MARIA MARIN

and 4 more

INTRODUCTION: The COVID-19 infection, along with various drugs administered for its treatment may prolong ventricular repolarization and QT interval, increasing the risk of potentially fatal arrhythmias. Electrocardiogram (ECG) tracing with conventional devices increases health worker exposure to COVID-19. METHODS: In sequential tests, corrected QT interval (QTc) of electrocardiographic tracing obtained with AliveCor® single-lead (DI) Kardia Mobile (KM) was compared to QTc obtained with a 12-lead ECG. Authors evaluated numeric precision (proportion of measurements with a difference <10 msec), and consistency between the two devices in determining QTc prolongation (QTc ≥470 ms in male, or ≥480 ms in female), with kappa statistics. RESULTS: Records of 128 hospitalized patients with a suspected or confirmed COVID-19 diagnosis in the Hospital Universitario San Ignacio, Bogotá D.C. (Colombia) were included. The QTc interval measured with KM was similar to the interval measured with conventional ECG (442.5 ± 40.5 vs. 442.4 ± 40.2 ms, p: 0.986). Numeric precision was 93%. Concordance between the two devices for determining QTc prolongation was excellent, both in females (kappa: 0.901) and males (kappa: 0.896). CONCLUSION: Single-lead electrocardiographic tracing obtained with the AliveCor® Kardia Mobile allows accurate QTc interval assessment. Since KM use is fast and practical, it is ideal for reducing the exposure time of healthcare workers in the COVID-19 pandemic. The KM is capable of detecting prolonged QTc during treatment in COVID-19 patients. KEY WORDS: Kardia Mobile; AliveCor; corrected QT; QT interval; smart phone, ventricular arrhythmias, COVID-19.

Diana Diaz-Cortes

and 2 more

Introduction: Regulatory agency approval of a drug signifies that the drug’s benefits outweigh the risks of administration. Intravenous immunoglobulin (IVIg) has been approved for some indications, but its use also extends to other off-label (non-approved) indications. This study analyzes the use and cost associated with IVIg treatment in a healthcare institution Methods: Descriptive, observational, cross-sectional, drug-utilization study. The study evaluates pattern, determinants of use, and costs of treatment with IVIg, comparing approved and off-label indications. Results: 66 patients were included. The most frequent indications of use were Guillain-Barré syndrome (50%) and immune thrombocytopenic purpura (22.7%). Ten (10) patients received IVIg for off-label indications, most frequently polymyositis/dermatomyositis (10.6%). A total of 156 individual prescriptions were registered, 45 of them off-label indications. The INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos, in Colombia) off-label administrations had a higher cost compared to approved ones ($16,713,213 vs $8,383,855, p<0.001). Similar results were found when comparing costs with FDA and EMA-approved indications ($13,881,994 vs 9,570,488, p: 0,015). Conclusion: Approximately a third of IVIg administrations are outside indications approved by regulatory agencies. Costs of off-label IVIg indications were significantly higher than approved ones. Consensus among agencies is required regarding IVIg, especially in off-label indications.