Rate Of Post-thrombotic Syndrome Research Articles

The background and role of catheter-directed thrombolysis evolving procedures for acute iliofemoral deep venous thrombosis.

Minimal invasive treatment such as early endovenous thrombus removal for iliofemoral deep venous thrombosis (DVT) emerged in the end of last century. The principle is catheter-directed thrombolysis (CDT) using either plasminogen activating agents alone, as ultrasound-assisted CDT, or in combination with mechanical devices as pharmaco-mechanical CDT. The interest for this treatment modality is the high rate of post-thrombotic syndrome (PTS) with anticoagulation (AC) alone, especially after iliofemoral DVT. Recently published randomized controlled trials (RCTs) comparing early thrombus removal with AC alone, as well as non-randomized studies, have demonstrated favorable rates, or at least a decrease of moderate and severe PTS, in favor of these procedures. This article will summarize the background and evolution of the procedures in the last three decades and discuss fundamental criteria for inclusion and exclusion, focusing on the procedures regarding thrombus age and location, technical issues, complications and results including different outcome measures for PTS, for which iliac DVT involvement is a massive risk factor to be prevented.

Endovascular Thrombectomy for Acute Iliofemoral Deep Venous Thrombosis Through a Jugular Approach with a Rotational Device.

To report the effectiveness of pharmacomechanical catheter-directed thrombolysis (PCDT) in the management of acute iliofemoral deep venous thrombosis (DVT) via the jugular vein using a slow rotation and large-tip device (SRD) in a large cohort of patients. From 2011 to 2021, 277 patients (mean age 45years, 59.2% women) were treated in 6 centres with PCDT for ilio-fémoral DVT. PCDT was performed via the jugular vein and consisted of one session of fragmentation-fibrinolysis, aspiration and, if needed, angioplasty with stenting. The aim of PCDT was to achieve complete clearance of the venous thrombosis and to restore iliofemoral patency. Residual thrombotic load was assessed by angiography, venous patency by duplex ultrasound and clinical effectiveness by the rate of post-thrombotic syndrome (Villalta score > 4). All patients were treated via the jugular vein using an SRD, and all but one were treated with fibrinolysis. Angioplasty with stenting was performed in 84.1% of patients. After the procedure, the residual thrombotic load at the ilio-fémoral region was < 10% in 96.1% of patients. The rate of major complications was 1.8% (n = 5), the rate of minor complications was 4% (n = 11), and one patient died from pulmonary embolism (0.4%) At a median follow-up of 24months, primary and secondary iliofemoral patency was 89.6% and 95.8%, respectively. The rate of PTS was 13.8% at 12months. PCDT via the jugular vein using an SRD is an efficient treatment for acute iliofemoral DVT and results in high long-term venous patency and low PTS rates. Level of evidence Level 4, Case series.

Is it necessary to wear compression stockings and how long should they be worn for preventing post thrombotic syndrome? A meta-analysis of randomized controlled trials

BackgroundPost thrombotic syndrome (PTS) is a serious complication of deep venous thrombosis (DVT). There were always debates on the efficacy of elastic compression stockings (ECS) in prevention for post thrombotic syndrome. ObjectiveTo assess effects of elastic compression stockings and ECS's wearing time on post thrombotic syndrome after diagnosis of deep venous thrombosis. MethodsPubMed, Cochrane Library, Embase, Web of Science were last searched on 23 November 2022 for studies assessing effects of elastic compression stockings or theirs wearing time on post thrombotic syndrome after diagnosis of deep venous thrombosis. Results9 randomized controlled trials were included. Wearing elastic compression stockings was associated with a statistically reduction in the overall post thrombotic syndrome rate (RR 0.73, 95 % CI 0.53 to 1.00; P = 0.05; I2 = 82 %). No significant difference in severe post thrombotic syndrome rate, recurrent deep venous thrombosis rate, and death rate was seen whether wearing elastic compression stockings or not. The pooled effect of studies comparing different wearing time of elastic compression stockings showed no significant difference in post thrombotic syndrome rate, severe and moderate post thrombotic syndrome rate, recurrent deep venous thrombosis syndrome rate and death rate. ConclusionsWearing ECS can reduce the risk of developing PTS after DVT and a wearing time of less than or equal to 1 year is comparable to 2 years wearing. The results support ECS's role as a foundation therapy for preventing PTS.

Endovascular Strategy for Inferior Vena Cava Thrombosis Secondary to Deep Venous Thrombosis of the Lower Extremities: Early Experience From Two Centres.

To evaluate the safety, feasibility and technical aspects of endovascular treatments for inferior vena cava (IVC) thrombosis secondary to deep venous thrombosis of the lower extremities. A retrospective study of patients from two centres who received endovascular treatment for IVC thrombosis from January 2015 to December 2020. Under the protection of the IVC filter, all lesions were treated with manual aspiration thrombectomy (MAT) followed by catheter-directed thrombolysis (CDT). Technical aspects, complications, IVC patency, Venous Clinical Severity Score (VCSS) score and Villalta score were recorded during the follow-up observation. Endovascular procedures including MAT and CDT were performed successfully in 36 patients (97.3%). The average duration of the endovascular procedure was 71minutes (range: 35-152min). To protect against fatal pulmonary artery embolism, 33 filters (91.7%) were deployed in the inferior renal IVC, while three patients (8.3%) received filter implantation in the retrohepatic IVC. No severe complications occurred during the procedure. In the follow-up observations, the cumulative primary and secondary patency rates in IVC were 95% and 100%, respectively. The patency rates for the iliac vein were as follows: a primary patency rate of 77% and a secondary patency rate of 85%. The average VCSS score was 5.9 ± 2.6, and the Villalta score was 3.9 ± 2.2. The rate of post thrombotic syndrome is 22% in our study as assessed by the villalta score (Villalta score>4). Endovascular treatment for IVC thrombosis secondary to DVT of the lower extremities is feasible, safe, and effective. This strategy alleviates venous insufficiency and results in a high patency rate in IVC.

Systematic Review and Meta-Analysis of the Pooled Rate of Post-Thrombotic Syndrome After Isolated Distal Deep Venous Thrombosis

Systematic Review and Meta-Analysis of the Pooled Rate of Post-Thrombotic Syndrome After Isolated Distal Deep Venous Thrombosis

Thrombus Signal on T1-Weighted Black-Blood MR Predicts Outcomes of Catheter-Directed Thrombolysis in Acute Deep Vein Thrombosis.

Catheter-directed thrombolysis (CDT) is an effective therapy for acute deep vein thrombosis (DVT). However, predicting the CDT outcomes remains elusive. We hypothesized that the thrombus signal on T1-weighted black-blood magnetic resonance (MR) can provide insight into CDT outcomes in acute DVT patients. A total of 117 patients with acute iliofemoral DVT were enrolled for T1-weighted black-blood MR before CDT in this prospective study. Based on the signal contrast between thrombus and adjacent muscle, patients were categorized into the iso-intense thrombus (Iso-IT), hyper-intense thrombus (Hyper-IT), and mixed iso-/hyper-intense thrombi (Mixed-IT) groups. Immediate treatment outcome (i.e., vein patency) and long-term treatment outcome (i.e., the incidence rate of postthrombotic syndrome) were accessed by the same expert. Histological analysis and iron quantification were performed on thrombus samples to characterize the content of fibrin, collagen, and the ratio of Fe3+ to total iron. Compared to Mixed-IT and Hyper-IT groups, the Iso-IT group had the best lytic effect (90.5 ± 1.6% vs. 78.4 ± 2.6% vs. 46.5 ± 3.3%, p < 0.001), lowest bleeding ratio (0.0 vs. 11.8 vs. 13.3, p < 0.001), and the lowest incidence rate of postthrombotic syndrome on 24 months (3.6 vs. 18.4 vs. 63.4%, p < 0.001) following CDT. The Iso-IT group had a significantly lower ratio of Fe3+ to total iron (93.1 ± 3.2% vs. 97.2 ± 2.1%, p = 0.034) and a higher content of fibrin (12.5 ± 5.3% vs. 4.76 ± 3.18%, p = 0.023) than Hyper-IT. Thrombus signal characteristics on T1-weighted black-blood MR is associated with CDT outcomes and possesses potential to serve as a noninvasive approach to guide treatment decision making in acute DVT patients. · Thrombus signal on T1-weighted black-blood MR is associated with lytic therapeutic outcome in acute DVT patients.. · Presence of iso-intense thrombus revealed by T1-weighted black-blood MRI is associated with successful thrombolysis, low bleeding ratio, and low incidence of the postthrombotic syndrome.. · T1-weighted thrombus signal characteristics may serve as a noninvasive imaging marker to predict CDT treatment outcomes and therefore guide treatment decision making in acute DVT patients..

Restoring Venous Patency with the ClotTriever Following Deep Vein Thrombosis

Although randomized data remain inconclusive, invasive endovenous therapy is increasingly favored in patients with extensive iliocaval or iliofemoral deep vein thrombosis (DVT) to reduce the rates of postthrombotic syndrome. Previously, pharmacomechanical thrombectomy was the therapy of choice, but the Inari ClotTriever device is an appealing, purely mechanical, alternative. It may reduce bleeding risk, intensive care unit admission, and the need for multiple procedures when compared with traditional thrombolysis. We present a series of 18 patients treated with the ClotTriever for extensive iliocaval or iliofemoral DVT. The Inari ClotTriever is a percutaneous mechanical thrombectomy system consisting of an expandable nitinol collection bag that is dragged along the vein wall, separating and capturing thrombus for collection into the retrieval sheath. We retrospectively reviewed all patients undergoing ClotTriever thrombectomy since the device became available at our quaternary referral center in June 2019. The review of these patients' records was determined to be exempt by our institutional review board. Eighteen patients underwent ClotTriever thrombectomy between June 2019 and November 2021. Most patients (N=16, 89%) presented within 2weeks of symptom onset, and identifiable provoking factors were present in all patients. The most common provoking factor was anatomy, with May-Thurner syndrome present in 8 patients. All patients had restoration of unimpeded venous flow in the treated segments, although 3 had some residual nonflow limiting thrombus. There were no bleeding events or repeat venous procedures. The median postprocedure length of stay of 2days. Postoperative venous imaging was performed in 15 patients and showed patency of the treated segment in 14 patients. Revised Clinical Venous Severity Scores were available in 14 patients during the course of follow-up. Of these, 9 patients' highest scores were 0, 2 patients' highest scores were 2, 2 patients' highest scores were 4, and 1 patient had a high score of8. Venous flow was re-established in all 18 patients treated with the ClotTriever in this series, with no bleeding complications, and median postprocedure length of stay of 2days. All patients with available follow-up, except 1, retained patency of the treated venous segments, and most had mild postthrombotic syndrome or none at all. These findings suggest that the ClotTriever is a safe and effective way to treat extensive iliocaval/femoral DVT.

First-in-human experience of the Bashir Endovascular Catheter in the treatment of iliocaval deep vein thrombosis.

Deep vein thrombosis (DVT) is a common disorder affecting approximately 900,000 new patients in the United States each year. Although the mainstay of treatment of DVT patients is therapeutic anticoagulation, some patients remain significantly symptomatic and therefore require more advanced interventions such as catheter-directed thrombolysis (CDT). We describe a case series of 13 patients with acute symptomatic inferior vena cava (IVC) and iliofemoral DVT that were treated with CDT using the Bashir Endovascular Catheter (BEC). We report the first-in-human use of BEC, which is a novel pharmacomechanical thrombolysis device. All the treated patients had complete and rapid resolution of their symptoms with excellent venous outflow. Despite initial promising results, larger studies using this catheter design will be needed to assess the role of BEC-directed therapy on rates of post-thrombotic syndrome and bleeding complications.

Validation of Outcome Instruments for Venous Thrombosis in Children

Background: The sharply increasing rate of venous thrombotic events (VTE) in children makes the development and validation of outcome instruments critical for future research and care. To date, there are insufficient validated tools to assess children following VTE. This has resulted in widely varied reported rates of post thrombotic syndrome (PTS) in children ranging from 10 to 70%, and a poor understanding of quality of life (QoL) outcomes in children following VTE.Methods: A clinical cohort of 85 children < 21 years of age with a history of VTE and 60 healthy pediatric controls from three tertiary care thrombosis clinics were enrolled in a consented, non-interventional study of PTS outcomes. All cases and controls were assessed using two previously published pediatric PTS scales (Manco-Johnson (MJ) and Modified Villalta (MV)), a generic pediatric health-related QoL scale (PedsQL) and a new venous specific QoL scale derived from a validated adult scale (Peds VEINES QL) [Goldenberg, Haematologica 2010; Kahn JTH 2006; Kahn J Clin Epidemiol 2006]. Forty-nine of the original cohort were assessed again by a second examiner 2 to 4 weeks later. Inter-rater reliability, test-retest reliability, content validity, construct validity, and convergent validity were assessed for each measurement instrument.Results: Using the MJ scale, 18.8% of children demonstrated physical signs of PTS with concomitant pain limiting participation. Using the MV 50.6% had mild PTS, 5.9% moderate and 1.2% severe. Pain was not a required element for any level of severity in the MV. The reliability and internal validity of all four measurement instruments was confirmed with standard psychometric tests (Table 1). All four instruments had high construct validity, with significant differences in outcomes between controls and the clinical VTE cohort (Table 2). Convergent validity was also confirmed with significant correlations between all four instruments (Table 3).Discussion: All four instruments demonstrated strong reliability between raters and over time. All four had high discriminability for children with PTS relative to healthy controls. The MJ instrument identified a functional outcome of pain limiting participation along with physical findings. The proportion of the VTE population positive for PTS using the MJ instrument was closer to the reported pediatric weighted mean [Goldenberg, above]. The MV identified some PTS in a majority of children following a VTE episode while not discriminating functional outcomes. Additionally, while all four instruments were significantly correlated with each other, the newly created Peds VEINES QL had higher convergent validity than the more general PedsQL. This indicates that the new PTS specific QoL scale provides a more accurate representation of the impact of PTS on QoL than more generic pediatric QoL scales. [Display omitted] DisclosuresBrandao:Boehringer Ingelheim: Consultancy, Research Funding.

Atorvastatin As an Adjunct Therapy in Patients with Acute Venous Thromboembolism

Background:Venous thromboembolism (VTE) has an estimated incidence of 1-2 per 1000. Despite anticoagulation, many patients suffer from its complications: VTE recurrence rate after an unprovoked VTE is 30%, and the rate of post-thrombotic syndrome is 25-50%. Statins are commonly used for cardiovascular diseases, and their anti-inflammatory properties have been shown to improve clot resolution in mouse models. Therefore, it could be a potential adjunct therapy for acute VTE to expedite clot resolution and reduce morbidities. Here we report initial data of a randomized open label study to investigate the effect of statins on biomarkers and clinical outcomes in patients with acute VTE.Objectives:To evaluate the effect of atorvastatin on thrombin generation, biomarkers and clinical outcomes in patients with acute VTE receiving anticoagulation. We hypothesize that the addition of atorvastatin can reduce thrombin generation and inflammation.Patients/Methods:Adult patients with newly diagnosed acute proximal acute proximal deep vein thrombosis (DVT) +/- pulmonary embolism (PE) were enrolled and randomized 1:1 to standard of care (SOC) (anticoagulation), or SOC plus atorvastatin 40 mg daily. Patients were enrolled within 21 days an acute VTE diagnosis. Fasting blood samples were drawn on enrollment, 3 months, and 9 months, for routine blood tests, thrombin generation, selective cytokines and lipidomic profiles. Clinical outcomes were monitored, including recurrent venous or arterial thromboses, major bleeding events, and post thrombotic symptoms evaluated by the Villalta score. Patients were excluded if they received thrombolysis or statins within 6 weeks prior to enrollment, had malignancy diagnosed within 2 years, pregnant or lactating. Thrombin generation assays were performed using a commercial kit (TECHNOTHROMBIN® TGA, Technoclone, Vienna, Austria) according to the manufacturer's instructions. Parameters recorded included peak thrombin concentration and endogenous thrombin potential (ETP). Two sample t-test were used to compare the differences of two arms with alpha of 0.05.Results:From February 2015 to June 2017, twenty patients were enrolled. Ten were randomized to each arm, SOC vs SOC+statin. The baseline characteristics are summarized in Table 1. The median age is 55.5 years, 50% are female, and 80% are Caucasians. All patients had proximal lower extremity DVT, while 4 (20%) had concurrent PE. All patients have completed 3 month follow-up and 17 (85%) have completed 9 month visits. Eleven patients (55%) were treated with warfarin, the remainder with rivaroxaban. Duration of anticoagulation was at the discretion of the treating physician, with seven patients (35%) continuing on anticoagulation at the most recent visit, resulting in a median duration of anticoagulation to be 6.1 (range 3.3-11.1) months. Two patients were lost to follow-up after the 3 month visit, and two refused the 9-month blood draw. No patients had recurrent VTE or major bleeding on study. Seven (70%) patients on SOC arm compared to 8 (80%) on SOC+statin arm had residual chronic DVT noted on ultrasound at 3 months. The median Villalta score for the affected extremity on enrollment for each arm was 5.5 vs 4.5 (SOC vs SOC+statin), and 4.5 vs 3.5 at 3 months. The mean LDL at 3 months is significantly reduced in patients on statin arm compared to SOC arm, while other markers are not different (Table 2).Figure 1 shows the differences between SOC and SOC+statin by ETP and peak thrombin, separated by visits. There are no significant differences between SOC and SCO+statin arms (Figure 1). Patients have higher thrombin peak and ETP at visit 3 (9 month visit) in both arms, which may be explained by 8 of 13 patients being off anticoagulation at visit 3. When analysis is done based on anticoagulation status at visit 3, reduced peak thrombin and ETP are found in patients on anticoagulation compared to those who are not.Conclusions:In this small pilot study, atorvastatin 40 mg daily did not reduce thrombin generation at 9 months, when used in combination with standard anticoagulation as treatment for an acute VTE. At present the study is limited by the small sample size due to slow recruitment. Atorvastatin did reduce LDL, and may alter inflammatory states, and further analyses of inflammatory markers and lipidomic are ongoing to evaluate the effect of atorvastatin on VTE-related inflammation. [Display omitted] DisclosuresNo relevant conflicts of interest to declare.

DEep VEin Lesion OPtimisation (DEVELOP) trial: protocol for a randomised, assessor-blinded feasibility trial of iliac vein intervention for venous leg ulcers

BackgroundVenous leg ulceration is a widespread, debilitating pathology with high recurrence rates. Conservative treatment using graduated compression dressings may be associated with unacceptable ulcer recurrence rates. Early superficial venous ablation encourages ulcer healing and reduces recurrence. However, many of this cohort display concomitant ilio-caval stenosis, which further contributes to lower limb venous hypertension and ulceration.An approach that combines early superficial venous ablation with early treatment of ilio-caval stenotic disease may significantly improve ulcer healing and recurrence rates. We question whether early iliac vein interrogation with intravascular ultrasound (IVUS), stenting of significant occlusive disease plus superficial venous ablation, in patients with active venous leg ulceration, will produce superior ulcer healing to standard therapy.MethodsThis is a prospective, multi-centre, randomised controlled, feasibility trial recruiting patients with lower limb venous ulceration and saphenous venous incompetence. Patients will be randomised to undergo either truncal ablation and compression therapy or truncal ablation, simultaneous iliac interrogation with intravascular ultrasound and stenting of significant (> 50%) iliac vein lesions plus compression therapy. The primary feasibility outcome will be the rate of eligible patient participation while the primary clinical outcomes will be ulcer healing and procedural safety. Secondary outcomes include time to healing, quality of life and clinical scores, ulcer recurrence rates and rates of post-thrombotic syndrome. Follow-up will be over a 5-year period. This feasibility trial is designed to include 60 patients. Should it be practicable a total of 594 patients would be required to adequately power the trial to definitively address ulcer-healing rates.DiscussionThis trial will be the first randomised trial to examine the role iliac interrogation and intervention in conjunction with standard operative therapy in the management of venous ulceration related to superficial truncal venous incompetence.Ethical committee referenceC.A. 2111 Galway Clinical Research Ethics CommitteeRegistrationClinical Trials.gov registration NCT03640689, Registered on 21 August 2018.

The efficacy of rotational pharmaco-mechanical thrombectomy in patients with acute iliofemoral deep vein thrombosis: Is the standard treatment of deep vein thrombosis changing?

In this study, we aimed to evaluate the efficiency of rotational thrombectomy device in pharmaco-mechanical thrombolysis for symptomatic acute ilio-femoral deep vein thrombosis. Between August 2013 and May 2018,82 patients with acute deep vein thrombosis comprising the iliofemoral segment whom underwent Pharmaco-mechanical thrombolysis were evaluated retrospectively. The Cleaner thrombectomy device was used. The resolution of thrombi was examined and graded. Development of post-thrombotic syndrome was assessed with Villalta scores. 75 patients (91.4%) had complete thrombus resolution. Between 50-99% resolution was noted in 6 patients (7.4%) and in one (1.2%) case less than %50 thrombus resolution was obtained. Seventy-five patients (91%) of the cohort could be treated in a single session; 7 patients (8.6%) required reintervention(s). Although improved post-thrombotic syndrome rates were lower at the short term, Villalta scores gradually increased during follow up. In conclusion, Pharmaco-mechanical thrombolysis with Cleaner thrombectomy device is a safe and beneficial method for the treatment of acute iliofemoral deep vein thrombosis. Long term follow up data of large volume multicenter studies are warranted.

A Systematic Review of Paediatric Deep Venous Thrombolysis

OBJECTIVES The aim was to assess the effectiveness and safety of catheter-directed thrombolysis in children with deep venous thrombosis and to evaluate its long-term effect. METHOD AND RESULTS EMBASE, Medline and Cochrane databases were searched to identify studies in which paediatric acute deep venous thrombosis patients received thrombolysis. Following title and abstract screening, seven cohort studies with a total of 183 patients were identified. Technical success was 82% and superior in regional rather than systemic thrombolysis (p < 0.00001). One cohort study identified significant difference in thrombus resolution at one year between thrombolytic and anticoagulant groups (p = 0.01). The complication rate was low, with incidence rates of major bleeding, pulmonary embolism and others at 2.8%, 1.8% and 8.4%, respectively. The overall post-thrombotic syndrome rate was 12.7%. The incidence of re-thrombosis ranged from 12.3% to 27%. CONCLUSION Thrombolysis for paediatric deep venous thrombosis is an effective and relatively safe therapeutic option, lowering the incidence of post-thrombotic syndrome and deep venous thrombosis recurrence.

The risk of post-thrombotic syndrome in patients with proximal deep vein thrombosis treated with the direct oral anticoagulants.

The novel direct oral anticoagulants (DOAC) have been shown to be at least as effective as and safer than conventional anticoagulants for the initial and long-term treatment of venous thromboembolic disorders. However, the rate of post-thrombotic syndrome (PTS) in patients with deep-vein thrombosis (DVT) treated with the DOACs is unknown. With the adoption of the Villalta scale, we assessed the rate of PTS at the end of the follow-up period in a consecutive series of 309 outpatients with acute proximal DVT who had received at least 3 months of treatment with a DOAC and had been followed-up for up to 3 years. The rate of PTS development was compared with that recorded in a historical cohort of 1036 consecutive patients who had been treated with vitamin K antagonists (VKA) and had received a similar follow-up examination. Logistic regression analysis, including propensity scoring to adjust for differing probabilities of undergoing VKA/DOAC, was used to identify predictors of PTS. PTS developed in 87 patients (28.2%) treated with the DOACs (severe in 12), and in 443 patients (42.8%) treated with VKAs (severe in 61). After adjusting for estimated propensity score, age, gender, concomitant symptoms of pulmonary embolism, duration of anticoagulation and development of residual vein thrombosis, the risk of PTS in the DOAC-treated patients was reduced by 54% in comparison to patients treated with conventional anticoagulation (odds ratio 0.46; 95% CI 0.33 to 0.63). We conclude that in comparison to VKAs, the use of the direct oral anticoagulants has the potential to offer a more favorable prognosis in terms of PTS development.

Single- versus multiple-stage catheter-directed thrombolysis for acute iliofemoral deep venous thrombosis does not have an impact on iliac vein stent length or patency rates

BackgroundIncomplete venous thrombolysis and residual nonstented iliac vein disease are known predictors of recurrent deep venous thrombosis (DVT). Controversy exists as to whether the number of thrombolysis sessions affects total stent treatment length or stent patency. The goal of this study was to evaluate the outcomes of patients who underwent single vs multiple catheter-directed lysis sessions with regard to stent extent and patency. MethodsConsecutive patients who underwent thrombolysis and stenting for acute iliofemoral DVT between 2007 and 2018 were identified and divided into two groups on the basis of the number of treatments performed (one vs multiple sessions). Operative notes and venograms were reviewed to determine the number of lytic sessions performed and stent information, including size, location, total number, and length treated. End points included total stent length, 30-day and long-term patency, and post-thrombotic syndrome (Villalta score ≥5). The χ2 comparisons, logistic regression, and survival analysis were used to determine outcomes. ResultsThere were 79 patients who underwent lysis and stenting (6 bilateral interventions; mean age, 45.9 ± 17 years; 48 female). Ten patients (12 limbs) underwent single-stage treatment with pharmacomechanical thrombolysis, and the remaining 69 (73 limbs) had two to four operating room sessions combining pharmacomechanical and catheter-directed thrombolysis. Patients who underwent a single-stage procedure were older and more likely to have a malignant disease. These patients received less tissue plasminogen activator compared with the multiple-stage group (17.2 ± 2.2 mg vs 27.6 ± 11.6 mg; P = .008). Average stent length was 8.8 ± 5.2 cm for the single-stage group vs 9.2 ± 4.6 cm for the multiple-stage group (P = .764). Patients who underwent a single-stage procedure had no difference in average length of stay from that of patients who underwent multiple sessions (8.5 days vs 5.9 days; P = .269). The overall 30-day rethrombosis rate was 7.3%. Two-year patency was 72.2% and 74.7% for the single and multiple stages, respectively (P = .909). The major predictors for loss of primary patency were previous DVT (hazard ratio [HR], 5.99; P = .020) and incomplete lysis (HR, 5.39; P = .014) but not number of procedures (HR, 0.957; P = .966). The overall post-thrombotic syndrome rate was 28.4% at 5 years and was also not associated with the number of treatment sessions. ConclusionsSingle- vs multiple-stage thrombolysis for DVT is not associated with a difference in extent of stent coverage. Patency rates remain high for iliac stenting irrespective of the number of lytic sessions, provided lysis is complete and the diseased segments are appropriately stented.

Post-thrombotic syndrome prevention – do we really know the predictive factors?

AbstractDespite an increasing knowledge and experience regarding deep vein thrombosis (DVT) treatment, the rate of post-thrombotic syndrome (PTS) remains still relatively high. According to the current knowledge it is still difficult to predict on the individual basis, who of the DVT patients will develop PTS as late complication of the vein thrombosis. Among the factors influencing the higher prevalence of PTS, the ipsilateral DVT recurrence is of the highest importance. The other factors which should be mentioned are age, obesity, previous chronic venous disease as well as a proximal DVT location or lack of symptoms’ resolution in the early treatment. Looking for the most effective PTS prevention method several clinical trials were performed regarding pharmacological DVT treatment, use of early mobilization and medical compression stocking as well as an implementation of the thrombectomy and thrombolysis. This paper presents a review of the current knowledge regarding the PTS predictive factors and prevention.

Catheter-directed thrombolysis vs. anticoagulation for the prevention and treatment of post-thrombotic syndrome in deep vein thrombosis: An updated systematic review and meta-analysis of randomized trials.

Background Oral anticoagulation therapy was the mainstay of deep vein thrombosis treatment but recently, catheter-directed thrombolysis has emerged as an alternative. Objective To compare the efficacy and safety of the two strategies. Methods Medline, Embase and Cochrane CENTRAL were reviewed. Outcomes of interest included post-thrombotic syndrome, thromboembolic events, mortality, bleeding risk and iliofemoral patency. A random effects model meta-analysis was performed. Heterogeneity was assessed with I square. Results Four randomized controlled trials (RCTs) including 1005 patients met the inclusion criteria. Catheter-directed thrombolysis was more likely to prevent overall post-thrombotic syndrome compared to anticoagulation only (OR: 0.32; 95% CI: 0.12–0.85; I2=87.2%), and to lead to iliofemoral vein patency (OR: 2.7; 95% CI: 1.08–6.75; I2=55.3%) but no difference was noted in thromboembolic events (OR = 0.5; 95% CI: 0.08–3.02, I2=55.1%), bleeding and mortality rates. Conclusions Catheter-directed thrombolysis can decrease post-thrombotic syndrome rates and improve iliofemoral vein patency compared to anticoagulation when used for the treatment of deep vein thrombosis.

Catheter-directed thrombolysis through anterior tibial vein for treating acute extensive deep venous thrombosis

ObjectiveThe objective of this study was to evaluate the feasibility, efficacy, and safety of catheter-directed thrombolysis (CDT) through an anterior tibial vein approach for acute extensive lower extremity deep venous thrombosis (DVT). MethodsThere were 125 consecutive patients with acute extensive lower extremity DVT who received CDT through an anterior tibial vein approach between October 2014 and June 2017. The patients with iliac vein compression syndrome were treated with balloon dilation and stent implantation after CDT. The thrombus score differences, limb circumference differences, venous patency, and complications were retrospectively analyzed. ResultsThe anterior tibial vein approach was successfully achieved in 118 patients (94.40% [118/125]). The mean thrombolysis time was 5.28 ± 1.10 days, and the average dose of urokinase was 3,903,400 ± 766,900 IU. Metal stents were placed in 50 patients (42.37% [50/118]). There were 109 patients (92.37% [109/118]) who had successful lysis (grade II and grade III lysis); 31 patients (91.18% [31/34]) achieved grade III lysis (no residual thrombus) within 3 days of symptom onset. In contrast, only 33.96% (18/53) of those treated within 4 to 7 days and 9.68% (3/31) of those treated after 7 days achieved grade III lysis. Compared with findings before CDT, the limb circumference above and below the knee was significantly reduced (7.22 ± 2.54 cm vs 1.58 ± 0.75 cm and 5.14 ± 1.41 cm vs 1.19 ± 0.49 cm, respectively). The incidence of bleeding was 10.17% (12/118). Six patients had puncture site bleeding, and three patients suffered major bleeding. One puncture site infection and two catheter-directed infections were observed during treatment. Two patients had accidental anterior tibial artery injury and recovered without complications, and no nerve injury occurred. During a follow-up of 19.39 ± 7.47 months (6-32 months), femoral venous insufficiency and popliteal venous insufficiency were present in 21.65% (21/97) and 30.93% (30/97) of the patients. The overall patency and post-thrombotic syndrome rates were 83.51% (81/97) and 21.65% (21/97). ConclusionsCDT through an anterior tibial vein approach is a feasible, effective, and safe method for acute extensive lower extremity DVT patients. In addition, the anterior tibial vein approach can be an alternative to the traditional CDT approach.

Just How Attractive is the ATTRACT Trial?

Venous thromboembolism (VTE) is a major public health issue; deep vein thrombosis (DVT) affects about 1/1000 patients. Each year, VTE kills more patients in Western Europe than breast cancer, prostate cancer, acquired immune deficiency syndrome (AIDS) and road traffic accidents combined and is responsible for the deaths of approximately 370,000 European citizens (Cohen et al. in Thromb Haemost 98:756-764, 2007; Bĕlohlávek et al. in Exp Clin Cardiol 18(2):129-138, 2013). The recently published ATTRACT trial (Acute Venous Thrombosis Thrombus Removal with Adjunctive Catheter-directed Thrombolysis) (Vedantham et al. in N Engl J Med 377:2240-2252, 2017) concluded that the addition of catheter-directed thrombolysis to standard therapy with anticoagulation and compression stockings offers no significant clinical benefit over standard therapy in terms of reduction in the rate of post-thrombotic syndrome (PTS) at 2years. It is the largest, prospective, multi-centre, randomised controlled trial (RCT) and represents the culmination over a decade of planning, execution and analysis. In this opinion article, we analyse why it was needed, what it demonstrated, some limitations, and the directions in which this important publication will take us.

A systematic review of paediatric deep venous thrombolysis.

The aim was to assess the effectiveness and safety of catheter-directed thrombolysis in children with deep venous thrombosis and to evaluate its long-term effect. EMBASE, Medline and Cochrane databases were searched to identify studies in which paediatric acute deep venous thrombosis patients received thrombolysis. Following title and abstract screening, seven cohort studies with a total of 183 patients were identified. Technical success was 82% and superior in regional rather than systemic thrombolysis (p < 0.00001). One cohort study identified significant difference in thrombus resolution at one year between thrombolytic and anticoagulant groups (p = 0.01). The complication rate was low, with incidence rates of major bleeding, pulmonary embolism and others at 2.8%, 1.8% and 8.4%, respectively. The overall post-thrombotic syndrome rate was 12.7%. The incidence of re-thrombosis ranged from 12.3% to 27%. Thrombolysis for paediatric deep venous thrombosis is an effective and relatively safe therapeutic option, lowering the incidence of post-thrombotic syndrome and deep venous thrombosis recurrence.