Venous thromboembolism following inpatient pediatric surgery: Analysis of 153,220 patients.
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ABSTRACT:
SUBMITTER: Sherrod BA
PROVIDER: S-EPMC6451662 | biostudies-literature | 2019 Apr
REPOSITORIES: biostudies-literature
Publications
Venous thromboembolism following inpatient pediatric surgery: Analysis of 153,220 patients.
Sherrod Brandon A BA McClugage Samuel G SG Mortellaro Vincent E VE Aban Inmaculada B IB Rocque Brandon G BG
Journal of pediatric surgery 20181010 4
<h4>Purpose</h4>To evaluate venous thromboembolism (VTE) rates and risk factors following inpatient pediatric surgery.<h4>Methods</h4>153,220 inpatient pediatric surgical patients were selected from the 2012-2015 NSQIP-P database. Demographic and perioperative variables were documented. Primary outcome was VTE requiring treatment within 30 postoperative days. Secondary outcomes included length of stay (LOS) and 30-day mortality. Prediction models were generated using logistic regression. Mortali ...[more]
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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.
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Project description:This article describes the population pharmacokinetics (PK) of dalteparin in pediatric patients with venous thromboembolism (VTE). A prospective multicenter open-label study was conducted in children who required anticoagulation for the treatment of VTE. The study population included children with and without cancer. The goal was to describe the pharmacokinetics of dalteparin using anti-Xa as a surrogate marker and to determine the dose required to achieve therapeutic anti-Xa levels (0.5-1.0 IU/mL). The anti-Xa data were supplemented with 2 published studies and analyzed using population pharmacokinetic approaches. The pharmacokinetics of dalteparin following subcutaneous injection in pediatric patients was described by a 1-compartment model with linear absorption and elimination. Body weight was added as a covariate on both CL/F and Vd/F as a power function with fixed exponents of 0.75 and 1.0, respectively. The estimates of CL/F and Vd/F in the full model were 929 mL/h and 7180 mL, respectively, for a reference female patient aged 12 years with body weight of 43 kg. Body weight-normalized CL/F decreased with age. Cancer status and sex did not have significant effects on CL/F and Vd/F. Simulations were conducted to select starting doses of dalteparin that would rapidly achieve therapeutic anti-Xa levels. These simulations suggested that the recommended starting doses of dalteparin administered subcutaneously in pediatric patients of different age cohort groups for treatment of VTE were 150 IU/kg every 12 hours (1 month to <2 years), 125 IU/kg every 12 hours (?2 to <8 years), and 100 IU/kg every 12 hours (?8 to <19 years).
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Project description:The presence of a vascular anomaly suggests that capillaries, veins, arteries, and/or lymphatic vessels have demonstrated abnormal development and growth. Often dilated and misshaped, these vessels augment normal flow of blood and lymphatic fluids that increases the overall risk to develop intralesional thrombosis. Abnormal endothelial and lymphoendothelial cells activate hemostasis and hyperfibrinolytic pathways through poorly understood mechanisms, which contribute to the development of localized intravascular coagulopathy. Vascular malformations, tumors, and complex combined syndromes demonstrate varying degrees of prothrombotic activity and consumptive coagulopathy depending on the vessels involved and the pattern and extent of abnormal growth. The clinical impact of venous thromboembolism in pediatric vascular anomalies varies from painful syndromes that disrupt quality of life to life-threatening embolic disease. There remains little literature on the study, evaluation, and treatment of thrombosis in pediatric vascular anomalies. However, there have been great advances in our ability to image complex lesions, to surgically and interventionally augment disease, and to provide enhanced supportive care including patient education, compression therapy, and strategic use of anticoagulation.
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Project description:ImportanceVenous thromboembolism (VTE), which includes deep venous thrombosis or pulmonary embolism, is the number 1 cause of preventable death in surgical patients. Current guidelines from the American College of Chest Physicians provide VTE prevention recommendations that are specific to individual surgical subspecialties; however, no guidelines exist for otolaryngology.ObjectiveTo examine the rate of VTE for various otolaryngology procedures compared with an established average-risk field (general surgery) and low-risk field (plastic surgery).Design, setting, and participantsThis cohort study compared the rate of VTE after different otolaryngology procedures with those of general and plastic surgery in the American College of Surgeons National Surgical Quality Improvement Program from January 1, 2005, through December 31, 2013. We used univariate and multivariable logistic regression analysis of clinical characteristics, cancer status, and Caprini score to compare different risk stratification of patients. Data analysis was performed from May 1, 2016, to April 1, 2017.ExposureSurgery.Main outcomes and measuresThirty-day rate of VTE.ResultsA total of 1?295?291 patients, including 31?896 otolaryngology patients (mean [SD] age, 53.9 [16.7] years; 14 260 [44.7%] male; 21 603 [67.7%] white), 27?280 plastic surgery patients (mean [SD] age, 50.5 [13.9] years; 4835 [17.7%] male; 17 983 [65.9%] white), and 1?236?115 general surgery patients (mean [SD] age, 54.9 [17.2] years; 484 985 [39.2%] male; 867 913 [70.2%] white) were compared. The overall 30-day rate of VTE was 0.5% for otolaryngology compared with 0.7% for plastic surgery and 1.2% for general surgery. We identified a high-risk group for VTE in otolaryngology (n?=?3625) that included free or regional tissue transfer, laryngectomy, composite resection, skull base surgery, and incision and drainage. High-risk otolaryngology patients experienced similar rates of VTE as general surgery patients across all Caprini risk levels. Low-risk otolaryngology patients (n?=?28?271) experienced lower rates of VTE than plastic surgery patients across all Caprini risk levels. Malignant tumors were associated with VTE; however, the rates varied by cancer type and were 11-fold greater for cancers of the upper aerodigestive tract compared with thyroid cancers (odds ratio, 10.97; 95% CI, 7.38-16.31). Venous thromboembolism was associated with a 14-fold higher 30-day mortality among otolaryngology patients (5.1% mortality with VTE vs 0.4% mortality without VTE; difference, 4.7%; 95% CI of the difference, 2.2%-9.3%).Conclusions and relevanceMost patients undergoing otolaryngology procedures are at low risk of VTE, indicating that guidelines for a low-risk population could be adapted to otolaryngology. Patients undergoing high-risk otolaryngology procedures should be considered as candidates for more aggressive VTE prophylaxis.
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Project description:ObjectiveVenous thromboembolism (VTE) is reported to occur in up to 33% of patients undergoing major vascular surgery. Despite this high incidence, patients inconsistently receive timely VTE chemoprophylaxis. The true incidence of VTE among patients receiving delayed VTE chemoprophylaxis is unknown. We sought to identify the association of VTE chemoprophylaxis timing on VTE risk, postoperative transfusion rates, and 30-day mortality and morbidity in patients undergoing major open vascular surgery.MethodsPatients undergoing major open vascular surgery (open abdominal aortic aneurysm [oAAA] repair, aortofemoral bypass, and lower extremity infrainguinal bypass [LEB]) were identified using the Michigan Surgical Quality Collaborative (MSQC) between July 2012 and June 2015. The VTE rate was compared between patients receiving early versus delayed VTE chemoprophylaxis. VTE chemoprophylaxis delay was defined as therapy initiation more than 24 hours after surgery. The risk-adjusted association of the chemoprophylaxis timing and VTE development was determined using multivariable logistic regression. Blood transfusion rates, 30-day mortality, and postoperative complications were compared across groups.ResultsA total of 2421 patients underwent major open vascular surgery, including 196 oAAA repair, 259 aortofemoral bypass, and 1966 LEB. The overall incidence of 30-day VTE was 1.40%, ranging from 1.12% for LEB to 3.57% for oAAA repair. Among patients receiving early VTE chemoprophylaxis, the rate of VTE was 0.78% versus 2.26% among those with a delay in VTE chemoprophylaxis (P = .002). When accounting for the preoperative risk of VTE, delayed chemoprophylaxis was associated with a significantly higher risk of VTE (odds ratio, 2.38; 95% confidence interval, 1.12-5.06; P = .024). The early VTE chemoprophylaxis group was associated with a significantly decreased risk of bleeding compared with those with a delay (14.31% vs 18.90%; P = .002). Overall 30-day mortality and postoperative complications were similar with the exception of an associated higher rate of infectious complications in the delayed VTE chemoprophylaxis group, including superficial surgical site infection (6.00% vs 4.06%; P = .028), pneumonia (3.25% vs 1.85%; P = .028), urinary tract infection (2.95% vs 1.57%; P = .020), and severe sepsis (3.05% vs 1.71%; P = .029).ConclusionsAlthough patients undergoing major open vascular surgery have a low risk of VTE at baseline, there is a significantly greater risk of developing VTE among patients who have a delay in the administration of VTE chemoprophylaxis. Postoperative transfusion rates were significantly lower among patients receiving early chemoprophylaxis. There were no differences in the 30-day mortality and postoperative complications, except for infectious complications. Given these findings, surgeons should consider early chemoprophylaxis in the postoperative setting after major open vascular surgery without contraindication.
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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.
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Project description:BackgroundDespite an increasing incidence of venous thromboembolism (VTE) in pediatric patients in tertiary care settings, relatively few pediatric physicians have experience with antithrombotic interventions.ObjectiveThese guidelines of the American Society of Hematology (ASH), based on the best available evidence, are intended to support patients, clinicians, and other health care professionals in their decisions about management of pediatric VTE.MethodsASH formed a multidisciplinary guideline panel that included 2 patient representatives and was balanced to minimize potential bias from conflicts of interest. The McMaster University GRADE Centre supported the guideline-development process, including updating or performing systematic evidence reviews (up to April of 2017). The panel prioritized clinical questions and outcomes according to their importance for clinicians and patients. The panel used the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach, including GRADE Evidence-to-Decision frameworks, to assess evidence and make recommendations, which were subject to public comment.ResultsThe panel agreed on 30 recommendations, covering symptomatic and asymptomatic deep vein thrombosis, with specific focus on management of central venous access device-associated VTE. The panel also addressed renal and portal vein thrombosis, cerebral sino venous thrombosis, and homozygous protein C deficiency.ConclusionsAlthough the panel offered many recommendations, additional research is required. Priorities include understanding the natural history of asymptomatic thrombosis, determining subgroup boundaries that enable risk stratification of children for escalation of treatment, and appropriate study of newer anticoagulant agents in children.
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