Predictive Factors of Stent Patency in Iliofemoral Venous Diseases in a Multicentre Cohort Study.

OBJECTIVE: This study assessed primary stent patency predictive factors in three groups of patients with history of lower limb (LL) vein thrombosis: non-thrombotic iliac vein lesion (NIVL), acute deep vein thrombosis (aDVT), and post-thrombotic syndrome (PTS). METHODS: Consecutive patients from January 2014 to December 2020 with history of LL vein stenting from seven hospitals were included. All patients received an iliac or common femoral venous stent and had at least a six month follow up available with stent imaging. Anticoagulant and antiplatelet therapy strategies employed after venous stenting are reported and compared between groups. RESULTS: This study included 377 patients: 134 NIVL, 55 aDVT, and 188 PTS. Primary patency was statistically significantly higher in the NIVL group (99.3%) compared with the PTS group (68.6%) (p < .001) and the aDVT group (83.6%) (p = .002). PTS patients received a statistically significantly greater number of stents (p < .001) and had more stents below the inguinal ligament (p < .001). Median follow up was 28.8 months (IQR 16, 47). Discontinuation of antiplatelet therapy at the last assessment was 83.6% for NIVL, 100% for aDVT, and 95.7% for the PTS group (p < .001). Discontinuation of anticoagulation therapy at the last assessment was 93.2% for NIVL, 25.0% for aDVT, and 70.3% for the PTS group (p < .001). The only predictor of worse primary patency in the aDVT group was long term anticoagulation before stenting. CONCLUSION: Patients with NIVL have better primary patency after venous stenting than patients with venous thrombotic disorders. Long term anticoagulation before stenting was the only factor associated with poorer primary patency in patients with aDVT.

Successful Secondary Endovascular Intervention in Pediatric Patients with Venous Thromboembolic Events.

BACKGROUND: In the past, pediatric patients with venous thromboembolic events (VTE) were treated with low-molecular-weight heparin (LMWH) which was successful in around 70% of the cases. However, anticoagulation alone might not restore patency in all patients, and advanced therapeutic options to prevent postthrombotic syndrome are needed. During recent years, endovascular interventions have become a treatment option for pediatric patients with persistent thrombotic occlusion, not only in life- or limb-threatening VTE. METHODS: We evaluated 12 consecutive patients (11-17 years) with newly diagnosed VTE being treated at our department during the last 4 years (2017-2020). In case follow-up examination showed persistent venoocclusion under anticoagulation, patients received secondary interventional therapy like recanalization, percutaneous transluminal angioplasty with or without catheter-directed thrombolysis, and stenting. Patients with no clinical signs of venoocclusion or regredient thrombosis in imaging examination received anticoagulation alone. RESULTS: Six of 12 (50%) patients underwent catheter intervention. Median time from diagnosis to intervention was 4 months (0-12 months). Reintervention was necessary in one (8%) case and complete recanalization failed in one (8%) case. There were no major bleeding events or other major postinterventional complications, no acute or late local recurrence, and all patients reported clinical improvement after the procedure. CONCLUSION: If endovascular intervention is used in teenage patients with persistent symptomatic VTE, reduction of postthrombotic symptoms is possible, even if intervention is performed secondary to failure of anticoagulation. Multidisciplinary treatment decisions can be based on the clinical course and follow-up imaging.

Stent patency rates and prognostic factors of endovascular intervention for iliofemoral vein occlusion in post-thrombotic syndrome.

OBJECTIVE: Post-thrombotic syndrome (PTS), an important complication of deep venous thrombosis (DVT), adversely affects patients' quality of life. Endovascular intervention in PTS can relieve symptoms rapidly with high therapeutic value. This study mainly focuses on how to improve postoperative stent patency rates and aims to find prognostic factors impacting patency. METHODS: According to the specific inclusion and exclusion criteria, PTS patients who underwent endovascular intervention at the First Affiliated Hospital of Sun Yat-sen University from December 1, 2014, to December 31, 2019, were included in this single-center prospective study. Follow-up data were collected and analyzed regularly over 2 years. RESULTS: Overall, 31 PTS patients were enrolled in the study. The mean age of these patients was 55.39 ± 11.81, including 19 male patients. Stent implantation was successful in 22 PTS patients, with a technical success rate of 70.97%. The average Villalta scores of the stent-implanted group and the non-stent-implanted group were 5.95 ± 2.57 and 5.78 ± 2.95, respectively, with no significant difference observed. In the stent-implanted group, the perioperative patency rate was 81.81% (18/22), and the follow-up patency rates were 68.18% (15/22) within 3 months, 59.09% (13/22) within 6 months, 45.45% (10/22) within 1 year, and 36.36% (8/22) within 2 years. Based on the stent placement segments, the 22 PTS patients were divided into two subgroups: the iliofemoral vein balloon dilation + iliofemoral vein stent implantation (FV-S) subgroup and the iliofemoral vein balloon dilation + iliac vein stent implantation (FV-B) subgroup. In the FV-S subgroup, the perioperative patency rate was 100.00% (14/14), and the follow-up patency rates were 85.71% (12/14), 71.43% (10/14), 57.14% (8/14) and 50.00% (7/14), which were higher than those for overall stent patency of all patients. The postoperative patency rates in the FV-B subgroup were 50.00% (4/8), 37.50% (3/8), 37.50% (3/8), 25.00% (2/8), and 12.50% (1/8). The secondary postoperative patency rates in the FV-B subgroup were 100.00% (8/8), 87.50% (7/8), 75.00% (6/8), 62.50% (5/8) and 50.00% (4/8). CONCLUSIONS: For PTS patients with iliofemoral vein occlusion but patent inflow, iliofemoral vein stent implantation is a more efficient therapeutic option than iliofemoral vein balloon dilation with iliac vein stent implantation for PTS patients.

Medium-term outcomes after inferior vena cava reconstruction for acute and chronic deep vein thrombosis and retroperitoneal fibrosis.

OBJECTIVE: In the present study, we evaluated the technical and clinical outcomes after endovascular inferior vena cava (IVC) reconstruction in patients with nonmalignant obstruction. METHODS: The preoperative, procedural, and follow-up medical records and imaging studies were retrospectively reviewed for 59 consecutive patients who had undergone endovascular IVC reconstruction for nonmalignant obstruction from February 2014 to January 2019. The patients were classified into three groups according to the quality of their infrainguinal inflow vessels. The outcomes measured were the primary, primary-assisted, and secondary patency rates, reintervention rates, and symptomatic resolution. RESULTS: The indications for treatment were post-thrombotic syndrome (n = 41), acute deep vein thrombosis (n = 12), and retroperitoneal fibrosis (n = 6). The median patient age was 37 years, 11 months, 71.2% were men, and 32.2% had a diagnosis of thrombophilia, with no significant difference in these demographics between the three inflow groups. The median follow-up duration was 2 years, 3 months (range, 6 months to 6 years, 5 months). The whole-cohort primary patency was 91.2%, 71.0%, and 24.1% at 1, 3, and 5 years, respectively. Secondary patency was 76.7% at 1 year and 66.4% at both 3 and 5 years. Inflow group A (no post-thrombotic disease in the femoral or deep femoral veins) demonstrated significantly higher primary patency compared with group B (stenotic disease in one or two infrainguinal inflow veins; P = .009) and significantly higher secondary patency than for both groups B (P = .008) and C (all three infrainguinal inflow veins had stenosed or femoral and/or deep femoral vein occlusion was present; P = .04). In post-thrombotic syndrome patients, the Villalta scores had decreased from a mean of 14.2 to 8.1 at 1 year and 6.8 at 2 years, and the Venous Insufficiency Epidemiological and Economic Study Quality of Life score had improved from a mean of 19.8 to 54.1 and 57.3 at 1 and 2 years, respectively. In the patients with acute deep vein thrombosis, the Villalta score was 2.8 at 1 year and 0 at 2 years. In the patients with retroperitoneal fibrosis, the Venous Insufficiency Epidemiological and Economic Study Quality of Life score had improved from a mean of 25.3 at baseline to 44 at 6 months. CONCLUSIONS: Endovascular IVC reconstruction for nonmalignant obstruction can achieve good patency and clinical improvement, although the outcomes were poorer for patients with post-thrombotic disease of the femoral and deep femoral veins.

Clinical outcomes of venous self-expanding stent placement for iliofemoral venous outflow obstruction.

OBJECTIVE: In the present study, we evaluated the feasibility of a self-expanding venous stent for treating iliofemoral venous obstruction. METHODS: The present retrospective study reviewed the data from 49 patients who had undergone Zilver Vena (Cook Medical, Bloomington, Ind) stent placement for treatment of iliofemoral venous obstruction from September 2017 to March 2019. All patients had undergone received follow-up duplex ultrasound examinations to assess for stent patency. The Villalta scores and Venous Clinical Severity Scores (VCSSs) were also calculated to stratify the postoperative improvement in disease. RESULTS: Of the 49 patients, 19 had had acute deep vein thrombosis, 7, nonthrombotic iliac venous lesions, and 23, post-thrombotic syndrome. At 1 year after Zilver Vena stent placement, the primary, assisted primary, and secondary patency rates were 93.8%, 95.9%, and 97.9%, respectively. The baseline median Villalta score before treatment for those with post-thrombotic syndrome was 19 (range, 11-30), and the median VCSS for the patients with post-thrombotic syndrome and nonthrombotic iliac venous lesions was 11 (range, 6-25). At 1 year after stent placement, the median Villalta score for the post-thrombotic syndrome patients was 4.0 (range, 2-18), and the median VCSS for the post-thrombotic syndrome and nonthrombotic iliac venous lesions patients was 3.0 (range, 2-12). CONCLUSIONS: Venous placement of self-expanding stents offers excellent 1-year patency rates and improved the outcomes of patients with iliofemoral venous obstruction caused by acute deep vein thrombosis, nonthrombotic iliac venous lesions, and post-thrombotic syndrome.

Surgical management of post-thrombotic syndrome in chronic venous thoracic outlet syndrome.

OBJECTIVE: Venous thoracic outlet syndrome (VTOS) is considered chronic when symptoms and venous stenosis or occlusion are present for >3 months after the initial primary upper extremity deep vein thrombosis event. Many of patients with chronic VTOS receive conservative treatment. However, a subset of these patients will have persistent post-thrombotic syndrome symptoms because of underlying causative anatomy. We present the results of a same admission treatment consisting of' transaxillary thoracic outlet decompression (TA-TOD), external venolysis, and, if necessary, treatment of residual intraluminal lesions with percutaneous transluminal angioplasty (PTA) for chronic VTOS. METHODS: All patients presenting from January 2015 to December 2019 with chronic VTOS and post-thrombotic syndrome complaints were evaluated. Patients with some degree of patency on venography or a chronic occlusion that could be recanalized using PTA preoperatively underwent TA-TOD, external venolysis, and immediate venography. Low-pressure diagnostic balloon inflation after first rib resection was used to identify residual lesions not evident by venography. If found, PTA was performed. Stent placement was reserved for patients with recurrent complaints due to residual lesions that had not been effectively treated by PTA. RESULTS: A total of 40 patients with chronic VTOS were evaluated, of whom 36 were included and treated according to the protocol. The remaining four patients had had a chronic occlusion that could not be recanalized preoperatively and these patients were, therefore, excluded. After TA-TOD, immediate venography showed patent vessels with residual stenosis in 31 patients. Of the five patients who had appeared to have no significant stenosis on venography, two showed narrowing with diagnostic balloon inflation of the subclavian vein, for a total of 33 patients (92%) with residual stenosis after TA-TOD. All 33 patients underwent formal venous PTA. Complications occurred in five patients. At a mean follow-up of 24 months, 30 of the 36 patients (83%) were free of symptoms. The mean thoracic outlet syndrome disability scale score was 1.97 ± 1.9. The mean Disability of the Arm Shoulder and Hand scale score was 16.16 ± 17.4. The median VEINES (venous insufficiency epidemiologic and economic study)-symptoms score was 53.90 (interquartile range, 10.54). The median VEINES-quality of life (QOL) score was 54.22 (interquartile range, 13.93). Finally, the mean 12-item short-form physical QOL component scale score was 47.97 ± 9.02. The thoracic outlet syndrome disability scale and Disability of the Arm Shoulder and Hand scale scores had significantly decreased (P < .01), and the 12-item short-form physical QOL component scale score had significantly improved (P < .01) compared with the baseline scores. A return to daily activities was achieved by 93% of the patients. CONCLUSIONS: The treatment of patients with chronic VTOS using a same admission treatment algorithm consisting of TA-TOD, external venolysis, and PTA is effective. Intermediate follow-up showed a high return to daily activity and significant improvement in functional outcome and physical QOL.

Effect of thrombophilia on clinical outcomes of chronic post-thrombotic patients after iliofemoral stenting with nitinol venous stents.

OBJECTIVE: Thrombophilia is a prothrombotic condition that increases the risk of venous thromboembolism. It is unclear whether the presence of thrombophilia alters the clinical outcomes after deep venous stenting. The aim of the present study was to examine the relationship between thrombophilia and outcomes after stenting for post-thrombotic syndrome. METHODS: Consecutive patients (2012-2017) receiving a nitinol venous stent for chronic post-thrombotic venous occlusive disease with a minimum of 18 months of follow-up in one center using the same anticoagulation protocol were included. The clinical history and thrombophilia testing results were reviewed. The outcomes were stent patency, which was assessed using duplex ultrasonography at 24 hours, 2 and 6 weeks, 3 months, 6 months, and annually thereafter; and reinterventions, which were performed when the stent diameter was <50% or occluded. RESULTS: Of the 136 patients who had undergone intervention, 55 (40%) had had a provoked deep vein thrombosis (DVT) and 81 (60%) had had an unprovoked DVT and had therefore undergone thrombophilia testing. Of the 81 patients, 38 (47%) had had either inherited (n = 19; 50%) or acquired (n = 19; 50%) thrombophilia. Of the 136 patients who had undergone stenting, 68 had required reintervention (50%) during follow-up to maintain stent patency. Of the 55 patients with a provoked DVT, 29 (53%) had required reintervention. Of the 81 patients with an unprovoked DVT, 39 (48%) had required reintervention (P = .420). Of the 38 patients with unprovoked DVT and thrombophilia, 17 (45%) had required reintervention. Of the 43 patients with unprovoked DVT and no thrombophilia, 22 (51%) had required reintervention (P = .766). The cumulative patency rate was 80% for patients with provoked DVT and 88% for those with unprovoked DVT (P = .193). The presence of thrombophilia was not associated with patency loss (92% cumulative patency for patients with thrombophilia and 84% for patients without thrombophilia; P = .307). CONCLUSIONS: Using our anticoagulation protocol, patients with and without thrombophilia had similar clinical outcomes after deep venous stenting and should not be excluded from iliofemoral venous stenting. We found no significant differences in outcomes in conjunction with appropriate postoperative anticoagulation therapy.

Venoplasty and stenting in post-thrombotic syndrome and non-thrombotic iliac vein lesion.

Introduction: Venous outflow obstruction is a common condition among patients with chronic venous insufficiency. Endovascular treatment is favourable over open surgery. This study aimed to assess stent patency and clinical outcome in venous outflow obstruction of lower limbs, and also to compare it between post-thrombotic syndrome and non-thrombotic iliac vein lesions.Material and methods: The study was a historical cohort study. Patients with chronic deep venous insufficiency referred to our tertiary referral centre who underwent venoplasty were recruited. Patients were divided into two groups: non-thrombotic-iliac-vein-lesions and post-thrombotic syndrome. Stent patency rate, clinical improvement and risk factors were evaluated during a six-months course after venoplasty.Results: One-hundred-sixty-four patients were included. Six-months primary, assisted primary and secondary patency rates were 98.86%, 100% and100% in the non-thrombotic-iliac-vein-lesions group and 88%, 93% and 96% in the post thrombotic syndrome groups (p-value = .005, p-value = .02, and p-value = .09, respectively). Pain, claudication and edema were the most common symptoms in both groups and significantly improved after six months. Early thrombosis in the PTS group was more common (9 vs. 1, P value = .007).Conclusion: Percutaneous stenting in patients with venous outflow obstruction is safe and effective with a high patency rate and significant decrease in clinical score in both post-thrombotic syndrome and non-thrombotic-iliac-vein lesions groups.

Endovascular Treatment of Post-thrombotic Venous Ilio-Femoral Occlusions: Prognostic Value of Venous Lesions Caudal to the Common Femoral Vein.

OBJECTIVES: To propose a scale of severity for post-thrombotic venous lesions (PTVLs) after ilio-femoral deep venous thrombosis and to compare the grade with the results of endovascular treatment of ilio-femoral PTVLs. METHODS: In this retrospective monocentric observational study, we included 95 patients treated for ilio-femoral PTVLs. We proposed a four-grade scale evaluating the severity of PTVLS caudal to the common femoral vein based on CT phlebography and per-operative phlebography. For most patients, venous patency was assessed with color duplex ultrasonography and the clinical efficacy of the intervention using the Villalta and CIVIQ scores. RESULTS: Recanalization was successful in 100% of patients with a morbidity rate of 4%. After a mean follow-up of 21 months, the overall primary patency was 75%, the assisted primary patency 82%, and the secondary patency 93%. Secondary patency was 100% for grade 0-1, 90% for grade 2, and 63% for grade 3 (p < 0.002). There was no correlation between the extension of stenting caudally of the common femoral vein and venous patency. The mean improvements in the Villalta and CIVIQ-20 scores were, respectively, 4.6 (p < 0.0001) and 18 (p < 0.0001); scores were not correlated with the grade of PTVLs in the thigh. CONCLUSION: Venous patency after endovascular treatment of ilio-femoral PTVLs was strongly linked to the severity of PTVLs caudal to the common femoral vein but not to the extent of stenting.

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.

[Endovascular Recanalization of Chronic Venous Outflow Obstructions]. / Endovenöse Rekanalisationen von chronischen Beckenvenenverschlüssen.

Approximately 60 % of patients with acute iliofemoral deep vein thrombosis recover without further symptoms. However, 40 % will have some degree of post-thrombotic syndrome (PTS) and 4 % will develop severe PTS. PTS is the most common complication; it reduces quality of life and increases DVT-related costs. The clinical symptoms and severity of PTS may vary; the most common symptoms include edema, pain, hyperpigmentation, lipodermatosclerosis, and ulceration. PTS is based on the principle of outflow obstruction, may be caused by venous hypertension, and may lead to valvular damage and venous reflux or insufficiency. A significant lumen reduction within the iliac vein system is defined by an aspect ratio ≥ 2. Recent technical developments and new dedicated venous stent techniques now give the opportunity to recanalize even complex venous outflow obstructions. First in man safety and efficacy data are very promising for the new dedicated venous stents, but long-term data are still missing.

Usefulness of Direct Computed Tomography Venography in Predicting Inflow for Venous Reconstruction in Chronic Post-thrombotic Syndrome.

PURPOSE: The purpose of this paper is to assess the applicability of direct computed tomography venography (DCTV) in assessing dominant inflow vein in the femoral confluence in extensive chronic iliofemoral venous obstruction, using venography as the gold standard. METHODS: All DCTVs performed in symptomatic patients with previous iliofemoral deep vein thrombosis subsequently submitted to venography in the period from January 2014 to August 2018 were retrospectively reviewed. Two groups were defined depending on whether the femoral vein (FV) or the deep femoral vein (DFV) was the dominant inflow on venography in order to identify predictors of DFV as dominant inflow in DCTV. Statistical analysis was performed with SPSS V25. RESULTS: A total of 30 DCTVs and subsequent venographies were reviewed. Venography identified the FV as the dominant inflow in 18 (60%) and the DFV in 12 (40%) patients. Predictors for DFV as dominant inflow were identified as follows: larger DFV diameter 50 mm and 250 mm below lesser trochanter (8.73 ± 4.34 mm vs. 11.9 ± 3.52 mm; p = 0.043 and 5.4 ± 3.90 mm vs. 8.90 ± 2.70 mm; p = 0.011); lower FV/DFV ratio 150 mm below lesser trochanter (11.39 ± 20.01 mm vs. 1.05 ± 0.47 mm; p = 0.043); and presence of FV scarring/synechiae, collaterals and abnormal wall thickness (p = 0.003, p = 0.003 and p < 0.0001). CONCLUSION: In cases of extensive chronic iliofemoral venous obstruction, especially when stent deployment into the DFV is entertained, the key to success is thorough pre-procedure planning focusing on choosing the access site. This study suggests DCTV is valuable in defining the dominant iliac vein inflow, but additional findings are necessary to validate these preliminary data.

Detecting stent geometry changes after venous recanalization using duplex ultrasound.

BACKGROUND: Patients with post-thrombotic syndrome due to chronic venous obstruction and resistant to conservative management can benefit from endovenous revascularization. The current study investigated the usefulness of duplex ultrasound in monitoring the stent changes over the time. METHOD: All duplex ultrasound images of treated patients were reviewed retrospectively. The stent diameter and area during the follow-up visits have been analyzed. RESULT: A total of 210 stents were placed in 137 limbs. Duplex ultrasound findings showed a decrease in area of stent in all patients (mean: 0.69 cm2). Reduction of stent area over the time was a predictor of stent patency (odds ratio: 0.910; confidence interval: 0.832-0.997). CONCLUSION: Duplex ultrasound has sufficient accuracy in detection of stent changes and its patency. There is a discrepancy between diameter of the stent lumen in vitro and after deployment in all patients. Stent occlusion is related to reduction of stent lumen over the time rather than the percent of the stenosis.

Systematic Review and Meta-Analysis of Iliofemoral Stenting for Post-thrombotic Syndrome.

OBJECTIVE: Stent placements are considered as a treatment for post-thrombotic syndrome (PTS) with iliofemoral obstruction, but the application of these iliofemoral venous stents has also caused a lot of controversy. The purpose of this systematic review and meta-analysis was to summarise the efficacy and safety of venous stents in PTS with obstruction in iliofemoral venous segments. METHODS: MEDLINE, EMBASE, and the Cochrane Central Register for Controlled Trials databases and key references were searched up to 15 January 2018. The main relevant outcomes included technical success, peri-operative complications, symptom resolution, a change of symptom scores, and long-term patency of the stents. RESULTS: Overall, 504 limbs of 489 patients from seven studies were included in this study. A GRADE assessment showed the quality of the evidence was "very low" for 11 relevant outcomes. The technical success rate was 95%. The pooled rate of complications including 30 day thrombotic event, per-operative venous injury, and back pain was 3.4%, 18.14%, and 52%, respectively. The rates of ulcer healing, pain and oedema relief were 75.66%, 52%, and 42%, respectively. The primary, assisted primary and secondary patency rates were 83.36%, 90.59%, and 94.32%, respectively, at 12 months and 67.98%, 82.26%, and 86.10%, respectively, at 36 months. CONCLUSIONS: Endovenous stenting has the potential to be effective and has a low risk of peri-operative complications. The quality of evidence to support this treatment is very low. Endovenous iliofemoral stenting should be considered a treatment option for PTS with iliofemoral obstruction.

The contemporary hybrid operative procedure for incapacitating post-thrombotic iliofemoral and vena caval obstruction improves procedural outcomes.

OBJECTIVE: Chronic, post-thrombotic iliofemoral and inferior vena caval obstruction is associated with debilitating morbidity. Venoplasty and stenting are often successful; however, in the presence of a diseased or occluded common femoral vein (CFV), failure is common. A hybrid operative procedure of open surgical CFV endovenectomy and endoluminal recanalization or bypass of the obstructed iliofemoral and vena caval segments has been developed and modified. The purpose of this report was to assess the technical evolution of this procedure on operative complications. METHODS: Thirty-one patients undergoing CFV endovenectomy and proximal ipsilateral endoluminal reconstruction (iliac, inferior vena caval) or contralateral outflow were analyzed. The initial techniques of patient management were compared with the present contemporary techniques, evaluating procedural complications and failures. The contemporary procedure evolved to include routine axial imaging, preoperative venography through the popliteal vein, preoperative passage of a guidewire or catheter into the patent vena cava, placement of an ipsilateral popliteal vein sheath for intraoperative and postoperative anticoagulation, routine patch closure, routine arteriovenous fistulas, routine completion intravascular ultrasound, and long-term anticoagulation with warfarin to a target international normalized ratio of 3.0 to 4.0. Procedure-related complications were compared between the initial and contemporary techniques. RESULTS: Of 17 patients treated with the early techniques, 15 (88%) had major complications: 5 iliofemoral thromboses, 4 major wound bleeds, 4 wound infections, and 2 CFV stenoses requiring reintervention. One iliac vein rupture treated with a stent graft thrombosed. Of 14 patients treated with the contemporary techniques, 2 (14%; P = .006) had major complications: 1 bleed and 1 infected seroma. One intraoperative iliac vein rupture, treated with a second stent relining the first, remains patent. CONCLUSIONS: Contemporary hybrid operative techniques for incapacitating post-thrombotic iliofemoral and vena caval obstruction increase procedural success and reduce complications compared with the initial approach. The contemporary techniques are recommended for patients undergoing hybrid operative management of post-thrombotic iliofemoral and vena caval occlusion involving the CFV.

Safety of the Atlas Gold Balloon in Treating Iliofemoral Veins: Experience From a Single Center.

BACKGROUND: We report on intraprocedural and up to 1-year outcomes on the safety of the Atlas Gold balloon (Bard) in iliofemoral venous interventions. METHODS: All patients who underwent iliofemoral vein compression treatment in our laboratory from September 1, 2013 to May 30, 2017 were identified and medical records were reviewed. The primary safety endpoint was the intraprocedural freedom from major device-related serious adverse events (≥95%) for the Atlas Gold balloon in iliofemoral venous treatment. RESULTS: Seventy-seven patients with iliac vein compression underwent intervention. Predilation was performed in 20 patients with the Atlas Gold balloon (mean diameter, 12.1 mm). The mean pressure was 5.2 atm (range, 3.0-14.0 atm). Post-stent dilation was performed in 61 patients treated with the Atlas Gold balloon (mean diameter: 17.0 mm; range: 12 to 22 mm), with a mean pressure of 6.8 atm (range, 2.0-20.0 atm). There was no stent thrombosis, target-lesion revascularization (TLR), or target-vessel revascularization (TVR) at 1 month. Symptom improvement was reported in 89% of patients. There were 58 patients assessed for patency in the total cohort at 262.7 days, of which 48 patients were postdilated with the Atlas Gold balloon. All stents were patent at 1 year, and there was no stent thrombosis, TLR, or TVR in the cohort treated with the Atlas Gold balloon. Symptom improvement continued at 1 year (37/45 Atlas Gold cohort). CONCLUSION: All patients postdilated with the Atlas Gold balloon exceeded the 95% safety benchmark set in this study. No balloon perforation, vessel laceration, or balloon-related intravascular events occurred.

Placement of closed-cell designed venous stents in a mixed cohort of patients with chronic venous outflow obstructions - short-term safety, patency, and clinical outcomes.

BACKGROUND: To evaluate the performance of a closed-cell designed venous stent for the treatment of chronic ilio-femoral venous outflow obstruction (VOO) in the shortterm. PATIENTS AND METHODS: Safety, stent patency and clinical outcome after placement of the Vici Venous Stent® in patients with chronic ilio-femoral venous obstruction were assessed retrospectively. Stent patency was evaluated by duplex ultrasound scanning, and clinical outcome was determined using the revised Venous Clinical Severity score (rVCSS). RESULTS: 75 patients (49 % female; median age 57 years; 82 limbs) with symptomatic significant VOO had stents placed in the ilio-femoral veins. Lower limb venous skin changes including ulcers (C-class in CEAP 4-6) were found in 31 patients (41 %). Nonthrombotic iliac vein lesions (NIVLs) and post-thrombotic obstruction (PTO) were found in 40 and 42 limbs, respectively. There were no safety issues. Cumulative primary, assisted-primary, and secondary stent patency in the entire cohort at 12 months were 94 %, 94 % and 96 %, respectively. Five limbs presented with stent occlusion. Two limbs had no intervention, 2/3 remained patent after reintervention. Clinical improvement (a decrease ≥ 2 rVCSS points) was observed in 81 %, 81 %, and 77 % of patients at 1 month, 6 months, and 12 months, respectively. There was a marked drop in the frequency of more marked pain and swelling (VCSS ≥ 2) from 62 % to 5 % and 93 % to 19 %, respectively. Four limbs had venous ulcers, three healed during the follow-up. Cumulative pri- mary stent patency at 12 months was 100 % and 87 % in patients with NIVL and PTO, respectively (p= 0.032). There was no statistical difference in clinical outcome between these subgroups. CONCLUSIONS: The Vici Venous Stent® placed in the ilio-femoral vein segment in patients with symptomatic VOO revealed no safety issues, had excellent primary patency and substantial symptom improvement. Long-term studies are needed to evaluate the durability of this stenting procedure.

Two Year Outcome After Chronic Iliac Vein Occlusion Recanalisation Using the Vici Venous Stent®.

OBJECTIVE/BACKGROUND: The aim was to assess two year outcomes with placement of the Vici Venous Stent® in patients with chronic iliofemoral venous occlusions (complete blockage). METHODS: This was a retrospective single centre study comprising patients treated with the Vici Venous Stent for venographically verified iliofemoral venous occlusion and post-thrombotic syndrome (Villalta score ≥ 5 points) at least 12 months after acute deep vein thrombosis. Venography and intravascular ultrasound were used peri-operatively; duplex ultrasound was used to assess stent patency during follow up. RESULTS: Eighty-eight patients (101 limbs) had stent placement between March 2014 and October 2016. Median pre-treatment Villalta score was 14 (range 5-33). Stenting extended across the inguinal ligament in 63 limbs (62%) in order to land in a healthy venous segment. Six patients (7%) required endophlebectomy and fistula creation. Median imaging follow up was 21 months (range 0-41 months). Primary, assisted primary and secondary patency rates at one year were 59%, 78%, and 87%, respectively, and two years 51%, 73%, and 82%, respectively. Forty-three limbs (43%) had re-intervention (lysis, venoplasty, and/or placement of stent) during follow up; median time to re-intervention was 32 days (range 0-520 days). At 24 months, 37 of 53 limbs (70%) with available Villalta assessment showed clinically significant improvement (>30% reduction of baseline score). Villalta scores at the 6, 12, and 24 month clinical follow up were significantly lower than before stenting (p < .001, all time points). In a subset analyses of limbs with stenting terminating above and below the inguinal ligament, secondary cumulative patency rates at 24 months were 90% and 79%, respectively; clinical outcome showed 58% vs. 73% of limbs with clinically significant improvement, respectively. There was no statistically significant difference in patency or clinical outcomes. CONCLUSION: The Vici Venous Stent is associated with a good secondary patency rate and durable and substantial symptomatic resolution in patients with chronic post-thrombotic occlusions, regardless of whether stents extended beneath the inguinal ligament.

[Results of endovascular treatment of obstructive lesions of veins of the iliofemoral segment]. / Rezul'taty éndovaskuliarnogo lecheniia obstruktivnykh porazhenii ven podvzdoshno-bedrennogo segmenta.

OBJECTIVE: The purpose of the study was to assess the immediate and remote results of endovascular treatment of obstructive lesions of the veins of the iliofemoral segment. PATIENTS AND METHODS: We performed balloon angioplasty and stenting for iliofemoral venous thrombosis in a total of 75 patients. Of these, 60 patients were subjected to stenting of post-thrombotic obstructions and 15 patients underwent stenting of non-thrombotic obstructive lesions of the iliac veins (for May-Thurner syndrome - in 11, for extravasal tumour-induced compression and cicatricial stenosis - in 4). Stenting was performed using self-expanding stents Wallstent (Boston Scientific, n=84) or S.M.A.R.T. (Cordis, Johnson & Johnson, n=16). The stent diameter varied from 12 to 18 mm depending on the venous segment to be stented. The average number of the implanted stents amounted to 1.3 per patient. Efficacy of endovascular intervention was evaluated by measuring the pressure gradient and malleolar circumference. The clinical result was determined by the Venous Clinical Severity Score (VCSS). RESULTS: Technical success of endovascular intervention amounted to 92%. Stent thrombosis in the immediate postoperative period occurred in 7 (9.3%) patients. Of these, three patients were subjected to catheter-directed thrombolysis with restoration of patency of the stented venous segment of the limb. Stent occlusion within 48 postoperative months was diagnosed in 4 cases. Two patients underwent successful repeat angioplasty and stenting. Stent restenosis of not less than 50% at 36 months of follow up was observed in 5 (16%) patients. Repeat stenting was performed in 1 case. Dynamic control of stent patency was carried out by means of ultrasonographic duplex scanning. Also performed were control multispiral computed tomography-phlebography and roentgen contrast-enhanced phlebography. Cumulative primary and secondary patency at 60 months in post-thrombotic lesions amounted to 72 and 81%, respectively, in non-thrombotic lesions to 85% (primary patency). The VCSS values demonstrated a significant decrease in manifestations of chronic venous insufficiency. The mean value of the composite parameter decreased from 14.2±4.2 to 7.5±2.6 (p<0.001), the malleolar circumference decreased from 272.3±6.7 to 250.6±6.1 mm (p<0.01). Permanent healing of trophic ulcers was noted in 5 (71%) patients. CONCLUSION: The method of endovascular angioplasty and stenting for obstructive lesions of the veins of the iliofemoral segment is a minimally invasive, safe, and highly effective therapeutic modality, which is confirmed by significant improvement of the limb's condition and good remote results of patency of the venous segments restored. Endovascular methods should be wider implemented into the clinical practice.

Treatment of Femoral Vein Obstruction Concomitant with Iliofemoral Stenting in Patients with Severe Post-thrombotic Syndrome.

BACKGROUND: The aim was to assess the clinical and anatomical outcomes of iliofemoral stenting, with concomitant femoral stenting or balloon angioplasty alone, in patients with severe post-thrombotic syndrome (PTS) and compromised inflow. METHODS: A database of patients with severe PTS who successfully underwent endovascular iliofemoral stenting was reviewed retrospectively. Patients with impaired inflow with chronic post-thrombotic obstructive lesions in the femoral vein (FV), but patent profunda vein, were selected and divided into two groups: the FV stenting (FV-S) group and the FV angioplasty (FV-A) group. Patients in the FV-S group were treated with concomitant iliofemoral and FV stenting, and patients in the FV-A group were treated with iliofemoral stenting and balloon angioplasty alone of the obstructed femoral vein. The clinical and stent outcomes were recorded and compared in the two groups. RESULTS: There were 45 patients in the FV-S group and 69 patients in the FV-A group. The groups were well matched for age, gender, and diseased limbs. The pre-procedural symptoms, CEAP classifications, VCSS scores, Villalta scores, and prevalence of active ulcers were also similar between the two groups. Immediate failure (<30 days post-procedure) in the femoral segment occurred more frequently in the FV-A group (70% in FV-A group vs. 24% in FV-S group, p < .001); however, all treated femoral vein segments had occluded at 12 months. There was no significant difference between the FV-S and FV-A groups in cumulative primary and secondary patency rates of the iliofemoral stent at 3 years (55% vs. 52%, p = .71, and 77% vs. 85%, p = .32, respectively). Complete pain relief, swelling relief, VCSS score, Villalta score, and freedom from ulcers at a median of 22 months (1-48 months) following the procedure were similar in the two groups. CONCLUSIONS: Stent placement to treat post-thrombotic iliofemoral obstruction with concomitant obstructed femoral vein but patent profunda vein shows cumulative patency rates and clinical outcomes similar to previous reports. Adjunctive femoral stenting or angioplasty of the obstructed femoral vein does not appear to improve clinical or stent outcomes in patients with severe PTS.