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Comparative evidence is needed when deciding which bariatric operation to undergo for long-term cardiovascular risk reduction. The Effectiveness of Gastric Bypass vs. Gastric Sleeve for Cardiovascular Disease (ENGAGE CVD) study compared the effectiveness of vertical sleeve gastrectomy (VSG) and Roux-en-Y gastric bypass (RYGB) operations for reduction of the American College of Cardiology and the American Heart Association–predicted 10-year atherosclerotic cardiovascular disease (ASCVD) risk 5 years after surgery. Data for this study came from a large integrated healthcare system in the Southern California region of the United States. This is one of the most ethnically diverse (64% non-White) bariatric populations in the literature. The ENGAGE CVD cohort consisted of 22,095 patients who underwent VSG or RYGB from 2009–2016. The VSG and RYGB were compared using a local instrumental variable approach to address observed and unobserved confounding, as well as to conduct heterogeneity of treatment effects for patients of different age groups, baseline-predicted 10-year CVD risk using the ASCVD risk score, and those who had type 2 diabetes (T2D) at the time of surgery. Patients (2771 RYGB and 6256 VVSG) were primarily women (80.6%), Hispanic or non-Hispanic Black (63.7%), and 46 ± 10 years of age, with a body mass index of 43.40 ± 6.5 kg/m2. The predicted 10-year ASCVD risk at surgery was 4.1% for VSG and 5.1% for RYGB, decreasing to 2.6% for VSG and 2.8% for RYGB 1 year postoperatively. By 5 years after surgery, patients remained with relatively low risk levels (3.0% for VSG and 3.3% for RYGB) and there were no significant differences in predicted 10-year ASCVD risk between VSG and RYGB at any time. Predicted 10-year ASCVD risk was low in this population and remained low up to 5 years for those with diabetes, Black and Hispanic patients, and older adults. Literature reporting significant differences between VSG and RYGB in 10-year ASCVD risk may be a result of residual confounding. • The Effectiveness of Gastric Bypass vs. Gastric Sleeve for Cardiovascular Disease (ENGAGE CVD) study compared the effectiveness of vertical sleeve gastrectomy (VSG) and Roux-en-Y gastric bypass (RYGB) operations for reduction of the American College of Cardiology (ACA) and the American Heart Association (AHA) predicted 10-year atherosclerotic cardiovascular disease (ASCVD) risk 5 years after surgery. • Patients (2,771 RYGB and 6,256 VSG) were primarily women (80.6%), Hispanic or non-Hispanic Black (63.7%), were 46±10 years old, with a BMI of 43.40±6.5 kg/m2. The predicted 10-year ASCVD risk at surgery was 4.1% for VSG and 5.1% for RYGB, decreasing to 2.6% for VSG and 2.8% for RYGB 1-year postoperatively. By 5 years after surgery, patients remained with relatively low risk levels (3.0% for VSG and 3.3% for RYGB) and there were no significant differences in predicted 10-year ASCVD risk between VSG and RYGB at any time. • For both operations, the prevalence of smoking began to increase immediately following surgery (p<.001). However, all other indicators used for the predicted 10-year ASCVD risk score significantly improved over time (p<.001). • Our findings suggest RYGB and VSG provide similar benefits for 10-year risk of cardiovascular disease. Literature reporting significant differences between VSG and RYGB in 10-year ASCVD risk may be a result of residual confounding. [ABSTRACT FROM AUTHOR]

Aims: To estimate short-term mortality rates for individuals with type 1 or type 2 diabetes diagnosed before age 20 years from the SEARCH for Diabetes in Youth study.Methods: We included 8358 individuals newly-diagnosed with type 1 (n = 6840) or type 2 (n = 1518) diabetes from 1/1/2002-12/31/2008. We searched the National Death Index through 12/31/2010. We calculated standardized mortality ratios (SMRs) based on age, sex, and race for the comparable US population in the geographic areas of the SEARCH study.Results: During 44,893 person-years (PY) of observation (median follow-up = 5.3 years), 41 individuals died (91.3 deaths/100,000 PY); 26 with type 1 (70.6 deaths/100,000 PY) and 15 with type 2 (185.6 deaths/100,000 PY) diabetes. The expected mortality rate was 70.9 deaths/100,000 PY. The overall SMR (95% CI) was 1.3 (1.0, 1.8) and was high among individuals with type 2 diabetes 2.4 (1.3, 3.9), females 2.2 (1.3, 3.3), 15-19 year olds 2.7 (1.7,4.0), and non-Hispanic blacks 2.1 (1.2, 3.4).Conclusions: Compared to the state populations of similar age, sex, and race, our results show excess mortality in individuals with type 2 diabetes, females, older youth, and non-Hispanic blacks. We did not observe excess short-term mortality in individuals with type 1 diabetes. [ABSTRACT FROM AUTHOR]

Randomized clinical trials (RCT) in populations having heart failure with reduced ejection fraction (HFrEF) include stringent selection criteria and may not be reflective of the general HF population. We assessed the representativeness of the GALACTIC-HF RCT in a real-world HFrEF population. We included Kaiser Permanente Southern California patients with a HF diagnosis and ejection fraction (EF) ≤ 40% from 2014-2018 using electronic health records. Four mutually exclusive cohorts were created. These include real-world cohorts: 1) not taking guideline-directed medical therapy (GDMT), 2) taking GDMT and RCT-like cohorts with: 3) EF ≤ 35% and 4) EF 36-40%. Hazard ratios (HR) and 95% confidence intervals (CI) for 30-day and 1-year all-cause mortality and, separately, hospitalization were calculated comparing cohorts. Among 12,772 HFrEF patients, 3,626 (28%) met strict GALACTIC-HF criteria with EF ≤ 35% and 884 (7%) met all GALACTIC-HF criteria except for EF, with an EF of 36-40%. Age (mean 71 years), sex (67% male), racial/ethnic distribution (48% non-Hispanic white, 18% black, 25% Hispanic), and baseline measures including heart rate were comparable between all cohorts. (Table) Overall, 30-day mortality and hospitalization were lower among all cohorts vs. the real-world cohort not taking GDMT. (Table) Similarly, the risk of 1-year mortality was lower among all cohorts vs. the real-world cohort not taking GDMT. The risk of 1-year hospitalization was only lower among the real-world cohort taking GDMT vs. the real-world cohort not taking GDMT Only 28% of HFrEF patients met complete GALACTIC-HF criteria. RCT-like cohorts had lower mortality, but similar 1-year hospitalization rates compared to real-world HFrEF patients not taking GDMT, suggesting the potential for additional treatment benefits. [ABSTRACT FROM AUTHOR]

Aims: To investigate the discontinuation of oral antihyperglycemic agents (OHA), and examine factors associated with OHA discontinuation, and the effect of OHA discontinuation on glycemic control and healthcare utilization among diabetes patients prescribed dual OHA therapy.Methods: We identified 23,612 adult patients aged >18years with a diagnosis of type 2 diabetes who initiated dual OHA therapy between 1/1/2005 and 6/30/2010. The date of initiation of the second OHA was defined as the index date. Discontinuation was defined as a gap >1.5 times the last days' supply without subsequent reinitiation.Results: Over 24months, 16.9% discontinued 1 OHA and 9.2% discontinued both. Patients who discontinued were more likely to be female, younger, Black or of Hispanic ethnicity, have more comorbidities, higher medication co-pays, start both OHAs together, have higher healthcare utilization before the index date and less likely to use prescription mail order compared with patients who did not discontinue. In multivariable regression models, patients who discontinued were more likely to be hospitalized or have emergency department visits during follow-up.Conclusions: Discontinuation of OHAs is common among patients with diabetes and is associated with several patient factors and increased healthcare utilization. Future research should further examine reasons for OHA discontinuation. [ABSTRACT FROM AUTHOR]

Because heart failure (HF) with reduced ejection fraction (HFrEF) and preserved ejection fraction (HFpEF) are different clinical entities with differing demographic characteristics, common HF outcomes may occur at different rates. Comparative outcome studies have been equivocal, and studies comparing resource utilization are scant. We used an observational cohort design to study 6,513 patients hospitalized for HF who had an EF measured during the hospitalization and were discharged alive within 30 days. We excluded 677 patients with borderline EF values (41% to 49%) and categorized the remaining as HFrEF (EF ≤40%, n = 2,205) and HFpEF (EF >50%, n = 3,631). Patients were followed for up to 1 year for all-cause re-hospitalization and mortality and annualized medical resource utilization. Patients with HFrEF and HFpEF experienced similar adjusted incidence rates of re-hospitalization, but those with HFrEF had a 39% increased risk of mortality at 30 days (rate ratio 1.39, 95% confidence interval 1.10 to 1.76) and 25% greater risk at 1 year (rate ratio1.25, 95% confidence interval 1.12 to 1.41). After adjustment for covariates, patients with HFpEF incurred significantly more annualized outpatient visits (21.5 vs 20.1, p = 0.002) and emergency room visits (3.24 vs 2.94, p = 0.002) than those with HFrEF, but absolute differences were small. High inpatient and pharmacy utilization did not differ. Our study suggests that whether a patient has HFrEF or HFpEF has little bearing on risk of re-hospitalization or inpatient resource utilization in the year after an HF hospitalization. Both groups experienced high mortality, but those with HFrEF had greater risk. In conclusion, from the standpoint of resource use, HF can be considered a single entity. [ABSTRACT FROM AUTHOR]

Heart failure (HF) hospitalization length of stay (LOS) has been associated with the risk of subsequent readmission and mortality. We identified 19,927 hospitalized patients with HF who were discharged alive from 2008 to 2011 from 3 Kaiser Permanente regions. In adjusted Cox models using LOS 3 to 4 days as the reference category, shorter LOS was not significantly associated with hospital readmissions. LOS of 5 to 10 days was associated with 17% greater risk of readmission within 30 days (hazard ratio [HR] 1.17, 95% confidence interval [CI] 1.07 to 1.28) and 9% greater risk within 1 year (HR 1.09, 95% CI 1.03 to 1.15). LOS of 11 to 29 days was associated with increased readmission risk of 52% at 30 days (HR 1.52, 95% CI 1.30 to 1.76) and 25% at 1 year (HR 1.25, 95% CI 1.16 to 1.35). Mortality risk within 30 days among those with LOS of 1 day was 47% lower (HR 0.53, 95% CI 0.43 to 0.65) and 32% lower at 1 year (HR 0.68, 95% CI 0.62 to 0.74). LOS of 2 days was associated with lower mortality risk of 17% (HR 0.83, 95% CI 0.76 to 0.90) at 1 year. At LOS 5 to 10 days, 30-day and 1-year risk of mortality was increased by 52% (HR 1.52, 95% CI 1.30 to 1.76) and 25% (HR 1.25, 95% CI 1.16 to 1.35), respectively. LOS of 11 to 29 days was associated with 171% higher mortality risk at 30 days (HR 2.71, 95% CI 2.19 to 3.35) and 73% at 1 year (HR 1.73, 95% CI 1.53 to 1.97). Longer LOS during the index HF hospitalization was associated with readmission and mortality within 30 days and 1 year independent of co-morbidities and cardiovascular risk factors. These results suggest that LOS may be a proxy for the severity of HF during the index hospitalization. [ABSTRACT FROM AUTHOR]

Hypercholesterolemia is a major modifiable risk factor for cardiovascular disease. Some, but not all, studies have shown that soy protein intake decreases total and low-density lipoprotein cholesterol and triglycerides and increases high-density lipoprotein cholesterol. The objective of this meta-analysis was to examine the effect of soy protein supplementation on serum lipid levels in adults. English language articles were retrieved by searching MEDLINE (1966 to February 2005) and the bibliographies of the retrieved articles. A total of 41 randomized controlled trials in which isolated soy protein supplementation was the only intervention and the net changes in serum lipids during intervention were reported. Information on study design, sample size, participant characteristics, intervention, follow-up duration, and treatment outcomes was independently abstracted using a standardized protocol. Using a random-effects model, data from each study were pooled and weighted by the inverse of their variance. Soy protein supplementation was associated with a significant reduction in mean serum total cholesterol (−5.26 mg/dl, 95% confidence interval [CI] −7.14 to −3.38), low-density lipoprotein cholesterol (−4.25 mg/dl, 95% CI −6.00 to −2.50), and triglycerides (−6.26 mg/dl, 95% CI −9.14 to −3.38) and a significant increase in high-density lipoprotein cholesterol (0.77 mg/dl, 95% CI 0.20 to 1.34). Meta-regression analyses showed a dose-response relation between soy protein and isoflavone supplementation and net changes in serum lipids. These results indicate that soy protein supplementation reduces serum lipids among adults with or without hypercholesterolemia. In conclusion, replacing foods high in saturated fat, trans-saturated fat, and cholesterol with soy protein may have a beneficial effect on coronary risk factors. [Copyright &y& Elsevier]

Background: In Western populations, waist circumference (WC) is more predictive of cardiovascular disease (CVD) risk than is body mass index (BMI). It is unclear whether the same is true in Asian populations. Objective: The objective was to examine the independent effects of WC and BMI on CVD risk factors in China. Design: CVD risk factors, BMI, and WC were measured in a nationally representative cross-sectional study of 15 540 Chinese adults aged 35-74 y. Results: Higher WC tertiles were associated with higher blood pressure and higher cholesterol, triacylglycerol, and glucose concentrations within each tertile of BMI and vice versa. In men, the odds of hypertension, dyslipidemia, and the metabolic syndrome (MS) increased with successive WC tertiles (1.0, 1.1, and 1.8, respectively, for hypertension; 1.0, 1.4, and 2.0, respectively, for dyslipidemia; and 1.0, 2.3, and 4.8, respectively, for MS; P for trend < 0.001 for all), even after adjustment for BMI. Similarly, the odds of hypertension, dyslipidemia, and MS increased with successive BMI tertiles (1.0, 1.5, and 2.6, respectively, for hypertension; 1.0, 1.3, and 1.8, respectively, for dyslipidemia; 1.0, 1.3, and 2.9, respectively for MS; P for trend <0.001 for all), even after adjustment for WC. However, BMI tertiles were not associated with the odds of diabetes after adjustment forWC(P for trend=0.67), whereas tertiles of WC were significantly associated with the odds of diabetes after adjustment for BMI (1.0, 1.6, and 2.1, respectively; P for trend =0.002). The results were similar in women. Conclusions: These data show that WC adds additional risk information to that of BMI in Chinese adults. Measurement of both WC and BMI in Chinese adults may enhance CVD risk stratification. [ABSTRACT FROM AUTHOR]

Background: Recent data suggest that current overweight and central adiposity guidelines based on Western populations are not appropriate for Asian populations. The published data among Chinese are insufficient to address this issue. Objective: We aimed to identify cutoffs for body mass index (BMI; in kg/m2) and waist circumference that confer increased risk of cardiovascular disease in Chinese adults as would be consistent with overweight and central adiposity. Design: A nationally representative, cross-sectional sample of 15 239 Chinese adults aged 35-74 y was studied. Results: Mean blood pressure, total cholesterol, LDL-cholesterol, triacylglycerol, and glucose values were incrementally higher and mean HDL-cholesterol values were incrementally lower with each unit increase in BMI and waist circumference in both men and women. Both the point at which sensitivity equaled specificity and the shortest distance in the receiver operating characteristic curves for hypertension, dyslipidemia, diabetes, or ⩾2 of these risk factors suggested a BMI cutoff of 24 and a waist circumference cutoff of 80 cm for both men and women. Conclusions: Lower cutoffs for BMI and waist circumference are needed in the identification of Chinese patients at high risk of cardiovascular disease. [ABSTRACT FROM AUTHOR]

An increasing number of patients are undergoing GI endoscopic procedures with active prescriptions for direct oral anticoagulants (DOACs). DOACs have been associated with a higher risk of GI bleeding (GIB) compared with warfarin. Our aims were to compare the risk of postendoscopic GIB and thromboembolic (TE) events among patients on DOACs versus warfarin. We conducted a retrospective cohort study of patients aged 18 years or older in a large integrated health care system in Southern California, who had undergone an outpatient GI endoscopic procedure and were taking a DOAC or warfarin between January 1, 2013, and October 1, 2019. We compared bleeding and thrombosis risk in the 30 days after the endoscopic procedure between the warfarin and DOAC groups using multivariate logistic regression analysis adjusted for covariates. Between January 1, 2013, and October 1, 2019, we identified 6765 outpatient GI endoscopic procedures in which patients received preprocedure prescriptions for either a DOAC (1587) or warfarin (5178). Overall, there was no significant difference in postprocedure GIB (odds ratio [OR], 1.165; 95% confidence interval [CI], 0.88-1.55; P =.291) or TE (OR, 0.929; 95% CI, 0.64-1.35; P =.703) between the DOAC and warfarin groups). Subgroup analysis revealed a higher risk of GIB associated with DOAC specifically with EGD procedures (OR, 1.8; 95% CI, 1.15-2.83; P =.011). There was no significant difference in the overall postendoscopic risk of GIB and TE events among patients with preprocedure use of DOACs compared with patients on warfarin. There may be a higher risk of GIB in patients taking DOACs and undergoing EGD. [ABSTRACT FROM AUTHOR]

Despite their effectiveness in reducing low-density lipoprotein cholesterol and cardiovascular disease risk, high-intensity statins are underutilized among adults with low-density lipoprotein cholesterol ≥190 mg/dL. This study determined whether a safety net program (SureNet) facilitating medication and laboratory test orders improved statin initiation and laboratory test completions after (SureNet period: April 2019–September 2021) and before implementation (pre-SureNet period: January 2016–September 2018). Kaiser Permanente Southern California members aged 20–60 years with low-density lipoprotein cholesterol ≥190 mg/dL and no statin use in previous 2–6 months were included in this retrospective cohort study. Statin orders within 14 days and statin fills, laboratory test completions, and improved low-density lipoprotein cholesterol within 180 days of the high low-density lipoprotein cholesterol (pre-SureNet) or outreach (SureNet period) were compared. Analyses were conducted in 2022. Overall, 3,534 and 3,555 adults were eligible for statin initiation during the pre-SureNet and SureNet periods, respectively. Overall, 759 (21.5%) and 976 (27.5%) had a statin approved by their physician during pre-SureNet and SureNet periods, respectively (p <0.001). After multivariable adjustment for demographics and clinical characteristics, adults during the SureNet period had a higher likelihood of receiving a statin order (prevalence ratio=1.36, 95% CI=1.25, 1.48), filling their statin (prevalence ratio=1.32, 95% CI=1.26, 1.38), completing their laboratories (prevalence ratio=1.41, 95% CI=1.26, 1.58), and improving low-density lipoprotein cholesterol (prevalence ratio=1.21, 95% CI=1.07, 1.37) than in pre-Surenet period. The SureNet program was able to improve prescription orders, fills, laboratory test completions, and lower low-density lipoprotein cholesterol. Optimizing both physician adherence to treatment guidelines; and patient adherence to the program may improve low-density lipoprotein cholesterol lowering. [ABSTRACT FROM AUTHOR]

• Monitoring the safety of vaccines containing novel adjuvants is important. • Risk of new-onset immune-mediated events after HepB-CpG versus HepB-alum was similar. • The risk of herpes zoster was not increased after HepB-CpG compared with HepB-alum. • No cases of anaphylaxis occurred after receipt of HepB-CpG. • This study did not identify safety concerns of HepB-CpG compared with HepB-alum. HepB-CpG (Heplisav-B) is a licensed hepatitis B vaccine with a novel adjuvant that requires 2 doses (0, 1 month) compared to HepB-alum (Engerix-B) which requires 3 doses (0, 1, 6 months). Monitoring safety outcomes following receipt of vaccines with novel adjuvants outside trial settings is important. Hence, as part of a post-marketing commitment, we compared the incidence of new-onset immune-mediated diseases, herpes zoster (HZ), and anaphylaxis among recipients of HepB-CpG versus HepB-alum. This cohort study included adults not on dialysis who received ≥1 dose of hepatitis B vaccine from 8/7/2018 to 10/31/2019, during which HepB-CpG was routinely administered in 7 of 15 Kaiser Permanente Southern California medical centers while HepB-alum was administered in the other 8 centers. Recipients of HepB-CpG or HepB-alum were followed through electronic health records for 13 months for occurrence of pre-specified new-onset immune-mediated diseases, HZ, and anaphylaxis identified using diagnosis codes. Incidence rates were compared using Poisson regression with inverse probability of treatment weighting when there was ≥80 % power to detect a relative risk (RR) of 5 for anaphylaxis and RR of 3 for other outcomes. Chart review to confirm new-onset diagnosis was conducted for outcomes with statistically significant elevated risk. There were 31,183 HepB-CpG and 38,442 HepB-alum recipients (overall 49.0 % female, 48.5 % age ≥50 years, and 49.6 % Hispanic). Among immune-mediated events that occurred frequently enough for formal comparison, rates among HepB-CpG versus Hep-B-alum recipients were similar except for rheumatoid arthritis (RA) (adjusted RR 1.53 [95 % CI: 1.07, 2.18]). After chart confirmation of new-onset RA, the adjusted RR was 0.93 (0.34, 2.49). The adjusted RR for HZ was 1.06 (0.89, 1.27). Anaphylaxis occurred in 0 HepB-CpG and 2 HepB-alum recipients. This large post-licensure study did not identify evidence of safety concerns for HepB-CpG compared to HepB-alum for immune-mediated diseases, HZ, or anaphylaxis. [ABSTRACT FROM AUTHOR]

Objective: To describe the prevalence of access and process barriers to health care and to examine their relationship to sociodemographic and disease factors in a large and diverse cohort of US youth with type 1 diabetes. Study design: A cross-sectional analysis of 780 youth who participated in the SEARCH for Diabetes in Youth Study and were diagnosed with type 1 diabetes in 2002-2005. Experience of barriers to care was collected from parent report on questionnaires. Analyses included multivariate regression models to predict the presence of specific barriers to care. Results: Overall, 81.7% of participants reported at least one barrier; the 3 most common were costs (47.5%), communication (43.0%), and getting needed information (48.4%). Problems with access to care, not having a regular provider, and receiving contextual care (care that takes into account personal and family context) were associated with poorer glycated hemoglobin levels. Adjusted multivariate models indicated that barriers related to access (regular provider, cost) were most likely for youth with low family income and those without public health insurance. Barriers associated with the processes of quality care (contextual care, communication) were more likely for Hispanic youth and those whose parents had less education. Conclusions: This study indicates that a large proportion of youth with type 1 diabetes experience substantial barriers to care. Barriers to access and those associated with processes of quality care differed by sociodemographic characteristics. Future investigators should expand knowledge of the systemic processes that lead to disparate outcomes for some youth with diabetes and assess potential solutions. [Copyright &y& Elsevier]

Objective: To test the hypothesis that a change in glycated hemoglobin (A1c) over a follow-up interval of approximately 2 years would be associated with concomitant changes in fasting lipids in individuals with type 1 diabetes (T1D). Study design: All subjects with T1D diagnosed in 2002-2005 in the SEARCH for Diabetes in Youth study with at least 2 study visits ∼12 and ∼24 months after an initial visit were included (age at initial visit, 10.6 ± 4.1 years; 48% female; diabetes duration, 10 ± 7 months; 76% non-Hispanic white; A1c = 7.7% ± 1.4%). Longitudinal mixed models were fit to examine the relationship between change in A1c and change in lipid levels (total cholesterol [TC], high-density lipoprotein-cholesterol [HDL-c], low-density lipoprotein-cholesterol [LDL-c], log triglycerides [TG], and non–HDL-c) with adjustment for possible confounders. Results: Change in A1c over time was significantly associated with changes in TC, HDL-c, LDL-c, TG, and non–HDL-c over the range of A1c values. For example, for a person with an A1c of 10% and then a 2% decrease in A1c 2 years later (to 8%), the model predicted concomitant changes in TC (−0.29 mmol/L, −11.4 mg/dL), HDL-c (0.03 mmol/L, 1.3 mg/dL), LDL-c (−0.23 mmol/L, −9.0 mg/dL), and non–HDL-c (−0.32 mmol/L, −12.4 mg/dL) and an 8.5% decrease in TG (mmol/L). Conclusions: Improved glucose control over a 2-year follow-up was associated with a more favorable lipid profile but may be insufficient to normalize lipids in dyslipidemic T1D youth needing to decrease lipids to goal. [ABSTRACT FROM AUTHOR]

Young adults may have high long-term atherosclerotic cardiovascular disease (ASCVD) risk despite low short-term risk. In this study, we sought to compare the performance of short-term and long-term ASCVD risk prediction tools in young adults and evaluate ASCVD incidence associated with predicted short-term and long-term risk. We included adults aged 18 to 39 years, from 2008 to 2009 in a U.S. integrated health care system, and followed them through 2019. We calculated 10-year and 30-year ASCVD predicted risk and assessed ASCVD incidence. Among 414,260 young adults, 813 had an incident ASCVD event during a median of 4 years (maximum 11 years). Compared with 10-year predicted risk, 30-year predicted risk improved reclassification (net reclassification index: 16%) despite having similar discrimination (Harrell's C: 0.749 vs 0.726). Overall, 1.0% and 2.2% of young adults were categorized as having elevated 10-year (≥7.5%) and elevated 30-year (≥20%) predicted risk, respectively, and 1.6% as having low 10-year (<7.5%) but elevated 30-year predicted risk. The ASCVD incidence rate per 1,000 person-years was 2.60 (95% CI: 1.92-3.52) for those with elevated 10-year predicted risk, 1.87 (95% CI: 1.42-2.46) for those with low 10-year but elevated 30-year predicted risk, and 0.32 (95% CI: 0.30-0.35) for those with low 10-year and 30-year predicted risk. The age- and sex-adjusted incidence rate ratio was 3.04 (95% CI: 2.25-4.10) comparing those with low 10-year but elevated 30-year predicted risk and those with low 10-year and 30-year predicted risk. Long-term ASCVD risk prediction tools further discriminate a subgroup of young adults with elevated observed risk despite low estimated short-term risk. [Display omitted] [ABSTRACT FROM AUTHOR]

Objectives: To examine prevalence of tobacco use and coexistence of cardiometabolic risk factors according to smoking status in youth with diabetes mellitus. Study design: Youth aged 10 to 22 years who participated in the SEARCH for Diabetes in Youth study (n = 3466) were surveyed about their tobacco use and examined for cardiometabolic risk factors: waist circumference, systolic and diastolic blood pressure, physical activity, and lipid profile. Results: The prevalence of tobacco use in youth aged 10 to 14 years, 15 to 19 years, and ≥20 years with type 1 diabetes mellitus was 2.7%, 17.1%, and 34.0%, respectively, and the prevalence in youth with type 2 diabetes mellitus was 5.5%, 16.4%, and 40.3%, respectively. Smoking was more likely in youth with annual family incomes <$50 000, regardless of diabetes mellitus type. Cigarette smoking was associated with higher odds of high triglyceride levels and physical inactivity in youth with type 1 diabetes mellitus. Less than 50% of youth aged 10 to 14 years (52.2% of participants) reported having ever been counseled by their healthcare provider to not smoke or to stop smoking. Conclusions: Tobacco use is prevalent in youth with diabetes mellitus. Aggressive tobacco prevention and cessation programs should be a high priority to prevent or delay the development of cardiovascular disease. [ABSTRACT FROM AUTHOR]

Objective: To estimate the prevalence of extreme obesity in a large, multiethnic contemporary cohort of children and adolescents. Study design: In a cross-sectional study, measured weight and height were extracted from electronic medical records of 710 949 patients aged 2 to 19 years (87.8% of eligible patients) who were enrolled in an integrated prepaid health plan in 2007 and 2008. Prevalence of extreme obesity was defined as body mass index (BMI)-for-age ≥1.2 times 95th percentile or BMI ≥35 kg/m2. Results: Extreme obesity was observed in 7.3% of boys and 5.5% of girls. The prevalence peaked at 10 years of age in boys and at 12 years of age with a bimodal distribution in girls (second peak at 18 years; P value for sex × age interaction = .036). The prevalence of extreme obesity varied in ethnic/racial and age groups, with the highest prevalence in Hispanic boys (as high as 11.2%) and African-American girls (as high as 11.9%). Conclusion: Extreme obesity in Southern California youth is frequently observed at relatively young ages. The shift toward extreme body weights is likely to cause an enormous burden of adverse health outcomes once these children and adolescents grow older. [Copyright &y& Elsevier]

Purpose: To estimate the association between hydroxymethylglutaryl-CoA inhibitor (statin) use and hip fracture.Methods: We conducted a population-based case-control study. Cases were 6774 male enrollees in a large managed care organization, aged 45 or more years, with an incident hip fracture from 1997 to 2006. Controls without fracture (n = 6774) were matched to cases on age, race, and medical center. Electronic information on pharmaceutical use was used to identify the dispensing of statins from 1991 forward.Results: Overall, 1884 (27.8%) cases and 2150 controls (31.7%) used a statin before index date (matched odds ratio [mOR] = 0.81, 95% confidence interval [CI] = 0.74-0.87). Adjustment for comorbidity burden strengthened the magnitude of the overall association (mOR = 0.68, CI = 0.62-0.74). The adjusted association was similar across age groups but was strongest among men aged 80 years or more (mOR = 0.62, CI = 0.54-0.71) and was most pronounced in African Americans (mOR = 0.43, CI = 0.28-0.64). Greater duration of statin use did not alter the odds ratios.Conclusions: These data add to the growing evidence of a potential protective effect of statin use on bone health. However, these results need to be replicated in a prospective study that can account for confounding by indication which may explain these findings. [ABSTRACT FROM AUTHOR]

Venous thromboembolism (VTE) is commonly treated with oral anticoagulants, including warfarin or direct oral anticoagulants (DOACs). Although DOACs are associated with favorable treatment satisfaction, few studies have assessed whether quality of life differs between DOAC and warfarin users. We invited adults enrolled in two California-based integrated health care delivery systems and with a history of VTE between January 1, 2015 and June 30, 2018 to complete a survey on their experience with anticoagulants. Health-related quality of life (QOL) was assessed using the RAND 36-item Short Form Health Survey (SF-36), which measures QOL in 2 general component scores (physical and mental). We used multivariable linear regression to compare mean QOL component scores between DOAC-users and warfarin-users, adjusting for patient and clinical characteristics. Overall, 2230 patients (43.1 % women and 31.8 % >75 years of age) taking anticoagulants answered at least 1 question on the SF-36, 975 taking DOACs and 1255 taking warfarin. After adjustment for patient-level factors, there were no significant differences in either physical component scores (39.2 v 38.3, p = 0.24) or mental component scores (48.5 v 49.0, p = 0.42) between DOAC and warfarin users. Health-related QOL did not significantly differ between DOAC and warfarin users with a history of VTE. • Health-related quality of life (QOL) is a key outcome measure in venous thromboembolism (VTE). • Little is known about differences in QOL for patients prescribed warfarin versus direct oral anticoagulants (DOACs). • We assessed QOL using RAND 36-item Short Form Health Survey (SF-36) in patients with VTE in Kaiser integrated healthcare system. • Among 2230 patients, there were no significant differences in physical or mental QOL scores between warfarin and DOAC users. [ABSTRACT FROM AUTHOR]

To date, there have been few studies evaluating outcomes of patients with atrial fibrillation (AF) who have experienced gastrointestinal (GI) hemorrhages. We examined short- and long-term mortality of major GI hemorrhage in patients with AF on and off warfarin in recent clinical care. We evaluated this association in the large Anticoagulation and Risk Factors in Atrial fibrillation (ATRIA) and ATRIA-Cardiovascular Research Network (CVRN) California community-based cohorts of patients with AF (study years 1996 to 2003 and 2006 to 2009, respectively), where all events were clinician adjudicated. We used proportional hazards regression with propensity score adjustment to estimate the short- (30 days) and long-term (>30 days for 1 year) mortality rate ratio for patients using warfarin compared with those who were not using warfarin at the time of GI hemorrhage. In the 414 ATRIA participants with major GI hemorrhage, 54% were taking warfarin at the time of the hemorrhage; in the 361 ATRIA-CVRN participants with major GI hemorrhage, 58% were taking warfarin. Warfarin use at the time of GI hemorrhage was not associated with 30-day mortality in the ATRIA cohort but was associated with significantly reduced 30-day mortality in the ATRIA-CVRN cohort (adjusted mortality rate ratio [95% confidence interval], ATRIA 0.97 [0.54 to 1.74]; ATRIA-CVRN 0.38 [0.17 to 0.83]). There was a modest suggestion of lower mortality on warfarin after 30 days in both cohorts. In conclusion, our study demonstrates that GI hemorrhages on warfarin are certainly no worse and may be less life threatening than those occurring off warfarin. These findings are in stark contrast to the deleterious effect of warfarin on mortality from intracranial hemorrhage and add another factor favoring anticoagulation in clinical decision making for patients with AF. [ABSTRACT FROM AUTHOR]

Abstract: Background: Observational studies suggest that moderate alcohol consumption may lower risk of myocardial infarction (MI) and coronary heart disease (CHD); yet, evidence for this comes almost entirely from Western populations. Methods: We conducted a prospective cohort study in 64,597 Chinese men aged ≥40 years who were free of clinical CHD at baseline examination. Data on frequency and type of alcohol consumed were collected at the baseline examination in 1991 using a standard protocol. Follow-up evaluation was conducted in 1999–2000, with a response rate of 94%. Results: Over 494,084 person-years of follow-up, we documented 725 (361 fatal) incident MI and 976 (588 fatal) incident CHD events. After stratification by province to account for multi-stage sampling design and adjustment for age, education, physical activity, cigarette smoking, body mass index, systolic blood pressure, urbanization (urban vs. rural), geographic variation (north vs. south) and history of diabetes, relative risk (95% confidence interval) of MI was 0.93 (0.70–1.24) for participants consuming 1 to 6 drinks/week, 0.66 (0.54–0.82) for those consuming 7 to 34 drinks/week, and 0.58 (0.41–0.81) for those consuming ≥35 drinks/week (p for linear trend <0.0001) compared to non-drinkers. The corresponding relative risks for CHD events were 0.99 (0.77–1.27), 0.67 (0.56–0.81), and 0.58 (0.44–0.78), respectively (p for linear trend <0.0001). Conclusion: Alcohol consumption may be related to lower risk of MI and CHD in middle-aged and older Chinese men. However, heavy alcohol consumption may lead to increased mortality from other causes; therefore, the implications of these findings should be interpreted cautiously. [Copyright &y& Elsevier]

Low transferrin saturation (TSAT) or reduced serum ferritin level are suggestive of iron deficiency but the relationship between iron parameters and outcomes has not been systematically evaluated in older adults with heart failure (HF) and anemia. We identified a multicenter cohort of adults age ≥ 65 years with HF and incident anemia (hemoglobin <13 g/dL [men] or < 12 g/dL [women]) between 2005 and 2012. Patients were included if ferritin (ng/mL) and TSAT (%) were evaluated within 90 days of incident anemia. HF hospitalizations and all-cause death were ascertained from electronic health records. Among 4103 older adults with HF and incident anemia, 47% had TSAT <20% and the median (IQR) ferritin was 126 (53, 256) ng/mL. In multivariable analyses, compared with TSAT ≥20%, patients with TSAT <20% were at increased risk of HF hospitalization for serum ferritin <100 ng/mL (adjusted HR [aHR] 1.40, 95% CI:1.16–1.70) and 100–300 ng/mL (aHR 1.24, 95% CI:1.01–1.52) but not for a ferritin >300 ng/mL (aHR 0.89, 95% CI 0.65–1.23). In addition, TSAT <20% was independently associated with an increased risk of all-cause death regardless of serum ferritin level (<100 ng/mL: aHR 1.42, 95% CI:1.20–1.68; 100–300 ng/mL: aHR 1.18, 95% CI:1.00–1.38; >300 ng/mL: aHR 1.33, 95% CI:1.06–1.69). Among older adults with HF and incident anemia who had iron studies tested, nearly half had a TSAT <20%, which was independently associated with higher rates of morbidity and death. • Among older adults with HF, ~55% of patients were found to have iron deficiency (i.e., ferritin <100 ng/mL or ferritin 100–300 ng/mL and TSAT <20%). • A TSAT <20% was independently associated with HF hospitalizations and all-cause death. • These findings remained unchanged in sensitivity analyses stratified by degree of systolic dysfunction (i.e., reduced vs. mid-range vs. preserved). [ABSTRACT FROM AUTHOR]

Introduction: With the growing emphasis on intensive blood pressure control, the potential for overtreatment and treatment-related adverse outcomes has become an area of interest. A large representative population within a real-world clinical environment with successful hypertension control rates was used to evaluate serious falls and syncope in people with low-treated systolic blood pressure (SBP).Methods: A cross-sectional study among medically treated hypertensive individuals within the Kaiser Permanente Southern California health system (2014-2015) was performed. Serious fall injuries and syncope were identified using ICD codes based on emergency department and hospitalization diagnoses. SBPs in a 1-year window were used to compare serious falls and syncope among individuals with SBP <110 mmHg vs ≥110 mmHg. Logistic regression was used to evaluate the association between low minimum and mean SBP and serious falls/syncope after adjustment for demographics, comorbidities, and medications.Results: In 477,516 treated hypertensive individuals, the mean age was 65 (SD=13) years and the mean SBP was 129 (SD=10) mmHg, with 27% having a minimum SBP <110 mmHg and 3% having mean SBP <110 mmHg. A total of 15,419 (3.2%) individuals experienced a serious fall or syncope or both during the observation window (5.7% among minimum SBP <110 mmHg and 5.4% among mean SBP <110 mmHg). The multivariable ORs for serious falls/syncope were 2.18 (95% CI=2.11, 2.25) for minimum SBP <110 mmHg and 1.54 (95%CI=1.43, 1.66) for mean SBP <110 mmHg compared with SBP ≥110 mmHg.Conclusions: Among treated hypertensive patients, both minimum and mean SBP less than 110 mmHg were associated with serious falls and syncope. Low treatment-related blood pressures deserve consideration given the emphasis on intensive blood pressure control. [ABSTRACT FROM AUTHOR]

Background There are limited data on the use of healthy lifestyles among adults who are candidates for primary prevention of atherosclerotic cardiovascular disease (ASCVD) with statin therapy due to a 10-year predicted risk ≥ 7.5%. We determined the prevalence of healthy lifestyle factors and their association with incident ASCVD and all-cause mortality in the Reason for Geographic and Racial Differences in Stroke study participants (n = 5709). Methods Lifestyle factors (non-obese waist circumference, physical activity ≥ 5 times-per-week, non-smoking, low saturated-fat-intake, highest Mediterranean diet score quartile) were assessed during an in-home examination and interviewer-administered questionnaires. Adjudicated incident ASCVD (nonfatal/fatal stroke, nonfatal myocardial infarction or coronary heart disease death) and all-cause mortality were identified through active participant follow-up. Results Overall, 5.1%, 28.9%, 36.9%, 21.7% and 7.5% had 0, 1, 2, 3, and ≥ 4 of the 5 healthy lifestyle factors studied. There were 377 incident ASCVD events (203 CHD events and 174 strokes) and 471 deaths during 5.8 and 6.0 median years of follow-up, respectively. ASCVD incidence rates (95% CI) per 1000-person-years associated with 0, 1, 2, 3 and ≥ 4 healthy lifestyles were 13.4 (7.3–19.5), 12.8 (10.4–15.2), 11.0 (9.0–12.9), 11.0 (8.3–13.7), and 8.7 (4.9–12.4), respectively. Mortality rates associated with 0, 1, 2, 3 and ≥ 4 healthy lifestyles were 20.6 (13.3–27.8), 15.9 (13.3–18.5), 13.1 (10.9–15.2), 12.6 (9.9–15.2) and 9.2 (5.3–13.2) per 1000-person-years, respectively. The use of more healthy lifestyles was associated with lower risks for ASCVD and mortality after multivariable adjustment. Conclusion Healthy lifestyles are underutilized among high-risk US adults and may substantially reduce their ASCVD risk. [ABSTRACT FROM AUTHOR]

We sought to compare the risk of end-stage renal disease (ESRD), ischemic heart event (IHE), congestive heart failure (CHF), cerebrovascular accident (CVA), and all-cause mortality among 470,386 individuals with resistant and nonresistant hypertension (non-RH). Resistant hypertension (60,327 individuals) was subcategorized into two groups: 23,104 patients with cRH (controlled on four or more medicines) and 37,223 patients with uRH (uncontrolled on three or more medicines) in a 5-year retrospective cohort study. Cox proportional hazard modeling was used to estimate hazard ratios adjusting for age, gender, race, body mass index, chronic kidney disease (CKD), and comorbidities. Resistant hypertension (cRH and uRH), compared with non-RH, had multivariable adjusted hazard ratios (95% confidence intervals) of 1.32 (1.27-1.37), 1.24 (1.20-1.28), 1.46 (1.40-1.52), 1.14 (1.10-1.19), and 1.06 (1.03-1.08) for ESRD, IHE, CHF, CVA, and mortality, respectively. Comparison of uRH with cRH had hazard ratios of 1.25 (1.18-1.33), 1.04 (0.99-1.10), 0.94 (0.89-1.01), 1.23 (1.14-1.31), and 1.01 (0.97-1.05) for ESRD, IHE, CHF, CVA, and mortality, respectively. Men and Hispanics had a greater risk for ESRD within all three cohorts. Individuals with resistant hypertension had a greater risk for ESRD, IHE, CHF, CVA, and mortality. The risk of ESRD and CVA were 25% and 23% greater, respectively, in uRH compared with cRH, supporting the linkage between blood pressure and both outcomes. [ABSTRACT FROM AUTHOR]

Aims: Diabetes is a leading cause of chronic kidney disease (CKD). Different methods of CKD ascertainment may impact prevalence estimates. We used data from 11 integrated health systems in the United States to estimate CKD prevalence in adults with diabetes (2005-2011), and compare the effect of different ascertainment methods on prevalence estimates. Methods: We used the SUPREME-DM DataLink (n = 879,312) to estimate annual CKD prevalence. Methods of CKD ascertainment included: diagnosis codes alone, impaired estimated glomerular filtration rate (eGFR) alone (eGFR < 60 mL/min/1.73 m²), albuminuria alone (spot urine albumin creatinine ratio > 30 mg/g or equivalent), and combinations of these approaches. Results: CKD prevalence was 20.0% using diagnosis codes, 17.7% using impaired eGFR, 11.9% using albuminuria, and 32.7% when one or more method suggested CKD. The criteria had poor concordance. After age- and sex-standardization to the 2010 U.S. Census population, prevalence using diagnosis codes increased from 10.7% in 2005 to 14.3% in 2011 (< 0.001). The prevalence using eGFR decreased from 9.7% in 2005 to 8.6% in 2011 (< 0.001). Conclusions: Our data indicate that CKD prevalence and prevalence trends differ according to the CKD ascertainment method, highlighting the necessity for multiple sources of data to accurately estimate and track CKD prevalence. [ABSTRACT FROM AUTHOR]

Aims: To assess associations between race/ethnicity, glycated hemoglobin (HbA1c), and glycemic control among youth with type 1 (T1D) or type 2 diabetes (T2D). Methods: The study sample was youth b 20 years old from the SEARCH California Center diagnosed from 2002 to 2009 who remained insured for at least one year. HbA1c at one year was from clinical data; HbA1c at diagnosis was from clinical data (81%) or imputed (19%). Multivariable logistic and linear regression models were used to examine associations between race/ethnicity and poor glycemic control (≥9.5%), HbA1c at oneyear, and change in HbA1c. Results: The study included 1162 Hispanic (52.3%), non-Hispanic White (NHW, 28.4%), African American (15.1%) and Asian/Pacific Islander (4.1%) youth. Among T1D youth (n = 789), Hispanics were 1.60 times as likely (95% CI 1.01–2.53) to have poor control at one year compared to NHWs, after adjustments. Among T2D youth (n = 373), only African American youth were significantly more likely (OR = 4.85; 95% CI 1.49–15.77) to have poor control at one year, after adjustments. HbA1c at one year and change in HbA1c did not differ by race/ethnicity. Conclusion: Poor glycemic control was evident one year after diagnosis in some minority youth with T1D or T2D in an integrated managed health care setting. [ABSTRACT FROM AUTHOR]

Aim: To examine the association of dietary fiber intake with inflammation and arterial stiffness among youth with type 1 diabetes (T1D) in the US. Methods: Data are from youth ≥ 10 years old with clinically diagnosed T1D for ≥ 3 months and ≥ 1 positive diabetes autoantibody in the SEARCH for Diabetes in Youth Study. Fiber intake was assessed by food frequency questionnaire with measurement error (ME) accounted for by structural sub-models derived using additional 24-h dietary recall data in a calibration sample and the respective exposure-disease model covariates. Markers of inflammation, measured at baseline, included IL-6 (n = 1405), CRP (n = 1387), and fibrinogen (n = 1340); markers of arterial stiffness, measured approximately 19 months post-baseline, were available in a subset of participants and included augmentation index (n = 180), pulse wave velocity (n = 184), and brachial distensibility (n = 177). Results: Mean (SD) T1D duration was 47.9 (43.2) months; 12.5% of participants were obese. Mean (SD) ME-adjusted fiber intake was 15 (2.8) g/day. In multivariable analyses, fiber intake was not associated with inflammation or arterial stiffness. Conclusion: Among youth with T1D, fiber intake does not meet recommendations and is not associated with measures of systemic inflammation or vascular stiffness. Further research is needed to evaluate whether fiber is associated with these outcomes in older individuals with T1D or among individuals with higher intakes than those observed in the present study. [ABSTRACT FROM AUTHOR]

Background. Chronic kidney disease (CKD) is a major public health burden in Western countries but little is known about its impact in developing countries. We estimated the prevalence and absolute burden of CKD in the general adult population in China. Methods. A cross-sectional survey was conducted in a nationally representative sample of 15,540 Chinese adults aged 35 to 74 years in 2000 and 2001. Serum creatinine was measured using the modified kinetic Jaffe reaction method at a central laboratory calibrated to the Cleveland Clinic Foundation laboratory. Glomerular filtration rate (GFR) was estimated using the simplified equation developed by the Modification of Diet in Renal Disease study. CKD was defined as an estimated GFR <60 mL/min/1.73m2. Results. Overall, the age-standardized prevalences of GFR 60 to 89, 30 to 59, and <30 mL/min/1.73m2 were 39.4%, 2.4%, and 0.14%, respectively, in Chinese adults aged 35 to 74 years. The overall prevalence of CKD (GFR <60 mL/min/1.73m2) was 2.53%, representing 11,966,653 persons (1.31% or 3,185,330 men and 3.82% or 8,781,323 women). The age-specific prevalence of CKD was 0.71%, 1.69%, 3.91%, and 8.14% among persons 35 to 44, 45 to 54, 55 to 64, and 65 to 74 years old, respectively. The age-standardized prevalence of CKD was similar in urban (2.60%) and rural (2.52%) residents but was higher in south China (3.05%) than in north China (1.78%) residents. Conclusion. Although the prevalence of CKD in China was relatively low, the population absolute burden is substantial. These data warrant a national program aimed at detection, prevention, and treatment of CKD in China. [ABSTRACT FROM AUTHOR]