Addressing the Impact of Deep Venous Stenting on the Management of Venous Ulcer.

BACKGROUND: Venous ulcers are a late and severe form of chronic venous insufficiency and account for 70% of all etiologies that cause leg ulcers in the lower limb, and they account for 20% of the 2.5 million cases complaining of chronic venous disease. Our study aims to investigate the effect of venous stenting of the deep veins on the healing of the venous ulcer. METHODS: This is a single-center, retrospective study conducted on prospectively recorded medical records of 78 patients with chronic deep venous diseases-C6 (either nonocclusive iliac venous lesion or post-thrombotic syndrome). Our lesion involved May-Thurner lesions, occlusions, insufficiencies, or stenoses owing to an affection of the venous outflow segment. All our patients underwent endovascular management, and those who did not respond successfully were transitioned to compression therapy. We then compared the outcomes of both groups in terms of ulcer healing and quality of life. RESULTS: A total of 78 patients (78 limbs), with a mean age of 39.6 ± 8.06 (range: 22-60) years, were treated. Fifty-four patients (67.9%) were males, and 24 (32.1%) were female. The etiology was primary nonocclusive iliac venous lesion in 12 limbs (16.2%) and secondary post-thrombotic obstructions in 66 (83.7%). Follow-up of the ulcer with compliance to compression therapy and standard care of the ulcer, sustained ulcer healing (reduction in ulcer area) was achieved in 60% of limbs, and most of the nonocclusive healing occurred within the first 3 months (P < 0.01). CONCLUSIONS: Our results show that deep venous stenting is associated with high wound healing rates. This rate reaches a statistically significant difference in 3 months, but this difference doesn't reach statistical significance at 6 months, with less recurrence and improved quality of life with a high cumulative patency rate, and compression therapy is the mainstay of the conservative management of venous ulceration.

The TOPOS study.

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

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

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

Three-Year Outcomes of the Abre Venous Self-Expanding Stent System in Patients with Symptomatic Iliofemoral Venous Outflow Obstruction.

PURPOSE: To report 36-month outcomes and subgroup analysis of the ABRE study evaluating the safety and effectiveness of the Abre venous self-expanding stent system for the treatment of symptomatic iliofemoral venous outflow obstruction disease. METHODS: The ABRE study was a prospective, multicenter, nonrandomized study that enrolled and implanted Abre venous stents in 200 participants (mean age 51.5 years [SD ± 15.9], 66.5% women) with symptomatic iliofemoral venous outflow obstruction at 24 global sites. Outcomes assessed through 36 months included patency, major adverse events, stent migration, stent fracture, and quality-of-life changes. Adverse events and imaging studies were adjudicated by independent clinical events committee and core laboratories, respectively. RESULTS: Primary, primary-assisted, and secondary patency through 36 months by Kaplan-Meier estimates were 81.6%, 84.8%, and 86.3%, respectively. The cumulative incidence of major adverse events through 36 months was 10.2%, mainly driven by 12 thrombosis events. Subgroup analyses demonstrated a primary patency of 76.5% in the acute deep vein thrombosis group, 70.4% in the postthrombotic syndrome group, and 97.1% in the nonthrombotic iliac vein lesion group through 36 months. The overall mean lesion length was 112.4 mm (SD ± 66.1). There were no stent fractures or migrations in this study. Quality of life and venous functional assessments demonstrated significant improvements from baseline to 36 months across all patient subsets. CONCLUSIONS: Results from the ABRE study demonstrated sustained patency with a good safety profile after implantation of a dedicated venous stent in patients with symptomatic iliofemoral venous outflow obstruction disease.

Quality of Life after Venous Stenting for Post-thrombotic Syndrome and the Effect of Inflow Disease.

OBJECTIVE: Patients with PTS experience an impaired quality of life (QoL). We aimed to study QoL in patients stented for post thrombotic syndrome (PTS) and analyze the influence of different parameters. METHODS: Patients stented for PTS after iliofemoral deep vein thrombosis were asked to complete the Chronic Venous Disease Quality of Life Questionnaire (CIVIQ-20) and the Short Form Health Survey (SF-36) in this cross-sectional study. All other data were collected retrospectively. Primary endpoints were median CIVIQ-20 and physical (PCS) and mental (MCS) component summary SF-36 scores. The influence of age, sex, and years between the procedure and completion of questionnaire were investigated using a multivariate linear regression model. Wilcoxon signed rank test compared the PCS and MCS with the normative. Effects of inflow from the deep femoral vein (DFV) and/or the femoral vein (FV) on QoL was analyzed in patients with patent stents. RESULTS: The response rate was 70.3% (n = 45/64). Time period (median) from stenting to questionnaire completion was 6.6 years (IQR: 8.0). Most stents were placed unilateral left-sided (73.3%). For patients with patent stents (n = 42) median CIVIQ-20 was 35.5 (IQR: 17.3), higher than the minimum of 20.0 (P < .001). Median PCS of 44.7 (IQR: 14.2) was lower (P < .001), and MCS of 55.9 (IQR: 7.1) higher (P = .001) than the normative (50.0). Time since stenting and sex were not associated with QoL. Age was a significant predictor [standardized coefficient ß = .36, P = .04] for QoL using the CIVIQ-20, but not for the SF-36. Inflow disease did not impact QoL, but patients with occluded stents (n = 3) had poor functioning levels. CONCLUSION: Quality of life is impaired after venous stenting for PTS, particularly physical functioning, among patients with an open stent, but was similar between patients with good and impaired inflow. Patients with a permanent stent occlusion had the lowest QoL.

Effect of body mass index on initial presentation and outcomes after stenting for quality of life-impairing chronic iliofemoral venous obstruction.

OBJECTIVE: The incidence of obesity has been increasing, with recent data indicating that the age-adjusted mean body mass index (BMI) is close to 30 kg/m2 in the United States. Prior studies have raised concerns for an increased incidence of chronic venous insufficiency in the obese population. We aimed to build on current knowledge by assessing the effects of BMI on the initial presentation and outcomes after intravascular ultrasound (IVUS) luminal area-guided stenting in patients presenting with quality of life (QOL)-impairing chronic iliofemoral venous obstruction (CIVO). METHODS: A retrospective analysis of contemporaneously entered electronic medical record data on 464 continuous patients (464 limbs) with initial iliofemoral stents (2014-2017) for QOL-impairing CIVO was performed. The characteristics evaluated and compared included the degree of iliofemoral compression, CEAP (clinical, etiologic, anatomic, pathophysiologic) clinical class, venous clinical severity score (VCSS), grade of swelling (GOS), visual analog scale (VAS) for pain score, ulcer healing, reflux (venous segmental disease score; venous filling index-90), calf pump function (ejection fraction; residual volume fraction), and quality of life (CIVIQ-20 [chronic lower limb venous insufficiency 20-item questionnaire]) for those with a BMI <30 kg/m2 (group I) and a BMI ≥30 kg/m2 (group II). Paired and unpaired t tests were used for comparisons of the clinical variables and a Kaplan-Meier analysis was used to evaluate stent patency. RESULTS: Of the 464 limbs in the study cohort, 122 were in group I and 342 in group II. The median BMI was 26.3 kg/m2 (interquartile range, 19.6-29.9 kg/m2) in group I and 38.9 kg/m2 (interquartile range, 30.0-66.9 kg/m2) in group II. The IVUS luminal area-determined degree of compression was higher in group I than in group II across the common iliac, external iliac, and common femoral segments (P < .01). The supine foot venous and femoral venous pressures were higher in group II than in group I (P < .001). The ejection fraction was higher (57.4% vs 45.6%; P = .0008) and residual volume fraction was lower (27.5% vs 40.5%; P = .0008) in group II than in group I. Although the baseline VCSS and GOS were lower in group I than in group II (P < .05), no differences were found in the VAS for pain scores or ulcer prevalence. The median follow-up was 22 months. At 24 months after stenting, improvement was found in the VCSS, GOS, and VAS for pain score in both groups. The CIVIQ-20 QOL score had improved from 58.1 to 18.8 in group I (P = .0002) and from 60 to 37.5 in group II (P < .0001). At 5 years, primary patency was 70% in group I and 73% in group II (P = .6) and primary assisted patency was 100% in both groups (P = .99) without a significant difference in the reintervention rate (P = .5). CONCLUSIONS: Obese patients with CIVO-impairing QOL have a lesser degree of iliofemoral venous stenosis, more severe venous hypertension, and better calf pump function than their nonobese counterparts. After stenting, no differences were found in the clinical, stent patency, or QOL-related outcomes between the two groups.

Comparison of endovascular strategy versus hybrid procedure in treatment of chronic venous obstructions involving the confluence of common femoral vein.

OBJECTIVE: Treatment of extensive chronic venous obstruction (CVO) with post-thrombotic trabeculation involving the common femoral vein with extension into the femoral vein or deep femoral vein remains a challenge and the best treatment technique for such cases is not clear. In the present study, we compared the results of endovascular alone vs endovascular with additional endophlebectomy (hybrid) procedures for such patients. METHODS: The medical records of 102 consecutive patients (108 limbs) treated between 2015 and 2020 for iliofemoral CVO extending to the femoral confluence were retrospectively reviewed. The patients were divided into two groups: the hybrid procedure (HP) and endovascular treatment (EN) groups. The HP group consisted of those treated with stent implantation and endophlebectomy of the common femoral vein with creation of an arteriovenous fistula. The EN group included those who had undergone stent implantation alone. The patency rates, complications, and clinical outcomes were analyzed. RESULTS: Of the 102 patients, 47 (49 limbs) were in the EN group and 55 (59 limbs) were in the HP group. The demographics of the two groups were similar with no statistically significant differences in cumulative primary, assisted primary, or secondary patency rates at 36 months (33.7% vs 36.3%, P = .839; 59.8% vs 64%, P = .941; 69% vs 72.7%, P = .851; respectively). The patients in the EN group, however, had better clinical improvement with a lower postoperative complication rate (P = .012), shorter procedure duration (P < .001), and shorter hospital stay (P = .025). CONCLUSIONS: The EN and HP both provided similar patency rates for patients with CVO extending into the femoral confluence. The endovascular strategy has the benefit of fewer postoperative complications and a shorter procedure duration and hospital stay compared with the HP.

Surgical and non-surgical approaches in the management of lower limb post-thrombotic syndrome.

Introduction: Post-thrombotic syndrome (PTS) is a common lifelong condition affecting up to 50% of those suffering from deep vein thrombosis (DVT). PTS compromises function and quality of life with subsequent venous ulceration in up to 29% of those affected.Areas covered: A literature review of surgical and non-surgical approaches in the prevention and treatment of PTS was undertaken. Notable areas include the use of percutaneous endovenous interventions and the use of graduated compression stockings (GCS) after acute proximal DVT.Expert opinion: In patients with acute iliofemoral DVT, we think it is important to have a frank conversation with the patient about catheter-directed thrombolysis, aiming to reduce the severity of PTS experienced. We advocate ultrasound-accelerated thrombolysis with adjunctive procedures, such as deep venous stenting for proximal iliofemoral DVT. For patients with isolated femoral DVT, we believe that anticoagulation and GCS should be recommended. In patients with established PTS, we recommend GCS for symptomatic relief. We recommend that patients engage in regular exercise where possible with the prospect of gaining symptomatic relief. For those with severe PTS that has a significant effect on quality of life, we discuss the patient's case at a multi-disciplinary team meeting to plan for endovenous intervention.

Comparing Safety and Efficacy of Rivaroxaban with Warfarin for Patients after Successful Stent Placement for Chronic Iliofemoral Occlusion: A Retrospective Single Institution Study.

OBJECTIVE: The aim was to compare the safety and effectiveness of rivaroxaban and warfarin as anticoagulants for treating patients with post-thrombotic syndrome (PTS) with chronic iliofemoral venous occlusion undergoing iliofemoral venous stenting. METHODS: This single institution retrospective study analysed patients with PTS with chronic iliofemoral venous occlusion who were prescribed rivaroxaban or warfarin for one year after successfully undergoing iliofemoral venous stenting. The primary safety and efficacy endpoints were bleeding complication rate and primary patency rate at one year. Secondary outcomes included Villalta score, symptom recurrence rate, ulcer healing rate, and clinically driven target lesion revascularisation (CD-TLR) rate during follow up. RESULTS: From January 2016 to December 2017, 154 legs from 154 patients were included in this study (69 in rivaroxaban group and 85 in warfarin group). The groups were well matched for patient demographics, clinical characteristics, and procedural details. There was no significant difference between the rivaroxaban group and warfarin group in bleeding complication rate (10% vs. 16%, p = .23, hazard ratio [HR] 0.58, 95% confidence interval [CI] 0.25 - 1.37) at one year, as well as major bleeding complication rate (0% vs. 2%, p = .20, HR 0.16, 95% CI 0.01 - 2.61) and minor bleeding complication rate (10% vs. 14%, p = .40, HR 0.67, 95% CI 0.27 - 1.66). The primary patency rate was higher in the rivaroxaban group at one year (84% vs. 71%, p = .049, HR 0.50, 95% CI 0.26 - 0.96) and at two years (79% vs. 63%, p = .037, HR 0.52, 95% CI 0.29 - 0.93). At a mean follow up of 24 months (range 1 - 42 months), the rivaroxaban group had a significantly lower post-operative Villalta score (4.87 ± 3.51 vs. 6.88 ± 5.85, p = .010, t = 2.64, 95% CI 0.50 - 3.52), lower rate of symptom recurrence (4% vs. 32%, p < .001), lower CD-TLR rates (3% vs. 13%, p = .039), and higher ulcer healing rate (90% vs. 59%, p = .004) than the warfarin group. CONCLUSION: For PTS patients with chronic iliofemoral venous occlusion undergoing iliofemoral venous stenting, rivaroxaban probably exhibited similar safety but superior efficacy to warfarin. However, further prospective control studies with large sample size are necessary to confirm the results.

Doppler ultrasound and contrast-enhanced ultrasound in detection of stent stenosis after iliac vein stenting.

BACKGROUND: To compare the diagnostic accuracy of Doppler ultrasound (DUS) with contrast-enhanced ultrasound (CEUS) for detection of iliac vein stent stenosis using multidetector computed tomography venography (MDCTV) as the reference method. METHODS: Patients with iliac vein obstructive disease treated with nitinol stents (Smart Control, Cordis, USA) between January 2016 and December 2017 were consecutively included in this study. DUS, CEUS, and MDCTV were carried out in all patients within one week of each other at 1 year post stenting to investigate the presence of stent compression and in-stent restenosis (ISR). RESULTS: The study included 139 patients (87 females; mean age 58 ± 15 years). For detecting stent compression, the kappa coefficient between the ultrasound modality of gray-scale imaging and MDCTV was 0.901, indicating very good agreement between these two modalities. ISR was detected in 50, 61, and 65 patients by DUS, CEUS, and MDCTV, respectively. DUS and CEUS (kappa = 0.449) and DUS and MDCTV (kappa = 0.516) had moderate agreement for ISR diagnosis, while for which CEUS and MDCTV (kappa 0.884) had very good agreement. The sensitivity and specificity of DUS and CEUS for diagnosing ISR were 63.1% and 90.8%, 87.8% and 97.3%, respectively. CONCLUSIONS: CEUS is probably superior to DUS in terms of diagnostic accuracy for the follow-up of patients with iliac vein stent stenosis.

Braided or laser-cut self-expanding nitinol stents for the common femoral vein in patients with post-thrombotic syndrome.

BACKGROUND: Chronic obstruction of the common femoral vein in patients with post-thrombotic syndrome after iliofemoral or iliocaval deep vein thrombosis has remained a challenge for endovascular treatment. The patency rates and clinical outcomes of laser-cut and braided nitinol stents extending to the common femoral vein have not yet been studied. METHODS: From the Swiss and Arnsberg Venous Stent Registries, we included 150 patients with post-thrombotic syndrome (mean age, 44 ± 16 years; 48% women) with laser-cut (n = 101) or braided nitinol (n = 49) stents placed into the common femoral vein across the inguinal ligament. Routine follow-up included duplex ultrasound examinations and assessment of clinical scores. The primary study outcomes were the primary and secondary patency rates at 12 months. RESULTS: Overall, the mean number of implanted stents was 2.6 ± 1.7. The proximal stent landing zone was the inferior vena cava in 32 patients (21%), the iliac vein in 106 patients (76%), and the common femoral vein in 5 patients (3%). The primary patency rate was 67.3% (95% confidence interval [CI], 58.0%-76.6%) in the laser-cut group and 86.7% (95% CI, 75.3%-98.1%) in the braided stent group (log-rank, P = .016). The corresponding secondary patency rates were 93.9% (95% CI, 89.2%-98.6%) and 100% (log-rank, P = .10). The median improvement in the Villalta score from baseline to the latest follow-up was 4 points (interquartile range, 2-6 points), without significant differences between the two groups. Symptomatic common femoral vein stent fractures were observed in four patients (4%) with laser-cut stents but in no patient with braided stents. CONCLUSIONS: The use of braided nitinol stents for common femoral vein obstruction appeared to be associated with favorable primary patency rates at 12 months compared with laser-cut nitinol stents. Further studies are needed to confirm that braided nitinol stents remain patent and might be less prone to fractures in the long term.

Association between deep vein thrombosis and stent patency in symptomatic iliac vein compression syndrome: Systematic review and meta-analysis.

BACKGROUND: The study intended to evaluate stent primary patency rates for patients with iliac vein obstruction related with iliac vein compression syndrome according to clinic presentation. METHODS: A systematic review and meta-analysis was conducted of studies that compared: unexposed patients with nonthrombotic iliac vein lesion (NIVL, group 1) vs exposed patients with iliac acute deep vein thrombosis (DVT, group 2); and NIVL (group 1) vs exposed patients with iliac vein obstruction and post-thrombotic syndrome (PTS, group 3). The following databases were searched: EMBASE, PubMed, Web of Science, Scopus, SciELO, and LILACS. Two reviewers independently selected the potential studies and extracted data. The pooled odds ratio (OR) and 95% confidence interval (95% CI) are shown for each outcome. RESULTS: Five studies with a total of 1050 participants and 1169 lower limbs were included. Five hundred eighty-eight lower limbs presented NIVL (50.3%), 91 lower limbs presented acute DVT (7.7%), and 490 lower limbs presented PTS (42%). The endovascular technical success rate of stenting did not differ in any of the groups: 99.6% in NIVL, 94.5% in acute DVT, and 96.5% in PTS (P = .0632). The primary stent patency rates in the 6-month follow-up were 98.3% in NIVL vs 90.9% in PTS, with a statistical difference showing reduced stent patency rates in PTS (OR, 0.17; 95% CI, 0.06-0.48; P = .0008; I2 = 0%), and 100% in the NIVL group vs 91.6% in acute DVT, with no statistical difference (OR, 0.30; 95% CI, 0.06-2.32; P = .30; I2 = 0%). The primary stent patency rates in the 12-month follow-up were 94.6% in NIVL vs 84.1% in PTS, with a statistical difference showing decreases stent patency rates in the PTS group (OR, 0.29; 95% CI, 0.14-0.63; P = .0008; I2 = 0%), and 91.1% in NIVL vs 90.9% in acute DVT, with no statistical difference (OR, 1.03; 95% CI, 0.26-4.07; P = .96; I2 = 0%). CONCLUSIONS: There is no statistical difference for the stent primary patency rates when the treatment is conducted in NIVL as compared with acute DVT lower limbs (at 6 and 12 months); therefore, other criteria must be considered for the indication of this treatment in NIVL patients. However, because there were better results of stent primary patency rates for NIVL vs PTS patients, this finding favors the treatment of acute DVT instead of PTS in lower limbs, once PTS renders smaller stent patency rates at 6 and 12 months.

Outcomes of endovascular venous stenting in patients on direct oral anticoagulants and antiplatelet therapy at a tertiary referral center.

BACKGROUND: Endovenous revascularization is the standard in the management of acute thrombotic, chronic post-thrombotic iliocaval or iliofemoral obstruction, and nonthrombotic iliac vein lesions. The purpose of this study is to describe our single-center experience of postprocedure anticoagulation and antiplatelet regimens used after endovenous revascularization for a variety of venous occlusive conditions. METHODS: We conducted a retrospective analysis of 100 consecutive patients who underwent endovenous stenting for iliocaval or iliofemoral obstruction from January 1, 2014, to April 30, 2018. Patients treated with direct oral anticoagulants, warfarin, or low-molecular-weight heparin (LMWH) with or without antiplatelet therapy were identified. Demographic, procedural, patency, and follow-up data were collected. Stent patency was evaluated using duplex Doppler ultrasound examination or contrast venography. RESULTS: Seventy-one of 100 patients were treated with direct oral anticoagulant therapy (DOAC). Sixteen (23%) were lost to follow-up, leaving 55 (77%) available for analysis. The mean follow-up was 14 months (range, 1-43 months) with 32 patients (58%) followed for 12 months or longer. Primary, primary-assisted, and secondary-assisted patency rates were 87%, 97%, and 98%, respectively, at 12 months. In the non-DOAC group (patients treated with warfarin or LMWH), these rates were 87%, 93%, and 95%, respectively, at 12 months. Antiplatelet therapy, including clopidogrel, aspirin, or both, was used in 53 of 55 patients in the DOAC cohort and 18 of 19 patients in the non-DOAC group. CONCLUSIONS: Our-single center retrospective analysis demonstrates acceptable primary patency rates when using DOAC therapy compared with those treated with warfarin or LMWH.

Long-term outcomes following use of a composite Wallstent-Z stent approach to iliofemoral venous stenting.

OBJECTIVE: An endovascular approach has essentially replaced open surgery in the management of symptomatic chronic obstructive iliofemoral venous disease. In the last several years, such a minimally invasive approach has shifted from use of Wallstents alone to a combination of Wallstent-Z stent (composite stenting) to better deal with the iliocaval confluence. This study evaluates the clinical and stent related outcomes following use of composite stenting. METHODS: A retrospective review of contemporaneously entered EMR data on 535 patients (545 limbs) with initial iliofemoral stents placed over a 4-year period from 2014 to 2017 for symptomatic chronic iliofemoral venous obstruction was performed. Patients who underwent stenting after intervention for acute deep venous thrombosis were excluded. The impact of stenting on clinical outcomes before and after the intervention were evaluated through use of the visual analog scale pain score (0-10), grade of swelling (0-4), and Venous Clinical Severity Score (0-27). Quality of life was appraised using the Chronic Venous Disease quality of life Questionnaire 20 instrument. Kaplan-Meier analysis was used to assess primary, primary assisted and secondary stent patencies, and paired and unpaired t-tests were used to examine clinical outcomes. RESULTS: Of the 545 limbs that underwent stenting, 183 were in men and 362 were in women. The median age was 60 years. Laterality was right in 205 limbs and left in 340 limbs. Post-thrombotic syndrome was seen in 441 limbs and nonthrombotic iliac vein lesions/May-Thurner syndrome in 104 limbs. At 24 months, visual analog scale pain score went from 5 to 2 (P < .0001), grade of swelling went from 3 to 1 (P < .0001), and Venous Clinical Severity Score went from 6 to 4 (P < .0001). Ulcers were present in 67 limbs and had healed in 49 limbs (73%) over a median follow-up of 26 months. Global Chronic Venous Disease quality of life Questionnaire scores improved from 60 to 36 (P < .0001) after stenting. Cumulative primary, primary-assisted, and secondary patencies at 60 months were 70%, 99% and 91%, respectively. Thirty limbs (5.5%) required contralateral stenting. There was only one instance (0.2%) of contralateral iliofemoral deep venous thrombosis. One hundred eleven limbs (20%) underwent reintervention, including for in-stent restenosis in 44 limbs, stent compression in 2 limbs, in-stent restenosis and stent compression in 48 limbs, and stent occlusion in 17 limbs. CONCLUSIONS: In patients undergoing iliofemoral venous stenting for obstructive disease, clinical improvement, quality of life improvement, and stent patencies after use of a composite stent configuration are comparable with those seen after exclusive use of Wallstents. However, the use of a composite stent configuration not only decreases the need for contralateral stenting to relieve chronic obstruction, but also decreases the incidence of contralateral iliofemoral deep venous thrombosis.

Iliocaval outflow obstruction in patients with venous ulcers in a small comparison study between patients with primary varicose veins and chronic deep vein disease.

OBJECTIVE: Iliocaval outflow obstruction was investigated in patients with venous ulcers caused by primary superficial disease and chronic deep vein disease METHODS: After clinical assessment, patients with healed or active venous leg ulcers underwent lower extremity duplex ultrasound examination to identify the presence of venous disease in the superficial, deep and perforating systems. Bilateral contrast venography and intravascular ultrasound examination were then performed to determine the presence and degree of iliocaval obstructive lesions. RESULTS: This retrospective study included a total of 59 patients with 71 legs presenting active or healed ulcer. There were 16 limbs (22.5%) with superficial venous reflux associated with normal infrainguinal deep veins (group I) and 55 limbs (77.5%) with infrainguinal post-thrombotic deep venous disease (group II). Using venography and intravascular ultrasound examination, the incidence of >50% of venous obstruction in the iliocaval system in groups I and II were 75% and 83.6%, respectively. All obstructive lesions in group I were nonthrombotic. However, group II included thrombotic, nonthrombotic and combinations of the two types of obstructions. Group II had more ulcers (1.73 ± 1.3 vs 1.17 ± 0.5; P = .03), larger ulcers (>6 cm in 34.1% vs 8.3%), longer duration of ulcers (71.3 ± 110.5 months vs 37.9 ± 40.4 months; P = .03), smaller diameter of refluxing superficial veins (7.7 ± 2.6 mm vs 15.1 ± 6.6 mm; P = .001), and higher incidence of occluded iliocaval systems (18 [32.7%] vs 0; P = .003) than group I. After the exclusion of bilateral cases and thrombotic obstructions, the incidence of >50% nonthrombotic obstruction in ipsilateral and contralateral sides was 76.5% and 24.4%, respectively (P = .003). CONCLUSIONS: The results of this study revealed that the majority of patients with venous ulcers with either infrainguinal primary superficial or post-thrombotic deep venous disease had an element of iliocaval venous obstruction.

Assessment of primary lymphedema and post-thrombotic lower limb edema patient's pathway.

OBJECTIVES: To assess: (1) lower limb primary lymphedema or post-thrombotic syndrome patient's pathway in terms of health care professional use and (2) if aetiology of edema has an impact on this pathway. METHODS: Ancillary survey of the transversal prospective CHROEDEM pilot study. Forty patients with either lower limb primary lymphedema or post-thrombotic syndrome were invited to participate. RESULTS: Seventy-five percent of primary lymphedema patients and 50% of post-thrombotic patients benefited from a multidisciplinary management (P=0.10) including the general practitioner, the vascular medicine physician and either a physiotherapist (particularly in case of primary lymphedema), a registered nurse (particularly in case of post-thrombotic syndrome). Main ambulatory health care professionals' correspondent of hospital-based vascular medicine physicians were general practitioners (80%) in post-thrombotic patients, and general practitioners (60%) and physiotherapists (45%) in primary lymphedema patients. Pharmacists were also involved in patient education. CONCLUSION: Management of primary lymphedema and post-thrombotic related chronic edema is usually multidisciplinary. General practitioners and vascular medicine physicians are the cornerstones of this management, that also involves the physiotherapist in case of primary lymphedema and in a lesser extent the registered nurse and the pharmacist. This suggests that these five healthcare professional should play a key role in case of development of standardized patient pathways for primary lymphedema and post-thrombotic syndrome.

The 2020 update of the CEAP classification system and reporting standards.

The CEAP (Clinical-Etiology-Anatomy-Pathophysiology) classification is an internationally accepted standard for describing patients with chronic venous disorders and it has been used for reporting clinical research findings in scientific journals. Developed in 1993, updated in 1996, and revised in 2004, CEAP is a classification system based on clinical manifestations of chronic venous disorders, on current understanding of the etiology, the involved anatomy, and the underlying venous pathology. As the evidence related to these aspects of venous disorders, and specifically of chronic venous diseases (CVD, C2-C6) continue to develop, the CEAP classification needs periodic analysis and revisions. In May of 2017, the American Venous Forum created a CEAP Task Force and charged it to critically analyze the current classification system and recommend revisions, where needed. Guided by four basic principles (preservation of the reproducibility of CEAP, compatibility with prior versions, evidence-based, and practical for clinical use), the Task Force has adopted the revised Delphi process and made several changes. These changes include adding Corona phlebectatica as the C4c clinical subclass, introducing the modifier "r" for recurrent varicose veins and recurrent venous ulcers, and replacing numeric descriptions of the venous segments by their common abbreviations. This report describes all these revisions and the rationale for making these changes.

Endophlebectomy of the common femoral vein and endovascular iliac vein recanalization for chronic iliofemoral venous occlusion.

BACKGROUND: Chronic post-thrombotic occlusion of the iliofemoral veins causes significant morbidity, which can be alleviated if venous drainage is restored. We report our technique of surgical endophlebectomy and patchplasty of the common femoral vein (CFV) in conjunction with iliac vein stenting to restore venous flow from the infrainguinal venous system to the vena cava. METHODS: There were 157 patients who underwent CFV endophlebectomy combined with iliocaval recanalization. Questionnaires were completed both preoperatively and postoperatively to allow comparison. These included the Clinical, Etiology, Anatomy, and Pathophysiology clinical classification; the Venous Clinical Severity Score; the Villalta scale; the Venous Insufficiency Epidemiological and Economic Study on Quality of Life/Symptoms; and the 36-Item Short Form Health Survey quality of life questionnaire. RESULTS: Mean follow-up duration was 14.4 ± 2.9 months (range, 10-29 months). The mean preoperative Venous Clinical Severity Score was 15.3 ± 2.2, and this fell to 6.1 ± 1.8 after treatment (P < .001). The mean preoperative Villalta score dropped from 12.7 ± 2.6 to 6.3 ± 1.4 (P < .001). The quality of life and symptom severity scores were improved after 3 months by 17.2 points for quality of life (P < .001) and 20.5 points for symptom severity (P < .001). Primary patency was 81% (124/153) and secondary patency was 89.5% (137/153) at 12 months. Wound complications related to groin incision and lymphatic fistulas were observed in 22.8% (35/153) and 28.7% (44/153), respectively. CONCLUSIONS: The hybrid operation of CFV endophlebectomy in conjunction with iliac vein recanalization should be considered a safe and effective treatment option in patients with severe post-thrombotic syndrome and iliofemoral veno-occlusive disease.

Ultrasound Aspects and Recanalization Rates in Patients with Lower-Limb Deep Venous Thrombosis Treated with Rivaroxaban.

BACKGROUND: In this article, we report the ultrasound aspects and recanalization rates of patients with deep venous thrombosis (DVT) in the lower limbs treated with the rivaroxaban, focusing on the recanalization rate and the ultrasonographic aspects. METHODS: This was a prospective and consecutive cohort study of patients admitted with DVT who were submitted to treatment with rivaroxaban for 6 months at the Division of Vascular and Endovascular Surgery, Hospital do Servidor Público Estadual, São Paulo, Brazil, between March 2016 and July 2018. RESULTS: Fifty-one patients with DVT were admitted to the Vascular Surgery Department and received rivaroxaban for 6 months. The follow-up time was 360 days. Analyses were performed at 180 and 360 days. The rate of total venous recanalization at 360 days was 76.4% (39 patients). The incidence of partial venous recanalization was 23.5% (12 patients). At the first month, 11 patients (21.7%) continued with total occlusion of the vein, with 4 patients (6.5%) with no residual thrombi. However, at 6 months, only 2 patients (2.2%) continued with total occlusion of the vein, with 26 patients (47.8%) with no residual thrombi. At 12 months, there were 39 patients (76.4%) with no residual thrombi. Univariate and multivariate logistic regression identified the following factors related to total venous recanalization: the absence of popliteal vein reflux (odds ratio [OR], 0.386; P = 0.007), no residual thrombi (OR, 3.213; P = 0.008), femoropopliteal clot length at 1 month (OR, 3.021; P = 0.016), femoropopliteal clot length at 6 months (OR, 2.234; P = 0.008). The incidence of post-thrombotic syndrome (PTS) at 12 months was 8.3%. CONCLUSIONS: In this study, patients who received oral rivaroxaban displayed satisfactory total vein recanalization rate after 6 months and 12 months. The factors associated with better total recanalization rates were the absence of popliteal vein reflux, the absence of residual thrombi in the veins, femoropopliteal clot length at 1 month (OR, 3.021; P = 0.016), and femoropopliteal clot length at 6 months (OR, 2.234; P = 0.008). Moreover, the incidence of PTS at 12 months was 8.3%.

Endovascular Treatment of an Anatomically Complex Iliac Lesion and a Review of Variant Iliac Venous Anatomy.

The diagnosis and treatment of pelvic venous disease is complicated by a number of potential venous anatomic variants. Stent-assisted recanalization of a chronically occluded left external iliac vein draining directly into the inferior vena cava, with absence of the left common iliac vein, is described here. Variant iliac venous anatomy is reviewed in 3 categories: additional iliac vessels, absence/shortening of iliac vessels, and deviations in the drainage pattern of iliac vessels. Additionally, variations of the ascending lumbar and iliolumbar veins, the identification of which can aid in the treatment of pelvic venous disease, are described.