A Retrospective Cohort Study of Patient Risk Factors and Pelvic Venous Reflux Patterns on Treatment Outcomes With Pelvic Vein Embolisation.

OBJECTIVE: To identify the effects of patient risk factors and pelvic venous reflux (PVR) patterns on treatment outcomes of Pelvic Vein Embolisation (PVE) for Pelvic Venous Disorder (PeVD). METHODS: We performed a retrospective cohort review assessing population, intervention, comparison, and outcomes (PICO) for women undergoing PVE for PVR January 2017-January 2021. We identified 190 patients who had completed both questionnaires and who had given consent for their information to be used for research (Median age 46, IQR 40-52). The distribution of pathological pelvic venous reflux found on transvaginal duplex ultrasound (TVDUS) was analysed for all patients. Pre- and post-procedure symptom burden scores were studied using a standardised questionnaire protocol. We used inferential univariate non-parametric statistics to describe our data. RESULTS: 190 cases were reviewed; 62.6% (119/190) premenopausal, 11.1% (21/190) perimenopausal, 25.3% (48/190) postmenopausal and menopausal status not documented 1% (2/190). 10.1% (19/188) were nulliparous (average age 34 years; range 20-55 years). There was a statistically significant improvement in all symptoms and in the appearance of varicosities on TVDUS post-PVE (P < 0.05) of the ovarian vein plexus, uterus plexus, arcuate veins, vaginal wall, peri-urethral, peri-anal, haemorrhoids, labial and proximal thigh. The locations of veins requiring embolisation having demonstrated reflux were analysed; 82.8% (154/186) underwent embolisation of at least one internal iliac vein tributary and ovarian vein embolisation. Age, parity, menopausal status and previous laparoscopy did not affect symptom improvement (P > 0.05). No significant complications such as coil migration were observed. CONCLUSIONS: PVE is an effective treatment for pelvic pain due to PeVD and its diagnosis should not be limited to multiparous women of childbearing age, as a significant proportion of patients who benefited from PVE were either nulliparous and/or postmenopausal.

Evaluating pharmacological THRomboprophylaxis in Individuals undergoing superficial endoVEnous treatment across NHS and private clinics in the UK: a multi-centre, assessor-blind, randomised controlled trial-THRIVE trial.

INTRODUCTION: Endovenous therapy is the first choice management for symptomatic varicose veins in NICE guidelines, with 56-70 000 procedures performed annually in the UK. Venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism (PE), is a known complication of endovenous therapy, occurring at a rate of up to 3.4%. Despite 73% of UK practitioners administering pharmacological thromboprophylaxis to reduce VTE, no high-quality evidence supporting this practice exists. Pharmacological thromboprophylaxis may have clinical and cost benefit in preventing VTE; however, further evidence is needed. This study aims to establish whether when endovenous therapy is undertaken: a single dose or course of pharmacological thromboprophylaxis alters the risk of VTE; pharmacological thromboprophylaxis is associated with an increased rate of bleeding events; pharmacological prophylaxis is cost effective. METHODS AND ANALYSIS: A multi-centre, assessor-blind, randomised controlled trial (RCT) will recruit 6660 participants from 40 NHS and private sites across the UK. Participants will be randomised to intervention (single dose or extended course of pharmacological thromboprophylaxis plus compression) or control (compression alone). Participants will undergo a lower limb venous duplex ultrasound scan at 21-28 days post-procedure to identify asymptomatic DVT. The duplex scan will be conducted locally by blinded assessors. Participants will be contacted remotely for follow-up at 7 days and 90 days post-procedure. The primary outcome is imaging-confirmed lower limb DVT with or without symptoms or PE with symptoms within 90 days of treatment. The main analysis will be according to the intention-to-treat principle and will compare the rates of VTE at 90 days, using a repeated measures analysis of variance, adjusting for any pre-specified strongly prognostic baseline covariates using a mixed effects logistic regression. ETHICS AND DISSEMINATION: Ethical approval was granted by Brent Research Ethics Committee (22/LO/0261). Results will be disseminated in a peer-reviewed journal and presented at national and international conferences. TRIAL REGISTRATION NUMBER: ISRCTN18501431.

Defining the Parameters for Endovenous Microwave Ablation to Achieve Equivalence With Endovenous Laser Ablation, Using the Porcine Liver Model.

AIMS: Endovenous microwave ablation (EMWA) is an endovenous thermoablation (EVTA) system to ablate incompetent truncal veins. Early results suggest that EMWA uses more power than endovenous laser ablation (EVLA) to get the same results. We aimed to define the parameters for EMWA, which give the same tissue ablation as EVLA, using the validated porcine liver model. METHODS: EVLA (1470 nm 600 micron radial fibre) treatments were performed at 6 W, 8 W and 10 W, at pullback speeds of 6, 7, 8 and 9 s/cm, giving Linear Endovenous Energy Densities (LEEDs) between 36 - 90 J/cm. Each combination of power and pullback was repeated 5 times. We then used EMWA in the same model. Powers of 35-75 W and pullback speeds of 4-9 s/cm were used (LEEDs 140-675 J/cm). Ablation tracts from both devices were analysed by 2 blinded observers, noting thermal spread and carbonisation. RESULTS: For each commonly used parameter for EVLA, we identified a range of parameters for EMWA that produced similar tissue ablation in the porcine liver model. To keep the pullback speeds within the usual range, powers of 35-75 W were needed with EMWA, with mean EMWA LEEDs 3.9 - 5.8 times higher than EVLA LEEDs. We found the quicker the pullback speed, the higher the multiple of EMWA LEED we needed to get the same effect. CONCLUSION: We have identified parameters for EMWA that gave equivalent tissue ablation in the porcine liver model to commonly used parameters used for EVLA. These need to be validated clinically, but as the model used has already been validated against clinical outcome in endovenous thermal ablation, there is little reason to suspect that these results would not be valid. As the power during EMWA is higher than EVLA, EVMA LEEDs are approximately 4-6 times higher than EVLA LEEDs to achieve the same thermal effect on the tissues.

899 serious adverse events including 13 deaths, 7 strokes, 211 thromboembolic events, and 482 immune reactions: The untold story of cyanoacrylate adhesive closure.

OBJECTIVE: The aim was to retrieve and analyse the serious adverse events of venous occlusion systems used in cyanoacrylate adhesive closure (CAC) submitted to regulatory agencies. METHODS: The Total Product Life Cycle (TPLC) database of the US Food and Drug Administration (FDA), the Database of Adverse Event Notifications (DAEN) of the Australian Therapeutic Goods Administration (TGA), and the Yellow Card database of the UK Medicines and Healthcare Products Regulatory Agency (MHRA) were reviewed. Three Freedom of Information (FOI) requests had to be submitted to the MHRA to obtain data. RESULTS: The TPLC contained 899 reports which included 13 cases of death, 7 strokes, 211 thromboembolic events, and 482 immune reactions. The DAEN recorded three reportable adverse events, and the MHRA recorded seven adverse incidents including one death. CONCLUSION: CAC is associated with serious adverse events including death. These events are under-reported in the medical literature and only sub-optimally reported to the regulatory agencies.

Syncope (fainting on standing from squatting) due to massive venous reflux into lower limb varicose veins - Case report.

A 42-year-old man presented with very large lower limb varicose veins bilaterally and an 8-month history of fainting when standing up from a squatting position. He had been investigated for syncope by a cardiologist with no abnormality found on electrocardiogram, echocardiogram, 24-h electrocardiogram or 48-h blood pressure monitoring. Venous duplex ultrasonography showed bilaterally great saphenous vein reflux, with each vein having a diameter of 23.5 and 24.0 mm at the groin, and a similar dilation along the whole vein to ankle. These veins were successfully ablated with endovenous laser ablation, immediately following which the syncope disappeared and has not returned. We calculate that before treatment, the patient had approximately 500 ml of blood refluxing passively with gravity from his deep venous system on standing into his incompetent great saphenous veins and associated varicosities, which would account for his postural syncope.

Participant Reported Improvement in Cellulite by Vari-Pad Apparel and Objective Measurements - A "First Use" Pilot Study.

Background: Cellulite affects 80-90% of post-pubertal females and, although cosmetic, has proven adverse psychological effects. A new compression garment with patented "vari-pad" technology has been developed, aiming to stimulate lymphatic return from the buttocks and thighs. The primary aim of this small pilot study was to assess participant satisfaction after using this garment in the short term and secondarily, to look for any objective improvements. Methods: Eighteen female participants (mean 47.5y, range 26-60) completed the study. There were 2 weeks of "stabilisation", 4 weeks of wearing the garment, and 2 weeks of further assessment. With the initial assessment, there were 9 visits for each participant. At each visit, weight, participant satisfaction (0-10), 3D images (Canfield, USA) and transcutaneous water content (LymphScanner, Delfin Technologies, Finland) and comfort (0-10) were recorded. Results: There was no significant weight change in any of the participants during the trial period. After 4 weeks of wearing the garment, there was a significant improvement in participant satisfaction of their cellulite (n = 15, p = 0.0036) with a mean improvement of 18.5%. 3D image analysis of dimple volume showed no significant change in buttock cellulite, a significant decrease in left thigh cellulite (n = 17, p = 0.0123), but not on the right (n = 14, p = 0.6890). There was a significant decrease of localised water (n = 36, p = 0.0041). Comfort was 86% (range 40-100%) and there were no adverse reactions to the garment. Conclusion: The vari-padded compression garment produced a significant improvement in participant satisfaction after just 4 weeks of treatment. Objective measurements failed to show a significant difference in cellulite on the buttocks but showed a significant improvement in the thighs by analysis of both dimple volumes and reduced transcutaneous water measurements. Further study is suggested to demonstrate if longer timeframes for use of the apparel will lead to further significant improvement in the appearance of cellulite. NCT Number: NCT05748678.

Sclerotherapy of lower limb veins: Indications, contraindications and treatment strategies to prevent complications - A consensus document of the International Union of Phlebology-2023.

BACKGROUND: Sclerotherapy is a non-invasive procedure commonly used to treat superficial venous disease, vascular malformations and other ectatic vascular lesions. While extremely rare, sclerotherapy may be complicated by serious adverse events. OBJECTIVES: To categorise contraindications to sclerotherapy based on the available scientific evidence. METHODS: An international, multi-disciplinary panel of phlebologists reviewed the available scientific evidence and developed consensus where evidence was lacking or limited. RESULTS: Absolute Contraindications to sclerotherapy where the risk of harm would outweigh any benefits include known hypersensitivity to sclerosing agents; acute venous thromboembolism (VTE); severe neurological or cardiac adverse events complicating a previous sclerotherapy treatment; severe acute systemic illness or infection; and critical limb ischaemia. Relative Contraindications to sclerotherapy where the potential benefits of the proposed treatment would outweigh the risk of harm or the risks may be mitigated by other measures include pregnancy, postpartum and breastfeeding; hypercoagulable states with risk of VTE; risk of neurological adverse events; risk of cardiac adverse events and poorly controlled chronic systemic illness. Conditions and circumstances where Warnings and Precautions should be considered before proceeding with sclerotherapy include risk of cutaneous necrosis or cosmetic complications such as pigmentation and telangiectatic matting; intake of medications such as the oral contraceptive and other exogenous oestrogens, disulfiram and minocycline; and psychosocial factors and psychiatric comorbidities that may increase the risk of adverse events or compromise optimal treatment outcomes. CONCLUSIONS: Sclerotherapy can achieve safe clinical outcomes provided that (1) patient-related risk factors and in particular all material risks are (1a) adequately identified and the risk benefit ratio is clearly and openly discussed with treatment candidates within a reasonable timeframe prior to the actual procedure; (1b) when an individual is not a suitable candidate for the proposed intervention, conservative treatment options including the option of 'no intervention as a treatment option' are discussed; (1c) complex cases are referred for treatment in controlled and standardised settings and by practitioners with more expertise in the field; (1d) only suitable individuals with no absolute contraindications or those with relative contraindications where the benefits outweigh the risks are offered intervention; (1e) if proceeding with intervention, appropriate prophylactic measures and other risk-mitigating strategies are adopted and appropriate follow-up is organised; and (2) procedure-related risk factors are minimised by ensuring the treating physicians (2a) have adequate training in general phlebology with additional training in duplex ultrasound, procedural phlebology and in particular sclerotherapy; (2b) maintain their knowledge and competency over time and (2c) review and optimise their treatment strategies and techniques on a regular basis to keep up with the ongoing progress in medical technology and contemporary scientific evidence.

Linear endovenous energy density (LEED) should always be quoted with the power used in endovenous thermal ablation - results from an in-vitro porcine liver model study.

BACKGROUND: Linear Endovenous Energy Density (LEED) is the energy used per cm of vein in endovenous thermal ablation (EVTA) but does not include time. This study examines the effect of time during EVTA. METHOD: EVTA was performed in a previously validated porcine liver model. LEEDs of 40, 60, 80 and 100 J/cm, using different powers were repeated 5 times each. Thermal spread, tissue carbonisation and device-tissue sticking during treatment were recorded. RESULT: LEED positively correlated to thermal spread and carbonisation of the tissue. Power was correlated with carbonisation but not thermal spread. Pullback had no correlations with thermal spread or carbonisation. Catheter sticking found occurred in powers >= 15 W or LEED >= 80 J/cm. CONCLUSION: LEED is a good measure of EVTA but does not include time. Power, which does include time, correlates with carbonisation and with device-tissue sticking. The power used must be quoted with the LEED.

Non-thrombotic superficial venous phlebitis secondary to Covid-19 vaccine or subsequent Covid-19 infection.

A 43-year-old woman presented with localised areas of prominent, tender superficial veins in her right arm and both legs, and chest pain, following the second dose of AstraZeneca vaccine and possible contemporaneous Covid-19 infection. Electrocardiogram, troponin and d-dimer had all been normal. However, a venous duplex ultrasound scan showed a perivenous inflammation without thrombosis in the areas of her limbs with prominent tender veins, but not elsewhere. We suggest that patients may present with prominent and tender superficial veins secondary to non-thrombotic phlebitis following Covid-19 infection or the AstraZeneca vaccine, which appears to be self-limiting. In addition, this case raises the possibility that Covid-19 infection or the AstraZeneca vaccine may directly affect cells in the vein wall, resulting in phlebitis without any evidence of thrombosis or microthrombosis. This phenomenon appears to be transient and self-limiting.

Current Best Practice in the Management of Varicose Veins.

This article outlines the current best practice in the management of varicose veins. "Varicose veins" traditionally means bulging veins, usually seen on the legs, when standing. It is now a general term used to describe these bulging veins, and also underlying incompetent veins that reflux and cause the surface varicose veins. Importantly, "varicose veins" is often used for superficial venous reflux even in the absence of visible bulging veins. These can be simply called "hidden varicose veins". Varicose veins usually deteriorate, progressing to discomfort, swollen ankles, skin damage, leg ulcers, superficial venous thrombosis and venous bleeds. Patients with varicose veins and symptoms or signs have a significant advantage in having treatment over conservative treatment with compression stockings or venotropic drugs. Small varicose veins or telangiectasia without symptoms or signs can be treated for cosmetic reasons. However, most have underlying venous reflux from saphenous, perforator or local "feeding veins" and so investigation with venous duplex should be mandatory before treatment. Best practice for investigating leg varicose veins is venous duplex ultrasound in the erect position, performed by a specialist trained in ultrasonography optimally not the doctor who performs the treatment. Pelvic vein reflux is best investigated with transvaginal duplex ultrasound (TVS), performed using the Holdstock-Harrison protocol. In men or women unable to have TVS, venography or cross-sectional imaging is needed. Best practice for treating truncal vein incompetence is endovenous thermal ablation. Increasing evidence suggests that significant incompetent perforating veins should be found and treated by thermal ablation using the transluminal occlusion of perforator (TRLOP) approach, and that incompetent pelvic veins refluxing into symptomatic varicose veins in the genital region or leg should be treated by coil embolisation. Bulging varicosities should be treated by phlebectomy at the time of truncal vein ablation. Monitoring and reporting outcomes is essential for doctors and patients; hence, participation in a venous registry should probably be mandatory.

Endovenous Laser Ablation (EVLA) for Treatment of Varicose Veins: A Comparison of EVLA with 1470 nm and 1940 nm Lasers.

INTRODUCTION: Endovenous laser ablation (EVLA) using 1470 nm, which targets water as its chromophore, has become the standard endovenous thermal treatment for incompetent truncal veins. Recently, there has been growing interest in the use of 1940 nm, due to the greater absorption by water. This increased absorption has led to claims that, with the longer wavelength, less power is needed to achieve the same biological effect during treatment, resulting in fewer adverse post-operative sequelae. METHODS: Review of the current literature comparing 1940 nm and 1470 nm EVLA, which includes both laboratory-based and clinical studies. Reports on the use of 1920 nm were combined with those on 1940 nm. RESULTS: Increased absorption of the longer wavelength by water results in more thermal damage closer to the EVLA device. Thus, there may be an advantage to using the longer wavelength in EVLA of thin-walled veins at low power. However, in saphenous veins, which have thicker walls, there is little evidence that this different energy distribution in the vein wall makes any clinical difference. Reduced pain is likely to be due to reduced power during treatment. This is likely to result in more long-term failures of ablation using 1940 nm. CONCLUSION: There is a difference in the distribution of thermal damage in the vein wall between EVLA at 1470 nm and 1940 nm. However, there is little evidence of any clinically significant difference when used in incompetent saphenous veins. Clinical studies looking for a difference need to report the size and wall thickness of the treated vein, the power used as well as the energy per centimetre (LEED), and long-term ablation rates in addition to early post-operative pain, induration, paraesthesia and ecchymosis. Also, power loss in different laser / fibre systems and technical differences, such as those that might allow blood to remain in the vein being treated, need to be considered.

No significant difference between 1940 and 1470 nm in endovenous laser ablation using an in vitro porcine liver model.

Current endovenous laser ablation (EVLA) practice favours 1470 nm, as water is a major chromophore for this wavelength. Water has a greater affinity for 1940 nm, leading to claims that lower powers or linear endovenous energy densities (LEEDs) are needed. We compared the thermal spread and carbonisation of EVLA using these two wavelengths, in the porcine liver model. Using the previously validated porcine liver model, we performed 5 treatments, at each power: 2 W, 4 W, 6 W, 8 W and 10 W using a standard pullback of 8 s/cm. This gave LEEDs for each wavelength of 16, 32, 48, 64 and 80 J/cm. Digital images were given random codes and analysed by two blinded observers. Thermal spread was measured using "SketchandCalc" online software and graded carbonisation from 0 (none) to 3 (black carbon tract). There was no significant difference in thermal spread between the two wavelengths at 6 W, 8 W and 10 W. At 2 W, the 1470-nm laser had a significantly increased thermal spread over the 1940 nm. Significantly more carbonisation was found with the 1940-nm laser compared to 1470 nm. In this model, there was no significant difference in thermal spread at powers of 6 W and more. At 2 W and potentially 4 W, 1470 nm showed spread than 1940 nm, due to increased absorption at the device/tissue interface. At powers and LEEDs used for saphenous ablation, we found no evidence to support reduced power or LEED when using 1940 nm. However, 1940 nm may be more advantageous than 1470 nm when ablating small thin-walled veins, near to the skin.

Testicular vein thrombosis mimicking epididymo-orchitis after suspected Covid-19 infection.

A 70-year-old man presented to our vein clinic with intermittent and recurrent left testicular and groin pain, clinically resembling epididymo-orchitis. He had never had any genitourinary problems until contracting a severe flu-like illness in January 2020, strongly suspected to have been Covid-19. He had failed to respond on four separate occasions to antibiotics prescribed by his GP and had only responded on these occasions to aspirin. Duplex ultrasonography at our clinic showed thrombosis of the left testicular vein with venous collateral formation. The testicle itself showed mild oedema, but a reduced arterial flow supporting the pain to be secondary to thrombosis. Covid-19 is known to be associated with venous thromboembolic disease, but usually in patients sick enough to be hospitalised and particularly in those requiring intensive care. This man appears to have had a left testicular vein thrombosis secondary to relatively mild Covid-19 infection, as he did not require hospitalisation.

Clinical dilemma of management: Cardiac arrest after microsclerotherapy for lower limb telangiectasia with liquid 0.3% aethoxysklerol or idiopathic cardiac arrest?

A 48-year-old woman attended to discuss a dilemma. She had suffered a cardiac arrest immediately following microsclerotherapy of leg telangiectasia with 0.3% aethoxysklerol. She had successful defibrillation and been transferred to hospital. In hospital, despite normal cardiac tests, she was diagnosed as having idiopathic cardiac arrest. The exposure to aethoxysklerol was discounted by her cardiologists as a cause of her arrest. Following the hospital protocol, she was strongly advised to have an implantable defibrillator. Cardiac arrest and myocardial infarction are documented after aethoxysklerol injection with proposed mechanisms being anaphylaxis, direct cardiotoxicity or endothelin-1 release. Before consenting to an implantable defibrillator, which may have its own complications in the long term, doctors and the patient need to be certain that this arrest was not due to a reaction to aethoxysklerol.

Retrograde endovenous laser ablation of the great saphenous vein using the superficial inferior epigastric vein as access vessel illustrated by a case report.

Endovenous thermal ablation is a first-line treatment for symptomatic varicose veins due to truncal vein reflux. Ablation of an incompetent great saphenous vein is usually performed from distally, with the vein access at the lowest point of reflux, or just below the knee. Occasionally there are patients in whom the great saphenous vein is difficult to access distally for reasons such as small vein diameter, scar tissue, vasospasm, difficult anatomy or multiple attempts with haematoma formation. In such cases, we access the great saphenous vein in a retrograde fashion by percutaneous cannulation of the superficial inferior epigastric vein, passing the catheter into the great saphenous vein just distal to the saphenofemoral junction and then down the vein to the required distal position. Ablation can then be performed, stopping the ablation in the great saphenous vein just distal to the junction of superficial inferior epigastric vein and great saphenous vein. We present a patient to illustrate our technique.

Three-year follow-up results of the prospective European Multicenter Cohort Study on Cyanoacrylate Embolization for treatment of refluxing great saphenous veins.

OBJECTIVE: Cyanoacrylate closure of refluxing saphenous veins has demonstrated excellent safety and effectiveness results in feasibility and pivotal studies. This article provides the 36-month follow-up results of a prospective, multicenter, nonrandomized cohort study. METHODS: A total of 70 patients were enrolled in a prospective, multicenter study conducted at seven centers in four European countries and underwent treatment of a solitary refluxing great saphenous vein with endovenous cyanoacrylate embolization without the use of tumescent anesthesia or postprocedure compression stockings. The primary effectiveness end point was freedom from recanalization (closure rate) of the great saphenous vein at 6 months. Safety was assessed by occurrence of adverse events after the procedure and during the 6-month follow-up period. Quality of life and clinical improvement parameters were measured before and after the procedure and through a 12-month follow-up period. Anatomic success and clinical improvement were assessed through 36 months after the procedure. RESULTS: Of 70 treated patients, 64 (91%) were available for the 3-year follow-up. The closure rates by Kaplan-Meier life table methods at 6-, 12-, 24-, and 36-month time points were 91.4%, 90.0%, 88.5%, and 88.5%, respectively. Through 36 months, the improvement in change of the mean venous clinical severity score over time was statistically significant by dropping from 4.3 at baseline to 0.9 at the 36-month follow-up (P < .001). CONCLUSIONS: The 3-year follow-up results of the prospective, multicenter eSCOPE study demonstrated the continued anatomic and clinical effectiveness of cyanoacrylate embolization over an extended follow-up period.