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Item Activated recombinant factor VIIa should not be used in patients with refractory variceal bleeding: it is mostly ineffective, is expensive, and may rarely cause serious adverse events(Wiley Blackwell (John Wiley & Sons), 2014-11) Sozio, Margaret S.; Chalasani, Naga; Department of Medicine, IU School of MedicineItem COVID-19-Related Thrombotic and Bleeding Events in Adults With Congenital Heart Disease(Elsevier, 2023-11-21) Fusco, Flavia; Krasuski, Richard A.; Sadeghi, Soraya; Rosenbaum, Marlon S.; Lewis, Matthew J.; Carazo, Matthew R.; Rodriguez, Fred H.; Halpern, Dan G.; Feinberg, Jodi L.; Galilea, Francisca A.; Baraona, Fernando; Cedars, Ari M.; Ko, Jong M.; Porayette, Prashob; Maldonado, Jennifer R.; Frogoudaki, Alexandra A.; Nir, Amiram; Chaudhry, Anisa; John, Anitha S.; Karbassi, Arsha; Ganame, Javier; Hoskoppal, Arvind; Frischhertz, Benjamin P.; Hendrickson, Benjamin; Rodriguez-Monserrate, Carla P.; Broda, Christopher R.; Tobler, Daniel; Gregg, David; Martinez-Quintana, Efrén; Yeung, Elizabeth; Krieger, Eric V.; Ruperti-Repilado, Francisco J.; Giannakoulas, George; Lui, George K.; Ephrem, Georges; Singh, Harsimran S.; Hasan, Almeneisi; Bartlett, Heather L.; Lindsay, Ian; Grewal, Jasmine; Nicolarsen, Jeremy; Araujo, John J.; Cramer, Jonathan W.; Bouchardy, Judith; Al Najashi, Khalid; Ryan, Kristi; Alshawabkeh, Laith; Andrade, Lauren; Ladouceur, Magalie; Schwerzmann, Markus; Greutmann, Matthias; Merás, Pablo; Ferrero, Paolo; Dehghani, Payam; Tung, Poyee P.; Garcia-Orta, Rocio; Tompkins, Rose; Gendi, Salwa M.; Cohen, Scott; Klewer, Scott E.; Hascoet, Sebastien; Upadhyay, Shailendra; Fisher, Stacy D.; Cook, Stephen; Cotts, Timothy B.; Kovacs, Adrienne H.; Aboulhosn, Jamil A.; Scognamiglio, Giancarlo; Broberg, Craig S.; Sarubbi, Berardo; Medicine, School of MedicineBackground: Altered coagulation is a striking feature of COVID-19. Adult patients with congenital heart disease (ACHD) are prone to thromboembolic (TE) and bleeding complications. Objectives: The purpose of this study was to investigate the prevalence and risk factors for COVID-19 TE/bleeding complications in ACHD patients. Methods: COVID-19-positive ACHD patients were included between May 2020 and November 2021. TE events included ischemic cerebrovascular accident, systemic and pulmonary embolism, deep venous thrombosis, myocardial infarction, and intracardiac thrombosis. Major bleeding included cases with hemoglobin drop >2 g/dl, involvement of critical sites, or fatal bleeding. Severe infection was defined as need for intensive care unit, endotracheal intubation, renal replacement therapy, extracorporeal membrane oxygenation, or death. Patients with TE/bleeding were compared to those without events. Factors associated with TE/bleeding were determined using logistic regression. Results: Of 1,988 patients (age 32 [IQR: 25-42] years, 47% male, 59 ACHD centers), 30 (1.5%) had significant TE/bleeding: 12 TE events, 12 major bleeds, and 6 with both TE and bleeding. Patients with TE/bleeding had higher in-hospital mortality compared to the remainder cohort (33% vs 1.7%; P < 0.0001) and were in more advanced physiological stage (P = 0.032) and NYHA functional class (P = 0.01), had lower baseline oxygen saturation (P = 0.0001), and more frequently had a history of atrial arrhythmia (P < 0.0001), previous hospitalization for heart failure (P < 0.0007), and were more likely hospitalized for COVID-19 (P < 0.0001). By multivariable logistic regression, prior anticoagulation (OR: 4.92; 95% CI: 2-11.76; P = 0.0003), cardiac injury (OR: 5.34; 95% CI: 1.98-14.76; P = 0.0009), and severe COVID-19 (OR: 17.39; 95% CI: 6.67-45.32; P < 0.0001) were independently associated with increased risk of TE/bleeding complications. Conclusions: ACHD patients with TE/bleeding during COVID-19 infection have a higher in-hospital mortality from the illness. Risk of coagulation disorders is related to severe COVID-19, cardiac injury during infection, and use of anticoagulants.Item Femoral Artery Closure Devices vs Manual Compression During Cardiac Catheterization and Percutaneous Coronary Intervention(Elsevier, 2022-06-29) Kreutz, Rolf P.; Phookan, Sujoy; Bahrami, Hamid; Sinha, Anjan K.; Breall, Jeffrey A.; Revtyak, George E.; Ephrem, Georges; Zenisek, Joseph R.; Frick, Kyle A.; Jaradat, Ziad A.; Abu Romeh, Ibrahim S.; O’Leary, Brian A.; Ansari, Hamza Z.; Ferguson, Andrew D.; Zawacki, Kevin E.; Hoque, Mohammad Z.; Iqtidar, Ali F.; Lambert, Nathan D.; von der Lohe, Elisabeth; Medicine, School of MedicineBackground: Femoral arterial access remains widely used despite recent increase in radial access for cardiac catheterization and percutaneous coronary intervention (PCI). Various femoral artery closure devices have been developed and are commonly used to shorten vascular closure times, with variable rates of vascular complications observed in clinical trials. We sought to examine the rates of contemporary outcomes during diagnostic catheterization and PCI with the most common femoral artery closure devices. Methods: We identified patients who had undergone either diagnostic catheterization alone (n = 14,401) or PCI (n = 11,712) through femoral artery access in the Indiana University Health Multicenter Cardiac Cath registry. We compared outcomes according to closure type: manual compression, Angio-Seal, Perclose, or Mynx. Access complications and bleeding outcomes were measured according to National Cardiovascular Data Registry standard definitions. Results: The use of any vascular closure device as compared to manual femoral arterial access hold was associated with a significant reduction in vascular access complications and bleeding events in patients who underwent PCI. No significant difference in access-site complications was observed for diagnostic catheterization alone. Among closure devices, Perclose and Angio-Seal had a lower rate of hematoma than Mynx. Conclusions: The use of femoral artery access closure devices is associated with a reduction in vascular access complication rates as compared to manual femoral artery compression in patients who undergo PCI.Item Monotherapy Anticoagulation to Expedite Home Treatment of Patients Diagnosed With Venous Thromboembolism in the Emergency Department: A Pragmatic Effectiveness Trial(American Heart Association, 2021) Kline, Jeffrey A.; Adler, David H.; Alanis, Naomi; Bledsoe, Joseph R.; Courtney, Daniel M.; d’Etienne, James P.; Diercks, Deborah B.; Garrett, John S.; Jones, Alan E.; Mackenzie, David C.; Madsen, Troy; Matuskowitz, Andrew J.; Mumma, Bryn E.; Nordenholz, Kristen E.; Pagenhardt, Justine; Runyon, Michael S.; Stubblefield, William B.; Willoughby, Christopher B.; Emergency Medicine, School of MedicineBackground: The objective was to test if low-risk emergency department patients with vitamin K antagonist (venous thromboembolism [VTE]; including venous thrombosis and pulmonary embolism [PE]) can be safely and effectively treated at home with direct acting oral (monotherapy) anticoagulation in a large-scale, real-world pragmatic effectiveness trial. Methods: This was a single-arm trial, conducted from 2016 to 2019 in accordance with the Standards for Reporting Implementation Studies guideline in 33 emergency departments in the United States. Participants had newly diagnosed VTE with low risk of death based upon either the modified Hestia criteria, or physician judgment plus the simplified PE severity index score of zero, together with nonhigh bleeding risk were eligible. Patients had to be discharged within 24 hours of triage and treated with either apixaban or rivaroxaban. Effectiveness was defined by the primary efficacy and safety outcomes, image-proven recurrent VTE and bleeding requiring hospitalization >24 hours, respectively, with an upper limit of the 95% CI for the 30-day frequency of VTE recurrence below 2.0% for both outcomes. Results: We enrolled 1421 patients with complete outcomes data, including 903 with venous thrombosis and 518 with PE. The recurrent VTE requiring hospitalization occurred in 14/1421 (1.0% [95% CI, 0.5%-1.7%]), and bleeding requiring hospitalization occurred in 12/1421 (0.8% [0.4%-1.5%). The rate of severe bleeding using International Society for Thrombosis and Haemostasis criteria was 2/1421 (0.1% [0%-0.5%]). No patient died, and serious adverse events occurred in 2.5% of venous thrombosis patients and 2.3% of patients with PE. Medication nonadherence was reported by patients in 8.0% (6.6%-9.5%) and was associated with a risk ratio of 6.0 (2.3-15.2) for VTE recurrence. Among all patients diagnosed with VTE in the emergency department during the period of study, 18% of venous thrombosis patients and 10% of patients with PE were enrolled. Conclusions: Monotherapy treatment of low-risk patients with venous thrombosis or PE in the emergency department setting produced a low rate of bleeding and VTE recurrence, but may be underused. Patients with venous thrombosis and PE should undergo risk-stratification before home treatment. Improved patient adherence may reduce rate of recurrent VTE.Item VIBe Scale: Validation of the Intraoperative Bleeding Severity Scale by Spine Surgeons(International Society for the Advancement of Spine Surgery (ISASS), 2022) Sciubba, Daniel M.; Khanna, Nitin; Pennington, Zach; Singh, Rahul K.; Orthopaedic Surgery, School of MedicineBackground: The Validated Intraoperative Bleeding Scale (VIBe Scale) was initially validated with surgeons who operate on cardiothoracic, abdominal, and pelvic cavities and fulfilled criteria for a clinician-reported scale. However, there is a need for a tool to aid in intraoperative blood management during spine surgeries. The purpose of the present study was to establish the reliability and consistency of the VIBe Scale as a tool for spine surgeons to assess intraoperative bleeding. Methods: Orthopedic (n = 16) and neurological (n = 9) spine surgeons scored videos depicting surgical bleeding and assessed the VIBe Scale's relevance and clarity. Inter- and intraobserver agreement (Kendall's W) were calculated for all surgeons and pooled with responses from the original study to establish agreement across specialties. Results: All of the spine surgeons indicated that the scale was clinically relevant for evaluating hemostasis and could be implemented in a clinical study. Twenty-two spine surgeons (88%) reported that the scale represents the range of bleeding site sizes and severities expected in their practice. Twenty-four spine surgeons (96%) indicated that the scale would be useful in communicating bleeding severity with other members of the surgical team. Interobserver agreement was acceptable (0.79) for orthopedic specialists, appreciable (0.88) for neurological specialists, and appreciable (0.88) for the combined specialists. Intraobserver agreement was excellent for orthopedic (0.91) and neurological (0.91) spine surgeons and excellent (0.96) for the combined specialists. Conclusions: The results highlight the reliability of the VIBe Scale and potential utility for quantifying intraoperative blood loss in spine surgery. Clinical relevance: The VIBe Scale may be useful for evaluating the efficacy of untested intraoperative hemostatic agents and for comparing the relative efficacy of 2 or more analogous agents. It may also prove useful for intraoperative staff by quantifying ongoing intraoperative blood loss and correlating losses with the potential transfusion and intraoperative hemostatic agent requirements.