polidocanol and Venous-Insufficiency

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

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

Ultrasound-guided sclerotherapy with foam is able to suppress blood flow in almost all types of varicose veins. The technique is efficient, simple, safe, inexpensive, and easily repeatable, although it requires training and skill. It should be considered as the best primary treatment for most varicose patients. Evaluation of long-term results, with regard to comparison with other techniques, should take into account all advantages and drawbacks and evaluate cost-effectiveness from a life-long point of view.

Topics: Drug Combinations; Follow-Up Studies; Humans; Injections, Intravenous; Polidocanol; Polyethylene Glycols; Sclerosing Solutions; Sclerotherapy; Sodium Tetradecyl Sulfate; Time Factors; Treatment Outcome; Venous Insufficiency

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

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

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

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

The ClariVein® system is an endovenous technique that uses mechano-chemical ablation to treat incompetent truncal veins. This study was conducted to identify the ideal Polidocanol dosage and form for mechano-chemical ablation in order to occlude the great saphenous vein. When adhering to safe dosage levels, sclerosants with higher concentrations potentially limit the extent of treatment. It has been demonstrated that this problem may be overcome by using Polidocanol as a microfoam. This paper was established on findings of a preliminary analysis.. The initial study was a single-blinded multicenter randomized controlled trial where patients are allocated to three treatment arms. Group 1 consisted of mechano-chemical ablation +2% Polidocanol liquid, group 2: mechano-chemical ablation +3% Polidocanol liquid and group 3: mechano-chemical ablation +1% Polidocanol foam. Eighty-seven, 34 males and 53 females (60.9%), mean age 55 years s.d. 16.0 (range 24-84), were enrolled in the study. Treatment length was 30 cm (range 10-30) for 95.2% of the patients. Mean operating time was 16 minutes (range 5-70). The mean saphenofemoral junction diameter (7.7 mm) was similar in all three groups. At 6 weeks post-treatment duplex ultrasound showed that 25 out of 25 = 100%, 27 out of 28 = 96.4% and 13 out of 23 = 56.5% were occluded in the mechano-chemical ablation + 2% Polidocanol liquid, mechano-chemical ablation + 3% Polidocanol liquid and mechano-chemical ablation + 1% Polidocanol microfoam respectively (p < 0.001). However, stricter scrutiny showed that the anatomical success rate defined as occlusion of at least 85% of the treated length to be 88.0%, 85.7% and 30.4% respectively (p < 0.001).. Mechano-chemical ablation using ClariVein® combined with 1% Polidocanol microfoam is significantly less effective and should not be considered as a treatment option of incompetent truncal veins. Further investigation to determine the ideal Polidocanol liquid dosage with mechano-chemical ablation is advocated and is being conducted accordingly.

Topics: Adult; Aged; Aged, 80 and over; Female; Humans; Male; Middle Aged; Polidocanol; Polyethylene Glycols; Saphenous Vein; Venous Insufficiency

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

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

The aim of this study was to evaluate occlusion rates of great saphenous veins (GSV) with a diameter between 5-10 mm that received a pre-treatment size reduction via perivenous tumescent application (TA) followed by catheter-directed foam sclerotherapy (CDFS).. A prospective blinded randomized clinical trial comparing the occlusion rates of GSV at 1-, 6-, and 12-month follow-up. Fifty patients were included and randomized into two groups. CDFS was performed accessing the GSV at knee level and applying 8 mL of 2% polidocanol-foam (EasyFoam) while the catheter was withdrawn. Strictly perivenous TA was performed in group 1 before applying the sclerosant agent. Occlusion rates and clinical scores were assessed by blinded examiners.. After 12 months in group 1 full occlusion was achieved in 73.9%, partial occlusion in 8.7%, and 17.4% were classified as treatment failure. In group 2, 75% of the targeted GSV were fully occluded, 20% were partially occluded, and 5% were diagnosed as treatment failure. Both groups showed a significant reduction of the vein diameter. Patient's tolerance and satisfaction with the treatment was high in both groups.. No benefit could be found using additional TA to reduce the vein diameter before the treatment.

Topics: Administration, Intravenous; Adult; Aged; Aged, 80 and over; Anesthesia, Local; Catheterization, Peripheral; Endovascular Procedures; Female; Humans; Male; Middle Aged; Patient Satisfaction; Pilot Projects; Polidocanol; Polyethylene Glycols; Prospective Studies; Saphenous Vein; Sclerosing Solutions; Sclerotherapy; Time Factors; Treatment Outcome; Ultrasonography; Venous Insufficiency; Young Adult

This study assessed changes in the calf muscle deoxygenated hemoglobin (HHb) level during light-intensity exercise after ultrasound-guided foam sclerotherapy (UGFS) for superficial venous insufficiency.. UGFS with 1% or 3% polidocanol foam (POL-F) was used to treat unilateral great saphenous vein reflux in 84 patients. Near-infrared spectroscopy (NIRS) was used to measure calf muscle HHb levels before and 3 months after UGFS. The calf venous HHb blood-filling index was calculated on standing, the calf venous HHb ejection index was obtained after one tiptoe movement, and the venous HHb retention index was obtained after 10 tiptoe movements. The primary end point was an evident improvement in calf muscle deoxygenation after UGFS. The secondary end point was obliteration of the great saphenous vein.. Treatment consisted of 1% POL-F in 48 limbs and 3% POL-F in the remaining 36. Ultrasound imaging at the 3-month follow-up demonstrated complete occlusion in 56.3% of the patients who received injections of 1% POL-F and in 66.7% of those who received injections of 3% POL-F. The difference in treatment outcome between the groups was not significant (P=.333). Reflux was absent in 39 limbs (81.3%) treated with 1% POL-F and in 34 limbs (94.4%) treated with 3% POL-F, and no significant difference was observed between the two groups (P=.076). Postsclerotherapy NIRS demonstrated significant reductions in the levels of the HHb filling index in both treatment groups (P=.039, P=.0001, respectively) and significant reductions in the levels of the HHb retention index (P<.0001, P=.008, respectively). However, the differences in the levels of the HHb ejection index before and after UGFS were not significant (P=.250, P=.084, respectively).. Our present findings suggest that changes in the values of these parameters may be of potential use for assessing the effects of foam sclerotherapy in patients with superficial venous insufficiency.

Topics: Adult; Aged; Aged, 80 and over; Exercise; Female; Follow-Up Studies; Hemoglobins; Humans; Leg; Male; Middle Aged; Muscle, Skeletal; Polidocanol; Polyethylene Glycols; Sclerosing Solutions; Sclerotherapy; Spectroscopy, Near-Infrared; Time Factors; Ultrasonography, Interventional; Venous Insufficiency

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

To evaluate the feasibility and safety of endovenous mechanochemical ablation (MOCA) for the treatment of great saphenous vein (GSV) incompetence.. The newly developed ClariVein device uses a technique that combines mechanical endothelial damage using a rotating wire with the infusion of a liquid sclerosant. Heating of the vein and tumescent anesthesia are not required; only local anesthesia is utilized at the insertion site. In a pilot study, 30 limbs in 25 patients (18 women; mean age 52 years) with GSV incompetence were treated with MOCA using polidocanol at 2 centers. Initial technical success, complications, patient satisfaction, and classification by venous clinical severity score (VCSS) were assessed 6 weeks after the treatment.. Initial technical success of MOCA was 100%. There were no major adverse events. Minor complications consisted of 9 local ecchymoses at the puncture site and superficial phlebitis that resolved within a week in 4 limbs. Duplex ultrasonography at 6 weeks showed 26 (87%) of 30 veins were completely occluded; 3 veins showed partial recanalization in the proximal (n = 2) and distal GSV. One patient had full segment recanalization and was successfully retreated. The VCSS significantly improved at 6 weeks (p < 0.001). Patient satisfaction was high, with a median satisfaction of 8.8 on a 0-10 scale.. This study showed that endovenous MOCA, using polidocanol, is feasible and safe in the treatment of GSV incompetence. Larger studies with a prolonged follow-up are indicated to prove the efficacy of this technique in terms of obliteration rates.

Topics: Ablation Techniques; Adult; Aged; Combined Modality Therapy; Equipment Design; Female; Humans; Male; Middle Aged; Netherlands; Patient Satisfaction; Pilot Projects; Polidocanol; Polyethylene Glycols; Prospective Studies; Saphenous Vein; Sclerosing Solutions; Sclerotherapy; Severity of Illness Index; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Color; Venous Insufficiency

The aim of this study was to compare the efficacy and side effects of ultrasound-guided foam sclerotherapy of the great saphenous vein using 1% and 3% polidocanol foam with a 3-year follow-up.. A multicentre prospective double-blind randomised clinical trial comparing the efficacy of 1% vs. 3% polidocanol sclerosant foam.. Patients with incompetence of the great saphenous vein (GSV) in CEAP clinical classes C2-5 (CEAP, Clinical-Etiology-Anatomy-Pathophysiology), with or without incompetence of the sapheno-femoral junction, were included. The Turbofoam method was used to create 1% and 3% polidocanol foam, which was injected into the GSV under ultrasound guidance, with a volume not exceeding 10 ml. Further foam sclerotherapy was carried out at 6 weeks, 3 and 6 months if required to abolish persistent venous reflux. The main outcome measure was the absence of saphenous reflux as assessed by ultrasound imaging at 6 months, 1, 2 and 3 years. Clinical severity (Venous Clinical Severity score (VCSS)) and quality of life (the Chronic Venous Insufficiency Questionnaire (CIVIQ)) scores were assessed.. A total of 143 patients were included; 1% group men = 18, women = 55, 3% group men = 19, women = 51. The abolition of venous reflux was: 1% group, 69% and 3% group, 85% at 6 months; 1% group, 79% and 3% group, 78% at 3 years (including additional injections at 6 months). Three asymptomatic thrombo-embolic events (2%) occurred. Local side effects (principally pigmentation and matting) were 9% in the 3% group and 6% in the 1% group at 3 years (N.S.). Clinical severity and quality of life scores improved by more than 20% at 6 months in both the groups, with no difference between the groups.. This is the first randomised clinical trial of ultrasound-guided foam sclerotherapy which is a 3-year follow-up and shows equivalent efficacy of 1% and 3% sclerosant foam.. 2006-07-05.

Topics: Dose-Response Relationship, Drug; Double-Blind Method; Female; Follow-Up Studies; Humans; Injections, Intravenous; Male; Middle Aged; Polidocanol; Polyethylene Glycols; Prospective Studies; Saphenous Vein; Sclerosing Solutions; Sclerotherapy; Time Factors; Tissue Adhesives; Treatment Outcome; Ultrasonography, Doppler, Color; Venous Insufficiency

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

To compare the relative efficacy of polidocanol (Aetoxisclerol, Kreussler, Germany) when used as a foam or liquid in the treatment of saphenous incompetence.. Multicentre, prospective, randomised controlled trial conducted in patients with incompetence of the great saphenous vein (GSV) with a truncal diameter of 4-8 mm. The great saphenous vein was injected using a single injection 2-2.5 ml of either 3% polidocanol or sclerosant foam containing one-fifth 3% polidocanol to four-fifths air (DSS technique). Clinical assessments and duplex ultrasound scanning were performed after 3 weeks and then every 6 months for 2 years. No re-injection was performed irrespective of the immediate result. The main outcome measure was elimination of GSV reflux.. Ninety-five patients participated in the study, 47 were randomised to the foam sclerosant group and 48 to the liquid group. No significant difference between the 2 groups was found regarding sex, age, height, weight and saphenous vein diameter. At 3 weeks, complete elimination of reflux was obtained in 17 of the 48 patients (35%) who received liquid sclerotherapy, versus 40 of the 47 subjects (85%) in the foam group (p<0.001, Chi squared). The incidence of immediate venous spasm and the length of the sclerotic reaction, occlusion measured by echography, were significantly greater in the foam group. There was no difference in the incidence of ecchymosis, inflammatory reactions or other side effects. Follow-up of 6, 12, 18 and 24 months confirms our early results published in 2003. In total only 5 patients were lost to follow-up at 2 years (all of them were in foam group). These patients were included in the final outcome analysis as treatment failures (success rates at 2 years: 53% in foam group and 12% in liquid group).. The sclerosant foam used in this study was more than twice as effective as the liquid from which the foam was prepared.

Topics: Administration, Topical; Aged; Dosage Forms; Female; Follow-Up Studies; Humans; Male; Middle Aged; Polidocanol; Polyethylene Glycols; Prospective Studies; Saphenous Vein; Sclerosing Solutions; Sclerotherapy; Treatment Outcome; Venous Insufficiency

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

Eighty subjects were treated with either 1 or 3% polidocanol foam to compare the efficacy and adverse sequelae of each concentration of polidocanol foam.. The objective was to compare the effects of two different concentrations of polidocanol foam.. During a 6-month period, we treated 80 consecutive patients with primary incompetent great saphenous veins in combination with saphenofemoral junction incompetence. These patients were treated with foam of either 1 or 3% polidocanol. Duplex analyses were made before treatment and in follow-up visits to determine the presence or absence of reflux.. After 1 year, there was a clinically relevant difference in percentage of patients with occlusion of the treated great saphenous vein between both groups: 69.5% in the 1% foam group versus 80.1% in the 3% foam group; however, this difference was not statistically significant (p=.249). After 1 year of follow-up, patients in the 3% polidocanol group noticed a larger cosmetic improvement than patients in the 1% group.. In the treatment of primary incompetent greater saphenous veins, 3% polidocanol foam seems to be more effective than 1% polidocanol foam. The side effects were approximately similar in both groups.

Topics: Female; Follow-Up Studies; Humans; Male; Middle Aged; Polidocanol; Polyethylene Glycols; Saphenous Vein; Sclerotherapy; Tissue Adhesives; Ultrasonography; Venous Insufficiency

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

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

Topics: Humans; Patients; Polidocanol; Sclerotherapy; 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

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

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

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

Chronic venous insufficiency is an important health problem; small saphenous vein (SSV) insufficiency is one of the leading causes and may affect up to 20% of adults. In addition to conventional treatment methods, endovenous treatment techniques have become popular in treatment of varicose veins. Herein, we report the outcomes of ultrasound-guided foam sclerotherapy (UGFS) in patients with symptomatic SSV insufficiency.. From January 2014 to June 2018, patients with primary SSV insufficiency treated with UGFS were followed to assess the effectiveness and safety of the procedure. A total of 31 lower limbs of 30 patients (18 females and 12 males), who attended control visits at 1 week, 1, 3, and 6 months, and yearly, after undergoing UGFS, were included in the study. The clinical results, occlusion rates, and the patients' preprocedure and postprocedure Venous Clinical Severity Scores were recorded.. The records show that, during the procedure, severe pain occurred at the time of injection in one patient (3%), vasovagal syncope in one patient (3%), hyperpigmentation in five patients (16%), and phlebitis in three patients (9%). It was also recorded that during follow-up 24 legs (78%) showed complete thrombosis and 7 legs (22%) had partial thrombosis. The mean Venous Clinical Severity Score for the patients before UGFS was 8.58 ± 3.78, and 7.25 ± 3.17 after the procedure. No major complications, including sural nerve injury and deep venous thrombosis, were seen during the follow-up period.. The results of this study show that UGFS is a simple, safe, and effective procedure for treatment in patients with symptomatic SSV insufficiency with acceptable side effects.

Topics: Adult; Chronic Disease; Female; Humans; Male; Middle Aged; Polidocanol; Prospective Studies; Saphenous Vein; Sclerosing Solutions; Sclerotherapy; Time Factors; Treatment Outcome; Ultrasonography, Interventional; Venous Insufficiency

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

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

This study measured patient outcomes among symptomatic patients with superficial chronic venous insufficiency who were treated with retrograde ultrasound-guided polidocanol microfoam 1% in a community setting.. Between March 2015 and June 2017, 250 symptomatic patients with C2-C6 chronic venous insufficiency received polidocanol microfoam 1% and were followed for 16 ± 7 months. Sixteen of the 250 patients (6.4%) had skin ulcers, and 56 (22.4%) were treated previously with thermal or surgical interventions. All patients underwent a duplex ultrasound venous incompetence study to map perforators and veins to be treated. Incompetent veins were accessed with a micropuncture needle distal to the midthigh perforator, approximately 10 cm above the knee fold. The leg was then elevated 45°. Under ultrasound guidance, the incompetent greater saphenous vein was closed with polidocanol microfoam 1%. A second injection was administered through the same catheter directing the microfoam to flow in a retrograde fashion through the incompetent venous valves to the ankle.. All patients completed the initial treatment; 55 (22.0%) required planned secondary treatment during the follow-up period for residual venous reflux in the below-knee greater saphenous vein. Complete elimination of venous valvular reflux and symptom improvement was documented in 236 patients (94.4%). Minor adverse events included asymptomatic deep vein thrombi (n = 2), common femoral vein thrombus extension (n = 1), and superficial venous thrombi (n = 4). Of the 16 patients with skin ulcers, 10 were C6 patients and 80% experienced wound closure within 4 weeks of treatment.. Retrograde administration of polidocanol microfoam 1% is a safe and effective treatment with important clinical benefit for superficial venous insufficiency in community practice.

Topics: Adult; Aged; Aged, 80 and over; Chronic Disease; Endovascular Procedures; Female; Humans; Leg Ulcer; Male; Middle Aged; Patient Satisfaction; Polidocanol; Polyethylene Glycols; Recovery of Function; Retreatment; Retrospective Studies; Sclerosing Solutions; Sclerotherapy; Time Factors; Treatment Outcome; Ultrasonography, Interventional; Venous Insufficiency; Wound Healing

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

The purpose of this prospective study was to evaluate the occlusion rate, clinical severity, disease specific health related quality of life (HRQoL), and safety in patients with great saphenous vein (GSV) reflux 3 years after a single treatment session of catheter directed foam sclerotherapy (CDFS) combined with peri-saphenous infiltration of tumescent local anaesthesia (TLA).. A total of 249 patients with symptomatic unilateral GSV incompetence underwent CDFS combined with TLA and were followed up for 3 years. The primary outcome was complete obliteration of the treated segment of the GSV. Secondary outcomes were changes in Venous Clinical Severity Score (VCSS) and Chronic Venous Insufficiency Quality of Life Questionnaire (CIVIQ) score, absence of above knee GSV reflux, and safety of treatment.. Three years after CDFS, the estimated cumulative proportion of persistently obliterated above knee GSV was 81.5%. Freedom from above knee GSV reflux was demonstrated in 89.6% of patients. Both the VCSS and CIVIQ score improved significantly (p < .0001 and <.0001, respectively). No major adverse events were encountered. Thrombophlebitis, skin pigmentation/matting, and transient scotomata were reported in 2%, 7.8%, and 0.8% of cases, respectively.. CDFS combined with TLA for treatment of GSV incompetence yields good mid-term results in terms of occlusion rate, clinical severity, patients' QoL, and safety.

Topics: Adult; Aged; Anesthesia, Local; Catheterization, Peripheral; Female; Humans; Male; Middle Aged; Polidocanol; Polyethylene Glycols; Prospective Studies; Quality of Life; Saphenous Vein; Sclerosing Solutions; Sclerotherapy; Severity of Illness Index; Surveys and Questionnaires; Time Factors; Treatment Outcome; Venous Insufficiency; Young Adult

To report the midterm results of mechanochemical ablation (MOCA) for treating great saphenous vein (GSV) insufficiency.. In a 1-year period, 85 consecutive patients (median age 51.4 years; 71 women) undergoing MOCA with polidocanol in 104 limbs were enrolled in a prospective registry. The patients were evaluated at baseline and during follow-up (4 weeks and 1, 2, and 3 years) using duplex ultrasound, the CEAP (clinical, etiologic, anatomic and pathophysiologic) classification, the Venous Clinical Severity Score (VCSS), the RAND Short Form 36-Item Health Survey (RAND-SF36), and the Aberdeen Varicose Vein Questionnaire (AVVQ). Primary outcome measures were clinical and anatomic success. Secondary outcome measures included general and disease-specific quality of life and reinterventions.. Technical success (99%) was achieved in all but 1 patient in whom technical problems with the device led to conversion to another method for treatment of 2 limbs. After a median follow-up of 36 months (interquartile range 12.5, 46.3), recanalization occurred in 15 (15%) of 102 successfully treated vein segments. Anatomic success was 92%, 90%, and 87% after 1, 2, and 3 years, respectively. The VCSS improved at all time intervals compared to the preprocedure median. The clinical success at 3 years was 83%. The AVVQ and RAND-SF36 scores showed an improvement at all time intervals compared to baseline values. Between 12 and 36 months, however, a significant deterioration was observed in VCSS, which was accompanied by worsening of disease-specific and general quality of life.. In the longest follow-up of MOCA to date, this study shows MOCA to be an effective treatment modality for GSV insufficiency at midterm follow-up, but clinical results seem to drop over time.

Topics: Ablation Techniques; Adult; Aged; Aged, 80 and over; Endovascular Procedures; Female; Humans; Male; Middle Aged; Polidocanol; Polyethylene Glycols; Prospective Studies; Registries; Saphenous Vein; Sclerosing Solutions; Sclerotherapy; Severity of Illness Index; Surveys and Questionnaires; Time Factors; Treatment Outcome; Ultrasonography, Doppler, Duplex; Venous Insufficiency; Young Adult

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

Thermal ablative techniques of varicose veins carry a risk of heat-related complications, including postoperative pain. Mechanochemical endovenous ablation (MOCA) might avoid these complications and reduce postoperative pain because of the absence of thermal energy. This study evaluated postoperative pain and quality of life after radiofrequency ablation (RFA) and MOCA for great saphenous vein (GSV) incompetence.. Sixty-eight patients with unilateral GSV incompetence were treated with either RFA or MOCA in this prospective observational study. Patients monitored their pain for the first 14 postoperative days on a 100-mm visual analog scale (VAS). They also completed the general (RAND 36-Item Short-Form Health Survey) and disease-specific (Aberdeen Varicose Vein Questionnaire) quality of life questionnaires before and 6 weeks after treatment.. Patients treated with MOCA reported significantly less postoperative pain than patients treated with RFA during the first 14 days after treatment (4.8 ± 9.7 mm vs 18.6 ± 17.0 mm; P < .001) (mean VAS over 14 days). The lower postoperative pain score was associated with a significantly earlier return to normal activities (1.2 ± 1.8 vs 2.4 ± 2.8 days; P = .02) and work resumption (3.3 ± 4.7 vs 5.6 ± 5.8 days, respectively; P = .02). At 6 weeks, patients in both groups perceived an improved change in health status and an improved disease-specific quality of life.. MOCA is associated with significantly less postoperative pain, faster recovery, and earlier work resumption compared with RFA in the treatment of GSV incompetence. MOCA and RFA are both related to a rapid improvement in quality of life.

Topics: Adult; Aged; Catheter Ablation; Chi-Square Distribution; Female; Health Status; Humans; Male; Middle Aged; Netherlands; Pain Measurement; Pain, Postoperative; Polidocanol; Polyethylene Glycols; Prospective Studies; Quality of Life; Registries; Saphenous Vein; Sclerosing Solutions; Sclerotherapy; Surveys and Questionnaires; Time Factors; Treatment Outcome; Venous Insufficiency

Topics: Ablation Techniques; Female; Humans; Male; Polidocanol; Polyethylene Glycols; Saphenous Vein; Sclerosing Solutions; Sclerotherapy; Venous Insufficiency

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

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

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

This clinical study evaluated prospectively adverse events immediately following ultrasound-guided foam sclerotherapy (UGFS) for the treatment of lower extremity venous valvular insufficiency. Incidence of side effects associated with carbon dioxide (CO(2)) foam was compared with a historical control using air-based foam. The literature on the subject was reviewed.. Vital signs were monitored during and immediately after UGFS, and adverse events were recorded for 24 hours following the procedure. The air-based foam group had 49 patients: 44 women and 5 men. The CO(2)-based foam group had 128 patients: 115 women and 13 men. CEAP class was C2EpAsPr, describing varicose veins, primary etiology, and saphenous reflux. UGFS followed thermal ablation of the great saphenous vein. Foam was prepared using the three-way tap technique to mix gas with 1% polidocanol in a 4:1 ratio. Segments of the great and small saphenous veins and their tributaries were treated with UGFS. Foam volumes injected were 27 +/- 10 (SD) (6-46 range) and 25 +/- 12 (6-57 range) mL for air- and CO(2)-based foams respectively (P = .39). Incidence of adverse events was compared by chi(2) statistics. Vital signs were compared by paired t test.. During the procedure, the average heart rate decreased by less than 5 bpm for both groups (P < .001), and blood pressure decreased by less than 3 mm Hg in the CO(2) group (P < .02). Respiratory rate, electrocardiogram, and pulse oxymetry did not change significantly in both air- and CO(2)-foam series (P > .05). Visual disturbances were experienced by 3.1% (4/128) and 8.2% (4/49) patients in the CO(2) and air groups respectively (P = .15). Respiratory difficulties or circumoral paresthesia each occurred in 0.8% (n = 1) of the CO(2) patients. Incidence of chest tightness (3.1% vs 18%), dry cough (1.6% vs 16%), or dizziness (3.1% vs 12%) were significantly lower in the CO(2) vs air groups (P < .02). Nausea occurred in 2% and 4% of the CO(2) and air-based foam groups (P = .53). Overall, the proportion of patients describing side effects decreased from 39% (19/49) to 11% (14/128) as CO(2) replaced air for foam preparation (P < .001). Similar findings were described in the literature of air-based foam but data on the use of physiological gas were rare.. Side effects decreased significantly if CO(2) rather than air was employed to make the sclerosing foam for chemical ablation of superficial veins of the lower extremity.

Topics: Adult; Aged; Aged, 80 and over; Air; Blood Pressure; Carbon Dioxide; Female; Heart Rate; Humans; Male; Middle Aged; Nausea; Polidocanol; Polyethylene Glycols; Respiratory Physiological Phenomena; Sclerotherapy; Venous Insufficiency

We sought to optimize sclerotherapy of the greater saphenous vein (GSV) by targeted application of foamed sclerosant by using a catheter.. We designed a new double-lumen catheter that is inserted into the GSV. Via one lumen, a balloon at the tip of the catheter can be inflated to stop the blood flow. Via the second lumen, the sclerosing agent can be injected and aspirated. This method enabled us to perform a targeted application of the sclerosing agent [catheter-assisted vein sclerotherapy (KAVS)]. In an open study, outpatients suffering from varicosis of the GSV received a foam sclerotherapy under ultrasound guidance, using the newly developed KAVS catheter.. Thirty patients with an insufficiency (reflux) of the GSV were treated with the newly developed KAVS method using foamed polidocanol. The intervention was well tolerated in all patients without the occurrence of serious side effects. In 27 of the 30 treated patients (90%), we found a closure of the GSV at control visits 6 weeks, 3 months, and 6 months after treatment.. The KAVS method represents a feasible approach for sclerotherapy of the GSV. The efficiency and treatment modalities need to be explored in further studies.

Topics: Adult; Aged; Catheterization, Peripheral; Female; Humans; Male; Middle Aged; Polidocanol; Polyethylene Glycols; Saphenous Vein; Sclerosing Solutions; Sclerotherapy; Venous Insufficiency

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

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