Derivo Embolization Device for the Treatment of Intracranial Aneurysms.

Background and Purpose- Flow diverter technology improvements are necessary to provide safe and good results and enable the treatment of a larger variety of aneurysms. We report a nationwide experience with the Derivo Embolization Device in the treatment of intracranial aneurysms. Methods- BRAIDED (Brazilian Registry of Aneurysms Assigned to Intervention With the Derivo Embolization Device) is a multicenter, prospective, interventional, single-arm trial of the Derivo Embolization Device for the treatment of intracranial aneurysms. The primary effectiveness end point was total aneurysm occlusion at 6- and 12-month angiographies. The secondary safety end point was the absence of serious adverse events during follow-up. Univariable and multivariable logistic regression was performed to identify predictors of aneurysm persistence, periprocedural complications, and adverse events during follow-up. Results- Between December 2016 and October 2018, 146 patients harboring 183 intracranial aneurysms were treated in 151 interventions at 7 centers. Derivo Embolization Device placement was technically successful in all patients. Most aneurysms (86.9%) were located at the internal carotid artery, and the mean diameter was 6.7 mm. At 6 months, 113 of 140 (80.7%) aneurysms met the study's primary end point, and 74 of 83 (89.2%) met the study's primary end point at 12 months. Saccular morphology of the aneurysm (odds ratio, 5.66; 95% CI, 1.01-31.77) and the presence of a branch arising from the sac (odds ratio, 6.36; 95% CI, 2.11-22.36) predicted persistence. A long duration of follow-up (odds ratio, 0.86; 95% CI, 0.78-0.95) predicted total occlusion. Of the 146 enrolled patients, 138 (94.5%) were treated without serious adverse events during follow-up. In the multivariable analysis, aneurysms located at a sidewall were less likely to experience these events than those located at bifurcations (odds ratio, 0.07; 95% CI, 0.01-0.51). Conclusions- The Derivo Embolization Device is a safe and effective treatment for intracranial aneurysms. Clinical Trial Registration- URL: http://plataformabrasil.saude.gov.br/login.jsf. Unique identifier: CAAE 77089717.7.1001.5125.

Dual-lumen balloon to increase onyx venous penetration in the treatment of spinal dural arteriovenous fistulas.

PURPOSE: Spinal dural arteriovenous fistulas (sDAVF) are the most common spinal vascular lesions. The arterialization of the recipient vein results in venous hypertension and chronic ischemia. Intravascular injection of acrylic glue in order to occlude the draining vein is the principle of endovascular treatment, but a significant portion of embolization procedures do not succeed. We present our initial experience of endovascular balloon augmented embolization of sDAVF using a dual-lumen balloon. CLINICAL PRESENTATION: Three patients harboring sDAVF were submitted to endovascular treatment by onyx injection assisted by a double-lumen balloon as the sole therapy. Control angiography demonstrated complete obliteration of the fistula in all cases with clinical improvement. CONCLUSION: Dual-lumen balloon onyx embolization of spinal dural arteriovenous fistulas appears to be an acceptable and feasible alternative.

Pipeline embolization device for the treatment of a traumatic intracranial aneurysm in a child.

INTRODUCTION: Traumatic intracranial aneurysms in children are rare and may occur as the result of closed or penetrating head trauma. Their natural history seems to be more aggressive. Most traumatic aneurysms have complex shape, tending to have a large neck or even a fusiform morphology. CASE REPORT: We present a case of a traumatic carotid artery aneurysm in a 9-year-old girl that was successfully treated with pipeline embolization device. DISCUSSION: Due to its dissecting nature, wall friability and lack of a substantial neck can make surgical clipping and selective coiling difficult and risky. Although endovascular parent artery occlusion is the best approach in the acute phase, in some situations it is not possible or very risky. In such scenario the use of flow diverter devices would be an alternative approach. Additionally, we discuss the potential advantages and risks of flow diverter deployment inside a developing vessel.

Casper vs. Closed-Cell Stent : Carotid Artery Stenting Randomized Trial.

OBJECTIVE: The aim of this trial was to compare the efficacy of closed-cell stents with Casper stents during carotid angioplasty stenting (CAS). METHODS: This was a randomized superiority trial in which 88 patients were enrolled. The primary end points were the incidence, number, and size of new ischemic brain lesions after CAS under distal embolic protection devices (EPD). The secondary end points included stroke, transient ischemic attack (TIA) and myocardial infarction (MI). Ischemic brain lesions were assessed by a diffusion-weighted magnetic resonance image (DW-MRI). Neurological outcomes were evaluated by means of the National Institutes of Health scale score (NIHSS) and the modified Rankin scale (mRS). RESULTS: Compared with closed-cell stents (n = 47), Casper stents (n = 41), resulted in no significant reduction in the incidence (44.7% versus 39%, P = 0.592), number (1.3 ± 1.8 versus 0.9 ± 1.5, p = 0.444), and size (3.9 ± 5.8 mm versus 2.8 ± 4.1 mm, p = 0.353) of new ischemic brain lesions. The global rate of stroke/TIA/MI was (2/88, 2.3%). Two TIA occurred during the hospitalization period, one in each group (1/41, 2.4% vs 1/47, 2.1%). One patient of the Casper group had an asymptomatic in-stent thrombosis. One patient of the control group had a MI (1/47, 2.1%) after discharge. CONCLUSION: The Casper stents did not show superiority in the rate of incidence, number and size of new silent ischemic brain lesions detect by DW-MRI when compared to close cell stents during CAS under distal EPD.

Endovascular Treatment of Tentorial Dural Arteriovenous Fistulas Using the Transarterial Approach as a First-Line Strategy.

BACKGROUND: In recent decades, endovascular approaches have become the standard treatment for most tentorial dural arteriovenous fistulas (TDAVFs). Although endovascular treatment (EVT) is associated with better clinical outcomes, the angiographic occlusion rates are lower than those of surgical or combined approaches. OBJECTIVE: To evaluate the efficacy and safety of EVT for TDAVFs using the transarterial approach (TAA) as a first-line strategy. METHODS: Clinical and radiological data from 45 consecutive patients with TDAVFs who underwent EVT at 2 centers were retrospectively reviewed. Patient demographics and clinical and angiographic data were registered. Postprocedural and 6-mo follow-up angiographic and clinical results were evaluated. Univariable and multivariable logistic regression were performed to identify angiographic occlusion predictors after the first session and predictors of clinical complications. RESULTS: An isolated TAA was used for 40 TDAVFs (88.9%). A total of 37 (82.2%) TDAVFs were completely occluded after a single EVT session, and 44 TDAVFs (97.8%) were completely occluded after the last procedure. The presence of fewer than 5 arterial feeders was a predictor for total occlusion after the first treatment session (odds ratio [OR], 18.9; 95% CI 2.06-173.57; P = .01). Six-month angiographic control was performed in 42 patients, and all TDAVFs were occluded. Good long-term neurological outcomes were observed in 41 patients (91.1%). Clinical complications occurred in 7 (15.6%) patients. They were related to the number of accessed arteries to perform TAA (odds ratio, 2.53; 95% CI 1.10-5.86; P = .03). The procedure-related mortality rate was 2.2%. CONCLUSION: TAA is a safe and effective treatment for TDAVFs.

Endovascular treatment of residual or recurrent intracranial aneurysms after surgical clipping.

OBJECTIVE: Total aneurysm occlusion is crucial for the prevention of rebleeding of a ruptured aneurysm or to avoid rupture of an unruptured lesion. Both surgical and endovascular embolization fail to achieve complete aneurysm occlusion in all the cases. The objective of the study was to establish the safety and efficacy of endovascular treatment for previously clipped residual or recurrent aneurysms. METHODS: This was an observational, retrospective study of patients harboring incompletely occluded intracranial aneurysms after clipping who underwent endovascular treatment. Patients were treated using 4 different techniques: (1) simple coiling, (2) balloon remodeling, (3) stent-assisted coiling, and (4) flow diversion. Analyses were performed to identify predictors of total aneurysm occlusion, recanalization and complications. RESULTS: Between May 2010 and September 2018, 70 patients harboring incompletely occluded intracranial aneurysms after clipping met the inclusion criteria in 5 centers. The mean residual aneurysm size was 7.5 mm. Fifty-nine aneurysms were unruptured. Total aneurysm occlusion was achieved in 75.3% of the aneurysms after 1 year. All aneurysms treated with flow diversion revealed complete occlusion according to control angiography. Recanalization was observed in 14.5%. Permanent morbidity and mortality occurred in 2.9% and 1.4% of the patients, respectively. CONCLUSIONS: Endovascular treatment of recurrent or residual aneurysms after surgical clipping was safe and efficacious. Flow diversion seems to be associated with better anatomical results. A more rigid study, a larger group of patients, and longterm follow-up are required to provide stronger conclusions about the best approach for residual clipped aneurysms.

Safety and Effectiveness of the Pipeline Flex Embolization Device With Shield Technology for the Treatment of Intracranial Aneurysms: Midterm Results From a Multicenter Study.

BACKGROUND: The safety and efficacy of the first generation of the Pipeline Embolization Device (PED; Medtronic Inc) have been proven in large case series. Ischemic events are one of the most common complications following treatment of aneurysms with flow diverters. The new PED Flex with Shield technology (PED Shield; Medtronic Inc) was introduced to minimize the rate of complications. OBJECTIVE: To evaluate the outcomes of patients harboring aneurysms treated with the PED Shield. METHODS: This was an observational, prospective, single-arm multicenter study of patients treated with the PED Shield. The primary safety endpoint was the absence of major neurological complications and death. The secondary effectiveness endpoint was angiographic occlusion at 6 and 12 mo. Technical complications were also reported. RESULTS: Between November 2017 and December 2018, 151 patients from 7 centers with 182 aneurysms were enrolled. The mean aneurysm size was 7.0 mm; 27 (14.8%) aneurysms were large, and 7 (3.8%) were giant. In 141 of 151 patients (93.4%), the primary endpoint was reached. The overall rate of periprocedural complications was 7.3%. Of the aneurysms, 79.7% met the study's secondary endpoint of complete occlusion at 6 mo and 85.3% at 12 mo. CONCLUSION: The PED Shield is a safe and effective treatment for intracranial aneurysms. The results regarding total occlusion and ischemic complications did not differ from those obtained in case series using previous versions of the PED. Long-term follow-up and comparative studies are required to provide stronger conclusions regarding the reduced thrombogenicity of this device.

Preliminary Experience with the TransForm Occlusion Balloon Catheter: Safety and Potential Advantages.

PURPOSE: Balloon-assisted coiling (BAC) has made the treatment of aneurysms with complex shape and broad neck possible, especially during the acute phase of hemorrhage. The authors present a prospective series of their preliminary experience with the TransForm occlusion balloon catheter (TOBC). METHODS: Between September 2015 to February 2016 a total of 20 patients underwent endovascular treatment assisted by TOBC of which 19 had 20 untreated aneurysms and 1 patient harboring a meningioma was submitted to balloon test occlusion (BTO). The TOBC was used to perform BAC and BTO for the treatment of vasospasms and to cross the neck of giant aneurysms (anchor technique). All data regarding the feasibility and safety of treatment with the device were collected prospectively. RESULTS: All patients completed treatment according to the modality previously chosen. The balloon was employed solely for remodeling in 17 patients, for anchor technique in 2, for both remodeling and vasospasm angioplasty in 1 and for BTO in 1 patient. The balloon could be navigated to the target aneurysm in all cases. Evaluation of postoperative anatomical results indicated total occlusion in 13 (72.2 %) aneurysms, neck remnants in 4 (22.2 %) and residual sac filling in 1 (5.5 %). There were two (9.5 %) complications related to treatment, all thromboembolic. No technical complications were observed. CONCLUSION: The TOBC was shown to be safe and effective for the treatment of intracranial aneurysms with BAC. In addition, it was successfully employed to perform angioplasty for vasospasm and BTO. Finally, it was used in the balloon anchor technique for the first time.

Transorbital Cavernous Sinus Direct Puncture : Alternative to treat dural arteriovenous fistula.

INTRODUCTION: The authors present a retrospective series of their clinical experience in the treatment of cavernous dural arteriovenous fistulas (DAVF) by direct transorbital puncture of the cavernous sinus as an alternative to the endovascular approach. METHODS: Between October 2012 and September 2014, eight patients harboring cavernous DAVF underwent percutaneous treatment by direct transorbital puncture of the cavernous sinus at three institutions. All patients presented with ocular symptoms. Standard endovascular approaches, including transvenous and transarterial routes, were primarily attempted without success in all cases. Direct puncture was performed through two different approaches, namely inferolateral and superomedial. The entry point was the inferior and superior eyelid, respectively. Embolization was performed with coils or Onyx (Covidien, Irvine, CA). Immediate and late angiographies were used to evaluate the occlusion of the fistula. RESULTS: Of the patients seven had complete occlusion of the cavernous DAVFs noted on the immediate and follow-up angiograms and one patient had residual filling but reduction of the shunt resulted in clinical improvement. None of the patients had worsening of neurological function. One case was complicated by inadvertent internal carotid puncture but without clinical manifestations. One patient experienced postoperative superior ophthalmic vein thrombosis. CONCLUSION: In very specific cases, when endovascular access is not possible or fails to occlude cavernous DAVF, direct transorbital puncture of the cavernous sinus was shown to be feasible, safe and very effective.

Endovascular treatment of pulsatile tinnitus associated with transverse sigmoid sinus aneurysms and jugular bulb anomalies.

Pulsatile tinnitus of vascular origin may arise in arterial or venous structures. Many authors have reported the association of pulsatile tinnitus with anomalies of dural venous sinuses and the jugular bulb. In such circumstances, mainly concomitantly with disabling tinnitus, endovascular treatment has been successfully employed. We describe here a new case of jugular bulb diverticulum associated with transverse sigmoid sinus stenosis, in a patient presenting with disabling pulsatile tinnitus. She was treated with dural sinus stenting and selective embolization of the diverticulum. In addition, we performed a literature review aiming to identify possible risk factors for developing the symptoms, as well as the safety and results of endovascular treatment.

Number of coils necessary to treat cerebral aneurysms according to each size group: a study based on a series of 952 embolized aneurysms.

OBJECTIVE: The Brazilian public health system determines a quantity of coils allowed to treat a cerebral aneurysm. The goal of this paper was to determine the number of coils necessary to treat an aneurysm based on size. METHODS: All patients harboring an aneurysm treated by endovascular approach between 1999 and 2003 were reviewed. RESULTS: There were 952 aneurysms included. Mean diameter sac was 8.2 mm with 7.9 coils per aneurysm. Out of 462 small aneurysms, mean size was 4.8 mm, with 4.6 coils/aneurysm used. A total of 315 medium aneurysms were treated, mean size was 8.6 mm, with 8.2 coils. Out of 135 large, mean size was 17 mm, with 16.1 coils. Forty giant aneurysms were treated with a mean size of 32 mm and 28.7 coils. CONCLUSIONS: We propose size as a reference to predict the number of coils necessary to treat each aneurysm: one coil for each millimeter of diameter.

Dural arteriovenous fistulas with direct cortical venous drainage treated with Onyx: a case series.

UNLABELLED: Dural arteriovenous fistulas (DAVFs) may have aggressive symptoms, especially if there is direct cortical venous drainage. We report our preliminary experience in transarterial embolization of DAVFs with direct cortical venous drainage (CVR) using Onyx. METHOD: Nine patients with DAVFs with direct cortical venous drainage were treated: eight type IV and one type III (Cognard). Treatment consisted of transarterial embolization using Onyx-18. Immediate post treatment angiographies, clinical outcome and late follow-up angiographies were studied. RESULTS: Complete occlusion of the fistula was achieved in all patients with only one procedure and injection in only one arterial pedicle. On follow-up, eight patients became free from symptoms, one improved and no one deteriorated. Late angiographies showed no evidence of recurrent DAVF. CONCLUSION: We recommend that transarterial Onyx embolization of DAVFs with direct cortical venous drainage be considered as a treatment option, while it showed to be feasible, safe and effective.

Selective endovascular treatment of a traumatic basilar aneurysm after endoscopic third ventriculostomy.

A 4-year-old girl suffered intraventricular and subarachnoid hemorrhage during endoscopic third ventriculostomy. Cerebral angiography revealed a traumatic basilar aneurysm secondary to basilar artery injury. The aneurysm was treated with selective endovascular embolization using Guglielmi detachable coils. We review some therapeutic features of traumatic basilar aneurysms after endoscopic third ventriculostomy and describe the feasibility of endovascular selective therapy to manage these lesions successfully.

Stent-grafts in the management of hemorrhagic complications related to hemostatic closure devices: report of two cases.

We report 2 cases of hemorrhagic complications related to use of the Angio-Seal hemostatic closure device that were successfully managed with stent-grafts. Two patients with subarachnoid hemorrhage were referred to our departments for endovascular treatment of ruptured intracranial aneurysms. The treatment was performed through a femoral access; the sheaths were removed immediately after the procedures, and the punctures sites closed by Angio-Seals. Both patients presented clinical signs of hypovolemic shock after treatment. The diagnosis of active bleeding through the puncture site was made by emergency digital subtraction angiography. The lesions were managed with stent-grafts. The use of stent-grafts proved to be efficient in the management of these life-threatening hemorrhagic complications following the use of the Angio-Seal hemostatic closure device.

Number of coils necessary to treat cerebral aneurysms according to each size group: a study based on a series of 952 embolized aneurysms / Quantidade de molas necessárias para o tratamento endovascular dos aneurismas cerebrais de acordo com seu tamanho: estudo baseado em uma série de 952 aneurismas embolizados

OBJECTIVE: The Brazilian public health system determines a quantity of coils allowed to treat a cerebral aneurysm. The goal of this paper was to determine the number of coils necessary to treat an aneurysm based on size. METHODS: All patients harboring an aneurysm treated by endovascular approach between 1999 and 2003 were reviewed. RESULTS: There were 952 aneurysms included. Mean diameter sac was 8.2 mm with 7.9 coils per aneurysm. Out of 462 small aneurysms, mean size was 4.8 mm, with 4.6 coils/aneurysm used. A total of 315 medium aneurysms were treated, mean size was 8.6 mm, with 8.2 coils. Out of 135 large, mean size was 17 mm, with 16.1 coils. Forty giant aneurysms were treated with a mean size of 32 mm and 28.7 coils. CONCLUSIONS: We propose size as a reference to predict the number of coils necessary to treat each aneurysm: one coil for each millimeter of diameter.

OBJETIVO: O sistema público brasileiro determina uma quantidade limitada de molas permitida para o tratamento endovascular dos aneurismas cerebrais. O objetivo deste trabalho foi determinar a quantidade de molas necessária para tratar um aneurisma usando tamanho como referência. MÉTODO: Foram revisados todos os pacientes com aneurismas embolizados entre 1999 e 2003. RESULTADOS: No total, 952 aneurismas foram analisados. O diâmetro médio foi de 8,2 mm, com 7,9 molas usadas por aneurisma. Do total, 462 aneurismas eram pequenos, com tamanho médio de 4,8 mm e 4,6 molas/aneurisma. Foram tratados 315 aneurismas médios, com tamanho médio de 8,6 mm e 8,2 molas/aneurisma. Dentre os 135 aneurismas grandes, o tamanho foi de 17 mm, com 16,1 molas/aneurisma. Foram tratados 40 aneurismas gigantes, com média de 32 mm e 28,7 molas/aneurisma. CONCLUSÃO: Propomos que se utilize o tamanho do aneurisma como referência para prever o número de molas necessário para embolização: uma mola para cada milímetro de tamanho do saco aneurismático.

Dural arteriovenous fistula of the lesser sphenoid wing region treated with Onyx: technical note.

A 45-year-old man presented with acute right orbital pain and right-sided headache. Magnetic resonance imaging (MRI) and cerebral angiography revealed a dural arteriovenous fistula (DAVF) of the lesser sphenoid wing region. The lesion was endovascularly treated by transarterial embolization with Onyx (ethyl vinyl alcohol; Micro Therapeutics, Irvine, Calif.). We review some anatomical and therapeutic features involving DAVFs of this region and describe the feasibility of the use of Onyx in the treatment of these lesions.

Dural arteriovenous fistulas with direct cortical venous drainage treated with Onyx®: a case series / Fístulas arteriovenosas durais com drenagem cortical direta tratadas com Onyx®: casuística

Dural arteriovenous fistulas (DAVFs) may have aggressive symptoms, especially if there is direct cortical venous drainage. We report our preliminary experience in transarterial embolization of DAVFs with direct cortical venous drainage (CVR) using Onyx®. METHOD: Nine patients with DAVFs with direct cortical venous drainage were treated: eight type IV and one type III (Cognard). Treatment consisted of transarterial embolization using Onyx-18®. Immediate post treatment angiographies, clinical outcome and late follow-up angiographies were studied. RESULTS: Complete occlusion of the fistula was achieved in all patients with only one procedure and injection in only one arterial pedicle. On follow-up, eight patients became free from symptoms, one improved and no one deteriorated. Late angiographies showed no evidence of recurrent DAVF. CONCLUSION: We recommend that transarterial Onyx® embolization of DAVFs with direct cortical venous drainage be considered as a treatment option, while it showed to be feasible, safe and effective.

As fistulas arteriovenosas durais (FAVDs) podem se manifestar com sintomas agressivos, especialmente se existe drenagem cortical direta. Relatamos nossa experiência preliminar na embolização transarterial de FAVDs com drenagem cortical direta usando Onyx®. MÉTODO: Nove pacientes com FAVDs com drenagem cortical direta foram tratados: oito do tipo IV e uma do tipo III (Cognard). O tratamento consistiu na embolização transarterial usando Onyx-18®. Angiografias imediatas pós-tratamento, evolução clínica e angiografias de controle tardias foram estudadas. RESULTADOS: A oclusão completa da fístula foi alcançada em todos pacientes através de um só procedimento e injeção em apenas um pedículo arterial. No seguimento, oito pacientes ficaram livres de sintomas, um melhorou e nenhum deteriorou. Angiografias tardias de controle não mostraram evidência de FAVD recorrente. CONCLUSÃO: Nós recomendamos que a embolização transarterial com Onyx® das FAVDs com drenagem cortical direta, seja considerada como uma opção terapêutica, uma vez que mostrou ser factível, segura e efetiva.