Truncal Veins Research Articles

Protocol-based treatment of spontaneous hemorrhage from varicose veins prevents recurrence of bleeding

BackgroundSpontaneous hemorrhage from erosion of varicose veins through the skin is a serious and occasionally fatal complication of varicose vein disease. Various treatments, both acute and delayed, have been advocated. Our two-step clinical protocol was designed to prevent further hemorrhage without delay and to provide durable freedom from recurrent bleeding. MethodsAll patients referred to our surgical vein practice with hemorrhage from varicose veins were entered into a prospective registry. On presentation, all patients underwent diagnostic duplex ultrasound for venous reflux. Immediate treatment consisted of ultrasound-guided polidocanol/CO2 foam sclerotherapy of the bleeding varicosity and adjacent veins. Subsequent endovenous ablation of underlying incompetent axial veins, with concurrent microphlebectomy when indicated, was scheduled and performed within 8 weeks. ResultsFifty-nine patients were referred with recent hemorrhage from varicose veins over a period of 4 years. Fifty-six (95%) had an ultrasound-identified tributary varicosity underlying the point of bleeding, and three had a skin-surface erosion only and no ultrasound-identified underlying tributary. Of the 59 study patients, 52 underwent prompt polidocanol/CO2 foam sclerotherapy, targeted to both the underlying tributary (when present) as well as the cutaneous bleeding varicosity. The remaining seven either declined sclerotherapy or were ineligible. Underlying incompetence of axial (great, small, or anterior saphenous) veins was found in 54 patients (92%). Of these patients with truncal vein incompetence, 48 underwent ablation—5 declined and 1 was too frail for any further intervention. There were no recurrent bleeds in the interval between immediate sclerotherapy and scheduled ablation. During a mean follow-up of 2.2 years, four patients (7%) had late, recurrent hemorrhage: one had failed to return for their scheduled ablation, two were on chronic anticoagulation, and one had severe right heart failure. All four were retreated without further recurrence. ConclusionsA two-step protocol of immediate ultrasound-guided foam sclerotherapy, followed within 8 weeks by endovenous ablation of incompetent axial veins and concurrent microphlebectomy, provided rapid and efficient treatment with durable freedom from subsequent hemorrhage.

First registry of patients treated with foam sclerotherapy using a new automated microfoam preparation device (2021-2022).

Objectives: To present results for the use of an automated microfoam preparation system (AMPS) in the treatment of varicose veins in a real-world setting.Method: We performed a descriptive study based on a prospective database of patients treated with foam sclerotherapy between February 2021 and December 2022. Polidocanol foam was prepared using a capsule containing sterile air or a low-nitrogen mix. We recorded volume per session, percentage of sclerosing drug, number of sessions, release of thrombus entrapment, complications, and adverse events. A univariate descriptive analysis was performed using Stata V.16.Results: Over a 23-month period, 185 patients (84.9% women, 15.1% men) underwent 685 sessions. Median age was 51.6 years (range, 16-79 years). Thread veins were the condition treated in 68.9% of sessions, tributaries in 7.2%, and truncal veins in 22.6%. The average volume per session was as follows: thread veins, 8mL; great saphenous vein (GSV), 6.9mL; and small saphenous vein (SSV), 4.3mL. The average drug concentration was as follows: thread veins, 0.18%; GSV, 1.49%; and SSV, 1.63%. The average number of sessions was 3.4 for thread veins, 2 for tributaries, 2.7 for the GSV, and 2.9 for the SSV. The occlusion rate at 15 months was 93.2% (41/43) for the great saphenous vein and 86% (13/15) for the small saphenous vein. We recorded a total of 21 complications (3.1% of sessions), 14 of which were minor complications (2% sessions), and 7 moderate adverse events (1% of sessions).Conclusions: This new device is highly versatile and can be used for preparing foam at all concentrations. It contributes to a high rate of occlusion in saphenous trunks, with a minimal number of sessions required for thread veins indicating that the system is a favorable option in the treatment of venous diseases. Additionally, the low frequency of residual pigmentation may be attributed to the system's ability to tailor the foam concentration to the individual case, thus supporting optimal outcomes.

Analytical solutions in the modeling of the endovenous laser ablation

We modeled the operative treatment of incompetent truncal veins using endovenous laser ablation (EVLA). The main concern regarding the thermoablative technique is tissue damage, which is correlated with (1) the energy provided by the laser power and (2) temperature distribution. Our objective was to accurate the two functions, namely the fluence rate and the temperature, depending on the thermoablative technique and the endovenous laser treatment (ELT). First, we considered three differential equations: diffusion, heat, and bioheat equations in the endovenous-perivenous multidomain to describe the lumen, the vein wall, the tissue pad, and the skin. Second, we examined the power source according to the Beer-Lambert law in the incident beam irradiance and the heat source as the so-called absorbed optical power density. Third, we checked out the heat transfer at the skin boundary according to Newton’s law of cooling, which stands for a Robin boundary condition. For this new model, we proposed exact solutions: applying differential equations techniques, we solved (1) a diffusion approximation of the radiative transfer equation under the considered power source, and (2) the coupled heat and bioheat equations under the considered heat source accomplished with the Robin boundary condition. Then, we graphically illustrated the fluence rate profile and discussed its time dependence and steady state. Besides, we discuss thermal damage to the vein-tissue system and present open problems.

From the experience of more than 1000 glue ablation procedures for varicose veins: how to do it

Cyanoacrylate adhesive closure (CAC) is currently one of the main non-thermal ablation modalities of incompetent saphenous veins. High efficacy and safety of the method is supported by international clinical practice guidelines as well as the real-world practice. In contrast to thermal ablation, CAC is advantageous in terms of low periprocedural pain and bruising, fast procedure time and postprocedural recovery, high patient comfort and satisfaction rates as well as avoidance of postprocedural compression. This publication summarises the practical tips and tricks of glue ablation procedure based on 5-year experience (2019–2023) at the “SM-Clinic” Phlebology Centre, Moscow. Indications for the preferred use of CAC are formulated, such as: low pain threshold; contraindications (or unwillingness) to postprocedural compression; extensive comorbidity and fragile patients; concomitant morbid obesity; the presence of axial reflux along the saphenous veins; the need for simultaneous ablation of several incompetent truncal veins; below-the-knee incompetence of saphenous veins, including recurrent varicose veins; extensive lipodermatosclerosis and/or venous leg ulcer; patient’s HIV and viral hepatitis positive status. A step-by-step interventional protocol of glue ablation is described, including the modified protocols of the procedure. The immediate and long-term outcomes of the CAC according to current data are discussed. Special attention is paid to adverse events following CAC, as well as technical aspects of their prevention. Despite high efficacy and safety profile, today’s limitations for adoption and wider use of CAC are cost issues and lack of reimbursement.

3-year clinical outcomes of A Singapore VenaSeal™ real world post-market evaluation Study (ASVS) for varicose vein ablation

IntroductionMedium-term clinical outcome data are lacking for cyanoacrylate glue (CAG) ablation for symptomatic varicose veins, especially from the Asian population.ObjectivesAim was to determine the 3-year symptomatic relief gained from using the VenaSeal™ device to close refluxing truncal veins from the Singaporean ASVS prospective registry.MethodsThe revised Venous Clinical Severity Score (rVCSS) and three quality of life (QoL) questionnaires were completed to assess clinical improvement in venous disease symptoms along with a dedicated patient satisfaction survey. 70 patients (107 limbs; 40 females; mean age of 60.9 ± 13.6 years) were included at 3 years.ResultsAt 3 years, rVCSS showed sustained improvement from baseline (5.00 to 0.00; p < 0.001) and 51/70 (72.9%) had improvement by at least 2 or more CEAP categories.Freedom from reintervention was 90% and 85.7% patients were extremely satisfied with the treatment outcome. No further reports of further hypersensitivity reactions after one year.ConclusionThe 3-year follow-up results of the ASVS registry demonstrated continued and sustained clinical efficacy with few reinterventions following CAG embolization in Asian patients with chronic venous insufficiency.Trial registrationClinicalTrials.gov Registration: NCT03893201.

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

BackgroundPolidocanol 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. MethodsWe 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. ResultsBetween 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). ConclusionsPEM 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.

The anterior saphenous vein. Part 2. Anatomic considerations in normal and refluxing patients. Endorsed by the American Vein and Lymphatic Society, the American Venous Forum, and the International Union of Phlebology

BackgroundThe term Anterior Accessory of the Great Saphenous Vein suggests this is a branch tributary vein despite this vessel’s anatomic features of a truncal vein. A multisocietal group suggested to designate this the anterior saphenous vein (ASV). This study was aimed to evaluate its ultrasound anatomy in normal and varicose limbs. MethodsThe clinical anatomy of the ASV was evaluated by narrative review of the literature. Additionally, the course of the ASV was evaluated in 62 limbs with no evidence of venous disease and 62 limbs with varicosities. ResultsThe ASV length, patterns of origin and termination are reported in both normal and patients with varicose veins. Discussion of the patterns is supported by the narrative review of the literature. ConclusionsThe ASV must be considered a truncal vein and its treatment modalities should be the same that for the great and small saphenous veins rather than a tributary vein.

The Anterior Saphenous Vein. Part 2. Anatomic considerations in normal and refluxing patients. Endorsed by the American Vein and Lymphatic Society, the American Venous Forum and the International Union of Phlebology.

The term Anterior Accessory of the Great Saphenous Vein suggest this is a branch tributary vein despite this vessel's anatomic features of a truncal vein. A multisocietal group suggested to designate this the Anterior Saphenous Vein (ASV). This study was aimed to evaluate its ultrasound anatomy in normal and varicose limbs. The clinical anatomy of the ASV was evaluated by narrative review of the literature. Additionally, the course of the ASV was evaluated in 62 limbs with no evidence of venous disease and 62 limbs with varicosities. The ASV length, patterns of origin and termination are reported in both normal and patients with varicose veins. Discussion of the patterns is supported by the narrative review of the literature. The ASV must be considered a truncal vein and its treatment modalities should be the same that for the great and small saphenous veins rather than a tributary vein.

Risk factors for recanalization of truncal veins following endoluminal ablation

BackgroundRecanalization 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. MethodsWe 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. ResultsA 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). ConclusionsThis 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.

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.

The anterior saphenous vein. Part 1. A position statement endorsed by the American Vein and Lymphatic Society, the American Venous Forum, and the International Union of Phlebology.

There is a lack of clarity regarding the terminology of the anterior accessory saphenous vein (AASV) that can impact treatment outcomes. Although use of the word "accessory" implies that the vein is a superficial tributary, evidence supports its role as a truncal vein, similar to the great and small saphenous veins, and warranting a change in terminology. A multisocietal panel was convened by the American Vein and Lymphatic Society (AVLS), the Union International of Phlebology (UIP), and the American Venous Forum (AVF). The group was charged with reviewing the existing anatomic and clinical literature pertaining to the term "anterior accessory saphenous vein" and to consider the need for alternative terminology. Based on the insights gathered from the literature review and extensive discussions, the panel recommends changing the terminology such that the "anterior accessory saphenous vein" (AASV) now be designated the anterior saphenous vein (ASV).

The anterior saphenous vein. Part 1. A position statement endorsed by the American Vein and Lymphatic Society, the American Venous Forum, and the International Union of Phlebology

BackgroundThere is a lack of clarity regarding the terminology of the anterior accessory saphenous vein (AASV) that can impact treatment outcomes. Although use of the word “accessory” implies that the vein is a superficial tributary, evidence supports its role as a truncal vein, similar to the great and small saphenous veins, and warranting a change in terminology. MethodsA multisocietal panel was convened by the American Vein and Lymphatic Society (AVLS), the Union International of Phlebology (UIP), and the American Venous Forum (AVF). The group was charged with reviewing the existing anatomic and clinical literature pertaining to the term “anterior accessory saphenous vein” and to consider the need for alternative terminology. ConclusionsBased on the insights gathered from the literature review and extensive discussions, the panel recommends changing the terminology such that the “anterior accessory saphenous vein” (AASV) now be designated the anterior saphenous vein (ASV).

Increased body mass index and vein diameter are associated with incomplete target vein closure following microfoam ablation of incompetent saphenous veins

ObjectivePatient characteristics and risk factors for incomplete or non-closure following thermal saphenous vein ablation have been reported. However, similar findings have not been clearly described following commercially manufactured polidocanol microfoam ablation (MFA). The objective of our study is to identify predictive factors and outcomes associated with non-closure following MFA of symptomatic, refluxing saphenous veins. MethodsA retrospective review of a prospectively maintained patient database was performed from procedures in our Ambulatory Procedure Unit. All consecutive patients who underwent MFA with commercially manufactured 1% polidocanol microfoam for symptomatic superficial vein reflux between June 2018 and September 2022 were identified. Patients treated for tributary veins only, without truncal vein ablation, were excluded. Patients were then stratified into groups: complete closure (Group I) and non-closure (Group II). Preoperative demographics, procedural details, and postoperative outcomes were analyzed. Preoperative variables that were significant on univariate analysis (prior deep venous thrombosis [DVT], body mass index [BMI] ≥30 kg/m2, and vein diameter) were entered into a multivariate logistic regression model with the primary outcome being vein non-closure. ResultsBetween June 2018 and September 2022, a total of 224 limbs underwent MFA in our ambulatory venous center. Of these, 127 limbs in 103 patients met study inclusion criteria. Truncal veins treated included the above-knee great saphenous vein (Group I: n = 89, 77% vs Group II: n = 7, 58%; P = .14), below-knee great saphenous vein (Group I: n = 7, 6% vs Group II: n = 0; P = .38), anterior accessory saphenous vein (Group I: n = 17, 15% vs Group II: n = 4, 33%; P = .12, and small saphenous vein (Group I: n = 4, 4% vs Group II: n = 1, 8%; P = .41). Complete closure (Group I) occurred in 115 limbs, and 12 limbs did not close (Group II) based on postoperative duplex ultrasound screening. The mean BMI in Group II (36.1 ± 6.4 kg/m2) was significantly greater than Group I (28.6 ± 6.1 kg/m2) (P < .001). Vein diameter of ≥10.2 mm was independently associated with truncal vein non-closure with an odds ratio of 4.8. The overall mean foam volume was 6.2 ± 2.7 ml and not different between the two cohorts (Group I: 6.2 ± 2.6 ml vs Group II: 6.3 + 3.5 ml; P = .89). Post MFA improvement in symptoms was higher in Group I (96.9%) compared with Group II (66.7%) (P = .001). The mean postoperative Venous Clinical Severity Score was also lower in Group I (8.0 ± 3.0) compared with Group II (9.9 ± 4.2) (P = .048). The overall incidences of ablation-related thrombus extension and DVT were 4.7% (n = 6) and 1.6% (n = 2), and all occurred in Group I. All were asymptomatic and resolved with anticoagulation. ConclusionsMicrofoam ablation of symptomatic, refluxing truncal veins results in excellent overall closure rates and symptomatic relief. BMI ≥30 kg/m2 and increased vein diameter are associated with an increased risk of saphenous vein non-closure following MFA. Non-closure is associated with less symptomatic improvement and a lower post-procedure reduction in Venous Clinical Severity Score. Despite the incidence of ablation-related thrombus extension and DVT in this study being higher than reported rates following thermal ablation, MFA is safe for patients with early postoperative duplex ultrasound surveillance and selective short-term anticoagulation.

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.

Stocking-only versus additional eccentric compression after below-the-knee truncal vein sclerotherapy: A SOVAECS prospective randomized within-person trial

ObjectiveAfter foam sclerotherapy in the truncal saphenous vein, the clinical effects of additional eccentric compression has not yet been explored. MethodsBetween April 2020 and February 2021, we enrolled 42 patients (84 limbs) who underwent bilateral endovenous combined therapy for great saphenous vein (GSV) reflux. Each patient received the same type of endovenous ablation in both above-the-knee GSVs (laser, radiofrequency, cyanoacrylate glue), and combined foam sclerotherapy was performed on both below-the-knee GSVs. Subsequently, we conducted a prospective randomized, single-blind, within-person study in which each patient's bilateral truncal saphenous vein of the calves underwent two different compression therapies: wearing of a regular class II compression stocking on one side (RC group) and additional eccentric compression on the other side (AC group). The primary end point was the occlusion range (score, 0-10) of the below-the-knee truncal GSV after foam sclerotherapy. The secondary outcomes were the pain score (visual analog scale score range, 0-10) of the paired limb, the required number of additional foam sclerotherapy sessions, compliance with compression therapy, and procedure-related complications. ResultsFor the above-the-knee GSV, endovenous laser treatment (n = 44), endovenous radiofrequency ablation (n = 14), and endovenous cyanoacrylate glue ablation (n = 26) were performed. The mean subcompression pressure of the medial calf in the supine and standing positions were 16.7 ± 2.34 mm Hg and 24.5 ± 6.6 mm Hg in the RC group and 38.5 ± 5.5 mm Hg and 45.3 ± 8.2 mm Hg in the AC group, respectively (P = .000). The secondary outcomes of pain score, number of additional foam sclerotherapy sessions, and pigmentation were not significantly different statistically between the two groups. The patient-reported satisfaction scores (range, 0-10) on compression at 24 hours postoperatively were 8.03 ± 1.9 for the AC group and 7.98 ± 1.9 for the RC group (P = .317; Wilcoxon signed ranks test). In both groups, the closure rate of the above-the-knee GSV at 1 month postoperatively was 100%. No procedure-related complications were identified within 1 month postoperatively, including no deep vein thrombosis, numbness, or skin necrosis requiring additional medical attention. ConclusionsThe 24 hours of additional eccentric compression on the truncal GSV compared with the use of a conventional knee-level stocking only did not yield any clinical advantages in terms of the occlusion range, postoperative pain, need for additional sclerotherapy, or skin pigmentation after foam sclerotherapy. The decision on which type of compression therapy to perform after foam sclerotherapy in the truncal vein should be comprehensively determined.

Safety and efficacy of endovenous thermal ablation for treatment of symptomatic varicose veins during summertime.

Background: Traditionally, varicose vein treatment is predominately performed during the colder seasons. However, data whether higher outdoor temperatures affect the outcome and/or complication rate of endovenous thermal ablation (ETA) for treatment of symptomatic varicose veins are missing. Patients and methods: In this observational study, the medical records of all patients who had ETA of the great saphenous vein (GSV), accessory saphenous vein (ASV), or small saphenous vein (SSV) between September 2017 and October 2020 were reviewed. Results: In total 846 ETA interventions in 679 patients with 1239 treated truncal veins and an average length of 69cm phlebectomy were included. The highest temperature recorded on and within the first 14 days after treatment was on average 19.0°C (SD±7.2°C) with a minimum and maximum of -1°C and 35.9°C. Interventions were categorized according to the recorded temperature (<25°C n=584; 25-29.9°C n=191; and ≥30°C n=71). The occlusion rates were excellent (99-100%) across groups. Despite a significantly higher proportion of patients with obesity, personal history of superficial vein thrombosis and length of phlebectomies in the high temperature groups, no significant difference regarding days of work loss, patients' satisfaction or complications including bleeding or thromboembolic events was observed. Infections were rare (0.8%), but more frequently observed in the 25-29.9°C group (2.6%; p=0.058). No infection was observed in the ≥30°C group and pain 6 weeks after the intervention was even lower (VAS 0.5±1.0 and 0.5±1.2 vs. 0.0±0.1, p=0.008). Conclusions: Given the minimal invasive nature of ETA, our results can reassure clinicians and patients that ETA varicose vein treatment is possible and safe throughout the year, even on hot summer days. A non-significant trend to more infections was observed but was not associated with other adverse outcomes such as prolonged analgetics intake or inability to work.

The story of N-butyl cyanoacrylate saphenous vein ablation

In 2009, our group was approached by an experienced radiologist who proposed to close refluxing saphenous veins with glue; an idea based on his experience with N-butyl cyanoacrylate (TRUFILL) embolization of cerebral arterial venous malformations. We henceforth began with a swine model, 1 Almeida J.I. Min R.J. Rabe R. McLean D.J. Madsen M. Cyanoacrylate adhesive for the closure of truncal veins: 60-day swine model results. Vasc Endovascular Surg. 2011; 45: 631-635 Crossref PubMed Scopus (74) Google Scholar and then moved to first-in-human studies 2 Almeida J.I. Javier J.J. Mackay E. Bautista C. Proebstle T. One-year follow-up of first human use of cyanoacrylate adhesive for treatment of saphenous vein incompetence. J Vasc Surg Venous Lymphatic Disord. 2013; 1: 174-180 Abstract Full Text Full Text PDF PubMed Scopus (122) Google Scholar for nonthermal ablation of the saphenous vein with their proprietary N-butyl cyanoacrylate glue. Of interest, during the regulatory development pathway, this product was approved as a device, not a drug. It's efficacy has proved excellent, and during the past decade cyanoacrylate closure (CAC) has been adopted widely worldwide. However, reports of hypersensitivity-related adverse events, and granulomas, have begun to surface. It is timely that Dr Athavale and his team have recently published an excellent systematic review on CAC. Based on the available literature, the adverse events related to cyanoacrylate glue can be divided into the following: phlebitis, hypersensitivity (type I and type IV), foreign body granuloma, endovenous glue induced thrombosis and infection. These adverse events may require prolonged steroid use or vein excision. Cyanoacrylate glue reactions: A systematic review, cases, and proposed mechanismsJournal of Vascular Surgery: Venous and Lymphatic DisordersVol. 11Issue 4PreviewCyanoacrylate glue closure was first used in humans 10 years ago to treat venous reflux of the axial veins. Studies have since shown its clinical efficacy in vein closure. However, great need exists to elucidate further the types of specific adverse reactions that cyanoacrylate glue can cause for better patient selection and to minimize these events. In the present study, we systematically reviewed the literature to identify the types of reported reactions. In addition, we explored the pathophysiology contributing to these reactions and proposed the mechanistic pathway with inclusion of actual cases. Full-Text PDF

Cyanoacrylate adhesive closure in the European and American 2022 clinical practice guidelines

Over the last decade non-thermal non-tumescent (NTNT) methods of truncal reflux elimination in chronic venous disease (CVD) are becoming increasingly popular. The main NTNT modalities are mechanochemical ablation and cyanoacrylate adhesive closure (CAC). The advantages of non-thermal ablation are avoidance of tumescent anesthesia, low periprocedural pain and bruising, high patient comfort and satisfaction rates. CAC method has an additional benefit of avoiding the postprocedural compression. CAC is one of promising non-thermal ablation procedures, that leads to truncal vein occlusion and reflux elimination via endovenous delivery of n-butyl-2-cyanoacrylate. This review is aimed at assessment of the updated European and American clinical practice guidelines on CVD management, particularly the role of CAC. Current evidence shows high efficacy and safety of the CAC, its advantages regarding the periprocedural pain and ecchymoses, risk of adverse events, closure rates in the long-term, procedure and recovery time and patients’ quality of life. Therefore, along the current gold standard of varicose vein treatment – thermal ablation, the updated 2022 European and American clinical practice guidelines have significantly emphasized the role of NTNT modalities in general and CAC in particular. Specifically, the European Society for Vascular Surgeons guidelines recommend CAC for patients with great saphenous vein (GSV) incompetence when the NTNT technique is preferred. American guidelines recommend both thermal and non-thermal ablation for the patients with symptomatic axial reflux of the GSV, depending on the available expertise of the treating physician and the preference of the patient.

Comparison of outcomes following polidocanol microfoam and radiofrequency ablation of incompetent thigh great and accessory saphenous veins

BackgroundMicrofoam ablation (MFA) and radiofrequency ablation (RFA) are both approved by the Food and Drug Administration for treatment of proximal saphenous truncal veins. The objective of our study was to compare early postoperative outcomes between MFA and RFA following treatment of incompetent thigh saphenous veins. MethodsA retrospective review of a prospectively maintained database was conducted of patients who underwent treatment of incompetent great saphenous veins (GSVs) or anterior accessory saphenous veins (AASVs) in the thigh. All the patients underwent duplex ultrasound of the treated leg at 48 to 72 hours postoperatively. Patients were excluded from analysis if concomitant stab phlebectomy was performed. Demographic data, CEAP (clinical, etiologic, anatomic, pathophysiologic) class, venous clinical severity score (VCSS), and adverse events were recorded. ResultsBetween June 2018 and September 2022, 784 consecutive limbs (RFA, n = 560; MFA, n = 224) underwent venous closure for symptomatic reflux. A total of 200 consecutive thigh GSVs and ASVs treated within the study period using either MFA (n = 100) or RFA (n = 100) were identified. The patients were predominantly women (69%) with a mean age of 64 years. The preoperative CEAP classification was similar between the MFA and RFA groups. The mean preoperative VCSS was 9.4 ± 2.6 for the RFA patients and 9.9 ± 3.3 for the MFA patients. Among the RFA patients, the GSV was treated in 98% and the AASV in 2% compared with the GSV in 83% and the AASV in 17% in the MFA group (P < .001). The mean operative time was 42.4 ± 15.4 minutes in the RFA group and 33.8 ±16.9 minutes in the MFA group (P < .001). The median follow-up was 64 days for the study cohort. The mean postoperative VCSS declined to 7.3 ± 2.1 in the RFA group and 7.8 ± 2.9 in the MFA group. Complete closure occurred in 100% of the limbs after RFA and 90% after MFA (P = .005). Eight veins were partially closed and two remained patent following MFA. The incidence of superficial phlebitis was 6% and 15% (P = .06) after RFA and MFA, respectively. Overall, symptomatic relief was 90% following RFA and 89.5% following MFA. The complete ulcer healing rate for the entire cohort was 77.8%. Deep venous proximal thrombus extension (RFA, 1%; vs MFA, 4%; P = .37) and remote deep vein thrombosis (RFA, 0%; vs MFA, 2%; P = .5) showed a trend toward being higher following MFA but the difference did not reach statistical significance. All were asymptomatic and resolved with short-term anticoagulation therapy. ConclusionsMFA and RFA are both safe and effective for treating incompetent thigh saphenous veins, with excellent symptomatic relief and a low incidence of postprocedure adverse thrombotic events. RFA resulted in improved complete closure rates following initial treatment compared with MFA. The operative times were shorter with MFA. Both modalities can be used for patients with active venous ulcers with good healing rates. Longer term studies are required to characterize the durability of MFA closure for above knee truncal veins.

Early results following comparison of radiofrequency and microfoam ablation of large diameter truncal veins demonstrate high closure rates and symptomatic relief

ObjectiveEndovenous closure of truncal veins with a large diameter (LD) (≥8 mm) has been associated with higher risk of post ablation thrombus propagation into the deep venous system. Similar findings after Varithena microfoam ablation (MFA) have not been characterized. The study objective was to analyze outcomes after both radiofrequency ablation (RFA) and MFA and of LD truncal veins. MethodsA retrospective review of a prospectively maintained database was performed. All patients who underwent MFA and RFA for LD symptomatic truncal vein reflux (≥8 mm) were identified. All patients had postoperative duplex (48-72 hours) scanning. Patients underwent subsequent clinical follow-up at 3 to 6 weeks. Demographic data, CEAP Classification, Venous Clinical Severity Score, procedure details, adverse thrombotic events, and follow-up data were abstracted. ResultsBetween June 2018 and September 2022, 784 consecutive limbs (RFA, n = 560; MFA, n = 224) underwent truncal vein (great, accessory, and small saphenous) closure for symptomatic reflux. Sixty-six limbs in the MFA group met inclusion criteria. Sixty-six consecutive limbs treated with RFA during the same time period were included as a comparison group. The mean truncal vein diameter treated was 10.5 mm (RFA, 10.0 mm; MFA, 10.9 mm). Twenty-nine limbs (44%) in the RFA group underwent concomitant phlebectomy. Tributary veins were concomitantly sclerosed in 34 MFA limbs (52%). Total procedural times were shorter in the MFA group (MFA, 31.6 minutes vs RFA, 55.7 minutes) (P < .001). Immediate closure rates were 100% and 95% in the RFA and MFA groups, respectively. Venous Clinical Severity Scores improved after treatment in both groups (RFA, from 9.5 to 7.8; P ≤ .001) (MFA, from 11.3 to 9.0; P ≤ .001). In the RFA and MFA groups, 83% and 79% of venous ulcers healed during the study period, respectively. Symptomatic superficial phlebitis occurred after RFA in 11% and 17% MFA. The incidence of postablation proximal deep venous thrombus extension was 3.0% in the RFA group and 6.1% in the MFA group, which was not statistically significant. All resolved with short-term oral anticoagulant therapy. No remote deep venous thromboses or pulmonary emboli occurred in either group. ConclusionsHigh early closure rates, symptom relief and ulcer healing rates can be achieved after RFA and MFA of LD saphenous veins. Both techniques can be used safely across a wide array of CEAP classes. Longer term studies are required to characterize the durability of MFA closure and sustained symptom relief in LD truncal veins.