Venous thromboembolism risk factors and usefulness of a risk scoring system in lower limb orthopedic surgery: A case-control study in Japan.
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ABSTRACT: Abstract
We previously developed a computerized clinical decision support system based on national consensus guidelines and previous studies. This system was used to assess the risk of venous thromboembolism. In this study, we examined the risk factors for venous thromboembolism in patients who underwent lower limb orthopedic surgery using our risk scoring system, to investigate the association between the total risk score and the occurrence of venous thromboembolism.We retrospectively evaluated the records of 649 patients who underwent lower limb orthopedic surgery at a tertiary care center in Japan between January 2015 and August 2018. Venous thromboembolism was confirmed using ultrasonography or computed tomography angiography. The computerized clinical decision support system was used throughout the hospitalization period. Independent risk factors for postoperative venous thromboembolism were identified using logistic regression analysis.Age (≥68 years) was significantly associated with an increased risk of venous thromboembolism (adjusted odds ratio: 1.06, 95% confidence interval: 1.03-1.09; P < 0.001). Furthermore, the Cochran-Armitage trend test revealed a significant positive correlation between the total risk score and the occurrence of venous thromboembolism (P < 0.001).Our risk scoring system may be used preoperatively to determine the need for venous thromboembolism prophylaxis. This study suggests that age (≥68 years) may be a risk factor for venous thromboembolism after lower limb orthopedic surgery. Additional studies are needed to validate these results.
SUBMITTER: Akamine A
PROVIDER: S-EPMC8797501 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundVenous thromboembolism (VTE) causes morbidity and mortality in the general population. Several events occur after lower limb orthopedic surgery, but the contribution from various types of lower limb surgery is not well known.ObjectiveTo investigate the postoperative incidence of VTE for all types of lower extremity orthopedic surgery compared with the background population.MethodsIndividual-level linkage of Danish nationwide register data for all Danish residents with first-time orthopedic surgery of the lower limb (1996-2017) and, for each of these, four controls from the general population matched on age, sex, and history of VTE. Adjusted hazard ratios (HR) compared the postoperative risk of VTE to the matched controls.ResultsIn total 7203 of the 1 012 823 patients with a first orthopedic procedure had a VTE within 180 days after surgery, corresponding to a postoperative cumulative incidence of 0.71% (95% confidence interval [CI], 0.70-0.73). The cumulative incidence of VTE among controls was 0.11% (95% CI, 0.11-0.12). The HR of VTE within the first 30 days after surgery below knee level was 20.5 (95% CI, 17.9-23.5) compared with matched controls. The HRs of VTE after minor distal procedures (eg, meniscectomy and arthroscopies) were 2.9 (95% CI, 1.9-4.4) to 7.1 (95% CI, 6.4-8.0).ConclusionAll types of lower limb orthopedic surgery including minor distal procedures were associated with higher rates of VTE compared with matched controls, in particular within the first 30 days after surgery.
| S-EPMC7845063 | biostudies-literature
Project description:Background:Patients with lower-limb trauma requiring immobilization have an increased risk of venous thromboembolism (VTE). While thromboprophylaxis for all patients seems not effective, targeted thromboprophylaxis in high risk patients may be an appropriate alternative. Therefore, we aimed to develop and validate a risk assessment model for VTE risk: the TRiP(cast) score (Thrombosis Risk Prediction following cast immobilization). Methods:In this prediction model study, for development, data were used from the MEGA study (case-control study into the etiology of VTE) and for validation, data from the POT-CAST trial (randomized trial on the effectiveness of thromboprophylaxis following cast immobilization) were used. Model discrimination was calculated by estimating the Area Under the Curve (AUC). For model calibration, observed and predicted risks were assessed. Findings:The TRiP(cast) score includes 14 items; one item for trauma severity (or type), one for type of immobilization and 12 items related to patients' characteristics. Validation analyses showed an AUC of 0.74 (95%CI 0.61-0.87) in the complete dataset (n = 1250) and 0.72 (95%CI 0.60-0.84) in the imputed data set (n = 1435). The calibration plot shows the degree of agreement between the observed and predicted risks (intercept 0.0016 and slope 0.933). Using a cut-off score of 7 points in the POT-CAST trial (incidence 1.6%), the sensitivity, specificity, positive and negative predictive values were 76.1%, 51.2%, 2.5%, and 99.2%, respectively. Interpretation:The TRiP(cast) score provides a helpful tool in daily clinical practice to accurately stratify patients in high versus low-risk categories in order to guide thromboprophylaxis prescribing. To accommodate implementation in clinical practice a mobile phone application has been developed. Funding:ZonMW VIMP grant:17110200011.
| S-EPMC7152815 | biostudies-literature
Project description:BackgroundThromboprophylaxis for patients with non-surgical isolated lower-limb trauma requiring immobilization is a matter of debate. Our aim was to develop and validate a clinical risk- stratification model based on Trauma, Immobilization and Patients' characteristics (the TIP score).MethodsThe TIP score criteria and the cut-off were selected by a consensus of international experts (n = 27) using the Delphi method. Retrospective validation was performed in a population-based case-control study (MEGA study). The potential score's impact in anticoagulant treatment was assessed in a prospective single-center observational cohort study.FindingsAfter four successive rounds, 30 items constituting the TIP score were selected: thirteen items for trauma, three for immobilization and 14 for patient characteristics were selected, each rated on a scale of 1 to 3. In the validation database, the TIP score had an AUC of 0·77 (95% CI 0.70 to 0.85). Using the cut-off proposed by the experts (≥5) and assuming a prevalence of 1·8%, the TIP scores had a sensitivity, specificity and negative predictive values of 89·9%, 30·7% and 99·4% respectively. In the prospective cohort, 84·2% (165/196) of all the patients concerned who presented at the emergency department had a low VTE risk not requiring thromboprophylaxis according to their TIP scores. The 3-month rate of symptomatic VTE was 1/196 [95% CI 0.1-2.8] this patient was in the sub-group TIP score ≥5.ConclusionFor patients with non-surgical lower-limb trauma and orthopedic immobilization, the TIP score allows an individual VTE risk-assessment and shows promising results in guiding thromboprophylaxis.
| S-EPMC6586277 | biostudies-literature
Project description:ImportanceThe size of the risk of recurrent venous thromboembolism (VTE) after surgery in patients with a history of VTE is not well known.ObjectivesTo estimate the risk of and to identify the factors associated with recurrent VTE in patients undergoing surgery who have a history of VTE.Design, setting, and participantsThis population-based, follow-up cohort study includes patients with VTE who participated in the Multiple Environment and Genetic Assessment (MEGA) study. Original data were collected from March 1999 to April 2010. Data analysis began in June 1999 and ended in April 2010.ExposuresSurgery following a first VTE.Main outcomes and measurementsKaplan-Meier analyses were used to estimate cumulative incidences of recurrent VTE. Cox regression with a time-dependent covariate (surgery) was used to calculate the hazard ratio (HR) for developing recurrent VTE after surgery compared with no surgery.ResultsOverall, 3741 patients (mean [SD] age, 48.4 [12.8] years; 2020 [54.0%] women) with a history of VTE were included in the analysis, amounting to 18 899 person-years, with a median (interquartile range) follow-up of 5.7 (3.0-7.2) years. Of the 3741 patients, 580 (15.5%) underwent surgery and 601 (16.1%) developed a recurrent thrombotic event. The 1-month cumulative incidence of recurrent VTE for all surgery types was 2.1% (95% CI, 1.2%-3.6%), which increased to 3.3% (95% CI, 2.1%-5.1%) at 3 months and 4.6% (95% CI, 3.1%-6.6%) at 6 months. At 6 months, risk of recurrent VTE ranged from 2.3% to 9.3%, depending on surgery type. In addition to surgery type, factor V Leiden mutation (HR, 3.4; 95% CI, 1.6-7.4) and male sex (HR, 2.7; 95% CI, 1.3-5.8) were associated with increased risk of recurrent VTE.Conclusions and relevanceSurgery was associated with an increased risk of recurrent VTE in patients with a history of VTE; risk remained high for up to 6 months after the procedure. This study suggests that high-risk individuals may be identified based on surgery type, sex, and the presence of factor V Leiden mutation. These findings stress the need for revision of the current thromboprophylactic approach to prevent recurrence in these patients.
| S-EPMC6512304 | biostudies-literature
Project description:BackgroundImmobilization of the lower limb is a risk factor for venous thromboembolism (VTE). Low molecular weight heparins (LMWHs) are anticoagulants, which might be used in adult patients with lower-limb immobilization to prevent deep venous thrombosis (DVT) and its complications. This is an update of the review first published in 2008.ObjectivesTo assess the effectiveness of low molecular weight heparin for the prevention of venous thromboembolism in patients with lower-limb immobilization in an ambulatory setting.Search methodsFor this update, the Cochrane Vascular Information Specialist searched the Specialised Register, CENTRAL, and three trials registers (April 2017).Selection criteriaRandomized controlled trials (RCTs) and controlled clinical trials (CCTs) that described thromboprophylaxis by means of LMWH compared with no prophylaxis or placebo in adult patients with lower-limb immobilization. Immobilization was by means of a plaster cast or brace.Data collection and analysisTwo review authors independently selected trials, assessed risk of bias and extracted data. The review authors contacted the trial authors for additional information if required. Statistical analysis was carried out using Review Manager 5.Main resultsWe included eight RCTs that fulfilled our criteria, with a total of 3680 participants. The quality of evidence, according GRADE, varied by outcome and ranged from low to moderate. We found an incidence of DVT ranging from 4.3% to 40% in patients who had a leg injury that had been immobilized in a plaster cast or a brace for at least one week, and who received no prophylaxis, or placebo. This number was significantly lower in patients who received daily subcutaneous injections of LMWH during immobilization, with event rates ranging from 0% to 37% (odds ratio (OR) 0.45, 95% confidence interval (CI) 0.33 to 0.61; with minimal evidence of heterogeneity: I² = 26%, P = 0.23; seven studies; 1676 participants, moderate-quality evidence). Comparable results were seen in the following groups of participants: patients with below-knee casts, conservatively treated patients (non-operated patients), operated patients, patients with fractures, patients with soft-tissue injuries, and patients with distal or proximal thrombosis. No clear differences were found between the LMWH and control groups for pulmonary embolism (OR 0.50, 95% CI 0.17 to 1.47; with no evidence of heterogeneity: I² = 0%, P = 0.56; five studies, 2517 participants; low-quality evidence). The studies also showed less symptomatic VTE in the LMWH groups compared with the control groups (OR 0.40, 95% CI 0.21 to 0.76; with minimal evidence of heterogeneity: I² = 16%, P = 0.31; six studies; 2924 participants; low-quality evidence). One death was reported in the included studies, but no deaths due to pulmonary embolism were reported. Complications of major adverse events were rare, with minor bleeding the main adverse events reported.Authors' conclusionsModerate-quality evidence showed that the use of LMWH in outpatients reduced DVT when immobilization of the lower limb was required, when compared with no prophylaxis or placebo. The quality of the evidence was reduced to moderate because of risk of selection and attrition bias in the included studies. Low-quality evidence showed no clear differences in PE between the LMWH and control groups, but less symptomatic VTE in the LMWH groups. The quality of the evidence was downgraded due to risk of bias and imprecision.
| S-EPMC6483324 | biostudies-literature
Project description:Essentials Thromboprophylaxis after lower limb injury is often based on complex risk stratification. Our systematic review identified variables predicting venous thromboembolism (VTE) in this group. Age and injury type were commonly reported to increase the odds of VTE (odds ratio 1.5-3.48). We found limited evidence to support the use of other risk factors within prediction models. SUMMARY: Background Patients immobilized after lower limb injury are at risk of venous thromboembolism (VTE). There is international variation in the use of thromboprophylaxis for such patients. Risk-based strategies have been adopted to aid decision making in many settings. The accuracy of these strategies is unclear. Objectives A systematic review was undertaken to identify all individual patient-identifiable risk factors linked to any VTE outcome following lower limb immobilization. Methods Several electronic databases were searched from inception to May 2017. Any studies that included a measurement of VTE as a patient outcome in adults requiring temporary immobilization (e.g. leg cast or brace in an ambulatory setting) for an isolated lower limb injury and reported risk factor variables were included. Descriptive statistics and thematic analysis were used to synthesize the evidence. Results Our database search returned 4771 citations, of which 15 studies reporting outcome data on 80 678 patients were eligible for analysis. Risk-factor associations were reported through regression analyses, non-parametric tests and descriptive statistics. All studies were assessed as at moderate or serious risk of bias using the ROBINS-I risk of bias tool. Advancing age and injury type were the only individual risk factors demonstrating a reproducible association with increased symptomatic and/or asymptomatic VTE rates. Several risk factors currently used in scoring tools did not appear to be robustly evaluated for subsequent association with VTE within these studies. Conclusions Clinicians should be aware of the limited evidence to support individual risk factors in guiding thromboprophylaxis use for this patient cohort.
| S-EPMC6392108 | biostudies-literature
Project description:BackgroundUpper limb arthroplasty is an increasingly used treatment modality for end-stage joint disease of the shoulder, elbow and wrist. Whilst complications have been reported, the risk of venous thromboembolism has received less attention when compared to the lower limb. Guidance to aid clinical decision-making remains limited. This review aims to ascertain whether venous thromboembolism prophylaxis is beneficial after upper limb major joint replacement surgery.MethodsA systematic review was performed in April 2019, utilising EMBASE, MEDLINE, Cochrane and Google Scholar. All clinical studies reporting venous thromboembolism incidence and risk reduction (after prophylaxis) in upper limb joint replacement were included.ResultsTwenty-four observational studies were identified. The reported incidence of venous thromboembolism ranged from 0.2% to 16% (weighted mean 0.68%) and 0.2% to 0.8% (weighted mean 0.49%) in shoulder and elbow arthroplasty, respectively. No records for wrist arthroplasty were found. In the literature, baseline venous thromboembolism risk of patients without an operation is reported as 0.5%.DiscussionThere is a lack of good quality evidence regarding the risks and benefits of venous thromboembolism prophylaxis in upper limb major joint replacement surgery. We recommend further research, ideally formal randomised controlled trials to guide recommendations. Although venous thromboembolism is rare in upper limb surgery, surgeons should remain vigilant to this possibility.
| S-EPMC8039759 | biostudies-literature
Project description:We carried out a dose-response model-based meta-analysis to assess venous thromboembolism (VTE) and bleeding with factor Xa (FXa) inhibitors (apixaban, edoxaban, rivaroxaban) and a thrombin inhibitor (dabigatran) compared with European (EU) (40 mg q.d.) and North American (NA) (30 mg Q12H) dose regimens of a low molecular weight heparin (enoxaparin) following orthopedic surgery. Statistically significant differences in both VTE and bleeding outcomes were found between the NA and EU doses of enoxaparin, with odds ratios (95% confidence interval) for the NA vs. EU dose of 0.73 (0.71-0.76) and 1.20 (1.14-1.29) for total VTE and major bleeding, respectively. At approved doses, estimated odds ratios vs. both doses of enoxaparin for the three FXa inhibitors (range: 0.35-0.75 for VTE; 0.76-1.09 for bleeding) compared with those for dabigatran (range: 0.66-1.21 for VTE; 1.10-1.38 for bleeding) suggested generally greater efficacy and less bleeding for the FXa inhibitors.
| S-EPMC5504485 | biostudies-literature
Project description:BackgroundGuidelines recommend extended chemoprophylaxis for venous thromboembolism in high-risk patients having operations for inflammatory bowel disease. Quantifying patients' risk of venous thromboembolism, however, remains challenging. We sought (1) to identify factors associated with postdischarge venous thromboembolism in patients undergoing colorectal resection for inflammatory bowel disease and (2) to develop a postdischarge venous thromboembolism risk calculator to guide prescribing of extended chemoprophylaxis.MethodsPatients who underwent an operation for inflammatory bowel disease from 2012 to 2018 were identified from the American College of Surgeons National Surgical Quality Improvement Program for colectomy and proctectomy procedure targeted modules. Postdischarge venous thromboembolism included pulmonary embolism or deep vein thrombosis diagnosed after discharge from the index hospitalization. Multivariable logistic regression estimated the association of patient/operative factors with postdischarge venous thromboembolism. A postdischarge venous thromboembolism risk calculator was subsequently constructed.ResultsOf 18,990 patients, 199 (1.1%) developed a postdischarge venous thromboembolism within the first 30 postoperative days. Preoperative factors associated with postdischarge venous thromboembolism included body mass index (1.9% with body mass index ≥35 vs 0.8% with body mass index 18.5-24.9; odds ratio 2.34 [95% confidence interval 1.49-3.67]), steroid use (1.3% vs 0.7%; odds ratio 1.91 [95% confidence interval 1.37-2.66]), and ulcerative colitis (1.5% vs 0.8% with Crohn's disease; odds ratio 1.76 [95% confidence interval 1.32-2.34]). Minimally invasive surgery was associated with postdischarge venous thromboembolism (1.2% vs 0.9% with open; odds ratio 1.42 [95% confidence interval 1.05-1.92]), as was anastomotic leak (2.8% vs 1.0%; odds ratio 2.24 [95% confidence interval 1.31-3.83]) and ileus (2.1% vs 0.9%; odds ratio 2.60 [95% confidence interval 1.91-3.54]). The predicted probability of postdischarge venous thromboembolism ranged from 0.2% to 14.3% based on individual risk factors.ConclusionPreoperative, intraoperative, and postoperative factors are associated with postdischarge venous thromboembolism after an operation for inflammatory bowel disease. A postdischarge venous thromboembolism risk calculator was developed which can be used to tailor extended venous thromboembolism chemoprophylaxis by individual risk.
| S-EPMC7856037 | biostudies-literature
Project description:BackgroundTo investigate the risk factors for postoperative venous thromboembolism (VTE) in patients undergoing spinal surgery.MethodsLiterature published in PubMed, Embase, the Cochrane Library, and Web of Science was systematically reviewed to assess risk factors for VTE following spinal surgery. The data analysis was conducted with STATA 12.0. Data were pooled using fixed-effects or random-effects models according to the heterogeneity among the included studies.ResultsTwenty-six studies involving 3,216,187 patients were included in this meta-analysis, and the total incidence of VTE after spinal surgery was 0.35% (0.15-29.38%). The pooled analysis suggested that the incidence of VTE after spinal surgery was higher in such aspects as increasing age (weighted mean difference [WMD] 0.55 years, 95% confidence interval [CI] 0.33-0.78, P < .001), female sex (odds ratio [OR] 1.12, 95% CI 1.01-1.25; P = .034), diabetes (OR 1.34, 95% CI 1.29-1.44; P < .001), chronic kidney disease (OR = 8.31, 95% CI 1.98-34.93; P = .004), nonambulatory preoperative activity status (OR 3.67, 95% CI 2.75-4.83; P < .001), D-dimer level (WMD 1.023, 95% CI 0.162-1.884; P = .02), long duration of operation (WMD 0.73, 95% CI 0.21-1.24; P = .006), spine fusion (OR 1.54, 95% CI 1.31-1.82; P < .001), and blood transfusion (OR 2.31, 95% CI 1.73-3.07; P < .001), and the differences were statistically significant. However, there were no significant differences in body mass index, obesity, hypertension, coronary heart disease, spondylolisthesis, intraoperative blood loss, surgical procedures (anterior lumbar interbody fusion vs posterior intervertebral fusion /translaminar lumbar interbody fusion), or surgical site (lumbar vs thoracic) (all P > .05).ConclusionBased on our meta-analysis, we identified several important factors that increased the risk of VTE after spinal surgery. We hope our study provides assistance to spine surgeons so that they can adequately analyze and assess risk factors in patients and then develop preventive measures to reduce the incidence of VTE.
| S-EPMC7373537 | biostudies-literature