Background Factor Xa (FXa) inhibitors, used for stroke prevention in atrial fibrillation and venous thromboembolism treatment and prevention, are the dominant non-Vitamin K oral anticoagulants on the market. While major bleeding may be less common with these agents compared to warfarin, it is always a risk, and little has been published on the most serious bleeding scenarios. This study describes a cohort of patients with FXa inhibitor-associated life-threatening bleeding events, their clinical characteristics, interventions and outcomes. Methods We performed a retrospective, 5-center review of FXa inhibitor-treated major bleeding patients. Investigators identified potential cases by cross-referencing ICD-9/10 codes for hemorrhage with medication lists. Investigators selected cases they deemed to require immediate reversal of coagulopathy, and reviewed charts for characteristics, reversal strategies and other interventions, and outcomes. Results A total of 56 charts met the inclusion criteria for the retrospective cohort, including 29 (52%) gastrointestinal bleeds (GIB), 19 (34%) intracranial hemorrhages (ICH) and 8 (14%) others. Twenty-four (43%) patients received various factor or plasma products, and the remainder received supportive care. Thirty-day mortality was 21% (n = 12). Re-anticoagulation within 30-days occurred in 23 (41%) patients. Thromboembolic events (TEEs) occurred in 6 (11%) patients. No differences were observed in outcomes by treatment strategy. Conclusions This cohort of FXa inhibitor-associated major bleeding scenarios deemed appropriate for acute anticoagulant reversal illustrates the variable approaches in the absence of a specific reversal agent.

Background and Purpose: Early detection of large vessel occlusion (LVO) stroke optimizes endovascular therapy and improves outcomes. Clinical stroke severity scales used for LVO identification have variable accuracy. We investigated a portable LVO-detection device (PLD), using electroencephalography and somatosensory-evoked potentials, to identify LVO stroke. Methods: We obtained PLD data in suspected patients with stroke enrolled prospectively via a convenience sample in 8 emergency departments within 24 hours of symptom onset. LVO discriminative signals were integrated into a binary classifier. The National Institutes of Health Stroke Scale was documented, and 4 prehospital stroke scales were retrospectively calculated. We compared PLD and scale performance to diagnostic neuroimaging. Results: Of 109 patients, there were 25 LVO (23%), 38 non-LVO ischemic (35%), 14 hemorrhages (13%), and 32 stroke mimics (29%). The PLD had higher sensitivity (80% [95% CI, 74–85]) and similar specificity (80% [95% CI, 77–83]) to all prehospital scales at their predetermined high probability LVO thresholds. The PLD had high discrimination for LVO ( C -statistic=0.88). Conclusions: The PLD identifies LVO with superior accuracy compared with prehospital stroke scales in emergency department suspected stroke. Future studies need to validate the PLD’s potential as an LVO triage aid in prehospital undifferentiated stroke populations.

The objective of this study is to analyze the derived 3-dimensional (3D) VCG spatial loop using a novel chaotic dynamics algorithm to identify the development of acute myocardial acute myocardial infarction (AMI). Methods: This is a case-controlled study in which digitized 12-lead ECGs were acquired from 109 patients presenting with complaints suggestive of AMI. The prevalence of AMI was 13.76% all of which demonstrated positive troponin I serum levels. The VCG 3D spatial loop was derived from each ECG using the VectraplexECG System (VectraCor Inc, Totowa, NJ) and then analyzed using a novel chaotic dynamics algorithm that yields several real-time electrical biomarker parameters including the fractal dimensions of the volume:surface area (FD Vol:SA) and area:length (FD A:L) relations of spatial cardiac vector motion in 3D space. Both full cycle PP and QT intervals were analyzed. ANOVA of means and standard errors were used to compare AMI positive vs. AMI negative cases to evaluate for statistical significance (p < 0.05). Results: The mean PP FD Vol:SA for AMI positive and negative cases were 2.295 AE 0.197 and 2.107 AE 0.177 respectively (p ¼ 0.000269). Mean QT FD Vol:SA for AMI positive and negative cases were 2.465 AE 0.054 and 2.261 AE 0.022 respectively (p ¼ 0.000697). Mean PP FD A:L for AMI positive and negative cases were 1.102 AE 0.033 and 1.157 AE 0.0075 respectively (p ¼ 0.0177). Mean QT FD A:L for AMI positive and negative cases were 1.127 AE 0.031 and 1.083 AE 0.007 respectively (p ¼ 0.0449). FD Vol:SA showed better discrimination than FD A:L for AMI. Conclusion: The VCG 3D spatial loop can be derived from scalar ECG leads {I, II, V2} directly from a cardiac monitor/ECG device in real-time. Chaotic dynamics analysis of the spatial loop suggests that fractal dimension relationships may be continuous, point-of-care cardiac electrical field biomarkers for the detection of AMI in patients presenting for evaluation and observation of chest pain equivalents.

Study Objectives: Patients presenting with intracranial hemorrhage in the setting of oral factor Xa (FXa) inhibitor use have a high inpatient and 30-day mortality. Andexanet received accelerated approval from the FDA in May 2018 for reversing life-threatening or uncontrolled bleeding associated with the use of rivaroxaban or apixaban. Our institution approved andexanet to formulary in June 2018 with restricted criteria, including intracranial hemorrhage. The purpose of this study is to describe patient outcomes during our first year of andexanet use for intracranial hemorrhage.Methods: This IRB-approved, retrospective, observational study included all patients admitted between June 2018 and May 2019 with a diagnosis of intracranial hemorrhage who received andexanet for FXa inhibitor reversal. Patients with spontaneous or traumatic bleed were included if they were taking apixaban, rivaroxaban or edoxaban. The primary outcome was hemostatic efficacy on repeat head computerized tomography (CT) defined as either excellent/good or poor based on the rating system adapted from the ANNEXA-4 trial. Other outcomes included time of presentation to andexanet administration, in-hospital mortality, and requirement of surgical intervention for the treatment of intracranial hemorrhage. Safety outcomes evaluated were inpatient mortality, incidence of thrombotic events during hospitalization and 30-day readmission due to thrombotic event.Results: Twenty-seven patients were treated with andexanet for ICH during the study time period. The majority of patients were male (74%) with a median age of 81 years and a baseline GCS of 14. Apixaban was the most common FXa inhibitor reversed (70.3%), followed by rivaroxaban (26%) and edoxaban (3.7%). The majority of patients took their last FXa inhibitor dose either 8-18 hours (51.9%) or less than 8 hours (33.3%) from time of bleed identification and most patients were treated with low dose andexanet (88.8%). Median (IQR) baseline hematoma volume for intracerebral hemorrhage (ICH) was 7.4 mL (1 -30.8), while baseline thickness for subdural hemorrhage (SDH) and subarachnoid hemorrhage (SAH) was 13 mm (7-21). Eleven (40.7%) patients experienced a spontaneous bleed [ICH 10 (91%); SDH 1 (9%)]. Sixteen (59.3%) patients experienced intracranial hemorrhage secondary to trauma [SDH/SAH 12 (75%); ICH 4 (25%)]. The median door-to-needle time was 1.24 hours. Three patients underwent hematoma evacuation prior to repeat head CT and one patient was discharged home prior to repeat CT scan; these patients were subsequently excluded from the primary outcome analysis. Of the remaining 23 patients, repeat head CT demonstrated excellent/good hemostatic efficacy in 19 (82.6%) patients and poor hemostatic efficacy in 4 (16.7%) of patients. A total of 15% of patients either expired (n¼3) or were discharged to hospice (n¼1). No patients experienced a thrombotic event by hospital discharge and no patients were readmitted within 30 days due to a thrombotic event.Conclusions: Excellent or good hemostatic efficacy was ob...

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