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Andexanet alfa: trials just leave us with more questions.
Res Pract Thromb Haemost
January 2025
Department of Cardiovascular Sciences, University of Birmingham, Birmingham, United Kingdom.
Andexanet Alfa in Acute Intracranial Hemorrhage in Patients Receiving an Oral Factor Xa Inhibitor (ANNEXA-I), the first ever randomized controlled trial of a reversal agent for direct oral anticoagulants, was published in 2024. The trial, which randomized patients with intracranial hemorrhage to andexanet alfa or usual care, was mandated by the United States Food and Drug Administration as part of its conditional approval in 2018. This approval was originally based on the single-arm trial, The Andexanet Alfa, a Novel Antidote to the Anticoagulation Effects of Factor Xa Inhibitors (ANNEXA-4).
View Article and Find Full Text PDFPolysorbates degrading enzymes in biotherapeutics - a current status and future perspectives.
Front Bioeng Biotechnol
January 2025
Pharmaceutical Development Biologicals, TIP, Boehringer Ingelheim Pharma GmbH & Co., KG, Innovation Unit, Biberach an der Riss, Germany.
Polysorbates, in particular polysorbate (PS) 20 and 80, are the most commonly used surfactants for stabilising biotherapeutics produced by biotechnological processes. PSs are derived from ethoxylated sorbitan (a derivative of sorbitol) esterified with fatty acids of varying chain length and degree of saturation. In the past, these surfactants have been reported to have specific liabilities.
View Article and Find Full Text PDFUse of Indocyanine Green (ICG) to Assess Myocardial Perfusion and Territorial Distribution of Vein Grafts Implanted on Coronary Arteries in an Porcine Model. A Potential Adjunct to Assist Revascularization Strategies and Training in Coronary Artery Bypass Grafting.
Rev Cardiovasc Med
January 2025
Cardiac Surgery, University of Cincinnati Medical Center, Cincinnati, OH 45202, USA.
Background: The fluorescent dye indocyanine green (ICG) has been used to identify anatomical structures intraoperatively in coronary artery bypass grafting (CABG). This study aimed to evaluate the feasibility of using ICG to assess graft patency and territorial distribution of myocardial reperfusion during CABG.
Methods: Porcine arrested hearts (n = 18) were used to evaluate territorial distribution of native coronary arteries and of a coronary bypass constructed with porcine saphenous vein graft (SVG) using ICG.
Seeing Ourselves in Others: Understanding and Addressing Biases in Medical School Admissions Processes.
Perspect Med Educ
January 2025
Hartford Hospital and the Institute of Living, Hartford, Connecticut, USA.
Purpose: Medical school admissions is a vital area for advancing diversity, equity, and inclusion (DEI). Integrating bias recognition and management (BRM) within the context of admissions is critical in advancing DEI. However, there is a dearth of empirically informed literature on BRM in the admissions context.
View Article and Find Full Text PDFPredictive value of the systemic immune inflammation index in recurrence of atrial fibrillation after radiofrequency catheter ablation.
World J Cardiol
January 2025
Department of Internal Medicine-II, Paracelsus Medical University Salzburg, Salzburg 5020, Austria.
The recurrence of atrial fibrillation (AF) in patients after successful radiofrequency catheter ablation (RFCA) appears to be an unresolved clinical issue and needs to be clearly elucidated. There are many factors associated with AF recurrence, such as duration of AF, male sex, concomitant heart failure, hemodynamic parameters, chronic obstructive pulmonary disease, hypertension, obstructive sleep apnea, hyperthyroidism, smoking and obesity. However, the inflammatory changes are strongly associated with electrical and structural cardiac remodeling, cardiac damage, myocardial fibrotic changes, microvascular dysfunction and altered reparative response.
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