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Background: After left ventricular assist device (LVAD) for end-stage heart failure, cognitive function should improve due to increased cerebral perfusion. However, stroke (a well-known LVAD complication) and even subclinical cerebral ischemia may also occur and manifest as transient or permanent cognitive decline. We sought to describe the incidence and predictors of cognitive decline after LVAD using a valid, sensitive assessment tool. Methods: As part of the INTERMACS registry, cognitive function was assessed before LVAD and at each follow-up with the Trailmaking B Test (TBT), where a subject is timed connecting 25 dots labeled with alternating, consecutive numbers and letters (1, A, 2, B, etc.). The TBT can detect several forms of cognitive impairment, including subclinical stroke. Longer times are worse, and cognitive decline was defined as a clinically important increase from baseline to highest follow-up score using Cohen’s D Effect Size (0.2*baseline SD = 13 s). Patients who completed baseline and at least 1 follow-up TBT were included. Multivariable logistic regression was used to examine the association between patient characteristics and cognitive decline after LVAD. Results: Among 1151 LVAD patients, median age was 60-69, 19% were female, and 40% were INTERMACS profile 1-2 (cardiogenic shock or declining despite inotropes) at implant. Among patients with 12-mo follow-up, mean TBT score improved from 126 at baseline to 123 at 1 yr. In the total cohort, 333 (29%) patients had significant cognitive decline within 12 mo of LVAD placement. Increasing age, chronic renal disease, better baseline TBT score (shorter time), and higher INTERMACS profiles (≥ 3; less severe heart failure) were significantly associated with greater odds of cognitive decline (Figure). Conclusion: In a large LVAD registry, cognitive decline occurred in over a quarter of patients in the year after LVAD and was associated with older age, renal disease, higher baseline cognitive function, and more stable heart failure at implant. These results define the frequency of an important adverse event and provide new insights regarding outcomes after LVAD. Future studies are needed to explore the association of transient and permanent cognitive decline with subsequent stroke, health status, and mortality in patients after LVAD placement.

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.

Introduction: The DECIDE-LVAD Trial demonstrated the benefit of a decision support tool for patients considering destination-therapy left ventricular assist device (DT LVAD) implantation. We hypothesized that patients with low health literacy or numeracy may have benefited most from the intervention. Methods: We used the Rapid Estimate of Adult Literacy in Medicine (REALM-R) and the Subjective Numeracy Scale (SNS) to assess patients’ health literacy and numeracy, respectively. A REALM-R score of six or less out of eight identified patients at risk for poor literacy based on the original measure validation. An SNS score less than four out of six identified patients with poor subjective numeracy based on the mean score of the DECIDE-LVAD cohort. We assessed the effect of the decision support tool on LVAD knowledge and values-treatment concordance—concordance between patients’ stated values and their treatment outcome of LVAD or continued medical therapy—and their interaction with health literacy and numeracy. This interaction was assessed using linear mixed models for LVAD knowledge and the difference in Kendall’s tau correlation coefficient for values-treatment concordance. Results: Of the 248 DECIDE-LVAD patients, 228 with complete literacy and numeracy data were analyzed: 51% (116) had high literacy and numeracy; 18 (8%) had low literacy and high numeracy; 55 (25%) had high literacy and low numeracy; 39 (17%) had low scores for both measures. Average age was 63, 15% were female, 19% were racial/ethnic minorities. Patients with high scores for both measures were older, had more formal education, and higher total household income compared to the other 3 groups. Patients with low literacy and/or numeracy had significantly lower LVAD knowledge scores at baseline. In all groups, LVAD knowledge improved over time. The difference in LVAD knowledge between those with low literacy and high literacy decreased over time (baseline difference 9.4%, p=0.002; 6 month follow-up difference 1.4%, p=0.65). In those with high literacy, the decision support tool intervention increased the LVAD knowledge score by 4.2% relative to the control (p=0.15), while in those with low literacy, the intervention increased the score by 10.6% (p=0.04). For patients with low literacy, values-treatment concordance improved with use of the decision support tool (control vs. intervention tau: 0.234 vs 0.673, p=0.028). We did not observe differences in the effect of the intervention by participant numeracy score. Conclusion: All patient groups in the DECIDE-LVAD cohort of patients considering DT LVAD had improved LVAD knowledge with the use of the decision support tool. We did not observe a differential effect of the intervention by numeracy score. Compared to those with higher health literacy, patients with low health literacy improved their LVAD knowledge and values-treatment concordance after the intervention.

Background: Several chronic diseases can contribute to functional disability. However, little is known about functional disability and its progression overtime in chronic heart failure (HF). We aimed to investigate the prevalence and progression of difficulty with activities of daily living (ADLs) and its association with mortality in patients with HF. Methods: We enrolled Southeastern Minnesota residents with HF into a longitudinal study from September 2, 2003 through January 31, 2012. A patient’s difficulty with 9 ADLs (feeding themselves, dressing, toileting, housekeeping, climbing stairs, bathing, walking, using transportation, managing medications) was assessed by questionnaire. Patients were followed for all-cause mortality. Using Rasch analysis to determine the order of ADL difficulty, patients were divided into 3 categories (minimal, moderate, severe difficulty). Predictors of ADL difficulty were assessed using negative binomial regression and the association between ADL difficulty and death with Cox proportional hazard regression. Results: Among 1128 patients (mean age 74.7 years, 49.2% female), most (59.4%) reported difficulty with one or more ADLs at enrollment, with 272 (24.1%) and 146 (12.9%) reporting moderate and severe difficulty, respectively. The independent predictors of difficulty with ADLs were older age, female sex, diabetes, morbid obesity, cerebrovascular disease, dementia, anemia, and unmarried status. After a mean (SD) follow-up of 3.2 (2.4) years, 615 (54.5%) patients had died. There was a stepwise increase in the risk of death as difficulty with ADLs increased ( Figure ). After adjusting for age, sex, and comorbidity, the HR (95% CI) for mortality was 1.52 (1.25-1.83, p<0.001) for patients with moderate and 2.28 (1.82-2.85, p<0.001) for those with severe difficulty with ADLs compared to those with minimal difficulty (p for trend<0.001). In most patients (73.5%), difficulty with ADLs was stable over time. However, survivors reporting persistently severe or worsening ADL difficulty in a second assessment (median 9 months later) were at an increased risk of subsequent mortality (adjusted HR 2.08, 95% CI 1.70-2.55, p<0.001). Conclusions: Functional disability is common in patients with HF, can progress over time, and is independently associated with adverse prognosis.

Background: Heart failure (HF) has an overall poor prognosis, with only half of patients surviving more than 5 years after diagnosis. Although it is recommended that all patients with HF have advance directives (ADs) in place before the end of life is imminent, the use of ADs in these patients has not been well studied. Methods: We prospectively enrolled all Olmsted County residents presenting with active HF from October 2007 through October 2011 into a longitudinal community cohort study which included an echocardiogram and administration of health status questionnaires at enrollment. Information from ADs completed prior to enrollment was manually abstracted from the patient’s medical record. Results: A total of 608 patients were enrolled during the study period (mean age 74.0 years, 54.9% male, 49.9% with preserved EF [EF≥50%], 65.3% NYHA functional class 3 or 4). Mortality was high; 164 (27.0%) patients died after a mean follow-up of 1.8 years with estimated 1-year mortality of 14.3%. At the time of enrollment, only 249 (41.0%) patients had ADs, and they were completed an average of 3.3 years prior. Although most ADs appointed a proxy decision-maker (91.1%), less than half addressed patient wishes regarding use of cardiopulmonary resuscitation (41.4%), mechanical ventilation (38.7%), administration of artificial nutrition (38.6%), or hemodialysis (10.0%) at the end of life. AD use was more common in older individuals (p<0.001); 60.7% of those ≥80 years had an AD vs. 13.6% of those who were <60 years old. While ADs were more common in women than men (46.7% vs. 36.2%, respectively) and in those with preserved EF (47.2% vs. 34.0% in those with reduced EF), differences were not significant after adjustment for age. AD use was no more common in patients with worse NYHA functional class or health status as measured by the Kansas City Cardiomyopathy Questionnaire. Conclusions: Despite a high mortality rate, over half of community patients with HF do not have ADs, and existing AD fail to address important medical decisions common at the end of life. Further work is needed to identify potential barriers to AD use in HF patients, and to determine whether their use has any impact on patient outcomes, including end of life resource utilization.

Introduction: Frailty has recently been shown to be associated with increased risk of death after continuous-flow left ventricular assist device (CF-LVAD) implantation as destination therapy (DT), but no data exists specifically analyzing its association with specific early and late adverse events. Methods: Between February 2007 and May 2014, 251 patients (205 male) underwent primary implantation of CF-LVAD at our institution; 157 (63%) were implanted as DT and preoperative frailty assessment was available in 96 pt. Frailty was identified in 58/96 (60%) patients according to the deficit index (31 impairments, disabilities and comorbidities) and defined as > 25% deficits. Age (67 vs. 64 years, p=0.12), male sex (79% vs. 87%, 0.63), chronic kidney disease (64% vs. 63%, p=0.74), creatinine (1.7 vs. 1.5, p=0.1), hemoglobin (11.6 vs. 11.5, p=0.98), and albumin levels (3.7 vs. 3.8, p=0.53) were similar between frail and non-frail pt, while diabetes (59% vs. 13%, p<0.001), ischemic etiology (64% vs. 45%, p=0.04), and preop balloon pump (50% vs. 26%, p=0.01) were significantly different. Results: All patients underwent CF-LVAD implantation and cardiopulmonary bypass time was similar between groups (102 vs. 111 min., p=0.3). There were no significant differences in early adverse events between frail and non-frail pt, including inotrope duration (120 vs. 96 hr., p=0.11), right ventricular failure (19% vs. 13%, p=0.44), respiratory failure (26% vs. 18%, p=0.34), acute renal failure (16% vs. 13%, p=0.69), and hepatic dysfunction (16% vs. 13%, p=0.69). Median length of stay (20 vs. 16 days, p=0.25) and early mortality (12% vs. 8%, p=0.48) were also similar. During a median follow up of 2 years with 224 patient/years of support, any GI bleed (43% vs. 42%, p=0.79), any thromboembolic event (34% vs. 39%, p=0.74), and driveline infection (10% vs. 26%, p=0.052). Conclusions: In this select cohort of patients, frailty did not portend higher risk of adverse events after CF-LVAD implantation for DT despite prior observation that late survival is reduced in these patients. These findings are extremely important in patient selection and counseling of patients prior to LVAD implantation.

Background: Heart failure (HF) patients are experiencing an epidemic of hospitalizations. Nevertheless, data on the frequency and distribution of hospitalizations over the course of the disease are lacking. Methods: We determined the rates of hospitalizations during periods of follow-up in Olmsted County, MN residents with incident HF from 2000-2010. HF was identified using ICD-9 code 428 and validated by the Framingham criteria. All hospitalizations were obtained for the 2 years following incident HF and each was categorized as due to HF, other cardiovascular (ICD-9 codes 390-427, 429-459), or non-cardiovascular causes. Follow-up was divided into discrete time periods (epochs): 0-30, 31-182, 183-365, and 366-730 days. Negative binomial regression examined associations between epochs of follow-up time and hospitalizations. Results: Among 1702 incident HF patients (mean age 76, 44% male), 1143 (67%) were hospitalized at index. Over the 2 year follow-up, 3008 hospitalizations were observed among 1136 patients, and 351 patients were hospitalized within 30 days of incident HF (median time from HF to hospitalization: 11 days). The majority of hospitalizations were due to non-cardiovascular causes (63% vs. 14% HF, 23% other cardiovascular); however, a larger proportion of HF and other cardiovascular hospitalizations were observed within the first 30 days (52% non-cardiovascular, 18% HF, 30% other cardiovascular) compared to the other time periods. The rate of hospitalization was highest within the first 30 days and was similar across sex, presentation of incident HF (inpatient, outpatient), and type of HF (preserved (≥50%), reduced (<50%) ejection fraction) (Table). Conclusions: HF patients experience high rates of hospitalizations, particularly within the first 30 days, and the majority of hospitalizations are for non-cardiovascular causes. Continued efforts to manage comorbid conditions and reduce hospitalizations in HF patients are needed.