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.

Three-year results of a randomized controlled trial comparing mechanochemical and thermal ablation in the treatment of insufficient great saphenous veins.

OBJECTIVE: Mechanochemical ablation (MOCA) is a nonthermal nontumescent method of treating saphenous vein insufficiency. The feasibility and short-term results of MOCA are good, but its long-term results are unknown. A randomized study was performed to compare MOCA with endovenous laser ablation (EVLA) and radiofrequency ablation (RFA) in the setting of unilateral great saphenous vein (GSV) insufficiency. METHODS: Venous outpatient clinic patients with varicose veins (CEAP class C2-C4) caused by GSV insufficiency were invited to participate in the study; in total, 132 patients met the inclusion criteria and were willing to participate. Patients were randomized to treatment (2:1:1 for MOCA, EVLA, and RFA, respectively). The state of the GSV with duplex Doppler ultrasound examination and the disease-specific quality of life were assessed at 1 month, 1 year, and 3 years after the treatment. RESULTS: Some patients declined to continue in the study after randomization; in total, 117 patients underwent treatment. At 3 years, the occlusion rate was significantly lower with MOCA than with either EVLA or RFA (82% vs 100%; P = .005). Quality of life was similar between the groups. In the MOCA group, GSVs that were larger than 7 mm in diameter preoperatively were more likely to recanalize during the follow-up period. The partial recanalizations of proximal GSV observed at 1 year progressed during the follow-up. CONCLUSIONS: MOCA is a feasible treatment option in an outpatient setting, but its technical success rates are inferior compared with endovenous thermal ablation. Its use in large-caliber veins should be considered carefully.

Mechanochemical Endovenous Ablation of Varicose Veins in Pediatric Patients with Klippel-Trénaunay Syndrome: Feasibility, Safety, and Initial Results.

PURPOSE: To evaluate feasibility, safety, and results of endovenous mechanochemical ablation (MOCA) for treatment of persistent embryonic and dysplastic veins in pediatric patients with Klippel-Trénaunay syndrome (KTS). MATERIALS AND METHODS: Thirteen MOCA procedures were performed in 11 patients (age range, 4-16 years) with KTS and symptomatic persistent embryonic or dysplastic veins during a 24-month period. All patients were evaluated with color Doppler (CD) ultrasound (US), contrast-enhanced MR imaging, and venography to assess the anatomy of the target vessels and patency of the deep venous system. All procedures were performed under general anesthesia with a ClariVein catheter and liquid sodium tetradecyl sulfate as the sclerosing agent. US and fluoroscopic guidance were used in all cases. Technical success rate, primary occlusion rate, adverse effects, and recanalization rates were evaluated. Clinical and radiological (CD US) controls were performed 1 day, 7 days, 1 month, and 6 months after the procedure and once a year thereafter, with a mean follow-up of 16 months (range, 6-25 months). RESULTS: Technical success and primary occlusion were achieved in all patients with no adverse events. During the follow-up period, CD US demonstrated partial recanalization and symptom recurrence in 2 patients (18%), 14 and 18 months after the initial procedure. These 2 patients had a second ablation procedure with no recanalization or symptom recurrence during the subsequent follow-up period. CONCLUSIONS: MOCA is feasible and appears to be a safe and effective technique for treatment of varicose veins in pediatric patients with KTS.

Sclerotherapy treatment of a large venous malformation invading the bladder wall related to Klippel-Trenaunay syndrome.

We report the case of a 35-year-old woman who presented with recurrent macroscopic haematuria and known diagnosis of Klippel-Trenaunay syndrome. Imaging and cystoscopy identified an extensive venous malformation involving a large area of the bladder wall. Holmium laser therapy was ineffective at obtaining symptom control. Following a multidisciplinary team meeting, transvenous sclerotherapy with sodium tetradecyl sulphate was performed under image guidance. A reduction in venous density was observed on cystoscopy and the patient has had complete resolution of symptoms within 6 weeks and continued to be asymptomatic up to 24-month follow-up. We propose that transvenous sclerotherapy is considered first-line treatment in this clinical setting.

Salivary gland ablation: introducing an interventional radiology treatment alternative in the management of sialorrhea.

BACKGROUND: Sialorrhea is common in children with neurological disorders and leads to social isolation, aspiration pneumonia and increased caregiver burden. Sialorrhea management includes anticholinergic medications and a variety of surgeries, but these are limited by side effects, recurrence and risks. OBJECTIVE: We present our method of salivary gland ablation, an interventional radiology treatment for sialorrhea, and report safety and efficacy data from pediatric patients who underwent salivary gland ablation. MATERIALS AND METHODS: Salivary gland ablation uses image-guided sotradecol and ethanol dual-drug injection into the salivary glands. Submandibular and sublingual glands are injected percutaneously using ultrasound. Parotid glands are injected retrograde through Stensen ducts using fluoroscopy. We conducted a retrospective review of the medical records of patients who underwent salivary gland ablation at our institution between 2005 and 2019. Pre- and post-procedure Drooling Frequency and Drooling Severity (DFDS) scale scores were compared and caregiver satisfaction was assessed. We devised two cohorts, one to study patient safety and a subcohort to study clinical efficacy using DFDS scores. RESULTS: One hundred and seventy salivary gland ablation procedures were performed in the 99 patients comprising the safety cohort. Of the procedures, 88.8% resulted in no or minimal complications. Respiratory difficulty, temporary nerve palsy and infection represent the majority of the 11.2% of patients who experienced periprocedural complications. There were no complications resulting in permanent sequelae. Twenty-seven patients met our inclusion criteria for the efficacy subcohort with a mean follow-up time of 5.4 years. DFDS at follow-up decreased from a median score of nine to a seven post-procedure (P=0.000018). The proportion of caregivers who were satisfied with the procedure increased as more glands were ablated, which suggests a causal link between the number of glands ablated and the outcome. CONCLUSION: Salivary gland ablation is a safe and effective procedure with the potential for permanent decrease in symptoms related to sialorrhea.

A Review of Sclerosing Foam Stability in the Treatment of Varicose Veins.

BACKGROUND: Varicose veins are common clinical entities. Foam sclerotherapy is a minimally invasive and simple procedure; however, the side effects, efficacy, and stability of sclerosing foam are not ideal. OBJECTIVE: To summarize the current studies on sclerosing foam stability and promote foam sclerotherapy development. MATERIALS AND METHODS: We reviewed the literature before June 2018 and included only representatives studies on sclerosing foam stability. We summarized the foam half-life time (FHT) of polidocanol (POL) under 17 preparation conditions and the FHT of sodium tetradecyl sulfate under 21 preparation conditions. The preparation conditions included various combinations of temperature, liquid-gas ratio, preparation method, etc. RESULTS: The FHT of POL varied between 40 and 4,000 seconds under different conditions. The FHT of sodium tetradecyl sulfate varied from 25.7 to 390 seconds. The higher the drug concentration, the lower the temperature required to increase foam stability. The addition of surfactant greatly increased foam stability. For different gas compositions, the FHT sequence was as follows: CO2 < CO2 + O2 < O2 < air. CONCLUSION: Foam stability can be improved by changing the preparation conditions; therefore, the role of surfactants and predictive methods for FHT are worth investigating further.

Effectiveness and Safety of Sclerotherapy for Treatment of Low-Flow Vascular Malformations of the Oropharyngeal Region.

PURPOSE: To evaluate the efficacy and safety of sclerotherapy with sodium tetradecyl sulfate (STS) and bleomycin for treatment of venous malformations (VMs) of the oropharyngeal region. MATERIALS AND METHODS: A retrospective study of 33 patients with 46 VMs of the buccal and pharyngolaryngeal cavity associated with impairment of eating, respiration, or elocution was performed. Individual lesions were divided based on their anterior or posterior location, using the base of the tongue as an anatomic landmark. Lesion size was estimated with the use of orthogonal measurements on magnetic resonance or ultrasound images before and after treatment to assess radiologic response. Sclerotherapy sessions were performed under ultrasound, fluoroscopic, and, if needed, endoscopic guidance. Clinical response was assessed with the use of the Manchester Orofacial Pain Disability Scale. Methods for airway management were also compiled. RESULTS: Following sclerotherapy, average VM diameter was reduced by 31.4% (P < .0001) on a per-patient basis and by 30.8% (P < .0001) on a per-lesion basis. The Manchester score improved by an average of 37.0% (P = .013). Four patients reported a worsening of symptoms, and 11 patients experienced symptomatic recurrence. Complications include pneumonia (5 patients) and urgent placement of a post-procedure tracheostomy (4 patients). Patients with posterior malformations experienced more complications (emergency tracheostomies in 4 and pneumonias in 4). CONCLUSIONS: Sclerotherapy using STS is an efficient treatment for venous malformations of the buccal and pharyngolaryngeal cavity but can lead to significant complication for posterior lesions. Careful assessment of the airway is needed before treatment, and prophylactic tracheotomy should be considered in patients with posterior lesions.

Combined Nd:YAG laser and bleomycin sclerotherapy under the same anesthesia for cervicofacial venous malformations: A safe and effective treatment option.

INTRODUCTION: Extensive cervicofacial venous malformations (VM) pose significant challenges to a patient's quality of life (altered breathing, dysphagia, dysarthria). Treatment options include: 1) Surgical debulking; 2) Sclerotherapy; 3) laser therapy; or 4) Combined modalities. Recent studies have demonstrated the importance of multimodality and multidisciplinary management of these patients. However, no studies have described combined single anesthetic laser and sclerotherapy treatment. We sought to demonstrate the safety and efficacy of combined Nd:YAG laser and sclerotherapy under the same anesthetic administration. METHODS: Retrospective review of 8 patients (Age 6 mo -74 yrs, x͂ 31) with extensive cervicofacial VM with significant airway involvement. Patients were treated with combined suspension laryngoscopy with Nd:YAG laser of airway VM followed by image guided direct puncture sclerotherapy using bleomycin in the airway VM and sodium tetradecyl sulfate (STS) foam in the cervicofacial VM during the same anesthetic encounter. RESULTS: All 8 patients had extensive cervicofacial VMs that were symptomatic with snoring or orthopnea. Four of the patients had previously been treated at outside institutions with residual disease or significant complications. All patients remained intubated post procedure (Avg. 1.07 days) and tolerated extubation without re-intubation or any major complications. The average length of hospital stay was 3.2 days, of which 1.9 days were spent in the ICU. Patients reported symptomatic improvement or had decreased VM disease on MRI follow up. CONCLUSION: Combined Nd:YAG laser therapy and sclerotherapy allows treatment of both superficial and deep components of VMs in a safe and efficient manner. In addition, suspension laryngoscopy provides improved visualization and access for the interventional radiologist in difficult to reach areas for sclerotherapy.

Sclerotherapy for intramuscular vascular malformations: A single-center experience.

BACKGROUND: Vascular malformations isolated to skeletal muscles are rare and often debilitating due to pain and very challenging to treat. Multi-modal management options include compression garments, medical therapy, sclerotherapy, and surgical resection. METHODS: A retrospective review of patients who underwent sclerotherapy for intramuscular venous malformations (IVM) between 2008 and 2016 was performed. Demographics, indications, and clinical follow-up were analyzed. RESULTS: Twenty patients underwent sclerotherapy for IVM. Six males and 14 females underwent 58 procedures. All patients presented with pain and were treated initially with compression garments. Median age at first treatment was 13years (+/- 5.06years). Initial protocol consisted of 2 sclerotherapy procedures with sodium tetradecyl sulfate (STS) within a 2-3month interval. Median volume of the lesion was 40cm3 (+/- 28.7), mostly located in the lower extremities (15/20). Median number of treatments was 2 (+/- 1.95). Treatment prior to puberty resulted in a median symptom-free time of 4years (+/- 2.18), while after puberty resulted in a symptom-free time of 2years (+/- 2.28). Two patients had an underlying coagulopathy and were admitted for observation and peri-procedural Lovenox. No procedure related complications were noted with a median follow-up of 4years (+/- 2.27). CONCLUSION: IVMs are rare but can be incapacitating secondary to pain. Sclerotherapy is a useful minimally invasive procedure generally requiring at least two consecutive treatments. Treatment of patients prior to puberty appears to provide a more durable result, and surgical resection may be avoided. TYPE OF STUDY: retrospective. LEVEL OF EVIDENCE: IV.

Lymphatic malformation with acquired Horner syndrome in an infant.

An infant presented with right upper eyelid ptosis and was subsequently diagnosed with acquired Horner syndrome. Further evaluation revealed a right-sided cervicothoracic lymphatic malformation. At 13 weeks of age, the child underwent percutaneous intracystic sclerotherapy with a mixture of sodium tetradecyl sulphate and ethanol. Twenty-one weeks after initial treatment, ophthalmic examination showed complete resolution of the blepharoptosis and pupillary miosis. Percutaneous sclerotherapy not only effectively treated the space-occupying lymphatic malformation but also reversed the Horner syndrome that was presumably induced by neural tension (more likely) or compression.

Use of an intravenous sclerosing foam (3% sodium tetradecyl sulfate) for treatment of orbital varix in a dog.

A 6-month-old intact male Standard Dachshund was referred for evaluation of a soft tissue swelling above the right eye. Examination of the right eye revealed mild lateral deviation of the globe, normal vision, and a dorsonasal soft tissue swelling. Examination of the posterior segment was normal. Dual-phase computed tomography angiography was consistent with an orbital varix of the angularis oculi and right dorsal external ophthalmic veins with no evidence of arterial involvement. Treatment involved fluoroscopically guided coil embolization of the venous outflow with nine platinum microcoils, followed by sclerotherapy of the varix using 1.5 mL of 3% sodium tetradecyl sulfate foam. Moderate-to-marked swelling was noted at the treatment site in the weeks following therapy, which gradually resolved. At final reexamination 3 months post-therapy, complete sclerosis and resolution of the orbital varix were documented. To the authors' knowledge, this is the first reported case involving the use of a sclerotic agent for successful treatment of a venous malformation in a dog.

Long-Term Outcomes of Balloon-Occluded Retrograde Transvenous Obliteration for the Treatment of Gastric Varices: A Comparison of Ethanolamine Oleate and Sodium Tetradecyl Sulfate.

PURPOSE: This study was performed to compare the long-term outcomes of balloon-occluded retrograde transvenous obliteration (BRTO) for gastric varices using ethanolamine oleate (EO) and sodium tetradecyl sulfate (STS). METHODS: From January 2002 to June 2015, 142 patients underwent BRTO for the treatment of gastric varices using EO (n = 59) or STS (n = 83). We retrospectively reviewed the follow-up data related to the obliteration of gastric varices, rebleeding, and clinical complications. The cumulative recurrence rates of gastric varices after BRTO in each group were analyzed using the Kaplan-Meier method and compared using the log-rank test. RESULTS: The median follow-up periods were 23.9 (range 0.2-170.7) months in the BRTO with EO group and 19.9 (range 0.2-84.7) months in the BRTO with STS group. Technical success was achieved in 53 of 59 (89.8%) cases in the BRTO with EO group and 80 of 83 (96.4%) cases in the BRTO with STS group. The clinical success rates were 94.9% (56/59) in the BRTO with EO group and 96.4% (80/83) in the BRTO with STS group. The cumulative 1-, 3-, and 5-year recurrence rates for gastric varices were 3.8, 9.4, and 9.4% in the BRTO with EO group and 1.3, 2.5, and 3.8% in the BRTO with STS group, respectively (p = 0.684). CONCLUSIONS: BRTO using STS has comparable long-term outcomes to BRTO using EO for gastric varices.

Implication of foam sclerosant inactivation by human whole blood in a laboratory setting.

Background During sclerotherapy, it has been recommended to confirm intravenous placement of the needle by aspirating blood into the sclerosant syringe. This may inactivate some, or all of the sclerosant. Aims To quantify the volume of human blood needed to completely inactivate 1 ml of sodium tetradecyl sulphate, and comparing fresh blood and blood that has been stored in an ethylenediaminetetraacetic acid tube. Methods A series of manual titrations were carried out following a procedure developed at STD Pharmaceutical Products Ltd (Hereford, UK) and listed in the British Pharmacopeia. Three percent of sodium tetradecyl sulphate stock solutions were made with increasing volumes of blood and titrated against benzethonium chloride to determine the active concentration (% w/v) of sodium tetradecyl sulphate remaining in the solution. Results A calculated approximation showed 0.3 ml of blood is required to fully inactivate 1 ml of 3% sodium tetradecyl sulphate when made into a foam. A comparison was made between the use of fresh blood and blood stored in ethylenediaminetetraacetic acid tubes. Blood stored in ethylenediaminetetraacetic acid tubes showed more inactivation of sodium tetradecyl sulphate, but this was not significant at the P ≤ 0.05 level. Conclusion The data from our study have shown that a minimum of 0.3 ml of fresh blood is required to inactivate 1 ml of 3% sodium tetradecyl sulphate as a foam and it is not significantly affected by storing blood in an ethylenediaminetetraacetic acid tube. Our methodology suggests that during foam sclerotherapy treatment, blood should not be aspirated into the syringe to confirm position, and that ultrasound guidance is more appropriate for needle placement.

Vascular sclerosing effects of bleomycin on cutaneous veins: a pharmacopathologic study on experimental animals.

BACKGROUND:: Varicose veins and the complications of venous disease are common disorders in humans. OBJECTIVE:: To study the effects of bleomycin as a potential new sclerosing agent and its adverse events in treating varicose veins. METHODS:: Bleomycin-loaded liposomes 0.1ml was injected in the dorsal ear veins of white New Zealand rabbits. Sodium tetradecyl sulfate was used as a positive control. Normal saline was used as negative control. The blood vessels of the treated ears were photographed before and at one hour and two, eight and 45 days after treatment. Biopsies from the treated areas were obtained for histological examination. Blood samples were collected to determine any possible toxicity. RESULTS:: Bleomycin by itself was ineffective; therefore, liposomes were used as a vector to deliver bleomycin to the vein lumen. Subsequently, bleomycin started showing its sclerosing effects. Toxicity monitoring showed no apparent hematologic, pulmonary, hepatic or renal toxicities. This study revealed that bleomycin induced vasculitis, which led to vascular occlusion, which was observed on day 1 and day 8. No bleomycin-related injury was noted by histopathological examination of lung sections. The calculation of the lung/body weight coefficient indicated that edema was present in the experimental groups compared with the negative and positive controls. STUDY LIMITATIONS:: Relatively small number of experimental animals used. CONCLUSIONS:: This study showed that bleomycin-loaded liposomes were able to induce vasculitis and vascular occlusion without any toxicity or complications. It might be useful, hence, to treat patients suffering from Varicose veins and other ectatic vascular diseases with this agent.