Holmium laser enucleation of the prostate for a case of transition zone prostate cancer.

Standard treatment approaches for localized prostate cancer remain limited to active surveillance, radiotherapy, and radical prostatectomy. We present a case of transition zone prostate cancer that was treated with holmium laser enucleation of the prostate, a procedure that is normally reserved for the management of benign prostatic hyperplasia.

Successful Endovascular Treatment of a Traumatic Cervical Arteriovenous Fistula After a Carotid Paraganglioma Resection: A Case Report.

Traumatic cervical arteriovenous fistulas are rare, accounting for only 4% of all arteriovenous fistulas. They can be caused by penetrating, or rarely, blunt trauma, resulting in high-pressure arterial blood draining directly into a vein, decreasing distal perfusion. They are seldom reported as a complication of a carotid paraganglioma surgical resection. Historically, arteriovenous fistulas were treated initially conservatively, after that, surgically; nowadays, endovascular treatment, when feasible, is the preferred method as it offers advantages over surgery. This case report describes a rare traumatic cervical arteriovenous fistula that developed after a carotid paraganglioma resection and was successfully treated using coils and Onyx embolic agent via endovascular embolization. After successful embolization, the patient had a smooth recovery and remained stable. In conclusion, vascular injury seems to be the only constant in all acquired cervical arteriovenous fistulas independent of the trauma mechanism; and endovascular treatment, when feasible, is preferred over surgery as it offers superior advantages.

Prospective study on embolization of intracranial aneurysms with the pipeline device (PREMIER study): 3-year results with the application of a flow diverter specific occlusion classification.

BACKGROUND: The pipeline embolization device (PED; Medtronic) has presented as a safe and efficacious treatment for small- and medium-sized intracranial aneurysms. Independently adjudicated long-term results of the device in treating these lesions are still indeterminate. We present 3-year results, with additional application of a flow diverter specific occlusion scale. METHODS: PREMIER (prospective study on embolization of intracranial aneurysms with pipeline embolization device) is a prospective, single-arm trial. Inclusion criteria were patients with unruptured wide-necked intracranial aneurysms ≤12 mm. Primary effectiveness (complete aneurysm occlusion) and safety (major neurologic event) endpoints were independently monitored and adjudicated. RESULTS: As per the protocol, of 141 patients treated with a PED, 25 (17.7%) required angiographic follow-up after the first year due to incomplete aneurysm occlusion. According to the Core Radiology Laboratory review, three (12%) of these patients progressed to complete occlusion, with an overall rate of complete aneurysm occlusion at 3 years of 83.3% (115/138). Further angiographic evaluation using the modified Cekirge-Saatci classification demonstrated that complete occlusion, neck residual, or aneurysm size reduction occurred in 97.1%. The overall combined safety endpoint at 3 years was 2.8% (4/141), with only one non-debilitating major event occurring after the first year. There was one case of aneurysm recurrence but no cases of delayed rupture in this series. CONCLUSIONS: The PED device presents as a safe and effective modality in treating small- and medium-sized intracranial aneurysms. The application of a flow diverter specific occlusion classification attested the long-term durability with higher rate of successful aneurysm occlusion and no documented aneurysm rupture. TRIAL REGISTRATION: NCT02186561.

Morphometric analysis of airways in pre-COPD and mild COPD lungs using continuous surface representations of the bronchial lumen.

Introduction: Chronic Obstructive Pulmonary Disease (COPD) is a prevalent respiratory disease that presents a high rate of underdiagnosis during onset and early stages. Studies have shown that in mild COPD patients, remodeling of the small airways occurs concurrently with morphological changes in the proximal airways. Despite this evidence, the geometrical study of the airway tree from computed tomography (CT) lung images remains underexplored due to poor representations and limited tools to characterize the airway structure. Methods: We perform a comprehensive morphometric study of the proximal airways based on geometrical measures associated with the different airway generations. To this end, we leverage the geometric flexibility of the Snakes IsoGeometric Analysis method to accurately represent and characterize the airway luminal surface and volume informed by CT images of the respiratory tree. Based on this framework, we study the airway geometry of smoking pre-COPD and mild COPD individuals. Results: Our results show a significant difference between groups in airway volume, length, luminal eccentricity, minimum radius, and surface-area-to-volume ratio in the most distal airways. Discussion: Our findings suggest a higher degree of airway narrowing and collapse in COPD patients when compared to pre-COPD patients. We envision that our work has the potential to deliver a comprehensive tool for assessing morphological changes in airway geometry that take place in the early stages of COPD.

Added Value of Selective Intra-arterial Cone-Beam CT Angiography in the Management of Visceral Artery Aneurysms.

PURPOSE: The aim of this study is to evaluate the value of selective intra-arterial cone-beam computed tomography angiography (CBCTA) relative to conventional computed tomography angiography (CTA) in understanding visceral artery aneurysm (VAA) morphology, and its impact on treatment planning. MATERIALS AND METHODS: Between January 2017 and August 2021, all patients who had a diagnosis of VAA and underwent intraoperative CBCTA imaging were retrospectively reviewed. Impact on treatment decisions, optimal C-arm angulations derived from CBCTA, and additional radiation exposure were reported. Two blinded independent reviewers qualitatively reviewed CBCTA and conventional CTA images. A 5-point Likert scale (1=poor image quality, 5=excellent image quality) was used to assess the overall image quality of each modality. Number of vessels arising from the aneurysm sac was counted. RESULTS: A total of 16 patients had a diagnosis of VAA during the study period, of whom 10 patients had intraoperative CBCTA and conventional CTA available for review. Out of 10 patients, 7 underwent successful endovascular treatment, 2 were deemed not amenable for endovascular embolization based on intraoperative CBCTA findings, and 1 had resolved pseudoaneurysm. Total fluoroscopy time and radiation dose (dose area product [DAP] and skin dose) for all procedures were 27.7 ± 19.9 minutes, 28 362 (±18 651) µGy*m2, and 1879 (±1734) mGy, respectively. Radiation exposure from CBCTA (DAP and skin dose) was 5703 (±3967) µGy*m2 and 223.6 (±141.3) mGy, respectively. In patients who underwent endovascular treatment, the proportional DAP from CBCTA was 18.3% (±15.3%) of the total procedural radiation dose. Qualitative rating of overall image quality of CBCTA images was superior to CTA images (mean score: 4.55 vs 3, p<0.001). More branch vessels arising from the VAA were identified by all reviewers in CBCTA as compared with conventional CTA (median, min-max: 3, 0-4 vs 2,1-3 vessels). CONCLUSION: Intraoperative CBCTA after selective intra-arterial contrast injection, with better spatial resolution, provided better delineation of visceral aneurysm morphology as compared with conventional, intravenous CTA and enabled optimal treatment planning at a reasonable additional radiation exposure. CLINICAL IMPACT: Visceral artery aneurysms (VAA) are often diagnosed incidentally by conventional computed tomographic angiography (CTA). Endovascular treatment typically requires selective angiographies at multiple projections to better understand aneurysm morphology, location, and efferent branch vessels. Intra-arterial cone-beam CT angiography (CBCTA) for VAA has the advantage of selective contrast opacification, better spatial resolution, and three-dimensional/multi-planar visualization of aneurysm morphology. In addition, CBCTA enables identification of optimal C-arm working projection for subsequent endovascular treatment. The aim of this study is to evaluate the value of intraoperative CBCTA relative to conventional CTA in understanding visceral artery aneurysm morphology and its impact on treatment planning.

Endovascular treatment of pancreaticoduodenal aneurysm with braided stent-assisted coil embolization using intraoperative cone-beam computed tomography guidance.

Pancreaticoduodenal arterial arcade aneurysms are rare but are prone to rupture. We report the case of a 60-year-old woman with an asymptomatic pancreaticoduodenal artery aneurysm and concomitant celiac trunk occlusion that was treated using an endovascular approach. After percutaneous transfemoral access and superior mesenteric artery cannulation, intraoperative cone-beam computed tomography angiography was performed to better understand the aneurysm morphology and provide image guidance. On selecting the optimal working projection, the aneurysm and distal parent vessel were cannulated and treated by braided stent (low-profile visualized intraluminal support; MicroVention)-assisted coil embolization. Completion angiography and cone-beam computed tomography confirmed successful exclusion of the aneurysm sac and a patent pancreaticoduodenal arcade with a well-apposed stent.

Safety and efficacy results of the Flow Redirection Endoluminal Device (FRED) stent system in the treatment of intracranial aneurysms: US pivotal trial.

OBJECTIVE: To evaluate the safety and effectiveness of the Flow Redirection Endoluminal Device (FRED) flow diverter in support of an application for Food and Drug Administration approval in the USA. METHODS: 145 patients were enrolled in a prospective, single-arm multicenter trial. Patients with aneurysms of unfavorable morphology for traditional endovascular therapies (large, wide-necked, fusiform, etc) were included. The trial was designed to demonstrate non-inferiority in both safety and effectiveness, comparing trial results with performance goals (PGs) established from peer-reviewed published literature. The primary safety endpoint was death or major stroke (National Institutes of Health Stroke Scale score ≥4 points) within 30 days of the procedure, or any major ipsilateral stroke or neurological death within the first year. The primary effectiveness endpoint was complete occlusion of the target aneurysm with ≤50% stenosis of the parent artery at 12 months after treatment, and in which an alternative treatment of the target intracranial aneurysm had not been performed. RESULTS: 145 patients underwent attempted placement of a FRED device, and one or more devices were placed in all 145 patients. 135/145 (93%) had a single device placed. Core laboratory adjudication deemed 106 (73.1%) of the aneurysms large or giant. A safety endpoint was experienced by 9/145 (6.2%) patients, successfully achieving the safety PG of <15%. The effectiveness PG of >46% aneurysm occlusion was also achieved, with the effectiveness endpoint being met in 80/139 (57.6%) CONCLUSION: As compared with historically derived performance benchmarks, the FRED flow diverter is both safe and effective for the treatment of appropriately selected intracranial aneurysms. CLINICAL REGISTRATION NUMBER: NCT01801007.

Safety of the APOLLO Onyx delivery microcatheter for embolization of brain arteriovenous malformations: results from a prospective post-market study.

BACKGROUND: Catheter retention and difficulty in retrieval have been observed during embolization of brain arteriovenous malformations (bAVMs) with the Onyx liquid embolic system (Onyx). The Apollo Onyx delivery microcatheter (Apollo) is a single lumen catheter designed for controlled delivery of Onyx into the neurovasculature, with a detachable distal tip to aid catheter retrieval. This study evaluates the safety of the Apollo for delivery of Onyx during embolization of bAVMs. METHODS: This was a prospective, non-randomized, single-arm, multicenter, post-market study of patients with a bAVM who underwent Onyx embolization with the Apollo between May 2015 and February 2018. The primary endpoint was any catheter-related adverse event (AE) at 30 days, such as unintentional tip detachment or malfunction with clinical sequelae, or retained catheter. Procedure-related AEs (untoward medical occurrence, disease, injury, or clinical signs) and serious AEs (life threatening illness or injury, permanent physiological impairment, hospitalization, or requiring intervention) were also recorded. RESULTS: A total of 112 patients were enrolled (mean age 44.1±17.6 years, 56.3% men), and 201 Apollo devices were used in 142 embolization procedures. The mean Spetzler-Martin grade was 2.38. The primary endpoint was not observed (0/112, 0%). The catheter tip detached during 83 (58.5%) procedures, of which 2 (2.4%) were unintentional and did not result in clinical sequelae. At 30 days, procedure related AEs occurred in 26 (23.2%) patients, and procedure-related serious AEs in 12 (10.7%). At 12 months, there were 3 (2.7%) mortalities, including 2 (1.8%) neurological deaths, none of which were device-related. CONCLUSION: This study demonstrates the safety of Apollo for Onyx embolization of bAVMs. CLINICAL TRIAL REGISTRATION: CNCT02378883.

Prospective study on embolization of intracranial aneurysms with the pipeline device: the PREMIER study 1 year results.

BACKGROUND: Preliminary clinical studies on the safety and efficacy of the pipeline embolization device (PED) for the treatment of small/medium aneurysms have demonstrated high occlusion rates with low complications. OBJECTIVE: To evaluate the safety and effectiveness of the PED for treatment of wide necked small and medium intracranial aneurysms. METHODS: PREMIER is a prospective, multicenter, single arm trial. Patients were treated with the PED for unruptured wide necked aneurysms, measuring ≤12 mm along the internal carotid artery or vertebral artery, between July 2014 and November 2015. At 1 year post-procedure, the primary effectiveness endpoint was complete occlusion (Raymond grade 1) without major parent vessel stenosis (≤50%) or retreatment, and the primary safety endpoint was major stroke in the territory supplied by the treated artery or neurologic death. RESULTS: A total of 141 patients were treated with PEDs (mean age 54.6±11.3 years, 87.9% (124/141) women). Mean aneurysm size was 5.0±1.92 mm, and 84.4% (119/141) measured <7 mm. PED placement was successful in 99.3% (140/141) of patients. Mean number of PEDs implanted per patient was 1.1±0.26; a single PED was used in 92.9% (131/141) of patients. At 1 year, 97.9% (138/141) of patients underwent follow-up angiography with 76.8% (106/138) of patients having met the study's primary effectiveness endpoint. The combined major morbidity and mortality rate was 2.1% (3/140). CONCLUSIONS: Treatment of wide necked small/medium aneurysms with the PED results in high rates of complete occlusion without significant parent vessel stenosis and low rates of permanent neurologic complications. TRIAL REGISTRATION: NCT02186561.

Efectos fisiológicos de las terapias de soporte respiratorio no invasivo y su potencial rol postextubación / Physiological effects of non-invasive respiratory support therapies and their potential post-extubation role

Posterior a una extubación programada existe un porcentaje de pacientes que fracasa y requiere reintubación (~20%), este evento es conocido como fracaso de extubación, el cual se asocia con mayor morbimortalidad. Para prevenir el fracaso de extubación se han propuesto terapias como la ventilación no invasiva (VNI) y la cánula nasal de alto flujo (CNAF). Estas terapias son capaces de entregar soporte respiratorio postextubación y justifican su uso en los efectos fisiológicos que son capaces de inducir, en dónde el impacto sobre el esfuerzo respiratorio e intercambio de gases sería fundamental. Con esta racionalidad fisiológica se han desarrollado diversos estudios en diferentes contextos clínicos, esto con el fin de dilucidar cuál terapia es la mejor alternativa. En esta revisión narrativa pretendemos describir y analizar los diversos efectos fisiológicos que induce la VNI y la CNAF

The safety and effectiveness of the LVIS stent system for the treatment of wide-necked cerebral aneurysms: final results of the pivotal US LVIS trial.

INTRODUCTION: The LVIS stent system (LVIS and LVIS Junior) is a self-expanding, retrievable, microstent system indicated for the treatment of wide-necked cerebral aneurysms (WNAs). The present pivotal study was performed to evaluate the safety and effectiveness of this device. METHODS: The US LVIS pivotal trial was a prospective, multicenter, single-arm, interventional study conducted at 21 US centers. The study enrolled 153 adults with WNAs of the anterior and posterior circulations. The study was conducted under good clinical practices and included independent adjudication of all adverse events. The primary effectiveness endpoint was defined as successful aneurysm treatment with the LVIS System as evidenced by complete (100%) aneurysm occlusion at 12 months on conventional angiography without retreatment and without significant (≥50%) stenosis of the treated artery at 12 months as determined by an independent core laboratory. The primary safety endpoint was defined as the rate of stroke or death within 30 days, or ipsilateral stroke or neurologic death with 12 months. RESULTS: One hundred and fifty-three patients enrolled at 21 investigational sites underwent attempted LVIS-assisted coil embolization. The mean age was 58.3±10.5 years and the majority of the participants (110/153, 71.9%) were female. Fifty-seven aneurysms (57/153, 37.3%) arose from the anterior cerebral artery, 43 (43/153, 28.1%) from the internal carotid artery, 17 (17/153, 11.1%) from the middle cerebral artery, 27 (27/153, 17.6%) from the basilar artery, six (6/153,3.9 %) from the PCA, and two from the vertebral artery. A single aneurysm arose from the superior cerebellar artery. The mean aneurysm dome height was 6.0±2.2 mm and mean width 5.5±2.3 mm. Mean neck width was 4.2±1.4 mm. A total of 22 participants presented for re-treatment of a previously ruptured (>30 days prior to treatment) target aneurysm. The primary effectiveness endpoint was observed in 70.6% (108/153) in the intent to treat population (ITT). Of the evaluable participants with follow-up 12-month angiography, 79.1 % (110/139) demonstrated complete occlusion- 92.1% (128/139) in this population demonstrated ≥95% occlusion and 95% demonstrated ≥90% occlusion (132/139). Eight participants (5.2%, 8/153) had at least one primary safety event in the ITT population. CONCLUSION: The LVIS stent system allows safe and highly effective coil embolization of WNAs. CLINICAL REGISTRATION NUMBER: NCT01793792.

Standards of practice in acute ischemic stroke intervention: International recommendations.

This article was first published in JNIS. Cite this article as: Pierot L, Jayaraman MV, Szikora I, et al. Standards of practice in acute ischemic stroke intervention: international recommendations. Journal of NeuroInterventional Surgery. Published Online First: 28 August 2018. doi: 10.1136/neurintsurg-2018-014287.

Unique percutaneous direct puncture technique for occlusion of a hypoglossal canal dural arteriovenous fistula.

PURPOSE: To report percutaneous transcranial puncture, embolization and occlusion of a very symptomatic hypoglossal canal/anterior condylar vein dural arteriovenous fistula (DAVF) using syngo iGuide navigational software in a patient in whom transarterial and transvenous embolization and surgery had failed. METHODS: After unsuccessful arterial and venous embolization and surgical treatment of a symptomatic hypoglossal canal DAVF, a 47-year-old man was transferred for further management. With exquisite anatomic detail provided by C-arm cone-beam computed tomography (CBCT) equipment (Artis zee Biplane, Dyna CT VC21H, Siemens Healthcare GmbH, Germany) and syngo iGuide needle guidance navigational software (Siemens Healthcare GmbHy) for planning a safe direct approach, the hypoglossal/anterior condylar vein, the dominant outflow vein of the fistula, was needle punctured percutaneously at the hypoglossal foramen and occluded with ethylene vinyl alcohol copolymer liquid embolic agent (Onyx, Medtronic, Minneapolis, Minnesota, USA) after placing two anchoring platinum coils (Target detachable coils, Stryker Neurovascular, Fremont, California, USA). RESULTS: After a year of progressively severe left eye proptosis, chemosis and increased intraocular pressure, the symptoms quickly subsided after this embolization and the patient was symptom free at his 3-month and later checkups. CONCLUSION: With guidance and imaging provided by CBCT and syngo iGuide navigational software, an otherwise untreatable DAVF was successfully embolized and obliterated by an aggressive unique percutaneous trans-cranial needle puncture of the dominant outflow vein in the hypoglossal canal.

Variables clínicas y funcionales asociadas al riesgo de muerte en el seguimiento a largo plazo en pacientes con enfermedad pulmonar obstructiva crónica / Clinical and functional variables associated to long-term mortality in COPD patients

Background: Identifying risk factors for long-term mortality in patients with chronic obstructive pulmonary disease (COPD) could improve their clinical management. Aim: To examine the clinical variables associated to long-term mortality in a cohort of COPD patients. Patients and Methods: A clinical and respiratory functional assessment, chest computed tomography and clinical follow up for five years was carried out in 202 COPD patients aged 66 ± 9 years (59% males), active or former smokers of 10 or more pack-years. Results: Thirty four percent of patients were active smokers, consuming 46 ± 23 packs/year, 86% had comorbidities, especially chronic cardiovascular and metabolic diseases. Forty-six patients died in the five years follow-up (5-year mortality was therefore 22.8%). In the univariate analysis, the main risk factors associated to long-term mortality were an older age, male sex, dyspnea severity, severe exacerbation risk, chronic respiratory failure, magnitude of lung emphysema, airflow obstruction and lung hyperinflation, reduction of thigh muscle cross-sectional area and physical activity limitation. In the multivariate analysis, the three independent risk factors for long-term mortality were dyspnea severity, chronic hypoxemia and exercise limitation measured with the six minutes' walk test. Conclusions: Systematic clinical assessment allowed to identify the main risk factors associated with long-term mortality in patients with COPD, which could be used in planning preventive and management programs aimed at the high-risk population.

Angiographic and clinical outcomes of balloon remodeling versus unassisted coil embolization in the ruptured aneurysm cohort of the GEL THE NEC study.

BACKGROUND AND PURPOSE: GEL THE NEC (GTN) was a multicenter prospective registry developed to assess the safety and efficacy of HydroSoft coils in treating intracranial aneurysms. We compared the angiographic and clinical outcomes of aneurysms treated with balloon assisted coil embolization (BACE) versus unassisted coil embolization (CE) in the ruptured aneurysm cohort. MATERIALS AND METHODS: GTN was performed at 27 centers in five countries. Patients aged 21-90 years with a ruptured aneurysm 3-15 mm in size were eligible for enrollment. We analyzed demographics/comorbidities, aneurysm location, and geometry, including maximum diameter, neck size, and dome to neck ratio, immediate and long term angiographic outcomes (graded by an independent core laboratory using the modified Raymond Scale), and procedure related adverse events. Angiographic and clinical outcomes were studied using χ2and t tests. RESULTS: Of the 599 patients in the GTN, 194 met the inclusion criteria. 84 were treated with BACE and 110 with CE. There were more prior smokers in the BACE group (p=0.01). The BACE group also had more vertebrobasilar aneurysms (p=0.006) and a larger mean neck size (p=0.02). More aneurysms were immediately completely occluded in the BACE group (p=0.02) Procedure- related major morbidity and mortality were no different between the techniques (p=0.4 and p=1, respectively). CONCLUSIONS: In this prospective ruptured aneurysm cohort from the GTN, BACE resulted in greater occlusion rates compared with unassisted CE with similar morbi-mortality.

The Casper carotid artery stent: a unique all metal micromesh stent designed to prevent embolic release.

BACKGROUND: Stroke due to the release of embolic debris during the placement of a stent to correct carotid artery stenosis is a constant procedural and peri-procedural threat. The new all metal Casper stent has been created with two layers of nitinol, the inner layer of which has pores diminutive enough to prevent embolic release. OBJECTIVE: To evaluate the safety, effectiveness, and utility of the double layer nitinol Casper carotid artery stent in the treatment of patients with severe carotid artery stenosis. METHODS: 19 patients with severe internal carotid artery stenosis, 14 symptomatic and 5 asymptomatic, were treated with the Casper stent. After stent placement, angiographic and cone beam CT images were recorded in all patients. RESULTS: The unique low profile delivery system allowed for easy stent placement, re-sheathing, and repositioning of the stent. The large cell external layer produced excellent apposition to the artery wall. The inner layer prevented prolapse of atherosclerotic debris through the device. Plaque coverage was achieved; residual stenosis ranged from 0% to 20%. Long term angiographic follow-up in 5 patients showed wall apposition of the device covering the lesion and no restenosis. There were no procedure related complications. Two patients experienced a delayed ischemic stroke, likely related to inconsistent medical management. CONCLUSIONS: The Casper has been an excellent stent for the treatment of internal carotid artery stenosis and its internal micromesh layer has been effective in preventing plaque prolapse. It provides the flexibility of large cell stents and the inner layer provides maximum protection against plaque prolapse.

GEL THE NEC: a prospective registry evaluating the safety, ease of use, and efficacy of the HydroSoft coil as a finishing device.

BACKGROUND AND PURPOSE: The HydroSoft coil was developed as a finishing coil, ideally to be placed along the aneurysm neck to enhance intracranial aneurysm healing. The GEL THE NEC (Gaining Efficacy Long Term: Hydrosoft, an Emerging, New, Embolic Coil) multicenter registry was developed to assess the safety and efficacy of HydroSoft coils in treating intracranial aneurysms. We report angiographic and clinical results of this prospective registry. MATERIALS AND METHODS: GEL THE NEC was performed at 27 centers in five countries. Patients aged 21-90 years with a ruptured or unruptured aneurysm 3-15 mm in size were eligible for enrollment. The following variables were obtained: demographics/comorbidities, aneurysm geometry, adjunctive devices used, proportion of patients in whom HydroSoft coils were successfully placed, and long-term angiographic outcomes (graded by an independent core laboratory using the Modified Raymond Scale), and procedure-related adverse events. Predictors of good angiographic outcome were studied using χ2 and t-tests. RESULTS: A total of 599 patients with 599 aneurysms were included in this study. HydroSoft coils were successfully deployed in 577 (96.4%) patients. Procedure-related major morbidity and mortality were 0.5% (3/599) and 1.3% (8/599), respectively. The most common perioperative complications were iatrogenic vasospasm (30/599, 5.0%), thromboemboli (27/599, 4.5%), and aneurysm perforation (16/599, 2.7%). At last angiographic follow-up (mean 9.0±6.3 months), the complete occlusion rate was 63.2% (280/442) and near complete occlusion rate was 25.2% (107/442). The core laboratory read recanalization rate was 10.8% (46/425) and the retreatment rate was 3.4% (20/599). CONCLUSIONS: Endovascular treatment of intracranial aneurysms with HydroSoft coils resulted in complete/near complete occlusion rates of 88% and a major complication rate of 1.8%. TRIAL REGISTRATION NUMBER: NCT01000675.

Final results of the US humanitarian device exemption study of the low-profile visualized intraluminal support (LVIS) device.

INTRODUCTION: The low-profile visualized intraluminal support (LVIS) device is a new, braided, intracranial microstent designed for stent-assisted coiling. OBJECTIVE: To present the results of a single-arm, prospective, multicenter trial of the LVIS for treatment of wide-necked intracranial aneurysms. METHODS: 31 patients with unruptured, wide-necked (neck ≥4 mm or dome:neck ratio ≤2) intracranial aneurysms were treated with the LVIS device and bare platinum coils at six US centers (investigational device exemption G110014). Clinical follow-up was conducted at 30 days and 6 months. Angiographic follow-up was performed at 6 months. The primary safety endpoint was any major stroke or death within 30 days or major ipsilateral stroke or neurological death within 6 months. 'Probable benefit' was defined as ≥90% angiographic occlusion at 6 months. An independent core laboratory adjudicated the angiographic results. An independent clinical events committee adjudicated the clinical endpoints. RESULTS: Average aneurysm size was 7.2 mm (SD 3.8) and average neck width was 4.6 mm (SD 1.8). 68% of patients had a dome:neck ratio ≤2. LVIS placement was technically successful in 29/31 patients (93.5%). No primary safety endpoints occurred during the study (0%). No patient had a higher modified Rankin Score at 6 months than at baseline. 26/28 (92.9%) treated aneurysms with 6-month angiographic follow-up demonstrated ≥90% angiographic occlusion. 21/28 (75%) were completely occluded at follow-up. CONCLUSIONS: The LVIS device facilitated the coil embolization of wide-necked intracranial aneurysms with high rates of technical success, an excellent safety profile, and very high rates of complete and near-complete occlusion at follow-up. TRIAL REGISTRATION NUMBER: NCT01541254.