Venous Clinical Severity Score Research Articles

Enhancing patient comfort in varicose vein treatment through combined lidocaine and ropivacaine tumescent anesthesia

ObjectiveTo compare the analgesic effects of specific tumescent anesthetic solutions composed of lidocaine, ropivacaine, or a combination of lidocaine and ropivacaine during endovenous radiofrequency ablation for the treatment of great saphenous vein varicosities.MethodThis study included 149 patients with lower limb varicose veins who were admitted to our department between 2019 and 2023. The patients were randomly assigned to three groups: the lidocaine group (Group I), the ropivacaine group (Group II), and the lidocaine + ropivacaine group (Group III). Intraoperative vital signs, intraoperative and postoperative visual analog scale (VAS) pain scores, and long-term treatment outcomes were assessed using the venous clinical severity score (VCSS) based on clinical performance.ResultsThere were no significant differences in age, body mass index, operative time, or blood loss among the three groups (P ≥ 0.05). The differences in the mean arterial pressure and heart rate during surgery in Group II were significantly greater than those in Groups I and III (P < 0.05). The intraoperative VAS scores in Group II were higher than those in Groups I and III (P < 0.05) and at 8 and 12 h postoperatively. There were no significant differences in VCSS among the groups (P ≥ 0.05).ConclusionThe use of a tumescent anesthetic solution composed of lidocaine and ropivacaine significantly improved patient comfort during the perioperative period without affecting surgical outcomes. This formulation can be considered safe and reliable for preparing tumescent anesthesia solutions.

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.

Clinical efficacy of sodium aescinate administration following endovenous laser ablation for varicose veins.

Endovenous interventions and minimally invasive procedures are effective in the management of varicose veins. However, they can cause postoperative discomfort. To evaluate the clinical efficacy of sodium aescinate (SA) in improving edema, pain, vein-specific symptoms, and quality of life in patients following endovenous laser ablation (EVLA) for varicose veins. In this single-center randomized controlled trial (RCT), patients were allocated into two groups: in Group A, 60mg SA was administered twice daily for 20days, and in Group B (control), no venoactive drug was prescribed. The Clinical-Etiology-Anatomy-Pathophysiology (CEAP) classification system for chronic venous disorders was used to assess the varicose veins. The circumferences of the calf and ankle were recorded for evaluating edema. The 10-point Visual Analog Scale (VAS), Venous Clinical Severity Score (VCSS), and Aberdeen Varicose Veins Questionnaire (AVVQ) were used to measure the pain intensity, overall varicose vein severity, and patient's quality of life, respectively. The study included 87 patients (mean age, 59.9 ± 10.7years; 54 men) with CEAP class C2-C5 varicose veins who underwent EVLA and phlebectomy or foam sclerotherapy. The calf circumference recovered quicker in Group A than in Group B by days 10, 21, and 30 (difference from baseline was 1.04 ± 0.35 vs 2.39 ± 1.15 [p < .001], 0.48 ± 0.42 vs1.73 ± 1.00 [p < .001], and 0.18 ± 0.64 vs 0.82 ± 0.96 [p < .001], respectively). The ankle circumference recovered quicker in Group A than in Group B by days 10 and 21 (the difference from baseline was 1.37 ± 0.52 vs 2.36 ± 0.93 [p < .001] and 0.58 ± 0.60 vs 1.14 ± 0.88 [p = .002], respectively). Pain relief was achieved quicker in Group A than in Group B (0.257 ± 1.097 [p = .0863] vs 0.506 ± 1.250 [p = .0168] by day 21). There were no significant differences in the VCSS and AVVQ scores between both groups. There were no drug-related adverse effects. SA, in combination with compression therapy, can relieve edema and alleviate pain in patients following EVLA for varicose veins.

Radiofrequency ablation for the treatment of great saphenous venous insufficiency using a newly developed VENISTAR catheter: A preliminary study.

This study was aimed to assess the preliminary outcomes of radiofrequency ablation (RFA) using a newly developed catheter (VENISTAR) for the treatment of incompetent great saphenous veins (GSVs). In this prospective observational study, endovenous RFA using a VENISTAR catheter was performed on 16 saphenous veins in 12 patients between August and November 2019. Patients' pre- and post-procedural data were recorded. Doppler ultrasound imaging and clinical evaluation were performed at 1week and 1, 3, and 6months to determine the efficacy and safety of the treatment. Technical success and complete closure of the targeted GSVs immediately after the procedure were observed in all 16 limbs (100%). However, one patient (one limb) was found to have partial occlusion without significant reflux after 1week of follow-up. Kaplan-Meier analysis yielded a complete occlusion rate of 93% at 6months of follow-up. The Venous Clinical Severity Scores at the time of all follow-up were significantly lower than those at baseline (3.3 ± 1.1 at baseline to 0.6 ± 0.6, 0.3 ± 0.6, 0.1 ± 0.4, and 0.2 ± 0.4 at 1week and 1, 3, and 6months, respectively) (p < .001). Mild post-procedural pain was noted in 7 and 4 limbs at 1week and 1month, respectively. Grade 1 ecchymosis over the ablated segment was noted in 5 (35.7%) of 14 limbs at 1-week follow-up. Endovenous treatment of GSV insufficiency using a new VENISTAR radiofrequency catheter has been shown to be feasible, effective, and safe throughout the 6-month follow-up.

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

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

Pivotal Evaluation of Novel Dedicated Venous Stent for Iliofemoral Venous Obstruction: A Prospective Cohort Study.

The purpose was to evaluate the clinical outcomes of a dedicated venous stent with the tripartite composite segments for the treatment of iliofemoral venous obstruction (IVO) in a mixed cohort of nonthrombotic iliac vein lesion (NIVL) and post-thrombotic syndrome (PTS) over a period of 12 months. The Grency Trial is a prospective, multicenter, single-arm, open-label, pivotal study, which was conducted at 18 large tertiary hospitals in China from August 2019 to October 2020. A total of 133 hospitalized patients were screened and 110 patients with clinical, etiology, anatomical, and pathophysiology clinical class (CEAP) clinical grade C>3 and iliac vein stenosis >50% or occlusion, including 72 patients with NIVL and 38 patients with PTS, were implanted with Grency venous stents. Primary endpoint was stent patency at 12 months follow-up, and secondary outcomes were technical success; improvement in venous clinical severity score (VCSS) at 3, 6, and 12 month follow-up; and rates of clinical adverse events. Among 110 patients who were implanted with Grency venous stents, 107 patients completed the 12 month follow-up. All 129 stents were successfully implanted in 110 limbs. Twelve-month primary patency rate was 94.39% [95% confidence interval [CI]=88.19%-97.91%] overall, and 100% [94.94%-100%] and 83.33% [67.19%-93.63%] in the NIVL and PTS subgroups, respectively. Venous clinical severity score after iliac vein stenting improved significantly up to 12 months follow-up. There were 3 early major adverse events (1 intracerebral hemorrhage and 2 stent thrombosis events related to anticoagulation therapy), and 7 late major adverse events (1 cardiovascular death, 1 intracranial hemorrhage with uncontrolled hypertension, and 5 in-stent restenosis cases without stent fractures or migration). The Grency venous stent system appeared excellent preliminary safe and effective for IVO treatment. Further large-scale studies with longer-term follow-up are needed to evaluate long-term patency and durability of stent. The design of venous stents for iliofemoral venous obstruction (IVO) must address engineering challenges distinct from those encountered in arterial stenting. The Grency venous stent, a nitinol self-expanding stent specifically tailored for IVO, features a composite structure designed to meet the stent requirements of various iliac vein segments. The Grency Trial is a prospective, multicenter, single-arm, open-label pivotal study aimed at evaluating the efficacy and safety of the Grency stent system. Following a 12-month follow-up period, the Grency venous stent system has demonstrated both safety and efficacy in treating iliofemoral venous outflow obstruction.

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.

Compression Therapy after Thermal Ablation of Varicose Veins: A Meta-Analysis.

To investigate whether compression therapy after thermal ablation of varicose veins can improve the prognosis of patients. Systematic research were applied for Chinese and English electronic databases(PubMed, Web of Science, Cochrane Library, CNKI, Wanfang, VIP Databases). Eligible prospective studies that comparing the efficacy of compression therapy and non-compression therapy on patients after thermal ablation of varicose veins were included. The interest outcome such as pain, quality of life (QOL), venous clinical severity score (VCSS), time to return to work and complications were analyzed. 10 studies were of high quality, and randomized controlled trials involving 1,545 patients met the inclusion criteria for this study. At the same time, the meta-analysis showed that the application of compression therapy improved pain (SMD: -0.51, 95% CI: -0.95, -0.07) but exhibited no statistically significant effect on QOL (SMD: 0.04, 95% CI: -0.08, 0.16), VCSS (MD: -0.05, 95% CI: -1.19, 1.09), time to return to work (MD: -0.43, 95% CI: -0.90, 0.03), total complications (RR: 0.54, 95% CI: 0.27, 1.09), and thrombosis (RR: 0.71, 95% CI: 0.31, 1.62). Compression therapy after thermal ablation of varicose veins can slightly relieve pain, but it has not been found to be associated with improvement in other outcomes.

Efficacy and safety of mechanochemical ablation versus laser ablation in the treatment of primary great saphenous vein reflux: A randomized, open, parallel controlled clinical trial.

To evaluate the efficacy of a new mechanochemical ablation (MOCA) device versus endovenous laser ablation (EVLA) for primary great saphenous vein (GSV) reflux. Prospectively analyze the demographics, treatment detail and outcomes data of 57 primary GSV reflux patients. Patients were randomly assigned to MOCA or EVLA group with random envelope method. Primary endpoint was 6-month closure rate of GSV. Secondary endpoint including technical success rate, the venous clinical severity score (VCSS), chronic venous insufficiency questionnaire (CIVIQ-20) score and visual analogue scale (VAS) for pain. The procedures were well tolerated according to the VAS score. The 6-month closure rate was 85.71% in MOCA and 96.55% in EVLA group (p = .194). Significant changes were observed in regard of VCSS and CIVIQ-20 score at 6-month follow-up. Skin paresthesia occurred in 0 in MOCA and 5 in EVLA group. The new MOCA device is safe and effective in treating primary great saphenous vein reflux. The 6-month closure rate is non-inferior compared with EVLA. However, the long-term results need further follow-up.

Impact of native iliac vein aspect ratio on initial clinical presentation and outcomes following stenting for symptomatic chronic iliofemoral venous obstruction

Venous stenting has become the first line of treatment for patients with symptomatic chronic iliofemoral venous obstruction (CIVO) who have failed conservative therapy. Intravascular ultrasound (IVUS) interrogation with use of normal minimal luminal diameters or areas has become the standard to confirm diagnosis as well as determine adequacy of stenting. However, aspect ratio (ratio between the maximal and minimal luminal diameters) has also been put forth as a possible metric for determining adequacy of stenting. This study explores the utility of the native iliac vein and stent aspect ratios in determining initial presentation and outcomes post stenting. A retrospective analysis of contemporaneously entered data on patients who underwent stenting for quality-of-life (QoL) impairing clinical manifestations of CIVO who had failed conservative therapy formed the study cohort. The limbs were grouped into 3 at the time of intervention using IVUS determined native vein aspect ratio, Group I: those with a ratio of <1.4; Group II - those with a ratio of 1.41 to 1.99 and Group III with a ratio of >2. Characteristics appraised initially and post stenting included venous clinical severity score (VCSS), Grade of swelling (GOS), VAS pain score and the CIVIQ - 20 quality of life (QoL) score. ANOVA and paired/unpaired t- tests were used for comparison of clinical/QoL variables, while Kaplan - Meier analysis was used to evaluate stent patencies with log-rank test used to discriminate between different curves. There were a total of 236 limbs (236 patients). The median age for the entire cohort was 62 years (range 16-92 years). There were 161 women in the study and left laterality was more common (137 limbs). Post thrombotic obstruction was noted in 201 limbs (86%). The median BMI was 36. There were 54 (23%), 64 (27%) and 118 (50%) limbs in groups I, II and III respectively. Median follow up was 65 months. For the entire cohort, post stenting, VCSS improved from 6 to 4 (p<0.0001) at 3 months and remained at 4 at 6 months (p<0.0001), 12 months (p<0.0001) and 24 months (p<0.0001). GOS for the entire cohort improved from 3 to 1 (p<0.0001) at 3 months and remained at 1 at 6 months (p<0.0001), 12 months (p<0.0001) and 24 months (p<0.0001). VAS pain score for the entire cohort the VCSS improved from 7 to 0 (p<0.0001) at 3 months, went up to 2 (p<0.0001) at 6 months and remained at 2 (p<0.0001) at 12 months. At 24 months the VAS pain score worsened to 3 (p<0.0001). For the entire cohort, the CIVIQ-20 score improved from 62 to 40 (p<0.0001). There was no difference in the GOS, VAS pain score or CIVIQ-20 score between the groups at baseline or at 6-, 12- and 24-months post intervention. At 60 Months, the primary stent patency was 89% for Group I, 80% for Group II and 75% for Group III (p =0.85); the primary assisted stent patency was 100% for Group I, 98% for Group II and 98% for Group III (p=0.5); secondary patency was 100% for Groups II and III (p>0.5). Reintervention was pursued for QoL impairing clinical manifestations in 53 (22%) limbs without a significant difference between the 3 groups (p=0.13). Native vein aspect ratio does not appear to determine initial clinical presentation/quality of life or impact clinical/quality of life outcomes post stenting in patients undergoing stenting for quality-of-life impairing symptoms of CIVO who have failed conservative therapy. Post-stenting there was an improvement in the aspect ratios (97% in Group I and 3% in Group 2) compared to the pre-stenting native vein aspect ratios (23% in Group I, 27% in Group II and 50% in Group III). IVUS determined minimal cross-sectional luminal area and not aspect ratios should be used for confirmation of the diagnosis of CIVO and assessing the adequacy of stenting.

The TOPOS study.

Background: We aimed to study the long-term safety and efficacy of oblique venous stents for post-thrombotic syndrome (PTS) with iliac vein compression. Patients and methods: In the multinational, prospective, single-arm TOPOS study, PTS patients scheduled for endovascular therapy with the sinus-Obliquus® stent and optional distal extension with the sinus-Venous® or sinus-XL Flex® stent were enrolled at eight European vascular centres between October 2016 and December 2020. The primary outcome was primary stent patency at 24 months, and secondary outcomes included the clinical course of PTS (Villalta score, revised Venous Clinical Severity Score [rVCSS], Visual Analog Scale [VAS] of pain), quality of life changes (Chronic Venous Insufficiency Quality of Life Questionnaire, CIVIQ-20), and device-related complications. Results: We enrolled 60 patients (mean age 46±15 years, 68% women, 13% active ulcers): 80% required stent extension (70% below the inguinal ligament). The primary patency rate at 24 months was 80.7% (95%CI 68.1-90.0%); it was higher in patients without vs. those with stent extension (90.9% vs. 78.3%, p=.01). Compared to baseline, the Villalta, rVCSS, pain VAS, and CIVIQ-20 decreased by a median of 8 (interquartile range (IQR): 4-11), 5 (IQR: 3-7), 3 (IQR: 2-5), and 17 (IQR: 6-22) points, respectively; p<.001 for all parameters. Overall, 9 events of acute stent occlusion, 4 symptomatic stent stenosis, and 1 pulmonary embolism occurred. We did not observe major bleeding events or contralateral thrombosis. Conclusions: Endovascular treatment with the oblique stent and optional stent extension was safe and resulted in high patency rates at 24 months. The reduction in PTS severity was substantial and persisted over 2-year follow-up.

Effects of high ligation plus endovenous laser therapy in patients with varicosis of great saphenous vein and type 2 diabetes.

To analyze the effects of high ligation plus endovenous laser therapy on intraoperative blood loss, postoperative visual analogue scale (VAS) score, and complications in patients with varicosis of great saphenous vein and type 2 diabetes. About 61 patients with varicosis of great saphenous vein and type 2 diabetes treated at our hospital were included. About 32 patients (37 affected limbs) receiving conventional surgery were included in control group, while 29 patients (34 affected limbs) receiving high ligation plus endovenous laser therapy were included in study group. The intraoperative blood loss, operation time, length of postoperative hospital stay, postoperative VAS scores, blood glucose levels, Venous Clinical Severity Score (VCSS), and incidence of complications were compared between the two groups. Compared with the control group, there were less intraoperative blood loss (P < .05), shorter operation time (P < .05), and shorter length of postoperative hospital stay in the study group (P < .05). Besides, there was also lower VAS scores at different time points after surgery in the study group than in the control group (P < .05). Blood glucose levels were decreased in both groups after surgery (P < .05). Moreover, VCSS was decreased in either group at 3 months after surgery (P < .05). Blood glucose levels of patients in the study group were lower than those of the control group after surgery (P < .05). The VCSS was also lower in the study group at 3 months after surgery than in the control group (P < .05). High ligation with endovenous laser therapy for varicosis of great saphenous vein in patients with type 2 diabetes was safe and feasible.

Effect of Yoga in Industrial Workers with Chronic Venous Insufficiency: A Randomized Controlled Trial.

Background and objective: Prolonged standing is one of the significant contributors to chronic venous insufficiency (CVI) in industry workers. Yoga is proven to be an effective therapy in treating occupational hazards. The current study aimed to investigate the effect of yoga on CVI among industry workers. Methodology: Male workers (n = 100) from machinery manufacturing industries in Bangalore meeting the inclusion and exclusion criteria were recruited for the study. The yoga group received a specifically designed yoga module for 6 days a week for 12 weeks, and the control group was offered lifestyle suggestions. Plasma homocysteine was used as the primary outcome variable, whereas Venous Clinical Severity Score, ankle brachial pressure index (ABPI), ankle and calf circumference, CVI questionnaire, and Chalder fatigue scale were assessed as secondary variables at baseline and the end of 12 weeks of intervention. Results: Eighty-eight participants (yoga = 43, control = 45) completed the study. A one-way analysis of covariates (ANCOVA) was used to determine the significant differences between groups in the post-values. A significant difference was found between groups in plasma homocysteine (partial eta squared = 0.34, p < 0.001). All variables, except for ABPI, calf circumference, and ankle circumference, had shown statistically significant differences between the yoga and control groups after 12 weeks of intervention, with moderate to high effect sizes. There were no significant adverse events associated with the intervention. Conclusions: Yoga practices can reduce the symptoms of CVI along with vascular inflammation as indicated by reduced plasma homocysteine. Overall, yoga practices are found to be safe and efficacious for managing CVI. IEC Reference Number: RES/IEC-SVYASA/184/2021 Trial Registration Number (If Clinical Trial): CTRI/2021/02/030944.

Can plethysmography have a greater place in the diagnosis, treatment and follow-up of chronic venous insufficiency?

Objectives: Chronic venous insufficiency (CVI) is one of the most common venous diseases. CVI is an important clinical picture with a high prevalence, low quality of life, and high diagnosis and treatment costs. Therefore, diagnosis, follow-up, and treatment are important for the patient's socioeconomic and life quality. In this study, we aimed to better examine a test used in the diagnosis, treatment, and follow-up of CVI. Methods: In this retrospective study, 683 patients diagnosed with CVI, who had endovenous laser ablation (EVLA) indications were evaluated between June 2013 and November 2018. EVLA procedure performed on all patients. Preoperative, postoperative 1st and 6th month Doppler USG (ultrasonography), plethysmography, and VCSS (Venous Clinical Severity Score) questionnaire was made to all patients. Results: As a result of our study, we found that there was a significant difference between the preoperative plethysmography and VCSS results of the patients and the postoperative 1st and 6th month results. With the significant difference in the VCSS questionnaire, we have shown that plethysmography gives accurate results in the diagnosis and treatment of CVI since it is an individual, quantitative, and easy test. Conclusions: EVLA is an effective and safe method in patients with venous insufficiency. Since Doppler USG is person and device dependent, we think that plethysmography, which can be used in every clinical setting and provides quantitative results independent of the person, can be used more frequently in the diagnosis and treatment of venous insufficiency. In addition, we think that plethysmography can be used as a valuable additional method in the diagnosis and follow-up of such patients, due to the venous hemodynamic data that Doppler USG cannot provide.

Final 3-Year Study Outcomes from the Evaluation of the Zilver Vena Venous Stent for the Treatment of Symptomatic Iliofemoral Venous Outflow Obstruction (VIVO Clinical Study)

PurposeTo report 3-year outcomes from a prospective, multicenter, nonrandomized, single-arm study designed to assess the safety and effectiveness of the BLIND TEXT for the treatment of symptomatic iliofemoral venous outflow obstruction. Materials and MethodsThe BLIND study included patients with symptomatic obstruction of 1 iliofemoral venous segment (ie, 1 limb), characterized by a CEAP clinical classification of ≥3 or a Venous Clinical Severity Score (VCSS) for pain of ≥2. Patients were retrospectively grouped based on baseline clinical presentation as postthrombotic syndrome (PTS), nonthrombotic left iliac vein (NIVL) obstruction, or acute deep vein thrombosis (aDVT). Clinical improvement was assessed by change in VCSS, VDS, CIVIQ-20 scores, and CEAP C classification. Stent performance was evaluated by rates of patency by ultrasound (US), freedom from clinically driven reintervention, and freedom from stent fracture. ResultsThe 3-year results for the 243 patients in the BLIND cohort included a 90.3% rate of patency by US and a 92.6% rate of freedom from clinically driven reintervention. The 3-year rates of patency by US for the NIVL, aDVT, and PTS groups were 100%, 84.0%, and 86.1%, respectively. Sustained clinical improvement through 3 years was demonstrated by changes in VCSS, VDS, CIVIQ-20, and CEAP C classification. No stent fractures were observed. ConclusionsThe BLIND study demonstrated sustained high rates of patency and freedom from clinically driven reintervention and improvements in venous clinical symptoms through 3 years. Each patient group (NIVL, aDVT, and PTS) showed clinical improvement and sustained patency through 3 years; some variation existed among groups (eg, only the NIVL group had a 100% patency rate).

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

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

Factors associated with lack of clinical improvement after vein ablation in the vascular quality initiative

BackgroundInsurance companies have adopted variable and inconsistent approval criteria for chronic venous disease (CVD) treatment. Although vein ablation (VA) is accepted as the standard of care for venous ulcers, the treatment criteria for patients with milder forms of CVD remain controversial. This study aims to identify factors associated with a lack of clinical improvement (LCI) in patients with less severe CVD without ulceration undergoing VA to improve patient selection for treatment. MethodsWe performed a retrospective analysis of patients undergoing VA for CEAP C2 to C4 disease in the Vascular Quality Initiative varicose veins database from 2014 to 2023. Patients who required intervention in multiple veins, had undergone prior interventions, or presented with CEAP C5 to C6 disease were excluded. The difference (Δ) in venous clinical severity score (VCSS; VCSS before minus after the procedure) was used to categorize the patients. Patients with a ΔVCSS of ≤0 were defined as having LCI after VA, and patients with ≥1 point decrease in the VCSS after VA (ΔVCSS ≥1) as having some benefit from the procedure and, therefore, “clinical improvement.” The characteristics of both groups were compared, and multivariable regression analysis was performed to identify factors independently associated with LCI. A second analysis was performed based on the VVSymQ instrument, which measures patient-reported outcomes using five specific symptoms (ie, heaviness, achiness, swelling, throbbing pain, and itching). Patients with LCI showed no improvement in any of the five symptoms, and those with clinical improvement had a decrease in severity of at least one symptom. ResultsA total of 3544 patients underwent initial treatment of CVD with a single VA. Of the 3544 patients, 2607 had VCSSs available before and after VA, and 420 (16.1%) had LCI based on the ΔVCSS. Patients with LCI were more likely to be significantly older and African American and have CEAP C2 disease compared with patients with clinical improvement. Patients with clinical improvement were more likely to have reported using compression stockings before treatment. The vein diameters were not different between the two groups. The incidence of complications was overall low, with minor differences between the two groups. However, the patients with LCI were significantly more likely to have symptoms after intervention than those with improvement. Patients with LCI were more likely to have technical failure, defined as vein recanalization. On multivariable regression, age (odds ratio [OR], 1.01; 95% confidence interval [CI], 1.00-1.02) and obesity (OR, 1.47; 95% CI, 1.09-2.00) were independently associated with LCI, as was treatment of less severe disease (CEAP C2; OR, 1.82; 95% CI, 1.30-2.56) compared with more advanced disease (C4). The lack of compression therapy before intervention was also associated with LCI (OR, 6.05; 95% CI, 4.30-8.56). The analysis based on the VVSymQ showed similar results. ConclusionsLCI after VA is associated with treating patients with a lower CEAP class (C2 vs C4) and a lack of compression therapy before intervention. Importantly, no significant association between vein size and clinical improvement was observed.

Single-session mechanical thrombectomy for iliofemoral deep vein thrombosis using a dual mechanism of action device combining basket and rotational thrombectomy

ObjectiveInterventional treatments for acute iliofemoral deep vein thrombosis (DVT) remain controversial after publication of the Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis (ATTRACT) study. Interventions have been shown to reduce post-thrombotic syndrome severity and improve quality of life in DVT patients, but have been accompanied by risk of major bleeding from thrombolytics. We describe thrombus removal using a novel combined basket-rotational thrombectomy device that minimizes the need for thrombolytics or repeat procedures. MethodsThe aim of this prospective, nonrandomized, multicenter, first-in-human study of 19 patients with acute iliofemoral DVT was to evaluate the safety and performance of the Pounce venous thrombectomy system ≤12 months after treatment. The primary performance end point was defined as procedural success through achievement of Society of Interventional Radiology (SIR) grade II lysis in treated vessels with freedom from procedural adverse events. Secondary end points included venous disease severity assessments using the Villalta scale and the Venous Clinical Severity Score, patient quality-of-life measurement using the Venous Insufficiency Epidemiological and Economic Study-Quality of Life questionnaire, and calf circumference measurements taken at baseline, 24 hours, and 1 month. ResultsThe primary end point of complete or near-complete thrombus removal (Society of Interventional Radiology grade II or III) was achieved in all patients. All study device-related safety end points were met, with no major bleeding or device-related adverse events. Of the 19 patients treated, 16 (84.2%) did not receive thrombolytics during the procedure. Post-thrombotic syndrome (Villalta scale >4) was identified in 17 of 19 patients (89.5%) at baseline, 4 of 13 patients (30.8%) available for follow-up at 6 months, and 2 of 11 patients (18.2%) at 12 months. The median Venous Clinical Severity Score decreased (P < .001) from 8.5 (interquartile range [IQR], 7-10) at baseline to 4 (IQR, 2-4) at 1 month after the procedure and was similar at 6 months (2; IQR, 2-5) and 12 months (2; IQR, 1.5-3) after the procedure. The median Venous Insufficiency Epidemiological and Economic Study-Quality of Life questionnaire score improved (P < .001) by 39 from baseline (57; IQR, 53.5-74) to 1 month (96; IQR, 86-101) after the procedure, and remained high at 6 months (99; IQR, 75-103) and 12 months (98; IQR, 94.5-100). The median calf circumference decreased (P = .089) from 39 cm (IQR, 35-47.8 cm) at baseline to 36 cm (IQR, 32.5-40.5 cm) at 24 hours after the procedure and was 34.5 cm (IQR, 33.2-38.5 cm) at 1 month. ConclusionsThe Pounce device is safe and effective for removal the of thrombus in patients with acute iliofemoral DVT. Initial results demonstrate improvements in venous disease severity and patient quality of life.

Satisfactory result of great saphenous vein endovenous laser ablation until below the knee on active venous leg ulcer: a case series

Background Active venous leg ulcer (VLU) is the most severe manifestation of chronic venous disease which not only affects patients’ health, but also decreases the quality of life, and delivers economic burdens. Treatment of superficial venous reflux with early endovenous laser ablation (EVLA) has been associated with reducing ulcer recurrence levels and promoting faster VLU healing. We reported three cases of patients with active VLU undergoing EVLA with different approaches. Case illustration Three patients came with complaint of leg ulcer, diagnosed with C6sEpAsdPr, with venous clinical severity scores (VCSS) of 15, 23, and 22 respectively. Severe great saphenous veins (GSV) reflux was found in all patients by duplex ultrasound examination. The second patient had undergone above-the-knee EVLA. All patients underwent EVLA using 1470-nano meter wavelength laser device and ELVeS radial fiber (Biolitec, Bonn, Germany). The laser energy protocol used was 6 W linear endovenous energy density (LEED) 50 J/cm for proximal until media ATK GSV ablation, 5 W LEED 40 J/cm for media ATK until proximal below-the-knee (BTK) GSV, and 2 W LEED 20 J/cm for proximal until distal BTK GSV. The third patient was also treated with EVLA for small saphenous vein severe reflux. Follow-up until 6 months post-EVLA showed significant healing of the ulcer with 14, 16, and 17 VCSS reduction consecutively without any complication. Conclusion We’ve reported three cases of patients with active VLU undergoing EVLA until BTK with significant results. The EVLA of GSV until BTK where there is still significant reflux is safe and provides satisfactory results in patients with VLU.

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

ObjectiveTo compare radiofrequency ablation (RFA) and cyanoacrylate closure (CAC) for large-diameter great saphenous vein insufficiency (GSV) between diameters of 12 and 16 mm. Material-MethodsThis study is a single-centre retrospective study. Subjects who underwent endovenous treatment with RFA (Group A) or CAC (Group B) for GSV insufficiency between June 2015 and June 2021 who were followed up for at least 2 years were included in the study. Subjects who had a 12 to 16 mm target vessel diameter and subjects with grade 3 and grade 4 reflux were included. Subjects’ demographic data (age, sex), body mass indices (BMI), clinical, aetiological, anatomic, pathophysiologic (CEAP) classification, GSV diameter, reflux grade, target vessel length, preoperative venous clinical severity score (VCSS), procedural time, postoperative 1st-day pain scores, postoperative 14th-day patient satisfaction scale and postoperative complications were noted. In follow-up, subjects were evaluated with duplex ultrasonography and VCSS at 1, 6, 12 and 24 months. ResultsIn total, 142 subjects were included (n=71 for both groups). The mean GSV diameter was 13,21±1,00 for Group A and 13,51±0,97 for Group B. The groups did not differ in terms of age, sex, BMI, CEAP classification, GSV diameter, reflux grade, target GSV length, preoperative VCSS, complications, postoperative 24-hour pain status or postoperative 14-day patient satisfaction scale (p>0.05 for all comparisons). The procedure time was significantly shorter in Group B (34,68±4,22 min for Group A vs. 22,59±4,5 min for Group B, p=0,001). In the 1-month and 6-month Duplex ultrasonography of the subjects, partial closure and patency rates in Group B were significantly higher than those in Group A (p=0.003 and p=0.025, respectively). At the 12- and 24-month evaluation, closure rates did not show a statistically significant difference between the groups (p=0.056 and p=0.090, respectively). Preoperative and 1-month VCSS measurements did not show a statistically significant difference between groups (p>0.05 for all comparisons). The 6- and 12-month 24-month VCSS measurements of Group A were significantly higher than those in Group B. (p=0.043, p=0.009 and p=0.002, respectively). ConclusionBoth RFA and CAC were found to be effective in the treatment of large-diameter GSV incompetency. The complication rates were similar between the two techniques. CAC had a shorter procedure time. Although the closure rates in the early postoperative period were better in the RFA group, long-term follow-up demonstrated similar patency rates. The functional results in the long-term follow-up were better in the RFA group.