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.

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.

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.

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.

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.

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.

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.

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%.

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.

Midterm outcomes in postpartum women following endovenous treatment for acute iliofemoral deep vein thrombosis.

BACKGROUND: The development of post-thrombotic syndrome (PTS) after iliofemoral deep vein thrombosis (DVT) continues to be a considerable issue for both pregnant and postpartum women with rates as high as 70% among those managed with anticoagulation alone. This study aims to characterize the outcomes of interventional treatment for acute iliofemoral DVT in this at-risk population. METHODS: A retrospective analysis of all postpartum patients treated for acute iliofemoral DVT with lysis and stenting between January 2012 and December 2017 at a referral center. Patient demographics, risk factors, procedural factors. and complications were collected. Post-treatment outcomes were compared with all nonpostpartum females treated within the same time period. These included the severity of PTS evaluated using the Villalta scale, duration of vessel patency and factors affecting reintervention timing and success. Further detailed review of cases needing reintervention was also conducted through a retrospective review of documentation and an analysis of all imaging by a consultant radiologist. RESULTS: A total of 11 postpartum women were identified. The median age was 28 years (range, 22-41 years) and intervention was performed at a median of 3 weeks after birth (range 2-12 weeks). No major or minor complications associated with intervention were reported in any patients. The median Villalta score was 3 at 6 months, improving to 2 at 12 months. Overall, two patients were classified as mild having PTS (18%), with no cases of moderate to severe PTS. On comparison with nonpostpartum (n = 68) Villalta scores, no significant difference in outcome was observed at 6 months (median score, 3; range, 0-15 months; P = .95) or at 1 year (median score, 1; range, 0-15; P = .84). Cumulative patency at 1 year was found to be 64% in postpartum women compared with 93% in nonpostpartum women. The postpartum state was found to be a significant predictor of cumulative patency loss (hazard ratio, 0.10; 95% confidence interval, 0.02-0.62; P = .01). However, no significant difference in primary and primary-assisted patency was observed. Of the postpartum patients, 55% required reintervention (6/11) compared with 29% of nonpostpartum patients (20/68). The mean time to initial reintervention was 62 days (range, 7-233 days). Reintervention was unsuccessful in all cases presenting with 100% vessel occlusion (4/11), but successful in both cases with partial occlusion (2/11). Analysis of the etiologic factors associated with reintervention revealed that all reintervention cases were associated with technical failure to fully lyse and stent beyond residual disease at the initial procedure. No technical, flow, or hematologic factors were identified in the four cases that retained primary patency. CONCLUSIONS: This study suggests that percutaneous intervention to achieve early thrombus removal and venous stenting provides a favorable alternative to conservative therapies owing to its potential to decrease the severity of PTS. Completion of lysis and adequate stenting of disease is essential to prevent reocclusion, for which reintervention carries a lower likelihood of success. Further research is warranted to further characterize the appropriate management of postpartum women with iliofemoral DVT.

Persistent symptoms after endovenous thermal ablation may suggest proximal venous outflow obstruction.

OBJECTIVE: Proximal venous outflow obstruction (PVOO) in the iliac veins and superficial venous disease are inter-related in ways not fully understood. We observed among our patients undergoing vein stent placement for PVOO a significant number having had prior endovenous thermal ablations (EVTA) in their history. This study was undertaken to better characterize these patients and develop an algorithm in their management. METHODS: In a combined retrospective and prospective data registry of 682 patients who underwent vein stent placement for chronic PVOO at a single institution from March 2013 to November 2017, 100 limbs of 99 patients (14.5% of all patients) had a history of EVTA or other superficial venous procedures before their vein stenting. Limbs with dilated truncal veins on ultrasound examination or limbs that underwent poststent EVTA or superficial venous procedures were excluded. The mean age of these 99 patients was 60.2 years (range, 28-88 years; standard deviation, 13.855). Fifty-one percent of the patients were male. The most common presenting symptom of the patient cohort was edema (n = 59), followed by venous-related skin changes (n = 22). RESULTS: Bilateral stents were performed in 58%, with a mean number of 2.06 stents per patient. EVTA was the primary superficial vein procedure in 97%. Bilateral EVTA were performed in 53% and unilateral EVTA in 47%. The mean time between the first EVTA to vein stenting was 1202.7 days. Patients were followed at 30 days, 90 days, 6 months, 1 year, and >1 year. The outcome for each patient at each postoperative visit was compared with preoperative parameters (subject's assessment, physical examination, and provider assessment) and was scored as follows: -1 (worse than preoperative), 0 (no change), +1 (mildly improved), +2 (significantly improved), or +3 (completely recovered). The mean outcome score at 30 days was 1.63 (84 patients), 2.05 at 90 days (62 patients), 2.09 at 6 months (74 patients), 1.93 at 1 year (54 patients), and 1.97 at >1 year (39 patients). CONCLUSIONS: Approximately 15% of patients undergoing vein stent placement for chronic PVOO have an antecedent history of superficial venous disease and EVTA. PVOO should be considered and the patient evaluated accordingly if symptoms persisted or recurred after EVTA. Vein stent placement among these patients with PVOO will result in further symptomatic relief, but complete symptomatic relief is not observed in everyone. The algorithm for the management of these patients warrants further investigation.

Evaluation of incidence and clinical significance of obturator hook sign as a marker of chronic iliofemoral venous outflow obstruction in computed tomography venography.

OBJECTIVE: The aim of this paper was to describe the obturator hook sign (OHS), a distinctive dilated angled vein similar to a hook, by computed tomography venography (CTV). It is identified mainly on direct CTV (DCTV) as opposed to indirect CTV (ICTV), evidencing obturator vein engorgement as a marker of hemodynamically significant collateralization and representing an indirect sign for chronic iliac vein outflow obstruction. METHODS: All CTV studies of lower limbs performed from January 2014 to August 2018 in Galway University Hospital and the Galway Clinic were retrospectively reviewed. Data were analyzed using SPSS software (version 25.0; IBM Corp, Armonk, NY). RESULTS: In total, 531 CTV studies were reviewed, of which 122 (23%) were performed for acute deep venous thrombosis, 183 (35%) for follow-up after iliac stenting, and 109 (21%) for etiologic study of chronic venous disease. For the purpose of analysis for the presence of OHS, only first-time CTV studies were included in patients who were never submitted to venous intervention (n = 296), of which 40 were DCTV (14%) and 256 were ICTV (86%). Two groups were defined according to whether OHS was present, and significant predictors were identified: female sex (P = .038), younger age (P < .0001), DCTV (P < .0001), nonthrombotic iliac vein lesion (P < .001), past history of iliofemoral deep venous thrombosis (P < .0001), and dilated pelvic veins (P < .0001). OHS was significantly more common in chronic occlusions compared with chronic stenosis or acute occlusion (P < .0001). Findings from DCTV and ICTV were compared with results from ascending venography as the "gold standard," and the sign proved to have high specificity and positive predictive value (100% for both tests), whereas sensitivity and negative predictive value were low for both DCTV (65% [95% confidence interval (CI), 43%-84%] and 11% [95% CI, 7%-18%], respectively) and ICTV (8% [95% CI, 4%-14%] and 6% [95% CI, 9%-20%], respectively). From analysis of the remaining CTVs, particularly follow-up after iliac stenting, an interesting fact was recognized: successful venous stenting was associated with OHS disappearance, and stent occlusion was also sometimes associated with OHS reappearance or appearance de novo. CONCLUSIONS: The identification of hemodynamically significant lesions in patients with clinically significant chronic venous disease is the aim of any form of imaging. In this study, we have depicted a previously undescribed sign that is straightforward to identify, particularly in DCTV, immediately pointing us toward hemodynamically significant chronic iliac venous outflow obstruction diagnosis. It is too early to call it pathognomonic, but perhaps comparative analysis involving data from additional centers could lead to this conclusion.

Angioscopy: Direct visualization of chronic venous occlusion, May-Thurner syndrome, and other applications in phlebology.

BACKGROUND: Angioscopy has been widely used in the diagnosis and management of vascular disorders and in particular in coronary artery disease. However, few applications have been developed in the diagnosis or management of venous disease. METHODS: Endovenous angioscopy was performed to explore applications of this modality in phlebology. Procedures were performed in a sterile setting. Access was obtained by ultrasound guidance and a 9F introducer sheath. An 8.5F videoscope was used to visualize target veins. Continuous saline irrigation was used to displace blood and to clear the visual field. RESULTS: Fifteen procedures were performed. We describe diagnostic or interventional applications of endovenous angioscopy that include diagnosis and characterization of chronic venous occlusion, deployment of venous stents, angioscopy-guided thrombectomy, foam sclerotherapy, and endovenous laser ablation. Chronic venous occlusion was observed to be fibrotic rather than thrombotic. CONCLUSIONS: Endoscopic imaging of the venous system has great potential to improve access and to guide endovenous interventions. Chronic venous occlusion in post-thrombotic syndrome is a fibrotic process, and chronic venous fibrosis is a better description of the type of occlusion and should replace chronic venous thrombosis.

Evaluation of anticoagulant and antiplatelet therapy after iliocaval stenting: Factors associated with stent occlusion.

OBJECTIVE: Iliocaval stenting has gained increased use over recent years for a variety of indications, including May-Thurner syndrome (MTS), post-thrombotic syndrome (PTS), and acute deep vein thrombosis (DVT). METHODS: A retrospective review of 155 patients undergoing iliocaval venous stenting at a large teaching hospital was performed. Clinical and procedural data, mode and duration of anticoagulation or antiplatelet therapy, and outcomes were recorded. RESULTS: Forty-five patients were treated for MTS, 49 for PTS. and 61 for acute DVT. The median follow-up was 19 months (interquartile range, 9-30 months). Primary patency rates were 97.8% in the MTS group, 85.7% in PTS, and 85.2% for the acute DVT group. Stent restenosis or occlusion occurred in one patient with MTS (2.2%), seven patients with PTS (14%), and nine patients with acute DVT (15%). An ipsilateral DVT recurred in 7 patients with PTS (14%) and 15 patients with acute DVT (25%). The stents that occluded had a tendency toward longer length (162.2 vs 125.2 mm; P = NS) and extension into the common femoral vein (18.8 vs 5.3%; P = NS). The patent stent group had statistically larger nominal diameter stents (P = .013). The duration of anticoagulation did not seem to be a significant factor in stent patency. CONCLUSIONS: Stent diameter has a significant influence on iliocaval stent patency rates.

Update on diagnosis and treatment strategies in patients with post-thrombotic syndrome due to chronic venous obstruction and role of endovenous recanalization.

OBJECTIVE: After a first episode of lower extremity deep venous thrombosis, post-thrombotic syndrome (PTS) develops in 20% to 50% of patients despite adequate anticoagulation. Symptoms of PTS can vary from leg swelling to venous ulceration with disabling venous claudication. It significantly affects the patient's quality of life and has considerable socioeconomic consequences. This review gives an update on diagnosis and current treatment strategies in patients with PTS due to chronic venous obstruction, in particular regarding the role of endovenous procedures. METHODS: This review article is based on a selective literature search in PubMed and the Cochrane Library. The terms "postthrombotic syndrome," "post-thrombotic syndrome," "chronic venous obstruction," "venous outflow obstruction," and "venous stent" were used as keywords. Selected publications addressed the diagnosis of and therapy for PTS. Acute deep venous thrombosis, thrombolysis, case reports, complications as a result of caval vein filters, animal experiments, PTS of the upper extremity, and PTS in children were excluded. RESULTS: In addition to conservative treatment of PTS, the following invasive procedures are also available: open surgical reconstructions, hybrid procedures, and endovenous recanalization of the occluded iliocaval venous tract with stent angioplasty. Since introduction of dedicated venous stents in 2012, technical success, patency rates, and improvement in quality of life have been at least as good as results of open surgical reconstruction if not better. CONCLUSIONS: First-line treatment should be conservative therapy. In case of therapy-resistant PTS with poor quality of life, the possibility of an invasive treatment should be evaluated. All invasive procedures are recommended with low levels of evidence. Therefore, deciding on an invasive treatment and type of procedure should be made individually. Because PTS is rarely a threat to life or limb, a minimally invasive treatment is preferred. Therefore, endovenous recanalization appears to be appropriate as the therapy of choice. In patients with involvement of the femoral confluence, endophlebectomy of the common femoral vein in addition to venous recanalization is inevitable to ensure an adequate inflow into the recanalized venous tract. It also secures a sufficient drainage of blood from the peripheral venous system. Because this hybrid procedure is burdened with a significantly higher risk of complications, strict criteria must be fulfilled to legitimize the indication for this procedure. For the best possible results to be achieved, the following perioperative and postoperative management must be considered: therapeutic anticoagulation, early mobilization, compression therapy, and systematic follow-up with duplex ultrasound.

Long-Term Results of Endovascular Treatment of Chronic Iliofemoral Venous Obstructive Lesions.

OBJECTIVE: To evaluate the long-term results in endovascular treatment of iliofemoral venous obstructive lesions. METHODS: From January 2009 to March 2017, 75 patients were admitted for endovascular treatment of chronic obstructive lesions of the iliofemoral veins. Of these, 60 patients underwent stenting of postthrombotic obstructions and 15 patients stenting of nonthrombotic obstructive lesions of the iliac veins (May-Thurner syndrome in 11, for tumor-induced compression and cicatricial stenosis in 4). Dynamic control of stent patency was carried out by means of duplex ultrasound. Efficacy of endovascular intervention was evaluated by measuring the venous pressure gradient and malleolar circumference. The clinical result was determined by the Venous Clinical Severity Score (VCSS). RESULTS: Technical success of endovascular intervention in postthrombotic occlusions of iliac vein was 92% and in nonthrombotic iliac vein lesions was 100%. Cumulative primary and secondary patency in postthrombotic lesions at 60 months amounted to 72% and 81%, respectively, in nonthrombotic lesions to 85% (primary patency). Reinterventions were successfully performed in 6 patients including catheter-directed thrombolysis (3 patients) and stenting (3 patients). The mean VCSS score fell from 14.2 (4.2) to 7.5 (2.6; P < .001). The quality of life was improved; its mean score decreased from 62.6 (18.7) to 48.7 (12.8; P < .01). CONCLUSION: Endovascular angioplasty and stenting for obstructive lesions of the iliofemoral veins is a minimally invasive, safe, and highly effective method of treatment, which is confirmed by a significant improvement of the limb's condition and good long-term results of patency of the restored venous segments.