Time course of ischemic and bleeding burden in consecutive patients undergoing transcatheter aortic valve replacement (FOCUS-ONE Registry).

BACKGROUND AND AIMS: Ischemic or bleeding events might occur after transcatheter aortic valve replacement (TAVR), with the potential to hamper clinical outcomes. This study aimed to characterize the average daily ischemic risks (ADIRs) and the average daily bleeding risks (ADBRs) over 1-year in all consecutive patients undergoing TAVR. METHODS: ADBR included all bleeding events according to VARC-2 definition, and ADIR included cardiovascular deaths, myocardial infarction and ischemic stroke. ADIRs and ADBRs were assessed within different timeframes post TAVR: acute (0-30 days), late (31-180 days), and very late (>181 days). Generalized estimating equations were used to test the least squares mean differences for the pairwise comparison of ADIRs and ADBRs. Our analysis was performed in the overall cohort and according to antithrombotic strategy (LT-OAC vs No LT-OAC). RESULTS: Ischemic burden was higher than bleeding burden, independently from the indication to LT-OAC, and in all timeframes examined. In the overall population, ADIRs were three-fold ADBRs (0.0467 [95% CI, 0.0431-0.0506] vs 0.0179 [95% CI, 0.0174-0.0185]; p < 0.001*). While ADIR was significantly higher in the acute phase, ADBR was relatively stable in all timeframes analysed. Of note, in LT-OAC population, OAC + SAPT group showed lower ischemic risk and higher bleeding events compared with OAC alone (ADIR: 0.0447 [95% CI: 0.0417-0.0477] vs 0.0642 [95% CI: 0.0557-0.0728]; p < 0.001*, ADBR 0.0395 [95% CI: 0.0381-0.0409] vs 0.0147 [95% CI: 0.0138-0.0156]; p < 0.001*). CONCLUSIONS: In patients undergoing TAVR Average daily risk fluctuates over time. However, ADIRs overcome ADBRs in all timeframes, especially in the acute phase and regardless of antithrombotic strategy adopted.

Serum vitamin B12 levels and glycemic fluctuation in patients with type 2 diabetes mellitus.

Purpose: The aim of the study was to explore the correlation between serum vitamin B12 levels and glycemic fluctuation in patients with type 2 diabetes mellitus (T2DM). Methods: This study included 202 T2DM patients in whom blood glucose levels were recorded using a continuous glucose monitoring system retrospectively. Glycemic fluctuation was determined using the average daily risk range (ADRR), a diabetes-specific measure of the risk for hyper- and hypoglycemia. Results: Serum vitamin B12 levels were higher in T2DM patients with wider glycemic fluctuations than in those with minor glycemic fluctuations (p < 0.001). We observed a positive correlation between serum vitamin B12 levels and ADRR in both T2DM patients who received and did not receive metformin therapy (r = 0.388, p < 0.001 and r = 0.280, p = 0.004, respectively). Multiple linear regression analysis showed that serum vitamin B12 levels were independently correlated with ADRR in T2DM patients who received and did not receive metformin therapy (beta = 0.367, p < 0.001 and beta = 0.410, p < 0.001, respectively). Conclusions: Serum vitamin B12 levels are correlated with glycemic fluctuation in patients with T2DM and may serve as an underlying useful biomarker of glycemic fluctuation in T2DM patients, treated with or without metformin therapy.

Average Daily Risk Range (ADRR) in Young Children With Type 1 Diabetes.

OBJECTIVE: The objective was to examine the utility of the average daily risk range (ADRR) in young children with type 1 diabetes. METHODS: Self-monitored blood glucose (BG) data and A1c values were collected from 134 children (ages 2-6). Other measures of BG variability and diabetes care were calculated using self-monitored BG data. ADRR, A1c, and other glycemic indices were compared to assess their distinctiveness and utility as measures of BG variability and glycemic control. RESULTS: Of young children's ADRR values, 72% were in the "high-risk" range using adult guidelines. ADRR and A1c were highly correlated with indicators of hyperglycemia but only weakly correlated with measures of hypoglycemia. ADRR was moderately correlated with minimum BG value in the past 30 days but not percentage of BG values below 70 mg/dL. A1c was not correlated with either measure of hypoglycemia. CONCLUSIONS: ADRR values confirm the high degree of BG variability present in young children with type 1 diabetes, particularly as compared with adults. New ADRR risk guidelines are needed for pediatric patients. ADRR and A1c are adequate indicators of hyperglycemia in young children. However, both ADRR and A1c failed to effectively capture hypoglycemia risk in this sample, and neither ADRR nor A1c can take the place of review of raw BG data to evaluate BG variability in young children.