ABSTRACT
OBJECTIVE: To assess the outcomes and potential predictors of residual leak after implantation of the GORE CARDIOFORM Septal Occluder (GSO) in secundum atrial septal defects (ASDs). BACKGROUND: The non-self-centering design of the GSO could lead to residual leak at the edge of the device. Outcomes of residual leak are poorly understood. METHODS: Retrospective, multicenter review of patients treated with the GSO for the pivotal and continued access study. Procedural, echocardiographic, and follow up data were reviewed. Multivariate analysis was performed to determine predictors of leak at implant and outcomes of these leaks. RESULTS: There were 370 total ASD device closures with the GSO, 65 (17.56%) of which were found to have residual leak at implantation. Patients with residual leak had larger defects (10.33 ± 3.05 mm vs. 9.13 ± 2.89 mm, p = .006) and smaller aortic rims (4.87 ± 3.33 mm vs. 6.17 ± 3.78 mm, p = .019), as compared to those without leak. Larger devices were implanted (p = .008) and more devices per case (p = .007) were utilized in the residual leak cohort as compared to those without leak. Overall, among patients with residual leak, there was a significant decrease in leak size over 1 year, from 1.55 ± 0.75 mm to 0.25 ± 0.74 mm (p < .001), with the majority (87.6%) disappearing by 12-month follow-up. CONCLUSIONS: Residual leak at implantation can be seen after ASD device closure with the GSO, more commonly in larger defects with smaller retroaortic rims. The vast majority of these leaks completely resolve by 1 year follow up.
Subject(s)
Cardiac Catheterization/instrumentation , Heart Septal Defects, Atrial/therapy , Septal Occluder Device , Adolescent , Cardiac Catheterization/adverse effects , Child , Child, Preschool , Clinical Trials as Topic , Female , Heart Septal Defects, Atrial/diagnostic imaging , Heart Septal Defects, Atrial/physiopathology , Humans , Male , Prosthesis Design , Retrospective Studies , Time Factors , Treatment Outcome , United StatesABSTRACT
[This corrects the article DOI: 10.3389/fnut.2019.00034.].
ABSTRACT
Background: The Hispanic/Latino population in the US is experiencing high rates of obesity and cardio-metabolic disease that may be attributable to a nutrition transition away from traditional diets emphasizing whole plant foods. In the US, plant-based diets have been shown to be effective in preventing and controlling obesity and cardio-metabolic disease in large samples of primarily non-Hispanic subjects. Studying this association in US Hispanic/Latinos could inform culturally tailored interventions. Objective: To examine whether the plant-based diet pattern that is frequently followed by Hispanic/Latino Seventh-day Adventists is associated with lower levels of adiposity and adiposity-related biomarkers. Methods: The Adventist Multiethnic Nutrition Study (AMEN) enrolled 74 Seventh-day Adventists from five Hispanic/Latino churches within a 20 mile radius of Loma Linda, CA into a cross-sectional study of diet (24 h recalls, surveys) and health (anthropometrics and biomarkers). Results: Vegetarian diet patterns (Vegan, Lacto-ovo vegetarian, Pesco-vegetarian) were associated with significantly lower BMI (24.5 kg/m2 vs. 27.9 kg/m2, p = 0.006), waist circumference (34.8 in vs. 37.5 in, p = 0.01), and fat mass (18.3 kg vs. 23.9 kg, p = 0.007), as compared to non-vegetarians. Adiposity was positively associated with pro-inflammatory cytokines (Interleukin-6) in this sample, but adjusting for this effect did not alter the associations with vegetarian diet. Conclusions: Plant-based eating as practiced by US-based Hispanic/Latino Seventh-day Adventists is associated with BMI in the recommended range. Further work is needed to characterize this type of diet for use in obesity-related interventions among Hispanic/Latinos in the US.
