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BackgroundSarcoidosis is an inflammatory disease characterized by the formation of granulomas, which involve the heart in up to 25% of patients. Cardiac sarcoidosis can lead to life threatening arrhythmias and heart failure. While corticosteroids have been used as a treatment for over 50 years, they are associated with hypertension, diabetes, and weight gain, further increasing cardiovascular risk. Interleukin-1 (IL-1) is the prototypical proinflammatory cytokine that works to activate the nuclear transcription factor NF-kB, one of the targets of glucocorticoids. IL-1 also plays an important role also in the pathophysiology of heart disease including atherosclerosis, myocardial infarction, and myocarditis.MethodsBuilding on a network of research collaborators developed in the Cardiac Sarcoidosis Consortium, we will investigate the feasibility and tolerability of treatment of CS with anakinra at two National Institute of Health Clinical and Translational Science Award (CTSA) hubs with expertise in cardiac sarcoidosis. In this pilot study, up to 28 patients with cardiac sarcoidosis will be recruited to compare the administration of an IL-1 blocker, anakinra, 100 mg daily on top of standard of care versus standard of care only for 28 days and followed for 180 days. Utilizing surrogate endpoints of changes in systemic inflammatory biomarkers and cardiac imaging, we aim to determine whether IL-1 blockade with anakinra can combat systemic and cardiac inflammation in patients with cardiac sarcoidosis.DiscussionThe current trial demonstrates an innovative collaborative approach to clinical trial development in a rare, understudied disease that disproportionately affects females and minorities.Trial RegistrationThe trial was registered prospectively with ClinicalTrials.gov on July 12, 2019, identifier NCT04017936.

To assess the prognostic value of positron emission tomography (PET) imaging in patients undergoing evaluation for known or suspected cardiac sarcoidosis (CS) while not on active immunotherapy. Previous studies have attempted to identify the value of PET imaging to aid in risk stratification of patients with CS, however, most cohorts have included patients currently on immunosuppression, which may confound scan results by suppressing positive findings. We retrospectively analyzed 197 patients not on immunosuppression who underwent 18F-fluorodeoxyglucose (FDG) PET scans for evaluation of known or suspected CS. The primary endpoint of the study was time to ventricular arrhythmia (VT/VF), or death. Candidate predictors were identified by univariable Cox proportional hazards regression. Independent predictors were identified by performing multivariable Cox regression with stepwise forward selection. Median follow-up time was 531 [IQR 309, 748] days. 41 patients met the primary endpoint. After stepwise forward selection, left ventricular ejection fraction (LVEF) (HR 0.98, 95% CI 0.96-0.99, P = 0.02), history of VT/VF (HR 4.19, 95% CI 2.15-8.17, P

BACKGROUND: Resting oxygen consumption (VO(2)) is often estimated and frequently used to guide therapeutic decisions in symptomatic heart failure (HF) patients. The relationship between resting VO(2) and symptomatic HF and the accuracy of estimations of VO(2) in this population are unknown. METHODS AND RESULTS: We performed a cross-sectional study of HF patients (n=691) and healthy controls (n=77). VO(2) was measured using a metabolic cart and estimated VO(2) was calculated using the Dehmer, LaFarge, and Bergstra formulas and the thermodilution method. The measured and estimated VO(2) were compared, and the potential impact of estimations was determined. In the multivariable model, resting VO(2) decreased with increasing NYHA class in a stepwise fashion (β NYHA class IV vs controls=−36 ml O(2)/min, P

Background: Obesity is common in heart failure with preserved ejection fraction (HFpEF), and a hypocaloric diet can improve functional capacity. Malnutrition, sarcopenia, and frailty are also frequently present, and calorie restriction could harm some patients. Resting metabolic rate (RMR) is an essential determinant of caloric needs; however, it is rarely measured in clinical practice. The accuracy of commonly used predictive equations in HFpEF is unknown. Methods: RMR was measured with indirect calorimetry in 43 patients with HFpEF undergoing right heart catheterization at the University of Michigan, and among 49 participants in the SECRET trial (Study of the Effects of Caloric Restriction and Exercise Training in Patients With Heart Failure and a Normal Ejection Fraction); SECRET patients also had dual-energy X-ray absorptiometry body composition measures. Measured RMR was compared with RMR estimated using the Harris Benedict, Mifflin-St Jeor, World Health Organization, and Academy for Nutrition and Dietetics equations. Results: All predictive equations overestimated RMR (by >10%, P P 2 =0.56). Conclusions: Commonly used predictive equations systematically overestimate measured RMR in patients with HFpEF. Direct measurement of RMR may be needed to effectively tailor dietary guidance in this population. Registration: URL: https://www.clinicaltrials.gov ; Unique Identifier: NCT00959660.

BACKGROUND The successful management of heart failure (HF) involves guideline-based medical therapy as well as self-management behavior. As a result, the management of HF is moving toward a proactive real-time technological model of assisting patients with monitoring and self-management. OBJECTIVE The aim of this paper was to evaluate the efficacy of enhanced self-management via a mobile app intervention on health-related quality of life, self-management, and HF readmissions. METHODS A single-center randomized controlled trial was performed. Participants older than 45 years and admitted for acute decompensated HF or recently discharged in the past 4 weeks were included. The intervention group (“app group”) used a mobile app, and the intervention prompted daily self-monitoring and promoted self-management. The control group (“no-app group”) received usual care. The primary outcome was the change in Minnesota Living with Heart Failure Questionnaire (MLHFQ) score from baseline to 6 and 12 weeks. Secondary outcomes were the Self-Care Heart Failure Index (SCHFI) questionnaire score and recurrent HF admissions. RESULTS A total of 83 participants were enrolled and completed all baseline assessments. Baseline characteristics were similar between the groups except for the prevalence of ischemic HF. The app group had a reduced MLHFQ at 6 weeks (mean 37.5, SD 3.5 vs mean 48.2, SD 3.7; P=.04) but not at 12 weeks (mean 44.2, SD 4 vs mean 45.9, SD 4; P=.78), compared to the no-app group. There was no effect of the app on the SCHFI at 6 or 12 weeks. The time to first HF readmission was not statistically different between the app group and the no-app group (app group 11/42, 26% vs no-app group 12/41, 29%; hazard ratio 0.89, 95% CI 0.39-2.02; P=.78) over 12 weeks. CONCLUSIONS The adaptive mobile app intervention, which focused on promoting self-monitoring and self-management, improved the MLHFQ at 6 weeks but did not sustain its effects at 12 weeks. No effect was seen on HF self-management measured by self-report. Further research is needed to enhance engagement in the app for a longer period and to determine if the app can reduce HF readmissions in a larger study. CLINICALTRIAL ClinicalTrials.gov NCT03149510; https://clinicaltrials.gov/ct2/show/NCT03149510

Background Patients with heart failure (HF) are at risk of cognitive dysfunction, including decreased directed attention. Directed attention is critical for performing daily activities including HF self-care by facilitating one to follow instructions or train-of-thought when there are interferences in which presented stimuli are in conflict with one another. The Multi-Source Interference Task (MSIT) is a computerized neuropsychological test that examines the function of the dorsal anterior cingulate cortex, the neurological substrate for directed attention. However, the MSIT has not been used in past HF studies. Objective The purpose of the study was to examine construct validity of the MSIT in HF. Methods Baseline data were obtained from a cognitive intervention study among patients with HF (n = 22) and age- and education-matched healthy adults (n = 20). Construct validity was evaluated using t tests to examine differences between patients with HF and healthy adults and congruent and incongruent MSIT trials. Pearson’s correlations were computed to examine relationships between the MSIT and Trail-Making Test, Stroop Test, and Attentional Function Index. Results Compared with healthy adults, patients with HF demonstrated worse performance (i.e., slower response times and higher error rates) on MSIT. Patients with HF had worse performance on MSIT incongruent trials than congruent trials. Interference z scores of MSIT did not correlate with Trail-Making Tests A and B and Stroop Test interference z scores, but the MSIT interference z scores correlated with perceived attention function measured by Attentional Function Index. Discussion Construct validity of the MSIT was supported, in part, among patients with HF. The MSIT is a sensitive measure of detecting worse directed attention among patients with HF compared with healthy adults. The preliminary findings support the use of the MSIT as a measure of directed attention in HF. Confirmation is warranted for current findings in larger samples

Purpose Regional nodal irradiation, including radiation therapy (RT) to the internal mammary node (IMN) region, improves oncologic outcomes in patients with node-positive breast cancer. Concern remains, however, given the proximity of the IMNs to the heart and the association between cardiac RT exposure and toxicity. The objective of the study was to evaluate rates of ischemic cardiac events (ICEs) and associated risk with treatment of the IMN region. Methods and Materials The cardiac outcomes of 2126 patients treated with adjuvant breast RT or breast and nodal RT from 1984 to 2007 at a single institution were reviewed. The primary endpoint was an ICE following RT initiation. The association between IMN RT and ICEs was assessed using Cox proportional hazards models. Treatment with both IMN RT and 3-dimensional (3D) conformal radiation therapy (CRT) began in 1997; therefore, subset analyses of patients with only 3D CRT were performed to minimize bias associated with improved treatment technique. Results The median follow-up period was 9.3 years. An ICE occurred in 87 patients (4.1%). No increased 10-year rate of ICEs was observed with IMN RT compared with no IMN RT in the total cohort (3.2% [95% confidence interval (CI), 2.4%-4.3%] vs 3.4% [95% CI, 1.5%-7.5%]; hazard ratio [HR], 0.88; P=.73). Similarly, no statistically significant difference was noted in the 3D CRT–planned, left-sided disease subset (5.1% [95% CI, 1.8%-14.1%] vs 4.0% [95% CI, 2.0%-8.0%]; HR, 1.18, P=.76). On multivariate analysis, adjusting for cardiac risk factor imbalances, no significantly increased hazard was noted with IMN RT (HR, 1.84; P=.28) in the 3D CRT–planned, left-sided disease subset. Conclusions No statistically significant association between IMN RT and ICEs was demonstrated in a review of patients treated at a single institution from 1984 to 2007. Given the long natural history and low overall rate of ICEs, continued follow-up of this study, as well as additional studies in the 3D CRT era, is warranted to confirm these results. Minimizing cardiac exposure, when treating a limited IMN field, is critical to limit excess risk of ICEs.

In heart failure (HF), attention may be decreased because of lowered cerebral blood flow and increased attentional demands needed for self-care. Guided by the Attention Restoration Theory, the objective was to test the efficacy of the natural restorative environment (NRE) intervention on improving attention and mood among HF patients and healthy adults. A randomized crossover pilot study was conducted among 20 HF patients and an age- and education-matched comparison group of 20 healthy adults to test the efficacy of the NRE intervention compared with an active control intervention. Neuropsychological tests were administered to examine attention, particularly attention span, sustained attention, directed attention, and attention switching, at before and after the intervention. Mood was measured with the Positive and Negative Affect Schedule. No significant differences were found in attention and mood after the NRE intervention compared with the control intervention among the HF patients and the healthy adults. In analyses with HF patients and healthy adults combined (n = 40), significant differences were found. Compared with the control intervention, sustained attention improved after the NRE intervention (P = .001) regardless of the presence of HF. Compared with the healthy adults, HF patients performed significantly worse on attention switching after the control intervention (P = .045). The NRE intervention may be efficacious in improving sustained attention in HF patients. Future studies are needed to enhance the NRE intervention to be more efficacious and tailored for HF patients and test the efficacy in a larger sample of HF patients.

Introduction Malnutrition and weight loss among patients with heart failure with reduced ejection fraction (HFrEF) are associated with poor functional status, hospitalization, and death. Nutritional interventions might benefit patients with HFrEF, but few data on resting metabolic rate (RMR) are available to guide such programs. We sought to clarify the relationship between heart failure (HF) severity and RMR and the accuracy of commonly used estimations of RMR in this population. Hypothesis We hypothesized that worsening HF severity would impact RMR and that commonly used estimations of RMR would be inaccurate. Methods We measured RMR with a metabolic cart in 548 consecutive patients with HFrEF at the University of Michigan from 2011 to 2015. The primary outcome of interest was measured RMR using the Weir formula: RMR= 1440*[3.94 VO2 (l/min) + 1.11* VCO2 (l/min)] kcal/day. The primary independent variable was HF severity determined by New York Heart Association function class (NYHA FC). Linear regression adjusted for age, gender, weight, and height was performed to evaluate the impact of HF severity on RMR. Measured RMR and estimations of RMR using the Harris Benedict, Mifflin-St Jeor, and World Health Organization equations, both overall and by NYHA FC, were compared using paired t-tests. Results Patients were aged (mean ± SD) 59 ± 13 years, 73% male, and had an ejection fraction of 19 ± 7%; measured RMR was 1488 ± 416 kcal per day. Worsening HF severity was associated with reduced RMR. In the multivariable model, the predicted RMR for NYHA FC IV patients was -177.5 (95% CI, -246.7 to -108.3, p Conclusions Worsening HF severity is associated with decreasing RMR in patients with HFrEF and discordance of estimations increased with worsening NYHA FC. Estimations of RMR have the potential to introduce clinically meaningful (>10%) error in RMR. Improved understanding of these issues, including their relationship with other measures of HF severity and with body composition, will be necessary to promote adequate nutritional intake for patients with HFrEF.

Heart failure is a clinical syndrome in which abnormal cardiac function causes either a failure of the heart to pump blood at a rate matching the requirement of metabolizing tissues, or a situation in which filling pressures are elevated, or frequently both conditions simultaneously. Patients with impaired cardiac pumping function experience symptoms related to abnormal perfusion and retention of vascular fluid volume. The cardinal symptoms of heart failure include fatigue or exercise intolerance, dyspnea, and edema, although other related symptoms may also occur. Heart failure may be caused by disorders of the pericardium, myocardium, heart valves, or great vessels, but most patients manifest the syndrome through abnormalities in systolic function. Reduction in myocardial contractility is more commonly referred to as systolic dysfunction and may also coexist with chamber filling abnormalities, also referred to as diastolic dysfunction. This chapter focuses on patients with heart failure due to systolic dysfunction.

Aortic valve (AV) repair (AVr) using a central coaptation stitch or bioprosthetic AV replacement (AVR) are most commonly performed at the time of durable left ventricular assist device implant to address AV insufficiency (AI).Prospective data collection on 46 patients undergoing left ventricular assist device implant from 2007 through 2018 who received concomitant AVr (n = 40) or AVR (n = 6) was retrospectively analyzed to assess freedom from recurrent aortic insufficiency. Paired Wilcoxon rank-sum test was used to compare echocardiographic findings. Mantel-Cox statistics were used to analyze survival.For AVr, central coaptation led to a mean decrease in AI severity by 2.1 ± 1.0 grades (P.001). Three patients (7.5%) had recurrence of at least moderate AI by 3 years. In comparison, all patients in the AVR group had mild or less AI on subsequent follow-up. Success of AVr in downgrading AI severity was associated with a smaller aortic root diameter (P = .011) and sinotubular junction diameter (P = .003). An aortic root diameter greater than 3.5 cm was predictive of less improvement in AI severity compared with 3.5 cm or less (1.83 ± 1.03 versus 2.47 ± 0.80 grades of improvement; P = .038). Duration of cardiopulmonary bypass was 32 minutes longer and duration of aortic cross-clamp was 38 minutes longer for AVR versus AVr cohorts. No difference in 30-day (P = .418) or overall survival (P = .572) between the AVr and AVR groups was seen.Aortic valve repair for addressing AI has a recurrence rate of 7.5% at 3 years. Success in downgrading AI is more likely with a smaller aortic root. No difference in survival was observed between AVr and AVR.

Purpose: Previous literature demonstrates higher prescribing rates by providers after contact with a pharmaceutical representative or after obtaining drug information from an external source. This study aims to evaluate the effectiveness of an Electronic Health Record (EHR), pharmacist-based, population health intervention on physician prescribing patterns of sacubitril/valsartan in patients at Michigan Medicine General Cardiology clinics. Methods: The institutional review board approved this prospective, cluster-randomized controlled study. Patients seen by providers at the General Cardiology clinics of Michigan Medicine between 3/21/2017 and 6/1/2018 were included. Twenty-seven cardiology providers were clustered based on specialty. Fourteen providers were included in the intervention group while 13 providers were included in the control group. Within each arm, study personnel prospectively screened patients by preliminarily filtering those with a diagnosis of systolic heart failure and a left ventricular ejection fraction (LVEF) of 40% or less. Practice-based guideline criteria were then used to determine final patient eligibility. Intervention notifications were sent by pharmacists to providers using the EHR inbox within two-weeks prior to the clinic visit. The primary endpoint for this study was the proportion of patients prescribed sacubitril/valsartan within three months following the appointment. Baseline demographic data was collected on intervention patients. Additionally, the reasons for ineligibility were collected on all patients. Results: A total of 1559 patients were included (intervention=763, control=796). Fifty-two patients met eligibility criteria for sacubitril/valsartan (intervention=16, control=36). Of eligible patients, two in the intervention group and one in the control group had sacubitril/valsartan initiated (12.5% vs. 2.8%, OR 5.0, 95% CI 0.42-59.7, p=0.22). Of the 14 interventions that were not accepted, there was a common provider and 79% of the messages were ignored. The main reasons for ineligibility were patients not taking a dose of angiotensin converting enzyme (ACE) inhibitor or angiotensin-receptor blocker (ARB) equivalent to enalapril 10 mg twice daily (92.6%) or not currently taking an ACE inhibitor or ARB (5.1%). Conclusion: Few patients met practice-based guideline criteria which reflected a conservative approach to initiating sacubitril/valsartan and limited sacubitril/valsartan initiation. EHR inbox interventions may be limited since most of the messages were ignored. Future research should explore tools to aid in optimizing medication therapy for patients with systolic heart failure which may lead to more successful pharmacist-based, population health interventions for this patient population.

Centrifugal (CFG) and axial flow (AX) left ventricular assist devices have different hydrodynamic properties that may impact the effectiveness of left ventricular unloading. We sought to determine whether patients implanted with the HeartWare HVAD (CFG) and HeartMate II (AX) had a similar degree of hemodynamic support by comparing parameters measured using echocardiography and right heart catheterization. Using our prospectively collected database, we identified 268 patients implanted with the AX and 93 with the CFG. Demographic characteristics were similar between groups. AX patients had a significantly lower INTERMACS score. Baseline ventricular dimension, mitral regurgitation, right ventricular systolic pressure, right atrial pressure, mean pulmonary artery pressure, cardiac output, and pulmonary vascular resistance were similar. Wedge pressure was higher, and left ventricular ejection fraction was lower at baseline in the AX. After implantation, there was a greater reduction of right atrial pressure, pulmonary capillary wedge pressure, mean pulmonary artery pressure, and left ventricular internal diameter during diastole in the AX cohort. After implantation, cardiac output by Fick calculation showed a greater improvement in the AX group. These results demonstrate that both AX and CFG devices resulted in left ventricular unloading; however, AX devices may offer advantages in the magnitude of left ventricular unloading, which could have implications in myocardial recovery or reduction in pulmonary vascular resistance before transplantation.

Background: We evaluated the diagnostic and prognostic value of quantification of myocardial flow reserve (MFR) with positron emission tomography (PET) in orthotopic heart transplant patients. Methods and Results: We retrospectively identified orthotopic heart transplant patients who underwent rubidium-82 cardiac PET imaging. The primary outcome was the composite of cardiovascular death, acute coronary syndrome, coronary revascularization, and heart failure hospitalization. Cox regression was used to evaluate the association of MFR with the primary outcome. The relationship of MFR and cardiac allograft vasculopathy severity in patients with angiography within 1 year of PET imaging was assessed using Spearman rank correlation and logistic regression. A total of 117 patients (median age, 60 years; 71% men) were identified. Twenty-one of 62 patients (34%) who underwent angiography before PET had cardiac allograft vasculopathy. The median time from orthotopic heart transplant to PET imaging was 6.4 years (median global MFR, 2.31). After a median of 1.4 years, 22 patients (19%) experienced the primary outcome. On an unadjusted basis, global MFR (hazard ratio, 0.22 per unit increase; 95% confidence interval, 0.09–0.50; P P =0.004) were associated with the primary outcome. Decreased MFR independently predicted the primary outcome after adjustment for other variables. In 42 patients who underwent angiography within 12 months of PET, MFR and stress myocardial blood flow were associated with moderate–severe cardiac allograft vasculopathy (International Society of Heart and Lung Transplantation grade 2–3). Conclusions: MFR assessed by cardiac rubidium-82 PET imaging is a predictor of cardiovascular events after orthotopic heart transplant and is associated with cardiac allograft vasculopathy severity.

Background: Cardiac toxicity has been well documented following adjuvant breast cancer radiation therapy (RT) using outdated treatment methods. Limited information exists, however, regarding cardiac outcomes following contemporary RT fields and techniques. Inclusion of the internal mammary nodal (IMN) field for appropriately selected patients with breast cancer coincided with our department’s transition to computed-tomography (CT) based planning. The objectives of this study, therefore, were to assess the risk of ischemic cardiac events following IMN irradiation and to assess the risks following CT-based versus two-dimensional (2D) planning. Methods: All patients treated with adjuvant RT for breast cancer and without history of additional chest RT from January 1, 1984 – December 31, 2007 in our department were assessed. CT planning for breast cancer began for select patients in 1997 and was used for all patients as of 2001. The inclusion of the IMN region was determined by review of our clinical database. Ischemic cardiac endpoints were defined as myocardial infarction, coronary artery bypass grafting procedure, angioplasty/stent placement, and/or diagnosis of coronary artery disease. A text-based and diagnosis code-based search was used to flag possible endpoints which were then confirmed by manual chart review. Hypertension (HTN), diabetes (DM), hyperlipidemia (HLD), and anthracycline use were identified by a diagnosis code-based search. Results: We identified 2,126 patients who received adjuvant RT. Median follow-up was 9.6 years. 311 (14.6%) patients had IMNs targeted and 1,813 (85.3%) did not (data not available for 2 patients). RT to the IMNs was not associated with a higher risk of ischemic cardiac events (HR: 0.88, P = 0.731). 1,072 (50.4%) patients had CT planning, 1,003 (47.2%) had 2D planning, and no information was available for 51 (2.4%) patients. Overall, there were 56 (5.6%) ischemic events in the 2D cohort and 27 (2.5%) in the CT cohort. After truncating follow-up to 10 years to account for differential potential follow-up, there were 28 (2.8%) and 23 (2.2%) ischemic cardiac events, respectively. The table lists the association of patient and treatment characteristics and risk of ischemic cardiac events. HTN, HLD, and DM were each associated with a significantly increased risk of ischemic cardiac events. Conclusions: After reviewing all patients treated in our department for breast cancer from 1984 – 2007, we were unable to find an association between IMN irradiation and ischemic cardiac events. CT-based planning has been shown to allow accurate targeting of the IMNs. These data suggest that even with inclusion of the IMNs, CT-based planning minimizes dose to the heart and coronary arteries thereby decreasing the risk of ischemic cardiac toxicity. These results will be followed with time. Association between characteristics and ischemic cardiac eventsCharacteristicHazard Ratio95% Confidence IntervalP-valueRT to the IMNs0.880.42-1.830.7312D vs. CT planning1.140.68-1.910.613Left vs. right1.210.79-1.850.372Anthracycline use0.750.44-1.260.270HTN5.612.06-15.300.001HLD1.901.25-2.900.003DM3.111.99-4.86 Citation Format: Adam L Liss, Kent A Griffith, Reshma Jagsi, Jean M Moran, Robin B Marsh, Todd M Koelling, Lori J Pierce. Association between ischemic cardiac events and targeting of the internal mammary nodal region with adjuvant radiation for breast cancer [abstract]. In: Proceedings of the Thirty-Seventh Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2014 Dec 9-13; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2015;75(9 Suppl):Abstract nr P1-15-01.

The objective of this study was to determine if a Web application that promoted mindfulness of the progress of the chronic disease through self-monitoring improved quality of life in heart failure.This was a prospective single-center single-group study. Participants were instructed how to use the Web application and to perform self-monitoring daily for 12 weeks. A comprehensive physical exam, assessment of New York Heart Association (NYHA) class, the Minnesota Living with Heart Failure Questionnaire (MLHFQ), and an evaluation of self-management were performed in person at baseline and at 12 weeks.Participants consisted of older (mean, 59 years), predominantly female (63%) adults with NYHA class II or III symptoms. NYHA classification (preintervention versus postintervention, 2.5±0.13 versus 2.0±0.13; p=0.0032) and MLHFQ score (55.7±4.6 versus 42.6±5.1, respectively; p=0.0078) improved over 12 weeks of self-monitoring. A trend toward improvement was also demonstrated in weight (preintervention versus postintervention, 209±9.6 pounds versus 207±9.4 pounds; by paired t test, p=0.389), number of times exercised per week (1.29±0.5 versus 2.5±0.6, respectively; p=0.3), and walk distance (572±147 yards versus 845±187 yards, respectively; p=0.119). Jugular venous distention (preintervention versus postintervention, 8.1±0.6 cm versus 6.7±0.3 cm; p=0.083) and peripheral edema (29.2% versus 16.7%, respectively; p=0.375) decreased after 12 weeks of self-monitoring via the Web application.A Web application for self-monitoring heart failure over 12 weeks improved both NYHA classification and MLHFQ score. The trend in improved physical activity and physical exam support these outcomes. The number of patients reporting a sodium-restricted diet increased over the 12 weeks, which may have led to the positive findings.

We sought to determine the safety of regadenoson (REG) stress testing in patients who have undergone orthotopic heart transplantation (OHT). Routine screening for cardiac allograft vasculopathy (CAV) is necessary after OHT. Adenosine stress is contraindicated after heart transplantation due to supersensitivity in denervated hearts. Safety of regadenoson stress following OHT has not been well studied. We retrospectively reviewed data from OHT patients (N = 123) who were referred to REG stress testing. Medical records were reviewed to determine hemodynamic and ECG response to regadenoson and to identify adverse reactions. No serious adverse events occurred. No life-threatening arrhythmias or hemodynamic changes occurred. Common side-effects related to regadenoson were observed, dyspnea being the most frequent (66.7%). On average the heart rate rose from 82.8 ± 12 to 95.7 ± 13.4 bpm (P

Background: Bridging the Discharge Gap Effectively (BRIDGE) is a cardiac transitional care clinic. BRIDGE has demonstrated improved patient outcomes for some populations. This study sought to determine if differences in outcomes (readmissions, ED visits, death) exist for Caucasian and non-Caucasian patients based on BRIDGE attendance and socioeconomic status (SES). Methods: Data on patients referred to BRIDGE from 2008-2014 were analyzed. Patients were split into two cohorts (Caucasian and non-Caucasian) and outcomes for each were independently compared by BRIDGE attendance and SES. Non-low SES was defined as income > $48,600 (200% poverty line for a family of 4) and low SES was income ≤ $48,600. Demographics and outcomes were compared between groups. Results: Of 2964 patients, 15.1% were non-Caucasian (n=448). Caucasians were significantly older than non-Caucasians (66.16±14.29 v 59.14±14.75, p Conclusions: BRIDGE attendance was associated with improved outcomes in Caucasians that were not seen in non-Caucasians, with the exception of reduced mortality. Also, SES appears to impact non-Caucasians more than Caucasians, with low SES non-Caucasians having higher readmission rates and lower BRIDGE attendance than non-low SES non-Caucasians. Differences seen may be biased due to unevenly distributed groups (i.e. age and diagnosis). Efforts to target these vulnerable populations are warranted to reduce disparities.

Background: Heart failure (HF) has high in-hospital mortality and is associated with high readmission rates. Reasons for and ways to avoid HF readmissions are unclear. We explored readmission diagnoses and guideline adherence, as a proxy for avoidability, among patients readmitted after index hospitalization for HF. Method: From 2008-2014, 3381 patients were referred to the BRIDGE transitional care clinic. Retrospective data was derived for 64 of the 154 HF patients who were readmitted within 30 days. Patients were assigned cohorts by readmission diagnosis: “HF or HF related,” “non-HF related other cardiac,” or “non-cardiac, non-HF related.” Patient and provider adherence to ACCF/AHA HF guidelines, including sodium and fluid restrictions, weight monitoring, outpatient follow-up, and medication, were assessed to determine readmission avoidability. Results: Data were collected for 64 pts of whom 62 had complete data. The mean age was 70.3±10.3 years; the majority were male (n=40, 64.5%) and white (n=54, 87.1%). HF diagnoses accounted for 58.1% (n=36) of readmissions; 19.4% (n=12) were for non-HF cardiac diagnoses and 22.6% (n=14) were for non-cardiac diagnoses. Overall provider guideline adherence at discharge was high (82.3%). Providers frequently documented providing education on sodium (77.4%) and fluid restrictions (54.8%), as well as daily weights (88.7%). Patients reported compliance with sodium (94.2%) and fluid restrictions (89.2%), daily weights (96.5%), and medications (96.7%). Patients readmitted for HF had lower guideline adherence than non-HF cardiac or non-cardiac diagnoses for both provider (n=26, 72.7%; p=.046) and patient (n=28, 77.8%, p=.248). HF was also the most frequent readmission diagnoses when provider guidelines were not adhered (n=10, 90.9%). Conclusion: Over 40% of HF readmissions within 30 days of discharge were non-HF related, half of which were also non-cardiac. Overall adherence to guidelines for both patients and providers was high, suggesting that many readmissions post-index hospitalization for HF may be unavoidable. When guidelines were not adhered to, patients were more likely to be readmitted for HF related diagnoses. Further research is needed to discern whether further reductions in readmission rates can be achieved through improved guideline adherence.

Introduction Heart failure (HF) is the most common hospital discharge diagnosis among older adults. As a result, the management of HF is moving toward a proactive real-time technological model of assisting patients with monitoring and self-management. Hypothesis Our hypothesis was that a patient-centered mobile application, ManageHF, would reduce Minnesota Living with Heart Failure Questionnaire (MLHFQ) at 6 and 12 weeks post-hospital discharge compared to usual care. Methods A single-center randomized controlled trial was performed. Patients were included if they were greater than 45 years of age, had a left ventricular ejection fraction (LVEF) 40% (with LA size >40 mm or BNP > 200 pg/ml or NT-proBNP > 800 pg/ml) and were currently admitted or recently discharged for acute on chronic decompensated HF. Patients were excluded for any of the following: unstable coronary syndromes within 8 weeks, primary valvular heart disease, constrictive pericardial disease, uncorrected thyroid disease, dialysis or creatinine >4.0 mg/dL, a hospice candidate, active cancer, pulmonary fibrosis, discharged to a setting other than home, or required a chronic inotrope. The intervention group used a mobile application, ManageHF, along with a Fitbit wearable and scale. The mobile application prompted active self-monitoring and provided a health status indicator to promote self-management. The control group received usual care. The primary outcome was the change in MLHFQ from baseline to 6 and 12 weeks using mixed models. Secondary outcomes were the Self-Care Heart Failure Index (SCHFI) questionnaire and HF admissions. Results Eighty-two patients were enrolled and completed all baseline assessments. Baseline characteristics were similar between groups with the exception of HF type. The intervention group had a reduced MLHFQ at 6 weeks (p=0.026) but not at 12 weeks (p=0.61) compared to control (Figure). There was no effect of the intervention on the SCHFI or any of its subcomponents at 6 or 12 weeks. The time to first HF admission was not statistically different between the two groups (HR 0.85, 95% CI 0.36-2.0, p=0.71). Median number of days the intervention group performed self-monitoring was 63 days. Conclusion ManageHF improved MLHFQ at 6 weeks, but did not sustain its effects at 12 weeks. No effect was seen on self-care measured by SCHFI. Further research is needed to enhance engagement in the app for a longer period of time and to determine if the app can reduce HF admissions in a larger study.

BACKGROUND The self-care regimen necessary in heart failure (HF) is notably complex. A complication to integrating new knowledge and behaviors is that impaired cognition has been frequently reported in patients with HF, which significantly impacts patients' health, admission and mortality rates, and instrumental activities of daily living. OBJECTIVE The identification of reliable cognitive screening tools to assess potential difficulties in performing self-care for cardiac populations is essential. As such, the current purposes were to evaluate the validity and stability of the International Shopping List (ISL) auditory learning subtest from the computerized CogState battery as a screening tool in HF populations, determine the ISL's ability to predict functional declines, and evaluate the task's sensitivity in myocardial infarction. METHODS Forty patients with chronic HF were enrolled in a longitudinal study evaluating the impact of a cognitive training intervention. Baseline neuropsychological and behavioral measurements before treatment were used in the current study, including measures of auditory memory, orientation, verbal fluency, processing speed, and activities of daily living, and a subset of patients (n = 17) received repeat testing at 8 weeks on some tasks. Analyses also were performed with patients organized based on myocardial infarction status. RESULTS The current study indicated that the ISL performed comparably with an established measure of auditory memory (Hopkins Verbal Learning Test-Revised; r = 0.70, P < .001), displayed adequate coefficients of stability (r = 0.53-0.68), and successfully predicted declines over time in daily functioning (β = .47, P < .001) in our HF sample. CONCLUSIONS The computerized CogState auditory memory subtest, the ISL, seems to be a beneficial tool in evaluating cognitive change in HF patients. Particularly given its cross-cultural sensitivity and ease of administration and scoring, this task may provide assistance to quickly and reliably monitor memory functioning in these vulnerable patients and gauge their potential for self-care behaviors.

Twenty-three percent to 50% of heart failure (HF) patients have memory loss. Objectives were to (a) characterize major allelic frequency of 2 variants in apolipoprotein ( APOE) gene in HF patients, (b) evaluate differences in memory and serum brain-derived neurotrophic factor (BDNF) levels based on APOE ε4 allele(s), and (c) estimate effect sizes (ESs) and confidence intervals (CIs). In this pilot, 29 HF patients were enrolled and 26 completed. Recall and delayed recall memory were measured at baseline and 12 weeks. Serum was collected at baseline and 8 weeks. Seven (24.1%) patients had APOE ε4 allele. No significant differences were found in recall and delayed recall memory or serum BDNF levels based on APOE ε4 allele. ESs were small to medium; CIs indicated ES precision was small. Future studies are needed to fully understand how genotypic and neuropsychological phenotypic variables influence response to computerized cognitive training.

OBJECTIVES: To determine the prevalence of cognitive impairment in older adults with heart failure (HF). DESIGN: Cross-sectional analysis of the 2004 wave of the nationally representative Health and Retirement Study linked to 2002 to 2004 Medicare administrative claims. SETTING: United States, community. PARTICIPANTS: Six thousand one hundred eighty-nine individuals aged 67 and older. MEASUREMENTS: An algorithm was developed using a combination of self- and proxy report of a heart problem and the presence of one or more Medicare claims in administrative files using standard HF diagnostic codes. On the basis of the algorithm, three categories were created to characterize the likelihood of a HF diagnosis: high or moderate probability of HF, low probability of HF, and no HF. Cognitive function was assessed using a screening measure of cognitive function or according to proxy rating. Age-adjusted prevalence estimates of cognitive impairment were calculated for the three groups. RESULTS: The prevalence of cognitive impairment consistent with dementia in older adults with HF was 15%, and the prevalence of mild cognitive impairment was 24%. The odds of dementia in those with HF were significantly higher, even after adjustment for age, education level, net worth, and prior stroke (odds ratio = 1.52, 95% confidence interval = 1.14–2.02). CONCLUSION: Cognitive impairment is common in older adults with HF and is independently associated with risk of dementia. A cognitive assessment should be routinely incorporated into HF-focused models of care. JA m Geriatr Soc 60:1724–1729, 2012.

Despite positive associations with rejection, the clinical value of B-type natriuretic peptide (BNP) monitoring in heart transplant recipients has not been established. We sought to determine the predictive value of changes in serial BNP level for identifying patients with acute allograft rejection.BNP, hemodynamics and biopsies were obtained for 205 transplant recipients who underwent a total of 4,007 endomyocardial biopsy procedures. Samples analyzed were collected ≥ 180 days post-transplant, without evidence of rejection on the immediately preceding biopsy. Using a repeated-measures multivariate model, we assessed the association of change in BNP with Grade ≥ 3A (2R) rejection. We also determined predictive values of various cut-off thresholds of change in serial BNP levels to predict Grade ≥ 3A rejection.There were 47 episodes of Grade ≥ 3A rejection among the 1,350 samples analyzed. Median change in serial BNP (ΔBNP) for those with Grade ≥ 3A rejection was 20 pg/ml (IQR -26 to 169 pg/ml) and among those with Grade3A rejection was -4 pg/ml (IQR -34 to 22 pg/ml, p = 0.003). On multivariate analysis, ΔBNP remained the most potent independent predictor of Grade ≥ 3A rejection (p = 0.001). ΔBNP100 pg/ml predicted increased risk of Grade ≥ 3A rejection (OR = 5.3, p0.001) with high specificity (93.3%) and positive predictive value (13.0%) and excellent negative predictive value (97.3%).Change in serial BNP level is an independent predictor of cardiac allograft rejection. With wide availability, rapid turnaround, low cost, favorable positive predictive value and excellent negative predictive value, serial BNP monitoring has several advantages for non-invasive monitoring of heart transplant recipients for acute cardiac allograft rejection.

Background and Aims Identification of patients with heart failure (HF) at high risk of hospital readmission is critical to refine processes for reducing readmission rates. We hypothesized that patients with higher 6-min walk (6MW) distance at the time of hospital discharge are at low risk for early readmission. Methods We prospectively enrolled 265 patients admitted with HF and left ventricular systolic dysfunction. 6MW testing was administered prior to discharge. Multivariate logistic regression analysis was performed to determine the relationship between 6MW distance and 30-day readmission, stratifying by ≤400 m and >400 m. Results Two hundred ten patients underwent 6MW testing prior to discharge. Patients with 6MW >400 m had a 30-day readmission rate of 15.9%, whereas patients with 6MW ≤400 m had a 30-day readmission rate of 30.3% ( p = 0.016). Patients requiring readmission within 30 days had a median 6MW of 30 m, whereas patients not requiring readmission at 30 days walked 338 m ( p = 0.012). 6MW distance predicted freedom from readmission at 30 days (OR: 0.435, 95% CI 0.21–0.9, p = 0.025). Other independent predictors of 30-day readmission included history of gout (0.117, 0.021–0.637, p = 0.013), use of angiotensin-converting enzyme inhibitor or accepted alternative (0.372, 0.169–0.820, p = 0.014) and blood urea nitrogen level (1.019, 1.003–1.035, p = 0.020). Conclusions Low 6MW distance predicts early hospital readmission in patients with HF. Programs seeking to produce systems that are effective in reducing early hospital readmission may desire to incorporate 6MW testing during HF hospital care.

Recent studies report surprisingly low rates of implantable cardioverter defibrillator (ICD) placement for primary prevention against sudden cardiac death among patients with heart failure and left ventricular systolic dysfunction. Reasons for the low rates of utilization are not well understood. The authors examined ICD implantation rates at a university-based tertiary care center and used multivariable analysis to identify independent factors associated with ICD utilization. The ICD implantation rate for 850 eligible patients was 70%. Forty-seven (18%) patients refused implantation; women were twice as likely to refuse compared to men (8% vs 4%, P=.013). Race was not associated with utilization. On multivariable analysis, independent predictors of implantation included having a heart failure specialist (odds ratio [OR], 8.13; P

Objectives This study sought to develop a model that estimates the post-operative risk of right ventricular (RV) failure in left ventricular assist device (LVAD) candidates. Background Right ventricular failure after LVAD surgery is associated with increased morbidity and mortality, but identifying LVAD candidates at risk for RV failure remains difficult. Methods A prospectively collected LVAD database was evaluated for pre-operative clinical, laboratory, echocardiographic, and hemodynamic predictors of RV failure. Right ventricular failure was defined as the need for post-operative intravenous inotrope support for >14 days, inhaled nitric oxide for ≥48 h, right-sided circulatory support, or hospital discharge on an inotrope. An RV failure risk score (RVFRS) was created from multivariable logistic regression model coefficients, and a receiver-operating characteristic curve of the score was generated. Results Of 197 LVADs implanted, 68 (35%) were complicated by post-operative RV failure. A vasopressor requirement (4 points), aspartate aminotransferase ≥80 IU/l (2 points), bilirubin ≥2.0 mg/dl (2.5 points), and creatinine ≥2.3 mg/dl (3 points) were independent predictors of RV failure. The odds ratio for RV failure for patients with an RVFRS ≤3.0, 4.0 to 5.0, and ≥5.5 were 0.49 (95% confidence interval [CI] 0.37 to 0.64), 2.8 (95% CI 1.4 to 5.9), and 7.6 (95% CI 3.4 to 17.1), respectively, and 180-day survivals were 90 ± 3%, 80 ± 8%, and 66 ± 9%, respectively (log rank for linear trend p = 0.0045). The area under the receiver-operating characteristic curve for the RVFRS (0.73 ± 0.04) was superior to that of other commonly used predictors of RV failure (all p Conclusions The RVFRS, composed of routinely collected, noninvasive pre-operative clinical data, effectively stratifies the risk of RV failure and death after LVAD implantation.

Iron deficiency is common in heart failure (HF), and intravenous (IV) iron therapy has been associated with improved clinical status in ambulatory patients with HF. There are limited data to support the safety and efficacy of IV iron administration in patients with acute HF. This was a retrospective cohort study of patients admitted to the University of Michigan Health System for HF with low iron studies during admission. Patients were grouped based on the receipt of IV iron therapy. Study outcomes included change in hemoglobin, 30-day readmission, and adverse events. Forty-four patients who received IV iron and 128 control patients were identified. The mean dose of IV iron received was 1,057 (±336) mg. IV iron resulted in a significantly greater increase in hemoglobin over time (p = 0.0001). The mean change in hemoglobin in the iron and control groups was 0.74 g/dl and 0.01 g/dl at day 7 and 2.61 g/dl and 0.23 g/dl at day 28, respectively. Thirty-day readmission rates were 30% and 22% for patients in the iron and control groups, respectively (p = 0.2787). In conclusion, total dose infusion IV iron is well tolerated and associated with significant improvement in hemoglobin in acute HF.

Idiopathic premature ventricular complexes (PVCs) usually are considered benign, even when frequent. However, case reports have demonstrated a possible link between frequent PVCs and left ventricular (LV) dysfunction. In addition, frequent PVCs recently were demonstrated to be associated with increased LV dimensions and cardiomyopathy.Among 60 consecutive patients with idiopathic, frequent PVCs (10/hour), a reduced LV ejection fraction (EF; mean 34% +/- 13%) was present in 22 (37%) patients. Patients with decreased LV function had a greater PVC burden on a 24-hour Holter monitor than patients with normal EF (37% +/- 13% vs. 11% +/- 10% of all QRS complexes; P.0001). There was a significant inverse correlation between the PVC burden and the EF before ablation (r = 0.73, P.0001).The PVCs originated in the right ventricular outflow tract in 31 (52%) of 60 patients, the LV outflow tract in 9 (15%) of 60 patients, and in other sites in 13 (22%) of 60 patients. The site of PVC origin could not be determined in seven patients. Ablation was completely successful in 48 (80%) patients. In patients with an abnormal EF before ablation, LV function normalized in 18 (82%) of 22 patients from a baseline of 34% to 59% +/- 7% (P.0001) within 6 months. In the four patients in whom ablation was ineffective, the EF further declined from 34% +/- 10% to 25% +/- 7% (P = .06) during follow-up. In a control group of 11 patients with a similar PVC burden (30% +/- 8%) and a reduced EF (28% +/- 13%) who did not undergo ablation, the EF remained unchanged in 10/11 patients over 19 +/- 17 months of follow-up and one patient underwent heart transplantation.LV dysfunction in the setting of frequent, idiopathic PVCs may represent a form of cardiomyopathy that can be reversed by catheter ablation of the PVCs.

BACKGROUND. Radiation therapy (RT), a critical component of breast-conserving therapy for breast cancer, has been associated with coronary artery disease (CAD) in numerous older studies, but the risk may be lower with modern techniques. METHODS. Observed rates of cardiac events in 828 patients treated with breast-conserving surgery and RT at the University of Michigan were compared with expected rates. Relations between potential risk factors and actuarial rates of first CAD event were analyzed. RESULTS. Observed risks of cardiac events were lower than expected. The standardized incidence ratio (SIR) of myocardial infarction (MI) was 0.44 (95% confidence interval [CI]: 0.21–0.70). The SIR of MI or CAD requiring intervention was 0.50 (95% CI: 0.27–0.68). With a median follow-up of 6.8 years, 12 (1.4%) patients had at least 1 MI on follow-up and 20 (2.4%) had at least 1 MI or CAD requiring intervention. Median age at first cardiac event was 75.9 years (range, 43.1–91.5). Median interval from RT to occurrence of the first cardiac event was 3.7 years (range, 13 days to 15.4 years). The 10-year cumulative incidence of MI was 1.2% and cumulative incidence of MI or CAD requiring intervention was 2.7%. On multivariate analysis, age, diabetes mellitus, active smoking, and laterality of RT were significant predictors of MI. Age and active smoking were significant predictors of MI or CAD requiring intervention. CONCLUSIONS. Patients in this series had lower risk of ischemic cardiac events than expected. Although small in absolute magnitude, patients radiated to the left side did have a statistically significant increased risk of MI. These findings support further investigation of techniques to minimize the long-term cardiac risks faced by breast cancer patients. Cancer 2007 © 2007 American Cancer Society.

Introduction: Attention is critical to performing self-care and is impaired in 25% of patients with heart failure (HF). Although HF patients may have greater attentional demands from their chronic condition, reasons for their impaired attention have included altered oxygenation to the brain, but not mental effort. Purpose: To compare attention between HF patients and age-matched healthy adults and examine relationships between attention and mental effort, blood pressure (BP), and oxygen saturation (SpO2). Methods: Baseline data were included from 40 participants (20 HF, 20 healthy) enrolled in a cognitive intervention study. Attention was measured using 4 neuropsychological tests (Multi-Source Inference Task (MSIT), Stroop, Trail Making (TMT), Digit Span Tests) and perceived attention by Attentional Function Index (AFI). Mental effort for chronic disease was measured by a self-report questionnaire. BP and SpO2 were measured during testing. Descriptive statistics, t-tests, X2 tests, and Pearson correlations were conducted. Significance level was .05. Results: Demographics were similar for HF and healthy groups (age = 60 vs 59 yrs, education = 15 yrs for both). Mean LVEF was 37% and NYHA class was 2.5 in HF patients. Compared with healthy adults, HF patients performed poorer on 3 tests of attention. On TMT, HF patients took 40% longer to complete test A (41 vs 27, p = .001) and B (100 vs 60 sec, p = .002). Similarly, HF patients had slower responses and more errors on MSIT and Stroop test (p = .007 - .045). Patients with HF scored lower in AFI than healthy adults (p < .001). Compared with healthy adults, HF patients had greater mental effort (p = .014), lower BP (110/66 vs 124/74mmHg) and SpO2 (96.6 vs 97.6%). Greater mental effort was related to slower responses on TMT-A and MSIT, more errors on MSIT and Stroop test, and poorer AFI (p = Conclusions: Patients with HF had poorer attention than healthy adults. Poorer attention was associated with increased mental effort and lower oxygen saturation. Future studies are needed to improve attention and to evaluate if improving oxygen and mental effort improve attention in larger samples.

Aims and objectives The objective of this retrospective study was to evaluate reasons heart failure patients decline study participation, to inform interventions to improve enrollment. Background Failure to enrol older heart failure patients (age > 65) and women in studies may lead to sampling bias, threatening study validity. Design This study was a retrospective analysis of refusal data from four heart failure studies that enrolled 788 patients in four states. Methods Chi-Square and a pooled t-test were computed to analyse refusal data (n = 300) obtained from heart failure patients who were invited to participate in one of the four studies but declined. Results Refusal reasons from 300 patients (66% men, mean age 65·33) included: not interested (n = 163), too busy (n = 64), travel burden (n = 50), too sick (n = 38), family problems (n = 14), too much commitment (n = 13) and privacy concerns (n = 4). Chi-Square analyses showed no differences in frequency of reasons (p > 0·05) between men and women. Patients who refused were older, on average, than study participants. Conclusions Some reasons were patient-dependent; others were study-dependent. With ‘not interested’ as the most common reason, cited by over 50% of patients who declined, recruitment measures should be targeted at stimulating patients’ interest. Additional efforts may be needed to recruit older participants. However, reasons for refusal were consistent regardless of gender. Relevance to clinical practice Heart failure researchers should proactively approach a greater proportion of women and patients over age 65. With no gender differences in type of reasons for refusal, similar recruitment strategies can be used for men and women. However, enrolment of a representative proportion of women in heart failure studies has proven elusive and may require significant effort from researchers. Employing strategies to stimulate interest in studies is essential for recruiting heart failure patients, who overwhelmingly cited lack of interest as the top reason for refusal.

Purpose To examine whether stroke risk is elevated in American breast cancer patients treated with modern techniques, as well as whether supraclavicular radiation therapy (RT) is associated with increased risk. Methods Observed rates of stroke in 820 eligible early-stage breast cancer patients treated at the University of Michigan Hospital (Ann Arbor, MI) were compared with expected rates. Relationships between potential risk factors and actuarial rate of first stroke were analyzed. Results Median follow-up was 6.8 years. Twenty patients had at least one cerebrovascular accident (CVA) in follow-up; 35 patients had at least one CVA or transient ischemic attack (CVA/TIA). The standardized incidence ratios were 1.74 (0.94 to 2.37) for CVA and 1.68 (1.003 to 2.06) for CVA/TIA. The absolute excess risk per 1,000 patients per year was 1.67 for CVA and 2.76 for CVA/TIA. On bivariate analysis, factors significantly associated with actuarial rate of first CVA included hypertension (P = .002), age (P < .0001), coronary artery disease (P = .001), atrial fibrillation (P = .009), and supraclavicular RT (P = .021). Factors associated with CVA/TIA were hypertension (P < .001), coronary artery disease (P = .002), and age (P < .0001). Tamoxifen use alone was not significant (P = .19), but tamoxifen combined with baseline hypertension led to increased risk of CVA/TIA (log-rank P < .0001). On multivariate analysis, only age (P < .001) and hypertension (P = .003) remained significant predictors of CVA/TIA. Age was the only significant predictor of CVA alone (P < .001). Conclusion American breast cancer survivors may have an elevated risk of stroke compared with the general population, but the absolute excess risk is low. This study found no significant association between supraclavicular RT and stroke after controlling for other factors.

Background The effect of spironolactone on clinical outcomes in patients with mild heart failure is unclear. Methods and Results We performed a retrospective analysis of 482 consecutive patients with left ventricular ejection fraction ≤40% and New York Heart Association I-II symptoms. Major cardiac event (MCE) was defined as death, left ventricular assist device implantation, or United Network of Organ Sharing 1 cardiac transplantation. Proportional hazards analysis was used to determine predictors of MCE and to derive an adjusted hazard for spironolactone therapy. Spironolactone was prescribed to 279 (58%) patients and mean follow-up was 1029 days. After controlling for predictors of clinical events, spironolactone treatment was associated with a trend for lower risk of MCE or heart failure rehospitalization (HR, 0.68; 95% CI, 0.43–1.07; P = .095). Exploration of interaction terms between medications revealed that treatment with the combination of spironolactone and thiazide diuretics was associated with lower risk of clinical events (HR, 0.32; 95% CI, 0.12–0.89; P = .029). Conclusion In subjects with mild heart failure treated with a thiazide diuretic, the use of spironolactone is associated with reduced risk of MCE or heart failure rehospitalization. A randomized controlled trial is necessary to accurately define the clinical effects of spironolactone in patients with mild heart failure.

The implementation of guidelines into everyday practice does not always seem straightforward. In this primer article, Eagle and colleagues provide a summary of efforts to improve care for acute coronary syndromes in the Guidelines Applied in Practice program in Michigan, highlighting particularly methods that could be transferable to other cardiovascular subspecialties. The American College of Cardiology Acute Myocardial Infarction Guidelines Applied in Practice program in Michigan, USA, was an initiative designed to improve the quality of cardiovascular care by bringing the American College of Cardiology/American Heart Association practice guidelines to the point of care. The program consisted of three different projects, involving a total of 33 hospitals. The program was implemented in five phases—planning, tool implementation, monitoring of tool use, remeasurement and reporting of results—by use of a collaborative model, which included a series of learning sessions for staff members that focused on the five phases. The goal was to identify the highest care priorities for patients with acute coronary syndromes and to incorporate these into the care itself. This aim was achieved with a standardized set of clinical-care tools, such as admission orders and discharge contracts; the use of such tools is associated with improvement in adherence to guidelines. Strategies were, however, tailored to each hospital by local teams. Performance was assessed by the use of tracking tools, which facilitate rapid improvement by enabling key performance indicators founded on the guidelines to be monitored. Using qualitative surveys of the project leaders, we identified an optimum timeline and correlations between hospital-specific attributes and greater or lesser success in achieving positive change. In this review, we describe our experience and identify the most useful strategies for future implementation of such a project.

Background— Although interventions combining patient education and postdischarge management have demonstrated benefits in patients with chronic heart failure, the benefit attributable to patient education alone is not known. We hypothesized that a patient discharge education program would improve clinical outcomes in patients with chronic heart failure. Methods and Results— We conducted a randomized, controlled trial of 223 systolic heart failure patients and compared the effects of a 1-hour, one-on-one teaching session with a nurse educator to the standard discharge process. Subjects were contacted by telephone at 30, 90, and 180 days to collect information about clinical events, symptoms, and self-care practices. The primary end point of the study was the total number of days hospitalized or dead in the 180-day follow-up period. Subjects randomized to receive the teaching session (n=107) had fewer days hospitalized or dead in the follow-up period (0 and 10 days, median and 75th percentiles) than did controls (n=116, 4 and 19 days; P =0.009). Patients receiving the education intervention had a lower risk of rehospitalization or death (relative risk, 0.65; 95% confidence interval, 0.45 to 0.93; P =0.018). Costs of care, including the cost of the intervention, were lower in patients receiving the education intervention than in control subjects by $2823 per patient ( P =0.035). Conclusions— The addition of a 1-hour, nurse educator–delivered teaching session at the time of hospital discharge resulted in improved clinical outcomes, increased self-care measure adherence, and reduced cost of care in patients with systolic heart failure.

Purpose: Although angiotensin-converting enzyme (ACE) inhibitors are recommended for all patients with systolic heart failure, prior studies suggest that elderly cohorts are less likely to receive such therapy. The purpose of this study was to determine the age dependence of adherence to guideline-based medical care in hospitalized heart failure patients. Methods: We performed a multicenter observational cohort study including 613 patients admitted to participating hospitals with a primary diagnosis of heart failure with ejection fraction ≤40%. This cohort was divided into four age groups (group 1: Results: ACE inhibitors were administered to 83% of ideal heart failure patients, and this rate was similar for all age groups. Elderly patients received significantly lower ACE inhibitor dosages compared to their younger counterparts (168, 148, 125 and 117 mg captopril in groups 1, 2, 3, and 4, respectively, p = 0.001). Lower creatinine clearance (p < 0.001), prior residence in a long-term care facility (p = 0.037), intolerance to ACE inhibitors (p = 0.006), lower blood pressure (p = 0.005), absence of a history of hypertension (p = 0.005), and no prior heart failure hospitalizations within the past year (p = 0.001) were found to be independent predictors of low ACE inhibitor dosing. Conclusions: In this heart failure benchmarking project, elderly patients received guideline-based ACE inhibitor therapy at similar rates, but at lower doses, compared to their younger counterparts.

To compare the estimated radiation doses delivered to the cardiac chambers (CC) and coronary arteries (CA) for 5 postmastectomy radiotherapy (PMRT) techniques.A dosimetry study of 20 left-sided PMRT cases was conducted. Cardiac chambers (left and right atria [LA/RA] and left and right ventricles [LV/RV]) and coronary vessels (left main [LM], left anterior descending [LAD], left circumflex [LCX], right coronary [RCA] and posterior descending [PDA] arteries) were contoured on contrast-enhanced CT scans and verified by a cardiologist (T.K.). Five PMRT techniques were applied to each case; 50 Gy in 2 Gy fractions was delivered to the chest wall +/- internal mammary node targets. The techniques were: (1) standard tangents (TAN); (2) cobalt (Co); (3) reverse hockey stick (RHS); (4) mixed photon/electron beam (20/80); and (5) partially wide tangent fields (PWTF). Three-dimensional dose calculations for 100 plans were performed for all structures. Plans were compared by using the mean dose (Dmean) and the volume that received more than 30 Gy (V(30)) and 45 Gy (V(45)) for each structure.Cobalt and 20/80 techniques delivered higher Dmeans to the whole heart and individual cardiac chambers (RA, RV, LA, and LV) as compared with the other three techniques. The heart received a Dmean of 21.03 +/- 3.5 Gy from Co and 11.87 +/- 5.22 Gy from 20/80. The remaining techniques delivered heart Dmeans of 2.90-4.94 Gy. When V(30) was used as a metric, all techniques had comparably low V(30) to the heart, except for Co, which resulted in a significantly higher irradiated volume of right-sided cardiac chambers (59.06% +/- 30.7 for RA F-test0.0001; and 61.46% +/- 22.13 for RV, F-test0.0001). Dmean to the proximal LAD (LAD_p) was significantly higher for RHS (17.64 +/- 7.43 Gy) and 20/80 (20.52 +/- 8.36 Gy) and lowest for PWTF (9.5 +/- 4.16 Gy). The Dmean for the distal LAD (LAD_d) was significantly lower with PWTF (11.02 +/- 7.34 Gy) than with all other techniques, including TAN (p0.0001). Similar results for PWTF and TAN were observed when V30 and V45 were used.Cardiac substructures receive the most radiation exposure after PMRT with CO, 20/80 or both and least exposure with PWTF. Although TAN resulted in significant sparing of the majority of the cardiac structures, a significantly higher dose and volume of LAD was exposed when compared with PWTF. Although the clinical relevance of these dose differences is not clearly understood, these dosimetric estimates can serve as a baseline in the development of new techniques for locoregional treatment that will further reduce cardiac exposure.

Objectives: To assess left ventricular systolic and diastolic function in adult patients with cystic fibrosis using radionuclide ventriculography. Background: Although myocardial fibrosis has been described in autopsy specimens of patients with cystic fibrosis, the possibility that myocardial dysfunction may occur during life in adult patients with cystic fibrosis has not been explored. Methods: To assess the possibility of cardiac dysfunction occurring in cystic fibrosis, we studied 40 patients with advanced cystic fibrosis with first-pass radionuclide ventriculography and compared them to 9 patients with advanced bronchiectasis and 18 normal control subjects. Results: Indexes of right ventricular systolic function were similarly impaired in patients with cystic fibrosis and patients with bronchiectasis. Left ventricular ejection fraction of patients with cystic fibrosis, patients with bronchiectasis, and normal control subjects did not differ. Fractional left ventricular filling at 50% of diastole, an index of diastolic function, was significantly lower in patients with cystic fibrosis (54 ± 13%, mean ± SD) in comparison to patients with bronchiectasis (66 ± 4%, p=0.009) or normal control subjects (69 ± 14, p=0.0002). The contribution of atrial systole to total diastolic left ventricular filling was greater in patients with cystic fibrosis (38 ± 18%) than in patients with bronchiectasis (21 ± 4%, p=0.01) or normal control subjects (25 ± 12%, p=0.01). Conclusions: Patients with advanced cystic fibrosis demonstrate impaired left ventricular distensibility when compared to normal control subjects and patients with bronchiectasis. Patients with cystic fibrosis may be at risk of heart failure due to right ventricular dysfunction or left ventricular diastolic dysfunction.