Mild Post-thrombotic Syndrome Research Articles

Sequelae and post-thrombotic syndrome after venous thromboembolism in acute lymphoblastic leukemia survivors treated on the NOPHO ALL2008 protocol.

The treatment of acute lymphoblastic leukemia (ALL) is frequently complicated by toxicity, including venous thromboembolism (VTE) affecting roughly 8% of patients. VTE can lead to post-thrombotic syndrome (PTS), a group of signs and symptoms developed as a complication to deep venous thrombosis (DVT), imposing risk of permanent disability and reduced quality of life (QoL). PTS prevalence ranges from 0% to 70%, reflecting very heterogenous cohorts and assessment tools. We aimed to estimate sequelae, including PTS and QoL in children and adults (<45years old) who had a DVT during ALL treatment. PTS and QoL scores were obtained through use of Villalta and Modified Villalta Scale, PedsQL, and Short Form-36 questionnaires. The cohort comprised 20 children (<18years) and seven adults (median age: 12.9years, range: 2-44years) at the time of DVT diagnosis. In total, 25 ALL survivors underwent PTS examination. The examination took place when survivors were 7-48years (median age: 20.3years, median follow-up time 6.8years). QoL was assessed correlating cases with three matching ALL survivors without VTE. Two adults (15.4%) showed mild or moderate PTS. Eight children (66.7%) were diagnosed with mild PTS, while three cases had collaterals as sole symptoms. Pain or symptoms affecting daily life were reported by 16%. No difference in QoL was found (p=.9). This study underscores the need for comprehensive population-based investigations with validation of PTS instruments in ALL survivors.

Diagnosis, Management and Outcomes in Children with Paget Schroetter Syndrome: A Retrospective Cohort Study

Introduction Venous thoracic outlet syndrome occurs secondary to the extrinsic compression and impingement of the subclavian vein as it passes through the thoracic outlet, eventually resulting in upper extremity effort thrombosis, or Paget-Schroetter syndrome (PSS). This rare condition typically affects the dominant arm of athletic young adults with a history of repeated overhead activities. At Boston Children's Hospital (BCH), a multidisciplinary team of hematologists, interventional radiologists, and vascular surgeons manage these patients according to a standardized protocol including anticoagulation, pharmaco-mechanical thrombolysis, venoplasty, and decompressive rib-resection surgery. Herein we report the clinical and radiological outcomes of a cohort of patients with PSS managed at BCH. Objective The principle objective of this retrospective cohort study was to review the diagnosis, pharmacological, interventional radiology and surgical management, complications, and long-term outcomes of sequential pediatric patients (≤21 years) treated for PSS at BCH over a 3.5-year period of time (January 1, 2020 to July 31, 2023). Methods This study was performed as a part of an ongoing quality improvement initiative and was deemed exempt by the Institutional Review Board. Eligible patients were defined as children (≤21 years) with PSS per criteria established by the Society for Vascular Surgery. Clinical and demographic data, including post-thrombotic syndrome (PTS) scores of eligible patients were abstracted from their medical records. PTS evaluation at BCH is typically performed 6-12 months after DVT diagnosis using both the modified Villalta and Manco-Johnson instruments. Major bleeding, and recurrent/progressive thromboses were defined per published guidelines by the International Society on Thrombosis and Haemostasis. Standard statistical methods were used - median (range) for continuous variables and frequency with 95% CI for categorical data. Results The study cohort consisted of 20 patients (9 female). PSS was confirmed based on dynamic imaging with provocative maneuvers for all patients. Median (range) age at DVT diagnosis was 17 (15-21) years. Thirteen patients were diagnosed at an outside hospital and referred to BCH for further management. Fourteen patients received upfront anticoagulation with low molecular weight heparin of whom 13 patients were transitioned to a DOAC. Six patients were started on DOACs upfront. Fifteen subjects (75%) received upfront endovascular intervention at diagnosis. Median interval between DVT diagnoses to endovascular intervention was 5 (1-118) days. All patients underwent decompressive rib-resection surgery. Median interval between DVT diagnosis and surgery was 12 (7-39) weeks. Three patients (15%) developed major bleeding and 3 (15%) patients developed recurrent/progressive thrombosis after surgery. Two of the 3 patients who developed major bleeding were anticoagulated with a DOAC pre-operatively, which had been held for 48 hours before surgery. All subjects had a planned post-operative venogram, 14 (70%) of whom underwent completion venoplasty. Anticoagulation was discontinued in 18/20 (90%) patients with a median duration of therapy of 19.5 (14-60) weeks. Four patients (20%) were noted to have an underlying thrombophilia (Factor 5 R506Q [2]; Factor 2 G20210A [1]; Protein S deficiency [1]). End-of-therapy imaging was obtained for all patients - 17 (85%) had complete thrombus resolution, while two (10%) had partial thrombus resolution. Seventeen (85%) patients have undergone evaluation for PTS, of whom 12 (71%) were noted to have mild PTS and 2 (12%) have moderate-severe PTS as defined by the modified Villata instrument. Discussion Greater than 90% of pediatric patients with PSS who were treated per our institutional multi-disciplinary protocol had complete or partial thrombus resolution. Additionally, only 12% of patients reported moderate to severe PTS on follow-up and were prescribed sequential compression sleeves. Lastly, DOACs appear to be safe and efficacious in this cohort, though based on our internal data, we now interrupt DOACs for 72 hours before decompressive surgery.

Cost Effectiveness of Early Endovenous Thrombus Removal for Acute Iliofemoral Deep Vein Thrombosis in the United Kingdom

Early clot removal using endovascular intervention aims to reduce post-thrombotic syndrome (PTS) following iliofemoral deep venous thrombosis (DVT). This may reduce long term morbidity but incurs a higher initial cost. This study examined the cost effectiveness of catheter-directed thrombolysis (CDT) and pharmacochemical thrombectomy (PMT) compared with oral anticoagulation (OAC) alone for treatment of acute iliofemoral DVT in the United Kingdom. A combined decision tree (acute DVT complications) and Markov model [long term complications (PTS)] was used decision analytic modelling with five states: no PTS, mild PTS, moderate PTS, severe PTS, and dead. All patients started with acute DVT. Patients who survived acute complications transitioned into the Markov model. Cycle time was 6 months. A healthcare payer perspective and lifetime horizon was used, adjusting for excess mortality due to history of thrombosis. Data for probabilities, transition probabilities, mortality, and utilities were obtained from published literature. Cost data were obtained from UK NHS tariffs and published literature. Outcomes were mean lifetime cost, quality-adjusted life years (QALYs), and cost effectiveness. Over a patient's lifetime, OAC was more costly (£37 206) than CDT (£32 043) and PMT (£36 288). Mean lifetime QALYs for OAC (12.9) were lower than CDT (13.5) and PMT (13.3). Therefore, in the incremental cost effectiveness analysis, both CDT and PMT were dominant: CDT was less costly (- £5 163) and more effective (+0.6 QALYs) than OAC, and PMT was also less costly (-£917) and more effective (+0.3 QALYs) than OAC. Results were robust to univariate sensitivity analyses, but probabilistic sensitivity analyses suggested considerable parameter uncertainty. Early interventional treatment of iliofemoral DVT is cost effective in the UK. Future clinical and epidemiological studies are needed to characterise parameter uncertainty. Further analysis of modern practice, alternative treatments, and optimised care models is warranted.

Catheter-based therapies and short-term outcomes in the oncological patients with acute inferior vena cava thrombosis: a single centre experience.

To investigate the safety and effectiveness of catheter-based therapy (CBT) using AngioJet rheolytic thrombectomy (ART) device or large lumen catheter (LLC) in the oncological patients with inferior vena cava thrombosis (IVCT). This was a retrospective study including eligible patients with IVCT treated with CBT coupled with dose-reduced thrombolysis as the first-line treatment from February 1, 2015 to January 1, 2022. The baseline demographics, comorbidities, clinical characteristics, treatment details, course data were all reviewed. A total of 33 patients (mean age 58.8 years, 57.6% male) was included, of whom 17 patients underwent ART and 16 underwent LLC aspiration, the technical success rates were 100%. All patients subsequently underwent catheter-directed thrombolysis relative to reduced-dose thrombolysis. At the end of catheter-directed thrombolysis, clinical success was achieved in 26 (78.8%) patients. In the subgroup analysis, ART seemed to receive a slightly higher rate of thrombus removal Grade III (47.1% vs 12.5%, p = .057). The symptoms of leg pain and swelling post-treatment were significantly improved in both groups (p < .001). Except for transient macroscopic hemoglobinuria occurring in patients with ART, none of all patients suffered from procedure-related adverse events and major complications. Minor complications such as bleeding events occurred in 6.1% (2/33) of patients. At the 6 month follow-up, the incidence of recurrent thrombosis and mild post-thrombotic syndrome (PTS) were 9.7% (3/31) and 6.5% (2/31). CBT is a safe and effective modality for the management of IVCT in the oncological patients, leading to high levels of technical and clinical success, symptoms alleviation, as well as a low incidence of minor complication, mild PTS and recurrence. The available data and evidence of endovascular therapy (ET) on oncologic patients with IVCT remains insufficient. The purpose of present single center retrospective study including 33 oncological patients is to investigate the preliminary safety and efficacy of CBT using ART device or LLC. The results demonstrated that CBTs are safe and effective as an ET modality in majority of eligible patients with symptomatic acute cancer-associated IVCT, indicating high levels of technical and clinical success, symptoms alleviation, as well as a low prevalence of minor complication, mild post-thrombotic syndrome and recurrence. Furthermore, they have the advantages of accelerated reduction of thrombus burden in a moderate time, speedy restoration of blood flow, but at the risk of potentially increased economic cost. Notably, in the condition of parallel time and dosages of lytic agents, ART tends to achieve a slightly higher thrombus removal Grade III than LLCA.

The effects of pharmacomechanical thrombolysis treatment administered to patients with iliofemoral deep vein thrombus

Aim: In this study, the mid-term results of the pharmacomechanical thrombolysis treatment administered in patients with iliofemoral acute-subacute (patients with symptoms less than 21 days old whose DVT was diagnosed with physical examination and duplex ultrasonography) deep vein thrombus (DVT) were investigated. The cases were evaluated in terms of disease-related quality of life, and the presence of post-thrombotic syndrome (PTS) which occurred in patients after previous DVT and treatment, and if present, its severity was determined. Material and Methods: Disease-related status of 40 patients (24 males, 16 females; mean age 44; age interval 20-80 years) treated due to iliofemoral acute-subacute DVT with interventional method between July 2013 and January 2017 were retrospectively analyzed two years after the interventional treatment. These patients were considered as mid-term patients. The patients were evaluated with VEINES-QOL/Sym quality of life scale and the Villalta scale. The occurrence and severity of PTS, the presence of venous ulcer, and the diameter difference between legs were evaluated. Results: No venous ulcer was present in our cases. In the evaluation made with Villalta scale, PTS was not observed in 20 out of 40 cases, mild PTS was found in 15, moderate PTS in 4, and severe PTS was observed in 1 case. Conclusion: We have concluded that pharmacomechanical thrombolysis treatment administered in well-selected patients reduced the severity of PTS and increased the quality of life associated with disease in DVT treatment.

Early outcomes of mantis pharmacomechanical thrombectomy system combined with catheter-directed thrombolysis for treatment of acute iliofemoral deep vein thrombosis

Aim: The purpose of this research was to investigate the early outcomes of pharmacomechanical thrombectomy (PMT) with the Mantis device and adjunctive catheter-directed thrombolysis (CDT) for the treatment of acute iliofemoral deep vein thrombosis (IFDVT). Material and Methods: Twenty patients with symptomatic acute IFDVT were successfully treated with the Mantis rotational thrombectomy device and CDT, between August 2020 and March 2021. Patients' demographical, clinical and follow-up data were obtained and analysed retrospectively. Villalta and Pain Severity scores were utilized to assess the patients for the occurrence of post-thrombotic syndrome (PTS). Results: The procedural success rate was 100%. All cases presented early clinical improvement. No device related complications were encountered. Reocclusion was observed in 3 (15%) patients. Pre-procedural median pain score was 7 (range: 6–8) and 1 (range: 0–7) at 12-month following thrombectomy (P &lt; .001). Pre-procedural median Villalta score was 7 (range: 3–11) and 1 (range: 0–13) at 12-month following thrombectomy (P&lt;.001). At 12-month follow-up, no PTS was reported in 15 (75%) patients, mild PTS was reported in 2 (10%) patients, moderate PTS was reported in 2 (10%) patients and no severe PTS was observed. Conclusion: The Mantis PMT system with CDT seems to be an efficient treatment approach for acute IFDVT with encouraging early results.

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.

Percutaneous Mechanical Thrombectomy for Acute Symptomatic Iliofemoral Deep Venous Thrombosis Patients With Recent Aneurysmal Subarachnoid Hemorrhage

Purpose: To investigate the efficacy, safety, and mid-term outcomes of percutaneous mechanical thrombectomy (PMT) for acute symptomatic iliofemoral deep venous thrombosis (DVT) patients with recent (within 4 weeks) aneurysmal subarachnoid hemorrhage (aSAH). Materials and methods: From January 2016 to February 2020, 11 acute symptomatic iliofemoral DVT patients with a recent history of aSAH were enrolled in this study. All patients had a history of aneurysm ligation or clipping previously, computed tomography (CT) scans revealed ventricular hemorrhage had been absorbed obviously and no residual aneurysm. The mean time of DVT onset after aSAH ictus was 19.2±4.5 days, and the mean Glasgow score was 6.8 ± 0.7 (range, 6–8). These patients underwent PMT with an 8 French Aspirex®S device (Straub Medical AG, Wangs, Switzerland), subsequent stenting was performed to relieve the underlying stenosis, followed by anticoagulation alone. The procedure-related complications were assessed after intervention. The follow-ups were conducted up to 1 year, the patency was evaluated via duplex ultrasonography, and the incidence of post-thrombotic syndrome (PTS) was evaluated using the Villalta scale. Results: Grade III (>90%) clearance was achieved in all 11 patients. Stenting was performed in 7 patients (63.6%). There were no cerebral rebleeding events or other severe complications except 1 puncture site bleeding during treatment. A total of 90.9% (10 of 11) of patients were alive at the 12 month follow-up, and 7 patients achieved a good functional outcome. At the 1 year follow-up, there was 1 patient (10%) with mild PTS. The ultrasound showed that the patency of the iliofemoral veins was 100%, and femoral valvular incompetence was observed in 1 patient. Conclusion: Percutaneous mechanical thrombectomy seems to be a feasible and safe treatment for acute iliofemoral DVT in selected patients with recent aSAH, and it shows promising results in restoring patency and reducing the risk of PTS.

Stenting in the common femoral vein does not increase posthrombotic syndrome or rethrombosis

Abstract Background In lower limbs deep venous thrombosis (DVT) scenario there is evidence that favours catheter guided invasive treatment. The treatment with stenting in the common femoral vein could be related with a diminished permeability in the inflow of the deep femoral vein. There is scarce data of the clinical follow up of this treatment. Purpose To analize and compare clinical and procedural outcomes in endovenous interventions that required stent placement in the common femoral vein because of residual lesion vs interventions that did no require such treatment. Methods From May 2010 to December 2020, 122 endovenous interventions were performed, within these 74 were DVT compromising the iliofemoral territory. Two groups were defined: Group A 28 (38%) that required stent placement in the common femoral vein and Group B 46 (62%) that did not required such treatment. Results Baseline characteristics were Group A vs Group B n (%) respectively: Median age 41.1±16.7 vs 40.5±18.8; female 23 (82) vs 27 (58); smoking 7 (25) vs 14 (30); cancer 1 (4) vs 7 (15); prior prolonged rest 7 (25) vs 14 (30); concomitant diagnosis of pulmonary embolism 7 (25) vs 17 (37). Within the female population 2 (7) vs 1 (2) were in puerperium; 6 (21) vs 6 (13) were under contraceptive therapy. Regarding the diagnosis of DVT 21 (75) vs 37 (80) were acute; 7 (25) vs 9 (19) were chronic. Compromised vessels were primitive iliac vein 21 (75) vs 38 (82); external iliac vein 6 (21) vs 18 (39); superficial femoral vein 11 (39) vs 8 (17); May-Thurner syndrome 14 (50) vs 20 (43). As regards the aspects of the intervention 15 (53) vs 34 (74) had a filter implanted in the inferior vena cava; thrombolytics were infused in 20 (71) vs 32 (70); manual thrombectomy was performed in 8 (27) vs 17 (37); mechanical thrombectomy 11 (39) vs 19 (41); pre dilation with balloon was performed in 22 (79) vs 39 (85); dedicated venous stents were implanted in 22 (78) vs 39 (85); not dedicated venous stents in 13 (46) vs 11 (24). Technique success was achieved in 28 (100) vs 45 (98) p=1; major bleeding occurred 0 vs 2 (4) p=0.5; rethrombosis 3 (10) vs 9 (20) p=0.25; intrahospital death 1 (4) vs 2 (4) p=1; early reintervention was needed 1 (4) vs 2 (4) p=1, radiation dose (min) 35.4±20.2 vs 30.1±17.0 p=0.2; Contrast (ml) 216.5±76.8 vs 217.3±90.8 p=0.9. During follow up (34.1±31.5 vs 22.3±16.4) image control was performed in 27 (96) vs 39 (85) p=0.23 with either doppler or chest computed tomography angiography. Post thrombotic syndrome (PTS) symptoms were classified with Villalta Score assuming that 0–4 points had no PTS, 5–9 points presented mild PTS, 10–14 points moderate PTS, &amp;gt;14 points severe PTS, in Group A 1 (4) presented mild PTS vs Group B 2 (4) mild PTS p=1, 1 (2) moderate PTS. Conclusions Endovenous treatment with stent placement in the common femoral vein did not required more reinterventions nor had more complications nor had more PTS that the interventions without stent placement. Funding Acknowledgement Type of funding sources: None. Table 1. Basal CharacteristicsTable 2. Outcomes

Our Treatment Outcomes in Patients with Acute Deep Vein Thrombosis Associated with Congenital Inferior Vena Cava Agenesis

Introduction: In this study, we present the treatment outcomes of patients with acute deep venous thrombosis (DVT) associated with congenital agenesis of the inferior vena cava (IVCA). Patients and Methods: In this retrospective study, the clinical findings and follow-up data of patients who were scheduled for an interventional procedure due to acute DVT in 2019-2021 and who were found to have IVCA in venography were analyzed retrospectively. Results: A total of 11 patients with acute DVT associated with IVCA were identified during the study period. Eight of the patients (72.7%) were male. The mean age of the patients was 25.5 ± 6.5 years (16-36 years). Five of the patients were followed up with conservative medical treatment. Endovascular procedure was performed in six patients. At the end of the first year, moderate post-thrombotic syndrome was found in 1 patient and mild post-thrombotic syndrome was detected in 2 patients. Patients who received only medical treatment had a significantly higher Villalta score at the end of the first year than patients who received endovascular treatment (6.6 ± 4.1 and 2.1 ± 1.9, p= 0.04). Conclusion: Congenital IVCA is a rare diagnosis that should be kept in mind in young patients with deep venous thrombosis. In these patients, endovascular approach may be effective to prevent postthrombotic syndrome.

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.

Catheter-Directed Thrombolysis for Acute Deep Vein Thrombosis: Experience from a Canadian Thrombosis Referral Centre

BACKGROUNDConventional management strategies for DVT with parenteral and/or oral anticoagulants are effective in the prevention of thrombus extension and embolization but do not actively eliminate thrombus. This poses ongoing risk of injury to the venous valves and consequently development of the post-thrombotic syndrome (PTS). Catheter-directed thrombolysis (CDT) involves the local delivery of a low dose of thrombolytic agent directly to the venous thrombus, resulting in acute reduction in clot burden while limiting the systemic thrombolytic effect.Recommendations from clinical practice guidelines differ dramatically on the use of CDT for lower limb DVTs. Results from recent prospective randomized control trials suggest that those individuals who derive benefit must be carefully selected. We describe the clinical features and outcomes of patients who received CDT for lower limb DVT management at a major referral centre for thromboembolic disease. Additionally, cross-sectional follow-up of these patients was performed to estimate the incidence and severity of PTS.METHODSWe conducted a retrospective cohort analysis on all adult patients who had undergone CDT for lower limb DVT management at St. Joseph's Healthcare Hamilton (SJHH), ON, Canada. Retrospective data were collected through use of electronic and chart-based medical records. The presence and severity of PTS was measured using the Villalta scale.RESULTSFrom 2011 to 2016, 15 patients underwent CDT at SJHH (Table 1).12/15 patients were female. Average patient age was 43.2 years (range 20 to 86 years). All patients had risk factors for venous thromboembolism (VTE); 7/15 patients had 2 risk factors. The most commonly identified transient risk factor was use of the oral contraception pill (5/15). May Thurner syndrome (5/15) was the most common permanent VTE risk factor. All patients were deemed to be at low risk of bleeding (platelets > 100,000, INR < 1.6, no known bleeding diathesis).All patients had DVTs that were iliofemoral in location; 2/15 presented with phlegmasia cerulea dolens. The average time between DVT diagnosis to CDT was 6.5 days. Prophylactic IVC filters were inserted prior to CDT in 3/15 patients. Pharmacomechanical thrombolysis with angioplasty was the most common form of CDT (6/15 patients).Complications from CDT were seen in 8/15 patients (Table 2). Recurrent VTE (3/15) and neurologic deficits in the affected leg (3/15) were the most common complications. There were no deaths attributable to CDT. All patients were managed with anticoagulant therapy post-procedure. The type and duration of anticoagulation was variable (Table 2). The Villalta score was calculated for 6/15 patients. Mild PTS was seen in 4/6 patients; 2/6 did not have PTS (average Villalta score 5.83).CONCLUSIONSCatheter-directed thrombolysis appears to be a well-tolerated treatment option for iliofemoral DVT. Complications were seen in 53% of patients and were frequently mild and self-resolving. The results of our study suggest that patients under 45 years of age who receive prompt thrombolysis, within 7-14 days of DVT diagnosis, are most likely to derive benefit from CDT. The clinical characteristics of patients described here are largely in accordance with those recommended by the 2016 CHEST guidelines.Due to the limited sample size in our study, it is unclear if CDT is beneficial in reducing rates of PTS. Additional studies are needed to clarify potential risks and benefits of this treatment approach. [Display omitted] DisclosuresNo relevant conflicts of interest to declare.

Outcomes and Risk Factors Associated with Thrombosis Recurrence and Post-Thrombotic Syndrome in Children and Adolescents with May-Thurner Syndrome

Introduction : May-Thurner syndrome (MTS) is a condition in which the right iliac artery compresses the left iliac vein, predisposing affected individuals to venous outflow obstruction and deep vein thrombosis (DVT). Despite the frequency of this anatomic variant, found in 20-25% of adults, not everyone with this variant will develop a DVT. Adults with MTS are treated with catheter-directed thrombolysis (CDT), anticoagulation, and often iliac vein stent placement. There is no standard of care established for pediatric MTS patients. The aims of this study are to 1) describe risk factors, clinical factors, and outcomes (complications of CDT, recurrence rate, post-thrombotic syndrome) in a pediatric MTS cohort and 2) determine what factors are associated with thrombus resolution, recurrence, and development of post-thrombotic syndrome (PTS).Methods : A retrospective cohort of children (0-21 years) diagnosed with MTS and DVT were identified between January 1, 2012 and July 15, 2017. MTS was confirmed by CT venogram, MR venogram, intravascular ultrasound, and/or conventional endovascular venography. Patient demographic, clinical, and thrombophilic risk factors, clinical outcomes (resolution, recurrence, PTS using modified Villalta scale), and bleeding complications were abstracted from review of the electronic medical record. Bleeding complications were defined by ISTH definitions for pediatric trials. Student's t test, Wilcoxon rank sum test, Chi square test and logistic regression analysis were used for statistical analysis (SAS v9.4, Cary, NC, USA).Results : The cohort was comprised of 23 subjects, 65% of them female (n=15), with a median age at presentation of 16.1 years (9.9-19.7 years). The median follow-up time was 505 days. The most frequent risk factor was thrombophilia (n=10), which included Factor V Leiden mutation (n=6), antithrombin deficiency (n=3), protein S deficiency (n=3), lupus anticoagulant (n=3), prothrombin gene mutation (n=1), protein C deficiency (n=1), or more than one thrombophilia (n=3). Other risk factors included hormone therapy (n=8), obesity (n=7), family history of DVT (n=6), immobility (n=5), central line (n=2), lupus (n=1), pregnancy (n=1), trauma (n=1), surgery (n=1), nephrotic syndrome (n=1), and retroperitoneal fibrosis (n=1). One subject had no risk factor, while 14 (61%) had multiple risk factors. Among the subjects, 78% underwent CDT (n=18) and 83% had stent placement (n=19). The remaining subjects will have future stent placement. Following CDT, there were no major bleeding complications (1 minor and 1 clinically relevant non-major bleeding complication). Other complications included pain (n=8), hemolysis (n=7), hemoglobinuria (n=2), hypofibrinogenemia requiring cryoprecipitate infusion (n=2), and transient increase in creatinine (n=1). Primary patency, defined as >90% patency of vessel diameter in the first week after CDT, was achieved in 91% (n=21). Thrombosis resolution was seen in 91% (n=21) of the cohort. Anticoagulant treatment prescribed included enoxaparin (65%), rivaroxaban (30%) and warfarin (26%). In univariate analyses, the only factor associated with thrombus resolution was primary patency (p=0.0012). DVT recurred in 13% (n=3), with a median time of 32 days off anticoagulation. The only factor associated with recurrence was antithrombin deficiency (p=0.048). Ten subjects (43%) had no evidence of PTS and 13 had mild PTS (57%). There were no significant factors associated with the development of PTS.Conclusions : To our knowledge, this is the largest retrospective cohort of pediatric subjects with MTS and DVT. Underlying thrombophilia was the most common risk factor found, suggesting that patients diagnosed with MTS warrant thrombophilia evaluation. Bleeding complications associated with CDT were minimal and non-bleeding complications were transient, demonstrating that CDT is safe in the pediatric population. Efficacy of CDT in this population is supported by the finding that primary patency is an important factor for thrombosis resolution. Lastly, thrombosis recurrence was not uncommon (13%) and was likely to occur soon after stopping anticoagulation. These findings demonstrate that multicenter studies are needed in children with MTS to evaluate the efficacy of CDT to achieve thrombus resolution, and that evaluation of thrombophilic risk factors should be considered. DisclosuresNo relevant conflicts of interest to declare.

CAVA (Ultrasound-Accelerated Catheter-Directed Thrombolysis on Preventing Post-Thrombotic Syndrome) Trial: Long-Term Follow-Up Results.

BackgroundThe CAVA (Ultrasound‐Accelerated Catheter‐Directed Thrombolysis Versus Anticoagulation for the Prevention of Post‐Thrombotic Syndrome) trial did not show a reduction of post‐thrombotic syndrome (PTS) after additional ultrasound‐accelerated catheter‐directed thrombolysis in patients with acute iliofemoral deep vein thrombosis at 1‐year follow‐up. This prespecified analysis of the CAVA trial aimed to determine the impact of additional thrombolysis on outcomes of PTS at long‐term follow‐up.Methods and ResultsPatients aged 18 to 85 years with a first‐time acute iliofemoral deep vein thrombosis were included and randomly assigned (1:1) to either standard treatment plus ultrasound‐accelerated catheter‐directed thrombolysis or standard treatment alone. The primary outcome was the proportion of PTS (Villalta score ≥5 on 2 occasions ≥3 months apart or venous ulceration) at the final follow‐up visit. Additionally, PTS according to the International Society on Thrombosis and Haemostasis (ISTH) consensus definition was assessed to allow external comparability. Major bleedings were the main safety outcome. At a median follow‐up of 39.0 months (interquartile range, 23.3–63.8), 120 patients (79.8%) participated in the final follow‐up visit: 62 from the intervention group and 58 from the standard treatment group. PTS developed in 19 (30.6%) versus 26 (44.8%) patients, respectively (odds ratio [OR], 0.54; 95% CI, 0.26 to 1.15 [P=0.11]), with an absolute difference between groups of −14.2% (95% CI, −32.0% to 4.8%). Using the ISTH consensus definition, a significant reduction in PTS was observed (29 [46.8%] versus 40 [69.0%]) (OR, 0.40; 95% CI, 0.19–0.84 [P=0.01]) with an absolute difference between groups of −22.2% (95% CI, −39.8% to −2.8%). No new major bleedings occurred following the 12‐month follow‐up.ConclusionsThe impact of additional ultrasound‐accelerated catheter‐directed thrombolysis on the prevention of PTS was found to increase with time. Although this study was limited by its sample size, the overall findings indicate a reduction of mild PTS without impact on quality of life.RegistrationURL: https://www.clinicaltrials.gov; Unique identifier: NCT00970619.

First Experience of Endovascular Recanalization and Stenting of the Chronic Post-Thrombotic Occlusion of the Inferior Vena Cava and Both Common Iliac Veins in Krasnodar Krai

Aim. To present the first experience of a successful endovascular recanalisation and stenting of chronic post-thrombotic occlusion of the inferior vena cava and both common iliac veins in Krasnodar Krai.Methods and materials. A man, 72 years old, was admitted with the complaints of intermittent claudication, pronounced edema of both lower limbs, compaction and hyperpigmentation of the skin of the lower legs. Using ultrasound and computed tomography angiography, chronic post-thrombotic occlusion of the inferior vena cava and common iliac veins was established. The severe course of post-thrombotic syndrome (15 points on the Villalta scale) and the failure of conservative treatment were regarded as indications for performing endovascular surgery. Through puncture accesses in both common femoral veins and in the right internal jugular vein, guides were introduced through the occlusion zone, and balloon angioplasty was performed, followed by stenting of the common iliac veins and the inferior vena cava.Results. In-hospital and 4-month treatment results were analysed. The postoperative period was uneventful. The patient noted a decrease in the feeling of heaviness and edema in the lower extremities, as well as an increase in walking distance. A follow-up examination was performed following 4 months. The functional status significantly improved. The Villalta score was 4 points (absence or mild post-thrombotic syndrome). Ultrasound examination and computed tomography angiography established the patency of the stents in the inferior vena cava and in the common iliac veins.Conclusion. Endovascular recanalisation and stenting of the inferior vena cava and common iliac veins is an effective treatment for severe post-thrombotic syndrome.

Surgical thrombectomy for iliofemoral deep vein thrombosis: Patient outcomes at 8.5 years.

IntroductionDeep vein thrombosis (DVT) is a frequent burden and a post-thrombotic syndrome (PTS) can be a serious long-term consequence. Iliofemoral DVT should be associated with severe forms of PTS. Therefore an early thrombus removal has been recommended in specific conditions. The aim of this study was to find out both, the long-term results after surgical thrombectomy of iliofemoral DVT in respect of the development of PTS as well as the venous hemodynamics after surgery concerning venous reflux and venous obstruction.MethodsSixty-seven patients who underwent surgical thrombectomy between the years 2000 and 2014 were included in this study; iliofemoral DVT was present in 52 of these patients. 35 patients could be reinvestigated after a mean follow-up of 8.5 years. CEAP (Clinical-Etiological-Anatomical-Pathophysiological) and Villalta scores were recorded in order to describe and assess PTS. Follow-up examinations included a detailed duplex mapping. Venous hemodynamics were measured by digital photoplethysmography and venous occlusion plethysmography.ResultsThe primary patency rate of the iliofemoral segment was 88% after 8.5 years. 48% of all patients showed reflux in deep vein segments. Mild or moderate PTS occurred in 57% of all patients. Notably, there was no patient with an active ulcer or severe PTS. The mean venous outflow volume of all patients in the treated legs was 66.1 ml/100ml/min and significantly less than in the controlled contralateral non-treated legs (p<0.05). The mean venous refilling time was 16.3 seconds, while the mean value of the non-treated contralateral legs was 25.6 seconds and therefore significantly higher (p<0.05).ConclusionEven though venous hemodynamics are significantly inferior in the treated legs, this study demonstrates excellent patency rates and good clinical outcome after surgical thrombectomy of iliofemoral veins.

Midterm outcome of pharmacomechanical catheter-directed thrombolysis combined with stenting for treatment of iliac vein compression syndrome with acute iliofemoral deep venous thrombosis

ObjectiveThis study assessed the effectiveness and safety of percutaneous mechanical thrombectomy and catheter-directed thrombolysis combined with stent placement in the management of iliac vein compression syndrome with acute iliofemoral deep venous thrombosis (DVT). MethodsFrom December 2014 to April 2016, there were 46 patients with DVT who underwent percutaneous mechanical thrombectomy and catheter-directed thrombolysis and stenting for acute proximal DVT with computed tomography-verified iliofemoral stenosis. The Venous Registry Index was used for evaluating the degree of patency after pharmacomechanical thrombolysis; the prevalence of post-thrombotic syndrome (PTS) in the follow-up was assessed according to the Villalta scale. For up to 24 months, conditions of the patients were assessed using periodic duplex ultrasound scans. ResultsFor all patients, the technical success rate was 100%; no major bleeding or 30-day mortality was observed. Overall, the 6-, 12-, and 24-month primary patency rates were 97.8%, 95.7%, and 91.1%, respectively. There was a significant reduction in Venous Registry Index (9.82 ± 1.74 to 1.15 ± 1.02; P < .05) after the procedure. According to the Villalta score, only one patient developed mild PTS and none developed severe PTS. Symptomatic pulmonary embolism was not observed during the hospitalization. The mean hospital stay was 6.5 ± 1.7 days. ConclusionsThis technique provides a safe and effective treatment option for patients with acute proximal DVT caused by vein compression syndrome.

Long-Term Outcome of Catheter-Directed Thrombolysis in Pregnancy-Related Venous Thrombosis.

BackgroundVenous thromboembolism (VT) is a leading cause of maternal mortality and morbidity worldwide. Catheter-directed thrombolysis (CDT) is an effective and safe treatment modality for VT patients. However, the long-term outcome of CDT in pregnancy-related venous thrombosis are unclear. The aim of this study was to assess long-term results of pregnancy-related VT patients.Material/MethodsWe reviewed 41 pregnancy-related deep venous thrombosis (DVT) patients who underwent CDT from February 2008 to May 2015. Clinical data, including demographic variables, disease location, vascular risk factors, treatment regimen, interventional procedure and complications, were collected retrospectively. Clinical and color-duplex ultrasonography were performed to monitor venous patency during follow-up. Post-thrombotic syndrome (PTS) was assessed with the Villalta scale and quality of life (QOL) was evaluated by the VEINES-QOL/Sym questionnaire.ResultsTwenty-three patients underwent spontaneous abortion or induced abortion within 3 months before DVT, and 18 patients had DVT during the first 3 months after delivery. Technical success was achieved in all patients. Grade III (complete) lysis was obtained in 15 patients and grade II (partial) lysis was obtained in 21 patients. The follow-up period was 3 years. Twenty-eight patients had venous patency at 3-year follow-up; 36.6% of patients developed mild or moderate PTS (Villalta score 5–14) and 4.8% with severe PTS (Villalta score ≥15). VEINES-QOL/Sym scores were 55.24±7.35 and 53.25±6.65, respectively.ConclusionsCatheter-directed thrombolysis is a reliable and safe treatment modality for postnatal or abortion patients with DVT. CDT can reduce the incidence rate of PTS and increase the quality of life.

Pharmacomechanical catheter-directed thrombolysis for acute iliofemoral deep vein thrombosis: our case series.

This is a retrospective study on Pharmacomechanical Catheter-Directed Thrombolysis (PCDT) in the treatment of acute iliofemoral Deep Vein Thrombosis (DVT). From March 2013 to November 2016, 22 patients (26 limbs), median age 46.7 years with acute (<21 days) extensive iliofemoral DVT underwent Percutaneous Mechanical Thrombectomy (PMT) with Aspirex (Straub Medical, Wangs, Switzerland), followed by Catheter-Directed Thrombolysis (CDT). Subsequent endovascular stenting was performed for underlying obstruction. The follow-ups were conducted up to 1 year, in two Centers by experienced operators. Post-Thrombotic Syndrome (PTS) was evaluated by assessing the Villalta Scale (VS) and measuring orthostatic venous pressure. Post-operative iliofemoral vein patency was restored in almost all cases (95.5%). Standard urokinase dose was 80.000 IU per hour; mean infusion time was 32.5 hours. Stenting was performed in 15 cases (68%). Median follow-up was 19.9 months (6-48 months); 21/22 patients completed the 12 months follow-up. At 30 days follow-up symptoms disappeared in 21/22 cases (95.5%), with one case (4.5%) of DVT recurrence. At 1-year follow-up there were 3 cases (14.2%) of mild PTS; 18 patients (85.8%) were free from PTS. At 1-year follow-up venous pressure measurement showed normal values in 11 cases (52.4%), mild hypertension in 7 patients (33.3%), moderate hypertension (80-100 mmHg) in 2 cases (9.5%) and severe hypertension (110 mmHg) in one case (4.8%). Neither major nor minor complications were observed. PMT with Aspirex combined with CDT with urokinase seems to be a safe and effective treatment for acute iliofemoral DVT and it shows promising results in reducing the risk of PTS. Thus, we suggest a controlled trial with this treatment strategy.

Treatment-Related Outcomes in Paget–Schroetter Syndrome—A Cross-Sectional Investigation

To investigate treatment-related outcomes, namely radiological clot resolution, post-thrombotic syndrome (PTS), and health related quality-of-life (HRQoL) scores, in children with Paget-Schroetter syndrome (PSS) undergoing multidisciplinary management, including anticoagulation and decompressive rib-resection surgery, with or without thrombolytic therapy. We identified all patients treated for PSS at our institution between the years 2010 and 2017. Baseline clinical and radiologic data were abstracted from medical records. Two validated survey instruments to quantify PTS and HRQoL were mailed to eligible patients. Standard statistical methods were used to summarize these measures. In total, 22 eligible patients were identified; 10 were treated with thrombolysis followed by anticoagulation and rib resection, and 12 were treated with anticoagulation and rib resection alone. Nineteen patients responded to the survey instruments. Median age at deep vein thrombosis diagnosis and survey completion were 16.3 and 20.4 years, respectively. Nineteen of 22 patients had thrombus resolution on radiologic follow-up. Fourteen of 19 survey respondents reported signs/symptoms of PTS of which the majority (12/14) reported mild PTS. Aggregate total, physical, and psychosocial HRQoL scores reported were 90.6, 96.7, and 93.3, respectively. Thrombolytic therapy was not associated with a significant improvement in radiologic, clinical or HRQoL outcomes. Most patients with PSS had complete thrombus resolution on imaging. Only 11% of survey respondents reported moderate PTS. The entire cohort reported excellent HRQoL scores. The role for thrombolytic therapy in the management of childhood PSS remains incompletely elucidated.