polidocanol and Varicose-Veins

Skin hyperpigmentation after sclerotherapy with polidocanol-containing sclerosants is a common local side effect. Sclerotherapists should be familiar with factors that trigger hyperpigmentation after sclerotherapy with polidocanol-containing sclerosants. A systematic literature review of works reporting hyperpigmentation after sclerotherapy for telangiectasias, reticular veins, side branches and truncal varices with polidocanol-containing sclerosants was performed. Reported incidence rates, follow-up periods and potentially triggering factors were assessed and analysed. The search yielded 1687 results; of these, 27 reports met the inclusion criteria. The incidence of hyperpigmentation seemed to increase with higher concentrations of polidocanol and was more evident after sclerotherapy for epifascial veins than for intrafascial truncal veins when the polidocanol concentration was more than 0.25%. Regarding sclerotherapy for telangiectasias and reticular veins, the incidence of hyperpigmentation ranged between 2% and 25% for polidocanol 0.25% (liquid and foam), between 12.5% and 67.9% for polidocanol 0.5% (liquid and foam) and between 13% and 73% for polidocanol 1% (liquid and foam). Regarding truncal veins, the incidence ranged from 7% to 45.8% for polidocanol 1% (liquid and foam), from 16% to 17% for polidocanol 2% (foam) and from 7.4% to 32.5% for polidocanol 3% (liquid and foam). Regarding the treatment of side branches, the incidence of hyperpigmentation ranged from 5.6% to 53% for both foam and liquid sclerotherapy. Regarding the duration of hyperpigmentation, there are few data describing reticular veins and telangiectasias. Hyperpigmentation persisting for more than 6 months has been reported to have an incidence of up to 7.5%. Hyperpigmentation persisting for more than 1 year after foam polidocanol 1%-3% treatment for truncal veins has an incidence ranging from 8.1% to 17.5%. Other factors such as higher volumes and compression therapy after treatment seem to have a minor influence. Data regarding hyperpigmentation after polidocanol-related sclerotherapy are poor and should be improved by higher-quality research.

Topics: Humans; Hyperpigmentation; Polidocanol; Polyethylene Glycols; Sclerosing Solutions; Sclerotherapy; Telangiectasis; Treatment Outcome; Varicose Veins

Polidocanol is an FDA-approved treatment of incompetent great saphenous veins, accessory saphenous veins, and visible varicosities of the great saphenous vein system, but numerous other off-label dermatological applications have been reported.. To describe the various off-label dermatological clinical uses of polidocanol, as well as efficacy and adverse effects.. The review of studies searchable on PubMed from 2004 to 2021 describing clinical uses of polidocanol to determine efficacy and adverse effects associated with various dermatologic applications.. Polidocanol has shown efficacy in the treatment of mucocele of minor salivary gland, hemangioma, upper extremity veins, reticular veins of the chest, facial veins, pyogenic granuloma, lymphangioma circumscriptum, digital mucous cyst, mixed skin ulcers, cutaneous focal mucinosis, seromas, glomuvenous malformations, acne cysts, lymphocele, and dissecting cellulitis. Commonly reported side effects include pain, erythema, swelling, ecchymosis, and ulceration. Most sources were case reports and small prospective studies, as such the strength of data supporting many uses is limited by small sample sizes and lack of controls.. Although polidocanol is currently only FDA approved for incompetent great saphenous veins, accessory saphenous veins, and visible varicosities of the great saphenous vein system, the use of polidocanol has been selected for a variety of off-label clinical applications.

Topics: Humans; Off-Label Use; Polidocanol; Prospective Studies; Saphenous Vein; Sclerosing Solutions; Sclerotherapy; Treatment Outcome; Varicose Veins; Venous Insufficiency

Varicose veins are chronic venous defects that affect >20% of the population in developed countries. Among potential treatments, sclerotherapy is one of the most commonly used. It involves endovenous injection of a surfactant solution (or foam) in varicose veins, inducing damage to the endothelial layer and subsequent vessel sclerosis. Treatments have proven to be effective in the short-term, however recurrence is reported at rates of up to 64% 5-year post-treatment. Thus, once diagnosed with varicosities there is a high probability of a permanently reduced quality of life. Recently, foam sclerotherapy has become increasingly popular over its liquid counterpart, since foams can treat larger and longer varicosities more effectively, they can be imaged using ultrasound, and require lower amounts of sclerosing agent. In order to minimize recurrence rates however, an investigation of current treatment methods should lead to more effective and long-lasting effects. The literature is populated with studies aimed at characterizing the fundamental physics of aqueous foams; nevertheless, there is a significant need for appropriate product development platforms. Despite successfully capturing the microstructural evolution of aqueous foams, the complexity of current models renders them inadequate for pharmaceutical development. This review article will focus on the physics of foams and the attempts at optimizing them for sclerotherapy. This takes the form of a discussion of the most recent numerical and experimental models, as well as an overview of clinically relevant parameters. This holistic approach could contribute to better foam characterization methods that patients may eventually derive long term benefit from.

Topics: Dosage Forms; Humans; Polidocanol; Rheology; Sclerosing Solutions; Sclerotherapy; Solutions; Varicose Veins; Water

Varicose veins are common clinical entities. Foam sclerotherapy is a minimally invasive and simple procedure; however, the side effects, efficacy, and stability of sclerosing foam are not ideal.. To summarize the current studies on sclerosing foam stability and promote foam sclerotherapy development.. We reviewed the literature before June 2018 and included only representatives studies on sclerosing foam stability. We summarized the foam half-life time (FHT) of polidocanol (POL) under 17 preparation conditions and the FHT of sodium tetradecyl sulfate under 21 preparation conditions. The preparation conditions included various combinations of temperature, liquid-gas ratio, preparation method, etc. RESULTS: The FHT of POL varied between 40 and 4,000 seconds under different conditions. The FHT of sodium tetradecyl sulfate varied from 25.7 to 390 seconds. The higher the drug concentration, the lower the temperature required to increase foam stability. The addition of surfactant greatly increased foam stability. For different gas compositions, the FHT sequence was as follows: CO2 < CO2 + O2 < O2 < air.. Foam stability can be improved by changing the preparation conditions; therefore, the role of surfactants and predictive methods for FHT are worth investigating further.

Topics: Drug Compounding; Drug Stability; Gases; Half-Life; Humans; Injections, Intravenous; Polidocanol; Sclerosing Solutions; Sclerotherapy; Sodium Tetradecyl Sulfate; Surface-Active Agents; Temperature; Time Factors; Varicose Veins

Scope Varithena® is a recently approved commercially available drug/delivery unit that produces foam using 1% polidocanol for the management of varicose veins. The purpose of this review is to examine the benefits of foam sclerotherapy, features of the ideal foam sclerosant and the strengths and limitations of Varithena® in the context of current foam sclerotherapy practices. Method Electronic databases including PubMed, Medline (Ovid) SP as well as trial registries and product information sheets were searched using the keywords, 'Varithena', 'Varisolve', 'polidocanol endovenous microfoam', 'polidocanol' and/or 'foam sclerotherapy/sclerosant'. Articles published prior to 20 September 2016 were identified. Results Foam sclerosants have effectively replaced liquid agents due to their physiochemical properties resulting in better clinical outcomes. Medical practitioners commonly prepare sclerosant foam at the bedside by agitating liquid sclerosant with a gas such as room air, using techniques as described by Tessari or the double syringe method. Such physician-compounded foams are highly operator dependent producing inconsistent foams of different gas/liquid compositions, bubble size, foam behaviour and varied safety profiles. Varithena® overcomes the variability and inconsistencies of physician-compounded foam. However, Varithena® has limited applications due to its fixed sclerosant type and concentration, cost and lack of worldwide availability. Clinical trials of Varithena® have demonstrated efficacy and safety outcomes equivalent or better than physician-compounded foam but only in comparison to placebo alone. Conclusion Varithena® is a promising step towards the creation of an ideal sclerosant foam. Further assessment in independent randomised controlled clinical trials is required to establish the advantages of Varithena® over and above the current best practice physician-compounded foam.

Topics: Humans; Polidocanol; Polyethylene Glycols; Sclerosing Solutions; Sclerotherapy; Varicose Veins

Topics: Aged; Anticoagulants; Humans; Injections, Intravenous; Male; Myocardial Infarction; Polidocanol; Polyethylene Glycols; Risk Factors; Sclerosing Solutions; Sclerotherapy; Treatment Outcome; Ultrasonography, Interventional; Varicose Veins

Sclerotherapy is an important part of the treatment of varicose veins. It may also be performed in patients with contraindications for operative procedures. By adjusting the mode of application (liquid or foam) and the concentration it can be used for the treatment of all vein types. In comparison to other treatment options it is especially well suited for the treatment of spider veins and reticular veins, pudendal varicosity and so called "feeding" varicose veins in the proximity of venous leg ulcers. A current European guideline, which was approved by 23 European phlebologic societies, supports the good international standardization of this treatment technique.

Topics: Dosage Forms; Dose-Response Relationship, Drug; Guideline Adherence; Humans; Polidocanol; Polyethylene Glycols; Sclerotherapy; Stockings, Compression; Telangiectasis; Varicose Ulcer; Varicose Veins

Topics: Drug Costs; Humans; Injections, Intravenous; Polidocanol; Polyethylene Glycols; Sclerosing Solutions; Sclerotherapy; Treatment Outcome; Varicose Veins

Venous disorders rank among the most frequent diseases in the German population. Early diagnostic investigation and treatment can prevent their progression and may reduce the risk for secondary diseases. The therapeutic spectrum for varicose veins includes conservative as well as interventional and surgical methods. Because it is minimally invasive and well-tolerated, sclerotherapy represents an important treatment method for venous insufficiency, recurrent varicosis and venous malformations. We review the role of sclerotherapy as a treatment option of chronic venous insufficiency in dermatology.

Topics: Aftercare; Contraindications; Dose-Response Relationship, Drug; Evidence-Based Medicine; Humans; Polidocanol; Polyethylene Glycols; Sclerotherapy; Stockings, Compression; Varicose Ulcer; Varicose Veins

The objective of the study was to review the literature reporting visual disturbance (VD)following sclerotherapy for varicose veins. Underlying mechanisms will be discussed. A literature search of the databases Medline and Google Scholar was performed. Original articles including randomized trials, case series and case reports reporting VD in humans following sclerotherapy for varicose veins were included. Additional references were also obtained if they had been referenced in related publications. The search yielded 4948 results of which 25 reports were found to meet the inclusion criteria. In larger series with at least 500 included patients the prevalence of VD following sclerotherapy ranges from 0.09% to 2%. In most reports foam sclerotherapy was associated with VD (19); exclusive use of liquid sclerosant was reported in two cases, some reports included foam and liquid sclerosant (4). There were no persistent visual disorders reported. VD occurred with polidocanol and sodium tetradecyl sulphate in different concentrations (0.25–3%). Various forms of foam preparation including various ways of foam production and the liquid –air ratio (1 or 2 parts of liquid mixed with 3, 4 or 5 parts of air) were reported in association with the occurrence of VD. VDs following sclerotherapy for varicose veins are rare and all reported events were transient. Bubble embolism or any kind of embolism seems unlikely to be the only underlying mechanism. A systemic inflammatory response following sclerotherapy has been suggested. Further research to clarify the mechanism of action of sclerosants is required.

Topics: Embolism; Female; Humans; Male; MEDLINE; Polidocanol; Polyethylene Glycols; Sclerosing Solutions; Sclerotherapy; Sodium Tetradecyl Sulfate; Telangiectasis; Varicose Veins; Vision Disorders

Endovenous foam sclerotherapy (EFS) is used widely throughout the USA for the treatment of venous disorders. The purpose of the quantitative meta-analysis was to systematically and comprehensively evaluate the literature to provide accurate estimates of safety and efficacy outcomes for this procedure.. A comprehensive electronic search of published literature in several databases was performed using a wide variety of MESH headings. In addition, meeting abstracts and bibliographies of selected references were reviewed for eligible papers. Two reviewers abstracted selected treatment-related data.. Of 684 identified manuscripts and abstracts reviewed, 104 papers were abstracted and analysed. More than 50% were published between 2004 and 2008. EFS was found to be effective with similar vein occlusion rates to laser therapy, but less effective than surgery. In addition, major adverse effects were rare.. EFS is a safe and effective therapy for the treatment of venous disorders.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Anticoagulants; Child; Child, Preschool; Endovascular Procedures; Female; Glycerol; Humans; Infant; Male; Middle Aged; Polidocanol; Polyethylene Glycols; Postoperative Complications; Sclerosing Solutions; Sclerotherapy; Sodium Tetradecyl Sulfate; Stockings, Compression; Treatment Outcome; Ultrasonography, Interventional; Varicose Veins; Vascular Diseases; Veins

According to the guidelines and the manufacturer's information, pregnancy is a contraindication for sclerotherapy with Polidocanol. However, in some cases sclerotherapy has been conducted in a period when the pregnancy is not known by the patient. When pregnancy is diagnosed, patients and gynecologists often ask the phlebologist if there is an indication for the interruption of pregnancy. Up to now, there is only rare information on sclerotherapy, polidocanol and pregnancy. Current knowledge is summed up in this article together with case reports. The existing case reports and mainly retrospective case series on intended or accidentally conducted sclerotherapy with common sclerosants and doses show no increased risk for the mother and the unborn child. However, in view of the limited literature data available and the high probability for spontaneous regression of varicose veins postpartum, sclerotherapy should be avoided in pregnancy, if possible. Conservative measures during pregnancy or an elimination of varicose veins before pregnancy should be preferred. In single cases e.g. painful genitoanal varices, the use of sclerotherapy can be helpful even during pregnancy. Thereby, a very thorough clarification of the mother with a final written consent and an implementation according to the guidelines are especially important. According to the current data, there is no reason for an interruption after a sclerotherapy that has been conducted during undetected pregnancy.

Topics: Adult; Female; Humans; Live Birth; Polidocanol; Polyethylene Glycols; Pregnancy; Pregnancy Tests; Pregnancy Trimester, First; Risk Assessment; Risk Factors; Sclerosing Solutions; Sclerotherapy; Telangiectasis; Treatment Outcome; Varicose Veins

Sclerotherapy is popular for the treatment of lower extremity telangiectasias and varicose and reticular veins. Although a large number of sclerosants are commonly employed, there are few data that directly compare their advantages and drawbacks.. To analyze and present the differences between sclerosants that make them more or less suitable agents in specific clinical applications.. A systemic review of published medical literature that compares and contrasts different classes of sclerosants is presented.. There is no perfect sclerosant that is complication free and 100% effective. The ability to match the sclerosant to the clinical problem being approached makes the availability of more Food and Drug Administration-approved sclerosants appealing.. Modern sclerosants that have been subjected to rigorous experimental and clinical trials will provide even more efficacious and safer patient treatments.

Topics: Clinical Trials as Topic; Detergents; Drug Approval; Drug Interactions; Drug Storage; Humans; Microbubbles; Polidocanol; Polyethylene Glycols; Sclerosing Solutions; Sclerotherapy; Sodium Tetradecyl Sulfate; United States; United States Food and Drug Administration; Varicose Veins

Sclerotherapy with polidocanol microfoam injection under duplex guidance is a new treatment for venous malformations associated with Klippel-Trenaunay syndrome. Multidetector-row computed tomography (MDCT) venography is extremely helpful in the assessment of disease extension and the planning of therapy. Observation In this particular case, MDCT venography demonstrated the origin, course, and relationship to adjacent anatomical structures of aberrant vessels that configure the superficial venous system with an anatomically normal and patent deep venous system. At the end of the treatment, which consisted of 8 sessions of microfoam sclerotherapy within 12 months, a considerable reduction in the number and size of the percutaneously treated aberrant veins was observed. The obvious clinical improvement was objectively demonstrated with MDCT venography, which showed clear reduction in the number and size of treated veins. Further clinical investigation performed because of isolated migraine episodes related to the sclerotherapy session revealed that the patient had a patent foramen ovale. A transcranial Doppler examination during the procedure showed middle cerebral artery bubbles, which indicated right-to-left shunt. No cerebral damage was observed in a subsequent diffusion-weighted magnetic resonance examination.. Microfoam sclerotherapy is an effective treatment option in patients with Klippel-Trenaunay syndrome. MDCT venography allows diagnosis of the disease, planning of therapy, and assessment of response to treatment. Although foam-induced microembolism is a common phenomenon during sclerotherapy, in this report we demonstrate that polidocanol microfoam prepared with a low-nitrogen gas mixture is safe in a patient with a patent foramen ovale.

Topics: Abnormalities, Multiple; Adult; Female; Follow-Up Studies; Foramen Ovale, Patent; Humans; Injections, Intravenous; Klippel-Trenaunay-Weber Syndrome; Phlebography; Polidocanol; Polyethylene Glycols; Risk Assessment; Sclerosing Solutions; Sclerotherapy; Severity of Illness Index; Time Factors; Treatment Outcome; Varicose Veins

Polidocanol is a liquid surfactant having endothelial cell lytic properties. In the form of a controlled, dispensed microfoam it is administered endovenously as a sclerosing agent in the treatment of varicose veins.. This review summarizes efficacy of polidocanol endovenous microfoam sclerotherapy using a proprietary dispensing system to control foam characteristics and gas content for treating varicose veins.. We reviewed in vitro, Phase I, Phase II and limited Phase III data for polidocanol microfoam with a focus on controlled foam formulation in therapy.. Clinical trials of controlled dispensing of polidocanol microfoam provide evidence of effective treatment of chronic venous insufficiency with low toxicity, minimal risk and few complications.

Topics: Chemistry, Pharmaceutical; Clinical Trials as Topic; Dosage Forms; Embolism, Air; Humans; Injections, Intravenous; Polidocanol; Polyethylene Glycols; Sclerosing Solutions; Sclerotherapy; Varicose Veins; Venous Insufficiency

To review published evidence concerning treatment of varicose veins using ultrasound-guided foam sclerotherapy (UGFS) to assess the safety and efficacy of this treatment.. Medical literature databases including MedLine, Embase and DH-DATA were searched for recent literature concerning UGFS. Papers describing the early results and later outcome have been assessed and their main findings were included in this summary.. Few randomized studies have been published in this field and much of the available data come from clinical series reported by individual clinicians. It is clear that foam sclerotherapy is far more effective than liquid sclerotherapy and that ultrasound imaging allows the treatment to be delivered accurately to affected veins. There is evidence that 3% polidocanol foam is no more effective than 1% polidocanol foam. The optimum ratio of gas to liquid is 4:1, although a range of ratios is reported in the published work. There is a wide variation in the volume used as well as the method by which it is injected. The use of carbon dioxide foam reduces the systemic complications, particularly visual disturbance, as compared with air foams. Very few serious adverse events have been reported in the literature despite the widespread use of this method. Rates of recanalization of saphenous trunks following UGFS are similar to those observed after endovenous laser and endovenous RF ablation of veins, as well as the residual incompetence after surgical treatment.. UGFS is a safe and effective method of treating varicose veins. The relative advantages or disadvantages of this treatment in the longer term have yet to be published.

Topics: Air; Carbon Dioxide; Clinical Trials as Topic; Detergents; Dosage Forms; Embolism, Air; Follow-Up Studies; Humans; Injections, Intravenous; Microbubbles; Polidocanol; Polyethylene Glycols; Randomized Controlled Trials as Topic; Saphenous Vein; Sclerosing Solutions; Sclerotherapy; Solutions; Treatment Outcome; Ultrasonography, Doppler, Duplex; Ultrasonography, Interventional; Varicose Veins; Vision Disorders

To describe and report incidence and frequency of side-effects and complications of sclerotherapy with foamed sclerosing agents. To explain, when possible, their pathophysiology and to indicate possible manoeuvres and techniques to limit them.. Review of current literature and personal research.. Complications of foam sclerotherapy include complications of sclerotherapy in general and specific complications of foamed sclerosing agents. Side-effects related to the sclerosing compounds are also taken into account.. Complications and side-effects of careful foam sclerotherapy remain uncommon. However, more research is needed to understand them better and to further reduce their incidence. Their description to patients in the course of the informed consent is a prerequisite to any sclerosing treatment.

Topics: Cough; Detergents; Dosage Forms; Embolism, Air; Humans; Intracranial Embolism; Ischemic Attack, Transient; Microbubbles; Polidocanol; Polyethylene Glycols; Sclerosing Solutions; Sclerotherapy; Sodium Tetradecyl Sulfate; Thrombosis; Ultrasonography, Interventional; Varicose Veins; Vision Disorders

Topics: Female; Humans; Middle Aged; Polidocanol; Polyethylene Glycols; Proctoscopy; Rectum; Sclerosing Solutions; Sclerotherapy; Ultrasonography; Varicose Veins

The history and possible adverse sequelae of polidocanol (Aethoxysklerol) and the sclerotherapy technique used on 1500 patients in 5000 procedures is reviewed.

Topics: Anesthesia, Local; Clothing; Humans; Polidocanol; Polyethylene Glycols; Posture; Sclerosing Solutions; Telangiectasis; Varicose Veins

To compare the outcomes of ultrasound guided foam sclerotherapy (UGFS) and endovenous laser ablation (EVLA) to treat isolated small saphenous vein (SSV) incompetence in a multicentre randomised controlled study (RCT; ClinicalTrials.gov identifier: NCT05468450).. Patients aged ≥ 18 years undergoing isolated SSV treatment (reflux > 0.5 seconds) were randomised to UGFS or EVLA. Patients treated with UGFS were allowed one additional truncal treatment at six weeks. Tributary treatments (phlebectomy or sclerotherapy) were permitted after six months. Participants were assessed at eight days, six months, and one, two, and three years. The primary endpoint was the absence of SSV reflux (> 0.5 seconds). Secondary outcomes included clinical scores and quality of life (QoL) scores. All analyses were done by intention to treat.. Of 1 522 screened patients, 161 were randomised to UGFS (n = 82) and EVLA (n = 79). Only 3% of patients who received UGFS had the second (allowed) treatment and 86% of patients completed the three year study. Forty-one and 19 tributary treatments (by sclerotherapy) were performed in 27 UGFS patients (33%) and 15 EVLA patients (19%), respectively. The complete absence of reflux at three years was significantly better after EVLA (86%) than after UGFS (56%) (odds ratio [OR] 5.36, 95% confidence interval [CI] 2.31 - 12.44; risk ratio 1.59, 95% CI 1.26 - 2.01). Two deep vein thromboses (DVTs; one femoropopliteal and one gastrocnemius) and one endovenous heat induced thrombosis occurred in the EVLA group. Seven DVTs were seen in the UGFS group, including two partial popliteal DVTs and five gastrocnemius vein thromboses (four asymptomatic and incidental on day 8 screening). At three years, there was no difference between groups for the following: rate of visible varices (p = .87), revised Venous Clinical Severity Score (p = .28), and QoL (p = .59). Patient satisfaction scores were high in both groups (median score: EVLA 97/100 and UGFS 93/100; p = .080). Symptoms were significantly improved in both groups. (p < .001) CONCLUSION: Technical success was better for EVLA than for UGFS three years after SSV treatment. This agrees with studies that have reported on these treatments in the great saphenous vein. However, improvements in clinical outcome were similar for both groups.

Topics: Humans; Laser Therapy; Polidocanol; Quality of Life; Saphenous Vein; Sclerotherapy; Treatment Outcome; Varicose Veins; Venous Insufficiency

Postablation deep vein thrombosis (DVT) represents a potentially serious complication after Varithena polidocanol endovenous microfoam (PEM) ablation. The following primary outcomes were assessed: whether (1) adjunctive apixaban anticoagulation or (2) mechanical deep venous system (DVS) saline flushing could decrease saphenofemoral junction (SFJ) thrombus extension (postablation superficial thrombus extension [PASTE]) and/or DVT compared with compression alone, after great saphenous vein (GSV) PEM ablation.. Varithena 1% PEM ablation patients were randomized to (1) SFJ compression, (2) compression and DVS saline flushing, or (3) compression, DVS saline flushing, and 5 days of postprocedural 5 mg oral apixaban anticoagulation twice daily. Duplex imaging was obtained 7 to 10 days after PEM ablation and PASTE/DVT incidence (primary end point) was compared between groups at this time point.. We treated 304 limbs in 257 patients with PEM. Overall, 103 limbs received SFJ compression (group C, 33.8%), 101 received compression and deep venous flushing (group D, 32.9%), and 100 received compression, deep flush, and anticoagulation (group A, 33.2%). Mean ultrasound follow-up time was 9.7 days (all patients) with a primary GSV closure rate of 92.4%. SFJ PASTE (II-IV) occurred in 0.9%, 1.0%, and 0% (groups C, D, and A, respectively). DVT occurred in 16.7%, 14.7%, and 1.98% (groups C, D, and A; χ. (1) Neither adjunctive DVS flushing nor anticoagulation decreased clinically relevant SFJ PASTE (II-IV) incidence, which remained similarly low across all groups and ranged between 0% and 1%, regardless of adjunctive DVS flushing or anticoagulation. This rate was significantly lower than prior reports (2.3%-4.1%). (2) DVS flushing had no influence on the rate of DVT. Observed PEM-induced DVT incidence using SFJ compression alone or compression with DVS flushing (16.7% and 14.7%, respectively) was significantly higher than prior reports (2.5%-9.6%). This finding may relate to the greater extent of AK/BK GSV territory treated in the present study. (3) Five days of postprocedural oral apixaban anticoagulation, 5 mg given twice daily, significantly decreased DVT occurrence to 1.98%, compared with nonanticoagulated patients (16.7%). This finding is comparable with the DVT rates reported after endovenous thermal ablation (0.7-1.7%). (4) Postprocedural apixaban anticoagulation may have a significant preventive role in decreasing DVT occurrence after PEM ablation.

Topics: Anticoagulants; Fibrinolytic Agents; Humans; Polidocanol; Prospective Studies; Saphenous Vein; Treatment Outcome; Varicose Veins; Venous Insufficiency; Venous Thrombosis

Cryo-Laser & Cryo-Sclerotherapy (CLaCS) is a technique which combines thermal sclerotherapy and injection sclerotherapy. Telangiectasias and small varicosities are targeted by a transdermal laser and right after receive injection sclerotherapy. A cooling device blows -20°C air onto the skin and needle in a pre-, parallel-, and post-fashion.. Our objective was to establish if there is a difference in result and complications by varying the sclerosing agent but keeping the same ND:Yag long pulse laser parameters in the treatment of small varicosities.. Fifty five patients were enrolled prospectively and randomized to two groups; in the group 1 dextrose 75% was the sclerosing agent used in combination with the ND:Yag long pulse laser and, in the group 2, the same laser technique was used but the sclerosing agent was polidocanol 0.3% and dextrose 67%.. The results were evaluated 30 days after the treatment by the patients and for blinded evaluators using before and after standardized photos with and without augmented reality. In the patient's perspective and in the blinded evaluation of the regular photos, no differences between the groups were found. Both groups had low rates of hyperpigmentation and bruising with no statistical difference. Patients treated with polidocanol had less pain after the treatment and a better clearance rate in the photos with augmented reality. No major complications were found.. The treatment of small varicosities with CLaCS using Dextrose 75% or polidocanol 0.3% and Dextrose 67.5% is a safe and effective procedure and both sclerosing agents can be used with similar results. Possibly, in the polidocanol group more nonvisible reticular veins were cleared, but the implication of this find is not clear.

Topics: Glucose; Humans; Laser Therapy; Lasers, Solid-State; Polidocanol; Polyethylene Glycols; Sclerosing Solutions; Sclerotherapy; Telangiectasis; Treatment Outcome; Varicose Veins

This study aimed to compare patient-reported outcomes after technical success (TS) and technical failure (TF) in treating great saphenous vein incompetence (GSV) with ClariVein.. A subanalysis of a previous trial was conducted on symptomatic GSV incompetence patients who received ClariVein treatment with 2% or 3% polidocanol (POL) and were followed for 6 months. Blinding was implemented for observers and patients, and data from both POL groups were combined. TS was defined as at least 85% occlusion of the treated vein, while TF indicated failure to meet TS criteria. Secondary outcomes included Venous Clinical Severity Score (VCSS), Aberdeen Varicose Vein Questionnaire (AVVQ), and Short-Form 36 Health Survey Questionnaire (SF-36).. Among the 364 patients included, the TS rate was 64.5%. Comparison of VCSS, AVVQ, and SF-36 scores between TS and TF groups did not yield significant differences.. This study indicates no significant variation in VCSS, AVVQ, and SF-36 scores between patients experiencing TS and TF following ClariVein treatment for GSV insufficiency.

Topics: Endovascular Procedures; Humans; Patient Reported Outcome Measures; Polidocanol; Quality of Life; Saphenous Vein; Treatment Outcome; Varicose Veins; Venous Insufficiency

The purpose of the present study was to identify the ideal polidocanol (POL) concentration for mechanochemical ablation (MOCA) of the great saphenous vein (GSV) using the ClariVein system (Merit Medical, South Jordan, Utah).. We performed a multicenter, randomized, controlled, single-blind trial with a follow-up period of 6 months. Patients with symptomatic primary truncal GSV incompetence were randomized to MOCA + 2% POL liquid (2% group) or MOCA + 3% POL liquid (3% group). The primary outcome was technical success (TS), defined as an open part of the treated vein segment of ≤10 cm in length. The secondary outcomes were alternative TS, defined as ≥85% occlusion of the treated vein segment, postoperative pain, venous clinical severity scores, Aberdeen varicose vein questionnaire scores, and short-form 36-item health survey questionnaire scores, and complications.. From 2012 to 2018, 364 patients (375 limbs) were included, of which, 189 limbs were randomly allocated to the 2% group and 186 to the 3% group. The TS rate at 6 months was 69.8% in the 2% group vs 78.0% in the 3% group (P = .027). A higher overall TS rate was seen in GSVs of ≤5.9 mm compared with GSVs >5.9 mm (84.3% vs 59.5%, respectively; P < .001). The alternative TS rate at 6 months was 61.4% in the 2% group and 67.7% in the 3% group (P = .028). The venous clinical severity scores, Aberdeen varicose vein questionnaire scores, and most short-form 36-item health survey questionnaire domains had improved in both groups (P < .002). Postprocedural pain was low. Two pulmonary embolisms and two deep vein thromboses were seen. Superficial venous thrombosis had occurred more often in the 3% group (18 vs 8 in the 2% group; P = .033).. The results from the present study showed a higher success rate for MOCA with 3% POL liquid than for MOCA with 2% POL liquid at 6 months of follow-up. However, the difference in quality of life was not significant. Long-term follow-up studies are required to investigate whether these results will be sustained in the future.

Topics: Endovascular Procedures; Humans; Polidocanol; Saphenous Vein; Single-Blind Method; Treatment Outcome; Varicose Veins; Venous Insufficiency

We compared the safety, need for additional foam sclerotherapy, and 1-year venous clinical severity score (VCSS) improvement in the limbs of patients with chronic venous disease and great saphenous vein (GSV) reflux. These patients had undergone endovenous laser ablation (EVLA) using a 1470-nm diode laser and concurrent foam sclerotherapy (1% polidocanol) through the access sheath (transluminal injection of foam sclerotherapy [TLFS]) or EVLA and concurrent direct-puncture ultrasound-guided foam sclerotherapy (UGFS).. In the present study, we screened 467 patients (577 legs) with symptomatic primary GSV reflux for randomization to either TLFS with EVLA (n = 103 legs; TLFS group) or UGFS with EVLA (n = 94 legs; UGFS group). The exclusion criteria were (1) recurrent varicose veins after previous intervention; (2) hypersensitivity reaction to sclerotherapy; (3) acute deep vein thrombosis; (4) serious lower limb ischemic disease; (5) a coagulation disorder; and (6) simultaneous EVLA of both GSVs and small saphenous veins. The correlations of the VCSS changes with the clinical features, such as age, sex, CEAP (clinical, etiologic, anatomic, pathophysiologic) classification, total amount of sclerosant used at the original procedure, multiple punctures (more than two) for sclerotherapy at the original procedure, the use of TLFS, and linear endovenous energy density, were estimated using logistic regression.. No significant differences in the distribution of the CEAP classification were observed between the two groups. After 12 months of follow-up, all truncal veins were occluded. The VCSS had significantly improved in the TLFS group compared with the UGFS group (UGFS, -7.4 ± 1.8; TLFS, -8.7 ± 1.5; P < .0001). Multivariate analysis revealed that TLFS was the only significant factor for an improved VCSS (hazard ratio, 0.63; 95% confidence interval, 0.32-0.96; P < .0001). The need for additional second-stage sclerotherapy was significantly avoided in the TLFS group (n = 10; 10%) compared with the UGFS group (n = 51; 54%; P < .0001).. TLFS combined with EVLA is a safe and feasible procedure that improves the VCSS and reduces the need for additional second-stage interventions compared with UGFS combined with EVLA.

Topics: Aged; Catheter Ablation; Dosage Forms; Endovascular Procedures; Female; Humans; Injections; Laser Therapy; Male; Middle Aged; Polidocanol; Prospective Studies; Saphenous Vein; Sclerosing Solutions; Sclerotherapy; Treatment Outcome; Ultrasonography; Varicose Veins

Sclerotherapy is considered to be the method of choice for the treatment of telangiectatic varicose veins (C1 veins). Whereas the use of compression stockings after sclerotherapy is recommended, little is known about the impact of compression on the outcome of sclerotherapy. The aim of this study was to assess the influence of compression on the outcome of injection sclerotherapy of C1 varicose veins.. There were 100 legs of 50 consecutive patients with chronic venous insufficiency (C1) included. After randomization per patient, both legs were treated with sclerotherapy in a predefined area of the thigh (measuring 100 cm. There was no discernible difference between the groups in terms of clinical outcome or side effects after 4 weeks. Whereas inter-rater reliability was high, there was no correlation between the raters and patients in terms of outcome. In 55% of the treated legs, the patients deemed the result of the treatment to be good; in 27% of the treated legs, fair; and in 18%, poor. Postprocedure hyperpigmentation occurred in 13% of patients and was comparable in both groups. Compression therapy was found to be comfortable by the majority (58%) of patients.. One week of postinterventional compression therapy had no clinical benefit compared with no compression.

Topics: Chronic Disease; Combined Modality Therapy; Germany; Humans; Injections, Intravenous; Polidocanol; Prospective Studies; Sclerosing Solutions; Sclerotherapy; Stockings, Compression; Telangiectasis; Time Factors; Treatment Outcome; Varicose Veins; Venous Insufficiency

Sclerotherapy for the treatment of varicose veins is one of the most common medical procedures performed in the Western world, and hyperpigmentation is one of the most frequent, dreaded, minor adverse events. There has recently been some interest in investigating the inflammatory response of the local endothelium after sclerotherapy and the possible benefits of venoactive drugs because of their pleiotropic properties. The aim of this study was to evaluate whether adding a venoactive drug (sulodexide) to the standard sclerotherapy treatment protocol for patients with varicose veins can reduce the occurrence of postsclerotherapy hyperpigmentation.. We carried out a prospective, multicenter, randomized controlled trial with a parallel group design. It included 720 patients with telangiectasia, reticular veins, or varicose veins who were candidates for sclerotherapy. Patients with reflux in deep system or saphenous veins were excluded. Group A consisted of 354 patients who received an oral dose of sulodexide twice a day for 7 days before scheduled sclerotherapy; the treatment then continued for 3 months. Group B consisted of 366 patients who received the standard sclerotherapy protocol. Polidocanol was used as the sclerosing agent, and 20 to 30 mm Hg compression stockings were used in both groups for 7 days. Control photographs were taken, and a follow-up examination took place after 1 month and 3 months. Computer software was used to analyze the treated area for incidence of hyperpigmentation, total area of hyperpigmentation, skin tone increase in the hyperpigmented area, vein disappearance, and incidence of major bleeding. The sample size was calculated to give a statistical power of 80%. Student t-test and the χ. A total of 609 patients completed the 3-month follow-up: 312 in group A and 297 in group B. After 1 month, the incidence of hyperpigmentation was 8.7% in group A and 14.8% in group B (P = .01). Group A developed an average area of hyperpigmentation of 10.7% compared with 18.2% in group B (P = .01), and the skin tone of the hyperpigmented area was lower in group A than in group B (P = .02). However, the latter difference was not significant after 3 months. The overall vein disappearance rate was similar in both groups.. Our analysis shows that by adding a venoactive drug (sulodexide) to the standard sclerotherapy protocol, the occurrence of hyperpigmentation is reduced without affecting the desired therapeutic vein elimination response.

Topics: Adult; Female; Glycosaminoglycans; Humans; Hyperpigmentation; Male; Mexico; Middle Aged; Polidocanol; Prospective Studies; Sclerosing Solutions; Sclerotherapy; Skin Pigmentation; Telangiectasis; Time Factors; Treatment Outcome; Varicose Veins

Objectives * Varithena 017 Investigator Group: Michael Vasquez, MD, Venous Institute of Buffalo, Amherst, NY; Antonios Gasparis, MD, Stony Brook University Medical Center, Stony Brook, NY; Kathleen Gibson, MD, Lake Washington Vascular, Bellevue, WA; James Theodore King, MD, Vein Clinics of America, Oakbrook Terrace, IL; Nick Morrison, MD, Morrison Vein Institute, Scottsdale, AZ; Girish Munavalli, MD, Dermatology, Laser & Vein Specialists of the Carolinas, Charlotte, NC; Eulogio J. Sanchez, MD, Batey Cardiovascular Center, Bradenton, FL. Varithena® is a trademark of Provensis Ltd, a BTG International group company. To determine the efficacy and safety of polidocanol endovenous microfoam (PEM 0.5%, 1.0%) and placebo each administered with endovenous thermal ablation. Methods A multicenter, randomized, placebo-controlled, blinded study was conducted in patients with great saphenous vein incompetence and symptomatic and visible superficial venous disease. Co-primary endpoints were physician-assessed and patient-assessed appearance change from Baseline to Week 8. Results A total of 117 patients received treatment (38 placebo, 39 PEM 0.5%, 40 PEM 1%). Physician-rated vein appearance at Week 8 was significantly better with PEM ( p = 0.001 vs. placebo); patient-assessed appearance trended similarly. Polidocanol endovenous microfoam provided improvements in clinically meaningful change in patient-assessed and physician-assessed appearance ( p < 0.05), need for additional treatment ( p < 0.05), saphenofemoral junction reflux elimination, symptoms, and QOL. In PEM recipients, the most frequent adverse event was superficial thrombophlebitis (35.4%) Conclusions Endovenous thermal ablation + PEM significantly improved physician-assessed appearance at Week 8, increased the proportion of patients with a clinically meaningful change in appearance, and reduced need for additional treatment. www.clinicaltrials.gov (NCT01197833).

Topics: Adult; Aged; Endovascular Procedures; Female; Humans; Male; Middle Aged; Polidocanol; Polyethylene Glycols; Saphenous Vein; Thrombophlebitis; Varicose Veins; Venous Insufficiency

Objectives A randomized, placebo-controlled, multicenter study was conducted to evaluate the safety and efficacy of polidocanol endovenous microfoam (1%, Varithena® [polidocanol injectable foam], BTG International Ltd.). Methods Patients (n = 77) with symptomatic, visible varicose veins were randomized to treatment with either Varithena 1% or placebo. Results Varithena provided greater mean changes from Baseline in patient-reported assessments of symptoms (e.g., heaviness, achiness, swelling, throbbing, itching [HASTI®] score 30.7 points vs 16.7 points, p = 0.0009, primary endpoint; and modified Venous Insufficiency Epidemiological and Economic Study-Quality-of-Life/Symptoms [m-VEINES-QOL/Sym; p < 0.001]), physician-assessed VCSS, and physician- and patient-assessed appearance compared with placebo. The HASTI score correlated highly with the modified-VEINES-QOL/Sym and Chronic Venous Insufficiency Questionnaire-2 scores (r = 0.7 to > 0.9, p ≤ 0.001). Adverse events included contusion, incision-site hematoma, and limb discomfort. Venous thrombus adverse events were reported as mild and generally resolved without sequelae. Conclusions Varithena provided significantly greater symptom relief and improvement in leg appearance compared with placebo. Adverse events were generally mild and transient. ( www.clinicaltrials.gov [NCT00758420]).

Topics: Adult; Aged; Female; Femoral Vein; Humans; Male; Middle Aged; Polidocanol; Polyethylene Glycols; Saphenous Vein; Sclerosing Solutions; Varicose Veins; Venous Insufficiency

To evaluate the effect of ultrasound-guided foam sclerotherapy (UGFS) in a single session combined with great saphenous vein (GSV) high ligation for severe lower extremity varicosis classified as C4-C6, compared with GSV stripping plus multistab avulsion or transilluminated powered phlebectomy (TIPP).. From January 2012 to December 2014, 177 patients with primary GSV insufficiency, classified as C4-C6, were randomized into the UGFS group or the control group. The UGFS group was managed by GSV high ligation and foam sclerotherapy in one session under the surveillance of ultrasonography, whereas the control group received GSV high ligation and stripping combined with multistab avulsion or TIPP. The patients were followed up at 1, 6, and 12 months after treatment. Outcome assessments included reflux recurrence rate, procedure-related adverse events, hemodynamic parameters, revised Venous Clinical Severity Score (VCSS), and Aberdeen Varicose Vein Questionnaire (AVVQ) score. The medical cost and operating time of the 2 groups were also compared.. In total, 73 patients received UGFS, whereas 90 patients underwent traditional surgery. Sixty-five patients in the UGFS group (89.0%) and 74 patients in the control group (82.2%) completed the follow-up. At the end of 12 months, the cumulative reflux recurrence rate was 13.8% in the UGFS group and 13.5% in the control group (P = 0.955). In the UGFS and control groups, minor complications (27.7% vs. 21.6%, P = 0.406) and major complications (3.1% vs. 2.7%, P = 0.895) were not significantly different. Compared with baseline values, obvious improvements of the venous filling index, VCSS, and AVVQ scores after treatment were confirmed in both groups (P < 0.001). The average operating and recovery times were much shorter (38.3 vs. 81.2 min, 5.4 vs. 9.6 days, P < 0.001, respectively), and the average hospital cost was much lower ($853 vs. $1,575, P < 0.001) in the UGFS group than in the control group. The patient satisfaction rate reached 92.3% in the UGFS group and 89.2% in the control group 12 months after operation (P = 0.270).. Our outcomes indicated that UGFS combined with GSV high ligation was safe and effective for severe lower extremity varicosis.

Topics: Adult; Aged; China; Combined Modality Therapy; Cost-Benefit Analysis; Female; Hemodynamics; Hospital Costs; Humans; Length of Stay; Ligation; Male; Middle Aged; Operative Time; Patient Satisfaction; Polidocanol; Polyethylene Glycols; Prospective Studies; Recurrence; Retreatment; Saphenous Vein; Sclerosing Solutions; Sclerotherapy; Severity of Illness Index; Surveys and Questionnaires; Time Factors; Treatment Outcome; Ultrasonography, Interventional; Varicose Veins; Vascular Surgical Procedures

Objective To evaluate the relationship between patient-reported symptoms and functional and psychological impact of varicose veins following treatment with polidocanol endovenous microfoam (PEM) 1%. Methods Data were pooled from two randomized trials on VV treatment. Wilson-Cleary health outcomes path model was applied to evaluate impact of VVSymQ™ symptom score improvement on modified VEINES-QOL/Sym functional and psychological scores. Change scores were evaluated for (i) PEM 1% versus placebo groups and (ii) quartiles of symptom improvement. Cumulative distribution function curves were generated to compare percentage of patients with various levels of functional and psychological improvement including clinically meaningful improvement across two treatment groups. Multivariable regression models of change scores and clinically meaningful changes were estimated. Results In 221 patients (109 PEM 1%; 112 placebo), PEM 1% was associated with median improvements of 2.5 points and 4.0 points on the m-VEINES-QOL/Sym functional limitations and m-VEINES-QOL/Sym psychological limitations scores, compared to 0 and 1.0 point improvements, respectively, for placebo. Cumulative distribution function curves revealed that 20-30% more patients in PEM 1% group achieved clinically meaningful functional and psychological improvement versus placebo group. Conclusions Patients with above-average symptom improvement had better functional and psychological improvement. PEM 1% treatment had higher odds of clinically meaningful functional and psychological improvement.

Topics: Adult; Humans; Middle Aged; Polidocanol; Polyethylene Glycols; Self Report; Varicose Veins

This multicenter, parallel group study was designed to determine if a single administration of ≤15 mL of pharmaceutical-grade polidocanol endovenous microfoam (PEM, now approved in the United States as Varithena [polidocanol injectable foam], BTG International Ltd.) could alleviate symptoms and improve appearance of varicose veins in a typical population of patients with moderate to very severe symptoms of superficial venous incompetence and visible varicosities of the great saphenous vein (GSV) system.. The primary endpoint was patient-reported venous symptom improvement measured by change from baseline to Week 8 in 7-day average VVSymQ score. Co-secondary endpoints measured improvement in appearance of visible varicose veins from baseline to Week 8, as measured by the Independent Photography Review-Visible Varicose Veins (IPR-V(3)) and Patient Self-assessment of Visible Varicose Veins (PA-V(3)) scores. Patients were randomized to five groups: PEM 0.125% (control), 0.5%, 1%, 2%, or placebo. Adverse events (AEs) were recorded at each study visit. Tertiary endpoints measured duplex ultrasound response, changes in venous clinical severity score, and the modified Venous Insufficiency Epidemiological and Economic Study-Quality of Life/Symptoms.. At Week 8, VVSymQ scores for the pooled PEM group (0.5% + 1% + 2%; p < .0001) and individual dose concentrations (p < .001) were significantly superior to placebo. Mean changes from baseline to Week 8 in IPR-V3 and PA-V(3) scores were significantly greater for pooled PEM than for placebo (p < .0001). Most AEs were mild and resolved without sequelae. No pulmonary emboli were reported.. This study demonstrated that a single administration of up to 15 mL of PEM is a safe, effective, and convenient treatment for the symptoms of superficial venous incompetence and the appearance of visible varicosities of the GSV system. Doses of 0.5%, 1%, and 2% PEM appear to have an acceptable risk-benefit ratio.

Topics: Adult; Female; Humans; Injections, Intravenous; Male; Middle Aged; Patient Satisfaction; Polidocanol; Polyethylene Glycols; Quality of Life; Saphenous Vein; Sclerosing Solutions; Sclerotherapy; Severity of Illness Index; Surveys and Questionnaires; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; United States; Varicose Veins; Venous Insufficiency

The objectives of this study were to assess the durability of response to treatment with polidocanol endovenous microfoam (Varithena; Provensis Ltd, a BTG International group company) and to assess the long-term safety of the study patients.. This report presents efficacy and safety data from the day after visit 5/week 8 (the primary end point of the study) through the 1-year study visit. As the approved dose concentration is 1%, this analysis focuses on those patients who were randomized to polidocanol endovenous microfoam 1% at study visit 2. Because the objective of the 1-year analysis was to assess the durability of response to treatment with polidocanol endovenous microfoam 1%, the 1-year efficacy analyses based on the efficacy population included all patients who were randomized and received at least one treatment with polidocanol endovenous microfoam 1%. Efficacy end points in the Polidocanol Endovenous Microfoam Versus Vehicle for the Treatment of Saphenofemoral Junction Incompetence (VANISH-2) trial were evaluated at 1 year (n = 221; 96% of those completed the primary end-point measurement at week 8) and included the following: Varicose Vein Symptoms Questionnaire (VVSymQ, Provensis Ltd) score, an assessment of symptoms by patients using electronic daily diaries; Independent Photography Review: Visible Varicose Veins (IPR-V(3)) and Patient Self-assessment of Visible Varicose Veins (PA-V(3)) scores, the assessment of appearance by an Independent Physician Review panel and by patient self-assessment, respectively; duplex ultrasound response (physiologic response to treatment); Venous Clinical Severity Score (disease severity); and Venous Insufficiency Epidemiological and Economic Study on Quality of Life (VEINES-QOL) score (quality of life).. Of the 230 patients who completed visit 5/week 8, 56 received polidocanol endovenous microfoam 1% at visit 2/week 0 and were subsequently assessed for efficacy at visit 5/week 8 and visit 10/1 year (one patient of the 57 who completed visit 5/week 8 received a nonpolidocanol endovenous microfoam intervention and was not included in the assessment). At 1 year after the first study treatment, patients treated with polidocanol endovenous microfoam demonstrated consistent, durable, and clinically meaningful improvements in symptoms, as measured by reductions in mean VVSymQ score; appearance, as measured by IPR-V(3) (clinician assessment) and PA-V(3) (patient self-assessment) scores; disease severity, as measured by the Venous Clinical Severity Score; and quality of life, as measured by the VEINES-QOL score. At 1 year, there were no new venous thrombus adverse events (VTAEs) and no clinically important sequelae in patients who had a VTAE in the study. In addition, there were no serious adverse events that were determined by the investigator to be related to the study drug. No new safety signals were identified. In patients who previously had a VTAE, none had a recurrence of thrombus or evidence of post-thrombotic syndrome at 1 year.. Treatment with polidocanol endovenous microfoam 1% led to durable, clinically meaningful, and ongoing improvements at 1 year in varicose vein symptoms and appearance. Serious adverse events were those expected during long-term follow-up of the population of patients studied and were unrelated to treatment.

Topics: Adult; Aged; Female; Humans; Laser Therapy; Male; Middle Aged; Polidocanol; Polyethylene Glycols; Quality of Life; Saphenous Vein; Sclerosing Solutions; Surveys and Questionnaires; Treatment Outcome; Varicose Veins; Venous Insufficiency; Young Adult

VANISH-2 Investigator Group: K Gibson, Bellevue, WA, USA; M Goldman, San Diego, CA, USA; P Hertzman, Los Alamos, NM, USA; S Hirsch, Pittsburgh, PA, USA; R Hye, San Diego, CA, USA; M Isaacs, Walnut Creek, CA, USA; M Plaza-Ponte, Monroeville, PA, USA; S Rathbun, Oklahoma City, OK, USA; J Rhodes, Rochester, NY, USA; G Rosenberg, Frederick, MD, USA; M Schul, Lafayette, IN, USA; M Stanbro, Greenville, SC, USA; and R Weiss, Hunt Valley, MD, USA To determine efficacy and safety of polidocanol endovenous microfoam in treatment of symptoms and appearance in patients with saphenofemoral junction incompetence due to reflux of the great saphenous vein or major accessory veins.. Patients were randomized equally to receive polidocanol endovenous microfoam 0.5%, polidocanol endovenous microfoam 1.0% or placebo. The primary efficacy endpoint was patient-reported improvement in symptoms, as measured by the change from baseline to Week 8 in the 7-day average electronic daily diary VVSymQ™ score. The co-secondary endpoints were the improvement in appearance of visible varicosities from baseline to Week 8, as measured by patients and by an independent physician review panel.. In 232 treated patients, polidocanol endovenous microfoam 0.5% and polidocanol endovenous microfoam 1.0% were superior to placebo, with a larger improvement in symptoms (VVSymQ (-6.01 and-5.06, respectively, versus -2.00; P < 0.0001) and greater improvements in physician and patient assessments of appearance (P < 0.0001). These findings were supported by the results of duplex ultrasound and other clinical measures. Of the 230 polidocanol endovenous microfoam-treated patients (including open-label patients), 60% had an adverse event compared with 39% of placebo; 95% were mild or moderate. No pulmonary emboli were detected and no clinically important neurologic or visual adverse events were reported. The most common adverse events in patients treated with polidocanol endovenous microfoam were retained coagulum, leg pain and superficial thrombophlebitis; most were related to treatment and resolved without sequelae.. Polidocanol endovenous microfoam provided clinically meaningful benefit in treating symptoms and appearance in patients with varicose veins. Polidocanol endovenous microfoam was an effective and comprehensive minimally invasive treatment for patients with a broad spectrum of vein disease (clinical, etiology, anatomy, pathophysiology clinical class C2 to C6) and great saphenous vein diameters ranging from 3.1 to 19.4 mm. Treatment with polidocanol endovenous microfoam was associated with mild or moderate manageable side effects. VVSymQ is an important new, validated instrument for symptom assessment in patients with varicose veins.

Topics: Adolescent; Adult; Aged; Female; Humans; Male; Middle Aged; Polidocanol; Polyethylene Glycols; Quality of Life; Saphenous Vein; Sclerosing Solutions; Sclerotherapy; Severity of Illness Index; Treatment Outcome; Ultrasonography, Doppler, Duplex; Varicose Veins; Venous Insufficiency; Young Adult

To assess the efficacy and safety of a new method of clearing varicose veins in the long term. It consists of applying the long-pulsed Nd:YAG laser following the injection of polidocanol microfoam, in two consecutive sessions, treating both legs in full in each session.. Randomized, Polidocanol-controlled, blind evaluation clinical trial comparing the results between 79 legs treated with Polidocanol and 517 treated with Polidocanol + Laser. Photographs were taken preoperatively and at three months, two years and three years after treatment, as well as patient self-assessments.. Polidocanol + Laser is much more effective than polidocanol microfoam in clearing venulectasias with a diameter under 4 mm (p < 0.001). After three years, clearing percentages of 89% (Class I veins), 94% (Class II veins) and 95% (Class III veins) are observed, in comparison to 15%, 18% and 17%, respectively when only polidocanol was applied. No unexpected adverse effects were found and 86% of patients stated they were Satisfied or Very Satisfied.. The method leads to safe, fast and apparently permanent results. The treatment session lasts less than 1 h, and could become a first-choice treatment for the removal of all types of varicose veins with a diameter under 4 mm.

Topics: Adult; Aged; Combined Modality Therapy; Female; Follow-Up Studies; Humans; Laser Therapy; Lasers, Solid-State; Leg; Middle Aged; Polidocanol; Polyethylene Glycols; Sclerosing Solutions; Sclerotherapy; Single-Blind Method; Telangiectasis; Treatment Outcome; Varicose Veins; Young Adult

The prevalence of chronic venous disease is high and occurs more frequently in females. According to the clinical, etiological, anatomical, and pathological classification (CEAP) definition, the reticular veins are included in the C1 class and are mainly associated with aesthetic complaints. Several invasive techniques are used for treatment, including mini phlebectomy, laser ablation, and radiofrequency ablation. However, a wide range of sclerosing agents may serve as minimally invasive alternatives, promoting chemical sclerosis of the vein wall. Although this technique is routinely performed around the world, there is no consensus on the most efficacious and safe chemical agent to be used.. Inclusion criteria are women between 18 and 69 years old with at least 10 cm long reticular veins in the lower limbs, on the outer side of the leg/thigh. Patients with CEAP 2 to 6, or with allergies, pregnancy, performing breastfeeding, or with any dermatologic or clinical problems will be excluded. Patients with venous ultrasound mapping showing involvement of saphenous trunks and/or a deep venous system will also be excluded. Patients will be randomized into two groups, one receiving 75% pure glucose and the other group receiving 0.2% polidocanol diluted in 70% glucose. Just one limb and one session per patient will be performed. The sclerosing agent volume will not exceed 5 mL. Clinical follow-up will include visits on days 7 and 60, always with photographic documentation.. This project aims to enroll 96 patients and subject them to a double-blind treatment after the randomization process. The design is intended to evaluate efficacy through a primary end point and safety through a secondary end point. Forty-eight patients have currently been enrolled. Preliminary results for these patients showed that 25 received treatment, 2 were excluded, and 22 returned after 7 days and showed no greater adverse events. To date, establishing efficacy criteria has not been possible, and no patients have reached the 60-day return point. These data may help doctors choose the best chemical agent for the treatment of reticular veins.. ClinicalTrials.gov Identifier: NCT02054325, 3/02/2014.

Topics: Adolescent; Adult; Aged; Brazil; Chronic Disease; Clinical Protocols; Double-Blind Method; Female; Glucose Solution, Hypertonic; Humans; Lower Extremity; Middle Aged; Polidocanol; Polyethylene Glycols; Prospective Studies; Research Design; Sclerosing Solutions; Sclerotherapy; Telangiectasis; Time Factors; Treatment Outcome; Varicose Veins; Young Adult

The authors propose a new classification of telangiectasias: conditions involving demonstrated reflux are classified as type A telangiectasias; clustered, spider telangiectasias not related to reflux and with vein diameters of >0.2 mm are classified as type B, while isolated telangiectatic veins of ≤0.2 mm diameter are classed as type C. This histological and pathophysiological approach is the basis for the Authors' Multi-Therapy Treatment Protocol (MTT).. The treatment regimen provides for initial treatment of type A telangiectasias with just conventional reflux sclerotherapy, followed three weeks later by treatment of type B telangiectasias with 0.25-0.5% polidocanol foam, associated with both external compression and tumescent vasoconstriction (START technique). This is then followed after a further three months by dermal stimulation with mesoglycan (LIDS technique) to reinforce the district underlying the type C telangiectasias. The MTT Protocol was used on 63 patients (125 limbs). A 12-month follow-up showed the treatment regimen to provide better aesthetic and functional results than classical sclerotherapy, with few adverse effects and greater patient satisfaction.

Topics: Adult; Aged; Combined Modality Therapy; Drug Administration Schedule; Endothelium, Vascular; Female; Glycosaminoglycans; Hemorheology; Humans; Leg; Male; Middle Aged; Patient Satisfaction; Patient Selection; Polidocanol; Polyethylene Glycols; Saphenous Vein; Sclerosing Solutions; Sclerotherapy; Stockings, Compression; Telangiectasis; Treatment Outcome; Ultrasonography; Varicose Veins; Viscoelastic Substances; Young Adult

To assess efficacy and safety of polidocanol (POL) versus placebo in the treatment of C1 and C2 non-saphenous varicose veins in Chinese patients.. Patients were randomly assigned to POL or placebo. POL 0.5%, 1% and 3% were administered depending on varicose vein type. Response after 12 weeks was defined as Grade 4 or 5 on a digital imaging-based five-point scale (C1 veins) or occlusion and/or absence of reflux >0.5 second (C2 veins). Safety was evaluated with a five-point scale and standard safety assessments.. Two hundred and eighty-five patients were treated. POL 0.5%, 1% and 3% were each superior to placebo (P < 0.001); response rates: 87.1% versus 13.6%, 86.4% versus 12.5% and 88.6% versus 4.3%, respectively. Significantly more POL than placebo patients were satisfied/very satisfied with treatment. POL was well tolerated, with mostly symptoms at the injection site reported.. Sclerotherapy with POL 0.5%, 1% and 3% was efficacious and safe in Chinese patients.

Topics: Adult; Asian People; China; Double-Blind Method; Female; Humans; Lower Extremity; Male; Middle Aged; Patient Safety; Patient Satisfaction; Placebos; Polidocanol; Polyethylene Glycols; Prospective Studies; Saphenous Vein; Sclerosing Solutions; Sclerotherapy; Surveys and Questionnaires; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Varicose Veins

New minimally invasive treatment modalities, such as ultrasound-guided foam sclerotherapy (UGFS), are becoming more popular. In a multicentre randomized controlled non-inferiority trial, the effectiveness and costs of UGFS and surgery for treatment of the incompetent great saphenous vein (GSV) were compared.. Patients with primary great saphenous varicose veins were assigned randomly to either UGFS or surgical stripping with high ligation. Recurrence, defined as reflux combined with venous symptoms, was determined on colour duplex scans at baseline, 3 months, 1 year and 2 years after initial treatment. Secondary outcomes were presence of recurrent reflux (irrespective of symptoms), reduction of symptoms, health-related quality of life (EQ-5D(™)), adverse events and direct hospital costs.. Two hundred and thirty patients were treated by UGFS and 200 underwent GSV stripping. The 2-year probability of recurrence was similar in the UGFS and surgery groups: 11·3 per cent (24 of 213) and 9·0 per cent (16 of 177) respectively (P = 0·407). At 2 years, reflux irrespective of venous symptoms was significantly more frequent in the UGFS group (35·0 per cent) than in the surgery group (21·0 per cent) (P = 0·003). Mean(s.d.) hospital costs per patient over 2 years were €774(344) per patient for UGFS and €1824(141) for stripping.. At 2-year follow-up, UGFS was not inferior to surgery when reflux associated with venous symptoms was the clinical outcome of interest. UGFS has the potential to be a cost-effective approach to a common health problem. Registration numbers: NCT01103258 (http://www.clinicaltrials.gov) and NTR654 (http://www.trialregister.nl).

Topics: Adult; Aged; Aged, 80 and over; Ambulatory Surgical Procedures; Costs and Cost Analysis; Female; Hospital Costs; Humans; Injections, Intravenous; Male; Middle Aged; Polidocanol; Polyethylene Glycols; Recurrence; Retreatment; Saphenous Vein; Sclerosing Solutions; Sclerotherapy; Treatment Outcome; Ultrasonography, Interventional; Varicose Veins; Venous Insufficiency

Conventional sclerotherapy of varicose vein is performed by injection of a sclerosing substance into the vein. The modern use of foam in sclerotherapy in which sclerosants can be transformed into fine-bubbled foam by special techniques is developed. Many studies report about the better efficacy of foam therapy than conventional liquid therapy.. To assess the efficacy of sclerosant Polidocanol in foam form compared to liquid form and to determine safety profile by monitoring the complications (Pain, inflammation and pigmentation).. Randomized controlled trial study, fifty patients with symptomatic varicose veins underwent duplex ultrasonography for measurement of the diameter of the varices. All patients underwent one session of sclerotherapy with both sclerosants (foam and liquid Polidocanol). Efficacy was assessed at 15, 30 and 90 days after the sclerotherapy by duplex ultrasound and the safety was evaluated at 15, 30, 90 days.. The efficacy of sclerosis was reported in total occlusion of 46 sites (92.0%) in foam therapy and of 38 sites (76.0%) in Polidocanol liquid therapy after 90 days. The differences of occlusion for the two groups were statistically significant, foam therapy showed greater results than that of Polidocanol liquid therapy at 15 days, 30 days and 90 days after therapy Pain and hyperpigmentation were significantly higher in foam group than that in liquid group at 15 days and 30 days.. Foam sclerotherapy has greater efficacy for treating varicose veins comparing to conventional liquid sclerotherapy. However Pain, inflammation, and hyperpigmentation appeared more often with foam Polidocanol therapy.

Topics: Adult; Aged; Female; Humans; Male; Middle Aged; Polidocanol; Polyethylene Glycols; Saphenous Vein; Sclerosing Solutions; Sclerotherapy; Treatment Outcome; Ultrasonography, Doppler, Duplex; Varicose Veins

Compression sclerotherapy has been satisfactorily used for half a century for the treatment of varicose veins of the lower extremities. The effect of sclerosing solutions is that of making endofibrosis and vascular damage via producing endothelial injury. Different sclerosing agents were used by applying many different sclerotherapy methods. In recent years, sclerosing foam has been introduced in sclerotherapy with the goal of increasing the efficacy in the treatment of varicose veins. It is still uncertain whether foam or liquid form is superior. The aim of this study is to determine the efficacy and safety of the sclerosant polidocanol - which is a well-known detergent-type sclerosing agent - in foam form compared with liquid form.. A total of 100 women patients with telengiectases and small varicose veins of less than 4 mm were included in this study. The patients were divided into two groups according to presenting dates. Fifty patients who presented first were classified as the first group. They were treated with Tessari's foam sclerotherapy method. The second fifty patients who presented later were placed in the second group. They were treated with the liquid form of polidocanol. Extremity veins that did not have insufficiency at the saphenofemoral junction were divided into three groups as <1 mm, 1-2 mm and >2 but <4 mm, and the veins were treated with 0.25%, 0.5% or 1% of polidocanol, respectively. Clinical improvement, patients' complaints and side-effects were determined after treatment.. Complete disappearance was determined in 84% of patients in the foam form group and in 72% in the liquid form group. Although polidocanol in foam form's success rate was higher than the liquid form of polidocanol to clear the vessels, this result did not reach statistical significance (P = 0.148). There was no significant difference also in the side effects between each group.. Compression sclerotherapy is an effective and useful method for treating small varicose veins and telengiectases. Both polidocanol foam and polidocanol liquid forms are effective and safe sclerosing agents. The rates of side-effects were similar for both sclerotherapy methods. Although efficacy to clear the small varicose veins and telengiectases with foam polidocanol seems to be more successful than with liquid polidocanol, it is early to declare the superiority of the foam sclerotherapy method.

Topics: Adult; Dizziness; Dosage Forms; Ecchymosis; Female; Humans; Leg Ulcer; Male; Pharmaceutical Solutions; Polidocanol; Polyethylene Glycols; Sclerosing Solutions; Sclerotherapy; Skin Pigmentation; Treatment Outcome; Varicose Veins; Vasculitis

To compare the proportion of foam sclerosant that enters deep veins between multiple injections of <0.5 ml foam per injection and a few injections of >0.5 ml foam per injection.. One hundred and seven patients with superficial venous incompetence were randomised to receive either multiple injections of <0.5 ml 1% polidocanol (POL) -foam (multiple injections) or a few injections of >0.5 ml 1% POL-foam per injection (few injections) for the treatment of varicose tributaries. All patients then received ultrasound-guided foam sclerotherapy for refluxing great saphenous vein (GSV) using 3% POL-foam. Only a single session was allowed per patient in order to standardise treatment. Qualitative ultrasonographic inspection of the foam was carried out during a 5-min period before compression was applied. Post-sclerotherapy surveillance was done at day 3, 2 weeks, 1 month, 3 months, and 6 months.. Fifty-six limbs in 53 patients were treated with multiple injections and the remaining 56 limbs in 54 patients were treated with a few injections. There were no significant differences in age or male:female ratio between the groups. The mean volume of 1% POL-foam was 2.2 S.D. 0.6 ml (range: 0.7-4.0 ml) in the multiple injections group and 2.5 S.D. 0.6 ml (range: 1.0-4.0 ml) in the few injections group (p=0.003). The mean volume of 3% POL was 1.5 ml (range: 0.7-3.0 ml) and 1.4 ml (range: 0.7-3.0 ml), respectively (p=0.137). Ultrasonographic inspection immediately after sclerotherapy demonstrated that foam was distributed significantly more commonly in the deep veins of patients treated with a few injections (p=0.0003). Two (4%) of the patients treated with a few injections developed migraine during the procedure, but recovered quickly with no further complications. There was no significant difference in the success rate between the groups at 6 months (p=0.257).. These findings suggest that multiple small-dose injections can reduce the amount of foam sclerosant and the risk of foam sclerosant entering the deep veins in patients with superficial venous insufficiency.

Topics: Adult; Aged; Aged, 80 and over; Female; Humans; Injections; Lower Extremity; Male; Middle Aged; Polidocanol; Polyethylene Glycols; Saphenous Vein; Sclerosing Solutions; Sclerotherapy; Ultrasonography, Doppler, Color; Ultrasonography, Doppler, Duplex; Ultrasonography, Interventional; Varicose Veins; Venous Insufficiency; Young Adult

The aim of this study was to compare the recurrent rates of varicose veins after treatment with two surgical techniques: 3-S saphenectomy and 3-S saphenectomy with distal sclerosis.. 105 patients with trunk varicose veins were randomly assigned. The control group consisted of 51 patients who underwent the 3-S saphenectomy technique (the sapheno-femoral junction sclerosis with foam, saphenectomy and distal phlebectomies); test group: 3-S saphenectomy with distal sclerosis technique (the sapheno-femoral junction sclerosis with foam, saphenectomy and distal segment sclerosis).. Overall recurrence: group I 35.3%, group II 57.4% (p < 0.001). Trunk recurrence: group I 17.7%, group II 38.9% (p = 0.028). Collateral recurrence: group I 9.8%, group II 11.1% (p = 1). Perforator vein recurrence: group I 5.9%, group II 5.6% (p = 1). Reticulated recurrence: group I 2%, group II 1.9% (p = 1).. The substitution of Müller phlebectomy instead of foam sclerosis, is not a better treatment of the distal venous segment, and has a greater recurrence rate. The 3-S saphenectomy technique is the most suitable for the treatment for trunk varicose veins.

Topics: Female; Humans; Male; Middle Aged; Polidocanol; Polyethylene Glycols; Recurrence; Saphenous Vein; Sclerosing Solutions; Sclerotherapy; Varicose Veins; Vascular Surgical Procedures

To assess the safety and efficacy of sclerotherapy of the great saphenous vein (GSV) comparing standardised polidocanol foam to liquid polidocanol in a randomised controlled trial (RCT).. A multicentre randomised controlled clinical trial was carried out in which saphenous trunks were treated by sclerotherapy. 106 patients with primary varicose veins due to an incompetent GSV were treated with either standardised 3% polidocanol foam or 3% liquid polidocanol. The primary efficacy criterion was elimination of reflux (<0.5 sec) measured 3 cm below the sapheno-femoral junction (SFJ) by duplex ultrasonography 3 months after the last injection.. A significantly greater number of patients were successfully treated by foam sclerotherapy resulting in 69% elimination of reflux compared to 27% patients treated with liquid sclerosant. The secondary endpoints of vein occlusion, reflux time, refilling time and patient satisfaction also improved significantly more in the foam group. The mean number of treatment sessions was 1.3 in the foam group compared to 1.6 in the liquid group. Differences between study centres occurred with a mean of 96% reflux elimination in 6 centres versus 39% in 4 other centres. Centres with a high response rate injected a higher mean volume (4.3 vs. 3.6 ml) in the first session in a vein with a smaller diameter (7.5 mm vs. 8.4 mm). No difference in adverse drug reactions was observed between treatment groups.. Standardised 3% polidocanol foam is more efficient and equally safe compared to 3% liquid polidocanol for treatment of GSV. In comparison to other studies a relatively small volume was injected into relatively large veins.

Topics: Adult; Aged; Female; Germany; Humans; Male; Middle Aged; Patient Satisfaction; Polidocanol; Polyethylene Glycols; Prospective Studies; Saphenous Vein; Sclerosing Solutions; Sclerotherapy; Severity of Illness Index; Surveys and Questionnaires; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Varicose Veins; Venous Insufficiency

To compare 1% and 3% POL foam in treating the great saphenous vein (GSV) by ultrasound guided sclerotherapy.. Multicentre, prospective, randomised, double-blind trial with 2 year-follow-up.. 148 patients with GSV reflux (saphenous trunk diameter 4-8 mm) were randomised to undergo ultrasound guided foam sclerotherapy using either 1% or 3% POL foam in a single session. Foam production was standardised using a sterile disposable syringe kit including sterile air and the Turbofoam machine. Duplex ultrasonography was used to assess the outcome at 3 weeks, 6 months, 1 year, 18 months and 2 years. The main criterion of success was the disappearance of the venous reflux. The length of occlusion of the vein (only measured at 3 week-echography assessment) was a secondary criterion. Side effects were assessed.. 74 patients were included in each group. The mean volume of foam injected was 4.4 ml for the 3% group and 4.6 ml for the 1% group. After 3 weeks, reflux was abolished in 96% (71 patients) of the 3% group and 88% (68 patients) of the 1% group (NS). The mean occlusion length of the vein was 38 cm for the 3% group and 34 for the 1% group (NS). After 2-years, reflux was absent in 69% of the 3% group and 68% of the 1% group (NS). 14 patients were lost to follow-up at 2 years.. This study demonstrates equivalent efficacy for 1% POL and 3% POL foam in sclerotherapy of the GSV where the trunk is less than 8 mm in diameter. These data obtained two years of follow-up confirm our previously reported 6 month-follow-up data published in 2005.

Topics: Adult; Dosage Forms; Dose-Response Relationship, Drug; Double-Blind Method; Female; Follow-Up Studies; Humans; Male; Middle Aged; Polidocanol; Polyethylene Glycols; Prospective Studies; Radiography; Recurrence; Saphenous Vein; Sclerosing Solutions; Sclerotherapy; Ultrasonography, Interventional; Varicose Veins

Varicose veins are a common disorder and many treatment methods are available.. The aim of this study was to evaluate the short-term efficacy of foam sclerotherapy and the safety of performing the treatment in an outpatient clinic without ultrasound guidance. METHODS This was a prospective, nonrandomized study with foam sclerotherapy. All the patients were assessed before and after the procedure with a CEAP (Clinical, Etiology, Anatomy, Pathology) class and clinical score. At the same visit, duplex scanning was performed to evaluate the anatomic distribution of the varicose disease. The mean age of the patients was 49.2 years (SD,+/-10.6 years; median, 50.0 years). Altogether 41% of the legs had undergone a previous operation and 24% were recurrences. The follow-up time was 3 months.. Twenty-five patients with 27 legs were treated successfully using foam sclerotherapy without ultrasound guidance. Twenty-one cases (78%) involved the great saphenous vein and 6 cases (22%) involved the small saphenous vein. The mean bandage time was 7.7 days (SD,+/-2.50 days; median, 8.50 days). The CEAP score decreased 73% after the procedure from 2.61 (SD,+/-0.80; median, 2.0) to 0.71 (SD,+/-0.95; median, 0; p<.001). and the mean clinical score decreased 45% from 4.45 (SD,+/-1.96; median, 4.0) to 2.46 (SD,+/-1.50; median, 2.0; p<.001), respectively. Three months after the treatment, duplex scanning showed saphenofemoral reflux in 63% of the legs and saphenopopliteal reflux in 40% of the legs. The most common complication was postoperative thrombophlebitis (66%). Other minor complications included pain (38%) and hematoma (4%). There were no major complications. Subjectively, 71% of the patients assessed the procedure as good or excellent and 29% as acceptable or poor.. Foam sclerotherapy is also an effective and safe procedure when performed without duplex guidance. Thrombophlebitis is frequent when using a high concentration of polidocanol and a short bandage time. The high frequency of saphenofemoral and saphenopopliteal junction reflux after the procedure can have a negative effect on the long-term results.

Topics: Ambulatory Care; Female; Follow-Up Studies; Hematoma; Humans; Male; Middle Aged; Pain; Polidocanol; Polyethylene Glycols; Prospective Studies; Recurrence; Sclerosing Solutions; Sclerotherapy; Treatment Outcome; Ultrasonography; Varicose Veins

Foam sclerotherapy of the great saphenous vein is a relatively new and promising treatment option for patients with axial reflux. Its usefulness may be limited by low primary occlusion rates. We present a standard technique for catheter-directed foam sclerotherapy, which facilitates foam delivery precisely to its intended site of action and potentially improves occlusion rates.. A consecutive series of 53 patients were treated with foam sclerotherapy using a standard technique for foam delivery at Malmö University Hospital between September 2006 and April 2007. Patients were treated with 3% polidocanol foam through an introducer sheath, which was inserted percutaneously over a guidewire in the great saphenous vein (GSV). All successfully treated patients were examined by colour duplex one week after the procedure.. Primary technical success with delivery of foam along the length of the GSV was achieved in 50 of 53 limbs (94%). All treated GSVs were occluded at one week duplex.. The use of an endovascular sheath inserted percutaneously over a guidewire under duplex ultrasound control is feasible in most patients and has resulted in high primary occlusion rates.

Topics: Catheterization; Feasibility Studies; Humans; Polidocanol; Polyethylene Glycols; Saphenous Vein; Sclerosing Solutions; Sclerotherapy; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Color; Ultrasonography, Doppler, Duplex; Ultrasonography, Interventional; Varicose Veins; Venous Insufficiency

To assess the efficacy and safety of sclerotherapy performed with polidocanol foam compared to liquid polidocanol.. Controlled clinical trial with 1 year follow up in which each patient acted as his/her own control. A total of 75 patients (six men and 69 women) with reticular or postoperative varices were enrolled and sclerotherapy was performed with liquid and with foam (Tessari method) using the same quantity of sclerosant for homogeneous varicose regions, to a total of 150 procedures. The sclerosant concentration was adjusted according to the vein diameter as assess by ultrasonography. The foam group was given 50% lower concentrations of sclerosant than liquid sclerosant group. Clinical assessment (pain, inflammation, pigmentation) and ultrasound examination (diameter of the lumen and length of sclerosed vein) were carried out at 15, 30, 90, and 365 days.. Foam allowed complete sclerosis at 90 days in 94.4% of patients compared with 53% for liquid (p<.001) and also allowed a more extensive venous sclerosis (10.1cm compared with 7.2 cm; p<.001). Pain, signs of inflammation, and pigmentation appeared more often with foam sclerosis, with significant difference. The degree of satisfaction was similar for both techniques.. Efficacy of venous sclerosis with foam seems to be greater than with liquid although there is a higher risk of minor secondary effects.

Topics: Adult; Aged; Double-Blind Method; Female; Follow-Up Studies; Humans; Injections, Intravenous; Male; Middle Aged; Patient Satisfaction; Polidocanol; Polyethylene Glycols; Sclerosing Solutions; Treatment Outcome; Ultrasonography, Doppler, Duplex; Varicose Veins

Twenty subjects were treated with either polidocanol (POL) or sodium tetradecyl sulfate (STS) to compare the efficacy and adverse sequelae of each agent.. To determine the safety and efficacy of two widely used sclerosing agents.. After the exclusion of saphenofemoral junction incompetency, each subject's leg veins were categorized by size (< 1, 1-3, and 3-6 mm in diameter). Each leg was then randomized to be treated with 0.5%, 1%, or 1% foam of POL or 0.25%, 0.5%, or 0.5% foam of STS according to vein size. An independent panel of four physicians, blinded to treatment, performed randomized photographic evaluations obtained pretreatment and 12 weeks post-treatment. Subject satisfaction index and overall clinical improvement assessment were also obtained.. An average 83% improvement was noted for all vein sizes in all subjects with both POL and STS after a single treatment. Subjects were satisfied with treatment, regardless of the sclerosing agent used or the vein size treated. There was no statistically significant difference in adverse effects between each group.. Both POL and STS are safe and effective sclerosing agents in the treatment of varicose and telangiectatic leg veins. Both are very tolerable and demonstrate similar post-treatment sequelae.

Topics: Double-Blind Method; Female; Humans; Male; Patient Satisfaction; Polidocanol; Polyethylene Glycols; Prospective Studies; Sclerosing Solutions; Sclerotherapy; Sodium Tetradecyl Sulfate; Telangiectasis; Treatment Outcome; Varicose Veins

The objective of this study was to investigate the efficacy of sclerotherapy for varicose veins in a randomized blinded study.. Twenty-five patients with varicose veins (C(2-4), E(P), A(SP), P(R)) were included. Fourteen subjects received polidocanol (Aethoxysklerol) and 11 patients received normal saline injections. Compression was applied for 1 week. One, 4, and 12 weeks later controls were performed using duplex ultrasonography. The quotient of venous by arterial volume flow was used as quantitative hemodynamic pattern. Patients and the examiner were unaware of which liquid had been injected.. In comparison to group 2, 76.8% of the veins treated with polidocanol were completely occluded (p<0.0001). In group 1 the venoarterial flow index decreased from 1.45+/-0.66 to 1.06+/-0.2 (p=0.05). In 11 occluded veins of 14 (group 1), the venoarterial flow index decreased from 1.5+/-0.07 to 0.98+/-0.12 (p<0.05), which is a level found in competent veins. In group 2, the venoarterial flow index remained stable increased.. Injection sclerotherapy using polidocanol (Aethoxysklerol) is efficient to obliterate varicose veins and to improve venous hemodynamics.

Topics: Female; Humans; Leg; Male; Middle Aged; Polidocanol; Polyethylene Glycols; Prospective Studies; Sclerosing Solutions; Sclerotherapy; Sodium Chloride; Treatment Outcome; Ultrasonography, Interventional; Varicose Veins

To compare the short and long term results of different techniques of compression sclerotherapy.. In the past 10 years the authors treated 1622 pts due to chronic venous insufficiency. There were 3 groups of patients: 1) Pts treated by Sigg's technique using Aethoxysclerol, 2) Pts treated by Fegan's technique with Fibrovein, and 3) Pts treated by Fegan's procedure, but using a combination of both sclerosants. In all cases, the techniques of empty vein, bubble air, uninterrupted 6-week compression and forced mobilisation were used.. In the group of pats. treated by Sigg's procedure, the average cure rate was 67.47% after 6 months, 60.3% after 5 years of follow-up. In Fegan's group this rate was 83.6% after 6 months and 78.54% after 5 year assessment. Statistically, significant differences were found only by the disappearance of varices and reduction of pain in favour of Fegan's technique. In the group of pts treated by Fegan's (Aethoxysclerol + Fibrovein) this rate after 5 years was 86%. The only statistically significant difference was found by the disappearance of varices in favour of Fegan's technique using a combination of 2 detergent sclerosants.. Sclerotherapy is effective when properly executed in any length of vein no matter how dilated it has become. The recurrences are attributed more to inadequate technique than to the shortcoming of the procedure. Sclerotherapy is miniinvasive, with few complications, and can be repeated on out-patient basis. (Tab. 1, Ref. 22.).

Topics: Bandages; Follow-Up Studies; Humans; Polidocanol; Polyethylene Glycols; Recurrence; Sclerosing Solutions; Sclerotherapy; Sodium Tetradecyl Sulfate; Varicose Veins

Foamed sclerosing agents have been used with enthusiasm by phlebologists for more than 5 decades. Any type of varicose veins can and has been treated with this technique. Numerous publications have stressed the advantages of foamed sclerosing agents on the basis of empiric and experimental criteria and have described various individual techniques to prepare foams. Until now, however, no comparative study for the treatment of large varicose veins with foam or liquid exists.. The purpose of this first randomized, prospective, multicenter trial was to study the elimination of reflux, the rate of recanalization, and possible side effects of foam sclerotherapy (FS) compared with conventional liquid sclerotherapy for the greater saphenous vein (GSV).. Eighty-eight patients were randomized into two groups: One group was treated with sclerosing foam (45 patients) and the other with sclerosing liquid (43 cases). Sclerotherapy was performed with direct puncture of the vessel under duplex guidance. The reference sclerosing agent was polidocanol in a 3% solution. The foam was prepared using the Double Syringe System (DSS) method. Only one injection of 2.0 or 2.5 mL liquid or foam was allowed, depending on the diameter of the GSV. Results were assessed according to the protocol.. Follow-up after 3 weeks showed 84% elimination of reflux in the GSV with DSS foam versus 40% with liquid sclerosant (P < 0.01). At 6 months, six recanalizations were found in the liquid group versus two in the foam group. After 1 year, no additional recanalization was observed with either foam or liquid. Longer term studies are underway. Side effects did not differ between both groups.. The efficacy of sclerosing foam (DSS) compared with sclerosing liquid in therapy of the GSV is superior, a finding that had already gained empirical recognition but for which there has not been any clinical evidence to date.

Topics: Dosage Forms; Humans; Polidocanol; Polyethylene Glycols; Prospective Studies; Saphenous Vein; Sclerosing Solutions; Sclerotherapy; Varicose Veins

One hundred twenty-nine patients were treated with either polidocanol (POL) or sodium tetradecyl sulfate (STS) to compare the efficacy and adverse sequelae of each agent.. To determine the safety and efficacy of two sclerosing solutions.. Each patient's leg veins that did not have incompetence from the saphenofemoral junction (SFJ) were divided into three categories by size (<1 mm, 1-3 mm, 3-6 mm). Each leg was randomly treated with either 0.25%, 0.5%, or 1.5% of STS or 0.5%, 1.0%, or 3% of POL respective of size. An independent, three-panel, blindly randomized photographic examination was obtained pretreatment and at 4 and 16 weeks. Patient satisfaction index and overall clinical improvement assessment were also obtained.. All patients had an average of 70% improvement and were 70-72% satisfied in all vein categories treated with either solution. There was no significant difference in adverse effects between each group except for a decrease in ulcerations and swelling in the POL group.. Both STS and POL are safe and effective sclerosing solutions for varicose and telangiectatic leg veins.

Topics: Double-Blind Method; Humans; Leg; Polidocanol; Polyethylene Glycols; Prospective Studies; Sclerosing Solutions; Sclerotherapy; Sodium Tetradecyl Sulfate; Telangiectasis; Treatment Outcome; Varicose Veins

An ongoing study of the safety and effectiveness of polidocanol by 98 investigators in Australia infecting 16,804 limbs over 2 years.. To evaluate the complications of polidocanol and compare its effectiveness and complications with sodium tetradecyl sulphate (STD) and hypertonic saline.. A single-arm prospective study of polidocanol complications and its effectiveness as a sclerosant was performed. This was compared with each investigator's previous experience with other sclerosing agents. Patients had either varicose veins or venule ectasias and/or spider veins (telangiectasia). A total of 16,804 limbs were injected by 98 investigators. Sclerotherapy was performed with 0.5% or 1% polidocanol for telangiectasias or spider veins, and with 3% polidocanol for varicose veins. The effectiveness of the sclerotherapy and any complications were reported during a 2-year period.. There were very few complications reported with polidocanol. There were no reported deaths or anaphylaxis. The investigators with previous experience of other sclerosants considered that the effectiveness of polidocanol was superior to STD (85%) and hypertonic saline (84%). Ninety percent of investigators considered that polidocanol had less frequent complications than STD, and 80% considered that these were less severe. Seventy-four percent considered that polidocanol had fewer side effects than hypertonic saline, and 74% considered that these were less severe.. Polidocanol is an effective sclerosant that has few complications.

Topics: Anesthetics, Local; Double-Blind Method; Humans; Hypertonic Solutions; Polidocanol; Polyethylene Glycols; Sclerosing Solutions; Sodium Tetradecyl Sulfate; Telangiectasis; Varicose Veins

Like esophageal varices, cardiac varices are often treated with endoscopic variceal ligation (EVL). However, we previously reported that EVL for cardiac varices may be associated with a high risk of rebleeding from the ulcer if the O-ring spontaneously drops off early. The efficacy and safety of para-variceal endoscopic injection sclerotherapy (EIS) with polidocanol for the treatment of cardiac varices in children and adolescents were evaluated.. Eleven patients under 18 years of age with portal hypertension who underwent para-variceal EIS with polidocanol for cardiac varices with red signs, which were considered to be at high risk of bleeding, were retrospectively reviewed.. One session of para-variceal polidocanol-EIS was performed for each of the 11 patients. One patient experienced temporary hypoxia due to aspiration of saliva when the tracheal intubation tube was removed after the procedure but recovered by endotracheal suctioning; there were no other adverse events. In six of the eight cases in which efficacy could be evaluated, eradication of cardiac varices was achieved.. Para-variceal polidocanol-EIS may be considered instead of EVL for small cardiac varices with red signs in pediatric patients with cardiac varices.

Topics: Adolescent; Child; Esophageal and Gastric Varices; Gastrointestinal Hemorrhage; Humans; Ligation; Polidocanol; Recurrence; Retrospective Studies; Sclerotherapy; Varicose Veins

Microfoam ablation (MFA) and radiofrequency ablation (RFA) are both approved by the Food and Drug Administration for treatment of proximal saphenous truncal veins. The objective of our study was to compare early postoperative outcomes between MFA and RFA following treatment of incompetent thigh saphenous veins.. A retrospective review of a prospectively maintained database was conducted of patients who underwent treatment of incompetent great saphenous veins (GSVs) or anterior accessory saphenous veins (AASVs) in the thigh. All the patients underwent duplex ultrasound of the treated leg at 48 to 72 hours postoperatively. Patients were excluded from analysis if concomitant stab phlebectomy was performed. Demographic data, CEAP (clinical, etiologic, anatomic, pathophysiologic) class, venous clinical severity score (VCSS), and adverse events were recorded.. Between June 2018 and September 2022, 784 consecutive limbs (RFA, n = 560; MFA, n = 224) underwent venous closure for symptomatic reflux. A total of 200 consecutive thigh GSVs and ASVs treated within the study period using either MFA (n = 100) or RFA (n = 100) were identified. The patients were predominantly women (69%) with a mean age of 64 years. The preoperative CEAP classification was similar between the MFA and RFA groups. The mean preoperative VCSS was 9.4 ± 2.6 for the RFA patients and 9.9 ± 3.3 for the MFA patients. Among the RFA patients, the GSV was treated in 98% and the AASV in 2% compared with the GSV in 83% and the AASV in 17% in the MFA group (P < .001). The mean operative time was 42.4 ± 15.4 minutes in the RFA group and 33.8 ±16.9 minutes in the MFA group (P < .001). The median follow-up was 64 days for the study cohort. The mean postoperative VCSS declined to 7.3 ± 2.1 in the RFA group and 7.8 ± 2.9 in the MFA group. Complete closure occurred in 100% of the limbs after RFA and 90% after MFA (P = .005). Eight veins were partially closed and two remained patent following MFA. The incidence of superficial phlebitis was 6% and 15% (P = .06) after RFA and MFA, respectively. Overall, symptomatic relief was 90% following RFA and 89.5% following MFA. The complete ulcer healing rate for the entire cohort was 77.8%. Deep venous proximal thrombus extension (RFA, 1%; vs MFA, 4%; P = .37) and remote deep vein thrombosis (RFA, 0%; vs MFA, 2%; P = .5) showed a trend toward being higher following MFA but the difference did not reach statistical significance. All were asymptomatic and resolved with short-term anticoagulation therapy.. MFA and RFA are both safe and effective for treating incompetent thigh saphenous veins, with excellent symptomatic relief and a low incidence of postprocedure adverse thrombotic events. RFA resulted in improved complete closure rates following initial treatment compared with MFA. The operative times were shorter with MFA. Both modalities can be used for patients with active venous ulcers with good healing rates. Longer term studies are required to characterize the durability of MFA closure for above knee truncal veins.

Topics: Catheter Ablation; Female; Humans; Male; Middle Aged; Polidocanol; Radiofrequency Ablation; Retrospective Studies; Saphenous Vein; Thigh; Treatment Outcome; Varicose Veins; Venous Insufficiency

Patients requiring thermal or chemical ablation of below knee (BK) truncal veins often have their proximal saphenous veins treated initially and comprise a study population with multilevel, refractory chronic venous insufficiency. The study objective was to assess the outcomes after microfoam ablation of BK truncal and tributary veins in patients with a history of proximal great saphenous vein (GSV) ablation or stripping.. A retrospective review of a prospectively maintained database was performed. All the patients who had undergone endovenous chemical ablation with commercially manufactured polidocanol microfoam for symptomatic BK truncal vein reflux after a previous saphenous ablation or stripping were identified. The patients had undergone duplex ultrasound scanning 48 to 72 hours after the procedure; those who had not adhered to the recommended follow-up protocol were excluded. The demographic data, CEAP (clinical, etiologic, anatomic, pathophysiologic) classification, venous clinical severity score (VCSS), procedure details, adverse thrombotic events, and follow-up data were abstracted.. Between April 2018 and April 2021, 201 limbs were treated for symptomatic superficial truncal vein reflux with microfoam ablation. Of the 201 limbs, 68 in 49 patients met the inclusion criteria for the present study. The veins treated included the BK GSV (n = 45) and small saphenous vein (n = 23). The median follow-up was 97 days (range, 33-457 days) for the entire cohort. Most patients (63%) had a preoperative CEAP classification of C4 to C6. The median preoperative VCSS was 12.5. All the limbs that had undergone microfoam ablation in this cohort had a previously treated proximal ipsilateral GSV, with either thermal ablation or stripping. The median postoperative VCSS after BK treatment decreased to 10 (P < .001). The closure rate at the last follow-up was 96%. The overall symptomatic relief was 78% at the last follow-up. The absolute ulcer healing rate during the study period was 64% (16 of 25 ulcers had healed). One patient had developed thrombus extension into the popliteal vein, which resolved with anticoagulation therapy. One asymptomatic patient had developed nonocclusive thrombus in a gastrocnemius vein after small saphenous vein ablation. Because she was asymptomatic, anticoagulation therapy was not prescribed. Postoperative pain, phlebitis, and swelling were reported in 12%, 12%, and 2% of patients, respectively, and all had resolved at the last follow-up visit. Three limbs treated with chronic oral anticoagulant agents had had recanalized truncal veins during the study period after initial closure. No pulmonary emboli or neurologic adverse events were reported. No symptoms of saphenous or sural nerve injury had occurred.. Endovenous chemical ablation with commercially manufactured polidocanol microfoam of BK truncal veins is a safe and effective treatment for patients with severe, refractory chronic venous insufficiency and prior saphenous interventions. This technique results in excellent overall closure rates and symptomatic relief with low adverse venous thrombotic events, across a wide range of CEAP classes.

Topics: Ablation Techniques; Aged; Databases, Factual; Endovascular Procedures; Female; Humans; Male; Middle Aged; Polidocanol; Retrospective Studies; Saphenous Vein; Sclerosing Solutions; Time Factors; Treatment Outcome; Varicose Veins; Venous Insufficiency

To evaluate outcomes among symptomatic patients with superficial chronic venous insufficiency treated with retrograde ultrasound-guided polidocanol endovenous microfoam 1% (PEM) or endovenous laser ablation (EVLA).. This study is a retrospective chart review from a single vein center between October 2013 and June 2019. Procedures were performed on 1070 patients with Clinical, Etiologic, Anatomic, and Pathophysiologic class 2 to 6 disease and symptomatic superficial venous reflux of the great saphenous vein or anterior accessory saphenous vein.. PEM was used for 550 procedures and patients were followed for 43 ± 13 months; EVLA was used for 520 procedures and patients were followed for 57 ± 18 months. After complete treatment, the elimination of reflux was documented in 93.5% (514/550) and 92.8% (482/520) of the PEM and EVLA procedures, respectively. During the follow-up period, 18% of patients treated with EVLA returned for additional treatment to address residual symptoms in the affected leg. In C6 patients treated with PEM, 69% of ulcers (11/16) healed in less than 1 month, compared with 5% of patients (1/21) treated with EVLA. In C4 patients with lesions, resolution of spontaneous bleeding was 100% in both groups. There were no neurological or cardiac adverse events in the PEM group. Minor complications included asymptomatic deep vein thrombosis (0.5%), one common femoral vein thrombus extension, and superficial venous thrombosis (4%) in the PEM group and asymptomatic deep vein thrombosis (0.8%) and two endovenous heat-induced thromboses in the EVLA group.. PEM is comparable in safety and efficacy with EVLA for the treatment of saphenous reflux and associated symptoms. PEM was an effective intervention for most patients with C6 disease. Closure rates in both groups were maintained 36 months after treatment.

Topics: Humans; Laser Therapy; Polidocanol; Retrospective Studies; Saphenous Vein; Treatment Outcome; Ultrasonography, Interventional; Varicose Veins; Venous Insufficiency; Venous Thrombosis

Venous insufficiency in the small saphenous vein (SSV) is significantly less common than venous insufficiency in the great saphenous vein; the impact of popliteal vein reflux on SSV closure procedural outcomes has yet to be studied.. A retrospective analysis was performed on 150 SSV closure procedures from 2015 to 2019. Preoperative demographic analysis was performed, after which univariate analyses were performed for postoperative occlusion rates and combined rates of endothermal heat-induced thrombus (EHIT) and endovenous foam-induced thrombus (EFIT).. The cohort had a mean age of 58 years, and 116 (77%) were female. Fifty-four patients had C2 disease, 76 had C3 disease, 15 had C4 disease, 1 had C5 disease, and 4 had C6 disease. Twenty-three patients (15.3%) were noted to have popliteal vein reflux on their initial venous insufficiency ultrasound study, compared with 127 (84.6%) who did not. Treatment modalities included 84 radiofrequency ablations (56.0%), 37 polidocanol endovenous microfoam (24.6%), and 29 laser ablations (19.3%). When comparing patients with popliteal vein reflux with those without, there was no significant difference in the occlusion rates at their immediate postoperative visit (99.2% vs 95.6%) or at their 6-month postoperative visit (92.1% vs 91.3%). EHIT/EFIT was noted in 4 of the 23 patients with popliteal vein reflux compared with 4 of the 127 patients without popliteal vein reflux (17.3% vs 3.1%; P = .01). All eight instances of EHIT/EFIT were classified as either arteriovenous fistula class I or II EHIT or EFIT, and all were successfully treated without progression to deep vein thrombosis.. The presence of popliteal vein reflux has no impact on postoperative occlusion rates at 6 months; however, it is associated with a significantly increased rate in EHIT and EFIT. Patients should be counseled on this increased risk should they undergo SSV treatment with known popliteal vein reflux.

Topics: Female; Humans; Laser Therapy; Male; Middle Aged; Polidocanol; Popliteal Vein; Retrospective Studies; Saphenous Vein; Thrombosis; Treatment Outcome; Varicose Veins; Venous Insufficiency

The endovascular technique of mechanochemical ablation (MOCA) has become popular in treating patients with saphenous reflux. We reported the histopathological findings in human ex-vivo incompetent great saphenous veins following treatment with saline, polidocanol, mechanical ablation and MOCA using ClariVein device.. Twenty-four vein GSV specimens were obtained via traditional surgery and treated with four methods: Group A: 0.9% normal saline (NS); Group B: 3% polidocanol; Group C: mechanical ablation + 0.9% NS; Group D: mechanical ablation + 3% polidocanol (MOCA). Hematoxylin and eosin (HE), Masson's trichrome and immunohistochemical staining were performed on each specimen and integrated optical densities were measured with vWF and a-SMA stains and statistically evaluated. vWF staining was used to assess endothelial damage and a a-SMA staining was used to assess media injury.. HE and Masson's trichrome staining of Groups C and D revealed severe damage to the endothelium and media compared to Groups A and B. The statistical result of vWF staining showed the damage of endothelium was significantly increased by Group D compared to Groups A, B and C. The statistical result of a-SMA staining showed the damage of media was significantly increased by Groups C and D compared to Groups A and B.. The mechanism of MOCA was caused by both endothelium damage and media tearing. The damage of endothelium was significantly increased by MOCA when compared with mechanical ablation alone.

Topics: Ablation Techniques; Humans; Polidocanol; Saphenous Vein; Sclerotherapy; Treatment Outcome; Varicose Veins; Venous Insufficiency

Initial phase III clinical studies with polidocanol endovenous microfoam (PEM) demonstrated its safety and efficacy in the treatment of superficial venous reflux. In those studies, the primary outcome requirement was to assess the improvement in symptoms related to superficial venous disease. The goal of the present study was to evaluate the efficacy of PEM technology in routine clinical practice-specifically, the closure rates after treatment.. We performed an observational study during which data were prospectively collected from 2 vein centers using an electronic database. Patients with CEAP (clinical, etiologic, anatomic, pathophysiologic) class ≥2 and symptomatic superficial axial reflux (great saphenous vein, anterior accessory saphenous vein, and small saphenous vein) were included and followed up prospectively. PEM was used to treat the saphenous vein and varicosities. The CEAP classification was used to classify chronic venous disease, and the venous clinical severity score (VCSS) was applied to measure the disease severity. Pain and discomfort were assessed using a visual analog scale, and the residual veins were assessed by physical examination.. PEM was used to treat superficial reflux in 60 patients. The CEAP classification was C2 for 32 patients, C3 for 14, C4 for 10, and C5 for 4 patients. The average pretreatment VCSS was 7.3. The saphenous vein diameter was 6.5 mm, and the average length was 31 cm. The average volume of PEM used to treat the saphenous veins was 9.3 mL. The closure rate at 3 and 6 months was 93% (54 of 58) and 93% (51 of 55), respectively. The VCSS had improved from 7.3 to 1.4. Complications included 1 case of deep vein thrombosis (1.7%), 5 patients (8.3%) with thrombophlebitis, and 4 patients (6.6%) with skin pigmentation.. PEM is safe and effective for the treatment of saphenous reflux and varicosities. The early closure rates using PEM were maintained at 6 months and are comparable to the results reported with nonthermal, nontumescent technologies and thermal tumescent technologies.

Topics: Female; Humans; Male; Middle Aged; New Jersey; New York; Polidocanol; Prospective Studies; Saphenous Vein; Sclerosing Solutions; Sclerotherapy; Time Factors; Treatment Outcome; Varicose Veins; Venous Insufficiency

The aim of the present study was to investigate the early results of mechanochemical ablation (MOCA) for the treatment of small saphenous vein (SSV) incompetence.. We performed a single-center, retrospective analysis of a prospectively collected database of 60 patients treated with MOCA for single-axis SSV incompetence. All procedures were performed with the patient under local anesthesia using the ClariVein catheter (Merit Medical, South Jordan, Utah) combined with 2% polidocanol and, where appropriate, additional microphlebectomy. The primary study endpoint was to assess the SSV occlusion rate at the 1-, 6-, and 12-month follow-up examinations. The secondary endpoints included the Venous Clinical Severity Score, quality of life (QoL) assessment, periprocedural pain, and further complications after the intervention and during the follow-up period. Patient QoL was assessed using the Aberdeen Varicose Vein Questionnaire. Pain was measured using a 100-mm visual analog scale.. Technical success was achieved in 100% of the cases. The mean visual analog scale score on the first postoperative day was 15 mm. No major events were recorded. No neurological complications or deep vein thrombosis were observed. Minor complications included ecchymosis in 3.3% of cases (2 of 60), transient phlebitis of the SSV in 5% of cases (3 of 60), and itching in 3.3% of cases (2 of 60). At the 1-, 6-, and 12-month follow-up examinations, the occlusion rate was 100% (60 of 60), 98.3% (57 of 58), and 92.6% (50 of 54). The median Venous Clinical Severity Score had significantly decreased from 5 (interquartile range [IQR], 3-6) at baseline to 2 (IQR, 1-4) at the 1-month follow-up (P < .001), 1 (IQR, 1-2) at the 6-month follow-up (P < .001) and 1 (IQR, 0-1) at the 12-month follow-up (P < .001). The mean Aberdeen Varicose Vein Questionnaire score had improved from the baseline score of 25 ± 14.61 to 15.81 ± 13.76 at the 1-month follow-up (P < .001), to 9.81 ± 7.42 at the 6-month follow-up (P < .001) and 4.73 ± 3.32 at the 12-month follow-up (P < .001).. The results of our study have shown that MOCA is a feasible, safe, and painless procedure for the treatment of SSV incompetence with an occlusion rate of 92.6% at the 12-month examination. No sural nerve injuries or other major complications were observed. The procedure also provided good clinical results and positive effects on patient QoL.

Topics: Adult; Aged; Catheterization, Peripheral; Chronic Disease; Female; Humans; Male; Middle Aged; Pain; Polidocanol; Quality of Life; Retrospective Studies; Sclerosing Solutions; Sclerotherapy; Time Factors; Treatment Outcome; Varicose Veins; Venous Insufficiency

Thrombus extension into the deep venous system following superficial vein chemical ablation with Varithena polidocanol microfoam has been reported. The objective of this study was to assess the effect of intraoperative improved techniques during treatment for patients with symptomatic varicose veins and their impact on extension of thrombus into deep veins.. A retrospective review of a prospectively maintained database was performed. All patients who underwent endovenous chemical ablation with polidocanol microfoam (Varithena, Boston Scientific, Marlborough, Mass) for symptomatic superficial axial and tributary vein reflux were identified. Patients had postoperative duplex (48-72 hours) scanning after the procedure; those who did not adhere to the recommended follow-up were excluded. Demographic data, CEAP Classification, Venous Clinical Severity Score, procedure details, and follow-up data were abstracted.. Between April 2018 and August 2020, 157 limbs in 122 patients were treated with Varithena microfoam; 129 limbs in 99 patients met our inclusion criteria. Veins treated included the great saphenous vein (n = 89), anterior accessory saphenous vein (n = 15), small saphenous vein (n = 14), and tributary veins (n = 56). Adjunctive techniques during treatment included intraoperative elevation of the limb to greater than 45°, ultrasound mapping and digital occlusion of large perforator veins, limitation of foam volume per session, injection of sterile saline before treatment, and compression of the limb in the elevated position. The preoperative Venous Clinical Severity Score was 11.4 and decreased after treatment to 9.7. The immediate closure rate was 95% with 81% overall symptomatic relief at last follow-up. The mean follow-up was 113.5 days for the entire cohort; two limbs (1.5%) required postoperative anticoagulation for thrombus extension into the deep venous system (common femoral vein n = 1; popliteal vein n = 1) postoperatively for a mean of 22 days. Both resolved with anticoagulation. One asymptomatic limb developed a femoral vein deep venous thrombosis and one symptomatic late deep venous thrombosis was noted 4 months after the procedure. Postoperative pain and phlebitis were reported in 15.6% and 14.8% of patients, respectively, and all had resolved at last follow-up. No pulmonary emboli were noted and no neurologic or visual adverse events were recorded.. Adjunctive techniques during microfoam ablation decreased thrombotic complications in our series compared with those reported in earlier phase III clinical trials. Excellent early closure and symptomatic improvement were also noted. Endovenous microfoam ablation with Varithena is a safe and effective nontumescent, nonthermal alternative to laser and radiofrequency ablation.

Topics: Anticoagulants; Humans; Patient Positioning; Polidocanol; Retrospective Studies; Saline Solution, Hypertonic; Saphenous Vein; Sclerosing Solutions; Sclerotherapy; Ultrasonography, Doppler, Duplex; Varicose Ulcer; Varicose Veins; Venous Insufficiency; Venous Thrombosis

The varicose veins of the lower extremities showed earthworm-like dilatation and venous protrusion of the lower extremities. Polidocanol foam sclerotherapy, as a minimally invasive treatment with rapid recovery, less trauma and not easy to relapse, has achieved good results in clinical, but it is lack of evidence-based medicine. The purpose of this study is to evaluate the efficacy and safety of polidocanol in the treatment of varicose veins of the lower extremities by meta-analysis.. Chinese National Knowledge Infrastructure, Wanfang Database, Chinese Scientifific Journals Database, China Biology Medicine disc, PubMed, EMBASE database, Web of Science, and Cochrane Library will be used as search sources to conduct for randomized controlled trials of polidocanol in the treatment of varicose veins of lower extremities. The search time is set from the establishment of the database in December 2020 in this study. Two researchers independently extract, delete files, extract data and evaluate the quality. Revman software version 5.3 will be used for statistical analysis of data.. In this study, the efficacy and safety of polidocanol in the treatment of varicose veins of the lower extremities will be evaluated in terms of total effective rate, incidence of complications and recurrence rate.. This study will provide reliable evidence-based evidence for the clinical application of polidocanol in the treatment of varicose veins of lower extremities.. Private information from individuals will not be published. This systematic review also does not involve endangering participant rights. Ethical approval will not be required. The results may be published in a peer-reviewed journal or disseminated at relevant conferences.. DOI 10.17605/OSF.IO/AUR4X.

Topics: Age Factors; Humans; Lower Extremity; Meta-Analysis as Topic; Polidocanol; Postoperative Complications; Randomized Controlled Trials as Topic; Recurrence; Research Design; Sclerosing Solutions; Severity of Illness Index; Sex Factors; Systematic Review as Topic; Varicose Veins

Several treatment modalities have been postulated to improve the efficacy of varicose vein treatment. Addition of glycerine to the sclerosing material has been documented to increase its viscosity and subsequently prolong the duration of stability, in addition to the direct sclerosing effect of glycerine. This histological and immunohistochemical study investigated the efficacy of addition of glycerine 72% to sclerotherapy on the human varicose vein.. After surgical stripping of great saphenous veins, three equal segments were resected between two clamps. Specimen 1 was injected with saline only, specimen 2 was exposed to foam sclerosant 2%, and specimen 3 was exposed to a mixture of foam sclerosant 2% and glycerine 72%. All segments were left for 5min. Vein segments were then processed for histological and immunohistochemical study.. Microscopically, haematoxylin and eosin-stained specimen 1 showed endothelial swelling, cytoplasmic eosinophilia and pyknotic nuclei. The media showed sarcoplasm vacuolisation and necrosis. Specimen 3 showed hypereosinophilic sarcoplasm of the smooth muscle fibres. Oedema was less evident, with a relative decrease in the thickness of the wall compared with specimen 2. Immunohistochemically, the expression of smooth muscle actin was weak in specimen 3 compared with specimens 1 and 2. Expression of CD31 antibody was much reduced in specimen 2 which showed conserved islands of endothelial cells. By contrast, there was a complete loss of endothelial cells in specimen 3.. Addition of glycerine 72% to foam sclerosant has a more damaging effect on human vein wall.

Topics: Actins; Drug Combinations; Edema; Endothelium; Glycerol; Humans; Immunohistochemistry; Muscle, Smooth, Vascular; Platelet Endothelial Cell Adhesion Molecule-1; Polidocanol; Saphenous Vein; Sclerosing Solutions; Varicose Veins; Viscosity

To evaluate the incidence and clinical relevance of silent nontarget occlusion (NTO) of superficial and deep veins occurring after ultrasound-guided foam sclerotherapy (UGFS) that can be detected by serial duplex ultrasound scan (DUS).. This retrospective analysis evaluated the medical records of patients treated with UGFS at a private clinic in Moscow, Russia from 2015 to 2017. All patients underwent serial DUS at 1 to 2 weeks and 1, 3, 6, and 12 months after UGFS.. During the observation period, 268 patients were treated with UGFS, using physician compounded polidocanol foam 257 lower limbs of 196 patients (73%) with varicose veins who underwent DUS at 1 to 2 weeks after the last session of UGFS (inclusion time-point): 139 women and 57 men (mean age: 44.2 ± 12.2 years) with the following CEAP clinical class distribution: C2, 74.0%; C3, 20.0%; C4, 4.5%; and C5, 1.5%. NTO at the inclusion time-point occurred in 60 limbs (23.3%) of 57 patients (28.5%) and was symptomatic only in three limbs (1.2%). Most occlusions were localized in the untreated great saphenous vein trunk (. The frequency of nontarget vein occlusion after UGFS revealed by serial DUS may be as high as 23.3%. These occlusions tend to resolve within six months and are not associated with symptomatic VTE.

Topics: Adult; Aged; Electronic Health Records; Female; Humans; Incidence; Male; Middle Aged; Polidocanol; Retrospective Studies; Russia; Saphenous Vein; Sclerosing Solutions; Sclerotherapy; Ultrasonography, Doppler, Duplex; Varicose Veins; Venous Insufficiency; Venous Thrombosis

Mechanochemical endovenous ablation is a nonthermal method to ablate superficial incompetent veins. The aim of this paper was to assess short-term complications and 5-year follow-up outcomes.. This is a retrospective single-center study of data collected prospectively. We treated, in an outpatient setting, 395 primary, symptomatic, unilateral, incompetent varicose saphenous veins. No patients were treated bilaterally in the same session. The majority were great saphenous veins (92.3%), and the others were small saphenous veins. Procedures were performed with a mechanochemical endovenous occlusion catheter (ClariVein endovenous occlusion catheter; Merit Medical, South Jordan, Utah) and polidocanol 2% in liquid form.. Follow-up was available for 329 patients treated between September 2012 and September 2017 with a mean follow-up time of 20 ± 18 months (range, 6-60 months). Technical success was achieved in 99.5%; in two patients, we were unable to complete the procedures because of vein spasm leading to catheter damage and inability to infuse the sclerosant. Follow-up was performed with clinical evaluation and duplex ultrasound scan at 1 week, 1 month, 6 months, and 1 year and then once every year. The overall survival rate free from recanalization was 92.4%. Anatomic success is 94% at 1 year, 91% at 2 years, 88% at 3 years, 88% at 4 years, and 84% at 5 years. The follow-up at 5 years includes 23 patients, 5 of whom presented with recanalization; moreover, in this series, in 36% of cases, the veins completely disappeared on duplex ultrasound scan.. The ClariVein catheter is associated with a good occlusion rate, comparable with other techniques including thermal techniques, without major complications.

Topics: Ablation Techniques; Adult; Aged; Aged, 80 and over; Endovascular Procedures; Female; Humans; Italy; Male; Middle Aged; Polidocanol; Retrospective Studies; Saphenous Vein; Sclerosing Solutions; Sclerotherapy; Time Factors; Treatment Outcome; Varicose Veins; Vascular Access Devices; Venous Insufficiency; Young Adult

The aim of this study was to evaluate the safety and clinical outcomes of percutaneous sclerotherapy of venous disorders of the labia majora in patients with vascular malformations of the lower limbs.. Thirty percutaneous sclerotherapy treatments were performed over a 6-year period among 17 female patients with symptomatic venous malformation (VM) or secondary varicosis of the labia majora. Four patients were treated with sclerotherapy alone, 13 patients had additional procedures to control the VM before sclerotherapy. Polidocanol was used as sclerosant. Indications for sclerotherapy included pain, bleeding, thrombophlebitis, and swelling. Genitourinary symptoms were recorded. The number of treatments and procedure-related complications were registered. Complications were classified according to the Society of Interventional Radiology (SIR) classification system (grade A-E). The 3-month postintervention follow-up included magnetic resonance imaging, clinical examination, and a symptom-related questionnaire. If no reintervention was necessary, consultation was scheduled biannually.. All patients had local swelling and pain; only a fraction of the patients had further symptoms with bleeding or thrombophlebitis (47% each). Eight patients required reintervention. No major complications were observed; minor complications such as postprocedural swelling occurred in 29% (SIR grade A), pain occurred in 17% (SIR grade B), and skin blistering developed in 5% (SIR grade B). Upon follow-up examination after a median of 40 months, 76% showed complete relief of symptoms, and 23% reported partial relief. All patients reported a substantial reduction in pain (75% >5 points in visual analogue scale) and swelling (88% complete cessation).. Percutaneous sclerotherapy is a safe and effective treatment option of VM and secondary varicosis of the labia majora.

Topics: Adult; Child; Female; Humans; Middle Aged; Polidocanol; Regional Blood Flow; Retrospective Studies; Sclerosing Solutions; Sclerotherapy; Time Factors; Treatment Outcome; Varicose Veins; Vascular Malformations; Veins; Vulva; Young Adult

Foam sclerotherapy is the process of using an aqueous foam to deliver surfactant to a varicose vein to damage vein wall endothelial cells, causing the vein to spasm, collapse and ultimately be re-absorbed into the body. Aqueous foams are complex fluids that can exhibit a significant yield stress and high effective viscosity which depend on their composition, particularly the bubble size and liquid fraction.. To characterise the properties of foams used for varicose vein sclerotherapy and determine their effectiveness in the displacement of blood during sclerotherapy.. Foams are modelled as yield stress fluids and their flow profiles in a model vein are predicted. Values of the yield stress are determined from experimental data for three different foams using the Sauter mean of the bubble size distribution. Along with the measured liquid fraction of the foams, this information is collected into a Bingham number which entirely characterises the process of sclerotherapy.. Polydispersity in bubble size has a strong effect on the yield stress of a foam and the Sauter mean of the size distribution better captures the effects of a few large bubbles. Reducing the polydispersity increases the yield stress, and a higher yield stress results in a larger plug region moving along the vein, which is more effective in displacing blood. The width of the plug region is proportional to the Bingham number, which also has a quadratic dependence on the liquid fraction of the foam. Assuming typical values for the rate of injection of a foam, we predict that for a vein of diameter 5 mm, the most effective foams have low liquid fraction, a narrow size distribution, and a Bingham number B ≈ 4.5.. The Sauter mean radius provides the most appropriate measure of the bubble size for sclerotherapy and the Bingham number then provides a simple measure of the efficacy of foam sclerotherapy in a vein of a given size, and explains the ability of different foams to remove varicose veins. Foams containing small bubbles, with a narrow size distribution, and a low liquid fraction are beneficial for sclerotherapy.

Topics: Endothelial Cells; Humans; Polidocanol; Polyethylene Glycols; Sclerosing Solutions; Sclerotherapy; Varicose Veins

Polidocanol is an FDA-approved sclerosant indicated for treating uncomplicated spider veins and reticular veins in the lower extremities. Despite restrictions against compounding drugs that are essentially copies of FDA-approved or commercially available products, polidocanol is also available from compounding pharmacies and outsourcing facilites. Compounded drug products are not FDA-approved and have not undergone premarket FDA review for safety, effectiveness, and quality. Seven samples of polidocanol were obtained from three compounding pharmacies and analyzed using high pressure liquid chromatography. None of the samples contained the labeled concentration of polidocanol and five contained excessive levels of impurities. Since the potency and purity of compounded polidocanol injection cannot be assured, physicians who use these products should consider FDA-approved products to ensure optimal safety and efficacy.\ \ J Drugs Dermatol. 2019;18(11):1124-1127.

Topics: Chromatography, High Pressure Liquid; Drug Compounding; Humans; Polidocanol; Sclerosing Solutions; Varicose Veins

Sclerotherapy continues to be the treatment of choice for varicose veins in the legs. However, isolated treatment using microfoam or lasers requires a high number of sessions to eliminate them. In 2013, we published results about the efficacy and safety 3 years after the combined treatment with microfoam injections and subsequent application of Nd:YAG laser. The aim of this paper is to clinically evaluate the treatment of varices in a control visit after 5 years, when polidocanol microfoam is used and is immediately irradiated in the tissue with 1064-nm Nd:YAG laser beam. The outcome persistence after 5 years was studied in the legs that had received combined treatment and had been studied 3 years after treatment. Patients were contacted by phone, interviewed, and examined with echo-Doppler. Out of the 259 patients who were contacted, 221 agreed to make the appointment, although in the end, only 202 came, which meant analysing 404 legs. At 5 years, the clearance rates were very high: patients were included in class CEAP C1 showing vessels of from 0.5 to 3 mm diameter. The patients showed a high level of satisfaction. Regarding adverse effects, only 4 cases of hypopigmentation described in the previous publication persisted. Although the action mechanisms between the microfoam and the Nd:YAG laser must still be elucidated, it is notable that combining microfoam with laser exposure obtained a complete, effective treatment of legs in only 2 sessions, with high clearance rates and high level of satisfaction among patients.

Topics: Combined Modality Therapy; Female; Humans; Lasers, Solid-State; Leg; Middle Aged; Patient Satisfaction; Polidocanol; Sclerosing Solutions; Sclerotherapy; Treatment Outcome; Varicose Veins

Several sclerosing agents are used to treat chronic venous diseases. Although they do not seem to differ in terms of efficacy, their safety profiles might differ.. To compare the safety profile of sclerosing agents through an analysis of the World Health Organization pharmacovigilance database.. The authors performed a disproportionality analysis using the proportional reporting ratio (PRR) method to compare pharmacovigilance signals between each sclerosing agent among 6 adverse event syndromes of interest: hypersensitivity reactions, arterial thromboembolic disorders, venous thromboembolic disorders, cardiac arrhythmias, visual/neurological disturbances, and skin ulcerations. The cutoff for signal detection was defined by a logPRR lower boundary 95% confidence interval (CI) ≥0 and number of cases n ≥3.. Of 1,227 Individual Case Safety Reports (ICSRs) identified, after removal of ICSRs with unselected indications, the authors selected 472 reports for the analysis. The authors found that polidocanol is associated with more reporting of venous embolic/thrombotic events (logPRR = 1.38 [95% CI 1.27-1.49]), ethanolamine with the higher pharmacovigilance disproportionality signal of cardiac arrhythmias (logPRR = 0.80 [95% CI 0.51-1.09]), and STS with more reporting of allergic reactions (logPRR = 1.79 [95% CI 1.59-1.98]).. The safety profile of sclerosing agents significantly differs and should guide benefit-risk ratio assessment of such agents.

Topics: Adverse Drug Reaction Reporting Systems; Databases, Factual; Drug-Related Side Effects and Adverse Reactions; Ethanolamine; Humans; Pharmacovigilance; Polidocanol; Risk Assessment; Sclerosing Solutions; Sodium Tetradecyl Sulfate; Telangiectasis; Varicose Veins; Vascular Malformations; World Health Organization

The procedure aims to show our results with a novel nontumescent, nonthermal technique to treat varicose veins. The V-block occlusion stent is a minimally invasive device for treating reflux of the great saphenous vein (GSV). It is an office-based procedure that does not require tumescence anesthesia. The V-block stent is a self-expandable device that functions as a vein occluder and blood clot trap. Once the V-block is in place, further treatment of the saphenous vein such as ultrasound-guided sclerotherapy can be performed. The V-block device is intended to eliminate the possibility of forwarding passage of clot and sclerosant (embolization) to the deep and pulmonary circulations.. Patients were treated in an outpatient setting with the V-block occluding device. Follow-up was performed using duplex ultrasound to assess occlusion of the saphenous vein as well as the Aberdeen Varicose Vein Questionnaire and Venous Severity Scoring to determine changes in quality of life after the procedure. Patients were followed up at 1 week, 1 month, and 3 months after V-block placement. Duplex scanning was performed to confirm GSV occlusion at all follow-up visits. After deployment of the occlusion stent, a maximum of 2% polidocanol foam was injected with a double barrel syringe which simultaneously evacuated blood from the greater saphenous vein. Follow-up assessment for safety included evaluation of potential complications, device migration, and potential injury at the deployment site.. Fifty-one symptomatic subjects with documented GSV reflux were enrolled in the study. Complete occlusion of the GSV was achieved in 98% of the patients during the 7-day postprocedural visit. There was no injury at the deployment site. No migration of the V-block device was observed. No deep vein thrombosis or any other complication was recorded. One patient of the 50 patients and 51 procedures experienced an adverse event, phlebitis that resolved under conservative therapy within 4 days with no residual effect. There was a significant improvement in the Aberdeen Vein quality of life measurements and the pain scores. After 3 years, 18 patients were willing to undergo a duplex follow-up examination. The occlusion rate after 3 years was 77.8. There were no device-related complications after this period.. The study demonstrated a good safety and performance profile without any major adverse events. The primary end point of vein occlusion and obliteration was met.

Topics: Aged; Endovascular Procedures; Female; Humans; Male; Middle Aged; Polidocanol; Prosthesis Design; Quality of Life; Retrospective Studies; Saphenous Vein; Sclerosing Solutions; Sclerotherapy; Stents; Surveys and Questionnaires; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Ultrasonography, Interventional; Varicose Veins

Since the first reports on foam sclerotherapy, multiple studies have been conducted to determine the physical properties and behavior of foams, but relatively little is known about their biological effects on the endothelial cells lining the vessel wall. Moreover, a systematic comparison of the biological performance of foams produced with different methods has not been carried out yet. Herein, a 2D in vitro method was developed to compare efficacy of commercially available polidocanol injectable foam (PEM, Varithena) and physician-compounded foams (PCFs). Endothelial cell attachment upon treatment with foam was quantified as an indicator of therapeutic efficacy, and was correlated with foam physical characteristics and administration conditions. An ex vivo method was also developed to establish the disruption and permeabilisation of the endothelium caused by sclerosing agents. It relied on the quantitation of extravasated bovine serum albumin conjugated to Evans Blue, as an indicator of endothelial permeability. In our series of comparisons, PEM presented a greater overall efficacy compared to PCFs, across the different biological models, which was attributed to its drainage dynamics and gas formulation. This is consistent with earlier studies that indicated superior physical cohesiveness of PEM compared to PCFs.

Topics: Aerosols; Cells, Cultured; Endothelial Cells; Human Umbilical Vein Endothelial Cells; Humans; Models, Biological; Permeability; Polidocanol; Sclerosing Solutions; Sclerotherapy; Varicose Veins

Although foam sclerotherapy to varicose veins is now a popular treatment because of its high efficacy and safety, some neurologic complications have recently been reported. Presently, the effectiveness and safety of intravenous recombinant tissue-type plasminogen activator therapy to stroke following foam sclerotherapy remain unclear. Here, we report the case of a 68-year-old woman whose ischemic symptoms following foam sclerotherapy were treated by intravenous recombinant tissue-type plasminogen activator. After she was admitted, the venous thrombosis in her right soleus vein and a patent foramen ovale causing the right-to-left shunt were revealed. Thus, we diagnosed the ischemic symptoms were due to paradoxical embolism following foam sclerotherapy. After intravenous recombinant tissue-type plasminogen activator therapy, there was no complication and the outcome was good. Our case suggests the effectiveness and the safety of intravenous recombinant tissue-type plasminogen activator therapy to paradoxical embolism following foam sclerotherapy.

Topics: Administration, Intravenous; Aged; Embolism, Paradoxical; Female; Fibrinolytic Agents; Foramen Ovale, Patent; Humans; Polidocanol; Polyethylene Glycols; Recombinant Proteins; Sclerosing Solutions; Sclerotherapy; Stroke; Tissue Plasminogen Activator; Varicose Veins; Venous Thrombosis

Chronic venous insufficiency (CVI) is a widely prevalent condition. Saphenous venous reflux is the most common underlying pathology that leads to CVI. Endovenous thermal ablations (ETA) are the current gold standard. However, some patients present with some unique challenges making ETA less ideal. Nonthermal nontumescent therapies could be considered as alternative therapy in these patients.. DUS demonstrated reflux in the great saphenous vein (GSV), anterior accessory GSV, and/or the small saphenous vein. Pain scores and VCSS were reduced 4 days and 6 weeks after treatment. These lower scores were maintained for up to 1 year after treatment.. PEM use in C3-C6 patients resulted in successful improvement in VCSS, CVI symptoms, and wound healing among patients in whom ETA was not considered to be the optimal therapy.

Topics: Aged; Aged, 80 and over; Chronic Disease; Endovascular Procedures; Female; Hemodynamics; Humans; Male; Middle Aged; Polidocanol; Retrospective Studies; Saphenous Vein; Sclerosing Solutions; Sclerotherapy; Severity of Illness Index; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Varicose Veins; Venous Insufficiency; Wound Healing

Ultrasound-guided foam sclerotherapy (UGFS) is a low-cost and minimally invasive treatment option for varicose veins. There is a relative paucity of outcome reports.. UGFS procedures at a tertiary public hospital between 2010 and 2017 were studied. Either the great saphenous vein (GSV) or small saphenous vein (SSV) was treated. Pretreatment, in-treatment, 6-week, and 1-year post-treatment ultrasound reports were analyzed. The primary outcome was to determine whether vein diameter predicts obliteration failure.. There were 457 treatments completed in 290 patients. The GSV was targeted in 372 (81%). Mean vein diameters of the GSV were not different from those of the SSV (GSV, 5.7 mm; SSV, 6.2 mm; P = .18); 109 (24%) had a Clinical, Etiology, Anatomy, and Pathophysiology score of at least 4. Of the 457 UGFS procedures, 360 (78.8%) were for primary veins. Baseline information, including vein diameter, was not different between primary and recurrent veins. At 6 weeks, complete obliteration, partial recanalization, and complete recanalization rates were 54.9%, 29.1%, and 16%, respectively. Of those with complete obliteration at 6 weeks, the recanalization rate at 1 year was 25%. Increasing vein diameter was associated with recanalization at 1 year (obliteration, 4.9 mm; recanalization, 5.7 mm; P = .03), especially for primary veins (4.8 vs 5.8 mm; P = .009). Multivariate analysis showed similar outcome. Vein diameter of >6 mm had good specificity (88%) but poor sensitivity (43%) for predicting obliteration failure. There were 15 (3%) new-onset deep venous thromboses reported on follow-up, all of which were from treatment of primary veins (P = .049).. Only 44% of UGFS procedures were observed to have complete obliteration at 1 year after a single intervention. Significant recanalization developed at 1 year. Increased vein diameter was associated with recanalization. The impact on clinical recurrence is unknown.

Topics: Adult; Aged; Female; Humans; Male; Middle Aged; Polidocanol; Retrospective Studies; Risk Factors; Saphenous Vein; Sclerosing Solutions; Sclerotherapy; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Ultrasonography, Interventional; Varicose Veins

Background Sclerotherapy has been gaining increased acceptance and popularity as an effective therapy for the treatment of varicose veins. This attention has fed growing interest into the safety and potential complications of this procedure. There is no evidence of pulmonary complications from foam sclerotherapy in humans; however, animal studies have shown possible damage. The aim of this study is to show the changes in rat pulmonary parenchyma after the injection of 1% polidocanol Tessari foam into the peripheral vein using histological analysis of the inflammatory and fibrosis processes. Methods Twenty-four Wistar rats were divided into the following four groups: 24 h polidocanol, seven-day polidocanol, 28-day polidocanol, and control group. After the foam was injected into the lateral saphenous vein, the lungs of the rats were removed for histological analysis. Results Alveolar edema was observed in only the 24 h group (P < 0.005). Vessel thickening was observed in the seven-and 28-day groups (P < 0.001). Interstitial fibrosis was found in only the 28-day group (P = 0.006). There was no evidence of venous or arterial thrombosis in either group. Conclusion Polidocanol Tessari foam injection into rat peripheral veins causes alveolar edema, vessel thickening, and interstitial fibrosis.

Topics: Animals; Fibrosis; Humans; Inflammation; Lung; Lung Diseases; Male; Polidocanol; Polyethylene Glycols; Pulmonary Alveoli; Rats; Rats, Wistar; Saphenous Vein; Sclerosing Solutions; Sclerotherapy; Treatment Outcome; Varicose Veins; Veins; Venous Insufficiency

Fluids and drugs formulated for intravenous infusion may potentially promote the growth of microorganisms that can cause infections. The aim of this study is to test the sterility of sclerosing foam.. Polidocanol was used for the production of the foam. The Tessari method was used in order to generate the foam. The preparation was carried out both in the operating theater and in an outpatient room. A validation test with microorganisms was also performed.. The measurements showed no evident growth of microorganisms and in the validation tests the foam appeared to even display bacteriostatic and/or bactericide properties.. Sclerosing foam seems to be safe from a microbiological point of view.

Topics: Air; Air Microbiology; Drug Contamination; Female; Humans; Male; Polidocanol; Polyethylene Glycols; Sclerosing Solutions; Varicose Veins

Foam sclerotherapy is an effective treatment strategy for varicose veins and venous malformations. Foam stability varies according to foam composition, volume, and injection technique.. To evaluate the stability of polidocanol (POL) foam with the addition of hyaluronic acid (HA).. Group A: 2 mL of 1% POL + 0 mL of 1% HA + 8 mL of air; Group B: 2 mL of 1% POL + 0.05 mL of 1% HA + 8 mL of air; Group C: 2 mL of 1% POL + 0.1 mL of 1% HA + 8 mL of air. Tessari's method was used for foam generation. The half-life, or the time for a volume of foam to be reduced to half of its original volume, was used to evaluate foam stability. Five recordings were made for each group.. The half-life was 142.8 (±4.32) seconds for 1% POL without the addition of HA, 310.6 (±7.53) seconds with the addition of 0.05 mL of 1% HA, and 390.4 (±13.06) seconds with the addition of 0.1 mL of 1% HA.. The stability of POL foam was highly increased by the addition of small amounts of HA.

Topics: Arteriovenous Malformations; Drug Stability; Half-Life; Humans; Hyaluronic Acid; Polidocanol; Polyethylene Glycols; Sclerosing Solutions; Sclerotherapy; Varicose Veins

To report the outcome of a series of patients with chronic venous disease due to incompetence of the great saphenous vein (GSV) managed by ultrasound-guided foam sclerotherapy (USGFS).. Controlled clinical trial with maximum 5-year follow-up of results of USGFS of the GSV with new parameters of the procedure.. This research analyzes the results of USGFS of the GSV (395 GSV) and its tributaries in 326 patients with varicose veins of the lower extremities over the period from January 2009 to January 2014 with the following parameters of the procedure: 60° limb elevation, calf bandage, and cooled foam injection.. Ultrasound control of 395 GSV after the first injection of sclerosant from the sixth to the eighth day revealed GSV occlusion in the femoral segment with the absence of reflux in 94.9% of cases (375 GSV). After 5-year follow-up, GSV occlusion was diagnosed in 91.9% of cases.. Our improved technique of foam sclerotherapy allows improving immediate and long-term results. This technique is characterized by the low incidence of side effects and complications.

Topics: Adult; Chronic Disease; Female; Humans; Male; Middle Aged; Polidocanol; Polyethylene Glycols; Republic of Belarus; Retrospective Studies; Saphenous Vein; Sclerosing Solutions; Sclerotherapy; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Ultrasonography, Interventional; Varicose Veins; Venous Insufficiency

The problem of varicose veins in the lower leg is a common disease and associated with long-term morbidity. It has usually been treated using high ligation with stripping and endovenous ablation surgery of the great saphenous vein. The aim of this paper is to report our own series of patients treated by ultrasound guided catheter directed foam sclerotherapy for the chemical ablation of great saphenous vein.. The study involved 108 legs with symptomatic varicose veins (C2-4) secondary to great saphenous vein insufficiency. The great saphenous vein was accessed at knee level. With the method of Tessari sclerosant foam was made (2 mL 3% polidocanol and 8 mL air) and delivered along the great saphenous vein while the catheter was withdrawn. At two and fifty two weeks after treatment the patients were evaluated.. Catheter-directed foam sclerotheraphy was successfully performed in all of the patients. Venous Clinic Severity Score was reduced significantly (P<0.05). Eighty nine percent of the GSV were completely occluded, 4% were partly occluded and 7% were recanalized. No serious side-effects occurred.. Catheter-directed foam sclerotheraphy is a safe, simple and minimally invasive procedure. Patient satisfaction was good and the occlusion rate is promising after a single treatment.

Topics: Adult; Catheterization, Peripheral; Feasibility Studies; Female; Humans; Male; Polidocanol; Polyethylene Glycols; Saphenous Vein; Sclerosing Solutions; Sclerotherapy; Severity of Illness Index; Treatment Outcome; Ultrasonography, Interventional; Varicose Veins

A 23-year-old woman developed painful skin necrosis after injections with lauromacrogol 400 for varicose veins. This complication, called embolia cutis medicamentosa or Nicolau syndrome, is characterised by acute pain and necrosis of the skin, subcutaneous tissue and muscle. Surgical intervention by local excision seems to be the best therapy.

Topics: Drug Eruptions; Female; Humans; Necrosis; Polidocanol; Polyethylene Glycols; Sclerosing Solutions; Sclerotherapy; Skin; Skin Diseases; Varicose Veins

Sclerotherapy is the targeted chemical ablation of varicose veins by intravenous injection of a liquid or foamed sclerosing drug. The treated veins may be intradermal, subcutaneous, and/or transfascial as well as superficial and deep in venous malformations. The aim of this guideline is to give evidence-based recommendations for liquid and foam sclerotherapy.. This guideline was drafted on behalf of 23 European Phlebological Societies during a Guideline Conference on 7-10 May 2012 in Mainz. The conference was organized by the German Society of Phlebology. These guidelines review the present state of knowledge as reflected in published medical literature. The regulatory situation of sclerosant drugs differs from country to country but this has not been considered in this document. The recommendations of this guideline are graded according to the American College of Chest Physicians Task Force recommendations on Grading Strength of Recommendations and Quality of Evidence in Clinical Guidelines.. This guideline focuses on the two sclerosing drugs which are licensed in the majority of the European countries, polidocanol and sodium tetradecyl sulphate. Other sclerosants are not discussed in detail. The guideline gives recommendations concerning indications, contraindications, side-effects, concentrations, volumes, technique and efficacy of liquid and foam sclerotherapy of varicose veins and venous malformations.

Topics: Chronic Disease; Europe; Female; Humans; Male; Polidocanol; Polyethylene Glycols; Sclerosing Solutions; Sclerotherapy; Societies, Medical; Sodium Tetradecyl Sulfate; Varicose Veins

The results of investigation on impact of the foam form of sclerosant in experiment on 80 mongrel white rats, were presented. Sclerosing action of 0.5%, 2%, 3% solution of polydocanol in a microfoam form was studied after its infusion into lateral caudal vein of the rat. Quantity of preparation 0,5 cm3 was determined in accordance to the vein volume. Clinical and macroscopic estimation of the preparation action on internal organs and caudal rat's vein was conducted on the 10th min, every day during 1 week and on the 30th day. When the foam form of sclerosant is introduced intravenously there was not observed thrombotic complications of posterior vena cava and specific macroscopic changes in internal organs, not depending from its concentration, what witnesses security of the method, and selection of the sclerosant solution concentration must depend on the vessel diameter.

Topics: Animals; Dosage Forms; Male; Polidocanol; Polyethylene Glycols; Rats; Sclerosing Solutions; Sclerotherapy; Tail; Varicose Veins

The aim of our case series was to show the therapeutic effect and the safety of the use of polidocanol foam in ultrasound-guided sclerotherapy treatment of relatively small postoperative seromas after varicose vein surgery.. We treated six patients with postoperative seromas after varicose vein surgery that were refractory to conventional treatments including compression dressings, repeated needle aspirations and manual lymph drainage.. A complete regression of the fluid collections was seen after one and two ultrasound-guided injections of polidocanol foam into the seroma cavity in two cases, respectively. Up to five treatment sessions and up to four further needle aspirations were necessary for the remaining two patients until complete regression of the seromas. No side-effects were reported.. This is the first case series to report of the regression of postoperative seromas after varicose vein surgery induced by polidocanol foam sclerotherapy.

Topics: Adult; Aged; Female; Humans; Male; Middle Aged; Polidocanol; Polyethylene Glycols; Postoperative Complications; Sclerosing Solutions; Sclerotherapy; Seroma; Ultrasonography; Varicose Veins

According to the current guidelines for sclerotherapy hypercoagulability and thrombophilia with or without deep venous thrombosis are seen as relative contraindication for this treatment. But often such patients have an indication for a sclerotherapy. Recommendations for additional anticoagulation for sclerotherapy are missing.. In this retrospective analysis (2009 - 2010), 54 patients with deep venous thrombosis and/or pulmonal embolism in their medical history that had had foam-sclerotherapy of truncal or tributary veins with polidocanol 0.5 - 3 % without prior anticoagulation therapy were included. In addition to compression treatment (23 - 32 mmHg) for 3 weeks patients were treated with enoxaparin 40 mg once a day for 3 days after sclerotherapy. Clinical and duplex controls were conducted before every treatment and 2 - 3 weeks after the last injection.. Sclerotherapy was done on one (30/54) or on both (24/54) legs. In 2/54 legs a truncal vein and in all patients tributaries were treated. The volume per treatment session averaged 3.3 ml foam (2 - 6 ml). The patients had undergone an average of 4.9 treatments (1 - 11); altogether 262 sessions. There were no cases of deep venous thrombosis or symptomatic pulmonary embolism. In 7/262 treatments (2.7 %) symptomatic localized phlebitis occurred and in 2/262 (0.8 %) patients an ascending phlebitis beyond the sclerotherapy region was observed.. Based on current data, foam sclerotherapy can be regarded as safe in patients with anamnestic thromboembolism when co-treated with compression therapy (23 - 32 mmHg) and enoxaparin 40 mg once per day for 3 days post sclerotherapy. The current study is the first with a standardized regime. In view of the limitations of this study there should be further randomized controlled trials.

Topics: Anticoagulants; Combined Modality Therapy; Drug Administration Schedule; Enoxaparin; Humans; Polidocanol; Polyethylene Glycols; Postthrombotic Syndrome; Recurrence; Retrospective Studies; Risk Factors; Sclerotherapy; Thromboembolism; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Varicose Veins

To investigate the value of endovenous laser ablation (ELA) and concomitant ultrasound-guided foam sclerotherapy (USGFS) in patients with chronic venous insufficiency.. During a 6-year period, concomitant USGFS of the varicose veins were performed in 504 out of 610 patients who underwent ELA for truncal or perforating vein insufficiency. In these 504 patients (944 legs; bilateral in 440 patients), the incompetent veins were greater saphenous vein in 615 legs, small saphenous vein in 118 veins, perforating veins in 42 legs, and a combination of these in 169 legs. In all patients, after ELA of the incompetent veins, USGFS was performed for the remaining varicosities with 1-3% polidocanol foam. Patients were followed up clinically and with color Doppler ultrasound at 1, 6, and 12 months.. ELA was technically successful in all cases, although another venous puncture was necessary in 29 legs. Concomitant USGFS was also technically successful in all cases, but one to three additional sclerotherapy sessions were performed in 203 legs with persistent varicosities. During the follow-up, recanalization of the laser-ablated refluxing veins occurred in 16 legs (1.7%) and was treated with repeat ELA or USGFS. Major complications occurred in 1.4% of the treated legs and included skin necrosis and calf vein thrombosis.. ELA and concomitant foam sclerotherapy is feasible and effective. The procedures are associated with a low complication rate and can be performed in both legs in the same session. Concomitant use of laser and foam may potentially decrease the recanalization rate of laser-ablated vessels.

Topics: Adult; Chronic Disease; Female; Humans; Laser Therapy; Leg; Male; Polidocanol; Polyethylene Glycols; Retrospective Studies; Saphenous Vein; Sclerosing Solutions; Sclerotherapy; Treatment Outcome; Ultrasonography, Doppler, Color; Ultrasonography, Interventional; Varicose Veins

Some leg telangiectasias may be refractory to treatment, including sclerotherapy and lasers.. To describe the innovative Sclerotherapy in Tumescent Anesthesia of Reticular veins and Telangiectasias (START) approach to achieving good results in such patients, which also proves effective in treating reticular veins.. Because compression enhances the rate of success of sclerotherapy of C1 veins (telangiectasias and reticular), Ringer solution (with or without lidocaine-epinephrine) was injected subcutaneously before, during, or immediately after sclerotherapy of therapy-refractory C1 veins. This tumescence ensures an intratissular compression of the injected vessels for at least 1 hour.. In the last 6 years, we have treated more than 300 patients. Telangiectasias that had resisted several previous treatments faded or disappeared in the majority of the cases treated, but the rate of complications (pigmentation, necrosis of small areas, and tiny scars) was higher than with usual sclerotherapy.. Developed after observing the good results achieved by perioperative sclerotherapy of telangiectasias during ambulatory phlebectomy, the START technique is an effective and economic treatment of therapy-resistant telangiectasias, although because the rate of complications is higher than with usual sclerotherapy of C1 veins, it should be performed only by experienced phlebologists and only on therapy-refractory vessels.

Topics: Anesthesia, Local; Female; Humans; Leg; Male; Polidocanol; Polyethylene Glycols; Sclerosing Solutions; Sclerotherapy; Telangiectasis; Varicose Veins; Vision Disorders

The goal of this study was to investigate the laser light scattering involved in the laser irradiation process of polidocanol foam samples.. Clinical experimental results proved that exposure of tissues impregnated with foaming polidocanol to laser radiation emitted at 1064 nm improved the efficacy of the treatment. Previous absorption studies on Aethoxysclerol 2% solution before and after exposure to Nd:YAG (1064 nm) laser beam have not shown important spectral modifications of it.. To achieve the purpose of this work, we produced polidocanol foam using the Tessari method. The batch was passed between the two syringes ~40 times. The resulting foam was stable for 5-6 min. A 10 mm optical cell containing the foam sample was introduced into a home-made Raman spectroscopy system, in which the laser radiation used to excite the Raman emission was the second harmonic (532 nm) of a pulsed Nd:YAG laser beam. The detection was made by a high resolution spectrograph and ICCD camera.. The obtained Raman spectra were more intense in foam form than in simple solution. The laser light elastic scattering produced a larger optical path of the beam in the sample, and consequently, a larger absorption of it by the foam components that enhance the laser Raman scattering.. The effect of the laser light may be expanded if the polidocanol is used as foam, because then the light scattering in the tissue becomes more important and the beam absorption becomes larger.

Topics: Humans; In Vitro Techniques; Lasers, Solid-State; Polidocanol; Polyethylene Glycols; Sclerosing Solutions; Sclerotherapy; Spectrum Analysis, Raman; Varicose Veins

Foam sclerotherapy has been proven to be a safe and effective treatment for superficial venous insufficiency, but transient visual and neurologic disturbances continue to be reported. These side effects have been theorized to be related to the presence of air or gases in the sclerosing foam that results in "bubble" migration into the cerebral circulation. We present a differing hypothesis that significant amounts of endothelin are released from the treated veins, amounts capable of causing these complications.. We tested the release of endothelin 1 (ET-1) in 12 rats after sclerotherapy with sodium tetradecyl sulfate (STS) in liquid and foam preparations. In 11 human subjects, we measured ET-1 in systemic circulation and in a draining vein after foam sclerotherapy with polidocanol.. Rats treated with STS showed a significant increase in ET-1 levels 1 and 5 minutes after foam sclerotherapy. Patients treated with foam sclerotherapy showed a marked increase in ET-1 levels that correlated significantly with local ET-1 levels.. Evidence of ET-1 release represents a plausible relationship explaining neurologic and visual disturbances reported after sclerotherapy.

Topics: Analysis of Variance; Animals; Disease Models, Animal; Endothelin-1; Gases; Humans; Polidocanol; Polyethylene Glycols; Rats; Sclerosing Solutions; Sclerotherapy; Sodium Tetradecyl Sulfate; Varicose Veins

Foam sclerosants are widely used in sclerotherapy and have been accepted as more effective than the liquid form; however, there is no consensus about the most applicable and effective concentration.. The aim of this study was to investigate the histopathological changes caused by various widely used concentrations of foam sclerosant.. Fifty-six varicose vein segments of 5-10 mm diameter were gently resected and exposed to various concentrations of foam sclerosant (0.5%, 1%, 2%, 3%) for 5 min, and were then prepared for routine histopathological examination. A total damage scoring system, including the presence of endothelial swelling, intimal thickening, cellular vacuolization in the muscle layer, edema in the tunica media and extent of necrosis, was established.. The total damage score of the foam sclerosant groups was significantly higher than that of the control group (median 2.75 vs 1, p = 0.007). The highest damage score was achieved by 1% and 2% foam sclerosants (3.5 and 2.5). No significant difference was found among the different concentrations of sclerosant, although the 1% group caused more severe damage at a near significant level (p = 0.074).. Significant pathological damage can be caused by even the lowest doses of foam sclerosant. The most injurious concentrations were found to be 1% and 2%, morphologically. A working concentration of 1% could thus be preferable to 0.5%, especially in larger veins. Further in-vivo studies are needed in order to validate these findings.

Topics: Dose-Response Relationship, Drug; Humans; Necrosis; Polidocanol; Polyethylene Glycols; Sclerosing Solutions; Sclerotherapy; Varicose Veins; Veins

Foam generated by manual agitation of liquid sclerosant with air or gas is routinely utilized to treat refluxing veins. Although generally well tolerated, serious neurological events have been reported. The composition and properties of the foam, including bubble size and gaseous components, may contribute to the potential for microcirculatory obstruction and cerebral ischemia. We tested an ultra-low nitrogen polidocanol endovenous microfoam with controlled bubble size and density and hypothesized that patients at risk due to the presence of middle cerebral artery (MCA) bubble emboli during microfoam injection would not demonstrate evidence of clinical or subclinical cerebral infarction.. Patients with great saphenous vein incompetence were treated with ultra-low nitrogen (≤ 0.8%) polidocanol endovenous microfoam injected under ultrasound guidance. Patients with right-to-left shunt were included to evaluate the safety of cerebral arterial bubbles. All patients with MCA emboli detected by transcranial Doppler during endovenous microfoam ablation received intensive surveillance for microinfarction, including brain magnetic resonance imaging and measurement of cardiac troponin-I.. MCA bubble emboli were detected in 60 of 82 treated patients; 22 patients had no detectable emboli. Among patients with MCA bubbles detected, 49 (82%) had ≤ 15 bubbles. No patients developed magnetic resonance imaging abnormalities, neurological signs, or elevated cardiac troponin.. Patients treated with foamed liquid sclerosants are commonly exposed to cerebrovascular gas bubbles. In this series of 60 high-risk patients with MCA bubble emboli during or after treatment with ultra-low nitrogen polidocanol endovenous microfoam, there was no evidence of cerebral or cardiac microinfarction. The results of this study cannot be generalized to foams compounded using bedside methodologies, since the composition of these foams is substantially different.

Topics: Adolescent; Adult; Cerebral Infarction; Embolism, Air; Endovascular Procedures; Female; Humans; Intracranial Embolism; Magnetic Resonance Imaging; Male; Middle Aged; Middle Cerebral Artery; Myocardial Infarction; Polidocanol; Polyethylene Glycols; Saphenous Vein; Sclerosing Solutions; Sclerotherapy; Ultrasonography, Doppler, Duplex; Ultrasonography, Doppler, Transcranial; Ultrasonography, Interventional; Varicose Veins; Young Adult

Topics: Anemia; Colonoscopy; Endoscopy, Digestive System; Gastrointestinal Hemorrhage; Humans; Iron; Jejunum; Male; Middle Aged; Polidocanol; Polyethylene Glycols; Sclerotherapy; Varicose Veins

Topics: Cerebral Infarction; Embolism, Air; Endovascular Procedures; Humans; Polidocanol; Polyethylene Glycols; Saphenous Vein; Sclerosing Solutions; Sclerotherapy; Ultrasonography, Doppler, Duplex; Ultrasonography, Interventional; Varicose Veins

The bleeding from various veins can be intense and may be mistaken for arterial haemorrhage. Several fatal cases are reported due to delay of treatment and inappropriate first aid. We describe five cases of haemorrhage from varicose veins that were treated with foam sclerotherapy. Polidocanol foam was injected in the various veins using ultrasound guidance. There was no recurrence of haemorrhage in any patient during the 17.4 months follow-up period. Foam sclerotherapy can be performed easily in an out-patient clinic setting. This method is an ideal therapy for haemorrhage from varicose veins because it mitigates problematic varicose veins.

Topics: Adult; Aged; Female; Hemorrhage; Humans; Male; Middle Aged; Polidocanol; Polyethylene Glycols; Sclerosing Solutions; Sclerotherapy; Varicose Veins

Duplex ultrasound guidance of foam sclerotherapy has been established as a routine and standard treatment of varicose veins, but duplex-guided technique is not perfect because of its inherent shortcomings, and correlative complications have been reported. Moreover, not every country or region of the world can use duplex ultrasound guidance for foam sclerotherapy.. To describe an original technique of using radiologically guided foam sclerotherapy for the treatment of leg varicose veins and to evaluate the technical feasibility and early results.. Fifty-nine legs of 41 patients (23 male, 18 female; median age 47, range 25-75) with leg varicose veins treated using radiologically guided foam sclerotherapy were assessed. Polidocanol 1% was foamed 1:4 with air using the Tessari method. Foam sclerotherapy of the superficial varicosities and the great saphenous veins (GSVs) were performed using the filling-defects technique under radiologic guidance. Postoperative compression was maintained for 15 days. Clinical outcome was assessed according to clinical criteria.. The procedure was technically successful in all 59 legs. At a median 9.0 months (range 6-12 months) of follow-up, the clinical outcome was full success in 53 legs (89.8%), and partial success in six legs (10.2%). There was no evidence of recurrence of varices or GSV reflux during follow-up. Minor complications included skin pigmentation in 27 legs (45.8%), and superficial thrombophlebitis in 18 legs (30.5%). No major complications or systemic events occurred.. Radiologically guided foam sclerotherapy could be a safe, effective, and technically feasible treatment for varicose veins.

Topics: Adult; Aged; Angiography, Digital Subtraction; Compression Bandages; Female; Fluoroscopy; Humans; Male; Middle Aged; Polidocanol; Polyethylene Glycols; Retrospective Studies; Saphenous Vein; Sclerosing Solutions; Sclerotherapy; Treatment Outcome; Varicose Veins

Ultrasound-guided foam sclerotherapy is increasing in popularity as a method to treat varicose veins of the lower extremities. In 2001, we began using ultrasound-guided foam sclerotherapy to treat varicose veins of the lower extremities. The outcomes of our treatment are described in this study.. One hundred four patients underwent ultrasound-guided foam sclerotherapy for 138 extremities over a 5-year period, from January 2004 to December 2008, at Tokyo Women's Medical University Hospital. The outcomes were studied retrospectively using chart review. The average age, sex, and recurrence rates were calculated. At 24 months after treatment, the primary and secondary success rates were analyzed.. The mean age of the patients was 63.2; 30 (22%) were male. Twenty-five (27%) patients had recurrences in 35 (34%) extremities. At 24 months, the primary success rate was 62.2%, and the secondary success rate was 75.8%.. None of the patients experienced adverse events. The recurrence rates were slightly higher than those of other published data, which may be due to the lower dose of foam used in GSV. In summary, ultrasound-guided foam sclerotherapy can be easily and effectively performed in an outpatient clinical setting. The authors have indicated no significant interest with commercial supporters.

Topics: Adult; Aged; Aged, 80 and over; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Polidocanol; Polyethylene Glycols; Recurrence; Retrospective Studies; Sclerosing Solutions; Sclerotherapy; Treatment Outcome; Ultrasonography, Interventional; Varicose Veins

Sclerotherapy with foam is becoming increasingly popular for the treatment of varicose veins. There is no consensus on the necessity of sterile air or other gases to produce foam.. To evaluate the potential risk of bacterial inoculation of polidocanol (POL) foam using room air and the antimicrobial properties of polidocanol.. The amount of airborne microorganisms was quantitatively measured. Four bacterial strains were tested for susceptibility to polidocanol: Staphylococcus aureus, Staphylococcus epidermidis, Pseudomonas aeruginosa, and Streptococcus pyogenes.. Air measurements varied as a result of air movement and the number of people in the room. Although the risk of introducing one colony-formin unit can be calculated as less than 1 in 330, the clinical relevance is still to be determined. No inhibition of bacterial growth was achieved with POL in of any of the tested strains.. Foam sclerotherapy with POL prepared in a standard treatment room is a safe procedure without the risk of introducing a severe bacterial complication. The use of sterile air, nitrogen, or carbon dioxide is unnecessary and will make foam sclerotherapy with POL more elaborate and more expensive to use.

Topics: Air Microbiology; Bacterial Infections; Colony Count, Microbial; Humans; Microbial Sensitivity Tests; Polidocanol; Polyethylene Glycols; Pseudomonas aeruginosa; Sclerosing Solutions; Sclerotherapy; Staphylococcus aureus; Staphylococcus epidermidis; Sterilization; Streptococcus pyogenes; Varicose Veins

How foam is created for sclerotherapy varies and is not standardized. Moreover, the effect of several factors on the quality of the foam is not well studied.. To investigate the effects of different parameters on foam stability and bubble size.. As a measure of foam stability, foam half time (FHT) and bubble size distribution were determined for various parameters (polidocanol (POL) concentration, freshness of the POL, syringe size, liquid-to-air ratio, number of pump cycles, and needle size) in the foam creation process.. FHT was 115 to 157 seconds for POL 1% and 143 to 192 seconds for POL 3%. The other parameters had a limited effect on FHT. POL foam 1% (t=0 seconds) had a mean bubble size of 71 ± 9 μm that increased when the foam was maintained horizontally in the syringe: 102 ± 12 μm) at 30 seconds and 121 ± 20 μm at 60 seconds. The other parameters had no significant influence on bubble size distribution.. Higher concentration of POL and rapid injection optimize foam stability and bubble size distribution, but other important foam characteristics are largely independent of differences in the generation and injection of foam. The authors have indicated no significant interest with commercial supporters.

Topics: Humans; Injections; Polidocanol; Polyethylene Glycols; Sclerosing Solutions; Sclerotherapy; Syringes; Varicose Veins

Bleeding of parastomal varices is an unusual complication of portal hypertension. We report a case with recurrent parastomal variceal bleeding who had chronic liver disease secondary to autoimmune hepatitis and who had undergone abdominoperineal resection for rectal cancer. She presented four episodes of parastomal variceal bleeding in one month and was successfully treated with combined polidocanol and cyanoacrylate glue.

Topics: Colostomy; Cyanoacrylates; End Stage Liver Disease; Female; Hepatitis, Autoimmune; Humans; Polidocanol; Polyethylene Glycols; Rectal Neoplasms; Recurrence; Tissue Adhesives; Varicose Veins

With the recent US Food and Drug Administration (FDA) approval of polidocanol in the United States, there has been a resurgence of interest in sclerotherapy. Despite the popularity of laser therapy, sclerotherapy remains the gold standard for treating spider and reticular veins. Although this traditional method of treatment has been around for more than 100 years, better sclerosing agents and newer techniques have made sclerotherapy safer and more efficacious than ever before. This article is a primer for physicians interested in updating their skills in sclerotherapy. It reviews common sclerosants, sclerotherapy techniques, patient evaluation, complications, and recent advancements in sclerotherapy.

Topics: Algorithms; Contraindications; Humans; Polidocanol; Polyethylene Glycols; Saphenous Vein; Sclerosing Solutions; Sclerotherapy; Stockings, Compression; Thrombophlebitis; Varicose Veins

Varicose veins are common and increasingly are being treated by less invasive endoscopic methods such as foam sclerotherapy. Patent foramen ovale (PFO) is also common, present in approximately one-quarter of adults. PFO allows bubbles introduced by foam sclerotherapy to cross into the general circulation, potentially causing cerebral artery gas embolization with unevaluated consequences.. Men and women aged 18 to 60 years with symptomatic varicose veins (CEAP C(3-5)) responded to an advertisement to recruit volunteers for a study on endovenous microfoam ablation (EMA). Participants' veins were screened by duplex ultrasound imaging, and those with isolated great saphenous vein (GSV) incompetence were tested for right-to-left (R-L) vascular shunt using transcranial Doppler (TCD) of the middle cerebral artery to detect the presence of bubble emboli after an injection of an agitated saline, blood, and air mixture as a contrast at rest and with the Valsalva maneuver.. Of 221 participants tested for R-L shunt, 85 (38.5%) were positive at rest (95% confidence interval [CI], 32.5-45.2) and 114 (51.8%) were positive after the Valsalva maneuver (95% CI, 45.4-58.5). A total 130 patients (58.8%) were positive for R-L shunt at rest or after Valsalva (95% CI, 52.5%-65.1%). This is significantly higher than the reported 26% prevalence of PFO in the general population (95% CI, 24.4-30.1).. The prevalence of R-L shunt in patients with GSV incompetence CEAP C(3-5) in this study was higher than expected in the general population. TCD does not differentiate between intracardiac shunts and intrapulmonary shunts, so this observation needs further investigation. This link between R-L shunt and varicose veins is novel and, whether etiologic or functional, may improve the understanding of both conditions. The findings have importance in the treatment of varicose veins with foam sclerotherapy and EMA.

Topics: Adult; Coronary Circulation; England; Female; Foramen Ovale, Patent; Humans; Intracranial Embolism; Male; Middle Aged; Polidocanol; Polyethylene Glycols; Prevalence; Pulmonary Circulation; Regional Blood Flow; Saphenous Vein; Sclerosing Solutions; Sclerotherapy; Severity of Illness Index; Ultrasonography, Doppler, Duplex; Ultrasonography, Doppler, Transcranial; United States; Valsalva Maneuver; Varicose Veins; Venous Insufficiency; Young Adult

Topics: Adult; Dermatitis; Female; Humans; Polidocanol; Polyethylene Glycols; Recurrence; Sclerosing Solutions; Sclerotherapy; Ultrasonography; Varicose Veins

Foam sclerotherapy is a safe, effective and increasingly widespread method of treating varicose veins. A case of ischemic stroke is described with reversible symptoms five days after polidocanol foam sclerotherapy was repeated in a 48-year-old female patient with a patent foramen ovale that was undetected at the time of sclerotherapy. The first foam sclerotherapy treatment had been tolerated well without complications. While acute neurological events immediately after sclerotherapy for varicose veins have been described repeatedly in the literature, this report is only the third case described worldwide of paradoxical embolism as a possible late complication of foam sclerotherapy for varicose veins.

Topics: Embolism; Female; Humans; Middle Aged; Polidocanol; Polyethylene Glycols; Sclerotherapy; Stroke; Tissue Adhesives; Ultrasonography; Varicose Veins; Venous Insufficiency

Although foam sclerotherapy of varicose tributaries is common in daily practice, scientific evidence for the optimal sclerosant-concentration and session-frequency is still low. This study aimed to increase the knowledge on foam sclerotherapy of varicose tributaries and to evaluate the efficacy and safety of foam sclerotherapy with 0.5 % polidocanol in tributaries with 3-6 mm in diameter.. Analysis of 110 legs in 76 patients. Injections were given every second or third day. A maximum of 1 injection / leg and a volume of 2 ml / injection were administered per session. Controls were performed approximately 6 months and 12 months after the start of therapy.. 110 legs (CEAP C2-C4) were followed up for a period of 14.2 +/- 4.2 months. Reflux was eliminated after 3.4 +/- 2.7 injections per leg. Insufficient tributaries were detected in 23.2 % after 6.2 +/- 0.9 months and in 48.2 % after 14.2 +/- 4.2 months, respectively. Only 30.9 % (34 / 110) of the legs required additional therapy. In 6.4 % vein surgery was performed, in 24.5 % similar sclerotherapy was repeated. Significantly fewer sclerotherapy-sessions were required compared to the initial treatment (mean: 2.3 +/- 1.4, p = 0.0054). During the whole study period thrombophlebitis (8.2 %), hyperpigmentation (14.5 %), induration in the treated region (9.1 %), pain in the treated leg (7.3 %) and migraine (0.9 %) occurred. One patient with a history of thrombosis developed thrombosis of a muscle vein (0.9 %). After one year there were just hyperpigmentation (8.2 %) and induration (1.8 %) left. No severe adverse effect occurred.. Foam sclerotherapy with injections of 0.5 % polidocanol every 2nd or 3rd day, is a safe procedure for varicose tributaries. The evaluation of efficacy is difficult, as it can hardly be said whether the detected tributaries in the controls are recurrent veins or have recently developed in the follow-up period. The low number of retreated legs indicates a high efficacy and satisfaction of the patients.

Topics: Aged; Female; Humans; Injections, Intravenous; Male; Middle Aged; Polidocanol; Polyethylene Glycols; Retrospective Studies; Sclerosing Solutions; Sclerotherapy; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Varicose Veins

To determine the incidence of side effects following treatment of varicose veins with carbon dioxide-oxygen (CO(2)/O(2)) foam sclerotherapy, and to compare results with historical controls using CO(2)- or air-based foams.. Cohort study with prospective data collection, private clinic setting.. The patient population consisted of one hundred patients, 95% women, age 52 SD 13 years-old, CEAP class C(2)EpAsPr.. Patients underwent ultrasound-guided foam sclerotherapy following thermal ablation of saphenous trunks; 1-3% polidocanol and 70%CO(2)-30%O(2) gas were mixed in a 1:4 proportion. Volume injected averaged 22 SD 11 (range: 2-46) mL. Vital signs were monitored for 1 h; side effects were recorded up to 24 h post treatment. Incidence of side effects was compared to CO(2)- and air-based foam data.. Heart rate decreased from 73 SD 11 at the start to 68 SD 9 bpm (p < 0.001, paired t-test) following the procedure. Systolic and diastolic pressures, 127/75 SD 18/14 mmHg, respiratory rate, 15 SD 4 rpm and pO(2), 98 SD 2%, did not change significantly. Itching (7) or leg pain (24) reporting was similar to that for air-based foam (p = NS). Lack of reported chest tightness and/or dry cough was superior to our previous data with CO(2) or air foam (p < 0.05). Reporting of dizziness (1) was less than that for air-based foam (p = 0.002). The incidence of visual disturbance (2%), was comparable with that for CO(2) (3%) or air (8%) foam, but too few cases were available for meaningful statistical analysis.. Foam sclerotherapy using CO(2)/O(2) foam was well tolerated by patients and resulted in fewer side effects than similar treatment using air foams.

Topics: Adult; Aged; Carbon Dioxide; Female; Humans; Lower Extremity; Male; Middle Aged; Oxygen; Polidocanol; Polyethylene Glycols; Prospective Studies; Sclerosing Solutions; Sclerotherapy; Time Factors; Treatment Outcome; Ultrasonography, Interventional; Varicose Veins

Sclerotherapy involves the injection of a sclerosing agent for the elimination of intracutaneous, subcutaneous, and transfascial varicose veins.. To update guidelines for sclerotherapy of varicose veins.. The guidelines for sclerotherapy of varicose veins of the German Society of Phlebology were updated and modified through a review of the available literature.. Published clinical series and controlled clinical trials provide evidence to support the elimination of intracutaneous and subcutaneous varicose veins using sclerotherapy. Allergic skin reactions occur occasionally as allergic dermatitis, contact urticaria, or erythema. Anaphylaxis is rare. Transient migraine headaches present more frequently in patients treated with foam sclerotherapy than liquid sclerotherapy.. Sclerotherapy is the method of choice for the treatment of small-caliber varicose veins (reticular varicose veins, spider veins). If performed properly, sclerotherapy is an efficient treatment method with a low incidence of complications.

Topics: Contraindications; Germany; Humans; Polidocanol; Polyethylene Glycols; Sclerosing Solutions; Sclerotherapy; Varicose Veins

AIMS Short- and mid-term side effects of sclerotherapy, in particular with polidocanol (lauromacrogol 400), have been previously described in our registry of 12,173 sessions. The objective of this follow-up registry was to evaluate the long-term incidence of adverse events with polidocanol.. The physicians involved in the initial French registry were contacted and asked to partake in the follow-up survey. Initially included patients were controlled at the latest possible date to determine whether a complication had occurred after the end of the initial survey.. Data on 1,605 patients included in the French registry were reviewed with a maximum follow-up of 60 months, covering 3,357 patient years. Five (0.4%) adverse events were observed in patients treated with liquid polidocanol and 46 (1.1%) in patients treated with polidocanol foam. The most frequent side effects were visual disturbances (n=14), and the most severe were muscular vein thrombosis (n=8). The onset of side effects was mostly observed directly after sclerotherapy or in the 6 months after (84% in the first year). One deep vein thrombosis recurrence occurred in a patient with heterozygote Factor V Leiden after stopping anticoagulant treatment (foam sclerotherapy).. Foam sclerotherapy is a recognized reference method in the treatment of varicose veins of all types. This study demonstrates that polidocanol is a safe sclerosing agent in the short and long term.

Topics: Adverse Drug Reaction Reporting Systems; Female; France; Humans; Incidence; Longitudinal Studies; Male; Polidocanol; Polyethylene Glycols; Registries; Sclerosing Solutions; Sclerotherapy; Telangiectasis; Varicose Veins

To evaluate the technical feasibility and preliminary results of endovenous foam sclerotherapy using a microcatheter in varicose tributaries followed by endovenous laser treatment (EVLT) of incompetent saphenous veins.. From July 2005 to August 2006, 312 patients (M:F=139:173, mean age 45.8) who presented with varicose veins with reflux in the saphenofemoral, saphenopopliteal junction or tributaries were enrolled. Under ultrasound or fluoroscopy guidance, selective microcatheterization and endovenous foam slcerotherapy were first performed in varicose tributaries, followed by EVLT (980 nm) of incompetent saphenous veins. Follow-up at 1-week and 1-, 3-, and 6-month intervals was done.. Technical success was seen in 410 of 411 limbs (99%). Continued closure of the saphenous veins and the complete sclerosis of varicose tributaries were noted in 332 of 373 limbs (89%) at the 1-month follow-up, all 307 limbs (100%) at the 3-month follow-up, and all 274 limbs (100%) at the 6-month follow-up. No serious complication was noted.. Endovenous foam sclerotherapy using a microcatheter in varicose tributaries followed by EVLT in incompetent saphenous veins is a safe, effective, and technically feasible treatment for varicose veins. It not only reduces additional sclerotherapy and technical failure, but also makes multiple therapeutic sessions unnecessary.

Topics: Adult; Aged; Angioscopy; Catheterization, Peripheral; Equipment Design; Feasibility Studies; Female; Fluoroscopy; Follow-Up Studies; Humans; Low-Level Light Therapy; Male; Middle Aged; Miniaturization; Phlebography; Polidocanol; Polyethylene Glycols; Retrospective Studies; Saphenous Vein; Sclerosing Solutions; Sclerotherapy; Tissue Adhesives; Treatment Outcome; Varicose Veins; Young Adult

Foam sclerotherapy of varicose veins has recently proven to be an effective, economic and safe treatment modality. The present study attempts to evaluate the haemodynamic changes after sclerotherapy in addition to the clinical results.. In a prospective observation trial, 67 sites (2/3 of which were recurrent varicose [RV] veins after previous treatment) in 53 patients were treated with polidocanol foam, and the results were assessed clinically, by duplex, photoplethysmography and strain gauge plethysmography.. With the exception of two sites (3.0%), all treatments resulted at least in an improvement, and about 80% of the treated veins were completely occluded as demonstrated by duplex ultrasound examination. The haemodynamical results accordingly reflected a significant improvement of the venous function. Patients with post-thrombotic syndrome showed poorer results.. Foam sclerotherapy is a highly effective and safe method for the treatment of primary and RV veins.

Topics: Aged; Female; Hemodynamics; Humans; Male; Middle Aged; Plethysmography; Polidocanol; Polyethylene Glycols; Prospective Studies; Sclerosing Solutions; Sclerotherapy; Treatment Outcome; Varicose Veins; Veins

A 37-year-old male was treated with 9 ml of 3% polidocanol foam, and he immediately reported photopsiae lasting a few minutes, though without migraine. Two hours after sclerotherapy, the patient developed speech disturbance for a few minutes. A pathological examination revealed nothing except a patent foramen ovale (PFO). Given the contrast between the high prevalence of PFO in general population and the extremely low incidence of neurological deficits after foam sclerotherapy, these deficits may only arise due to as-yet-unknown aetiology.

Topics: Adult; Foramen Ovale, Patent; Humans; Male; Polidocanol; Polyethylene Glycols; Risk Factors; Sclerosing Solutions; Sclerotherapy; Speech Disorders; Stockings, Compression; Ultrasonography, Doppler, Duplex; Ultrasonography, Interventional; Varicose Veins; Vision Disorders

The authors herein share their experience gained in comprehensive treatment of patients diagnosed with lower-limb varicose disease treated by means of one the most state-of-the-art technologies, i. e., radiofrequency ablation. The work deals with the outcomes of managing a total of seventy-eight patients suffering from lower-limb varicose diseases with valvular insufficiency of the great saphenous vein. All the patients were subjected to radiofrequency ablation of the compromised great saphenous vein by means of the portable radiofrequency device "Surgitron" manufactured by the Company "Ellman International" (USA). Examination included ultrasonographic duplex and triplex scanning of the veins of the lower extremities. Intraoperative radiofrequency ablation of the great saphenous vein was performed by means of an original appliance consisting of a metallic probe whose length corresponded to that of the lower extremity concerned, with a figure-of-eight olive at the distal end and external plastic tube catheter. The construction of the probe made it possible to maximally free the great saphenous vein from blood through the lateral ports of the catheter, to reduce the risk of complications, to diminish the duration of the intervention, and to increase its effectiveness. Efficacy of radiofrequency ablation of the great saphenous vein amounted to 93.6%, with recanalization of the greater saphenous vein being established in five (6.4%) patients. Good functional and cosmetically pleasing therapeutic outcomes were observed in the majority of the patients (87.2%).

Topics: Adult; Catheter Ablation; Combined Modality Therapy; Female; Humans; Male; Middle Aged; Patient Satisfaction; Polidocanol; Polyethylene Glycols; Saphenous Vein; Sclerosing Solutions; Sclerotherapy; Time Factors; Treatment Outcome; Ultrasonography, Doppler; Varicose Veins; Venous Insufficiency

Topics: Embolism, Air; Foramen Ovale, Patent; Heart Diseases; Humans; Intracranial Embolism; Polidocanol; Polyethylene Glycols; Sclerosing Solutions; Sclerotherapy; Varicose Veins

Topics: Biopsy; Female; Humans; Middle Aged; Patch Tests; Polidocanol; Polyethylene Glycols; Sclerosing Solutions; Skin; Urticaria; Varicose Veins

To study the short term results of combined peroperative foam sclerotherapy (PFS) and surgical treatment for recurrent varicose veins.. PFS was used to treat 129 limbs with recurrent varices: 100 great saphenous (GSV), 29 small saphenous veins (SSV). Foam was prepared with 1% polidocanol mixed with 4 times its volume of air. The 100 GSVs comprised 28 trunks directly connected with the femoral vein, 28 connected to a lymph node venous network, 11 associated with perforators and 33 isolated trunks. The 29 SSVs comprised 4 trunks directly connected to the popliteal vein, 7 isolated trunks, 15 popliteal perforators and 3 recanalisations after SSV stripping. All operations included phlebectomies. In twenty limbs re-ligation of the SFJ and 4 SPJs was carried out. All were performed under local anaesthesia in an ambulatory setting. Patients were assessed clinically and by colour duplex ultrasound after 3 and 40 days follow-up.. 120 patients (93%) showed complete obliteration of saphenous trunks, junctions and varices. The 9 incomplete obliterations were 3 venous recanalisations in the SSV compartment and 6 perforators (4 popliteal and 2 femoral). Two asymptomatic deep venous thromboses were detected by colour duplex 3 days after operation.. PFS facilitates surgical treatment of recurrent varicose veins. There is a small risk of post-operative deep vein thrombosis.

Topics: Adult; Aged; Combined Modality Therapy; Female; Humans; Male; Middle Aged; Polidocanol; Polyethylene Glycols; Recurrence; Saphenous Vein; Sclerosing Solutions; Sclerotherapy; Treatment Outcome; Varicose Veins

The author began to deal with injection sclerotherapy 25 years ago, which is still being practised by him to this day.. Experience is drawn from 115 000 injections given to 4025 limbs of 3107 patients. The mean age is 41.7 years, 80.3% of patients were women.. For decades, medicines necessary for sclerotherapy (polidocanol, tetradecylsulphate) have been available in Hungary. At the same time diagnosis and method have developed both abroad and in Hungary. Instead of the previously used standard standing position, the patient is either sitting or lying during the puncture. The diameter of the needle used is smaller than earlier. Previously at the injection the patient was lying and her leg was raised, but now usually she is in the same position as during the puncture. The amount of given medicine at one session was 1 x 0.2 ml, later 4 and 6 x 0.5 ml, but now the allowed maximal dosage is 28 ml 0.5%.. Treatments were successful in every case and there were not any serious complications. This method has an outstanding importance in the treatment of intracutaneous venectases and reticular varicosis but side branches and perforators can be cured as well. As is well known, varicosity is a progressive disease and the sclerotherapy can be repeated unrestricted. It is therefore suitable for its treatment in the long run. Strong reactions and complications: The most common strong reactions are fainting, suffusion, phlebitis and pigmentation at the site of the injection.. Very rarely blistering, allergic reaction and deep venous thrombosis. The latter is highly focused, therefore the patient's thrombophilic history is revealed. The authors' results and the survey in Hungary showed 1.5% complication in treated patients including one non serious deep venous thrombosis. The recently introduced ultrasound-guided foam sclerotherapy of the leg is suitable for the injection of stem varicosities. Successful treatments were carried out not only in the lower leg but also in upper limb varicosities, vascular malformations, venous lake of the lip and hemorrhoidal nodes. The sclerotherapy and operation rather supplement each other than compete.. Sclerotherapy has proved to be suitable for the therapy of lower limb varicosity and some other venous dilatations.

Topics: Adult; Aged; Aged, 80 and over; Contraindications; Disease Progression; Female; Humans; Injections, Intravenous; Lower Extremity; Male; Middle Aged; Polidocanol; Polyethylene Glycols; Retreatment; Retrospective Studies; Saphenous Vein; Sclerosing Solutions; Sclerotherapy; Sodium Tetradecyl Sulfate; Time Factors; Treatment Outcome; Ultrasonography; Varicose Veins

The aim was to explore the current experience and practice of vascular surgeons in the United Kingdom and Ireland regarding foam sclerotherapy for varicose veins.. A postal questionnaire was sent to 609 members of the Vascular Society of Great Britain and Ireland.. There were 281 responses (47%). Seventy surgeons (25%) used foam sclerotherapy. Most use it selectively; few (29%) offer it to all patients. It was more likely to be used for recurrent varices (71%), in older patients (61%) and for smaller non-saphenous varices (67%). The majority of surgeons (69%) used sodium tetradecyl sulphate and up to a maximum of 10-12 ml of foam. The majority used ultrasound guidance (95%), leg elevation (69%) and direct pressure over the saphenofemoral or saphenopopliteal junction during injection (63%). Eighty per cent used compression bandaging after treatment, usually for 7 days (44%). Ninety percent advised compression stockings, usually Class II (64%) for 14 days (39%). Serious complications were few, but eleven surgeons had seen a deep vein thrombosis, two had seen a patient with a stroke and one a transient ischaemic attack.. Foam sclerotherapy was used by a quarter of surgeons who replied to the survey. Aspects of technique varied considerably and studies to determine optimal techniques are needed. Serious complications with the technique were rare.

Topics: Cerebrovascular Disorders; Health Care Surveys; Humans; Ireland; Patient Selection; Polidocanol; Polyethylene Glycols; Practice Patterns, Physicians'; Sclerosing Solutions; Sclerotherapy; Societies, Medical; Sodium Tetradecyl Sulfate; Stockings, Compression; Surveys and Questionnaires; United Kingdom; Varicose Veins; Venous Thrombosis; Vision Disorders

Topics: Adult; Dosage Forms; Dose-Response Relationship, Drug; Double-Blind Method; Female; Follow-Up Studies; Humans; Male; Middle Aged; Polidocanol; Polyethylene Glycols; Radiography; Randomized Controlled Trials as Topic; Saphenous Vein; Sclerosing Solutions; Sclerotherapy; Ultrasonography, Interventional; Varicose Veins

Over the past decade, there has been a renewed interest in venous disease by the vascular community. This is predominantly because of new advances in endovenous treatment and practice economics. To broaden the services provided, vascular surgeons want to learn about sclerotherapy. Most commonly used for cosmetic concerns, it also plays a role in the broad spectrum of venous pathology treatment. The supplies and equipment needed with an overview of available sclerosants are discussed. Basic techniques and compression therapy are reviewed. This article will serve as a basic primer for successfully adding sclerotherapy to your practice.

Topics: Detergents; Humans; Polidocanol; Polyethylene Glycols; Sclerosing Solutions; Sclerotherapy; Telangiectasis; Varicose Veins

The authors have analyzed the strategy and results of treatment of varicose disease of lower extremities in 452 patients on an outpatient basis. It was shown that the Troyanov-Trendelenburg operation should be used as the first stage of treatment, and sclerotherapy should be carried on after the 4th day.

Topics: Ambulatory Care; Endothelium, Vascular; Follow-Up Studies; Humans; Injections, Intravenous; Middle Aged; Outpatients; Photomicrography; Polidocanol; Polyethylene Glycols; Retrospective Studies; Sclerosing Solutions; Sclerotherapy; Sodium Tetradecyl Sulfate; Time Factors; Treatment Outcome; Varicose Veins; Vascular Surgical Procedures; Veins

This report describes an ischemic stroke after foam injection sclerotherapy of varicose veins in a patient with a patent foramen ovale. Foam injection sclerotherapy has created resurgence in the minimally invasive treatment of varicose veins. The United States Food and Drug Administration halted a clinical phase 2 trial of a commercial preparation of polidocanol microfoam in 2003 because of concerns relating to possible gas embolism. These trials were recommenced in July 2005. Neurologic complications such as transient visual disturbances and transient confusional states have previously been reported. This case, with its strong circumstantial evidence, illustrates the previously unconfirmed potential for embolic complications using this technique.

Topics: Humans; Male; Middle Aged; Polidocanol; Polyethylene Glycols; Sclerosing Solutions; Sclerotherapy; Stroke; Varicose Veins

A 35-year-old woman has suffered from faintness with cardiovascular failure at the end of a sclerotherapy session for varix management. The injected product was Aeloxisclerol (DCI lauromacrogal 400). The death came up very quickly. The autopsy didn't reveal any traumatic lesion. The anaphylactic choc could be ruled out. Macroscopically, the heart showed a right ventricular dilatation. The toxicological analysis didn't reveal any medicinal substances. Histology showed the presence of lipid degeneration of all the right-ventricle wall The discussion is carried out on the role played by this previous health-state on the onset of death, and also on the incidence of sclerotherapy using this product. and the onset of death. We are carrying out this discussion by taking in mind the nature of the product injected and the information available in the literature concerning the lipid degeneration of cardiac muscle. Quickly after this case, the AFSSAPS (The French Agency for Sanitary Security of Health Products) has emitted an written alert which correlates with the requirements of principles of precaution although it is not founded on the totality of investigation results done for this medicolegal case.

Topics: Adult; Diagnostic Errors; Fatal Outcome; Female; Humans; Polidocanol; Polyethylene Glycols; Sclerosing Solutions; Varicose Veins

The aim was to assess the early efficacy and complications of ultrasound-guided foam sclerotherapy (UGFS) in a cohort of patients with varicose veins.. Of 192 consecutive patients referred with varicose veins over 15 months, only 11 chose surgery; the rest underwent UGFS treatment. Polidocanol was foamed 1 : 3 with air. Under ultrasound control via butterfly or Seldinger cannulation, 1 per cent foam was injected into superficial veins and 3 per cent foam into saphenous trunks, up to a total volume of 14 ml. Outcome was defined as complete when occlusion of the saphenous trunk and/or over 85 per cent of the varicosities was achieved, and partial closure when less.. In 163 legs, complete occlusion occurred after one intervention, a further 32 after a second, and one after a third (overall 91 per cent). Of the remainder, all other legs achieved partial occlusion after up to three interventions, apart from two legs with great saphenous vein (GSV) incompetence, which failed. All 23 legs with small saphenous veins had complete occlusion after one intervention compared with 64 of 97 legs with GSV incompetence (P < 0.010). Occlusion rates were also higher when the GSV was cannulated directly: 56 of 70 versus 8 of 27 (P < 0.001).. UGFS achieved early complete occlusion safely in over 90 per cent of legs with varicose veins.

Topics: Adult; Aged; Aged, 80 and over; Cohort Studies; Female; Humans; Male; Middle Aged; Polidocanol; Polyethylene Glycols; Sclerosing Solutions; Sclerotherapy; Treatment Outcome; Ultrasonography, Interventional; Varicose Veins

To report the outcome of a series of patients with chronic venous disease due to incompetence of saphenous trunks managed by ultrasound guided foam sclerotherapy (UFS).. A group of 808 patients comprise this series. CEAP clinical class for limbs was C1: 15%, C2: 81%, C3: 0.5%, C4: 2%, C5: 0.2%, C6: 0.4%. UFS using 1% polidocanol (107 limbs), 1% sodium tetradecyl (102 limbs), 3% sodium tetradecyl (900 limbs) was employed to treat incompetent saphenous trunks. In patients with unilateral varices 1 treatment was required in 43% of patients and 2 treatments in 48% of patients to obliterate incompetent saphenous trunks and varices. For bilateral varices 2 treatments were required in 40% of patients and 3 treatments in 46% of cases. The clinical outcome and patency of treated veins on duplex ultrasonography was assessed at a mean follow-up interval of 11 months.. A total of 459 limbs were available for assessment at a follow-up interval of 6 months or greater. The CEAP clinical stage was C0:182 limbs, C1: 241, C2: 22, C3: 0, C4: 11, C5: 2, C6:1. The GSV had remained obliterated in 88% of limbs and the SSV in 82% of limbs. Recurrent venous incompetence following previous surgery was as effectively treated by UFS as primary incompetence.. This technique is useful in the management of chronic venous disease as an alternative to surgery.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Chronic Disease; Female; Humans; Male; Middle Aged; Polidocanol; Polyethylene Glycols; Recurrence; Saphenous Vein; Sclerosing Solutions; Sclerotherapy; Severity of Illness Index; Sodium Tetradecyl Sulfate; Treatment Outcome; Ultrasonography, Interventional; Varicose Veins; Vascular Patency

To describe patients presenting with sciatic nerve varices (SNV), presenting pitfalls in diagnosis and management.. Case series.. Patients were investigated using duplex ultrasonography pre-operatively in three cases. Treatment was undertaken both by surgery and by foam sclerotherapy.. Clinically, SNV appeared just below the popliteal skin crease, lateral to the small saphenous vein (SSV). In two cases SNV occurred alone, in two further cases SNV occurred in conjunction with varices from other sources. Symptoms of 'sciatic' pain were present in all. Foam sclerotherapy (1% Polidocanol) was undertaken in one case with a varix. Complete obliteration of the vein and resolution of all symptoms was achieved at the 1-month follow-up examination. Surgical management was used in the other cases.. The sciatic nerve vein follows the fibular saphenous nerve (lying superficial to the fascia in the leg). This nerve arises from the common peroneal nerve (in the popliteal fossa), and is a major branch of the sciatic nerve. Varices of the associated vein appear to be the result of a dysplasia. This condition may be more common than is currently recognised.

Topics: Humans; Polidocanol; Polyethylene Glycols; Sciatic Nerve; Sclerosing Solutions; Sclerotherapy; Treatment Outcome; Ultrasonography, Doppler, Duplex; Varicose Veins; Vascular Surgical Procedures

Foam sclerotherapy is an increasingly popular modality in the treatment of varicose veins. Worldwide, the most popular agents used are sodium tetradecyl sulfate (STS) and polidocanol (POL). The double-syringe system technique to make foam out of a sclerosing solution and air has received wide attention for its ease and reproducibility. This study examined the possibility that the relative silicone content of various disposable connectors may affect overall foam stability. We also evaluated the differences in the stability of foam between STS and POL.. In the first part of the study, one nondisposable stainless steel connector and five disposable plastic connectors were used to create foam from STS 0.50% and air. The procedure was then repeated to produce foam from POL 0.50% and air from each of the six different connector types. As a measure of foam stability, once foam was created with each type of connector, the time required for half of the original volume of sclerosing solution to settle was recorded. In the second part of the study, foam was created with a nondisposable stainless steel connector only and various concentrations of STS and POL. Foam stability was then measured for these different concentrations of sclerosants.. The time for sclerosing solution to settle to half of its initial volume was found to vary according to the specific sclerosant and concentration used, with no statistically significant variation based on connector type.. The type of connector used in the double-syringe system technique to produce foam for sclerotherapy is not a factor in foam stability. Sclerosing solutions differ in their foaming stability.

Topics: Dosage Forms; Humans; Plastics; Polidocanol; Polyethylene Glycols; Sclerosing Solutions; Sclerotherapy; Silicones; Sodium Tetradecyl Sulfate; Stainless Steel; Varicose Veins

Topics: Adult; Arteries; Diagnosis, Differential; Drug Eruptions; Female; Humans; Injections; Leg; Polidocanol; Polyethylene Glycols; Purpura; Sclerosing Solutions; Sclerotherapy; Varicose Veins

Sclerosant microfoam is composed of microbubbles of room or air carbon dioxide (CO(2)). When air is mixed into the surfactant liquid sclerosant, microbubbles of reduced diameter can be obtained of sufficient stability to be injected into the vessels. The area of liquid on the surface is enormously increased in inverse proportion to the diameter of the bubble. Polidocanol in microfoam form displaces the blood from the vessel, permitting homogeneous contact between the sclerosant and the endothelium and facilitating endothelial destruction, and is visible in real time by ultrasonography. The concentration and volume of microfoam can be adjusted according to the disease treated. In the case of home-made foams, however, the volume of gas that can be injected is limited by the low solubility of nitrogen, and only the concentration can be modified. CO(2) is a nontoxic and highly soluble physiological gas, and large amounts can be administered. Here, we report the technique and long-term outcomes of ultrasound-guided injection of polidocanol microfoam in the treatment of large varicose long saphenous veins, postsurgical recurrence varicose veins, varicose ulcers, and venous vascular malformations.

Topics: Female; Humans; Male; Polidocanol; Polyethylene Glycols; Saphenous Vein; Sclerosing Solutions; Sclerotherapy; Treatment Outcome; Ultrasonography, Interventional; Varicose Ulcer; Varicose Veins; Venous Insufficiency

This paper analyses the results of sclerotherapy provided to 89 patients with small pelvis varicosis. Selection of the treatment technology depended on the clinical variant of disease. In patients with damage to the parietal venous system of the pelvis, the treatment was realized by multiple repeat injections of a sclerosing agent to the pelvic veins in a minimal dose which may induce only proliferative processes in varicose vein walls. Elastic compression was not applied. Women with the syndrome of blood overfilling of the pelvic organs (visceral pattern of lesion) were provided sclerotherapy of the left ovarian vein followed by its pharmacological spasm. The treatment results were evaluated by clinical examination of patients, duplex scanning end estimation of the quality of life based on the patients' self-estimation according to the recommendations of the International Association of Phlebologists. Excellent results were obtained in 32.6%, good in 46.1%, satisfactory in 19.1% and unsatisfactory results in 2.2% of patients.

Topics: Adult; Female; Humans; Male; Pelvis; Polidocanol; Polyethylene Glycols; Sclerosing Solutions; Sclerotherapy; Sodium Tetradecyl Sulfate; Varicose Veins

Topics: Adult; Female; Humans; Injections, Intravenous; Male; Middle Aged; Migraine with Aura; Polidocanol; Polyethylene Glycols; Varicose Veins; Vision Disorders

To review the use of sclerosing foam in the treatment of varicose veins, to describe the different techniques of foam preparation, and to report the complications of our 3-year experience with this treatment.. From November 1997 to the end of October 2000, 453 patients were treated with a sclerosing foam for large, medium, and minor varicosities with sodium tetradecylsulfate (STS) or polidocanol (POL). A first group of 257 patients (90 for minor varicosities and 167 for medium to large veins) received a sclerosing foam according to the Monfreux technique. From December 1999 to October 2000, 196 patients were treated with a sclerosing foam prepared according to Tessari's method (36 for minor size veins or teleangectasias and 170 for medium-large veins). Every patient was studied with (color-flow) duplex scanning before and after the treatment and large vein injections were administered under duplex guide.. The immediate success rate was 88.1% in the first group for the medium-large veins. In the same districts we registered an early success rate in 93.3% for the patients treated with the Tessari's method. The complication rate (mostly minor complications) was 8.5% in the first group and 7.1% in the second group.. The use of sclerosing foam may become an established therapy in the treatment of varicose veins with a high success rate, low cost, and low major complication rate. According to our actual experience and knowledge, the safe amount of foam should not exceed the 3-ml limit, but further advancements could come from standardization of the foam preparation technique.

Topics: Humans; Polidocanol; Polyethylene Glycols; Retrospective Studies; Sclerosing Solutions; Sclerotherapy; Sodium Tetradecyl Sulfate; Telangiectasis; Treatment Outcome; Varicose Veins

Sclerotherapy is in general a very safe method for the treatment of teleangiectasias and reticular varicose veins done by an experienced therapist. The complication-rate is very low, with the use of Polidocanol the rate of skin-necrosis ranges between 0.001 and 0.2%, the incidence of superficial thrombophlebitis is 0.08%, the incidence of an allergic reaction is reported with 0.2%. The sclerotherapy of large perforating veins and the long or short saphenous veins is controversially discussed. The results of prospective randomized studies show better results with operative treatment in comparison to sclerotherapy. The recurrence-rate of sclerotherapy of the long saphenous vein varies between 22 and 37% after 3 years, between 40 and 70% after 5 years and 94% after 10 years. Before starting the sclerotherapy the extension of the varicose vein disease should be diagnosed correctly. The diagnosis can be obtained with duplex-ultrasound, that gives either functional and morphologic information about the deep and superficial venous system.

Topics: Follow-Up Studies; Humans; Polidocanol; Polyethylene Glycols; Randomized Controlled Trials as Topic; Recurrence; Sclerotherapy; Varicose Veins

Topics: Drug Approval; Humans; Necrosis; Polidocanol; Polyethylene Glycols; Sclerosing Solutions; Sclerotherapy; Sodium Tetradecyl Sulfate; United States; United States Food and Drug Administration; Varicose Veins

Irritation of superficial nerves is known to be a frequently ocurring and quickly healing side effect in the sclerosing of varicose veins. Persistent severe neuropathy is a rarely seen complication, although the generally used substance, aethoxysclerol (polidocanol, chemical name polyethylenglycolmonododecylether), has a neurotoxic potential. Whether a nerve lesion appears or not depends as well on the concentration and quantity of the applied medicament and on the distance between the nerve and the place of drug administration. Intravaricose, intraarterial and paravasal injection can cause nerve damage. In a single case report the pathophysiology, clinical course and neurophysiological findings of a subtotal lesion of a profound peroneal nerve at the back of the foot is described as a rarely occurring but typical complication of sclerosing varicose veins. Medicolegal aspects are especially considered.

Topics: Adult; Expert Testimony; Female; Foot; Germany; Humans; Malpractice; Peroneal Nerve; Polidocanol; Polyethylene Glycols; Sclerotherapy; Varicose Veins

Macrosclerotherapy in combination with compression has proven to be safe and effective in the treatment of varicose veins. Local compression is increased by pads, according to Laplace law. Firm rolls of cotton wool are fixed over the course of the entire vein to increase local compression and to reduce complications. Additional compression is given by a combination of a class I (daytime and nighttime) and class II (daytime only) medical compression hosiery.. To evaluate the effectiveness and side effects of sclerocompression therapy with cotton wool rolls in combination with medical compression hosiery.. Prospective study with 100 patients (120 legs) with primary varicose veins, which are treated with polidocanol as sclerosant with the empty vein technique. Immediately after the injection, a long cotton wool roll is placed over the entire vein and fixed. Additional compression is obtained with class I and class II medical compression hosiery. The interface pressure on the skin, just under the cotton wool roll, is measured on 12 legs with the aid of an interface pressure measuring instrument (Oxford Pressure Monitor).. Good sclerosing results are obtained in all patients. Side effects are classified as early and late. In 16 patients, minor side effects which needed no treatment are observed. In only 3 cases (2.5%), intravascular blood clots (2) and phlebitis (1) needed incision and expression. The mean interface pressure of all measuring sensors under the cotton wool roll is 84 mm/Hg (68 to 122 mm/Hg).. This study proves the high effectiveness of a cotton wool roll compression right at the place of treatment. By using these long cotton wool compression rolls, the compression part of sclerocompression therapy becomes more effective and much easier to perform.

Topics: Animals; Bandages; Gossypium; Humans; Polidocanol; Polyethylene Glycols; Prospective Studies; Sclerosing Solutions; Sclerotherapy; Treatment Outcome; Varicose Veins

Typically, embolia cutis medicamentosa is reported after intramuscular injections of drugs. We describe a case of embolia cutis medicamentosa after sclerotherapy of intracutaneous veins of the foot with a polidocanol solution of 1%. Under therapy with intravenous alprostadil, pentoxifyllin, internal steroids and anticoagulation with heparin, the lesions healed completely without necrosis.

Topics: Aged; Ankle; Drug Eruptions; Female; Foot Dermatoses; Humans; Polidocanol; Polyethylene Glycols; Sclerosing Solutions; Sclerotherapy; Skin; Varicose Veins

Cutaneous sclerosis, a process that results in hardening of the skin, is the hallmark of scleroderma and sclerodermoid disorders. Cutaneous sclerosis is usually classified as secondary or primary, depending on the presence or absence of underlying diseases. Primary cutaneous sclerosis is a feature of idiopathic inflammatory processes that are often associated with autoimmune disorders, whereas secondary cutaneous sclerosis arises in the context of many pathological processes of varying causes, including chronic graft-vs-host disease, defined metabolic or genetic disorders, and exposure to certain infectious organisms, drugs, or chemicals.. Three patients had localized cutaneous sclerosis overlying the site of a surgically removed (stripped) great saphenous vein. In all 3 patients, lesions were clinically characterized by multiple hypopigmented and indurated plaques distributed linearly along the path of the preexisting vein. Extensive history, physical examination, and diagnostic tests did not reveal known predisposing factors for cutaneous sclerosis.. Although the observed association of sclerodermiform dermatitis and venous stripping in these 3 patients does not imply a causal relationship, the absence of other identifiable predisposing factors and the striking linear distribution of the cutaneous lesions along the path of the preexisting vein are suggestive. This poststripping sclerodermiform dermatitis may be a rare late complication of saphenous vein stripping.

Topics: Adult; Female; Humans; Hypopigmentation; Lichen Sclerosus et Atrophicus; Male; Middle Aged; Panniculitis; Polidocanol; Polyethylene Glycols; Postoperative Complications; Risk Factors; Saphenous Vein; Scleroderma, Localized; Sclerosing Solutions; Sclerotherapy; Varicose Veins

The objective of all forms of sclerotization by substances irritating the endothelium is the production of a permanent fibrous venous occlusion and reflux points controlling the abnormal flow of venous blood. The high percentage of relapses after surgery-as high as 65% within five years after surgery was the authors' motivation for the evaluation of results of two sclerotization technique: Sigg's Swiss method using Aethoxysclerol as the sclerotizing substance and Fegan's English method using S.T.D. substance.. In 1974 to 1994 the authors sclerotized a total of 3161 patients, 84% women (mean age 43.7 years-range 15 to 78) and 16% men (men age 47.3 years-range 17 to 73). In 1973 to 1983 they used Sigg's technique with Aethoxysclerol (0.5 to 4% concentration). This group comprised 1325 patients. In 1983 to 1994 they used only the English technique described by Fegan, using S.T.D. The latter group comprised 1836 patients. In patients where there were doubts about the condition of the deep and perforating venous system they used as a diagnostic method aimed phlebography under sciascopic control (134 patients-4.2%) and as to non-invasive examination methods duplex sonography (235 patients-7.45%) and light reflex rheography (50 patients-1.5%). Comparison of the results did not reveal any statistically significant differences. The best effect was achieved with rapid and complete healing of ulcerations in chronic venous insufficiency in as many as 93/92%. More complications were recorded when using S.T.D., such as necroses at the site of administration, temporary teleangiectasias and hyperpigmentations, the statistical significance being p < 0.05. The most frequent complication when using Aethoxysclerol were collapses in hypotensive patients, the statistical significance being similar.. The authors evaluate the two techniques as simple, effective and safe. They can be used as alternatives of surgical treatment. The advantage is that treatment is ambulatory, it leaves the vena saphena intact in situ and does not involve anaesthetic and surgical risks.

Topics: Adolescent; Adult; Aged; Female; Humans; Male; Middle Aged; Polidocanol; Polyethylene Glycols; Sclerosing Solutions; Sodium Tetradecyl Sulfate; Varicose Veins

A 53-year-old man had been passing tarry stools and bright red blood per rectum for 6 days. He had a history of pyloroplasty for duodenal ulcers, alcoholic liver cirrhosis, stage B in Child's classification, a Le Veen shunt for ascites, grade I oesophageal varices and several episodes of intestinal bleeding of uncertain cause on repeated endoscopies. Haemoglobin levels was now 4.4 g/dl. Neither oesophago-gastro-duodenoscopy nor colposcopy, radiological examination of the small intestine nor scintigraphy discovered the source of bleeding. Computed tomography revealed varices in the horizontal part of the duodenum, confirmed by arteriography.. At a second endoscopy, this time with a long scope, acute bleedings were seen in the venous convolutions and stopped with 4 ml Polidocanol. Bleeding recurred after 10 days, thought to be due to persisting portal hypertension. A transjugular intrahepatic portosystemic stent shunt (TIPSS) was inserted to lower the pressure. Colour-coded Doppler examination at the time of another bleeding 10 weeks later demonstrated occlusion of the TIPSS. It was re-opened by balloon catheter dilatation, since when there have been no further episodes of bleeding.. The implantation of a TIPSS is a new causative treatment for recurrent bleeding from ectopic varices due to portal hypertension that cannot be treated by endoscopy.

Topics: Angiography; Duodenoscopy; Duodenum; Gastrointestinal Hemorrhage; Humans; Hypertension, Portal; Male; Middle Aged; Polidocanol; Polyethylene Glycols; Portasystemic Shunt, Surgical; Recurrence; Sclerosing Solutions; Stents; Tomography, X-Ray Computed; Varicose Veins

Varicose veins of the leg with saphenous trunk incompetence have been treated surgically. However, recently we have switched to sclerotherapy, and the preliminary results have been satisfactory. We examined varicosities in the leg by color-coded duplex scanning to evaluate venous incompetence and the results of sclerotherapy. Our sclerotherapy procedure was performed as follows: the varicosed branches were punctured and less than 5 ml of 3% polidocanol was injected with the patient's legs raised; an elastic bandage was applied for 3-7 days. Before sclerotherapy, saphenous incompetence was detected in 31 out of 32 limbs. One to two weeks after sclerotherapy, 22 limbs with greater saphenous trunk incompetence were re-examined. The saphenous trunk was occluded with thrombus and saphenous incompetence had diminished in 16 limbs, and there was excellent sclerosis of the distal varicosities. The saphenous trunk was not sclerosed in six limbs. The varicosity was sclerosed in two out of these six limbs. We followed up the healing course of the saphenous vein thrombosis in nine limbs for up to 6 months. Six recanalizations of the saphenous veins were observed, however, clinically the distal varicosity did not recur in any of these limbs. Sclerotherapy appears to be a clinically useful method capable of replacing surgery.

Topics: Adult; Aged; Female; Humans; Male; Middle Aged; Polidocanol; Polyethylene Glycols; Saphenous Vein; Sclerosing Solutions; Sclerotherapy; Thrombophlebitis; Ultrasonography, Doppler, Color; Varicose Veins; Venous Insufficiency; Wound Healing

Topics: Adult; Female; Humans; Ischemic Attack, Transient; Polidocanol; Polyethylene Glycols; Sclerosing Solutions; Sclerotherapy; Varicose Veins

Topics: Humans; Ischemic Attack, Transient; Polidocanol; Polyethylene Glycols; Sclerosing Solutions; Sclerotherapy; Varicose Veins

Topics: Humans; Polidocanol; Polyethylene Glycols; Sclerosing Solutions; Sodium Tetradecyl Sulfate; Varicose Veins

Polidocanol is a sclerosing solution that is highly valued by clinicians and patients for its painlessness, high efficacy, excellent safety profile, low incidence of side effects, and for the rarity of its allergic reactions. Previous estimates of the incidence of allergic reactions have ranged from 0 to 0.06%.. Improved recognition of systemic allergy to polidocanol is desirable for both clinicians and for patients. We have attempted to describe two cases recently observed in our population and to provide an improved upper-bounds estimate for the true population incidence of allergy to polidocanol.. We report two recent cases of mild systemic allergic reaction to polidocanol in a population of 689 exposed patients, for an observed incidence of 0.3% in our patient population. We have calculated a 95% confidence upper-bound estimate of 0.91% for the incidence of polidocanol allergy in the general population.. Allergy to polidocanol may be more common than previously recognized. Careful questioning of previously treated patients and more prolonged observation of patients after treatment may yield a larger number of recognized cases.

Topics: Adult; Drug Eruptions; Female; Humans; Polidocanol; Polyethylene Glycols; Pruritus; Sclerosing Solutions; Urticaria; Varicose Veins

Polidocanol is a widely used sclerosing agent that was first developed as a local anesthetic. In France it is used in varicose veins as well as in telangiectases.. To improve the knowledge of the effects of polidocanol and provide recommendations for better use.. Based on 12 years of experience in treating nearly 11,000 patients with polidocanol, the author reviews his observations. A theoretical model of dilution of sclerosing agents in injected veins is provided.. The author observed: seven cases of minor urticaria, occurrence of grey veil when used under the air-block technique, one case of cutaneous necrosis (5 cm3), and some small epidermic necrosis (1-mm diameter) and neither shock nor severe adverse reaction.. Polidocanol is characterized by its spasmogenic action on veins, excellent local tolerance, and a very low incidence of general reactions. Low concentrations (0.3 to 0.6%) can be used for the treatment of quite large varicose veins if an adequate volume is injected.

Topics: Adult; Female; Humans; Male; Necrosis; Polidocanol; Polyethylene Glycols; Sclerosing Solutions; Sclerotherapy; Skin; Urticaria; Varicose Veins

Topics: Aged; Ambulatory Surgical Procedures; Bandages; Benzyl Alcohols; Drug Combinations; Female; Humans; Iodides; Ligation; Male; Middle Aged; Polidocanol; Polyethylene Glycols; Recurrence; Saphenous Vein; Sclerosing Solutions; Sclerotherapy; Sodium; Varicose Veins

Three female patients had serious anaphylactic reactions to sclerotherapy with polidocanol (Aethoxysklerol) within 15 minutes after administration for varicose veins in the legs. Two of them received the drug for the first time. The first patient developed cardiac arrest which was successfully treated. The second patient showed signs of an adult respiratory distress syndrome, while in the third the ECG was compatible with cardiac ischaemia. Recovery was complete and uneventful in all patients. The incidence of allergic reactions to polidocanol has been estimated at 1:10,000. In view of the considerable underreporting of adverse reactions we feel that the frequency of severe anaphylactic reactions to this drug may be underestimated.

Topics: Adult; Aged; Anaphylaxis; Female; Humans; Middle Aged; Polidocanol; Polyethylene Glycols; Sclerosing Solutions; Varicose Veins

A useful technique for enhancing the visualization of microvaricosities of the legs is presented. This allows for easy, rapid, and accurate treatment of even the minutest vessels.

Topics: Administration, Topical; Humans; Injections, Intravenous; Polidocanol; Polyethylene Glycols; Preoperative Care; Sclerosing Solutions; Varicose Veins

Sclerotherapy is enjoying great popularity as a technique to eliminate unsightly spider and varicose veins. This study of 200 charts reveals a high success rate and a low incidence of long-term adverse sequelae. To minimize complications, several suggestions are made based on clinical observations. As with any procedure, experience, meticulous technique, and good patient rapport are at the heart of its success.

Topics: Betamethasone; Contraceptives, Oral; Female; Heparin; Humans; Pigmentation Disorders; Polidocanol; Polyethylene Glycols; Sclerosing Solutions; Sodium Chloride; Varicose Veins

Rectal varices represent a rare condition even in cases of portal hypertension. A case of bleeding ano-rectal varices presenting as the first manifestation of portal hypertension is reported. Treatment by sclerotherapy was successful.

Topics: Aged; Aged, 80 and over; Female; Humans; Polidocanol; Polyethylene Glycols; Rectum; Sclerosing Solutions; Varicose Veins

Topics: Adolescent; Adult; Aged; Humans; Middle Aged; Polidocanol; Polyethylene Glycols; Radiography; Sclerotherapy; Varicose Veins

A patient with anorectal varices is reported. Anorectal varices are a rare cause of rectal bleeding and are often erroneously diagnosed as bleeding hemorrhoids. However, the subcutaneous extension of the varices should alert the clinician. Although local treatment such as ligation of the varices has been advocated, in the presence of portal hypertension a more radical operation is recommended. A portosystemic shunt, preferably between the inferior mesenteric vein and the vena cava or renal vein, is then the treatment of choice.

Topics: Aged; Combined Modality Therapy; Female; Gastrointestinal Hemorrhage; Humans; Liver Cirrhosis, Biliary; Polidocanol; Polyethylene Glycols; Rectum; Varicose Veins; Veins

Topics: Aged; Colon; Colostomy; Gastrointestinal Hemorrhage; Humans; Hypertension, Portal; Male; Polidocanol; Polyethylene Glycols; Postoperative Complications; Rectal Neoplasms; Sclerosing Solutions; Varicose Veins

Thirteen patients with acute or recent bleeding from gastro-oesophageal varices were treated by sclerotherapy using flexible fiberoptic endoscope. Primary haemostasis was obtained in 10 of 11 admissions with active bleeding. Three patients have been treated for gastric varices with the same method. Such treatment has not been reported before. During the follow-up period, three patients died, two of variceal haemorrhage and one of pneumonia. Ten patients are still alive 2-53 months after the first admission. A total of 117 treatment courses were given, on an average 9 per patient. Complications included superficial mucosal necrosis without clinical consequences in several cases, 3 patients developed oesophageal and gastric ulcers and one moderate oesophageal stenosis. Rebleeding occurred in 4 patients, in 2 of them because of ulcers at the sites of injections.

Topics: Adolescent; Adult; Aged; Child; Endoscopy; Esophageal and Gastric Varices; Female; Fiber Optic Technology; Follow-Up Studies; Gastrointestinal Hemorrhage; Humans; Male; Middle Aged; Polidocanol; Polyethylene Glycols; Sclerosing Solutions; Stomach; Varicose Veins

A case of successful treatment of a bleeding duodenal varix in a patient with portal hypertension and compensated cryptogenic cirrhosis (Child A) is reported. The 42-year-old man had a history of recurrent gastrointestinal hemorrhage over 14 years. In 1966 he underwent a portocaval shunt operation. Angiography in 1968 revealed a thrombosis of the shunt as well as of the splenic vein. Splenectomy was performed because of hypersplenism. In 1980 bleeding from esophageal varices occurred and was treated by sclerotherapy. Seven weeks after sclerotherapy massive bleeding from a duodenal varix occurred. Sclerotherapy of the duodenal varix via a flexible endoscope proved successful. Since then, during a follow-up period of 15 months, the patient has had no further bleeding episodes.

Topics: Adult; Duodenoscopy; Duodenum; Gastrointestinal Hemorrhage; Humans; Male; Polidocanol; Polyethylene Glycols; Sclerosing Solutions; Varicose Veins