Feasibility, safety, and efficacy of endovascular treatment of anterior cranial fossa dural arteriovenous fistulas: a systematic review and meta-analysis with a subanalysis for Onyx.

Dural Arteriovenous Fistulas (dAVFs) of the anterior cranial fossa (ACF) are uncommon but carry a high risk of hemorrhage and pose substantial treatment challenges. Recent advancements in endovascular treatment (EVT), including the introduction of novel liquid embolic agents, have markedly bolstered EVT's role in managing ACF-dAVFs, with notable series published in the last five years. We aimed to assess the feasibility, safety, and efficacy of EVT for ACF-dAVFs. We searched Medline, Scopus, Web of Science, and Cochrane Library databases following PRISMA guidelines. Eligible studies included those with ≥ 5 patients undergoing embolization of ACF-dAVFs, detailing both angiographic and clinical outcomes. We used single proportion analysis with 95% confidence intervals under a random-effects model, I2 to assess heterogeneity, and Baujat and sensitivity analysis to address high heterogeneity. Publication bias was assessed by funnel-plot analysis and Egger's test. Outcomes included complete occlusion following embolization, unsuccessful endovascular embolization attempts, incomplete occlusion following embolization, symptom resolution or clinical improvement following embolization, recurrence; procedure-related complications, morbidity, and mortality. Additionally, a subanalysis for studies exclusively utilizing Onyx™ embolic system was done. Eighteen studies comprising 231 ACF-dAVF were included. Unsuccessful endovascular embolization attempts rate was 2%. Complete occlusion rate was 85%, with 4% of complications. Incomplete occlusion rate was 10%. Successfully embolized patients experienced either symptom resolution or clinical improvement in 94% of cases. Morbidity and mortality rates were 1% and 0%, respectively. Onyx subanalyses showed an overall rate of 0% for unsuccessful attempts, 95% for complete occlusion, and 5% for incomplete occlusion. Symptom resolution or clinical improvement was 98% and recurrence rate was 0%. EVT for ACF-dAVF is highly feasible, effective, and safe, with a low rate of complications, morbidity, and mortality. The subanalyses focusing on Onyx embolizations revealed superior efficacy and safety outcomes compared to the findings of the primary analyses involving all included studies.

Onyx®, A New Tool for Intraoperative Localization of Liver Lesions.

BACKGROUND: Precise preoperative localization of liver tumors facilitates successful surgical procedures, Intraoperative ultrasonography is a sensitive imaging modality. However, the presence of small non-palpable isoechoic intraparenchymal lesions may be challenging intraoperatively. METHODOLOGY AND MATERIAL DESCRIPTION: Onyx® is a non-adhesive liquid agent comprised of ethylene-vinyl alcohol usually used dissolved in dimethyl-sulfoxide and suspended micronized tantalum powder to provide contrast for visualization under fluoroscopy and ultrasonography and a macroscopic black shape. This embolization material has been increasingly used for the embolization of intracranial arteriovenous malformations. We present the novel application of Onyx® on liver surgery. CURRENT STATUS: We present the case of a female, 55 years-old, whose medical history revealed an elective sigmoidectomy (pT3N1a). After 17 months of follow up, by PET-CT scan, the patient was diagnosed of a small intraparenchymal hypo-attenuated 13 mm tumor located at segment V consistent with metachronous colorectal liver metastasis. Open metastasectomy was performed, ultrasonography-guided Onyx® infusion was delivered the day after, intraoperative ultrasonography showed a palpable hyperechoic material with a posterior acoustic shadowing artifact around the lesion. Onyx® is a promising new tool, without any previous application on liver surgery, feasible with advantages in small not palpable intraparenchymal liver lesions.

Delayed Migration of Onyx Embolic Agent after Preoperative Embolization of an Arteriovenous Malformation in a Pediatric Patient: A Case Report and Review of the Literature.

INTRODUCTION: Brain arteriovenous malformations (AVMs) are increasingly being treated with Onyx liquid embolic agent (Onyx, Medtronic, Inc.). The phenomenon of delayed Onyx migration is not well documented in the literature. Moreover, the clinical presentation associated with Onyx migration is not well understood. CASE PRESENTATION: A pediatric patient with a history of neonatal seizures was referred to our institution upon experiencing daily headaches with photophobia, phonophobia, and sleep disturbance. Cerebral angiography revealed an AVM of the medial left cerebellar hemisphere. Preoperative embolization with Onyx liquid embolic achieved 25% closure of the AVM nidus. Upon developing worsening headaches the following day, new perinidal parenchymal edema was revealed on MRI, and urgent angiography demonstrated delayed migration of Onyx into the venous drainage. The patient underwent emergency resection of the AVM due to the risk of hemorrhage resulting from venous outflow obstruction. CONCLUSION: Our report and literature review demonstrate that while the delayed, unexpected migration of Onyx embolic material has been alluded to in a handful of papers, this phenomenon is not well documented. Future research is needed to understand the frequency of delayed Onyx migration from brain AVMs and the possible clinical presentations to look for. The sudden development of headaches and other signs of perilesional edema, in particular, should prompt repeat angiographic examination due to the possibility of delayed liquid embolic migration.

Efficacy and Safety of Ethylene-Vinyl Alcohol (EVOH) Copolymer-Based Non-Adhesive Liquid Embolic Agents (NALEAs) in Transcatheter Arterial Embolization (TAE) of Acute Non-Neurovascular Bleeding: A Multicenter Retrospective Cohort Study.

Background and Objectives: Transcatheter arterial embolization (TAE) is part of the daily practice of most interventional radiologists worldwide. The ideal liquid embolic agent is far from being identified. Non-adhesive liquid embolic agents (NALEA) harden from the outside to the inside, resulting in deep penetration, known as "magma-like" progression, which permits a more distal embolization with good control of the embolic material. This multicenter retrospective cohort study aims to assess the efficacy, feasibility and safety of transcatheter arterial embolization (TAE) with ethylene-vinyl alcohol (EVOH)-based NALEAs (Onyx and Squid) in acute bleeding outside of the neurovascular area. Materials and Methods: This study is a multicenter analysis of retrospectively collected data of consecutive patients who had undergone, from January 2015 to December 2022, transcatheter arterial embolization with non-adhesive EVOH-based agents in the setting of acute non-neurovascular bleeding. Results: Fifty-three patients underwent transcatheter arterial embolization for acute non-neurovascular bleeding. Eight (15.1%) procedures were performed in patients with coagulopathy. The most used concentration of EVOH-based NALEAs was 34 (i.e., 8%), with a mean dose of 0.5 (±0.3) mL. The mean CT-to-groin time, the mean procedure time, the mean CT-to-embolization time and the mean fluoroscopy time were 22.9 (±12.4) min, 27.5 (±7) min, 50.3 (±13.1) min and 7.5 (±2.8) min, respectively. Technical success was achieved in all cases with a 96.2% clinical success rate. Complications were recorded in six (11.3%) patients. No statistically significant differences were observed between the group of patients with coagulopathy and the group of patients without coagulopathy in terms of efficacy and safety endpoints. Conclusions: Transcatheter arterial embolization (TAE) performed with non-adhesive EVOH-based embolic agents is an effective, feasible and safe strategy for the management of acute non-neurovascular bleeding, even in the subgroup of patients with coagulopathy.

[Dural Arteriovenous Fistula:Indications and Outcomes].

The diagnosis of dural arteriovenous fistulas(DAVF)has advanced with the development of imaging techniques. The indication for treatment of DAVF is generally based on classification according to the venous drainage pattern, which determines whether the presentation is benign or aggressive. In recent years, with the introduction of Onyx, transarterial embolization has been increasingly used, and outcomes have improved, although some conditions are more suitable for transvenous embolization. It is important to select an optimal approach based on location and angioarchitecture. Since DAVF is a rare vascular disease with limited evidence, further validation of clinical results is needed to provide more established treatment guidelines.

Embolization in pelvic venous disorders using ethylene vinyl alcohol copolymer (Onyx®) and Aetoxysclerol: a prospective evaluation of safety and long-term efficacy.

OBJECTIVES: To prospectively evaluate the safety and efficacy of embolization using ethylene vinyl alcohol copolymer (Onyx®) and Aetoxysclerol for treatment of pelvic venous disorders (PeVD). METHODS: This prospective study was approved by the institutional ethics review board. Ten clinical parameters were retained for evaluation of PeVD (pelvic pain, dyspareunia, post-coital pain, menstruation pain, lower limbs pain, difficulty walking, aesthetic discomfort, impact on daily working life, psychological impact and impact on daily life), measured on a visual analogue scale (VAS) between 0 and 10, and a global score out of 100 was noted before embolization, after 3 months during the imaging follow-up, and at the end of follow-up by phone call. The main criterion was clinical efficacy of embolization defined by an impairment score < 40/100 and a 50% decrease in overall score. Complications were recorded. Visualization of Onyx® on MRI 3 months after embolization was noted. RESULTS: Between July 2017 and May 2019, 73 consecutive women (mean age ± SD [range]: 41 ± 11 years [25-77]) treated by embolization with Onyx® and Aetoxysclerol were included. The median follow-up was 28 months [Q1-Q3: 24.0-29.2] (range: 18.1-34.5). The median initial VAS impairment score was 39/100 [29.75-48.50] (12-58). Clinical efficacy was obtained for 70 patients (70/73, 95.9%), and the median VAS impairment score at the end of follow-up was significantly lower at 3 [0.00-7.25] (0-73) (p < 0.0001). Four minor complications occurred. Onyx® was visualized on DIXON sequence of MRI for all patients. CONCLUSION: Embolization using Onyx® and Aetoxysclerol for PeVD is safe and effective. KEY POINTS: • Embolization using Onyx® and Aetoxysclerol for pelvic venous disorders is safe and effective. • Imaging follow-up is facilitated by visualization of Onyx® on MRI DIXON sequences.

Micro-balloon-assisted embolization of anterior cranial fossa dural arteriovenous fistula via a trans-ophthalmic approach - a technical report and case series.

PURPOSE: Dural arteriovenous fistulas (dAVF) account for approximately 10-15% of all intracranial arteriovenous abnormalities. dAVFs carry a significant risk of mortality, particularly in cases of acute hemorrhage, of up to 10%. A small proportion of these dAVFs are found in the anterior cranial fossa (ACF), of which the rate of hemorrhage can be as high as up to 91%. The Scepter Mini (SM) is the smallest dual-lumen micro-balloon (MB) available for neurointerventional practice. It consists of a 2.8 French outer diameter, with a 2.2 mm × 9 mm semi-compliant balloon providing a working length of 165 cm. The SM is navigated with a 0.008-inch wire making it a particularly attractive tool accessible to the pedicles normally reached with liquid embolization micro-catheters. METHODS: Five consecutive patients over a 1-year period between 2020 and 2021 were evaluated and treated for ACF dAVF using a liquid embolization approach using the SM balloon. All patients were treated using ethylene-vinyl alcohol copolymer (EVOH), of which Squid 18 and/or Squid 12 were the chosen viscosities. Control angiograms were performed for all patients post-embolization. RESULTS: All patients demonstrated complete occlusion of the ACF dAVF on immediate post-treatment angiography. No immediate complications were encountered; particularly, there were no reports of visual field deficit in any of the patients. CONCLUSION: The MB is a valuable adjunctive tool that can enhance the safety and efficacy of trans-ophthalmic embolization of ACF dAVFs, providing additional protection to the retinal and posterior ciliary arteries against unwanted reflux of liquid embolic agent.

Cost-Effectiveness Analysis of Transcatheter Arterial Embolization Techniques for the Treatment of Gastrointestinal Bleeding in the United States.

OBJECTIVES: Gastrointestinal (GI) bleeding is a common medical emergency associated with significant mortality. Transcatheter arterial embolization first was introduced by Rosch et al as an alternative to surgery for upper GI bleeding. The clinical success in patients with GI bleeding treated with transcatheter arterial embolization previously has been reported. However, there are no cost-effectiveness analyses reported to date. Here we report cost-effectiveness analysis of N-butyl 2-cyanoacrylate glue (NBCA) and ethylene-vinyl alcohol copolymer (Onyx) versus coil (gold standard) for treatment of GI bleeding from a healthcare payer perspective. METHODS: Fixed-effects modeling with a generalized linear mixed method was used in NBCA and coil intervention arms to determine the pooled probabilities of clinical success and mortality with complications with their confidence intervals, while the Clopper-Pearson model was used for Onyx to determine the same parameters. Models were provided by the "Meta-Analysis with R" software package. A decision tree was built for cost-effectiveness analysis, and Microsoft Excel was used for probabilistic sensitivity analysis. The cost-effective option was determined based on the incremental cost-effectiveness ratio and scatter plots of incremental cost versus incremental quality-adjusted life-years. RESULTS: Comparing scatter plots and incremental cost-effectiveness ratio results, -$1024 and -$1349 per quality-adjusted life-year for Onyx and N-butyl 2-cyanoacrylate glue, respectively, Onyx was the least expensive and most effective intervention. CONCLUSION: Onyx was the dominant strategy regardless of threshold values. Our analyses provide a framework for researchers to predict the target clinical effectiveness for early-stage TAE interventions and guide resource allocation decisions.

Polypropylene and polyvinylidene fluoride transobturator slings for the treatment of female stress urinary incontinence: 1-Year outcomes from a multicentre randomized trial.

AIMS: To compare the effectiveness and safety of polypropylene (PP) and polyvinylidene fluoride (PVDF) transobturator tapes (TOT) for the treatment of female stress urinary incontinence (SUI). METHODS: This is a multicentre randomized trial. Women with SUI or stress-predominant mixed urinary incontinence and scheduled for a TOT procedure were randomized to PP or PVDF slings. The primary outcome was 1-year cure or improvement rate using composite criteria. Complications were also compared. Relationships with outcomes were analyzed using multivariable logistic regressions models. RESULTS: From April 2016 to January 2018 285 participants were randomized. PP and PVDF slings showed similar high cure or improvement rate (91.0% vs. 95.6%, p = .138). Improvement in validated questionnaires was also similar. PVDF slings were associated with a lower rate of de novo urgency incontinence (adjusted odds ratio = 0.35; 95% confidence interval = 0.15-0.80). We found no statistical differences in complications rates, although a higher incidence of long-term pain events were observed in the PP group. The study is underpowered to find differences in specific complications owing to the low number of events. CONCLUSION: PP and PVDF TOTs are equally effective, although PVDF is associated with fewer cases of de novo urgency incontinence. Further studies are needed to give robust conclusions on safety profiles.

A Damp-and-Push Technique for the Copolymer (Onyx) Embolization of Dural Arteriovenous Fistula.

BACKGROUND: Copolymer (Onyx) embolization is an effective treatment for dural arteriovenous fistula (dAVF), however, some dAVFs have multiple, high-flow feeding vessels, resulting in insufficient embolization. For the treatment of such patients, we have developed a novel flow-control technique, the 'damp-and-push technique'. The purpose of this study was to evaluate the technical efficiency and safety of this technique. METHODS: Seven patients who had been diagnosed with intracranial dAVF were treated by transarterial Onyx embolization using the damp-and-push technique between 2016 and 2019. This technique was designed to reduce blood flow to the shunt site using a balloon catheter in the major feeding vessel other than the one injected with Onyx, leading to better Onyx penetration and enabling more controlled embolization of complex dAVFs. Retrospectively collected data were reviewed to assess the occlusion rates and clinical outcomes. RESULTS: The dAVF was at a transverse sinus-sigmoid sinus junction in four patients, in the superior sagittal sinus in two, and in the tentorium in one. Five cases were Cognard type Ⅱb and two cases were Cognard type Ⅳ. All the patients were treated by transarterial Onyx injection via the main feeding vessel, combined with flow reduction in the other main feeding vessel using a balloon catheter. Complete occlusion was achieved in six patients and elimination of cerebral venous reflux was achieved in all the patients. There were no immediate or delayed post-interventional complications. CONCLUSIONS: Transarterial Onyx embolization of dAVF using the damp-and-push technique is safe and yields a high complete occlusion rate.

Ethylene Vinyl Alcohol Copolymer Embolization for Acute Renal Hemorrhage: Initial Experience in 24 Cases.

OBJECTIVE. The purpose of this study was to assess the efficacy and safety of ethylene vinyl alcohol (EVOH) copolymer (Onyx, Medtronic) for embolization for acute renal hemorrhage. MATERIALS AND METHODS. Between October 2006 and June 2018, 24 consecutive patients were treated by embolization with EVOH copolymer for acute renal hemorrhage at Hôpital Bichat-Claude-Bernard. CT angiography was performed in all patients before treatment. Technical success was defined as the complete occlusion of the bleeding artery on final renal angiogram. Clinical success was defined as the absence of rebleeding after embolization. Complications mid procedure, infarcted renal area on final angiogram, and renal function 1 week after embolization were retrospectively analyzed. RESULTS. Active bleeding was observed in all cases. The causes of acute renal hemorrhage were iatrogenic in 12 patients, vascular malformation in four patients, renal tumor in four patients, and unknown in four patients. EVOH copolymer was the sole embolic agent used in 16 patients. In eight patients, EVOH copolymer was used after persistent bleeding after embolization with coils. Technical and clinical success rates were 100%. No patient required surgery or new embolization during a mean follow-up period of 35 months (range, 6-86 months). No serious complications were attributable to EVOH copolymer. The mean infarcted renal area was 10% (range, 5-30%). Renal function, available for 16 (67%) patients, was not altered 1 week after embolization. CONCLUSION. EVOH copolymer is safe and effective for embolization of acute renal hemorrhage, either as a first-line embolic agent or after failure of coil embolization.

[New approaches to embolization of aneurysms (liquid embolic agents)]. / Neue Wege zur Embolisation von Aneurysmen (Flüssigembolisat).

Various materials are currently available for the endovascular treatment of aneurysms. The choice of material depends on the location and configuration of the aneurysm. To ensure optimal aneurysm treatment, the filling material must incorporate the aneurysm and isolate it from the parent vessel by forming an endothelial layer and neointima proliferation along the aneurysm neck. As a result, the aneurysm can be permanently isolated from the blood flow and the weakened vessel wall can be stabilized in the long term in order to prevent subsequent rupture. Bare metal coils are currently most commonly used. In recent years, liquid embolic agents have increasingly been developed for the endovascular treatment of aneurysms. One of the reasons is that the injected fluid completely fills the aneurysm lumen, so there is no gap between the filling material and the aneurysm wall, regardless of the shape of the aneurysm. Most of the preclinical and clinical studies are available for Onyx. In particular for the treatment of mycotic aneurysms and distal aneurysms of the posterior circulation, liquid embolization with Onyx has already proven to be a possible, effective treatment method.

Embolization of brain arteriovenous malformations with the diluted Onyx technique: initial experience.

PURPOSE: Insufficient nidus occlusion is a matter of great concern to routine Onyx embolization of brain arteriovenous malformations (AVMs). This paper described an efficient method which using the diluted Onyx embolization technique to treat brain AVM. METHODS: The diluted Onyx technique was performed in a series of 15 patients with brain AVMs (10 males, 5 females; age range, 11-44 years). It consists of initial embolization with routine Onyx-18, followed by the diluted Onyx (1.5 mL of Onyx-18 diluted with 0.5 mL of DMSO) through the same microcatheter. The technical skills and angiographic and clinical outcomes were analyzed. RESULTS: A total of 15 embolization sessions were performed with diluted Onyx via 16 arterial feeders in these 15 patients. Each patient underwent one attempt of diluted Onyx through a single feeder except one patient. In this patient, the AVM was simultaneously embolized with diluted Onyx through double microcatheters which were placed in two feeders. When the length of reflux reached to 2 cm (or close to the determined length) and the embolic material could not move distally any more despite some rounds of "injection-reflux-waiting," regular Onyx 18 was changed to diluted Onyx. Antegrade flow of embolic material into the nidus was observed in 12 cases but failed in 3. An average of 90% (range 55-100%) estimated size reduction was achieved, and 6 AVMs were completely obliterated. No functionally relevant complications occurred. CONCLUSION: The diluted Onyx technique could be a useful adjunct to routine Onyx embolization which may offer more embolic material penetrating into the nidus of AVM, but additional work is needed to validate this technique.

Laparoscopic bilateral cervicosacropexy: introduction to a new tunneling technique.

INTRODUCTION AND HYPOTHESIS: To elevate and suspend the apical end of the vagina, the uterosacral ligaments (USL) were replaced by polyvinylidene fluoride (PVDF) structures. These PVDF structures were placed in the peritoneal folds of the USL at the pelvic wall to mimic the lateral and backward tension and to avoid rectal obstruction. A special tunneling device was used, which allowed the semi-circular placement of the structure without destroying the peritoneum. METHODS: A 59-year-old woman with mixed urinary incontinence and apical prolapse (pelvic organ prolapse quantification system, POP-Q, stage 2) of the uterus underwent laparoscopic bilateral USL replacement. USLs were replaced by PVDF structures by performing the cervicosacropexy (CESA) technique using a semi-circular tunneling device. RESULTS: Apical support was restored (POP-Q stage 0), and the patient was continent thereafter. The tunneling device was pulled through the peritoneal folds of the USLs toward the cervix. The new USL structures were brought to their physiological position. The new technique did not lead to any complications and did not cause any side effects during 1-year follow-up. CONCLUSIONS: Restoration of apical prolapse and urinary continence was achieved by bilateral USL replacement using a semi-circular tunneling device that was inserted through the lateral abdominal trocar incision.

Ultrasound visualization of sacrocolpopexy polyvinylidene fluoride meshes containing paramagnetic Fe particles compared with polypropylene mesh.

INTRODUCTION AND HYPOTHESIS: Paramagnetic Fe particles can be added during synthetic mesh production to allow visibility on magnetic resonance imaging. Our aim was to evaluate whether transperineal ultrasound (TPUS) allows visualization, measurement, and characterization of polyvinylidene fluoride (PVDF mesh) containing Fe particles compared with regular polypropylene (PP) meshes used for sacrocolpopexy. METHODS: Women up to 1.5 years after laparoscopic sacrocolpopexy who were implanted with a PP or PVDF mesh underwent clinical examination and 2D, 3D, and 4D TPUS. Acquired volumes were analyzed offline for mesh position at rest and maximal Valsalva and for mesh dimensions and characteristics, with the operator blinded to group assignment. The two groups were compared. RESULTS: There were 17 women in the PP and 25 in the PVDF mesh group, without differences in baseline demographics. None had significant prolapse, recurrence, symptoms, or complications. On TPUS, mesh was visible in all patients both caudally (perineal) and cranially but was more echogenic in the PVDF mesh group. Mesh length from distal to proximal that was visible on TPUS was longer for PVDF mesh, for both anterior and posterior vaginal arms (all P < 0.05), and for mesh above the vaginal apex (P = 0.002). The inferior aspects of the mesh showed areas of double mesh layers, suggesting folding in 80% of women in both groups, without symptoms. CONCLUSIONS: PVDF mesh permits clearer visualization and is seen over a longer stretch on TPUS, with longer visible mesh arms. The latter can be due to differences in operative technique, presence of microparticles, implant textile structure, or patient characteristics.

Print-based self-help interventions for smoking cessation.

BACKGROUND: Many smokers give up smoking on their own, but materials that provide a structured programme for smokers to follow may increase the number who quit successfully. OBJECTIVES: The aims of this review were to determine the effectiveness of different forms of print-based self-help materials that provide a structured programme for smokers to follow, compared with no treatment and with other minimal contact strategies, and to determine the comparative effectiveness of different components and characteristics of print-based self-help, such as computer-generated feedback, additional materials, tailoring of materials to individuals, and targeting of materials at specific groups. SEARCH METHODS: We searched the Cochrane Tobacco Addiction Group Trials Register, ClinicalTrials.gov, and the International Clinical Trials Registry Platform (ICTRP). The date of the most recent search was March 2018. SELECTION CRITERIA: We included randomised trials of smoking cessation with follow-up of at least six months, where at least one arm tested print-based materials providing self-help compared with minimal print-based self-help (such as a short leaflet) or a lower-intensity control. We defined 'self-help' as structured programming for smokers trying to quit without intensive contact with a therapist. DATA COLLECTION AND ANALYSIS: We extracted data in accordance with standard methodological procedures set out by Cochrane. The main outcome measure was abstinence from smoking after at least six months' follow-up in people smoking at baseline. We used the most rigorous definition of abstinence in each study and biochemically validated rates when available. Where appropriate, we performed meta-analysis using a random-effects model. MAIN RESULTS: We identified 75 studies that met our inclusion criteria. Many study reports did not include sufficient detail to allow judgement of risk of bias for some domains. We judged 30 studies (40%) to be at high risk of bias for one or more domains.Thirty-five studies evaluated the effects of standard, non-tailored self-help materials. Eleven studies compared self-help materials alone with no intervention and found a small effect in favour of the intervention (n = 13,241; risk ratio (RR) 1.19, 95% confidence interval (CI) 1.03 to 1.37; I² = 0%). We judged the evidence to be of moderate certainty in accordance with GRADE, downgraded for indirect relevance to populations in low- and middle-income countries because evidence for this comparison came from studies conducted solely in high-income countries and there is reason to believe the intervention might work differently in low- and middle-income countries. This analysis excluded two studies by the same author team with strongly positive outcomes that were clear outliers and introduced significant heterogeneity. Six further studies of structured self-help compared with brief leaflets did not show evidence of an effect of self-help materials on smoking cessation (n = 7023; RR 0.87, 95% CI 0.71 to 1.07; I² = 21%). We found evidence of benefit from standard self-help materials when there was brief contact that did not include smoking cessation advice (4 studies; n = 2822; RR 1.39, 95% CI 1.03 to 1.88; I² = 0%), but not when self-help was provided as an adjunct to face-to-face smoking cessation advice for all participants (11 studies; n = 5365; RR 0.99, 95% CI 0.76 to 1.28; I² = 32%).Thirty-two studies tested materials tailored for the characteristics of individual smokers, with controls receiving no materials, or stage-matched or non-tailored materials. Most of these studies used more than one mailing. Pooling studies that compared tailored self-help with no self-help, either on its own or compared with advice, or as an adjunct to advice, showed a benefit of providing tailored self-help interventions (12 studies; n = 19,190; RR 1.34, 95% CI 1.20 to 1.49; I² = 0%) with little evidence of difference between subgroups (10 studies compared tailored with no materials, n = 14,359; RR 1.34, 95% CI 1.19 to 1.51; I² = 0%; two studies compared tailored materials with brief advice, n = 2992; RR 1.13, 95% CI 0.86 to 1.49; I² = 0%; and two studies evaluated tailored materials as an adjunct to brief advice, n = 1839; RR 1.72, 95% CI 1.17 to 2.53; I² = 10%). When studies compared tailored self-help with non-tailored self-help, results favoured tailored interventions when the tailored interventions involved more mailings than the non-tailored interventions (9 studies; n = 14,166; RR 1.42, 95% CI 1.20 to 1.68; I² = 0%), but not when the two conditions were contact-matched (10 studies; n = 11,024; RR 1.07, 95% CI 0.89 to 1.30; I² = 50%). We judged the evidence to be of moderate certainty in accordance with GRADE, downgraded for risk of bias.Five studies evaluated self-help materials as an adjunct to nicotine replacement therapy; pooling three of these provided no evidence of additional benefit (n = 1769; RR 1.05, 95% CI 0.86 to 1.30; I² = 0%). Four studies evaluating additional written materials favoured the intervention, but the lower confidence interval crossed the line of no effect (RR 1.20, 95% CI 0.91 to 1.58; I² = 73%). A small number of other studies did not detect benefit from using targeted materials, or find differences between different self-help programmes. AUTHORS' CONCLUSIONS: Moderate-certainty evidence shows that when no other support is available, written self-help materials help more people to stop smoking than no intervention. When people receive advice from a health professional or are using nicotine replacement therapy, there is no evidence that self-help materials add to their effect. However, small benefits cannot be excluded. Moderate-certainty evidence shows that self-help materials that use data from participants to tailor the nature of the advice or support given are more effective than no intervention. However, when tailored self-help materials, which typically involve repeated assessment and mailing, were compared with untailored materials delivered similarly, there was no evidence of benefit.Available evidence tested self-help interventions in high-income countries, where more intensive support is often available. Further research is needed to investigate effects of these interventions in low- and middle-income countries, where more intensive support may not be available.

Onyx embolization of a ruptured anterior inferior cerebellar artery in a neonate.

Aneurysmal subarachnoid hemorrhage (SAH) is rare in neonates. The authors present a unique report of a neonate with SAH from anterior inferior cerebellar artery (AICA) aneurysm rupture that was successfully treated with Onyx embolization. This case report demonstrates the utility of Onyx embolization for posterior circulation aneurysms in neonates and the successful management of SAH in this population.

Transarterial embolization of peripheral high-flow arteriovenous malformation with ethylene vinyl alcohol copolymer (Onyx®): single-center 10-year experience.

PURPOSE: High-flow arteriovenous malformations (AVMs) are complex vascular lesions for which transcatheter embolization is considered as first-choice treatment nowadays. Multiple embolizing agents have been described, and among them, Onyx® seems to be promising; this is a liquid embolic agent, originally applied in neurointerventional radiology and recently adopted also in peripheral embolizations. The aim of this study is to report on a 10-year experience of transarterial embolization of peripheral high-flow AVM with Onyx® in terms of technical and clinical outcomes. MATERIALS AND METHODS: Retrospective analysis was conducted on patients affected by high-flow AVM and treated electively by transarterial embolization with Onyx®. Data collection included: preinterventional clinical radiological evaluations, procedural data and post-procedural clinical radiological assessment. Technical and clinical success was evaluated; follow-up was conducted 30 days after the last treatment session and yearly in case of success. RESULTS: Sixteen patients have been included, totally 38 embolizing procedures. Additional embolizing agents were required in 5 patients. Technical success was obtained in 11 patients; at 30-day follow-up, 15 patients showed improvements in symptoms, even those with incomplete embolization; however, after almost 1 year from treatment accomplishment, 7 patients showed relapse of symptoms and presented radiological signs of AVM recurrence. No clinically relevant complications occurred. CONCLUSIONS: In this series, in accordance with previous but limited published data, Onyx® appeared safe and technically effective to embolize high-flow peripheral AVM with transarterial approach. Clinical radiological follow-up is mandatory because new feeder recruitment has to be expected; patients should be informed of the concrete possibility of multiple treatment sessions.

Migration of Ethylene Vinyl Alcohol Co-Polymer in the Urinary Tract Successfully Managed.

Selective embolization is the treatment of choice for traumatic renal pseudoaneurysm. The use of ethylene vinyl alcohol copolymer (EVOH) was recently described as an embolic agent in peripheral lesions. The aim of a good embolic agent is to: achieve rapid and effective embolization; reach and fill distal vasculature targeted for embolization; be easy to prepare and use. Moreover, it should be highly radiopaque, controllable during administration, biocompatible and cost-effective. EVOH is a non-adhesive embolic agent and its efficacy is independent from the coagulant status. The risk of non-targeted embolization should be reduced by the good radio-opacity of the embolic material that is injected under continuous fluoroscopy. Nevertheless, symptomatic EVOH migration was described. We report a unique case of embolization of a renal pseudoaneurysm and migration of EVOH in the urinary tract. Retrograde trans-urethral removal of the migrated embolic agent was successfully performed. Our case report indicates that EVOH may not be appropriate when a fistula with renal calyx is suspected, even if its migration in the urinary tract may be managed.

Results of an innovative bulking agent in patients with stress urinary incontinence who are not optimal candidates for mid-urethral sling surgery.

AIMS: To assess the efficacy and safety of peri-urethral bulking injections (PBI) with an innovative bulking material (PDMS-U) in women with stress-urinary incontinence (SUI) who are not optimal candidates for mid-urethral sling surgery. METHODS: A prospective study was performed in women with SUI who, for several reasons, have a relative contraindication for a mid-urethral sling procedure. These reasons include: (i) recurrent SUI after a prior SUI surgical procedure; (ii) a history of oncologic gynaecological surgery; (iii) a history of neurologic disease resulting in voiding problems; (iv) a maximal flow rate of less than 15 mL per second or; (v) women with a contraindication for surgery with general or regional anaesthesia. All women were treated with PBI consisting of PDMS-U, a bulking agent that polymerizes in situ. The primary outcome was subjective improvement, defined as "a little better" to "very much better" on the PGI-I. Secondary outcomes included objective cure, disease specific quality of life and adverse events. RESULTS: Subjective improvement was reported by 18 (90%) of the 20 included patients. The subjective cure rate was 56% and the objective cure rate was 65%. There was a statistically significant improvement of all domain scores of the UDI-6, IIQ-7, and PISQ-12 at 6 months follow up. Abnormal post voiding residual volume (>150 mL) was the most common adverse event (40%), but persisted in only one patient, based on the patient's preference for a catheter. CONCLUSIONS: PBI with PDMS-U is a viable treatment option in women with a relative contra-indication for mid-urethral sling surgery.