Antiphospholipid syndrome (APS) is an autoimmune condition characterized by thrombosis and pregnancy morbidity. 1 Thrombotic APS variably involves arterial, venous, and microvascular circulations.The pathophysiology of thrombotic APS is thought to involve the generation of autoantibodies that bind to the major B-cell epitope on domain I of the β 2 -glycoprotein. This binding and subsequent thrombus formation occurs through intermediary processes that likely include oxidative stress, 2 complement activation, 3 and neutrophils 4 invoking a "2-hit" process of initial endothelial disruption followed by thrombus formation. 5 Laboratory diagnostic criteria for APS include the presence of any one of the qualifying antibody isotypes (anticardiolipin IgG or IgM, anti-β 2 -glycoprotein-1 IgG or IgM) and titers, or the presence of a lupus anticoagulant (LA) initially and again at least 12 weeks later.Anticoagulant therapy is the mainstay of treatment for thrombotic APS, and due to the high risk for thrombosis progression and recurrence, indefinite anticoagulation is often considered. 6 Even with use of vitamin K antagonists (VKA) the annual rate of recurrent thrombosis is at least 1.5% 7 and potentially as high as 30% over 5 years. 8,9 Direct oral anticoagulants (DOACs) offer a simpler therapeutic regimen with greater convenience than VKA therapy, and are approved for the treatment and secondary prevention of venous thromboembolism (VTE). 10,11 There remains great interest to offer APS patients an alternative to VKA therapy, provided that this is safe and effective. The limited available evidence from prospective and retrospective studies was presented in a systematic review 12 and a patient-level meta-analysis. 13 Concerningly, these analyses reported recurrent thrombosis rates around 15% among APS patients treated with DOACs with as high as a 4-fold increased risk for recurrence among those patients that have all 3 APS lab tests positive-"triple positivity." 13 These publications have significant limitations (eg, meta-analyses include multiple case reports with an n = 1 that potentially amplify selection and publication biases, patients that experienced thrombosis on other anticoagulants prior to receiving a DOAC were included, and studies were retrospective).There are 5 small randomized controlled trials involving DOAC treatment of patients with APS and a history of thrombosis. The first (RAPS) randomized 116 patients with APS and a history of VTE to either rivaroxaban 20 mg daily or dose-adjusted warfarin (target International Normalized Ratio [INR], 2.5). 14 The investigators reported that the percentage change in endogenous thrombin potential at 42 days for rivaroxaban was inferior to that of warfarin; but no thromboembolic events occurred over the 210-day follow-up in either group. The authors concluded that rivaroxaban might be an effective and safe alternative in patients with APS and previous VTE. The TRAPS (Rivaroxaban in Thrombotic Antiphospholipid Syndrome) study compared rivaroxaban 20 mg daily to warfarin (ta...
Background Some hospitalized medical patients experience venous thromboembolism (VTE) following discharge. Prophylaxis extended beyond hospital discharge (extended duration thromboprophylaxis [EDT]) may reduce this risk. However, EDT is costly and can cause bleeding, so selecting appropriate patients is essential. We formerly reported the performance of a mortality risk prediction score (Intermountain Risk Score [IMRS]) that was minimally predictive of 90‐day hospital‐associated venous thromboembolism (HA‐VTE) and major bleeding (HA‐MB). We used the components of the IMRS to calculate de novo risk scores to predict 90‐day HA‐VTE (HA‐VTE IMRS) and major bleeding (HA‐MB IMRS). Methods From 45 669 medical patients we randomly assigned 30 445 to derive the HA‐VTE IMRS and the HA‐MB IMRS. Backward stepwise regression and bootstrapping identified predictor covariates from the blood count and basic chemistry. These candidate variables were split into quintiles, and the referent quintile was that with the lowest event rate for HA‐VTE and HA‐MB; respectively. A clinically relevant rate of HA‐VTE and HA‐MB was used to inform outcome rates. Performance was assessed in the derivation set of 15 224 patients. Results The HA‐VTE IMRS and HA‐MB IMRS area under the receiver operating curve (AUC) in the derivation set were 0.646, and 0.691, respectively. In the validation set, the HA‐VTE IMRS and HA‐MB IMRS AUCs were 0.60 and 0.643. Conclusions Risk scores derived from components of routine labs ubiquitous in clinical care identify patients that are at risk for 90‐day postdischarge HA‐VTE and major bleeding. This may identify a subset of patients with high HA‐VTE risk and low HA‐MB risk who may benefit from EDT.
Background Discharged medical patients are at risk for venous thromboembolism (VTE). It is difficult to identify which discharged patients would benefit from extended duration thromboprophylaxis. The Intermountain Risk Score is a prediction score derived from discrete components of the complete blood cell count and basic metabolic panel and is highly predictive of 1‐year mortality. We sought to ascertain if the Intermountain Risk Score might also be predictive of 90‐day postdischarge hospital‐associated VTE (HA‐VTE). Methods We applied the Intermountain Risk Score to 60 064 medical patients who survived 90 days after discharge and report predictiveness for HA‐VTE. Area under the receiver operating curve analyses were performed. We then assessed whether the Intermountain Risk Score improved prediction of 2 existing VTE risk assessment models. Results The Intermountain Risk Score poorly predicted HA‐VTE (area under the curve = 0.58; 95% confidence interval [CI], 0.56‐0.60). Each clinical risk assessment model was superior to the Intermountain Risk Score (UTAH area under the curve, 0.63; Kucher area under the curve, 0.62; Intermountain Risk Score area under the curve, 0.58; P < .001 for each comparison). Adding the Intermountain Risk Score to these scores did not substantially improve the performance of either risk assessment model (UTAH + Intermountain Risk Score, 0.65; Kucher + Intermountain Risk Score, 0.64). Conclusion The Intermountain Risk Score demonstrated poor predictiveness for HA‐VTE when compared to existing risk assessment models. Adding the Intermountain Risk Score to existing risk assessment models did not improve upon either risk assessment model alone to justify the added complexity.
Identify hospitalized medical patients who at discharge have significant risk for hospital-associated venous thromboembolism (HA-VTE) or major bleeding (HA-MB) to inform extended-duration thromboprophylaxis (EDT) decisionmaking.
Objective The aim of this study was to determine the impact of sleep-disordered breathing on quality of life (QOL) in children with aerodigestive disease compared to children without aerodigestive disease. Methods Retrospective, IRB-approved, single-institution review of OSA-18 survey results administered to an unselected population of pediatric otolaryngology patients, some of whom had also been seen in the multidisciplinary aerodigestive clinic, was carried out. Results 476 non-aerodigestive patients and 43 aerodigestive patients were compared using total OSA-18 score and the summed scores from the 5 domains that comprise the OSA-18: (1) sleep disturbance, (2) physical suffering, (3) emotional distress, (4) daytime problems, and (5) caregiver concern. Sleep-related QOL was significantly worse for children with aerodigestive disease compared to those without aerodigestive disease across domains of sleep disturbance (P = 0.011), physical suffering (P = 0.028), and caregiver concern (P = 0.016). Total OSA-18 scores were in the mild impact range, and they did not differ significantly between the two populations. Conclusion While the focus of many aerodigestive programs is on the pathophysiological relationship between the upper digestive tract, the laryngotracheal airway, and the lungs, the present study elucidates a significant impact of upper airway obstruction during sleep on the QOL of children with aerodigestive disease. In recognition of this impact, certain airway centers have added a multidisciplinary approach to upper airway obstruction to their aerodigestive treatment armamentarium. At the minimum, airway treatment centers should consider systematic screening of all children with aerodigestive disease for QOL burden related to OSA.
Background Venous thromboembolism (VTE) risk is increased in patients with COVID‐19 infection. Understanding which patients are likely to develop VTE may inform pharmacologic VTE prophylaxis decision making. The hospital‐associated venous thromboembolism–Intermountain Risk Score (HA‐VTE IMRS) and the hospital‐associated major bleeding–Intermountain Risk Score (HA‐MB IMRS) are risk scores predictive of VTE and bleeding that were derived from only patient age and data found in the complete blood count (CBC) and basic metabolic panel (BMP). Objectives We assessed the HA‐VTE IMRS and HA‐MB IMRS for predictiveness of 90‐day VTE and major bleeding, respectively, among patients diagnosed with COVID‐19, and further investigated if adding D‐dimer improved these predictions. We also reported 30‐day outcomes. Patients/Methods We identified 5047 sequential patients with a laboratory confirmed diagnosis of COVID‐19 and a CBC and BMP between 2 days before and 7 days following the diagnosis of COVID‐19 from March 12, 2020, to February 28, 2021. We calculated the HA‐VTE IMRS and the HA‐MB IMRS for all patients. We assessed the added predictiveness of D‐dimer obtained within 48 hours of the COVID test. Results The HA‐VTE IMRS yielded a c‐statistic of 0.70 for predicting 90‐day VTE and adding D‐dimer improved the c‐statistic to 0.764 with the corollary sensitivity/specificity/positive/negative predictive values of 49.4%/75.7%/6.7%/97.7% and 58.8%/76.2%/10.9%/97.4%, respectively. Among hospitalized and ambulatory patients separately, the HA‐VTE IMRS performed similarly. The HA‐MB IMRS predictiveness for 90‐day major bleeding yielded a c‐statistic of 0.64. Conclusion The HA‐VTE IMRS and HA‐MB IMRS predict 90‐ and 30‐day VTE and major bleeding among COVID‐19 patients. Adding D‐dimer improved the predictiveness of the HA‐VTE IMRS for VTE.
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