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OBJECTIVE: To compare the rate of venous thromboembolism (VTE) in surgical inpatients with pharmacological thromboprophylaxis and additional graduated compression stockings (GCSs) versus pharmacological thromboprophylaxis alone. BACKGROUND: Surgical inpatients have elevated VTE risk; recent studies cast doubt on whether GCS confers additional protection against VTE, compared with pharmacological thromboprophylaxis alone. METHODS: The review followed "Preferred Reporting Items for Systematic Reviews and Meta-analyses" guidelines using a registered protocol (CRD42017062655). The MEDLINE and Embase databases were searched up to November 2022. Randomized trials reporting VTE rate after surgical procedures, utilizing pharmacological thromboprophylaxis, with or without GCS, were included. The rates of deep venous thrombosis (DVT), pulmonary embolism, and VTE-related mortality were pooled through fixed and random effects. RESULTS: In a head-to-head meta-analysis, the risk of DVT for GCS and pharmacological thromboprophylaxis was 0.85 (95% CI: 0.54-1.36) versus for pharmacological thromboprophylaxis alone (2 studies, 70 events, 2653 participants). The risk of DVT in pooled trial arms for GCS and pharmacological thromboprophylaxis was 0.54 (95% CI: 0.23-1.25) versus pharmacological thromboprophylaxis alone (33 trial arms, 1228 events, 14,108 participants). The risk of pulmonary embolism for GCS and pharmacological prophylaxis versus pharmacological prophylaxis alone was 0.71 (95% CI: 0.0-30.0) (27 trial arms, 32 events, 11,472 participants). There were no between-group differences in VTE-related mortality (27 trial arms, 3 events, 12,982 participants). CONCLUSIONS: Evidence from head-to-head meta-analysis and pooled trial arms demonstrates no additional benefit for GCS in preventing VTE and VTE-related mortality. GCS confer a risk of skin complications and an economic burden; current evidence does not support their use for surgical inpatients.
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Embolia Pulmonar , Tromboembolia Venosa , Humanos , Tromboembolia Venosa/prevenção & controle , Tromboembolia Venosa/etiologia , Anticoagulantes/uso terapêutico , Meias de Compressão/efeitos adversos , Complicações Pós-Operatórias/prevenção & controle , Complicações Pós-Operatórias/tratamento farmacológico , Pacientes Internados , Embolia Pulmonar/prevenção & controleRESUMO
OBJECTIVE: This systematic review and meta-analysis aimed to appraise recent evidence assessing patency outcomes at various time points in patients with superior vena cava, subclavian, and brachiocephalic vein stenosis who had undergone stenting. DATA SOURCES: PubMed, Scopus, and Cochrane Library databases were searched for studies up to December 2022. REVIEW METHODS: Measured outcomes included technical success rate, primary, primary assisted, and secondary patency at various time points. A subgroup analysis was also conducted to compare malignant and benign obstruction. GRADE was used to assess the certainty of evidence. RESULTS: Thirty nine studies reporting outcomes in 1 539 patients were included in the meta-analysis. Primary patency up to one year after the procedure was 81.5% (95% CI 74.5 - 86.9%). Primary patency declined after one year to 63.2% (95% CI 51.9 - 73.1%) at 12 - 24 months. Primary assisted patency and secondary patency at ≥ 24 months were 72.7% (95% CI 49.1 - 88.0%) and 76.6% (95% CI 51.1 - 91.1%). In the subgroup analysis, primary patency was significantly higher in patients with a malignant stenosis compared with a benign stenosis at 1 - 3 and 12 - 24 months. No significant difference was seen for pooled secondary patency rates when comparing the malignant and benign subgroups. GRADE analysis determined the certainty of evidence for all outcomes to be very low. CONCLUSION: Stenting is an effective intervention for benign and malignant stenosis of the superior vena cava, subclavian, and brachiocephalic veins. Primary patency rates were good up to one year after the procedure, with 81.5% of stents retaining patency at 6 - 12 months. Patency rates declined after one year, to 63.2% primary and 89.3% secondary patency at 12 - 24 months, showing improved outcomes following re-intervention. High quality evidence is lacking. More research is needed to investigate patency outcomes and the need for surveillance or re-intervention programs.
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OBJECTIVE: To identify the rate of post-thrombotic syndrome (PTS) after isolated distal deep venous thrombosis (IDDVT) by performing a meta-analysis of the rate of PTS across randomised and observational studies. DATA SOURCES: MEDLINE, Embase, the Cochrane Controlled Trials Register, Clinicaltrials.gov, European Union Clinical Trials, International Standard Randomised Controlled Trial Number, and the Australian and New-Zealand Trials Registries. REVIEW METHODS: This review followed PRISMA guidelines using a registered protocol (CRD42021282136). Databases were searched up to December 2021 and prospective studies reporting the development of post-thrombotic syndrome were included; these were pooled with the meta-analysis. RESULTS: The results showed a post-thrombotic rate of 17% (95% CI 11 - 26%) (seven studies, 217 cases, 1 105 participants). Heterogeneity was high (I2 = 89%). On meta-regression, the rate of post-thrombotic syndrome was not correlated with the length of follow up (p = .71). Three studies (302 participants) reported the severity of post-thrombotic syndrome: 78% were mild (Villalta score 5 - 9); 11% were moderate (Villalta score 10 - 14), and 11% were severe (Villalta score ≥ 15). CONCLUSION: The risk of post-thrombotic syndrome after IDDVT was one in five and the risk of severe clinical manifestations, including ulceration, was one in 50. There was significant clinical, methodological, and statistical heterogeneity between studies and a substantial risk of bias from pooled studies. Randomised trials to support interventions for prevention of post-thrombotic syndrome are urgently needed.
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Síndrome Pós-Trombótica , Trombose Venosa , Humanos , Trombose Venosa/complicações , Trombose Venosa/tratamento farmacológico , Estudos Prospectivos , Austrália , Síndrome Pós-Trombótica/etiologia , Síndrome Pós-Trombótica/prevenção & controle , MEDLINERESUMO
BACKGROUND: Endovascular stenting of the deep venous system has been proposed as a method to treat patients with symptomatic iliofemoral outflow obstruction. The purpose of this systematic review and meta-analysis was to compare the effectiveness of this treatment at 1-year following the development of dedicated venous stents. METHOD AND RESULTS: We searched MEDLINE and EMBASE for studies evaluating the effectiveness of venous stent placement. Data were extracted by disease pathogenesis: non-thrombotic iliac vein lesions (NIVL), acute thrombotic (DVT), or post-thrombotic syndrome (PTS). Main outcomes included technical success, stent patency at 1 year and symptom relief. A total of 49 studies reporting outcomes in 5154 patients (NIVL, 1431; DVT, 950; PTS, 2773) were included in the meta-analysis. Technical success rates were comparable among groups (97%-100%). There were no periprocedural deaths. Minor bleeding was reported in up to 5% of patients and major bleeding in 0.5% upon intervention. Transient back pain was noted in 55% of PTS patients following intervention. There was significant heterogeneity between studies reporting outcomes in PTS patients. Primary and cumulative patency at 1 year was: NIVL-96% and 100%; DVT-91% and 97%; PTS (stents above the ligament)-77% and 94%, and; PTS (stents across the ligament)-78% and 94%. There were insufficient data to compare patency outcomes of dedicated and nondedicated venous stents in patients with acute DVT. In NIVL and PTS patients, stent patency was comparable at 1 year. There was inconsistency in the use of validated tools for the measurement of symptoms before and after intervention. When reported, venous claudication, improved in 83% of PTS patients and 90% of NIVL patients, and ulcer healing occurred in 80% of PTS patients and 32% of NIVL patients. CONCLUSIONS: The first generation of dedicated venous stents perform comparably in terms of patency and clinical outcomes to non-dedicated technologies at 1 year for the treatment of patients with NIVL and PTS. However, significant heterogeneity exists between studies and standardized criteria are urgently needed to report outcomes in patients undergoing deep venous stenting.
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Procedimentos Endovasculares , Síndrome Pós-Trombótica , Procedimentos Endovasculares/efeitos adversos , Humanos , Síndrome Pós-Trombótica/diagnóstico por imagem , Síndrome Pós-Trombótica/etiologia , Síndrome Pós-Trombótica/terapia , Estudos Retrospectivos , Stents , Resultado do Tratamento , Grau de Desobstrução VascularRESUMO
OBJECTIVE: Percutaneous thrombus removal is used for the treatment of iliofemoral deep vein thrombosis (DVT), but the efficacy of different treatment modalities has not yet been determined. The aim of this study was to compare the outcomes of patients treated with additional AngioJet pharmacomechanical thrombectomy (PCDT) vs. catheter directed lysis (CDT) alone. METHODS: A retrospective review of all patients who received thrombolysis for the treatment of symptomatic acute iliofemoral DVT between 2011 and 2017 was carried out. Outcome measures included the incidence of post-thrombotic syndrome (PTS), procedural outcomes (lytic exposure), the incidence of complications, and vessel patency. All patients were followed up for a minimum of one year. RESULTS: A total of 151 limbs were treated, 70 limbs with PCDT and 81 limbs with CDT alone. Demographic data and prevalence of risk factors were comparable. Incidence of PTS (Villalta score at one year) showed no significant difference (22.2% PCDT vs. 24.7% CDT alone, p = .74). Use of PCDT resulted in a non-statistically significant trend for fewer bleeds (n = 4/63 [6.3%] vs. 13/76 [17.1%]; relative risk 0.37, 95% confidence interval [CI] 0.13-1.08; p = .07), a statistically significant reduction in lysis duration (40 h [95% CI 34-46] vs. 53 h [95% CI 49-58]; p < .001) and a reduction in lytic dose (49 mg [95% CI 42-55] vs. 57 mg [95% CI 52-61]; p = .011) compared with CDT. This reduction was accentuated in 24 cases primarily treated with AngioJet PowerPulse mode (27 h, 95% CI 20-34 [p < .001] and 42 mg, 95% CI 34-50 [p = .009]). Incidences of complications were comparable between groups, with one death due to an intracranial haemorrhage following CDT. Although the incidence of haemoglobinuria was increased following PCDT (12/63 [19.0%] vs. 3/76 [3.9%]; p = .006), no significant difference in acute kidney injury was observed (3/63 [4.8%] vs. 1/76 [1.3%]; p = .33). No significant difference in vessel patency over two years was observed (p = .73). CONCLUSION: The use of PCDT for the treatment of iliofemoral DVT was observed to provide comparable patient outcomes, comparable vessel patency, an acceptable safety profile, and reduced overall lytic dose.
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Veia Femoral , Fibrinolíticos/administração & dosagem , Veia Ilíaca , Trombectomia , Terapia Trombolítica , Trombose Venosa/terapia , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Terapia Combinada , Bases de Dados Factuais , Feminino , Veia Femoral/diagnóstico por imagem , Veia Femoral/fisiopatologia , Fibrinolíticos/efeitos adversos , Humanos , Veia Ilíaca/diagnóstico por imagem , Veia Ilíaca/fisiopatologia , Londres , Masculino , Pessoa de Meia-Idade , Síndrome Pós-Trombótica/etiologia , Estudos Retrospectivos , Fatores de Risco , Trombectomia/efeitos adversos , Terapia Trombolítica/efeitos adversos , Fatores de Tempo , Resultado do Tratamento , Grau de Desobstrução Vascular , Trombose Venosa/diagnóstico por imagem , Trombose Venosa/fisiopatologia , Adulto JovemRESUMO
Reactive oxygen species (ROS) have physiological roles as second messengers, but can also exert detrimental modifications on DNA, proteins and lipids if resulting from enhanced generation or reduced antioxidant defense (oxidative stress). Venous thrombus (DVT) formation and resolution are influenced by ROS through modulation of the coagulation, fibrinolysis, proteolysis and the complement system, as well as the regulation of effector cells such as platelets, endothelial cells, erythrocytes, neutrophils, mast cells, monocytes and fibroblasts. Many conditions that carry an elevated risk of venous thrombosis, such as the Antiphospholipid Syndrome, have alterations in their redox homeostasis. Dietary and pharmacological antioxidants can modulate several important processes involved in DVT formation, but their overall effect is unknown and there are no recommendations regarding their use. The development of novel antioxidant treatments that aim to abrogate the formation of DVT or promote its resolution will depend on the identification of targets that enable ROS modulation confined to their site of interest in order to prevent off-target effects on physiological redox mechanisms. Subgroups of patients with increased systemic oxidative stress might benefit from unspecific antioxidant treatment, but more clinical studies are needed to bring clarity to this issue.
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Espécies Reativas de Oxigênio/metabolismo , Trombose Venosa/metabolismo , Antioxidantes/farmacologia , Antioxidantes/uso terapêutico , Suplementos Nutricionais , Desenvolvimento de Medicamentos , Humanos , Trombose Venosa/tratamento farmacológicoRESUMO
OBJECTIVE/BACKGROUND: The aim was to assess two year outcomes with placement of the Vici Venous Stent® in patients with chronic iliofemoral venous occlusions (complete blockage). METHODS: This was a retrospective single centre study comprising patients treated with the Vici Venous Stent for venographically verified iliofemoral venous occlusion and post-thrombotic syndrome (Villalta score ≥ 5 points) at least 12 months after acute deep vein thrombosis. Venography and intravascular ultrasound were used peri-operatively; duplex ultrasound was used to assess stent patency during follow up. RESULTS: Eighty-eight patients (101 limbs) had stent placement between March 2014 and October 2016. Median pre-treatment Villalta score was 14 (range 5-33). Stenting extended across the inguinal ligament in 63 limbs (62%) in order to land in a healthy venous segment. Six patients (7%) required endophlebectomy and fistula creation. Median imaging follow up was 21 months (range 0-41 months). Primary, assisted primary and secondary patency rates at one year were 59%, 78%, and 87%, respectively, and two years 51%, 73%, and 82%, respectively. Forty-three limbs (43%) had re-intervention (lysis, venoplasty, and/or placement of stent) during follow up; median time to re-intervention was 32 days (range 0-520 days). At 24 months, 37 of 53 limbs (70%) with available Villalta assessment showed clinically significant improvement (>30% reduction of baseline score). Villalta scores at the 6, 12, and 24 month clinical follow up were significantly lower than before stenting (p < .001, all time points). In a subset analyses of limbs with stenting terminating above and below the inguinal ligament, secondary cumulative patency rates at 24 months were 90% and 79%, respectively; clinical outcome showed 58% vs. 73% of limbs with clinically significant improvement, respectively. There was no statistically significant difference in patency or clinical outcomes. CONCLUSION: The Vici Venous Stent is associated with a good secondary patency rate and durable and substantial symptomatic resolution in patients with chronic post-thrombotic occlusions, regardless of whether stents extended beneath the inguinal ligament.
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Procedimentos Endovasculares , Veia Ilíaca/cirurgia , Síndrome Pós-Trombótica/cirurgia , Stents , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Angioplastia com Balão/efeitos adversos , Procedimentos Endovasculares/métodos , Feminino , Humanos , Veia Ilíaca/diagnóstico por imagem , Masculino , Pessoa de Meia-Idade , Resultado do Tratamento , Grau de Desobstrução Vascular/fisiologia , Adulto JovemRESUMO
Surgical inpatients are at increased risk of venous thromboembolism (VTE). Current national guidelines recommend a combination of pharmacological (chemoprophylaxis) and mechanical thromboprophylaxis to reduce VTE risk. For most patients, mechanical thromboprophylaxis is provided via application of graduated compression stockings (GCS). This editorial reviews the evidence surrounding the efficacy and safety of GCS in VTE prevention, and makes a recommendation regarding their continued use in surgical inpatients.
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Meias de Compressão , Tromboembolia Venosa , Humanos , Tromboembolia Venosa/prevenção & controle , Complicações Pós-Operatórias/prevenção & controle , Pacientes InternadosRESUMO
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.
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Síndrome Pós-Trombótica , Trombose Venosa , Humanos , Terapia Trombolítica/efeitos adversos , Veia Femoral/diagnóstico por imagem , Veia Ilíaca/diagnóstico por imagem , Resultado do Tratamento , Ensaios Clínicos Controlados Aleatórios como Assunto , Trombose Venosa/diagnóstico por imagem , Trombose Venosa/terapia , Trombectomia/efeitos adversos , Síndrome Pós-Trombótica/diagnóstico por imagem , Síndrome Pós-Trombótica/etiologia , Síndrome Pós-Trombótica/terapia , Doença AgudaRESUMO
BACKGROUND: Pelvic venous disorders (PeVD) encompass a variety of conditions linked to chronic pelvic pain in women. However, PeVD remain underdiagnosed due to the absence of universally accepted diagnostic criteria. The complexity of PeVD classifications across specialties leads to delays in treatment. This scoping review aims to fill a gap in PeVD diagnosis and management by identifying all existing scoring or grading systems to lay the foundation for standardized clinical scoring tools for PeVD. METHODS: This scoping review was undertaken according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping reviews. Online databases were searched up to April 2023. Studies implementing a scoring or grading system for patients with confirmed or suspected PeVD were included. Scores or grading systems were classified into four main categories based on their use in the study: screening, diagnosis, measure of disease severity, and measure of response to treatment. RESULTS: Of the 2976 unique records identified, 82 were reviewed in full, and 20 were included in this study. The publication dates ranged from 1984 to 2023 (median, 2018; interquartile range, 2003-2022). A total of 21 scores and/or grading systems were identified. Of these 21 scores, 10 (47.6%) were clinical scores, and 10 (47.6%) were scores based on radiological findings; one study included a score that used both clinical and radiological findings. The identified scores were used in various settings. Of the 21 scores, 2 (9.52%) were used for screening in a tertiary care setting; 3 (14.3%) were used to establish the PeVD diagnosis; 8 (38.1%) were used to assess disease severity; and 8 (38.1%) were used as measures of response to treatment. Of the eight scores assessing disease severity, four (50.0%) assessed the degree of dilatation of pelvic veins and four (50%) assessed the severity of reflux. Only three of the scores were validated. CONCLUSIONS: This scoping review identified a range of scoring and grading systems for PeVD. We note a lack of a validated scoring system, both clinical and radiological, for screening and assessment of disease severity. This is an important first step in developing validated disease-specific scoring systems for patient screening, appropriate referral, assessment of symptom severity, and assessment of the response to treatment.
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OBJECTIVE: There is increasing recognition that health systems need to measure and improve the value of patient care by measuring outcomes. Chronic pelvic pain secondary to pelvic venous insufficiency can have a significant impact on the quality of life (QOL) of women affected. Despite growing recognition, pelvic venous disorders (PeVDs), an important cause of chronic pelvic pain, remain underdiagnosed. Developing a core outcome set (COS) for benchmarking care delivery enhances the standardization of care. However, there is no consensus regarding a standardized minimum set of outcomes for PeVD. We aimed to generate a list of outcomes reported in previous PeVD treatment studies to lay the foundation for developing a COS for PeVD. METHODS: This scoping review was undertaken according to the PRISMA-ScR guidelines. Initially, screening, full-text review and extraction was conducted on studies published between 2018 and 2023. Subsequently, the search was expanded using 1-year intervals, until, over a 1-year interval, no new outcomes were recorded. Closely related outcomes were classified into domains, and domains into three core areas: disease-specific, treatment-related, and QOL-related outcomes. RESULTS: Of the 1579 records identified, 51 publications were included. From these studies, 108 different outcomes were identified. The median number of outcomes per study was 8 (interquartile range, 6-13). Closely related outcomes were organized into 42 outcome domains, which were then categorized into 3 core outcome areas; 47.6% (20/42) were disease specific, 35.7% (15/42) treatment related, and 16.7% (7/42) were QOL related. Of the 51 included studies, disease-specific outcomes were identified in 96.1% of the studies (49/51), treatment-related outcomes in 94.1% (48/51), and QOL outcomes in only 13.7% (7/51). CONCLUSIONS: There was significant heterogeneity in outcomes reported in PeVD studies. Most PeVD treatment studies evaluated disease-specific and treatment-related outcomes of PeVD, but few reported outcomes that measured the impact on QOL. These findings will inform the next steps in developing a COS for PeVD.
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BACKGROUND: Insurance companies have adopted variable and inconsistent approval criteria for chronic venous disease (CVD) treatment. Although vein ablation (VA) is accepted as the standard of care for venous ulcers, the treatment criteria for patients with milder forms of CVD remain controversial. This study aims to identify factors associated with a lack of clinical improvement (LCI) in patients with less severe CVD without ulceration undergoing VA to improve patient selection for treatment. METHODS: We performed a retrospective analysis of patients undergoing VA for CEAP C2 to C4 disease in the Vascular Quality Initiative varicose veins database from 2014 to 2023. Patients who required intervention in multiple veins, had undergone prior interventions, or presented with CEAP C5 to C6 disease were excluded. The difference (Δ) in venous clinical severity score (VCSS; VCSS before minus after the procedure) was used to categorize the patients. Patients with a ΔVCSS of ≤0 were defined as having LCI after VA, and patients with ≥1 point decrease in the VCSS after VA (ΔVCSS ≥1) as having some benefit from the procedure and, therefore, "clinical improvement." The characteristics of both groups were compared, and multivariable regression analysis was performed to identify factors independently associated with LCI. A second analysis was performed based on the VVSymQ instrument, which measures patient-reported outcomes using five specific symptoms (ie, heaviness, achiness, swelling, throbbing pain, and itching). Patients with LCI showed no improvement in any of the five symptoms, and those with clinical improvement had a decrease in severity of at least one symptom. RESULTS: A total of 3544 patients underwent initial treatment of CVD with a single VA. Of the 3544 patients, 2607 had VCSSs available before and after VA, and 420 (16.1%) had LCI based on the ΔVCSS. Patients with LCI were more likely to be significantly older and African American and have CEAP C2 disease compared with patients with clinical improvement. Patients with clinical improvement were more likely to have reported using compression stockings before treatment. The vein diameters were not different between the two groups. The incidence of complications was overall low, with minor differences between the two groups. However, the patients with LCI were significantly more likely to have symptoms after intervention than those with improvement. Patients with LCI were more likely to have technical failure, defined as vein recanalization. On multivariable regression, age (odds ratio [OR], 1.01; 95% confidence interval [CI], 1.00-1.02) and obesity (OR, 1.47; 95% CI, 1.09-2.00) were independently associated with LCI, as was treatment of less severe disease (CEAP C2; OR, 1.82; 95% CI, 1.30-2.56) compared with more advanced disease (C4). The lack of compression therapy before intervention was also associated with LCI (OR, 6.05; 95% CI, 4.30-8.56). The analysis based on the VVSymQ showed similar results. CONCLUSIONS: LCI after VA is associated with treating patients with a lower CEAP class (C2 vs C4) and a lack of compression therapy before intervention. Importantly, no significant association between vein size and clinical improvement was observed.
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Técnicas de Ablação , Humanos , Masculino , Feminino , Estudos Retrospectivos , Pessoa de Meia-Idade , Idoso , Resultado do Tratamento , Fatores de Risco , Técnicas de Ablação/efeitos adversos , Varizes/cirurgia , Varizes/diagnóstico por imagem , Varizes/fisiopatologia , Bases de Dados Factuais , Índice de Gravidade de Doença , Doença Crônica , Adulto , Seleção de Pacientes , Fatores de Tempo , Medição de RiscoRESUMO
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.
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Síndrome Pós-Flebítica , Síndrome Pós-Trombótica , Trombose Venosa , Humanos , Terapia Trombolítica/efeitos adversos , Terapia Trombolítica/métodos , Qualidade de Vida , Síndrome Pós-Trombótica/diagnóstico por imagem , Síndrome Pós-Trombótica/etiologia , Síndrome Pós-Trombótica/prevenção & controle , Trombose Venosa/complicações , Trombose Venosa/diagnóstico por imagem , Trombose Venosa/terapia , Síndrome Pós-Flebítica/etiologia , Hemorragia/complicações , Veia Ilíaca , Anticoagulantes/uso terapêutico , Catéteres/efeitos adversos , Resultado do TratamentoRESUMO
OBJECTIVE: National guidelines in the United Kingdom have recommended regular exercise for individuals with venous leg ulceration. However, data on the effects of exercise on ulcer healing and recurrence are sparse. In the present study, we aimed to quantify the evidence for exercise regarding venous ulcer healing with respect to the primary outcomes of the proportion of healed ulcers and rate of ulcer recurrence. The secondary outcomes were improvement in ulcer symptoms, ulcer healing time, quality of life, compliance, and adverse events reported. METHODS: The review followed PRISMA (preferred reporting items for systematic reviews and meta-analyses) guidelines using a registered protocol (CRD42021220925). The MEDLINE and Embase databases and Cochrane Central Register of Controlled Trials, ClinicalTrials.gov, European Union Clinical Trials, and International Standard Randomised Controlled Trial Number registries were searched up to April 6, 2022 and included studies comparing exercise therapy and compression vs compression alone. Data for the proportion of healed ulcers were pooled using a fixed effects meta-analysis. RESULTS: After screening 1046 reports, 7 were included, with 121 participants allocated to exercise therapy and 125 to compression alone. All the reports were of randomized controlled trials and had reported ulcer healing at 12 weeks, with a pooled relative risk of ulcer healing of 1.38 for exercise vs compression (95% confidence interval, 1.11-1.71). Only one study had reported on recurrence; thus, data pooling was not performed. No differences between exercise and usual care were demonstrated. Compliance with exercise ranged from 33% to 81%. The included studies demonstrated low enrollment and a high risk of bias. Also, most of the trials had failed to demonstrate any differences in activity completed between the intervention and control arms. CONCLUSIONS: A paucity of studies has examined leg ulcer recurrence after exercise programs, with no evidence to show that exercise is beneficial. Furthermore, the quality of evidence supporting exercise as an adjunct to ulcer healing is very low, and the trials demonstrated serious methodologic flaws, chiefly in recording the activity undertaken by the participants in the intervention arm. Future randomized controlled trials should implement activity monitoring and standardize the reporting of key patient, ulcer, and reflux characteristics to enable future meaningful meta-analyses to determine the role of exercise as an adjunct to venous leg ulceration healing.
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Úlcera Varicosa , Humanos , Úlcera Varicosa/terapia , Úlcera Varicosa/tratamento farmacológico , Úlcera , Qualidade de Vida , Cicatrização , Terapia por Exercício/efeitos adversosRESUMO
Patient-reported outcome measures (PROMs) are patient-completed instruments that capture patient-perceived health status and well-being. PROMs measure disease impact and outcomes of care as reported by those who experience the disease. After pulmonary embolism or deep vein thrombosis, patients may face a broad spectrum of complications and long-term sequelae beyond the usual quality-of-care indicators of recurrent venous thromboembolism (VTE), bleeding complications, and survival. The full impact of VTE on individual patients can only be captured by assessing all relevant health outcomes from the patient's perspective in addition to the traditionally recognized complications. Defining and measuring all important outcomes will help facilitate treatment tailored to the needs and preferences of patients and may improve health outcomes. The International Society on Thrombosis and Haemostasis Scientific and Standardization Committee Subcommittee on Predictive and Diagnostic Variables in Thrombotic Disease endorsed the International Consortium for Health Outcomes Measurement (ICHOM) VTE project on development of a standardized set of patient-centered outcome measures for patients with VTE. In this communication, the course and result of the project are summarized, and based on these findings, we propose recommendations for the use of PROMs during clinical follow-up of patients with VTE. We describe challenges to implementation of PROMs and explore barriers and enablers.
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Embolia Pulmonar , Trombose , Tromboembolia Venosa , Trombose Venosa , Humanos , Tromboembolia Venosa/terapia , Tromboembolia Venosa/tratamento farmacológico , Trombose Venosa/terapia , Trombose Venosa/tratamento farmacológico , Trombose/tratamento farmacológico , Embolia Pulmonar/terapia , Embolia Pulmonar/tratamento farmacológico , Comunicação , Medidas de Resultados Relatados pelo Paciente , Anticoagulantes/uso terapêuticoRESUMO
Published scientific evidence demonstrate the current spread of healthcare misinformation in the most popular social networks and unofficial communication channels. Up to 40% of the medical websites were identified reporting inappropriate information, moreover being shared more than 450,000 times in a 5-year-time frame. The phenomenon is particularly spread in infective diseases medicine, oncology and cardiovascular medicine. The present document is the result of a scientific and educational endeavor by a worldwide group of top experts who selected and analyzed the major issues and related evidence-based facts on vein and lymphatic management. A section of this work is entirely dedicated to the patients and therefore written in layman terms, with the aim of improving public vein-lymphatic awareness. The part dedicated to the medical professionals includes a revision of the current literature, summing up the statements that are fully evidence-based in venous and lymphatic disease management, and suggesting future lines of research to fulfill the still unmet needs. The document has been written following an intense digital interaction among dedicated working groups, leading to an institutional project presentation during the Universal Expo in Dubai, in the occasion of the v-WINter 2022 meeting.
Assuntos
Comunicação , Gerenciamento Clínico , HumanosRESUMO
OBJECTIVES: Exercise improves haemodynamic parameters in patients with chronic venous disease. There is a paucity of evidence on its effect in post-thrombotic syndrome (PTS). The aim of this systematic review is to assess the impact of exercise in PTS. METHODS: Adhering to PRISMA guidelines and following PROSPERO registration (CRD42021220924), MEDLINE, Cochrane Library, EMBASE database, and trial registries were searched on 19th May 2022. RESULTS: One article met the inclusion criteria and a narrative synthesis was carried out. The included randomised controlled trial reported a between-group mean difference of 4.6 points (p = .027) in the VEINES-QOL score and -2.0 points (p = .14) in the Villalta score, in favour of exercise therapy. The statistical significance threshold was not reached. CONCLUSION: Data on exercise in PTS remains sparse but exercise appears to be a safe intervention. In the context of this literature, a potential future trial and outcome reporting measures are suggested.
Assuntos
Síndrome Pós-Trombótica , Trombose Venosa , Humanos , Qualidade de Vida , Trombose Venosa/terapia , Síndrome Pós-Trombótica/terapia , Exercício Físico , Terapia por Exercício , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
The International Consortium for Health Outcomes Measurement assembled an international working group of venous thromboembolism experts and patient representatives to develop a standardised minimum set of outcomes and outcome measurements for integration into clinical practice and potentially research to support clinical decision making and benchmarking of quality of care. 15 core outcomes important to patients and health-care professionals were selected and categorised into four domains: patient-reported outcomes, long term consequences of the disease, disease-specific complications, and treatment-related complications. The outcomes and outcome measures were designed to apply to all patients with venous thromboembolism aged 16 years or older. A measurement tool package was selected for inclusion in the core standard set, with a minimum number of items to be measured at predefined timepoints, which capture all core outcomes. Additional measures can be introduced to the user by a cascade opt-in system that allows for further assessment if required. This set of outcomes and measurement tools will facilitate the implementation of the use of patient-centred outcomes in daily practice.
Assuntos
Tromboembolia Venosa , Consenso , Humanos , Avaliação de Resultados em Cuidados de Saúde , Medidas de Resultados Relatados pelo Paciente , Tromboembolia Venosa/terapiaRESUMO
OBJECTIVE: Thrombophilia is a prothrombotic condition that increases the risk of venous thromboembolism. It is unclear whether the presence of thrombophilia alters the clinical outcomes after deep venous stenting. The aim of the present study was to examine the relationship between thrombophilia and outcomes after stenting for post-thrombotic syndrome. METHODS: Consecutive patients (2012-2017) receiving a nitinol venous stent for chronic post-thrombotic venous occlusive disease with a minimum of 18 months of follow-up in one center using the same anticoagulation protocol were included. The clinical history and thrombophilia testing results were reviewed. The outcomes were stent patency, which was assessed using duplex ultrasonography at 24 hours, 2 and 6 weeks, 3 months, 6 months, and annually thereafter; and reinterventions, which were performed when the stent diameter was <50% or occluded. RESULTS: Of the 136 patients who had undergone intervention, 55 (40%) had had a provoked deep vein thrombosis (DVT) and 81 (60%) had had an unprovoked DVT and had therefore undergone thrombophilia testing. Of the 81 patients, 38 (47%) had had either inherited (n = 19; 50%) or acquired (n = 19; 50%) thrombophilia. Of the 136 patients who had undergone stenting, 68 had required reintervention (50%) during follow-up to maintain stent patency. Of the 55 patients with a provoked DVT, 29 (53%) had required reintervention. Of the 81 patients with an unprovoked DVT, 39 (48%) had required reintervention (P = .420). Of the 38 patients with unprovoked DVT and thrombophilia, 17 (45%) had required reintervention. Of the 43 patients with unprovoked DVT and no thrombophilia, 22 (51%) had required reintervention (P = .766). The cumulative patency rate was 80% for patients with provoked DVT and 88% for those with unprovoked DVT (P = .193). The presence of thrombophilia was not associated with patency loss (92% cumulative patency for patients with thrombophilia and 84% for patients without thrombophilia; P = .307). CONCLUSIONS: Using our anticoagulation protocol, patients with and without thrombophilia had similar clinical outcomes after deep venous stenting and should not be excluded from iliofemoral venous stenting. We found no significant differences in outcomes in conjunction with appropriate postoperative anticoagulation therapy.