Polidocanol-foam treatment of varicose veins: Quality-of-life impact compared to conventional surgery.

BACKGROUND AND OBJECTIVE: Lower limb varicose veins are a prevalent disease associated with several available treatment options, including conventional surgery and polidocanol foam sclerotherapy. However, few studies have analyzed therapeutic modality outcomes based on Patient-Reported Outcome Measures (PROMs). This large sample-size study was designed to evaluate the outcomes of polidocanol foam sclerotherapy compared to conventional surgery based on an analysis of PROMs. METHODS: This was a prospective, observational, and qualitative study of 205 patients who underwent varicose vein treatment with either polidocanol foam sclerotherapy (57 patients, 90 legs) or conventional surgery (148 patients, 236 legs). Patients were preoperatively assessed and re-evaluated 30 days after the procedure using the Venous Disease Severity Score (VCSS) and specific venous disease quality-of-life questionnaires (VEINES-QoL/Sym). RESULTS: Both treatments significantly improved VCSS and VEINES results 30 days after the procedure (p < 0.05). However, surgery promoted greater improvements in VCSS (on average 4.02-points improvement, p < 0.001), VEINES-QoL (average 8-points improvement, p < 0.001), and VEINES-Sym (average 11.66 points improvement, p < 0.001) than did sclerotherapy. Postoperative pain and aesthetic concerns about the legs were the domains of the questionnaires in which the results varied the most between the treatment modalities, with worse results for sclerotherapy. CONCLUSION: Both polidocanol foam sclerotherapy and conventional surgery positively impact patients' quality of life after 30 days, but the improvement is more significant for patients who undergo conventional surgery.

Whole-lesion assessment of volume and signal changes after sclerotherapy of extremity venous malformations.

PURPOSE: To investigate quantitative changes in MRI signal intensity (SI) and lesion volume that indicate treatment response and correlate these changes with clinical outcomes after percutaneous sclerotherapy (PS) of extremity venous malformations (VMs). METHODS: VMs were segmented manually on pre- and post-treatment T2-weighted MRI using 3D Slicer to assess changes in lesion volume and SI. Clinical outcomes were scored on a 7-point Likert scale according to patient perception of symptom improvement; treatment response (success or failure) was determined accordingly. RESULTS: Eighty-one patients with VMs underwent 125 PS sessions. Treatment success occurred in 77 patients (95 %). Mean (±SD) changes were -7.9 ± 24 cm3 in lesion volume and -123 ± 162 in SI (both, P <.001). Mean reduction in lesion volume was greater in the success group (-9.4 ± 24 cm3) than in the failure group (21 ± 20 cm3) (P =.006). Overall, lesion volume correlated with treatment response (ρ = -0.3, P =.004). On subgroup analysis, volume change correlated with clinical outcomes in children (ρ = -0.3, P =.03), in sodium tetradecyl sulfate-treated lesions (ρ = -0.5, P =.02), and in foot lesions (ρ = -0.6, P =.04). SI change correlated with clinical outcomes in VMs treated in 1 PS session (ρ = -0.3, P =.01) and in bleomycin-treated lesions (ρ = -0.4, P =.04). CONCLUSIONS: Change in lesion volume is a reliable indicator of treatment response. Lesion volume and SI correlate with clinical outcomes in specific subgroups.

Sclerotherapy of the Post renal Transplant Lymphoceles: A Meta-Analysis.

PURPOSE: This study evaluated the effectiveness of sclerotherapy in treating lymphoceles after kidney transplantation, focusing on factors such as recurrence rates and procedural success. MATERIALS AND METHODS: Retrospective studies using sclerotherapy as the only form of treatment for postrenal transplant lymphoceles were included. All studies used percutaneous transcatheter sclerotherapy as treatment, and the success rate of the intervention was recorded. Sixty-one references were obtained by manually searching the MEDLINE (n = 20), Embase (n = 41), and Cochrane Library databases (n = 0) for retrospective research studies that included the keywords "sclerotherapy post renal transplant lymphoceles." After removing 3 duplicates, 50 of the remaining articles were excluded after the screening, and the remaining studies were extracted for demographic data and our primary outcome of the success rate of sclerotherapy. RESULTS: A descriptive analysis of the outcomes and complication rates associated with sclerotherapy interventions for lymphoceles is provided. A high degree of variation across the different studies was observed. According to the Kruskal-Wallis test, there was no correlation between the sclerosant used and the sclerotherapy complication rate (P = .472) or the success rate (P = .591). There was also no correlation between the gender of the patient and the success rate; however, there was a significant difference in the complication rate by gender (P < .005). CONCLUSIONS: In conclusion, different sclerosant products have been used for therapy with no consensus on the most efficacious product because the success rate has been variable. In addition, the gender of the patient may influence the complication rates associated with sclerotherapy for lymphoceles in patients post-kidney transplant.

The Stability of Physician-Compounded Foam is Influenced by the Angle of Connector.

BACKGROUND: Foam sclerotherapy is an effective treatment for varicose veins and venous malformations, with its efficacy influenced by foam stability. The methods for preparing physician-compounded foam (PCF) are the double syringe system (DSS) and Tessari method. Few studies have been performed to compare the PCF stability produced by the 2 methods and their mechanisms. We aim to compare the stability of PCF produced by 2 two methods in the same connector and explore the reasons for the difference. METHODS: Foam was generated by the 2 methods under different circumstances. In the Tessari method, 2 syringes were connected at right angles (90°) by a 3-way tap. In the DSS method, 2 syringes were connected by the same 3-way tap in a straight line (180°). The stability and uniformity of foam produced by the 2 methods were compared using foam half-time and optical microscopy, respectively. Assuming that the difference in foam stability between the 2 methods was related to the angles of a connector, we compared the foam stability when 2 syringes were connected with a plastic connector bent to different angles. RESULTS: The DSS method could produce more uniform foam with longer foam half-time than the Tessari method, which was related to the angle of the connector. CONCLUSIONS: The stability of PCF is influenced by the angle of the connector.

Percutaneous Sclerotherapy of Large Venous Malformations Using Consecutive Polidocanol and Bleomycin Foam: MR Imaging Volumetric and Quality-of-Life Assessment.

PURPOSE: To retrospectively evaluate sclerotherapy using consecutive polidocanol and bleomycin foam (CPBF) for large untreated venous malformations (VMs) and/or those resistant to prior treatment. MATERIALS AND METHODS: This retrospective study included all patients treated with CPBF for untreated VMs larger than 10 mL and/or refractory to treatment between May 2016 and October 2019. Baseline and follow-up VM volumes were measured on fat-suppressed T2-weighted magnetic resonance (MR) imaging. Outcome was evaluated on postprocedural MR imaging volumetry and by a retrospective survey assessing clinical response and adverse events. Imaging response was considered good for volume reduction from 50% to 70% and excellent for volume reduction ≥70%. Symptoms and quality-of-life (QoL) scores were compared before and after CPBF sclerotherapy. RESULTS: Forty-five patients (mean age, 16 years; range, 1-63 years; 25 males) with 57 VMs were analyzed and treated by 80 sclerotherapy. Sixty percent (27 of 45) of patients had undergone prior treatment for VM. Median VM volume was 36.7 mL (interquartile range, 84 mL) on pretherapy MR imaging. Good and excellent results after the last sclerotherapy were achieved in 36% (16 of 45) and 29% (13 of 45) of patients, respectively, corresponding to a decrease of >50% in 60% (34 of 57) of VMs. QoL score increased by at least 3 points, regardless of initial symptoms. Most patients did not desire additional sclerotherapy owing to near complete symptomatic relief, even for patients who did not achieve a good response. Swelling, pain, and motor impairment scores significantly improved after CPBF. Adverse events included fever (44%, 15 of 34) and nausea/vomiting (29%, 10 of 34). CONCLUSIONS: CPBF sclerotherapy represents an effective therapy for large and/or refractory VMs with minimal adverse events.

Intralesional injection of bleomycin in the management of low flow vascular malformations: Results and factors affecting the outcome.

OBJECTIVE: Ethanol has been a commonly used sclerosant for low-flow vascular malformations, but it carries a high risk of complications. Bleomycin has been recently introduced as a potentially effective treatment. The aim of this study was to evaluate the safety and efficacy of bleomycin intralesional injection for the treatment of low-flow vascular malformations and determine the different factors affecting the outcome. PATIENTS AND METHODS: A total of fifty patients with low-flow vascular malformations were enrolled in the study between April 2020 and March 2022. All patients underwent preoperative duplex ultrasound and magnetic resonance angiography. The procedure was performed under ultrasound and fluoroscopic guidance. All patients were assessed for the objective improvement, ultrasound assessment, and patient-reported outcome. RESULTS: The overall rate of objective improvement was 79.53% (78.05% in venous and 87.5% in lymphatic malformations), whereas 81.25% of the patients showed a degree of size reduction or complete obliteration on postoperative ultrasound. The patient-reported outcome analysis showed a statistically significant improvement in the mean score for the pain, overall symptoms, and self-confidence. On regression analysis, the only factor associated with poor objective outcome was diffuse lesions (ill-defined or extending in more than one body region or one compartment). No major complications were recorded. CONCLUSIONS: Bleomycin intralesional injection is a safe and effective treatment for low-flow vascular malformations.

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.

Polymerisation of cyanoacrylates: The effect of sclero-embolic and contrast agents.

OBJECTIVES: The objective is to investigate the interaction of sclero-embolic and contrast agents with the polymerisation of medical grade n-butyl-cyanoacrylates. METHODS: An in vitro spectrophotometric absorbance method was developed to detect changes in light transmission to measure n-BCA polymerisation. The initiation and the rate-of-polymerisation of mixtures of n-BCA with sclero-embolic and contrast agents were investigated. RESULTS: Initiation of polymerisation: VENABLOCK™ and HISTOACRYL® were the fastest agents to polymerise, while VENASEAL™ was the slowest. Rate of polymerisation: Hypertonic saline inhibited the polymerisation of all n-BCAs, while hypertonic glucose prolonged the polymerisation rate. ETHANOL and detergent sclerosants had no effect. Contrast agents OMNIPAQUE™ and ULTRAVIST® initiated and prolonged the polymerisation of n-BCA, but in contrast, LIPIODOL® failed to initiate the process. CONCLUSIONS: The commercially available medical cyanoacrylates differ in their polymerisation rates. These polymerisation rates are further affected when these products are used in conjunction with other compounds, such as sclero-embolic and contrast agents.

Endovenous Microwave Ablation Versus Radiofrequency Ablation for the Treatment of Lower Limb Varicose Veins.

BACKGROUND: This study aimed to retrospectively compare the clinical outcomes of endovenous microwave versus radiofrequency ablation combined with foam sclerotherapy in patients with lower limb varicose veins. METHODS: We identified patients with lower limb varicose veins treated with endovenous microwave ablation or radiofrequency ablation with foam sclerotherapy between January 2018 and June 2021 at our institution. Patients were followed-up for 12 months. Clinical results, including the pre-post-Aberdeen Varicose Vein Questionnaire and post-Aberdeen Varicose Vein Questionnaire and Venous Clinical Severity Score, were compared. Complications were documented and treated accordingly. RESULTS: We included 287 cases (295 limbs total; endovenous microwave ablation + foam sclerosing agent: n = 142, 146 limbs; radiofrequency ablation + foam sclerosing agent: n = 145, 149 limbs). The operative time was shorter for endovenous microwave ablation than radiofrequency ablation (42.58 ± 15.62 min vs. 65.46 ± 24.38 min, P < 0.05); however, other procedural parameters did not differ. Furthermore, hospitalization costs for endovenous microwave ablation were lower than those for radiofrequency ablation (21,063.74 ± 850.47 yuan vs. 23,312.40 ± 1,035.86 yuan, P < 0.05). At the 12-month follow-up, the great saphenous vein closure rate was similar in both groups (endovenous microwave ablation, 97% [142/146] vs. radiofrequency ablation, 98% [146/149]; P > 0.05). Additionally, the satisfaction or incidence rates of complications were not different among the groups. In both groups, the Aberdeen Varicose Vein Questionnaire and Venous Clinical Severity Score values were significantly lower 12 months postsurgery than before surgery; however, the postoperative values did not differ. CONCLUSIONS: Endovenous microwave ablation effectively treated lower limb varicose veins, with similar short-term effects as radiofrequency ablation. Moreover, it had a shorter operative time and was less expensive than endovenous radiofrequency ablation.

Usefulness of antegrade foam sclerotherapy for portal hypertensive variceal bleeding.

PURPOSE: This study investigates the usefulness of antegrade variceal embolization using sclerosant foam to evaluate technical success and clinical outcomes in cases of hypertensive variceal bleeding. METHODS: A total of 16 patients underwent percutaneous antegrade variceal embolization using foam sclerotherapy from August 2019 to January 2022. Among the patients, 12 cases were of gastroesophageal varices, two were rectal varices, and one case each was duodenal and jejunal varices, respectively. Sodium tetradecyl sulfate (STS) foam was used as a detergent for variceal bleeding sclerotherapy at various anatomical locations. The detergent was used in a foam form to promote clinical outcomes and enable the effective embolization of the entire blood vessel wall, including the ventral side, against gravity. Furthermore, STS foam could be used to help sufficiently deliver the drug to distal segments. A balloon catheter was also used to block the antegrade flow and prevent the dilution of the sclerosant. Technical success was defined as the completion of sclerotherapy for variceal bleeding as planned before the procedure to achieve the disappearance of variceal bleeding. Clinical success was defined as the complete obliteration of varices without recurrent bleeding during the follow-up period after the procedure. RESULTS: Technical success was 81.3%, and clinical success was 84.6%. Additionally, 15/16 of the procedures were emergencies, and there were no complications related to the procedure. CONCLUSION: Antegrade foam sclerotherapy using 3% STS for variceal bleeding is clinically safe and effective. Moreover, antegrade foam sclerotherapy can be a useful treatment option for patients with active variceal bleeding in emergency cases.

Topical injection of sclerosant to treat cheek subcutaneous venous malformation resulting in blindness: a case report.

Loss of vision after topical injection of sclerosant is a rare and uncommon complication. We describe a case with vision loss following the facial injections of physician-compounded (PCP) foam sclerotherapy which was created by room air. A 3-year-old boy underwent injection of 5ml polidocanol foamed with room air to treat the venous malformation on the cheek near the left orbit. The boy experienced the whole facial swelling on day 2 after the third injection, especially involving the left side, the visual acuity in the left eye was counting fingers at 30 cm and the swelling reduced at 7 days later after referral. Fundus examination on day 15 revealed hemorrhage inferior to the optic disc and fluorescein angiography revealed blocked fluorescein. The OCT on day 15 showed the edema of the nerve fiber layer beside the fovea. The patient's hearing was also impaired. PCP foam sclerotherapy with room air produced in typical concentrations, preparations as well as volumes always causes vision loss among children. Continued evaluation on the effects of product, gas, volume, and patient age identify optimal approaches will avoid the toxicity and side-effects caused by facial foam sclerotherapy.

Impact of puberty on procedure frequency for treatment of simple head and neck lymphatic and venous malformations.

OBJECTIVE: Puberty has been shown to accelerate growth of vascular malformations, including lymphatic (LM) and venous malformations (VM). This study aims to compare the number of procedures performed before and after puberty in patients with LM and VM to assess whether the onset of puberty results in higher treatment frequency. METHODS: A retrospective review of head and neck LM and VM patients who were evaluated between January 2009 and December 2019 was performed. Patient demographics, lesion characteristics, and procedural details were recorded. For the purposes of this study, 11 years or older in females and 12 years or older in males were the established cut-offs for the onset of puberty. RESULTS: After initial screening of 357 patients, 83 patients were included in the study based on inclusion criteria. There were 34 patients with LM (41 %) and 49 with VM (59 %). The mean age at diagnosis was 6.1 ± 10.9 years (LM: 4.2 ± 7.0, VM: 7.4 ± 12.9, p = 0.489). 68 patients underwent treatments, which included sclerotherapy, surgical excision, and/or laser. For all patients, the average number of lifetime treatments when initiated before puberty was 3.78 ± 2.81 and when initiated after puberty was 2.17 ± 1.37 (p = 0.022). Patients diagnosed pre-puberty were more likely to undergo treatments vs. those diagnosed after puberty (OR 10.00, 95 % CI: 2.61-38.28, p < 0.001). CONCLUSION: We found that the number of treatments was fewer in those who started treatment after puberty. This finding suggests that providers may elect to proceed with observation in asymptomatic patients, given that waiting until after the onset of puberty has not shown an increase in the procedural load on patients.

Efficiency and clinical results of bleomycin injection in the treatment of lymphatic malformations.

Background: Lymphatic malformations (LMs) are rare congenital anomalies. The traditional treatment is surgical excision, but intralesional sclerosing agent injection is also preferred as the first-choice treatment because of postoperative frequent recurrences, poor cosmetic results, and high complication rate. We aimed to evaluate the efficacy of sclerosing agent injection used in the treatment of LMs in children. Materials and Methods: We retrospectively analyzed the children who were treated for LM between January 2011 and January 2022. The lesion sizes of the patients who were injected with sclerosant (Bleomycin) under sedation anesthesia, measured by ultrasound before and after the treatment, were recorded, and the difference between them was statistically evaluated. Results: Fifteen patients were retrospectively analyzed. The mean age was 45.2 ± 14.1 months. Of these, ten (66.6%) were male and five (33.3%) were female (F/M = 1/2). The mean age of male patients was 55 ± 20.1 months; the mean age of female patients was 25.8 ± 11. Seven patients had a single dose, two had twice, and six had three and more. The mean measurable size of macrocystic lesions before treatment was 55.2 ± 28.4 mm; after treatment, it was 23.8 ± 18.2 mm. Although no measurable shrinkage was detected in microcystic lesions, it was observed that the lesion shrank to allow surgical resection. With the statistical analysis, it was seen that there was a statistically significant difference between the dimensions before and after the treatment (P < 0.05) and the sclerosant injection had a great effect on the treatment (R: 0.89). Conclusion: Intralesional injection of bleomycin is less effective for microcystic or mixed-type LMs, but provides an effective reduction for a safe surgical procedure. It is an effective treatment for macrocystic lesions.

Review of outcomes of using lower ethanol concentration (83%) in percutaneous ultrasound-guided renal cyst sclerotherapy in dogs.

BACKGROUND: Percutaneous renal cyst sclerotherapy (PRCS) as a treatment for renal cysts is usually performed with a high concentration of ethanol (≥ 90%). This study reviewed cases in which a lower concentration of ethanol (83%) was used for the procedure in dogs. METHODS: Records of cases of renal cysts treated by sclerotherapy using 83% ethanol in dogs were reviewed. Outcomes of the treatment were evaluated by comparing volumes of renal cysts before the procedure and the volumes after treatment, using ultrasound images with the volume reduction rates classified as follows: < 50% of initial volume (failed); ≥ 50% but < 80% of initial volume (partial success); ≥ 80% but < 95% of initial volume (great success); ≥ 95% of initial volume (complete success). RESULTS: Out of nine dog kidneys, renal cysts sclerotherapy with 83% ethanol achieved partial success in one kidney, great success in four, and complete success in the other four. No side effect was observed. The mean of the volume-reduction rates was 90.00 ± 11.00 while the minimum and maximum reduction rates were 65% and 100%, respectively. CONCLUSIONS: The lower ethanol concentration (83%) is good for disinfecting kidneys in PRCS.

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.