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.

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.

[Analysis on clinical efficacy, safety and economy of Shaobei injection and elastic band ligation in the treatment of grade II or III hemorrhoids].

Objective: Currently, various treatments such as hemorrhoidectomy, ligation and sclerotherapy injection can be applied in grade II or III hemorrhoids. This study aims to compare the clinical efficacy, safety and economy between Shaobei injection and elastic band ligation in treating patients with grade II or grade III hemorrhoids. Methods: A retrospective cohort study was used. Clinical data of 60 patients with grade II or grade III hemorrhoids at Department of Anorectal Surgery of the Sixth Affiliated Hospital, Sun Yat-sen University between January 2019 and October 2019 were collected. Patients were divided into two groups according to surgical methods. Patients in the Shaobei group received Shaobei injection (n=28), and those in the ligation group received elastic band ligation (n=32). Inclusion criteria: (1) diagnosis of grade II or III hemorrhoid; (2) application of Shaobei injection or elastic band ligation; (3) age between 18-75 years old. Exclusion criteria: (1) comorbidity with anal fissure, anal fistula, anal sinusitis or other perianal diseases; (2) patients with mental disorder or poor compliance; (3) incomplete clinical or follow-up data. Recurrent rate, postoperative pain, anal edema, anal distension, total cost of hospitalization, length of hospitalization, and postoperative life quality EQ-5D-3L score were compared between the two groups at postoperative 6-month. Results: No significant difference was observed in the baseline data (including Nystrom hemorrhoid symptom score) between the two groups (all P>0.05), except gender ratio [male proportion: Shaobei 75% (21/28) vs. ligation 37.5%(12/32), χ(2)=8.485, P=0.004]. No significant difference in recurrent rate was found between the two groups [14.3% (4/28) vs. 9.4% (3/32), χ(2)=0.035, P=0.851]. Compared to the ligation group, Shaobei group showed less pain at postoperative day 1 [VAS median (range): 2 (1-6) vs. 3 (1-7), Z=2.814, P=0.005] and postoperative day 7 [VAS median (range): 0 (0-2) vs. 1 (0-4), Z=3.149, P=0.002]; lower anal edema ratio at postoperative day 1 [10.7% (3/28) vs. 34.4% (11/32), Z=4.673, P=0.037]; lower anal distension ratio at postoperative day 1 [7.1% (2/28) vs. 28.1% (9/32), Z=4.391, P=0.048]; less hospitalization cost [(6343.5±1444.1) yuan vs. (10 587.1± 1719.0) yuan, t=12.515, P<0.001] and shorter postoperative hospital stay [median (range): 1 (1-5) days vs. 3 (1-6) days, Z=5.879, P<0.001]. The EQ-5D-3L scores of two groups were significantly improved six months after treatment [Shaobei group: (0.90±0.16) vs. (0.73±0.14); ligation group: (0.91±0.13) vs. (0.74±0.10); both P<0.001], while there was no statistically significant difference between the two groups (t=0.130, P=0.897). No complications such as massive hemorrhage, infection, iatrogenic anal fistula, rectal stricture and local induration occurred after the injection. Conclusions: Shaobei injection is effective and safe in treating grade II or III hemorrhoids. Compared with elastic band ligation, it can reduce morbidity of complications and hospitalization expenses.

Ethanol Sclerotherapy versus Laparoscopic Surgery for Endometrioma Treatment: A Prospective, Multicenter, Cohort Pilot Study.

STUDY OBJECTIVE: To compare the cost-effectiveness of ultrasound (US)-guided aspiration and ethanol sclerotherapy versus laparoscopic surgery for benign-appearing ovarian endometrioma. DESIGN: Prospective, cohort pilot study. SETTING: Multiple centers, Spain. PATIENTS: Forty patients with suspected ovarian endometrioma identified by US, with a maximum diameter of 35 to 100 mm, of whom 33 met inclusion criteria. INTERVENTIONS: The study group (n = 17) underwent US-guided aspiration plus sclerotherapy with ethanol, and the control group (n = 14) underwent laparoscopic cystectomy. MEASUREMENTS AND MAIN RESULTS: Recurrence, complications, and direct costs were compared. One of 17 sclerotherapy patients recurred (5.9%) compared with 4 of 14 laparoscopic surgery patients (28.6%) (odds ratio 0.18, 0.01-1.53). No serious adverse effects (Clavien-Dindo ≥ III) were observed in the sclerotherapy group; 1 patient in the surgery group had a Clavien-Dindo IIIb complication. Median hospital direct costs were significantly lower in the sclerotherapy group than those in the surgery group-266 euros versus 2189 euros. CONCLUSION: Ethanol sclerotherapy seems to be cost-effective for endometrioma and also appears to reduce complications. In this pilot study, recurrence was not higher than with conventional surgery.

Treatment of chronic venous insufficiency in Latin America.

OBJECTIVE: Venous disease is common in Latin America, with an estimated 68.11% prevalence of chronic venous disease. The diverse social, political, and economic characteristics of the many nations that make up Latin America mean that different conditions affect how these diseases are diagnosed and treated, which may differ markedly from the way they are treated by the health care systems of the United States and Europe. Our goal was to review the current state of treatment of chronic venous insufficiency (CVI) in Latin America. METHODS: This is a narrative review of the medical literature on the subject and synthesizes sometimes fragmentary information on CVI across a large and diverse region. RESULTS: CVI represents an unmet medical need in Latin America. Conservative treatments, such as compression stockings, may be used at first, and there are nonpharmacologic and complementary and alternative medicine approaches in use. Endovenous approaches, such as endovenous thermal ablation, have largely replaced surgical interventions. In Europe and the United States, such procedures are mainly carried out in ambulatory facilities, whereas they are mainly performed in the hospital in Latin America. CONCLUSIONS: Recent strong economic growth in Latin America and improvements in social security and health care suggest that innovative approaches to chronic venous disease and CVI will be implemented.

A Comparative Study of Percutaneous Aspiration with Sclerotherapy and Laparoscopic Marsupialization for Symptomatic Simple Renal Cysts.

Background: Percutaneous aspiration with sclerotherapy (PAS) and laparoscopic marsupialization (LM) are minimally invasive treatment modalities for renal cysts. We aimed to compare the efficacy and cost/effectiveness of LM and PAS for the treatment of simple symptomatic renal cysts. Methods: Data were prospectively collected from three health care institutions in which 80 patients with symptomatic simple renal cysts underwent a single session of PAS with 95% ethanol (PAS group, n = 40) or underwent LM under general anesthesia (LM group, n = 40) between March 2012 and May 2016. We compared the patient profile, duration of procedure, duration of hospital stay, radiological and symptomatic success rates, treatment costs, and incidence of complications between the two groups. Results: At the 6-month follow-up, the radiological success rate in the LM group was significantly greater than that in the PAS group (97.5% versus 60%; P < .001). The symptomatic success rate was comparable in the two groups (95% versus 90%; P = .675). The treatment failure rate did not significantly differ between the two groups (5.0% versus 17.5%, P = .154). The mean total cost in the PAS and LM groups was 1256 USD and 2343 USD, respectively (P = .001). No significant between-group difference was noted regarding the overall complication rate (P = .615). Conclusions: Both LM and PAS are effective and safe procedures for the treatment of symptomatic simple renal cysts. A single session of PAS seems to be a cost-effective method for the management of symptomatic simple renal cysts.

A 1470-nm laser combined with foam sclerotherapy in day surgery: a better choice for lower limb varicose veins.

Day surgery is being more and more adopted by clinicians. Higher wavelength lasers give patients better experience than lower wavelength lasers, which makes it more suitable for day surgery. This study compares the short- and mid-term efficacy, postoperative morbidity, and patient satisfaction of "1470-nm endovenous laser ablation (EVLA) combining foam sclerotherapy in day surgery" with "810-nm EVLA with high ligation combining foam sclerotherapy in hospital surgery" on great saphenous vein (GSV) insufficiency postoperatively. A single-institution historical cohort study of 194 patients was performed in Shanghai Ninth People's Hospital, China. Ninety-seven patients received 1470-nm EVLA combining foam sclerotherapy in day surgery ("1470-nm group"), and 97 patients received 810-nm EVLA with high ligation combining foam sclerotherapy in hospital surgery recommended by guidelines ("810-nm group"). No significant difference was found between the 1470-nm group and the 810-nm group in terms of GSV occlusion rate (both 100%), complication rate, and recurrence rate (8.2 vs. 11.3%) during the period of 1-12 months after surgery. Serious complications in the 1470-nm group and 810-nm group were 0 and 1.0%. Minor complications in the 1470-nm group and 810-nm group were ecchymosis at 20.6 and 18.6%, edema at 69.1 and 63.9%, and paresthesia around ankle at 0 and 3.1%, respectively. Advantage of the 1470-nm group over the 810-nm group was statistically significant considering the patient perioperative comfort and economic cost. Treatment of 1470-nm EVLA combining foam sclerotherapy in day surgery has similar efficacy as the 810-nm EVLA with high ligation combining foam sclerotherapy in hospital surgery in GSV insufficiency and is more comfortable with less incision, hospitalization procedure, and medical costs. It may be a new option for patients who are afraid or unable to be hospitalized.

Transparent cap-assisted endoscopic sclerotherapy in esophageal varices: a randomized-controlled trial.

BACKGROUND AND AIM: Endoscopic treatment is widely accepted as the first-line therapy selection for esophageal variceal bleeding. Nevertheless, endoscopic injection sclerotherapy requires experienced endoscopists and is associated with a high risk of bleeding. Our study evaluates the feasibility and efficacy of transparent cap-assisted endoscopic sclerotherapy in the management of esophageal varices. PATIENTS AND METHODS: A randomized-controlled trial was conducted in a tertiary referral center from April 2015 to May 2016. Patients who received endoscopic sclerotherapy were randomized in a blinded manner into two groups: the transparent cap-assisted group (n=59) and the control group (n=61). RESULTS: The average injection sites were reduced in the transparent cap-assisted group compared with the control group (1.2±0.4 vs. 1.4±0.05, P=0.000), whereas no difference was observed in the dosage of lauromacrogol (16.97±4.91 vs. 16.85±4.57, P=0.662) and the hemorrhage that occurred during injection made no difference (50.8 vs. 61.0%, P=0.276); yet, salvage hemostasis methods were used in only nine patients in the transparent cap-assisted group compared with 17 patients in the control group (25.0 vs. 38.7%, P=0.0936). The cost of each procedure in the cap-assisted group was ¥2578 (1878-4202), whereas it was ¥3691 for the control group (2506-5791) (P=0.023). Moreover, in both groups, no esophageal constriction was observed during the 6-month follow-up period, whereas the rebleeding rate between two groups showed no statistical significance in 6 months (89.8 vs. 93.4%, P=0.563). CONCLUSION: Transparent cap-assisted sclerotherapy provided a clear field of vision and helped to fix the targeted veins, thus significantly reducing the use of the salvage hemostasis method during sclerotherapy injection hemorrhage. It is also associated with reduced injection sites and endoscopic therapy cost.

Randomized controlled trial of scleroligation versus band ligation alone for eradication of gastroesophageal varices.

BACKGROUND AND AIMS: Gastric varices develop in 5% to 33% of patients with portal hypertension. Their most common form is concomitant gastroesophageal varices. Scleroligation (combined sclerotherapy and band ligation) has been used successfully in management of esophageal varices but has not been evaluated previously in the management of gastroesophageal varices. The aim of this work was evaluation of a new scleroligation technique for management of bleeding gastroesophageal varices regarding efficacy, adverse events, variceal recurrence, and survival. METHODS: This study was conducted on 120 cirrhotic patients with bleeding gastroesophageal varices, whom we divided randomly into 2 groups of 60 patients each-a band ligation group and a scleroligation group. RESULTS: The mean number of sessions was lower in the scleroligation group than in the band ligation group (2.22 ± 0.92 and 3.43 ± 0.67, respectively) (P < .001), as were the duration of treatment and total number of bands used. Cost and survival were comparable in the 2 groups. There was no significant difference between the 2 maneuvers regarding adverse events, recurrence rates, or rebleeding rates after obliteration. Recurrence was significantly higher in patients with larger varices, ulceration, and postprocedure pyrexia. Rebleeding was significantly higher among those who experienced postprocedure pyrexia and developed or had worsening of gastric antral vascular ectasia. CONCLUSIONS: Scleroligation appears to achieve a faster rate of eradication with fewer treatment sessions and total number of bands deployed to achieve variceal obliteration than band ligation and is comparable in cost and in adverse event and recurrence rates. (Clinical trial registration number: NCT02646202.).

Prospective Randomized Study of Ultrasound-Guided Foam Sclerotherapy Combined with Great Saphenous Vein High Ligation in the Treatment of Severe Lower Extremity Varicosis.

BACKGROUND: To evaluate the effect of ultrasound-guided foam sclerotherapy (UGFS) in a single session combined with great saphenous vein (GSV) high ligation for severe lower extremity varicosis classified as C4-C6, compared with GSV stripping plus multistab avulsion or transilluminated powered phlebectomy (TIPP). METHODS: From January 2012 to December 2014, 177 patients with primary GSV insufficiency, classified as C4-C6, were randomized into the UGFS group or the control group. The UGFS group was managed by GSV high ligation and foam sclerotherapy in one session under the surveillance of ultrasonography, whereas the control group received GSV high ligation and stripping combined with multistab avulsion or TIPP. The patients were followed up at 1, 6, and 12 months after treatment. Outcome assessments included reflux recurrence rate, procedure-related adverse events, hemodynamic parameters, revised Venous Clinical Severity Score (VCSS), and Aberdeen Varicose Vein Questionnaire (AVVQ) score. The medical cost and operating time of the 2 groups were also compared. RESULTS: In total, 73 patients received UGFS, whereas 90 patients underwent traditional surgery. Sixty-five patients in the UGFS group (89.0%) and 74 patients in the control group (82.2%) completed the follow-up. At the end of 12 months, the cumulative reflux recurrence rate was 13.8% in the UGFS group and 13.5% in the control group (P = 0.955). In the UGFS and control groups, minor complications (27.7% vs. 21.6%, P = 0.406) and major complications (3.1% vs. 2.7%, P = 0.895) were not significantly different. Compared with baseline values, obvious improvements of the venous filling index, VCSS, and AVVQ scores after treatment were confirmed in both groups (P < 0.001). The average operating and recovery times were much shorter (38.3 vs. 81.2 min, 5.4 vs. 9.6 days, P < 0.001, respectively), and the average hospital cost was much lower ($853 vs. $1,575, P < 0.001) in the UGFS group than in the control group. The patient satisfaction rate reached 92.3% in the UGFS group and 89.2% in the control group 12 months after operation (P = 0.270). CONCLUSIONS: Our outcomes indicated that UGFS combined with GSV high ligation was safe and effective for severe lower extremity varicosis.

Cost-Effectiveness Analysis of Percutaneous Sclerotherapy for Venous Malformations.

PURPOSE: To assess cost-effectiveness of sclerotherapy for venous malformations (VMs) to improve patient quality of life (QOL). MATERIALS AND METHODS: This prospective study enrolled 28 patients with symptomatic VMs who underwent sclerotherapy. EuroQol-5 Dimension (EQ-5D) and Short-Form 36 (SF-36) Health Survey were used to measure health-related QOL. Questionnaires were collected before and 1, 3, 6, and 12 months after sclerotherapy. Quality-adjusted life years (QALYs) were calculated using EQ-5D score as a measure of health utility. Medical costs obtained from the hospital accounting system and other costs of staff, drugs, materials, and angiographic equipment were calculated for each procedure. Cost-effectiveness was analyzed using incremental cost-effectiveness ratio (ICER) as the medical cost/gain of QALYs. RESULTS: Median EQ-5D scores improved from 0.768 (range, 0.705-1) to 1 (range, 0.768-1) after 6 months (P = .023) and 1 (range, 0.768-1) after 12 months (P = .063). The gain of QALYs at 12 months was 0.043. The mean medical cost was ¥281,228 ($2,337). The pain group (baseline bodily pain scale of SF-36 score < 70) showed greater improvement in median EQ-5D score, from 0.705 (range, 0.661-0.768) to 0.768 (range, 0.705-1) after 6 months (P = .041) and 0.768 (range, 0.768-1) after 12 months (P = .049). ICER at 12 months was ¥6,600,483 ($54,840) in the overall group and decreased to ¥3,998,113 ($33,218) in the pain group, < ¥6,000,000 ($49,850), threshold for acceptance of a public health benefit in Japan, even accounting for 50% increase in costs. CONCLUSIONS: Sclerotherapy was cost-effective for improving QOL for symptomatic VMs, especially for patients with moderate to severe pain.

Foam sclerotherapy.

Foam sclerotherapy is a minimally invasive treatment for lower limb varicose veins. Current evidence indicates that its efficacy may not be as high as surgery or endovenous ablation. The minimally invasive nature of the treatment however means that it has a wide application, and it can be particularly useful in patients who are not suitable for other types of treatment. NICE guidelines recommend its use as a second line after endovenous ablation. Complication rates are low and most of these are of little clinical consequence.

A Cost-effectiveness Analysis of Surgery, Endothermal Ablation, Ultrasound-guided Foam Sclerotherapy and Compression Stockings for Symptomatic Varicose Veins.

OBJECTIVE: The aim was to investigate the cost-effectiveness of interventional treatment for varicose veins (VV) in the UK NHS, and to inform the national clinical guideline on VV, published by the National Institute of Health and Care Excellence. DESIGN: An economic analysis was constructed to compare the cost-effectiveness of surgery, endothermal ablation (ETA), ultrasound-guided foam sclerotherapy (UGFS), and compression stockings (CS). The analysis was based on a Markov decision model, which was developed in consultation with members of the NICE guideline development group (GDG). METHODS: The model had a 5-year time horizon, and took the perspective of the UK National Health Service. Clinical inputs were based on a network meta-analysis (NMA), informed by a systematic review of the clinical literature. Outcomes were expressed as costs and quality-adjusted life years (QALYs). RESULTS: All interventional treatments were found to be cost-effective compared with CS at a cost-effectiveness threshold of £20,000 per QALY gained. ETA was found to be the most cost-effective strategy overall, with an incremental cost-effectiveness ratio of £3,161 per QALY gained compared with UGFS. Surgery and CS were dominated by ETA. CONCLUSIONS: Interventional treatment for VV is cost-effective in the UK NHS. Specifically, based on current data, ETA is the most cost-effective treatment in people for whom it is suitable. The results of this research were used to inform recommendations within the NICE guideline on VV.

Clinical effectiveness and cost-effectiveness of foam sclerotherapy, endovenous laser ablation and surgery for varicose veins: results from the Comparison of LAser, Surgery and foam Sclerotherapy (CLASS) randomised controlled trial.

BACKGROUND: Foam sclerotherapy (foam) and endovenous laser ablation (EVLA) have emerged as alternative treatments to surgery for patients with varicose veins, but uncertainty exists regarding their effectiveness in the medium to longer term. OBJECTIVES: To assess the clinical effectiveness and cost-effectiveness of foam, EVLA and surgery for the treatment of varicose veins. DESIGN: A parallel-group randomised controlled trial (RCT) without blinding, and economic modelling evaluation. SETTING: Eleven UK specialist vascular centres. PARTICIPANTS: Seven hundred and ninety-eight patients with primary varicose veins (foam, n = 292; surgery, n = 294; EVLA, n = 212). INTERVENTIONS: Patients were randomised between all three treatment options (eight centres) or between foam and surgery (three centres). PRIMARY OUTCOME MEASURES: Disease-specific [Aberdeen Varicose Vein Questionnaire (AVVQ)] and generic [European Quality of Life-5 Dimensions (EQ-5D), Short Form questionnaire-36 items (SF-36) physical and mental component scores] quality of life (QoL) at 6 months. Cost-effectiveness as cost per quality-adjusted life-year (QALY) gained. SECONDARY OUTCOME MEASURES: Quality of life at 6 weeks; residual varicose veins; Venous Clinical Severity Score (VCSS); complication rates; return to normal activity; truncal vein ablation rates; and costs. RESULTS: The results appear generalisable in that participants' baseline characteristics (apart from a lower-than-expected proportion of females) and post-treatment improvement in outcomes were comparable with those in other RCTs. The health gain achieved in the AVVQ with foam was significantly lower than with surgery at 6 months [effect size -1.74, 95% confidence interval (CI) -2.97 to -0.50; p = 0.006], but was similar to that achieved with EVLA. The health gain in SF-36 mental component score for foam was worse than that for EVLA (effect size 1.54, 95% CI 0.01 to 3.06; p = 0.048) but similar to that for surgery. There were no differences in EQ-5D or SF-36 component scores in the surgery versus foam or surgery versus EVLA comparisons at 6 months. The trial-based cost-effectiveness analysis showed that, at 6 months, foam had the highest probability of being considered cost-effective at a ceiling willingness-to-pay ratio of £20,000 per QALY. EVLA was found to cost £26,107 per QALY gained versus foam, and was less costly and generated slightly more QALYs than surgery. Markov modelling using trial costs and the limited recurrence data available suggested that, at 5 years, EVLA had the highest probability (≈ 79%) of being cost-effective at conventional thresholds, followed by foam (≈ 17%) and surgery (≈ 5%). With regard to secondary outcomes, health gains at 6 weeks (p < 0.005) were greater for EVLA than for foam (EQ-5D, p = 0.004). There were fewer procedural complications in the EVLA group (1%) than after foam (7%) and surgery (8%) (p < 0.001). Participants returned to a wide range of behaviours more quickly following foam or EVLA than following surgery (p < 0.05). There were no differences in VCSS between the three treatments. Truncal ablation rates were higher for surgery (p < 0.001) and EVLA (p < 0.001) than for foam, and were similar for surgery and EVLA. CONCLUSIONS: Considerations of both the 6-month clinical outcomes and the estimated 5-year cost-effectiveness suggest that EVLA should be considered as the treatment of choice for suitable patients. FUTURE WORK: Five-year trial results are currently being evaluated to compare the cost-effectiveness of foam, surgery and EVLA, and to determine the recurrence rates following each treatment. This trial has highlighted the need for long-term outcome data from RCTs on QoL, recurrence rates and costs for foam sclerotherapy and other endovenous techniques compared against each other and against surgery. TRIAL REGISTRATION: Current Controlled Trials ISRCTN51995477. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 19, No. 27. See the NIHR Journals Library website for further project information.

Assessment of thrombotic adverse events and treatment patterns associated with varicose vein treatment.

OBJECTIVE: This retrospective study assessed varicose vein treatment patterns and associated thrombotic complications in a real-world setting. METHODS: A retrospective study was conducted with health care claims data from Truven Health, covering more than 40 million insured lives per year and representing all U.S. census regions. The study sample included subjects aged ≥ 18 years with a new diagnosis of varicose veins who had received at least one invasive treatment (eg, surgery, endovenous thermal ablation [radiofrequency or laser], or sclerotherapy [liquid or foam]). The adverse events of interest included a coded diagnosis of deep venous thrombosis (DVT) or pulmonary embolism within 30 days of a claim for invasive treatment. Patients treated between January 1, 2008, and June 30, 2012, were observed for up to 2 years after diagnosis. RESULTS: There were 985,632 unique subjects diagnosed with varicose veins; of them, a total of 131,887 subjects met all of the study criteria: 63,033 (47.8%) having multiple therapies; 22,980 (17.4%) having laser ablation; 21,637 (16.4%) having radiofrequency ablation; 12,708 (9.6%) having sclerotherapy; and 11,529 (8.7%) having surgery. The mean age of the sample was 52.8 years, ranging from 51.5 years (surgery cohort) to 54.5 years (radiofrequency ablation cohort); 77% of the sample was female, ranging from 71% (radiofrequency ablation cohort) to 92% (sclerotherapy cohort). The mean time to treatment after diagnosis was 105 days, ranging from 75 days (sclerotherapy cohort) to 116 days (radiofrequency ablation cohort). The diagnosed prevalence (percentage of subjects within each treatment cohort) of DVT was as follows: radiofrequency ablation, 4.4%; multiple therapies--same day, 3.4%; laser ablation, 3.1%; multiple therapies--deferred, 2.6%; surgery, 2.4%; and sclerotherapy, 0.8%. For pulmonary embolism, the diagnosed prevalence was as follows: radiofrequency ablation, surgery, and laser ablation, 0.3% each; and multiple therapies--same day, multiple therapies--deferred, and sclerotherapy, 0.2% each. CONCLUSIONS: Thrombotic complications associated with invasive varicose vein treatments in the real-world setting may be higher than what has been reported in clinical trials, particularly in regard to DVT after endovenous thermal ablation therapy. A better understanding of these patterns of adverse events may have an impact on new strategies to safely and effectively manage patients with varicose veins.

A randomized trial comparing treatments for varicose veins.

BACKGROUND: Ultrasound-guided foam sclerotherapy and endovenous laser ablation are widely used alternatives to surgery for the treatment of varicose veins, but their comparative effectiveness and safety remain uncertain. METHODS: In a randomized trial involving 798 participants with primary varicose veins at 11 centers in the United Kingdom, we compared the outcomes of foam, laser, and surgical treatments. Primary outcomes at 6 months were disease-specific quality of life and generic quality of life, as measured on several scales. Secondary outcomes included complications and measures of clinical success. RESULTS: After adjustment for baseline scores and other covariates, the mean disease-specific quality of life was slightly worse after treatment with foam than after surgery (P=0.006) but was similar in the laser and surgery groups. There were no significant differences between the surgery group and the foam or the laser group in measures of generic quality of life. The frequency of procedural complications was similar in the foam group (6%) and the surgery group (7%) but was lower in the laser group (1%) than in the surgery group (P<0.001); the frequency of serious adverse events (approximately 3%) was similar among the groups. Measures of clinical success were similar among the groups, but successful ablation of the main trunks of the saphenous vein was less common in the foam group than in the surgery group (P<0.001). CONCLUSIONS: Quality-of-life measures were generally similar among the study groups, with the exception of a slightly worse disease-specific quality of life in the foam group than in the surgery group. All treatments had similar clinical efficacy, but complications were less frequent after laser treatment and ablation rates were lower after foam treatment. (Funded by the Health Technology Assessment Programme of the National Institute for Health Research; Current Controlled Trials number, ISRCTN51995477.).

Systematic review, network meta-analysis and exploratory cost-effectiveness model of randomized trials of minimally invasive techniques versus surgery for varicose veins.

BACKGROUND: A Health Technology Assessment was conducted to evaluate the relative clinical effectiveness and cost-effectiveness of minimally invasive techniques (foam sclerotherapy (FS), endovenous laser ablation (EVLA) and radiofrequency ablation (RFA)) for managing varicose veins, in comparison with traditional surgery. METHODS: A systematic review of randomized clinical trials (RCTs) was undertaken to assess the effectiveness of minimally invasive techniques compared with other treatments, principally surgical stripping, in terms of recurrence of varicose veins, Venous Clinical Severity Score (VCSS), pain and quality of life. Network meta-analysis and exploratory cost-effectiveness modelling were performed. RESULTS: The literature search conducted in July 2011 identified 1453 unique citations: 31 RCTs (51 papers) satisfied the criteria for effectiveness review. Differences between treatments were negligible in terms of clinical outcomes, so the treatment with the lowest cost appears to be most cost-effective. Total FS costs were estimated to be lowest, and FS was marginally more effective than surgery. However, relative effectiveness was sensitive to the model time horizon. Threshold analysis indicated that EVLA and RFA might be considered cost-effective if their costs were similar to those for surgery. These findings are subject to various uncertainties, including the risk of bias present in the evidence base and variation in reported costs. CONCLUSION: This assessment of currently available evidence suggests there is little to choose between surgery and the minimally invasive techniques in terms of efficacy or safety, so the relative cost of the treatments becomes one of the deciding factors. High-quality RCT evidence is needed to verify and further inform these findings.

Mechanochemical endovenous Ablation versus RADiOfrequeNcy Ablation in the treatment of primary great saphenous vein incompetence (MARADONA): study protocol for a randomized controlled trial.

BACKGROUND: Radiofrequency ablation (RFA) is associated with an excellent outcome in the treatment of great saphenous vein (GSV) incompetence. The use of thermal energy as a treatment source requires the instillation of tumescence anesthesia. Mechanochemical endovenous ablation (MOCA) combines mechanical endothelial damage, using a rotating wire, with the infusion of a liquid sclerosant. Tumescence anesthesia is not required. Preliminary experiences with MOCA showed good results and low post-procedural pain. METHODS/DESIGN: The MARADONA (Mechanochemical endovenous Ablation versus RADiOfrequeNcy Ablation) trial is a multicenter randomized controlled trial in which 460 patients will be randomly allocated to MOCA or RFA. All patients with primary GSV incompetence who meet the eligibility criteria will be invited to participate in this trial. The primary endpoints are anatomic and clinical success at a one-year follow-up, and post-procedural pain. The secondary endpoints are technical success, complications, operation time, procedural pain, disease-specific quality of life, time taken to return to daily activities and/or work, and cost-efficiency analyses after RFA or MOCA. Both groups will be evaluated on an intention to treat base. DISCUSSION: The MARADONA trial is designed to show equal results in anatomic and clinical success after one year, comparing MOCA with RFA. In our hypothesis MOCA has an equal anatomic and clinical success compared with RFA, with less post-procedural pain. TRIAL REGISTRATION: Clinicaltrials NCT01936168.

Medical liability insurance claims after treatment of varicose veins.

OBJECTIVE: Since insight into the reason for filing claims after treatment of varicose veins of the lower extremity might help prevent future claims, we determined the incidence of and reasons for medical liability insurance claims after such treatments in the Netherlands. METHOD: We performed a retrospective review of all medical liability insurance claims after varicose vein treatment handled by MediRisk between January 1993 and December 2007. RESULTS: A total of 144 claims were filed of which 104 were closed by the end of the study period. Nerve injury (n = 28), skin necrosis following sclerotherapy (n = 17), deep vein injury (n = 11) and insufficient communication (n = 9) accounted for more than 60% of all claims. Claims were equally distributed among registrars and consultants. Some 41 of the 104 closed claims were accepted. In 27 of the accepted cases, the physician had obviously failed in providing the care as expected from a medical practitioner allowed to perform these treatments. The majority of these 27 claims were due to injury of nerves (n = 11) or deep veins (n = 9). CONCLUSION: The incidence of claims after treatment of varicose veins in the Netherlands is low. Proper knowledge of anatomy and adequate communication, along with the introduction of less invasive treatments might prevent future claims.