COmpressioN following endovenous TreatmenT of Incompetent varicose veins by sclerotherapy (CONFETTI).

OBJECTIVE: The evidence for post-foam sclerotherapy compression stockings for varicose veins is limited. Thus, we examined the effects of post-procedural compression stockings on varicose vein patients undergoing foam sclerotherapy. METHODS: The CONFETTI study was a prospective, single-center, randomized controlled trial. Patients with foam sclerotherapy-suitable varicose veins were randomly assigned to the compression group (CG) or the no compression stockings group (NCG) for 7 days. The primary outcome was post-procedural pain measured on a 100-mm visual analog scale for 10 days. Secondary outcomes included clinical severity, generic and disease-specific quality of life scores, return to normal activities and/or work, occlusion rates, degree of ecchymosis, CG compliance, and complications. Patients were reviewed at 2 weeks and 6 months. RESULTS: A total of 139 patients were consented to and randomly assigned. The intention-to-treat analysis included 15 patients who did not receive the allocated intervention. Both groups had similar baseline characteristics. Of the patients, 63.3% and 55.4% returned for follow-up at 2 weeks and 6 months, respectively. Most of the veins treated were tributaries. The CG experienced significantly lower pain scores than the NCG, with median scores of 7 mm and 19 mm, respectively (Mann-Whitney U-test; P = .001). At 2 weeks, no differences were observed in ecchymosis or the time to return to normal activities or work. Both groups showed improvements in clinical severity and quality of life, and occlusion rates were comparable. The NCG experienced one deep venous thrombosis and superficial thrombophlebitis, whereas the CG experienced two superficial thrombophlebitis. CONCLUSIONS: The CONFETTI study suggests that short-term post-procedural compression stockings are beneficial for reducing post-procedure pain.

Pain Outcomes Following Mechanochemical Ablation vs Cyanoacrylate Adhesive for the Treatment of Primary Truncal Saphenous Vein Incompetence: The MOCCA Randomized Clinical Trial.

Importance: Endovenous thermal ablations (ETAs) are recommended as first-line treatment for truncal vein reflux, have a short recovery time, and are cost-effective. However, ETAs are associated with discomfort during tumescent anesthesia infiltration. To minimize discomfort, nonthermal, nontumescent ablation techniques had emerged in the form of mechanochemical ablation (MOCA) and cyanoacrylate adhesive injection (CAE). Objective: To assess pain scores immediately after truncal ablation using a 100-mm visual analog scale and 10-point number scale to compare pain-related outcomes following mechanochemical ablation vs cyanoacrylate adhesive treatment. Design, Setting, and Participants: The Multicenter Randomized II Clinical Trial Comparing Mechanochemical Ablation vs Cyanoacrylate Adhesive for the Treatment of Primary Truncal Saphenous Veins Incompetence study was a prospective multicenter randomized clinical trial conducted at 3 sites between November 2017 and January 2020. Inclusion criteria were primary great or small saphenous varicose veins; exclusion criteria included recurrent varicose veins, current deep venous thrombosis, or serious arterial disease. There were 392 participants screened, 225 were excluded, and 167 participants underwent randomization. Four participants did not receive allocated intervention and were included in the intention-to-treat analysis. Follow-up took place at 2 weeks, and 3, 6, and 12 months. Interventions: Patients with primary truncal vein incompetence were randomized to receive either MOCA or CAE. Main Outcomes and Measures: The primary outcome measure was pain score immediately after completing truncal ablation using a 100-mm visual analog scale (VAS) and a 10-point number scale. Secondary outcome measures included degree of ecchymosis, occlusion rates, clinical severity, and generic and disease-specific quality of life (QoL) scores. Results: Of 167 study participants, 99 (59.3%) were women, and the mean (SD) age was 56 (15.8) years. Overall, 155 truncal veins treated (92.8%) were great saphenous veins. Demographic data and baseline status were comparable between treatment groups. A total of 73 patients (47%) underwent adjunctive treatment of varicosities. Overall median (IQR) maximum pain score after truncal treatment was 23 mm (10-44) on the VAS and 3 (2-5) on the number scale, showing no significant difference in median (IQR) pain measured by VAS (MOCA, 24 [11.5-44.7] mm vs CAE, 20 [9.0-42.0] mm; P = .23) or by number scale (MOCA, 4 [2-5] vs CAE, 3 [2-4]; P = .18). Both groups demonstrated significant and comparable improvement in clinical severity, generic and disease-specific QoL scores, and complete occlusion rates. Four patients treated with CAE developed minor complications (superficial thrombophlebitis and thrombus extensions). Conclusions and Relevance: To our knowledge, this was the first randomized clinical trial directly comparing nontumescent ablation techniques. The study demonstrated that the MOCA and CAE techniques have a similar periprocedural pain score. Trial Registration: ClinicalTrials.gov Identifier: NCT03392753.

Cost-effectiveness analysis of current varicose veins treatments.

OBJECTIVE: To analyze the effectiveness and cost effectiveness of technologies for treatment of varicose veins over 5 years-conservative care, surgery (high ligation and stripping), ultrasound-guided foam sclerotherapy (UGFS), endovenous laser ablation (EVLA), and radiofrequency ablation (RFA), mechanochemical ablation (MOCA), and cyanoacrylate glue occlusion (CAE). METHODS: A systematic review was updated and used to construct a Markov decision model. Outcomes were reintervention on the truncal vein, retreatment of residual varicosities and quality-adjusted life years (QALY) and costs over 5 years. RESULTS: UGFS has a significantly greater reintervention rate than other procedures; there is no significant difference between the other procedures. The cost per QALY of EVLA vs UGFS in our base-case model is £16,966 ($23,700) per QALY, which is considered cost effective in the UK. RFA, MOCA, and CAE have greater procedure costs than EVLA with no evidence of greater benefit for patients. CONCLUSIONS: EVLA is the most cost-effective therapeutic option, with RFA a close second, in adult patients requiring treatment in the upper leg for incompetence of the GSV. MOCA, UGFS, CAE, conservative care, and high ligation and stripping are not cost effective at current prices in the UK National Health Service. MOCA and CAE seem to be promising, but further evidence on the effectiveness, reinterventions, and health-related quality of life is needed, as well as how cost effectiveness may vary across settings and reimbursement systems.

Randomized Controlled Trial of Compression After Endovenous Thermal Ablation of Varicose Veins (COMETA Trial).

BACKGROUND: The 21st century has witnessed a rise in the use of endovenous thermal ablation. Being highly clinically and cost-effective and improving the quality of life of patients, they are now considered to be the "gold-standard" treatment for varicose veins. Post-intervention management, especially in terms of postoperative compression, however, remains unclear. As a result, a randomized study was undertaken to investigate the effects of wearing compression stockings after varicose vein treatment. METHOD: Patients with saphenous vein reflux undergoing treatment with endothermal ablation (with or without concurrent phlebectomies) were randomized to receive either 7 days of compression stockings or no stockings. The primary outcome measure for this study was the pain score over the first 10 postoperative days. The pain scores, clinical score, time to return to normal activities, and ecchymosis were assessed. Patients were followed-up at 2 weeks and 6 months post-ablation. RESULTS: In total, 206 patients were randomized, 49% of them to the compression group. The mean age was 49.7 (±16) years and approximately 51% of the population was male. The median pain score in the compression group using a visual analog scale was significantly lower on days 2-5, compared to the no compression group. Those having concurrent phlebectomies and compression stockings also had significantly better pain scores on days 1-3, day 5, and day 7. Improvement in the median venous clinical severity score was noted at 6-month follow-up, but this was not significant. No difference in the generic- or disease-specific quality of life was observed and the time to return to activities was similar. There were no differences in the degree of ecchymosis between the 2 groups and both groups had similar occlusion rates. CONCLUSIONS: These results indicate that wearing compression stockings after endothermal ablation is advantageous in the first few days after treatment and is especially beneficial for those having concurrent phlebectomies.

Foam sclerotherapy versus ambulatory phlebectomy for the treatment of varicose vein tributaries: study protocol for a randomised controlled trial.

BACKGROUND: Ambulatory phlebectomies and foam sclerotherapy are two of the most common treatments for varicose vein tributaries. Many studies have been published on these treatments, but few comparative studies have attempted to determine their relative effectiveness. METHODS/DESIGN: This is a prospective single-centre randomised clinical trial. Patients with primary truncal vein incompetence and varicose vein tributaries requiring treatment will be assigned randomly to either ambulatory phlebectomies or foam sclerotherapy. The primary outcome measure is the re-intervention rate for the varicose vein tributaries during the study period. The secondary outcomes include the degree of pain during the first two post-operative weeks and the time to return to usual activities or work. Improvements in clinical scores, quality of life scores, occlusion rates and cost-effectiveness for each intervention are other secondary outcomes. The re-intervention rate will be considered from the third month. DISCUSSION: This study compares ambulatory phlebectomies and foam sclerotherapy in the treatment of varicose vein tributaries. The re-intervention rates, safety, patient experience and the cost-effectiveness of each intervention will be assessed. This study aims to recruit 160 patients and is expected to be completed by the end of 2019. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03416413 . Registered on 31 January 2018.

Endovenous Management of Varicose Veins.

Varicose veins are a very common condition and have been the subject of a recent proliferation of treatment modalities. The advent of the endovenous treatment era has led to a confusing array of different techniques that can be daunting when making the transition from traditional surgery. All modalities offer excellent results in the right situation, and each has its own treatment profile. Thermal ablation techniques have matured and have a reassuring and reliable outcome, but the arrival of nonthermal techniques has delivered further options for both patient and surgeon. This article provides an overview of the different treatment devices and modalities available to the modern superficial vein surgeon and details the currently available evidence and summation analysis to help surgeons to make an appropriate treatment choice for their patients.

Mechanochemical ablation versus cyanoacrylate adhesive for the treatment of varicose veins: study protocol for a randomised controlled trial.

BACKGROUND: Thermal ablation techniques have become the first-line treatment of truncal veins in the management of chronic venous disease (CVD). Despite excellent outcomes, these methods are often associated with pain; generally due to their use of heat and the necessity of fluid infiltration around the vein. More recently, novel non-thermal techniques, such as mechanochemical ablation (MOCA) and cyanoacrylate adhesive (CAE) have been developed to overcome these unwelcome effects. So far, the novel techniques have been found to have similar efficacy to thermal methods, yet no direct comparisons between the non-thermal treatment techniques have been conducted to date, giving rise to this study. METHODS/DESIGN: This is a prospective, multicentre, randomised clinical trial, recruiting patients with truncal saphenous incompetence. Patients will be randomised to undergo either MOCA or CAE truncal ablation, followed by treatment of any varicosities. All patients will be required to wear compression stockings for 4 days post intervention. The primary outcome measure is the pain score immediately following completion of truncal ablation, measured by a 100-mm Visual Analogue Scale (VAS). The secondary outcomes are entire treatment pain scores, clinical scores, quality of life scores, occlusion rates, time to return to usual activities/work at 2 weeks, 3, 6 and 12 months. Re-intervention rate will be considered from the third month. Cost-effectiveness will be assessed for each intervention at 12 months. The study is powered to detect a mean 10-mm difference in maximum pain score. Allowing for loss to follow-up, the total target recruitment is 180 patients. DISCUSSION: The study will be the first study to compare MOCA against CAE and is designed to determine which method causes less pain. Completion of this study is expected to be the end of 2019. TRIAL REGISTRATION: ClinicalTrials.gov, ID: NCT03392753 . Registered on 17 November 2017.

The advent of non-thermal, non-tumescent techniques for treatment of varicose veins.

Varicose veins are common and their management has undergone a number of changes over the years. Surgery has been the traditional treatment option, but towards the 21st century, new endovenous thermal ablation techniques, namely, radiofrequency ablation and endovenous laser ablation, were introduced which have revolutionised the way varicose veins are treated. These minimally invasive techniques are associated with earlier return to normal activity and less pain, as well as enabling procedures to be carried out as day cases. They are, however, also known to cause a number of side-effects and involve infiltration of tumescent fluid which can cause discomfort. Non-thermal, non-tumescent methods are believed to be the answer to these unwelcome effects. Ultrasound-guided foam sclerotherapy is one such non-thermal, non-tumescent method and, despite a possible lower occlusion, has been shown to improve the quality of life of patients. The early results of two recently launched non-thermal, non-tumescent methods, mechanochemical ablation and cyanoacrylate glue, are promising and are discussed.

Inferior vena cava filters for prevention of venous thromboembolism in obese patients undergoing bariatric surgery: a systematic review.

OBJECTIVE: The use of inferior vena cava (IVC) filters for prevention of venous thromboembolism (VTE) in bariatric surgery is a contentious issue. We aim to review the evidence for the use of IVC filters in bariatric surgical patients, describe trends in practice, and discuss challenges in developing evidence-based guidelines. BACKGROUND: The incidence of VTE in modern bariatric procedures with traditional methods of thromboprophylaxis, such as sequential calf compression devices and perioperative low molecular weight heparin, is approximately 2%. METHODS: A systematic review of the literature was conducted according to PRISMA guidelines. We searched Medline up until July 2013 with the terms "bariatric filter" and "gastric bypass filter." Two investigators independently screened search results according to an agreed list of eligibility criteria. RESULTS: Eighteen studies were included. There were no randomized controlled trials. Data from controlled cohort studies suggest that those who undergo IVC filter insertion preoperatively may be at higher risk of developing deep vein thrombosis (DVT) and pulmonary embolism (PE). A small cohort of patients with multiple risk factors for VTE benefitted from reduced PE-related mortality after preoperative IVC filter insertion. Data from 12 case series reporting VTE outcomes from a total of 497 patients who underwent preoperative IVC filter insertion demonstrated DVT rates of 0% to 20.8% and PE rates ranging from 0% to 6.4%. CONCLUSIONS: Published data reporting the safety and efficacy of IVC filter use in bariatric surgical patients is highly heterogeneous. There is no evidence to suggest that the potential benefits of IVC filters outweigh the significant risks of therapy.

Ambulatory varicosity avulsion later or synchronized (AVULS): a randomized clinical trial.

OBJECTIVE: A randomized clinical trial assessing the difference in quality of life and clinical outcomes between delayed and simultaneous phlebectomies in the context of endovenous truncal vein ablation. BACKGROUND: Endovenous ablation has replaced open surgery as the treatment of choice for truncal varicose veins. Timing of varicosity treatment is controversial with delayed and simultaneous pathways having studies advocating their benefits. A previous small randomized study has shown improved outcomes for simultaneous treatment. METHODS: Patients undergoing local anesthetic endovenous thermal ablation were randomized to either simultaneous phlebectomy or delayed varicosity treatment. Patients were reviewed at 6 weeks, 6 months, and 1 year with clinical and quality of life scores completed, and were assessed at 6 weeks for need for further varicosity intervention, which was completed with either ultrasound-guided foam sclerotherapy or local anesthetic phlebectomy. Duplex ultrasound assessment of the treated trunk was completed at 6 months. RESULTS: 101 patients were successfully recruited and treated out of 221 suitable patients from a screened population of 393. Patients in the simultaneous group (n = 51) showed a significantly improved Venous Clinical Severity Score at all time points, 36% of the delayed group required further treatment compared with 2% of the simultaneous group (P < 0.001). There were no deep vein thromboses, with 1 superfificial venous thrombosis in each group. CONCLUSIONS: Combined endovenous ablation and phlebectomy delivers improved clinical outcomes and a reduced need for further procedures, as well as early quality of life improvements.

The disparate management of superficial venous thrombosis in primary and secondary care.

OBJECTIVES: Superficial venous thrombosis is common and traditionally considered a benign condition requiring only symptomatic treatment. Recent evidence, however, advocates more aggressive management. Extensive guidance is available but actual practice is unknown. This study aimed to assess the management of superficial venous thrombosis by general practitioners (primary care physicians) and vascular surgeons. METHODS: A 19-question validated electronic survey was created and circulated by e-mail to general practitioners and vascular surgeons in the United Kingdom. The survey evaluated presentation, investigation and treatment of superficial venous thrombosis. RESULTS: Three hundred sixty-nine surveys were returned from 197 vascular surgeons and 172 general practitioners. Most clinicians saw less than 20 cases a year, with 40% of clinicians not performing any investigations. Venous duplex was the investigation of choice in over 55%. Treatment with anti-inflammatory drugs was widespread, but anticoagulation and compression were seldom prescribed. Follow-up and treatment duration were disparate. DISCUSSION: The management of superficial venous thrombosis varies widely despite good levels of evidence and guidance. Investigation and treatment of superficial venous thrombosis show marked differences both between and within groups. Improvements in education are required to optimise the treatment pathway and advance patient care.

Open repair versus fenestrated endovascular aneurysm repair of juxtarenal aneurysms.

BACKGROUND: Open repair is the gold standard management for juxtarenal aneurysms. Fenestrated endovascular aneurysm repair (FEVAR) is indicated for high-risk patients. The long-term outcomes of FEVAR are largely unknown, and there is no Level I comparative evidence. This systematic review and meta-analysis of case series compares elective juxtarenal aneurysm surgery by open repair and FEVAR. METHODS: A systematic literature search was conducted for all published studies on elective repair of juxtarenal aneurysms by FEVAR and open repair. The MEDLINE, EMBASE, and Cochrane databases were searched from 1947 to April 2013. The exclusion criteria were case series of <10 patients or ruptured aneurysms. The primary outcomes were perioperative mortality and postoperative renal insufficiency. The secondary outcomes were secondary reinterventions and long-term survival. RESULTS: We identified 35 case series with data on 2326 patients. Perioperative mortality was 4.1% in open repair and FEVAR case series (odds ratio for open repair with FEVAR, 1.059; 95% confidence interval, 0.642-1.747; P = .822). Postoperative renal insufficiency was not significantly different (odds ratio for open repair with FEVAR, 1.136; 95% confidence interval, 0.754-1.713; P = .542). FEVAR patients had higher rates of secondary reintervention, renal impairment during follow-up, and a lower long-term survival compared with open repair patients. CONCLUSIONS: FEVAR and open repair have similar short-term outcomes but have diverging long-term outcomes that may be secondary to the selection bias of FEVAR being offered to high-risk patients. FEVAR is a favorable option in high-risk patients, and open repair remains viable as the gold standard.

Retrograde mechanochemical ablation of the small saphenous vein for the treatment of a venous ulcer.

We present the first case of retrograde ablation of the small saphenous vein to treat active venous ulceration. A 73-year-old gentleman with complicated varicose veins of the left leg and a non-healing venous ulcer despite previous successful endovenous treatment to his left great saphenous vein underwent mechanochemical ablation of his small saphenous vein with the ClariVein® system, under local anaesthetic, using a retrograde cannulation technique. Post-operatively the patient had improved symptomatically and the ulcer size had reduced. This report highlights that patients with small saphenous vein incompetence and active ulceration can be treated successfully with retrograde mechanochemical ablation.

Socio-economic impact of endovenous thermal ablation techniques.

Varicose veins are common and cause extensive morbidity; however, the value of treatment is under-appreciated. Many procedures allow the treatment of varicose veins with minimal cost and extensive literature supporting differing minimally invasive approaches. In this article, we investigate the current literature regarding treatment options, clinical outcome and the cost-benefit economics associated with varicose vein treatment. The practice of defining clinical outcome with quality of life (QOL) assessment is explained to provide valid concepts of treatment success beyond occlusion rates.

Cyanoacrylate glue for the treatment of great saphenous vein incompetence in the anticoagulated patient.

The Sapheon Venaseal Closure System (Sapheon Inc, Santa Rosa, Calif), using cyanoacrylate glue, has provided a new modality of treatment, with patients treated without both tumescent anesthesia and postoperative compression. We present the first case of great saphenous vein occlusion performed using glue while the patient was fully anticoagulated with warfarin. This was tolerated well, and the treated vein showed complete early occlusion at 8 weeks; however at 6 months, extensive recanalization was demonstrated on duplex imaging.

Improving the management of varicose veins.

Up to 30% of the UK population are affected by varicose veins. They are a manifestation of increased venous pressure in the lower limb caused by impaired venous return. Primary varicosities result from poor drainage from the superficial to the deep venous system. Secondary varicosities arise as a result of underlying pathology impeding venous drainage, such as deep venous thrombosis or increased intra-abdominal pressure caused by a mass, pregnancy or obesity. Patients with bleeding varicose veins should be referred to a vascular service immediately. Referral is also indicated in the following cases: symptomatic primary or recurrent varicose veins; lower limb skin changes thought to be caused by chronic venous insufficiency; superficial vein thrombosis and suspected venous incompetence; a venous leg ulcer or healed venous leg ulcer. Imaging is crucial in the assessment of the superficial and deep venous system to enable assessment of venous competence. The gold standard imaging technique is colour duplex ultrasonography. Duplex ultrasound should be used to confirm the diagnosis of varicose veins and the extent of truncal reflux, and to plan treatment for patients with suspected primary or recurrent varicose veins. Superficial vein ligation, phlebectomy and stripping have been the mainstay of treatment. In recent years, new techniques have been developed that are minimally invasive, enabling treatment of superficial venous incompetence with reduced morbidity. NICE recommends that endothermal ablation, in the form of radiofrequency or laser treatment, should be offered as treatment for patients with confirmed varicose veins and truncal reflux.

Diagnosis and surgical management of free-floating thrombus within the carotid artery.

OBJECTIVE: Free-floating thrombus (FFT) of the carotid artery is a rare condition of currently unknown etiology. Less than 150 cases have been described in the published world literature to date. DESIGN AND SETTING: We present 6 consecutive cases of carotid FFT, identified prospectively from 5000 carotid duplex scans over a 34-month period in a single tertiary center for vascular surgery. RESULTS: All 6 cases involved the left carotid bifurcation in neurologically symptomatic individuals. In 5 of the 6 cases, FFT occurred in the absence of a significantly stenosing atheromatous plaque and was not associated with an elevation in velocity on duplex. The patients were all treated with surgical thromboendarterectomy, with good result. CONCLUSIONS: Duplex imaging can underestimate the degree of stenosis. Free-floating thrombus presents a challenge in diagnosis due to its rapidly evolving nature. The management of FFT by acute thromboendarterectomy appears to be safe and effective in limiting further focal neurological sequelae.