Acute Iliofemoral Deep Vein Thrombosis Research Articles

Effectiveness and safety of early versus routine switching from low-molecular-weight heparin to maintenance therapy of rivaroxaban for acute iliofemoral vein thrombosis: a retrospective cohort study

ObjectivesThe anticoagulation strategy of switching to rivaroxaban after one week of initial low-molecular-weight heparin (LMWH) therapy is recommended by a guideline for the treatment of acute iliofemoral deep vein thrombosis (DVT). However, the initial rivaroxaban dose in the switching strategy, as well as the effectiveness and safety of the early switching（less than one week ）to rivaroxaban, remain inadequately substantiated. We aimed to evaluate the effectiveness and safety of early switching from LMWH to maintenance therapy of rivaroxaban (20 mg once daily) for acute iliofemoral DVT. MethodsA retrospective cohort study was conducted using data from patients with acute iliofemoral DVT who received initial LMWH anticoagulation followed by rivaroxaban maintenance therapy. The clinical outcomes were compared between early (LMWH course ≤ 7 days) and routine (LMWH course > 7 days) switching strategies within 3 months of initiating anticoagulation. Results217 patients were included, 59 (27.2%) receiving early switching and 158 (72.8%) receiving routine switching. Compared with routine switching, patients with early switching had a significantly shorter hospital stay (7 days vs. 14 days, p < 0.001). The length of hospital stay was significantly positively correlated with the duration of LMWH (r = 0.762, p < 0.001). The incidences of recurrent venous thromboembolism (5.1% vs. 2.5%, p = 0.606), major bleeding (0% vs. 1.9%, p = 0.564), clinically relevant non-major bleeding (1.7 % vs. 2.5%, p = 1.000) and all-cause mortality (6.8 % vs. 2.5%, p = 0.283) were not statistically different between the two groups. ConclusionsDirect early switching from LMWH to maintenance therapy of rivaroxaban is effective and safe for acute iliofemoral DVT.

A contemporary overview of the management of acute ilio-femoral deep vein thrombosis; why, how and where next?

A contemporary overview of the management of acute ilio-femoral deep vein thrombosis; why, how and where next?

Fibrinogen levels and clot properties identify patients who benefit from catheter-directed thrombolysis after DVT

AbstractUltrasound-accelerated catheter–directed thrombolysis (UA-CDT) to improve patency after deep vein thrombosis (DVT) has not conclusively been shown to prevent postthrombotic syndrome (PTS) but might benefit patients who are unlikely to obtain patency with standard treatment. We hypothesized that these patients could be selected based on their fibrin clot properties. To study this, patients with acute iliofemoral DVT from the CAVA (Ultrasound-Accelerated Catheter-Directed Thrombolysis Versus Anticoagulation for the Prevention of Post-thrombotic Syndrome) trial had blood samples taken at inclusion. Fibrin clot properties in plasma were determined by turbidimetric clotting (lag time and maximal turbidity) and lysis assays (time to 50% lysis and lysis rate), permeation assay, and confocal microscopy (fiber density), as well as levels of fibrin clot modifiers fibrinogen and C-reactive protein (CRP). Patency was defined as >90% iliofemoral vein compressibility at 12-month ultrasound. PTS was defined as ≥5 Villalta score at 6 or 12 months. In total, 91 of 152 patients were included, including 43 with additional UA-CDT and 48 with standard treatment. Patients with additional UA-CDT more often obtained patency (55.8 vs 27.1%) Patients who obtained patency had longer lag times and lower maximal turbidity, fibrinogen, and CRP; only maximal turbidity and fibrinogen remained associated when adjusting for treatment, thrombus load, and body mass index. Fibrinogen levels had an optimal cutoff at 4.85 g/L. Low fibrinogen levels best predicted patency. Additional UA-CDT decreased the risk of PTS only in patients with high fibrinogen. Therefore, additional UA-CDT might prevent PTS in selected patients based on routinely measured fibrinogen levels. This study was registered at www.ClinicalTrials.gov as #NCT00970619.

Initial experience with the ambulatory management of acute iliofemoral deep vein thrombosis with May-Thurner syndrome with percutaneous mechanical thrombectomy, angioplasty and stenting

ObjectivePatients undergoing intervention for acute iliofemoral deep vein thrombosis (IFDVT) with May-Thurner syndrome (MTS) typically require inpatient (IP) hospitalization for initial treatment with anticoagulation and management with pharmacomechanical thrombectomy. Direct oral anticoagulants and percutaneous mechanical thrombectomy (PMT) devices offer the opportunity for outpatient (OP) management. We describe our approach with these patients. MethodsPatients receiving intervention for acute IFDVT from January 2020 through October 2022 were retrospectively reviewed. Patients undergoing unilateral thrombectomy, venous angioplasty, and stenting for IFDVT with MTS comprised the study population and were divided into two groups: (1) patients admitted to the hospital and treated as IPs and (2) patients who underwent therapy as OPs. The two groups were compared regarding demographics, risk factors, procedural success, complications, and follow-up. ResultsA total of 92 patients were treated for IFDVT with thrombectomy, angioplasty, and stenting of whom 58 comprised the IP group and 34 the OP group. All 92 patients underwent PMT using the Inari ClotTriever (Inari Medical), intravascular ultrasound, angioplasty, and stenting with 100% technical success. Three patients in the IP group required adjuvant thrombolysis. There was no difference in primary patency of the treated IFDVT segment at 12 months between the two groups (IP, 73.5%; OP, 86.7%; P = .21, log-rank test). ConclusionsPatients with acute IFDVT and MTS deemed appropriate for thrombectomy and iliac revascularization can be managed with initiation of ambulatory direct oral anticoagulant therapy and subsequent return for ambulatory PMT, angioplasty, and stenting. This approach avoids the expense of IP care and allows for effective use of resources at a time when staffing and supply chain shortages have led to inefficiencies in the provision of IP care for nonemergent conditions.

Single-session mechanical thrombectomy for iliofemoral deep vein thrombosis using a dual mechanism of action device combining basket and rotational thrombectomy

ObjectiveInterventional treatments for acute iliofemoral deep vein thrombosis (DVT) remain controversial after publication of the Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis (ATTRACT) study. Interventions have been shown to reduce post-thrombotic syndrome severity and improve quality of life in DVT patients, but have been accompanied by risk of major bleeding from thrombolytics. We describe thrombus removal using a novel combined basket-rotational thrombectomy device that minimizes the need for thrombolytics or repeat procedures. MethodsThe aim of this prospective, nonrandomized, multicenter, first-in-human study of 19 patients with acute iliofemoral DVT was to evaluate the safety and performance of the Pounce venous thrombectomy system ≤12 months after treatment. The primary performance end point was defined as procedural success through achievement of Society of Interventional Radiology (SIR) grade II lysis in treated vessels with freedom from procedural adverse events. Secondary end points included venous disease severity assessments using the Villalta scale and the Venous Clinical Severity Score, patient quality-of-life measurement using the Venous Insufficiency Epidemiological and Economic Study-Quality of Life questionnaire, and calf circumference measurements taken at baseline, 24 hours, and 1 month. ResultsThe primary end point of complete or near-complete thrombus removal (Society of Interventional Radiology grade II or III) was achieved in all patients. All study device-related safety end points were met, with no major bleeding or device-related adverse events. Of the 19 patients treated, 16 (84.2%) did not receive thrombolytics during the procedure. Post-thrombotic syndrome (Villalta scale >4) was identified in 17 of 19 patients (89.5%) at baseline, 4 of 13 patients (30.8%) available for follow-up at 6 months, and 2 of 11 patients (18.2%) at 12 months. The median Venous Clinical Severity Score decreased (P < .001) from 8.5 (interquartile range [IQR], 7-10) at baseline to 4 (IQR, 2-4) at 1 month after the procedure and was similar at 6 months (2; IQR, 2-5) and 12 months (2; IQR, 1.5-3) after the procedure. The median Venous Insufficiency Epidemiological and Economic Study-Quality of Life questionnaire score improved (P < .001) by 39 from baseline (57; IQR, 53.5-74) to 1 month (96; IQR, 86-101) after the procedure, and remained high at 6 months (99; IQR, 75-103) and 12 months (98; IQR, 94.5-100). The median calf circumference decreased (P = .089) from 39 cm (IQR, 35-47.8 cm) at baseline to 36 cm (IQR, 32.5-40.5 cm) at 24 hours after the procedure and was 34.5 cm (IQR, 33.2-38.5 cm) at 1 month. ConclusionsThe Pounce device is safe and effective for removal the of thrombus in patients with acute iliofemoral DVT. Initial results demonstrate improvements in venous disease severity and patient quality of life.

Quality of Life After Early Clot Removal for Acute Iliofemoral Deep Vein Thrombosis

To evaluate patient reported outcome measures after early clot removal for acute deep vein thrombosis (DVT), using the Chronic Venous Disease Quality of Life Questionnaire (CIVIQ-20) and the Short Form Health Survey (SF-36). Cross sectional design. Patients who underwent early clot removal between June 2012 and November 2021 were asked to complete the two questionnaires once. Lower CIVIQ-20 and higher SF-36 scores indicate better quality of life (QoL). Primary endpoints were the median scores. The one sample Wilcoxon signed rank test was used to compare SF-36 physical and mental component summary (PCS and MCS) to the normative and CIVIQ-20 to the minimum. Secondary, non-parametric independent t test or Fisher's exact test examined how age, sex, body mass index, stent placement, re-intervention, and time of questionnaire completion related to QoL. Multivariable linear regression tested whether various variables were associated with QoL. The response rate was 73.5% (n= 39). Median time of questionnaire completion was 1.8 years (interquartile range [IQR] 3.1) after clot removal. The median CIVIQ-20 of 29.0 (IQR 28.0) was slightly higher than the minimum value 20.0 (p < .001). The median PCS (50.5, IQR 16.6) and median MCS (50.2, IQR 14.2) did not differ from the normative of 50.0. However, wide IQRs indicated impairments for a subgroup of patients. None of the tested variables affected QoL except for the finding that re-interventions had a significantly negative impact on the SF-36 MCS (standardised β coefficient of-0.4, p= .030). Overall patient reported outcome measures were satisfactory after early clot removal, but impaired physical and mental functioning levels were present in a subgroup of patients. Re-interventions were found to have a negative impact on mental QoL. This finding was independent of time that had passed between the procedure and questionnaire completion. This study emphasises that mental functioning deserves attention, besides the widely recognised physical consequences after invasive acute iliofemoral DVT treatment.

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.

Comparative outcomes of catheter-directed thrombolysis versus AngioJet pharmacomechanical catheter-directed thrombolysis for treatment of acute iliofemoral deep vein thrombosis

ObjectiveThe objective of this study was to compare the outcomes of pharmacomechanical thrombolysis and thrombectomy (PCDT) plus catheter-directed thrombolysis (CDT) vs CDT alone for the treatment of acute iliofemoral deep vein thrombosis (DVT) and summarize the clinical experience, safety outcomes, and short- and long-term efficacy. MethodsWe performed a 4-year retrospective, case-control study. A total of 95 consecutive patients with acute symptomatic iliofemoral deep vein thrombosis (DVT) with a symptom duration of ≤7 days involving the iliac and/or common femoral veins underwent endovascular interventions. The patients were divided into two groups according to their clinical indications: PCDT plus CDT vs CDT alone. Statistical analyses were used to compare the clinical characteristics and outcomes between the two groups. Additionally, the patients were followed up for 3 to 36 months after treatment, and the proportions of post-thrombotic syndrome (PTS) and moderate to severe PTS were analyzed using the Kaplan-Meier survival method. ResultsA total of 95 consecutive patients were analyzed in this retrospective study, of whom, 51 underwent CDT alone and 44 underwent PCDT plus CDT. Between the two groups, in terms of immediate-term efficacy and safety, significant differences were found in the catheter retention time (60.64 ± 12.04 hours vs 19.42 ± 4.04 hours; P < .001), dosages of urokinase required (5.82 ± 0.81 million units vs 1.80 ± 0.64 million units; P < .001), the detumescence rate at 24 hours postoperatively (48.46% ± 8.62% vs 76.79% ± 7.98%; P = .026), the descent velocity of D-dimer per day (2266.28 ± 1358.26 μg/L/D vs 3842.34 ± 2048.02 μg/L/D; P = .018), total hospitalization stay (6.2 ± 1.40 days vs 3.8 ± 0.70 days; P = .024), number of postoperative angiograms (2.4 ± 0.80 vs 1.2 ± 0.30; P = .042), and grade III venous patency (>95% lysis: 54.5% vs 68.6%; P = .047). Furthermore, during the follow-up period, significant differences were found in the incidence of PTS (Villalta scale ≥5 or a venous ulcer: 47.0% vs 27.7%; P = .037), and the incidence proportion of moderate to severe PTS at 12 months (15.7% vs 4.5%; P = .024) and 24 months (35.3% vs 11.4%; P = .016). ConclusionsCompared with CDT alone, in the iliofemoral DVT subgroup with a symptom duration of ≤7 days, PCDT plus CDT could significantly relieve early leg symptoms, shorten the hospitalization stay, reduce bleeding complications, promote long-term venous patency, and decrease the occurrence of PTS and the incidence proportion of moderate to severe PTS. Thus, the short- and long-term outcomes both support the superiority of PCDT plus CDT vs CDT in this subgroup.

Delphi Consensus on Reporting Standards in Clinical Studies for Endovascular Treatment of Acute Iliofemoral Venous Thrombosis and Chronic Iliofemoral Venous Obstruction.

Acute iliofemoral deep vein thrombosis and chronic iliofemoral venous obstruction cause substantial patient harm and are increasingly managed with endovascular venous interventions, including percutaneous mechanical thrombectomy and stent placement. However, studies of these treatment elements have not been designed and reported with sufficient rigor to support confident conclusions about their clinical utility. In this project, the Trustworthy consensus-based statement approach was utilized to develop, via a structured process, consensus-based statements to guide future investigators of venous interventions. Thirty statements were drafted to encompass major topics relevant to venous study description and design, safety outcome assessment, efficacy outcome assessment, and topics specific to evaluating percutaneous venous thrombectomy and stent placement. Using modified Delphi techniques for consensus achievement, a panel of physician experts in vascular disease voted on the statements and succeeded in reaching the predefined threshold of >80% consensus (agreement or strong agreement) on all 30 statements. It is hoped that the guidance from these statements will improve standardization, objectivity, and patient-centered relevance in the reporting of clinical outcomes of endovascular interventions for acute iliofemoral deep venous thrombosis and chronic iliofemoral venous obstruction in clinical studies and thereby enhance venous patient care.

RETRACTED: Australian and New Zealand Society for Vascular Surgery clinical practice guidelines on venous outflow Obstruction of the femoral-iliocaval veins

BackgroundThe overall goal of this report is to provide a high-level, practical approach to managing venous outflow obstruction (VOO) in Australia and New Zealand. MethodsA group of vascular surgeons from the Australian and New Zealand Society for Vascular Surgery with specific interest, training, and experience in the management of VOO were surveyed to assess current local practice. The results were analyzed and areas of disagreement identified. Following this, the group performed a literature review of consensus guidelines published by leading international organizations focused on the management of chronic venous disease, namely the Society for Vascular Surgery, American Venous Forum, European Society for Vascular Surgery, American Vein and Lymphatic Society, Cardiovascular and Interventional Radiology Society of Europe, and American Heart Association. These guidelines were compared against the consensus statements obtained through the surveys to determine how they relate to Australian and New Zealand practice. In addition, selected key studies, reviews, and meta-analyses on venous stenting were discussed and added to the document. Finally, a selection of statements with >75% agreement was voted on, and barriers to the guideline's applicability were identified. ResultsThe document addresses two key areas: patient selection and technical aspects of venous stenting. Regarding patient selection, patients with a CEAP (Clinical-Etiologic-Anatomic-Physiologic) score of ≥3 or a venous clinical severity score for pain of ≥2, or both, and evidence of >50% stenosis on venography, computed tomography venography, magnetic resonance venography, and/or intravascular ultrasound should be considered for venous stenting (level of recommendation Ib) Patients undergoing thrombus removal for acute iliofemoral deep vein thrombosis, in whom a culprit stenotic lesion has been uncovered, should be considered for venous stenting (level of recommendation Ib). Patients with chronic pelvic pain, deep dyspareunia, postcoital pain affecting their quality of life, when other causes have been ruled out, should be considered for venous stenting (level of recommendation Ic). Asymptomatic patients should not be offered venous stenting (level of recommendation IIIc). ConclusionsPatients with deep VOO have been underdiagnosed and undertreated for decades; however, in recent years, interest from physicians and industry has grown substantially. The advent of simpler and safer treatment options has revolutionized its management, but, unfortunately, formal training for venous disease has not grown at the same rate. Simplifying the technology and training required can result in inconsistent outcomes. These guidelines are aimed at developing standards of care and will serve as an educational platform for future developments.

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.

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..

Evolution of deep vein thrombosis treatment from leeches to mechanical thrombectomy.

Deep vein thrombosis (DVT) is one of the most common diseases in developed countries with significant socioeconomic consequences. The severity of DVT lies in the potential for life-threatening pulmonary embolism and the development of chronic venous insufficiency, referred to as post-thrombotic syndrome. Virchow contributed to the understanding of the pathophysiological events that lead to thrombosis by describing three basic risk mechanisms. The first therapeutic attempts in the 17th century included venepuncture and the application of leeches. The first anticoagulant drug was heparin, which entered clinical practice after 1935. Subsequent commercialization of oral vitamin K antagonists (warfarin) and the advent of low molecular weight heparin along with compression therapy allowed the expansion of outpatient treatment of DVT. Recently, new oral anticoagulants have been introduced, leading to improved safety due to lower risk of bleeding complications and simplification of the treatment process. The next step in the development of therapeutic options are invasive methods of early thrombus removal, which significantly shorten the process and aim to reduce the occurrence of late complications. These methods include local catheter-directed thrombolysis using tissue plasminogen activator, mechanical thrombectomy and their combination called pharmaco-mechanical thrombectomy. The latter is currently used in patients with acute ilio-femoral DVT.

Endovascular Management of Acute Iliofemoral Deep Vein Thrombosis.

Lower extremity deep vein thrombosis (DVT) is frequently encountered in clinical practice. Postthrombotic syndrome (PTS) is a common sequela of DVT and encompasses a wide variety of symptoms, including severe pain, edema, and ulceration, all of which may contribute to a negative impact on quality of life. Studies have demonstrated that acute thrombosis of the iliofemoral venous segment is correlated with high rates of PTS, increased severity of symptoms, and high rates of thrombus recurrence, despite patients receiving treatment with standard-of-care anticoagulation therapy. Endovascular interventions, including catheter-directed thrombolysis, pharmacomechanical thrombectomy, and mechanical thrombectomy, have generated significant interest as a method for reduction of short-term symptom severity and potential reduction of downstream PTS severity. While there is high-quality evidence evaluating the role of catheter-directed and pharmacomechanical thrombectomy for acute iliofemoral DVT, newer mechanical-only devices that utilize thrombectomy without fibrinolytic medication are less studied. Currently, there are limited data evaluating the efficacy and safety of these treatment modalities, although investigations are ongoing.

Predictors of Clinical Outcomes of Pharmacomechanical Catheter-Directed Thrombolysis for Acute Iliofemoral Deep Vein Thrombosis: Analysis of a Multicenter Randomized Trial

PurposeTo identify the baseline patient characteristics that predict who will benefit from pharmacomechanical catheter-directed thrombolysis (PCDT) of acute iliofemoral deep vein thrombosis (DVT). Materials and MethodsIn the Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis (ATTRACT) multicenter randomized trial, 381 patients with acute iliofemoral DVT underwent PCDT and anticoagulation or anticoagulation alone. The correlations between baseline factors and venous clinical outcomes were evaluated over 24 months using post hoc regression analyses. Interaction terms were examined to evaluate for differential effects by treatment arm. ResultsPatients with clinically severe DVT (higher baseline Villalta score) experienced greater effects of PCDT in improving 24-month venous outcomes, including moderate or severe postthrombotic syndrome (PTS) (odds ratios [ORs] and 95% confidence intervals [CIs] per unit increase in the baseline Villalta scores were as follows: for PCDT, OR, 1.08 [95% CI, 1.01–1.15]; for control, OR, 1.20 [95% CI, 1.12–1.29]; Pinteraction = .03), PTS severity (between-arm differences in the Villalta [Pinteraction = .004] and Venous Clinical Severity Scale [VCSS] [Pinteraction = .002)] scores), and quality of life (between-arm difference in the Venous Insufficiency Epidemiological and Economic Study Quality of Life score; Pinteraction = .025). Patients with previous DVT had greater effects of PCDT on 24-month PTS severity than those in patients without previous DVT (mean [95% CI] between-arm difference in the Villalta score, 4.2 [1.56–6.84] vs 0.9 [−0.44 to 2.26], Pinteraction = .03; mean [95% CI] between-arm difference in the VCSS score, 2.6 [0.94–4.21] vs 0.3 [−0.58 to 1.14], Pinteraction = .02). The effects of PCDT on some but not all outcomes were greater in patients presenting with left-sided DVT (Villalta PTS severity, Pinteraction = .04; venous ulcer, Pinteraction = .0499) or a noncompressible popliteal vein (PTS, Pinteraction = .02). The effects of PCDT did not vary by sex, race, ethnicity, body mass index, symptom duration, hypertension, diabetes, or hypercholesterolemia. ConclusionsIn patients with acute iliofemoral DVT, greater presenting clinical severity (higher baseline Villalta score) and a history of previous DVT predict enhanced benefits from PCDT.

Impact of concomitant popliteal vein thrombosis in patients with acute iliofemoral deep vein thrombosis treated with endovascular early thrombus removal.

Background: Catheter-based thrombus removal (CBTR) reduces the risk of moderate to severe post-thrombotic syndrome (PTS) in patients with acute iliofemoral deep vein thrombosis (IF-DVT). However, the impact of concomitant popliteal DVT on clinical and duplex sonographic outcomes is unknown. Patients and methods: In this post-hoc analysis including the entire cohort of the randomized controlled BERNUTIFUL trial (48 patients), we compared clinical (incidence/severity of PTS assessed by Villalta score and revised venous clinical severity scores, rVCSS), disease-specific quality-of-life (QOL, CIVIQ-20 survey) and duplex sonographic outcomes (patency, reflux, post-thrombotic lesions) at 12 months follow-up between patients with IF-DVT with and without concomitant popliteal DVT treated by CBTR. Results: Overall, 48 IF-DVT patients were included (48% men, median age of 50 years), of whom 17 (35%) presented with popliteal DVT. At baseline, patients with popliteal DVT were older, had a higher body mass index and more important leg swelling. At 12 months, freedom from PTS (93% vs 87%, P=0.17), median total Villalta score (1 vs 1.5; P=0.46), rVCSS (2 vs 1.5, P=0.5) and disease-specific QOL (24 points vs 24 points, P=0.72) were similar between patient with and without popliteal DVT, respectively. Duplex sonographic outcomes were similar, except for more frequent popliteal post-thrombotic lesions and reflux (P=0.02) in patients with popliteal DVT. Conclusions: Relevant clinical outcomes 1 year after successful CBTR were favorable, regardless of the presence or absence of concomitant popliteal DVT. However, post-thrombotic popliteal vein lesions and reflux are more frequent in IF-DVT patients with popliteal involvement. Their impact on long-term outcomes remains to be investigated.

Acute left iliofemoral vein thrombosis: Comparison between simple and bony May-Thurner syndrome in CT venography.

To explore the etiology of May-Thurner syndrome (MTS) with acute iliofemoral deep vein thrombosis (DVT) regarding imaging findings and clinical features. We retrospectively analyzed 57 patients with acute left iliofemoral DVT from 2015 to 2020. The diameter of left common iliac vein (LCIV) at the maximal compression site and its percent compression regarding the average diameter of the uncompressed iliac vein were recorded in central and distal portions of the LCIV according to the location in the quadrant of lumbar vertebral body. Compression was categorized into simple and bony MTS; Simple MTS as LCIV compressed by the right common iliac artery (RCIA) versus Bony MTS as LCIV by lower lumbar degenerative changes regardless of RCIA compression. Initial computed tomographic venography (CTV) regarding chronic change of LCIV such as fibrotic atrophy or cordlike obliteration, extent of thrombus, and lumbar degenerative changes were evaluated. Therapeutic effect after initial therapy was assessed in follow-up CTVs after 3-6months. All patients showed LCIV compression with 19 simple MTS (mean age, 42.8 ± 14.1years [23-67years]; 12 females; symptom for 4.4 ± 5.5days) and 38 bony MTS (mean age, 73.0 ± 10.2years [49-85years]; 26 females; symptom for 5.5 ± 4.8days). There was significant difference in age (p < .001) and no significant difference in sex or symptom duration between two groups (p = .691 and 0.415, respectively). All simple MTS showed compression only in the central LCIV and half of bony MTS showed compression in both central and distal LCIV (p < .001). Among the lumbar degenerative changes, symmetric anterolateral osteophyte (p < .001) and asymmetric osteophyte (p < .001) were significantly associated with bony MTS, but not scoliosis (p = .799), compared to simple MTS. Although there was no significant difference in chronic change of LCIV, thrombosis extent, and therapeutic effect between two groups (p > .05), chronic change of LCIV showed significant difference between single and dual compression (23.7% vs. 57.9%, p = .024) and residual thrombus after initial therapy was occurred in 21.1% of single compression and 47.4% in dual compression with non-significant trend (p = .082). Bony MTS related to lumbar degenerative changes with acute iliofemoral DVT occurs in older patients, presenting more than one stenosis at LCIV, inducing more chronic change with possibly weaker therapeutic effect than simple MTS.

The Effect of Balloon-Assisted Pharmacomechanical Catheter-Directed Thrombolysis on the Patency and Post-Thrombotic Syndrome in Patients with Acute Iliofemoral Deep Vein Thrombosis: Is it Really Necessary or Not?

The objective of this study was to describe the contribution and advantage of balloon-dilatation of iliac and femoral veins following pharmacomechanical catheter-directed thrombolysis (PCDT) on the development of post-thrombotic syndrome (PTS). From October 2018 and January 2022, 85 patients with acute total occlusion of the iliac and femoral veins were treated with PCDT. The cohort was divided into 2 groups depending on the utilization of concomitant balloon dilatation of iliac and femoral veins (Group 1, n=34, 40.0%) or not (Group 2, n=51, 60.0%) during the PCDT. All patients underwent duplex ultrasound scanning for evaluating the patency of iliac veins and recanalization rates at 3, 6, and 12months postoperatively. The Villalta score was used to score the severity of PTS at 12months postoperatively. Patients who underwent balloon-assisted PCDT (group 1) exhibited significantly higher primary patency rates in common iliac vein (CIV) (recanalization 84.3±14.6%, P=0.003), external iliac vein (EIV) (recanalization 82.8±17.2, P=0.003) and common femoral vein (CFV) (recanalization 88.1±12.1%, P=0.038) compared with the group 2 at the end of 12months follow-up. Only 2 patients underwent venous stenting in follow-up due to severe venous claudication, however, 13 patients were required iliac vein stenting due to severe PTS proved with a high Villalta score at 12-month follow-up. The d-dimer level at 1-year follow-up had also significantly lower in Group 1 due to higher rates of patency and lower thrombosis burden. The most common bleeding events were hematuria (n=4) or oozing in the puncture site (n=4). This study showed that balloon-assisted PCDT reduces the risk of PTS, is more successful in common iliac vein recanalization, reduces the need for the venous stent, and even lowers the D-dimer levels of the patients compared to routine PCDT alone.

Outcomes from a tertiary care center using a catheter thrombectomy system for managing acute iliofemoral deep vein thrombosis

ObjectiveThe aim of the present study was to report a large, single-center experience using the ClotTriever thrombectomy system (Inari Medical, Irvine, CA) for the management of acute iliofemoral (IF) deep vein thrombosis (DVT). One limitation of all endovascular devices for the treatment of acute IF-DVT has been the inability to completely remove all acute thrombus and the need for adjunctive thrombolysis with its attendant risk of bleeding complications. MethodsA single-center retrospective review of consecutive patients with acute IF-DVT treated with the ClotTriever thrombectomy system (Inari Medical) is reported. Procedural efficacy was evaluated by an independent core imaging laboratory (Syntactx, New York, NY). Both procedural and in-hospital safety were assessed during the index hospitalization. The treated vein patency was assessed using duplex ultrasound at 30 days after the procedure. ResultsA total of 96 patients were included in the present retrospective review, 40 of whom (40%) had contraindications to thrombolytic therapy. In terms of efficacy, 93 patients (97%) had ≥75% thrombus removal. During the index hospitalization, two patients (2%) had experienced a symptomatic pulmonary embolus. However, no mortality, major bleeding, or device-related complications had occurred in the study population. Of the 96 patients, 64 had undergone duplex ultrasound at 30 days after the procedure. Of the 64 patients, 62 had normal flow (97%), 53 (83%) had normal compressibility, and 11 (17%) had partial compressibility. ConclusionsThe ClotTriever thrombectomy catheter was both safe and effective in our cohort of patients with acute IF-DVT outside a randomized clinical trial.

Combined pharmacomechanical thrombectomy with selective catheter-directed thrombolysis in patients with acute proximal deep vein thrombosis.

Background The aim of this study was to evaluate the characteristics and the outcomes of combined percutaneous pharmacomechanical thrombectomy with selective catheter-directed thrombolysis for acute iliofemoral deep vein thrombosis. Methods Between March 2018 and February 2020, a total of 37 patients (21 males, 16 females; mean age: 55±13.8 years; range, 21 to 79 years) with symptomatic acute iliofemoral vein thrombosis who underwent combined percutaneous pharmacomechanical thrombectomy and catheter-directed thrombolysis were retrospectively analyzed. All patients received a three-step therapy: (i) insertion of a temporary inferior vena cava filter, (ii) percutaneous pharmacomechanical thrombectomy via rotational mechanical thrombectomy device with an adjuvant 0.15 mg/kg recombinant tissue-type plasminogen activator alteplase, and (iii) catheter-directed thrombolysis with continuous 1 mg/h tissue-type plasminogen activator alteplase. Data including demographic characteristics of the patients, bleeding complications, technical success, and adjuvant angioplasty rates were analyzed. The Kaplan-Meier analysis was used to evaluate freedom from re-thrombosis at 3, 6, and 12 months of follow-up was calculated. Results The majority of the patients had left-sided (n=22, 59.4%) proximal deep vein thrombosis. Successful insertion of the inferior vena cava filter was achieved in 97.2% (n=36) of patients. The technical success rate was 89.1% (n=33). Adjuvant venous angioplasty was performed in four patients (10.8%) and no venous stents were used. No major bleeding was occurred, while minor bleeding was observed mostly in the form of hematuria (n=12, 32.4%). No mortality was observed. The 3, 6, and 12-month freedom from re-thrombosis rates were 96.3%, 92.6%, and 86.0%, respectively. Conclusion Combined percutaneous pharmacomechanical thrombectomy and catheter-directed thrombolysis seems to be an effective and safe treatment of the iliofemoral acute deep vein thrombosis with acceptable minor bleeding complications post-interventionally.