polidocanol and Thrombophlebitis

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

Different catheters (angiography, single-balloon) have been used for foam sclerotherapy of the great saphenous vein (GSV).. Is there greater efficacy and safety in the use of a double-balloon catheter?. Twenty patients were treated with a double-balloon catheter and 3% polidocanol foam. Follow-up after one day, one and six weeks, six and 12 months.. Up to week six complete success was seen in 95% (19/20) patients. Only eight patients attended the checks after six and 12 months. The occlusion rates were 75% (6/8, 6 months) resp. 50% (4/8, 12 months). A further 10 patients refused these checks as they were free of symptoms but could be questioned. Side-effects were haematoma (100%), limited phlebitis (15%) and one extended thrombophlebitis followed by hyperpigmentation.. A double-balloon catheter is a safe treatment option for foam sclerotherapy of the GSV. However, in this case series efficacy is not superior to the use of an angiography-catheter, a single-balloon catheter or just the direct puncture of the vein.

Topics: Adult; Aged; Aged, 80 and over; Catheterization; Catheters; Female; Hematoma; Humans; Male; Middle Aged; Phlebitis; Polidocanol; Polyethylene Glycols; Saphenous Vein; Sclerotherapy; Thrombophlebitis

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 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

The effects of five sclerosants used for treating esophageal varices on blood coagulation and fibrinolysis, systemic hemodynamics, and vascular endothelial cells were studied in mongrel dogs. With each sclerosant, hemolysis and a decrease in the platelet count were observed. Changes in the blood coagulation system occurred immediately after sclerosant administration. Prolongation of the PT and APTT and decreases in fibrinogen and alpha 2-PI were seen in the thrombin (TH), sodium tetradecyl sulfate (STS), and ethanolamine oleate (EO) groups. Polidocanol (PO) and absolute ethanol (ET) had less pronounced effects on these systems. A transient decrease in the cardiac index (CI), pulmonary artery pressure (PAP) and pulmonary artery resistance (PAR) was observed with the administration of the sclerosants, especially in the TH and STS groups. Excessive vascular endothelial damage was observed in the ET group, marked damage was seen in the EO and STS groups and slight damage was recorded in the PO and TH groups.

Topics: Animals; Blood Coagulation; Dogs; Endothelium, Vascular; Esophageal and Gastric Varices; Fibrinolysis; Hemodynamics; Oleic Acids; Platelet Count; Polidocanol; Polyethylene Glycols; Sclerosing Solutions; Sodium Tetradecyl Sulfate; Thrombin; Thrombophlebitis

The treatment of leg telangiectases with the carbon dioxide or argon laser results in a low success rate and an unacceptable risk of scarring. Sclerotherapy is effective; however, pigmentation and telangiectatic matting induced by extravasation of RBCs and excessive posttreatment inflammation are common. We conducted a clinical and histologic study of therapy with the 585 nm pulsed dye laser alone and in combination with subtherapeutic sclerotherapy in the rabbit ear vein model. The pulsed dye laser alone was effective when 10 joule/cm2 was used. In combination with immediate injection of the sclerosant, effective endosclerosis occurred with all tested laser energies (8 to 10 joule/cm2).

Topics: Animals; Combined Modality Therapy; Ear; Endothelium, Vascular; Erythrocytes; Laser Therapy; Polidocanol; Polyethylene Glycols; Rabbits; Random Allocation; Sclerosing Solutions; Sclerotherapy; Telangiectasis; Thrombophlebitis; Veins