Systematic review of the safety and efficacy of foam sclerotherapy for venous disease of the lower limbs

Background: Foam sclerotherapy is a potential treatment for lower limb venous disease. Methods: A systematic review, with no restriction on study design, to assess the safety and efficacy of foam sclerotherapy. Results: 69 studies were included. For serious adverse events including pulmonary embolism and deep vein thrombosis, the median event rates were less than 1%. Median rate for visual disturbance was 1.4%. Median rates for some other adverse events were more common, including headache (4.2%), thrombophlebitis (4.7%), matting/skin staining/pigmentation (17.8%) and pain at the site of injection (25.6%). Median rate for complete occlusion of treated veins was 87.0% and for recurrence or development of new veins was 8.1%. Evidence from meta-analysis for complete occlusion suggests that foam sclerotherapy is associated with a lower rate compared with surgery (RR 0.86, 95% CI 0.67 to 1.10) and a higher rate compared with liquid sclerotherapy (RR 1.39, 95% CI 0.91 to 2.11). However, there was substantial heterogeneity across the studies in the meta-analysis. Conclusion: Serious adverse events were rare. There is insufficient evidence to reliably compare the effectiveness of foam sclerotherapy with other minimally invasive therapies or surgery. Evidence from high quality randomised controlled trials is required.This manuscript is based on a systematic review commissioned and funded by the National Institute for Health and Clinical Excellence (NICE) through its Interventional Procedures Programme. The Health Services Research Unit is supported by a core grant from the Chief Scientist Office of the Scottish Executive Health Department

Foam-in-Vein: Rheological Characterisation of Liquid Sclerosing Foams Using a Pipe Viscometer

Sclerotherapy is one of the most common and least-invasive treatment methods for varicose veins. While bench-top properties of sclerosing foams (e.g., bubble size distribution and foam half-life) have been studied previously, their flow behaviour and its relationship to therapeutic efficacy remain largely uncharacterised. To address this research gap, the present study reports on a novel approach for the rheological characterisation of sclerosing foams aimed at obtaining clinically-applicable data. A pipe viscometry apparatus was employed under conditions that mimic the end-point therapeutic application of foams. Polidocanol (1% v/v) foams of various liquid-to-gas volume ratios (1:3, 1:4 and 1:5) were formulated manually using the Tessari and DSS (double syringe system) methods across a clinically-relevant range of shear rates (≈ 7 s^{-1} – 400 s^{-1}), in polytetrafluoroethylene pipes of different diameters (2.48 mm and 4.48 mm). Additionally, end-effect and wall-slip correction methods were utilised to model the nominal rheology of sclerosing foams. The rheological data were fitted into a power-law model to obtain fluid flow index (n) and fluid consistency index (K) of sclerosing foams, followed by an in-depth statistical analysis of the power-law indices. The observed rheological behaviour of sclerosing foams is shown to be dependent on vessel diameter and liquid-to-gas ratio, while the type of manual formulation technique used appears to be statistically insignificant towards foam rheology. Sclerosing foams behaved as shear-thinning fluids with observed flow indices ranging 0.238 < n < 0.445, while the observed consistency indices ranged 2.977 < K < 12.49. The nominal (end-effect corrected) rheology of foams was shown to follow similar trends concerning liquid-to-gas ratio and formulation technique, independent of the tube diameter. The power-law characterisation of sclerosing foam rheology provided evidence of a quasi-static drainage effect that affected foam viscosity during slower injections. Wall-slip correction failed to provide physically meaningful results and statistical analysis suggested that the type of manual formulation technique used has no impact on the outcome of sclerotherapy on larger varicosities. Overall, results suggest a direct correlation between foam dryness and viscosity. Based on the developed rheological model, this work also demonstrates that low injection flowrates could yield higher therapeutic efficacy in dilated varicose veins

Coil-Assisted Retrograde Transvenous Obliteration (CARTO) for the Treatment of Portal Hypertensive Variceal Bleeding: Preliminary Results.

ObjectivesTo describe the technical feasibility, safety, and clinical outcomes of coil-assisted retrograde transvenous obliteration (CARTO) in treating portal hypertensive non-esophageal variceal hemorrhage.MethodsFrom October 2012 to December 2013, 20 patients who received CARTO for the treatment of portal hypertensive non-esophageal variceal bleeding were retrospectively evaluated. All 20 patients had at least 6-month follow-up. All patients had detachable coils placed to occlude the efferent shunt and retrograde gelfoam embolization to achieve complete thrombosis/obliteration of varices. Technical success, clinical success, rebleeding, and complications were evaluated at follow-up.ResultsA 100% technical success rate (defined as achieving complete occlusion of efferent shunt with complete thrombosis/obliteration of bleeding varices and/or stopping variceal bleeding) was demonstrated in all 20 patients. Clinical success rate (defined as no variceal rebleeding) was 100%. Follow-up computed tomography after CARTO demonstrated decrease in size with complete thrombosis and disappearance of the varices in all 20 patients. Thirteen out of the 20 had endoscopic confirmation of resolution of varices. Minor post-CARTO complications, including worsening of esophageal varices (not bleeding) and worsening of ascites/hydrothorax, were noted in 5 patients (25%). One patient passed away at 24 days after the CARTO due to systemic and portal venous thrombosis and multi-organ failure. Otherwise, no major complication was noted. No variceal rebleeding was noted in all 20 patients during mean follow-up of 384±154 days.ConclusionsCARTO appears to be a technically feasible and safe alternative to traditional balloon-occluded retrograde transvenous obliteration or transjugular intrahepatic portosystemic shunt, with excellent clinical outcomes in treating portal hypertensive non-esophageal variceal bleeding

Prospective randomized efficacy of ultrasound-guided foam sclerotherapy compared with ultrasound-guided liquid sclerotherapy in the treatment of symptomatic venous malformations

ObjectiveTo compare the clinical outcome between ultrasound-guided foam sclerotherapy (UGFS) and ultrasound-guided liquid form sclerotherapy (UGLS) in patients with venous malformations (VM).MethodsEighty-nine patients with symptomatic VM were treated with ultrasound-guided sclerotherapy. There were 22 males and 67 females with mean age of 14.5 years. The sclerosing agents used were 1% polidocanol (POL) or 10% ethanolamine oleate (EO). POL was injected predominantly into smaller, superficial lesions, whereas EO was used for large, deeper lesions. Foam sclerosing solution was provided using Tessari’s method. Patients were randomized to receive either UGFS or UGLS. Post-sclerotherapy surveillance was done at 6 months after last session using duplex ultrasound. Findings obtained by duplex scanning were divided into four groups: (1) disappeared group: the venous space was occluded and was totally shrunk; (2) partially recanalized group: the venous space was partially recanalized and was partially shrunk; (3) totally recanalized group: the venous space was totally recanalized and returned at the same size; and (4) worsened group: the venous space was totally recanalized and became worse.ResultsForty-nine patients were treated with UGFS and the remaining 40 were treated with UGLS. There were no significant differences in age and men:women ratio. There was no significant difference in the anatomic distribution of VMs between the two groups. The amount of POL was significantly smaller in patients who were treated with UGFS (P = .022). Similarly, there was a significant reduction in the use of EO in patients treated with UGFS (P = .005). The proportion of VM with total disappearance and partial recanalization was significantly higher in patients treated with UGFS (P = .002). No major complications related to sclerotherapy were encountered in both groups.ConclusionsThese findings suggest that UGFS could have greater promise compared with UGLS in the treatment of VMs

Treatment of Low-flow Vascular Malformations by Ultrasound-guided Sclerotherapy with Polidocanol Foam: 24 Cases and Literature Review

AbstractObjectivesTreatment by sclerotherapy has been suggested as a first-line treatment of low-flow vascular malformations. This study reports our experience in treating low-flow vascular malformations by ultrasound-guided sclerosis with polidocanol foam at the Vascular Medicine Department in Grenoble, France.DesignRetrospective single-centre consecutive series.Materials and methodsBetween January 2006 and December 2009, we analysed the complete records of patients with symptomatic low-flow vascular malformations of venous, lymphatic or complex type (Klippel–Trenaunay syndrome, KTS) treated by ultrasound-guided sclerosis. The therapeutic indication was always validated by the Consultative Committee for vascular malformations of the University Hospital of Grenoble. All vascular malformations were classified according to the Hamburg Classification. The sclerosing agent was polidocanol used as foam.ResultsA total of 24 patients between 7 and 78 years were treated (19 venous malformations, three KTSs and two venous-lymphatic malformations). The concentrations of polidocanol used ranged from 0.25% to 3%. The average number of sessions was 2.3 (1–16). After a median follow-up at 5 months after the last session, 23 out of 24 patients reported a decrease in pain; in nine cases (37.5%), over 50% reduction in size was observed, and in 14 cases (58.3%), a reduction of less than 50% of the original size was obtained. Two minor side effects were reported.ConclusionsTreatment by ultrasound-guided sclerosis using polidocanol foam seems to be well tolerated and can improve the symptoms of low-flow malformations without the risks of more aggressive sclerosing agents, such as ethanol

Effect of Hyaluronic Acid and Pluronic-F68 on the Surface Properties of Foam as a Delivery System for Polidocanol in Sclerotherapy

The use of foams to deliver bioactive agents and drugs is increasing in pharmaceutics. One example is the use of foam as a delivery system for polidocanol (POL) in sclerotherapy, with the addition of bioactive compounds to improve the delivery system being a current subject of study. This work shows the influence of two bioactive additives on the structure and stability of POL foam: hyaluronic acid (HA) and Pluronic-F68 (F68). HA is a natural non-surface-active biopolymer present in the extracellular matrix while F68 is a surface-active poloxamer that is biocompatible with plasma-derived fluids. Both additives increase the bulk viscosity of the sample, improving foam stability. However, HA doubled and F68 quadruplicated the foam half lifetime of POL. HA reduced the size and polydispersity of the bubble size distribution and increased the surface elasticity with respect to POL. Both facts have a positive impact in terms of foam stability. F68 also altered bubble structure and increased surface elasticity, again contributing to the enhancement of foam stability. The surface characterization of these systems is important, as in foam sclerotherapy it is crucial to assure the presence of POL at the surface of the bubbles in order to deliver the sclerosant agent in the target vein.Junta de Andalucia NANOFOAM-PI12.2956Instituto de Salud Carlos III Spanish Government MAT2017-82182-R RTI2018-101309-B-C21Consejeria de Economia, Conocimiento, Empresas y UniversidadEuropean Union (EU) SOMM17/6109/UG

A Rare Xanthogranulomatous Oophoritis Presenting as Ovarian Cancer

Xanthogranulomatous inflammation is an uncommon form of chronic inflammation that is destructive to affected organs; it is characterized by the presence of lipid-filled macrophages with admixed lymphocytes, plasma cells, and neutrophils. Only a few cases of xanthogranulomatous oophoritis have been reported to date. We describe a rare case of xanthogranulomatous oophoritis with involvement of omentum

Special cases of sclerotherapy

In this article the basic rules for sclerotherapy of varicose veins in some special cases are discussed. These include varicose veins in pregnant women, sclerotherapy in patients against the background of treatment with indirect anticoagulants, in patients with pronounced postphlebitic syndrome, sclerotherapy of various gangliomas and the so-called accelerated sclerotherapy, as well as sclerotherapy of limbs with lipoedema and lymphedema.A thorough review of the main European schools working in this field—Swiss, French, German and Irish—has been carried out.The authors have summarized the experience of prominent sclerotherapists and give specific practical advice