Iliofemoral Vein Obstruction Research Articles

One-year outcomes of a novel venous stent for symptomatic iliofemoral venous obstruction: prospective cohort study

BackgroundA stent with characteristics of a hybrid design may have advantages in improving the patency of symptomatic iliofemoral vein obstruction. This study assessed the safety and effectiveness of the V-Mixtent Venous Stent in treating symptomatic iliofemoral outflow obstruction.MethodsEligible patients had a Clinical-Etiologic-Anatomic-Physiologic (CEAP) C classification of ≥ 3 or a Venous Clinical Severity Score (VCSS) pain score of ≥ 2. The primary safety endpoint was the rate of major adverse events within 30 days. The primary effectiveness endpoint was the 12-month primary patency rate. Secondary endpoints included changes in VCSS from baseline to 6 and 12 months, alterations in CEAP C classification, Chronic Venous Disease Quality of Life Questionnaire (CIVIQ-14) scores at 12 months, and stent durability measures.ResultsBetween December 2020 and November 2021, 171 patients were enrolled across 15 institutions. A total of 185 endovenous stents were placed, with 91.81% of subjects receiving one stent and 8.19% receiving 2 stents. Within 30 days, only two major adverse events occurred (1.17%; 95% confidence interval [CI], 0.14–4.16%), below the literature-defined performance goal of 11% (P < .001). The 12-month primary patency rate (91.36%; 95% CI, 85.93–95.19%; P < .001) exceeded the literature-defined performance goal. VCSS changes from baseline demonstrated clinical improvement at 6 months (− 4.30 ± 3.66) and 12 months (− 4.98 ± 3.67) (P < .001). Significant reduction in symptoms, as measured by CEAP C classification and CIVIQ-14, was observed from pre-procedure to 12 months (P < .001).ConclusionsThe 12-month outcomes confirm the safety and effectiveness of the V-Mixtent Venous Stent in managing symptomatic iliofemoral venous outflow obstruction, including clinical symptom improvement compared to before treatment.

Endovascular treatment of chronic ilio-femoral vein obstruction with extension below the inguinal ligament in patients with post-thrombotic syndrome

ObjectiveThis study aimed to evaluate postoperative outcomes of patients with chronic iliofemoral venous outflow obstruction and post-thrombotic syndrome (PTS) who underwent endovascular recanalization and stenting across the inguinal ligament. MethodsAll consecutive patients with chronic iliofemoral venous outflow obstruction and PTS were included in the analysis, from January 2018 and February 2022. Preoperative, intraoperative, and postoperative outcomes were assessed. Primary endpoints analyzed were major adverse events (MAEs) at 30 days and primary patency rate at 2 years of follow-up. Secondary endpoints assessed were secondary patency rate, target vessel revascularization, and clinical improvement evaluated with the Venous Clinical Severity Score (VCSS) classification, Villalta scale, and visual analog scale (VAS), respectively. ResultsA total of 63 patients (mean age, 48.1 ± 15.5 years; female, 61.9%) were evaluated. No intraoperative and 30-day postoperative complications were documented. The technical success rate was achieved at 100%. Overall, one in-stent occlusion and five in-stent restenosis were detected during follow-up. The primary patency rate was 93.7% (95% confidence interval [CI], 87.8%-99.9%) and 92.1% (95% CI, 85.6%-99%), at 1- and 2-year follow-up, respectively (Kaplan-Meier analysis). Target vessel revascularization was conducted in two cases, resulting in a secondary patency of 98.4% (95% CI, 95.4%-100%) at 2 years of follow-up. Stent fracture and/or migration were not observed during follow-up. A significant clinical improvement in the patient’s quality of life was documented. The median improvement of VCSS and Villalta scores were 4 (interquartile range, 2-7; P = .001), and 3 (interquartile range, 1.5-5; P = .001) vs baseline at the last follow-up. Overall, pain reduction of 17 mm on the VAS scale was documented at 2 years of follow-up. At multivariate analysis, presence of trabeculation into the femoral vein and deep femoral vein (odds ratio, 1.89; 95% CI, 0.15-6.11; P = .043), and Villalta scale >15 points at admission (odds ratio, 1.89; 95% CI, 0.15-6.11; P = .043) were predictive for in-stent occlusion during the follow-up. ConclusionsThe use of a dedicated venous stent across the inguinal ligament was safe and effective for the treatment of symptomatic iliofemoral venous disease with acceptable primary and secondary patency rates at 2 years of follow-up.

Ultrasound-guided stenting in the common femoral vein for accurate stent distal landing.

Venous stenting has been reported with excellent clinical results; however, inadequate inflow can increase the risk of stent occlusion. When extending the stent into the common femoral vein (CFV), it is essential to ensure adequate inflow from the femoral vein, deep femoral vein (DFV), and great saphenous vein. Accurate identification of the distal landing zone (DLZ) of the stent is crucial to ensure adequate inflow. The DLZ is usually determined by venography or intravascular ultrasound (IVUS) with reference to bony landmarks. However, the uncertainty can lead to misidentification of the DLZ and inadequate stent placement, resulting in stent occlusion. From December 2016 to December 2022, 42 venous stent placements were performed in 40 patients with post-thrombotic iliofemoral vein obstruction and/or stenosis. Three patients had developed early stent occlusion owing to a misidentified DLZ. To improve accuracy in identifying the DLZ during venous stenting, ultrasound-guided placement was performed in the CFV of five patients (four on the left and one on the right) with post-thrombotic changes in the CFV and occlusion of the common iliac vein and external iliac vein. The distal end of the stent was adjusted just above the saphenofemoral junction in two cases and just proximal to the DFV confluence in three cases. Stent placement was verified using both long-axis ultrasound and fluoroscopy. Ultrasound images of the CFV region provided clear visualization of the stent deployment site and accurate landmark locations, such as the saphenofemoral junction and DFV confluence, allowing for precise adjustments during stent deployment. This technique enabled easier and more definitive identification of other branches of the CFV than previously provided by IVUS and venography. No complications were observed in any of the 42 cases, and long-term patency was achieved at the final follow-up after stenting (average, 10months; range, 3-14months). Ultrasound-guided stenting in the CFV allows for real-time and accurate stent deployment with precise adjustment to the optimal DLZ. Using this technique, combined with venography and IVUS, missed distal lesions and subsequent stent occlusion can be prevented, potentially contributing to better treatment outcomes.

A Comparison of Patient and Device Issues Reported for Recalled Venous Stent Systems

The first two Food and Drug Administration (FDA)-approved stents for treatment of iliofemoral vein obstruction, Boston Scientific's Vici and BD's Venovo venous stent systems, were both recalled in early 2021 within years of entering the market. Given the recent addition of patient issues as a publicly reported variable by the FDA Manufacturer and User Facility Device Experience (MAUDE) database, we set forth to analyze adverse event reports in MAUDE to better characterize issues reported for each system. MAUDE was queried for all adverse event reports for brands "Vici" and "Venovo" from their respective US FDA market approval dates to August 19, 2021. Reported device issues, patient issues, and interventions performed for each adverse event were compiled and compared using Fisher's exact test. A total of 50 unique adverse event reports were compiled for the Vici system and 341 for the Venovo system. The most common device issue reported for the Vici system was migration (48% vs. 0%; P=0.0001) versus activation failure in Venovo (85% vs. 4%; P=0.0001). A significantly higher proportion of Venovo reports specified no patient complications or symptoms (90% vs. 26%; P=0.0001), with no intervention performed (89% vs. 32%; P=0.001). A significantly higher proportion of Vici devices were extracted (8% vs. 2%; P=0.01), required use of a new device (26% vs. 5%; P=0.0001), and required application of a second stent within the venous stent initially placed (28% vs. 2%; P=0.0001). The rate of intervention with balloon expansion was not significantly different between the Vici and Venovo systems (6% vs. 2%; P=0.08). While 2 venous stent systems were recalled simultaneously, significant differences exist between reported device issues in MAUDE and whether patient injury was involved and well described. Our data suggest that despite recent improvements to MAUDE reporting, additional standardization with specificity regarding patient issues and interventions is needed to assist vascular surgeons monitoring real-time adverse event trends for vascular devices.

Device Complications and Outcomes Before and After FDA Recall of the VICI and Venovo Venous Stent Systems

The first two Food and Drug Administration (FDA) approved stents specific for iliofemoral vein obstruction, the VICI (Boston Scientific, Marlborough, MA) and Venovo (Becton, Dickinson and Co, Franklin Lakes, NJ) venous stent systems, were recalled on April 12, 2021 and May 12, 2021, respectively, within years of entering the market. We analyzed the publicly reported adverse events in the FDA Manufacturer and User Facility Device Experience (MAUDE) database to better characterize the predominant device and patient issues reported for each system over their recall timelines.

Hypercoagulable States Among Patients Undergoing Vein Stent Placement for Chronic Iliofemoral Vein Obstruction

We undertook this study to determine the prevalence of hypercoagulation states with known history of a prior deep vein thrombosis (DVT) and intraoperative findings of post phlebitis vascular changes (PPVC), which indicated the observed stenosis was likely owing to a remote DVT.

Analysis of Publicly Reported Adverse Events In The Vici And Venovo Venous Stent Systems

<h3>INTRODUCTION AND OBJECTIVES</h3> The first two FDA approved stents for treatment of iliofemoral vein obstruction, Boston Scientific's VICI and BD's Venovo Venous Stent Systems, were both recalled early 2021, within years of entering market. We set forth to analyze publicly reported adverse events in the FDA Manufacturer and User Facility Device Experience (MAUDE) database to better characterize predominant device and patient issues reported for each system. <h3>METHODS</h3> MAUDE was queried for all adverse event reports for brands "VICI" and "Venovo" from their respective US FDA market approval dates to August 19, 2021. Reported device issues, patient issues, device return status, and intervention performed for each adverse event were compiled and compared utilizing Fisher's exact test. <h3>RESULTS</h3> A total of 50 adverse event reports were compiled for the VICI system and 341 for the Venovo system. The most common device issue reported was migration in VICI (48% vs 0%; p=0.0001) versus activation failure in Venovo (85% vs 4%; p=0.0001). A higher proportion of Venovo adverse event reports specified no patient complications or symptoms (90% vs 26%; p=0.0001) and device return to manufacturer (13% vs 2%, p=0.07). There were several significant differences between interventions reported following adverse events for each respective device (Table) <h3>CONCLUSIONS</h3> While two venous stent systems were recalled simultaneously, significant differences exist between reported device issues in MAUDE and whether patient injury was involved. Our data suggests that despite recent addition of patient issues to MAUDE reporting, standardized inclusion of reporting specific interventions would greatly assist vascular surgeons monitoring real-time adverse event trends for vascular devices.

The sonographer's use of spectral Doppler in the common femoral vein for the assessment of iliac vein obstructions: A retrospective audit

AbstractIntroductionIliac vein obstructions account for 2%–3% of all lower limb deep vein thromboses (DVT). Delayed diagnosis can lead to a higher risk of limb ischemia in the acute setting and post‐thrombotic syndrome in the chronic setting. The purpose of this audit was to determine whether sonographers were taking and interpreting waveforms correctly at the common femoral vein (CFV).MethodsA retrospective audit was performed of all the DVT patients (n = 375) over the course of 3 months. Changes in phasicity during Valsalva, respiration or augmentation of the spectral waveform at the CFV was recorded.ResultsWithin the cohort group of 375 examinations assessed. Only 277 (74%) patients had spectral traces taken at the level of the CFV. 29 (10%) patients had persistent monophasic waveforms that did not change significantly when a Valsalva manoeuvre was performed, eight patients (2%) had confirmed iliofemoral vein obstruction with either ultrasound or computed tomography venogram.ConclusionThe audit results show that spectral traces at the CFV are not always being taken or assessed effectively in clinical practice for various reasons; highlighting a potential clinical risk. With a combination of education, improved department protocols and workflow strategies, the standard of sonography should be improved.

Oxygen uptake kinetics during exercise reveal central and peripheral limitation in patients with iliofemoral venous obstruction

ObjectivePulmonary oxygen uptake (V˙O2) kinetics measured during the initiation of exercise mirror energetic transition during daily activity. The aim of this study was to elucidate the pathophysiological mechanisms of exercise limitation of patients with chronic iliofemoral vein obstruction after deep vein thrombosis by measuring V˙O2 kinetics compared with patients with peripheral arterial disease (PAD) and healthy individuals. MethodsEleven patients with iliofemoral vein obstruction (7 men; age, 20-65 years), seven patients with PAD (all men; age 44-60 years) and eight healthy participants (5 men; age 28-58 years) were studied. Participants performed upper and lower limb symptom-limited cardiopulmonary exercise tests on cycle ergometers; and four repeat lower limb tests at a constant work rate corresponding with 90% of the gas exchange threshold for determining V˙O2 kinetics. ResultsPhase I V˙O2 amplitude in the constant work rate tests (percent increase over resting V˙O2), representing the initial surge in cardiac output caused by the emptying of leg veins, was 59 ± 19% in the iliofemoral vein obstruction group, 73 ± 22% in PAD, and 85 ± 26% in healthy participants (P = .055 for iliofemoral vein obstruction vs healthy). Phase II V˙O2 kinetics, which largely reflect the kinetics of O2 consumption in the exercising muscles, were slower in iliofemoral vein obstruction (tau = 42 ± 6 seconds), and PAD (tau = 49 ± 19 seconds), compared with healthy participants (23 ± 4 seconds; P < .01). ConclusionsSlow phase II V˙O2 kinetics reflect a slow onset of muscular aerobic metabolism in both iliofemoral vein obstruction and PAD. The low amplitude phase I of V˙O2 kinetics observed in iliofemoral vein obstruction suggests a damped cardiodynamic phase, consistent with decreased venous return from the obstructed veins. These abnormalities of V˙O2 kinetics may contribute to exercise intolerance in iliofemoral vein obstruction and PAD.

Endovascular treatment of iliofemoral vein obstruction below the inguinal ligament using a new-dedicated stent: early experience from a single center.

The aim of this study was to assess our experience with a new commercially available venous stent as an extension below the inguinal ligament in patients with iliofemoral venous outflow obstruction involving the common femoral vein. We treated 16 patients with iliofemoral venous outflow occlusion and post-thrombotic syndrome (PTS) (mean age: 52.5±20.2; female: 87.5%) with the Blueflow Venous Stent (plusmedica GmbH & Co. KG, Düsseldorf, Germany) between 2019 and 2020. All patients had unilateral venous disease with >50% stenosis in the iliofemoral veins. The primary endpoints assessed were technical success, primary and secondary patency rate at 1 year of follow-up, respectively. Clinical improvement was assessed with the Villalta Scale, revised venous clinical severity score (rVCSS) classification and visual analog-scale (VAS) respectively. The technical success rate was 100%. No intraoperative and 30-days postoperative complications were documented. The primary and secondary patency rates were 80.2% and 100% respectively, at 1 year of follow-up. One in-stent occlusion and two in-stent restenosis were detected during follow-up. Stent fracture and/or migration were not observed during follow-up. A significant improvement in the Villalta Scale and rVCSS score was documented with a median score of 3 (IQR: 2-6) and 2.5 (IQR: 1-5) versus baseline at the last follow-up. A pain reduction of 18 mm on the VAS scale was documented at 1-year follow-up. In this cohort of patients, the Blueflow Venous Stent across the inguinal ligament was safe and effective for the treatment of symptomatic iliofemoral venous disease, with a high primary patency rate at 1-year of follow-up. However, longer follow-up and larger cohorts are still needed.

Genetic biases related to chronic venous ulceration.

Chronic wounds represent a major socioeconomic problem. Chronic venous ulceration is one of the least well-understood types of chronic wounds. A chronic venous ulcer arises as a result of chronic venous insufficiency (CVI), which affects approximately 10-35% of people in the developed world, yet not all people with CVI develop ulceration. The question of why some patients with CVI develop chronic ulceration and others do not, still remains unanswered. Risk factors for the development of chronic ulceration are poorly understood and include age, residual iliofemoral vein obstruction, residual deep incompetence, persistent venous hypertension, obesity and genetics. The genetic aspects of CVI have only been vaguely evaluated. This paper reports on a literature review of the variation in genetic polymorphisms and gene expression associated with the development of a chronic venous ulceration.

Long-term clinical outcomes and technical factors with the Wallstent for treatment of chronic iliofemoral venous obstruction

BackgroundFactors affecting long-term clinical outcome and stent patency after iliofemoral venous stenting remain complex and ill-defined. Also, consensus is lacking among clinicians regarding the continuing role for the Wallstent (Boston Scientific, Marlborough, Mass) as dedicated nitinol-based venous stents become available. We undertook this study to review our long-term results using Wallstents and to evaluate the potential role of this stent in the future. MethodsFrom 2007 to 2014, there were 77 limbs in 67 consecutive patients that received Wallstents for chronic iliofemoral vein obstruction. Intravascular ultrasound (IVUS) and venography were used to assess lesion type and extent. Baseline clinical severity was assessed with Venous Clinical Severity Score (VCSS) and Clinical, Etiology, Anatomy, and Pathophysiology (CEAP) classification. Clinical improvement was assessed with VCSS at 12, 24, and 36 months. VCSS change ≥4 points was considered significant improvement. Patency was assessed with duplex ultrasound. A retrospective review of patients' records and imaging was conducted to assess baseline and procedural factors associated with long-term clinical outcomes. ResultsLesions were nonthrombotic in 42 limbs (55%) and left-sided in 48 limbs (62%). Ten patients were treated for bilateral venous disease. Patients were predominantly male (55%); median age was 63 years (range, 47-83 years). Median baseline VCSS was 9 (range, 3-23). IVUS and venography estimated equal vessel compromise length in 37 limbs (48%). IVUS estimated a longer lesion in 32 limbs (42%). Stenting correlated with venography and IVUS in 37 limbs (48%) and more closely aligned with IVUS in 35 limbs (45%). Stents extended into the common femoral vein (CFV) in 17 limbs (22%) and into the inferior vena cava in 6 limbs (8%). Sixty-five (97%) patients had available imaging follow-up (median, 50 months). At 72 months, primary patency in the overall cohort was 87%; assisted primary patency and secondary patency were both 95%. In the nonthrombotic subset, assisted primary patency and secondary patency were 100%; primary patency was 97%. In the post-thrombotic subset, primary patency was 75%; assisted primary patency and secondary patency were 88%. Three early failures occurred. Eight patients required reintervention (range, 0.5-80 months); five interventions were to maintain patency. Cox multivariate regression identified that CFV disease predicted later complications. At last VCSS follow-up per patient (median, 26 months), 52 patients (68%) showed ≥4-point VCSS improvement. None had score worsening. ConclusionsVenous stenting with Wallstents for iliofemoral post-thrombotic or compressive obstruction proved safe and effective through long-term follow-up, with excellent patency rates. The majority of patients exhibited significant clinical improvement. CFV occlusive disease predicts increased complications.

Chronic iliofemoral vein obstruction – an under-recognized cause of exercise limitation

Local symptoms of chronic venous insufficiency after deep vein thrombosis (DVT) are well described, but little is known about the effect of residual venous obstruction on exercise capacity. We tested our hypothesis that chronic residual iliofemoral vein occlusion (IFVO) after DVT may impair exercise capacity. Nine post-DVT patients with residual IFVO and effort intolerance were studied; a comparison cohort consisted of 11 healthy volunteers. Exercise tolerance was assessed by bimodality incremental symptom-limited cardiopulmonary testing, using leg and arm ergometers. In healthy subjects, leg vein obstruction was modelled by application to the thighs of cuff tourniquets inflated to 30–40 mmHg. Leg exercise tolerance as measured by oxygen uptake at peak exercise (peak ⩒’O2) was reduced in patients (median 50% predicted (range 36–83%) vs. 88% predicted (67–129%) in normal subjects, p < 0.001). Arm exercise tolerance was also reduced in patients, but less severely than in the legs – the median arm: leg ratio of peak ⩒’O2 was 0.95 (0.77–1.43) in patients vs. a normal ratio of 0.73 (0.6–1.0) in healthy subjects (p < 0.003). In healthy subjects, bilateral leg vein obstruction by tourniquets reduced peak ⩒’O2 in leg exercise to 76% predicted (range 55–108%; p < 0.001 vs. standard test). In conclusion, the comparison of arm vs. leg exercise capacity in post-DVT patients with residual IFVO and the effect of experimental venous obstruction (thigh tourniquets) in healthy subjects suggest that reduced exercise capacity in patients was at least partially caused by reduced venous return. Chronic venous obstruction should be recognized as a cause of exercise limitation.

Endovascular treatment of post-thrombotic and non-thrombotic iliofemoral venous outflow obstructions with self-expanding nitinol stents.

The aim of the study was to investigate venous patency and clinical outcomes for endovascular treatment of iliofemoral venous obstruction in patients with post-thrombotic syndrome (PTS) and non-thrombotic iliac vein lesion (NIVL) with dedicated self-expanding nitinol stents. Data were collected from the prospective Swiss Venous Stent Registry, enrolling consecutive patients with a standardized follow-up procedure since January 2008. Patency was evaluated by duplex sonography and clinical outcome by various scores including the Villalta score at baseline, three, six, and 12 months, and then annually after endovascular therapy. Overall, 93 patients (64 PTS, 29 NIVL) were analysed. Mean follow-up time was 20 ± 16 (range 3-70) months. A total of 11 (12 %) patients had a stent occlusion, all of which occurred in the PTS group, and 13 (14 %) patients had a symptomatic stent stenosis. Primary patency was 79 % (95 % CI 68-87 %) at 12 months and 72 % (95 % CI 59-82 %) at 24 months. In PTS patients, primary patency at 12 months was 75 % (95 % CI 61-84 %) vs. 89 % (95 % CI 63-97 %) in NIVL patients (p = 0.10). Secondary patency at 24 months was 94 % (95 % CI 84-98 %) in PTS and 100 % in NIVL, p = 0.19). Overall, 62 (67 %) patients were free from PTS at the latest follow-up with a Villalta score < 5 points. Predictive factors for the loss of primary patency were stents placed below the inguinal ligament (OR 2.59, 95 % CI, 0.99-6.84, p = 0.05). In symptomatic patients with chronic iliofemoral vein obstruction, endovascular therapy with self-expanding nitinol stents was associated with favourable patency rates and clinical improvement in the majority of patients.

Invited Commentary.

This report concludes that intravascular ultrasound (IVUS) imaging is more sensitive for assessing treatable iliofemoral vein stenosis compared with multiplanar venography and frequently leads to revised treatment plans and the potential for improved clinical outcome. The authors also state that a 50% stenosis is of clinical relevance. Unfortunately, there is no scientific proof to support this statement, although some reports suggest it to be of any value. Venography versus intravascular ultrasound for diagnosing and treating iliofemoral vein obstructionJournal of Vascular Surgery: Venous and Lymphatic DisordersVol. 5Issue 5PreviewThe Venogram vs IVUS for Diagnosing Iliac vein Obstruction (VIDIO) trial was designed to compare the diagnostic efficacy of intravascular ultrasound (IVUS) with multiplanar venography for iliofemoral vein obstruction. Full-Text PDF

Venography versus intravascular ultrasound for diagnosing and treating iliofemoral vein obstruction

The Venogram vs IVUS for Diagnosing Iliac vein Obstruction (VIDIO) trial was designed to compare the diagnostic efficacy of intravascular ultrasound (IVUS) with multiplanar venography for iliofemoral vein obstruction. During a 14-month period beginning July 2014, 100 patients with chronic Clinical, Etiologic, Anatomic, and Pathophysiologic clinical class C4 to C6 venous disease and suspected iliofemoral vein obstruction were enrolled at 11 U.S. and 3 European sites. The inferior vena cava and common iliac, external iliac, and common femoral veins were imaged. Venograms were measured for vein diameter; IVUS provided diameter and area measurements. Multiplanar venograms included three views: anteroposterior and 30-degree right and left anterior oblique views. A core laboratory evaluated the deidentified images, determining stenosis severity as the ratio between minimum luminal diameter and reference vessel diameter, minimal luminal area, and reference vessel area. A 50% diameter stenosis by venography and a 50% cross-sectional area reduction by IVUS were considered significant. Analyses assessed change in procedures performed on the basis of imaging method and concordance of measurements between each imaging method. Venography identified stenotic lesions in 51 of 100 subjects, whereas IVUS identified lesions in 81 of 100 subjects. Compared with IVUS, the diameter reduction was on average 11% less for venography (P< .001). The intraclass correlation coefficient was 0.505 for vein diameter stenosis calculated with the two methods. IVUS identified significant lesions not detected with three-view venography in 26.3% of patients. Investigators revised the treatment plan in 57 of 100 cases after IVUS, most often because of failure of venography to detect a significant lesion (41/57 [72%]). IVUS led to an increased number of stents in 13 of 57 subjects (23%) and the avoidance of an endovascular procedure in 3 of 57 subjects (5%). Overall, IVUS imaging changed the treatment plan in 57 patients; 54 patients had stents placed on the basis of IVUS detection of significant iliofemoral vein obstructive lesions not appreciated with venography, whereas 3 patients with significant lesions on venography had no stent placed on the basis of IVUS. IVUS is more sensitive for assessing treatable iliofemoral vein stenosis compared with multiplanar venography and frequently leads to revised treatment plans and the potential for improved clinical outcome.

Analysis of Threshold Stenosis by Multiplanar Venogram and Intravascular Ultrasound for Predicting Clinical Improvement After Iliofemoral Vein Stenting: Results From the VIDIO Study

Selection of patients for iliofemoral vein stenting requires the identification and quantification of stenotic lesions with imaging such as multiplanar venography (MPV) and intravascular ultrasound (IVUS). The Venogram Versus Intravascular Ultrasound for Diagnosing Iliofemoral Vein Obstruction (VIDIO) trial showed IVUS to be more sensitive than MPV for identifying “significant” iliofemoral vein stenosis. To date, the comparative utility of these imaging studies using the customary 50% treatment threshold for stenosis severity has not been prospectively validated against clinical improvement. The multicenter VIDIO trial prospectively enrolled 100 symptomatic patients (clinical, etiologic, anatomic, and pathophysiologic [CEAP] class 4-6) with suspected iliofemoral venous outflow disease. Venous stenting for presumed significant iliofemoral vein stenosis was performed on 68 patients. Each underwent baseline and poststenting MPV and IVUS to compare the diagnostic and clinical utility of the tests. Based on imaging, stenosis was characterized as nonthrombotic (ie, compression) in 48 patients and post-thrombotic (ie, luminal scar, sclerotic vein contraction) in 20 patients. The Revised Venous Clinical Severity Score was the clinical index for which anatomic imaging measurements were consistently related to patient outcome. A 4-point reduction in the Revised Venous Clinical Severity Score between baseline and 6 months was used as an indicator of clinical improvement for calculating sensitivities and specificities for MPV-determined percentage diameter reduction and IVUS-determined percentage diameter and area reduction. Receiver operating characteristic curve analysis was used to determine the optimal diameter and area thresholds for clinical improvement. The validity of each imaging measure was assessed with respective areas under the curve (AUCs), calculating P values estimating the probability that a measure was of greater value than chance alone. Clinical improvement after stenting was best predicted by IVUS-determined baseline stenosis, either by diameter (AUC, .64; P = .046; cutoff >55.7%) or area reduction (AUC, .64; P = .043; cutoff >53.6%). MPV-determined baseline stenosis was not predictive (AUC, .58; P = .290; cutoff >51.9%). Evaluating lumen improvement from baseline to after intervention revealed that IVUS-determined area change was the best measure (AUC, .70; P = .003; cutoff >40.5%), followed by IVUS-determined diameter change (AUC, .66; P = .020; cutoff >45.6%). MPV-determined diameter change did not predict clinical improvement (AUC, .56; P = .370; cutoff >37.5%). In the 48-patient nonthrombotic subset, IVUS diameter measurements of baseline stenosis were significantly predictive (AUC, .67; P = .029; cutoff >61.2%). MPV was not predictive (AUC, .61; P = .17; cutoff >51.9%). The measurement with the most predictive utility for clinical improvement was stenotic change in the nonthrombotic subset, with an AUC of .75 for both IVUS area and diameter measurements (P = .001). MPV-determined diameter change in the nonthrombotic subset had borderline predictive utility for symptom improvement (AUC, .66; P = .05). At the time of intervention, IVUS appears to have better predictive utility than MPV for identifying iliofemoral vein stenosis in CEAP class 4-6 patients that, when treated, results in significant symptom improvement. These findings for the entire cohort corroborate the conventional 50% threshold as defining a clinically significant stenosis that, when stented, has significant predictive value for symptom improvement. In nonthrombotic patients, however, a higher threshold of >61% diameter stenosis may better predict clinical improvement.

Percutaneous closure of adjunctive arteriovenous fistulas after surgical reconstruction of iliac veins

In open surgical reconstruction for chronic iliofemoral and iliocaval vein obstruction, addition of an arteriovenous fistula (AVF) can improve patency. The AVF is usually taken down in a second surgical procedure several months after the initial reconstruction. With the advancement of endovascular techniques, percutaneous closure of the fistula has become an option. We have completed percutaneous endovascular takedown of AVFs after surgical reconstruction of iliofemoral veins in three patients using an occlusion device. Complete occlusion was achieved in all cases, and no short-term complications were noted. Endovascular occlusion seems particularly appealing as further surgery in a groin usually scarred by previous open procedures can be avoided.

Venogram Versus Intravascular Ultrasound for Diagnosing and Treating Iliofemoral Vein Obstruction (VIDIO): Report From a Multicenter, Prospective Study of Iliofemoral Vein Interventions

Venogram Versus Intravascular Ultrasound for Diagnosing and Treating Iliofemoral Vein Obstruction (VIDIO): Report From a Multicenter, Prospective Study of Iliofemoral Vein Interventions

Clinical Assessment of Endovascular Stenting Compared with Compression Therapy Alone in Post-thrombotic Patients with Iliofemoral Obstruction

The study aimed to evaluate the clinical results of stent placement in post-thrombotic patients with iliofemoral obstruction compared with results in those treated with elastic compression stockings (ECS). A retrospective analysis of post-thrombotic patients with iliofemoral obstruction was conducted in a single institution from January 2007 to December 2012. Duplex ultrasound and selective phlebography were performed in patients with chronic venous disease and previous deep venous thrombosis (DVT). Post-thrombotic syndrome (PTS) with iliofemoral vein obstruction (Villalta score ≥10) was diagnosed in 216 patients. Among these, 122 patients were treated by stent placement, and the remaining 94 patients were treated conservatively with 30-40 mmHg ECS therapy. Technical success, stent patency rates, and complications were recorded after the interventions. Results including Villalta score, pain, edema, ulcer, and popliteal vein reflux were assessed in both groups. Percutaneous iliofemoral venous stenting was successful in 116 of 122 patients (95.1%) without major complications. Follow up periods ranged from 3 to 58 months (median 21 months). Cumulative primary, assisted primary, and secondary stent patency rates at 3 years were 68.9%, 79.0%, and 91.6%, respectively. Among patients with severe PTS, the Villalta score decreased significantly with endotreatment, compared to the score of those treated by ECS therapy (16.12 ± 4.91 vs. 10.98 ± 5.89, p < .01). However, there was no significant score improvement between the two therapies in patients with moderate PTS (6.59 ± 2.37 vs. 5.75 ± 3.03, p = .22). There was a significantly higher 24 month recurrence free ulcer healing rate in the endotreatment groups (86.6% vs. 70.6%, p < .01). Both edema and pain improved significantly in the two groups. The popliteal vein reflux rate showed no significant change after endotreatment. Endovascular treatment is a safe, effective, and feasible method to correct the iliofemoral obstruction of PTS. Only post-thrombotic patients with severe PTS as assessed by the Villalta score appear to benefit from the endovascular treatment.