RESUMEN
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.
Asunto(s)
Síndrome Postrombótico , Humanos , Síndrome Postrombótico/diagnóstico por imagen , Síndrome Postrombótico/etiología , Síndrome Postrombótico/terapia , Consenso , Stents , Sociedades Médicas/normas , Anticoagulantes/uso terapéutico , Anticoagulantes/administración & dosificaciónRESUMEN
This study aimed to evaluate the safety and efficacy of pharmacomechanical catheter-directed thrombolysis (PCDT) and stenting for treating acute iliofemoral deep venous thrombosis (DVT) combined with iliac vein compression syndrome (IVCS), and to identify the predictors of stent restenosis. Patients with acute proximal DVT combined with IVCS underwent PCDT and stenting from January 2017 to December 2022 were enrolled. Primary and secondary patency were assessed by duplex ultrasound (DUS). The morbidity of postthrombotic syndrome (PTS) was assessed by the Villalta score. Risk factors for stent restenosis were assessed using univariate and multivariate Cox regression models. Total of 254 patients were included. The mean follow-up time was 36.06 ± 17.66 months. The primary patency rates at 1 year, 3 years, and 5 years were 92.5%±1.7%, 85.4%±2.4%, and 82.4%±2.9%, respectively. The incidence of stent restenosis was 14.2%. Discontinuation of anticoagulants within one year [hazard ratio (HR) = 5.03; P = .048] was the factor associated with acute in-stent thrombosis. Previous DVT history (HR =2.29; P = .037) and stent placement across the inguinal ligament (HR =6.70; P < .001) were identified as independent risk factors significantly associated with stent restenosis. The overall PTS rate was 19.3%. PCDT with stenting is safe and effective for patients with iliofemoral DVT secondary to IVCS, leading to low rates of PTS. Previous DVT history and stents placed across the inguinal ligament may be predictors of stent restenosis. Furthermore, stent restenosis typically occurs within one year and is mainly caused by acute thrombosis due to discontinuation of anticoagulants.
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Vena Ilíaca , Stents , Trombosis de la Vena , Humanos , Masculino , Femenino , Trombosis de la Vena/etiología , Stents/efectos adversos , Factores de Riesgo , Persona de Mediana Edad , Síndrome de May-Thurner/complicaciones , Síndrome de May-Thurner/terapia , Adulto , Resultado del Tratamiento , Anciano , Síndrome Postrombótico/etiologíaRESUMEN
The post-thrombotic syndrome PTS occurs when a relevant residual thrombus load remains after a deep vein thrombosis and/or the function of the venous valves is disturbed. The knowledge of the different types of PTS generates individualized therapeutic and secondary prophylactic approaches. Immediate compression, movement in compression garments and an effective anticoagulation are crucial for both the prevention and the outcome of post thrombotic syndromes.
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Anticoagulantes , Síndrome Postrombótico , Humanos , Síndrome Postrombótico/prevención & control , Síndrome Postrombótico/etiología , Síndrome Postrombótico/diagnóstico , Anticoagulantes/uso terapéutico , Trombosis de la Vena/prevención & control , Trombosis de la Vena/diagnóstico , Medias de CompresiónRESUMEN
Post-thrombotic syndrome (PTS) is one of the most common long-term complications of lower extremity deep vein thrombosis (DVT). In order to study the long-term adverse prognosis of patients with DVT, explore the influencing factors for the prognosis of DVT, and provide a reliable reference for future research in the field of venous thrombosis, we collected and summarized information about the incidence of PTS, the PTS score and grading, the associated symptoms and drug-related adverse reactions in 501 patients with DVT. In our study, 54.1% of patients with DVT (271 of 501) experienced indications and manifestations of PTS, the male to female ratio was approximately 1:1. During the long-term follow up, the most common symptoms of PTS were anterior tibial edema and pain. By statistical analysis, we found that the outcome of thrombosis was the influencing factor of PTS score (1-4 points, P<.05). The grading of PTS was primarily influenced by the history of varicose veins and DVT in the lower extremities. The duration of taking antithrombotic drugs affected the outcome of thrombosis (P<.05), especially among the female patients. In addition, varied factors, such as lower extremity DVT complicated with pulmonary embolism and the duration of antithrombotic drug use were found to increase the chances of experiencing drug-related adverse reactions (odds ratio [OR]=2.798, 95% confidence interval [CI]: 1.413-5.541 / OR=2.778, 95% CI: 1.231-6.269). The above 2 factors were significant only among female patients with DVT (OR=4.03, 95% CI: 1.608-10.103 / OR=3.918, 95% CI: 1.123-13.669).
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Trombosis de la Vena , Humanos , Femenino , Masculino , Trombosis de la Vena/epidemiología , Trombosis de la Vena/etiología , Persona de Mediana Edad , Estudios de Seguimiento , Pronóstico , Anciano , Adulto , Síndrome Postrombótico/etiología , Síndrome Postrombótico/epidemiología , Anciano de 80 o más Años , Estudios de Cohortes , Factores de Riesgo , Factores de TiempoRESUMEN
BACKGROUND: Postthrombotic syndrome (PTS) refers to manifestations of chronic venous insufficiency after a deep vein thrombosis (DVT). The risk of developing moderate-to-severe PTS in the very long term is largely unknown and particularly in case of distal DVT. Furthermore, the impact of DVT vs other causes of chronic venous insufficiency on long-term manifestations of PTS is also unknown. OBJECTIVES: To assess the very long-term risk of moderate-to-severe PTS after DVT and the role that DVT plays in PTS symptoms. METHODS: Patients with lower-limb DVT enrolled in the multicenter Optimisation de l'interrogatoire dans l'evaluation du risque thromboembolique veineux (OPTIMEV) study underwent a very long-term telephone follow-up. We assessed i) the proportion of moderate-to-severe PTS (assessed with the patient-reported Villalta score) according to DVT extent and ii) the population attributable fraction that DVT plays in patients' moderate-to-severe PTS manifestations. RESULTS: Fourteen years after DVT, moderate-to-severe PTS developed in 35 of 185 patients with distal DVT (18.9%; 95% CI, 13.5%-25.3%), 11 of 47 patients with popliteal DVT (23.4%; 95% CI, 12.3%-38.0%), and 27 of 74 patients with iliofemoral DVT (36.5%; 95% CI, 25.6%-48.5%). The population attributable fraction of DVT in moderate-to-severe symptoms of PTS was 25.7% (-18.1% to 53.3%) in patients with distal DVT, 27.3% (-63.7% to 67.7%) in patients with popliteal DVT, and 43.1% (+0.7%-67.4%) in patients with iliofemoral DVT. CONCLUSION: In the very long term after DVT, a quarter of patients have moderate-to-severe PTS manifestations. However, the impact of the DVT on these manifestations appears nonpredominant and varies according to DVT extent. Distal DVT does not significantly increase the risk of developing moderate-to-severe PTS.
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Síndrome Postrombótico , Índice de Severidad de la Enfermedad , Trombosis de la Vena , Humanos , Síndrome Postrombótico/etiología , Síndrome Postrombótico/diagnóstico , Trombosis de la Vena/complicaciones , Trombosis de la Vena/etiología , Trombosis de la Vena/diagnóstico , Femenino , Masculino , Persona de Mediana Edad , Factores de Riesgo , Factores de Tiempo , Anciano , Medición de Riesgo , Insuficiencia Venosa/complicaciones , Adulto , Francia/epidemiología , Estudios de SeguimientoRESUMEN
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.
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Anticoagulantes , Síndrome Postrombótico , Trombosis de la Vena , Humanos , Síndrome Postrombótico/etiología , Síndrome Postrombótico/epidemiología , Síndrome Postrombótico/prevención & control , Anticoagulantes/uso terapéutico , Anticoagulantes/efectos adversos , Trombosis de la Vena/epidemiología , Trombosis de la Vena/tratamiento farmacológico , Trombosis de la Vena/etiología , Factores de Riesgo , IncidenciaRESUMEN
OBJECTIVE: The aim of this study was to study the risk factors influencing the occurrence of moderate to severe post-thrombotic syndrome (PTS) within 2 years in patients with subacute lower extremity deep vein thrombosis (DVT). METHODS: Seventy patients who developed moderate to severe PTS within 2 years after subacute lower extremity DVT from June 2018 to June 2022 were retrospectively selected as the case group. They were matched 1:1 by sex and age (±5 years) with 70 patients who did not develop moderate to severe PTS during the same follow-up period as the control group. Multiple logistic regression, stratified analysis, and interaction analyses were used to explore the risk factors for moderate to severe PTS. RESULTS: The multiple logistic regression model showed that patients with iliofemoral vein thrombosis had a significantly increased risk of developing moderate to severe PTS within 2 years. Patients who underwent intraluminal intervention treatment during hospitalization had a significantly reduced risk. The odds ratios were 4.000 (95% confidence interval, 1.597-10.016) for the femoral-popliteal vein thrombosis and 0.262 (95% confidence interval, 0.106-0.647) for the anticoagulation treatment group. The stratified analysis showed that intraluminal intervention treatment was a protective factor against moderate to severe PTS within 2 years across different strata of hypertension, thrombus type, body mass index, duration of anticoagulation, and wearing compression stockings. Additionally, there was an interaction between thrombus type and treatment method, with intraluminal intervention treatment having a more pronounced effect on preventing moderate to severe PTS in patients with iliofemoral vein thrombosis. CONCLUSIONS: Iliofemoral vein thrombosis is a risk factor for the development of moderate to severe PTS within 2 years in patients with subacute lower extremity DVT. Intraluminal intervention treatment can reduce the risk of moderate to severe PTS, especially in patients with iliofemoral vein thrombosis.
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Vena Femoral , Síndrome Postrombótico , Índice de Severidad de la Enfermedad , Trombosis de la Vena , Humanos , Síndrome Postrombótico/etiología , Síndrome Postrombótico/prevención & control , Femenino , Masculino , Factores de Riesgo , Trombosis de la Vena/etiología , Trombosis de la Vena/diagnóstico por imagen , Trombosis de la Vena/terapia , Trombosis de la Vena/complicaciones , Persona de Mediana Edad , Estudios Retrospectivos , Factores de Tiempo , Medición de Riesgo , Vena Femoral/diagnóstico por imagen , Adulto , Anciano , Vena Ilíaca/diagnóstico por imagen , Anticoagulantes/uso terapéutico , Estudios de Casos y Controles , Resultado del TratamientoRESUMEN
Objectives: Post-thrombotic syndrome (PTS) is a frequent and important consequence of deep vein thrombosis (DVT) for Behcet`s disease (BD) patients. Although various clinical scales are used to diagnose PTS, Villalta scale was accepted as the standard tool to diagnose and grade the severity of PTS. Poor quality of life (Qol) in the general population was defined for patients with PTS, however, studies in BD patients with PTS is limited. Our aim was to compare the performance of different scales to assess venous disease in BD patients with a history of DVT and to assess the relationship with quality of life.Methods: Patients with BD (n = 194, M/F:157/37, age:39.1 ± 9.5 years) with a DVT history were investigated. Villalta, VCSS,CEAP scale and SF 36,Veines scales were used to assess venous disease and QoL respectively.Results: Among BD patients, 120 (61.9 %) patients were classified as having PTS by Villalta and of patients 18% had severe PTS. Half of patients with CEAP score <4 were classified as having PTS. Also, 42% of patients with CEAP>4 and almost two third of VCSS classified severe CVD patients was grouped in severe PTS by Villalta scale. VCSS and Villalta classified PTS patients had decreased disease specific and general Qol scores compared to the patients without PTS. Also, severe PTS group (by VCSS) had decreased veines QoL scores and PCS compared to mild/moderate group.Conclusion: BD patients with DVT have a high risk of PTS. Our results show that both Villalta scale and VCSS should be used to assess venous disease BD patients with DVT. However, VCSS classified severity of PTS can show better correlation with venous disease -specific QoL.
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Síndrome de Behçet , Calidad de Vida , Índice de Severidad de la Enfermedad , Trombosis de la Vena , Humanos , Síndrome de Behçet/complicaciones , Síndrome de Behçet/diagnóstico , Femenino , Masculino , Adulto , Persona de Mediana Edad , Síndrome Postrombótico/etiología , Síndrome Postrombótico/diagnósticoRESUMEN
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.
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Síndrome Postrombótico , Trombosis de la Vena , Humanos , Trombosis de la Vena/diagnóstico , Síndrome Postrombótico/diagnóstico , Síndrome Postrombótico/etiología , Femenino , Masculino , Persona de Mediana Edad , Medición de Riesgo/métodos , Estudios Retrospectivos , Extremidad Inferior/irrigación sanguínea , Factores de Riesgo , Modelos Logísticos , Adulto , Árboles de Decisión , Anciano , Curva ROC , Algoritmos , NomogramasRESUMEN
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 (2020) vs. 350 (263416), 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 (2.3215.82) umol/L vs. 4.53 (2.876.08) 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.
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Bases de Datos Factuales , Fibrinolíticos , Trombectomía , Terapia Trombolítica , Trombosis de la Vena , Humanos , Estudios Retrospectivos , Masculino , Femenino , Terapia Trombolítica/efectos adversos , Trombosis de la Vena/terapia , Trombosis de la Vena/diagnóstico por imagen , Trombosis de la Vena/tratamiento farmacológico , Trombosis de la Vena/fisiopatología , Persona de Mediana Edad , Resultado del Tratamiento , Trombectomía/efectos adversos , Trombectomía/instrumentación , Fibrinolíticos/administración & dosificación , Fibrinolíticos/efectos adversos , Adulto , Factores de Tiempo , Anciano , Síndrome Postrombótico/etiología , Síndrome Postrombótico/terapia , Cateterismo Periférico/efectos adversos , Factores de Riesgo , Calidad de Vida , Enfermedad AgudaRESUMEN
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.
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Procedimientos Endovasculares , Calidad de Vida , Stents , Úlcera Varicosa , Cicatrización de Heridas , Humanos , Femenino , Masculino , Persona de Mediana Edad , Úlcera Varicosa/terapia , Úlcera Varicosa/fisiopatología , Úlcera Varicosa/etiología , Estudios Retrospectivos , Adulto , Resultado del Tratamiento , Factores de Tiempo , Adulto Joven , Procedimientos Endovasculares/instrumentación , Procedimientos Endovasculares/efectos adversos , Síndrome Postrombótico/etiología , Síndrome Postrombótico/terapia , Síndrome Postrombótico/fisiopatología , Síndrome Postrombótico/diagnóstico por imagen , Enfermedad Crónica , Vena Ilíaca/diagnóstico por imagen , Vena Ilíaca/fisiopatología , Grado de Desobstrucción VascularRESUMEN
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.
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Procedimientos Endovasculares , Vena Ilíaca , Síndrome Postrombótico , Diseño de Prótesis , Stents , Grado de Desobstrucción Vascular , Humanos , Femenino , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Resultado del Tratamiento , Adulto , Procedimientos Endovasculares/instrumentación , Procedimientos Endovasculares/efectos adversos , Factores de Tiempo , Vena Ilíaca/fisiopatología , Vena Ilíaca/diagnóstico por imagen , Síndrome Postrombótico/terapia , Síndrome Postrombótico/fisiopatología , Síndrome Postrombótico/etiología , Europa (Continente) , Calidad de VidaRESUMEN
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).
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Procedimientos Endovasculares , Vena Femoral , Vena Ilíaca , Síndrome Postrombótico , Diseño de Prótesis , Stents , Grado de Desobstrucción Vascular , Humanos , Femenino , Masculino , Vena Ilíaca/diagnóstico por imagen , Vena Ilíaca/fisiopatología , Persona de Mediana Edad , Vena Femoral/diagnóstico por imagen , Vena Femoral/fisiopatología , Resultado del Tratamiento , Estudios Prospectivos , Factores de Tiempo , Procedimientos Endovasculares/instrumentación , Procedimientos Endovasculares/efectos adversos , Síndrome Postrombótico/fisiopatología , Síndrome Postrombótico/terapia , Síndrome Postrombótico/diagnóstico por imagen , Síndrome Postrombótico/etiología , Anciano , Adulto , Trombosis de la Vena/terapia , Trombosis de la Vena/fisiopatología , Trombosis de la Vena/diagnóstico por imagen , Estados Unidos , Calidad de Vida , Evaluación de la DiscapacidadRESUMEN
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.
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Fibrinógeno , Terapia Trombolítica , Trombosis de la Vena , Humanos , Trombosis de la Vena/tratamiento farmacológico , Trombosis de la Vena/sangre , Trombosis de la Vena/etiología , Fibrinógeno/análisis , Fibrinógeno/metabolismo , Masculino , Femenino , Persona de Mediana Edad , Terapia Trombolítica/métodos , Anciano , Síndrome Postrombótico/etiología , Síndrome Postrombótico/prevención & control , AdultoAsunto(s)
Fístula Arteriovenosa , Extremidad Inferior , Síndrome Postrombótico , Humanos , Síndrome Postrombótico/etiología , Síndrome Postrombótico/diagnóstico por imagen , Fístula Arteriovenosa/diagnóstico por imagen , Fístula Arteriovenosa/complicaciones , Fístula Arteriovenosa/cirugía , Fístula Arteriovenosa/etiología , Extremidad Inferior/irrigación sanguínea , Masculino , Femenino , Resultado del Tratamiento , Persona de Mediana EdadRESUMEN
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.
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Procedimientos Endovasculares , Vena Femoral , Vena Ilíaca , Diseño de Prótesis , Calidad de Vida , Stents , Grado de Desobstrucción Vascular , Adulto , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Procedimientos Endovasculares/instrumentación , Procedimientos Endovasculares/efectos adversos , Vena Femoral/diagnóstico por imagen , Vena Femoral/fisiopatología , Vena Ilíaca/diagnóstico por imagen , Vena Ilíaca/fisiopatología , Síndrome de May-Thurner/diagnóstico por imagen , Síndrome de May-Thurner/terapia , Síndrome de May-Thurner/fisiopatología , Síndrome Postrombótico/diagnóstico por imagen , Síndrome Postrombótico/fisiopatología , Síndrome Postrombótico/etiología , Síndrome Postrombótico/terapia , Estudios Prospectivos , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento , Trombosis de la Vena/diagnóstico por imagen , Trombosis de la Vena/fisiopatología , Trombosis de la Vena/terapiaRESUMEN
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.
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Síndrome Postrombótico , Medias de Compresión , Trombosis de la Vena , Femenino , Humanos , Masculino , Enfermedad Aguda , Medicina Basada en la Evidencia , Extremidad Inferior/irrigación sanguínea , Síndrome Postrombótico/prevención & control , Síndrome Postrombótico/etiología , Síndrome Postrombótico/terapia , Prevalencia , Ensayos Clínicos Controlados Aleatorios como Asunto , Factores de Riesgo , Resultado del Tratamiento , Trombosis de la Vena/terapia , Trombosis de la Vena/complicaciones , Trombosis de la Vena/prevención & controlRESUMEN
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.
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Anticoagulantes , Vena Femoral , Vena Ilíaca , Síndrome Postrombótico , Trombectomía , Trombosis de la Vena , Humanos , Trombosis de la Vena/diagnóstico por imagen , Trombosis de la Vena/terapia , Femenino , Masculino , Persona de Mediana Edad , Vena Femoral/diagnóstico por imagen , Vena Femoral/cirugía , Vena Ilíaca/diagnóstico por imagen , Vena Ilíaca/fisiopatología , Síndrome Postrombótico/diagnóstico por imagen , Síndrome Postrombótico/etiología , Síndrome Postrombótico/terapia , Anticoagulantes/uso terapéutico , Anticoagulantes/administración & dosificación , Resultado del Tratamiento , Trombectomía/efectos adversos , Factores de Tiempo , Anciano , Factores de Riesgo , Sistema de Registros , Adulto , Incidencia , Modelos Logísticos , Puntaje de Propensión , Terapia Trombolítica/efectos adversosRESUMEN
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.