polidocanol and Varicose-Ulcer

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

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

To compare polidocanol foam sclerotherapy with surgical treatment of patients with primary chronic venous insufficiency and active ulcer treated at a single vascular center.. Fifty-eight limbs of 56 patients with active ulcers were prospectively randomized to undergo either surgical treatment or foam sclerotherapy. Patients completed the Aberdeen Varicose Veins Questionnaire (AVVQ), the Venous Clinical Severity Score (VCSS), and Venous Disability Score (VDS). The follow-up was 502 ± 220 days.. The ulcer healed in 100% and 91.3% of patients treated with surgery or foam sclerotherapy, respectively (P > 0.05). There were no significant differences in AVVQ, VCSS, and VDS between the 2 groups after the procedures (P = 0.45, 0.58, and 0.66, respectively; Mann-Whitney U test). Complications occurred in 14.2% and 13.0% in the surgical and foam sclerotherapy groups, respectively.. Surgical treatment and foam sclerotherapy achieved high rates of ulcer healing, without a statistically significant difference. Both treatments led to significant improvements in VCSS, VDS, AVVQ scores, demonstrating improvements in clinical outcomes and quality of life.

Topics: Adult; Brazil; Chronic Disease; Disability Evaluation; Female; Humans; Male; Middle Aged; Polidocanol; Polyethylene Glycols; Prospective Studies; Quality of Life; Sclerosing Solutions; Sclerotherapy; Severity of Illness Index; Surveys and Questionnaires; Time Factors; Treatment Outcome; Varicose Ulcer; Vascular Surgical Procedures; Venous Insufficiency; Wound Healing

Chronic venous hypertension, triggered by venous reflux and/or obstruction, leads to skin changes and venous leg ulcers (VLUs). Compression therapy is the standard of care, but many wounds remain unhealed. The objectives of this study were to observe the effects of endovenous chemical ablation with commercially available 1% polidocanol injectable microfoam on VLU healing and recurrence rates.. The VIEW VLU study was a multicenter, open-label, phase IV registry of patients with active VLUs resulting from venous insufficiency of the great saphenous vein and/or anterior accessory saphenous vein systems who underwent ablation with 1% polidocanol microfoam. Primary outcomes included wound healing rate (change in wound perimeter), wound closure at 12 weeks after treatment, and time to wound closure. Secondary outcomes included VLU recurrence, numeric pain score at the ulcer location, EuroQol five-dimension five-level questionnaire quality-of-life index, and the Venous Clinical Severity Score. Patients were followed for 12 months.. We enrolled 76 patients (80 ulcers) from 14 sites across the United States and Canada (mean age 63.6 ± 13.7 years, 39.5% female, mean body mass index 36.3). Of the enrollees, 96.3% presented with great saphenous vein incompetence. The mean baseline wound perimeter was 117.2 ± 107.4 mm and 26.3% of wounds (21/80) were circumferential. The mean ulcer age was 34.8 ± 51.8 weeks at first presentation and the mean compression therapy duration was 26.4 ± 35.9 weeks. The median wound perimeter decreased by 16.3% from baseline in the first 2 weeks after the procedure and by 27.0% at 12 weeks. By 12 weeks, 53.8% of wounds (43/80) were healed. The median time to ulcer closure by Kaplan-Meier analysis was 89 days (95% confidence interval, 62.0-117.0). In a Kaplan-Meier analysis of initially healed wounds, 88.9% (95% confidence interval, 76.9-94.8) remained closed at 12 weeks after closure. The mean numeric pain scores (ulcer site) improved by 41.0% and 64.1% at 12 weeks and 12 months after the procedure, respectively. The health-related quality-of-life index (scale of 0-1) improved from 0.65 ± 0.27 at baseline to 0.72 ± 0.28 at 12 weeks and 0.73 ± 0.30 at 12 months. By 12 weeks after treatment, the mean target leg Venous Clinical Severity Score had significantly decreased by 5.8 points, and by 12 months it had decreased by 10.0 points.. Treatment with 1% polidocanol microfoam was associated with promising wound healing rates and low recurrence rates for VLUs, despite a challenging patient population with recalcitrant ulcers, a large percentage of which were circumferential, in patients with high body mass indexes.

Topics: Aged; Female; Humans; Infant; Male; Middle Aged; Pain; Polidocanol; Sclerotherapy; Treatment Outcome; Ulcer; Varicose Ulcer; Wound Healing

To evaluate the use of inframalleolar access for endovenous ablation when treating advanced venous disease with nonthermal nontumescent (NTNT) techniques.. This single-center retrospective study included 109 patients with advanced venous disease, treated using inframalleolar access between May 2018 and March 2020. NTNT techniques included ClariVein (Merit Medical Systems, South Jordan, Utah) and ScleroSafe (VVT Medical, Kefar Sava, Israel). Outcomes measured were postprocedure pain, leg edema, ulcer healing and recurrence rates, and venous insufficiency recurrence.. Seventy-seven patients (70%) were treated with ClariVein and 32 (30%) with ScleroSafe. Postprocedure pain score (range, 0-10) after 1 week decreased from a preprocedure median of 5 (interquartile range, 3-6) to 1 ((interqartiel range, 0-2) (P = .0001). Complete wound healing was achieved in 38 patients (43.7%) after 30 days and in 71 patients (81.6%) after 90 days. One patient developed an ulcer recurrence and six developed venous insufficiency recurrence. There was no reported nerve or skin injuries.. NTNT ablation techniques using inframalleolar access are effective and safe without risk of nerve damage. Their use facilitates ulcer healing and limits pain in patients with advanced disease.

Topics: Aged; Endovascular Procedures; Female; Humans; Male; Middle Aged; Polidocanol; Recurrence; Retrospective Studies; Saphenous Vein; Sclerosing Solutions; Sclerotherapy; Sodium Tetradecyl Sulfate; Time Factors; Treatment Outcome; Varicose Ulcer; Venous Insufficiency; Wound Healing

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

High recurrence and high costs of treatment are the main problems with venous ulcer management. Therefore, it is of utmost importance to target the exact pathological cause. The role of cutaneous microvalves reflux in the pathogenesis of these ulcers has been confirmed. In this study, 20 chronic venous leg ulcers were prospectively subjected to foam sclerotherapy injection into periulcer veins using direct visualization by AccuVein AV400. Patients having infected ulcers, acute deep vein thrombosis, hypercoagulability, Ankle-Brachial Index <0.9, pregnancy, and/or allergy to the sclerosant were excluded. Endpoints included rates of ulcer size reduction, complete healing, ulcer recurrence, and procedure-related complications. Aethoxysklerol 1% was used in all cases to produce foam employing the double-syringe system. The mean reduction in ulcer surface area, postinjection, was 75% after 8 weeks and 91% after 12 weeks. Nineteen ulcers (95%) healed in a median time of 8 weeks, range 3 to 17 weeks. At 1 year of follow-up, 18 patients (90%) were still ulcer-free, while 1 patient's ulcer (5%) recurred 19 weeks postinjection. No major complications were encountered. Periulcer foam sclerotherapy injection, guided by vein visualization technology, should be one of the main lines of treatment of venous leg ulcers. It offers good results with regard to rapid ulcer healing and low recurrence rate without major risk. Randomized controlled trials are needed to establish these conclusions.

Topics: Chronic Disease; Female; Humans; Lasers; Leg Ulcer; Male; Middle Aged; Outcome and Process Assessment, Health Care; Polidocanol; Regional Blood Flow; Sclerosing Solutions; Sclerotherapy; Secondary Prevention; Varicose Ulcer; Veins; Wound Healing

In foam sclerotherapy for varicose veins, ultrasound can track the spread of foam in only one direction. We hypothesized that using fluoroscopy in combination with ultrasound can reveal the spread of foam to deep veins through perforator veins and to other varicose veins in different directions. In this study, we examined the safety and effectiveness of ultrasound- and fluoroscopy-guided foam sclerotherapy for lower extremity venous ulcers.. This retrospective study included all patients receiving ultrasound- and fluoroscopy-guided foam sclerotherapy for varicose ulcers (Clinical, Etiology, Anatomy, and Pathophysiology class 6) of the lower extremities at the Fourth Affiliated Hospital of Jiangsu University (Zhenjiang, China) between May 1, 2016, and April 30, 2018. Polidocanol foam sclerosant was injected through indwelling needles (placed every 20 cm for saphenous veins and every 5-10 cm for others) into the varicose veins. When the contrast medium in the target vessels was replaced by the hypointense foam sclerosant or on signs of foam entry into the perforator veins under fluoroscopy, the injection was stopped and the site was manually pressed. All patients received postprocedure compression with elastic bandages until ulcer healing and compression stockings (30-40 mm Hg) thereafter.. A total of 35 patients (42 limbs) were included. The maximal ulcer diameter was 3.6 ± 1.4 cm (range, 1.1-5.8 cm). The number of injection sites ranged from 3 to 10; total foam amount ranged from 4.5 to 35 mL. All 35 patients completed 12-month follow-up. Ulcer healing rate was 100%, and 1-year recurrence rate was 2.9%. The Venous Clinical Severity Score was 12.98 ± 3.91 before treatment, decreasing to 3.02 ± 2.39 at 12 months (P < .01). Superficial thrombophlebitis developed in 21 (50%) limbs. No deep venous thrombosis or pulmonary embolism was observed during follow-up. Among the 33 limbs (27 patients) with ultrasound examination at 12 months, 28 (84.8%) limbs had complete occlusion and the remaining 5 (15.2%) had recanalization.. Ultrasound- and fluoroscopy-guided foam sclerotherapy is safe and effective for the treatment of venous ulcers of the lower extremities.

Topics: Adult; Aged; Compression Bandages; Female; Fluoroscopy; Humans; Male; Middle Aged; Polidocanol; Radiography, Interventional; Retrospective Studies; Sclerosing Solutions; Sclerotherapy; Time Factors; Treatment Outcome; Ultrasonography, Interventional; Varicose Ulcer; Wound Healing

Topics: Adult; Aged; Aged, 80 and over; Chronic Disease; Female; Humans; Leg; Male; Middle Aged; Polidocanol; Sclerosing Solutions; Sclerotherapy; Treatment Outcome; Ultrasonography, Interventional; Varicose Ulcer

Refluxing perforators contribute to venous ulceration. We sought to describe patient characteristics and procedural factors that (1) impact rates of incompetent perforator vein (IPV) thrombosis with ultrasound-guided sclerotherapy (UGS) and (2) impact the healing of venous ulcers (CEAP 6) without axial reflux.. A retrospective review of UGS of IPV injections from January 2010 to November 2012 identified 73 treated venous ulcers in 62 patients. Patients had no other superficial or axial reflux and were treated with standard wound care and compression. Ultrasound imaging was used to screen for refluxing perforators near ulcer(s). These were injected with sodium tetradecyl sulfate or polidocanol foam and assessed for thrombosis at 2 weeks. Demographic data, comorbidities, treatment details, and outcomes were analyzed. Univariate and multivariable modeling was performed to determine covariates predicting IPV thrombosis and ulcer healing.. There were 62 patients (55% male; average age, 57.1 years) with active ulcers for an average of 28 months with compression therapy before perforator treatment, and 36% had a history of deep venous thrombosis and 30% had deep venous reflux. At a mean follow-up of 30.2 months, ulcers healed in 32 patients (52%) and did not heal in 30 patients (48%). Ulcers were treated with 189 injections, with an average thrombosis rate of 54%. Of 73 ulcers, 43 ulcers (59%) healed, and 30 (41%) did not heal. The IPV thrombosis rate was 69% in patients whose ulcers healed vs 38% in patients whose ulcers did not heal (P < .001). Multivariate models demonstrated male gender (P = .03) and warfarin use (P = .01) negatively predicted thrombosis of IPVs. A multivariate model for ulcer healing found complete IPV thrombosis was a positive predictor (P = .02), whereas a large initial ulcer area was a negative predictor (P = .08). Increased age was associated with fewer ulcer recurrences (P = .05). Predictors of increased ulcer recurrences were hypertension (P = .04) and increased follow-up time (P = .02). Calf vein thrombosis occurred after 3% (six of 189) of injections.. Thrombosis of IPVs with UGS increases venous ulcer healing in a difficult patient population. Complete closure of all IPVs in an ulcerated limb was the only predictor of ulcer healing. Men and patients taking warfarin have decreased rates of IPV thrombosis with UGS.

Topics: Adult; Aged; Aged, 80 and over; Anticoagulants; Comorbidity; Female; Humans; Injections, Intravenous; Linear Models; Logistic Models; Male; Middle Aged; Multivariate Analysis; Odds Ratio; Polidocanol; Polyethylene Glycols; Recurrence; Retrospective Studies; Risk Factors; Sclerosing Solutions; Sclerotherapy; Sex Factors; Sodium Tetradecyl Sulfate; Time Factors; Treatment Outcome; Ultrasonography, Interventional; Varicose Ulcer; Venous Thrombosis; Warfarin; Wound Healing; Young Adult

Topics: Female; Humans; Male; Polidocanol; Polyethylene Glycols; Sclerosing Solutions; Sclerotherapy; Sodium Tetradecyl Sulfate; Varicose Ulcer; Venous Thrombosis; Wound Healing

Our objective was to chronicle our experience in using sclerosant foam to treat severe chronic venous insufficiency (CVI). Forty-four patients with 60 limbs severely affected by severe CVI were entered into the study. They had lipodermatosclerosis, CEAP 4 (seven limbs); atrophie blanche or scars of healed venous ulcerations, CEAP 5 (18 limbs); and frank, open venous ulcers, CEAP 6 (35 limbs). Patients and limbs were collected into three groups. In group I, all limbs were treated with compression without intervention. Group II consisted of crossover patients who failed compression treatment. Group III consisted of patients treated promptly with sclerosant foam therapy without a waiting period of compression. A standing Doppler duplex reflux examination was done in all cases. Compression was by Unna boot or long stretch elastic bandaging. Foam was generated from Polidocanol 1%, 2%, or 3% by the two-syringe technique and administered under ultrasound guidance. Posttreatment compression was used for 14 days. In addition to clinical and ultrasound evaluation at 2, 7, 14, and 30 days, venous severity scoring was noted at entry and discharge. In group I, 12 patients were discharged from care within 6 weeks of initiating compression. All eight of the class 6 limbs had healed. Group II consisted of four CEAP class 5 limbs and eight class 6 limbs that had failed to heal with compression. Five of eight venous ulcers healed within 2 weeks, two more healed by 4 weeks, and one required 6 weeks to heal. In group III, 7 of 11 venous ulcers healed within 2 weeks and four more within 4 weeks. Venous severity scores reflected the success of treatment, with the greatest change occurring in group III and the least in group I. Limbs treated with foam had a statistically better outcome than those without (p = 0.041). One patient failed foam sclerotherapy, another had pulmonary emboli 4 months after foam treatment, and a single medial gastrocnemius thrombus was discovered 24 hr after treatment. Treatment of severe CVI with compression and foam sclerotherapy causes more rapid resolution of the venous insufficiency complications and does so without an increase in morbidity.

Topics: Adult; Aged; Aged, 80 and over; Bandages; Chronic Disease; Female; Humans; Leg; Male; Middle Aged; Polidocanol; Polyethylene Glycols; Sclerosing Solutions; Sclerotherapy; Ultrasonography; Varicose Ulcer; Venous Insufficiency

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