Mean Venous Clinical Severity Score Research Articles

PROMISING RESULTS OF ULTRASOUND GUIDED FOAM SCLEROTHERAPY FOR TREATING CHRONIC VENOUS ULCERS.

Despite advances in wound care, the dressing and management of chronic ulcers on lower limbs (LL) remains unsatisfactory. The simplicity, cost-efficiency, and diverse application possibilities of ultrasound guided foam sclerotherapy make it an attractive and effective approach to treat patients with no access or contraindications to more invasive methods. To evaluate the healing rate of chronic venous ulcers (CEAP C6) in patients treated with ultrasound guided foam sclerotherapy. From January 2018 to December 2020, 279 patients (336 legs) classified at the first consultation as stage 6 for CEAP (clinical, etiological, anatomical, pathophysiological classification) were followed during treatment of axial venous reflux in saphenous and tributary veins with Polidocanol (AethosxysklerolR) foam and evaluated at 52 weeks for complete healing rates or ≥ 50% ulcer size reduction, using Kaplan-Meier statistics and Cox regression to study the influence of covariates. Average age of the 279 patients was 55 years. Of these, 156 (56%) showed complete healing in 52 weeks and 89 (32%) had a wound area reduction above 50%. Ulcer size severity, lymphedema and reduced dorsiflexion of the ankle were significantly associated with healing difficulty. Time of ulcer progression up to beginning of treatment (p < 0.01), ulcer size (p = 0.01), lymphedema (p = 0.006), reduced dorsiflexion of the ankle (p = 0.01) and age equal to or greater than 65 years (p = 0.003) were significantly associated with difficulty in healing. Patients with a mean Venous Clinical Severity Score (VCSS) of 18.7 had a better prognosis (18.7 vs 22.5; p<0.001). Most patients with chronic venous ulcers (CEAP 6) treated with foam sclerotherapy achieved healing or significant improvement within 52 weeks. Healing was highly influenced by time until treatment, ulcer size, reduced dorsiflexion of the ankle and/or lymphedema presence and use of compression therapy.

Efficacy and safety of a dedicated venous stent for the treatment of iliofemoral venous obstruction: A single center experience

Background Endovascular recanalization with venous stenting is the preferred treatment for iliofemoral venous obstruction. We reviewed our institutional experience and mid-term outcomes with endovascular therapy for iliofemoral venous obstruction using the VenovoTM Self-expanding Venous Stent (BARD Peripheral Vascular, Inc., Tempe, AZ, USA). Methods Between October 2022 and March 2024, patients with iliofemoral venous obstruction treated with VenovoTM Self-expanding Venous Stents were retrospectively analyzed. Patients were monitored at 3, 6, and 12 months. The primary endpoint was 12-month primary patency, defined as computed tomography venography-derived stenosis &lt;50% and no target venous revascularization. Secondary endpoints included stent intimal hyperplasia and pain venous clinical severity scores (VCSSs). Results We evaluated 51 limbs from 40 patients (mean age: 61.7 ± 10.7 years; 26 females), including three acute deep venous thrombosis (DVT)cases, six post-thrombotic syndrome (PTS) cases, and 42 non-thrombotic iliofemoral vein lesion cases. All (100%) underwent successful endovascular treatment, with five undergoing combined stent deployment. The interventional operation-related complication rate was 1/51 (1.96%). The median follow-up was 14.6 months (range: 12–18 months). The primary patency rate at 1 year was 90%. Freedom from stent intimal hyperplasia at 12 months was 74.51% (38/51), and 3.92% (2/51) had in-stent stenosis &gt;50%, which was reduced after high-pressure balloon dilation at 6 months. The mean VCSS decreased from a baseline of 13.1.7 ± 3.7 to 3.3 ± 1.6 at 12 months ( p &lt; .0001). No complications were noted during follow-up. Conclusions Stenting iliofemoral venous obstruction using the VenovoTM Self-expanding Venous Stent appears to be safe and effective, with a high rate of 1-year clinical patency and a low reintervention rate.

Eight year results of patients with varicose vein underwent endovenous occlusion using n-butyl cyanoacrylate.

To present the 8-year results of 180 patients on whom we performed endovenous occlusion using N-butyl cyanoacrylate in 2014. We have previously published the 30-month results for 168 patients available for follow-up. Thirteen more patients were lost to follow-up in the 8-year research period. The remaining 155 patients underwent clinical examinations and their Venous Clinical Severity Score (VCSS) values were recorded. Doppler ultrasonography was performed, and whether the saphenous vein was occluded, or whether partial or complete recanalization were present was evaluated. The mean age of the 155 patients we were able to follow-up was 47.4 ± 11.8 years. Sixty-eight of the patients were men, and 87 were women. Mean VCSS scores were 10.2 before the procedure, 2.7 at 30 months, and 2.6 ± 0.7 at 8years. Complete recanalization was observed in seven patients over the 8years, and partial recanalization in six. Occlusion rates were 94.1% at 30 months and 91.7% at 8years. The long-term results of the use of N-butyl cyanoacrylate in the treatment of patients with varices are highly satisfying in terms of a high ablation rate.

Safety and efficacy assessment of the Inno-Xmart venous stent system in managing symptomatic iliofemoral venous obstruction: a 12-month outcome analysis.

This study aims to evaluate the safety and efficacy of the dedicated Inno-Xmart braided venous stent system (Suzhou Innomed Medical Device Co., Ltd., Jiangsu, China) in treating symptomatic iliofemoral venous obstruction. This clinical study followed a prospective, multicentre, single-arm design with the application of an objective performance goal. Patients diagnosed with symptomatic iliofemoral venous obstruction who met the eligibility criteria of this study were enrolled and treated with the Inno-Xmart venous stent system. The safety endpoints included the assessment of stent fracture, satisfaction of delivery system and 12-month incidence rate of major adverse events (MAEs). The primary efficacy endpoint focused on evaluating the 12-month primary patency rate through venography as determined by core laboratory. Secondary efficacy endpoints included surgical success rate, 6-month primary patency rate and the changes in quality of life from baseline to 6- and 12-month follow-up intervals. Between September 18, 2019, and April 26, 2021, 193 patients were successfully enrolled across 18 research institutions. The surgical success rate was 95.3% (184/193), the 12-month MAE rate was 5.1% (9/178) with no stent fractures or migrations. The 12-month primary patency rate for the participants was 96.1%, significantly surpassing the literature-derived objective performance of 80% (95% confidence interval [CI], 92.1-98.4; P < 0.0001). In addition, the mean venous clinical severity score (VCSS) and Chronic Venous Disease Quality of Life Questionnaire (CIVIQ) scores at the 6- and 12-month follow-ups were significantly lower than the preoperative scores (P < 0.001). The innovative, dedicated braided venous stent designed to address symptomatic iliofemoral venous obstruction demonstrates a high technical success rate, low complication rates, and impressive mid-term (12-month) patency. It effectively enhanced the quality of life for patients and holds promising prospects for a wide range of applications. The clinical study was officially registered in the "Chinese Clinical Trial Registry" (Registration number: ChiCTR2000040216, date of registration: November 25th, 2020).

Long-term outcomes of mechanochemical ablation using the Clarivein device for the treatment of great saphenous vein incompetence

ObjectiveThe short-term anatomical success rates of mechanochemical ablation using the Clarivein device (Merit Medical) in the treatment of great saphenous vein (GSV) incompetence are high. However, the anatomical success rates seem to drop over time. The aim of this study was to determine the long-term outcomes of GSV treatment using the Clarivein and to assess whether specific anatomical features better correlate with clinical or quality of life (QoL)-related outcomes. MethodsThis is a single-center, prospective cohort study in follow-up of a multicenter, randomized controlled trial using Clarivein with liquid polidocanol for the treatment of GSV incompetence. The primary outcome was anatomical success (AS), defined as complete occlusion or a recanalized segment, irrespective of reflux, of <10 cm in length. In addition, reflux-free anatomical success (RF-AS) was determined, and defined as complete occlusion or a recanalized segment with <10 cm of reflux. Clinical success was assessed using the Venous Clinical Severity Score (VCSS), and QoL was assessed using the Dutch version of the Aberdeen Varicose Vein Questionnaire (DAVVQ) and the 36-Item Short Form Health Survey (SF-36). Subgroup analyses were performed based on whether AS or RF-AS was achieved or not. ResultsA total of 109 patients (115 limbs) were included. The mean follow-up time was 8.4 ± 0.9 years (range, 5.5-10.3 years). AS was seen in 60.5% of limbs, and RF-AS was seen in 72.8% of limbs. Compared with baseline, the overall mean VCSS improved from 5.3 ± 2.4 to 4.1 ± 2.4, and the overall median DAVVQ score from 13.5 (interquartile range [IQR], 8.7-20.0) to 10.5 (IQR, 5.3-16.2) (P < .001). Improvement in VCSS was only significant in patients with successful treatment: from 5.5 ± 2.7 to 3.7 ± 2.5 (P < .001) if AS was achieved and from 5.0 ± 1.7 to 4.5 ± 1.9 (P = .20) if AS was not achieved. The same results were found for DAVVQ scores: improvement from13.5 (IQR, 8.7-20.6) to 10.3 (IQR, 3.0-14.5) (P < .01) if AS was achieved and from 12.9 (IQR, 8.3-19.3) to 10.8 (IQR, 6.7-18.2) (P = .35) if AS was not achieved. Regarding the overall SF-36 scores, the domains of vitality, mental health, and general health worsened significantly. ConclusionsIn over 8 years of follow-up, the anatomical success rate after the treatment of GSV incompetence using the Clarivein device decreased to 60.5%. However, clinical scores and disease-specific QoL still improved significantly compared with baseline. We found no convincing evidence that the absence of reflux correlates better with clinical and QoL-related outcomes compared with recanalization irrespective of reflux.

Effect of Micronized Purified Flavonoid Fraction on Venous Hemodynamics Evaluated Using Digital Photoplethysmography in Patients with Chronic Venous Disease

Micronized purified flavonoid fraction (MPFF) is the most widely prescribed and well-studied venoactive drug available for the treatment of chronic venous disease (CVD). Photoplethysmography (PPG) is used to quantitatively measure venous hemodynamics and provide information about the overall function of the venous system. The aim of this study was to use digital PPG to evaluate the effects of MPFF on venous hemodynamics in patients with CVD. Patients diagnosed with CVD at an outpatient clinic in Bursa, Turkey between February 2018 and July 2020 were assessed for inclusion in this retrospective analysis. Patients who complied with the advised treatment strategy (MPFF 1,000mg tablets taken orally once daily and compression garments) and attended follow-up visits were included in the analysis. Digital PPG was used to measure venous refilling time (VRT) and venous pumping capacity (VPC) at diagnosis and 6months of follow-up. The Venous Clinical Severity Score (VCSS) was also obtained at these visits, and patients completed the 20-item Chronic Venous Insufficiency Questionnaire (CIVIQ-20). In total, 721 patients (mean age 52years) with C0-C4 CVD were included in the study. PPG showed that VRT and VPC increased significantly from 19.0sec to 2.0%, respectively, at diagnosis to 27.4 and 4.9%, respectively, at 6months (both P<0.05). Mean VCSS improved significantly from 7.9 at diagnosis to 3.1 at 6months (P<0.05). Mean CIVIQ-20 score also improved significantly at the 6-month follow-up (20.1 vs 38.6 at diagnosis; P<0.01). In patients with C0-C4 CVD, 6months of MPFF treatment plus the wearing of compression garments was associated with statistically significant improvements in venous hemodynamic parameters measured by PPG, as well as measures of clinical severity and quality of life.

Single-procedure 8Fr rheolytic pharmacomechanical thrombectomy for treatment of acute iliofemoral deep venous thrombosis

PurposeWe hypothesize that single-procedure venous-specific rheolytic thrombectomy for treatment of acute iliofemoral deep venous thrombosis (DVT) will result in improved clinical symptoms as measured by the venous clinical severity score (VCSS), as well as durable venous patency, with decreased hemorrhagic risks and costs associated with conventional catheter-directed therapy and prolonged lytic exposure.Materials and methodsThirty-three consecutive patients with symptomatic, unilateral, iliofemoral DVT who were treated with single-procedure therapy using the 8Fr rheolytic thrombectomy catheter were retrospectively analyzed from 2012–2021. ed data included technical success (> 95% clearance of acute thrombus), adverse events (AEs), and clinical and imaging outcomes at 1-month and 1-year.ResultsTechnical success was achieved in all 33 patients. Mean pre-procedure VCSS was 7.5 with mean edema and pain sub-scores of 2.6 and 1.8, respectively. Post-procedural total mean VCSS at one month was significantly improved (mean post-procedure VCSS = 0.3, mean reduction of 7.2, P < 0.01). Clinical improvement was sustained at 1-year (mean total VCSS = 0.2, P < 0.01). Primary patency was achieved in all patients at 1-month and 30 (91%) patients at 1-year. Among the 3 patients in which primary patency was not achieved at 1-year, primary-assisted patency was achieved in 2 patients. Secondary patency was achieved in the remaining patient at 1-year. No hemorrhagic AEs occurred in this study.ConclusionThis study suggests that single-procedure venous-specific rheolytic thrombectomy for treatment of acute iliofemoral DVT is safe and effective, resulting in durable clinical and radiographic results at one year, while also limiting hemorrhagic risks, mitigating costs of admission, and expediting patient discharge.

Effect of junctional reflux on the venous clinical severity score in patients with insufficiency of the great saphenous vein (JURY study)

ObjectiveEffective treatment options are available for chronic venous insufficiency associated with superficial venous reflux. Although many patients with C2 and C3 disease based on the CEAP (Clinical-Etiological-Anatomical-Pathophysiological) classification have combined great saphenous vein (GSV) and saphenofemoral junction (SFJ) reflux, some may not have concomitant SFJ reflux. Several payors have determined that symptom severity in patients without SFJ reflux does not warrant treatment. In patients planned for venous ablation, we tested whether Venous Clinical Severity Scores (VCSS) are equivalent in those with GSV reflux alone compared with those with both GSV and SFJ reflux. MethodsThis cross-sectional study was conducted at 10 centers. Inclusion criteria were: candidate for endovenous ablation as determined by treating physician; 18 to 80 years of age; GSV reflux with or without SFJ reflux on ultrasound; and C2 or C3 disease. Exclusion criteria were prior deep vein thrombosis; prior vein ablation on the index limb; ilio-caval obstruction; and renal, hepatic, or heart failure requiring prior hospitalization. An a priori sample size was calculated. We used multiple linear regression (adjusted for patient characteristics) to compare differences in VCSS scores of the two groups at baseline, and to test whether scores were equivalent using a priori equivalence boundaries of +1 and −1. In secondary analyses, we tested differences in VCSS scores in patients with C2 and C3 disease separately. ResultsA total of 352 patients were enrolled; 64.2% (n = 226) had SFJ reflux, and 35.8% (n = 126) did not. The two groups did not differ by major clinical characteristics. The mean age of the cohort was 53.9 ± 14.3 years; women comprised 74.2%; White patients 85.8%; and body mass index was 27.8 ± 6.1 kg/m2. The VCSS scores in patients with and without SFJ reflux were found to be equivalent; SFJ reflux was not a significant predictor of VCSS score; and mean VCSS scores did not differ significantly (6.4 vs 6.6, respectively, P = .40). In secondary subset analyses, VCSS scores were equivalent between C2 patients with and without SFJ reflux, and VCSS scores of C3 patients with SFJ reflux were lower than those without SFJ reflux. ConclusionsSymptom severity is equivalent in patients with GSV reflux with or without SFJ reflux. The absence of SFJ reflux alone should not determine the treatment paradigm in patients with symptomatic chronic venous insufficiency. Patients with GSV reflux who meet clinical criteria for treatment should have equivalent treatment regardless of whether or not they have SFJ reflux.

Comparison of Doppler Ultrasound and Clinical Features of Patients With and Without Femoral Hernia in Lower Extremity Venous Insufficiency Patients.

In this study, we aim to evaluate Doppler ultrasound (US) and clinical features of patients with and without femoral hernia (FH) in lower extremity chronic venous insufficiency (CVI) patients.We retrospectively analyzed prospectively collected data of 1364 limbs with the CVI suspected. Femoral hernia was detected in 32 of the limbs, and the control group was formed with 32 limbs without FH. All limbs were evaluated with Valsalva maneuver and augmentation method to detect venous reflux in FH group. Venous reflux rates in the Doppler US, venous clinical severity scores (VCSSs), and clinical classes of Clinical-Etiology-Anatomy-Pathophysiology classification were compared statistically in both groups.The mean VCSS was 3.87 ± 0.74 in the FH group and 2.68 ± 0.65 in the control group, which was statistically significant ( P = 0.04). In the more severe clinical classes of Clinical-Etiology-Anatomy-Pathophysiology (C4-6), the number of limbs in the FH group was higher than in the control group (8 and 4, respectively). Doppler US examinations showed venous reflux in 22 of 32 limbs in the FH group and 19 of 32 patients in the control group, and there was a statistically significant difference ( P = 0.029). In the FH group, reflux could be shown only by augmentation method in the vast majority of limbs (16 of 22, 73%).In conclusion, VCSS and reflux rates are higher in limbs with CVI accompanied by FH. In addition, FH may cause false negative results in the evaluation of CVI. The use of augmentation method in limbs with FH can help avoid false negatives.

Alt Ekstremite Venöz Yetmezlik tedavisinde n-butil siyanoakrilat embolizasyonu: Tek merkez kısa ve orta dönem retrospektif sonuçlarımız

Objective: The present study aimed to evaluate the efficacy of cyanoacrylate embolization and to analyze the short- to mid-term results of cyanoacrylate embolization procedures to treat great saphenous vein insufficiency.&#x0D; Materials and Methods: 582 patients treated with cyanoacrylate embolization due to severe incompetence of the great saphenous vein were included in the study and analyzed retrospectively. Patients were evaluated clinically on the first month, sixth month, first year and second year after the operation. The treated limbs were evaluated and recorded separately.&#x0D; Results: In the postoperative period, reflux was assessed at the level of 0.5 sec in 2 (0.3%) patients in the 12th month, and 1 sec in 2 (0.3%) patients in the 24th month. The patients stated that minor complications such as pain, burning, fatigue, itching 98.8% healing in the 12th month. Deep vein thrombosis, which is a major complication, was seen in 1(0.2%) patient at the 12th month. Preoperatively documented mean venous clinical severity score from 8.86±1.59 to 0.88±0.61 (p

Correlation of Venous Clinical Severity Score With Dermatology Life Quality Index Among Patients With Chronic Venous Insufficiency: A Cross-Sectional Study.

IntroductionChronic venous insufficiency (CVI) is characterized by inadequate functioning of venous valves in the lower limb. CVI is associated with a significant reduction in patient’s quality of life (QOL). The severity of CVI was determined by CEAP (clinical, etiological, anatomical, pathophysiological) classification and venous clinical severity score (VCSS). The study is aimed to evaluate and correlate Dermatology Life Quality Index (DLQI) with VCSS, CEAP in patients with CVI.MethodsA cross-sectional study of 57 patients with CVI was conducted over a period of 12 months. A sociographic survey, clinical and severity grading using CEAP classification, and VCSS were done for all venous doppler confirmed patients. QOL was evaluated by validated DLQI questionnaires using English and native languages Hindi and Marathi.ResultsA total of 57 patients with a male to female ratio of 6.1:1 and a mean age of 51.68 years were included in the study. CEAP grading in patients showed 49.12% (C4a), 21.05% (C6), 15.7% (C4b), 7.01% (C3), 3.50% (C2 and C5). Mean VCSS and DLQI were 11.47 and 10.12, respectively; 49.12%, 40.35%, 10.53% of patients had a moderate, very large, and small impact on DLQI respectively, positively correlating to VCSS (P < 0.001).ConclusionFrom this study, it was observed that VCSS and CEAP positively correlated with DLQI, and the impact increases in proportion with the seriousness of the disease.

Abstract No. 52 ▪ FEATURED ABSTRACT Three-year results from the prospective, multicenter VERNACULAR trial: treatment of iliofemoral venous disease with the self-expanding Venovo venous stent

To assess performance and safety of the Venovo venous stent, a self-expanding stent specifically designed for the treatment of iliofemoral vein occlusions. Investigators in the international, multicenter VERNACULAR study enrolled 170 patients—93 post-thrombotic syndrome (PTS) and 77 non-thrombotic iliac vein lesion (NIVL) —at 22 centers in the United States, Europe, and Australia. Primary endpoints were major adverse events (MAEs) through 30 days and 12-month primary patency, defined as freedom from target vessel revascularization and freedom from thrombotic occlusion and duplex-ultrasound derived stenosis >50%. Secondary outcomes included the Venous Clinical Severity Score (VCSS) Pain Assessment, Quality of Life (CIVIQ-20), target lesion revascularization (TLR), and stent fracture assessment (Yale venographic core laboratory) through 36 months. Freedom from MAEs through 30 days was 93.5%, non-inferior to a pre-specified performance goal (PG) of 89% (P = 0.032) while primary patency at 12 months was 88.3%, superior to a PG of 74% derived from the venous stent literature (P < 0.0001). Follow up at two years was 86.4% (147/170 patients). Primary patency at 24 months was 83.2% (90% CI 77.3%, 89.1%); 77.3% for the PTS subgroup and 95.2% for the NIVL patients. Primary patency estimated by Kaplan-Meier survival analysis was 84.3% for the ITT group at 760 days. The 24-month TLR rate was 10.9% resulting in a freedom from TLR of 89.4% (95% CI 83.6%, 93.7%). The mean VCSS Pain Score improved from 0.6 at 12 months to 0.4 (95% CI: 0.46, 0.74) at 24-months with an overall improvement from baseline of 1.9 (median 2.0); CIVIQ-20 scores at two years also improved (15.6 points) from baseline values. No stent fractures were observed at 12 or 24 months. 36-month follow-up is ongoing. The Venovo venous stent was deployed successfully in obstructive iliofemoral vein lesions (acute technical success: 100%). Primary patency was 88.3% at 12 months and 83.2% at 24 months. Reintervention rates were low, with no stent fractures reported through two years. Final, three-year results of the VERNACULAR Study will be presented at SIR 2021.

Pattern of Chronic Venous Insufficiency among Patients Presenting to a Vascular Surgery Clinic in Low- to Middle-Income Countries (LMIC): A Cross-Sectional Study.

Objective: To measure the pattern and severity of chronic venous insufficiency (CVI) in patients presenting to a vascular surgery clinic in Pakistan.Materials and Methods: This cross-sectional study has examined patients presenting with CVI for the first time. Patients were assessed for severity of the disease using clinical, etiological, anatomical and pathological (CEAP) score and venous clinical severity score (VCSS). Patients were then divided into two groups depending on the severity of the disease: ‘mild/moderate’ CVI if the CEAP classification was ≤C3 or VCSS was <5 and ‘severe’ if CEAP classification was >3 or VCSS was ≥5. Both groups were then compared to determine the factors associated with the more ‘severe’ form of CVI.Results: During the study duration, 121 patients presented with CVI with mean age of 47.83±12.02 years; 74 (61.2%) were female. Mean body mass index of the patients was 32.49±18.3 kg/m2. Mean VCSS was 5.49±3.84, indicating most patients presented with the severe form of CVI. Field workers were determined to be three to five times more likely to present with severe CVI compared to housewives and office workers.Conclusion: Majority of the patients who presented to a tertiary care facility had the severe form of CVI. Thus, there is a need to raise awareness on this disease at community level.

Venous outcomes at 1 year after using the femoral vein as a conduit for passage of percutaneous femoropopliteal bypass

ObjectiveThe DETOUR 1 study was performed to assess the safety of the femoral vein as a "pass through" conduit for covered stent placement during fully percutaneous femoropopliteal bypass, also known as the DETOUR procedure. MethodsAt eight participating centers in this prospective, single-arm, international trial, 78 patients (82 femoropopliteal lesions) were enrolled. All patients had patent femoral veins measuring ≥10 mm in diameter at baseline. The DETOUR procedure involved delivery of a series of TORUS stent grafts, deployed from contralateral common femoral artery access, to the ipsilateral proximal superficial femoral artery, with entry into the femoral vein and re-entry into the arterial vasculature at the above-the-knee popliteal artery. The TORUS stent grafts are deployed in an overlapping configuration as an arterial-arterial conduit. Due to this novel transvenous approach, we assessed specific considerations related to the venous system to analyze the risk of risk of venous thromboembolic complications. Symptomatic deep vein thrombosis, nonocclusive material associated with the graft such as benign endovenous graft-associated material, pulmonary embolism, Venous Clinical Severity Score (VCSS) and Villalta scores, and luminal occupancy by the stent graft were assessed as the ratio of cross-sectional areas of the stent graft to the native vein at baseline and 1 year after the procedure. ResultsA duplicate femoral vein was present in 20.7% of cases. The majority of patients (86.8%) had a femoral vein luminal area preservation of ≥55%. Thirty-two patients experienced an increase in the vein diameter over time after the procedure, but this pattern of venous remodeling was not uniform. The patients who had a compensatory increase in the vein diameter had a smaller average baseline vein diameter compared with the patients who did not have a compensatory increase in vein diameter (P = .0414). Only two patients (2.4%) developed ipsilateral symptomatic deep vein thrombosis) through 1 year of follow-up. There were no pulmonary embolism in any patient in the series. The overall VCSS and Villata scores did not change during follow-up. Mean VCSS and Villata were 0.8 ± 1.4 and 0.5 ± 1.1 at 1 year, compared with 0.6 ± 1.0 and 0.4 ± 0.9 at baseline, respectively. ConclusionsAs a percutaneous alternative to open surgical bypass for complex femoropopliteal peripheral arterial disease, the transvenous bypass has a low rate of deep venous thrombotic and obstructive complications. Cross-sectional vein area is preserved, and in some patients, the compensatory vein diameter increases with time, supporting the feasibility and safety of using the lower extremity deep venous system as a pass-through conduit for the DETOUR percutaneous femoropopliteal bypass. Trial RegistrationNCT02471638.

Iliac vein pathology and short-term stenting outcomes in a South-East Asian population: A single-centre experience.

Current literature regarding iliofemoral intervention and stenting is mostly based on Western populations. We present our experience of iliofemoral stenting for chronic venous disease within a South-East Asian population. This is a single-centre retrospective review of a prospectively collected registry. Seventy-one patients with 105 limbs underwent iliac vein IVUS and stenting between 2016 and 2019. All patients underwent pre-procedure ultrasound venous scan and MRI venogram. Pre- and post-operative CEAP classification, Villalta score and Venous Clinical Severity Score (VCSS), technical results, stent patency rates and complication rates are documented. Seventy-six per cent of the cases are non-thrombotic iliac vein lesion, and 68% of patients have C4 to C6 disease. Ten percentage of patients had acute thrombosis on presentation. There was 100% technical success. A 6- and 7-point reduction in the mean VCSS and Villalta score, respectively, were noted post-stenting (baseline of 10 points and P<0.001 in both categories). Post-stenting ulcer healing rate was 91% at 6 and 12months. One-year ulcer recurrence and cellulites recurrence were at 8% and 7%, respectively. One unplanned 30-day readmission (not related to procedure) and no 30-day mortality were noted. Bleeding complication from anticoagulation was 3%. There was 10% in-stent non-flow limiting stenosis on surveillance. One-year primary patency was 91%, and secondary patency was 100%. Within our series, iliofemoral stenting has 100% technical success, with statistically significant reduction in VCSS and Villalta score, good wound healing rates, low ulcer and cellulites recurrence and good primary and secondary patency rates at 1year.

A randomized clinical trial of the effects of saphenous and perforating veins radiofrequency ablation on venous ulcer healing (VUERT trial).

To investigate whether radiofrequency endovenous ablation (RFA) of saphenous and perforating veins increases venous leg ulcer (VLU) healing rates and prevents ulcer recurrence. This prospective, open-label, randomized, controlled, single-center trial recruited 56 patients with VLU divided into: compression alone (CR, N = 29) and RFA plus compression (RF, N = 27). Primary endpoints were ulcer recurrence rate at 12 months; and ulcer healing rates at 6, 12, and 24 weeks. Secondary endpoints were ulcer healing velocity; and Venous Clinical Severity Score (VCSS). Recurrence was lower in the RF group (p < .001), as well as mean VCSS after treatment (p = .001). There were no significant between-group differences in healing rates. Healing velocity was faster in the RF group (p = 0.049). In the RF group, 2 participants had type 1 endovenous heat-induced thrombosis (EHIT). RFA plus compression is an excellent treatment for VLU because of its safety, effectiveness, and impact on ulcer recurrence reduction and clinical outcome.Registration: Clinicaltrials.gov, NCT03293836, clinicaltrials.gov.

Favorable long-term results of endovenous laser ablation of great and small saphenous vein incompetence with a 1470-nm laser and radial fiber

ObjectiveScarce information is available on the long-term results of endovenous laser ablation (EVLA) for great saphenous vein (GSV) or small saphenous vein (SSV) insufficiency. We sought to provide data on the status of patients at least 9 years after EVLA. MethodsIn 2018, we undertook a cross-sectional survey of ambulatory patients who had undergone EVLA in our tertiary care center in 2008-2009. Of 240 eligible patients, 5 died of causes not related to EVLA, 20 refused to participate, and 12 were lost to follow-up. Thus, 203 patients were re-evaluated; of them, 161 (79%) had GSV insufficiency and 42 (21%) had SSV insufficiency. The mean follow-up was 114 months (standard deviation, 11 months). All included patients underwent an echocardiography-color Doppler (ECD) evaluation, a clinical visit, and a standardized medical history. We assessed the competence of the junction and of the treated and untreated saphenous trunk and the presence of recurrent varicose veins. The trunk was considered ablated if it was nonvisible on B-mode or, when visible, if it was noncompressible or without flow or reflux on color flow Doppler analysis. Any recurrent varicose vein with the leakage point located in the treated saphenous vein was considered a failure. We asked patients about the effect of EVLA on their preoperative complaints and about any new or recurrent symptoms. We also recorded any complication or additional subsequent treatment and all data necessary to calculate the clinical class (C of the Clinical, Etiology, Anatomy, and Pathophysiology [CEAP] classification) and the Venous Clinical Severity Score (VCSS). Finally, we investigated potential associations between the study outcomes and variables by multiple logistic regression techniques. ResultsSome 10 years after EVLA, we performed a single clinical and ECD evaluation in 203 patients. Only one recanalization (0.5%; 95% confidence interval, 0.0-2.7) of the treated GSV trunk was observed in an otherwise asymptomatic patient. Up to 98% of patients were asymptomatic or significantly improved after EVLA. Additional subsequent treatments occurred in 21% of patients with GSV insufficiency and 5% of patients with SSV insufficiency. Three complications were observed, two in the GSV group (varicophlebitis, saphenous nerve damage) and one (varicophlebitis) in the SSV group. The mean C class of CEAP and the mean VCSS were significantly lower at the end of follow-up, both in patients with GSV insufficiency (C class, 3.2 vs 1.5 [P = .00001]; VCSS, 6.3 vs 1.6 [P = .001]) and in patients with SSV insufficiency (C class, 2.9 vs 1.1 [P = .00001]; VCSS, 5.4 vs 0.7 [P = .001]). Only the maximum diameter of the GSV at the junction independently correlated with ECD-confirmed reflux in the treated saphenous trunk or in the anterior accessory saphenous vein (odds ratio, 1.10; 95% confidence interval, 1.01-1.21). ConclusionsEVLA using a 1470-nm diode laser with radial fibers provides stable and valuable long-term results in patients with either GSV or SSV insufficiency.

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

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

Ultrasonography-guided foam sclerotherapy in patients with small saphenous vein insufficiency

PurposeChronic venous insufficiency is an important health problem; small saphenous vein (SSV) insufficiency is one of the leading causes and may affect up to 20% of adults. In addition to conventional treatment methods, endovenous treatment techniques have become popular in treatment of varicose veins. Herein, we report the outcomes of ultrasound-guided foam sclerotherapy (UGFS) in patients with symptomatic SSV insufficiency. MethodsFrom January 2014 to June 2018, patients with primary SSV insufficiency treated with UGFS were followed to assess the effectiveness and safety of the procedure. A total of 31 lower limbs of 30 patients (18 females and 12 males), who attended control visits at 1 week, 1, 3, and 6 months, and yearly, after undergoing UGFS, were included in the study. The clinical results, occlusion rates, and the patients' preprocedure and postprocedure Venous Clinical Severity Scores were recorded. ResultsThe records show that, during the procedure, severe pain occurred at the time of injection in one patient (3%), vasovagal syncope in one patient (3%), hyperpigmentation in five patients (16%), and phlebitis in three patients (9%). It was also recorded that during follow-up 24 legs (78%) showed complete thrombosis and 7 legs (22%) had partial thrombosis. The mean Venous Clinical Severity Score for the patients before UGFS was 8.58 ± 3.78, and 7.25 ± 3.17 after the procedure. No major complications, including sural nerve injury and deep venous thrombosis, were seen during the follow-up period. ConclusionsThe results of this study show that UGFS is a simple, safe, and effective procedure for treatment in patients with symptomatic SSV insufficiency with acceptable side effects.

3:18 PM Abstract No. 84 Iliac and femoral vein occlusive disease treated with a self-expanding venous stent: 24-month results from the prospective, multicenter VERNACULAR trial

To assess the performance of a self-expanding stent specifically designed for veins (VENOVO Venous Stent) for the treatment of iliac and femoral vein occlusions. The VERNACULAR study was conducted at 22 centers in the United States, Europe, and Australia. The intent-to-treat population included 170 patents, 93 postthrombotic syndrome patients (PTS) and 77 non-thrombotic iliac vein lesion patients (NIVL). Primary endpoints were major adverse events (MAEs) through 30 days and 12-month primary patency, defined as freedom from target vessel revascularization and freedom from thrombotic occlusion and duplex-ultrasound derived stenosis >50%. Secondary outcomes included primary patency, the Venous Clinical Severity Score (VCSS) Pain Assessment, Quality of Life (CIVIQ-20), and target lesion revascularization (TLR) at 24 months. Radiographs were assessed for stent fracture by the venographic core laboratory. Freedom from MAEs through 30 days was 93.5%, non-inferior to a performance goal (PG) of 89% (P = 0.032) while primary patency at 12 months was 88.3%, superior to a PG of 74% derived from the venous stent literature (P < 0.0001). Follow-up at two years was 86.4% (147/170 patients). Primary patency at 24 months was 83.2% (90% CI 77.3%, 89.1%); 77.3% for the PTS subgroup and 95.2% for the NIVL patients. Primary patency estimated by Kaplan-Meier survival analysis was 84.3% for the ITT group at 760 days. The 24-month TLR rate was 10.9% resulting in a freedom from TLR of 89.4% (95% CI 83.6%, 93.7%). The mean VCSS Pain Score improved from 0.6 at 12 months to 0.4 (95% CI: 0.46, 0.74) at 24-months with an overall improvement from baseline of 1.9 (median, 2.0); CIVIQ-20 scores at two years also improved (15.6 points) from baseline values. No stent fractures were observed at 12 or 24 months. Observations from the VERNACULAR trial at two years supported the 12-month results. The VENOVO stent could be deployed successfully in obstructive iliofemoral vein lesions. Primary patency was 88.3% at 12 months and 83.2% at 24 months. Reintervention rates were low, with no stent fractures reported through two years.