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INTRODUCTION: The United States Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) dataset represents a unique source for post-market surveillance data on adverse events (AE). An analysis of AE with percutaneous mechanical circulatory support (pMCS) devices has previously been reported specifically for microaxial flow pumps. The characteristic AE for the intra-aortic balloon pump (IABP) have not been similarly analyzed or reported. MATERIAL AND METHODS: All events in the MAUDE dataset between January 1, 2016 and December 31, 2021 were reviewed involving the Linear, Mega and Sensation devices (Datascope/Getinge, Wayne New Jersey). Data was analyzed by two authors and categorized based on AE type, date, event type and device-related or patient-related AE. RESULTS: A total of 2795 AE were reported over five years. Device malfunction (91.4 %) was the most frequent classification followed by death (5.6 %) and injury (3.0 %). Catheter deformation/fracture/leak accounted for 37.9 % of total AEs. The most common patient event categorization was asymptomatic (90.8 %). Vessel damage/hemorrhage occurred in 1.4 % of reports. Death occurred in 5.6 % of reports and was associated with cardiac arrest in 110 of 156 events. Thrombus formation was described in 1.1 % of AEs. Device optic AE were common and unique to Sensation catheters. Calibration errors were also more common with Sensation (4.6 % versus 1.3 %) compared to other models. CONCLUSIONS: Publicly reported AE with IABPs are predominantly device malfunctions without clinical sequelae. Injury, vascular damage, bleeding and thrombosis AEs are not frequent amongst reported AEs. Emphasis should be placed on understanding mechanisms of device malfunction in order to improve both reliability and user experience.
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Hemorragia , Estados Unidos , Humanos , United States Food and Drug Administration , Reproducibilidad de los Resultados , Bases de Datos FactualesRESUMEN
Radiation therapy is the standard of care for achieving cure for many thoracic malignancies, but it can result in long-term cardiovascular sequelae such as valve disease. We describe a rare case of severe aortic and mitral stenosis due to prior radiation therapy for giant cell tumor treated successfully with percutaneous aortic and off-label mitral valve replacements. (Level of Difficulty: Intermediate.).
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BACKGROUND AND AIMS: We aimed at investigating whether diabetes is associated with progression in coronary plaque components. METHODS: We identified 142 study subjects undergoing serial coronary computed tomography angiography. The resulting propensity score was applied 1:1 to match diabetic patients to non-diabetic patients for clinical risk factors, prior coronary stenting, coronary artery calcium (CAC) score and the serial scan interval, resulting in the 71 diabetes and 71 non-diabetes patients. Coronary plaque (total, calcified, non-calcified including fibrous, fibrous-fatty and low attenuation plaque [LAP]) volume normalized by total coronary artery length was measured using semi-automated plaque software and its change overtime between diabetic and non-diabetic patients was evaluated. RESULTS: The matching was successful without significant differences between the two groups in all matched variables. The baseline volumes in each plaque also did not differ. During a mean scan interval of 3.4 ± 1.8 years, diabetic patients showed a 2-fold greater progression in normalized total plaque volume (TPV) than non-diabetes patients (52.8 mm3vs. 118.3 mm3, p = 0.005). Multivariable linear regression model revealed that diabetes was associated with normalized TPV progression (ß 72.3, 95%CI 24.3-120.3). A similar trend was observed for the non-calcified components, but not calcified plaque (ß 3.8, 95%CI -27.0-34.7). Higher baseline CAC score was found to be associated with total, non-calcified and calcified plaque progression. However, baseline non-calcified volume but not CAC score was associated with LAP progression. CONCLUSIONS: The current study among matched patients indicates diabetes is associated with a greater plaque progression. Our results show the need for strict adherence of diabetic patients to the current preventive guidelines.
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Angiografía por Tomografía Computarizada/métodos , Angiografía Coronaria/métodos , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Vasos Coronarios/diagnóstico por imagen , Diabetes Mellitus , Tomografía Computarizada Multidetector/métodos , Placa Aterosclerótica , Interpretación de Imagen Radiográfica Asistida por Computador/métodos , Programas Informáticos , Anciano , Automatización , California , Enfermedad de la Arteria Coronaria/metabolismo , Enfermedad de la Arteria Coronaria/patología , Vasos Coronarios/química , Vasos Coronarios/patología , Diabetes Mellitus/diagnóstico , Progresión de la Enfermedad , Femenino , Fibrosis , Humanos , Modelos Lineales , Lípidos/análisis , Modelos Logísticos , Masculino , Persona de Mediana Edad , Análisis Multivariante , Valor Predictivo de las Pruebas , Puntaje de Propensión , Estudios Retrospectivos , Factores de Riesgo , Factores de Tiempo , Calcificación Vascular/diagnóstico por imagenRESUMEN
Genetic variation can have important consequences for populations: high population genetic diversity is typically associated with ecological success. Some mechanisms that account for these benefits assume that local social groups with high genetic diversity are more successful than low-diversity groups. At the same time, active decision-making by individuals can influence group genetic diversity. Here, we examine how maternal decisions that determine group genetic diversity influence the viability of Drosophila melanogaster larvae. Our groups contained wild-type larvae, whose genetic diversity we manipulated, and genetically marked 'tester' larvae, whose genotype and frequency were identical in all trials. We measured wild-type and tester viability for each group. Surprisingly, the viability of wild-type larvae was neither augmented nor reduced when group genetic diversity was altered. However, the viability of the tester genotype was substantially depressed in large, high-diversity groups. Further, not all high-diversity groups produced this effect: certain combinations of wild-type genotypes were deleterious to tester viability, while other groups of the same diversity-but containing different wild-type genotypes-were not deleterious. These deleterious combinations of wild-type genotypes could not be predicted by observing the performance of the same tester and wild-type genotypes in low-diversity groups. Taken together, these results suggest that nonadditive interactions among genotypes, rather than genetic diversity per se, account for between-group differences in viability in D. melanogaster and that predicting the consequences of genetic diversity at the population level may not be straightforward.