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The U.S. Food & Drug Administration (FDA) regulates the marketing of manufacturers’ in vitro diagnostic tests (IVDs), including assays for the detection of SARS-CoV-2.

Objectives: To determine the prevalence and relationship of frailty and health status measures among residents of long-term care [nursing homes (NH) and assisted living (AL)] facilities. Resident and methods: Residents ≥ 65 years who are residents of NH and AL facilities at La Crosse county, Wisconsin, were assessed for frailty (gait speed, unintended weight loss, and grip strength), comorbidity (Charlson index), and quality of life (QOL) [Short Form (SF)-36]. Results: Among 96 participants (57 from NH and 39 from AL), 78% were frail. The prevalence of frailty (77% vs. 79%), comorbidity (2.0 vs. 2.0), and poor health status did not differ between residents of NH and AL living facilities. Frail residents were older and had higher comorbidity index (2.0 vs. 0, p=0.02), including diabetes mellitus, hypertension, and heart failure. Frailty had the strongest correlation with the SF-36 Physical Component Score (r=-0.45), Figure. It exhibited weaker associations with comorbidity and the SF-36 Mental Component Score. Overall, SF-36 for physical component was lower among frail residents (33 vs. 48, p<0.001). Following adjustments by linear regression, compared to those without frailty, frail residents had lower adjusted quality of life scores. Conclusion: Frailty was highly prevalent among residents of long-term care facilities and did not differ between NH and AL facilities. We noted significant correlations between frailty, comorbid conditions, and poor quality of life.

Background: Prior ATPIII lipid guidelines recommended statin therapy for patients with clinical ASCVD to achieve low density lipoprotein cholesterol (LDL-C) targets, while the 2013 ACC/AHA lipid guidelines recommend high-intensity statin therapy for all ASCVD patients. How closely these recommendations are followed in routine clinical practice is unknown. Methods: We evaluated statin use, intensity, and LDL-C values in 1,483 patients with ASCVD (coronary heart disease, cerebrovascular disease, and peripheral arterial disease) enrolled and seen serially at 62 geographically dispersed US cardiology and primary care clinics in the Patient and Provider Assessment of Lipid Management (PALM) Registry between May - September 2015. Factors associated with high intensity statin use (atorvastatin ≥40 mg or rosuvastatin ≥20 mg daily) and LDL-C <70 mg/dL were evaluated in multivariable logistic regression. Results: Of 1,483 ASCVD patients, 86.2% were on a statin, but only 31.4% were on a high-intensity statin. Overall, 64.0% had an LDL-C <100 mg/dL, but only 29.0% had an LDL-C <70 mg/dL. Factors associated with high-intensity statin use in multivariable regression were younger age (OR 0.74 per 10 year increase, p<0.001, 95% CI 0.66-0.83), male sex (OR 1.69, p<0.001, 95% CI, 1.32-2.16), cerebrovascular disease (OR 1.55, p=0.008, 95% CI 1.12-2.13), coronary heart disease (OR 2.42, p<0.001, 95% CI 1.67-3.50), and being seen by a cardiologist (OR 1.35, p =0.04, 95% CI 1.01-1.81). Factors associated with an increased likelihood of LDL-C<70 were male sex (OR 1.55, p=0.001, 95% CI 1.20-2.01), white (OR 1.62, p=0.03, 95% CI 1.04-2.5-, diabetes (OR 1.64, p<0.001, 95% CI 1.29-2.09) and being seen by a cardiologist (OR 1.94, p<0.001, 95% CI 1.41-2.67). Discussion: Substantial gaps in care remain for secondary prevention of ASCVD despite simplified recommendations. While the majority of patients with ASCVD in community practice are on a statin, only one-third are on high intensity statins and over two-thirds have LDL ≥70 mg/dL.

Background: Patients are surviving longer after myocardial infarction (MI), but little is known about the occurrence and predictors of subsequent hospitalizations. Methods: We identified all Olmsted Count residents with incident MI from 1987-2008 and evaluated Olmsted County hospitalizations through 2009. ICD-9 codes were used to determine the primary reason for hospitalization. To account for repeated events, Andersen-Gill models were used to examine the predictors of hospitalization post-MI. Patients were censored at death or last follow-up. Results: A total of 2617 patients (mean 67 years, 41% female, 32% with ST-elevation MI) were diagnosed with incident MI from 1987-2007 and survived MI hospitalization. Over a mean follow-up of 7.1 years, 10116 hospitalizations occurred equating to a median of 3 (range 0 to 43) per person. Only 37.5% (n=3793) of hospitalizations were due to cardiovascular causes, and of these, most were due to ischemic heart disease (n= 1865, 49.2%) and heart failure (n= 733, 19.3%). The proportion of non-cardiovascular hospitalizations increased over time and was higher in women than men, but did not differ by ST-segment status. Several factors were associated with the risk of hospitalization after adjusting for year of diagnosis and sex (Figure). Biomarker levels were not predictors of hospitalization risk. Conclusions: Two-thirds of hospitalizations among incident MI survivors in the community are for non-cardiovascular reasons, and this proportion has increased. Comorbidities are important predictors of recurrent hospitalizations. Therapies focused solely on MI management may be insufficient to prevent the majority of future admissions.

Background: The increasing prevalence of heart failure (HF) and high associated costs has spurred investigation of factors related to adverse outcomes in these patients. Reports to date present discrepant evidence regarding the link between depression and HF outcomes, and only scarce data related to healthcare utilization in the form of emergency department (ED) visits are available. Purpose: To evaluate the relationship of depression with healthcare utilization and death among HF patients in the community. Methods: Residents of Olmsted, Dodge, and Fillmore, MN counties with HF were prospectively recruited between October 2007 and December 2010, and completed a 9-item Patient Health Questionnaire (PHQ-9) for depression categorized as: none-minimal (PHQ-9 score 0-4), mild (5-9), or moderate-severe (≥10). Anderson-Gill models were used to determine if depression predicted hospitalizations and ED visits while proportional hazards regression estimated hazard ratios for death. Results: Among 411 HF patients (mean age 73±13, 58% male), 15% had moderate-severe depression, 27% mild, and 58% none-minimal. Over a mean follow-up of 1.5 years, 613 hospitalizations, 786 ED visits, and 75 deaths occurred. The risk of all adverse outcomes increased stepwise with increasing severity of depression (Table). After adjustment for key clinical characteristics, moderate-severe depression was associated with nearly a 2-fold increased risk of hospitalization and ED visits, and almost a 4-fold increased risk of death. These results are independent of coexisting comorbidities. Conclusions: Depression is frequent among HF patients in the community and independently predicts a significant increase in the use of healthcare resources and mortality. Greater attention to the recognition and management of depression in HF may improve clinical outcomes and decrease healthcare utilization and expenditures in these patients. Hazard Ratios (95%CI) for Hospitalizations and All-Cause Mortality by Severity of Depression None-Minimal Mild Moderate-Severe P for trend Hospitalizations Crude 1.00 (ref) 1.23 (0.91-1.66) 2.01 (1.39-2.89) <0.001 Fully-Adjusted * 1.00 (ref) 1.15 (0.86-1.54) 1.93 (1.37-2.71) 0.001 Emergency Department Visits Crude 1.00 (ref) 1.42 (1.03-1.96) 1.99 (1.42-2.79) <0.001 Fully-Adjusted * 1.00 (ref) 1.39 (1.00-1.93) 1.98 (1.40-2.79) <0.001 All-Cause Mortality Crude 1.00 (ref) 1.53 (0.87-2.68) 3.33 (1.95-5.70) <0.001 Fully-Adjusted * 1.00 (ref) 1.55 (0.88-2.74) 3.84 (2.21-6.68) <0.001 * Adjusted for age, sex, and Charlson comorbidity index

Objective: To determine among community heart failure (HF) patients whether frailty is associated with an increased risk of hospitalization, emergency department (ED) visits and death, independently of comorbidities. Background: Frailty is associated with adverse outcomes in some populations; however the prognostic value of frailty among HF patients is not fully documented, particularly for healthcare utilization. Methods: Olmsted, Dodge and Fillmore County residents with HF between 10/2007 and 12/2010 were prospectively recruited to undergo frailty assessment. Frailty was defined as 3 or more of the following: unintentional weight loss >10 lbs. in 1 year, physical exhaustion, weak grip strength, and slowness and low activity measured by the SF-12 physical component score. Intermediate frailty was defined as having 1-2 components. To account for repeated events, Anderson-Gill modeling was used to determine if frailty predicted hospitalization or ED visits. Cox proportional hazards regression examined associations between frailty and death. Results: Among 409 patients (mean age 73±13, 58% male), 19% were frail and 55% had intermediate frailty. Within one year, 449 hospitalizations, 523 ED visits and 34 deaths occurred. There was a positive graded association between frailty and hospitalization and ED visits (Table). After adjustment for age, sex, ejection fraction and comorbidity, frailty was associated with an 80% increased risk of hospitalization and a 60% increased risk of ED visits. Frailty was also associated with more than a 2-fold increased risk of death after adjustment. Conclusion: In the community, frailty is prevalent and is a strong and independent predictor of hospitalizations, ED visits and death among HF patients. As it is independent from coexisting comorbidities, frailty defines new avenues for intervention and should be formally assessed clinically. Hazard Ratios (95% CI) for Hospitalizations, Emergency Department Visits and Death by Frailty Status Not Frail Intermediate Frail Frail P for trend Hospitalization Crude 1.00 1.46 (1.05-2.02) 2.15 (1.45-3.19) <0.001 Fully-adjusted 1.00 1.29 (0.94-1.77) 1.82 (1.22-2.73) 0.005 Emergency Department Visits Crude 1.00 1.59 (1.14-2.21) 1.88 (1.22-2.90) 0.002 Fully-adjusted 1.00 1.46 (1.05-2.05) 1.58 (1.01-2.48) 0.034 Death Crude 1.00 1.40 (0.73-2.69) 3.98 (2.01-7.90) <0.001 Fully-adjusted 1.00 0.87 (0.44-1.73) 2.42 (1.19-4.95) 0.003

Background: Participation in cardiac rehabilitation (CR) has been shown to decrease mortality following acute myocardial infarction (MI), but its impact on rehospitalizations requires examination. Methods: We included patients who were hospitalized with first-ever MI in Olmsted County Minnesota from 1987-2010 and survived to hospital discharge. Participation in CR within the first 30 days following MI was determined using billing data and was analyzed as a time-dependent covariate. The association between CR participation and all-cause rehospitalization was analyzed using Andersen-Gill models to account for repeated events. As CR participation is a non-randomized intervention, we adjusted for propensity to participate after fitting a logistic regression model using 13 factors significantly associated with participation on univariate analysis. Patients were censored at the time of death or last follow-up. Results: Among 2991 patients (mean age 67 years, 59% male, 31% ST elevation MI), 1480 (49%) participated in CR following acute MI hospital discharge (first session occurred at a mean of 9 days post-discharge). Most patients (75%) were rehospitalized at least once during a mean follow-up of 7.6 years, and CR participation was associated with reduced risk of rehospitalization. The rehospitalization rates were 39% and 59% at one year for participants and non-participants, respectively. In unadjusted analysis, CR participation was associated with a markedly decreased risk of rehospitalization (HR 0.51, 95% CI 0.49-0.53, p<0.001). After adjusting for propensity to participate, the association between CR participation and all-cause rehospitalization persisted (HR 0.70, 95% CI 0.67-0.73, p<0.001). Conclusions: CR participation is associated with a markedly reduced risk of rehospitalization after incident MI. In addition to reducing mortality, improving CR participation rates may have a large impact post-MI healthcare resource use.

Background: We recently developed an index of socioeconomic status (SES) termed HOUSES ( HOU sing-based index of S ocio E conomic S tatus) to overcome the absence of SES measures in common data sources. HOUSES has been associated with various childhood health outcomes to a similar extent as other measures of SES. Whether it is associated with outcomes in adults is unknown. To address this question, we assessed whether HOUSES was associated with mortality after MI. Methods: We conducted a population-based cohort study among all Olmsted County, MN residents with MI who were prospectively identified using predetermined criteria from November 1, 2002 to May 31, 2006. HOUSES was formulated based on a z-score for housing value, actual square footage, and numbers of bedrooms and bathrooms and categorized into quartiles. The 1-year mortality rate post MI was compared among subjects with different SES by HOUSES based on a log-rank test. Results: Among 696 patients with MI; 623 (90%) were successfully geo-coded to address and real property data. Of these 623 subjects, 594 (95%) were white and 263 (42%) female; the mean age was 68±15 years. Spearman correlation coefficient between HOUSES and education level was 0.23 (p<0.001). Mortality rates at 1 year following MI were 20% (95%CI: 13 - 26), 18% (11 - 24), 14% (8 - 19), and 16% (10 - 21) for patients in the first (lowest SES), second, third, and fourth quartiles (highest SES) of the HOUSES index, respectively (p=0.032). This association between HOUSES and mortality after MI was primarily explained by age and comorbid conditions which were associated with HOUSES. Cardioprotective drugs such as aspirin, beta-blocker, and statins were not associated with HOUSES nor accounted for the association between HOUSES and mortality after MI. Conclusions: Despite the lack of a strong correlation with other SES measure (i.e. no redundancy), HOUSES may be useful for overcoming the paucity of conventional SES measures in commonly used datasets in epidemiological research concerning cardiovascular disease among adults.

Background: Acute aortic syndrome (AAS) includes aortic dissection (AD), intramural hematoma (IMH) and penetrating aortic ulcer (PAU) and confers high rates of aortic related events. However, the risk of cardiovascular (CV) events in this patient group is unknown. The aim of this study was to define the rates of CV events in an incident cohort of AAS patients. Methods: Medical records and death certificates of all Olmsted County, MN residents with a diagnosis of AAS from 1995-2015 were reviewed and compared to age- and sex- matched population controls. Primary outcome was non-aortic CV mortality. Secondary outcome was overall mortality and first time non-fatal CV event (myocardial infarction (MI), heart failure (HF) or stroke). Events were analyzed using Cox proportional hazards regression adjusting for comorbidities. Results: Of 133 patients with AAS (77 AD, 21 IMH, 35 PAU) 57% were male, median age was 72 (SD 14) and median follow-up was 10 years. Overall survival in AAS cases and controls was 62% versus 83% at 5 years and 44% versus 60% at 10 years (adj HR 1.8, p<.001, 95% CI 1.3-2.4). CV death occurred in 21 (29%) of 73 AAS decedents due to HF (9), MI (5), other cardiac causes (5), stroke (1) and peripheral vascular disease (1). CV-related survival at 5 and 10 years after AAS diagnosis (91% and 81%) was not significantly different from controls (95% and 86%) after adjustment for comorbidities (adj HR 1.8, p=.1, 95% CI 0.9-3.6). AAS was associated with an increased risk of any first time CV event (adj HR 2.6, p<.001, 95% CI 1.6-4.4; Figure), first time diagnosis of MI (adj HR 2.8, p<.001, 95% CI 1.7-4.7) and HF (adj HR 3.2, p<.001, 95% CI 1.6-6.2) but not stroke. When excluding acute events within 14 days of diagnosis, AAS was still associated with a significantly higher mortality (adj HR 1.6, p=.011, 95% CI 1.1-2.4) and an increased risk of any first time CV event (adj HR 2.2, p=.018, 95% CI 1.1-4.1), first time MI (adj HR 2.2, p=.012, 95% CI 1.2-4.1) and HF (adj HR 2.9, p=.006, 95% CI 1.4-6.2) but not stroke. Conclusions: AAS is associated with a higher overall mortality and an increased risk of any first time CV event, first time MI and HF that persists beyond the acute phase. These data highlight the risk of CV events among those with AAS and implicate the need for long-term cardiovascular management in these patients.