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Calcium-phosphate levels, linked to vascular dysfunction in chronic kidney disease, may represent novel risk factors for coronary heart disease, stroke, and death in community-dwelling adults. We tested this hypothesis over 12.6 years of follow-up in the prospective, community-based Atherosclerosis Risk in Communities Study (n = 15,732). At baseline, mean (SD) values were 9.8 (0.4) mg/dL for serum calcium, 3.4 (0.5) mg/dL for serum phosphate, 33.6 (5.3) mg 2/dL 2 for calcium-phosphate product, 54.2 (5.7) years for age, and 93.1 (21.5) mL/min per 1.73 m 2 for glomerular filtration rate (GFR). Shared associations of calcium, phosphate, and calcium-phosphate product included older age, female sex, African American race, cigarette-years, current cigarette smoking, low body mass index, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, triglycerides, low serum albumin, low GFR, low caloric intake, and phosphorus intake. With adjustment for age, demographic characteristics, comorbid conditions, albumin, and GFR, calcium-associated hazards ratios for coronary heart disease, stroke, and death were, respectively, 1.01 (95% confidence interval 0.96-1.06), 1.16 (1.07-1.26, P = .0005), and 1.03 (0.98-1.08); phosphate-associated hazards ratios were 1.03 (0.98-1.08), 1.11 (1.02-1.21, P = .0219), and 1.14 (1.09-1.20, P < .0001); calcium-phosphate product-associated hazards ratios were 1.03 (0.98-1.08), 1.15 (1.05-1.26, P = .0017), and 1.15 (1.09-1.20, P < .0001). Although calcium, phosphate, and calcium-phosphate product levels exhibit complex associations with traditional cardiovascular risk factors and outcomes, they may be potentially modifiable risk factors for stroke and death in community-dwelling adults.

Background/Objectives: Antihypertensive treatment is crucial for preventing major adverse cardiovascular events, but suboptimal adherence remains a challenge. Methods: This is a secondary analysis of routine care data from a large pragmatic trial comparing two thiazide diuretics: chlorthalidone (CTD) and hydrochlorothiazide (HCTZ). In the trial, 13,523 older hypertensive patients were randomized from 72 Veterans Affairs medical centers. Medication possession ratio (MPR), reflecting adherence to either study medication (CTD or HCTZ), was used and compared across all randomized patients. Results: The overall median MPR was 95% for all randomized patients and 80% for 6656 individuals who reached 2.4 years for the average follow-up. Lower MPR was observed in Black, separated, urban-living, and comorbid patients. About 30% of the participants (n = 4022) were categorized as non-adherent using a definition of MPR < 80%. Those with baseline systolic blood pressure ≥ 136, recent smoking history, and prior heart failure and Black participants had decreased odds of having an MPR ≥ 80%, while increased odds of reaching that threshold were observed in those who had an eGFR ≥ 60, received ≥3 antihypertensive medications, were married, or resided in rural areas. Conclusions: This analysis provided assessment of real-world medication adherence in a sizable older hypertensive cohort. The proportion of non-adherence found in our analysis was comparable to national trends for US older adults taking blood pressure medications. Identifying sociodemographic characteristics and health conditions associated with non-adherence can help clinicians design targeted interventions for improved adherence to clinically prescribed medications. This is important as hypertension and the older adult population are both expected to grow significantly in the future.

Background/Aims: It is not known whether sarcopenia is associated with levels of kidney function in community-dwelling adults. Methods: Subjects were adult Third National Health and Nutrition Examination Survey participants in whom bioimpedance was performed (n = 13,770). Class I sarcopenia was defined as a skeletal mass index of 1–2 standard deviations below and class II sarcopenia as <2 standard deviations below young adult values. Results: A monotonic association existed between increasing sarcopenia prevalence and declining glomerular filtration rate: ≧90 ml/min/1.73 m 2 , 22.8% class I, 3.8% class II sarcopenia; 60–89 ml/min/1.73 m 2 , 33.6% class I, 5.3% class II sarcopenia, and <60 ml/min/1.73 m 2 , 50.7% class I, 9.4% class II sarcopenia (p < 0.0001). This association dissipated when adjustment was made for older age and more comorbidity. Multivariate associations (p < 0.05) of sarcopenia and chronic kidney disease included: older age; low income-to-poverty ratio; overweight; lack of exercise; low carbohydrate, fat and protein intake; hypercalcemia; low 25-hydroxy-vitamin D 3 ; higher diastolic blood pressure, and insulin resistance. Conclusion: Sarcopenia is common in community-dwelling adults with chronic kidney disease. Although causality cannot be assumed, several associations may be susceptible to intervention.

Atherosclerotic renovascular disease in United States patients aged 67 years or older: Risk factors, revascularization, and prognosis. Although atherosclerotic renovascular disease is increasingly recognized in chronic kidney disease, few national level studies have examined its clinical epidemiology. Claims data from a 5% random sample of the United States Medicare population were used to select patients without atherosclerotic renovascular disease in the 2 years preceding December 31, 1999 (N = 1,085,250), followed until December 31, 2001. The incidence of atherosclerotic renovascular disease was 3.7 per 1000 patient-years. Major antecedent associations [P < 0.05, with adjusted hazards ratios (HR) > 1.5] included chronic kidney disease (adjusted HR 2.54), hypertension (2.42), peripheral vascular disease (2.00), and atherosclerotic heart disease (1.70). Adverse event rates after incident atherosclerotic renovascular disease greatly exceeded those in the general population (P < 0.0001): atherosclerotic heart disease, 303.9 per 1000 patient-years (vs. 73.5 in the general population); peripheral vascular disease, 258.6 (vs. 52.2); congestive heart failure, 194.5 (vs. 56.3); cerebrovascular accident or transient ischemic attack, 175.5 (vs. 52.9); death, 166.3 (vs. 63.3); and renal replacement therapy, 28.8 (vs. 1.3). Among atherosclerotic renovascular disease patients, 16.2% underwent a renal revascularization procedure, percutaneously in 96%. Revascularization was not associated with renal replacement therapy, congestive heart failure, or death but was associated with atherosclerotic heart disease (adjusted HR 1.42) (P = 0.004) and peripheral vascular disease (adjusted HR 1.38) (P = 0.002). Atherosclerotic renovascular disease is strongly associated with cardiovascular disease, both past and future. Absolute cardiovascular risk exceeds that of renal replacement therapy. Renal revascularization is used selectively and shows inconsistent associations with cardiovascular outcomes, renal replacement therapy, and death.

Background/Objectives: Identifying social determinants of health (SDOH) is important for effective clinical care. The ICD-10 introduced diagnostic categories to describe patients’ adverse SDOH, but these codes are infrequently used across health systems, presenting challenges to implement data-driven healthcare. This study illustrates SDOH code utilization within a setting that is recognized as one of the largest integrated healthcare systems across the United States. Methods: Real-world clinical data were used with ICD-10 SDOH records obtained from 13,523 participants randomized into the Diuretic Comparison Project, a pragmatic trial conducted within the Veterans Affairs (VA) Health Care System between 2016 and 2022. SDOH code utilization was assessed across study years and among the specialized outpatient clinics. Results: A total of 29,305 SDOH records were identified, and 99.2% were from outpatient encounters. Social, mental, and housing care services generated the most SDOH records. Moreover, 3894 (28.8%) participants had at least one SDOH record during the 6-year period. Particular, 6.9% of participants had a record in the first year, and this increased to 7.6%, 8.1%, 8.7%, 9.6%, 10.3% in consecutive years. Conclusions: Our results suggest that SDOH code utilization has continued to improve within the VA, but SDOH assessments may not occur annually or be performed systematically within an integrated health setting. Much work is needed to develop universal screening tools and mandate routine SDOH evaluations. Nevertheless, a persistent increase in the counts of ICD-10 SDOH records shows a positive movement towards systematic documentation, supporting service providers to efficiently identify patients with adverse SDOH.

Background Patients with chronic kidney disease (CKD) are at increased risk for multiple adverse events, several of which have been proven to be less likely with the use of sodium-glucose cotransporter-2 inhibitors (SGLT2i). As a result, guidelines now recommend SGLT2i be given to those with mild to moderate CKD and type 2 diabetes. The objective of this study is to evaluate if a pharmacist-driven SGLT2i prescribing initiative among eligible patients with CKD and diabetes within the VA could more rapidly improve the adoption of SGLT2i via a pragmatic approach aligned with learning health systems. Methods Eligible patients will be identified through an established VA diabetes dashboard. Veterans with an odd social security number (SSN), which is effectively a random number, will be the intervention group. Those with even SSNs will serve as the control while awaiting a second iteration of the same interventional program. The intervention will be implemented in a rolling fashion across one Veterans Integrated Service Network. Our primary outcome is initiation of an SGLT2i. Secondary outcomes will include medication adherence and safety-related outcomes. Discussion This project tests the impact of a pharmacist-driven medication outreach initiative as a strategy to accelerate initiation of SGLT2i. The results of this work will not only illustrate the effectiveness of this strategy for SGLT2is but may also have implications for increasing other guideline-concordant care. Furthermore, the utilization of SSNs to select Veterans for the first wave of this program has created a pseudo-randomized interventional trial supporting a pragmatic learning health system approach. Trial registration ISRCTN12374636.

Background/aims The Diuretic Comparison Project (DCP) was a pragmatic clinical trial comparing rates of cardiovascular events between hydrochlorothiazide or chlorthalidone. VA primary care providers (PCPs) and their patients were participants in the study. Veterans ≥ 65 years taking hydrochlorothiazide were randomized to continue on hydrochlorothiazide or switch to chlorthalidone. Participating providers could decline the randomization of their patients. Providers were surveyed about their experience with DCP, and to ascertain providers’ understanding of and attitudes towards embedded pragmatic trials. Methods A questionnaire was emailed to PCPs that provided informed consent to participate in the study. The survey asked about provider experience with the trial including interest in the study question, awareness of the study and educational materials, impact on the provider-patient relationship, burden of study participation, and their attitudes towards pragmatic trials. Respondents could also add free text comments. Results There were 180 completed surveys. Of those, most found the trial question of interest (91%) and found the time required to participate in the trial was reasonable (67%). Only 2 (1%) felt the study had a negative impact on the provider-patient relationship. 97% of providers were as comfortable with (59%) or more comfortable with (32%) DCP compared to traditional randomized controlled trials. Conclusion Responding providers’ experience with DCP and their attitudes towards pragmatic trials were positive. Primary care providers indicated willingness to participate in future pragmatic trials if burden is low and it does not negatively impact patient care. Results support continued use of pragmatic embedded clinical trials in primary care. Clinical trial registration NCT02185417. Registered 9 July 2014. https://clinicaltrials.gov/ct2/show/NCT02185417 .

Atherosclerotic renovascular disease (ARVD) is an increasingly recognized clinical condition that is diagnosed predominantly in older patients. Here we used annual United States Medicare 5% Denominator Files and studied 16,036,904 patients, 66 years of age and older, to quantify trends in diagnostic rates, associations, treatment, and outcomes of ARVD over a 13-year period. Overall, there was an ARVD rate of 3.09 per 1000 patient-years, which rose progressively with an adjusted hazard ratio of 3.35, comparing data from 1992 to 2004. Within 6 months of disease diagnosis, 13.4% of patients had undergone revascularization. A biphasic pattern of revascularization was found where the adjusted hazard ratios significantly increased in a progressive manner until 1999, following which there was a decline through 2004, which was not significant. The method of revascularization changed markedly over time with endovascular intervention steadily replacing direct surgical revascularization. As a time-dependent variable, ARVD was associated with excess mortality in each calendar year, albeit with declining hazard ratio estimates in more recent years. Among patients with this disease, revascularization was associated with mortality adjusted hazard ratios <1 in each year. Our study shows the diagnosis of ARVD has substantially risen in the United States but the survival implications were not fully explained by other comorbid vascular diseases.

Acute kidney injury (AKI) after heart surgery is associated with increased mortality. We sought to determine whether prophylactic perioperative administration of N-acetylcysteine (NAC) prevents postoperative AKI in patients with chronic kidney disease undergoing cardiac surgery (clinical trials.gov identifier NCT00211653). In this prospective, randomized, placebo-controlled, double-blinded clinical trial, 102 patients with chronic kidney disease who underwent heart surgery at the Minneapolis Veterans Affairs Medical Center were randomized to either NAC (n = 50) 600 mg PO twice daily or placebo (n = 52) for a total of 14 doses (3 preoperative). The primary outcome was maximum change in creatinine from baseline within 7 days after surgery. Secondary outcome was AKI (ie, >0.5 mg/dL or ≥25% increase in creatinine from baseline). Creatinine increased in both groups (0.45 ± 0.7 mg/dL in NAC vs 0.55 ± 0.9 mg/dL in placebo, P = .53) and peaked on postoperative day 5. Acute kidney injury occurred in 41 patients (22 NAC vs 19 placebo, P = .44) by postoperative day 5, but persisted in only 14 (7 NAC vs 7 placebo, P = .94) by day 30. In multivariable analysis, perioperative NAC was unassociated with AKI (relative risk 1.2, 95% CI, 0.8-1.9, P = .34). Five patients (3 NAC vs 2 placebo, P = .68) underwent hemodialysis, and 5 (2 NAC vs 3 placebo, P = 1.0) died perioperatively. There was no difference in lengths of stay in the intensive care unit (4.9 ± 7 days in NAC vs 6.5 ± 9 days in placebo, P = .06) and the hospital (13.2 ± 13 days in NAC vs 16.7 ± 17 days in placebo, P = .12). Prophylactic perioperative NAC administration does not prevent AKI after cardiac surgery.

OBJECTIVES/SPECIFIC AIMS: We set out to describe important associations and outcomes among those requiring maintenance renal replacement therapy with the patient volume per provider. METHODS/STUDY POPULATION: Through the combination of several large administrative datasets, including the United States Renal Data System (n=237,485), the American Medical Association Master file (n=6249), and Medicare data limited to 2012, we compared characteristics of patients, by quintile of patient/provider volume. χ 2 and logistic regression, adjusted for various patient and provider factors for categorical and continuous variables, was used for baseline comparisons, respectively. Cox regression, adjusted for patient, provider, and socioeconomic variables, was used to calculate risks for important clinical outcomes such as kidney transplant listing, transplant receipt, and all-cause mortality. RESULTS/ANTICIPATED RESULTS: There is a threshold patient volume at which important clinical outcomes, including kidney transplantation and all-cause mortality, may be influenced. Higher patient volume is associated with adverse patient outcome. Those receiving care from providers with the highest patient volumes are less likely to receive kidney transplantation, live in a more rural area, and be non-White. DISCUSSION/SIGNIFICANCE OF IMPACT: There is a need to identify novel and potentially modifiable factors associated with patient outcome among those with end-stage kidney disease on maintenance renal replacement therapy. Provider level variables, such as patient volume, is one such variable. As nephrologists are often tasked with the care of variable numbers of patients on dialysis, a better understanding of this association is an unmet need.