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European Journal of Internal Medicine Oct 2022Portal vein thrombosis (PVT) may be associated with negative outcomes in patients with liver cirrhosis. However, the prevalence and incidence of PVT in liver cirrhosis... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Portal vein thrombosis (PVT) may be associated with negative outcomes in patients with liver cirrhosis. However, the prevalence and incidence of PVT in liver cirrhosis are heterogeneous among studies and have not been sufficiently determined yet.
METHODS
The PubMed, EMBASE, and Cochrane Library databases were searched. Eligible studies would explore the prevalence and/or incidence of PVT in liver cirrhosis without hepatocellular carcinoma or abdominal surgery. Pooled proportion with 95% confidence interval (CI) was calculated using a random-effect model. Factors associated with the presence/occurrence of PVT were also extracted.
RESULTS
Among the 8549 papers initially identified, 74 were included. Fifty-four studies explored the prevalence of PVT in liver cirrhosis with a pooled prevalence of 13.92% (95%CI=11.18-16.91%). Based on cross-sectional data, Child-Pugh class B/C, higher D-dimer, ascites, and use of non-selective beta-blockers (NSBBs) were associated with the presence of PVT in liver cirrhosis. Twenty-three studies explored the incidence of PVT in liver cirrhosis with a pooled incidence of 10.42% (95%CI=8.16-12.92%). Based on cohort data, Child-Pugh class B/C, higher model of end-stage liver disease score, higher D-dimer, lower platelets count, decreased portal flow velocity, ascites, use of NSBBs, and moderate or high-risk esophageal varices could predict the occurrence of PVT in liver cirrhosis.
CONCLUSION
Approximately one seventh of cirrhotic patients have PVT, and one tenth will develop PVT. Progression of liver cirrhosis and portal hypertension seems to be in parallel with the risk of PVT. Prospective studies with detailed information about classification and extension of PVT in liver cirrhosis are needed.
Topics: Adrenergic beta-Antagonists; Ascites; Cross-Sectional Studies; Humans; Liver Cirrhosis; Portal Vein; Prospective Studies; Venous Thrombosis
PubMed: 35688747
DOI: 10.1016/j.ejim.2022.05.032 -
Physical Therapy Aug 2022No matter the practice setting, physical therapists work with patients who are at risk for or who have a history of venous thromboembolism (VTE). In 2016, the first...
No matter the practice setting, physical therapists work with patients who are at risk for or who have a history of venous thromboembolism (VTE). In 2016, the first clinical practice guideline (CPG) addressing the physical therapist management of VTE was published with support by the American Physical Therapy Association's Academy of Cardiovascular and Pulmonary Physical Therapy and Academy of Acute Care, with a primary focus on lower extremity deep vein thrombosis (DVT). This CPG is an update of the 2016 CPG and contains the most current evidence available for the management of patients with lower extremity DVT and new key action statements (KAS), including guidance on upper extremity DVT, pulmonary embolism, and special populations. This document will guide physical therapist practice in the prevention of and screening for VTE and in the management of patients who are at risk for or who have been diagnosed with VTE. Through a systematic review of published studies and a structured appraisal process, KAS were written to guide the physical therapist. The evidence supporting each action was rated, and the strength of statement was determined. Clinical practice algorithms based on the KAS were developed that can assist with clinical decision-making. Physical therapists, along with other members of the health care team, should implement these KAS to decrease the incidence of VTE, improve the diagnosis and acute management of VTE, and reduce the long-term complications of VTE.
Topics: Evidence-Based Practice; Humans; Physical Therapists; Pulmonary Embolism; Risk Factors; Upper Extremity Deep Vein Thrombosis; Venous Thromboembolism
PubMed: 35567347
DOI: 10.1093/ptj/pzac057 -
The Cochrane Database of Systematic... Apr 2023Deep vein thrombosis (DVT) is a condition in which a clot forms in the deep veins, most commonly of the leg. It occurs in approximately one in 1000 people. If left... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Deep vein thrombosis (DVT) is a condition in which a clot forms in the deep veins, most commonly of the leg. It occurs in approximately one in 1000 people. If left untreated, the clot can travel up to the lungs and cause a potentially life-threatening pulmonary embolism (PE). Previously, a DVT was treated with the anticoagulants heparin and vitamin K antagonists. However, two forms of direct oral anticoagulants (DOACs) have been developed: oral direct thrombin inhibitors (DTIs) and oral factor Xa inhibitors, which have characteristics that may be favourable compared to conventional treatment, including oral administration, a predictable effect, lack of frequent monitoring or dose adjustment and few known drug interactions. DOACs are now commonly being used for treating DVT: recent guidelines recommended DOACs over conventional anticoagulants for both DVT and PE treatment. This Cochrane Review was first published in 2015. It was the first systematic review to measure the effectiveness and safety of these drugs in the treatment of DVT. This is an update of the 2015 review. OBJECTIVES: To assess the effectiveness and safety of oral DTIs and oral factor Xa inhibitors versus conventional anticoagulants for the long-term treatment of DVT.
SEARCH METHODS
The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase and CINAHL databases and the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to 1 March 2022.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) in which people with a DVT, confirmed by standard imaging techniques, were allocated to receive an oral DTI or an oral factor Xa inhibitor compared with conventional anticoagulation or compared with each other for the treatment of DVT. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. Our primary outcomes were recurrent venous thromboembolism (VTE), recurrent DVT and PE. Secondary outcomes included all-cause mortality, major bleeding, post-thrombotic syndrome (PTS) and quality of life (QoL). We used GRADE to assess the certainty of evidence for each outcome.
MAIN RESULTS
We identified 10 new studies with 2950 participants for this update. In total, we included 21 RCTs involving 30,895 participants. Three studies investigated oral DTIs (two dabigatran and one ximelagatran), 17 investigated oral factor Xa inhibitors (eight rivaroxaban, five apixaban and four edoxaban) and one three-arm trial investigated both a DTI (dabigatran) and factor Xa inhibitor (rivaroxaban). Overall, the studies were of good methodological quality. Meta-analysis comparing DTIs to conventional anticoagulation showed no clear difference in the rate of recurrent VTE (odds ratio (OR) 1.17, 95% confidence interval (CI) 0.83 to 1.65; 3 studies, 5994 participants; moderate-certainty evidence), recurrent DVT (OR 1.11, 95% CI 0.74 to 1.66; 3 studies, 5994 participants; moderate-certainty evidence), fatal PE (OR 1.32, 95% CI 0.29 to 6.02; 3 studies, 5994 participants; moderate-certainty evidence), non-fatal PE (OR 1.29, 95% CI 0.64 to 2.59; 3 studies, 5994 participants; moderate-certainty evidence) or all-cause mortality (OR 0.66, 95% CI 0.41 to 1.08; 1 study, 2489 participants; moderate-certainty evidence). DTIs reduced the rate of major bleeding (OR 0.58, 95% CI 0.38 to 0.89; 3 studies, 5994 participants; high-certainty evidence). For oral factor Xa inhibitors compared with conventional anticoagulation, meta-analysis demonstrated no clear difference in recurrent VTE (OR 0.85, 95% CI 0.71 to 1.01; 13 studies, 17,505 participants; moderate-certainty evidence), recurrent DVT (OR 0.70, 95% CI 0.49 to 1.01; 9 studies, 16,439 participants; moderate-certainty evidence), fatal PE (OR 1.18, 95% CI 0.69 to 2.02; 6 studies, 15,082 participants; moderate-certainty evidence), non-fatal PE (OR 0.93, 95% CI 0.68 to 1.27; 7 studies, 15,166 participants; moderate-certainty evidence) or all-cause mortality (OR 0.87, 95% CI 0.67 to 1.14; 9 studies, 10,770 participants; moderate-certainty evidence). Meta-analysis showed a reduced rate of major bleeding with oral factor Xa inhibitors compared with conventional anticoagulation (OR 0.63, 95% CI 0.45 to 0.89; 17 studies, 18,066 participants; high-certainty evidence). AUTHORS' CONCLUSIONS: The current review suggests that DOACs may be superior to conventional therapy in terms of safety (major bleeding), and are probably equivalent in terms of efficacy. There is probably little or no difference between DOACs and conventional anticoagulation in the prevention of recurrent VTE, recurrent DVT, pulmonary embolism and all-cause mortality. DOACs reduced the rate of major bleeding compared to conventional anticoagulation. The certainty of evidence was moderate or high.
Topics: Humans; Anticoagulants; Antithrombins; Factor Xa Inhibitors; Rivaroxaban; Dabigatran; Venous Thromboembolism; Neoplasm Recurrence, Local; Venous Thrombosis; Pulmonary Embolism; Hemorrhage
PubMed: 37058421
DOI: 10.1002/14651858.CD010956.pub3 -
BMJ (Clinical Research Ed.) Jul 2019To determine the rate of a first recurrent venous thromboembolism (VTE) event after discontinuation of anticoagulant treatment in patients with a first episode of... (Meta-Analysis)
Meta-Analysis
Long term risk of symptomatic recurrent venous thromboembolism after discontinuation of anticoagulant treatment for first unprovoked venous thromboembolism event: systematic review and meta-analysis.
OBJECTIVES
To determine the rate of a first recurrent venous thromboembolism (VTE) event after discontinuation of anticoagulant treatment in patients with a first episode of unprovoked VTE, and the cumulative incidence for recurrent VTE up to 10 years.
DESIGN
Systematic review and meta-analysis.
DATA SOURCES
Medline, Embase, and the Cochrane Central Register of Controlled Trials (from inception to 15 March 2019).
STUDY SELECTION
Randomised controlled trials and prospective cohort studies reporting symptomatic recurrent VTE after discontinuation of anticoagulant treatment in patients with a first unprovoked VTE event who had completed at least three months of treatment.
DATA EXTRACTION AND SYNTHESIS
Two investigators independently screened studies, extracted data, and appraised risk of bias. Data clarifications were sought from authors of eligible studies. Recurrent VTE events and person years of follow-up after discontinuation of anticoagulant treatment were used to calculate rates for individual studies, and data were pooled using random effects meta-analysis. Sex and site of initial VTE were investigated as potential sources of between study heterogeneity.
RESULTS
18 studies involving 7515 patients were included in the analysis. The pooled rate of recurrent VTE per 100 person years after discontinuation of anticoagulant treatment was 10.3 events (95% confidence interval 8.6 to 12.1) in the first year, 6.3 (5.1 to 7.7) in the second year, 3.8 events/year (95% confidence interval 3.2 to 4.5) in years 3-5, and 3.1 events/year (1.7 to 4.9) in years 6-10. The cumulative incidence for recurrent VTE was 16% (95% confidence interval 13% to 19%) at 2 years, 25% (21% to 29%) at 5 years, and 36% (28% to 45%) at 10 years. The pooled rate of recurrent VTE per 100 person years in the first year was 11.9 events (9.6 to 14.4) for men and 8.9 events (6.8 to 11.3) for women, with a cumulative incidence for recurrent VTE of 41% (28% to 56%) and 29% (20% to 38%), respectively, at 10 years. Compared to patients with isolated pulmonary embolism, the rate of recurrent VTE was higher in patients with proximal deep vein thrombosis (rate ratio 1.4, 95% confidence interval 1.1 to 1.7) and in patients with pulmonary embolism plus deep vein thrombosis (1.5, 1.1 to 1.9). In patients with distal deep vein thrombosis, the pooled rate of recurrent VTE per 100 person years was 1.9 events (95% confidence interval 0.5 to 4.3) in the first year after anticoagulation had stopped. The case fatality rate for recurrent VTE was 4% (95% confidence interval 2% to 6%).
CONCLUSIONS
In patients with a first episode of unprovoked VTE who completed at least three months of anticoagulant treatment, the risk of recurrent VTE was 10% in the first year after treatment, 16% at two years, 25% at five years, and 36% at 10 years, with 4% of recurrent VTE events resulting in death. These estimates should inform clinical practice guidelines, enhance confidence in counselling patients of their prognosis, and help guide decision making about long term management of unprovoked VTE.
SYSTEMATIC REVIEW REGISTRATION
PROSPERO CRD42017056309.
Topics: Anticoagulants; Humans; Recurrence; Risk Assessment; Time; Venous Thromboembolism; Withholding Treatment
PubMed: 31340984
DOI: 10.1136/bmj.l4363 -
Annals of Medicine Dec 2023The purpose of this meta-analysis was to evaluate the postoperative clinical outcomes of elderly patients who underwent the direct anterior approach (DAA) versus those... (Meta-Analysis)
Meta-Analysis Review
Direct anterior approach versus posterolateral approach for total hip arthroplasty in the treatment of femoral neck fractures in elderly patients: a meta-analysis and systematic review.
OBJECTIVE
The purpose of this meta-analysis was to evaluate the postoperative clinical outcomes of elderly patients who underwent the direct anterior approach (DAA) versus those who received posterolateral approach (PLA) for total hip arthroplasty (THA) in the treatment of femoral neck fractures.
METHODS
An electronic search was conducted in databases including PubMed, Embase, Web of Science, the Cochrane Library, and CNKI from their inception to January 2022. We calculated the odds ratio (OR) and mean difference (MD) with 95% confidence intervals (CIs) to assess the effect of DAA compared to PLA for the management of total hip arthroplasty (THA) in elderly patients using the dichotomous or continuous method with a random or fixed-effect model.
RESULTS
15 studies involving 1284 patients were included; 640 patients receiving DAA and 644 patients receiving PLA. DAA had a longer surgery duration than PLA [WMD = 9.41, 95% CI (4.64, 14.19), =95.5%]; The amount of postoperative drainage [WMD= -3.88, 95% CI (-5.59, -2.17), =98.3%], length of incision [WMD= -3.88, 95% CI (-5.59, -2.17), =98.3%], blood loss [WMD= -3.88, 95% CI (-5.59, -2.17), =98.3%], hospitalization time [WMD= -3.88, 95% CI (-5.59, -2.17), =98.3%], and postoperative bedtime [WMD = -5.56,95% CI (-7.11, -4.01), =99.0%], were similar between the two groups ( < 0.05). The HHS at 1 month, 12 months postoperatively [WMD = 7.58, 95%CI (5.70,9.46), =89.5%; WMD= 2.56, 95%CI 0.11,5.00, =93.2%] and the incidence of LFCN in patients were higher in the DAA group (OR = 2.91, 95% CI 1.26 to 6.71, =0.0%), while fewer patients in the DAA group suffered from postoperative dislocation than in the PLA group (OR = 0.26, 95% CI 0.11 to 0.60, =0.0%). No significant difference was observed in HHS at 1 week, 3 months, and 6 months postoperatively, VAS postoperatively at each time point, acetabular anteversion angle, acetabular abduction angle, wound infection, deep vein thrombosis, and intraoperative fracture ( > 0.05).
CONCLUSIONS
DAA offers a quicker functional recovery and is less invasive with an earlier return to daily activities in older THA patients than PLA. However, DAA was found to be associated with a high incidence of lateral femoral cutaneous nerve injury and a low incidence of postoperative dislocation.Key messagesThe present study aims to evaluate the clinical outcomes in elderly patients receiving DAA versus PLA for THA in the treatment of femoral neck fractures by mate-analysis.DAA offers a quicker functional recovery and is less invasive with an earlier return to daily activities in older THA patients. No significant difference was observed between the colchicine and comparators in terms of the need for HHS at 1 week, 3 months, and 6 months postoperatively, VAS postoperatively, acetabular anteversion angle, acetabular abduction angle, and complications (wound infection, deep vein thrombosis, and intraoperative fracture).
Topics: Aged; Humans; Arthroplasty, Replacement, Hip; Femoral Neck Fractures; Treatment Outcome; Venous Thrombosis
PubMed: 37000019
DOI: 10.1080/07853890.2023.2193424 -
The American Journal of Emergency... Nov 2020Vasopressors are mainstay treatment for patients in shock and are usually infused through central venous catheters (CVCs). However, CVCs are associated with risk of... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Vasopressors are mainstay treatment for patients in shock and are usually infused through central venous catheters (CVCs). However, CVCs are associated with risk of infection or delay from the needs of confirmation of placement. Infusing vasopressor through peripheral venous catheter (PIVs) could be an alternative in the Emergency Departments (ED) but data regarding complications is inconclusive. We performed a random-effects meta-analysis to assess literature involving prevalence of complications from infusing vasopressors via PIVs.
METHODS
We searched PubMed, EMBASE and Scopus databases from beginnings to 02/02/2020 to identify relevant randomized control trials, cohort, case-control studies. We excluded case reports. Authors assessed studies' quality with Newcastle-Ottawa Scale and Cochrane Risk of Bias tool. Kappa score was used to assess interrater agreement. Outcome was complications as direct results from infusing vasopressors through PIVs.
RESULTS
We identified 325 articles and included 9 studies after reviewing 16 full text articles. Our analysis included 1835 patients whose mean age was 63 (Standard Deviation 12) years and 48% was female. There were 122 (7%) complications, of which 117 (96%) were minor. The meta-analysis with random effects showed the pooled prevalence of complications as 0.086 (95%CI 0.031-0.21). Studies reporting infusion safety guidelines had significantly lower prevalence of complications (0.029, 95%CI 0.018-0.045), compared to those not reporting a safety guideline (0.12, 95%CI 0.038-0.30, p = 0.024).
CONCLUSION
There was low prevalence of complications as a direct result from infusing vasopressors through PIVs. Studies with safety guidelines were associated with significantly lower prevalence of complications. Further studies are needed to confirm our observations.
Topics: Catheterization, Central Venous; Catheterization, Peripheral; Central Venous Catheters; Emergency Service, Hospital; Erythema; Extravasation of Diagnostic and Therapeutic Materials; Humans; Infusions, Intravenous; Intensive Care Units; Practice Guidelines as Topic; Shock; Time-to-Treatment; Vasoconstrictor Agents; Venous Thrombosis
PubMed: 33039229
DOI: 10.1016/j.ajem.2020.09.047 -
Journal of Vascular Surgery. Venous and... Jan 2021The American Venous Forum (AVF) and the Society for Vascular Surgery set forth these guidelines for the management of endothermal heat-induced thrombosis (EHIT). The...
The American Venous Forum (AVF) and the Society for Vascular Surgery set forth these guidelines for the management of endothermal heat-induced thrombosis (EHIT). The guidelines serve to compile the body of literature on EHIT and to put forth evidence-based recommendations. The guidelines are divided into the following categories: classification of EHIT, risk factors and prevention, and treatment of EHIT. One major feature is to standardize the reporting under one classification system. The Kabnick and Lawrence classification systems are now combined into the AVF EHIT classification system. The novel classification system affords standardization in reporting but also allows continued combined evaluation with the current body of literature. Recommendations codify the use of duplex ultrasound for the diagnosis of EHIT. Risk factor assessments and methods of prevention including mechanical prophylaxis, chemical prophylaxis, and ablation distance are discussed. Treatment guidelines are tailored to the AVF EHIT class (ie, I, II, III, IV). Reference is made to the use of surveillance, antiplatelet therapy, and anticoagulants as deemed indicated, and the recommendations incorporate the use of the novel direct oral anticoagulants. Last, EHIT management as it relates to the great and small saphenous veins is discussed.
Topics: Administration, Oral; Anticoagulants; Consensus; Evidence-Based Medicine; Fibrinolytic Agents; Humans; Laser Therapy; Platelet Aggregation Inhibitors; Radiofrequency Ablation; Treatment Outcome; Venous Insufficiency; Venous Thrombosis
PubMed: 33012690
DOI: 10.1016/j.jvsv.2020.06.008 -
The Cochrane Database of Systematic... Mar 2021Venous thromboembolism (VTE), although rare, is a major cause of maternal mortality and morbidity. Some women are at increased risk of VTE during pregnancy and the early... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Venous thromboembolism (VTE), although rare, is a major cause of maternal mortality and morbidity. Some women are at increased risk of VTE during pregnancy and the early postnatal period (e.g. caesarean section, family history of VTE, or thrombophilia), and so prophylaxis may be considered. As some methods of prophylaxis carry risks of adverse effects, and risk of VTE is often low, benefits of thromboprophylaxis may be outweighed by harms.
OBJECTIVES
To assess the effects of thromboprophylaxis during pregnancy and the early postnatal period on the risk of venous thromboembolic disease and adverse effects in women at increased risk of VTE.
SEARCH METHODS
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (18 October 2019). In addition, we searched ClinicalTrials.gov and the WHO International Clinical Trials Registry Platform (ICTRP) for unpublished, planned and ongoing trial reports (18 October 2019).
SELECTION CRITERIA
Randomised trials comparing one method of thromboprophylaxis with placebo or no treatment, or two (or more) methods of thromboprophylaxis.
DATA COLLECTION AND ANALYSIS
At least two review authors assessed trial eligibility, extracted data, assessed risk of bias, and judged certainty of evidence for selected critical outcomes (using GRADE). We conducted fixed-effect meta-analysis and reported data (all dichotomous) as summary risk ratios (RRs) with 95% confidence intervals (CIs).
MAIN RESULTS
Twenty-nine trials (involving 3839 women), overall at moderate to high risk of bias were included. Trials were conducted across the antenatal, peripartum and postnatal periods, with most in high-income countries. Interventions included types and regimens of heparin (low molecular weight heparin (LMWH) and unfractionated heparin (UFH)), hydroxyethyl starch (HES), and compression stockings or devices. Data were limited due to a small number of trials in comparisons and/or few or no events reported. All critical outcomes (assessed for comparisons of heparin versus no treatment/placebo, and LMWH versus UFH) were considered to have very low-certainty evidence, downgraded mainly for study limitations and imprecise effect estimates. Maternal death was not reported in most studies. Antenatal (± postnatal) prophylaxis For the primary outcomes symptomatic thromboembolic events pulmonary embolism (PE) and/or deep vein thrombosis (DVT), and the critical outcome of adverse effects sufficient to stop treatment, the evidence was very uncertain. Symptomatic thromboembolic events: - heparin versus no treatment/placebo (RR 0.39; 95% CI 0.08 to 1.98; 4 trials, 476 women; very low-certainty evidence); - LMWH versus UFH (RR 0.47; 95% CI 0.09 to 2.49; 4 trials, 404 women; very low-certainty evidence); Symptomatic PE: - heparin versus no treatment/placebo (RR 0.33; 95% CI 0.02 to 7.14; 3 trials, 187 women; very low-certainty evidence); - LMWH versus UFH (no events; 3 trials, 287 women); Symptomatic DVT: - heparin versus no treatment/placebo (RR 0.33; 95% CI 0.04 to 3.10; 4 trials, 227 women; very low-certainty evidence); - LMWH versus UFH (no events; 3 trials, 287 women); Adverse effects sufficient to stop treatment: - heparin versus no treatment/placebo (RR 0.49; 95% CI 0.05 to 5.31; 1 trial, 139 women; very low-certainty evidence); - LMWH versus UFH (RR 0.07; 95% CI 0.01 to 0.54; 2 trials, 226 women; very low-certainty evidence). Peripartum/postnatal prophylaxis Vaginal or caesarean birth When UFH and no treatment were compared, the effects on symptomatic thromboembolic events (RR 0.16; 95% CI 0.02 to 1.36; 1 trial, 210 women; very low-certainty evidence), symptomatic PE (RR 0.16; 95% CI 0.01 to 3.34; 1 trial, 210 women; very low-certainty evidence), and symptomatic DVT (RR 0.27; 95% CI 0.03 to 2.55; 1 trial, 210 women; very low-certainty evidence) were very uncertain. Maternal death and adverse effects sufficient to stop treatment were not reported. Caesarean birth Symptomatic thromboembolic events: - heparin versus no treatment/placebo (RR 1.30; 95% CI 0.39 to 4.27; 4 trials, 840 women; very low-certainty evidence); - LMWH versus UFH (RR 0.33; 95% CI 0.01 to 7.99; 3 trials, 217 women; very low-certainty evidence); Symptomatic PE: - heparin versus no treatment/placebo (RR 1.10; 95% CI 0.25 to 4.87; 4 trials, 840 women; very low-certainty evidence); - LMWH versus UFH (no events; 3 trials, 217 women); Symptomatic DVT: - heparin versus no treatment/placebo (RR 1.30; 95% CI 0.24 to 6.94; 5 trials, 1140 women; very low-certainty evidence); LMWH versus UFH (RR 0.33; 95% CI 0.01 to 7.99; 3 trials, 217 women; very low-certainty evidence); Maternal death: - heparin versus placebo (no events, 1 trial, 300 women); Adverse effects sufficient to stop treatment: - heparin versus placebo (no events; 1 trial, 140 women). Postnatal prophylaxis No events were reported for LMWH versus no treatment/placebo for: symptomatic thromboembolic events, symptomatic PE and symptomatic DVT (all 2 trials, 58 women), or maternal death (1 trial, 24 women). Adverse effects sufficient to stop treatment were not reported. We were unable to conduct subgroup analyses due to lack of data. Sensitivity analysis including the nine studies at low risk of bias did not impact overall findings.
AUTHORS' CONCLUSIONS
The evidence is very uncertain about benefits and harms of VTE thromboprophylaxis in women during pregnancy and the early postnatal period at increased risk of VTE. Further high-quality very large-scale randomised trials are needed to determine effects of currently used treatments in women with different VTE risk factors. As sufficiently large definitive trials are unlikely to be funded, secondary data analyses based on high-quality registry data are important.
Topics: Anticoagulants; Bias; Cesarean Section; Female; Heparin; Heparin, Low-Molecular-Weight; Humans; Pregnancy; Pregnancy Complications, Hematologic; Puerperal Disorders; Randomized Controlled Trials as Topic; Venous Thrombosis
PubMed: 33779986
DOI: 10.1002/14651858.CD001689.pub4 -
Journal of Vascular Surgery. Venous and... Nov 2023The aim of this study was to investigate the technical feasibility, operative techniques, safety, and efficacy outcomes of procedures aimed at correcting deep venous... (Review)
Review
OBJECTIVE
The aim of this study was to investigate the technical feasibility, operative techniques, safety, and efficacy outcomes of procedures aimed at correcting deep venous reflux, in patients with chronic venous insufficiency.
METHODS
We performed systematic literature searches in PubMed, Embase, and Web of Science from databases' inception to February 2022. We included systematic reviews, randomized controlled trials, and observational studies describing surgical procedures to treat patients with deep reflux due to primary and secondary incompetence, post-thrombotic syndrome (PTS). Proportion meta-analyses were performed for all the efficacy and safety outcomes.
RESULTS
We included 57 studies in the quantitative synthesis: three randomized controlled trials including 252 patients and 54 case series including 4004 patients. Studies included a median of 38 patients, with a mean age of 51 years; 52% of them were males. Forty percent of studies included 2291 patients with primary incompetence, 29% of studies included 595 patients with PTS, and 31% of studies included 1118 patients with both diseases. As for primary incompetence, pooled estimates for all procedures showed an 89% (95% confidence interval [CI], 82%-94%) of ulcer healing, 10% (95% CI, 4%-18%) ulcer recurrence, 98% (95% CI, 93%-100%) valve patency, 84% (95% CI, 78%-90%) valve competence, 0.05% (1/1904 patients) pulmonary embolism, 1% (95% CI, 0%-3%) wound infections, 5% (95% CI, 1%-9%) hematoma, 2% (95% CI, 0%-6%) lymphocele, 2% (95% CI, 1%-4%) thrombosis, 85% (95% CI, 74%-94%) pain improvement, 89% (95% CI, 65%-100%) edema improvement, and 85% (95% CI, 73%-93%) lipodermatosclerosis improvement. Patients with PTS showed less favorable outcomes: 82% (95% CI, 71%-91%) of ulcer healing, 18% (95% CI, 5%-36%) ulcer recurrence, 88% (95% CI, 78%-96%) valve patency, 78% (95% CI, 66%-88%) valve competence, no pulmonary embolism, 6% (95% CI, 0%-22%) wound infections, 6% (95% CI, 3%-10%) hematoma, 5% (95% CI, 1%-12%) lymphocele, 7% (95% CI, 1%-16%) thrombosis, 79% (95% CI, 59%-94%) pain improvement, 75% (95% CI, 61%-88%) edema improvement, and 64% (95% CI, 9%-100%) lipodermatosclerosis improvement.
CONCLUSIONS
The number of studies included in each meta-analysis are limited, and knowing how this element can affect the statistical power, as well as the absence of comparative control groups, it is not possible to draw definitive conclusions. Nevertheless, deep venous reconstructive surgery for reflux may increase the probability of clinical improvement in patients affected by chronic venous insufficiency. Outcomes appear to be satisfactory even if possible adjunctive procedures may be required over the course of the patient's lifetime. Consequently, a strict follow-up protocol is required to maintain outcomes. Further studies are required to evaluate deep venous reconstructive surgery for reflux particularly as to how it compares with the more recently introduced endovenous approaches.
PubMed: 37453548
DOI: 10.1016/j.jvsv.2023.07.003 -
The Cochrane Database of Systematic... Jan 2021Standard treatment for deep vein thrombosis (DVT) aims to reduce immediate complications. Use of thrombolytic clot removal strategies (i.e. thrombolysis (clot dissolving... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Standard treatment for deep vein thrombosis (DVT) aims to reduce immediate complications. Use of thrombolytic clot removal strategies (i.e. thrombolysis (clot dissolving drugs), with or without additional endovascular techniques), could reduce the long-term complications of post-thrombotic syndrome (PTS) including pain, swelling, skin discolouration, or venous ulceration in the affected leg. This is the fourth update of a Cochrane Review first published in 2004.
OBJECTIVES
To assess the effects of thrombolytic clot removal strategies and anticoagulation compared to anticoagulation alone for the management of people with acute deep vein thrombosis (DVT) of the lower limb.
SEARCH METHODS
The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL and AMED and the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registries to 21 April 2020. We also checked the references of relevant articles to identify additional studies.
SELECTION CRITERIA
We considered randomised controlled trials (RCTs) examining thrombolysis (with or without adjunctive clot removal strategies) and anticoagulation versus anticoagulation alone for acute DVT.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures as recommended by Cochrane. We assessed the risk of bias in included trials with the Cochrane 'Risk of bias' tool. Certainty of the evidence was evaluated using GRADE. For dichotomous outcomes, we calculated the risk ratio (RR) with the corresponding 95% confidence interval (CI). We pooled data using a fixed-effect model, unless we identified heterogeneity, in which case we used a random-effects model. The primary outcomes of interest were clot lysis, bleeding and post thrombotic syndrome.
MAIN RESULTS
Two new studies were added for this update. Therefore, the review now includes a total of 19 RCTs, with 1943 participants. These studies differed with respect to the thrombolytic agent, the doses of the agent and the techniques used to deliver the agent. Systemic, loco-regional and catheter-directed thrombolysis (CDT) strategies were all included. For this update, CDT interventions also included those involving pharmacomechanical thrombolysis. Three of the 19 included studies reported one or more domain at high risk of bias. We combined the results as any (all) thrombolysis interventions compared to standard anticoagulation. Complete clot lysis occurred more frequently in the thrombolysis group at early follow-up (RR 4.75; 95% CI 1.83 to 12.33; 592 participants; eight studies) and at intermediate follow-up (RR 2.42; 95% CI 1.42 to 4.12; 654 participants; seven studies; moderate-certainty evidence). Two studies reported on clot lysis at late follow-up with no clear benefit from thrombolysis seen at this time point (RR 3.25, 95% CI 0.17 to 62.63; two studies). No differences between strategies (e.g. systemic, loco-regional and CDT) were detected by subgroup analysis at any of these time points (tests for subgroup differences: P = 0.41, P = 0.37 and P = 0.06 respectively). Those receiving thrombolysis had increased bleeding complications (6.7% versus 2.2%) (RR 2.45, 95% CI 1.58 to 3.78; 1943 participants, 19 studies; moderate-certainty evidence). No differences between strategies were detected by subgroup analysis (P = 0.25). Up to five years after treatment, slightly fewer cases of PTS occurred in those receiving thrombolysis; 50% compared with 53% in the standard anticoagulation (RR 0.78, 95% CI 0.66 to 0.93; 1393 participants, six studies; moderate-certainty evidence). This was still observed at late follow-up (beyond five years) in two studies (RR 0.56, 95% CI 0.43 to 0.73; 211 participants; moderate-certainty evidence). We used subgroup analysis to investigate if the level of DVT (iliofemoral, femoropopliteal or non-specified) had an effect on the incidence of PTS. No benefit of thrombolysis was seen for either iliofemoral or femoropopliteal DVT (six studies; test for subgroup differences: P = 0.29). Systemic thrombolysis and CDT had similar levels of effectiveness. Studies of CDT included four trials in femoral and iliofemoral DVT, and results from these are consistent with those from trials of systemic thrombolysis in DVT at other levels of occlusion.
AUTHORS' CONCLUSIONS
Complete clot lysis occurred more frequently after thrombolysis (with or without additional clot removal strategies) and PTS incidence was slightly reduced. Bleeding complications also increased with thrombolysis, but this risk has decreased over time with the use of stricter exclusion criteria of studies. Evidence suggests that systemic administration of thrombolytics and CDT have similar effectiveness. Using GRADE, we judged the evidence to be of moderate-certainty, due to many trials having small numbers of participants or events, or both. Future studies are needed to investigate treatment regimes in terms of agent, dose and adjunctive clot removal methods; prioritising patient-important outcomes, including PTS and quality of life, to aid clinical decision making.
Topics: Acute Disease; Anticoagulants; Hemorrhage; Humans; Lower Extremity; Postthrombotic Syndrome; Randomized Controlled Trials as Topic; Thrombolytic Therapy; Time Factors; Treatment Outcome; Varicose Ulcer; Venous Thrombosis
PubMed: 33464575
DOI: 10.1002/14651858.CD002783.pub5