-treatment angiography, adequate occlusion (neck remnant or total occlusion) was observed in all patients. Short- and long-term follow-up angiography showed adequate occlusion of the aneurysms. CONCLUSIONS: In this small, retrospective single-center analysis we showed that Y-stent assisted coiling with braided stents is a safe and feasible technique. Moreover, it has a high immediate occlusion rate and very good long-term stability.


Asunto(s)
Embolización Terapéutica/métodos , Aneurisma Intracraneal/terapia , Anciano , Angiografía Cerebral , Humanos , Aneurisma Intracraneal/diagnóstico por imagen , Aneurisma Intracraneal/patología , Persona de Mediana Edad , Estudios Retrospectivos , Stents , Resultado del Tratamiento
5.
J Neuroradiol ; 47(5): 349-352, 2020 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-31400432

RESUMEN

BACKGROUND AND PURPOSE: The PHASES score was formulated to predict the 5-year risk of rupture for intracranial aneurysms. We retrospectively analyzed all patients treated in our institution for aneurysmal SAH and applied the PHASES score to estimate the probable predicted risk of bleeding in this group of patients. METHODS: Between February 2015 and August 2018, all patients with aneurysmal SAH were retrospectively analyzed and the PHASES score was applied. A total of 155 patients were included with a mean age of 53.8years, including 60 males and 95 females. RESULTS: Of our patients 110 (70.9%) had a PHASES score of below or equal to 5, with a hemorrhagic risk of up to 1.3% over 5years. If we analyze the patients with a risk of below 2% this figure increases to 122 patients (78.7%). Of these 99.3% were European and 0.6% were Japanese (1 patient). In 86 patients (55.4%), the aneurysm was smaller than 5mm and in 10 patients (6.4%) the aneurysm was located in the posterior circulation. CONCLUSION: Of our patients 78.7% had less than a 2% 5-year rupture risk based on their PHASES score, highlighting the discrepancy of the rupture risk calculated with the PHASES score when hypothetically applied to this group of patients. In the hypothetical scenario that our patients had unruptured aneurysms, our retrospective analysis shows that the PHASES score may only provide a weak tool for clinicians to use in the decision-making process as to whether or not to treat these aneurysms.


Asunto(s)
Aneurisma Roto/etiología , Aneurisma Roto/terapia , Aneurisma Intracraneal/complicaciones , Aneurisma Intracraneal/terapia , Medición de Riesgo/métodos , Hemorragia Subaracnoidea/etiología , Hemorragia Subaracnoidea/terapia , Adulto , Anciano , Anciano de 80 o más Años , Toma de Decisiones , Europa (Continente) , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Factores de Riesgo
6.
Eur Radiol ; 29(2): 645-653, 2019 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-30019142

RESUMEN

OBJECTIVES: To establish dose reference levels (RLs) for stroke interventions while carefully analysing the impact of clinical and technical parameters on patient exposure. METHODS: The study retrospectively analysed data from 377 stroke patients prospectively collected between 15 October 2015 and 30 March 2017 at a single, level-3 stroke centre equipped with Philips Allura Clarity systems. Local dose RLs were first derived as the 75th percentile of the dose area product (DAP), cumulative air kerma (Ka,r), fluoroscopy time (FT) and the number of images (NI). Univariate and multivariate negative binomial regressions were considered for the statistical analysis to investigate the dose variability with clinical and technical parameters such as patient's age and sex, occlusion removal technique, number of passages, single-plane or biplane equipment, etc. RESULTS: Local stroke dose RLs were derived in terms of total DAP (162 Gy cm2), Ka,r (854 mGy), FT (42 min) and NI (559). Gender (relative dose multiplier (RDM) 1.31; 95% CI 1.12-1.45), number of passages (RDM 1.22 per passage; 95% CI 1.10-1.22) and procedure success (RDM 0.52, 95% CI 0.55-0.80) proved to be key parameters affecting patient dose. Meanwhile the statistical analysis did not find any difference in relative dose received by patients owing to age, baseline NIHSS score, occlusion removal technique, posterior circulation, support of an anaesthesiologist or use of biplane equipment. CONCLUSIONS: Stroke dose RLs introduced in this work promote the optimisation of patient doses. Male gender, number of passages and success of recanalisation are independent key parameters affecting patient dose. KEY POINTS: • Stroke dose RLs derived in terms of total DAP (162 Gy cm 2 ), K a,r (854 mGy), FT (42 min) and NI (559) will help optimise the radiation safety of patients treated with mechanical thrombectomy. • Male gender (relative dose multiplier 1.31; 95% CI 1.12-1.45), number of passages (RDM 1.22 per passage; 95% CI 1.10-1.22) and success of recanalisation TICI score > 2b (RDM 0.52, 95% CI 0.55-0.80) are independent key parameters affecting patient dose. • Stent retriever or aspiration technique showed no significant difference in terms of the dose delivered to the patient; neither technique should be favoured for dosimetric reasons provided that there is no difference regarding clinical outcomes.


Asunto(s)
Fluoroscopía/normas , Dosis de Radiación , Accidente Cerebrovascular/diagnóstico por imagen , Accidente Cerebrovascular/cirugía , Trombectomía/métodos , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Angiografía Cerebral/métodos , Angiografía Cerebral/normas , Femenino , Fluoroscopía/métodos , Humanos , Masculino , Persona de Mediana Edad , Protección Radiológica/métodos , Protección Radiológica/normas , Radiometría/métodos , Estudios Retrospectivos , Stents , Trombectomía/normas , Adulto Joven
7.
J Neuroradiol ; 44(4): 262-268, 2017 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-28478112

RESUMEN

BACKGROUND: Recent reports have revealed a worsening of aneurysm occlusion between WEB treatment baseline and angiographic follow-up due to "compression" of the device. OBJECTIVE: We utilized computational fluid dynamics (CFD) in order to determine whether the underlying mechanism of this worsening is flow related. METHODS: We included data from all consecutive patients treated in our institution with a WEB for unruptured aneurysms located either at the middle cerebral artery or basilar tip. The CFD study was performed using pre-operative 3D rotational angiography. From digital subtraction follow-up angiographies patients were dichotomized into two groups: one with WEB "compression" and one without. We performed statistical analyses to determine a potential correlation between WEB compression and CFD inflow ratio. RESULTS: Between July 2012 and June 2015, a total of 22 unruptured middle cerebral artery or basilar tip aneurysms were treated with a WEB device in our department. Three patients were excluded from the analysis and the mean follow-up period was 17months. Eleven WEBs presented "compression" during follow-up. Interestingly, device "compression" was statistically correlated to the CFD inflow ratio (P=0.018), although not to aneurysm volume, aspect ratio or neck size. CONCLUSION: The mechanisms underlying the worsening of aneurysm occlusion in WEB-treated patients due to device compression are most likely complex as well as multifactorial. However, it is apparent from our pilot study that a high arterial inflow is, at least, partially involved. Further theoretical and animal research studies are needed to increase our understanding of this phenomenon.


Asunto(s)
Circulación Cerebrovascular/fisiología , Embolización Terapéutica/instrumentación , Procedimientos Endovasculares/instrumentación , Hemodinámica/fisiología , Aneurisma Intracraneal/fisiopatología , Aneurisma Intracraneal/terapia , Angiografía de Substracción Digital , Arteria Basilar/diagnóstico por imagen , Angiografía Cerebral , Femenino , Humanos , Imagenología Tridimensional , Aneurisma Intracraneal/diagnóstico por imagen , Masculino , Persona de Mediana Edad , Arteria Cerebral Media/diagnóstico por imagen , Estudios Retrospectivos
8.
Neuroradiology ; 58(9): 887-91, 2016 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-27312475

RESUMEN

INTRODUCTION: The Woven EndoBridge (WEB) system is an innovative device under evaluation for its capacity to treat wide-neck bifurcation intracranial aneurysms. The purpose of this study is to evaluate the use of the different occlusion scales available in clinical practice. METHODS: Seven WEB-experienced neurointerventionalists were provided with 30 angiographic follow-up data sets and asked to grade each evaluation point according to the Bicêtre Occlusion Scale Score (BOSS), firstly based on DSA images only then using additional C-Arm VasoCT analysis. This BOSS evaluation was then converted into the WEB Occlusion Scale (WOS) and into a dichotomized scale (complete occlusion or not). To estimate the inter-rater agreement among the seven raters, an overall kappa coefficient [1] and its standard error (SE) were computed. RESULTS: Using the five-grade BOSS, raters showed "moderate" agreement (kappa = 0.56). Using the three-grade WOS, agreement appeared slightly better (kappa = 0.59). Strongest inter-rater agreement was observed with a dichotomized version of the scale (complete occlusion or not), which enabled an "almost perfect" agreement (kappa = 0.88). VasoCT consistently enhanced the agreement particularly with regards depicting intra-WEB residual filling. CONCLUSION: The WOS is a consistent means to angiographically evaluate the WEB device efficiency. But the five-grade BOSS scale allows to identify aneurysm subgroups with differing risks of recurrence and/or rehemorrhage, which needs to be separated especially at the initial phase of evaluation of this innovative device. The additional use of VasoCT allows better inter-rater agreement in evaluating occlusion and specially in depicting intra-WEB persistent filling.


Asunto(s)
Prótesis Vascular , Angiografía Cerebral/métodos , Angiografía por Tomografía Computarizada/métodos , Procedimientos Endovasculares/instrumentación , Aneurisma Intracraneal/diagnóstico por imagen , Aneurisma Intracraneal/terapia , Stents , Análisis de Falla de Equipo , Humanos , Diseño de Prótesis , Resultado del Tratamiento
9.
Neuroradiology ; 56(9): 755-61, 2014 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-24930127

RESUMEN

INTRODUCTION: Endovascular treatment of ruptured wide-neck bifurcation aneurysms presents a challenge. While still under evaluation, the Woven Endobridge (WEB) aneurysm embolization system has so far shown promising results in the treatment of complex bifurcation aneurysms. We aimed to evaluate the feasibility and short-term follow-up of endovascular treatment of ruptured wide-neck aneurysm with the WEB device. METHODS: Six patients referred to our institution for acute symptomatic subarachnoid hemorrhage (SAH) and treated with the WEB device were enrolled in this study. Clinical presentations, technical details, intraoperative and postoperative complications, and outcomes were recorded. Immediate and 3-month angiographic results were also evaluated. RESULTS: Three middle cerebral artery (MCA) and three anterior communicating artery aneurysms were treated between 1 and 14 days after rupturing. Average dome width was 5.8 mm (range 5-7), average neck size was 4.5 mm (range 4-5), and average dome-to-neck ratio was 1.3 (range 1-1.7). The WEB system was the exclusive treatment and was successfully deployed in all cases. Per procedural thromboembolic events occurred in two cases and were treated with intra-arterial administration of antiplatelet agents without any clinical consequences. The modified Rankin Scale (mRS) score at discharge was 0 for all patients. The 3-month angiographic follow-up showed adequate occlusion in four of our six patients (67 %). CONCLUSION: From this preliminary study, the high feasibility rate and lack of need for systematic antiplatelet agents favor the WEB device providing a solution for endovascular treatment of ruptured wide-neck bifurcation aneurysms during the acute phase. However, further studies are needed to evaluate the complication rate and long-term efficiency.


Asunto(s)
Aneurisma Roto/cirugía , Procedimientos Endovasculares/instrumentación , Aneurisma Intracraneal/cirugía , Adulto , Aneurisma Roto/patología , Estudios de Factibilidad , Femenino , Humanos , Aneurisma Intracraneal/patología , Masculino , Persona de Mediana Edad , Estudios Retrospectivos
10.
Neuroradiology ; 56(3): 245-9, 2014 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-24449134

RESUMEN

INTRODUCTION: Cerebral blood volume (CBV) measurement by flat panel detector CT (FPCT) in the angiography suite seems to be a promising tool for patient management during endovascular therapies. A steady state of contrast agent distribution is mandatory during acquisition for accurate FPCT CBV assessment. To the best of our knowledge, this was the first time that steady-state parameters were studied in clinical practice. METHODS: Before the CBV study, test injections were performed and analyzed to determine a customized acquisition delay from injection for each patient. Injection protocol consisted in the administration of 72 mL of contrast agent material at the injection rate of 4.0 mL/s followed by a saline flush bolus at the same injection rate. Peripheral or central venous accesses were used depending on their availability. Twenty-four patients were treated for different types of neurovascular diseases. Maximal attenuation, steady-state length, and steady-state delay from injection were derived from the test injections' time attenuation curves. RESULTS: With a 15 % threshold from maximum attenuation values, average steady-state duration was less than 10 s. Maximum average steady-state duration with minimal delay variation was obtained with central injection protocols. CONCLUSION: With clinically acceptable contrast agent volumes, steady state is a brief condition; thus, fast rotation speed acquisitions are needed. The use of central injections decreases the variability of steady-state's delay from injection. Further studies are needed to optimize and standardize injection protocols to allow a larger diffusion of the FPCT CBV measurement during endovascular treatments.


Asunto(s)
Determinación del Volumen Sanguíneo/métodos , Encéfalo/fisiopatología , Angiografía Cerebral/métodos , Modelos Cardiovasculares , Tomografía Computarizada por Rayos X/métodos , Ácidos Triyodobenzoicos/farmacocinética , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Velocidad del Flujo Sanguíneo , Volumen Sanguíneo , Encéfalo/diagnóstico por imagen , Simulación por Computador , Medios de Contraste/farmacocinética , Femenino , Humanos , Masculino , Tasa de Depuración Metabólica , Persona de Mediana Edad , Interpretación de Imagen Radiográfica Asistida por Computador/métodos , Reproducibilidad de los Resultados , Sensibilidad y Especificidad , Adulto Joven
11.
Neuroradiology ; 55(3): 345-50, 2013 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-23179298

RESUMEN

INTRODUCTION: Endovascular treatment of dural arteriovenous malformation is challenging especially if the related dural venous sinus is patent and might be usable for normal venous drainage. METHODS: A new particular venous balloon remodeling technique was described in the treatment of transverse-sigmoid dural arteriovenous malformation by using transarterial Onyx. The goal was obliteration of the malformation with preservation of the dural sinus. Two illustrative cases with 6-month follow-up result were narrated. RESULTS: The penetration of Onyx in the dural arterial feeders was well achieved. Obliteration of the malformation with preservation of the dural sinus was finally demonstrated. CONCLUSION: Transvenous balloon assistance is a useful and feasible technique in the treatment of dural arteriovenous malformation when sinus preservation is in concern.


Asunto(s)
Oclusión con Balón/métodos , Malformaciones Vasculares del Sistema Nervioso Central/terapia , Dimetilsulfóxido/administración & dosificación , Polivinilos/administración & dosificación , Anciano , Malformaciones Vasculares del Sistema Nervioso Central/diagnóstico , Femenino , Hemostáticos/administración & dosificación , Humanos , Inyecciones Intravenosas , Masculino , Persona de Mediana Edad , Resultado del Tratamiento
12.
Neuroradiology ; 55(11): 1373-8, 2013 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-24057085

RESUMEN

INTRODUCTION: Solitaire AB stent-assisted coiling facilitates the endovascular treatment of wide-necked intracranial aneurysms. Solitaire Aneurysm Remodeling is the first prospective, consecutive, European multicentric study whose main objective was to evaluate the safety, short-, and long-term efficacy of the Solitaire AB stent. This first analysis is focused on the short-term results. METHODS: After exclusion of one patient, 66 Solitaire AB stents were used to treat via endovascular approach 64 aneurysms (63 patients) in seven European centers. Technical and clinical complications were recorded. A core laboratory evaluated the angiographic efficacy by using the Raymond classification scale. RESULTS: The mean width of aneurysm sac was 7.5 mm, and the mean diameter of aneurysm neck was 4.7 mm. Complete occlusion was achieved in 27 aneurysms (42.2 %); neck remnant was seen in 25 aneurysms (39.1 %) and aneurysm remnant in 12 aneurysms (18.7 %). Technical and clinical complications related to the procedure were encountered in eight patients (12.7 %). Postprocedural modification of the clinical status was observed in one patient (1.6 %). No patients died (0 %); one had a permanent deficit (1.6 %), and one had a transient deficit (1.6 %). Treatment-related mortality was 0 %, and permanent morbidity was 1.6 %. CONCLUSION: The Solitaire AB stent has an excellent rate of technical success navigation with the absence of dislodgement. The safety and short-term efficacy are comparable to those previously reported with coiling alone. Mid- and long-term follow-up will be required to elucidate the impact of the Solitaire AB stent on recanalization rate.


Asunto(s)
Prótesis Vascular/estadística & datos numéricos , Aneurisma Intracraneal/mortalidad , Aneurisma Intracraneal/cirugía , Stents/estadística & datos numéricos , Adulto , Anciano , Anciano de 80 o más Años , Análisis de Falla de Equipo , Europa (Continente)/epidemiología , Femenino , Humanos , Aneurisma Intracraneal/diagnóstico por imagen , Masculino , Persona de Mediana Edad , Prevalencia , Estudios Prospectivos , Diseño de Prótesis , Radiografía , Factores de Riesgo , Tasa de Supervivencia , Resultado del Tratamiento
13.
J Neurointerv Surg ; 15(6): 552-557, 2023 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-35803731

RESUMEN

BACKGROUND: Evaluating a new endovascular treatment for intracranial aneurysms must not only demonstrate short-term safety and efficacy, but also evaluate longer-term outcomes (eg, delayed complications, anatomical results, retreatment). The current analysis reports the 5-year clinical and anatomical results of Woven EndoBridge (WEB) treatment in two European combined trial populations (WEBCAST (WEB Clinical Assessment of Intrasaccular Aneurysm Therapy) and WEBCAST-2). METHODS: All adverse events occurring between the procedure and 5-year follow-up were independently evaluated by an expert. Aneurysm occlusion was evaluated by an independent core laboratory using a three-grade scale: complete occlusion, neck remnant, and aneurysm remnant. In cases where data were not available at 5-year follow-up, the last observation carry forward (LOCF) method was used. RESULTS: The safety and efficacy populations comprised 100 patients and 95 aneurysms, respectively. No adverse event related to the device occurred after the procedure during the 5-year follow-up period. Mortality at 5 years was 7.0% (7/100 patients) including mortality related to the WEB (0/100, 0.0%), the procedure (1/100, 1.0%), and another condition (6/100, 6.0%). At 5 years, complete aneurysm occlusion was observed in 49/95 (51.6%) aneurysms, neck remnant in 25/95 (26.3%), and aneurysm remnant in 21/95 (22.1%). Retreatment rate at 5 years was 11.6% (11/95 aneurysms). CONCLUSIONS: This analysis conducted in a population of patients with wide-neck bifurcation aneurysms confirms WEB's safety profile. Additional evidence demonstrates good stability of aneurysm occlusion with adequate occlusion (complete occlusion or neck remnant) at 5 years in 77.9% of aneurysms with a low retreatment rate (11.6%). CLINICAL TRIAL REGISTRATION: WEBCAST and WEBCAST-2: Unique identifier: NCT01778322.


Asunto(s)
Embolización Terapéutica , Procedimientos Endovasculares , Aneurisma Intracraneal , Humanos , Resultado del Tratamiento , Estudios de Seguimiento , Estudios Prospectivos , Procedimientos Endovasculares/métodos , Aneurisma Intracraneal/diagnóstico por imagen , Aneurisma Intracraneal/cirugía , Embolización Terapéutica/métodos , Estudios Retrospectivos
14.
J Neurointerv Surg ; 15(5): 446-451, 2023 May.
Artículo en Inglés | MEDLINE | ID: mdl-35428742

RESUMEN

BACKGROUND: Woven EndoBridge (WEB) devices are becoming a reliable option for the treatment of wide-neck bifurcation aneurysms, but clear predictive factors are still missing to understand the one in five aneurysm remnant rate. OBJECTIVE: To evaluate occlusion outcomes after WEB treatment to identify potential determinants of aneurysm occlusion. METHODS: A single-center database with consecutive aneurysms treated with WEB between July 2012 and October 2021 was reviewed for potential determinants of aneurysm adequate occlusion (defined as a Bicêtre Occlusion Scale Score (BOSS) of 0, 0', 1 or 2), through univariate and multivariable analysis. Patients without angiographic follow-up were excluded. RESULTS: 215 of 247 individual aneurysms were included in the final analysis, of which 59 (27%) were ruptured. Mean age of patients was 56 years (range 23-90 years) and 65% were female. Mean angiographic follow-up was at 18 months (range 3-97 months). Adequate and complete occlusion were achieved in 171/215 (79.5%) and 135/215 (62.8%) of cases, respectively. Aneurysm irregular shape (aOR=0.42, 95% CI 0.20 to 0.88; p=0.02), aneurysm height (aOR=0.79, 95% CI 0.66 to 0.94; p<0.01), and WEB shape modification (aOR=0.98, 95% CI 0.97 to 1.00; p=0.02) were all independent predictors of aneurysm recurrence, whereas the WEB oversizing ratio (WEB width/aneurysm mean width) (aOR=16.4, 95% CI 1.4 to 266.7; p=0.04) was an independent predictor of adequate occlusion. CONCLUSION: In this study we demonstrated that a width oversizing strategy of the WEB device was an independent predictor of aneurysm angiographic occlusion. Conversely, aneurysm height, irregular aneurysm, and WEB shape modification were all independent determinants of angiographic aneurysm remnant. These results may help to select aneurysms suitable for the WEB device and WEB sizing.


Asunto(s)
Embolización Terapéutica , Procedimientos Endovasculares , Aneurisma Intracraneal , Humanos , Femenino , Adulto Joven , Adulto , Persona de Mediana Edad , Anciano , Anciano de 80 o más Años , Masculino , Aneurisma Intracraneal/diagnóstico por imagen , Aneurisma Intracraneal/terapia , Estudios de Seguimiento , Resultado del Tratamiento , Procedimientos Endovasculares/métodos , Estudios Retrospectivos , Angiografía Cerebral , Embolización Terapéutica/métodos
15.
J Neurointerv Surg ; 15(7): 650-654, 2023 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-35882550

RESUMEN

BACKGROUND: The CLinical Assessment of WEB device in Ruptured aneurYSms (CLARYS) study has shown that the endovascular treatment of ruptured bifurcation aneurysms with the Woven EndoBridge (WEB) is safe and effective and provides protection against rebleeding at 1 month and 1 year. The 12-month angiographic follow-up is an important endpoint of the study. METHODS: The CLARYS study is a prospective multicenter study conducted in 13 European centers. The study enrolled 60 patients with 60 ruptured aneurysms of the anterior and posterior circulation. The study was conducted with an independent assessment of safety outcomes and imaging. RESULTS: Sixty patients with 60 ruptured bifurcation aneurysms to be treated with the WEB were included. Fifty-three aneurysms (88.3%) had a broad base with a dome to neck ratio <2 (mean 1.6). Of these, 46 patients were evaluated by an independent core laboratory with follow-up imaging performed at 12 months or before eventual retreatment. At 1 year, 19/46 aneurysms (41.3%) were completely occluded (Raymond-Roy grade I), 21/46 (45.7%) had a residual neck and 6/46 (13.0%) had residual aneurysm filling. Adequate occlusion was reported in 40/46 (87%) aneurysms. Six patients underwent target aneurysm retreatment. CONCLUSIONS: The CLARYS study has previously shown that the use of the WEB in the endovascular treatment of ruptured bifurcation aneurysms provides effective protection against rebleeding with a good safety profile. The angiographic occlusion rates at 1 year reported here are comparable to those already seen in previous multicenter studies which primarily included unruptured aneurysms.


Asunto(s)
Aneurisma Roto , Procedimientos Endovasculares , Aneurisma Intracraneal , Humanos , Resultado del Tratamiento , Estudios Prospectivos , Aneurisma Intracraneal/diagnóstico por imagen , Aneurisma Intracraneal/cirugía , Procedimientos Endovasculares/métodos , Aneurisma Roto/diagnóstico por imagen , Aneurisma Roto/cirugía
16.
J Neurointerv Surg ; 14(1)2022 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-33727411

RESUMEN

BACKGROUND: The Woven EndoBridge (WEB) shape modification (WShM) during follow-up may be a potential cause of poor angiographic outcomes. WShM predisposing factors have not yet been determined. Our systematic use of rotational cone beam computed tomography (VasoCT) imaging during follow-up allowed us to perform the first quantitative analysis of the shape of WEBs over time. Our goal was to identify possible strategies to reduce the occurrence of this phenomenon. METHODS: All patients treated in our hospital with a WEB device between October 2015 and January 2019 were included. Using VasoCT acquisitions, systematically performed after implantation and during follow-up, we analyzed WEB morphology. WShM was defined as the percentage reduction in the distance between the two WEB markers. RESULTS: Sixty-three aneurysms treated with a WEB device were finally included in this analysis. At the last follow-up (mean 15.5 months), mean WShM was 48%±24. The mean WShM was significantly higher in the aneurysm recurrence group than in the adequate occlusion group (51±6.5% vs 36±3.4%, difference 15% points (95% CI 0.7 to 30); p<0.05). Conversely, the extent of WShM did not directly correlate with occlusion rates. Indeed, 32% of completely occluded aneurysms presented severe WShM (≥50%). Importantly, the absence of WShM guaranteed complete occlusion in our study (n=12). We demonstrated that oversizing the width of the WEB significantly correlated with WShM reduction during follow-up (r=-0.38, p=0.002). CONCLUSION: WShM can be partly overcome by use of an appropriate width oversizing strategy that could lead to improved angiographic results.


Asunto(s)
Embolización Terapéutica , Procedimientos Endovasculares , Aneurisma Intracraneal , Angiografía , Humanos , Aneurisma Intracraneal/diagnóstico por imagen , Aneurisma Intracraneal/cirugía , Estudios Retrospectivos , Resultado del Tratamiento
17.
J Neurointerv Surg ; 14(4): 362-365, 2022 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-33975921

RESUMEN

BACKGROUND: Woven EndoBridge (WEB) device treatment of wide-neck bifurcation aneurysms has proved to be safe and effective, but the use of these devices in sidewall aneurysms has been reported only in a small number of case series. OBJECTIVE: To report our results in a cohort of consecutive patients in whom a WEB device was used as first-line treatment for posterior communicating artery (PComA) aneurysms. METHODS: We conducted a retrospective analysis of a prospectively maintained database of PComA aneurysms treated with a WEB device in our institution from June 1, 2012 to November 15, 2020. Clinical and radiological findings were evaluated at immediate and last follow-up. RESULTS: A total of 219 aneurysms were treated with a WEB device, including 15 PComA aneurysms in 15 patients, 10 of which were ruptured. Aneurysms were wide necked, with a mean aspect ratio of 1.6 (range 0.7-3.0) and a mean neck size of 4.2 mm (range 2.6-7.4 mm). No intraoperative rupture occurred and only one thromboembolic event was noted. Among the group with at least a 3-month digital subtraction angiography (DSA) follow-up, complete and adequate occlusion were obtained in 54% and 72%, respectively (average follow-up 13 months). Re-treatment was needed for two initially ruptured aneurysms. No procedure-related morbidity or mortality was reported. CONCLUSION: This series suggests the high safety profile of WEB devices even when used in off-label indications. Treatment with these devices seems to be a valuable strategy for ruptured wide-neck PComA aneurysms, avoiding the need for antiplatelet medication. However, occlusion rates should be investigated in further larger studies.


Asunto(s)
Aneurisma Roto , Embolización Terapéutica , Procedimientos Endovasculares , Aneurisma Intracraneal , Aneurisma Roto/terapia , Embolización Terapéutica/métodos , Procedimientos Endovasculares/métodos , Humanos , Aneurisma Intracraneal/diagnóstico por imagen , Aneurisma Intracraneal/cirugía , Estudios Retrospectivos , Resultado del Tratamiento
18.
J Neurointerv Surg ; 14(8): 807-814, 2022 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-34493578

RESUMEN

BACKGROUND: The primary goal of the CLARYS study is to assess the protection against rebleeding when treating ruptured bifurcation aneurysms with the Woven EndoBridge (WEB) device. METHODS: The CLARYS study is a prospective, multicenter study conducted in 13 European centers. Patients with ruptured bifurcation aneurysms were consecutively included between February 2016 and September 2017. The primary endpoint was defined as the rebleeding rate of the target aneurysm treated with the WEB within 30 days postprocedure. Secondary endpoints included periprocedural and postprocedural adverse events, total procedure and fluoroscopy times, and modified Rankin Scale score at 1 month and 1 year. RESULTS: Sixty patients with 60 ruptured bifurcation aneurysms to be treated with the WEB were included. A WEB device was successfully implanted in 93.3%. The rebleeding rate at 1 month and 1 year was 0%. The mean fluoroscopy time was 27.0 min. Twenty-three periprocedural complications were observed in 18 patients and resolved without sequelae in 16 patients. Two of these complications were attributed to the procedure and/or the use of the WEB, leading to a procedure/device-related intraoperative complication rate of 3.3%. Overall mortality at 1 month and 1 year was 1.7% and 3.8%, respectively and overall morbidity at 1 month and 1 year was 15% and 9.6%, respectively. WEB-related 1-month and 1-year morbidity and mortality was 0%. CONCLUSIONS: The interim results of CLARYS show that the endovascular treatment of ruptured bifurcation aneurysms with the WEB is safe and effective and, in particular, provides effective protection against rebleeding. It may induce profound change in the endovascular management of ruptured bifurcation aneurysms.


Asunto(s)
Aneurisma Roto , Embolización Terapéutica , Procedimientos Endovasculares , Aneurisma Intracraneal , Aneurisma Roto/diagnóstico por imagen , Aneurisma Roto/cirugía , Embolización Terapéutica/métodos , Procedimientos Endovasculares/métodos , Humanos , Aneurisma Intracraneal/diagnóstico por imagen , Aneurisma Intracraneal/cirugía , Estudios Prospectivos , Prótesis e Implantes , Estudios Retrospectivos , Resultado del Tratamiento
19.
Neuroradiology ; 53(1): 23-30, 2011 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-20480156

RESUMEN

INTRODUCTION: The pipeline embolization device (PED, Chestnut Medical, Menlo Park, CA, USA) has been used in our department since September 2008. The first-generation PED had limited radio-opacity. Before September 2008, we began obtaining an angiographic computed tomography (ACT) before and after each procedure to detect intracranial complications. We retrospectively examined the ACT of our patient's with the PED to evaluate the in vivo stent morphology. METHODS: Twelve patients had a PED placed in our department from September 2008 to January 2009. The stent morphology (stent profile and wall apposition) of three segments of each stent was evaluated. RESULTS: Metal coils adjacent to the stent created too much artifact to evaluate the stent morphology in 4 of 12 patients. Two of the 12 patients were excluded for other reasons. Post-processing of the ACT images was necessary to optimize the evaluation of the stent morphology. Six intracranial PEDs could be adequately evaluated by the ACT, and for these particular cases, 18 of 18 stent segments showed an optimal stent profile and 14 of 18 stent segments showed optimal arterial wall apposition. CONCLUSION: ACT provided detailed images of the morphology of the PED in six patients. ACT helped detect two stent segments that required balloon dilation to improve the stent-arterial wall apposition; and during the retrospective analysis (after refining post-processing techniques), we identified one additional stent with suboptimal arterial wall apposition. The main limitation of the ACT was the additional radiation dose to the patient.


Asunto(s)
Angiografía Cerebral/métodos , Embolización Terapéutica/instrumentación , Aneurisma Intracraneal/diagnóstico por imagen , Aneurisma Intracraneal/cirugía , Stents , Cirugía Asistida por Computador/métodos , Tomografía Computarizada por Rayos X , Anciano , Diseño de Equipo , Análisis de Falla de Equipo , Femenino , Humanos , Masculino , Persona de Mediana Edad , Resultado del Tratamiento
20.
Neuroradiology ; 53(9): 659-67, 2011 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-20981414

RESUMEN

INTRODUCTION: Morphology of the Silk stent (Balt, Montmorency, France) after deployment is not fully understood, especially in tortuous vessels. An in vitro study was conducted to study morphology and flow-diverting parameters of this stent. METHODS: Two sets of different-sized and curved polytetrafluoroethylene tubes were studied. To simulate the aneurysm neck, a small hole was created in a tube. A stent was placed in each of the different tubes. Angiographic computerized tomography and macroscopic photography were then obtained. The images were analyzed to calculate a Percentage of Area Coverage (PAC). RESULTS: Good stent conformability was observed. The PAC was 21% in the straight model with matched stent and vessel diameter. In the straight model with an oversized stent, the PAC was increased. In the curved models, dynamic wire repositioning occurred. The repositioning was affected by the size of the stent and the angle of the vessel curve. Compared to the straight model, this increased the PAC in two instances: on the convexity (oversized stent), and on the concavity (matched stent and vessel diameter). The PAC did not significantly change at the sides of the curve. CONCLUSIONS: By design, the wires of the silk stent move relative to each other. In a curved model, the PAC is different at the convexity, concavity, and lateral walls. The stent diameter affects the PAC. These results are clinically relevant because it is desirable to maximize and minimize the PAC across the aneurysm neck and branch vessel orifice, respectively.


Asunto(s)
Aneurisma/diagnóstico por imagen , Aneurisma/terapia , Ensayo de Materiales/instrumentación , Politetrafluoroetileno , Diseño de Prótesis/instrumentación , Seda , Stents , Tomografía Computarizada por Rayos X , Humanos , Ensayo de Materiales/métodos , Diseño de Prótesis/métodos
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