Superficial Reflux Research Articles

Unveiling the hidden pathologies: preoperative endoscopic findings in patients with obesity undergoing bariatric surgery

BackgroundObesity is closely associated with upper gastrointestinal disorders. The recommendations for routine preoperative esophagogastroduodenoscopy (EGD) before bariatric surgery remains a topic of debate. This study aimed to describe the pathological endoscopic findings in individuals qualified for bariatric surgery.MethodsRetrospective analysis was conducted on preoperative gastroscopy reports of patients who underwent bariatric surgery at our hospital between October 2022 and October 2023.ResultsA total of 405 patients were included in the study. The two most prevalent endoscopic findings during EGD in this patient cohort were chronic superficial gastritis (326/405, 80.5%) and reflux esophagitis (82/405, 20.2%). Some patients exhibited two or more abnormalities. Patients with reflux esophagitis were older, had a higher proportion of men, higher BMI, higher rates of smoking and drinking compared to those without it (P = 0.033, P < 0.001, P = 0.003, P = 0.001, and P = 0.003, respectively). Morbid obesity (P = 0.037), smoking habits (P = 0.012), and H. pylori infection (P = 0.023) were significant risk factors for reflux esophagitis in male patients, while age (P = 0.007) was the sole risk factor in female patients. No statistically significant differences were observed in surgical procedures between LA-A and B groups (P = 0.382), but statistically significant differences were noted between the nondiabetic and diabetic groups (P < 0.001).ConclusionsPreoperative EGD can unveil a broad spectrum of pathologies in patients with obesity, suggesting the need for routine examination before bariatric surgery. The findings of this study can guide bariatric surgeons in developing tailored treatments and procedures, thus significantly enhancing prognosis. Gastroscopy should be performed routinely in Chinese patients planning to undergo bariatric surgery.

Sub-ulcer Foam Sclerotherapy in Patients with Venous Leg Ulcer, Analysis and Technical Aspects of 134 Consecutive Patients.

For this retrospective study, we analyzed the sub-ulcer foam sclerotherapy technique in patients with venous leg ulcer (VLU). This study included 134 patients treated with sub-ulcer foam sclerotherapy at the Oulu University Hospital vascular outpatient clinic from January 2012 to December 2021. All included patients received sub-ulcer foam sclerotherapy as part of the treatment strategy for superficial venous insufficiency. Compression therapy and local wound care were organized for VLU treatment. A follow-up visit was scheduled for one month after the sub-ulcer foam sclerotherapy. Change in ulcer size, local (skin necrosis, infection) or systemic (deep vein thrombosis, pulmonary embolism) complications, and time to ulcer healing were monitored. The occurrence of major limb-related complications (amputation, surgical revision) was monitored for one year postoperatively. One month after sub-ulcer treatment, ulcers were smaller or completely healed in 108 (81%) patients. Ulcer healing was completed in 123 (92%) patients at one year and 131 (98%) patients at two years. Complications were recorded in four (3%) patients, three (2%) who were diagnosed with erysipelas requiring antibiotic treatment and one (1%) patient diagnosed with local dermatitis. During the one-year follow-up, no major limb-related complications (surgical revisions or amputations) arose. Sub-ulcer foam sclerotherapy may be a feasible addition to superficial vein reflux elimination in patients with VLU and a low risk for complications.

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.

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.

Effectiveness of iliac vein stenting combined with endovenous laser treatment of recurrent varicose veins associated with iliac vein compression.

Iliac vein compression syndrome (IVCS) is an underlying cause of varicose vein (VV) recurrence after venous surgery. However, the management of recurrent varicose veins (RVVs) combined with IVCS has rarely been reported. This study aimed to investigate the outcomes of a one-stop procedure to correct outflow obstruction and superficial reflux for patients with RVVs and IVCS. A retrospective analysis was conducted of 102 consecutive patients diagnosed with RVVs. Computed tomography venography (CTV) was performed to confirm IVCS. The cases were divided into 2 groups: the IRVVs group, including patients with RVVs and IVCS (n=48), and the RVVs group, including patients with RVVs only (n=54). The characteristics, vein reflux, and clinical, etiological, anatomical, and pathophysiological (CEAP) distribution were investigated. Then, the IRVVs group patients who underwent endovenous laser ablation (EVLA) (n=39) were divided into a further 2 groups: the EVLA + S group (n=19), who received EVLA and stenting of iliac vein, and the EVLA group (n=20), who received EVLA treatment alone. The great/small saphenous vein (GSV/SSV) trunk occlusion, VV recurrence, visual analogue scale (VAS), and venous clinical severity score (VCSS) were investigated. The prevalence rate of femoral vein reflux was 81.2% in IRVVs group and 50% in RVVs group (P<0.05). In the IRVVs group, 72.9% of patients manifested as CEAP clinical class >3, which was higher than that in RVVs group (48.1%) (P<0.05). The 12-month GSV/SSV occlusion rate in the EVLA + S and EVLA groups were 94.7% and 90.0%, respectively. Totals of 9 patients in EVLA + S group and 6 patients in EVLA group had active venous ulcers, and the ulcer healing time in EVLA + S group was significantly shorter (27.22±7.12 vs. 46.67±9.83 days, P<0.05). The reductions in the VAS and VCSS values between baseline, 1 month, and 12 months in the EVLA + S group were more obvious than those in EVLA group (P<0.05). The one-stop combination treatment of iliac venous stenting and EVLA in patients with RVVs and IVCS is safe and effective and provides prominent symptom relief, improved quality of life, and a more satisfactory ulcer healing than EVLA alone.

How to Evaluate and Choose the Proper Treatments for Patients with Lower Extremity Venous Disease

With an increasing number of interventional and noninterventional treatment options available for venous disorders, it is important that patients undergo a thorough and systematic evaluation. Clinical evaluation should include a personal and family history of venous thromboembolism (VTE), varicose veins, and thrombophilia as these factors affect response and recurrence of disease. Patient should undergo diagnostic and quality of life assessment using validated tools to monitor response to treatment. Duplex ultrasound, both deep and superficial veins, documenting both obstruction and reflux is initial imaging with CT and MRI indicated to document pelvic, iliac vein, and IVC patency and pathology. Conservative therapy including compression, healthy lifestyle with diet, and exercise. New and novel interventional therapies are available for patients with venous disease with recent randomized controlled trials and multisocietal guidelines providing evidence-based recommendations for patients with superficial and deep venous disease. Since the use of anticoagulant and antiplatelet therapies post venous intervention is not well studied nor standardized, patients should routinely undergo evaluation for ongoing risk of recurrent thrombosis and stent occlusion. Finally, patients should be counseled that superficial and deep venous disease is a chronic and often progressive disease, and follow-up at least annually is recommended.

O018 Determining the relationships between venous reflux patterns, clinical severity, and health-related quality of life

Abstract Introduction Various classification systems have been created to describe the anatomical distribution of venous reflux, including the VEIN-TERM and Clinical-Etiology-Anatomy-Pathophysiology (CEAP) classification. It is still unclear whether different reflux patterns correlate with health-related quality of life (HRQoL) and clinical severity. Methods Some 507 chronic venous disease patients and 105 asymptomatic controls underwent duplex ultrasound assessment. Patients were stratified according to VEIN-TERM and the CEAP classification systems. The Aberdeen Varicose Vein Questionnaire (AVVQ) score was used to compare HRQoL and the Venous Clinical Severity Score (VCSS) was used to compare clinical severity between groups. Results Patients were significantly older than controls (p&amp;lt;0.00001). All VEIN-TERM reflux patterns had significantly greater VCSS than no reflux (p&amp;lt;0.001). Superficial axial and combined axial reflux were associated with significantly greater VCSS than superficial segmental reflux (p&amp;lt;0.001, p=0.042 respectively). All VEIN-TERM reflux types had significantly worse AVVQ scores than no reflux (p&amp;lt;0.03). However, there were no significant differences in AVVQ scores across all VEIN-TERM reflux patterns. Most CEAP reflux patterns had increased VCSS and worse AVVQ scores when compared to no reflux (all p&amp;lt;0.05), except for deep reflux, and deep and perforator reflux only. The deep, superficial and perforator reflux group had significantly higher VCSS (p=0.013) and AVVQ (p&amp;lt;0.001) versus the superficial reflux only group. Conclusion When compared to no reflux, both classification systems show associations of any reflux pattern with worse VCSS and AVVQ scores. Combined reflux patterns were associated with the greatest clinical severity and worst HRQoL scores.

Iliocaval venous obstruction is common in patients with venous ulceration who also have superficial venous reflux: should we stent the iliac outflow, ablate the superficial reflux, or do both and, if so, in what order?

Iliocaval venous obstruction is common in patients with venous ulceration who also have superficial venous reflux: should we stent the iliac outflow, ablate the superficial reflux, or do both and, if so, in what order?

Chronic Venous Disease of the Lower Extremities: A State-of-the Art Review.

Chronic venous disease is a common disease, the prevalence of which increases with age, and can cause debilitating symptoms that adversely affect the quality of life. The risk factors include family history, female sex, obesity, pregnancy, parity, and history of deep vein thrombosis. Moreover, it is associated with venous obstruction, reflux, or both, which, in turn, leads to ambulatory venous hypertension. Chronic venous disease is the leading cause of leg ulcers, which place a significant cost burden on the health care system. Compression therapy remains the cornerstone of treatment, particularly for more advanced disease. Superficial saphenous vein reflux can be associated with significant symptoms. Catheter techniques, both thermal and nonthermal, have demonstrated efficacy and safety in successful closure and symptom improvement. Deep vein obstruction can be broadly divided into thrombotic and nonthrombotic and can lead to symptomatic chronic venous disease. Recanalization using balloons and stents has been increasingly used and studied in such patients. It is critical to develop training opportunities and guidelines to improve evidence-based and appropriate care for cardiologists treating chronic venous disease.

Correlation between reflux time and venous clinical severity score in patients undergoing saphenous vein ablation: A prospective study

It is unclear whether reflux time independently correlates with severity of symptoms in patients with great saphenous vein reflux. Eighty patients (mean age 64+/-12.7years, 56% female) undergoing great saphenous vein (GSV) ablation for symptomatic reflux were assessed prospectively. Fifty-seven underwent ablation with radiofrequency, 23 with cyanoacrylate adhesive. Venous clinical severity score (VCSS) was assessed at, or prior to the time of ablation. The highest reflux time in the GSV was selected. VCSS values ranged from 2 to 20 (median 7). Mean reflux time was 5.3 s (+/-3.3). The Spearman rank correlation yielded a value of rs = -0.123, p (2-tailed) = .279, which was not significant. The patients with concomitant deep vein reflux had higher VCSS (p < .05). Analysis of patients with only superficial vein reflux (n = 45) also demonstrated a poor correlation between VCSS and reflux time (rs = -0.051, p (2-tailed) = .741). This prospective study did not demonstrate a correlation between reflux time and VCSS.

Clinical tolerance of untreated reflux after iliac vein stent placement

BackgroundWe have recently demonstrated in a large patient cohort that the prevalence and severity of reflux will improve in most limbs after stenting and that most limbs will not develop new-onset reflux. In the present report, we have focused on the long-term clinical outcomes associated with untreated reflux in the same patient cohort who had undergone iliofemoral venous stenting without correction of residual reflux. MethodsThe clinical outcomes data from 1379 limbs treated with only iliac vein stenting without correction of superficial or deep reflux from 1997 to 2018 were analyzed (23-year follow-up period). Of the 1379 limbs, 632 (46%) had had preexisting reflux before stenting and 747 (54%) had did not. The reflux data (reflux segmental score, air plethysmography, ambulatory venous pressure) for these patients have been previously reported in detail. The subsets were compared perioperatively with each other using the following variables: grade of swelling, visual analog scale for pain score, venous clinical severity score, venous stasis dermatitis, ulceration, and quality of life measures. ResultsBoth groups demonstrated improvements in the venous clinical severity score, grade of swelling, visual analog scale score, and quality of life. No differences were found in ulcer healing (5% vs 3% for limbs with and without prestent reflux, respectively) and resolution of dermatitis (6% vs 5% for limbs with and without prestent reflux, respectively) between the two groups. Of the 632 limbs with preexisting reflux, 218 (34%) had had axial reflux and 414 had had nonaxial reflux (66%). The clinical outcomes were similar between the two groups. Using a multisegment reflux score, the limbs with prestent reflux (n = 632) were divided into two groups. A segmental score of ≥3 indicated severe reflux and a score of <3 indicated moderate reflux. Of these 632 limbs, 161 (25%) had severe reflux and 471 (75%) had moderate reflux. The two groups demonstrated similar outcomes for most clinical parameters. The post-thrombotic limbs and nonthrombotic limbs also showed similar outcomes. ConclusionsThe long-term follow-up of patients after iliac vein stenting showed that uncorrected reflux is well tolerated by most patients across most clinical measures.

Relationship between iliofemoral venous stenting and femoropopliteal deep venous reflux

ObjectiveSevere presentations of chronic venous insufficiency can result from reflux or obstruction at the deep venous, perforator, or superficial venous levels. Iliofemoral venous stenting can be used to address central venous obstruction; however, its effects on deep venous reflux (DVR) have remained unclear. The purpose of the present study was to evaluate the effects of iliac vein stenting on femoropopliteal DVR with the hypothesis that ultrasound evidence of DVR would remain absent or would have improved after iliac vein stenting. MethodsThe present study was a retrospective review of patients who had undergone iliofemoral venous stenting from 2013 to 2018. The patients were divided into two cohorts according to the preprocedural presence (group A) or absence (group B) of femoropopliteal DVR. Baseline patient variables were collected, including age, gender, CEAP (clinical, etiologic, anatomic, pathophysiologic) class, presence of concomitant superficial or perforator reflux, deep vein thrombosis history, and additional venous interventions. The primary outcome evaluated was the persistent absence or resolution of DVR on the latest venous duplex ultrasound at follow-up. Other outcomes included the follow-up CEAP classification and the need for secondary deep venous interventions. ResultsA total of 275 consecutive patients had undergone iliofemoral venous stenting. Of the 275 patients, 58 had presented with DVR (group A). A comparison of groups A and B revealed that group A had had a greater likelihood of prior deep vein thrombosis (P = .0001) and a higher frequency of superficial venous ablation. The remaining demographic variables did not differ significantly between the two groups. Of the 58 patients in group A, DVR had resolved at follow-up in 17 (P = .0001). When stratified by level, 7 of these 17 patients had had isolated popliteal reflux. In group B, DVR had developed at follow-up in 6 of the 217 patients. The CEAP class had improved from before intervention (C0, 1.1%; C1, 0.4%; C2, 1.8%; C3, 41.4%; C4, 24.9%; C5, 5.9%; C6, 24.5%) to the latest follow up (C0, 4.9%; C1, 1.9%; C2, 5.7%; C3, 34.2%; C4, 22.8%; C5, 17.1%; C6, 13.3%). Significant improvement had occurred in C6 disease within both groups (group A, 16 of 58 [27.6%; P = .0078]; group B, 19 of 217 [8.8%; P = .0203]). ConclusionsFor patients who undergo iliofemoral venous stenting, DVR could improve if present initially and is unlikely to develop if not present before stenting. A cohort of patients had experienced persistent DVR and warranted further evaluation. Prospective studies are required to corroborate the safety, efficacy, and durability of iliofemoral venous stenting for patients with DVR.

Factors associated with delayed venous ulcer healing after endovenous intervention for superficial venous insufficiency

ObjectiveThis retrospective trial analyzed the effect of predetermined variables on venous ulcer healing after endovenous ablation of insufficient veins. MethodsA total of 259 patients presenting 273 venous leg ulcers (VLUs) at Oulu University Hospital vascular outpatient clinic between January 2010 and December 2020 were included in the study. In addition to compression therapy, all patients received endovenous ablation (endothermal ablation and/or foam sclerotherapy) to promote venous healing. The hazard ratio (HR) for an ulcer to heal was analyzed in univariate analysis of predetermined factors, including age, sex, recurrent venous ulcer, presence of great saphenous vein or small saphenous vein reflux, persistent superficial vein reflux after ablation, recanalization in treated segments, ulcer age, body mass index >35 kg/m2, history of deep vein thrombosis, history of erysipelas, ability to move, smoking, hypertension, atrial fibrillation, coronary artery disease, diabetes mellitus, and cardiac insufficiency. Logistic regression was used in a multivariate analysis to identify independent risk factors for ulcer healing. ResultsIn the univariate analysis, healing was negatively associated with persistent superficial vein reflux after ablation (HR, 0.117; 95% confidence interval [CI], 0.088-0.354), recanalization in treated segments (HR, 0.161; 95% CI, 0.060-0.433), nonambulatory patient (HR, 0.322; 95% CI, 0.130-0.800), history of deep vein thrombosis (HR, 0.518; 95% CI, 0.294-0.910), and presence of small saphenous vein reflux (HR, 0.565; 95% CI, 0.384-0.830). Independent risk factors included persistent superficial vein reflux after ablation (HR, 0.123; 95% CI, 0.0051-0.295). All the patients in the persistent superficial vein reflux group had their VLUs eventually healed after further endovenous treatment. ConclusionsWhen treating patients with VLUs, persistent superficial vein reflux after ablation was negatively associated with ulcer healing. After additional endovenous ablative treatment, ulcers with persistent reflux eventually healed.

Early Results With a New Endovenous Radiofrequency Ablation Catheter, Venclose®

Endovenous Radio-frequency Ablation (RFA) has become a common treatment for chronic venous insufficiency. The Medtronic® Closurefast catheter was previously the only RFA catheter approved for use in this procedure. In 2018 VenClose® Company's new device was approved. As there has been little literature on this new device, we examined our results with this new alternative. Patients with symptomatic venous insufficiency had their lower extremities mapped via ultrasound. If superficial reflux (>.5 s) was found the patients were recommended a 6-week conservative course of compression stockings, elevation, and NSAIDs. If conservative treatment failed, the patient was scheduled for an RFA. The procedure was done at the outpatient clinic, instructions were given to return for follow-up in 3-5days, and every 3months thereafter for the first year. 1032 procedures were performed over 14months. We had 503 patients, 69% female, mean age 54 ± 12. Under the CEAP system, clinical manifestation portion, the majority of our limbs were class C3 and class C4. The majority of veins closed were GSV above knee and SSV. Follow-up duration ranged from 1 to 276days (Mean (M) = 10 SD: 20days). Our success rate was 99.32% at initial follow-up. We observed EHITs in 12 cases (1.16%), 8 of which were class I, 2 of which were class II, and 2 of which were class III. We noted SVTs of proximal varicose veins in 40 cases (3.88%) and SVT of distal GSV in 4 cases (.38%). There were 4 (.38%) cases of DVT, 3 in calf muscular veins (.29%), and one in a perforator vein (.09%). We observed two cases of puncture abscess (.193%), 8 cases of infection at the puncture site (.77%), with 8 infections occurring at locations other than the puncture site and not as a result of the procedure. These preliminary results indicate that this new machine and catheter are promising with low rates of EHIT, recanalizations, and other complications. It is important to research this catheter and further studies should continue to follow up to examine recanalization rates over a more long-term follow-up.

Axial ablation versus terminal interruption of the reflux source (AAVTIRS): a randomised controlled trial

BackgroundTreatment of superficial venous reflux has been shown to improve ulcer healing time and reduce the risk of ulcer recurrence. Terminal ablation of the reflux source (TIRS) is an alternative to formal endovenous ablation or surgery which can be performed by injecting sclerosant foam into the peri-ulcer plexus of the veins. TIRS has been shown to be successful and in our experience is the option preferred by many patients, when offered as an alternative to axial ablation (AA).AimTo determine if the proportion of ulcers healed within 6 months of endovenous treatment differs between patients undergoing AA of varicose veins or TIRS by peri-ulcer foam sclerotherapy.MethodsAAVTIRS is an assessor-blinded randomised controlled trial. Patients will be recruited from a dedicated ulcer clinic in Roscommon University Hospital and from the vascular surgical clinics in University Hospital Galway. All patients attending the ulcer clinic will be screened for eligibility.RandomisationRandom computer-generated sequence is stratified by ulcer size. Allocation will be concealed using sealed opaque envelopes.BlindingAssessors reviewing wounds at follow -p visits will be blinded to patient allocation.Primary endpointThe proportion of ulcers healed within 6 months of enrolment.DiscussionThis will be the first time that TIRS has been evaluated with a properly powered randomised trial in the setting of venous ulcer management. Streamlining the management of venous ulcers has broad health economic benefits. If it is found that TIRS is superior or non-inferior to AA, then a less expensive, less invasive injection can be offered as an alternative to AA in an attempt to encourage the healing of venous ulcers. If AA is found to be superior to TIRS, then this would suggest that all patients undergoing ablation in the management of venous ulcers should have their superficial reflux fully treated, building on the evidence of the EVRA trial.Trial registrationClinicalTrials.gov NCT04484168. Registered on 23 July 2020

Effectiveness of Cyanoacrylate Closure and Compression Therapy Compared with Compression Therapy Alone in Healing of Venous Leg Ulcer Caused by Superficial Vein Reflux: A Randomized Controlled Trial

The objective of this study was to compare venous leg ulcer (VLU) healing rate at 24 weeks in CEAP C6 patients with superficial vein reflux (SVR) between patients treated with compression therapy alone and patients treated with early cyanoacrylate closure (CAC) of SVR combined with compression therapy.

Management of Post-thrombotic Syndrome: A Comprehensive Review.

Post-thrombotic syndrome (PTS) is the most common long-term complication of acute deep venous thrombosis (DVT). The cumulative incidence of PTS in the first two years after the first acute DVT diagnosis approximates 25%. This study aims to summarize the most recent updates and provide a comprehensive review of the current management of PTS. We searched MEDLINE/PMC/NCBI Bookshelf (PubMed), Cochrane, Embase, Scopus, ClinicalTrials, and OpenGrey databases for relevant articles in English published from the establishment of each separate database until February 9, 2021. PTS constitutes the most frequent long-term complication of lower limb deep venous thrombosis (DVT). Lifestyle changes and compression treatment represent an integral part of PTS management and have a clear benefit to offer in PTS patients. Pharmacological treatment with phlebotonic and non-phlebotonic medications, such as micronized purified flavonoid fraction (MMPF) and sulodexide, respectively, may have a more central and significant role in PTS management than previously thought. The introduction of percutaneous transluminal venoplasty (PTV) and stenting has again raised our expectations with the field, along with new concerns and considerations. There is a growing number of studies that report promising results on patientoriented outcomes on PTS patients who were treated with PTV and stenting. Moreover, hybrid (endovascular/ surgical) interventions may also represent a safe and efficacious treatment option for a subset of patients with PTS. Patient selection criteria for endovascular and hybrid interventional treatment should be carefully set and standardized. Post-operative care after venoplasty is an important field of future research with potential clinical impact. Management of deep and superficial reflux remains controversial. Hopefully, future prospective studies shall provide more robust evidence on the management of PTS.

Endovenous microfoam ablation of below knee superficial truncal veins is safe and effective in patients with prior saphenous treatment across a wide range of CEAP classes

ObjectivePatients requiring thermal or chemical ablation of below knee (BK) truncal veins often have their proximal saphenous veins treated initially and comprise a study population with multilevel, refractory chronic venous insufficiency. The study objective was to assess the outcomes after microfoam ablation of BK truncal and tributary veins in patients with a history of proximal great saphenous vein (GSV) ablation or stripping. MethodsA retrospective review of a prospectively maintained database was performed. All the patients who had undergone endovenous chemical ablation with commercially manufactured polidocanol microfoam for symptomatic BK truncal vein reflux after a previous saphenous ablation or stripping were identified. The patients had undergone duplex ultrasound scanning 48 to 72 hours after the procedure; those who had not adhered to the recommended follow-up protocol were excluded. The demographic data, CEAP (clinical, etiologic, anatomic, pathophysiologic) classification, venous clinical severity score (VCSS), procedure details, adverse thrombotic events, and follow-up data were abstracted. ResultsBetween April 2018 and April 2021, 201 limbs were treated for symptomatic superficial truncal vein reflux with microfoam ablation. Of the 201 limbs, 68 in 49 patients met the inclusion criteria for the present study. The veins treated included the BK GSV (n = 45) and small saphenous vein (n = 23). The median follow-up was 97 days (range, 33-457 days) for the entire cohort. Most patients (63%) had a preoperative CEAP classification of C4 to C6. The median preoperative VCSS was 12.5. All the limbs that had undergone microfoam ablation in this cohort had a previously treated proximal ipsilateral GSV, with either thermal ablation or stripping. The median postoperative VCSS after BK treatment decreased to 10 (P < .001). The closure rate at the last follow-up was 96%. The overall symptomatic relief was 78% at the last follow-up. The absolute ulcer healing rate during the study period was 64% (16 of 25 ulcers had healed). One patient had developed thrombus extension into the popliteal vein, which resolved with anticoagulation therapy. One asymptomatic patient had developed nonocclusive thrombus in a gastrocnemius vein after small saphenous vein ablation. Because she was asymptomatic, anticoagulation therapy was not prescribed. Postoperative pain, phlebitis, and swelling were reported in 12%, 12%, and 2% of patients, respectively, and all had resolved at the last follow-up visit. Three limbs treated with chronic oral anticoagulant agents had had recanalized truncal veins during the study period after initial closure. No pulmonary emboli or neurologic adverse events were reported. No symptoms of saphenous or sural nerve injury had occurred. ConclusionsEndovenous chemical ablation with commercially manufactured polidocanol microfoam of BK truncal veins is a safe and effective treatment for patients with severe, refractory chronic venous insufficiency and prior saphenous interventions. This technique results in excellent overall closure rates and symptomatic relief with low adverse venous thrombotic events, across a wide range of CEAP classes.

Compression Therapy Is Not Contraindicated in Diabetic Patients with Venous or Mixed Leg Ulcer.

The aim of this study was to investigate if compression therapy (CT) can be safely applied in diabetic patients with Venous Leg Ulcers (VLU), even when a moderate arterial impairment (defined by an Ankle-Brachial Pressure Index 0.5–0.8) occurs as in mixed leg ulcers (MLU). Materials and methods: in one of our previous publications we compared the outcomes of two groups of patients with recalcitrant leg ulcers. Seventy-one patients were affected by mixed venous and arterial impairment and 109 by isolated venous disease. Both groups were treated by tailored inelastic CT (with compression pressure <40 mm Hg in patients with MLU and >60 mm Hg in patients with VLU) and ultrasound guided foam sclerotherapy (UGFS) of the superficial incompetent veins with the reflux directed to the ulcer bed. In the present sub analysis of the same patients we compared the healing time of 107 non-diabetic patients (NDP), 69 with VLU and 38 with MLU) with the healing time of 73 diabetic patients (DP), 40 with VLU and 33 with MLU. Results: Twenty-five patients were lost at follow up. The results refer to 155 patients who completed the treatment protocol. In the VLU group median healing time was 25 weeks for NDP and 28 weeks in DP (p = 0.09). In the MLU group median healing time was 27 weeks for NDP and 29 weeks for DP (p = −0.19). Conclusions: when providing leg ulcer treatment by means of tailored compression regimen and foam sclerotherapy for superficial venous refluxes, diabetes has only a minor or no effect on the healing time of recalcitrant VLU or MLU.

Long-term Clinical and Cost-effectiveness of Early Endovenous Ablation in Venous Ulceration

One-year outcomes from the Early Venous Reflux Ablation (EVRA) randomized trial showed accelerated venous leg ulcer healing and greater ulcer-free time for participants who are treated with early endovenous ablation of lower extremity superficial reflux. To evaluate the clinical and cost-effectiveness of early endovenous ablation of superficial venous reflux in patients with venous leg ulceration. Between October 24, 2013, and September 27, 2016, the EVRA randomized clinical trial enrolled 450 participants (450 legs) with venous leg ulceration of less than 6 months' duration and superficial venous reflux. Initially, 6555 patients were assessed for eligibility, and 6105 were excluded for reasons including ulcer duration greater than 6 months, healed ulcer by the time of randomization, deep venous occlusive disease, and insufficient superficial venous reflux to warrant ablation therapy, among others. A total of 426 of 450 participants (94.7%) from the vascular surgery departments of 20 hospitals in the United Kingdom were included in the analysis for ulcer recurrence. Surgeons, participants, and follow-up assessors were not blinded to the treatment group. Data were analyzed from August 11 to November 4, 2019. Patients were randomly assigned to receive compression therapy with early endovenous ablation within 2 weeks of randomization (early intervention, n = 224) or compression with deferred endovenous treatment of superficial venous reflux (deferred intervention, n = 226). Endovenous modality and strategy were left to the preference of the treating clinical team. The primary outcome for the extended phase was time to first ulcer recurrence. Secondary outcomes included ulcer recurrence rate and cost-effectiveness. The early-intervention group consisted of 224 participants (mean [SD] age, 67.0 [15.5] years; 127 men [56.7%]; 206 White participants [92%]). The deferred-intervention group consisted of 226 participants (mean [SD] age, 68.9 [14.0] years; 120 men [53.1%]; 208 White participants [92%]). Of the 426 participants whose leg ulcer had healed, 121 (28.4%) experienced at least 1 recurrence during follow-up. There was no clear difference in time to first ulcer recurrence between the 2 groups (hazard ratio, 0.82; 95% CI, 0.57-1.17; P = .28). Ulcers recurred at a lower rate of 0.11 per person-year in the early-intervention group compared with 0.16 per person-year in the deferred-intervention group (incidence rate ratio, 0.658; 95% CI, 0.480-0.898; P = .003). Time to ulcer healing was shorter in the early-intervention group for primary ulcers (hazard ratio, 1.36; 95% CI, 1.12-1.64; P = .002). At 3 years, early intervention was 91.6% likely to be cost-effective at a willingness to pay of £20 000 ($26 283) per quality-adjusted life year and 90.8% likely at a threshold of £35 000 ($45 995) per quality-adjusted life year. Early endovenous ablation of superficial venous reflux was highly likely to be cost-effective over a 3-year horizon compared with deferred intervention. Early intervention accelerated the healing of venous leg ulcers and reduced the overall incidence of ulcer recurrence. ClinicalTrials.gov identifier: ISRCTN02335796.