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1.  Digoxin Use and Lower 30-Day All-Cause Readmission for Medicare Beneficiaries Hospitalized for Heart Failure 
The American journal of medicine  2013;127(1):61-70.
BACKGROUND
Heart failure is the leading cause for hospital readmission, the reduction of which is a priority under the Affordable Care Act. Digoxin reduces 30-day all-cause hospital admission in chronic systolic heart failure. Whether digoxin is effective in reducing readmission after hospitalization for acute decompensation remains unknown.
METHODS
Of the 5153 Medicare beneficiaries hospitalized for acute heart failure and not receiving digoxin, 1054 (20%) received new discharge prescriptions for digoxin. Propensity scores for digoxin use, estimated for each of the 5153 patients, were used to assemble a matched cohort of 1842 (921 pairs) patients (mean age, 76 years; 56% women; 25% African American) receiving and not receiving digoxin, who were balanced on 55 baseline characteristics.
RESULTS
30-day all-cause readmission occurred in 17% and 22% of matched patients receiving and not receiving digoxin, respectively (hazard ratio {HR} for digoxin, 0.77; 95% confidence interval {CI}, 0.63–0.95). This beneficial association was observed only in those with ejection fraction <45% (HR, 0.63; 95% CI, 0.47–0.83), but not in those with ejection fraction ≥45% (HR, 0.91; 95% CI, 0.60–1.37; p for interaction, 0.145), a difference that persisted throughout first 12-month post-discharge (p for interaction, 0.019). HRs (95% CIs) for 12-month heart failure readmission and all-cause mortality were 0.72 (0.61–0.86) and 0.83 (0.70–0.98), respectively.
CONCLUSIONS
In Medicare beneficiaries with systolic heart failure, a discharge prescription of digoxin was associated with lower 30-day all-cause hospital readmission, which was maintained at 12 months, and was not at the expense of higher mortality. Future randomized controlled trials are needed to confirm these findings.
doi:10.1016/j.amjmed.2013.08.027
PMCID: PMC3929967  PMID: 24257326
Digoxin; heart failure; hospital readmission
2.  Disparities In Access To Specialized Epilepsy Care 
Epilepsy research  2013;107(0):10.1016/j.eplepsyres.2013.08.003.
OBJECTIVE
To examine the impact of individual and community characteristics on access to specialized epilepsy care.
METHODS
This retrospective cross-sectional study analyzed data from the California State Inpatient Sample, the State Ambulatory Surgery Database, and the State Emergency Department Database, that were linked with the 2009 Area Resource File and the location of the National Association of Epilepsy Center’s epilepsy centers. The receipt of video-EEG monitoring was measured and used to indicate access to specialized epilepsy care in subjects with persistent seizures, identified as those who had frequent seizure-related hospital admissions and/or ER visits. A hierarchical logistic regression model was employed to assess barriers to high quality care at both individual and contextual levels.
RESULTS
Among 115,632 persons with persistent seizures, individuals who routinely received care in an area where epilepsy centers were located were more likely to have access to specialized epilepsy care (OR: 1.81, 95% CI: 1.20, 2.72). Interestingly, the availability of epilepsy centers did not influence access to specialized epilepsy care in people who had private insurance. In contrast, uninsured individuals and those with public insurance programs including Medicaid and Medicare had significant gaps in access to specialized epilepsy care. Other individual characteristics such as age, race/ethnicity, and the presence of comorbid conditions were also associated with disparities in access to specialized care in PWE.
CONCLUSION
Both individual and community characteristics play substantial roles in access to high quality epilepsy care. Policy interventions that incorporate strategies to address disparities at both levels are necessary to improve access to specialized care for PWE.
doi:10.1016/j.eplepsyres.2013.08.003
PMCID: PMC3818489  PMID: 24008077
Epilepsy; Healthcare access; Healthcare disparities
3.  Prediabetes is not an independent risk factor for incident heart failure, other cardiovascular events or mortality in older adults: Findings from a population-based cohort study 
International journal of cardiology  2013;168(4):3616-3622.
Background
Whether prediabetes is an independent risk factor for incident heart failure (HF) in non-diabetic older adults remains unclear.
Methods
Of the 4602 Cardiovascular Health Study participants, age ≥ 65 years, without baseline HF and diabetes, 2157 had prediabetes, defined as fasting plasma glucose (FPG) 100–125 mg/dL. Propensity scores for prediabetes, estimated for each of the 4602 participants, were used to assemble a cohort of 1421 pairs of individuals with and without prediabetes, balanced on 44 baseline characteristics.
Results
Participants had a mean age of 73 years, 57% were women, and 13% African American. Incident HF occurred in 18% and 20% of matched participants with and without prediabetes, respectively (hazard ratio {HR} associated with prediabetes, 0.90; 95% confidence interval {CI}, 0.76–1.07; p = 0.239). Unadjusted and multivariable-adjusted HRs (95% CIs) for incident HF associated with prediabetes among 4602 pre-match participants were 1.22 (95% CI, 1.07–1.40; p = 0.003) and 0.98 (95% CI, 0.85–1.14; p = 0.826), respectively. Among matched individuals, prediabetes had no independent association with incident acute myocardial infarction (HR, 1.02; 95% CI, 0.81–1.28; p = 0.875), angina pectoris (HR, 0.93; 95% CI, 0.77–1.12; p = 0.451), stroke (HR, 0.86; 95% CI, 0.70–1.06; p = 0.151) or all-cause mortality (HR, 0.99; 95% CI, 0.88–1.11; p = 0.840).
Conclusions
We found no evidence that prediabetes is an independent risk factor for incident HF, other cardiovascular events or mortality in community-dwelling older adults. These findings question the wisdom of routine screening for prediabetes in older adults and targeted interventions to prevent adverse outcomes in older adults with prediabetes.
doi:10.1016/j.ijcard.2013.05.038
PMCID: PMC3939803  PMID: 23731526
Prediabetes; Diabetes; Heart failure; Older adults; Propensity-matched study
4.  Rate-Control versus Rhythm-Control Strategies and Outcomes in Septuagenarian Patients with Atrial Fibrillation 
The American journal of medicine  2013;126(10):10.1016/j.amjmed.2013.04.021.
Background
The prevalence of atrial fibrillation substantially increases after 70 years of age. However, the effect of rate-control versus rhythm-control strategies on outcomes in these patients remains unclear.
Methods
In the randomized Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM) trial, 4060 patients (mean age, 70, range, 49–80 years) with paroxysmal and persistent atrial fibrillation were randomized to rate-control versus rhythm-control strategies. Of these, 2248 were 70–80 years, of whom 1118 were in the rate-control group. Propensity scores for rate-control strategy were estimated for each of the 2248 patients and were used to assemble a cohort of 937 pairs of patients receiving rate-control versus rhythm-control strategies, balanced on 45 baseline characteristics.
Results
Matched patients had a mean age of 75 years, 45% were women, 7% were non-white, and 47% had prior hospitalizations due to arrhythmias. During 3.4 years of mean follow-up, all-cause mortality occurred in 18% and 23% of matched patients in the rate-control and rhythm-control groups, respectively (hazard ratio {HR} associated with rate-control, 0.77; 95% confidence interval {CI}, 0.63–0.94; p=0.010). HRs (95% CIs) for cardiovascular and non-cardiovascular mortality associated with rate-control were 0.88 (0.65–1.18) and 0.62 (0.46–0.84), respectively. All-cause hospitalization occurred in 61% and 68% of rate-control and rhythm-control patients, respectively (HR, 0.76; 95% CI, 0.68–0.86). HRs (95% CIs) for cardiovascular and non-cardiovascular hospitalization were 0.66 (0.56–0.77) and 1.07 (0.91–1.27).
Conclusion
In septuagenarian patients with atrial fibrillation, compared with rhythm-control, a rate-control strategy was associated with significantly lower mortality and hospitalization.
doi:10.1016/j.amjmed.2013.04.021
PMCID: PMC3818786  PMID: 24054956
atrial fibrillation; rate control; rhythm control; hospitalization; mortality; propensity score; older adults
5.  Design and rationale of studies of neurohormonal blockade and outcomes in diastolic heart failure using OPTIMIZE-HF registry linked to Medicare data 
International journal of cardiology  2011;166(1):230-235.
Background
Heart failure (HF) is the leading cause of hospitalization for Medicare beneficiaries. Nearly half of all HF patients have diastolic HF or HF with preserved ejection fraction (HF-PEF). Because these patients were excluded from major randomized clinical trials of neurohormonal blockade in HF there is little evidence about their role in HF-PEF.
Methods
The aims of the American Recovery & Reinvestment Act-funded National Heart, Lung, and Blood Institute-sponsored “Neurohormonal Blockade and Outcomes in Diastolic Heart Failure” are to study the long-term effects of angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, beta-blockers, and aldosterone antagonists in four separate propensity-matched populations of HF-PEF patients in the OPTIMIZE-HF (Organized Program to Initiate Life-Saving Treatment in Hospitalized Patients with Heart Failure) registry. Of the 48,612 OPTIMIZE-HF hospitalizations occurring during 2003–2004 in 259 U.S. hospitals, 20,839 were due to HF-PEF (EF ≥40%). For mortality and hospitalization we used Medicare national claims data through December 31, 2008.
Results
Using a two-step (hospital-level and hospitalization-level) probabilistic linking approach, we assembled a cohort of 11,997 HF-PEF patients from 238 OPTIMIZE-HF hospitals. These patients had a mean age of 75 years, mean EF of 55%, were 62% women, 15% African American, and were comparable with community-based HF-PEF cohorts in key baseline characteristics.
Conclusions
The assembled Medicare-linked OPTIMIZE-HF cohort of Medicare beneficiaries with HF-PEF with long-term outcomes data will provide unique opportunities to study clinical effectiveness of various neurohormonal antagonists with outcomes in HF-PEF using propensity-matched designs that allow outcome-blinded assembly of balanced cohorts, a key feature of randomized clinical trials.
doi:10.1016/j.ijcard.2011.10.089
PMCID: PMC3465528  PMID: 22119116
Diastolic heart failure; neurohormonal antagonists; OPTIMIZE-HF; Medicare
6.  Angiotensin-Converting Enzyme Inhibitors and Outcomes in Heart Failure and Preserved Ejection Fraction 
The American journal of medicine  2013;126(5):401-410.
BACKGROUND
The role of angiotensin-converting enzyme (ACE) inhibitors in patients with heart failure and preserved ejection fraction remains unclear.
METHODS
Of the 10,570 patients ≥65 years with heart failure and preserved ejection fraction (≥40%) in OPTIMIZE-HF (2003–2004) linked to Medicare (through December, 2008), 7304 were not receiving angiotensin receptor blockers and had no contraindications to ACE inhibitors. After excluding 3115 patients with pre-admission ACE inhibitor use, the remaining 4189 were eligible for new discharge prescriptions for ACE inhibitors, and 1706 received them. Propensity scores for the receipt of ACE inhibitors, calculated for each of the 4189 patients, were used to assemble a cohort of 1337 pairs of patients, balanced on 114 baseline characteristics.
RESULTS
Matched patients had a mean age of 81 years, mean ejection fraction of 55%, 64% were women and 9% African American. Initiation of ACE inhibitor therapy was associated with lower risk of the primary composite endpoint of all-cause mortality or heart failure hospitalization during 2.4 years of median follow-up (hazard ratio {HR}, 0.91; 95% confidence interval {CI}, 0.84–0.99; p=0.028), but not with individual endpoints of all-cause mortality (HR, 0.96; 95% CI, 0.88–1.05; p=0.373) or heart failure hospitalization (HR, 0.93; 95% CI, 0.83–1.05; p=0.257).
CONCLUSION
In hospitalized older patients with heart failure and preserved ejection fraction not receiving angiotensin receptor blockers, discharge initiation of ACE inhibitor therapy was associated with a modest improvement in the composite endpoint of total mortality or heart failure hospitalization, but had no association with individual endpoint components.
doi:10.1016/j.amjmed.2013.01.004
PMCID: PMC3656660  PMID: 23510948
ACE inhibitors; Heart Failure; Preserved Ejection Fraction
7.  Renin-Angiotensin Inhibition in Diastolic Heart Failure and Chronic Kidney Disease 
The American journal of medicine  2013;126(2):150-161.
BACKGROUND
The role of renin-angiotensin inhibition in older patients with diastolic heart failure and chronic kidney disease remains unclear.
METHODS
Of the 1340 patients (age ≥65 years), with diastolic heart failure (ejection fraction ≥45%) and chronic kidney disease (estimated glomerular filtration rate <60 ml/min/1.73 m2), 717 received angiotensin-converting enzyme inhibitors or angiotensin receptor blockers. Propensity scores for the use of these drugs, estimated for each of the 1340 patients, were used to assemble a cohort of 421 pairs of patients, receiving and not receiving these drugs, who were balanced on 56 baseline characteristics.
RESULTS
During more than 8 years of follow-up, all-cause mortality occurred in 63% and 69% of matched patients with chronic kidney disease receiving and not receiving angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, respectively (hazard ratio {HR}, 0.82; 95% confidence interval {CI}, 0.70–0.97; p=0.021). There was no association with heart failure hospitalization (HR, 0.98; 95% CI, 0.82–1.18; p=0.816). Similar mortality reduction (HR, 0.81; 95% CI, 0.66–0.995; p=0.045) occurred in a subgroup of matched patients with an estimated glomerular filtration rate <45 ml/min/1.73 m2. Among 207 pairs of propensity-matched patients without chronic kidney disease, the use of these drugs was not associated with mortality (HR, 1.03; 95% CI, 0.80–1.33; p=0.826) or heart failure hospitalization (HR, 0.99; 95% CI, 0.76–1.30; p=0.946).
CONCLUSIONS
A discharge prescription for angiotensin-converting enzyme inhibitors or angiotensin receptor blockers was associated with a significant reduction in all-cause mortality in older patients with diastolic heart failure and chronic kidney disease including those with more advanced chronic kidney disease.
doi:10.1016/j.amjmed.2012.06.031
PMCID: PMC3575519  PMID: 23331442
Angiotensin-converting enzyme inhibitors; Angiotensin receptor blockers; Chronic kidney disease; Diastolic heart failure
8.  Aldosterone Antagonists and Outcomes in Real-World Older Patients with Heart Failure and Preserved Ejection Fraction 
JACC. Heart failure  2013;1(1):40-47.
Objectives
The purpose of this study was to examine the clinical effectiveness of aldosterone antagonists in older patients with heart failure and preserved ejection fraction (HF-PEF).
Background
Aldosterone antagonists improve outcomes in HF and reduced EF. However, their role in HF-PEF remains unclear.
Methods
Of the 10,570 hospitalized older (age ≥65 years) HF-PEF (EF ≥40%) patients in Medicare-linked OPTIMIZE-HF (Organized Program to Initiate Lifesaving Treatment in Hospitalized Patients with Heart Failure) trial, 8013 had no prior aldosterone antagonist use and no current contraindications, of whom 492 (6% of 8013) received new prescriptions for aldosterone antagonists. We assembled a matched cohort of 487 pairs of patients receiving and not receiving aldosterone antagonists, who had similar propensity to receive these drugs, and were balanced on 116 baseline characteristics.
Results
Patients had a mean age of 80 years, a mean EF of 54%, 59% were women, and 8% were African American. During 2.4 year of mean follow-up (through December, 2008), the primary composite endpoint of all-cause mortality or HF hospitalization occurred in 392 (81%) and 393 (81%) patients receiving and not receiving aldosterone antagonists, respectively (hazard ratio {HR}, 0.97; 95% confidence interval {CI}, 0.84–1.11; p=0.628). Aldosterone antagonists had no association with all-cause mortality (HR, 1.03; 95% CI, 0.89–1.20; p=0.693) or HF hospitalization (HR, 0.88; 95% CI, 0.73–1.07; p=0.188). Among 8013 pre-match patients, multivariable-adjusted HR for primary composite endpoint associated with aldosterone antagonist use was 0.93 (95% CI, 0.83–1.03; p=0.144).
Conclusions
In older HF-PEF patients, aldosterone antagonists had no association with clinical outcomes. Findings from the ongoing randomized controlled TOPCAT (Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist) trial will provide further insights into their effect in HF-PEF.
doi:10.1016/j.jchf.2012.08.001
PMCID: PMC3694622  PMID: 23814702
Aldosterone antagonists; Heart failure; Preserved ejection fraction
9.  Patient characteristics associated with venous thromboembolic events: a cohort study using pooled electronic health record data 
Objective
To demonstrate the potential of de-identified clinical data from multiple healthcare systems using different electronic health records (EHR) to be efficiently used for very large retrospective cohort studies.
Materials and methods
Data of 959 030 patients, pooled from multiple different healthcare systems with distinct EHR, were obtained. Data were standardized and normalized using common ontologies, searchable through a HIPAA-compliant, patient de-identified web application (Explore; Explorys Inc). Patients were 26 years or older seen in multiple healthcare systems from 1999 to 2011 with data from EHR.
Results
Comparing obese, tall subjects with normal body mass index, short subjects, the venous thromboembolic events (VTE) OR was 1.83 (95% CI 1.76 to 1.91) for women and 1.21 (1.10 to 1.32) for men. Weight had more effect then height on VTE. Compared with Caucasian, Hispanic/Latino subjects had a much lower risk of VTE (female OR 0.47, 0.41 to 0.55; male OR 0.24, 0.20 to 0.28) and African-Americans a substantially higher risk (female OR 1.83, 1.76 to 1.91; male OR 1.58, 1.50 to 1.66). This 13-year retrospective study of almost one million patients was performed over approximately 125 h in 11 weeks, part time by the five authors.
Discussion
As research informatics tools develop and more clinical data become available in EHR, it is important to study and understand unique opportunities for clinical research informatics to transform the scale and resources needed to perform certain types of clinical research.
Conclusions
With the right clinical research informatics tools and EHR data, some types of very large cohort studies can be completed with minimal resources.
doi:10.1136/amiajnl-2011-000782
PMCID: PMC3534456  PMID: 22759621
Clinical informatics; demonstrating return on IT investment; developing/using clinical decision support (other than diagnostic) and guideline systems; developing/using computerized provider order entry; enhancing the conduct of biological/clinical research and trials; methods for integration of information from disparate sources; monitoring the health of populations; personal health records and self-care systems
10.  Angiotensin receptor blockers and outcomes in real-world older patients with heart failure and preserved ejection fraction: a propensity-matched inception cohort clinical effectiveness study 
European Journal of Heart Failure  2012;14(10):1179-1188.
Aims
To examine the clinical effectiveness of angiotensin receptor blockers (ARBs) in older patients with heart failure and preserved ejection fraction (HF-PEF).
Methods and results
Of the 10 570 hospitalized HF-PEF patients, aged ≥65 years, EF ≥40%, in OPTIMIZE-HF (2003–2004), linked to Medicare data (up to 31 December 2008), 3806 were not receiving angiotensin-converting enzyme inhibitors or prior ARB therapy. Of these, 303 (8%) patients received new discharge prescriptions for ARBs. Propensity scores for the receipt of ARBs, estimated for each of the 3806 patients, were used to assemble a cohort of 296 pairs of patients receiving and not receiving ARBs, who were balanced on 114 baseline characteristics. Patients had a mean age of 80 years, mean EF of 55%, 69% were women, and 12% were African American. During 6 years of follow-up, the primary composite endpoint of all-cause mortality or HF hospitalization occurred in 79% (235/296) and 81% (241/296) of patients receiving and not receiving ARBs, respectively [hazard ratio (HR) associated with ARB use 0.88, 95% confidence interval (CI) 0.74–1.06; P = 0.179]. ARB use had no association with individual endpoints of all-cause mortality (HR 0.93, 95% CI 0.76–1.14; P = 0.509), HF hospitalization (HR 0.90, 95% CI, 0.72–1.14; P = 0.389), or all-cause hospitalization (HR 0.91, 95% CI 0.77–1.08; P = 0.265). These associations remained unchanged when we compared any (prevalent and new prescriptions) ARB use vs. non-use in a separately assembled propensity-matched cohort of 1137 pairs of HF-PEF patients.
Conclusions
In real-world older HF-PEF patients, ARB use was not associated with improved clinical outcomes.
doi:10.1093/eurjhf/hfs101
PMCID: PMC3448391  PMID: 22759445
Angiotensin receptor blockers; Heart failure; Preserved ejection fraction
11.  History of Hypertension and the Effects of Eplerenone in Patients with Acute Myocardial Infarction Complicated by Systolic Heart Failure 
Hypertension  2008;52(2):271-278.
In the Eplerenone Post-Acute Myocardial Infarction Heart Failure Efficacy and Survival Study (n=6632), eplerenone-associated reduction in all-cause mortality was significantly greater in those with a history of hypertension (Hx-HTN). There were 4007 patients with Hx-HTN (eplerenone: n=1983) and 2625 patients without Hx-HTN (eplerenone: n=1336). Propensity scores for eplerenone use, separately calculated for patients with and without Hx-HTN, were used to assemble matched cohorts of 1838 and 1176 pairs of patients. In patients with Hx-HTN, all-cause mortality occurred in 18% of patients treated with placebo (rate, 1430/10 000 person-years) and 14% of patients treated with eplerenone (rate, 1058/10 000 person-years) during 2350 and 2457 years of follow-up, respectively (hazard ratio [HR]: 0.71; 95% CI: 0.59 to 0.85; P<0.0001). Composite end point of cardiovascular hospitalization or cardiovascular mortality occurred in 33% of placebo-treated patients (3029/10 000 person-years) and 28% of eplerenone-treated patients (2438/10 000 person-years) with Hx-HTN (HR: 0.82; 95% CI: 0.72 to 0.94; P=0.003). In patients without Hx-HTN, eplerenone reduced heart failure hospitalization (HR: 0.73; 95% CI: 0.55 to 0.97; P=0.028) but had no effect on mortality (HR: 0.91; 95% CI: 0.72 to 1.15; P=0.435) or on the composite end point (HR: 0.91; 95% CI: 0.76 to 1.10; P=0.331). Eplerenone should, therefore, be prescribed to all of the post–acute myocardial infarction patients with reduced left ventricular ejection fraction and heart failure regardless of Hx-HTN.
doi:10.1161/HYPERTENSIONAHA.107.109314
PMCID: PMC3782417  PMID: 18559720
Eplerenone; hypertension; myocardial infarction; heart failure; morbidity; mortality
12.  Measuring Disparities: Bias in the SF-36v2 among Spanish-speaking Medical Patients 
Medical care  2011;49(5):480-488.
Background
Many national surveys have found substantial differences in self-reported overall health (SROH) between Spanish-speaking Hispanics and other racial/ethnic groups. However, because cultural and language differences may create measurement bias, it is unclear whether observed differences in SROH reflect true differences in health.
Objectives
This study uses a cross-sectional survey to investigate psychometric properties of the SF-36v2 for subjects across four racial/ethnic and language groups. Multi-group latent variable modeling was used to test increasingly stringent criteria for measurement equivalence.
Subjects
Our sample (N = 1281) included 383 non-Hispanic whites, 368 non-Hispanic blacks, 206 Hispanics interviewed in English and 324 Hispanics interviewed in Spanish recruited from outpatient medical clinics in two large urban areas.
Results
We found weak factorial invariance across the four groups. However, there was no strong factorial invariance. The overall fit of the model was substantially worse (change in CFI > .02, RMSEA change > .003) after requiring equal intercepts across all groups. Further comparisons established that the equality constraints on the intercepts for Spanish-speaking Hispanics were responsible for the decrement to model fit.
Conclusions
Observed differences between SF-36v2 scores for Spanish speaking Hispanics are systematically biased relative to the other three groups. The lack of strong invariance suggests the need for caution when comparing SF-36v2 mean scores of Spanish-speaking Hispanics with those of other groups. However, measurement equivalence testing for this study supports correlational or multivariate latent variable analyses of SF-36v2 responses across all four subgroups, since these analyses require only weak factorial invariance.
doi:10.1097/MLR.0b013e31820fb944
PMCID: PMC3078179  PMID: 21430580
disparities; measurement self-reported health; race/ethnicity; SF-36v2
13.  Association between smoking and outcomes in older adults with atrial fibrillation 
Tobacco smoking is a risk factor for atrial fibrillation (AF), but little is known about the impact of smoking in patients with AF. Of the 4060 patients with recurrent AF in the Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM) trial, 496 (12%) reported having smoked during the past two years. Propensity scores for smoking were estimated for each of the 4060 patients using a multivariable logistic regression model and were used to assemble a matched cohort of 487 pairs of smokers and nonsmokers, who were balanced on 46 baseline characteristics. Cox and logistic regression models were used to estimate the associations of smoking with all-cause mortality and all-cause hospitalization, respectively, during over 5 years of follow-up. Matched participants had a mean age of 70 ± 9 years (± S.D.), 39% were women, and 11% were non-white. All-cause mortality occurred in 21% and 16% of matched smokers and nonsmokers, respectively (when smokers were compared with nonsmokers, hazard ratio = HR = 1.35; 95% confidence interval = 95% CI = 1.01–1.81; p = 0.046). Unadjusted, multivariable-adjusted and propensity-adjusted HR (95% CI) for all-cause mortality associated with smoking in the pre-match cohort were: 1.40 (1.13–1.72; p = 0.002), 1.45 (1.16–1.81; p = 0.001), and 1.39 (1.12–1.74; p = 0.003), respectively. Smoking had no association with all-cause hospitalization (when smokers were compared with nonsmokers, odds ratio = OR = 1.21; 95% CI = 0.94–1.57, p = 0.146). Among patients with AF, a recent history of smoking was associated with an increased risk of all-cause mortality, but had no association with all-cause hospitalization.
doi:10.1016/j.archger.2011.05.027
PMCID: PMC3358565  PMID: 21733581
Atrial fibrillation; Smoking; Mortality; Propensity score
14.  Impairment of activities of daily living and incident heart failure in community-dwelling older adults 
European Journal of Heart Failure  2012;14(6):581-587.
Aims
Instrumental activities of daily living (IADLs) are tasks that are necessary for independent community living. These tasks often require intact physical and cognitive function, the impairment of which may adversely affect health in older adults. In the current study, we examined the association between IADL impairment and incident heart failure (HF) in community-dwelling older adults.
Methods and results
Of the 5795 community-dwelling adults, aged ≥65 years, in the Cardiovascular Health Study, 5511 had data on baseline IADL and were free of prevalent HF. Of these, 1333 (24%) had baseline IADL impairment, defined as self-reported difficulty with one or more of the following tasks: using the telephone, preparing food, performing light and heavy housework, managing finances, and shopping. Propensity scores for IADL impairment, estimated for each of the 5511 participants, were used to assemble a cohort of 1038 pairs of participants with and without IADL impairment who were balanced on 42 baseline characteristics. Centrally adjudicated incident HF occurred in 26% and 21% of matched participants with and without IADL impairment, respectively, during >12 years of follow-up [matched hazard ratio (HR) 1.33; 95% confidence interval (CI) 1.11–1.59; P = 0.002]. Unadjusted and multivariable-adjusted HRs for incident HF before matching were 1.77 (95% CI 1.56–2.01; P < 0.001) and 1.33 (95% CI 1.15–1.54; P < 0.001), respectively. IADL impairment was also associated with all-cause mortality (matched HR 1.19; 95% CI 1.06–1.34; P = 0.004).
Conclusion
Among community-dwelling older adults free of baseline HF, IADL impairment is a strong and independent predictor of incident HF and mortality.
doi:10.1093/eurjhf/hfs034
PMCID: PMC3359859  PMID: 22492539
Instrumental activities of daily living; Incident heart failure; Propensity score
15.  Rheumatic heart disease and risk of incident heart failure among community-dwelling older adults: a prospective cohort study 
Annals of Medicine  2011;44(3):253-261.
Background
Little is known about the association of rheumatic heart disease (RHD) with incident heart failure (HF) among older adults.
Design
Cardiovascular Health Study, a prospective cohort study.
Methods
Of the 4751 community-dwelling adults ≥65 years, free of prevalent HF at baseline, 140 had RHD, defined as self-reported physician-diagnosed RHD along with echocardiographic evidence of left-sided valvular disease. Propensity scores for RHD, estimated for each of the 4751 participants, were used to assemble a cohort of 720, in which 124 and 596 participants with and without RHD respectively were balanced on 62 baseline characteristics.
Results
Incident HF developed in 33% and 22% of matched participants with and without RHD respectively during 13 years of follow-up (hazard ratio when RHD was compared to no-RHD, 1.60; 95% confidence interval, 1.13–2.28; P=0.008). Pre-match unadjusted, multivariable-adjusted and propensity-adjusted hazard ratios (95% confidence intervals) for RHD-associated incident heart failure were 2.04 (1.54–2.71; P<0.001), 1.32 (1.02–1.70; P=0.034) and 1.55 (1.14–2.11; P=0.005) respectively. RHD was not associated with all-cause mortality (HR, 1.09; 95% CI, 0.82–1.45; P=0.568).
Conclusion
RHD is an independent risk factor for incident HF among community-dwelling older adults free of HF, but has no association with mortality.
doi:10.3109/07853890.2010.530685
PMCID: PMC3116996  PMID: 21254894
Heart failure; rheumatic heart disease; older adults
16.  Incident Coronary Revascularization and Subsequent Mortality in Chronic Heart Failure: A Propensity-Matched Study 
Introduction
Ischemic heart disease (IHD) is common in heart failure (HF), yet the association between incident coronary revascularization and mortality in these patients has not been examined in a propensity-matched study.
Methods
In the Digitalis Investigation Group trial, 2853 patients without coronary revascularization and 120 patients with coronary revascularization during the first three years were alive at the end of three years. We used propensity scores to match 119 and 357 patients with and without coronary revascularization. Matched Cox regression models were used to estimate hazard ratio (HR) and 95% confidence interval (CI) for mortality during the fourth year of follow-up, for all patients and by the mean left ventricular ejection fraction (LVEF) of 35%.
Results
Coronary revascularization was associated with higher mean LVEF (36 % versus 32 %; p<0.0001) and prevalence of angina pectoris (48% versus 32%; p<0.0001) but fewer prior myocardial infarction (80% versus 87%; p=0.023), all of which were balanced post-match. All-cause mortality occurred in 5.9% and 6.2% patients respectively with and without coronary revascularization (HR for coronary revascularization, 0.95; 95% CI, 0.39–2.32; p=0.910). HR for mortality associated with coronary revascularization for patients with LVEF ≤35% and >35% were respectively 1.34 (95% CI, 0.48–3.71; p=0.578) and 0.61 (95% CI, 0.13–2.87; p=0.532).
Conclusion
Chronic HF patients with IHD receiving coronary revascularization were more likely to have angina and higher LVEF. However, in a balanced propensity-matched cohort, there was no association between coronary revascularization and mortality. The LVEF-associated variation in mortality needs to be prospectively studied.
doi:10.1016/j.ijcard.2008.10.049
PMCID: PMC2904513  PMID: 19081647
heart failure; revascularization; mortality; outcomes
17.  Renin-angiotensin inhibition in systolic heart failure and chronic kidney disease 
The American Journal of Medicine  2012;125(4):399-410.
Background
The role of renin-angiotensin inhibition in older systolic heart failure patients with chronic kidney disease remains unclear.
Methods
Of the 1665 patients, age ≥65 years, with systolic heart failure (ejection fraction <45%) and chronic kidney disease (estimated glomerular filtration rate <60 ml/min/1.73 m2), 1046 received angiotensin-converting enzyme inhibitors or angiotensin receptor blockers. Propensity scores for the receipts of these drugs, estimated for each of the 1665 patients, were used to assemble a matched cohort of 444 pairs of patients receiving and not receiving these drugs who were balanced on 56 baseline characteristics.
Results
During over 8 years of follow-up, all-cause mortality occurred in 75% and 79% of matched patients with chronic kidney disease receiving and not receiving angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, respectively (hazard ratio {HR}, 0.86; 95% confidence interval {CI}, 0.74–0.996; p=0.045). There was no significant association with heart failure hospitalization (HR, 0.86; 95% CI, 0.72–1.03; p=0.094). Similar mortality reduction (HR, 0.83; 95% CI, 0.70–1.00; p=0.046) occurred in a subgroup of matched patients with estimated glomerular filtration rate <45 ml/min/1.73 m2. Among 171 pairs of propensity-matched patients without chronic kidney disease, the use of these drugs was associated with significant reduction in all-cause mortality (HR, 0.72; 95% CI, 0.55–0.94; p=0.015) and heart failure hospitalization (HR, 0.71; 95% CI, 0.52–0.95; p=0.023).
Conclusions
Discharge prescription of angiotensin-converting enzyme inhibitors or angiotensin receptor blockers was associated with a significant modest reduction in all-cause mortality in older systolic heart failure patients with chronic kidney disease including those with more advanced chronic kidney disease.
doi:10.1016/j.amjmed.2011.10.013
PMCID: PMC3324926  PMID: 22321760
systolic heart failure; chronic kidney disease; angiotensin-converting enzyme inhibitors; angiotensin receptor blockers
18.  A propensity‐matched study of the effect of diabetes on the natural history of heart failure: variations by sex and age 
Heart  2007;93(12):1584-1590.
Background
Poor prognosis in heart failure (HF) patients with diabetes is often attributed to increased co‐morbidity and advanced disease. Further, this effect may be worse in women.
Objective
To determine whether the effect of diabetes on outcomes and the sex‐related variation persisted in a propensity score‐matched HF population, and whether the sex‐related variation was a function of age.
Methods
Of the 7788 HF patients in the Digitalis Investigation Group trial, 2218 had a history of diabetes. Propensity score for diabetes was calculated for each patient using a non‐parsimonious logistic regression model incorporating all measured baseline covariates, and was used to match 2056 (93%) diabetic patients with 2056 non‐diabetic patients.
Results
All‐cause mortality occurred in 135 (25%) and 216 (39%) women without and with diabetes (adjusted HR = 1.67; 95% CI = 1.34 to 2.08; p<0.001). Among men, 535 (36%) and 609 (41%) patients without and with diabetes died from all causes (adjusted HR = 1.21; 95% CI = 1.07 to 1.36; p = 0.002). Sex–diabetes interaction (overall adjusted p<0.001) was only significant in patients ⩾65 years (15% absolute risk increase in women; multivariable p for interaction = 0.005), but not in younger patients (2% increase in women; p for interaction = 0.173). Risk‐adjusted HR (95% CI) for all‐cause hospitalisation for women and men were 1.49 (1.28 to 1.72) and 1.21 (1.11 to 1.32), respectively, also with significant sex–diabetes interaction (p = 0.011).
Conclusions
Diabetes‐associated increases in morbidity and mortality in chronic HF were more pronounced in women, and theses sex‐related differences in outcomes were primarily observed in elderly patients.
doi:10.1136/hrt.2006.113522
PMCID: PMC2095739  PMID: 17488764
19.  Effect of Warfarin on Outcomes in Septuagenarian Patients with Atrial Fibrillation 
The American Journal of Cardiology  2011;109(3):370-377.
Anticoagulation has been shown to reduce ischemic stroke in atrial fibrillation (AF). However, concerns remain regarding their safety and efficacy in those ≥70 years of age who comprise most AF patients. Of the 4060 patients (mean age, 65 years; range, 49–80 years) in the Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM) trial, 2248 (55% of 4060) were 70–80 years of age, 1901 of whom were receiving warfarin. Propensity score for warfarin use, estimated for each of the 2248 patients, were used to match 227 of the 347 no-warfarin patients (in 1:1, 1:2 or 1:3 sets) with 616 warfarin patients, who were balanced on 45 baseline characteristics. All-cause mortality occurred in 18% and 33% of matched patients receiving and not receiving warfarin, respectively, during up to six (mean, 3.4) years of follow-up (hazard ratio {HR} when warfarin use was compared with its non-use, 0.58; 95% confidence interval {CI}, 0.43–0.77; p<0.001). All-cause hospitalization occurred in 64% and 67% of matched patients receiving and not receiving warfarin, respectively (HR associated with warfarin use, 0.93; 95% CI, 0.77–1.12; p=0.423). Ischemic stroke occurred in 4% and 8% of matched patients receiving and not receiving warfarin, respectively (HR associated with warfarin use, 0.57; 95% CI, 0.31–1.04; p=0.068). Major bleeding occurred in 7% and 10% of matched patients receiving and not receiving warfarin, respectively (HR associated with warfarin use, 0.73; 95% CI, 0.44–1.22; p=0.229). In conclusion, warfarin use was associated with reduced mortality in septuagenarian AF patients but had no association with hospitalization or major bleeding.
doi:10.1016/j.amjcard.2011.09.023
PMCID: PMC3390022  PMID: 22118824
atrial fibrillation; warfarin; mortality; propensity score; older adults
20.  Outcomes in younger and older adults with chronic advanced systolic heart failure: a propensity-matched study 
International Journal of Cardiology  2010;154(2):128-133.
Background
Older age is an independent predictor of all-cause mortality in patients with mild to moderate heart failure (HF). Whether older age is also an independent predictor of mortality in patients with more advanced HF is unknown.
Methods
Of the 2707 Beta-Blocker Evaluation of Survival Trial (BEST) participants with ambulatory chronic HF (New York Heart Association class III/IV and left ventricular ejection fraction <35%), 1091 were elderly (≥65 years). Propensity scores for older age, estimated for each of the 2707 patients, were used to assemble a cohort of 603 pairs of younger and older patients, balanced on 66 baseline characteristics.
Results
All-cause mortality occurred in 33% and 36% of younger and older matched patients respectively during 4 years of follow-up (hazard ratio {HR} associated with age ≥65 years, 1.05; 95% confidence interval {CI}, 0.87—1.27; P=0.614). HF hospitalization occurred in 38% and 40% of younger and older matched patients respectively (HR, 1.01; 95% CI, 0.84–1.21; P=0.951). Among 603 pairs of unmatched and unbalanced patients, all-cause mortality occurred in 28% and 36% of younger and older patients respectively (HR, 1.34; 95% CI, 1.10–1.64; P=0.004) and HF hospitalization occurred in 34% and 40% of younger and older unmatched patients respectively (HR, 1.24; 95% CI, 1.03–1.50; P=0.024).
Conclusion
Significant bivariate associations suggest that older age is a useful marker of poor outcomes in patients with advanced chronic systolic HF. However, lack of significant independent associations suggests that older age per se has no intrinsic effect on outcomes in these patients.
doi:10.1016/j.ijcard.2010.09.006
PMCID: PMC3116091  PMID: 20947188
Age; heart failure; mortality; hospitalization
21.  A Propensity-Matched Study of the Association of Diabetes Mellitus with Incident Heart Failure and Mortality among Community-Dwelling Older Adults 
The American Journal of Cardiology  2011;108(12):1747-1753.
Diabetes mellitus (DM) is a risk factor for incident heart failure (HF) in older adults. However, to what extent this association is independent of other risk factors remains unclear. Of the 5464 community-dwelling adults ≥65 years in the Cardiovascular Health Study without baseline HF, 862 had DM (fasting plasma glucose levels ≥126 mg/dl, or treatment with insulin or oral hypoglycemic agents). Propensity scores for DM were estimated for each of the 5464 participants and were used to assemble a cohort of 717 pairs of participants with and without DM, who were balanced on 65 baseline characteristics. Incident HF occurred in 31% and 26% of matched participants with and without DM, respectively, during over 13 years of follow-up (hazard ratio {HR} when DM was compared with no DM, 1.45; 95% confidence interval {CI}, 1.14–1.86; p=0.003). Among the 5464 pre-match participants, unadjusted and multivariable-adjusted HRs for incident HF associated with DM were 2.22 (95% CI, 1.94–2.55; p<0.001) and 1.52 (95% CI, 1.30–1.78; p<0.001), respectively. All-cause mortality occurred in 57% and 47% of matched participants with and without DM respectively (HR, 1.35; 95% CI, 1.13–1.61; p=0.001). Among matched participants, DM-associated HRs for incident peripheral arterial disease, incident acute myocardial infarction and incident stroke were 2.50 (95% CI, 1.45–4.32; p=0.001), 1.37 (95% CI, 0.97–1.93; p=0.072), and 1.11 (95% CI, 0.81–1.51; p=0.527), respectively. In conclusion, the association of DM with incident HF and all-cause mortality in community-dwelling older adults without HF is independent of major baseline cardiovascular risk factors.
doi:10.1016/j.amjcard.2011.07.046
PMCID: PMC3324944  PMID: 21943936
heart failure; diabetes mellitus; mortality; older adults; propensity-matched
22.  Intrinsic Association of Widowhood With Mortality in Community-Dwelling Older Women and Men: Findings From a Prospective Propensity-Matched Population Study 
Objectives.
Widowhood is associated with increased mortality. However, to what extent this association is independent of other risk factors remains unclear. In the current study, we used propensity score matching to design a study to examine the independent association of widowhood with outcomes in a balanced cohort of older adults in the United States.
Methods.
We used public-use copies of the Cardiovascular Health Study data obtained from the National Heart, Lung, and Blood Institute. Of the 5,795 community-dwelling older men and women aged 65 years and older in Cardiovascular Health Study, 3,820 were married and 1,436 were widows or widowers. Propensity scores for widowhood, estimated for each of the 5,256 participants, were used to assemble a cohort of 819 pairs of widowed and married participants who were balanced on 74 baseline characteristics. The 1,638 matched participants had a mean (± standard deviation) age of 75 (±6) years, 78% were women, and 16% African American.
Results.
All-cause mortality occurred in 46% (374/819) and 51% (415/819) of matched married and widowed participants, respectively, during more than 11 years of median follow-up (hazard ratio associated with widowhood, 1.18; 95% confidence interval, 1.03–1.36; p = .018). Hazard ratios (95% confidence intervals) for cardiovascular and noncardiovascular mortalities were 1.07 (0.87–1.32; p = .517) and 1.28 (1.06–1.55; p = .011), respectively. Widowhood had no independent association with all-cause or heart failure hospitalization or incident cardiovascular events.
Conclusions.
Among community-dwelling older adults, widowhood was associated with increased mortality, which was independent of confounding by baseline characteristics and largely driven by an increased noncardiovascular mortality. Widowhood had no independent association with hospitalizations or incident cardiovascular events.
doi:10.1093/gerona/glr144
PMCID: PMC3252210  PMID: 21903611
Widowhood; Spousal loss; Mortality; Hospitalization; Older adults
23.  A Propensity-Matched Study of the Comparative Effectiveness of Angiotensin Receptor Blockers versus Angiotensin-Converting Enzyme Inhibitors in Heart Failure Patients Age ≥65 Years 
The American Journal of Cardiology  2011;108(10):1443-1448.
The comparative effectiveness of angiotensin-converting enzyme inhibitors (ACEIs) versus angiotensin receptor blockers (ARBs) in real-world older heart failure (HF) patients remains unclear. Of the 8049 hospitalized HF patients ≥65 years discharged alive from 106 Alabama hospitals, 4044 received discharge prescriptions of either ACEIs (n=3383) or ARBs (n=661). Propensity scores for ARB use, calculated for each of 4044 patients, were used to match 655 (99% of 661) patients receiving ARBs with 661 patients receiving ACEIs. The assembled cohort of 655 pairs of patients was well-balanced on 56 baseline characteristics. During over 8 years of follow-up, all-cause mortality occurred in 63% and 68% of matched patients receiving ARBs and ACEIs respectively (hazard ratio {HR} associated with ARB use, 0.86; 95% confidence interval {CI}, 0.75–0.99; p=0.031). Among the 956 matched patients with data on left ventricular ejection fraction (LVEF), the association between ARB (versus ACEI) use was significant only in 419 patients with LVEF≥45% (HR, 0.65; 95% CI, 0.51–0.84; p=0.001) but not in the 537 patients with LVEF <45% (HR, 1.00; 95% CI, 0.81–1.23; p=0.999; p for interaction= 0.012). HRs (95% CIs) for HF hospitalization associated with ARBs use were 0.99 (0.86–1.14; p=0.876) overall, 0.80 (0.63–1.03; p=0.080) among those with LVEF≥45% and 1.14 (0.91–1.43; p=0.246) among those with LVEF <45% (p for interaction, 0.060). In conclusion, in older HF patients with preserved LVEF, a discharge prescription of ARBs (versus ACEI) was associated with lower mortality and a trend toward lower HF hospitalization, findings which need replication in other HF populations.
doi:10.1016/j.amjcard.2011.06.066
PMCID: PMC3324349  PMID: 21890091
Heart failure; Older; Mortality; ACEI; ARB
24.  Isolated diastolic hypotension and incident heart failure in older adults 
Hypertension  2011;58(5):895-901.
Aging is often associated with increased systolic blood pressure and decreased diastolic blood pressure. Isolated systolic hypertension or an elevated systolic blood pressure without an elevated diastolic blood pressure is a known risk factor for incident heart failure in older adults. In the current study, we examined whether isolated diastolic hypotension, defined as a diastolic blood pressure <60 mm Hg and a systolic blood pressure ≥100 mm Hg, is associated with incident heart failure. Of the 5795 Medicare-eligible community-dwelling adults age ≥65 years in the Cardiovascular Health Study, 5521 were free of prevalent heart failure at baseline. After excluding 145 individuals with baseline systolic blood pressure <100 mm Hg, the final sample included 5376 participants, of whom 751 (14%) had isolated diastolic hypotension. Propensity scores for isolated diastolic hypotension were calculated for each of the 5376 participants and used to match 545 and 2348 participants with and without isolated diastolic hypotension, respectively who were balanced on 58 baseline characteristics. During over 12 years of median follow-up, centrally-adjudicated incident heart failure developed in 25% and 20% of matched participants with and without isolated diastolic hypotension respectively (hazard ratio associated with isolated diastolic hypotension, 1.33; 95% confidence interval, 1.10–1.61; p=0.004). Among the 5376 pre-match individuals, multivariable-adjusted hazard ratio for incident heart failure associated with isolated diastolic hypotension was 1.29 (95% confidence interval, 1.09–1.53; p=0.003). As in isolated systolic hypertension, among community-dwelling older adults without prevalent heart failure, isolated diastolic hypotension is also a significant independent risk factor for incident heart failure.
doi:10.1161/HYPERTENSIONAHA.111.178178
PMCID: PMC3390027  PMID: 21947466
aging; blood pressure; diastolic; heart failure; pulse pressure
25.  Hypoalbuminaemia and incident heart failure in older adults 
European Journal of Heart Failure  2011;13(10):1078-1086.
Aims
To test the hypothesis that baseline hypoalbuminaemia is associated with incident heart failure (HF) in community-dwelling older adults.
Methods and results
Of the 5795 community-dwelling adults aged ≥65 years in the Cardiovascular Health Study, 5450 were free of centrally adjudicated prevalent HF at baseline, and also had data on baseline serum albumin. Of these, 599 (11%) had hypoalbuminaemia, defined as baseline serum albumin levels ≤3.5 mg/dL. Propensity scores for hypoalbuminaemia were calculated for each patient and used to assemble a matched cohort of 582 pairs of participants with and without hypoalbuminaemia, who were well balanced on 58 baseline characteristics. Using Cox regression models, we estimated the association of hypoalbuminaemia with centrally adjudicated incident HF during 9.6 years of median follow-up. Matched participants had a mean (±SD) age of 74 (±6) years, 62% were women, and 16% were African Americans. Incident HF occurred in 25 and 20% of matched participants with and without hypoalbuminaemia, respectively [hazard ratio when hypoalbuminaemia was compared with normoalbuminaemia, 1.40; 95% confidence interval, 1.05–1.85; P = 0.020]. Pre-match unadjusted, multivariable-adjusted, and propensity-adjusted hazard ratios (95% confidence intervals) for incident HF associated with hypoalbuminaemia were 1.33 (1.12–1.58; P = 0.001), 1.33 (1.11–1.60; P = 0.002), and 1.25 (1.04–1.50; P= 0.016), respectively. The combined endpoint of incident HF or all-cause mortality occurred in 59 and 50% of matched participants with and without hypoalbuminaemia, respectively (hazard ratio, 1.33; 95% confidence interval, 1.11–1.61; P= 0.002).
Conclusions
Among community-dwelling older adults without HF, baseline hypoalbuminaemia was associated with increased risk of incident HF during 10 years of follow-up.
doi:10.1093/eurjhf/hfr088
PMCID: PMC3177540  PMID: 21807662
Heart failure; Hypoalbuminaemia; Mortality; Propensity score

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