Differences In Venous Thromboembolism Rates Research Articles

Efficacy of low-dose direct oral anticoagulants (DOACs) for venous thromboembolism prophylaxis in newly diagnosed multiple myeloma.

e19521 Background: The venous thromboembolism (VTE) risk is high in newly diagnosed multiple myeloma (NDMM) patients, especially within 6 months of beginning treatment and with the use of immunomodulatory-drug (IMiD)-based regimens. SAVED and IMPEDE VTE scores assess risk and NCCN guidelines recommend their use. Few studies have explored optimal thromboprophylaxis agent by risk category which has led to varied treatment strategies. We share our institutional experience using DOACs vs aspirin in NDMM patients and explore incidence of VTE, utility of SAVED and IMPEDE scores, and patient safety. Methods: We retrospectively analyzed outcomes of NDMM patients aged 18 and above from January 2018 to June 2022. Patients receiving anticoagulation for other indications or unable to safely take aspirin or DOACs were excluded. The primary outcome was incidence of VTE in the first 6 months of treatment. Secondary outcomes included patient and treatment factors contributing to VTE risk, comparison of VTE scoring calculators: SAVED vs IMPEDE VTE, and safety of low dose DOAC therapy. Fisher’s exact and Wilcoxon rank sum tests were used to compare patient characteristics between 6-month VTE status. Results: Of 347 NDMM patients that were included, 21% experienced VTE within 6 months. Of those who took aspirin, 20.2% had 6-month VTE. For DOACs, 21.4% taking apixaban and 21.7% taking rivaroxaban had 6-month VTE. There was no significant difference in VTE rate between DOAC or ASA groups (p=0.90). Patients with SAVED score ≥2 (p<0.0006) or prior VTE history (p<0.0001) had significantly higher 6-month VTE rates . Characteristics including age>80, sex, race, BMI>25, IMPEDE score, presence of high-risk cytogenetics, existing use of aspirin or low molecular weight heparin, or transplant status showed no significant difference in VTE rate. Conclusions: This is one of the largest retrospective studies examining efficacy and safety of DOACs in NDMM. Initial analysis showed no significant difference in 6-month VTE rate between NDMM patients treated with aspirin or DOAC therapy. SAVED score appears to delineate high risk VTE patients vs IMPEDE. Follow-up will assess 12-month, 18-month, and overall VTE rates. Bleeding events and analysis for additional high-risk correlates, such as choice of induction regimen, will be presented. This highlights the need for ongoing trials evaluating risk-assigned thromboprophylaxis in patients with MM. [Table: see text]

Thromboembolic Events After Robotic Radical Cystectomy: A Comparative Analysis of Extended and Limited Prophylaxis

ObjectiveTo compare limited (only inpatient) venous thromboembolism (VTE) prophylaxis after robot-assisted radical cystectomy (RARC) to limited plus extended prophylaxis. There is little consensus on postoperative VTE prophylaxis regimens after RARC with data mostly extrapolated from other cancers. MethodsRetrospective review of all RARC patients at our center between 2014-2022, identifying two groups: patients after a prospectively implemented protocol (January 2018 to present) utilizing a prolonged 21-day postoperative course of either enoxaparin 40mg daily or apixaban 2.5mg twice daily after discharge, or patients prior to January 2018 receiving only limited VTE prophylaxis during their immediate postoperative inpatient stay. Primary outcome: incidence of symptomatic VTE confirmed with imaging within 90-days postoperatively. Secondary outcomes: major hemorrhage, complications, readmission, and mortality within 30-days postoperatively. Descriptive statistics depicted baseline patient characteristics, operative information, and complications. Differences were compared between groups. Logistic regression was used to determine associations between variables and primary outcome. ResultsEighty-six patients received limited prophylaxis and 364 received extended prophylaxis. Twelve (2.7%) patients experienced VTE within 90-days postoperatively: (10 [2.7%] extended vs. 2 [2.3%] limited, p = 0.9). Upon stratification into EAU “low-risk” or “high +intermediate-risk” groups, no statistically significant difference in VTE rates was seen between the extended or limited groups. When controlling for prophylaxis regimen, intracorporeal approach was found to be predictive of a lower with a lower risk of VTE (p = 0.019). ConclusionsLimited and extended prophylaxis showed no significant differences in VTE rates among RARC patients. Further studies are necessary for RARC patients to improve guidelines.

Aspirin is Not for Everyone: Discharge to Non-home Facilities After Total Hip and Knee Arthroplasty Increases Risk of Venous Thromboembolism

BackgroundPatients discharged to non-home facilities (NHD) after total hip arthroplasty (THA) and total knee (TKA) arthroplasty experience higher rates of adverse events and may require more aggressive venous thromboembolism (VTE) chemoprophylaxis. Our aim was to compare the rates of VTE in NHD patients and those discharged home (HD) after THA/TKA. Our secondary aim was to determine VTE rates within HD and NHD groups when stratified by chemoprophylactic regimen. MethodsA retrospective cohort of primary THA and TKA patients were stratified into HD and NHD, then allocated into groups by chemoprophylactic regimen on discharge: aspirin alone (AA), more aggressive (MA) chemoprophylaxis, and other regimens (other). The primary outcome was VTE. Rates of VTE in HD and NHD patients, as well as AA and MA regimens, were analyzed using a generalized linear regression model. ResultsSix thousand three hundred seventy-nine patients were included with 1.03% experiencing VTE. HD had lower rates of VTE compared to NHD (0.83% vs 2.17%, P < .001). AA had similar rates of VTE compared to MA (0.99% vs 1.08%, P = .82). NHD patients had a lower VTE rate with MA vs AA prophylaxis (1.47% vs 3.83%, P = .016). HD patients treated with AA vs MA had no difference in VTE rates (0.76% vs 0.96%, P = .761). ConclusionsNHD patients have higher rates of VTE than HD patients. However, NHD patients have significantly lower rates of VTE on MA chemoprophylaxis compared to those on AA. Providers should consider prescribing MA VTE chemoprophylaxis for NHD patients. Prospective, randomized studies are necessary to confirm these recommendations.

Comparison of Venous Thromboembolism Outcomes after COVID-19 and Influenza Vaccinations.

Background Published data on the risk of venous thromboembolism (VTE) with coronavirus disease 2019 (COVID-19) vaccines are scarce and inconclusive, leading to an unmet need for further studies. Methods A retrospective, multicentered study of adult patients vaccinated for one of the three approved COVID-19 vaccines in the United States of America and a pre-COVID-19 cohort of patients vaccinated for influenza at two institutions: Mayo Clinic Enterprise sites and the Medical College of Wisconsin, looking at rate of VTE over 90 days. VTE was identified by applying validated natural language processing algorithms to relevant imaging studies. Kaplan-Meier curves were used to evaluate rate of VTE and Cox proportional hazard models for incident VTE after vaccinations. Sensitivity analyses were performed for age, sex, outpatient versus inpatient status, and type of COVID-19 vaccine. Results A total of 911,381 study subjects received COVID-19 vaccine (mean age: 56.8 [standard deviation, SD: 18.3] years, 55.3% females) and 442,612 received influenza vaccine (mean age: 56.5 [SD: 18.3] years, 58.7% females). VTE occurred within 90 days in 1,498 (0.11%) of the total 1,353,993 vaccinations: 882 (0.10%) in the COVID-19 and 616 (0.14%) in the influenza vaccination cohort. After adjusting for confounding variables, there was no difference in VTE event rate after COVID-19 vaccination compared with influenza vaccination (adjusted hazard ratio: 0.95 [95% confidence interval: 0.85-1.05]). No significant difference in VTE rates was observed between the two cohorts on sensitivity analyses. Conclusion In this large cohort of COVID-19-vaccinated patients, risk of VTE at 90 days was low and no different than a pre-COVID-19 cohort of influenza-vaccinated patients.

Outcomes from a prospectively implemented protocol using apixaban after robot-assisted radical cystectomy.

To compare the safety and efficacy of oral apixaban with that of injectable enoxaparin after robot-assisted radical cystectomy (RARC) for venous thromboembolism (VTE) thromboprophylaxis. We conducted a retrospective review of prospectively collected data for all RARC patients treated at our tertiary care centre between 2018 and 2022. The study included two groups: patients who were subject to a prospectively implemented protocol from October 2021 to the present, comprising a 21-day postoperative course of apixaban 2.5 mg twice daily after discharge, and patients treated prior to October 2021 who received enoxaparin 40 mg daily. Baseline demographics and clinical characteristics, such as VTE (defined as deep vein thrombosis and pulmonary embolism), were analysed. The primary outcome was incidence of symptomatic VTE confirmed with definitive imaging within 90 days of RARC. Secondary outcomes included major bleeding, complications, readmission, and mortality within 30 days postoperatively. Descriptive statistics included baseline patient characteristics, operative information and complications. Differences in baseline characteristics and postoperative data were compared between groups. Multivariate logistic regression was used to determine associations between variables and the primary outcome. A total of 124 patients received apixaban and 250 patients received enoxaparin prophylaxis. Ten patients (2.7%) experienced a VTE within 90 days postoperatively (two [1.6%] apixaban group vs eight [3.2%] enoxaparin group; P = 0.5). After patient stratification into European Association of Urology risk groups, no statistically significant difference in VTE rates was seen between groups in the apixaban (2.7% high- + intermediate-risk group vs 1.1% low-risk group; P = 0.5) and enoxaparin cohorts (4.3% high- + intermediate-risk group vs 2.5% low-risk group; P = 0.5). On multivariate logistic regression, no variables were associated with the development of the primary outcome. Prophylaxis with apixaban and enoxaparin showed no statistically significant differences in VTE rates among RARC patients. Apixaban appears to be safe and effective for VTE prophylaxis after RARC.

Impact of Institutional Prophylaxis Guidelines on Rates of Pediatric Venous Thromboembolism Following Trauma - a Multicenter Study from the Pediatric Trauma Society Research Committee.

A paucity of data exists with regard to the incidence, management, and outcomes of venous thromboembolism (VTE) in injured children. We sought to determine the impact of institutional chemoprophylaxis guidelines on VTE rates in a pediatric trauma population. A retrospective review of injured children (<15 years) admitted between 2009-2018 at ten pediatric trauma centers was performed. Data was gathered from institutional trauma registries and dedicated chart review. The institutions were surveyed as to whether they had chemoprophylaxis guidelines in place for high risk pediatric trauma patients, and outcomes were compared based on the presence of guidelines using chi-square analysis (p < 0.05). 45,202 patients were evaluated during the study period. Three institutions (28,359 patients, 63%) had established chemoprophylaxis policies during the study period ("Guidelines"); the other seven centers (16,843 patients, 37%) had no such guidelines ("Standard"). There were significantly lower rates of VTE in the Guidelines group, but these patients also had significantly fewer risk factors. Amongst critically injured children with similar clinical presentations, there was no difference in VTE rate. Specifically within the Guidelines group, 30 children developed VTE. The majority (17/30) were actually not indicated for chemoprophylaxis based on institutional guidelines. Still, despite protocols only one VTE patient in the Guidelines group who was indicated for intervention ended up receiving chemoprophylaxis prior to diagnosis. No consistent ultrasound screening protocol was in place at any institution during the study. The presence of an institutional policy to guide chemoprophylaxis for injured children is associated with a decreased overall frequency of VTE, but this disappears when controlling for patient factors. However, the overall efficacy is impacted by a combination of deficits in guideline compliance and structure. Further prospective data is needed to help determine the ideal role for chemoprophylaxis and protocols in pediatric trauma.Level IV, therapeutic/care management.

Low-Dose Heparin Infusion as Venous Thromboembolism Chemoprophylaxis in Patients With Blunt Cerebrovascular Injury

IntroductionBlunt cerebrovascular injury (BCVI) can result in devastating stroke. Because of operative inaccessibility, the most common treatment for BCVI is aspirin or a low-dose systemic heparin infusion. While it is assumed that low dose heparin infusion imparts venous thromboembolism (VTE) prophylaxis, this has not been evaluated in the BCVI population. The purpose of this study was to evaluate VTE rates in patients receiving low-dose heparin infusion as treatment for BCVI. MethodsPatients diagnosed with BCVI between 2014 and 2018 were reviewed for initiation of low-dose systemic heparin treatment. VTE was defined as a deep vein thrombosis or pulmonary embolism. BCVI patients without systemic heparin treatment were compared to BCVI patients with heparin treatment for overall VTE rates. Comparisons were also made to injured patients without a BCVI in our Trauma Activation Protocol (TAP) database. ResultsDuring the 5-year study period, 265 patients were identified with a BCVI. The majority (61%) were men with a median injury severity score (ISS) 22 (interquartile range [IQR]:14-33). Of these patients, 146 (55.1%) received a heparin infusion to treat BCVI. VTE was identified in eight of these patients (5.5%). Compared to TAP patients (n = 1020) who received standard dosing of VTE chemoprophylaxis, there was no difference in VTE rates compared to BCVI patients who were started on a low dose heparin infusion (3% versus 5.5%, P = 0.16). Area under the receiver operating characteristics (AUROC) was used to evaluate the predictive power of time to initiation of heparin infusion (AUC = 0.64 95% CI 0.42-0.85, P = 0.2) and time to reaching PTT goal (AUC = 0.52 95% CI 0.27-0.77, P = 0.83) as a predictor VTE events. ConclusionsLow dose heparin infusion is frequently used as an initial treatment of BCVI. In injured patients with BCVI, a low dose heparin infusion is associated with a low rate of VTE, comparable to injured patients without BCVI that received standard VTE chemoprophylaxis.

822: COMPARISON OF CHEMOPROPHYLACTIC AGENT SELECTION ON VENOUS THROMBOEMBOLISM IN LARGE BURN PATIENTS

Introduction: Burn patient venous thromboembolism (VTE) rates can range from 0.2 to 43%, with chemical thromboprophylaxis shown to independently decrease mortality. There is a paucity of data on effectiveness, safety, and appropriateness of agent selection for patients with large burns. Methods: This retrospective cohort study included adult patients (age ≥18) with large burns (total body surface area, TBSA ≥15%) who were admitted to a Regional Burn Center. Patients were excluded if they had therapeutic anticoagulation resumed within 24 hours of admission, VTE chemoprophylaxis agent switched within the first 48 hours, VTE chemoprophylaxis delayed ≥48 hours of admission, death or comfort care within 48 hours of admission. The primary outcome compared VTE rates between patients receiving chemoprophylaxis with subcutaneous heparin versus enoxaparin. Patient groups were categorized by the first chemoprophylaxis agent administered for 48 hours. Secondary outcomes identified rate of switching chemoprophylactic agents and incidence of therapeutic anticoagulation orders. Safety outcomes compared heparin-induced thrombocytopenia, in-hospital mortality, and number of transfusions. Results: A total of 50 patients (enoxaparin, n=35; heparin, n=15) were included. There were no differences in baseline characteristics. VTE incidence was not statistically significantly different between enoxaparin and heparin (1 [2.9%] vs 2 [13.3%], p=0.21). Subgroup analysis of TBSA 15% to 30% and TBSA >30% found no difference in rates of VTE between enoxaparin and heparin. No difference was found between enoxaparin and heparin for rates of switching chemoprophylactic agent (10 [28.6%] vs 3 [20%], p=0.73), for full dose anticoagulation orders (3 [8.6%] vs 3 [20%], p=0.35), or HIT positive tests (1 [14.3%] vs 2 [22.2%], p=1.0). Compared to the enoxaparin group, patients receiving heparin had higher in-hospital mortality (6 [17.1%] vs 7 [46.7%], p< 0.05). There was no difference in transfusions between groups. Conclusions: VTE rates were similar in adult patients with large burns regardless of chemoprophylactic agent selection. Larger studies are necessary to confirm the impact of chemoprophylaxis choice and timing of initiation on VTE incidence.

Implementing guidelines for risk-stratified thromboprophylaxis among gynecologic oncology patients: A quality improvement initiative

Objective(s)Risk-stratified thromboprophylaxis is recommended for oncology patients with a Khorana risk score (KS) ≥ 2 receiving cancer-directed therapy. We describe a quality improvement (QI) initiative designed to increase adherence to thromboprophylaxis guidelines for patients with gynecologic malignancies initiating outpatient treatment. MethodsProvider awareness and documentation of venous thromboembolism (VTE) risk assessment and thromboprophylaxis eligibility were identified as key QI drivers. Starting May 2021, a KS calculator and thromboprophylaxis algorithm were incorporated into outpatient documentation templates. Patients with gynecologic malignancies initiating outpatient therapy from January – December 2021 were eligible. The primary process measure was the percentage of patients with KS eligibility documented each month during the baseline (Jan – Apr) versus implementation (May – Dec) periods. Rate of appropriate thromboprophylaxis initiation and incidence of VTE served as outcome measures. Incidence of adverse bleeding events served as the balancing measure. Results337 patients accounted for the initiation of 383 treatment regimens, including 128 in the baseline period and 255 in the implementation period. KS documentation increased significantly between the baseline and implementation periods (7% vs 62.4%, p < 0.001). 73 of the 177 eligible patients (46.2%; 166 unique patients) had appropriate documentation; of these, 57 initiated thromboprophylaxis. There was no difference in VTE rates or adverse bleeding events between eligible patients who initiated thromboprophylaxis compared with those who did not (12.3% vs 15.6%; p = 0.65 and 7.0% vs 8.2%; p = 1.0, respectively). Conclusion(s)This QI initiative resulted in greater adherence to risk-stratified thromboprophylaxis guidelines. No bleeding signals were identified. Studies addressing cost, medication adherence, and long-term outcomes are necessary.

No Difference in Venous Thromboembolism Outcomes after COVID-19 and Influenza Vaccinations

Background: Despite several large studies showing no increased risk for overall venous thromboembolism (VTE) after COVID-19 vaccination, lingering concern remains among some patients and physicians. This may be due to large observational studies that have shown higher rates of VTE after COVID-19 vaccination compared to influenza vaccinations. Methods: The aim of this study was to compare VTE rates after COVID-19 and influenza vaccinations in a large cohort in the United States with robust multivariable adjustment of comorbidities to exclude residual confounding. Adult COVID-19 vaccinated (Pfizer, Moderna, or Janssen) patients between 11/1/2020 and 11/1/2021 and influenza vaccinated patients between 7/1/2019 and 4/1/2020 were analyzed using electronic medical records. The primary outcome was imaging confirmed acute VTE (upper or lower extremity deep vein thrombosis or pulmonary embolism) occurring within 90-days after the vaccination. Results: A total of 1,146,024 vaccinations were identified with influenza (N=354,015) or COVID-19 vaccines (n=792,009: Pfizer, n= 452,950, Moderna, n= 290,606, and Janssen (Johnson & Johnson), n= 48,453). The mean age of patients with COVID-19 and influenza vaccinations was numerically similar (56.8 vs 57.0). Most vaccinated patients were female (56.1%), and most were white (88.6%). Small, but statistically significant differences were found in nearly all baseline comorbidities between the two types of vaccines (Table 1). Mean Charlson comorbidity scores were higher in influenza vaccinated patients compared to COVID-19 vaccinated patients (1.53 vs 1.34, p<0.001). In the 90 days after vaccination, a total of 443 VTE events occurred after influenza vaccination and 793 occurred after COVID-19 vaccination (0.13% vs 0.10%, p<0.001). The unadjusted hazard ratio (HR) demonstrated a higher risk of VTE after influenza vaccination when compared to COVID-19 vaccinations (HR 1.22, 95% CI 1.08-1.37). The time to first VTE by type of vaccine is shown in the Figure. After multivariable adjustment (all significant comorbidity differences in Table) there was no statistically significant difference in VTE rates between the COVID-19 and influenza vaccines (aHR 0.97, 95% CI 0.83-1.13). Conclusion: In this large cohort of COVID-19 vaccinated patients in the United States, the risk of VTE after vaccination after accounting for differences in comorbidities was no different than a pre-COVID-19 historical cohort of influenza vaccinated patients. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

Extended postoperative thromboprophylaxis after pancreatic resection for pancreatic cancer is associated with decreased risk of venous thromboembolism in the minimally invasive approach.

Pancreatic ductal adenocarcinoma (PDAC) is associated with increased venous thromboembolism (VTE). We sought to compare rates of bleeding complications and VTE in patients receiving extended postoperative thromboprophylaxis (EPT) to those who did not, and identify risk factors for VTE after pancreatectomy for PDAC. This is a retrospective review of pancreatectomies for PDAC. EPT was defined as 28 days of low molecular weight heparin. Multivariable analysis (MVA) was performed to identify independent risk factors of VTE. Of 269 patients included, 142 (52.8%) received EPT. Of those who received EPT, 7 (4.9%) suffered bleeding complications, compared to 6 (4.7%) of those who did not (p = 0.938). There was no significant difference in VTE rate at 90 days (2.8% vs. 2.4%, p = 0.728) or at 1 year (6.3% vs. 7.9%, p = 0.624). On MVA, risk factors for VTE included worse performance status, lower preoperative hematocrit, R1/R2 resection, and minimally invasive (MIS) approach. Among those who received EPT, there was no difference in VTE rate between MIS and open approach. EPT was not associated with a difference in VTE risk or bleeding complications. MIS approach was associated with a higher risk of VTE; however, this was significantly lower among those who received EPT.

Effect of knee arthroscopy on subsequent total knee arthroplasty: Meta-analysis

To evaluate effect of knee arthroscopy on prognosis of subsequent total knee arthroplasty (total knee arthroplasty, TKA) by Meta-analysis. Databases including PubMed, Embase, Cochrane Library, CNKI, Wanfang and other databases were searched by computer from establishing to October 2020 to collect literatures on effect of knee arthroscopy on prognosis of subsequent TKA. Quality evaluation and data extraction were carried out according to inclusion, exclusion criteria and literature screening. Newcastle-Ottawa Scale (NOS) was used to evaluate literature quality of non-randomized controlled studies. RevMan 5.3 software was applied to Meta-analysis on revision rate, reoperation rate, postoperative stiffness rate, periprosthetic infection rate, postoperative venous thrombosis venous thromboembolism(VTE) rate and postoperative knee flexion range of motion after TKA. Eight literatures were finally included with totally sample size of 182 815 patients. Among them, 6 998 patients were in knee arthroscopy group and 175 817 patients were in knee arthroscopy group. Meta-analysis results showed that there were statistical differences in revision rate after TKA[OR=1.66, 95%CI(1.37, 2.00), P<0.000 01], re-operation rate[OR=2.31, 95%CI(1.59, 3.36), P<0.000 1], postoperative stiffness rate[OR=1.78, 95%CI(1.02, 3.11), P=0.04] and infection rate around prosthesis[OR=1.40, 95%CI(1.19, 1.66), P<0.000 1]. While there were no difference in VTE rate[OR=1.06, 95%CI(0.83, 1.35), P=0.64], postoperative knee flexion range of motion[MD=-1.21, 95%CI(-3.07, 0.65), P=0.20]. Knee arthroscopy has a negative impact on subsequent TKA surgery. Previous arthroscopic increased risk of stiffness, periprosthetic joint infection, revision and reoperation after TKA, but there was no significant difference in postoperative knee flexion range of motion and incidence of VTE.

Aspirin May Be a Suitable Prophylaxis for Patients with a History of Venous Thromboembolism Undergoing Total Joint Arthroplasty.

In recent years, aspirin has become a popular agent for venous thromboembolism (VTE) prophylaxis following total joint arthroplasty (TJA). Yet patients with a history of VTE are often given more aggressive prophylactic agents because of their increased baseline risk. The purpose of this study was to assess whether aspirin is an effective prophylactic agent in patients with a history of VTE. This was a single-institution, retrospective cohort study. The electronic clinical records of 36,333 patients undergoing TJA between 2008 and 2020 were reviewed. Data on demographic characteristics, comorbidities, intraoperative factors, and postoperative complications were collected. A propensity score-matched analysis was performed, as well as a multivariate regression analysis to account for confounders. Of the 36,333 patients undergoing TJA, 1,087 patients (3.0%) had a history of VTE and were not receiving chronic non-aspirin. The risk for subsequent VTE was significantly higher (p = 0.03) in patients with a history of VTE (1.4%) compared with patients without prior VTE (0.9%). However, the incidence of VTE was not significantly lower (p = 0.208) in patients with a history of VTE who received aspirin (0.4%) compared with patients who received other VTE prophylaxis (1.5%). Propensity score matching showed no difference in VTE rates between the 2 groups (2.2% compared with 0.55%; p = 0.372). In a regression analysis accounting for VTE risk, the administration of aspirin was not associated with an increased risk for subsequent VTE (adjusted odds ratio, 0.32 [95% confidence interval, 0.02 to 1.66]; p = 0.274). Our findings suggest that, although patients with a history of VTE have an increased baseline risk for subsequent VTE, aspirin may be a suitable VTE prophylaxis in this group of patients. Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Compression following treatment of superficial venous incompetence: systematic review.

International guidelines recommend postprocedural compression when treating symptomatic superficial venous incompetence (SVI). This updated review of RCTs investigated the requirement for postprocedural compression and how it can be applied optimally. The National Institute for Health and Care Excellence's Healthcare Databases Advanced Search engine was used to identify all English-language RCTs of compression following treatment for SVI. Outcomes of interest included postprocedural pain, venous thromboembolism, health-related quality of life (HRQoL), and anatomical occlusion. A total of 18 studies were included comprising some 2584 treated limbs. Compression was compared with no compression in four studies, nine studies compared different durations of compression, and a further five compared different types of compression. A 1-2-week period of compression was associated with a mean reduction of 11 (95 per cent c.i. 8 to 13) points in pain score on a 100-mm visual analogue scale compared with a shorter duration (P < 0.001). This was associated with improved HRQoL and patient satisfaction. Longer durations of compression did not add further benefit. There was low-quality evidence suggesting that 35-mmHg compression with eccentric thigh compression achieved lower pain scores than lower interface pressures. There were no significant differences in venous thromboembolism rates or technical success in any group, including no compression. Postprocedural compression of 1-2 weeks after SVI treatment is associated with reduced pain compared with a shorter duration. The optimal interface pressure and type of compression, and the impact on venous thromboembolism risk, remain to be determined.

First-Line Osimertinib in Patients with EGFR-Mutant Advanced Non-Small Cell Lung Cancer: Outcome and Safety in the Real World: FLOWER Study.

Osimertinib became the standard treatment for patients with untreated EGFR-mutant advanced non-small cell lung cancer (aNSCLC) following results reported in the phase III randomized FLAURA trial. Because of strict exclusion criteria, patient populations included in pivotal trials are only partially representative of real-world patients. We designed an observational, prospective, multicenter study enrolling patients with EGFR-mutant aNSCLC receiving first-line osimertinib to evaluate effectiveness, safety, and progression patterns in the real-world. At data cutoff, 126 White patients from nine oncology centers were included. At diagnosis, 16 patients (12.7%) had a performance status (PS) ≥2 and 38 (30.2%) had brain metastases. Overall response rate (ORR) was 73%, disease control rate (DCR) 96.0%. After a median follow-up of 12.3 months, median time to treatment discontinuation (mTTD) was 25.3 months, median progression-free-survival (mPFS) was 18.9 months and median overall survival (mOS) was not reached (NR). One hundred and ten patients (87%) experienced adverse events (AEs), 42 (33%) of grade 3-4, with venous thromboembolism (VTE) as the most common (n = 10, 7.9%). No difference in rates of VTE was reported according to age, PS, comorbidity, and tumor load. We observed longer mTTD in patients without symptoms (NR vs. 18.8 months) and with fewer than three metastatic sites at diagnosis (NR vs. 21.4 months). Patients without brain metastases experienced longer mPFS (NR vs. 13.3 months). No difference in survival outcome was observed according to age, comorbidity, and type of EGFR mutation. Isolated progression and progression in fewer than three sites were associated with longer time to treatment discontinuation (TTD). Osimertinib confirmed effectiveness and safety in the real world, although thromboembolism was more frequent than previously reported.

QS5: Extended Venous Thromboembolism Prophylaxis May Not Be Necessary For DIEP Flap Breast Reconstruction

Purpose:Based on the 2005 Caprini Risk Assessment Model (RAM) for venous thromboembolism (VTE), the American Society of Plastic Surgeons (ASPS) established prevention guidelines in 2011 recommending one week of postoperative chemoprophylaxis for patients scoring between 3 and 6 and extended anticoagulation (up to four weeks) for patients scoring 7 or higher after a major procedure. Most patients who undergo deep inferior epigastric perforator (DIEP) flap breast reconstruction, while generally healthier than high-risk patient subgroups (e.g., head/neck cancer patients) in plastic surgery, would similarly be deemed high risk. At our institution, we avoid the blanket application of prolonged anticoagulation, and instead favor individualized regimens based on the patient’s unique risk factors and perioperative course, resulting in an overall limited use of chemoprophylaxis. The aim of this study is to describe our institutional experience in thromboembolism prevention and to assess the necessity of extended prophylaxis in DIEP flap patients.Methods:Patients who underwent DIEP flap reconstruction from August 2011 to March 2020 by one attending plastic surgeon were included. Charts were retrospectively reviewed looking at patient demographics, VTE prophylaxis regimens, and development of postoperative complications including deep vein thrombosis (DVT) and pulmonary embolism (PE) within 60 days of surgery. Patients were considered positive for DVT or PE if diagnosed radiographically on ultrasound or CT scan, respectively. Caprini scores were calculated for all patients.Results:249 patients (439 flaps) were included in this study, with an average age of 50.6 and an average BMI of 27.1 kg/m2. Four patients had a history of thrombotic events. In terms of indication for procedure, 237 patients had a confirmed diagnosis of breast cancer, ten had a genetic predisposition, one had a congenitally absent breast, and one required reconstruction for acquired breast deformity. Out of the 249 patients in the cohort, 245 patients received chemoprophylaxis with unfractionated heparin only during hospitalization (average length of stay, 3.3 days), while four patients were additionally anticoagulated with enoxaparin for at least two weeks after discharge. The cohort’s average Caprini score was 6.0, with 72.7 percent of patients scoring between 3 and 6 and 26.5 percent of patients scoring 7 or higher. One patient, who scored a 7 and received limited prophylaxis, developed DVT postoperatively in the left femoral and popliteal veins. There were no cases of PE. There was no significant difference in VTE rate between patients who received chemoprophylaxis consistent with ASPS guidelines (0%, n=8) and those who did not (0.4%, n=241) (p=0.86).Conclusions:Despite our limited use of chemoprophylaxis, our overall VTE incidence of 0.4 percent is low compared to other published rates in literature. Presenting the largest institutional cohort of DIEP flap patients to date in the analysis of postoperative VTE, this current work suggests that extended prophylaxis may not be warranted, and it further serves as impetus to re-evaluate the 2005 Caprini RAM in this subgroup of plastic surgery patients.

Impact of Weight-Band Dosing of Tinzaparin for Venous Thromboembolism Prophylaxis on Persistent Wound Drainage in Adult Patients Undergoing Hip and Knee Arthroplasty.

Persistent wound drainage and venous thromboembolism (VTE) are potential complications of total joint arthroplasty, and these risks can be challenging to balance in clinical practice. Anecdotal observation has suggested that following joint arthroplasty, persistent wound drainage occurs more frequently with higher body weight and higher doses of tinzaparin when compared with lower body weight and lower doses of tinzaparin. The overall purpose of this study was to describe the impact of a tinzaparin weight-band dosing table for VTE prophylaxis on wound healing, thrombosis, and bleeding outcomes in patients undergoing total joint arthroplasty. This retrospective chart review included patients who underwent total hip or knee arthroplasty and received tinzaparin for thromboprophylaxis per their weight-banding category. The primary outcome was the incidence of persistent wound drainage. Secondary outcomes include the occurrence of VTE and clinically important bleeding during hospital admission. A total of 231 patients were included in the analysis. There was no significant difference in persistent wound drainage between the 3 weight categories, and there were no differences in rates of VTE or clinically important bleeding. Concurrent use of low-dose acetylsalicylic acid was associated with a 3-fold increased risk of persistent wound drainage (risk ratio = 3.35; 95% CI = 2.14-5.24; P = 0.00003). In joint arthroplasty patients, we observed no significant difference in rates of persistent wound drainage between various weight categories receiving different weight-banded doses of tinzaparin. Our results do not suggest that the current weight-band dosing table for tinzaparin needs to be adjusted to optimize patient outcomes.

Venous Thromboembolism After Pelvic Osteotomy in Adolescent Patients: A Database Study Characterizing Rates and Current Practices.

Current risks and practices in medical prophylaxis of venous thromboembolism (VTE) after major elective lower extremity surgeries such as pelvic osteotomies have not been well-defined in the pediatric population. The purpose of this study was to (1) evaluate population rates of VTE in adolescents undergoing pelvic osteotomies, and (2) characterize current practices on types of VTE prophylaxis being utilized after pelvic osteotomies. The study evaluated the Pediatric Health Information System database between October 1, 2015 and January 1, 2020 for patients between 10 and 18 years of age meeting selected ICD-10 procedure and diagnosis codes relating to pelvic osteotomies. The rate of VTE was calculated within 90 days of index procedure. Types of pharmacologic prophylaxis were characterized. Continuous variables were compared with 2-sample t tests; proportions and categorical variables were compared with Fisher exact or χ2 tests, all with 2-tailed significance <0.05. Of 1480 included patients, 9 were diagnosed with VTE within 90 days of surgery (VTE rate: 0.61%). Four of 9 (44.4%) had received pharmacologic prophylaxis postoperatively. There were no differences in baseline demographics or length of stay between patients that did or did not develop VTE (P>0.05). Overall, 52.0% received at least one form of pharmacologic prophylaxis postoperatively. The most common pharmacologic prophylaxis used was aspirin (47.6%), of which 64.4% received 81 mg dosing. There was no difference in VTE rates in those with or without prophylaxis (0.52% vs. 0.70%, P=0.75). However, those prescribed prophylaxis were significantly older (15.2±2.3 vs. 13.6±2.4 y, P<0.0001) and had a higher proportion of females (71.8% vs. 54.6%, P<0.01). The overall rate of VTE in pediatric patients after pelvic osteotomies is non-negligible. There is heterogeneity in the type of anticoagulant utilized; however, VTE prophylaxis is most commonly prescribed in older adolescents and female patients. Guidelines for medical prevention of deep venous thrombosis and pulmonary embolism in the pediatric population are warranted after hip preservation surgery. Level IV, case series.

A184 INCIDENCE OF VENOUS THROMBOTIC EVENTS AND RISK FACTORS IN CHILDREN HOSPITALIZED WITH INFLAMMATORY BOWEL DISEASE: A RETROSPECTIVE, CASE-CONTROL STUDY

Abstract Background Limited research has been published to describe the incidence of venous thromboembolism (VTE) and relevant risk factors in Canadian children with inflammatory bowel disease (IBD). Aims The present study aimed to investigate the incidence of VTE amongst hospitalized pediatric IBD patients over a 10-year period and identify risk factors for the development of VTE. Methods A retrospective, matched case-control study was performed at McMaster Children’s Hospital. Hospitalized pediatric patients with IBD (&amp;lt;18 years old) from September 2009 to August 2020 were selected. Inpatient data was extracted from the medical record database, including baseline demographic data, thromboembolic events and potential risk factors for VTE. Results There were 890 hospitalizations of IBD patients during the study period. 15 (1.69%) were diagnosed with a VTE, including 4 males and 11 females (mean age 13.4±2.9 years old). 12 ulcerative colitis (UC) (80%) and 3 Crohn’s disease (CD) (20%) hospitalizations were comprised in the VTE group. There was a significant difference in VTE rate between females (2.7%) and males (0.8%) (P = 0.03). The VTE rate in the UC group (4.2%) was significantly higher than in the CD group (0.6%) (P = 0.001). The incidence of VTE amongst hospitalized IBD patients did not vary over the 10-year period (P = 0.496). Length of stay in hospital, albumin level and central venous catheter were shown to be significantly different, although they were not identified as independent risk factors (P &amp;gt;0 .05). Of the 15 hospitalizations with VTE, 6/15 (40%) were superficial VTEs in the extremities and 9/15 (60%) had a deep vein thrombosis (DVT) including 6 in the extremities and 3 in the abdomen. VTEs were associated with a peripheral line in 7 patients and with a PICC line in 4 hospitalizations. 2 of 9 (22%) with extremity DVT developed symptomatic pulmonary embolism. An inherited thrombotic condition was identified in 2 of 15 with VTEs. 12/15 (80%) with VTEs were symptomatic and all VTE related symptoms happened in patients with extremity thrombosis and pulmonary embolism. 7 of 15 (47%) VTEs were treated with anticoagulation therapy for 1–6 months. VTE related symptoms and repeat imaging tests significantly improved, and no patient developed a bleeding complication as a result of treatment. Conclusions The VTE rate in pediatric IBD patients was relatively low at McMaster Children’s hospital. Children with VTE were disproportionately females with ulcerative colitis compared with children with no VTE. Central venous line insertion may be correlated with the risk for VTE in children with IBD. Most VTEs and related symptoms happened in patients with extremity thrombosis and secondary pulmonary embolus. Anticoagulation therapy in children with IBD with active disease appears to be safe. Funding Agencies Kids Dig Health Funding from McMaster Children’s Hospital, McMaster University

Tranexamic Acid Is Safe in Patients with a History of Coronary Artery Disease Undergoing Total Joint Arthroplasty.

Tranexamic acid (TXA) is increasingly used to minimize blood loss during total joint arthroplasty (TJA). Although TXA has been shown to be highly effective in reducing operative blood loss, many surgeons believe that it places patients with coronary artery disease (CAD) or a history of coronary stents at an increased risk for myocardial infarction. The purpose of this study was to determine if TXA is safe to use in patients with a history of CAD or coronary stents. We performed a retrospective analysis at a single, tertiary academic medical center identifying consecutive total hip and knee arthroplasty cases over an 8-year period. From this cohort who received TXA intraoperatively, we identified patients with a history of CAD or coronary stents and determined the total myocardial infarction and venous thromboembolism (VTE) rates within a 90-day postoperative period. Chi-square analyses were used to identify differences in VTE rates between cohorts. A post hoc power analysis was also performed to determine whether our results were powered to detect a difference in VTE rates. In the 26,808 identified at-risk patients, there were no postoperative myocardial infarctions. No significant differences were observed for VTE rates compared with the control cohort using either topical or intravenous TXA, with regard to CAD (0.29% compared with 0.76%; p = 0.09) or coronary stents (0% compared with 0.76%; p = 0.14). Moreover, there was no significant difference observed in VTE rates when administration was subcategorized into intravenous and topical methods with regard to CAD (0.13% compared with 0.72%; p = 0.12) or coronary stents (0% compared with 0%; p = 1.0). In our series, topical and intravenous TXA were equally safe when used in patients with a history of CAD and coronary stents in comparison with the control cohort. With equal efficacy and risk of adverse events, we recommend intravenous TXA, which may enable easier institutional implementation. Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.