Deep Venous Stenting Research Articles

Classification of Factors Associated with Stenosis, Re-Occlusion and Subsequent Re-intervention, Following Deep Venous Stenting for Acute Iliofemoral Deep Venous Thrombosis

Introduction: Post thrombotic syndrome (PTS) is devastating sequela of acute iliofemoral deep venous thrombosis (DVT). Thrombolysis and deep venous stenting aims to restore vessel outflow and reduce PTS in accordance with the open vessel hypothesis. For a proportion of patients, despite initial interventional success, re-occlusion or stenosis will necessitate further treatment. This study aimed to determine and classify the causes of re-occlusion and stenosis following deep venous interventions for acute iliofemoral DVT, with identification of preventable factors to improve future treatment. Methods: A retrospective single centre cohort study of patients successfully lysed for treatment of iliofemoral DVT between November 2013 and 2017 was carried out. Patient records and imaging were examined for: baseline demographics, risk factors, extent of DVT, extent of vessel clearance, stents inserted, quality of in-flow, time to and success of re-intervention, anticoagulation compliance, and secondary vessel patency. Failure was classified as either technical, haematological, flow related or mixed. Technical causes were further subdivided into lack of stenting, failure to address inflow or outflow and device related failure. Results: 143 limbs were identified: 95 without further intervention (66%), and 48 limbs (34%) requiring re-intervention. 45% of cases occurred in the first 6 weeks, with a median time to re-intervention of 45 days. Re-intervention was successful in 31 cases (67%). This was achieved in all cases managed prior to complete vessel occlusion compared to 8/25 (32%) of those presenting with complete occlusion (p=0.001). Need for re-intervention was associated with a younger median age (44 vs. 31, p=0.002), IVC involvement (13% vs. 35%, p=0.002) and presence of a stent across the inguinal ligament (15% vs. 38%, p=0.002). Non-compliance with anticoagulation post-procedurally was found to be strongly associated with re-occlusion: relative risk 3.17 (95%CI 0.29-0.91, p=0.0001). Haematological issues were observed in 33% of re-intervention cases, flow-related issues in 44%% of re-intervention cases, and technical problems were observed in 54% of re-intervention cases. Four cases due to stent fracture or compression were observed. Identified problems were multifactorial in 27% of cases. Overall vessel salvage was achieved in 71% of cases with a single causative factor compared to 54% of cases classified as multifactorial. This did not translate into a statistically significant difference in secondary patency. Conclusion: Re-intervention occurred due to potentially preventable factors in a substantial proportion of patients. Re-intervention following complete vessel re-occlusion carries a lower likelihood of success. This study emphasises the need for precision in stenting technique, for post-procedural surveillance, and for adherence to anticoagulation in order to optimise patient outcome. Disclosure: Cook, BSCI, Optimed, Bard, Medtronic, Vesper, Veniti, Philips-Volcano, BTG

Timing is Everything: Importance of Early Duplex Surveillance in Predicting Risk of Re-intervention Following Deep Venous Stenting for the Treatment of Postthrombotic Syndrome

Timing is Everything: Importance of Early Duplex Surveillance in Predicting Risk of Re-intervention Following Deep Venous Stenting for the Treatment of Postthrombotic Syndrome

Early outcomes using dedicated venous stents in the upper limb of patients with venous thoracic outlet syndrome: A single centre experience

IntroductionSurgical management of Venous Thoracic Outlet Syndrome (vTOS) is based upon resection of the first rib. The optimal method to treat any residual venous scarring however remains unclear. The purpose of this study was to evaluate a single quaternary centre’s early and mid-term outcomes following endovascular reconstruction of the axillo-subclavian vein using dedicated venous stents in patients with VTOS.MethodologyA retrospective analysis of patients at Royal Prince Alfred Hospital, who underwent upper limb deep venous stenting as an adjunct in the treatment of vTOS was performed. All patients between 2012 and 2017 were included. Stent patency was assessed with duplex ultrasonography. All re-interventions and their indications were recorded.ResultsA total of 24 limbs in 21 patients (13 female, median age 44 yrs) were treated with dedicated venous stents between 2012 and 2017. All patients had resection of their first rib using a transaxillary approach. Nine patients initially presented with an acute DVT and underwent thrombolysis. In three of these patients a venous stent was placed before rib resection following completion of lysis. In the remainder, the median time for stent placement following surgery was 64 days. Median follow-up from stent insertion was 50 months. Primary, primary-assisted and secondary patency at 24 months was 55%, 95% and 100% respectively with one patient lost during follow-up. There were no major complications. A total of 14 re-interventions were performed on these patients. Three patients reported residual symptoms following stenting including heaviness (n = 1), bluish discolouration (n = 1) and prominent veins on the chest (n = 1) with the remainder asymptomatic.ConclusionIn this single centre study, endovascular reconstruction using dedicated venous stents appears to be an effective and safe method to reconstruct a damaged subclavian vein following rib resection in patients with vTOS.

Early Duplex Surveillance Following Deep Venous Stenting for the Treatment of Post- Thrombotic Syndrome can Predict Patients at Greatest Risk for Re-intervention

Background: Endovascular treatment of post-thrombotic syndrome using nitinol venous stents is associated with symptomatic improvement, but ∼40% require re-intervention. We examined whether ultrasound surveillance was sensitive for re-intervention, and whether it was possible to predict patients at greatest risk of re-intervention. Methods: Stent patency was assessed between 2012–2017 using duplex ultrasonography 24hrs, 2wks, 6wks, 3mths, 6mths, 1yr and yearly post-intervention. Maximum in-stent stenosis was calculated, with re-interventions performed when stent diameter reduction was >50%. Patient demographics were collected to determine which factors were associated with re- intervention. Results: Cumulative patency was 167/194 (86%). However, 79 (41%) patients required re-intervention to maintain patency, of which 40/79 (51%) occurred within 3wks of their procedure. Stenting across the inguinal ligament was associated with a higher risk of early re-intervention (HR 1.817; p=0.048, 95% CI [1.005–3.285]). Re-interventions immediately followed surveillance in 70/79 (87%) cases, and this was driven by scan results rather than symptom change. At 6wks, maximum in-stent stenosis <30% was a strong predictor of being low risk for re- intervention at 6mths (HR 0.038; p=0.003, 95% CI [0.004-0.322]). Conversely, maximum in- stent stenosis between 30-50% at 6wks was associated with a higher risk of re-intervention at 6mths (HR 29.90; p=0.002, 95% CI [3.519–253.989]). Conclusions: Ultrasound surveillance should occur at frequent intervals up to 3wks post deep venous stenting. Surveillance at 6wks could be used to differentiate between patients that require further surveillance before 6mths. These may include patients with maximum in-stent stenosis between 30-50% at 6wks and patients with stents crossing the inguinal ligament.

A systematic review on the use of deep venous stenting for acute venous thrombosis of the lower limb

The aim is to evaluate venous stent patency, the development of post-thrombotic syndrome, recurrence, quality of life and the optimal post-procedural anticoagulation regimen in the treatment of iliofemoral deep venous thrombosis. EMBASE and Medline databases were interrogated to identify studies in which acute deep venous thrombosis patients were stented. Twenty-seven studies and 542 patients were identified. Primary, assisted primary and secondary patency rates 12 months after stent placement ranged from 74 to 95, 90 to 95 and 84 to 100%, respectively. The observed post-thrombotic syndrome rate was 14.6%. The incidence of stent re-thrombosis was 8%. In 26% of studies, patients received additional antiplatelet therapy. Quality of life questionnaires employed in 11% of studies, demonstrating an improvement in the chronic venous insufficiency questionnaire (22.67 ± 3.01 versus 39.34 ± 6.66). Venous stenting appears to be an effective adjunct to early thrombus removal; however, further studies are needed to identify optimal anticoagulant regimen and effect on quality of life.

Antithrombotic Therapy Following Venous Stenting: International Delphi Consensus

Deep venous stenting is increasingly used in the treatment of deep venous obstruction; however, there is currently no consensus regarding post-procedural antithrombotic therapy. The aim of the present study was to determine the most commonly used antithrombotic regimens and facilitate global consensus. An electronic survey containing three clinical scenarios on venous stenting for non-thrombotic iliac vein lesions, acute deep vein thrombosis (DVT), and post-thrombotic syndrome was distributed to five societies whose members included vascular surgeons, interventional radiologists, and haematologists. The results of the initial survey (phase 1) were used to produce seven consensus statements, which were distributed to the respondents for evaluation in the second round (phase 2), along with the results of phase 1. Consensus was defined a priori as endorsement or rejection of a statement by≥67% of respondents. Phase 1 was completed by 106 experts, who practiced in 78 venous stenting centres in 28 countries. Sixty-one respondents (58% response rate) completed phase 2. Five of seven statements met the consensus criteria. Anticoagulation was the preferred treatment during the first 6-12 months following venous stenting for a compressive iliac vein lesion. Low molecular weight heparin was the antithrombotic agent of choice during the first 2-6 weeks. Lifelong anticoagulation was recommended after multiple DVTs. Discontinuation of anticoagulation after 6-12 months was advised following venous stenting for a single acute DVT. No agreement was reached regarding the role of long-term antiplatelet therapy. Consensus existed amongst respondents regarding anticoagulant therapy following venous stenting. At present, there is no consensus regarding the role of antiplatelet agents in this context.

A randomised controlled trial comparing venous stenting with conservative treatment in patients with deep venous obstruction: research protocol

IntroductionDeep venous obstruction (DVO) has a great impact on quality of life (QoL) comparable to angina pectoris or chronic pulmonary disease. Post-thrombotic scar formation and May-Thurner syndrome (MTS) are the...

A Systematic Review of Endovenous Stenting in Chronic Venous Disease Secondary to Iliac Vein Obstruction

Deep endovenous stenting to relieve chronic venous disease (CVD) secondary to post-thrombotic or non-thrombotic iliac vein obstruction is becoming increasingly well described. However, current and adequately reported systematic reviews on the topic are lacking. This report aimed to produce a systematic review and meta-analysis of the available data, reported to the Preferred Reporting Items for Systematic reviews and Meta-Analyses guideline. MEDLINE, EMBASE, and the Cochrane Central Register for Controlled Trials databases and key references were searched. Sixteen studies were included (14 before-and-after studies, 1 controlled before-and-after study, and 1 case series) encompassing successful deep venous stenting in 2373 and 2586 post-thrombotic or non-thrombotic limbs and patients respectively. The data were too heterogeneous to perform a meta-analysis. There were significant improvements in validated measures of the severity of CVD and venous disease-specific quality of life. Persistent ulcer healing rates ranged from 56% to 100% in limbs that had often already failed conservative management. Primary and secondary stent patency ranged from 32% to 98.7% and 66%-96% respectively. The major complication rate ranged from 0 to 8.7% per stented limb. A GRADE assessment demonstrated the quality of the evidence for five outcomes to be “Very Low” and one to be “Low” (ulcer healing). The quality of evidence to support the use of deep venous stenting to treat obstructive CVD is currently weak. The treatment does however appear promising and is safe and should therefore be considered as a treatment option while the evidence base is improved.

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

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). 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. 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. 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.

Outcome of venous stenting following catheter directed thrombolysis for acute proximal lower limb venous thrombosis: a prospective study with venous Doppler follow-up at 1-year.

Functional outcome of venous stent placement for the management of acute iliofemoral deep vein thrombosis (DVT) following catheter-directed thrombolysis (CDT), remain undefined. The purpose of this study was to assess immediate and intermediate term outcomes among patients treated with venous stenting following CDT in patients with proximal lower limb DVT. Thirty consecutive patients aged between 20-70years with proximal lower limb DVT formed the study group. The mean duration of CDT done with streptokinase was 4.5±1.3days. Patients with residual venous obstruction and/or large clot burden were treated further with venous angioplasty and/or stenting. Primary endpoint was to evaluate the safety, efficacy and patency of venous stenting in the management of incomplete result following CDT. After 12months, post-thrombotic syndrome (PTS) was assessed clinically using Villalta scale and deep venous patency was assessed through duplex ultrasound. We studied 8 (5 female and 3 male) patients with 9 (3 left and 6 right) limb involvement and 13 stent (4 balloon expandable and 9 self expandable) placement. All patients improved clinically immediately following venous stenting. Technical success was achieved in all patients. One patient developed pulmonary embolism during course of hospital stay. One patient had stent thrombosis and PTS and another patient died due to carcinoma breast during follow-up. Deep venous stenting is an effective mode of treatment in proximal acute lower limb DVT with high late patency rate up to 1-year.

The Effect of Deep Venous Stenting on Healing of Lower Limb Venous Ulcers

The Effect of Deep Venous Stenting on Healing of Lower Limb Venous Ulcers

Commentary on “The Effect of Deep Venous Stenting on Healing of Lower Limb Venous Ulcers”

It is now well accepted that placement of venous stents is the “method of choice” for treatment of pelvic venous outflow obstruction. George et al.1George R. Verma H. Ram B.L. Tripathi R.K. The effect of deep venous stenting on healing of lower limb venous ulcers.Eur J Vasc Endovasc Surg. 2014; x (xx–xx)Google Scholar performed computed tomography (CT) venography in patients with persistent venous leg ulcers after failed conservative treatment and superficial venous interventions. The authors proceeded with transfemoral/ascending phlebography when CT-venography findings suggested obstruction. Obstruction was found in 38 patients (44 limbs) and stents were placed. The actual number of patients tested to find these patients is not given. The endpoint was healing of the ulcer. The cumulative freedom from ulcer after stenting was at 2 years approximately 60%. This was achieved despite the presence of perforator insufficiency, deep reflux, and significant saphenous incompetence in 90%, 26%, and 10%, respectively, of patients with pre-intervention duplex scanning. Patients with healed ulcers continued to stay healed at a cumulative rate of approximately 83% at 2 years. This findings are line with the results of others as referred to in the study and point to the importance of iliofemoral venous outflow obstruction in the pathophysiology of venous ulcer formation. The prevalence of outflow obstruction in patients with recalcitrant venous ulcers is still unknown. It may be hard to decide since non-thrombotic iliac vein lesions are ubiquitous and we still don't know at what degree a venous stenosis is hemodynamically significant. I agree with the authors that it certainly appears to be worthwhile to search for an iliofemoral outflow obstruction in patients with leg ulcers, which are difficult to heal or recur with other treatment. The authors don't inform us what they considered a significant obstruction. In absence of lack of hemodynamic information, most would consider to treat an obstruction with a minimal diameter stenosis of >50% based on acceptable clinical outcome in patients stented with this criterion. Although very helpful in diagnosis and accurate placing of stents, intravascular ultrasound is unfortunately often too expensive to use. The authors used a so-called “trial angioplasty” or “diagnostic ballooning” when no obvious obstruction was seen. However, there is no information in the study what degree of “waisting” resulted in an intervention. The method has not been validated. I would caution those that use this technique. Large diameter balloons (especially if high pressure balloons are used) placed in the angle at the iliac confluence or at the internal iliac venous inflow may produce a false waist with the unfolding of the balloon. An accurate hemodynamic test for outflow obstruction, preferably non-invasive, needs to be developed to establish a defined indication for stenting. Until then awareness of the importance of obstruction, clinical signs and symptoms, and morphological criteria will have to do. A reduction of the ulcer size is not in itself an accepted endpoint, but could be used within a Venous Clinical Severity Score. A proper CEAP classification of the study patients was not given. It is difficult to analyze the reasons for lack of healing and recurrence of ulcers in this small amount of material. None was found. The presence of axial deep reflux, development of “new” reflux, occlusion of the stent system, recurrence of deep vein thrombosis, incompliance with concomitant compression therapy, etc., have certainly been pointed out in larger studies by others. The Effect of Deep Venous Stenting on Healing of Lower Limb Venous UlcersEuropean Journal of Vascular and Endovascular SurgeryVol. 48Issue 3PreviewTo report the outcomes of endovascular interventions on deep veins in patients with venous ulcers (C6). Full-Text PDF Open ArchiveRe. “The Effect of Deep Venous Stenting on Healing of Lower Limb Venous Ulcers”European Journal of Vascular and Endovascular SurgeryVol. 48Issue 6PreviewWe read with interest Peter Neglen's commentary on our paper.1,2 Full-Text PDF Open Archive

The Effect of Deep Venous Stenting on Healing of Lower Limb Venous Ulcers

To report the outcomes of endovascular interventions on deep veins in patients with venous ulcers (C6). This was a retrospective review of a case series. All patients with active venous ulceration who underwent endovascular interventions to the deep venous system from February 2011 to June 2013 were included. Patients with C6 disease who failed a trial of adequate compression therapy or superficial vein interventions were considered for evaluation of the deep veins. Patients with deep vein reflux or without significant venous reflux or with a previous history of deep vein thrombosis underwent computed tomographic venogram or ascending venogram. In the absence of intravenous ultrasound trial ballooning to look for a "waist" to identify subtle lesions was used. Lesions were stented with long Nitinol stents. Thirty-eight patients underwent deep vein stenting of 44 limbs with venous ulcers. The lesions were considered to be post-thrombotic in 31 limbs and non-thrombotic iliac vein lesions in 13 limbs. A mean of 1.8 stents were used per patient. There were no significant complications associated with the interventions. At a median follow-up of 15 months, the primary and assisted primary patency rates were 94% and 97%, respectively. Sustained ulcer healing was achieved in 60% of limbs. A further 20% of ulcers had reduced in size. Recurrent ulcers developed in 13% of limbs, and half of these healed with interventions for newly developed incompetence in superficial veins. Endovascular interventions to the deep veins appear to be an effective adjunct in achieving the healing of recalcitrant ulcers.

Short-Term Clinical Experience with a Dedicated Venous Stent.

Deep venous stenting has become the primary treatment option for chronic venous obstructive disease, both for iliac vein compression syndromes and post-thrombotic venous lesions, during the last decade. Until recently only arterial-designed materials were available; no dedicated venous stents were available. These venous stents are characterized by increased length, diameter, flexibility, and radial force. Recently, three such stents have become available. We report our early experience with one such devices; the Sinus Venous stent (OptiMed, Ettlingen, Germany). Between March 2012 and July 2013, 48 patients were treated with the Sinus Venous stent. These included six cases of stenting after thrombolysis for acute DVT, 11 cases of stenting for isolated iliac vein compression syndrome (May-Thurner), and 31 cases of stenting for chronic venous obstruction in post-thrombotic syndrome patients. Diagnosis of relevant obstruction was made by use of clinical evaluation combined with duplex ultrasound, magnetic resonance venography, and periprocedural venography. Patency control during follow-up was assessed with duplex ultrasound. Cumulative patency rate at 3 months was 83%, 84%, and 97 % for primary, primary assisted, and secondary patency, respectively. Differences in patency rate between the subgroups of acute thrombotic, post-thrombotic, and nonthrombotic exist, with the latter fairing significantly better. All reocclusions were treated by ancillary treatment modalities, including catheter directed thrombolysis, rePTA, and restenting. Morbidity was low, no clinically relevant pulmonary embolisms occurred, and mortality was nil. Short-term clinical results using the Sinus Venous stent are excellent, with acceptable morbidity rates, and no mortality. As already reported in other venous stenting series, thrombotic lesions have lower patency rates compared with nonthrombotic lesions.