Endovenous Thermal Ablation Research Articles

Retrospective review of endovenous thermic ablation alone versus combined with phlebectomy in the management of varicose veins

Background: Chronic venous disease (CVD) affects 25-30% of the adult population in developed countries, significantly impacting quality of life. Endovenous thermal ablation (EVTA) has replaced traditional saphenectomy, but the benefit of combining it with phlebectomy remains debated. This retrospective study compares varicose vein recurrence after EVTA with and without phlebectomy. Methods: A total of 155 patients from the general hospital of Mexico between 2021 and 2024, classified as CEAP C2-C6, were analyzed. Of these, 83 underwent EVTA with phlebectomy, and 72 underwent only EVTA. Demographic data were analyzed, and recurrence rates, technical success, and complications were compared using chi-square and student’s t tests (p<0.05). Results: Recurrence rates were lower in the phlebectomy group (14.5%) compared to the non-phlebectomy group (27.2%, p=0.04). The success rate was higher in the phlebectomy group (86.7%) compared to EVTA alone (65.2%, p=0.003). There were no significant differences in complications between the groups. Conclusions: EVTA with phlebectomy demonstrated better outcomes in terms of recurrence and clinical success. However, minor complications such as bruising should be considered when choosing the treatment.

Innovative Approaches and Future Directions in the Management and Understanding of Varicose Veins: A Systematic Review.

Varicose veins, a prevalent condition that primarily affects the lower limbs, present significant hurdles in diagnosis and treatment due to their diverse causes. This study dives into the complex hormonal, environmental, and molecular elements that influence varicose vein genesis, emphasizing the need for precise diagnostic methods and changing therapy approaches to improve patient outcomes. It investigates the epidemiology and demographic distribution of varicose veins, delves into their pathophysiology, and assesses diagnostic methods such as duplex ultrasonography and the CEAP classification system. In addition, the study discusses novel therapies such as sclerotherapy and endovenous thermal ablation, as well as the effectiveness of existing diagnostic methods in detecting chronic venous illnesses. By investigating venous wall remodeling and inflammatory pathways, it gives a thorough knowledge of varicose vein formation. The study calls for future research that focuses on patient-centered methods, bioengineering advances, digital health applications, and genetic and molecular studies to improve the accuracy and effectiveness of vascular therapy. As a result, a multidisciplinary literature analysis was done, drawing on insights from vascular medicine, epidemiology, genetics, and pharmacology, to consolidate existing knowledge and identify possibilities to enhance varicose vein diagnosis, treatment, and patient care outcomes.

Endovenous thermal ablation mid-term outcomes for the treatment of large diameter incompetent great saphenous veins.

The aim of this study was to assess the efficacy and safety of endovenous thermal ablation (EVTA) in treating large diameter, ≥12mm, incompetent great saphenous vein (GSV) in comparison to smaller ones. A retrospective comparative study was undertaken including 196 patients (205 limbs) undergoing EVTA. According to maximum GSV diameter patients were divided into two groups (group A <12mm, group B ≥12mm). Primary outcome was anatomic success defined as absence of reflux of GSV. Secondary outcomes were complications, postoperative pain using the 10-cm Visual Analog Scale (VAS) and improvement of Venous Clinical Severity Score (VCSS) and Chronic Venous Insufficiency Quality-of-Life Questionnaire (CΙVIQ-20) scores assessed at 7- days, 1month, 12months and 24months postoperatively. 118 patients with GSV diameter <12mm (group A) and 87 with GSV diameter ≥12mm (group B) were included. Patients' demographics, CEAP classification and length of ablated vein did not differ between the groups. Preoperative VCSS and VAS pain score were significant greater in group B (6.03 vs 6.94, p = .04 and 5.21 vs 5.77, p = .032, respectively). No differences in adverse events were observed post-operatively among groups. GSV occlusion rate at 1month was 98.3% (SE 1.3%) in group A and 96.5 % (2.2%) in group B (p = .3), at 12months 95.7% (SE 2%) and 94.2% (SE 2.8%) (p = .5), and at 24months 94% (SE 2.4%) and 93.1% (SE 3%) (p = .4) respectively. Both groups experienced significant and similar improvement in their VCSSs and CIVIQ scores postoperatively. In a subgroup analysis among different EVTA and GSV >12mm, 1470nm endovenous laser ablation (EVLA) and radiofrequency ablation (RFA) showed comparable results in terms of occlusion rates, complications, VCSS and CIVIQ scores. Endovenous thermal ablation techniques are efective and safe in the treatment of GSV incompetence regardless the diameter of the GSV. Both 1470nm EVLA and RFA techniques performed similar outcomes.

Value and limitations of postoperative duplex scans after endovenous thermal ablation

Value and limitations of postoperative duplex scans after endovenous thermal ablation

Comparative analysis of VenaBlock and VenaSeal Systems for catheter-guided endovenous cyanoacrylate closure in treating chronic venous insufficiency of the lower extremity: effectiveness and feasibility.

Cyanoacrylate adhesive closure (CAC) systems are widely used to treat varicose veins. In terms of efficacy and safety, these nonthermal, non-tumescent methods are noninferior to endovenous thermal ablation techniques. However, no published studies have compared products that use CAC systems. VenaSeal® (Medtronic, Santa Rosa, CA, USA) and VenaBlock® (Invamed) are the most commonly used CAC-based products worldwide. This study aimed to focus on the efficacy of these two commonly used products, with little emphasis on safety. Published full-text articles on the VenaBlock® and VenaSeal® systems were searched. Data for each product were evaluated by comparing them with each other in terms of effectiveness. In total, 1882 extremities from 11 studies using VenaBlock® and 524 extremities from eight studies using VenaSeal® were included and compared. Both devices were effective, and their cumulative recanalization-free survival rates were similar (P=0.188) at the 6-, 12-, 24-, 36-, and 60-month follow-ups. Both products improved the venous clinical severity score (VCSS) and quality of life (QoL) scores. VenaBlock® and VenaSeal® are effective in terms of cumulative recanalization-free survival rates, and no significant difference was found between the two groups (P=0.188). Both significantly improve the VCSS and QoL scores. CAC is feasible for the treatment of varicose veins.

The access and invasiveness-based classification of medical procedures to clarify non-invasive from different forms of minimally invasive and open surgery.

The rapid development of less invasive and traumatic medical procedures has resulted in a mixture of terms used to describe them, without any agreed definition for each. This is confusing to both medical professionals and patients and can lead to unrealistic patient expectations. The aim of this article is to show the current confused nomenclature and to suggest a new, simple classification based on access and invasiveness (AI) that can be applied to any medical procedure. We performed an online search for definitions for 'non-invasive', 'non-surgical', 'minimally invasive', 'minimal access', 'pinhole' and 'keyhole'. We then searched peer-reviewed medical papers (PRMPs) and patient facing websites (PFWs) for the following index procedures, to see which of the original 6 terms were used to describe them: transvaginal ultrasound, sclerotherapy for leg veins, botulinum toxin injections, dermal fillers, endovenous thermal ablation and laparoscopic gall bladder removal. We found a wide variety of definitions for each of the initial terms. In both PRMPs and PFWs, there were a variety of terms used for each index procedure (i.e.: transvaginal ultrasound, injections of sclerotherapy, botulinum toxin or dermal fillers being both 'non-invasive' and 'minimally invasive') showing confusion in the classification of procedures. We suggested the 'AI classification' based on access (A - none, B - natural orifice or C - penetrating an epithelial surface) and invasiveness (1 - none, 2 - surface damage, 3 - needle = <21G, 4 - cannula >21G but not a surgical trocar, 5 - surgical trocars or small incisions and 6 - incisions). The current confusion of terms used for procedures that are less invasive than the open surgical alternatives leads to confusion and possible false patient expectations. We have proposed an AI classification that can be applied easily to any procedure, giving a uniform classification for medical professionals and patients to understand.

Higher CEAP Classification Is Associated with Lower Odds of Improvement in Patient-Reported Outcomes After Endovenous Thermal Ablation

Higher CEAP Classification Is Associated with Lower Odds of Improvement in Patient-Reported Outcomes After Endovenous Thermal Ablation

Varicosis-Current treatment concepts

Varicosis is achronic progressive disease characterized by varicose veins of the lower extremities. Pain, swelling and heaviness of the legs are typical symptoms. These symptoms are caused by apathological venous reflux, arising from aweakness of the vein wall and progressive venous insufficiency. The indications for invasive surgery are the symptomatic clinical, etiological, anatomical, pathophysiological (CEAP) stages C2s-C6. Compression therapy and venoactive drugs can be recommended for conservative therapy. When it comes to surgical treatment conventional open vein surgery is associated with the best long-term results. Endovenous thermal ablation is associated with few postoperative complications and favors earlier mobilization of the patient. Sclerotherapy has become established with good clinical results for the ablation of reticular and telangiectatic veins, for recurrences and complicated vein anatomy.

Safety and efficacy of endovenous ablation in patients with a history of deep vein thrombosis

ObjectiveEndovenous ablation is the standard of care for patients with symptomatic superficial venous insufficiency. For patients with a history of deep vein thrombosis (DVT), concern exists for an increased risk of postprocedural complications, particularly venous thromboembolism. The objective of this study was to evaluate the safety and efficacy of endovenous thermal ablation in patients with a history of DVT. MethodsThe national Vascular Quality Initiative Varicose Vein Registry was queried for superficial venous procedures performed from January 2014 to July 2021. Limbs treated with radiofrequency or laser ablation were compared between patients with and without a DVT history. The primary safety end point was incident DVT or endothermal heat-induced thrombosis (EHIT) II-IV in the treated limb at <3 months of follow-up. The secondary safety end points included any proximal thrombus extension (ie, EHIT I-IV), major bleeding, hematoma, pulmonary embolism, and death due to the procedure. The primary efficacy end point was technical failure (ie, recanalization at <1 week of follow-up). Secondary efficacy end points included the risk of recanalization over time and the postprocedural change in quality-of-life measures. Outcomes stratified by preoperative use of anticoagulation (AC) were also compared among those with prior DVT. ResultsAmong 33,892 endovenous thermal ablations performed on 23,572 individual patients aged 13 to 90 years, 1698 patients (7.2%) had a history of DVT. Patients with prior DVT were older (P < .001), had a higher body mass index (P < .001), were more likely to be male at birth (P < .001) and Black/African American (P < .001), and had greater CEAP classifications (P < .001). A history of DVT conferred a higher risk of new DVT (1.4% vs 0.8%; P = .03), proximal thrombus extension (2.3% vs 1.6%; P = .045), and bleeding (0.2% vs 0.04%; P = .03). EHIT II-IV, pulmonary embolism, and hematoma risk did not differ by DVT history (P = NS). No deaths from treatment occurred in either group. Continuing preoperative AC in patients with prior DVT did not change the risk of any complications after endovenous ablation (P = NS) but did confer an increased hematoma risk among all endovenous thermal ablations and surgeries (P = .001). Technical failure was similar between groups (2.0% vs 1.2%; P = .07), although a history of DVT conferred an increased recanalization risk over time (hazard ratio, 1.90; 95% confidence interval, 1.46, 2.46; P < .001). The groups had comparable improvements in postprocedural venous clinical severity scores and Heaviness, Aching, Swelling, Throbbing, and Itching scores (P = NS). ConclusionsEndovenous thermal ablation for patients with a history of DVT was effective. However, appropriate patient counseling regarding a heightened DVT risk, albeit still low, is critical. The decision to continue or withhold AC preoperatively should be tailored on a case-by-case basis.

Obese patients with CEAP (clinical, etiology, anatomy, pathophysiology) C2 and C3 disease show enhanced symptom improvement after endovenous thermal ablation

ObjectiveEndovenous thermal ablation (EVTA) is a prevalent treatment option for patients with severe venous disease. However, the decision to intervene for patients with less severe disease (CEAP [clinical, etiology, anatomy, pathophysiology] C2 and C3) is less clear and becomes further complicated for patients with obesity, a pathology known to increase venous disease symptom severity. Therefore, the objective of this study was to use the Society for Vascular Surgery Vascular Quality Initiative database to evaluate outcomes after EVTA in obese patients with CEAP C2 and C3 venous insufficiency. MethodsUsing the Society for Vascular Surgery Vascular Quality Initiative database, we retrospectively analyzed the initial procedure of all patients with a CEAP clinical class of C2 or C3 who underwent EVTA from January 2015 to December 2021. Patients were grouped by obesity, defined as a body mass index of ≥30 kg/m2. The primary outcome was the change in venous clinical severity score (VCSS) from the procedure to the patient's initial follow-up. The secondary outcomes included the change in patient-reported outcomes at follow-up via the HASTI (heaviness, achiness, swelling, throbbing, itching) score, incidence of follow-up complications, and recanalization of treated veins. The change in the VCSS and HASTI score were analyzed using Student t tests, and complications and recanalization were assessed using the Fisher exact test. Significant outcomes were confirmed by multiple variable logistic regression. The remaining significant variables were then analyzed, with obesity categorized using the World Health Organization classification system to analyze how increasing obesity levels affect outcomes. ResultsThere were 8146 limbs that met the inclusion criteria, of which 5183 (63.6%) were classified as nonobese and 2963 (36.4%) as obese. Obesity showed no impact on improvement in the VCSS (−3.29 vs −3.35; P = .408). Obesity was found to be associated with a larger improvement in overall symptoms, as evidence by a greater improvement in the HASTI score (−7.24 vs −6.62; P < .001). Obese limbs showed a higher incidence of superficial phlebitis (1.5% vs 0.7%; P = .001), but no difference was found in recanalization or any other complication. ConclusionsThese data suggest that obese patients with CEAP clinical class C2 or C3 experience greater improvement in their perceived symptoms after EVTA with little difference in clinical improvement and complications compared with nonobese patients. Although obesity has been associated with increased severity of venous disease symptoms, obese patients are able to derive significant relief after treatment during the short term and may experience greater relief of symptoms than nonobese patients when treated at more mild disease presentations.

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

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. EVLA (1470nm 600micron radial fibre) treatments were performed at 6W, 8W and 10W, at pullback speeds of 6, 7, 8 and 9s/cm, giving Linear Endovenous Energy Densities (LEEDs) between 36 - 90J/cm. Each combination of power and pullback was repeated 5 times. We then used EMWA in the same model. Powers of 35-75W and pullback speeds of 4-9s/cm were used (LEEDs 140-675J/cm). Ablation tracts from both devices were analysed by 2 blinded observers, noting thermal spread and carbonisation. 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 35-75W 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. 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.

Study design of the VenaSeal Spectrum Program: Two randomized controlled trials and one single-arm prospective study of a cyanoacrylate closure system to treat early to advanced chronic venous disease

Background/ObjectiveChronic venous disease (CVD) affects >25% of adults in developed countries. It is usually a progressive disease; if left untreated, can lead to advanced disease such as venous ulceration. The VenaSeal Spectrum Program compares the VenaSeal closure system (VenaSeal) to the global standards of care for CVD: endothermal ablation and surgical stripping. It also investigates VenaSeal's usefulness for patients with venous leg ulcers (VLUs). A key component of this clinical program was to measure and quantify patient satisfaction with treatments related to discomfort, healing time, and effectiveness, which often has been overlooked in CVD research. This article describes the rationale and design of the VenaSeal Spectrum Program for patients with CVD. MethodsVenaSeal Spectrum is a prospective, postmarket, clinical trial program reporting outcomes from the periprocedural period through 5 years after treatment with VenaSeal. VenaSeal Spectrum has enrolled 506 participants at 32 sites in 10 countries requiring treatment for symptomatic Clinical, Etiological, Anatomical, and Pathophysiological Classification (CEAP) 2-6 CVD involving the truncal saphenous vein(s). The program is composed of three studies. Two randomized controlled trials compare VenaSeal ablation with either surgical stripping or endovenous thermal ablation in patients with symptomatic CEAP 2-5 disease. A single-arm prospective study investigates participants with active VLUs (CEAP 6) treated with VenaSeal. The unique primary end points for both randomized trials include both periprocedural and postprocedural patient treatment satisfaction measured by a new questionnaire (VenousTSQ) at 30 days post procedure and elimination of clinically relevant superficial truncal reflux in the target vein at index procedure. The primary end point for the VLU study is time to ulcer healing through 12 months. Secondary end points, which are more familiar to clinicians in this disease space, include time to return to work, complication rates, patient-reported outcome measures, and closure rates. ConclusionsVenaSeal Spectrum is a rigorously designed clinical study program with a large study population and unique patient-centric end points after treatment with VenaSeal for early to advanced symptomatic CVD. The studies report on the safety, effectiveness, and patient experience outcomes including two new primary end points assessing the specific needs of patients with venous insufficiency from the periprocedural period through 5-year follow-up.

Endovenous laser ablation for saphenous veins and tributaries - the LEST technique.

Endovenous thermal ablation is now one of the most important techniques for treating chronic venous insufficiency. Technical refinements and technological innovations have made it possible to employ the method not only in the saphenous veins, but also to treat superficial veins such as varicose tributaries. We describe a technique for surgical treatment of varicose veins using endovenous laser thermal ablation employing multiple punctures and present the experience at our service with analysis of 601 cases operated using this technique. Thermoablative treatment of tributary veins with multiple puncture sites expands the applications for endolaser in treatment of lower limb varicose veins, providing, comprehensive, safe, and effective treatment.

Thromboprophylaxis strategies in patients undergoing endovenous thermal ablation: a UK survey

Introduction: It remains unclear whether patients undergoing endovenous thermal ablation (EVTA) for superficial venous incompetence (SVI) should receive pharmacological thromboprophylaxis. A survey was conducted to assess current thromboprophylaxis practices across the UK in patients undergoing EVTA for SVI. Methods: To examine the thromboprophylaxis practices of clinicians performing EVTA for SVI in the UK, an online survey was developed using the Qualtrics online survey tool. The survey link was circulated via email to members of the multidisciplinary collaborative Vascular and Endovascular Research Network (VERN) and promoted through social media. The primary focus of the survey was to gather information regarding venous thromboembolism (VTE) prophylaxis during EVTA for SVI. Results: A total of 32 vascular surgeons and one vascular nurse specialist based in the UK participated in the survey. All respondents reported routine prescription of compression therapy in the immediate postoperative period. Of all the respondents, 67% (n=22) reported routine prescription of pharmacological thromboprophylaxis during the peri-procedural period. Extended prophylaxis was routinely offered by 15% (n=5) of all respondents. Among those who provided extended prophylaxis, the majority (80%, n=4) used low molecular weight heparin (LMWH), while 20% (n=1) opted for a direct-acting oral anticoagulant (DOAC). Conclusion: The findings from this survey indicate that a significant proportion of patients undergoing EVTA for SVI routinely receive pharmacological thromboprophylaxis, with a single perioperative dose of LMWH being the prevailing practice. However, there is a notable lack of robust high-quality evidence to substantiate this practice. Grade A evidence is required to assess the potential benefit of pharmacological thromboprophylaxis in the context of EVTA to guide the development of clinically relevant guidelines. Should pharmacological thromboprophylaxis prove to offer no additional benefit for this specific patient population, this could result in cost savings for the NHS and enable patients to avoid unwanted side effects associated with anticoagulation therapy.

Recurrent Recanalization After Endovenous Thermal Ablation for Recanalized Varicose Veins

Recurrent Recanalization After Endovenous Thermal Ablation for Recanalized Varicose Veins

Evaluation of Endovenous Laser Ablation in the Management of Varicose Veins.

Background The treatment of varicose veins has undergone tremendous changes over the years. High ligation of the saphenofemoral junction (SFJ) and stripping of the great saphenous vein (GSV) have been considered standard treatments for GSV insufficiency for over a century and are still adopted as the preferred method in the majority of surgical centers in North Africa. However, the increase in minimally invasive treatments such as endovenous thermal ablation (EVTA), radiofrequency ablation (RFA), ultrasound-guided foam sclerotherapy, and cryo-stripping has produced excellent results. Most patients who underwent these minimally invasive treatments were satisfied with their outcomes. Methodology and results In this clinical and prospective study, 30 cases (19 male and 11 female) of primary varicose veins underwent endovenous laser ablation (EVLA), and their outcomes were reviewed, and their results were satisfying to the patients. After EVLA with or without sclerotherapy, no major complications occurred (recurrence or recanalization) at the time of the study, although minor complications were quite common and included bruising or ecchymosis, postoperative pain that required analgesics, superficial thrombophlebitis, and skin burns that were very responsive to medical treatment. Conclusion Endovenous laser ablation continues to be a valid minimally invasive method for treating varicose veins with minimal complications and a very short recovery period, which appeals to patients.

Value and limitations of postoperative duplex scans after endovenous thermal ablation

BackgroundEndovenous thermal ablation (EVTA) of the lower extremity veins has risen to become the main treatment modality for symptomatic venous reflux disease. One of the main reported side effects of EVTA is recanalization. As of today, there is no clear protocol as to when follow-up duplex ultrasound scans should be performed. However, the standard for postoperative duplex after truncal ablation is within 1 week of the procedure. Our aim is to try to find whether there is a particular time period when postoperative duplex ultrasound scans should be performed to allow us to best diagnose recanalization. MethodsWe retrospectively analyzed 9799 procedures in 3237 patients with chronic venous insufficiency owing to great, small, and anterior accessory saphenous vein insufficiency from 2012 to 2018. We excluded 466 perforator veins. All 9799 procedures were performed using EVTA in patients who failed to respond to conservative management initially. Postoperative duplex ultrasound scans were performed within 1 week (3-7 days postoperatively). We defined a successful obliteration as lack of color flow on postoperative scan. We defined symptomatic recanalization as presence of reflux on duplex ultrasound examination in the targeted vessel at follow-up with symptom recurrence. Follow-ups were performed every 3 months in the first year and every 6 months thereafter. ResultsPatient ages ranged from 15 to 99 years. The median patient age at the time of the procedures was 63 years (interquartile range [IQR], 51-73 years). The median overall follow-up was 25 months (IQR, 4-56 months). The Clinical, Etiology, Anatomy, and Pathophysiology (CEAP) class of all the procedures were: C1, 21; C2, 208; C3, 3585; C4, 4680; C5, 188; and C6, 1117. There were 145 redo procedures performed after symptomatic recanalization was diagnosed in patients. CEAP class of the redo patients were: C1, 0; C2, 2; C3, 49; C4, 70; C5, 5; and C6, 19. ConclusionsMost patients underwent a redo procedure performed within the first year after the initial procedure. Conversely, there was great variability as to when redo procedures were performed. Because there is no defined pattern as to when these symptomatic occurrences arise, it may not be required to perform postoperative duplex ultrasound scans after EVTA routinely, but instead when a patient comes back with symptoms such as swelling.

Endovenous Thermal Ablation for Treatment of Symptomatic Saphenous Veins-Does the Body Weight Matter?

This study aimed to examine whether body weight may affect the effectiveness and safety of endovenous thermal ablation (ETA) for the treatment of symptomatic varicose veins. This retrospective single-center cohort study analyzed the outcomes and patient demographic data with a focus on the body weight of all patients who had ETA of symptomatic varicose veins between September 2017 and October 2020. A total of 1178 treated truncal veins from 636 patients were analyzed. The mean ± standard deviation body mass index (BMI) was 25.5 ± 4.9. In 2.3% of cases, the patients were underweight (BMI < 18.5), 31.0% were overweight (BMI > 25), and 16.6% were obese (BMI > 30). Complete truncal occlusion was observed 1 year post intervention in 97.6-100% and patients were satisfied or very satisfied in 96.2-100% across BMI groups. Pain was low but significantly higher in the patients with obesity 6 weeks post intervention (visual analog scale 0.84 ± 1.49) and a higher infection rate was observed in the patients with obesity (n = 4/132; 3.0%). No significant association was observed between BMI and bleeding or thromboembolic events. Patients with obesity experienced prolonged pain and more infections after ETA, but ETA for varicose vein treatment remains effective and safe, independent of the patient's BMI.

The safety and efficacy of transluminal injection of foam sclerotherapy after endovenous thermal ablation in varicose veins with large trunk: A retrospective cohort study

Abstract: CONTEXT: Closure rate of endovenous thermal ablation is limited by the trunk diameter of great saphenous vein. AIMS: This study aimed to investigate the safety and efficacy of transluminal injection of foam sclerotherapy (TLFS) after thermal ablation in improving the closure rate of primary varicose veins with large trunk. SUBJECTS AND METHODS: In this retrospective cohort study with 170 patients (189 legs), the outcomes of varicose veins patients treated with thermal ablation plus injection of sclerotherapy were compared with those treated with thermal ablation only. The primary outcome of this study was the rate of ablated segment closure after surgery and during patient follow-up. Propensity score matching model was used to eliminate the bias. RESULTS: After matching, 75 legs (65 patients) from the thermal ablation plus sclerotherapy group and 71 legs (66 patients) from the thermal ablation only group were further analyzed. The closure rate of the thermal ablation plus sclerotherapy group was 97.3%, which was significantly higher than that of the thermal ablation only group (87.3%, P = 0.048), and the closure rate of the thermal ablation plus sclerotherapy group remained higher during 1-year follow-up. No serious complications were observed in groups. CONCLUSIONS: TLFS can improve the efficacy of thermal ablation, increasing the closure rate of the ablation segment, and thus improving the symptoms.

Varicose Vein Education and Informed coNsent (VVEIN) study: a randomised controlled pilot feasibility study

IntroductionDoctors have a legal requirement and duty of care to ensure patients are enabled to make an informed decision about their treatment, including discussion of the benefits, risks and alternatives to a procedure. A patient-centred approach to consent has been firmly established in Ireland, and fundamental to this is the ability to engage in a dialogue that offers comprehensible information to patients. Telemedicine has revolutionised the way we can deliver care to patients in the modern era of computers, tablets, and smartphones, and its use has been rapidly expanded. Novel digital strategies to improve the informed consent process for surgical procedures have been increasingly under investigation over the last 10–15 years and may offer a low cost, accessible and tailored solution to consent for surgical interventions. Within vascular surgery, superficial venous interventions have been associated with a high number medicolegal claims and also represents an area within the specialty with rapidly evolving technology and techniques. The ability to communicate comprehensible information to patients has never been greater. Thus, the author’s aim is to explore whether it is feasible and acceptable to deliver a digital health education intervention to patients undergoing endovenous thermal ablation (EVTA) to supplement the consent process.MethodsThis is a prospective, single centre, randomised controlled, feasibility trial recruiting patients with chronic venous disease deemed suitable to undergo EVTA. Patients will be randomised to receive either standard consent (SC) or a newly developed digital health education tool (dHET). The primary outcome is feasibility; assessing the recruitment and retention rate of participants and assessing acceptability of the intervention. Secondary outcomes include knowledge retention, anxiety and satisfaction. This feasibility trial is designed to recruit 40 patients, which will allow for a moderate dropout rate. This pilot study will inform the authors of the appropriateness of an adequately powered multicentre trial.DiscussionTo examine the role of a digital consent solution for EVTA. This may improve and standardise the consent dialogue with patients and may have the potential to reduce claims related to poor consent processes and disclosure of risks.Ethical committee referenceEthical approval has been sought and received from both the Bon Secours Hospital and RCSI (202109017), on 14 May 2021 and 10 October 2021, respectively.Trial registrationClinicalTrials.gov Identifier: NCT05261412, registered on 1 March 2022