Severe Chronic Venous Insufficiency Research Articles

Differences in risk profile associated with varicose veins and chronic venous insufficiency - results from the Bonn Vein Study 1.

Background: The aim of this publication is to demonstrate similarities and differences in the association of risk factors with the prevalence of different manifestations of chronic venous disease (CVD), like varicose veins (VV), venous oedema (C3) and severe chronic venous insufficiency (CVI) in the population-based cross-sectional Bonn Vein Study 1 (BVS). Patients and methods: In the BVS 1 between 13.11.2000 and 15.3.2002, 3.072 participants, 1350 men and 1722 women, from a simple random sample of the general population of the city of Bonn and two rural townships aged 18-79 years were included. The overall response proportion was 59%. All participants answered a standardized questionnaire including information about socio-economic data, lifestyle, physical activity, medical history, and quality of life. Venous investigations were performed clinically and by a standardized duplex examination by trained investigators. The CEAP classification in the version of 1996 was used to classify the findings. Logistic regression models were performed for the association of possible risk factors with VV, venous edema (C3) and severe CVI (C4-C6). The predictive risk (PR) describes the association of the diseases and the possible influencing factors. Results: VV, venous oedema (C3) and severe CVI (C4-C6) have common risk factors like higher age, number of pregnancies, family history of VV and overweight or obesity. Female gender is significantly associated with VV and C3 but not with severe CVI (C4-C6). High blood pressure and urban living are only associated with C3 and C4-C6 disease whereas prolonged sitting is associated with C3 and lower social class with C4-C6 exclusively. Discussion: In many epidemiological studies risk factors were associated with chronic venous disorders in general. Our data show that VV, venous edema and severe CVI may have different risk profiles. Venous edema is more often associated with arterial hypertension and sedentary lifestyle whereas lower social class seems to be a risk factor for severe CVI including venous ulcers. Conclusions: The differences in the association of risk factors to VV, venous edema and severe CVI should be considered if prevention and treatment of chronic venous diseases are planned. As examples, compression stockings could be proposed in sitting profession to prevent oedema, VV patients with risk factors like obesity might benefit from early treatment for VV and obesity. More longitudinal evaluation of risk factors is necessary to evaluate the true risk profile of CVD.

The register as a tool for researching trends in phlebological care for the population of a large industrial center of Russia

Introduction. The Russian Phlebological Register began work in 2016 under the patronage of the Association of Phlebologists of Russia. The creation of a phlebological register in a separate municipal center of the country complements and enriches national plans. Aim. Тo investigate the trends in the organization of medical care to the population with chronic venous diseases (CVD) of a large industrial center using the phlebological register over the past 20 years. Materials and methods. The data of municipal and private medical institutions of Ekaterinburg from 2003 to 2022 are analyzed. Data on municipal hospitals (MHs) are provided by the TFOMS of the Sverdlovsk region. Data on private medical centers (PMCs) are obtained by exporting them from the electronic databases of each center. The statistics of phlebectomies (PhE), outpatient minimally invasive interventions and procedures are summarized. Results. Over the entire period of time, the number of classical phlebectomies in MHs decreased by 4 times – from 2300 (2003) to 587 (2022). At the same time, the development of minimally invasive procedures on the main veins in the PMCs increased from 313 (2003) to 4364 (2022). This made it possible to double the coverage of patients suffering from CVD with specialized medical care. In the structure of patients operated in MHs, the proportion of persons with severe chronic venous insufficiency (CVD C4–6) significantly decreased. The number of patients with superficial thrombophlebitis had a steady downward trend: the first 5 years (2003–2007) – about 200 PhE/year, then 5 years (2008–2012) – about 120 PhE/year, and from 2013 to 2022 < 100 PhE/year. Discussion. Private medical centers have consistently introduced the latest technologies, but endovasal laser coagulation remains the leader. Conclusion. The analysis of the register revealed a number of systemic changes in the organization of phlebological care.

The effect of transdermal combined product on the state of microcirculatory blood flow in patients with chronic venous insufficiency

Introduction. Treatment of patients with severe chronic venous insufficiency of the lower extremities is complex and along with compression therapy includes transdural use of drugs. Aim. To study the microcirculatory blood flow of the tissues of the distal segments of the lower limbs in patients with severe chronic venous insufficiency and the possibility of its correction with the use of a combined product for local application.Materials and мethods. The study included 40 patients suffering from varicose vein disease with chronic venous insufficiency of C3-C5 stages according to CEAP. In the main group of patients (n = 30) the transdermal combined product Detragel® was used; patients of the comparison group (n = 10) received only basic compression therapy of functional class II. The basis for the assessment of microcirculation of the lower limbs soft tissues was the analysis of the results of laser doppler flowmetry. Results. At local use of Detragel® in combination with elastic bandage in 91% of observations, there was a statically significant decrease of basal blood flow less than 4.0 pf. units (p < 0.05). The mean basal blood flow was 2.7 ± 0.6 pf. units (1.6–3.9 pf. units, 95% CI), which was consistent with normal values. Statistically significant decrease in veno-arteriolar response to 51.5 ± 10.8% (36.0–68.8%, 95% CI) was recorded in 75% of cases after 14 days of topical treatment, although veno-arteriolar response decreased to normal in only 53% of cases. Conclusion. Correction of microcirculatory disorders in patients with varicose vein disease should include local use of medicine.

Chronic compartment-syndrome of the lower limb: modern strategies for diagnosis and treatment

A review of the literature is presented, including data on the incidence, pathophysiology, and clinical picture of patients with chronic compartment syndrome (CCS) of the lower extremities. Chronic exercise compartment syndrome (CECS) is characterized by pain with repetitive exertion and increased intracompartmental pressure affecting the lower extremities in physically active patients. In severe chronic venous insufficiency of the lower extremities, chronic venous compartment syndrome (CVCS) develops, which is fundamentally different from previously known clinical pictures. Progressive dermatolipofasciosclerosis and cicatricial destruction of the fascia of the leg in patients with C4b-C6 clinical classes according to CEAP affect the pressure in the muscle-fascial compartments at each step. In severe cases, this leads to significant changes in the muscles, accompanied by chronic ischemia associated with necrosis and glycogen deficiency. The analysis of various diagnostic methods, conservative treatment and methods for performing surgical decompression of the CCS was carried out. The lack of a clear pathophysiology for CECS and CVCS complicates the diagnosis and treatment of this condition. Diagnosis of calf CCS is still based on pressure testing in the musculofascial compartments of the calf using the Pedowitz criteria, however standard procedures for this, including patient position, static or dynamic movements, muscles and equipment tested, are not agreed upon. In patients with CCS, if conservative treatment is ineffective, fasciotomy of the affected parts of the lower leg is the method of choice. Various techniques for fasciotomy of the lower leg include the traditional open fasciotomy, the semi-closed technique with one or more incisions, the minimally invasive technique using endoscopic compartment release, and the use of ultrasound guidance. Fasciectomy of the lower leg to correct CVCS is performed mainly for recurrence of trophic ulcers after shave therapy, severe calcification of the lower leg tissues and for the treatment of deep transfascial necrosis. Randomized, blinded, controlled trials are needed to further expand our knowledge of the diagnosis and treatment of CCS. 

Two-Year Results of a First-In-Human Study in Patients Surgically Implanted With a Bioprosthetic Venous Valve, the VenoValve in Patients With Severe Chronic Venous Insufficiency.

Two-year follow-up results from a first-in-human study of patients implanted with the VenoValve are evaluated for supporting the long-term clinical safety and performance of the device. Chronic Venous Insufficiency (CVI) involves improper functioning of lower limb vein valves and inability of these valves to move blood back towards the heart. CVI symptoms include swelling, varicose veins, pain, and leg ulcers. Currently, there is no cure for this condition and treatment options are limited. This study provides 2-year outcomes for 8 patients who were implanted with the bioprosthetic VenoValve for treating severe CVI with deep venous reflux measured at the mid-popliteal vein. The 6-month and 1-year results were previously published. Eleven patients with C5 & C6 CVI were implanted with VenoValve into the midthigh femoral vein and followed for 2 years. Assessed clinical outcomes include device-related adverse events, reflux time, disease severity, and pain scores. All 11 implant procedures were successful. Two-year follow-up data was obtained for 8 subjects: 1 patient died of non-device related causes, 1 was lost to follow-up, and 1 refused to follow-up due to the COVID-19 pandemic. No device-related adverse events occurred between the first and second years of follow-up. Reported 2-year clinical performance outcomes included significant decreases in mean reflux times of the mid-popliteal vein (61%), and significant improvements in mean scores for disease severity rVCSS (56%) and VAS pain (87%). Results from this study support long-term safety and effectiveness of the VenoValve for improving CVI severity by reducing reflux and thereby venous pressures in the lower extremities. With limited treatments for valvular incompetence involved in severe, deep venous CVI, the device may be considered as a novel therapy. A pivotal trial in the United States is currently being conducted to assess the device in a larger number of patients.

Race differences in iliofemoral vein stenting for chronic venous insufficiency.

Major disparities in outcomes by race are present throughout vascular surgery, yet little has been published on iliac vein stent outcomes by race. This retrospective study assessed iliac vein stent outcomes by patient race. Patients who underwent iliac vein stenting at a single institution for chronic venous insufficiency (CVI) from 2011 to 2021 were reviewed. Demographic, preoperative, perioperative, and postoperative data were collected. Self-reported race groups included Asian, Black, Hispanic, and White. Univariate differences were analyzed using χ2 tests for categorical variables and 1-way ANOVA for continuous variables. Outcomes included change in Venous Clinical Severity Score (VCSS) at interval timepoints relative to a preoperative baseline and reinterventions. Logistic regression models were used to determine the unadjusted and adjusted odds ratio (OR) of any minor and major reintervention. Multivariate regression models controlled for demographic and comorbidity characteristics. A total of 827 patients were included. Asian patients were younger and had a greater proportion of male patients, lower Body mass index (BMI), less smoking history, and fewer comorbidities. White patients were more likely to have a history of deep vein thrombosis (DVT). White patients presented with the most severe CVI symptoms as defined by both Clinical-Etiological-Anatomical-Pathophysiological (CEAP) classification and preoperative VCSS composite scores. There were no differences in acute DVT, number of stents deployed, and bilateral versus unilateral stent placement. Black patients had the longest average days of follow-up, followed sequentially by Hispanic, White, and Asian. Black patients had the most reinterventions, while Asian patients had the fewest. Asian patients were less likely to have a major reintervention. No differences in VCSS composite or change in VCSS were observed. In patients with CVI, Asian patients presented younger and healthier, while White patients presented with the most severe symptoms. No differences were observed in VCSS outcomes, though Black patients had the most reinterventions.

Superficial venous procedures can be performed safely and effectively in patients with deep venous reflux

BackgroundThe finding of concurrent deep venous reflux (DVR) when interrogating superficial venous reflux is common and might be a marker of more severe chronic venous insufficiency. However, the safety and clinical and patient-reported outcomes for patients undergoing superficial venous treatment in the presence of DVR remains underreported. Moreover, the factors associated with the persistence and disappearance of DVR after superficial vein treatment have not been evaluated. In the present study, we sought to address these questions. MethodsWe performed a review of the institutional vascular quality initiative database from June 2016 to June 2021. Consecutive patient limbs were identified that had undergone a superficial venous intervention and had duplex ultrasound evaluations available. These patients were divided into those with and without DVR. Those with DVR were further reviewed for anatomic details and the persistence or resolution of DVR after the procedure. The primary outcome was the venous clinical severity score (VCSS) at a follow-up >3 months. The secondary outcomes included the incidence of any postoperative deep vein thrombosis or endovenous heat-induced thrombosis, differences in patient-reported outcomes, rate of resolution of DVR, and factors associated with DVR persistence. Both univariate analysis and multivariate logistic regression were applied. ResultsOf the patients who had undergone superficial venous treatment, 644 patient limbs had had DVR and 7812 had not, for a prevalence of 7.6%. The DVR group was associated with a higher burden of chronic venous insufficiency. On univariate analysis, patient limbs, both with and without DVR, had improved significantly in the VCSS at <3 months of follow-up and were not significantly different. At >3 months of follow-up, the VCSS had again improved significantly compared with the VCSS at <3 months of follow-up. However, the difference between the two groups was statistically significant at the longer interval. The magnitude of improvement in the VCSS between the two groups at the longer follow-up were similar statistically (VCSS, 3.17 ± 3.11 vs 3.03 ± 2.93; P = .739). The HASTI (heaviness, achiness, swelling, throbbing, itching) score had similarly improved significantly in both groups but remained significantly higher in the DVR group during follow-up. On multivariate logistic regression, DVR was not associated with an increased VCSS at >3 months of follow-up. No intergroup difference was found in the incidence of postoperative deep vein thrombosis or endovenous heat-induced thrombosis. Of limbs with DVR, 40.8% no longer had evidence of detectable DVR at the latest follow-up venous duplex ultrasound, and DVR limited to a single segment was more likely than DVR in multiple segments to be no longer detectable. ConclusionsOur results have shown that superficial venous procedures are safe and effective in patients with DVR, leading to improvements in clinical and patient-reported outcomes similar to those for patients without DVR. In a large proportion of the treated limbs, especially those with DVR in a single segment, no evidence of DVR was found after superficial venous intervention. Although patients with DVR will have a higher burden of chronic venous insufficiency, they still appear to derive significant benefit from superficial venous treatment.

Three-year Results of the Surgical Implantation of the Bioprosthetic Valve: VenoValve, for Patients with Severe Chronic Venous Insufficiency, C5-C6 Disease

Currently, there are limited options to treat deep venous reflux. A first-in-human trial, with 3 years of follow-up, was conducted in Bogota, Colombia, as a nonrandomized, prospective, single-center study to assess the safety and performance of a bioprosthetic monocusp valve (Venovalve) surgically implanted in the femoral vein in C5 to C6 patients. Here we report our 3-year follow-up results.

One-Year First-in-Human Success for VenoValve in Treating Patients With Severe Deep Venous Insufficiency.

The clinical outcomes of this first-in-human (FIH) study provide safety and performance results 1 year after implantation of the VenoValve. Chronic venous insufficiency (CVI) is most often caused by valve failure in the venous system, which circulates blood from the lower limbs back to the heart and lungs. Severe diseases significantly influence quality of life, and current treatment options are limited. This study provides 1-year patient outcomes from 11 patients implanted with the VenoValve for treatment of severe deep venous CVI in C5 and C6 patients. Earlier results from 6-month follow-ups were previously published. This prospective FIH study assessed the safety and performance of the VenoValve surgically implanted in 11 patients with C5 and C6 disease. All patients were followed up for at least 1year. Assessments for adverse events, reflux time, disease severity, pain scores, and quality of life were reported. Implantation of VenoValve into the deep femoral vein was successful in all patients. Adverse events included 1 hematoma, 3 superficial wound infections, and 1 bleeding complication due to over-anticoagulation. One VenoValve became occluded due to patient non-compliance with anticoagulation medication. One-year clinical outcomes included significant decreases in mean reflux times (54%), and significant improvements in mean disease severity revised venous clinical severity score (56%), mean visual analog scale pain scores (76%), and Venous Insufficiency Epidemiologic and Economic Study QOL/sym scores. The promising results from this FIH study demonstrate sustained safety and effectiveness of the VenoValve at 1year post-implantation, and support further study for its use as a novel treatment for severe, deep venous CVI caused by valvular incompetence. A pivotal, prospective, non-blinded, single-arm, multi-center study in the United States with seventy-five (75) patients is in progress to assess the safety and effectiveness of VenoValve in these patients through 30 days and 6 months. The clinical trial is registered on ClinicalTrials.gov under identifier: NCT04943172 (https://clinicaltrials.gov/ct2/show/NCT04943172?term=hancock+jaffe&draw=2&rank=1).

Association of great saphenous vein diameter and clinical severity score after treatment of severe chronic venous insufficiency with foam sclerotherapy

Objectives: to evaluate the association of the greater saphenous vein (GSV) diameter in the treatment of patients with severe chronic venous insufficiency (C6 CEAP classification) with ultrasound-guided polidocanol foam sclerotherapy (UGFS).  Methods: A prospective, descriptive and analytical study of 28 patients (30 limbs) that underwent UGFS. Patients were divided into 2 subgroups by GSV diameter (&lt; 8 mm and ≥ 8 mm). Variables analyzed were ulcer healing, clinical intercurrences, clinical CEAP classification, Venous Clinical Severity Score (VCSS), diameter of the treated vein and presence of occlusion or recanalization by Doppler ultrasound. Patients were analyzed at the 1st, 3rd, and 6th months post-treatment. Results: The average age was 68.7 ± 10.5 years, 23 (82,1%) were women, and the average body mass index was 29.2 kg/m2. Although an improvement in VCSS score was observed during follow-up, no significant intergroup difference was noted. Seventeen (56%) limbs presented occlusion of the treated vein at the 1st month, 11 (36%) at the 3rd month, and 9 (30%) at the 6th month of follow-up. The ulcer healing rate was 56,6%. The average ulcer healing time was 90 days. Three (10%) patients presented with ulcer recurrence at the 6th month.  Survival analysis showed no significant difference in ulcer healing rate between subgroups after one year of follow-up (log-rank, p = 0,178). Conclusion: There was no difference between the subgroups of large and small VSM diameter in terms of symptom severity. However, significant reduction of VCSS and pain relief was observed after foam sclerotherapy.

Differences in health-related quality of life in patients with mild and severe chronic venous insufficiency: A systematic review and meta-analysis

ObjectiveChronic venous insufficiency (CVI) has a broad spectrum of clinical expression, ranging from mild to severe cases, which negatively impacts the health-related quality of life (HRQoL). However, the comparison in HRQoL between mild and severe CVI has not yet been systematically discussed, which could assist in the adoption of preventive strategies MethodsA systematic review and meta-analysis was conducted (protocol register https://osf.io/mr4aj/) following a search of the MEDLINE, CINAHL, Web of Science, LILACS, and Scopus databases, using the terms related to CVI and HRQoL. Observational studies that assessed the HRQoL in individuals with CVI in different degrees of severity were included, without date restriction ResultsWe retrieved 4750 titles and abstracts and 9 were included in this review. The HRQoL was worse in patients with severe CVI compared to mild patients at Short-form of Health Survey (SF-36) (mean difference 11.02, 95% CI from 8.62 to 13.43; p<0.001), Chronic Venous Insufficiency Quality Of Life Questionnaire (CIVIQ-14) (mean difference 13.07; 95% CI from 11.33 to 14.82; p<0.001) and Aberdeen Varicose Veins Questionnaire (mean difference 7.7; 95% CI: -12.82 to -2.58; p=0.003), especially in the physical domains. There was no difference in the HRQoL between severe and mild patients at CIVIQ-20 (p=0.09) ConclusionThe HRQoL was worse in the physical domains in patients with severe CVI when compared to mild patients. However, the heterogeneity of the results was high and the data should be interpreted with caution.

The presence of a pathologic perforator may be predictive of central venous pathology and multilevel disease in severe chronic venous insufficiency

ObjectivesThe treatment of a refluxing perforator is indicated in the setting of severe chronic venous insufficiency, but there are limited data on the presence of multilevel disease in these patients. This study sought to evaluate whether the presence of a pathologic perforator is predictive of the presence of central venous pathology. MethodsThis study was a retrospective review of the institutional Vascular Quality Initiative database. Consecutive patient limbs were identified that underwent intervention of refluxing perforators. The patients who underwent imaging, including magnetic resonance imaging or computed tomography (group A), were compared with those who did not undergo imaging (group B). The treated limbs in group A were also compared with the contralateral limbs as an internal control. Anatomical findings on imaging were analyzed by two independent investigators. The primary outcome was the presence and degree of central venous stenosis as measured by an orthogonal diameter reduction of >50% by axial imaging. Secondary outcomes included demographic and clinical differences between the two groups, frequency of central venous intervention, and duration of ulcer healing. Standard statistical analysis was performed. ResultsNinety-three patient limbs underwent treatment of a pathologic perforator, with 30 in group A and 63 in group B. The following demographic and clinical variables were higher in group A compared with group B: male sex, body mass index, deep venous thrombosis history, recent or active anticoagulation use, perforator diameter, Clinical Etiology Anatomy Pathophysiology class 4, 5, or 6, and Venous Clinical Severity Score. Radiographic analysis of group A revealed concordance of a treated pathologic perforator with an ipsilateral central venous stenosis in 53.3% of patients, and a higher frequency of common iliac vein stenosis (50% vs 21.4%, P = .024) and external iliac vein stenosis (20% vs 0%, P = .012) compared with the contralateral limbs. When separated by the left or right limb, the left limbs exhibited a greater degree of common iliac vein stenosis as compared with the contralateral limbs (50.7% ± 20.9% vs 16.3% ± 16.5%, P < .001) as well as a greater frequency of >50% common iliac vein stenosis (46.7% vs 13.3%, P = .046). The right limbs exhibited a greater frequency of >50% external iliac vein stenosis as compared with the contralateral limbs (33.3% vs 0%, P = .022). ConclusionsThis study suggests that patients with severe chronic venous insufficiency who undergo treatment for a pathologic perforator may have additional ipsilateral central venous pathology, supporting the presence of multilevel disease. Additional axial imaging might unmask central venous pathology and provide another option for treatment.

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

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

Clinical and hemodynamic outcome of morbidly obese patients with severe chronic venous insufficiency with and without bariatric surgery

ObjectiveObesity is associated with several medical problems, including chronic venous insufficiency resistant to usual conservative measures. Venous intervention in patients with a body mass index (BMI) >30 kg/m2 is associated with a higher anesthetic risk and recurrence rate. The aim of the present study was to compare the severity of venous insufficiency in terms of the clinical findings and hemodynamics between morbidly obese patients who had and had not undergone bariatric surgery (BS). MethodsA total of 123 patients with morbid obesity and severe venous manifestations were included in the present study. The patients were divided into two groups. Group A included 72 patients who had undergone BS, and group B included 51 patients who had not undergone BS. Assessments were performed using both disease-specific and physician-generated tools and duplex ultrasonography. ResultsOf the 123 patients, 66% were men. The mean patient age was 44 ± 8.2 years. All the patients were followed up for 1 year. The mean BMI for group A had decreased from 50.1 ± 5.6 kg/m2 to 32.9 ± 4.2 kg/m2 (P = .0001). However, the mean BMI for group B had increased from 49.2 ± 6.1 kg/m2 to 50 ± 5.7 kg/m2 (P = .16). For the patients with a history of venous ulcer, the Charing Cross Venous Ulceration Questionnaire score for group A had decreased 77.5 to 36.8 (P = .0001) compared with a decrease in group B from 77.34 to 75.36 (P = .13). In group A, the median Venous Disability Score had improved from 2 to 0 and the median Venous Clinical Severity Score from 8.6 to 2.1 compared with nonsignificant changes in group B. The number of patients with venous claudication had decreased from 8 to 2 (P = .036) in group A compared with no changes in group B. For group A, the mean 36-item short-form heath survey score had increased from 48 ± 6.8 to 81 ± 4.4 (P = .001) compared with an increase from 52 ± 8.8 to 59 ± 1.2 (P = .52) in group B. The mean common femoral vein diameter had decreased significantly in group A (7.3 ± 1.3 mm) compared with that in group B (8.93 ± 1.08; P = .0001). The peak venous velocity showed higher values for the patients who had undergone BS (group A, 14.9 ± 2.5 cm/s; group B, 10.75 ± 2.05 cm/s; P = .0001). Higher mean velocities and a lower diameter resulted in a higher wall shear stress in group A compared with that in group B (2.2 ± 1.1 dyn/cm2 vs 1.16 ± 0.52 dyn/cm2; P = .0001). ConclusionsThe patients who had lost weight after BS experienced noticeable improvements in chronic venous insufficiency compared with the patients who had not lost weight, including an increased rate of ulcer healing, a decreased incidence of venous claudication, and improved quality of life.

Practical experience with adjustable, non-extensible compression bandages in patients with nonhealing trophic ulcers

Introduction. The adjustable non-extensible compression bandage is a new product recently registered and approved for clinical use in the Russian Federation. The main indications for its use are severe chronic venous insufficiency and lymphedema, which cannot be corrected with traditional bandages and flat knit medical compressions. On the affected limb, an adjustable, non-extensible compression bandage allows high working pressure to be created at low, approaching zero, resting pressure. And depending on the tension of the velcro fastener, the working pressure can be adjusted between 20 and 50 mmHg or more. At the same time, the patient can maintain the actual pressure independently, regardless of the reduction in the volume of the limb. Low resting pressure makes it possible to use this type of bandage all day without the discomfort that is typical for traditional bandages and therapeutic compression knitwear felt by patients during sleep.Clinical case. Patient diagnosed with chronic lymphovenous insufficiency in both lower limbs. CEAP class C5 on the left, CEAP class C5 on the right. After undergoing acute iliofemoral thrombosis on the left, complicated by thromboembolism of small branches of the pulmonary artery, he was treated in a specialized vascular unit, where anticoagulant, antiplatelet and phlebotropic therapy was carried out. After the second episode of deep vein thrombosis, pain in the lower extremities, swelling of the tibia, skin itching and the appearance of small trophic ulcers started to worry, which temporarily closed against the background of increased compression therapy, prescription of phlebotropic drugs and local treatment. Subsequently, large trophic ulcers were formed on the inner surface of both shins above the ankle joint. An adjustable, non-extensible compression bandage was used on the right shin to correct chronic venous insufficiency and heal a trophic ulcer. The use of an adjustable, non-extensible compression bandage within 2 to 4 weeks resulted in the disappearance of chronic swelling, reduction of the pain syndrome, and then 5 months later – led to a reduction in trophic ulcer and the disappearance of infection signs.Conclusions. This clinical case of the successful closure of a large infected trophic ulcer that occurred after deep vein thrombosis against the background of coxarthrosis and which remained unhealed for 7 years clearly illustrates the broad possibilities of an adjustable, nonextensible compression bandage.

Iliac Venous Stenting for Outflow Obstruction Does Not Significantly Change the Quality of Life of Patients With Severe Chronic Venous Insufficiency

In patients with either healed (C5) or active (C6) venous ulcers, percutaneous iliac venous stenting for intravascular ultrasound-confirmed stenosis did not have a positive impact on quality of life (QoL). In a single-center study, 172 venous ulcer patients underwent iliocaval venography and intravascular ultrasound, with 109 patients having iliac vein stent placement for >50% stenosis between the years of 2006 and 2012. The remainder were treated medically. Less than half (47%) completed a QoL survey. Moderate persistent pain and postprocedure discomfort were reported in 43% of the stented and 58% of the nonstented patients. All other QoL criteria, including physical, psychological, and social activities, were similar between the cohorts. Venous ulcerations lead to significant morbidity with negative impacts on a patient's ability to engage in activities of daily living, to maintain an active lifestyle including social relationships, and to work. There have been many single-center and multicenter studies demonstrating improvements in QoL after stenting for iliac venous outflow obstruction, including several from high-volumes centers (see any study by Néglen and Raju). It behooves the treating physician to recommend interventions that are going to make an impact, heal the ulcer, and improve the patient's life. The Joint Society for Vascular Surgery and American Venous Forum Clinical Practice Guidelines (J Vasc Surg 2014;60:3S-59S) recommendation 6.14 states that “we recommend venous angioplasty and stent recanalization in addition to standard compression therapy to aid in venous ulcer healing and to prevent recurrence. [Grade - 1; Level of Evidence - C]” This study was a retrospective review with no QoL survey given as a baseline before intervention and no correlation with low QoL scores and lack of healing, stent thrombosis, or the impact of adjunctive venous procedures such as superficial venous ablation or phlebectomies. I also find this study interesting as the footnote states that the data were presented “in part” in 2014, but the manuscript was not submitted and published until 2019.

The intravascular ultrasound morphometry of iliac veins in subjects without severe chronic venous insufficiency and its implications for treatment indications and stent size selection.

The purpose of this study is to report the intravascular ultrasound morphometry of iliac veins and its relation to demographic and anthropometric factors in subjects without chronic venous insufficiency. Thirty-three patients, without chronic venous insufficiency - qualified to great saphenous vein stripping due to unilateral, primary varicose veins - participated in the study. During the surgery, left and right external iliac veins, common iliac veins and inferior vena cava were interrogated with intravascular ultrasound. The morphometric analysis included measurement of a cross-sectional area at normal, non-stenosed vein segments (ref-CSA) and at the point of the most prominent narrowing (minimal lumen area (MLA)). Based on these measurements, a percentage of stenosis (S%) and calculated lumen diameter of interrogated veins were determined according to the following formulas, S% = (ref-CSA-MLA)/ref-CSA × 100 and CLD = 2 × √(ref-CSA/π), respectively. Median ref-CSA, S% and calculated lumen diameter were 265.3 mm2, 45.8% and 18.4 mm for inferior vena cava; 193.9 mm2, 62.4% and 15.7 mm for left common iliac veins; 166.9 mm2, 35.7% and 14.2 mm for right common iliac veins; 136.5 mm2, 48.0% and 12.8 mm for left external iliac veins and 140.9 mm2, 46.3% and 13.5 mm for right external iliac veins. There were statistically significant differences between left and right common iliac veins ref-CSA, common iliac veins S% and common iliac veins calculated lumen diameter (p = 0.03, p < 0 and p = 0.03, respectively). The S% of left external iliac veins was greater in women 52.2 versus 37.2% in men (p = 0.04). Neither age nor anthropometric factors had any influence on the calculated lumen diameter of the analysed veins. A negative correlation between the left common iliac veins S% and the age was observed (p = 0.03). In adult subjects, the calculated lumen diameter of the common iliac veins is greater on the left side and is not influenced by age and body size. Common iliac vein stenosis occurs more frequently on the left side, decreases with age and tends to be more frequent in women.

Iliac venous stenting for outflow obstruction does not significantly change the quality of life of patients with severe chronic venous insufficiency.

PurposePercutaneous endovenous iliac stenting has emerged as a new modality in the treatment of advanced chronic venous insufficiency with outflow obstruction. However, the effect of this intervention on the quality of life remains unclear. We examined the impact of iliac venous stenting for outflow obstruction as compared to conservative medical management on the quality of life in severe chronic venous insufficiency patients.MethodsMedical records of all patients with CEAP class 5 and 6 disease (N = 172) who underwent ilio-caval venography with intravascular ultrasonography (IVUS) at a single institution over a seven-year period, were reviewed for this case–control study. Quality of life evaluation was performed utilizing the Chronic Venous Insufficiency Quality of Life Questionnaire (CIVIQ-20) one year after the index procedure.ResultsOf the 172 severe chronic venous insufficiency patients, 109 were stented and 63 patients were treated medically based on their venography and IVUS results. The indication for stenting was confirmation of IVUS determined surface area or diameter outflow stenosis of greater than 50% within the common or external iliac venous systems. Eighty patients (47%) responded with completed CIVIQ-20 questionnaires for analysis. Of these, 47 were from the stented group and 33 from the non-stented group. At least moderate persistent pain or discomfort post-procedure was reported by 20 (43%) stented group patients and 19 (58%) non-stented group patients. Scores for all the other criteria in the CIVIQ-20 were similar between the groups. The mean total CIVIQ-20 score was 45.23 and 47.13, respectively, in stented group and non-stented group patients. (p = 0.678).ConclusionThere was no significant difference in the quality of life reported by CEAP 5 and 6 patients who underwent iliac venous stenting versus those who were treated medically for presumed iliac outflow obstruction. Prospective studies are needed to determine the true value of iliac venous stenting based on IVUS criteria in the management advanced chronic venous insufficiency.

Preliminary report of a new type of braided vein stent in animals.

Iliofemoral vein stenosis or occlusion is a common cause of severe chronic venous insufficiency. Endovascular venous stenting has become a preferred treatment because it is minimally invasive and has a high safety profile. Despite the wide application of the wallstent, it is not specifically designed for veins. There are currently few studies on braided stents in the field of veins. We designed a novel braided vein stent, which has higher radial resistive force and more optimized looped ends structure compared with the wallstent. The purpose of this study was to evaluate the safety and performance of the stent in animals, providing a reference for further clinical trials. The Wallstent is used as a control group. The novel stent and the Wallstent were implanted in the iliac vein of sheep. After 30 days and 90 days, vascular injury, thrombus, neointima coverage, and luminal stenosis were evaluated through venous angiography, endoscopic observation of stent specimen and histopathology. Imaging, histology, and integration data were analyzed by t-test for comparisons between the groups. Two groups of stents were successfully implanted. Follow-up observation showed that there was no thrombosis or obstruction >50% occurred in any group and no significant differences in patency, vascular injury, or intimal hyperplasia compared with the Wallstent. The novel stent significantly increases the radial resistive force and does not increase vascular injury, thrombus and stent stenosis during 30-day and 90-day follow-up. The next step is to further validate the effectiveness of the stent through long-term animal observation and human clinical trials.

[S1 guideline on intermittent pneumatic compression (IPC)].

Under the direction of the German Society of Phlebology (Deutsche Gesellschaft für Phlebologie) and in cooperation with other specialist associations, the S1 guideline on intermittent pneumatic compression (IPC) was adopted in January 2018. It replaces the previous guideline from March 2005. The aim of the guideline is to optimize the indication and therapeutic use of IPC in vascular diseases and edema. An extensive literature search of MEDLINE, existing guidelines, and work relevant to the topic was performed. In view of the often methodologically weak study quality with often small numbers of cases and heterogeneous treatment protocols, recommendations can often only be derived from the available data using good clinical practice/expert consensus. Intermittent pneumatic compression is used for thromboembolism prophylaxis, decongestive therapy for edema, and to positively influence arterial and venous circulation to improve clinical symptoms and accelerate ulcer healing in both the outpatient and inpatient care setting. The therapy regimens and devices used depend on the indication and target location. They can be used as outpatient and inpatient devices as well as at home for long-term indications. A target indication is thrombosis prophylaxis. IPC should be used in severe chronic venous insufficiency (stages C4b to C6), in extremity lymphedema as an add-on therapy and in peripheral arterial occlusive disease (PAOD) with stable intermittent claudication or critical ischemia. IPC can be used in post-traumatic edema, therapy-resistant venous edema, lipedema and hemiplegia with sensory deficits and edema. Absolute and relative contraindications to IPC must be taken into account and risks considered and avoided as far as possible. Adverse events are extremely rare if IPC is used correctly. If the indication and application are correct-also as an add-on therapy-it is a safe and effective treatment method, especially for the treatment of the described vascular diseases and edema as well as thrombosis prophylaxis.