Venous recanalisation in the setting of post-thrombotic syndrome: An expert consensus from the French Society of Vascular Medicine (SFMV) and the French Society of Cardiovascular Imaging and Interventional Radiology (SFICV).

Several aspects of the management of post-thrombotic syndrome (PTS) are still a matter of debate, or not yet addressed in international guidelines. The objective of this expert consensus from the French Society of Vascular Medicine (SFMV) and the French Society of Cardiovascular Imaging (SFICV) was to define the main elements of diagnosis and treatment of this syndrome, and to develop a proposal for its preoperative, procedural and follow-up management. In this consensus, the following issues were addressed: clinical and ultrasound diagnosis; pre-procedural workup; indications and contraindications to venous recanalisation; procedures; clinical and duplex ultrasound reports; follow-up; long-term treatment; management of great saphenous vein incompetency; anticoagulant and antiplatelet therapy after venous stenting.

Interventional Treatment of Pediatric Venous Thromboembolic Disease.

This review explores the clinical presentation of lower extremity DVT and pulmonary embolism (PE), treatment strategies, and outcomes for venous thromboembolism (VTE) in the pediatric population. Traditional therapy for pediatric VTE was anticoagulation alone with thrombolysis and surgery reserved only in life or limb-threatening cases. Catheter-directed thrombolysis (CDT), pharmacomechanical thrombectomy (PMT) and mechanical thrombectomy (MT) have emerged as effective and safe treatment options for VTE management. Although most data are from adult studies, early pediatric studies suggest that these interventional procedures can be effective in children. The significant clinical impact of post-thrombotic syndrome (PTS) is also discussed, as PTS can lead to lifelong physical symptoms and psychosocial damage.

Percutaneous transluminal angioplasty of femoropopliteal veins for treatment of post-thrombotic syndrome.

Background: Controversy persists concerning the endovascular treatment of the post-thrombotic syndrome (PTS), particularly if femoropopliteal veins are involved. Methods: We screened consecutive patients with PTS who underwent percutaneous transluminal angioplasty (PTA) of femoropopliteal veins using posterior tibial or popliteal vein access who had at least 3-month follow-up. Our assessment included the evaluation of primary and secondary patency of the treated segments by Doppler ultrasound (DUS) and clinical outcomes measured by the change in Villalta score as well as ulcer healing. Results: Among 29 patients, 8 (27.7%) were women and the mean (SD) age was 53.3 (13.6) years. Posterior tibial vein and popliteal access were used in 26 (89.7%) and 3 patients (10.3%), respectively. 13 (44.8%) patients had prior (n = 11, 37.9%) or concomitant (n = 9, 31.0%) endovascular treatment of the iliac or common femoral veins. At a median follow-up of 395 days (Q1: 205-Q3: 756 days), primary patency of femoropopliteal veins was 79.3% (95% CI 64.6-94.1%) and secondary patency was 82.8% (95% CI, 69.0-96.5%). The percentage of patients with moderate or severe PTS according to the Villalta score decreased from baseline to last follow-up from 34.5% to 18.5% and from 31% to 14.8%, respectively (p<0.003). Overall, the mean (SD) Villalta score decreased from 11.5 (1.7) to 8.0 (1.7) (p<0.0001). Postprocedural complete ulcer healing occurred in 4 out of 5 (80%) patients. Two (6.9%) patients developed new ulcers. No major bleeding, pulmonary embolism, stroke, or death occurred. Conclusion: PTA of femoropopliteal veins via posterior tibial or popliteal vein access appears to improve the severity of PTS with acceptable patency rates.

Interventional treatment for post-thrombotic chronic venous obstruction: Progress and challenges.

Chronic venous obstruction, including nonthrombotic iliac vein lesions and post-thrombotic syndrome, presents a significant burden on patients' quality of life and health care systems. Venous recanalization and stenting have emerged as promising minimally invasive approaches, yet challenges in patient selection, procedural techniques, and long-term outcomes persist. This review synthesizes current knowledge on the interventional treatment of post-thrombotic syndrome, focusing on the evolution of endovascular techniques and stenting. Patient selection criteria, procedural details, and the characteristics of dedicated venous stents are discussed. Particular emphasis is given to the role of inflow and other anatomical considerations, along with postoperative management protocols for an optimal long-term outcome.

Addressing the Impact of Deep Venous Stenting on the Management of Venous Ulcer.

BACKGROUND: Venous ulcers are a late and severe form of chronic venous insufficiency and account for 70% of all etiologies that cause leg ulcers in the lower limb, and they account for 20% of the 2.5 million cases complaining of chronic venous disease. Our study aims to investigate the effect of venous stenting of the deep veins on the healing of the venous ulcer. METHODS: This is a single-center, retrospective study conducted on prospectively recorded medical records of 78 patients with chronic deep venous diseases-C6 (either nonocclusive iliac venous lesion or post-thrombotic syndrome). Our lesion involved May-Thurner lesions, occlusions, insufficiencies, or stenoses owing to an affection of the venous outflow segment. All our patients underwent endovascular management, and those who did not respond successfully were transitioned to compression therapy. We then compared the outcomes of both groups in terms of ulcer healing and quality of life. RESULTS: A total of 78 patients (78 limbs), with a mean age of 39.6 ± 8.06 (range: 22-60) years, were treated. Fifty-four patients (67.9%) were males, and 24 (32.1%) were female. The etiology was primary nonocclusive iliac venous lesion in 12 limbs (16.2%) and secondary post-thrombotic obstructions in 66 (83.7%). Follow-up of the ulcer with compliance to compression therapy and standard care of the ulcer, sustained ulcer healing (reduction in ulcer area) was achieved in 60% of limbs, and most of the nonocclusive healing occurred within the first 3 months (P < 0.01). CONCLUSIONS: Our results show that deep venous stenting is associated with high wound healing rates. This rate reaches a statistically significant difference in 3 months, but this difference doesn't reach statistical significance at 6 months, with less recurrence and improved quality of life with a high cumulative patency rate, and compression therapy is the mainstay of the conservative management of venous ulceration.

Final 3-Year Study Outcomes from the Evaluation of the Zilver Vena Venous Stent for the Treatment of Symptomatic Iliofemoral Venous Outflow Obstruction (The VIVO Clinical Study).

PURPOSE: To report 3-year outcomes from a prospective, multicenter, nonrandomized, single-arm study designed to assess the safety and effectiveness of the Zilver Vena Venous Stent for the treatment of symptomatic iliofemoral venous outflow obstruction. MATERIALS AND METHODS: The VIVO study included patients with symptomatic obstruction of 1 iliofemoral venous segment (ie, 1 limb), characterized by a Clinical, Etiological, Anatomic, Pathophysiology (CEAP) clinical classification of ≥3 or a Venous Clinical Severity Score (VCSS) for pain of ≥2. Patients were retrospectively grouped based on baseline clinical presentation as postthrombotic syndrome (PTS), nonthrombotic iliac vein (NIVL) obstruction, or acute deep vein thrombosis (aDVT). Clinical improvement was assessed by change in VCSS, Venous Disability Score, Chronic Venous Disease Quality of Life Questionnaire (CIVIQ-20) scores, and CEAP C classification. Stent performance was evaluated by rates of patency by ultrasound (US), freedom from clinically driven reintervention, and freedom from stent fracture. RESULTS: The 3-year results for the 243 patients in the VIVO cohort included a 90.3% rate of patency by US and a 92.6% rate of freedom from clinically driven reintervention. The 3-year rates of patency by US for the NIVL, aDVT, and PTS groups were 100%, 84.0%, and 86.1%, respectively. Sustained clinical improvement through 3 years was demonstrated by changes in VCSS, Venous Disability Score, CIVIQ-20, and CEAP C classification. No stent fractures were observed. CONCLUSIONS: The VIVO study demonstrated sustained high rates of patency and freedom from clinically driven reintervention and improvements in venous clinical symptoms through 3 years. Each patient group (NIVL, aDVT, and PTS) showed clinical improvement and sustained patency through 3 years; some variation existed among groups (eg, only the NIVL group had a 100% patency rate).

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

OBJECTIVE: Interventional 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. METHODS: The 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. RESULTS: The 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. CONCLUSIONS: The 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.

The role and principles of stenting in acute iliofemoral venous thrombosis.

Catheter-directed interventions for acute iliofemoral deep venous thrombosis (DVT) have been increasingly used over the past 15 years to target severe symptomatology and prevention of post-thrombotic syndrome incidence or reduce its severity if it were to develop. Aside from successful thrombus removal, adjunctive stents are frequently required to treat an uncovered lesion or significant residual thrombus to ensure quality of life improvement besides retarding DVT recurrence and post-thrombotic syndrome. As the evidence is mounting, the need and role for stenting, as well as the principles of an optimal technique, in the acute DVT setting are now better understood. Accumulating experience appears to favor stenting in the acute setting. The diameter of the stent, the length, the extent of overlapping, and the landing zones are crucial determinants of a successful durable outcome. This article endeavors to guide the interventionalist on stenting when encountering a patient with acute symptomatic iliofemoral DVT with concerns of quality of life impairment.

Three-Year Outcomes of the Abre Venous Self-Expanding Stent System in Patients with Symptomatic Iliofemoral Venous Outflow Obstruction.

PURPOSE: To report 36-month outcomes and subgroup analysis of the ABRE study evaluating the safety and effectiveness of the Abre venous self-expanding stent system for the treatment of symptomatic iliofemoral venous outflow obstruction disease. METHODS: The ABRE study was a prospective, multicenter, nonrandomized study that enrolled and implanted Abre venous stents in 200 participants (mean age 51.5 years [SD ± 15.9], 66.5% women) with symptomatic iliofemoral venous outflow obstruction at 24 global sites. Outcomes assessed through 36 months included patency, major adverse events, stent migration, stent fracture, and quality-of-life changes. Adverse events and imaging studies were adjudicated by independent clinical events committee and core laboratories, respectively. RESULTS: Primary, primary-assisted, and secondary patency through 36 months by Kaplan-Meier estimates were 81.6%, 84.8%, and 86.3%, respectively. The cumulative incidence of major adverse events through 36 months was 10.2%, mainly driven by 12 thrombosis events. Subgroup analyses demonstrated a primary patency of 76.5% in the acute deep vein thrombosis group, 70.4% in the postthrombotic syndrome group, and 97.1% in the nonthrombotic iliac vein lesion group through 36 months. The overall mean lesion length was 112.4 mm (SD ± 66.1). There were no stent fractures or migrations in this study. Quality of life and venous functional assessments demonstrated significant improvements from baseline to 36 months across all patient subsets. CONCLUSIONS: Results from the ABRE study demonstrated sustained patency with a good safety profile after implantation of a dedicated venous stent in patients with symptomatic iliofemoral venous outflow obstruction disease.

Comparison of anticoagulation vs mechanical thrombectomy for the treatment of iliofemoral deep vein thrombosis.

OBJECTIVE: To compare the comparative effects of treatment with contemporary mechanical thrombectomy (MT) or anticoagulation (AC) on Villalta scores and post-thrombotic syndrome (PTS) incidence through 12 months in iliofemoral deep vein thrombosis (DVT). METHODS: Patients with DVT in the Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis (ATTRACT) randomized trial and the ClotTriever Outcomes (CLOUT) registry were included in this analysis. Both studies evaluated the effects of thrombus removal on the incidence of PTS. Patients with bilateral DVT, isolated femoral-popliteal DVT, symptom duration of >4 weeks, or incomplete case data for matching covariates were excluded. Propensity scores were used to match patients 1:1 who received AC (from ATTRACT) with those treated with mechanical thrombectomy (from CLOUT) using nearest neighbor matching on nine baseline covariates, including age, body mass index, leg treated, provoked DVT, prior venous thromboembolism, race, sex, Villalta score, and symptom duration. Clinical outcomes, including Villalta score and PTS, were assessed. Logistic regression was used to estimate the likelihood of developing PTS at 12 months. RESULTS: A total of 164 pairs were matched, with no significant differences in baseline characteristics after matching. There were fewer patients with any PTS at 6 months (19% vs 46%; P < .001) and 12 months (17% vs 38%; P < .001) in the MT treatment group. Modeling revealed that, after adjusting for baseline Villalta scores, patients treated with AC had significantly higher odds of developing any PTS (odds ratio, 3.1; 95% confidence interval, 1.5-6.2; P = .002) or moderate to severe PTS (odds ratio, 3.1; 95% confidence interval, 1.1-8.4; P = .027) at 12 months compared with those treated with MT. Mean Villalta scores were lower through 12 months among those receiving MT vs AC (3.3 vs 6.3 at 30 days, 2.5 vs 5.5 at 6 months, and 2.6 vs 4.9 at 12 months; P < .001 for all). CONCLUSIONS: MT treatment of iliofemoral DVT was associated with significantly lower Villalta scores and a lower incidence of PTS through 12 months compared with treatment using AC. Results from currently enrolling clinical trials will further clarify the role of these therapies in the prevention of PTS after an acute DVT event.

Randomized controlled trials of interventions for acute iliofemoral deep venous thrombosis.

Venous thromboembolism (VTE), notably deep venous thrombosis (DVT), represents a significant cardiovascular disease with high morbidity from post-thrombotic syndrome (PTS). Recent advancements in early thrombus removal technologies have prompted randomized controlled trials (RCT) to assess their efficacy and safety, particularly for iliofemoral DVT (IF-DVT), which carries the greatest risk of developing PTS. This narrative review summarizes these trials and introduces upcoming innovations to evaluate acute intervention for IF-DVT. Specific technologies discussed include catheter-directed thrombolysis, pharmacomechanical catheter-directed thrombolysis, ultrasound-accelerated catheter-directed thrombolysis, and non-lytic mechanical thrombectomy. This review underscores the importance of patient selection, with those presenting with extensive, symptomatic IF-DVT likely to benefit most.

Principles of Optimal Antithrombotic Therapy for Iliac VEnous Stenting (POATIVES): A national expert-based Delphi consensus study.

OBJECTIVE: Management of antithrombotic therapy in patients undergoing venous stents has not yet reached consensus, and there are not any recommendations from published guidelines. We undertook a Delphi consensus from Chinese experts to develop recommendations regarding the preferred antithrombotic therapy in patients following venous stenting. METHODS: The phase 1 questionnaire was comprised of three clinical scenarios of venous stenting for non-thrombotic iliac vein lesions (NIVL), acute deep vein thrombosis (DVT), and post-thrombotic syndrome (PTS) and was sent to venous practitioners across China. In phase 2, the results of phase 1 were distributed to a panel of experts for evaluation along with a questionnaire encompassing a series of statements produced during phase 1. A modified Delphi method was used to reach consensus on recommendations through two rounds of surveys. RESULTS: The phase 1 questionnaire was completed by 283 respondents. In phase 2, an expert panel consisting of 28 vascular surgeons and interventional radiologists was assembled and voted 17 statements relating to antithrombotic management after venous stenting for NIVL (4 statements), DVT (6 statements), and PTS (7 statements). The majority of the statements about the antithrombotic agent selection received a high consensus strength. CONCLUSIONS: Based on the national Delphi consensus of Chinese experts regarding antithrombotic therapy following iliac venous stenting in three common scenarios, most of the statements could be used to guide antithrombotic management following venous stenting. Further studies are required to clarify controversial issues including the dose and duration of anticoagulants, the role of antiplatelet agents, especially in patients with NIVL.

Ilio-femoral venous stenting for post-thrombotic syndrome in women of childbearing age: efficacy and impact of pregnancy-a multi-center study by the French Society of Cardiovascular Imaging.

OBJECTIVE: We investigated the efficacy of iliofemoral venous stenting in women of childbearing age treated for post-thrombotic syndrome (PTS) and assessed the influence of pregnancy on stent occlusion. METHODS: A retrospective analysis was conducted on women of childbearing age who underwent endovascular stenting for PTS due to chronic iliocava occlusion across 15 centers from 2009 to 2020. The study assessed pregnancy rates, primary patency rates, secondary patency rates, and clinical efficacy using the Villalta score for PTS severity and the Chronic Venous Disease Quality of Life Questionnaire - version 20 (CIVIQ-20), 6-12 months after the procedure. The impact of pregnancy on stent occlusion was analyzed using classical and multi-state survival analyses. Prophylactic low-molecular-weight heparin or fondaparinux was administered to patients during pregnancy until 6 weeks post-partum. RESULTS: In total, 211 women with PTS underwent endovascular stenting, with a median age of 31 years (range: 16-42). Following recanalization, significant improvements were observed in the Villalta score (p < 0.0001) and the CIVIQ-20 score (p < 0.0001). Thirty-seven (17.6%) women became pregnant and 49 (23.2%) experienced stent occlusions. The 1-year and 5-year occlusion-free survival probabilities were 80.6% (95% confidence interval [CI]: 75.1-86.4%) and 66.6% (95% CI: 57.4-77.4%), respectively. There was no significant association between pregnancy and stent occlusion-free survival (hazard ratio = 1.00 [95% CI: 0.11-8.92], p = 0.9930). CONCLUSION: Iliofemoral venous stenting in women of childbearing age was an effective treatment for post-thrombotic syndrome, and it did not increase the risk for stent occlusion during pregnancy when accompanied by appropriate anticoagulation. CLINICAL RELEVANCE STATEMENT: This study demonstrates that pregnancy following iliofemoral venous stenting for post-thrombotic syndrome does not elevate the risk for stent occlusion. KEY POINTS: • The severity of post-thrombotic syndrome and the quality of life, as measured using the Villalta score and Chronic Venous Disease Quality of Life Questionnaire - version 20, respectively, showed significant improvements 6-12 months after iliofemoral venous stenting. • The occurrence of pregnancy after recanalization in women of childbearing age did not lead to a significant increase in the risk for stent occlusion.

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

OBJECTIVE: The 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. METHODS: We 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. RESULTS: A 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). CONCLUSIONS: Compared 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.

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

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

Long Term Follow Up, Causes for Re-intervention, and Consequences for Surveillance After Stenting for Proximal Deep Vein Obstruction.

OBJECTIVE: Venous stenting is performed increasingly for acute deep vein thrombosis (DVT) and post-thrombotic syndrome (PTS) with good short term patency results, but long term data are scarce. The purpose of this study was to evaluate long term outcome of stenting for acute DVT and PTS and to study causes of re-intervention. METHODS: All patients stented for acute DVT and PTS between May 2006 and November 2021 were included retrospectively in this single centre cohort study. Patency was studied by duplex ultrasound (DUS) or computed tomography. The primary endpoint was stent patency. Re-intervention free survival was calculated using Kaplan-Meier methods. Secondary endpoints were causes of re-intervention, using the Pouncey classification system (2022). Binary logistic regression was used to calculate odds ratios for predictors of re-intervention. RESULTS: A total of 114 patients were included, with 129 limbs involved (acute DVT n = 53; 41%), PTS n = 76; 59%). Median follow up was 2.3 years (interquartile range [IQR] 2.3) for acute DVT and 5.2 years (IQR 7.1) for PTS. Primary patency, secondary patency, and permanent occlusion were 73.5%, 98.1%, and 1.9% for acute DVT, and 63.2%, 92.1%, and 7.9% for PTS limbs. Overall, 41 limbs underwent at least one re-intervention: 14 in the acute DVT group and 27 for PTS. Most re-interventions (82.9%) were performed within the first year after stenting. Missed inflow, insufficient flow, and thrombosis despite anticoagulation were the most common causes of re-intervention. The strongest predictor for re-intervention for PTS was inflow disease (odds ratio 3.57, 95% confidence interval 1.26 - 10.13, p= .017). CONCLUSION: Long term patency of deep venous stenting is good. Re-interventions are typically performed in the first year and are potentially preventable by improving the procedure and patient selection. Since secondary patency rates are excellent, selected patients may be considered for discharge from long term surveillance.

Percutaneous mechanical thrombectomy to remove post-thrombotic obstructions and manage post-thrombotic syndrome-associated venous leg ulceration.

BACKGROUND: Up to one half of patients with a diagnosis of deep vein thrombosis will develop post-thrombotic syndrome (PTS). Patients with PTS can develop venous leg ulcers (VLUs) due to post-thrombotic obstructions (PTOs) that contribute to prolonged ambulatory venous hypertension. The current treatments for PTS, which include chronic thrombus, synechiae, trabeculations, and inflow lesions, do not target PTOs, and such obstructions can affect stenting success. The aim of the present study was to determine whether removal of chronic PTOs using percutaneous mechanical thrombectomy would promote VLU resolution and positive outcomes. METHODS: In this retrospective analysis, the characteristics and outcomes for patients with VLUs secondary to chronic PTO who were treated using the ClotTriever System (Inari Medical) between August 2021 and May 2022 were assessed. Technical success was considered the ability to cross a lesion and introduce the thrombectomy device. Clinical success was defined as a decrease of ≥1 in the severity category for the ulcer diameter using the revised venous clinical severity score (score 0, no VLU; score 1, mild VLU [size <2 cm]; score 2, moderate VLU [size 2-6 cm]; score 3, severe VLU [size >6 cm]) at the latest follow-up visit. RESULTS: A total of 11 patients with 15 VLUs on 14 limbs were identified. Their mean age was 59.7 ± 11.8 years, and four patients (36.4%) were women. The median VLU duration was 11.0 months (interquartile range [IQR], 6.0-17.0 months), and 2 patients had VLUs secondary to a deep vein thrombosis event >40 years previously. All treatments were performed in a single session, with technical success achieved in 100% of the 14 limbs. A median of five passes (IQR, four to six passes) with the ClotTriever catheter were performed per limb. Chronic PTOs were successfully extirpated, and intraprocedural intravascular ultrasound showed effective disruption of venous synechiae and trabeculations. Stents were placed in 10 limbs (71.4%). The time to VLU resolution or the latest follow-up was 12.8 ± 10.5 weeks, and clinical success was achieved for all 15 VLUs (100%), with the revised venous clinical severity score for the ulcer diameter improving from a median of 2 (IQR, 2-2) at baseline to a median score of 0 (IQR, 0-0) at last follow-up. The VLU area had decreased by 96.6% ± 8.7%. Of the 15 VLUs, 12 (80.0%) had resolved completely, and 3 had demonstrated near-complete healing. CONCLUSIONS: All patients showed complete or near-complete VLU healing within a few months after mechanical thrombectomy. Mechanical extirpation and interruption of chronic PTOs allowed for luminal gain and restoration of cephalad inflow. With additional investigation, mechanical thrombectomy with the study device could prove a vital component to the treatment of VLUs secondary to PTOs.

Meta-analysis of lytic catheter-based intervention for acute proximal deep vein thrombosis in the reduction of post-thrombotic syndrome.

OBJECTIVE: Post-thrombotic syndrome (PTS) is a common complication of deep vein thrombosis (DVT) that can result in significant morbidity for the patient with detrimental impact on their quality of life. Evidence supporting lytic catheter-based interventions (LCBI) undertaken for early thrombus reduction in acute proximal DVT for the prevention of PTS is conflicting. Despite this, rates of LCBIs are increasing. To summaries the existing evidence and pool treatment effects, a meta-analysis of randomized controlled trials assessing the efficacy of LCBIs in proximal acute DVT for the prevention of PTS was undertaken. METHODS: This meta-analysis was undertaken aligning with PRISMA guidelines following a protocol pre-registered on PROSPERO. Online searches of Medline and Embase databases, as well as the gray literature, were performed up to December 2022. Included articles were randomized controlled trials that studied the use of LCBIs with additional anticoagulation vs anticoagulation alone and had determined follow-up periods. Outcomes of interest were PTS development, moderate to severe PTS, major bleeding episodes, and quality-of-life measures. Subgroup analyses were performed for DVTs involving the iliac vein and/r common femoral vein. Meta-analysis was performed using a fixed effects model. Quality assessment was performed using the Cochrane Risk of Bias and GRADE assessment tools. RESULTS: Three trials were included in the final meta-analysis, the Post-thrombotic Syndrome after Catheter-directed Thrombolysis for Deep Vein Thrombosis (CaVenT), Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis (ATTRACT), and Ultrasound-accelerated Catheter-directed Thrombolysis Versus Anticoagulation for the Prevention of Post-thrombotic Syndrome (CAVA) trials, comprising 987 patients. Patients undergoing LCBIs had a reduced risk of PTS (relative risk [RR], 0.84; 95% confidence interval [CI], 0.74-0.95; P = .006) and a lower risk of developing moderate to severe PTS (RR, 0.75; 95% CI, 0.58-0.97; P = .03). LBCIs increased the risk of having a major bleed (RR, 2.03; 95% CI, 1.08-3.82; P = .03). In the iliofemoral DVT subgroup analysis, there was a trend toward decreasing the risk of developing PTS and moderate to severe PTS (P = .12 and P = .05, respectively). There was no significant difference in quality-of-life score (as measured by the Venous Insufficiency Epidemiological and Economic Study - Quality of Life/Symptoms) between the two groups (P = .51). CONCLUSIONS: Pooling of current best evidence suggests that LCBIs in acute proximal DVT decreases the rate of PTS and moderate to severe PTS with a number needed to treat of 12 and 18, respectively. However, this is complicated by a significantly higher rate of major bleeding with a number needed to treat of 37. This evidence supports the use of LCBIs in selected patients, including those who are at low risk of major bleeding.

Effectiveness and safety of catheter-directed thrombolysis in conjunction with percutaneous mechanical thrombectomy for acute iliofemoral deep vein thrombosis: A meta-analysis.

BACKGROUND: Patients with severe acute low iliofemoral deep vein thrombosis (DVT), such as phlegmasia cerulea dolens, benefit from catheter-directed thrombolysis (CDT). This meta-analysis investigated the effectiveness and safety of adjuvant percutaneous mechanical thrombectomy (PMT) during CDT compared with CDT alone in the treatment of acute iliofemoral DVT. METHODS: A meta-analysis was performed in accordance with the PRISMA guidelines. Medline, Embase, the Cochrane Library, China National Knowledge Internet, and Wanfang data were searched for studies on the management of acute iliofemoral DVT by means of CDT or CDT with adjuvant PMT. Randomized, controlled trials and nonrandomized studies were included. The primary outcomes were venous patency rate, major bleeding complications, and post-thrombotic syndrome occurrence within 2 years of the procedure. The secondary outcomes were thrombolytic time and volume, as well as the rates of thigh detumescence and iliac vein stenting. RESULTS: The meta-analysis included 20 eligible studies with a total of 1686 patients. The rates of venous patency (mean difference, 10.11; 95% confidence interval [CI], 5.59-14.62) and thigh detumescence (mean difference, 3.64; 95% CI, 1.10-6.18) of the adjuvant PMT group were higher than those of the CDT alone group. Compared with CDT alone, the adjuvant PMT group experienced fewer incidences of major bleeding complications (odds ratio, 0.45; 95% CI, 0.26-0.77) and occurrences of post-thrombotic syndrome within 2 years of the procedure (odds ratio, 0.55; 95% CI, 0.33-0.92). Furthermore, the duration of thrombolytic therapy was shorter, and the total dose of administered thrombolytics was lower with adjuvant PMT. CONCLUSIONS: Adjuvant PMT during CDT is associated with improved clinical outcomes and a lower incidence of major bleeding complications. The studies investigated were, however, single-center cohort studies, and future randomized controlled trials are needed to substantiate these findings.