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1.
J Cardiothorac Surg ; 19(1): 423, 2024 Jul 05.
Article in English | MEDLINE | ID: mdl-38970107

ABSTRACT

OBJECTIVE: To compare the treatment outcomes among percutaneous mechanical thrombectomy (PMT) with AngioJet, Catheter-directed thrombolysis (CDT), and a combination of both. METHODS: One hundred forty nine patients with acute or sub-acute iliac-femoral vein thrombosis accepting CDT and/or PMT were divided into three groups respectively: PMT group, CDT group, PMT + CDT group (PMT followed by CDT). The severity of thrombosis was evaluated by venographic scoring system. Technical success was defined as restored patent deep venous blood flow after CDT and/or PMT. Clinical follow-up were assessed by ultrasound or venography imaging. The primary endpoints were recurrence of DVT, and severity level of post-thrombotic syndrome (PTS) during the follow-up. RESULTS: Technical success and immediate clinical improvements were achieved on all patients. The proportion of sub-acute DVT and the venographic scoring in PMT + CDT group were significantly higher than that in CDT group and PMT group (proportion of sub-acute DVT: p = 0.032 and p = 0.005, respectively; venographic scoring: p < 0.001, respectively). The proportion of May-Thurner Syndrome was lower in PMT group than that in CDT and PMT + CDT group (p = 0.026 and p = 0.005, respectively). The proportion of DVT recurrence/stent thrombosis was significantly higher in CDT group than that in PMT + CDT group (p = 0.04). The severity of PTS was the highest in CDT group ( χ2 = 14.459, p = 0.006) compared to PMT group (p = 0.029) and PMT + CDT group (p = 0.006). CONCLUSION: Patients with sub-acute DVT, high SVS scoring and combined May-Thurner Syndrome were recommended to take PMT + CDT treatment and might have lower rate of DVT recurrence/stent thrombosis and severe PTS. Our study provided evidence detailing of PMT + CDT therapy.


Subject(s)
Thrombectomy , Thrombolytic Therapy , Venous Thrombosis , Humans , Male , Venous Thrombosis/therapy , Female , Middle Aged , Thrombolytic Therapy/methods , Thrombectomy/methods , Treatment Outcome , Adult , Retrospective Studies , Aged , Iliac Vein/surgery , Iliac Vein/diagnostic imaging , Combined Modality Therapy , Femoral Vein , Postthrombotic Syndrome , Mechanical Thrombolysis/methods , Phlebography
2.
Thromb Res ; 240: 109057, 2024 Aug.
Article in English | MEDLINE | ID: mdl-38875846

ABSTRACT

BACKGROUND: Post-thrombotic syndrome (PTS) is common in patients with deep vein thrombosis (DVT). It is unclear if different types of anticoagulant therapies (e.g. vitamin K antagonists (VKA), direct oral anticoagulants (DOACs) or low molecular weight heparin (LMWH)) are associated with different risks of PTS. We sought to assess the incidence rates of PTS development following a proximal DVT of the lower extremity managed with different types of anticoagulation regimens. METHODS: A systematic search of MEDLINE, EMBASE and PubMed, from inception to June 2023 was performed. The primary outcome was development of PTS. The secondary outcomes included severe PTS, venous ulcers, and major bleeding. Incidence rates were pooled using the random effects model and expressed as event per 100 patient-years with its associated 95 % confidence intervals (CI) using R software. RESULTS: A total of 21 (4342 patients) articles were included in the analysis. The adjusted pooled incidence of PTS was 15.1 (95 % CI: 8.7 to 26.1), 18.2 (95 % CI: 9.4 to 35.1) and 24.6 (95 % CI: 9.2 to 65.5) per 100 patient-years patients managed with VKA, DOAC and LMWH, respectively. The adjusted pooled incidence of severe PTS was 5.1 (95 % CI: 2.6 to 10.0) and 0.2 (95 % CI: 0.01 to 2.7) per 100 patient-years for VKAs and DOACs, respectively. CONCLUSIONS: The development of PTS is common in patients with proximal lower extremity DVT. The incidence rates of PTS seem to be similar across the different anticoagulation regimens, but severe PTS may be lower among patients receiving a DOAC.


Subject(s)
Anticoagulants , Postthrombotic Syndrome , Venous Thrombosis , Humans , Postthrombotic Syndrome/etiology , Postthrombotic Syndrome/epidemiology , Postthrombotic Syndrome/prevention & control , Anticoagulants/therapeutic use , Anticoagulants/adverse effects , Venous Thrombosis/epidemiology , Venous Thrombosis/drug therapy , Venous Thrombosis/etiology , Risk Factors , Incidence
3.
Int J Med Inform ; 187: 105468, 2024 Jul.
Article in English | MEDLINE | ID: mdl-38703744

ABSTRACT

PURPOSE: Our research aims to compare the predictive performance of decision tree algorithms (DT) and logistic regression analysis (LR) in constructing models, and develop a Post-Thrombotic Syndrome (PTS) risk stratification tool. METHODS: We retrospectively collected and analyzed relevant case information of 618 patients diagnosed with DVT from January 2012 to December 2021 in three different tertiary hospitals in Jiangxi Province as the modeling group. Additionally, we used the case information of 212 patients diagnosed with DVT from January 2022 to January 2023 in two tertiary hospitals in Hubei Province and Guangdong Province as the validation group. We extracted electronic medical record information including general patient data, medical history, laboratory test indicators, and treatment data for analysis. We established DT and LR models and compared their predictive performance using receiver operating characteristic (ROC) curves and confusion matrices. Internal and external validations were conducted. Additionally, we utilized LR to generate nomogram charts, calibration curves, and decision curves analysis (DCA) to assess its predictive accuracy. RESULTS: Both DT and LR models indicate that Year, Residence, Cancer, Varicose Vein Operation History, DM, and Chronic VTE are risk factors for PTS occurrence. In internal validation, DT outperforms LR (0.962 vs 0.925, z = 3.379, P < 0.001). However, in external validation, there is no significant difference in the area under the ROC curve between the two models (0.963 vs 0.949, z = 0.412, P = 0.680). The validation results of calibration curves and DCA demonstrate that LR exhibits good predictive accuracy and clinical effectiveness. A web-based calculator software of nomogram (https://sunxiaoxuan.shinyapps.io/dynnomapp/) was utilized to visualize the logistic regression model. CONCLUSIONS: The combination of decision tree and logistic regression models, along with the web-based calculator software of nomogram, can assist healthcare professionals in accurately assessing the risk of PTS occurrence in individual patients with lower limb DVT.


Subject(s)
Postthrombotic Syndrome , Venous Thrombosis , Humans , Venous Thrombosis/diagnosis , Postthrombotic Syndrome/diagnosis , Postthrombotic Syndrome/etiology , Female , Male , Middle Aged , Risk Assessment/methods , Retrospective Studies , Lower Extremity/blood supply , Risk Factors , Logistic Models , Adult , Decision Trees , Aged , ROC Curve , Algorithms , Nomograms
4.
Ann Vasc Surg ; 105: 265-274, 2024 Aug.
Article in English | MEDLINE | ID: mdl-38599493

ABSTRACT

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.


Subject(s)
Endovascular Procedures , Quality of Life , Stents , Varicose Ulcer , Wound Healing , Humans , Female , Male , Middle Aged , Varicose Ulcer/therapy , Varicose Ulcer/physiopathology , Varicose Ulcer/etiology , Retrospective Studies , Adult , Treatment Outcome , Time Factors , Young Adult , Endovascular Procedures/instrumentation , Endovascular Procedures/adverse effects , Postthrombotic Syndrome/etiology , Postthrombotic Syndrome/therapy , Postthrombotic Syndrome/physiopathology , Postthrombotic Syndrome/diagnostic imaging , Chronic Disease , Iliac Vein/diagnostic imaging , Iliac Vein/physiopathology , Vascular Patency
5.
Thromb Res ; 238: 11-18, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38643521

ABSTRACT

BACKGROUND: Post-thrombotic syndrome (PTS) is the main long-term complication of deep vein thrombosis (DVT). Several therapies are being evaluated to prevent or to treat PTS. Identifying the patients most likely to benefit from these therapies presents a significant challenge. OBJECTIVES: The objective of this review was to identify risk factors for PTS during the acute phase of DVT. ELIGIBILITY CRITERIA: We searched the PubMed and Cochrane databases for studies published between January 2000 and January 2021, including randomized clinical trials, meta-analyses, systematic reviews and observational studies. RESULTS: Risk factors for PTS such as proximal location of DVT, obesity, chronic venous disease, history of DVT are associated with higher risk of PTS. On the initial ultrasound-Doppler, a high thrombotic burden appears to be a predictor of PTS. Among the evaluated biomarkers, some inflammatory markers such as ICAM-1, MMP-1 and MMP-8 appear to be associated with a higher risk of developing PTS. Coagulation disorders are not associated with risk of developing PTS. Role of endothelial biomarkers in predicting PTS has been poorly explored. Lastly, vitamin K antagonist was associated with a higher risk of developing PTS when compared to direct oral anticoagulants and low molecular weight heparin. CONCLUSIONS: Several risk factors during the acute phase of VTE are associated with an increased risk of developing PTS. There is a high-unmet medical need to identify potential biomarkers for early detection of patients at risk of developing PTS after VTE. Inflammatory and endothelial biomarkers should be explored in larger prospective studies to identify populations that could benefit from new therapies.


Subject(s)
Postthrombotic Syndrome , Humans , Postthrombotic Syndrome/blood , Risk Factors , Venous Thrombosis/complications , Venous Thrombosis/blood , Biomarkers/blood
6.
Ann Vasc Surg ; 104: 307-314, 2024 Jul.
Article in English | MEDLINE | ID: mdl-38599487

ABSTRACT

BACKGROUND: This study aims to conduct a comparative analysis of the clinical efficacy and safety between pharmacomechanical thrombectomy (PMT) and catheter-directed thrombolysis (CDT) in the context of acute lower-extremity deep venous thrombosis (LEDVT). METHODS: A retrospective review of our institution's patient database spanning from February 2011 to December 2019 was performed to identify cases of acute LEDVT. The patients were categorized into 2 distinct groups based on the thrombolytic interventions administered: the PMT group, specifically denoting PMT with AngioJet in our investigation, and the CDT group. Comprehensive data sets encompassing patient demographics, risk factors, procedural specifics, thrombolysis grading, and complications were collected. Subsequent follow-up evaluations at the 2-year mark posttreatment included assessments of postthrombotic syndrome (PTS) and the quality of life. RESULTS: Among the 348 patients identified (mean age: 50.12 ± 15.87 years; 194 females), 200 underwent CDT during the early stage (2011 to 2017), while 148 received PMT between 2017 and 2019. Baseline data between the 2 groups exhibited no statistically significant differences. Thrombus scores significantly decreased in both cohorts posttherapy (each P < 0.001).Patients subjected to PMT demonstrated higher thrombolysis rates (77.35 ± 9.44% vs. 50.85 ± 6.72%), reduced administration of the thrombolytic agent urokinase [20 (20€20) vs. 350 (263€416), P < 0.001], larger limb circumference differences (above the knee: 6.03 ± 1.76 cm vs. 4.51 ± 1.82 cm, P < 0.001; below the knee: 2.90 ± 1.16 cm vs. 2.51 ± 0.90 cm, P < 0.001), and shorter lengths of stay (7.19 ± 3.11 days vs. 12.33 ± 4.77 days, P < 0.001). However, the PMT group exhibited a higher decline in hemoglobin levels (13.41 ± 10.59 g/L vs. 10.88 ± 11.41 g/L, P = 0.038) and an increase in creatinine levels [9.58 (2.32€15.82) umol/L vs. 4.53 (2.87€6.08) umol/L, P < 0.001] compared to the CDT group. No statistically significant differences were observed in the numbers of balloon angioplasty, stent implantation (each P > 0.050), and minor and major complications between the 2 groups. At the 1-year follow-up, PTS occurred in 13.51% of the PMT group compared to 26% of the CDT group (P = 0.025), with a higher incidence of moderate-severe PTS in the CDT group (8% vs. 2.7%, P = 0.036). At the 2-year follow-up, PTS was observed in 16.2% of the PMT group and 31.5% in the CDT group, P = 0.004. Preoperative and postoperative D-values of 36-Item Short Form Health Survey (SF-36) Physical Component Summary and SF-36 Mental Component Summary showed no statistically significant between-group differences. CONCLUSIONS: In our institutional experience, both PMT and CDT have proven to be effective and safe therapeutic approaches for managing acute LEDVT. PMT, in particular, demonstrated superior efficacy in achieving thrombosis resolution and mitigating the risk of PTS, affirming its role as a favorable intervention in this clinical context.


Subject(s)
Databases, Factual , Fibrinolytic Agents , Thrombectomy , Thrombolytic Therapy , Venous Thrombosis , Humans , Retrospective Studies , Male , Female , Thrombolytic Therapy/adverse effects , Venous Thrombosis/therapy , Venous Thrombosis/diagnostic imaging , Venous Thrombosis/drug therapy , Venous Thrombosis/physiopathology , Middle Aged , Treatment Outcome , Thrombectomy/adverse effects , Thrombectomy/instrumentation , Fibrinolytic Agents/administration & dosage , Fibrinolytic Agents/adverse effects , Adult , Time Factors , Aged , Postthrombotic Syndrome/etiology , Postthrombotic Syndrome/therapy , Catheterization, Peripheral/adverse effects , Risk Factors , Quality of Life , Acute Disease
8.
J Vasc Interv Radiol ; 35(6): 834-845, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38484910

ABSTRACT

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).


Subject(s)
Endovascular Procedures , Femoral Vein , Iliac Vein , Postthrombotic Syndrome , Prosthesis Design , Stents , Vascular Patency , Humans , Female , Male , Iliac Vein/diagnostic imaging , Iliac Vein/physiopathology , Middle Aged , Femoral Vein/diagnostic imaging , Femoral Vein/physiopathology , Treatment Outcome , Prospective Studies , Time Factors , Endovascular Procedures/instrumentation , Endovascular Procedures/adverse effects , Postthrombotic Syndrome/physiopathology , Postthrombotic Syndrome/therapy , Postthrombotic Syndrome/diagnostic imaging , Postthrombotic Syndrome/etiology , Aged , Adult , Venous Thrombosis/therapy , Venous Thrombosis/physiopathology , Venous Thrombosis/diagnostic imaging , United States , Quality of Life , Disability Evaluation
9.
Blood Adv ; 8(11): 2924-2932, 2024 Jun 11.
Article in English | MEDLINE | ID: mdl-38547453

ABSTRACT

ABSTRACT: Ultrasound-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.


Subject(s)
Fibrinogen , Thrombolytic Therapy , Venous Thrombosis , Humans , Venous Thrombosis/drug therapy , Venous Thrombosis/blood , Venous Thrombosis/etiology , Fibrinogen/analysis , Fibrinogen/metabolism , Male , Female , Middle Aged , Thrombolytic Therapy/methods , Aged , Postthrombotic Syndrome/etiology , Postthrombotic Syndrome/prevention & control , Adult
10.
Vasa ; 53(3): 217-224, 2024 May.
Article in English | MEDLINE | ID: mdl-38525891

ABSTRACT

Background: We aimed to study the long-term safety and efficacy of oblique venous stents for post-thrombotic syndrome (PTS) with iliac vein compression. Patients and methods: In the multinational, prospective, single-arm TOPOS study, PTS patients scheduled for endovascular therapy with the sinus-Obliquus® stent and optional distal extension with the sinus-Venous® or sinus-XL Flex® stent were enrolled at eight European vascular centres between October 2016 and December 2020. The primary outcome was primary stent patency at 24 months, and secondary outcomes included the clinical course of PTS (Villalta score, revised Venous Clinical Severity Score [rVCSS], Visual Analog Scale [VAS] of pain), quality of life changes (Chronic Venous Insufficiency Quality of Life Questionnaire, CIVIQ-20), and device-related complications. Results: We enrolled 60 patients (mean age 46±15 years, 68% women, 13% active ulcers): 80% required stent extension (70% below the inguinal ligament). The primary patency rate at 24 months was 80.7% (95%CI 68.1-90.0%); it was higher in patients without vs. those with stent extension (90.9% vs. 78.3%, p=.01). Compared to baseline, the Villalta, rVCSS, pain VAS, and CIVIQ-20 decreased by a median of 8 (interquartile range (IQR): 4-11), 5 (IQR: 3-7), 3 (IQR: 2-5), and 17 (IQR: 6-22) points, respectively; p<.001 for all parameters. Overall, 9 events of acute stent occlusion, 4 symptomatic stent stenosis, and 1 pulmonary embolism occurred. We did not observe major bleeding events or contralateral thrombosis. Conclusions: Endovascular treatment with the oblique stent and optional stent extension was safe and resulted in high patency rates at 24 months. The reduction in PTS severity was substantial and persisted over 2-year follow-up.


Subject(s)
Endovascular Procedures , Iliac Vein , Postthrombotic Syndrome , Prosthesis Design , Stents , Vascular Patency , Humans , Female , Male , Middle Aged , Prospective Studies , Treatment Outcome , Adult , Endovascular Procedures/instrumentation , Endovascular Procedures/adverse effects , Time Factors , Iliac Vein/physiopathology , Iliac Vein/diagnostic imaging , Postthrombotic Syndrome/therapy , Postthrombotic Syndrome/physiopathology , Postthrombotic Syndrome/etiology , Europe , Quality of Life
11.
J Vasc Surg Venous Lymphat Disord ; 12(3): 101859, 2024 May.
Article in English | MEDLINE | ID: mdl-38447878

ABSTRACT

BACKGROUND: The optimal treatment approach for patients with active venous leg ulcers (VLUs) and post-thrombotic syndrome (PTS) associated with great saphenous vein (GSV) reflux remains unclear. To address this gap, we retrospectively compared the outcomes of patients with post-thrombotic VLU with an intact GSV vs those with a stripped or ablated GSV. METHODS: We retrospectively analyzed data from 48 patients with active VLUs and documented PTS, who were treated at a single center between January 2018 and December 2022. Clinical information, including ulcer photographs, was recorded in a prospectively maintained digital database at the initial and follow-up visits. Two patient groups-group A (with an intact GSV) and group B (with a stripped or ablated GSV)-were compared in terms of time to complete healing, proportion of ulcers achieving complete healing, and ulcer recurrence during the follow-up period. RESULTS: There were no significant differences in age, gender, initial ulcer size, or ulcer duration between the two groups. All included patients had femoropopliteal post-thrombotic changes. Group A had significantly more completely healed ulcers (33 of 34 ulcers, 97%) compared with group B (10 of 14 ulcers, 71%) (P = .008). Group A also exhibited a significantly shorter time to complete ulcer healing (median: 42.5 days, interquartile range [IQR]: 65) compared with group B (median: 161 days, IQR: 530.5) (P = .0177), with a greater probability of ulcer healing (P = .0084). Long-term follow-up data were available for 45 of 48 patients (93.7%), with a mean duration of 39.6 months (range: 5.7-67.4 months). The proportion of ulcers that failed to heal or recurred during the follow-up period was significantly lower in group A (9 of 32 ulcers, 27%) compared with group B (11 of 13 ulcers, 85%) (P = .0009). In addition, in a subgroup analysis, patients with an intact but refluxing GSV (12 of 34) had a significantly shorter time to heal (median: 34 days, IQR: 57.25) (P = .0242), with a greater probability of ulcer healing (P = .0091) and significantly fewer recurrences (2 of 12, 16%) (P = .006) compared with group B. CONCLUSIONS: Our findings suggest that removal of the GSV through stripping or ablation in patients with post-thrombotic deep venous systems affecting the femoropopliteal segment may result in delayed ulcer healing and increased ulcer recurrence. Patients with an intact GSV had better outcomes, even when the refluxing GSV was left untreated. These findings emphasize the potential impact of GSV treatment on the management of VLUs in individuals with PTS. Further investigation is needed to validate these results and explore alternative therapeutic strategies to optimize outcomes for this patient population.


Subject(s)
Postthrombotic Syndrome , Varicose Ulcer , Venous Insufficiency , Humans , Ulcer , Retrospective Studies , Saphenous Vein/surgery , Treatment Outcome , Varicose Ulcer/therapy , Venous Insufficiency/surgery , Recurrence
12.
J Vasc Interv Radiol ; 35(5): 664-675.e5, 2024 May.
Article in English | MEDLINE | ID: mdl-38336032

ABSTRACT

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.


Subject(s)
Endovascular Procedures , Femoral Vein , Iliac Vein , Prosthesis Design , Quality of Life , Stents , Vascular Patency , Adult , Aged , Female , Humans , Male , Middle Aged , Endovascular Procedures/instrumentation , Endovascular Procedures/adverse effects , Femoral Vein/diagnostic imaging , Femoral Vein/physiopathology , Iliac Vein/diagnostic imaging , Iliac Vein/physiopathology , May-Thurner Syndrome/diagnostic imaging , May-Thurner Syndrome/therapy , May-Thurner Syndrome/physiopathology , Postthrombotic Syndrome/diagnostic imaging , Postthrombotic Syndrome/physiopathology , Postthrombotic Syndrome/etiology , Postthrombotic Syndrome/therapy , Prospective Studies , Risk Factors , Time Factors , Treatment Outcome , Venous Thrombosis/diagnostic imaging , Venous Thrombosis/physiopathology , Venous Thrombosis/therapy
14.
J Vasc Surg Venous Lymphat Disord ; 12(4): 101825, 2024 Jul.
Article in English | MEDLINE | ID: mdl-38278173

ABSTRACT

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.


Subject(s)
Anticoagulants , Femoral Vein , Iliac Vein , Postthrombotic Syndrome , Thrombectomy , Venous Thrombosis , Humans , Venous Thrombosis/diagnostic imaging , Venous Thrombosis/therapy , Female , Male , Middle Aged , Femoral Vein/diagnostic imaging , Femoral Vein/surgery , Iliac Vein/diagnostic imaging , Iliac Vein/physiopathology , Postthrombotic Syndrome/diagnostic imaging , Postthrombotic Syndrome/etiology , Postthrombotic Syndrome/therapy , Anticoagulants/therapeutic use , Anticoagulants/administration & dosage , Treatment Outcome , Thrombectomy/adverse effects , Time Factors , Aged , Risk Factors , Registries , Adult , Incidence , Logistic Models , Propensity Score , Thrombolytic Therapy/adverse effects
15.
J Vasc Surg Venous Lymphat Disord ; 12(3): 101816, 2024 May.
Article in English | MEDLINE | ID: mdl-38237677

ABSTRACT

OBJECTIVE: This study aimed to evaluate postoperative outcomes of patients with chronic iliofemoral venous outflow obstruction and post-thrombotic syndrome (PTS) who underwent endovascular recanalization and stenting across the inguinal ligament. METHODS: All consecutive patients with chronic iliofemoral venous outflow obstruction and PTS were included in the analysis, from January 2018 and February 2022. Preoperative, intraoperative, and postoperative outcomes were assessed. Primary endpoints analyzed were major adverse events (MAEs) at 30 days and primary patency rate at 2 years of follow-up. Secondary endpoints assessed were secondary patency rate, target vessel revascularization, and clinical improvement evaluated with the Venous Clinical Severity Score (VCSS) classification, Villalta scale, and visual analog scale (VAS), respectively. RESULTS: A total of 63 patients (mean age, 48.1 ± 15.5 years; female, 61.9%) were evaluated. No intraoperative and 30-day postoperative complications were documented. The technical success rate was achieved at 100%. Overall, one in-stent occlusion and five in-stent restenosis were detected during follow-up. The primary patency rate was 93.7% (95% confidence interval [CI], 87.8%-99.9%) and 92.1% (95% CI, 85.6%-99%), at 1- and 2-year follow-up, respectively (Kaplan-Meier analysis). Target vessel revascularization was conducted in two cases, resulting in a secondary patency of 98.4% (95% CI, 95.4%-100%) at 2 years of follow-up. Stent fracture and/or migration were not observed during follow-up. A significant clinical improvement in the patient's quality of life was documented. The median improvement of VCSS and Villalta scores were 4 (interquartile range, 2-7; P = .001), and 3 (interquartile range, 1.5-5; P = .001) vs baseline at the last follow-up. Overall, pain reduction of 17 mm on the VAS scale was documented at 2 years of follow-up. At multivariate analysis, presence of trabeculation into the femoral vein and deep femoral vein (odds ratio, 1.89; 95% CI, 0.15-6.11; P = .043), and Villalta scale >15 points at admission (odds ratio, 1.89; 95% CI, 0.15-6.11; P = .043) were predictive for in-stent occlusion during the follow-up. CONCLUSIONS: The use of a dedicated venous stent across the inguinal ligament was safe and effective for the treatment of symptomatic iliofemoral venous disease with acceptable primary and secondary patency rates at 2 years of follow-up.


Subject(s)
Endovascular Procedures , Postthrombotic Syndrome , Vascular Diseases , Humans , Female , Adult , Middle Aged , Femoral Vein , Quality of Life , Treatment Outcome , Endovascular Procedures/adverse effects , Iliac Vein , Postthrombotic Syndrome/therapy , Vascular Diseases/etiology , Stents , Ligaments , Retrospective Studies
16.
Dtsch Arztebl Int ; 121(6): 188-194, 2024 Mar 22.
Article in English | MEDLINE | ID: mdl-38260965

ABSTRACT

BACKGROUND: After an acute deep venous thrombosis (DVT) of the lower limb, 20% to 63% of patients develop post-thrombotic syndrome (PTS). In this review, we address the efficacy of compression therapy in the treatment of acute DVT of the lower limb, and for the prevention of PTS. METHODS: 12 randomized controlled trials (RCTs) and one meta-analysis, with a total of 3751 patients, were identified in a structured literature search. RESULTS: Two RCTs showed that adding compression therapy to drug treatment in the first 9 days of the acute phase of lower limb DVT led to more rapid pain relief (p<0.050) and less swelling (remaining difference in circumference, 1 cm versus 3 cm, p<0.050). As for the prevention of PTS, four RCTs showed a short-term benefit or no benefit of compression therapy. In three further RCTs, medical compression stockings (MCS) brought about a 16% to 27% absolute reduction of the frequency and severity of PTS (47% vs. 20 %, p<0.001; 40% vs. 21% (95% confidence intervals [29.9; 50.1] and [12.7; 29.5], respectively; and 58% vs. 42%, relative risk [RR] 0.73 [0,55; 0.96]). The benefit of MCS was also confirmed in a recent meta-analysis (RR 0.66 [0.44; 0.99], I2 = 88%). Thigh-length MCS were not superior to knee-length MCS for the prevention of PTS (33% vs. 36%, hazard ratio [HR] 0.93 [0.62; 1.41]). Individual, symptomoriented tailoring of the duration of treatment was not inferior to a fixed treatment duration of 24 months (29% vs. 28%; odds ratio [OR] 1.06 [0.78;1.44]). CONCLUSION: Compression therapy relieves symptoms in acute DVT and lessens the frequency and severity of PTS. It is therefore recommended as standard treatment.


Subject(s)
Postthrombotic Syndrome , Stockings, Compression , Venous Thrombosis , Female , Humans , Male , Acute Disease , Evidence-Based Medicine , Lower Extremity/blood supply , Postthrombotic Syndrome/prevention & control , Postthrombotic Syndrome/etiology , Postthrombotic Syndrome/therapy , Prevalence , Randomized Controlled Trials as Topic , Risk Factors , Treatment Outcome , Venous Thrombosis/therapy , Venous Thrombosis/complications , Venous Thrombosis/prevention & control
17.
J Vasc Surg Venous Lymphat Disord ; 12(2): 101739, 2024 Mar.
Article in English | MEDLINE | ID: mdl-38242205

ABSTRACT

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.


Subject(s)
Postthrombotic Syndrome , Venous Thrombosis , Humans , Fibrinolytic Agents/adverse effects , Delphi Technique , Venous Thrombosis/diagnostic imaging , Venous Thrombosis/drug therapy , Iliac Vein/diagnostic imaging , Postthrombotic Syndrome/diagnostic imaging , Postthrombotic Syndrome/etiology , Postthrombotic Syndrome/prevention & control , Stents , Retrospective Studies
18.
J Cardiovasc Surg (Torino) ; 65(1): 42-48, 2024 Feb.
Article in English | MEDLINE | ID: mdl-38226927

ABSTRACT

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.


Subject(s)
Postthrombotic Syndrome , Venous Thrombosis , Humans , Thrombolytic Therapy/adverse effects , Femoral Vein/diagnostic imaging , Iliac Vein/diagnostic imaging , Treatment Outcome , Randomized Controlled Trials as Topic , Venous Thrombosis/diagnostic imaging , Venous Thrombosis/therapy , Thrombectomy/adverse effects , Postthrombotic Syndrome/diagnostic imaging , Postthrombotic Syndrome/etiology , Postthrombotic Syndrome/therapy , Acute Disease
19.
J Vasc Surg Venous Lymphat Disord ; 12(1): 101688, 2024 Jan.
Article in English | MEDLINE | ID: mdl-37717788

ABSTRACT

BACKGROUND: Data on complications after upper extremity vein thrombosis (UEVT) are limited and heterogeneous. METHODS: The aim of the present study was to evaluate the pooled proportions of venous thromboembolism (VTE) recurrence, bleeding, and post-thrombotic syndrome (PTS) in patients with UEVT. A systematic literature review was conducted of PubMed, Embase, and the Cochrane Library databases from January 2000 to April 2023 in accordance with the PRISMA (preferred reporting items for systematic reviews and meta-analyses) guidelines. All studies included patients with UEVT and were published in English. Meta-analyses of VTE recurrence, bleeding, and of PTS after UEVT were performed to compute pooled estimates and associated 95% confidence intervals (CIs). Subgroup analyses of cancer-associated UEVT and catheter-associated venous thrombosis were conducted. Patients with Paget-Schroetter syndrome or effort thrombosis were excluded. RESULTS: A total of 55 studies with 15,694 patients were included. The pooled proportions for VTE recurrence, major bleeding, and PTS were 4.8% (95% CI, 3.8%-6.2%), 3.0% (95% CI, 2.2%-4.0%), and 23.8% (95% CI, 17.0%-32.3%), respectively. The pooled proportion of VTE recurrence was 2.7% (95% CI, 1.6%-4.6%) for patients treated with direct oral anticoagulants (DOACs), 1.7% (95% CI, 0.8%-3.7%) for patients treated with low-molecular-weight heparin (LMWH), and 4.4% (95% CI, 1.5%-11.8%) for vitamin K antagonists (VKAs; P = .36). The pooled proportion was 6.3% (95% CI, 4.3%-9.1%) for cancer patients compared with 3.1% (95% CI, 2.1%-4.6%) for patients without cancer (P = .01). The pooled proportion of major bleeding for patients treated with DOACs, LMWH, and VKAs, was 2.1% (95% CI, 0.9%-5.1%), 3.2% (95% CI, 1.4%-7.2%), and 3.4% (95% CI, 1.4%-8.4%), respectively (P = .72). The pooled proportion of PTS for patients treated with DOACs, LMWH, and VKAs was 11.8% (95% CI, 6.5%-20.6%), 27.9% (95% CI, 20.9%-36.2%), and 24.5% (95% CI, 17.6%-33.1%), respectively (P = .02). CONCLUSIONS: The results from this study suggest that UEVT is associated with significant rates of PTS and VTE recurrence. Treatment with DOACs might be associated with lower PTS rates than treatment with other anticoagulants.


Subject(s)
Neoplasms , Postthrombotic Syndrome , Upper Extremity Deep Vein Thrombosis , Venous Thromboembolism , Humans , Heparin, Low-Molecular-Weight/therapeutic use , Venous Thromboembolism/diagnosis , Venous Thromboembolism/epidemiology , Venous Thromboembolism/chemically induced , Incidence , Vitamin K , Anticoagulants/adverse effects , Hemorrhage/chemically induced , Hemorrhage/epidemiology , Hemorrhage/complications , Postthrombotic Syndrome/etiology , Postthrombotic Syndrome/complications , Upper Extremity Deep Vein Thrombosis/diagnostic imaging , Upper Extremity Deep Vein Thrombosis/epidemiology , Upper Extremity Deep Vein Thrombosis/etiology , Neoplasms/complications , Upper Extremity
20.
J Eur Acad Dermatol Venereol ; 38(2): 289-301, 2024 Feb.
Article in English | MEDLINE | ID: mdl-37731155

ABSTRACT

Post-thrombotic syndrome (PTS) is a common complication after deep vein thrombosis (DVT) and has a major impact on physical symptoms, quality of life (QoL) and economic costs. Relatively simple lifestyle interventions as physical exercise might reduce PTS severity and increase QoL. To evaluate the direct and long-term effects of physical activity in patients with an acute or previous DVT. We conducted a systematic review through an additional search from 2007 up to March 2022, to complement the comprehensive systematic review of Kahn et al. Articles evaluating the effect of exercise after a DVT including symptoms, QoL and the incidence and severity of PTS, were included. Quality of the studies was assessed using a GRADE-like checklist and results were reported according to the PRISMA Statement. Ten studies were included, seven randomized controlled trials and three cohort studies. We identified three types of physical activity based on timing and duration; (1) early mobilisation in the acute phase of the DVT; (2) short duration exercise 1 year after DVT and (3) prolonged exercise during follow-up after a previous DVT. Early mobilisation showed improvement in QoL and pain reduction and after 2 years it resulted in a significant reduction of PTS severity. Prolonged supervised exercise resulted in improvement of QoL. In addition, positive effects on symptoms of venous insufficiency and muscle functions were observed. None of the included studies reported an increased risk of PTS or worsening of symptoms due to physical activity. Physical exercise after a DVT is safe, improves QoL, reduces pain and decreases PTS severity. Lifestyle intervention such as guided individualized training programs can be a useful supplementary therapy for patients after a DVT or for PTS patients. Optimal training programs may be identified by further studies that improve patient-oriented outcomes for both adults and children after a DVT.


Subject(s)
Postthrombotic Syndrome , Venous Thrombosis , Adult , Child , Humans , Venous Thrombosis/complications , Quality of Life , Postthrombotic Syndrome/complications , Postthrombotic Syndrome/therapy , Exercise , Pain
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