Acute Iliofemoral Deep Vein Thrombosis Research Articles

Farmakomekanik katater aracılı tromboliz ile tedavi edilen akut ilyofemoral derin ven trombozlu hastalarda uzun süreli antikoagülasyonun karşılaştırmalı etkinliği

Aim: We aimed to compare the stability of pharmacologic profile, rate of symptomatic recurrent venous thromboembolism, major bleeding and the net clinical benefit on the regimen with vitamin K antagonist (VKA), low molecular weight heparin (LMWH) and direct oral anticoagulant (DOAC) for long-term anticoagulation in patients undergoing pharmaco-mechanical catheter-directed thrombolysis (PMCDT) for the treatment of deep vein thrombosis (DVT). Material and Methods: During the period from January 2019 until June 2019, data of 112 patients who underwent PMCDT for the treatment of acute iliofemoral DVT in our institution with long-term apixaban (Pfizer, Turkey) medication were prospectively collected (Group 1-DOAC). Data of control groups within January 2017- December 2018 period were collected retrospectively. Control groups consisted of PMCDT patients with extended LMWH (Tinzaparin, Abdi Ibrahim Pharma, Turkey) treatment (Group 2-LMWH; N=119) and with VKA (Coumadin, Eczacibasi Pharma, Turkey) treatment (Group 3- Control; N=111). Results: Patients treated with VKA showed a significant incompliance starting from third month up to one year. Patency rate diminished significantly below 70%. 32% of VKA patients were out of therapeutic range even in the first month leading to 40% at the end of the year. Likert Scale, Villalta/VCCS and VEINES-QOL-Sym scores confirmed the clinical data. Conclusion: This study highlights the potential role of DOAC as a reasonable alternative to VKAs/LMWH in the long-term anticoagulation strategy for DVT. We await larger clinical trials to support these findings and establish the role of DOAC as the standard of care for patients with DVT.

Trans-jugular AngioJet rheolytic thrombectomy for acute deep vein thrombosis: Alternative to overcome the limitation of patient's position.

To introduce a transjugular retrograde approach for AngioJet rheolytic thrombectomy (RT) just after transjugular placement of inferior vena cava filter (IVCF) to treat acute deep vein thrombosis (DVT). From September 2018 to April 2019, transjugular Angiojet RT using pulse spray method was performed just after transjugular placement of IVCF in five patients (M:F = 3:2, mean age 70 years). Patients less than 165 cm in height with acute (<14 days) iliofemoral DVT were unable to assume a prone position. All patients underwent pre- and postprocedural venography to estimate thrombus reduction grade. Computed tomography angiograms at 3 and 6 months postoperative were compared with baseline scans. Post-thrombotic syndrome (PTS) symptoms were evaluated according to Villalta score during 12-month follow-up. Mean procedure time for all procedures was 1.4 h. Thrombus was completely reduced in three patients and 50% to 99% reduction was noted in the other two. No patients had major complications during the hospital stay and follow-up period. Distal migration of IVCF occurred in one patient during the procedure and immediate IVCF repositioning was performed. No DVT remained in follow-up computed tomography scans of all patients. PTS did not develop in any patients during the follow-up period. In patients who are unable to assume a prone position, a transjugular retrograde approach with AngioJet RT just after transjugular placement of IVCF to treat acute lower extremity DVT was a time-saving and easy alternative. During the procedure, attention to the guiding catheter position and AngioJet device movement was required to avoid affecting the IVCF.

Single-Session Percutaneous Mechanical Thrombectomy Using the Aspirex®S Device Plus Stenting for Acute Iliofemoral Deep Vein Thrombosis: Safety, Efficacy, and Mid-Term Outcomes.

To assess the safety, efficacy and mid-term outcomes of single-session percutaneous mechanical thrombectomy (PMT) for acute symptomatic iliofemoral deep vein thrombosis (DVT) using the Aspirex®S device. Retrospective review of 30 patients (women, 23; mean age, 45.5 ± 19.9 years; range, 17–76) who underwent PMT with the 10-French Aspirex®S device (Straub Medical AG, Wangs, Switzerland) for acute DVT between December 2015 and March 2019. Procedures were performed by popliteal (n = 22) or jugular (n = 7) approach, or both (n = 1). Mean time from diagnosis to PMT was 5.5 ± 4.6 days (range, 2–11). Successful thrombus removal and venous patency restoration were achieved in all patients (100%). Fluid removal was 307.8 ± 66.1 mL (range, 190–410). Additional venous stenting rate was 100%. Mean procedural time was 107.3 ± 33.9 min (range, 70–180). No major complication occurred. The patient’s postprocedural course was uneventful in all cases, with hospital discharge within 2 days in 83.3%. Early in-stent rethrombosis occurred within 1 week in 3 patients, successfully managed by endovascular approach. Secondary stent patency rate was 86.7% at a mean follow-up of 22.3 ± 14.2 months (range, 6–48), as assessed by Duplex ultrasound. Single-session of PMT using the Aspirex®S device is a safe and effective therapeutic option in patients presenting with acute symptomatic iliofemoral DVT.

Outcomes of rheolytic thrombectomy in phlegmasia cerulea dolens.

The purpose of this study was to assess the clinical features of phlegmasia cerulea dolens and present the treatment outcomes with rheolytic thrombectomy device. From January 2014 and March 2019, 329 patients were diagnosed and hospitalized for acute iliofemoral deep vein thrombosis, and among those patients, seven patients diagnosed with lower extremity phlegmasia cerulea dolens were consecutively enrolled. Diagnosis of phlegmasia cerulea dolens was initially made on clinical findings followed by imaging with Doppler ultrasound. The rheolytic thrombectomy device was used in all patients with a combination of catheter-directed thrombolysis as an adjunctive therapy to facilitate more rapid thrombus clearance except for one patient who had a contraindication to the use of tissue plasminogen activator. Seven patients (four men, three women; median age, 63 years, range 52-68 years) were included. One patient had a relative contradiction to thrombolysis due to history of coronary artery bypass graft surgery; all other patients underwent pharmaco-mechanical thrombectomy with power pulse mode. The upper limit of 480 s was completed in all patients, and this time was not exceeded to prevent hemolysis-related complications. Six Fr catheters were used in four (57.1%) patients, and 8 Fr catheters were used in three patients (42.9%). Mean thrombolytic infusion duration was 28 ± 6.2 h for patients who received tissue plasminogen activator. After catheter-directed thrombolysis, total radiological success was achieved in two patients, and partial radiologic success was achieved in five patients; however, in all seven patients, clinical success was achieved. The mean duration for complete regression of cyanosis was 18.9 ± 8.1 h. Although no patients required blood replacement, mean decreases in hemoglobin and hematocrit were 2.7 ± 1.37g/dl and 6.42 ± 4.47%, respectively. Acute kidney injury developed in three patients (42.9%). One patient required continuous renal replacement therapy. No cardiac complication was observed. One (14.3%) patient died of ventilator-related pneumonia on postprocedural day 10. The median duration of intensive care unit stay and hospital stay were 72 h (min-max: 24-264 h) and six days (min-max: 5-33 days), respectively. Rheolytic thrombectomy was less invasive and effective strategy for early stage phlegmasia cerulea dolens at creating rapid thrombus clearance to establish clinical success and facilitate more conservative management with catheter-directed thrombolysis.

AngioJet Pharmacomechanical Thrombectomy and Catheter Directed Thrombolysis vs. Catheter Directed Thrombolysis Alone for the Treatment of Iliofemoral Deep Vein Thrombosis: A Single Centre Retrospective Cohort Study

Percutaneous thrombus removal is used for the treatment of iliofemoral deep vein thrombosis (DVT), but the efficacy of different treatment modalities has not yet been determined. The aim of this study was to compare the outcomes of patients treated with additional AngioJet pharmacomechanical thrombectomy (PCDT) vs. catheter directed lysis (CDT) alone. A retrospective review of all patients who received thrombolysis for the treatment of symptomatic acute iliofemoral DVT between 2011 and 2017 was carried out. Outcome measures included the incidence of post-thrombotic syndrome (PTS), procedural outcomes (lytic exposure), the incidence of complications, and vessel patency. All patients were followed up for a minimum of one year. A total of 151 limbs were treated, 70 limbs with PCDT and 81 limbs with CDT alone. Demographic data and prevalence of risk factors were comparable. Incidence of PTS (Villalta score at one year) showed no significant difference (22.2% PCDT vs. 24.7% CDT alone, p=.74). Use of PCDT resulted in a non-statistically significant trend for fewer bleeds (n=4/63 [6.3%] vs. 13/76 [17.1%]; relative risk 0.37, 95% confidence interval [CI] 0.13-1.08; p=.07), a statistically significant reduction in lysis duration (40h [95% CI 34-46] vs. 53h [95% CI 49-58]; p<.001) and a reduction in lytic dose (49mg [95% CI 42-55] vs. 57mg [95% CI 52-61]; p=.011) compared with CDT. This reduction was accentuated in 24 cases primarily treated with AngioJet PowerPulse mode (27h, 95% CI 20-34 [p<.001] and 42mg, 95% CI 34-50 [p=.009]). Incidences of complications were comparable between groups, with one death due to an intracranial haemorrhage following CDT. Although the incidence of haemoglobinuria was increased following PCDT (12/63 [19.0%] vs. 3/76 [3.9%]; p=.006), no significant difference in acute kidney injury was observed (3/63 [4.8%] vs. 1/76 [1.3%]; p=.33). No significant difference in vessel patency over two years was observed (p=.73). The use of PCDT for the treatment of iliofemoral DVT was observed to provide comparable patient outcomes, comparable vessel patency, an acceptable safety profile, and reduced overall lytic dose.

Mid- and Short-Term Efficacy of Percutaneous Mechanical Thrombectomy in the Treatment of Acute Iliofemoral Deep Vein Thrombosis

We aimed to evaluate the efficacy and safety of percutaneous mechanical thrombectomy (PMT) in treating acute iliofemoral deep vein thrombosis (DVT). We retrospectively analyzed the clinical data of 82 acute iliofemoral DVT patients between November 2017 and December 2018. The therapeutic effects were evaluated based on the thrombus removal rate and circumference changes 10cm above the affected knee. Incidence rates of pulmonary embolism were evaluated to determine the safety of the procedure. During follow-up, the incidence of postthrombotic syndrome (PTS) was evaluated using the Villalta score, whereas the patency rate of the iliac vein was evaluated via duplex ultrasonography and venography. The surgical success rate was 100%. We identified 48 patients with iliac vein compression syndrome (IVCS) intraoperatively: three of these underwent stent implantation and the others underwent percutaneous transluminal angioplasty (PTA). Grade II and III thrombus removal was achieved in 32.9% (27/82) and 67.1% (55/82) patients, respectively. Postoperative venography revealed that four patients had many floating thrombi under their inferior vena cava filters, which were not removed. The circumference 10cm above the affected knee decreased from 50.3±3.5cm preoperatively to 46.3±3.3cm postoperatively (P<0.05). During follow-up, a PTS incidence rate of 9.8% was observed. The patency rate of the iliac vein was 66.6% after stent implantation and 93.3% after PTA. PMT is feasible, safe, and effective for acute iliofemoral DVT. With regard to IVCS, we suggest PTA alone as a one-stage surgery, and the need of secondary stent implantation should be determined based on follow-up results.

Less frequent post-thrombotic syndrome after successful catheter-directed thrombolysis for acute iliofemoral deep vein thrombosis.

Post-thrombotic syndrome (PTS) occurs in 20-50% of patients with proximal deep vein thrombosis (DVT). In this study, we aimed to identify potential markers of thrombolysis success at the early stage and to clarify the relationship between early thrombolysis success and subsequent PTS development in patients with acute DVT in the iliac vein. Fifty-two consecutive patients with acute iliofemoral DVT who were treated with catheter-directed thrombolysis (CDT) within 21days of onset were enrolled. An infusion catheter with multiple side holes was placed to cover the thrombosed vessel entirely. Urokinase solution was administered either continuously or with the pulse-spray method at a dose of 480,000-720,000IU/day over the course of 2-7days. During CDT, unfractionated heparin (UFH) was infused simultaneously via the access sheath to prevent thrombus formation. Early success was defined as lysis grade ≥ 50% and restoration of forward flow. PTS was diagnosed based on the Villalta scale. Based on the lysis grading method, complete lysis (grade III) was achieved in 8 of 52 (16%) limbs. Lysis grade II (50-99%) was achieved in 35 of 52 (67%) limbs. Lysis grade I (< 50%) was achieved in 9 of 52 (17%) limbs. Therefore, grade II and grade III lytic outcomes (early success) were observed in 43 patients (83%). One-year clinical follow-up was performed for 43 patients (83%). PTS occurred in seven (16%) patients. Early success was more frequently observed in patients without PTS than in those with PTS (92% vs. 43%; P < 0.01). Early success was only significantly associated with PTS in the multivariate analysis. Patients with acute symptomatic iliofemoral DVT who had early success from CDT treatment during the acute phase less frequently progressed to PTS. Patients with early success tended to undergo the pulse-spray method and had a shorter interval from symptom onset to CDT. The use of pulse-spray method and early initiation of CDT since DVT onset were potential markers of thrombolysis success.

Comparative Study Between Medical Treatment and Intervention in Acute Iliofemoral DVT

Abstract Background The cornerstone of current management of deep vein thrombosis (DVT) are the routine use of anticoagulant therapy, graduated elastic compression stockings (ECS), and early ambulation. Thrombolytic therapy was previously reserved only for patients with life-, limb-, or organ-threatening complications. However, the Post-Thrombotic Syndrome (PTS) has been increasingly recognized as a frequent and serious long-term complication of DVT. In this study I will use systematic review techniques to compare between the medical and intervention management outcome and possible complications and I will try to find out if although of high expenses of the new techniques especially catheter directed thrombolysis CDT it worth it as regarding the post-operative care and complications. Objective To review the literature comparing between medical treatment of acute iliofemoral DVT and intervention in the form of endovenous or surgical management of acute iliofemoral DVT as regards short and long term benefits. Methodology A systematic Review of published English literature from their date of inception till 2018. Only published English literature will be included in the study. All studies from their inception date till 2018 will be included. Results The literature search from the specified electronic databases identified 179 articles. After application of the inclusion and exclusion criteria, 7 comparative studies were finally included in this systematic review. There were 5 randomized trials and 2 observational studies. 1 prospective and 1 was retrospective. Various other approaches were used in combination with conservative/pharmacological thrombolysis according to the underlying pathology A total of 631 patients underwent CDT compared to 675 patients who underwent conservative strategy for management of acute iliofemoral DVT Conclusion Pharmacological and pharmacomechanical thrombolysis offers significant benefits to proximal dvt patients in the long term period. However, it does not show an advantage over conservative management in short -term outcome. Furthermore, CDT carries more risk of bleeding and recurrent VTE in the shortterm. More randomized control studies focused on quality of life after conservative and endovasculat intervention in proximal dvt patients as well as on studies on newer generation devices is needed to provide more information for clinical decisions.

Catheter-directed thrombolysis vs pharmacomechanical catheter-directed thrombolysis in acute iliofemoral deep vein thrombosis

Purpose The aim was to compare the effectiveness of catheter directed thrombolysis (CDT) and pharmacomechanical catheter-directed thrombolysis (PCDT) in the treatment of acute, massive iliofemoral deep vein thrombosis. Patients and methods A prospective study was conducted on 50 patients in Zagazig University Hospitals between March 2014 and April 2018. The patients were randomized into two groups. Group A underwent CDT and group B underwent PCDT (ASPIREX). Primary end points were venous patency, complication rate, patient satisfaction, and quality of life Chronic Venous Insufficiency Questionnaire-20. Secondary end points were recurrence and occurrence of post-thrombotic syndrome (PTS), (the Villalta score and revised Venous Clinical Severity Score) within 24 months. Results Aspirex was successful in the majority of patients and grade III, II, and I thrombolysis was achieved in 56, 32, and 12% of patients, respectively, while in the CDT group of patients achieved 44, 36, and 20%, respectively. Recanalization was achieved in 88% patients. At 24 months 32% patients who received CDT presented with PTS compared with 20.83% in the PCDT group after exclusion of one patient who died. Three cases of severe PTS were reported in the CDT group. There was statistically significant difference in PTS at 6 months between the two groups. When comparing Chronic Venous Insufficiency Questionnaire-20 scores between the two groups, there was statistically significant difference between them at 6, 12, and 24 months with more improvement in Aspirex group. Conclusion Aspirex is an effective treatment for lower limb deep vein thrombosis, and the clinical results achieved were superior in comparison with CDT alone.

Acute iliofemoral deep vein thrombosis: does catheter-directed thrombolysis affect outcomes?

Purpose The aim was to assess the role of catheter-directed thrombolysis (CDT) in improving patency of the treated venous segments and to examine the correlation of residual thrombus with post-thrombotic syndrome (PTS). Background Iliofemoral deep vein thrombosis (DVT) is associated with severe post-thrombotic morbidity when treated with anticoagulation alone. CDT allows early removal of thrombus and reduce valvular reflux and PTS. Patients and methods This prospective randomized controlled two-arm study was conducted on 42 patients with iliofemoral DVT. The patients were randomly allocated into two groups according to the intervention performed. Group A: CDT followed by oral anticoagulants [N=21 (50%)], group B: standard DVT therapy [N=21 (50%)]. The follow-up period was 24 months. Results Patients of group A complained of less pain at 10 and 30 days (P=0.02 and 0.04, respectively). Also, there was significant decrease in leg circumference in group A at 10 and 30 days (P=0.001 and 0.03, respectively). A total of three (15%) clinically relevant nonmajor bleeding complications were reported in the CDT group. Using CDT is associated with less PTS at sixth month, 1 year, and 2 years; six (27.3%), seven (31.8%), and nine (40.9%), respectively, as compared with group B; 11 (47.8%), 13 (56.5%), and 15 (65.2%), respectively (P=0.024, 0.017, and 0.035, respectively). Conclusion Addition of CDT in the treatment of acute iliofemoral DVT was safe and tolerated by most of the patients with better effect to reduce leg pain and circumference. It was considered a protecting weapon to prevent PTS and thereby improving the quality of life and was related to achievement of higher iliac vein patency and less reflux.

Midterm outcomes in postpartum women following endovenous treatment for acute iliofemoral deep vein thrombosis

BackgroundThe development of post-thrombotic syndrome (PTS) after iliofemoral deep vein thrombosis (DVT) continues to be a considerable issue for both pregnant and postpartum women with rates as high as 70% among those managed with anticoagulation alone. This study aims to characterize the outcomes of interventional treatment for acute iliofemoral DVT in this at-risk population. MethodsA retrospective analysis of all postpartum patients treated for acute iliofemoral DVT with lysis and stenting between January 2012 and December 2017 at a referral center. Patient demographics, risk factors, procedural factors. and complications were collected. Post-treatment outcomes were compared with all nonpostpartum females treated within the same time period. These included the severity of PTS evaluated using the Villalta scale, duration of vessel patency and factors affecting reintervention timing and success. Further detailed review of cases needing reintervention was also conducted through a retrospective review of documentation and an analysis of all imaging by a consultant radiologist. ResultsA total of 11 postpartum women were identified. The median age was 28 years (range, 22-41 years) and intervention was performed at a median of 3 weeks after birth (range 2-12 weeks). No major or minor complications associated with intervention were reported in any patients. The median Villalta score was 3 at 6 months, improving to 2 at 12 months. Overall, two patients were classified as mild having PTS (18%), with no cases of moderate to severe PTS. On comparison with nonpostpartum (n = 68) Villalta scores, no significant difference in outcome was observed at 6 months (median score, 3; range, 0-15 months; P = .95) or at 1 year (median score, 1; range, 0-15; P = .84). Cumulative patency at 1 year was found to be 64% in postpartum women compared with 93% in nonpostpartum women. The postpartum state was found to be a significant predictor of cumulative patency loss (hazard ratio, 0.10; 95% confidence interval, 0.02-0.62; P = .01). However, no significant difference in primary and primary-assisted patency was observed. Of the postpartum patients, 55% required reintervention (6/11) compared with 29% of nonpostpartum patients (20/68). The mean time to initial reintervention was 62 days (range, 7-233 days). Reintervention was unsuccessful in all cases presenting with 100% vessel occlusion (4/11), but successful in both cases with partial occlusion (2/11). Analysis of the etiologic factors associated with reintervention revealed that all reintervention cases were associated with technical failure to fully lyse and stent beyond residual disease at the initial procedure. No technical, flow, or hematologic factors were identified in the four cases that retained primary patency. ConclusionsThis study suggests that percutaneous intervention to achieve early thrombus removal and venous stenting provides a favorable alternative to conservative therapies owing to its potential to decrease the severity of PTS. Completion of lysis and adequate stenting of disease is essential to prevent reocclusion, for which reintervention carries a lower likelihood of success. Further research is warranted to further characterize the appropriate management of postpartum women with iliofemoral DVT.

Endovenöse Rekanalisationen von chronischen Beckenvenenverschlüssen

Approximately 60 % of patients with acute iliofemoral deep vein thrombosis recover without further symptoms. However, 40 % will have some degree of post-thrombotic syndrome (PTS) and 4 % will develop severe PTS. PTS is the most common complication; it reduces quality of life and increases DVT-related costs. The clinical symptoms and severity of PTS may vary; the most common symptoms include edema, pain, hyperpigmentation, lipodermatosclerosis, and ulceration. PTS is based on the principle of outflow obstruction, may be caused by venous hypertension, and may lead to valvular damage and venous reflux or insufficiency. A significant lumen reduction within the iliac vein system is defined by an aspect ratio ≥ 2. Recent technical developments and new dedicated venous stent techniques now give the opportunity to recanalize even complex venous outflow obstructions. First in man safety and efficacy data are very promising for the new dedicated venous stents, but long-term data are still missing.

Patency of Nitinol Venous Stents in Peripartum Women Following Treatment for Acute Ilio-Femoral Deep Vein Thrombosis

Patency of Nitinol Venous Stents in Peripartum Women Following Treatment for Acute Ilio-Femoral Deep Vein Thrombosis

Prevention of Recurrence After Thrombolysis in Acute Iliofemoral Venous Thrombosis with Rivaroxaban (Prais Study): A Prospective, Randomized, Open Label, Multicenter Trial

Introduction: Recently new oral anticoagulants (NOAC) has replaced vitamin K antagonist (VKA) for the treatment of deep vein thrombosis (DVT). But the role of NOAC after thrombolysis of acute iliofemoral DVT is not yet defined. The aim of this randomized clinical trial is to compare the safety and efficacy of rivaroxaban versus VKA after thrombolysis of acute iliofemoral DVT. Methods: Patients were recruited from 7 hospitals in Korea. After successful thrombolysis or mechanical thrombectomy of acute iliofemoral DVT, 72 patients were randomized to standard anticoagulation (enoxaparin and warfarin) or rivaroxaban. Primary efficacy outcome was recurrence of any venous thromboembolism within 6 months. Secondary safety outcome were major bleeding and clinically relevant non-major bleeding (CRNMB). Other safety variables including any adverse events, vascular events, and all-cause mortality were also analyzed. Results: Intention-to-treat analysis was done for 67 patients (35 in rivaroxaban group, and 32 in VKA group). The primary outcome of recurrent VTE occurred in 4 patients in each group (11.4% vs 12.5%; hazard ratio[HR], 0.90; 95% confidence interval [CI], 0.21 to 3.96; P=1). Major bleeding or CRNMB developed in 1 patient in the rivaroxaban group and 3 patients in the VKA group (2.9% vs 9.4%, HR, 0.28; 95% CI, 0.03 to 2.88; P=0.34). Recurrence-free survival and significant bleeding-free survival at 6 month were not different in both groups. (P=0.28 and P=0.98, respectively) Conclusion: After thrombolysis of acute iliofemoral DVT, rivaroxaban was as effective as warfarin for the prevention of DVT recurrence. Rivaroxaban group showed a tendency of lower incidence of major bleeding/CRNMB. Rivaroxaban can safely replace warfarin in patients after successful thrombolysis for acute iliofemoral DVT. (Funded by Bayer Schering Pharma; ClinicalTrials.gov number, NCT01986192.)

Ultrasound-accelerated catheter-directed thrombolysis versus anticoagulation for the prevention of post-thrombotic syndrome (CAVA): a single-blind, multicentre, randomised trial

Early thrombus removal might prevent post-thrombotic syndrome by preserving venous function and restoring flow. Previous trials comparing additional catheter-directed thrombolysis to standard treatment showed conflicting outcomes. We aimed to assess the benefit of additional ultrasound-accelerated catheter-directed thrombolysis for the prevention of post-thrombotic syndrome compared with standard therapy in patients with iliofemoral deep-vein thrombosis. We did a multicentre, randomised, single-blind, allocation-concealed, parallel group, superiority trial in 15 hospitals in the Netherlands. Patients aged 18-85 years with a first-time acute iliofemoral deep-vein thrombosis and symptoms for no more than 14 days were randomly assigned (1:1) to either standard treatment with additional ultrasound-accelerated catheter-directed thrombolysis or standard treatment alone. Randomisation was done with a web-based automatic programme and a random varying block size (2-12), stratified by age and centre. Standard treatment included anticoagulant therapy, compression therapy (knee-high elastic compression stockings; 30-40 mmHg), and early ambulation. Additional ultrasound-accelerated catheter-directed thrombolysis was done with urokinase with a starting bolus of 250 000 international units (IU) in 10 mL NaCl followed by a continuous dose of 100 000 IU/h for a maximum of 96 h through the Ekos Endowave-system. Adjunctive percutaneous transluminal angioplasty, thrombosuction, or stenting was performed at the discretion of the physician who performed the intervention. The primary outcome was the proportion of patients with post-thrombotic syndrome at 12 months diagnosed according to the original Villalta criteria-a Villalta-score of at least 5 on two consecutive occasions at least 3 months apart or the occurrence of venous ulceration-and was assessed in a modified intention-to-treat population of all randomly assigned patients who passed screening and started treatment. The safety analysis was assessed in the same modified intention-to-treat population. This study is complete and is registered at ClinicalTrials.gov, NCT00970619. Between May 28, 2010, and Sept 18, 2017, 184 patients were randomly assigned to either additional ultrasound-accelerated catheter-directed thrombolysis (n=91) or standard treatment alone (n=93). Exclusion because of screening failure or early withdrawal of informed consent resulted in 77 patients in the intervention group and 75 in the standard treatment group starting allocated treatment. Median follow-up was 12·0 months (IQR 6·0-12·0). 12-month post-thrombotic syndrome occurred in 22 (29%) patients allocated to additional treatment versus 26 (35%) patients receiving standard treatment alone (odds ratio 0·75 [95% CI 0·38 to 1·50]; p=0·42). Major bleeding occurred in four (5%) patients in the intervention group, with associated neuropraxia or the peroneal nerve in one patient, and no events in the standard treatment group. No serious adverse events occurred. None of the four deaths (one [1%] in the intervention group vs three [4%] in the standard treatment group) were treatment related. This study showed that additional ultrasound-accelerated catheter-directed thrombolysis does not change the risk of post-thrombotic syndrome 1 year after acute iliofemoral deep-vein thrombosis compared with standard therapy alone. Although this trial is inconclusive, the outcome suggests the possibility of a moderate beneficial effect with additional ultrasound-accelerated catheter-directed thrombolysis. Further research is therefore warranted to better understand this outcome in the context of previous trials, preferably by combining the available evidence in an individual patient data meta-analysis. The Netherlands Organisation for Health Research and Development (ZonMw), Maastricht University Medical Centre, BTG-Interventional Medicine.

Treatment of Acute Iliofemoral Deep Vein Thrombosis; Does Catheter Directed Thrombolytic Therapy Change Outcomes?

Background: Iliofemoral deep vein thrombosis (DVT) is associated with severe post-thrombotic morbidity when treated with anticoagulation alone. Catheter- directed thrombolysis (CDT) allows early removal of thrombus and reduces valvular reflux and Post-thrombotic Syndrome (PTS). Patients and methods: This prospective randomized multi-center controlled two- arm blind study was conducted in 6 centers on 252 patients with iliofemoral DVT. Patients were randomly allocated by using simple random allocation cards method into two groups; Group (A): CDT followed by oral anticoagulation (N=126 (50%)), Group (B): Standard DVT therapy (N=126 (50%)). Follow-up was for 24 months. Results: Patients of group (A) significantly complained less pain at 10 &amp; 30 days (P-Value: 0.02 &amp; 0.04 respectively). Also there was significant decrease in leg circumference in group (A) at 10 &amp; 30 days (P-Value: 0.001 &amp; 0.03 respectively). Patency of iliac vein segment was significantly higher in group (A) during the 24 months follow up (P-Value &lt;0.001 (HS)). Patients in group (A) developed less PTS at six months, at one year and at two years (P-Value: 0.024, 0.017 and 0.035 respectively). Better Quality of life was observed in group (A) (P-Value: 0.003). Conclusion: Addition of catheter-directed thrombolysis in the treatment of acute iliofemoral DVT; was safe and tolerated by most of the patients with better effect to reduce leg pain &amp; circumference. It was considered a protecting weapon to prevent post-thrombotic syndrome and so improve quality of life and was related to achievement of higher iliac vein patency and less reflux.

Popliteal ven tutulumu olmayan akut iliofemoral ven trombozunun ultrasonla hızlandırılmış kateter aracılı trombolitik tedavisi: erken ve orta dönem sonuçlar

Purpose: Deep vein thrombosis is a life-threatening pathology which can lead to long-term morbidity due to post-thrombotic syndrome. The aim of this study was to assess early and midterm results of the patients undergoing ultrasound-accelerated catheter-directed thrombolysis for the treatment of acute iliofemoral deep venous thrombosis without popliteal vein thrombosis.Materials and Methods: A total of 18 patients (11 males, 7 females; mean age: 51.89±16.29 years; range, 16 to 72 years) who were diagnosed with acute iliofemoral deep vein thrombosis between November 2014 and December 2015 were included in this retrospective cross-sectional study. Results: Complete thrombolysis was successful in 88.9% (n=16) and in % 11.1 (n=2) patients with partial clot lysis. No pulmonary embolism was seen, while bleeding at the catheter-insertion site was observed in one patient. In another patient, underlying lesions were successfully treated with balloon angioplasty. No in-hospital mortality or severe complications were observed. The mean follow-up was 31.56±3.35 (range, 25 to 37 months). Ultrasound findings of all the patients were evaluated by a single experienced radiologist. Duplex ultrasound was performed at one month, six months, one year, and two years following intervention and the iliac vein patency rate was found to be 100%, while superficial femoral vein insufficiency was in 5.6% (n=1), 11.1% (n=2), 16.2% (n=3), and 16.2% (n=3), respectively.Conclusion: Based on our findings, ultrasound-accelerated catheter-directed thrombolysis is a safe and effective method for carefully selected patients with acute iliofemoral deep vein thrombosis without popliteal vein thrombosis

Clinical outcomes of manual aspiration thrombectomy for Ilio-femoral venous thrombosis in cancer patients.

e23145 Background: To determine the outcomes and feasibility of manual aspiration thrombectomy (MAT) for treatment of symptomatic ilio-femoral deep vein thrombosis (IFDVT) in cancer patients. Methods: In this retrospective study, one hundred and thirty-five consecutive patients (56 men; mean age, 63 years; 149 limbs) with acute (n = 113; 83.7%), subacute (n = 14; 10.4%), and chronic (n = 8; 5.9%) symptomatic IFDVT underwent MAT-based endovascular treatment, with adjunctive balloon angioplasty and stent placement performed in 94 patients. Degree of thrombus removal on venography and symptom improvement was assessed for evaluation of technical and clinical success, respectively. Results: Technical success (thrombus removal &gt; 50%) was achieved in 90.4%, and clinical success was observed in 71.5%. The primary patency rates were 88.1%, 81.6%, 76.0%, 74.1% and 69.1% at 1, 3, 6, 12, and 30 months, respectively. Recurrent IFDVT occurred in 19.3% of patients, 0.79 cases per patients-years of follow up. According to the analysis by causes of IFDVT, recurrent rate was 19.3%, 21.2%, and 14.3% in unknown, compression/invasion of the vein by cancerous mass, and May-Thurner syndrome groups, respectively (p = 0.798). No procedure-related complication developed. Conclusions: MAT is a feasible treatment option with favorable outcomes and minimal risk of complication in cancer patients with symptomatic IFDVT.

Single-Stage Treatment of AngioJet Rheolytic Thrombectomy and Stenting for Iliac Vein Compression Syndrome with Secondary Acute Iliofemoral Deep Vein Thrombosis

We sought to evaluate the feasibility, safety, and effectiveness of single-stage endovascular treatment with AngioJet rheolytic thrombectomy followed by stenting for iliac vein compression syndrome (IVCS) with secondary acute iliofemoral deep vein thrombosis (DVT). We conducted a multiple-center prospective nonrandomized study to enroll patients with left-sided acute iliac-common femoral DVT secondary to IVCS. We performed AngioJet rheolytic thrombectomy followed by stenting to evaluate the success rate, periprocedural complications, hospital stay, clinical outcomes, and stent-patency rate. A prospective cohort study of 19 consecutive patients diagnosed with IVCS and secondary acute iliac-common femoral DVT from October 2014 to April 2017 was conducted. The technique success rate was 94.7%, and the mean procedure time was 77minutes. The 1-year primary and secondary patency rate was 84.2% and 94.7%, respectively. Single-staged endovascular treatment with AngioJet rheolytic thrombectomy and stenting is feasible, safe, and effective for IVCS with secondary acute iliofemoral DVT.

Catheter-Directed Thrombolysis in Acute Iliofemoral Deep Vein Thrombosis with or without Stenting: A Case Series

Iliofemoral deep vein thrombosis (IFDVT) is a potentially devastating condition comprising a quarter of all cases of lower extremity DVT. It can lead to serious consequences such as pulmonary embolism, limb malperfusion, and post-thrombotic syndrome (PTS), which is a chronic sequela of IFDVT. We herewith present 18 IFDVT cases managed with catheter-directed thrombolysis at our hospital. Nine of these patients underwent stenting of the involved iliac veins. The remaining 9, who did not receive stenting, had a residual stenosis of more than 50% in the common femoral or iliac veins following the procedure. Based on a final residual stenosis of less than 50% in the iliac veins, we had 9 successful (patients with stenting) and 9 unsuccessful procedures (patients without stenting). In subsequent follow-ups at a median follow-up of 39.5 months, using the Villalta score, while only 2 out of the 9 patients who underwent stenting suffered PTS, 4 patients among the other 9 patients comprising the non-stenting group developed PTS. Our results support the notion that stenting might have a role in decreasing the PTS risk in patients undergoing catheter-directed thrombolysis.