Risk Of Venous Thromboembolic Events Research Articles

Venous Thromboembolism Risk Assessment in Inpatient and Ambulatory Otolaryngology Surgical Patients.

Venous thromboembolic events (VTEs) are a leading cause of postoperative morbidity, prolonged hospital stay, and increased cost. Recommendations for mechano- and chemoprophylaxis are currently based on the 2005 Caprini score, a screening tool developed to identify patients at risk for VTE. The Caprini risk assessment model (RAM) was designed for surgical impatients and has been tested in a number of surgical fields, including otolaryngology. However, the vast majority of otolaryngology cases are performed as ambulatory surgery. Simpler RAMs include the COBRA scoring system and Pannucci-NSQIP. Here, we evaluate risk stratification of otolaryngology surgical patients and correlate the findings of these three RAMs. Retrospective chart review. A retrospective chart review of 869 patients undergoing surgery by Weill Cornell faculty otolaryngologists between June and December 2022 was performed. Patient demographics, VTE risk factors, admission status, surgical subservice, and postoperative events were collected, and RAM scores were calculated for each patient. Wilcoxon and Kruskal-Wallis rank-sum tests were utilized to assess differences in VTE risk scores based on type of procedure and admission status, and Spearman's correlation was utilized to assess agreement between the three different scoring systems. Multivariate linear regressions were utilized to assess variables that impacted the Caprini, COBRA, and NSQIP RAMs. In total, two patients developed postoperative venous thromboembolism. Furthermore, there is a strong positive correlation between Caprini and COBRA RAMs (even when broken down by admission status, although it weakens in the inpatient population). There is a moderate positive correlation between Caprini and Pannucci-NSQIP in the full cohort, but that correlation is lost in the inpatient population. Otolaryngology surgical patients are at low risk of postoperative VTE. Caprini, Pannucci-NSQIP, and COBRA RAMs correlate well in determining ambulatory patients at risk for postoperative VTE and shorter, simpler RAMS such as COBRA and Pannucci-NSQIP can be used instead of Caprini RAM. 3 Laryngoscope, 2024.

Prevalence and clinical burden of venous thromboembolic events (VTEs) in contemporary total knee arthroplasties (TKAs) in US hospitals

IntroductionTotal knee arthroplasty (TKA) is a highly demanded procedure in orthopedic surgery, with over 1.3 million joint arthroplasties performed annually in the U.S. The increasing need for TKAs is driven by an aging population, rising obesity rates, and advances in surgical techniques. Venous thromboembolism (VTE), including pulmonary embolism (PE) and deep vein thrombosis (DVT), significantly impacts TKA patients' mortality and morbidity. Despite advances in prophylaxis and Enhanced Recovery After Surgery (ERAS) protocols reducing VTE incidence, survival rates have not markedly improved. This study aims to identify preoperative predictors of PE and DVT in TKA patients and examine their impact on hospital stays and mortality. MethodsA retrospective observational study was conducted using data from the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) database, focusing on 367,365 TKA patients from 2016 to 2021. Preoperative variables, including demographic factors, comorbidities, and functional status, were analyzed. Primary endpoints were PE and DVT predictors; secondary endpoints included 30-day mortality and prolonged hospital stay. Univariate and logistic regression analyses were performed using SPSS version 26. ResultsUnivariate analysis revealed significant associations of male gender, older age, Hispanic ethnicity, smoking, dyspnea, CHF, and COPD with DVT and PE. Multivariate analysis confirmed female sex, younger age, Hispanic ethnicity, and COPD as independent DVT predictors, and independent functional status, smoking, COPD, CHF, and metastatic malignancy as PE predictors. VTE prevalence was 1.09 % (0.67 % DVT, 0.42 % PE), with PE associated with higher mortality (0.78 %) and prolonged hospital stays. ConclusionDemographic and clinical variables significantly influence VTE risk post-TKA. Tailored interventions and comprehensive preoperative assessments are crucial for optimizing patient outcomes and reducing thrombotic risks.

8614 Low Dose Sublingual Estradiol Decreases Protein S, Generating a Potentially Pro-thrombotic Profile: Interim Results of a Controlled Prospective Pilot Study of Treatment-Naïve Trans Women

Abstract Disclosure: S. Bar On: None. I. Yaish: None. M. Barzilai: None. Y. Greenman: None. G. Gindis: None. Y. Moshe: None. K.M. Tordjman: None. Background: Sublingual estradiol (SLE) for gender-affirming hormone therapy (GAHT) of transgender women (TW) might obviate the need for an anti-androgen, and mitigate pro-coagulant changes. We recently showed that 2 mg E, divided into 4 daily sublingual doses, offers no clinical advantage over the same dose given orally in combination with cyproterone acetate (CPA)1. Furthermore, we showed that after each sublingual administration, serum estradiol (sE2) peaked to levels, the likes of which are achieved only during induction of ovulation with gonadotrophins. Hypothesis and Aim: Given the exceedingly high peak sE2 measured under SLE-GAHT, we hypothesized it could lead to partial acquired Protein S deficiency, a recognized pro-thrombotic state and risk factor for venous thromboembolic events (VTE). Our aim was to assess the hemostatic system under SLE in comparison with the standard combined oral (CO) approach. Design and Methods: In this ongoing open label study, treatment-naïve TW are assigned in a 1:1 ratio (15 in each arm) to either standard CO (2 mg E2 with 10 mg CPA once daily), or to SLE with 2 mg sublingual estradiol divided into 4 daily dose for 6 months (6M). An extensive battery of hemostatic biomarkers, including free Protein S antigen (fPS), are assessed at baseline (BL) and at 6M. Results: We herein report on 27 subjects (15 CO/12 SLE) who initiated treatment, 17 of whom have already completed it. The median age of the cohort is 20 y (IQR 19-27; range 18-42]. There were no BL differences between the groups. At 6M, none of the hemostatic markers differed between the groups except for fPS, which was significantly lower in the SLE group 79.7%±11.6% vs. 104.6%±5.6%, P=0.039. By paired comparisons for the entire group, fPS decreased from 104%.2±5.2% at BL to 95.8%±5.9% at 6M, P=0.003. This was entirely accounted for by the change in the SLE group, in which fPS went down from 95.7%±10.3% to 79.7%±11.6%, P<0.001; with some values reaching the fPS deficiency range. In contrast, fPS, remained unchanged under CO 108.9%±5.7% and 104.5%±5.2%, at BL and 6M respectively, P=0.153. Conclusions: The most notable interim finding was a clinically significant decrease in fPS under low dose SLE. Given the extreme peaks of sE2 we previously reported with this protocol, an acquired deficiency of this natural anti-coagulant was expected. These preliminary findings support our hypothesis, and raise the concern that GAHT of TW with chronic SLE might carry an increased long-term risk for VTE. 1 Yaish I, Gindis G, Greenman Y, et al. Sublingual Estradiol Offers no Apparent Advantage Over Combined Oral Estradiol and Cyproterone Acetate for Gender-Affirming Hormone Therapy of Treatment-Naive Trans Women: Results of a Prospective Pilot Study. Transgend Health. 2023;8(6):485-493. Published 2023 Dec 13. doi:10.1089/trgh.2023.0022 Presentation: 6/2/2024

8614 Low Dose Sublingual Estradiol Decreases Protein S, Generating a Potentially Pro-thrombotic Profile: Interim Results of a Controlled Prospective Pilot Study of Treatment-Naïve Trans Women

Abstract Disclosure: S. Bar On: None. I. Yaish: None. M. Barzilai: None. Y. Greenman: None. G. Gindis: None. Y. Moshe: None. K.M. Tordjman: None. Background: Sublingual estradiol (SLE) for gender-affirming hormone therapy (GAHT) of transgender women (TW) might obviate the need for an anti-androgen, and mitigate pro-coagulant changes. We recently showed that 2 mg E, divided into 4 daily sublingual doses, offers no clinical advantage over the same dose given orally in combination with cyproterone acetate (CPA)[1]. Furthermore, we showed that after each sublingual administration, serum estradiol (sE2) peaked to levels, the likes of which are achieved only during induction of ovulation with gonadotrophins. Hypothesis and Aim: Given the exceedingly high peak sE2 measured under SLE-GAHT, we hypothesized it could lead to partial acquired Protein S deficiency, a recognized pro-thrombotic state and risk factor for venous thromboembolic events (VTE). Our aim was to assess the hemostatic system under SLE in comparison with the standard combined oral (CO) approach. Design and Methods: In this ongoing open label study, treatment-naïve TW are assigned in a 1:1 ratio (15 in each arm) to either standard CO (2 mg E2 with 10 mg CPA once daily), or to SLE with 2 mg sublingual estradiol divided into 4 daily dose for 6 months (6M). An extensive battery of hemostatic biomarkers, including free Protein S antigen (fPS), are assessed at baseline (BL) and at 6M. Results: We herein report on 27 subjects (15 CO/12 SLE) who initiated treatment, 17 of whom have already completed it. The median age of the cohort is 20 y (IQR 19-27; range 18-42]. There were no BL differences between the groups. At 6M, none of the hemostatic markers differed between the groups except for fPS, which was significantly lower in the SLE group 79.7%±11.6% vs. 104.6%±5.6%, P=0.039. By paired comparisons for the entire group, fPS decreased from 104%.2±5.2% at BL to 95.8%±5.9% at 6M, P=0.003. This was entirely accounted for by the change in the SLE group, in which fPS went down from 95.7%±10.3% to 79.7%±11.6%, P<0.001; with some values reaching the fPS deficiency range. In contrast, fPS, remained unchanged under CO 108.9%±5.7% and 104.5%±5.2%, at BL and 6M respectively, P=0.153. Conclusions: The most notable interim finding was a clinically significant decrease in fPS under low dose SLE. Given the extreme peaks of sE2 we previously reported with this protocol, an acquired deficiency of this natural anti-coagulant was expected. These preliminary findings support our hypothesis, and raise the concern that GAHT of TW with chronic SLE might carry an increased long-term risk for VTE. [1] Yaish I, Gindis G, Greenman Y, et al. Sublingual Estradiol Offers no Apparent Advantage Over Combined Oral Estradiol and Cyproterone Acetate for Gender-Affirming Hormone Therapy of Treatment-Naive Trans Women: Results of a Prospective Pilot Study. Transgend Health. 2023;8(6): 485-493. Published 2023 Dec 13. doi:10.1089/trgh.2023.0022 Presentation: 6/2/2024

Venous Thromboembolic Events Following Revisional Gastric Bypass: An Analysis of the MBSAQIP Database from 2015 to 2019 Using Propensity Matching.

Primary bariatric surgery is associated with moderate-to-high risk of venous thromboembolic events (VTE); however, the risk for revisional surgery lacks granularity. Our primary objective was to define the risk of VTE following revisional Roux-en-Y gastric bypass (RYGB) compared to primary RYGB. Adults who underwent primary or revision/conversion RYGB between January 1, 2015, and December 31, 2019, with a BMI ≥ 35kg/m2 were identified in a bariatric specific database. VTE was defined as pulmonary embolus and/or deep venous thrombosis. Thirty-day VTE and transfusion rates were compared between the two groups using propensity score matching of 3:1. Primary RYGB was performed in 197,186 (92.4%) patients compared to 16,144 (7.6%) in the revisional group. Patients in the revisional group had fewer comorbidities than those undergoing primary RYGB. In the matched cohort of 64,258 procedures, there were 48,116 (74.9%) primary RYGB cases compared to 16,142 (25.1%) RYGB revisions. The rate of VTE was similar in the revisional surgery group compared to the propensity matched primary RYGB group (0.4% vs. 0.3%, p > 0.580); however, transfusion was more common in the revisional group (1.4% vs. 1.0%, p = 0.005). Revisional group had higher rates of readmission, reoperation, increased length of stay, and operation length ≥ 180min compared to matched primary RYGB group (p < 0.001). VTE rates for both primary and revisional RYGB are similar. Revisional RYGB cases impose increased risk of bleeding among other outcomes. Thus, identifying those at higher risk of complications is critical.

Development of venous thromboembolic event risk calculator for metabolic and bariatric surgery patients to reduce mortality

IntroductionVenous thromboembolic events (VTEs) after Metabolic and Bariatric Surgery (MBS) result in significant morbidity and are the leading cause of mortality. The objective of this study was to identify patients who are at a high risk for developing VTE and who may benefit from extended chemoprophylaxis following MBS. MethodsUsing the 2015-2019 Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) participant user file (PUF), we identified 696,069 patients who completed 30-day follow-up data and met the inclusion criteria. Using logistic regression analysis, we identified preoperative and postoperative risk factors associated with VTE and validated our model externally using the MBSAQIP 2020-2021 datasets (N = 273,692). The Hosmer–Lemeshow test was used for goodness of fit and calibration. We also compared our model’s discriminatory capability with that of other VTE risk assessment tools. We then used these risk factors to create an online open source application. ResultsThe overall incidence of VTE after MBS in the 696,069 (MBSAQIP 2015-2019 database) patients included in our analysis was .40% (2759 patients). Our model had a good predictive capability, with a C-statistic of .66. Our model also demonstrated good fit with a Hosmer–Lemeshow chi-square of 11.06 (P = .198). A cut-off point of .4% resulted in a sensitivity of 48.28%, with 24% of patients having a VTE risk greater than .4% within the 2015-2019 MBSAQIP dataset. Among all the perioperative factors selected in the PUF, high risk for VTE included African American race (AOR 1.625, P < .0001), operation length in minutes (AOR: 1.003, P < .0001), preop functional status (AOR 1.012, P = .007), procedure type (RYGB; AOR .768, P < .0001 and RBS; AOR .758, P = .019 with respect to sleeve), preop body mass index (BMI) (AOR 1.012, P < .001), history of pre-op vein thrombosis requiring therapy (AOR 5.041, P < .0001), post-op superficial or organ space surgical site infection (AOR 2.713, P < .0001), preop venous stasis (AOR 1.425, P = .019),at least one readmission within 30 days(AOR 1.583, P < .0001), or at least one reoperation within 30 days (AOR 4.399, P < .0001). ConclusionVTE after MBS can result in increased mortality rates. High-risk patients might benefit from extended chemoprophylaxis. Our model suggests that patients with a VTE risk ≥ .4% in the first 30 days following surgery may benefit from extended chemoprophylaxis.

Total Shoulder Arthroplasty in Patients With Hemophilia A: Greater Odds of Postoperative Bleeding and Thromboembolic Events but No Difference in 5-year Implant Survival.

Patients with hemophilia A can develop joint hemarthroses, degenerative changes, and eventually undergo total shoulder arthroplasty (TSA). Few data exist concerning complications and prosthesis survival after TSA in this population. (1) Is hemophilia A associated with more bleeding and thromboembolic adverse events after TSA relative to matched controls? (2) Is 5-year TSA prosthesis survival reduced in patients with hemophilia A compared with matched controls? The 2010 to 2022 PearlDiver M161 database was used to identify patients who underwent primary anatomic or reverse TSA. Given that the X-linked recessive condition hemophilia A presents nearly exclusively in males, male patients with hemophilia A who underwent TSA were matched 1:10 with male patients without hemophilia who underwent TSA based on age and Elixhauser comorbidity index (ECI). This yielded 73 patients with hemophilia A who underwent TSA who were matched 1:10 with 729 patients without hemophilia. Ninety-day adverse events were compared with multivariable analysis. Revision within 5 years was assessed using Kaplan-Meier analysis. Compared with the control cohort, patients with hemophilia had greater odds of bleeding issues (hematoma, OR 6.8 [95% CI 3.0 to 15.3]; p < 0.001; anemia, OR 2.5 [95% CI 1.5 to 4.2]; p < 0.001, transfusion, OR 5.0 [95% CI 2.4 to 10.3]; p < 0.001), venous thromboembolic events (VTE) (OR 1.9 [95% CI 1.1 to 3.1]; p = 0.01), and prosthetic loosening (OR 3.5 [95% CI 1.4 to 8.0]; p = 0.004). Based on available data, 5-year implant survival was not different in patients with hemophilia (97.3% [95% CI 93.6% to 100.0%]) relative to matched controls (95.2% [95% CI 93.4% to 97.2%]; p = 0.60). The elevated risks of both 90-day bleeding complications (hematoma, anemia, and transfusion) and VTE (DVT and PE) in patients with hemophilia emphasize the special challenges of carefully balancing factor replacement and VTE prophylaxis pre-, intra-, and postoperatively on an individual patient basis with careful hematologist coordination. Further study on Factor VIII levels and targets as well as tranexamic acid and VTE prophylaxis in this population is necessary to provide further guidance. Furthermore, 5-year implant survival was not different between patients with hemophilia and matched controls (patients without hemophilia) based on available data, suggesting that TSA survivorship remains durable and may be offered to patients in this population as indicated. Level III, therapeutic study.

The effect of SARS-CoV-2 on the incidence of post-operative venous sinus thrombosis following skull base procedures.

Sinus thrombosis is a common post-operative finding after posterior fossa surgery performed in the vicinity of the dural venous sinuses. The SARS-CoV-2 virus has been shown to confer an increased risk of venous thromboembolic events owing to eliciting a hyper-inflammatory and pro-thrombotic state. In this study, we examine the incidence of post-operative venous sinus thrombosis in patients undergoing peri-sigmoid posterior fossa surgery in the pre- and post-COVID era and investigate whether COVID infection confers an increased risk of sinus thrombosis. A retrospective review of a single institution case series of patients underwent peri-sigmoid surgery (retrosigmoid, translabyrinthine, or far lateral) approach. Relevant clinical variables were investigated that may confer an increased risk of sinus thrombosis. A total of 311 patients (178 in the pre-COVID era, and 133 operated on after the pandemic began in March 2020) are included in the study. The composite incidence of sinus thrombosis seen on post-operative imaging was 7.8%. The incidence of sinus thrombosis in the pre-COVID cohort was N = 12 patients (6.7%) versus N = 12 (9%) in the post-COVID cohort (p = 0.46). A history of COVID infection was not shown to confer an increased risk of post-operative sinus thrombosis (OR: 0.61; 95% CI: 0.08-4.79, p = 0.64). Only a small number of patients (N = 7, 2.3%) required either medical or surgical intervention for post-operative sinus thrombosis. The overall incidence of post-operative sinus thrombosis is similar in the pre- and post-COVID era. The findings of this study suggest that COVID infection is not associated with a higher risk of venous sinus thrombosis.

Thromboprophylaxis during neoadjuvant chemotherapy for bladder cancer reduces thromboembolism and bleeding.

To assess the risk of venous thromboembolic events (VTEs) and bleeding with or without thromboprophylaxis during neoadjuvant chemotherapy in bladder cancer patients scheduled for radical cystectomy. We conducted a retrospective cohort study in 4886 patients with non-metastatic bladder cancer undergoing cystectomy across 28 centres in 13 countries between 1990 and 2021. Inverse probability weighting analyses were performed to estimate the effect of thromboprophylaxis on VTE and bleeding. In 147 patients (3%) VTEs were recorded within the first year. These occurred a median (interquartile range [IQR]) of 127 (82-198) days after bladder cancer diagnosis. Bleeding events occurred in 131 patients (3%) within the first year. These occurred a median (IQR) of 101 (83-171) days after cancer diagnosis. In inverse probability weighting analyses, compared to patients without thromboprophylaxis during chemotherapy, patients with thromboprophylaxis had not only a lower risk of VTE (hazard ratio [HR] 0.32, 95% confidence interval [CI] 0.12-0.81; P = 0.016) but also a lower bleeding risk (HR 0.03, 95% CI 0.09-0.12; P <0.0001). The retrospective nature of the study was its main limitation. In this retrospective analysis, the benefit of thromboprophylaxis during neoadjuvant chemotherapy before cystectomy is in line with data from randomised trials in other malignancies. Our data suggest thromboprophylaxis is protective against VTEs and should be the standard of care during neoadjuvant chemotherapy.

Pulmonary perfusion in long-term survivors of COVID-19-related severe acute respiratory distress syndrome treated by extracorporeal membrane oxygenation.

COVID-19associates with a hypercoagulant state and an increased risk for venous thromboembolic events (VTEs). Whether severe COVID-19 infection requiringextracorporeal membrane oxygenation(ECMO) support might lead to chronic pulmonary perfusion abnormalities and chronic thromboembolic pulmonary disease/hypertension remains unclear. The purpose of this study was to evaluate chronic pulmonary perfusion abnormalities in long-term survivors of COVID-19-related severe acute respiratory distress syndrome (ARDS) treated by ECMOat our institution. Pulmonary perfusion was examined by ventilation/perfusion(V/Q) single-photon emission computed tomographyor V/Q planar scintigraphy at least 3 months after ECMO explantation, comorbidities and incidence of thromboembolic events were recorded as well. Of 172 COVID-19 patients treated by ECMO for severe COVID-19 pneumonia between March 2020 and November 2021, only 80 were successfully weaned from ECMO. Of those, 37 patients were enrolled into the present analysis (27% female, mean age 52 years). Median duration of ECMO support was 12 days. In 24 (65%) patients VTE was recorded in the acute phase (23 patients developed ECMO cannula-related deep vein thrombosis, 5 of them had also a pulmonary embolism, and one thrombus was associated with a central catheter). The median duration between ECMO explantation and assessment of pulmonary perfusion was 420 days. No segmental or larger mismatched perfusion defects were then detected in any patient. In conclusion, in long-term survivors of COVID-19-related ARDS treated by ECMO, no persistent pulmonary perfusion abnormalities were detected although VTE was common.

Venous thromboembolism incidence and association with overall survival in pancreatic cancer: A Finnish nationwide cohort study.

Pancreatic cancer (PC) is associated with a high risk of venous thromboembolic events (VTEs). We investigated the incidence of VTE before and after the diagnosis of PC and its association with overall survival. We identified PC patients diagnosed in 2013-2016 from the Finnish Cancer Registry. Data on healthcare visits and death were collected, along with follow-up data through the end of 2020. We compared patients who underwent radical-intent surgery (RIS) to those who underwent palliative treatment (PT) alone. We identified 4086 PC patients, of whom 343 (8.4%) underwent RIS and 3743 (91.6%) received PT. VTE incidence within 1 year before a PC diagnosis was higher in the PT (4.2%, n = 156) than in the RIS group (0.6%, n = 2; p < 0.001). The cumulative incidence of VTE at 12 and 24 months after a PC diagnosis was 6% (n = 21) and 9% (n = 31), respectively, within the RIS group, and 8% (n = 286) and 8% (n = 304) within the PT group. In the PT group, a VTE within 1 year before a PC diagnosis was independently associated with a worse survival {hazard ratio, HR 1.9 [95% confidence interval (CI) 1.6-2.2]}. In both groups, VTE after a PC diagnosis was associated with a worse survival [RIS group: HR 2.6 (95%CI 1.8-3.7) vs. PT group: HR 2.2 (95%CI 1.9-2.4)]. A VTE within 1 year before a PC diagnosis more often occurred among PT PC patients than among patients who underwent RIS. VTE might serve as a diagnostic clue to detect PC at an earlier stage.

Incidence of Venous Thromboembolism after Primary Total Hip Arthroplasty with Mechanical Prophylaxis in Hong Kong Chinese.

The incidence of deep vein thrombosis (DVT) following total hip arthroplasty (THA) without chemoprophylaxis could be as high as 50% in Caucasians. However, according to several subsequent studies, the incidence of venous thromboembolic events (VTE) in Asians was much lower. The routine use of chemoprophylaxis, which could potentially cause increased bleeding, infection, and wound complications, has been questioned in low-incidence populations. The objective of this study is to determine the incidence of VTE after primary THA without chemoprophylaxis in an Asian population using a fast-track rehabilitation protocol and to verify the safety profile for use of 'mechanical prophylaxis alone' in patients with standard risk of VTE. This is a retrospective cohort study of 542 Hong Kong Chinese patients who underwent primary THA without chemoprophylaxis. All patients received intermittent pneumatic compression and graduated compression stockings as mechanical prophylaxis. Multimodal pain management was applied in order to facilitate early mobilisation. Routine duplex ultrasonography was performed between the fourth and seventh postoperative day for detection of proximal DVT. All patients were Chinese (mean age, 63.0±11.9 years). Six patients developed proximal DVT (incidence rate, 1.1%). None of the patients had symptomatic or fatal pulmonary embolism. The incidence of VTE after primary THA without chemical prophylaxis can be low in Asian populations when following a fast-track rehabilitation protocol. Mechanical prophylaxis alone can be regarded as a reasonably safe practice in terms of a balanced benefit-to-risk ratio for Asian patients with standard risk of VTE.

Hospital acquired venous thromboembolism in children with sickle cell disease

Sickle cell disease (SCD) is well recognized as a hypercoagulablestate, however, it remains unclear whether a subgroup of children with SCD at higher risk of venous thromboembolic event (VTE) during hospitalization may benefit from thromboprophylaxis. Our objectives were to describe the clinical characteristics, outcomes and recurrence of hospital acquired VTE in patients with SCD younger than 21 years. This was a single center retrospective study. Data regarding demographics, reason for admission, location of VTE, risk factors like central venous catheter (CVC), intensive care unit (ICU) admission among others were extracted from electronic medical records over a 10-year study period (2011–2021). Recurrence of VTE at 1 and 5 years was assessed. Descriptive statistics were used as indicated. We identified a total of 20 VTE events over the 10-year study period. Six of these events occurred in those younger than 12 years of age. Fourteen (70%) VTE events occurred in the HbSS or HbSβThal0 genotypes compared to 6 (30%) in HbSC. Most common VTE was isolated pulmonary embolism (PE) (n = 10, 50%). VTE were most often associated with acute chest syndrome (ACS) (n = 14, 70%), ICU admissions (n = 10, 50%) and CVC (n = 5/9, 55%). One patient died from the VTE event. One patient with additional underlying risk factors had a recurrent VTE at 13 months. Our study suggests that ICU admission, ACS and presence of CVC increases the risk of VTE in children and young adults with SCD, but larger studies are indicated to validate our findings.

#1828 Venous thromboembolic events in ANCA associated vasculitis patients—data from Croatian referral center

Abstract Background and Aims Our aim was to investigate the prevalence of venous thromboembolic events (VTE) in a cohort of patients with ANCA-associated vasculitis (AAV) and define factors associated with the frequency of VTE considering there is data on high incidence of VTE in AAV patients. In these cohorts VTE occurred mostly early in the course of disease. Method This study included 114 consecutive AAV patients with biopsy proven renal involvement in the period from 2007-2017. Patients were classified according to clinical: granulomatosis with poliangitis (GPA), microscopic polingitis (MPA) and eosinophilic granulomatosis with poliangitis (EGPA) and serological phenotype: MPO-ANCA positive, PR3-ANCA positive, MPO- and PR3-ANCA positive and ANCA-negative. Ordinal variables were analysed using logistical regression test. Statistical analysis was done in MedCalc Statistical Software version 18.11.6 (MedCalc Software Bvba, Ostend, Belgium). Results In the cohort there were 64 (56%) females, mean age was 58 (IQR 16-84) with mean follow up time 46.9 months (IQR 1-127). Clinically there were 84 (73%) patients with MPA, 26 (22%) with GPA and 4 (5%) with EGPA. Serologically there were 20% PR3-ANCA, 54% MPO-ANCA, 8% MPO- and PR-3 ANCA positive patients and 18% ANCA-negative patients. Mean serum creatinine levels (SCr) was 380.9 μmol/l (IQR 65-1402). Mean BVAS (Brimingham vasculitis score) at the time of diagnosis of AAV was 17 (IQR 5-50) and at the time of VTE 0, 9 (0-22). Mean body weight was 71kg (IQR 48-110) and mean CRP was 84 mg/ml (IQR 0, 3-256). During the follow up 7 (6.14%) of the patients had VTE, with 4 having VTE in first month after the diagnosis and other two at month 14 and 19. Logistic regression showed the connection of weight (P = 0.0052) and CRP (0.0138) with VTE with odds ratio of 1,0829 for CRP (1.003-1.027) and 1.0150 for weight (1.0284-1.1736) respectively. There was no statistical significance for clinical or serological phenotype being associated with VTE nor for other clinical or laboratory parameters. Conclusion In our cohort patients with AAV were at risk of VTE, particularly within the first year following onset of disease. In this cohort the frequency of VTE did not depend of clinical or serological AAV phenotype, age or gender. Only CRP and body weight were associated significantly with VTE occurrence. Despite VTE rates in AAV patients, routine anticoagulation is not recommended in AAV patients, given the potential risk of bleeding complications. Prospective studies are needed to assess VTE risk stratification in AAV patients and to evaluate the both benefits and potential risks ratio of prophylactic anticoagulation in AAV patients.

Association of timing and agent for venous thromboembolism prophylaxis in patients with severe traumatic brain injury on venous thromboembolism events, mortality, neurosurgical intervention, and discharge disposition.

Trauma patients are at increased risk for venous thromboembolism events (VTEs). The decision of when to initiate VTE chemoprophylaxis (VTEP) and with what agent remains controversial in patients with severe traumatic brain injury (TBI). This comparative effectiveness study evaluated the impact of timing and agent for VTEP on outcomes for patients with severe TBI (Abbreviated Injury Scale head score of 3, 4, or 5). Data were collected at 35 Level 1 and 2 trauma centers from January 1, 2017, to June 1, 2022. Patients were placed into analysis cohorts: no VTEP, low-molecular-weight heparin (LMWH) ≤48 hours, LMWH >48 hours, heparin ≤48 hours, and heparin >48 hours. Propensity score matching accounting for patient factors and injury characteristics was used with logistic regression modeling to evaluate in-hospital mortality, VTEs, and discharge disposition. Neurosurgical intervention after initiation of VTEP was used to evaluate extension of intracranial hemorrhage. Of 12,879 patients, 32% had no VTEP, 36% had LMWH, and 32% had heparin. Overall mortality was 8.3% and lowest among patients receiving LMWH ≤48 hours (4.1%). Venous thromboembolism event rates were lower with use of LMWH (1.6% vs. 4.5%; odds ratio, 2.98; 95% confidence interval, 1.40-6.34; p = 0.005) without increasing mortality or neurosurgical interventions. Venous thromboembolism event rates were lower with early prophylaxis (2.0% vs. 3.5%; odds ratio, 1.76; 95% confidence interval, 1.15-2.71; p = 0.01) without increasing mortality ( p = 1.0). Early VTEP was associated with more nonfatal intracranial operations ( p < 0.001). However, patients undergoing neurosurgical intervention after VTEP initiation had no difference in rates of mortality, withdrawal of care, or unfavorable discharge disposition ( p = 0.7, p = 0.1, p = 0.5). In patients with severe TBI, LMWH usage was associated with lower VTE incidence without increasing mortality or neurosurgical interventions. Initiation of VTEP ≤48 hours decreased VTE incidence and increased nonfatal neurosurgical interventions without affecting mortality. Low-molecular-weight heparin is the preferred VTEP agent for severe TBI, and initiation ≤48 hours should be considered in relation to these risks and benefits. Therapeutic/Care Management; Level III.

Abstract PO2-01-09: Patient preferences for CDK4/6 inhibitor treatments in HR+/HER2− early breast cancer: a discrete choice survey study

Abstract Background: Patients (pts) with stage II/III HR+/HER2− early breast cancer (EBC) are at risk of recurrence that persists over years. The addition of a CDK4/6 inhibitor (CDK4/6i) to adjuvant endocrine therapy (ET) was investigated in monarchE, evaluating abemaciclib (ABE) in lymph node (LN)+ high-risk pts, and NATALEE, using ribociclib (RIB) in stage II/III disease, including pts with N0 disease. ABE was FDA approved in this indication in 2021, while NATALEE recently reported statistically significant iDFS results. Both efficacy and tolerability are relevant for pts treated in a curative setting. This prospective study evaluated the extent pts with EBC value different treatment (tx) attributes and how these may translate into preferences between the two CDK4/6i in the US. Methods: A web-based discrete choice experiment survey was conducted among pts with EBC between Jan and May 2023 before NATALEE results were available. Eligible pts were adult women in a US clinical practice setting with self-reported stage II/III HR+/HER2− EBC +/- prior chemotherapy receiving only adjuvant ET at the time of survey, who completed curative surgery 1-3 years ago. Pts selected the scenario that best reflected their preferences from a series of choice cards, each displaying a pair of hypothetical tx profiles. A total of 8 attributes related to efficacy (5-year iDFS), adverse events (AEs), monitoring requirements, tx duration, and schedule were included (Table 1). Attributes were included based on an initial pilot qualitative assessment that selected efficacy and safety attributes most relevant to pts, clinical input, and differentiating features between CDK4/6i. A conditional logit regression model was used to estimate preference weights and relative importance (RI) of each attribute. Utility scores, summarizing overall preference for CDK4/6i tx profiles, were estimated from the model, and various scenarios were tested. Subgroup analyses by menopausal status and BC stage will be presented. Results: 409 pts participated in the survey (median age, 53 years; White/Black/other race, 59%/23%/18%; BC stage II/III, 48%/52%; employed, 38%). Pt preferences for attributes that significantly impacted tx decision, in order of high to low RI, were higher efficacy (iDFS), lower risk of diarrhea, lower risk of fatigue, shorter tx duration, and lower risk of venous thromboembolic events. Attributes based on monitoring or schedule, including number of blood tests, number of EKGs, and tx schedule, did not affect tx choice (Table 2). Overall utility scores were consistently higher for reconstructed tx profiles that resembled RIB features, including under conservative scenarios where efficacy of RIB was assumed to be equivalent or lower than that of ABE. Conclusions: This study showed that, driven by strong preference for lower risk of AEs, pts with HR+/HER2− EBC prefer tx profiles that more closely resemble the clinical experience of receiving RIB. These pt preferences are important for shared decision making when discussing the addition of a CDK4/6i to adjuvant tx for eligible pts with HR+/HER2− EBC. Discrete Choice Experiment Attributes and Levels Estimated Preference Weight and Relative Importance Citation Format: Erica Mayer, Mary Lou Smith, Annie Guerin, Dominick Latremouille-Viau, Nisha C. Hazra, Yan Meng, Wendi Qu, Remi Bellefleur, Vaidyanathan Ganapathy, Liz Santarsiero, Robert Morlock, Maryam Lustberg. Patient preferences for CDK4/6 inhibitor treatments in HR+/HER2− early breast cancer: a discrete choice survey study [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO2-01-09.

Long-term incidence, risk factors and complications for venous thromboembolism in patients with systemic lupus erythematosus.

To compare frequency, incidence rates (IR), risk factors and outcomes of a first venous thromboembolic event (VTE) between patients with systemic lupus erythematosus (SLE) and controls. Using state-wide longitudinal hospital data from Western Australia (WA), we recorded venous thrombosis (VT) and pulmonary embolism (PE) in patients with SLE (n = 1854, median age 40, 86% female) and matched hospitalised controls (n = 12,107, median age 40 years, females 88.6%) in the period 1985-2015. Results presented are medians, frequency, IR per 1000 person years (PY) and odds, rate, or adjusted hazard ratios (OR/RR/a-HR) with 95% confidence intervals (CI). Patients with SLE had significantly higher odds (12.8 vs 3.3%; OR 4.26, CI 3.60-5.05) and IR for a first VTE (10.09 vs 1.52; RR 6.64; CI 5.56-7.79). Over the three study decades, the IR for PE declined in patients with SLE from 7.74 to 3.75/1000 PY (p < .01) with no changes observed for VT or in controls. VTE recurred more frequently in patients with SLE (24.1% vs 10.2 %) (p < .01). Antiphospholipid antibodies (aPL) (a-HR 4.24, CI 2.50-7.19), serositis (a-HR 2.70, CI 1.86-3.91), lupus nephritis (a-HR 1.75 CI 1.25-2.33) and thrombocytopenia (a-HR 1.65 (1.10-2.49) were the strongest disease risk factors for VTE only in patients with SLE, while arterial hypertension, smoking and obesity were independent VTE risk factors for both groups. VTE was not associated with an increased risk for arterial events, but PE increased the risk for pulmonary hypertension (PH) in both patients with SLE (a-HR 6.47, CI 3.73-11.23) and controls (a-HR 9.09, CI 3.50-23.63). VTE increased the risk of death in both patients with SLE (a-HR 2.02, CI 1.50-2.70) and controls (a-HR 6.63, CI 5.21-8.42) after 10 years of follow-up. VTE affected 12.8% of patients with SLE at six times the VTE rate in controls with aPL as the strongest, but not the only risk factor in SLE. The risk of PH was increased in both groups following PE, but VTE did not associate with an increased risk of arterial events.

Cervical Spine Surgery Following COVID-19 Infection: When is it Safe to Proceed?

Retrospective. We utilized the NIH National COVID Cohort Collaborative (N3C) database to characterize the risk profile of patients undergoing spine surgery during multiple time windows following the COVID-19 infection. While the impact of COVID-19 on various organ systems is well documented, there is limited knowledge regarding its effect on perioperative complications following spine surgery or the optimal timing of surgery after an infection. We asked the National COVID Cohort Collaborative for patients who underwent cervical spine surgery. Patients were stratified into those with an initial documented COVID-19 infection within 3 time periods: 0-2 weeks, 2-6 weeks, or 6-12 weeks before surgery. A total of 29,449 patients who underwent anterior approach cervical spine surgery and 46,379 patients who underwent posterior approach cervical spine surgery were included. Patients who underwent surgery within 2 weeks of their COVID-19 diagnosis had a significantly increased risk for venous thromboembolic events, sepsis, 30-day mortality, and 1-year mortality, irrespective of the anterior or posterior approach. Among patients undergoing surgery between 2 and 6 weeks after COVID-19 infection, the 30-day mortality risk remained elevated in patients undergoing a posterior approach only. Patients undergoing surgery between 6 and 12 weeks from the date of the COVID-19 infection did not show significantly elevated rates of any complications analyzed. Patients undergoing either anterior or posterior cervical spine surgery within 2 weeks from the initial COVID-19 diagnosis are at increased risk for perioperative venous thromboembolic events, sepsis, and mortality. Elevated perioperative complication risk does not persist beyond 2 weeks, except for 30-day mortality in posterior approach surgeries. On the basis of these results, it may be warranted to postpone nonurgent spine surgeries for at least 2 weeks following a COVID-19 infection and advise patients of the increased perioperative complication risk when urgent surgery is required.

Venous thromboembolism in patients with acute myeloid leukemia: development of a predictive model.

Patients with acute myeloid leukemia (AML) are at increased risk of venous thromboembolic events (VTE). However, thromboprophylaxis is largely underused. This study aimed to determine possible VTE development risk factors and to develop a novel predictive model. We conducted a retrospective cohort study of adult patients with newly diagnosed AML. We used univariate and multivariable logistic regression to estimate binary outcomes and identify potential predictors. Based on our final model, a dynamic nomogram was constructed with the goal of facilitating VTE probability calculation. Out of 626 eligible patients with AML, 72 (11.5%) developed VTE during 6 months of follow-up. Six parameters were independent predictors: male sex (odds ratio [OR] 1.82, 95% confidence interval [CI]: 1.077-2.065), prior history of thrombotic events (OR 2.27, 95% CI: 1.4-4.96), international normalized ratio (OR 0.21, 95% CI: 0.05-0.95), Eastern Cooperative Oncology Group performance status (OR 0.71, 95% CI: 0.53-0.94), and intensive therapy (OR 2.05, 95% CI: 1.07-3.91). The C statistics for the model was 0.68. The model was adequately calibrated and internally validated. The decision-curve analysis suggested the use of thromboprophylaxis in patients with VTE risks between 8 and 20%. We developed a novel and convenient tool that may assist clinicians in identifying patients whose VTE risk is high enough to warrant thromboprophylaxis.

Efficacy and safety of direct oral anticoagulants versus low-molecular-weight heparin for thromboprophylaxis after cancer surgery: a systematic review and meta-analysis.

Direct oral anticoagulants (DOACs) used as an alternative to low-molecular-weight heparin (LMWH) for thromboprophylaxis after cancer surgery for venous thromboembolic events (VTE) remains unclear. This study aimed to investigate the efficacy and safety of DOACs versus LMWH in these patients. A search of EMBASE, MEDLINE, Cochrane Central Register of Controlled Trials (CENTRAL), and Web of Science was carried out and included all randomized controlled trials (RCTs) and observational studies that directly compared DOACs with LMWH for thromboprophylaxis in patients after cancer surgery through July 25, 2023. The primary efficacy and safety outcomes were VTE, major bleeding, and clinically relevant non-major bleeding (CRNMB) within 30days of surgery. The risk of bias was assessed using the Cochrane Risk of Bias 2 (RoB2) tool for RCTs and ROBINS-I tool for non-randomized studies. This study was registered in PROSPERO (CRD42023445386). We retrieved 5149articles, selected 27 for eligibility, and included 10 studies (three RCTs and seven observational studies) encompassing 3054 patients who underwent postoperative thromboprophylaxis with DOACs (41%) or LMWH (59%). Compared to LMWH thromboprophylaxis, DOACs had a comparable risk of VTE (RR:0.69[95% CI:0.46-1.02], I2 = 0%), major bleeding (RR:1.55 [95% CI:0.82-2.93], I2 = 2%), and CRNMB (RR, 0.89 [95% CI, 0.4-1.98], I2 = 31%) during the 30-day postoperative period. Subgroup analysis of VTE and major bleeding suggested no differences according to study type, extended thromboprophylaxis, tumor types, or different types of DOAC. DOACs are potentially effective alternatives to LMWH for thromboprophylaxis in patients undergoing cancer surgery, without increasing the risk of major bleeding events.