Endovenous glue ablation for chronic venous insufficiency: A comprehensive 5-year assessment of clinical and hemodynamic outcomes.

OBJECTIVES: Chronic venous insufficiency is mainly caused by reflux, obstruction, or both. Endovenous glue ablation has become one of the widely used methods for treating reflux in recent years. Duplex ultrasonography is the most commonly used method for diagnosing and evaluating treatment. However, there is important information that plethysmographic venous hemodynamics provides, which Duplex USG cannot provide. This retrospective study aimed to evaluate the 5-year clinical, anatomical, and hemodynamic results of endovenous glue ablation in the treatment of chronic venous insufficience, accompanied by the data from the plethysmographic study. PATIENTS AND METHOD: Between January 2018 and August 2018, 133 patients with symptomatic CEAP 2-6 varicose veins with reflux of the great saphenous vein lasting longer than 0.5 seconds and a diameter of 5.5 mm in the standing great saphenous vein underwent EVGA. CEAP, VCSS, CIVIQ 20, Doppler USG, GSV diameters and insufficiency times, and hemodynamically Venous Refilling Time and Venous Half-Value Time measurements were performed before the procedure. In the same way, measurements were made at the 1st, 3rd, 6th, 12th, 24th, and 60th months of the patients who were called and came to the postoperative follow-up. RESULTS: Procedural success was 100%, and complete occlusion was observed %93 after treatment, at the 60 month. The improvement in VCSS (from 4.4 ± 1.3 to 1.7 ± 0.9), CIVIQ20 (from 8.5 ± 3.1 to 4.7 ± 2.0), VRT (from 20.3 ± 5.0 to 131.1 ± 4.0), and TH (from 2.8 ± 0.3 to 2.4 ± 0.2) was significant (p < .001 was for all). CONCLUSION: Endovenous glue ablation is a preferred method for the treatment of great saphenous vein insufficiency due to its ease of use and the comfort it provides to patients, as well as its effectiveness and safety. In particular, it can be considered an effective method for improving venous hemodynamics and relieving associated symptoms.

Identifying venous clinical severity score thresholds for Clinical-Etiology-Anatomy-Pathophysiology classifications of venous edema and higher.

OBJECTIVE: Venous Clinical Severity Score (VCSS) is a widely used standard for assessing and grading the severity of chronic venous disease (CVD). Prior research highlighted its high validity in detecting and quantifying venous disease. However, there is little, if any, known about the precise thresholds at which VCSS discriminates important stages of deep venous disease. This study sought to elucidate the diagnostic accuracy, thresholds, and correlation at which VCSS detects salient CEAP (Clinical-Etiology-Anatomy-Pathophysiology) classes in deep venous disease progression. METHODS: A registry of 840 patients who presented with chronic proximal venous outflow obstruction (PVOO) secondary to non-thrombotic iliac vein lesions from August 2011 to June 2021 was retrospectively analyzed. VCSS and CEAP classifications were used to evaluate preoperative symptoms. VCSS was compared to CEAP classes to determine the precise VCSS composite values at which the instrument was able to detect CEAP C3 and higher, C4 and higher, and C5 and higher. Receiver operative characteristic (ROC) curve and area under the curve (AUC) were used to evaluate VCSS for its ability to discriminate disease at these stages of CEAP classification. Spearman's rank coefficient was used to determine the correlation between CEAP VCSS composite as well as individual VCSS components (pain, varicose vein, edema, pigmentation, inflammation, induration, ulcer number, ulcer size, ulcer duration, compression). RESULTS: VCSS composite was able to detect venous edema (C3) and higher at a sensitivity of 68.9% and a specificity of 54.8% at an optimized threshold of 8.5 (AUC = 0.648; 95% C.I. = 0.575-0.721). To detect changes in skin and subcutaneous tissue from CVD (C4) and higher, an optimal threshold of 11.5 was found with a sensitivity of 51.7% and specificity of 76.5% (AUC = 0.694; 95% C.I. = 0.656-0.731). Healed venous ulcer (C4) and higher was detectable at an optimized threshold of 13.5 at a sensitivity of 67.7% and a specificity of 88.9% (AUC = 0.819; 95% C.I. = 0.766-0.873). The correlation between VCSS composites and CEAP was weak (ρ = 0.372; p < .001). Attributes of VCSS that reflect more severe venous disease correlated more closely with CEAP classes, namely pigmentation (ρ = 0.444; p < .001), inflammation (ρ = 0.348; p < .001), induration (ρ = 0.352; p < .001), number of active ulcers (ρ = 0.497; p < .001), active ulcer size (ρ = 0.485; p < .001), and ulcer duration (ρ = 0.497; p < .001). The correlation between CEAP class and the other four components of VCSS were not statistically significant. CONCLUSION: VCSS composite thresholds of 8.5, 11.5, and 13.5 are threshold values for detecting CEAP classification C3 and higher, C4 and higher, and C5 and higher, respectively. Consistent with prior work, VCSS appears to have a better ability to discriminate CVD at more severe CEAP classifications. In this registry, the correlation between VCSS and CEAP was found to be weak while components of VCSS that suggest more advanced disease exhibited the strongest correlation with CEAP.

[Method of determining disease severity in women with pelvic varicose veins]. / Sposob opredeleniia tiazhesti zabolevaniia u patsientok s varikoznoi bolezn'iu taza.

BACKGROUND: Using assessment scales in clinical and research practice is one of fundamental reference methods of evaluation in human pathological states. Pelvic vein varicosity is an independent nosological entity within the framework of chronic vein diseases. Currently, the clinical methods of assessment in the aspect of a patient-oriented approach in this type of disease are largely understudied and still not duly defined. AIM: The study was aimed at analyzing clinical outcomes of surgical treatment in the form of resection of the ovarian vein in female patients with pelvic varicose veins, based on the developed specialized scale of clinical assessment of disease severity. PATIENTS AND METHODS: We carried out an open prospective study of efficacy of resection of the ovarian vein in 37 women with pelvic varicose veins. The main criterion for assessment was a clinical method of determining manifestations of the disease by means of the Pelvic Venous Clinical Severity Score. RESULTS: According to the Pelvic Venous Clinical Severity Score, improvement of the condition was observed in 36 (97.3%) operated female patients and 1 (2.7%) woman turned out to have negative dynamics. The median of the composite score of the severity scale decreased form 11.78±5.06 points to 5.22±3.19 (p<0.05). The total positive gradient of the score amounted to 6.57±3 .65 points. A significant decrease in manifestations of severity was observed for 9 of the 10 clinical descriptors of the disease. CONCLUSION: The use of the suggested scale in practical assessment of the results made it possible to prove high efficacy of resection of the ovarian vein in women with pelvic varicose veins in the form of decreased intensity of the disease's symptomatology. The VCSS is an easy-to-fill-in tool, taking up little time, ensuring no influence of the physician's personality on the answers, presenting quantitative expression of therapeutic results.

Occlusion rate, venous symptoms and patient satisfaction after radiofrequency-induced thermotherapy (RFITT®): are there differences between the great and the small saphenous veins?

BACKGROUND: Previous studies on the therapy of insufficient saphenous veins mainly compare different treatment methods. Only a few investigate differences of a specific treatment option between the great (GSV) and the small saphenous vein (SSV). The aim of this study was to evaluate the efficacy, clinical improvement and patient satisfaction after radiofrequency-induced thermotherapy (RFITT®) with regard to the treated vein. PATIENTS AND METHODS: We included 65 patients (40 women, 25 men; mean age 54.75 years) who were treated with RFITT® for incompetent saphenous veins (n = 83: 62 GSV, 21 SSV). Occlusion rates were determined by duplex-sonography. Additionally, we performed a prospective analysis of venous symptoms and signs by means of a standardized questionnaire and of patient satisfaction using a semi-quantitative rating (1 = very good, 6 = insufficient). RESULTS: The GSV group showed a significantly greater reduction of venous symptoms in comparison to the SSV group (p = 0.005) despite no significant differences in long term occlusion rates (mean time after operation: 22 months) of 90 % in the GSV group and 81.8 % in the SSV group (p = 0.598). Following the procedure, detailed analysis revealed significantly more swelling (p = 0.022), feeling of heavy legs (p = 0.002) and nightly calf cramps (p = 0.001) in the SSV group. Additionally, RFITT® led to a significant improvement in patient satisfaction in the GSV group (from 1.93 at day 1 - 3 to 1.41 after 6 - 12 months, p = 0.009) but not in the SSV group (from 2.29 to 2.07, p = 0.43). CONCLUSIONS: With regard to the improvement of venous symptoms and patient satisfaction, the benefit of RFITT® is greater for patients with incompetent GSV compared to those with incompetent SSV.

Clinical Efficiency and Safety of Radiofrequency Ablation for Treating Incompetent Great Saphenous Veins in Aged Patients.

INTRODUCTION: Few studies have focused on the safety and efficacy of radiofrequency ablation (RFA) in treating incompetent great saphenous vein (GSV) in aged population. This study was designed to investigate the clinical efficacy of RFA in treating incompetent GSV in the aged patients. METHODS: In this retrospective study, we included 138 consecutive patients (involving 194 limbs) with a mean age of 63.0 years who underwent RFA and microphlebectomy or sclerotherapy due to symptomatic incompetent GSV with saphenofemoral junction reflux. Based on their ages, patients were classified into young group and aged group. Then we compared the preoperative and postoperative Clinical, Etiology, Anatomic, Pathophysiology (CEAP) classification, venous clinical severity score (VCSS) and chronic venous insufficiency questionnaire 14 (CIVIQ-14) score between the 2 groups. RESULTS: In both the young and aged groups, patients underwent RFA showed significant decrease in the CEAP and VCSS at month 1, 3 and 6 compared with immediately after RFA (month 0) (all P < .001). In addition, in both groups, significant increase was seen in the CIVIQ-14 score at month 1, 3 and 6 compared with month 0 (all P < .001). Compared with the young group, the post-RFA CEAP, VCSS and CIVIQ-14 scores showed no statistical differences in the aged group at the designated time points, respectively (all P > .05). CONCLUSIONS: RFA of GSV was effective for treating GSV in the aged population, which improved the CEAP, VCSS and CIVIQ-14.

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

OBJECTIVES: It is unclear whether reflux time independently correlates with severity of symptoms in patients with great saphenous vein reflux. METHODS: Eighty patients (mean age 64+/-12.7 years, 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. RESULTS: 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). CONCLUSION: This prospective study did not demonstrate a correlation between reflux time and VCSS.

Personal factors and postoperative changes in the revised Venous Clinical Severity Score of varicose veins.

OBJECTIVE: The primary aim of this observational study was to measure the Revised Venous Clinical Severity Score (rVCSS) in patients treated for varicose veins (VVs) owing to saphenous vein reflux. Treatment was by endovenous thermal ablation (ETA) alone or by ETA and ambulatory phlebectomy (AP). A secondary aim was to determine whether participant characteristics and treatment methods affect rVCSS and how the score changes over time. METHODS: We enrolled 44 men with 55 treated legs and 79 women with 105 treated legs (bilateral cases, 23.1%). Patients were treated and evaluated from April 2016 to September 2020. All legs were treated by ETA, and participants were divided into three groups depending on AP treatment: E0 group (40 legs), no AP; EP1 group (101 legs), AP performed only at one site above or below the knee; and EP2 group (19 legs), AP performed both above and below the knee. The rVCSS was measured in the treated legs up to five times: preoperatively and on postoperative days (POD) 1, 7, 90, and 180. RESULTS: The mean age was 67.5 ± 11.24 years (range, 32-87 years). No significant differences in medical history or demographics or lifestyle were found between the groups. The mean preoperative rVCSS also was not different between groups (E0, 4.4 ± 0.3 points; EP1, 4.6 ± 0.2 points; and EP2, 5.4 ± 0.4 points; P = .14). Factors associated with less improvement in the rVCSS were a high body mass index (P = .046) and the occurrence of endovenous heat-induced thrombosis (P = .001), and factors associated with more improvement in the rVCSS were hypertension (P = .026), hyperuricemia (P = .022), and wearing compression stockings (P = .013). The rVCSS decreased strongly at POD1 and then gradually decreased until POD180. It was not significantly different between EP1 and EP2, but it improved significantly earlier in these two groups than in the E0 group. The rVCSS at POD180 was as follows: E0, 1.633 ± 0.233 points; EP1, 1.003 ± 0.148 points; and EP2, 0.982 ± 0.322 points. CONCLUSIONS: Factors associated with less improvement in the rVCSS are a high body mass index and the occurrence of endovenous heat-induced thrombosis. Hypertension, hyperuricemia, and wearing compression stockings are associated with greater improvements in the rVCSS. Patients treated with ETA and AP tend to improve earlier than patients treated by ETA alone, but all patients improve to nearly the same level within 6 months.

Venous Clinical Severity Score has a suboptimal ability to detect improvement after iliac vein stenting across three years of follow-up.

OBJECTIVE: Venous Clinical Severity Score (VCSS) is currently the gold standard for measuring the severity of chronic venous disease, especially in patients with chronic proximal venous outflow obstruction (PVOO) secondary to non-thrombotic iliac vein lesions. Change in VCSS composite scores is often used to quantitatively measure the degree of clinical improvement after venous interventions. This study sought to assess the discriminative ability, sensitivity, and specificity of change in VCSS composites for detecting clinical improvement after iliac venous stenting. METHODS: A registry of 433 patients who underwent iliofemoral vein stenting for chronic PVOO from August 2011 to June 2021 was retrospectively analyzed. These 433 patients had follow-up exceeding 1 year after the index procedure. Change in VCSS composite and clinical assessment scores (CAS) were used to quantify improvement after venous interventions. CAS is an assessment by the operating surgeon based on patient self-reporting to assess the degree of improvement at each clinic visit compared with before the index procedure longitudinally across the treatment course of a patient. Patients are rated as worse (-1), no change (0), mildly improved (+1), significantly improved (+2), and asymptomatic/complete resolution (+3) at every follow-up visit as compared with their disease severity prior to the procedure based on patient self-report. This study defined improvement as CAS >0 and no improvement as CAS ≤0. VCSS was then compared with CAS. Receiver operative characteristic curve and area under the curve (AUC) were used to evaluate change in VCSS composite for its ability to discriminate between improvement and no improvement after intervention at each year of follow-up. RESULTS: Change in VCSS was a suboptimal measure for discriminating clinical improvement (1-year AUC, 0.764; 2-year AUC, 0.753; 3-year AUC, 0.715). Across all three time points, a change in VCSS threshold of +2.5 maximized the sensitivity and specificity of the instrument to detect clinical improvement. At 1 year, change in VCSS at this threshold was able to detect clinical improvement at a sensitivity of 74.9% and specificity of 70.0%. At 2 years, VCSS change had a sensitivity of 70.7% and specificity of 66.7%. At 3 years of follow-up, VCSS change had a sensitivity of 76.2% and specificity of 58.1%. CONCLUSIONS: Across 3 years, change in VCSS exhibited a suboptimal ability to detect clinical improvement in patients undergoing iliac vein stenting for chronic PVOO with considerable sensitivity but variable specificity at a threshold of 2.5.

Non-randomized comparative study of three methods for great saphenous vein ablation associated with mini-phlebectomy; 48 months clinical and sonographic outcome.

Background: Varicose veins are one of the earliest clinical features of superficial venous insufficiency (SVI) of the lower limbs that affects around 20-40% of the population with a lot of burden on patients' quality of life (QoL) and health systems if left untreated. They are defined as subcutaneous veins in the lower extremities which are dilated to ≥3 mm in diameter in the upright position and retrograde flow of >0.5 s in duration. (VVs) could occur in the great saphenous vein (GSV) or small saphenous vein (SSV) and/or in any of their tributaries. Methods: A prospective non-randomized comparative study for three methods of treatment of varicose veins was conducted. All symptomatic varicose veins with Clinical, Etiological, Anatomical, Pathophysiological (CEAP) Clinical classes of 2 or greater and demonstrated venous reflux with a duration of 0.5 s or greater on duplex ultrasound imaging GSV larger than 10 mm in diameter by duplex ultrasound were included. Results: A total of 150 patients with 183 legs in all three groups are treated. The mean age of the patients in all groups was comparable (37.32) years, and a total of 87% were women. Demographic and preoperative clinical features, presentations, and anatomic characteristics were comparable in all groups. Disfigurement was the main presenting complaint in all. All postoperative complications were significantly higher in the group of surgery over 48 months of follow up the degree of satisfaction measured by VCSS score was highest among the RFA group followed by the EVLA group. Conclusion: The results of our study suggest that the long-term results of endovenous thermal ablation methods (EVLA, RFA) are superior to open surgery for the management of varicose veins, with the RFA group showing better results in terms of improvement in QoL based on VCSS compared to the EVLA group.

Summary of diagnostic and characteristic parameters of C0 to C2 patients based on the CEAP2020 classification.

OBJECTIVES: Hemodynamic changes in C0 to C2 according to the clinical/etiological/anatomical/pathophysiological classification have not been analyzed extensively. We intend to investigate the characteristics of early stage venous disease using venous clinical severity score (VCSS), heaviness/ache/swelling/throbbing/itching (HASTI) score and duplex ultrasound (DUS) derived parameters. METHODS: From Aug. 2020 to Jul. 2021, consecutive patients were categorized according to the clinical/etiological/anatomical/pathophysiological 2020 classification. The vein diameter (mm), reflux time (s), cross-sectional area (cm2), peak and mean reflux velocity (cm/s), and total reflux volume (mL) were documented in the superficial system and deep system. VCSS and HASTI scores were assessed and DUS parameters were analyzed. A P value of less than .05 was considered statistically significant. RESULTS: We studied 257 consecutive patients (142 female) with 371 limbs. The mean age was 50.96 ± 13.27 years (range, 20-81 years; median, 53 years) with an average body mass index of 24.03 ± 2.96 kg/m2 (range, 17.00-33.06 kg/m2; median, 23.67 kg/m2). The proportion of clinical (C) category was as followed: 47 C0S (12.67%), 45 C1 (12.13%), and 279 C2 (75.20%). There were 42.6% of C0 and 62.2% of C1 associated with some form of venous reflux, Pr (pathology [P]-reflux). Reflux of the great saphenous vein above the knee (GSVa) was the most commonly affected vein segment from C0-2. C1 differed from C0 only by age and severity scores with a cut-off value of 1 for both VCSS and HASTI. Larger saphenous veins diameter (GSV and small saphenous vein) were seen in Pr (P-reflux) than Pn (P-none) of C0 cases. Larger deep vein diameters (common femoral vein, femoral vein, and popliteal vein) were evident in Pr versus Pn of C1 cases. In C2, the popliteal vein, saphenofemoral junction, and GSVa were dilated in Pr cases. CONCLUSIONS: Both HASTI and VCSS were discriminative from C0 to C2. C0 differed from C1 by age and severity scores as DUS characteristics were not significantly different between the two groups. Vessel diameter played a discriminative role in distinguishing Pn versus Pr cases in each C0-2 category. GSVa was the most frequent reflux segment irrespective of reflux types.

Performance of two clinical scales to assess quality of life in patients with post-thrombotic syndrome.

OBJECTIVE: We directly compared the Villalta scale and the Venous Clinical Severity Score (VCSS) to determine which of the two measures would be better at capturing clinically important cases of post-thrombotic syndrome (PTS) and PTS severity compared with patient-reported quality of life (QOL) scores. METHODS: We performed a secondary analysis of the ATTRACT (acute venous thrombosis: thrombus removal with adjunctive catheter-directed thrombolysis) trial study population. We calculated the correlations of the Villalta scores and VCSSs with QOL scores (short-form 36-item health survey [SF-36] physical component summary [PCS] and mental component summary [MCS]; and VEINES [venous insufficiency epidemiological and economic study]-QOL/symptom [VEINES-QOL/Sym] questionnaire) at each study visit (6, 12, 18, and 24 months of follow-up). The correlation of the random intercept (mean scores) and random slope (rate of change of the scores) among the Villalta scores, VCSS, and VEINES-QOL/Sym scores was assessed using a multivariate longitudinal model. RESULTS: The median correlation between Villalta scores and VCSSs was 0.72. The median correlation between the Villalta scores and VEINES-QOL and VEINES-Sym scores at all follow-up visits was -0.68 and -0.71, respectively. The median correlation between the Villalta scores and SF-36 PCS and MCS scores was -0.51 and -0.31, respectively. For the VCSSs, the median correlation with the VEINES-QOL and VEINES-Sym scores at all follow-up visits was -0.39 and -0.41, respectively. The median correlation between the VCSSs and SF-36 PCS and MCS scores was -0.32 and -0.13, respectively. The correlations between the random effects in the multivariate longitudinal models showed a similar pattern. The effect of covariate adjustment by age, sex, and body mass index was minor. CONCLUSIONS: The Villalta scores and VCSSs correlated strongly. The Villalta scale showed a substantially greater correlation with venous disease-specific and general QOL scores compared with the correlation with the VCSS. Our findings suggest that when a single scale is used to assess for clinically meaningful PTS, the Villalta scale will better capture the effects of PTS on patient-reported QOL.

Endovenous laser ablation of incompetent great saphenous veins with 1470-nm laser using bare tip and radial fibers results in similar short-term outcomes.

OBJECTIVE: The common side effects of endovenous laser ablation (EVLA) are pain and discomfort in the treated leg. We compared the pain and outcomes after EVLA using a 1470-nm laser with bare tip or radial fibers in the treatment of incompetent great saphenous veins (GSVs). METHODS: A total of 86 patients with primary varicose veins of the GSV were randomized to treatment using a 1470-nm laser and bare fiber (BF; n = 43) or radial fiber (RF; n = 43) during a 12-month period from January to December 2019. Patients were assessed clinically and using venous Doppler ultrasonography at 24 hours, 1 week, and 1 month. The periprocedural parameters and short-term outcomes of pain after the procedure, improvement in the Venous Clinical Severity Score (VCSS), and vein occlusion at 1 month were compared and analyzed. RESULTS: The linear endovenous energy density (65.7 J/cm vs 65.2 J/cm), tumescent local anesthetic solution used (627.4 mL vs 661.4 mL), treated GSV length, and number of hook phlebectomies were similar in both groups. The pain score at 8 hours (2.77 vs 2.70) and 1 week (2.81 vs 2.74) were similar in the BF and RF groups, respectively. The improvement in the VCSS was significant in both groups and was slightly better in the BF group, although the difference was not statistically significant. Both fiber types had 100% efficacy in terms of closure of the treated vein at 1 month. CONCLUSIONS: EVLA using a 1470-nm laser with a BF had similar outcomes in the short term compared with a RF of the same wavelength. Both fibers were associated with significant improvement in the VCSS at 1 month.

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

Introduction Chronic 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. Methods A 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. Results A 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). Conclusion From 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.

Randomized clinical trial of radiofrequency-induced thermotherapy combined with transilluminated powered phlebectomy versus high ligation and stripping for the treatment of lower limb varicose veins.

OBJECTIVE: The objective of this study was to evaluate the efficacy and safety of radiofrequency-induced thermotherapy (RFiTT) combined with transilluminated powered phlebectomy (TIPP) in the treatment of lower limb varicose veins (VVs) in comparison with high ligation and stripping (HLS) combined with TIPP. METHODS: The patients with lower limb VVs were randomly assigned to RFiTT combined with TIPP or HLS combined with TIPP. The primary end point was total closure rate of the great saphenous vein at 12 months. Secondary end points included Venous Clinical Severity Score and 14-item Chronic Venous Insufficiency Questionnaire score changes at 12 months and perioperative complications. RESULTS: The total closure rate of the great saphenous vein at 12 months was slightly lower in the RFiTT group (90.9% [90/99]) than in the HLS group (97.0% [98/101]) but not statistically significant (χ2 = 0.068; P = .08). Operation time, intraoperative blood loss, duration in hospital, duration in bed, and resumption of activities were statistically significantly better with RFiTT than with HLS. There were no significant differences between the groups in deep venous thrombosis, phlebitis, hematomas, pain, and infection. However, skin pigmentation and paresthesia were statistically significantly better with RFiTT than with HLS. At 12 months, both groups showed similar improvement from baseline in Venous Clinical Severity Score (1.28 ± 0.57 in the RFiTT group vs 1.33 ± 0.61 in the HLS group) and 14-item Chronic Venous Insufficiency Questionnaire score (67.32 ± 1.29 in the RFiTT group vs 67.45 ± 1.32 in the HLS group); however, neither group was superior to the other. CONCLUSIONS: RFiTT combined with TIPP is an effective treatment method for lower limb VVs and had a more satisfactory clinical outcome in surgical data, skin pigmentation, and paresthesia than HLS at the 12-month follow-up.

Clinical Efficacy of Conservative Treatment with Micronized Purified Flavonoid Fraction in Female Patients with Pelvic Congestion Syndrome.

INTRODUCTION: Pelvic congestion syndrome (PCS) may be effectively managed with conservative treatment in certain patients. Treatment with venoactive drugs is common, but supportive data are limited. This study evaluated the clinical efficacy of micronized purified flavonoid fraction (MPFF) in women with PCS. METHODS: In a single-blind, placebo-controlled study, women with duplex ultrasound diagnosis of pelvic varicose veins (PVV) and PCS were randomized to MPFF 1000 mg once daily or placebo for 2 months. Clinical manifestations of PCS were evaluated at baseline and end of treatment (M2) using three assessment tools: disease-specific quality of life (QoL) Pelvic Varicose Vein Questionnaire (PVVQ), Pelvic Venous Clinical Severity Score (PVCSS), and the Visual Analog Scale (VAS) for the main symptoms of the disease. RESULTS: A total of 83 women were included, 42 received MPFF and 41 received placebo. In the MPFF group, the mean global PVVQ QoL index decreased significantly from 45.1 ± 14.7 at baseline to 36.6 ± 10.6 at M2 (mean change: 8.2 ± 10.4); no significant change was observed in the control group (mean change: - 0.3 ± 4.0). The between-group difference was statistically significant (P < 0.001). Compared with control, significant improvements were observed in all four QoL parameters (pain, physical, social, psychological, all P < 0.001). The mean PVCSS summary score decreased significantly by 3.4 ± 3.4 in the MPFF group (P < 0.001) compared with a non-significant change of - 0.2 ± 1.6 in the control group (between-group difference P < 0.001). In the MPFF group, improvements were statistically significant for 6 out of 10 clinical manifestations of PCS measured using the PVCSS, including pain (mean change from baseline: 0.5 ± 0.7) heaviness (0.4 ± 0.7), discomfort (0.6 ± 0.7) and tenderness (0.3 ± 0.5). No significant improvements were observed in the control group. When measured by VAS, between-group differences were statistically significant for the overall summary score (P < 0.001) and for 8 out of 10 PCS symptoms, including: pain (mean MPFF change from baseline: 2.0 ± 2.2), heaviness (1.3 ± 2.1), discomfort (1.5 ± 2.0), tenderness (0.9 ± 1.9), and edema (1.3 ± 2.1). CONCLUSION: In women with PCS, conservative treatment with MPFF was associated with improved QoL and reduced symptom severity. MPFF may be considered an effective and safe treatment option for PCS in routine clinical practice.

Association between vein diameters, reflux characteristics, and clinical severity in patients with chronic venous insufficiency in Northwest China.

OBJECTIVE: Our goal was to summarize the relationship between vein diameters, reflux characteristics, and clinical severity in consecutive patients with chronic venous insufficiency (CVI) in Northwest China. METHODS: We evaluated 531 consecutive patients with CVI (249 women) who presented to the Department of Ultrasound of Xijing Hospital from September 2017 to July 2019. Reflux times and the mean diameters of the great saphenous, the small saphenous, and the calf perforator veins based on duplex ultrasound scans obtained in the standing position were recorded. Venous-specific assessment tools-the Heaviness, Achiness, Swelling, Throbbing, Itching (HASTI) score, the Venous Clinical Severity Score (VCSS), and the Clinical, Etiological, Anatomical, Pathophysiological (CEAP) class-were analyzed. Regression analysis was used to investigate the relationship between the clinical scores, vein diameters, and reflux times. A P value of less than .05 was considered statistically significant. RESULTS: We analyzed 531 consecutive patients with 728 limbs. The mean age was 55.24 ± 11.38 years; the mean body mass index (BMI) was 24.75 ± 3.49 kg/m2. Three hundred thirty-four patients (62.9%) presented with unilateral limb findings and 197 (37.1%), with bilateral limb involvement. No significant changes were noted in age and BMI across CEAP classes (F = 2.322 and F = 3.917, respectively; P > .05 for both). Both the HASTI score (r2 = 0.8741; P < .001) and the VCSS (r2 = 0.9257; P < .001) correlated with the CEAP class. The HASTI score strongly correlated with the mean diameters of the great saphenous and small saphenous veins (r2 = 0.9252, r2 = 0.6304, respectively; P < .001 for both) similarly to VCSS (r2 = 0.9396, r2 = 0.7195, respectively; P < .001 for both). The HASTI score and VCSS correlated equally with the mean diameters of the calf perforator veins (r = 0.7773 and r = 0.7781, respectively; P < .001 for both). In those with C6, both great saphenous vein (F = 4.608; P < .001) and small saphenous vein reflux times (F = 14.97; P < .001) were significantly higher than those in C1. Both the HASTI score and VCSS strongly associated with the reflux times of the great saphenous (r2 = 0.7706 and r2 = 0.8181, respectively; P < .001 for both) and small saphenous veins (r2 = 0.6470 and r2 = 0.7865, respectively; P < .001 for both). CONCLUSIONS: This analysis is one of the few epidemiologic studies of patients with CVI in Northwest China. Age and BMI did not correlate with CEAP class. Both the HASTI score and VCSS correlated strongly with the CEAP classification; vein diameters and reflux time in both the great saphenous vein and the small saphenous vein, indicating the validity of these outcome tools to venous hemodynamics and to CVI in general.

Clinical response to combination therapy in the treatment of varicose veins.

BACKGROUND: Varicose vein ablation procedures are being performed with increasing frequency; however, there is a lack of consensus on the relative efficacy of combined treatment of saphenous incompetence and symptomatic varicosities vs a staged approach. In this study, we examined the impact on symptom severity when a procedure to eliminate varicosities was added to standard endovenous saphenous ablation. METHODS: The Varicose Vein Module of the American Venous Registry was established by the American Venous Forum in 2010 and collected data from 48 physicians during a 5-year period. We analyzed patients with Clinical, Etiology, Anatomy, and Pathophysiology (CEAP) C2 disease severity and without prior treatment. Combination therapy (CT) was defined as the use of a procedure directly addressing visible varicosities (stab phlebectomy or injection of sclerosant into varicosity) combined with endovenous saphenous vein ablation. Unimodal therapy (UT) was defined as endovenous saphenous vein ablation alone (radiofrequency or laser). Change in symptom severity was assessed by the pretreatment and 1-month follow-up Venous Clinical Severity Score (VCSS). Univariate statistics compared the CT and UT groups, with P values obtained using the Student t-test or Pearson χ2 test as appropriate. A multivariable linear regression model assessed the association of CT with the change in VCSS. RESULTS: There were 526 patients included for analysis (UT, 97; CT, 429). UT patients were more likely to be white (85.6% vs 62.7%; P < .001), had a higher initial VCSS (6.71 vs 5.07; P < .001), and were assessed at an earlier follow-up visit (28.9 days postoperatively vs 33.3 days; P < .001). Compared with UT, CT was associated with an additional half-point reduction in VCSS on univariate analysis (-3.71 points for UT vs -4.20 for CT; P = .13). After treatment, CT was associated with significantly lower scores on the pain and varicose vein components of the VCSS (pain: 0.31 for UT vs 0.07 for CT [P = .0008]; varicose veins: 0.47 for UT vs 0.03 for CT [P < .001]). On the multivariable model, after adjustment for white race, day of follow-up, age group, and initial VCSS, CT was associated with an additional reduction in VCSS of 1.52 points compared with UT (P = .002). CONCLUSIONS: Invasive treatment of C2 chronic venous insufficiency improves symptom severity. Whereas treatment of venous reflux is essential to address venous symptoms, our results suggest that patients further benefit from additional direct treatment of varicosities. For selected patients, CT may present a more effective treatment strategy than saphenous ablation alone.

Correlation of Venous Clinical Severity Score and Venous Disability Score with Dermatology Life Quality Index in Chronic Venous Insufficiency.

BACKGROUND: Chronic venous insufficiency (CVI) is an underestimated public health problem involving the lower limbs. It exerts a significant impact on patient's quality of life (QoL). The severity of the disease was measured by venous clinical severity score (VCSS) and venous disability score (VDS). AIMS: The aim of the study was to evaluate VCSS, VDS, and dermatology life quality index (DLQI) among the patients of CVI and to evaluate the correlation among DLQI with VCSS, VDS, and leg ulcer. MATERIALS AND METHODS: In this institution-based cross-sectional study, clinically and sonographically confirmed cases of CVI were included. Clinical severity of the disease and disability were assessed by using VCSS and VDS, respectively. QoL was assessed by a validated DLQI questionnaire. Correlation between DLQI with VCSS and VDS was analyzed. The association between DLQI with different characteristics of the ulcer was also evaluated. RESULTS: Mean VCSS, VDS, and DLQI in the study population were 11 ± 4.96, 1.47 ± 0.67, and 6.94 ± 3.87, respectively. Both VCSS and VDS had a strong positive correlation with DLQI. The number of active ulcers, size of the ulcer, and duration of the ulcer had a strong positive correlation, whereas the age of onset of the disease had a negative correlation and duration of the disease had poor correlation with DLQI. Pain (P = 0.03) and edema (P = 0.04) had significant association with VDS. CONCLUSION: VCSS and VDS are important tools for measuring severity and disability in CVI, respectively. CVI had a strong impact on patients QoL more than it was thought hitherto.

Great saphenous vein sparing versus stripping in Trendelenburg operation for primary varicose veins: a prospective study.

<b>Objective:</b> The purpose of this study was to compare the outcome of the great saphenous vein (GSV) sparing versus stripping during Trendelenburg operation for varicose veins. <br><b>Methods:</b> This was a prospective randomized study of primary varicose vein patients who underwent Trendelenburg operation. Data of patients operated on over a period of 16 months was collected, including: below knee GSV diameter by Duplex Ultrasound and revised venous clinical severity score (rVCSS), calculated preoperatively and postoperatively at 2^nd, 4^th, and 8^th week. <br><b>Results:</b> A total of 36 patients undergoing Trendelenburg operation were included in the study. Nineteen patients underwent GSV sparing while 17 underwent stripping of GSV till just below the knee after juxtafemoral flush ligation of the great saphenous vein. There was a significant decrease in the below-knee GSV diameter (19% after 2 months) and rVCSS (60.8%) in the sparing group. The stripping group also showed an almost similar decrease in below-knee GSV diameter (19.6% after 2 months) and rVCSS (66.3%). However, no significant difference was found between the two groups in terms of change in GSV diameter (P = 0.467) and rVCSS (P = 0.781). <br><b>Conclusion:</b> Trendelenburg procedure with sparing of GSV can be done routinely for operative management of varicose veins, where surgery is needed.

Effectiveness of Endovenous Radiofrequency Ablation for Elderly Patients with Varicose Veins of Lower Extremities.

Objective: The purpose of this study was to evaluate safety and effectiveness of endovenous radiofrequency ablation (RFA) for elderly patients. Materials and Methods: We enrolled 140 patients (194 limbs) who underwent RFA for varicose veins of lower extremities. Patients were divided into two groups; elderly patients (more than 75 years old, E-group, n=36) and young patients (under 75 years old, Y-group, n=104), and perioperative data were analyzed and compared between two groups. Results: In E-group, there were more than patients with hypertension, ischemic heart disease, malignant tumor, and cerebrovascular disease. A partial recanalization was observed in only one limb (0.6%) in Y-group. Endovenous heat induced thrombosis (EHIT) was identified four limbs (2.8%) in Y-group and two limbs (4.1%) in E-group. All EHITs were class 1 by Kabnick classification, and they disappeared within one month after interventions, without antithrombotic therapy. No other major complications were observed. There were no significantly differences for preoperative mean venous clinical severity scores (VCSS) (Y : E=4.84 : 4.47) and postoperative VCSS (Y : E=1.16 : 1.19, 0.35 : 0.58, 0.15 : 0.06, 0.05 : 0.06 at 1, 3, 6, 12 months after) in both groups. Conclusion: RFA for elderly patients is a safe and effective strategy for varicose veins of lower extremities.