CIVIQ-20 Score Research Articles

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.

Vitis Vinifera Seed Extract Versus Micronized Purified Flavonoid Fraction for Patients with Chronic Venous Disease: A Randomized Noninferiority Trial

Venoactive drugs (VADs) based on Vitis vinifera extract are widely used in Korea. However, studies on the clinical effects and head-to-head comparisons with other groups of VADs are limited. This trial aimed to evaluate whether Vitis vinifera seed extract was noninferior to the micronized purified flavonoid fraction (MPFF) in relieving venous symptoms and improving quality of life in patients with chronic venous disease. In this double-blind prospective randomized trial, patients from 13 hospitals, who were diagnosed with venous incompetence by duplex ultrasound and classified as clinical class 1, 2, or 3 in the Clinical, Etiological, Anatomical, and Pathophysiological classifications were enrolled. The primary outcome was the change in the Chronic Venous Disease Quality of Life Questionnaire (CIVIQ-20) score at 8weeks from baseline. Secondary outcomes included changes in the Aberdeen Varicose Vein Questionnaire, visual analog scale, and Venous Clinical Severity Score at 4 and 8weeks from baseline. Moreover, the change in leg circumferences was measured at 8weeks and compared to baseline. In total, 303 patients were enrolled and randomly assigned to receive either Vitis vinifera seed extract (n=154) or MPFF (n=149). The CIVIQ-20 scores at 8weeks were significantly reduced compared to those at baseline in both groups. No significant intergroup difference in the change of CIVIQ-20 at 8weeks from baseline was observed (-8.31±14.63 vs. -10.35±14.38, P=0.29, 95% confidence interval -1.65 to 5.72). The lower limit of the 95% confidence interval was within the predefined noninferiority margin of 6.9. Furthermore, the Aberdeen Varicose Vein Questionnaire, visual analog scale, and Venous Clinical Severity Score scores significantly decreased at 4 and 8weeks after randomization compared with baseline in both groups. No significant differences were observed in the reduction of each score between groups. The calf circumference measured at 8weeks was significantly reduced compared to that at baseline in patients receiving Vitis vinifera seed extract. Vitis vinifera seed extract was noninferior to MPFF in relieving venous symptoms and improving the quality of life in patients with chronic venous disease.

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.

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

ObjectiveVenous stenting has become the first line of treatment for patients with symptomatic chronic iliofemoral venous obstruction (CIVO) in whom conservative therapy has failed. Intravascular ultrasound (IVUS) interrogation with the use of normal minimal luminal diameters or areas has become the standard to confirm the diagnosis and determine the adequacy of stenting. However, the aspect ratio (ratio between the maximal and minimal luminal diameters) has also been put forth as a possible metric for determining stent adequacy. This study explores the utility of the native iliac vein and stent aspect ratios in determining the initial presentation and outcomes after stenting. MethodsA retrospective analysis of contemporaneously entered data from patients who underwent stenting for quality of life (QoL)-impairing clinical manifestations of CIVO for whom conservative therapy had failed formed the study cohort. The limbs were grouped into three at the time of intervention using the 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, those with a ratio of ≥2. The characteristics appraised initially and after stenting included the venous clinical severity score, grade of swelling (GOS), visual analog scale (VAS) for pain score, and the CIVIQ-20 QoL score. Analysis of variance and paired and unpaired t tests were used for comparison of clinical and QoL variables, and Kaplan-Meier analysis was used to evaluate stent patency, with the log-rank test used to discriminate between different curves. ResultsThere 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 body mass index was 36 kg/m2. There were 54 (23%), 64 (27%), and 118 (50%) limbs in groups I, II, and III, respectively. The median follow-up was 65 months. For the entire cohort, after stenting, the venous clinical severity score improved from 6 to 4 (P < .0001) at 3 months and remained at 4 at 6 months (P < .0001), 12 months (P < .0001), and 24 months (P < .0001). The GOS for the entire cohort improved from 3 to 1 (P < .0001) at 3 months and remained at 1 at 6 months (P < .0001), 12 months (P < .0001), and 24 months (P < .0001). The VAS for pain score for the entire cohort improved from 7 to 0 (P < .0001) at 3 months, increased to 2 (P < .0001) at 6 months, and remained at 2 (P < .0001) at 12 months. At 24 months, the VAS for pain score worsened to 3 (P < .0001). For the entire cohort, the CIVIQ-20 score improved from 62 to 40 (P < .0001). There was no difference in the GOS, VAS for pain score, or CIVIQ-20 score between the groups at baseline or at 6, 12, and 24 months after intervention. At 60 months, the primary stent patency was 89% for group I, 80% for group II, and 75% for group III (P = .85). The primary assisted stent patency was 100% for group I, 98% for group II, and 98% for group III (P = .5). Secondary patency was 100% for groups II and III (P > .5). Reintervention was pursued for QoL-impairing clinical manifestations in 53 limbs (22%) without a significant difference between the three groups (P = .13). ConclusionsThe native vein aspect ratio does not appear to determine the initial clinical presentation or QoL or impact the clinical or QoL outcomes after stenting for CIVO. Following stenting, no patient had an aspect ratio >2, with 97% of patients having an aspect ratio ≤1.4 and the remaining 3% having an aspect ratio of 1.41 to 1.99. IVUS-determined minimal cross-sectional luminal area and not the aspect ratios should be used for confirmation of the diagnosis of CIVO and to assess the adequacy of stenting.

Quality of Life After Early Clot Removal for Acute Iliofemoral Deep Vein Thrombosis

To evaluate patient reported outcome measures after early clot removal for acute deep vein thrombosis (DVT), using the Chronic Venous Disease Quality of Life Questionnaire (CIVIQ-20) and the Short Form Health Survey (SF-36). Cross sectional design. Patients who underwent early clot removal between June 2012 and November 2021 were asked to complete the two questionnaires once. Lower CIVIQ-20 and higher SF-36 scores indicate better quality of life (QoL). Primary endpoints were the median scores. The one sample Wilcoxon signed rank test was used to compare SF-36 physical and mental component summary (PCS and MCS) to the normative and CIVIQ-20 to the minimum. Secondary, non-parametric independent t test or Fisher's exact test examined how age, sex, body mass index, stent placement, re-intervention, and time of questionnaire completion related to QoL. Multivariable linear regression tested whether various variables were associated with QoL. The response rate was 73.5% (n= 39). Median time of questionnaire completion was 1.8 years (interquartile range [IQR] 3.1) after clot removal. The median CIVIQ-20 of 29.0 (IQR 28.0) was slightly higher than the minimum value 20.0 (p < .001). The median PCS (50.5, IQR 16.6) and median MCS (50.2, IQR 14.2) did not differ from the normative of 50.0. However, wide IQRs indicated impairments for a subgroup of patients. None of the tested variables affected QoL except for the finding that re-interventions had a significantly negative impact on the SF-36 MCS (standardised β coefficient of-0.4, p= .030). Overall patient reported outcome measures were satisfactory after early clot removal, but impaired physical and mental functioning levels were present in a subgroup of patients. Re-interventions were found to have a negative impact on mental QoL. This finding was independent of time that had passed between the procedure and questionnaire completion. This study emphasises that mental functioning deserves attention, besides the widely recognised physical consequences after invasive acute iliofemoral DVT treatment.

The beneficial role of complex decongestive therapy in patients with symptomatic chronic iliofemoral venous obstruction with phlebolymphedema

ObjectivePhlebolymphedema has been noted to be one of the most common causes of lymphedema in the lower extremity in western societies. Although complex decongestive therapy (CDT) represents the mainstay of lymphedema treatment, its role for phlebolymphedema arising from chronic iliofemoral venous obstruction (CIVO) merits further exploration. We evaluated this through the use of a protocol of CDT first for limbs with CEAP (clinical, etiologic, anatomic, pathophysiologic) clinical C3 disease and stent correction of obstruction before CDT for those with more advanced disease (CEAP C4-C6). In the present study, we analyzed the outcomes after the use of such a protocol. MethodsWe analyzed prospectively collected data for 192 limbs (166 patients) that underwent treatment of quality-of-life (QoL) impairing symptoms from CIVO due to lymphoscintigraphically determined phlebolymphedema between 2017 and 2022. The characteristics evaluated included CEAP clinical class, venous clinical severity score (VCSS), grade of swelling (GOS), visual analog scale (VAS) pain score, QoL (CIVIQ-20 [20-item chronic venous disease quality of life questionnaire]), stenting for CIVO, and outcomes related to CDT and stenting. For the limbs undergoing CDT or stenting followed by CDT, the outcomes were evaluated at 6 weeks and 3, 6, and 12 months after completion of CDT. Paired and unpaired t tests, χ2 tests, and analysis of variance were used for comparisons of clinical variables. Kaplan-Meier analysis was used to evaluate stent patency, with the log-rank test used to discriminate between different curves. ResultsOf the 192 limbs (166 patients) in the entire cohort, 74 were in the C3 group and 118 were in the C4-C6 group. The median patient age was 63 years; 57 were men and 109 were women. In the C3 group, after CDT, improvement had occurred in the VCSS and VAS pain score at 6 weeks (P < .0001) and at 3 (P < .0001), 6 (P < .0001), and 12 (P < .0001) months. Improvement in the GOS was noted at 6 (P < .0001) and 12 (P = .0005) months. The CIVIQ-20 score improved from 63 to 38 (P = .009). Nine limbs (12%) in the C3 group required stenting after CDT. In the C4-C6 group, of the 118 limbs, 75 (64%) underwent stenting only and 43 (36%) underwent stenting followed by CDT for persistent QoL impairing symptoms. For this latter group, after CDT, improvement occurred in the VCSS, GOS, and VAS pain score at 6 weeks (P < .0001) and 3 (P < .0001), 6 (P < .0001), and 12 (P < .0001) months. The CIVIQ-20 score improved from 61 to 34 (P < .0001). The primary, primary assisted, and secondary patency in the C4-C6 group at 36 months was 92%, 100%, and 100%, respectively. ConclusionsFor CEAP C3 patients with phlebolymphedema due to CIVO, CDT should be a part of the first line of treatment. Stenting should be reserved for those with QoL impairing symptoms despite the use of CDT. Additionally, CDT helps provide symptom relief for patients with more advanced CEAP C4-C6 disease with persistent or residual edema after stenting. Further study is warranted.

Patient-Reported Outcomes of Endovascular Treatment of Post-Thrombotic Syndrome: Ancillary Study of a French Cohort.

Excellent outcomes of angioplasty/stenting for the post-thrombotic syndrome (PTS) have been reported, notably regarding objective criteria in the vast French SFICV cohort. Differences may exist between patient-reported and objective outcomes. We investigated this possibility by using validated scales because significative correlations are discordant in the literature between patency and patient-reported characteristics. Patient-reported outcomes seem to be a more consistent tool than radiologic patency for the diagnosis and follow-up of patients displaying PTS. We retrospectively reviewed the Villalta scale and 20-item ChronIc Venous dIsease quality-of-life Questionnaire (CIVIQ-20) scores recorded after endovascular stenting for PTS at 14 centres in France in 2009-2019. We also collected patency rates, pre-operative post-thrombotic lesion severity, and the extent of stenting. We performed multivariate analyses to identify factors independently associated with improvements in each of the two scores. The 539 patients, including 324 women and 235 men, had a mean age of 44.7 years. The mean Villalta scale improvement was 7.0 ± 4.7 (p < 0.0001) and correlated with the thrombosis sequelae grade and time from thrombosis to stenting. The CIVIQ-20 score was available for 298 patients; the mean improvement was 19.2 ± 14.8 (p < 0.0001) and correlated with bilateral stenting, single thrombosis recurrence, and single stented segment. The objective gains demonstrated in earlier work after stenting were accompanied by patient-reported improvements. The factors associated with these improvements differed between the Villalta scale and the CIVIQ-20 score. These results proved that clinical follow-up with validated scores is gainful in patients treated for PTS thanks to a mini-invasive procedure.

Hybrid endovenous laser ablation reduces the recurrence of varicose veins below the knee compared with radiofrequency ablation: a real-world study.

This study aimed to investigate the outcome of hybrid endovenous laser ablation (EVLA, 1470 nm) and radiofrequency ablation (RFA) procedures for varicose veins (VVs). We retrospectively analysed the clinical data of patients from July 2019 to December 2020. Eighty-four patients (121 limbs) underwent a hybrid EVLA procedure, and 108 patients (151 limbs) underwent an RFA procedure. The outcomes, venous clinical severity score (VCSS), chronic venous disease quality-of-life questionnaire (CIVIQ-20) score, and recurrence at 1, 6, and 12 months were collected. No differences in complications or 24-h pain scores were noted between the 2 procedures, but a lower dosage of foam sclerosant was used in the EVLA procedure than in the RFA procedure (p < 0.02). The postoperative VCSS and CIVIQ-20 scores in the 2 groups were significantly decreased compared with the scores before the procedure, and no differences in scores were noted between the 2 procedures at 1 month. However, the VCSS and CIVIQ-20 scores for the EVLA procedure were significantly better than those for the RFA procedure at 6 and 12 months (p < 0.05). Both procedures showed a similar great saphenous vein closure rate at 12 months. The EVLA procedure showed lower rates of overall recurrence (4.96% vs. 14.57%, OR = 3.27, 95% CI: 1.33-8.00, p = 0.01) and recurrence below the knee (4.13% vs. 11.92%, OR = 3.14; 95% CI: 1.18-8.35, p = 0.02). Moreover, the patient satisfaction score was greater for the EVLA procedure than for the RFA procedure (p < 0.02). The hybrid EVLA (1470 nm) procedure reduces VV recurrence below the knee and results in better quality-of-life scores.

Technique of stent sizing in patients with symptomatic chronic iliofemoral venous obstruction—the case for intravascular ultrasound-determined inflow channel luminal area-based stenting and associated long-term outcomes

ObjectiveFemoroiliocaval stenting has become the standard of care for patients with quality-of-life impairing chronic iliofemoral venous obstruction not responding to conservative measures. Although improvement after stenting has been noted in multiple large studies, sizing of stents has been subjective in nature with a general tendency to use smaller stents that would be required to relieve venous hypertension. This study evaluates the authors’ technique of using the intravascular ultrasound (IVUS) inflow channel luminal area to guide stent sizing. MethodsPatients who underwent femoroiliocaval stenting for quality-of-life impairing chronic iliofemoral venous obstruction and had failed conservative therapy from 2015 to 2021 were included in the study. Clinical outcomes including venous clinical severity score (VCSS), visual analog scale (VAS) pain score, and grade of swelling (GOS) were appraised before and after stenting. Also evaluated were quality of life (Chronic Venous Insufficiency Questionnaire-20 [CIVIQ-20] instrument) and stent outcomes including patencies and reinterventions. Comparisons were made between limbs that underwent placement of larger caliber stents (largest stent diameter >20 mm: >20 mm stent group) vs smaller caliber stents (largest stent diameter ≤20 mm: ≤20 mm stent group). t tests and analysis of variance were used to compare outcomes, whereas the Kaplan-Meier analysis was used to evaluate patencies with log rank used to compare the curves. ResultsA total of 300 patients (300 limbs) underwent stenting with a median age of 58 years. There was a preponderance of men (159 of 300), left laterality (176 of 300), and post-thrombotic syndrome (176 of 300). The median body mass index was 41. There were 120 limbs in the >20 mm stent group and 180 limbs in the ≤20 mm stent group. The median follow-up was 23 months. There was no significant difference in baseline VCSS, VAS pain score, or GOS between the two groups. However, there was a significant difference in IVUS-determined inflow channel luminal area between the two groups (228 mm2 >20 mm stent group vs 176 mm2 for ≤20 mm stent group [P < .0001]). After stenting there was a significant improvement in the VCSS, VAS pain score, and GOS at 6 weeks, 3, 6, 12, and 24 months (P < .0001) without any difference between the groups (P > .05). The CIVIQ-20 score also improved from 58 to 38 (P < .0001) for the entire cohort and for the two groups (P < .0001). Overall primary, primary-assisted, and secondary patencies at 60 months were 84%, 100%, and 100%, respectively. Reintervention rate was 10% without any difference between the groups. ConclusionsStent sizing using IVUS-determined inflow channel luminal area in patients undergoing stenting for quality-of-life impairing chronic iliofemoral venous obstruction resulted in a significant improvement in the VCSS, VAS pain score, GOS, and quality of life (CIVIQ-20) after stenting. Excellent stent patencies and low reintervention rates were also noted. IVUS-determined inflow channel luminal area represents an objective technique of stent sizing in comparison to the subjective techniques that currently exist.

Improvement following restoration of inline flow argues against comprehensive thrombus removal strategies and for selective stenting in acute symptomatic iliofemoral venous thrombosis

ObjectiveRandomized trials have demonstrated the benefit of thrombus removal strategies in iliofemoral deep venous thrombosis (IFDVT) in providing early symptom relief and decreasing the incidence of post-thrombotic syndrome (PTS), especially severe PTS. However, the impact of quantum of residual thrombus burden (RTB) on PTS as determined by intravascular ultrasound examination and the role of venous stenting in the acute setting have not been evaluated and represent the focus of this study. MethodsSixty-nine limbs (65 patients) undergoing thrombus removal for acute symptomatic IFDVT between 2015 and 2021 formed the study cohort. The Venous Clinical Severity Score (VCSS) (range, 0-27) grade of swelling (GOS) (range, 0-4), and visual analog scale (VAS) pain scores (range, 0-10) were evaluated initially and at 6, 12, and 24 months after thrombus removal. Quality of life was appraised using the CIVIQ-20 instrument. The extent of initial and RTB after the intervention was estimated using intravascular ultrasound examination. Grading was done as less than 50% (1), 50% to 99% (2), or 100% (3) of luminal thrombus fill within each segment (common femoral vein, external iliac vein, and common iliac vein) by a blinded rater and then combined to generate a total score. The use of stenting, both concurrent (severe residual stenosis/persistent occlusion) and delayed (quality of life impairing residual or recurrent symptoms), was evaluated. ResultsOf the 69 limbs, 53 underwent pharmacomechanical/mechanical thrombectomy (PMT), whereas 16 patients underwent PMT and catheter-directed thrombolysis with restoration of inline flow in all limbs. Post-intervention VCSS improved from 6 to 2 at 24 months (P < .0001). GOS improved from 4 to 0 at 24 months (P < .0001). The VAS pain score went from 5 to 0 at 6 months (P < .0001) and remained at 0 at 12 months (P < .0001), but increased to 3 at 24 months (P = .02). The CIVIQ-20 score improved from 38 to 22 (P = .001) over a median follow-up of 19 months. The median RTB total score improved from 9 to 4 (P < .0001). There was no impact of RTB total score (<3 vs >3) on VCSS (P = NS), GOS (P = NS), VAS pain score (P = NS) or CIVIQ-20 score (P = NS) at the various time points. Concurrent stenting was used in 23 limbs (33%) and delayed stenting was carried out in 10 limbs (14%). The median time to delayed stenting was 4 months after the initial thrombus removal intervention. ConclusionsIn patients undergoing PMT or PMT with catheter-directed thrombolysis for acute symptomatic IFDVT, the restoration of inline flow seems to be adequate to provide symptom relief and decrease the incidence of PTS. The extent of RTB does not seem to impact the VCSS, GOS, VAS pain score, or quality of life after such restoration. Stenting can be pursued selectively in the acute setting to help restore inline flow.

Short- and Mid-Term Outcomes of Endovascular Stenting for the Treatment of Post-Thrombotic Syndrome due to Iliofemoral and Caval Occlusive Disease: A Multi-Centric Study from the French Society of Diagnostic and Interventional Cardiovascular Imaging (SFICV).

To assess the results of endovascular treatment in a large population of patients suffering from post-thrombotic syndrome (PTS) due to iliocaval occlusive disease. In this retrospective multi-center study, 698 patients treated by stenting for PTS in 15 French centers were analyzed. Primary, primary assisted, and secondary patency rates were assessed, and clinical efficacy was evaluated using Villalta and Chronic Venous Insufficiency Questionnaire in 20 questions (CIVIQ-20) scores. Outcomes were compared against pre-operative CT-based severity of the post-thrombotic lesions in the thigh (4 grades). Technical success, defined as successful recanalization and stent deployment restoring rapid anterograde flow in the targeted vessel, was obtained in 668 (95.7%) patients with a complication rate of 3.9%. After a mean follow-up of 21.0months, primary patency, primary assisted patency, and secondary patency were achieved in 537 (80.4%), 566 (84.7%), and 616 (92.2%) of the 668 patients, respectively. Venous patency was strongly correlated to the grade of post-thrombotic changes in the thigh, with secondary patency rates of 96.0%, 92.9%, 88.4%, and 78.9%, respectively, for grades 0 to 3 (p = .0008). The mean improvements of Villalta and CIVIQ-20 scores were 7.0 ± 4.7 points (p < .0001) and 19.1 ± 14.8 points (p < .0001), respectively. Endovascular stenting as a treatment option for PTS due to chronic iliocaval venous occlusion generates a high technical success, low morbidity, high midterm patency rate, and clinical improvement. Venous patency was strongly correlated to the severity of post-thrombotic lesions in the thigh.

Severity of disease and treatment outcomes of anterior accessory great saphenous veins compared with the great saphenous vein

ObjectiveEndovenous therapies are currently the standard of care for the treatment of patients with symptomatic great saphenous vein (GSV) reflux. The effectiveness and long-term outcomes of these therapies for anterior accessory great saphenous veins (AAGSVs) are poorly defined. The objective of this investigation is to determine treatment outcomes in patients with symptomatic AAGSV reflux compared with patients with symptomatic GSV reflux. MethodsData were prospectively collected in the Center for Vein Restoration's electronic medical record system (NexGen Healthcare Information System, Irvine, Calif) and retrospectively analyzed. Treatment outcomes after a standalone ablation and ablation + phlebectomy were compared in patients with isolated AAGSV and GSV reflux. Treatment outcomes were assessed at 1 month and 6 months postprocedure using the revised Venous Clinical Severity Score (rVCSS) and the 20-item Chronic Venous Insufficiency Quality-of-Life Questionnaire (CIVIQ20) survey for quality of life. Medical and surgical comorbidities, Clinical-Etiological-Anatomical-Pathophysiological classification, body mass index, gender, race, and the average number of procedures performed were all analyzed. ResultsFrom January 2015 to December 2018, 31,186 patients and 49,193 limbs were assessed. Of these, 91 patients/103 limbs had isolated AAGSV reflux, and 7704 patients/10,371 limbs had isolated GSV reflux. There were 95% and 75% women in the isolated AAGSV and GSV groups, respectively (P ≤ .001). For the ablation-only patients, AAGSV (n = 57 patients/61 limbs) and GSV (n = 5349 patients/7191 limbs), there were no differences in preintervention (7.0 ± 2.0 vs 6.8 ± 2.8, P = .99), 1-month (4.0 ± 2.4 vs 3.9 ± 2.8, P = .99), and 6-month (3.9 ± 2.6 vs 3.9 ± 2.9, P = .55) rVCSS scores. Similar results were observed when ablations and phlebectomies were performed (AAGSV [n = 34 patients/42 limbs] and GSV [n = 1848 patients/2491 limbs]). CIVIQ20 scores for patients with isolated AAGSV and GSV were 53.3 ± 19.6 vs 50.6 ± 18.8 (P = .43) preintervention, 37.2 ± 17.6 vs 35.7 ± 15.9 (P = .91) at 1 month, and 41.3 ± 21.7 vs 35.1 ± 15.7 (P = .36) at 6 months, respectively. Postprocedure scores within groups improved at 1 and 6 months (P ≤ .02); however, 6-month AAGSV CIVIQ20 scores after an ablation increased slightly compared with 1-month scores and were not different to preintervention GSV scores (P = .07). When phlebectomies were performed with ablations, 6-month CIVIQ20 scores were similar between groups (P = .72). There was no difference in the average number of ablations in patients with phlebectomies in the AAGSV or GSV group (1.24 ± 0.44 vs 1.35 ± 0.49, P = .15). ConclusionsEndovenous therapies for the treatment of symptomatic AAGSVs demonstrate similar outcomes to patients with symptomatic GSV reflux. For standalone ablations, the rVCSS scores are similar between the groups; however, CIVIQ20 scores increase to preintervention levels in standalone ablation AAGSV patients at 6 months. This increase disappears when phlebectomies are performed with ablations. Based on these data, patients with symptomatic AAGSV treated with ablation also require treatment of the associated tributaries (varicosities) to achieve similar outcomes to patients with GSV, and this calls into question the effectiveness of ablation for isolated AAGSV reflux.

Utility of the 50% stenosis criterion for patients undergoing stenting for chronic iliofemoral venous obstruction

ObjectiveThe criterion for venous stenting in symptomatic chronic iliofemoral venous obstruction has been the arbitrary use of stenosis of ≥50%. In the present study, we evaluated the intravascular ultrasound (IVUS)-determined degree of stenosis in patients who had undergone stenting for quality of life (QOL)-impairing symptoms and assessed the utility of the 50% stenosis cutoff. MethodsA retrospective review of contemporaneously entered electronic medical record data from 480 continuous patients (480 limbs) with initial iliofemoral stents placed (2014 to 2017) for symptomatic chronic iliofemoral venous obstruction impairing their QOL was performed. The IVUS-determined normal minimal luminal areas for the common femoral vein (125 mm), external iliac vein (150 mm), and common iliac vein (200 mm) were used to group limbs as having <50% (low-grade stenosis [LGS]) or ≥50% (high-grade stenosis [HGS]) stenosis. The variables compared included the visual analog scale (VAS) for pain score, venous clinical severity score (VCSS; range, 0-27), ulcer healing, supine foot venous pressures, QOL (20-item chronic venous disease QOL questionnaire), and stent patency. A composite chronic venous insufficiency score (CCVIS) incorporating the VAS score, VCSS, and CIVIQ-20 score for predicting improvement after stenting was evaluated. ResultsOf the 480 limbs, 283 and 197 were in the LGS and HGS groups, respectively. A preponderance of women, left laterality, and post-thrombotic syndrome were noted in both groups. At baseline, although no difference was found in the VAS for pain score between groups, the LGS group had a higher VCSS than did the HGS group (P = .05). The baseline median supine foot venous pressure was 15 and 14 mm Hg in the LGS and HGS groups, respectively (P = .17). At 24 months after stenting, the mean VCSS had improved from 6.3 to 4.4 (P < .0001) and from 5.7 to 3.7 (P < .0001) in the LGS and HGS groups, respectively, without significant differences between the two groups (P = .07). A greater prevalence of ulcers was found in the LGS group (18% vs 11%; P = .04), with no differences in healing (P = .41) or recurrence rates (P = .36). The QOL scores had improved in both groups (LGS, from 58 to 37 [P < .0001]; HGS, from 61 to 35 [P < .0001]), without differences between the two groups (P > .3). No significant differences in stent patency or reinterventions rates were found. A baseline CCVIS of ≥84.5, ≥86.9, or ≥105.3 was needed for a 30-, 40-, and 50-point improvement in most limbs after stenting. ConclusionsThe degree of IVUS-determined iliofemoral venous stenosis did not appear to affect the initial clinical presentation, CEAP (clinical, etiologic, anatomic, pathophysiologic) clinical class, supine foot venous pressure, clinical improvement, QOL improvement, stent patency, or reintervention rates after stenting. Patients presenting with QOL-impairing symptoms in whom conservative treatment has failed merit consideration of correction of their obstruction even if the degree of stenosis is <50%. The use of a CCVIS might be helpful but requires further study.

Systematic literature review and network Meta-analysis of sulodexide and other drugs in chronic venous disease.

To assess the clinical efficacy of sulodexide, including a comparison with venoactive drugs (VAD) (micronized purified flavonoid fraction, MPFF; hydroxy-ethyl-rutosides, HR; calcium dobesilate;Ruscus extract combined with hesperidin methyl chalcone and vitamin C, Ruscus+HMC+VitC; horse chestnut seed extract, HCSE) and pentoxifylline in patients with chronic venous disease. We performed a literature search in MEDLINE, Embase, and Cochrane Library for randomized controlled trials (RCTs) and observational studies. Proportion of patients with complete venous ulcer healing was the primary outcome and lower leg volume, foot volume, ankle circumference and symptoms were the secondary outcomes. Bayesian network meta-analysis (NMA) was perfomed with random effects models using only RCTs. A meta-analysis of observational studies was performed for sulodexide because no RCT could be included in NMA for symptoms or signs. Forty-five RCTs and eighteen observational studies were identified. Sulodexide was included only in a single NMA for the proportion of patients with complete ulcer healing and it showed to have the highest probability of being the best treatment (48%) compared with pentoxifylline (37%) and MPFF (16%). MPFF was the most effective treatment in reducing lower leg volume, CIVIQ-20 score and pain VAS scale while calcium dobesilate and Ruscus+HMC+VitC were the most effective in reducing foot volume and ankle circumference respectively.Meta-analyses of observational studies for sulodexide showed that it improves significantly the scoring of pain, feeling of swelling, heaviness and parasthesiae measured by Likert scales. Sulodexide is at least as effective as pentoxifylline and more effective than MPFF in improving the rate of ulcer healing in patients with CVD. VADs are effective in improving venous symptoms and signs, as was also shown by sulodexide in the meta-analysis of observational studies. The relative effectiveness of sulodexide and VADs needs to be evaluated by an RCT in order to better inform clinical practice.

Extended Center for Vein Restoration study assessing comparative outcomes for the treatment of chronic venous insufficiency in Medicare- and non–Medicare-eligible patients

BackgroundWe previously reported that chronic venous insufficiency treatment of Medicare-eligible patients achieved outcomes similar to those for non–Medicare-eligible patients. The goal of the present investigation was to assess the long-term treatment outcomes and the effect of race in a larger patient cohort. MethodsFrom January 2015 to December 2019, we retrospectively reviewed the data from 131,268 patients who had presented for a lower extremity venous evaluation. We divided the patients into two groups by age: group A was aged ≥65 years and group B, <65 years. The treatments analyzed in each group were axial thermal ablation (TA), axial Varithena ablation (VA), TA plus phlebectomy, VA plus phlebectomy, and TA or VA with phlebectomy and ultrasound-guided foam sclerotherapy (UGFS). The treatment outcomes were assessed using the revised venous clinical severity score (rVCSS) and Chronic Venous Insufficiency Quality of Life 20-item questionnaire (CIVIQ-20) scores at the initial consultation and 1, 6, and 12 months after completion of the treatment plan. ResultsOf the 131,268 patients, 40,020 were in group A and 91,248 in group B, with an average age of 74.4 ± 6.6 and 49.9 ± 10.6 years, respectively. Of the 40,020 patients in group A, 15,697 (n = 25,234 limbs) had undergone TA and 1910 (n = 3222 limbs) had undergone VA. Of the 91,248 patients in group B, 35,220 (n = 53,717 limbs) had undergone TA and 2178 (n = 3672 limbs) had undergone VA. For the TA subgroups, all rVCSSs had significantly improved after treatment at each evaluation point (P ≤ .001). For the TA and VA plus phlebectomy with or without UGFS subgroup, the older patients (group A) required 6 months to develop the same degree of improvement as the younger patients (group B) at 1 month. When subdivided by race, all initial and 6-month rVCSSs and CIVIQ-20 scores within a race had improved and were better in group B, except for Asian and Hispanic patients (P ≤ .001). After TA or VA plus phlebectomy, with or without UGFS, the CIVIQ-20 outcomes had improved by 1 month in both groups, although the rVCSS lagged by 6 months in group A. No differences in the rVCSSs or CIVIQ-20 scores were observed between the groups treated with TA or VA. ConclusionsMedicare-eligible beneficiaries demonstrated improved outcomes similar to those of non–Medicare-eligible beneficiaries after ablation. When TA or VA plus phlebectomy with or without UGFS were examined, group A required 6 months to demonstrate rVCSSs equivalent to those of group B at 1 month. The CIVIQ-20 scores had improved by 1 month in both groups, regardless of the treatment modality. The difference in rVCSSs appeared to be driven by African American and white patients because Hispanic and Asian patients demonstrated equivalent results regardless of age. Patients treated with TA or VA demonstrated equivalent results.

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.

Prospective comparative study of different endovenous thermal ablation systems for treatment of great saphenous vein reflux

ObjectiveThe aim of our study was to compare three different endovenous thermal ablation (EVTA) modalities in the treatment of great saphenous vein (GSV) incompetence. MethodsWe performed a single-center, prospective, comparative cohort study that included consecutive patients undergoing EVTA of the GSV. Patients were treated with either segmental radiofrequency ablation (sRFA) or endovenous laser ablation (EVLA) with a 1470-nm dual radial fiber or with a 1470-nm jacket-tip fiber. The clinical classification CEAP (clinical, etiologic, anatomic, pathophysiologic), 10-cm visual analog scale scores for pain, Venous Clinical Severity Scores (VCSSs), and chronic venous insufficiency quality-of-life questionnaire (CIVIQ-20) scores were recorded. The primary outcome was clinical success, which was defined as the absence of reflux or recanalization of the GSV and procedure-related complications, assessed at 7 and 30 days and 1 year postoperatively. The secondary outcomes were the assessment of postoperative pain using the VAS and improvement in the VCSSs and CIVIQ-20 scores. ResultsA total of 153 patients (160 limbs) had undergone sRFA (sRFA group; n = 53 limbs), 1470-nm radial fiber EVLA (EVLA-R group; n = 55 limbs), or 1470-nm jacket-tip fiber EVLA (EVLA-J group; n = 52 limbs). The patient demographics, CEAP clinical class, and intraoperative details were comparable among the three groups. The GSV occlusion rate at 1 year was 93% in the sRFA group, 93% in the EVLA-R group, and 95% in the EVLA-J group. No major complications were observed postoperatively. Endothermal heat-induced thrombosis was observed in 2 (4.4%), 1 (2.2%), and 2 (4.4%) patients in the sRFA, EVLA-R, and EVLA-J groups, respectively (P > .5). The VCSS showed greater improvement in the EVLA-R group at 1 week compared with that in the sRFA (P = .05) and EVLA-J (P = .002) groups. Changes in the CIVIQ-20 score were in favor of the EVLA-R group at 7 days (−14.3 ± 10.3 vs −7.9 ± 5.9; adjusted difference, 6.06; 95% confidence interval [CI], 1.57-10.55; P = .01) and 30 days (−12 ± 8 vs −11.2 ± 7; adjusted difference, 5.5; 95% CI, 1.21-9.81; P = .02) postoperatively compared with the sRFA group and at 7 days compared with the EVLA-J group (−14.3 ± 10.3 vs −9.6 ± 7.9; adjusted difference, −4.4; 95% CI, −9.06 to 0.22; P = .05). Analyzing the different components of the CIVIQ-20, pain, and physical scores showed a greater reduction in the EVLA-R group in the early postoperative period compared with that in the sRFA and EVLA-J groups. ConclusionsAll three EVTA modalities showed equal effectiveness and safety for the treatment of GSV reflux. EVLA with the 1470-nm radial fiber showed better outcomes in terms of early postoperative VCSSs and pain and physical CIVIQ scores. The clinical and quality of life benefits were similar for all modalities at 1 year postoperatively.

Validation of the 3D SYM VEIN Symptom Assessment Tool

The aim was to validate the SYM VEIN consensus 3D scoring tool in chronic venous disease (CVD). This was a prospective cohort study with a total of 35 consecutive patients with CVD. Patients with CVD undergoing saphenectomy were assessed with the revised Venous Clinical Severity Score (r-VCSS), the CIVIQ-20 quality of life score questionnaire, and the SYM VEIN consensus statement 3D system, pre-operatively and four weeks post-operatively. The total 3D score was tested for reliability, construct validity, and responsiveness. The total 3D score demonstrated good reliability and internal consistency (Cronbach's alpha 0.85). Principal component analysis identified three groups of symptoms (paraesthesia, burning pain, and pruritus, vs. heaviness, sensation of swelling and aching/pain, vs. restless leg and throbbing pain) demonstrating a high intragroup correlation and likely to share similar pathophysiology, indicative of adequate construct validity. The total 3D score showed a significant correlation with r-VCSS and CIVIQ-20 score (rho .46, p=.005 and rho .65, p<.001, respectively) indicative of adequate convergent validity. After saphenectomy, significant reductions (p<.001) of the total 3D, and 3D scores for all but two individual venous symptoms were observed, indicative of excellent responsiveness. Median total 3D score was reduced from 31 to 6 (83.8% decrease, p<.001), median r-VCSS was reduced from 6 to 0 (100% decrease, p<.001), and median CIVIQ-20 score was reduced from 24 to 14 (40% decrease, p<.001). The difference of median percentage change between r-VCSS and CIVIQ-20 score vs. total 3D score was significant (p=.005 and p<.001, respectively). The total SYM VEIN 3D score has good reliability, construct validity and excellent responsiveness, although less prone to change after saphenectomy compared with r-VCSS.

Diosmin 600 in adjunction to rivaroxaban reduces the risk of post-thrombotic syndrome after femoropopliteal deep vein thrombosis: results of the RIDILOTT DVT study.

To assess the efficacy and safety of long-term diosmin 600 therapy added to rivaroxaban and elastic compression stockings (ECS) in patients with femoropopliteal deep vein thrombosis (DVT). This single-center, open-label randomized clinical trial RIDILOTT DVT enrolled patients with their first femoropopliteal DVT confirmed by duplex ultrasound scan (DUS). Participants were randomly allocated to the control group (standard treatment with rivaroxaban for six months and ECS for 12 months) or the experimental group (standard treatment with the additional use of diosmin 600 mg once daily for 12 months). Patients were followed for 12 months. The primary outcome was post-thrombotic syndrome (PTS), according to the Villalta Score (≥5). The secondary outcomes were deep vein recanalization, chronic venous disease (CVD) progression, the severity of PTS (Villalta), and CVD (VCSS), quality of life (CIVIQ-20), venous thromboembolism recurrence, and adverse event (AE). Ninety patients were randomized (45 per group). There were 56 men and 34 women with a mean age of 57.8±13.4 years, and 69% had clinically unprovoked DVT. PTS frequency at 12 months was significantly lower (8.9% vs. 48.9%) in the experimental group compared with control one (relative risk, 0.14; 95% confidential interval, 0.04-0.43, P<0.001). Adding diosmin 600 was associated with quicker and complete vein recanalization, lower CVD progression rate, and lower Villalta, VCSS, and CIVIQ-20 scores. There was no difference in recurrent DVT or AE. Adjunctive use of diosmin 600 to rivaroxaban and ECS in patients with femoropopliteal DVT can improve the clinical and ultrasound outcomes after 12 months of treatment.