Comparing mechanochemical endovenous ablation using Flebogrif with endovenous laser ablation in the treatment of primary great saphenous vein incompetence: protocol for a multicentre, open-label, non-inferiority, observer-blinded, randomised controlled trial (REBORN trial).

INTRODUCTION: Endovenous laser ablation (EVLA) is associated with an excellent outcome in the treatment of great saphenous vein (GSV) incompetence. However, the use of thermal ablation requires tumescent anaesthesia and is associated with a risk of thermal damage. Mechanochemical endovenous ablation (MOCA) is a non-thermal ablation (NTA) alternative, which combines mechanical endothelial damage with the infusion of a sclerosant liquid or foam. Tumescent anaesthesia is not required. Preliminary experiences with MOCA using the Clarivein device show less intraprocedural and postprocedural pain and a faster clinical improvement compared with EVLA. Flebogrif (Balton, Poland) is a relatively new MOCA device. To determine the role of MOCA using Flebogrif, a well-designed, randomised controlled clinical trial of sufficient sample size and follow-up time is required. In this article, we provide the study protocol for the REBORN trial, aiming to demonstrate that MOCA using Flebogrif is not inferior to EVLA for the outcome of anatomical success in the treatment of GSV incompetence. METHODS AND ANALYSIS: This multicentre, open-label, non-inferiority, observer-blinded, randomised controlled trial randomises patients who are diagnosed with GSV incompetence and aged 18-80 years between Flebogrif and EVLA. 310 patients in 3 participating centres (Northwest Clinics Alkmaar, Skin and Vein Clinic Oosterwal Alkmaar and Red Cross Hospital Beverwijk) will be included. The primary outcome is anatomical success at 12 months. Secondary outcomes are intraprocedural pain, operation time, technical success, postprocedural pain, safety, anatomical success during other follow-up moments, complications, clinical success, aesthetic result, disease-specific quality of life, reinterventions, anterior accessory saphenous vein reflux and neovascularisation. Patients will be followed up at 1 week, 1, 6, 12, 24 and 60 month(s) after treatment. ETHICS AND DISSEMINATION: The institutional review board (Medical Ethical Review Committee of the Vrije Universiteit Medical Center) approved this study on 17 May 2021 under case number 2020.0740. Written informed consent is obtained by the coordinating investigator from all participants prior to study enrolment. After completion of the trial, the results will be submitted to an international scientific journal for peer-reviewed publication. TRIAL REGISTRATION NUMBER: Overzicht van Medisch-wetenschappelijk Onderzoek in Nederland, NL-OMON25145, previously NL9527; Centrale Commissie Mensgebonden Onderzoek, NL74491.029.20.

Endovenous laser ablation (EVLA) 980 nm versus 1470 nm and the impact of fiber type: a systematic review and meta-analysis.

We sought to assess the efficacy and safety of endovenous laser ablation utilizing a 980 nm device versus a 1470 nm device in the treatment of lower limb venous insufficiency. We performed a systematic review adhering to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 statement. A research on PubMed, Scopus and Web of science for articles published by January 2024 was conducted. The primary endpoint was great saphenous vein (GSV) and truncal vein occlusion. Eleven studies encompassing 3061 patients and 3193 truncal veins, were included. The 1470 nm device demonstrated superior truncal vein and GSV occlusion outcomes compared to the 980 nm device at the early, one-year, and medium to long-term follow-up intervals. Odds ratios (OR) were 2.79(95%CI:1.31-5.94), 2.22(95%CI:1.21-4.07), and 2.02(95%CI:1.24-3.29) for truncal veins and 2.54(95%CI:1.119-5.41), 2.06(95%CI:1.07-3.95) and 2.04(95%CI:1.25-3.33) for GSV, across the respective intervals. While both devices demonstrated minimal, deep vein thrombosis (DVT), endovenous heat-induced thrombosis (EHIT) ≥ 2, and burn estimates, the 1470 nm device exhibited improved paresthesia, risk ratio (RR), 0.51(95%CI:0.34-0.77) and pain outcomes, standardized mean difference (SMD), -0.62(95%CI:-0.99to-0.25). Subgroup analysis displayed enhanced occlusion outcomes with the 1470 nm device for the six-month and one-year intervals, irrespective of fiber type. Radial fibers were associated with improved paresthesia outcomes (ß=-0.9520,p = 0.03). This review emphasized the enhanced efficacy of the 1470 nm device over the 980 nm device, regardless of fiber type. Radial fibers showed promise for improved paresthesia outcomes, suggesting similar safety profiles for both systems. Conclusive remarks on pain outcomes were impeded by data limitations.

[Varicosis-Current treatment concepts]. / Varikosis ­ aktuelle Therapiekonzepte.

Varicosis is a chronic 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 a pathological venous reflux, arising from a weakness 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.

Endovenous Microwave Ablation Versus Laser Ablation for Small Saphenous Vein Varicosis.

INTRODUCTION: Laser and radiofrequency ablation are two thermal ablation methods currently widely used to treat lower limb venous insufficiency. However, very few studies have been conducted on the use of microwaves, a form of thermal ablation, for the treatment of small saphenous vein (SSV) insufficiency. This study aimed to examine the efficacy and safety of endovenous microwave ablation (EMA) for the treatment of SSV insufficiency. METHODS: The clinical data of 126 patients (126 lower limbs) with SSV insufficiency (SSV trunk reflux time ≥ 500 ms on lower limb color Doppler ultrasound) treated at the Surgery Department of The Sixth People's Hospital of Zhuji from January 2020 to June 2022 were analyzed retrospectively; 64 patients underwent EMA and 62 underwent endovenous laser ablation (EVLA). The perioperative marker data [duration of surgery, duration of hospitalization, length of thermal ablation, duration of thermal ablation, number of incisions, and numerical pain rating scale (NPRS)], complication data [skin ecchymosis, skin burns, surgical site infection, paresthesia, deep vein thrombosis (DVT), and heat-induced thrombosis (EHIT)], venous clinical severity score (VCSS), chronic venous disease quality of life questionnaire (CIVIQ-20) before and 1, 3, 12 months after surgery, and SSV trunk occlusion rate at 12 months after surgery were compared between the two groups. RESULTS: No significant differences in the surgery or hospitalization durations were observed between the two groups. There were no significant differences in the length of the SSV that required thermal ablation between the two groups; however, the thermal ablation time was shorter in the EMA group than that in the EVLA group (6.14 ± 1.47 min vs 7.05 ± 1.16 min, P < 0.001). There were no statistical differences in the number of incisions, volume of tumescent solution used, or quantity of sclerosing foam used. The NPRS scores of the EMA group at 24 h and 72 h after surgery were significantly greater than those of the EVLA group (4.03 ± 0.98 vs 3.52 ± 1.28, P = 0.013; 3.78 ± 1.06 vs 3.15 ± 1.03, P = 0.001). Moreover, the two groups showed no significant difference in the NPRS score at 1 month (1.14 ± 0.84 vs 1.07 ± 0.75, P = 0.623). The EMA and EVLA group patients experienced similar postoperative complications. The VCSS and CIVIQ-20 score significantly improved at 1, 3, and 12 months after surgery. The VCSS and CIVIQ-20 scores were compared between the two groups at 12 months after surgery, and there were no significant differences (1.44 ± 0.63 vs 1.56 ± 0.56, P = 0.261; 24.24 ± 4.96 vs 25.19 ± 5.36, P = 0.304). There was no significant difference in the incidence of SSV trunk occlusion at 12 months after surgery between the two groups (95.31% vs 96.77%, OR 1.475; 95% CI 0.238-9.146, P = 1.000). CONCLUSION: EMA and EVLA are equally effective treatment methods for SSV insufficiency. EMA is associated with higher NPRS scores in the early postoperative period.

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

OBJECTIVE: Endovenous 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. METHODS: The 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. RESULTS: Among 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). CONCLUSIONS: Endovenous 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.

Factors associated with recanalization and reintervention following below knee polidocanol endovenous microfoam ablation for great saphenous and small saphenous veins.

BACKGROUND: Polidocanol endovenous microfoam (PEM) has been used to treat lower extremity venous reflux for almost one decade with specific advantages for below knee (BK) truncal veins where thermal ablation poses a risk of injury to adjacent nerves. The current literature of the BK segment often examines short-term outcomes with modest sample sizes. We aim to identify factors associated with recanalization and reintervention in this subset of patients. METHODS: We performed a retrospective study of a prospectively maintained database of patients from a single institution who underwent 1% PEM ablation for BK great saphenous vein (GSV) and small saphenous vein (SSV) reflux. Patients underwent duplex ultrasound (DU) within 7 days after injection, every 3 to 6 months for 1 year, and every 6 to 12 months thereafter. Patients with symptomatic recanalization underwent reintervention. The 26 patients lost to follow-up without DU after ablation were excluded. The factors associated with recanalization and reintervention were examined by multivariate and nonparametric analyses. RESULTS: Between March 2018 and July 2023, 411 patients (166 male, 245 female) with 573 treated limbs (284 right, 289 left) met the study criteria. Of the 573 included limbs, 457 (79.8%) had undergone prior above knee saphenous ablations. A total of 554 BK GSV and 42 SSV ablations were performed. The most recent DU was performed at a mean of 231 ± 329 days. The overall recanalization rate was 10.6% (55 GSVs and 8 SSVs) at a mean follow-up of 104 ± 180 days. Comparing the closed and recanalized veins, we found no significant difference in age (P = .90), treated laterality (P = .14), patient body mass index (P = .59), preprocedural CEAP (clinical-etiology-anatomy-pathophysiology) score (P = .79), recanalization rate in GSVs vs SSVs (P = .06), or administered PEM volume (P = .24). The recanalized veins had significantly larger preprocedural diameters than the veins that remained closed (recanalized, 4.9 mm; closed, 4.3 mm; P = .001). Men had higher incidence of recanalization than women (men, 14.2%; women, 8%; P = .015). Anticoagulation use was associated with recanalization (odds ratio, 1.96; 95% confidence interval, 1.1-3.6; P = .03). Early recanalization at the first DU accounted for 31 failures (49.2%) and had a significantly lower administered PEM volume compared with later recanalization (early, 4 mL; late, 5 mL; P = .025). There were no significant differences between the 33 recanalized patients requiring reintervention (52.4%) and the 30 who did not. Twenty-four reinterventions were performed with PEM, 100% of which remained closed at a median of 160 days (interquartile range, 257 days). CONCLUSIONS: PEM is successful for the treatment of BK GSV and SSV reflux with a closure rate of 89% at a mean of 231 days and shows promise as salvage therapy. Most cases of recanalization were noted in the early postprocedure period and were associated with a lower PEM volume. A larger vein diameter, male sex, and anticoagulation use are associated with higher rates of recanalization.

Valvar bypass surgery to ameliorate persistent lower limb edema caused by post-thrombotic syndrome: a case report and literature review.

Obstruction and/or reflux compromise during venous emptying can facilitate different pathophysiologies in chronic venous insufficiency (CVI). We present a patient with persistent lower limb CVI edema caused by post-thrombotic syndrome (PTS), who responded well to femoral vein valve therapy via axillary vein bypass after unsuccessful valvuloplasty, and led a normal life. During a 12 month observation period, bridging vessels completely restored original anatomical structures. In a literature study, no similar surgeries were reported, but we show that this operation may be feasible in selected patients.

Impact of great saphenous vein ablation on healing and recurrence of venous leg ulcers in patients with post-thrombotic syndrome: A retrospective comparative study.

BACKGROUND: The optimal treatment approach for patients with active venous leg ulcers (VLUs) and post-thrombotic syndrome (PTS) associated with great saphenous vein (GSV) reflux remains unclear. To address this gap, we retrospectively compared the outcomes of patients with post-thrombotic VLU with an intact GSV vs those with a stripped or ablated GSV. METHODS: We retrospectively analyzed data from 48 patients with active VLUs and documented PTS, who were treated at a single center between January 2018 and December 2022. Clinical information, including ulcer photographs, was recorded in a prospectively maintained digital database at the initial and follow-up visits. Two patient groups-group A (with an intact GSV) and group B (with a stripped or ablated GSV)-were compared in terms of time to complete healing, proportion of ulcers achieving complete healing, and ulcer recurrence during the follow-up period. RESULTS: There were no significant differences in age, gender, initial ulcer size, or ulcer duration between the two groups. All included patients had femoropopliteal post-thrombotic changes. Group A had significantly more completely healed ulcers (33 of 34 ulcers, 97%) compared with group B (10 of 14 ulcers, 71%) (P = .008). Group A also exhibited a significantly shorter time to complete ulcer healing (median: 42.5 days, interquartile range [IQR]: 65) compared with group B (median: 161 days, IQR: 530.5) (P = .0177), with a greater probability of ulcer healing (P = .0084). Long-term follow-up data were available for 45 of 48 patients (93.7%), with a mean duration of 39.6 months (range: 5.7-67.4 months). The proportion of ulcers that failed to heal or recurred during the follow-up period was significantly lower in group A (9 of 32 ulcers, 27%) compared with group B (11 of 13 ulcers, 85%) (P = .0009). In addition, in a subgroup analysis, patients with an intact but refluxing GSV (12 of 34) had a significantly shorter time to heal (median: 34 days, IQR: 57.25) (P = .0242), with a greater probability of ulcer healing (P = .0091) and significantly fewer recurrences (2 of 12, 16%) (P = .006) compared with group B. CONCLUSIONS: Our findings suggest that removal of the GSV through stripping or ablation in patients with post-thrombotic deep venous systems affecting the femoropopliteal segment may result in delayed ulcer healing and increased ulcer recurrence. Patients with an intact GSV had better outcomes, even when the refluxing GSV was left untreated. These findings emphasize the potential impact of GSV treatment on the management of VLUs in individuals with PTS. Further investigation is needed to validate these results and explore alternative therapeutic strategies to optimize outcomes for this patient population.

Risk factors for recanalization of truncal veins following endoluminal ablation.

BACKGROUND: Recanalization of target veins after treatment of superficial venous incompetence has clinical implications and may depend on the type of intervention. The aim of this study was to evaluate patient and procedural factors associated with truncal vein recanalization in a large study cohort using the Vascular Quality Initiative (VQI) Varicose Vein Registry. METHODS: We performed a retrospective review using the VQI Varicose Vein Registry from 2014 to 2018. We evaluated all procedures performed for truncal venous insufficiency. Demographic data and information about treatment modality were collected. Patients were separated into recanalization and nonrecanalization groups based on the status of the treated vein at follow-up ultrasound examination. The vein was only considered recanalized if the VQI noted complete recanalization of the target vein. Univariate and multivariate comparisons were performed as appropriate. RESULTS: A total of 10,604 procedures were performed in 7403 patients. The average age was 55.9 years and 70.3% of the patients were female. Patients with recanalization were more likely to have a history of phlebitis (P < .001) and had a higher mean body mass index (30.5 vs 32., kg/m2 ; P = .006) compared with those without recanalization. There was no difference in the use of compression therapy, anticoagulation, deep venous reflux, number of pregnancies, prior deep vein thrombosis, Venous Clinical Severity Score, and clinical-etiology-anatomy-pathophysiology between patients with and without recanalization. The number of truncal veins treated per procedure was higher in the recanalization group compared with the nonrecanalization group (2.36 vs 1.88; P = .001). After multivariate logistic regression, laser ablation was associated with higher rate of recanalization compared with radiofrequency ablation (P = .017). CONCLUSIONS: This study is the first to use VQI based data to describe risk factors for recanalization following treatment of truncal venous reflux. The use of laser ablation for truncal veins is associated with a higher risk for recanalization compared with radiofrequency ablation. Obesity, prior phlebitis, and number of veins treated were independently associated with increased rate of recanalization.

Disparities in access to endovenous treatment options in chronic lower extremity superficial venous insufficiency: A national 7-year analysis.

OBJECTIVE: The goal of this study was to analyze trends in treatment access for chronic superficial venous disease and to identify disparities in care. METHODS: This retrospective study was exempt from institutional review board approval. The American College of Surgeon National Surgical Quality Improvement Program database was used to identify patients who underwent vein stripping (VS) and endovenous procedures for treatment of chronic superficial venous disease. Endovenous options included radiofrequency ablation (RFA) and laser ablation. Data was available from 2011 to 2018 and demographic information was extracted for each patient identified by Current Procedural Terminology codes. For all racial and ethnic groups, trend lines were plotted, and the relative rate of change was determined within each specified demographic. RESULTS: There were 21,025 patients included in the analysis. The overall mean age was 54.2 years, and the majority of patients were female (64.8%). In total, 27.9%, 55.2%, and 16.9% patients underwent VS, RFA, and laser ablation, respectively. Patients who received laser ablation were older (P < .001). Hispanic ethnicity was associated with significantly lower odds of receiving endovascular thermal ablation (EVTA) over VS (odds ratio [OR], 0.71; 95% confidence interval [CI], 0.64-0.78; P < .001). American Indian/Alaska Native patients were more likely to receive EVTA over VS (OR, 4.02; 95% CI, 2.48-6.86); similarly, Native Hawaiian/Pacific Islander patients were more likely to receive EVTA over VS, although this difference was not statistically significant (OR, 1.44; 95% CI, 0.93-2.27). On multinomial regression, Hispanic patients were less likely to receive RFA over VS, whereas American Indian/Alaskan Native patients were more likely to receive RFA over VS. In all racial and ethnic groups, the percentage of endovenous procedures increased, whereas vein stripping decreased. CONCLUSIONS: Based on a hospital-based dataset, demographic indicators, including age, sex, race, and ethnicity, are associated with differences in endovenous treatments for chronic superficial venous insufficiency suggesting disparities in obtaining minimally invasive treatment options among certain patient groups.

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

OBJECTIVE: Endovenous 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. METHODS: Using 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. RESULTS: There 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. CONCLUSIONS: These 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.

Comparison of Radiofrequency Ablation and Cyanoacrylate Closure for Large-Diameter Great Saphenous Vein Insufficiency.

BACKGROUND: To compare radiofrequency ablation (RFA) and cyanoacrylate closure (CAC) for large-diameter great saphenous vein (GSV) insufficiency between diameters of 12 and 16 mm. METHODS: This study is a single-center retrospective study. Subjects who underwent endovenous treatment with RFA (Group A) or CAC (Group B) for GSV insufficiency between June 2015 and June 2021 who were followed up for at least 2 years were included in the study. Subjects who had a 12-mm to 16-mm target vessel diameter and subjects with grade 3 and grade 4 reflux were included. Subjects' demographic data (age, sex), body mass indices, clinical, etiological, anatomic, pathophysiologic classification, GSV diameter, reflux grade, target vessel length, preoperative venous clinical severity score (VCSS), procedural time, postoperative first-day pain scores, postoperative 14th-day patient satisfaction scale, and postoperative complications were noted. In follow-up, subjects were evaluated with duplex ultrasonography and VCSS at 1, 6, 12, and 24 months. RESULTS: In total, 142 subjects were included (n = 71 for both groups). The mean GSV diameter was 13.21 ± 1.00 for Group A and 13.51 ± 0.97 for Group B. The groups did not differ in terms of age, sex, body mass index, clinical, etiological, anatomic, pathophysiologic classification, GSV diameter, reflux grade, target GSV length, preoperative VCSS, complications, postoperative 24-hr pain status or postoperative 14-day patient satisfaction scale (P > 0.05 for all comparisons). The procedure time was significantly shorter in Group B (34.68 ± 4.22 min for Group A vs. 22.59 ± 4.5 min for Group B, P = 0.001). In the 1-month and 6-month Duplex ultrasonography of the subjects, partial closure and patency rates in Group B were significantly higher than those in Group A (P = 0.003 and P = 0.025, respectively). At the 12-month and 24-month evaluation, closure rates did not show a statistically significant difference between the groups (P = 0.056 and P = 0.090, respectively). Preoperative and 1-month VCSS measurements did not show a statistically significant difference between groups (P > 0.05 for all comparisons). The 6-month, 12-month, and 24-month VCSS measurements of Group A were significantly higher than those in Group B. (P = 0.043, P = 0.009 and P = 0.002, respectively). CONCLUSIONS: Both RFA and CAC were found to be effective in the treatment of large-diameter GSV incompetency. The complication rates were similar between the 2 techniques. CAC had a shorter procedure time. Although the closure rates in the early postoperative period were better in the RFA group, long-term follow-up demonstrated similar patency rates. The functional results in the long-term follow-up were better in the RFA group.

Editor's Choice - Short Term Cost Effectiveness of Radiofrequency Ablation and High Ligation and Stripping for Great Saphenous Vein Incompetence.

OBJECTIVE: Superficial venous incompetence (SVI) is a common disease that causes significant quality of life (QoL) impairment. There is a need for more health economic evaluations of SVI treatment. The aim of this study was to perform a cost effectiveness analysis in patients with great saphenous vein (GSV) incompetence comparing radiofrequency ablation (RFA), high ligation and stripping (HL/S), and no treatment or conservative treatment with one year follow up. METHODS: Randomised controlled trial economic analysis from an ongoing trial; 143 patients (156 limbs) with GSV incompetence (CEAP clinical class 2 - 6) were included. Treatment was performed with RFA or HL/S. Follow up was performed up to one year using duplex ultrasound, revised venous clinical severity score (r-VCSS), Aberdeen Varicose Vein Questionnaire (AVVQ), and EuroQol-5D-3L (EQ-5D-3L). RESULTS: Seventy-eight limbs were treated with RFA and HL/S respectively. No treatment or conservative treatment was assumed to have zero in treatment cost and no treatment benefit. In the RFA group, one limb had reflux in the GSV after one month and three limbs after one year. In HL/S, two limbs had remaining reflux in the treated area at one month and one year. Both disease severity (r-VCSS, p = .004) and QoL (AVVQ, p = .021 and EQ-5D-3L, p = .028) were significantly improved over time. The QALY gain was 0.21 for RFA and 0.17 for HL/S. The cost per patient was calculated as €1 292 for RFA and €2 303 for HL/S. The cost per QALY (compared with no treatment or conservative treatment) was €6 155 for RFA and €13 549 for HL/S. With added cost for days absent from work the cost per QALY was €7 358 for RFA and €24 197 for HL/S. The cost per QALY for both methods was well below the threshold suggested by Swedish National Board of Health. CONCLUSION: RFA is more cost effective than HL/S and no treatment or conservative treatment at one year follow up.

Mechanochemical ablation: disappointing long-term anatomic results and worsening symptoms.

An updated report on the five-year results in the treatment of great saphenous vein incompetence with mechanochemical ablation (MOCA) provides additional evidence for higher rates of anatomic recanalization compared to other treatment modalities and progressive worsening of symptoms with time.

Laser-sclerosing foam hybrid treatment, a non-tumescent technique for insufficient great saphenous vein ablation.

OBJECTIVE: We aim to report on the Laser-Sclerosing Foam Hybrid Treatment (LSFHT) and its outcomes when used on patients with great saphenous vein (GSV) insufficiency. METHODS: This was a single center retrospective cohort study on patients with GSV insufficiency that were treated with the LSFHT technique, a surgical procedure that comprises the use of both sclerosing foam and endovenous ablation and avoids the use of tumescent anesthesia. Occlusion rates and complications were reported. RESULTS: 139 legs from 106 patients were operated, achieving a 100% occlusion rate, while only a small burn and 2 popliteal vein thrombosis cases occurred. CONCLUSION: The study suggests that the LSFHT is a feasible fast procedure that proved both effective and safe for the treatment of GSV insufficiency.

[Randomized controlled study on the application effect of a new type of intravenous radiofrequency closed therapy system made in China and an imported system].

Objective: To compare the application effect of domestic and imported intravenous radiofrequency closure system in the treatment of primary varicose veins of lower extremities. Methods: This single-center prospective, non-inferiority randomized controlled trial was performed in the Department of Vascular Surgery, the Fourth Affiliated Hospital, Zhejiang University School of Medicine from January 2021 to January 2022. Patients with primary varicose veins of lower extremities who met the ataxation criteria were randomly assigned to the experimental group(domestic novel venous radiofrequency closure system) or the control group(imported venous radiofrequency closure system) in a ratio of 1∶1. The two groups of subjects were compared in terms of target vein closure rate, technical success rate, system operation performance, incidence of adverse events and incidence of serious adverse events(SAE) within 6 months after surgery. Quantitative data were compared by Mann-Whitney U test, and categorical data were compared by χ2 test and non-inferiority test. Results: A total of 80 subjects were included in the trial (41 in the experimental group and 39 in the control group), including 27 males and 53 females, aged (M(IQR)) 55(23) years (range:40 to 78 years). There were 48 cases of left lower limb and 32 cases of right lower limb. The technical success rate and system control performance between the groups were 100%.The incidence of adverse events (58.5% (24/41) vs. 61.5% (24/39), χ2=0.075, P=0.784), and the incidence of SAE (7.3% (3/41) vs. 5.1% (2/39), χ2=0.163, P=0.686) within 6 months after surgery in experimental group and control group had no statistical significance. There was one device-related adverse event in each of the two groups. In the experimental group, one patient developed endovenous heat-induced thrombosis after surgery and recovered after taking rivaroxaban tablets. One patient in the control group had pain in the upper right thigh for more than 1 day after operation, which was cured after using analgesic cream. No device-related SAE occurred. The venous closure rate of the experimental group was 100% (38/38) at 6 months after surgery, and that of the control group was 97.4% (37/38). The difference between the two groups was 2.63% (95%CI:-3.19 to 8.45, Z=4.865, P<0.01), and the 95%CI lower limit of the difference in target venous closure rate between two groups was greater than the non-inferiority threshold of -10.00%. Conclusion: The early application effect of the new domestic intravenous radiofrequency closure system in patients with primary varicose veins of lower extremities is in line with expectations, it is not inferior to the imported system.

The Novel Surgical Technique in the Cyanoacrylate Closure for Incompetent Great Saphenous Veins.

OBJECTIVE: The current Instructions for Use (IFU) of cyanoacrylate closure (CAC) is to start initial injection with the catheter tip positioned 5 cm distal to the sapheno-femoral junction (SFJ) to prevent endovenous glue-induced thrombosis (EGIT). However, this defensive design is responsible for the relatively long stump length. Although clinical studies on the long-term recurrence rate are still lacking, the long stump length can predict a higher long-term recurrence rate compared to other surgical methods. The author developed a novel surgical technique that can overcome the weakness of CAC, and the initial outcomes of this technique are described in this article. METHODS: This study retrospectively reviewed 25 great saphenous vein (GSV) in 20 patients who underwent CAC for incompetent GSV at our hospital. The procedure from puncturing the GSV to insertion of the catheter is the same as the conventional method. Place the catheter tip 2-3 cm below the SFJ before cyanoacrylate injection. After confirming the position of the SFJ with the longitudinal view of the ultrasound, press the GSV directly above the SFJ transversely with the second to fifth fingertips of the left hand. Then, the ultrasound probe is placed against the distal part of the fingertips, and CA injection is performed while GSV is monitored in real time. RESULTS: The mean stump length immediately after surgery was 19.3 (± 7.8) mm, with a range of .0-38.4 mm. The mean stump length after 1 week was 12.3 (± 7.4) mm and the range was .1-35.4 mm. The mean stump length after 1 month was 15.4 (± 10.1) mm, and the range was .0-35.4 mm. There was no case with EGIT or recanalization. CONCLUSIONS: The author confirmed the possibility of safely reducing stump length with this novel surgical technique, and expect that this method can help overcome the weakness of CAC.

Endovenous Microwave Ablation Versus Radiofrequency Ablation for the Treatment of Lower Limb Varicose Veins.

BACKGROUND: This study aimed to retrospectively compare the clinical outcomes of endovenous microwave versus radiofrequency ablation combined with foam sclerotherapy in patients with lower limb varicose veins. METHODS: We identified patients with lower limb varicose veins treated with endovenous microwave ablation or radiofrequency ablation with foam sclerotherapy between January 2018 and June 2021 at our institution. Patients were followed-up for 12 months. Clinical results, including the pre-post-Aberdeen Varicose Vein Questionnaire and post-Aberdeen Varicose Vein Questionnaire and Venous Clinical Severity Score, were compared. Complications were documented and treated accordingly. RESULTS: We included 287 cases (295 limbs total; endovenous microwave ablation + foam sclerosing agent: n = 142, 146 limbs; radiofrequency ablation + foam sclerosing agent: n = 145, 149 limbs). The operative time was shorter for endovenous microwave ablation than radiofrequency ablation (42.58 ± 15.62 min vs. 65.46 ± 24.38 min, P < 0.05); however, other procedural parameters did not differ. Furthermore, hospitalization costs for endovenous microwave ablation were lower than those for radiofrequency ablation (21,063.74 ± 850.47 yuan vs. 23,312.40 ± 1,035.86 yuan, P < 0.05). At the 12-month follow-up, the great saphenous vein closure rate was similar in both groups (endovenous microwave ablation, 97% [142/146] vs. radiofrequency ablation, 98% [146/149]; P > 0.05). Additionally, the satisfaction or incidence rates of complications were not different among the groups. In both groups, the Aberdeen Varicose Vein Questionnaire and Venous Clinical Severity Score values were significantly lower 12 months postsurgery than before surgery; however, the postoperative values did not differ. CONCLUSIONS: Endovenous microwave ablation effectively treated lower limb varicose veins, with similar short-term effects as radiofrequency ablation. Moreover, it had a shorter operative time and was less expensive than endovenous radiofrequency ablation.

Application of Femoral Nerve Block in Treating Great Saphenous Vein Insufficiency by Endovenous Radiofrequency Ablation Combined with Punctate Stripping.

PURPOSE: To evaluate the efficacy and safety of ultrasound-guided femoral nerve block (FNB) in treating great saphenous vein (GSV) insufficiency by endovenous radiofrequency ablation (EVRA) combined with punctate stripping (PS). METHODS: This was a single-center, retrospective cohort study. A total of 135 patients were divided into Group A (59 patients) and Group B (76 patients). All patients received tumescent anesthesia during the operation, and group A received an additional ultrasound-guided FNB before the procedure. Intraoperative and postoperative pain score, the volume of tumescent anesthesia solution (TAS), and other indicators were compared in two groups. RESULTS: Group A had a significantly lower intraoperative pain visual analog scale than group B (2.7 ± 1.2 vs 5.2 ± 1.5, P < 0.001). The volume of TAS in group A was significantly lower than that in group B (198 ± 26.6 ml vs 338 ± 34.7 ml, P < 0.001). Postoperative muscle strength of group A was significantly decreased compared with group B (54.2% vs 3.90%, P < 0.001); no patient had severe limitation of active movements in both groups, and all motor blocks recovered within 24 h. The incidence of skin ecchymosis in group A was lower than that in group B (18.6% vs 46.1%, P = 0.001). The operation duration of the two groups had no statistically significant difference. CONCLUSIONS: Ultrasound-guided FNB in treating GSV insufficiency by EVRA combined with PS significantly relieved intraoperative pain and reduced the dosage of TAS and the incidence of skin ecchymosis without increasing the complications of anesthesia or any other surgical complications.