Use of real-world data and clinical registries to identify new uses of existing vascular endografts: combined use of GORE EXCLUDER Iliac Branch Endoprosthesis and GORE VIABAHN VBX Balloon Expandable Endoprosthesis.

Objective: To assess the feasibility of collecting, examining and reporting observational, real-world evidence regarding the novel use of the GORE EXCLUDER Iliac Branch Endoprosthesis (IBE) in conjunction with the GORE VIABAHN VBX Balloon Expandable Endoprosthesis (IBE+VBX stent graft). Design: Multicentre retrospective cohort study. Setting: Four real-world data sources were used: a national quality improvement registry, a statewide clinical research network, a regional quaternary health system and two tertiary academic medical centres. Participants: In total, 30 patients with 37 IBE+VBX stent graft were identified. Of those, the mean age was 72±10.2 years and 90% were male. The cohort was 77% white, 10% black, 3% Hispanic and 10% other. Main outcome measures: Outcome measures included: proportion of percutaneous vs open surgical access, intensive care admission, intensive care unit (ICU) length-of-stay (LOS), total LOS, postoperative complications, discharge disposition and 30-day mortality. Results: The majority (89%) of cases were performed percutaneously, 5% required surgical exposure following failed percutaneous access and 6% required open surgical exposure outright. Nearly half (43%) required intensive care admission with a median ICU LOS of 1 day (range: 1-2). Median total LOS was 1 day (IQR: 1-2). There were zero postoperative myocardial infarctions, zero reported leg embolisations and no reported reinterventions. Access site complications were described in 1 of 28 patients, manifesting as a haematoma or pseudoaneurysm. Ultimately, 97% were discharged to home and one patient was discharged to a nursing home or rehabilitation facility. There were no 30-day perioperative deaths. Conclusions: This project demonstrates the feasibility of identifying and integrating real-world evidence, as it pertains to an unapproved combination of endovascular devices (IBE+VBX stent graft), for short-term outcomes analysis. This new paradigm of evidence has potential to be used for device monitoring, submission to regulatory agencies, or consideration in indication expansions and approvals with further efforts to systematise data collection and transmission mechanisms.

Taste and food reinforcement in non-overweight youth.

Food reinforcement is related to increased energy intake, cross-sectionally related to obesity and prospectively related to weight gain in children, adolescents and adults. There is very limited research on how different characteristics of food are related to food reinforcement, and none on how foods from different taste categories (sweet, savory, salty) are related to food reinforcement. We tested differences in food reinforcement for favorite foods in these categories and used a reinforcing value questionnaire to assess how food reinforcement was related to energy intake in 198 non-overweight 8- to 12-year-old children. Results showed stronger food reinforcement for sweet foods in comparison to savory or salty foods. In multiple regression models, controlling for child sex, minority status and age, average reinforcing value was related to total energy and fat intake, and reinforcing value of savory foods was related to total energy and fat intake. Factor analysis showed one factor, the motivation to eat, rather than separate factors based on different taste categories. Liking ratings were unrelated to total energy intake. These results suggest that while there are differences in the reinforcing value of food by taste groups, there are no strong differences in the relationship between reinforcing value of food by taste groups and energy or macronutrient intake.