Eight-year follow-up of a randomized clinical trial comparing ultrasound-guided foam sclerotherapy with surgical stripping of the great saphenous vein.

BACKGROUND: This was an 8-year follow-up of an RCT comparing ultrasound-guided foam sclerotherapy (UGFS) with high ligation and surgical stripping (HL/S) of the great saphenous vein (GSV). METHODS: Patients were randomized to UGFS or HL/S of the GSV. The primary outcome was the recurrence of symptomatic GSV reflux. Secondary outcomes were patterns of reflux according to recurrent varices after surgery, Clinical Etiologic Anatomic Pathophysiologic (CEAP) classification, Venous Clinical Severity Score (VCSS) and EuroQol Five Dimensions (EQ-5D™) quality-of-life scores. RESULTS: Of 430 patients originally randomized (230 UGFS, 200 HL/S), 227 (52·8 per cent; 123 UGFS, 103 HL/S) were available for analysis after 8 years. The proportion of patients free from symptomatic GSV reflux at 8 years was lower after UGFS than HL/S (55·1 versus 72·1 per cent; P = 0·024). The rate of absence of GSV reflux, irrespective of venous symptoms, at 8 years was 33·1 and 49·7 per cent respectively (P = 0·009). More saphenofemoral junction (SFJ) failure (65·8 versus 41·7 per cent; P = 0·001) and recurrent reflux in the above-knee GSV (72·5 versus 20·4 per cent; P = 0·001) was evident in the UGFS group. The VCSS was worse than preoperative scores in both groups after 8 years; CEAP classification and EQ-5D® scores were similar in the two groups. CONCLUSION: Surgical stripping had a technically better outcome in terms of recurrence of GSV and SFJ reflux than UGFS in the long term. Long-term follow-up suggests significant clinical progression of venous disease measured by VCSS in both groups, but less after surgery. Registration number: NCT02304146 (http://www.clinicaltrials.gov).

Endophlebectomy of the common femoral vein and arteriovenous fistula creation as adjuncts to venous stenting for post-thrombotic syndrome.

BACKGROUND: Good results have been reported for angioplasty and stenting of post-thrombotic lesions of the iliac and proximal femoral veins. If lesions at the origin of the superficial femoral and profunda veins are stented, the intraluminal synechiae can be pushed against the orifices of inflow vessels, potentially decreasing stent inflow. Surgical disobliteration of the common femoral vein (endophlebectomy) has been suggested to mitigate this problem. Because of a temporary increase in thrombogenicity, this procedure may be accompanied by arteriovenous fistula creation. METHODS: Data on consecutive patients treated by hybrid venous reconstruction, between December 2010 and May 2015, were analysed. Standard recording consisted of clinical scoring systems (including Villalta scale) and imaging. Patency was assessed with duplex ultrasonography. RESULTS: Seventy-six legs (70 patients) were included. Median follow-up was 379 (range 73-1508) days. Primary, assisted primary and secondary patency rates at 12 months were 51, 70 and 83 per cent respectively. Sixty per cent of loss of primary patency (24 of 40 legs) was related to common femoral vein stenosis, and the rest to rethrombosis. Other complications included wound infection (29 per cent) and lymphatic leak (39 per cent). The Villalta score had decreased by a median of 7 points at 1-year follow-up. CONCLUSION: The combination of venous stenting, endophlebectomy and arteriovenous fistula creation for patients with extensive post-thrombotic vein damage and severe post-thrombotic syndrome is feasible.

Editor's Choice - Reconstruction of the femoro-ilio-caval outflow by percutaneous and hybrid interventions in symptomatic deep venous obstruction.

OBJECTIVE/BACKGROUND: Deep venous obstruction is relatively prevalent in patients with chronic venous disease. Endovascular treatments and hybrid interventions can be used to relieve venous outflow obstructions. This paper assesses mid-term clinical outcomes and patency rates in a large cohort after percutaneous and hybrid interventions. METHODS: This was a prospectively analysed cohort study. Patients with symptomatic deep venous obstruction who presented at a tertiary referral hospital were divided into three groups: patients who underwent percutaneous stenting for non-thrombotic iliac vein compression syndrome (IVCS group); patients with post-thrombotic syndrome (PTS) treated by percutaneous stent placement (P-PTS group); and PTS patients with obstruction involving the veins below the saphenofemoral junction in which a hybrid procedure was performed, combining stenting with open surgical disobliteration (H-PTS group). Patency rates, complications, and clinical outcomes were analysed. RESULTS: A total of 425 lower extremities in 369 patients were treated. At 60 months, primary patency, assisted primary patency, and secondary patency rates were 90%, 100%, and 100% for IVCS, and 64%, 81%, and 89% for the P-PTS group, respectively. The H-PTS group, showed patency rates of 37%, 62%, and 72%, respectively, at 36 months. Venous claudication subsided in 90%, 82%, and 83%, respectively. At the 24 month follow-up, mean Venous Clinical Severity Score decreased for all patients and improvement in Villalta score was seen in post-thrombotic patients. The number of complications was related to the extent of deep venous obstruction in which patients in the H-PTS group showed the highest complication rates (81%) and re-interventions (59%). CONCLUSION: Percutaneous stent placement to treat non-thrombotic iliac vein lesions, and post-thrombotic ilio-femoral obstructions are safe, effective, and showed patency rates comparable with previous research. Patients with advanced disease needing a hybrid procedure showed a lower patency rate and more complications. However, when successful, the clinical outcome was favourable at mid-term follow-up and the procedure may be offered to selected patients.

Short-Term Clinical Experience with a Dedicated Venous Nitinol Stent: Initial Results with the Sinus-Venous Stent.

OBJECTIVE: Deep venous stenting has become the primary treatment option for chronic venous obstructive disease, both for iliac vein compression and post-thrombotic venous lesions. Until recently, only stents aimed at arterial pathology were used, because no dedicated venous stents were available. However, three such stents have now become available. These venous stents are characterized by increased length, diameter, flexibility, and radial force. This study reports an early experience with one of these devices; the sinus Venous stent (OptiMed GmbH, Ettlingen, Germany). METHODS: Between March 2012 and July 2014, 75 patients were treated with the sinus Venous stent: 35 cases of iliac vein compression syndrome and 40 cases of unilateral chronic obstruction in post-thrombotic syndrome (PTS). Diagnosis of relevant obstruction was made using clinical evaluation, duplex ultrasound, and magnetic resonance venography. Patency during follow up was assessed with duplex ultrasound. Clinical improvement was assessed by VCSS, Villalta score, rate of ulcer healing, and improvement of venous claudication. RESULTS: The cumulative patency rates at 3, 6, and 12 months were 99%, 96%, and 92%, respectively. The cumulative assisted primary patency rates were 99% at 3, 6, and 12 months. The cumulative secondary patency rate at 12 months was 100%. Differences exist in patency rate between the subgroups of non-thrombotic and post-thrombotic, with the first showing no re-occlusions. All re-thromboses in the PTS group were treated by ancillary treatment modalities. VCSS and Villalta score decreased significantly after stenting, as did venous claudication. Morbidity was low without clinically relevant pulmonary embolism, and mortality was nil. Although two out of seven ulcers healed temporarily, no ulcer remained healed at 12 months follow up. CONCLUSION: Short-term clinical results using the sinus Venous stent are excellent, with significant symptom reduction, low morbidity rates, and no mortality. Loss of stent patency is seen less often compared with arterial stents described in the literature.

Venous in-stent thrombosis treated by ultrasound accelerated catheter directed thrombolysis.

OBJECTIVE/BACKGROUND: Stent placement in the venous system is an increasingly used treatment modality in chronic venous obstruction and as additional treatment after thrombolytic therapy in ilio-femoral deep vein thrombosis (DVT). Experience in treating in-stent thrombosis with ultrasound accelerated catheter directed thrombolysis (UACDT) is reported. METHODS: A retrospective analysis of patients treated for venous stent occlusion, after percutaneous transluminal angioplasty (PTA) and stent placement for either chronic venous occlusive disease or persistent vein compression in patients with acute DVT was performed. Duration of occlusion and suspected clot age were assessed using patient complaints and typical findings on duplex ultrasonography (DUS). DUS and venography were used to assess patency and to determine the cause of re-occlusion. Acute treatment of occlusion was by UACDT. Additional procedures included PTA, stent placement, and creation of an arteriovenous (AV) fistula. RESULTS: Eighteen patients (median age 43 years; 67% male), treated for occluded stent tracts with UACDT between January 2009 and July 2014, were identified. Indications for initial stenting were treatment of chronic venous obstructive disease (12 patients) and treatment of underlying obstruction after initial thrombolysis in acute DVT (six patients). Technical success was achieved in 11/18 (61%) patients. Primary patency in 8/11 patients was 73% at last follow up (median follow up 14 months [range 0-41 months]). Additional treatments after successful lysis were re-stenting (seven patients) and creation of an AV fistula (six patients). CONCLUSION: Treatment with UACDT of recently occluded stent tracts is feasible and effective. Recanalization of the stent tract can be achieved in most cases. Additional interventions were frequently used after successful UACDT treatment. Suboptimal stent positioning caused the majority of the stent occlusions.

Physical activity monitoring in patients with peripheral arterial disease: validation of an activity monitor.

OBJECTIVES: The daily life physical activity (PA) of patients with peripheral arterial disease (PAD) may be severely hampered by intermittent claudication (IC). From a therapeutic, as well as research, point of view, it may be more relevant to determine improvement in PA as an outcome measure in IC. The aim of this study was to validate daily activities using a novel type of tri-axial accelerometer (Dynaport MoveMonitor) in patients with IC. METHODS: Patients with IC were studied during a hospital visit. Standard activities (locomotion, lying, sitting, standing, shuffling, number of steps and "not worn" detection) were video recorded and compared with activities scored by the MoveMonitor. Inter-rater reliability (expressed in intraclass correlation coefficients [ICC]), sensitivity, specificity, and positive predictive values (PPV) were calculated for each activity. RESULTS: Twenty-eight hours of video observation were analysed (n = 21). Our video annotation method (the gold standard method) appeared to be accurate for most postures (ICC > 0.97), except for shuffling (ICC = 0.38). The MoveMonitor showed a high sensitivity (>86%), specificity (>91%), and PPV (>88%) for locomotion, lying, sitting, and "not worn" detection. Moderate accuracy was found for standing (46%), while shuffling appeared to be undetectable (18%). A strong correlation was found between video recordings and the MoveMonitor with regard to the calculation of the "number of steps" (ICC = 0.90). CONCLUSIONS: The MoveMonitor provides accurate information on a diverse set of postures, daily activities, and number of steps in IC patients. However, the detection of low amplitude movements, such as shuffling and "sitting to standing" transfers, is a matter of concern. This tool is useful in assessing the role of PA as a novel, clinically relevant outcome parameter in IC.

Safety and feasibility of ultrasound-accelerated catheter-directed thrombolysis in deep vein thrombosis.

OBJECTIVE: One in four patients with primary iliofemoral deep vein thrombosis (DVT) develops post-thrombotic syndrome (PTS) within 1 year despite optimal standard anticoagulant therapy. Removal of thrombus by thrombolytic drugs may prevent PTS. The aim of this study was to assess the short-term safety and efficacy of ultrasound-accelerated catheter-directed thrombolysis (US-accelerated CDT). DESIGN: This was a prospective non-randomised interventional study with US-accelerated CDT for DVT. PATIENTS AND METHODS: Twelve patients with DVT (seven caval-iliofemoropopliteal, three iliofemoropopliteal, one femoropopliteal and one superior caval vein thrombosis) receiving standard anticoagulant and compression therapy, were treated with additional US-accelerated CDT (13 procedures) using the EKOS Endowave(®) system (EKOS Corporation, Bothell, WA, USA) between October 2008 and January 2010. RESULTS: Thrombolysis was successful in 85% (11/13), with complete clot lysis (>90% restored patency) and in one case with partial clot lysis (50-90% restored patency). No pulmonary embolism and one bleeding at the catheter-insertion site were observed. In three patients, underlying lesions were successfully treated with balloon angioplasty and stent insertion. Four patients developed early recurrent thrombosis due to untreated residual venous obstruction. CONCLUSION: US-accelerated CDT is a safe and promising treatment in patients with DVT. Residual venous obstruction should be treated by angioplasty and stent insertion to avoid early re-thrombosis.

Measurement of health-related quality of life with the Dutch translated Aberdeen Varicose Vein Questionnaire before and after treatment.

OBJECTIVE: This clinical trial evaluated the use of the Dutch translated Aberdeen Varicose Vein Questionnaire (AVVQ) and SF-36 before and after treatment in patients with clinical-severity classes 1-6 venous disease of the lower limb. METHODS: A total of 145 patients with symptomatic venous disease of the leg were included. Numbers of patients were evenly distributed among the six clinical-severity classes 1-6 (clinical, aetiology, anatomy and pathophysiology; CEAP). Patients completed two preoperative AVVQ questionnaires and one short-form health survey with 36 items (SF-36) questionnaire to evaluate test-re-test reliability of the AVVQ. Patients completed one postoperative AVVQ and SF-36 to evaluate the effect of treatment. RESULTS: The test (99%) and re-test responses (97%) of the AVVQ were sufficient. Internal consistency of the Dutch translated AVVQ showed a Cronbach's alpha of 0.76. Correlation of test and re-test of the AVVQ was high (rho=0.86, P<0.001). A significant negative association, by Spearman's correlation coefficient, was found between the preoperative baseline Dutch translated AVVQ score and all eight domains of the preoperative SF-36 (P<0.001). These significant associations were also found in the postoperative scores. The mean preoperative AVVQ score of 19.5 (SD 11.8) and mean postoperative AVVQ score of 16.1 (SD 12.0) differed significantly (P<0.01). Analysis of three subgroups of clinical-severity classes (C1-2, C3-4 and C5-6) showed significant score changes before and after surgery (P<0.01). Preoperative and postoperative SF-36 scores were not significantly different. CONCLUSIONS: This study established the use of the Dutch translated AVVQ as a valid, health-related quality of life (QOL) questionnaire for measuring QOL before and after treatment in patients with clinical-severity classes 1-6 venous disease of the leg.

Reliability and validity of the Dutch translated Aberdeen Varicose Vein Questionnaire.

OBJECTIVE: To evaluate reliability and validity of the Dutch translated Aberdeen Varicose Vein Questionnaire (AVVQ) for measuring health related quality of life (HR-QOL) in patients with venous disease in the lower limb. METHODS: The AVVQ consists of 13 questions related varicose veins. This study assessed feasibility, reliability and validity of the Dutch translated AVVQ in a sample of 145 patients with venous disease of the leg. Test and retest of the Dutch translated AVVQ were performed within a 2 week interval. RESULTS: There was a high test (99%) and retest (97%) response. Feasibility; AVVQ showed few missing answers (0.6%) and non-unique answers (0.2%). Regarding internal consistency; Cronbach's alpha exceeded 0.7 indicating a high level of concordance between the AVVQ questions (alpha=0.76). Test-retest reliability; Spearman's rho showed a significant strong association between test and retest scores (rho=0.87). Discriminative validity; AVVQ score was able to differentiate between subgroups of patients with different severity of venous disease according to the CEAP classification (Mann-Whitney U test, p<0.01). CONCLUSIONS: This study supports applications of the Dutch AVVQ in HR-QOL measurement in patients with venous disease in the Netherlands and the Flemish speaking part of Belgium.

[Guideline on 'The treatment of recurrent varicose veins'Supplement to the Dutch Guideline on Venous disease]. / Richtlijn 'Behandeling bij neo-varices'.

The Dutch Guideline on Venous disease was lacking a section on recurrent varicose veins. The newly issued supplement on recurrent varicose veins fills this gap and provides clinicians with solutions concerning the management of patients with recurrent varicose veins following earlier treatment. Because venous disease is nowadays considered to be an ongoing disease, patients with this disorder will often require life-long care and different treatment than patients who have never been treated before.

Effect of a new incision management system (PREVENA®) on wound healing after endophlebectomy of the common femoral vein: a case series.

BACKGROUND: New endovascular techniques facilitate treatment of complex deep vein obstructions in cases of post-thrombotic syndrome. In a relevant number of these patients, endophlebectomy including the implantation of an arteriovenous fistula between the common femoral artery and the femoral vein is indispensable in order to establish a good inflow. These procedures display a high risk of wound complications. Despite conservative efforts to prevent these postoperative complications, wound healing problems occur in more than 20 % of cases. The present case report is the first description of wound dressing using a PREVENA® incision management system in cases of endophlebectomy. CASE PRESENTATION: A single center's experience with the incision management system PREVENA®, which was used after endophlebectomy and venous stenting in complex hybrid procedures in three white men aged 46 years, 53 years, and 61 years is the subject of this case report. Although the surgical procedures were performed under therapeutical anticoagulation and took a couple of hours, no wound complications occurred. CONCLUSIONS: These encouraging results underline a potential benefit of the incision management system PREVENA® in cases of complex venous recanalization including endophlebectomy of the femoral vein as well as the implantation of an arteriovenous fistula.

Intravenous pressure changes in patients with postthrombotic deep venous obstruction: results using a treadmill stress test.

UNLABELLED: Essentials Little is known about the hemodynamic consequences of deep venous obstructive disease. We investigated pressure changes in 22 patients with unilateral postthrombotic obstruction. Common femoral vein pressure significantly increased after walking, compared to control limbs. Common femoral vein hypertension could explain the debilitating effect of venous claudication. Click to hear Dr Ten Cate's perspective on postthrombotic syndrome SUMMARY: Background Little is known about the hemodynamic consequences of deep venous obstructive disease. Objectives The aim of this study was to investigate the hemodynamic effect of postthrombotic obstruction of the iliofemoral veins and to determine what pressure parameters differentiate best between limbs with post-thrombotic obstructive disease of the iliofemoral veins and those without obstruction. Methods Twenty-two participants with unilateral obstruction of the iliac and common femoral veins underwent a standardized treadmill test with simultaneous bilateral invasive pressure measurements in the common femoral vein and dorsal foot vein. Results Mean age was 42.8 ± 11.9 years and 86.4% of participants were female. Postthrombotic limbs showed a mean common femoral vein (CFV) pressure increase of 28.1 ± 21.0 mmHg after walking, compared with 2.1 ± 6.2 mmHg in control limbs (26.0 mmHg difference; 95% confidence interval [CI], 17.1-34.9). Less difference was observed in the dorsal foot vein (net drop of 36.8 ± 22.7 mmHg in affected limbs vs. 48.7 ± 23.1 mmHg in non-affected limbs, 11.9 mmHg difference; 95% CI, -1.3 to 25.0). Change in CFV pressure after walking yielded the best discrimination between affected and non-affected limbs (area under the receiver operated characteristic curve of 0.94 [95% CI, 0.85-1.00], compared with 0.57 [95% CI, 0.37-0.76] in the dorsal foot vein, P < 0.001). Conclusions Common femoral vein pressure significantly increases during ambulation in patients with iliofemoral postthrombotic obstruction, which could explain the debilitating effects of venous claudication. This is an indication that patients with an iliofemoral obstruction may benefit from further treatment that resolves the deep vein obstruction. CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov/show/NCT01846780.

Interventional treatment of postthrombotic syndrome.

BACKGROUND: Postthrombotic syndrome (PTS) is the development of symptoms and signs of chronic venous insufficiency following deep vein thrombosis (DVT) and has a significant negative effect on the quality of life. The current understanding is that the clinical manifestation of PTS is related more to venous obstruction than it is to venous reflux. The use of interventional techniques for the treatment of venous obstruction and/or venous occlusion has rapidly increased in recent years. OBJECTIVE: This article summarizes the current concept of endovenous and hybrid interventions and presents the optimized treatment of choice in patients with chronic symptomatic venous obstruction. METHODS: We performed a systematic literature search in the Medline database to identify relevant studies on the treatment of patients with PTS. RESULTS: A meta-analysis of the relevant studies showed that this minimally invasive procedure is an effective treatment option with low morbidity and no mortality. Use of the newly developed dedicated venous stents showed promising results with good mid-term patency rates and a significant decrease in related symptoms. CONCLUSION: Interventional therapy for the treatment of symptomatic chronic venous obstruction has become the method of choice in recent years. More studies are needed to evaluate the long-term success rate of dedicated venous stents.

Endovascular brachytherapy for the prevention of restenosis after femoropopliteal angioplasty. Results of the VARA Trial.

AIM: Endovascular brachytherapy (EBT) has been proposed as a method to prevent restenosis. We performed a prospective randomised multicenter study to determine its efficacy for prophylaxis of restenosis after femoropopliteal percutaneous transluminal angioplasty (PTA). METHODS: Patients with symptomatic stenotic or totally occluding lesions in the femoropopliteal artery were randomised to be treated with PTA plus EBT or PTA alone. In case of EBT, 14 Gy was applied by an 192Ir source to the vessel wall. Clinical examination, ankle-brachial pressure index (ABPI) and duplex ultrasound were planned after 6 and 12 months. The primary endpoint was significant restenosis of the treated segment at duplex ultrasound after 12 months. RESULTS: Fifty-three of the 60 patients who eventually met the inclusion criteria could be studied. After 12 months, restenosis rates were 44% (12/27) in the PTA group versus 35% (8/23) in the PTA + EBT group (c2 test, P=0.51). There was no difference in mandatory reintervention between the 2 groups. Overall, EBT resulted in an absolute risk reduction of significant restenosis of 9%, yet in patients with totally occlusive disease this reduction was 32%. CONCLUSIONS: This study suggests an effect of EBT on the occurrence of restenosis only after PTA of occluded femoropopliteal lesions. Due to a too small number of patients analysed this difference is not statistically significant.

Thrombus age is ideally measured by history or MRV prior to thrombus removal.

Many factors are known to be important in order to achieve optimal results after thrombus removal for iliofemoral DVT. Not much is published in the literature about timing the treatment, though many guidelines recommend treatment within 14 days. This time span lies within the phrase of acute DVT according to the definition given in many reporting standards. This article will highlight the value of information acquired from patients directly regarding onset of symptoms versus information acquired from imaging with the purpose of a more precise selection of patients for catheter-directed thrombolysis for iliofemoral DVT. What is the value of clinical information acquired from patients and does the information from imaging have additional value?

Validation of the LET classification.

INTRODUCTION: Acute thrombus removal therapies may reduce post-thrombotic syndrome in certain deep venous thrombosis patients. The LET classification is designed to identify patients at high risk for developing post-thrombotic syndrome in the acute phase using thrombus location and extent. This study evaluates the use of the LET classification to predict post-thrombotic syndrome in a cohort of patients after deep venous thrombosis. METHODS: A cohort of 660 deep venous thrombosis patients was invited to participate and fill out a questionnaire with Quality of life questionnaires, basic information, a modified self-assessment version of the Villalta scale for post-thrombotic syndrome and potential confounders. Original data on thrombus extension was available, and the LET classes were determined. Obtained information was analysed using ANOVA and in a multiple logistic regression model to correct for confounders. All different LET classes were compared to post-thrombotic syndrome occurrence, post-thrombotic syndrome prediction and disease specific quality of life scores (VEINES-Sym/Qol). RESULTS: Three hundred and fifteen patients responded, and in 309 a post-thrombotic syndrome score was distilled. LET I,II,III (n = 63) had an odds ratio of 3.4(1.2-9.2) for predicting severe post-thrombotic syndrome, and LET II (n = 17) had an odds ratio of 5.1(1.3-20.8) compared to LET class I (n = 97). Both the VEINES-Sym and VEINES-Qol score were significantly lower for LET I,II,III compared to LET I, and LET II compared to LET I. CONCLUSION: The LET classification can be used to classify patients according to acute thrombus location and extent. Extensive and centrally located (LET I,II,III) deep venous thrombosis showed the highest probability in developing severe post-thrombotic syndrome and lower disease specific quality of life.

Diagnostic imaging of pelvic congestive syndrome.

Many female patients are affected by chronic pelvic pain and a significant number of referrals to the gynecology department result in a clinical suspicion of pelvic congestion syndrome. Additionally, patients referred to the vascular surgery department for venous disease can also present with complaints of a persistent dull lower abdominal pain in addition to typically distributed leg varicosities (that extend from the leg through the pelvic floor) which should be evaluated for the presence of pelvic congestion syndrome. In this article, we focus on imaging pelvic vein insufficiency and related (extending) varicosities: how should we evaluate the pelvic veins, what are the signs to look for, and what are the currently established criteria for (pre-interventional) imaging.