Effectiveness of polidocanol sclerotherapy in alleviating symptoms in patients with venous malformations.

OBJECTIVE: The objective of this study was to retrospectively evaluate the effectiveness of polidocanol in managing pain, swelling, functional limiting and cosmetic disorders in patients with venous malformations (VMs). METHODS: This retrospective study included patients who underwent sclerotherapy with polidocanol for VMs between 2020 and 2022. Patient records, imaging findings, and evaluation questionnaires used in the preprocedure and follow-up phases were reviewed. After sclerotherapy, patients were followed up at 1, 2, 3, and 6 months. During these visits, the previously used 11-point verbal numerical rating scale (from 0 [no pain] to 10 [worst pain thinkable]) was used to evaluate the severity of symptoms such as pain, swelling, cosmetic discomfort, and functional limitation, and patients were asked to report the number of days per week they experienced these symptoms owing to the VM. RESULTS: A total of 194 sclerotherapy procedures (mean, 1.6 ± 0.3 procedures) in 84 patients (55 female and 29 male patients; mean age, 22.45 ± 11.83 years) were conducted. The majority of these malformations (81%, or 68 patients) were located in the extremities. We found a significant decrease in pain, swelling, functional limitation, cosmetic appearance, and number of painful days between all time points, except for the comparison between months 3 and 6 (P < .001) CONCLUSIONS: Polidocanol sclerotherapy is a safe and effective treatment for VMs that significantly decreases patient complaints and has a very low complication rate. Particularly, following patients at short intervals and administering additional sclerotherapy sessions when necessary will significantly increase patient satisfaction.

Comparison of bleomycin polidocanol foam vs electrochemotherapy combined with polidocanol foam for treatment of venous malformations.

OBJECTIVE: This study aims to investigate the difference in safety and efficacy between two treatments for venous malformations (VMs), electrochemotherapy combined with polidocanol foam (ECP) and bleomycin polidocanol foam (BPF), providing alternative therapies for VMs. METHODS: We conducted a retrospective review of 152 patients with VMs treated with ECP and BPF. Pre- and post-treatment magnetic resonance images (MRIs) were collected, and clinical follow-up assessments were performed. Imaging results were used to calculate lesion volume changes. Clinical outcomes included changes in pain and improvements in perceived swelling. Patients were followed up at 1 week and 6 months after surgery. All emerging complications were documented in detail. RESULTS: Of the 152 patients, 87 (57.2%) received BPF treatment, and 65 (42.8%) received ECP treatment. The most common location of VMs was the lower extremities (92/152; 60.2%), and the most common symptom was pain (108/152; 71.1%). Forty-three patients had previously undergone therapy in the BPF group (43/87; 49.4%), whereas 30 patients had received prior treatment in the ECP group (30/65; 46.2%). The study found that the percentage of lesion volume reduction in the BPF group was not significantly different from that in the ECP group (75.00% ± 17.85% vs 74.69% ± 8.48%; P = .899). ECP was more effective when the initial lesion volume was greater than 30 mL (67.66% ± 12.34% vs 73.47% ± 8.00%; P = .048). Patients treated with BPF had significantly less posttreatment pain than those treated with ECP, in different baseline lesion size. In the overall sample, pain relief was significantly higher in the BPF group than in the ECP group (4.21 ± 1.19 vs 3.57 ± 0.76; P = .002). However, there was no difference in pain relief between the two groups for the treatment of initially large VMs (4.20 ± 0.94 vs 3.70 ± 0.87; P = .113). The ECP group was significantly more likely to develop hyperpigmentation (5/87; 5.75% vs 11/65; 16.92%; P = .026) and swelling (9/87; 10.34% vs 16/65; 24.62%; P = .019) 1 week after surgery than the BPF group. CONCLUSIONS: Our study demonstrates that both BPF and ECP are effective treatments for VMs, with BPF being a safer option. ECP is a better choice for patients with the initial lesion volume greater than 30 mL, but it is more likely to lead to early swelling and hyperpigmentation.

Sclerotherapy of Venous Malformations Using Polidocanol: Effectiveness, Safety, and Predictors of Outcomes and Adverse Events.

PURPOSE: To assess the effectiveness, safety, and predictors of outcomes and adverse events for percutaneous sclerotherapy using polidocanol for the treatment of venous malformations (VMs). METHODS: A retrospective single-center analysis was performed, including patients with VMs who were treated with sclerotherapy using polidocanol between January 2011 and November 2021 at a tertiary center. Demographic characteristics, clinical data, and radiologic features were analyzed, and the influence of patient- and VM-related factors on the subjective clinical outcome and adverse events were investigated using a multivariate logistic regression analysis. RESULTS: In total, 167 patients who received 325 treatment sessions were included in this study. Overall symptom improvement was observed in 67.5%, stable symptoms were observed in 25.0%, and worsening was reported in 7.5% (clinical follow-up, 1.04 ± 1.67 years). The total adverse event rate was 10.2%, with an overall rate of 4.2% for permanent adverse events within the cohort. In multivariate analysis, the clinical outcome was worse in children (P = .01; 57.1% symptom improvement in children [age, <18 years] and 79.7% in adults), and adverse events were more frequently observed after the treatment of VMs located at the extremities (P < .01; 8.4% for VMs of the extremities and 1.2% for VMs in other locations). CONCLUSIONS: Sclerotherapy using polidocanol can be an effective treatment option for VMs with an acceptable safety profile. However, it can be less effective in children, and adverse events can be more frequently expected for VMs of the extremities.

Sclerotherapy Improves Symptoms in Patients with Small and Moderate Diameter Low-Flow Vascular Malformations: A Prospective Cohort Study.

BACKGROUND: Vascular malformations are rare diseases and treatment remains controversial. Sclerotherapy is accepted as a minimally invasive treatment with good results; however, some patients do not report good response to sclerotherapy, and it is not clear which variables influence treatment outcome, preventing optimal patient selection. We hypothesized that large diameter lesions have reduced efficacy and satisfaction with sclerotherapy. Therefore, we prospectively evaluated the clinical response of low-flow vascular malformations treated with 1% polidocanol foam sclerotherapy and determined the correlation of symptom improvement with clinical variables. METHODS: Prospective cohort study of patients with symptomatic low flow vascular malformations treated at the Hospital das Clínicas between December 2016 and November 2018. Lesions were classified according to location, extension, diameter, type of vessels, margins, and symptoms. Sclerotherapy was performed by direct injection of 1% polidocanol foam, with a maximum volume of 10 ml per session. Symptom improvement was evaluated using the visual analog scale and patient-reported quality of life was assessed by the Short-form 6 dimensions (SF-6D) questionnaire. Follow-up was performed every 3 months after treatment. RESULTS: Forty lesions were treated in 38 patients, with 19 women and 19 men; median age was 20.5 years (range 4 months to 63 years). Most lesions (80%) were venous, and most commonly in the lower limbs (47.5%); 27.5% were superficial, 35% were deep, and 37.5% affected both compartments. The most common clinical presentations were deformity (95%), pain (78%), and functional limitation (58%); deep compartment lesions were more associated with functional limitation (69% vs. 27%; P = 0.030). Fifty-three per cent of lesions were >10 cm and were associated with increased numbers of psychosocial symptoms (P = 0.038). Two-hundred and forty-two sessions of sclerotherapy were performed, with 6 mean treatments per lesion (range 1-15). The mean follow-up time was 23 months (range 2-23 months). The most common complications were pain and local edema, without any major complications; some patients reported symptom recurrence (15% pain, 10% deformity, and 12% functional limitation). Sclerotherapy was associated with significant improvement of all symptoms (P < 0.001). However, lesions >10 cm were associated with poor improvement in deformity (P = 0.003). Quality of life improved for most patients (60%) and treatment satisfaction was high (82%). CONCLUSIONS: Treatment of low-flow vascular malformations with 1% polidocanol foam is safe and effective; sclerotherapy improves symptoms and quality of life. Large diameter lesions (>10 cm) are associated with increased treatment failure. A small percentage of patients reported recurrent symptoms and require other modalities for successful treatment.

Comparison of outcomes following polidocanol microfoam and radiofrequency ablation of incompetent thigh great and accessory saphenous veins.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Prospective randomized trial of antithrombotic strategies following great saphenous vein ablation using injectable polidocanol endovenous microfoam (Varithena).

OBJECTIVE: 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. METHODS: 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. RESULTS: 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; χ2, P = .002). Patients in group A receiving apixaban anticoagulation had a significant reduction in DVT compared with patients in group C (1.98% vs 16.7%, χ2; P < .001); likewise, patients in group A had a significantly decreased DVT occurrence compared with group D (14.7% vs 1.98%; χ2, P = .00162), whereas patients in groups C and D were not statistically different (16.7% vs 14.7%; χ2, P = .60). CONCLUSIONS: (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.

A systematic review and network meta-analysis of the effectiveness of sclerotherapy for venous malformation.

OBJECTIVE: Sclerotherapy for venous malformation has been widely used; however, no guidelines are available to assess the effectiveness of different sclerotherapy agents. We conducted a systematic review and network meta-analysis to investigate the effectiveness of sclerotherapy agents for venous malformations. METHODS: Three electronic databases were searched from their inception (1950) to April 29, 2021. Studies comparing the effectiveness of different sclerotherapy agents were included. The risk of bias within and across studies was assessed. Pairwise meta-analyses were conducted, followed by a network meta-analysis. We also assessed inconsistency and publishing bias using various approaches. RESULTS: Seven studies with 547 patients in six arms were included in the present study. We defined the response and complete response as two separate outcomes. Significant differences were observed in four comparisons with respect to the response (ethanol vs bleomycin, ethanol vs polidocanol, ethanol vs sodium tetradecyl sulfate, polidocanol vs sodium tetradecyl sulfate). No statistically significant differences were found in the other comparisons. The evidence network revealed that for the response outcome, ethanol ranked first, followed by pingyangmycin, polidocanol, sodium morrhuate, bleomycin, and, finally, sodium tetradecyl sulfate. For the complete response outcome, pingyangmycin had the best results, followed by sodium morrhuate, polidocanol, ethanol, bleomycin, and, finally, sodium tetradecyl sulfate. Major complications, such as facial nerve palsy, serious local swelling, and necrosis, had occurred mostly in the ethanol group and rarely in the other groups. Because of the limited data, no further analysis of major complications was conducted. Our confidence in the comparisons and rankings was low. We found no verified inconsistency or publishing bias in the present study using the existing approaches. CONCLUSIONS: Ethanol showed a significantly better response statistically compared with the other agents. However, ethanol had also resulted in the highest incidence of complications. Pingyangmycin showed the second-best response, best complete response, and a low rate of complications, respectively. Overall, pingyangmycin achieved excellent performance and balance in terms of the different outcomes. However, they could not be adequately recommended from the available data. More superior trials, especially randomized controlled trials, are needed in the future.

Skin hyperpigmentation after sclerotherapy with polidocanol: A systematic review.

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

Analysis of adverse events with sclerosants reported to the United States Food and Drug Administration.

OBJECTIVES: To analyze adverse events (AEs) related to sclerosants reported through the Federal Adverse Event Reporting System (FAERS). METHODS: We queried the FAERS database for all cases associated with sclerosants. Reports were analyzed and stratified based on severity of cases and patient death. RESULTS: A total of 1215 cases with 3124 reactions were identified among 4 sclerosants. "General disorder and administration site conditions" reaction group was prevalent in all sclerosants. For polidocanol, deep vein thrombosis and pulmonary embolism were the most common severe reactions while cardiac arrest was frequent in death cases. Anaphylaxis was common in fatalities of sodium tetradecyl sulfate. Ethanolamine oleate was associated with procedural errors, while morrhuate sodium resulted in few cases. CONCLUSION: Our analysis supports previous studies concerning common local symptoms, but also reveals serious and death associated reaction profiles specific to individual sclerosants. Practitioners should be knowledgeable on both non-lethal and fatal AEs for each sclerosant. The multitude of reports concerning serious reactions and deaths we report herein provide a cautionary reminder to venous practitioners and patients that sclerotherapy is not a trivial procedure.

A multicentre, open-label, single-arm phase II trial of the efficacy and safety of sclerotherapy using 3% polidocanol foam to treat second-degree haemorrhoids (SCLEROFOAM).

BACKGROUND: The aim of the present study was to evaluate the efficacy and safety of 3% polidocanol foam for treating 2nd-degree haemorrhoids. METHODS: A multicentre, open-label, single-arm, phase 2 trial involving 10 tertiary referral centres for haemorrhodal disease (HD) was performed. Between January and June 2019, patients with 2nd-degree haemorrhoids were prospectively included in this study. The primary outcome was to establish the success rate after one sclerotherapy session in terms of complete resolution of bleeding episodes one week after the injection. The Hemorrhoidal Disease Symptom Score (HDSS), the Short Health Scale for HD (SHS-HD) score and the Vaizey incontinence score were used to assess symptoms and their impact on quality of life and continence. Pain after the procedure, subjective symptoms and the amount and type of painkillers used were recorded. Patients were followed up for 1 year. RESULTS: There were 183 patients [111 males; 60.7%, mean age 51.3 ± 13.5 (18-75) years]. Complete resolution of bleeding was reached in 125/183 patients (68.3%) at 1 week and the recurrence rate was 12% (15/125). Thirteen patients (7.4%) underwent a second sclerotherapy session, while only 1 patient (1.8%) had to undergo a third session. The overall 1-year success rate was 95.6% (175/183). The HDSS and the SHS score significantly improved from a median preoperative value of 11 and 18 to 0 and 0, respectively (p < 0.001). There were 3 episodes of external thrombosis. No serious adverse events occurred. CONCLUSIONS: Sclerotherapy with 3% polidocanol foam is a safe, effective, painless, repeatable and low-cost procedure in patients with bleeding haemorrhoids.

Endovenous microfoam ablation of below knee superficial truncal veins is safe and effective in patients with prior saphenous treatment across a wide range of CEAP classes.

OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Inframalleolar access in endovenous treatment of venous ulcers and C5 disease with nonthermal nontumescent techniques.

PURPOSE: To evaluate the use of inframalleolar access for endovenous ablation when treating advanced venous disease with nonthermal nontumescent (NTNT) techniques. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

A multicenter, randomized, dose-finding study of mechanochemical ablation using ClariVein and liquid polidocanol for great saphenous vein incompetence.

BACKGROUND: 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). METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.

Polidocanol Sclerotherapy in Pyogenic Granulomas.

BACKGROUND: Polidocanol is a safe sclerosing agent with anesthetic properties and minimal skin toxicity. OBJECTIVE: To evaluate the efficacy, safety, and recurrence rates with polidocanol sclerotherapy in the treatment of pyogenic granulomas (PGs). METHODS AND METHODS: Thirty-nine patients with PG were injected with polidocanol 1% solution. Repeat injections were given weekly in case of incomplete clinical/dermoscopic resolution, until a maximum of 3 sittings. A higher strength (3%) was used for subsequent sessions in those with a minimal response to 1% solution. A final assessment for relapses was performed at 3, 6, and 12 months. RESULTS: All 39 patients achieved complete resolution (100% clearance rate), with most (n = 26) lesions resolving after the first sitting. Side effects noted were postprocedure pain (22), erythema (2), superficial ulceration (2), paresthesias (1), prominent edema (4), thrombophlebitis (1), cyanotic discoloration (1), purpuric staining around injection site (4), and mild local pruritus (1). The procedure was well tolerated across the age spectrum (4-63 years) included. CONCLUSION: We report polidocanol to be a highly effective, safe, and cost-effective sclerosant for treatment of PGs with no recurrences or need for special postprocedure care.

Treatment of superficial venous insufficiency in a large patient cohort with retrograde administration of ultrasound-guided polidocanol endovenous microfoam versus endovenous laser ablation.

OBJECTIVE: 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). METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Bikini textile contact dermatitis: A Sherlockian approach revealing 2,4-dichlorophenol as a potential textile contact allergen.

BACKGROUND: Different textile constituents may act as allergens and/or irritants and provoke textile contact dermatitis (TCD). OBJECTIVES: To report a case of TCD caused by ethylene glycol monododecyl ether and 2,4-dichlorophenol, present in a bikini. METHODS: A woman presented with an eczematous, pruritic rash in the area of the bikini straps and back. Patch testing was performed with the European baseline, textile, sunscreen, and photo-patch series, the bikini "as is", and ethanol and acetone extracts of the bikini. Thin-layer chromatography (TLC) of the extracts and gas chromatography-mass spectrometry (GC-MS) analysis were used to elucidate the culprit agents. RESULTS: Positive reactions were found to the bikini "as is" and to the ethanol and acetone extracts. Patch testing with TLC strips showed a strong reaction to spots-fractions 3 and 4. GC-MS was performed to identify substances in each fraction and those suspected to be skin sensitisers were patch tested. On day (D) 4 positive reactions to ethylene glycol monododecyl ether (irritant reaction) and 2,4-dichlorophenol (++) were observed. CONCLUSION: A myriad of chemical compounds can be found in clothing. Ethylene glycol monododecyl ether and 2,4-dichlorophenol were identified as the potential culprits of this bikini TCD.

Efficacy and safety of polidocanol in the treatment of varicose veins of lower extremities: A protocol for systematic review and meta-analysis.

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

Polidocanol Sclerotherapy for the Treatment of Pyogenic Granuloma in Children.

BACKGROUND: Pyogenic granuloma (PG) is a benign vascular lesion that is commonly observed in the skin and mucosa. Sclerotherapy is the first-line conservative treatment option for PG. OBJECTIVE: This retrospective study aimed to evaluate the efficacy of sclerotherapy with 1.0% polidocanol for the treatment of PG. MATERIALS AND METHODS: All patients who were clinically diagnosed with PG consecutively at the Pediatric Outpatient Service of Qilu Children's Hospital of Shandong University from March 2018 to October 2019 received sclerotherapy with 1.0% polidocanol. RESULT: The procedure resulted in the complete excision of PG, with inconspicuous scars. The procedure was well-tolerated, and recurrence was not observed. Allergic reactions, cutaneous necrosis, and pigmentary changes were not observed. CONCLUSION: Sclerotherapy with 1.0% polidocanol is considered an effective treatment for PGs in children. Early treatment was associated with a more favorable outcome.