Outcome of Heart Failure with Preserved Ejection Fraction in a Population-Based Study
R. Sacha Bhatia, M.D., M.B.A., Jack V. Tu, M.D., Ph.D., Douglas S. Lee, M.D., Ph.D., Peter C. Austin, Ph.D., Jiming Fang, Ph.D., Annick Haouzi, M.D., Yanyan Gong, M.Sc., and Peter P. Liu, M.D.
Background The importance of heart failure with preserved ejectionfraction is increasingly recognized. We conducted a study toevaluate the epidemiologic features and outcomes of patientswith heart failure with preserved ejection fraction and to comparethe findings with those from patients who had heart failurewith reduced ejection fraction.
Methods From April 1, 1999, through March 31, 2001, we studied2802 patients admitted to 103 hospitals in the province of Ontario,Canada, with a discharge diagnosis of heart failure whose ejectionfraction had also been assessed. The patients were categorizedin three groups: those with an ejection fraction of less than40 percent (heart failure with reduced ejection fraction), thosewith an ejection fraction of 40 to 50 percent (heart failurewith borderline ejection fraction), and those with an ejectionfraction of more than 50 percent (heart failure with preservedejection fraction). Two groups were studied in detail: thosewith an ejection fraction of less than 40 percent and thosewith an ejection fraction of more than 50 percent. The mainoutcome measures were death within one year and readmissionto the hospital for heart failure.
Results Thirty-one percent of the patients had an ejection fractionof more than 50 percent. Patients with heart failure with preservedejection fraction were more likely to be older and female andto have a history of hypertension and atrial fibrillation. Thepresenting history and clinical examination findings were similarfor the two groups. The unadjusted mortality rates for patientswith an ejection fraction of more than 50 percent were not significantlydifferent from those for patients with an ejection fractionof less than 40 percent at 30 days (5 percent vs. 7 percent,P=0.08) and at 1 year (22 percent vs. 26 percent, P=0.07); theadjusted one-year mortality rates were also not significantlydifferent in the two groups (hazard ratio, 1.13; 95 percentconfidence interval, 0.94 to 1.36; P=0.18). The rates of readmissionfor heart failure and of in-hospital complications did not differbetween the two groups.
Conclusions Among patients presenting with new-onset heart failure,a substantial proportion had an ejection fraction of more than50 percent. The survival of patients with heart failure withpreserved ejection fraction was similar to that of patientswith reduced ejection fraction.
Heart failure has classically been considered to be a clinicalsyndrome associated with cardiac dilatation and impaired cardiaccontractility.1 However, studies have found that increasingnumbers of patients presenting with clinical heart failure havean ejection fraction of more than 50 percent.1,2,3 This entity,which has been termed "heart failure with preserved ejectionfraction," is attributed to abnormalities of diastolic function,although the exact mechanism is debated.4,5
Prior data suggest that patients who have heart failure withpreserved ejection fraction tend to be older, to be female,and to have a history of hypertension.1,3,6,7 The prognosisfor such patients has been reported to be better than that forpatients who have heart failure with reduced ejection fraction.3,6,8,9,10However, most available data are based on ambulatory populations,with less information on patients admitted to the hospital withheart failure.3,6,8,9,10,11,12 The results of these studieshave been inconsistent or conflicting, and the estimates ofrates of mortality and rehospitalization vary widely, sincethey are derived from heterogeneous populations with differentinclusion criteria.2,6,13,14
We conducted a large, population-based cohort study to evaluatethe epidemiologic features and outcomes of patients with heartfailure with preserved ejection fraction and to compare thefindings with those from patients who had heart failure withreduced ejection fraction.
Methods
Patients
Between April 1, 1999, and March 31, 2001, we identified allnewly admitted patients with a primary discharge diagnosis ofheart failure from 103 hospitals in Ontario, Canada, as partof the Enhanced Feedback for Effective Cardiac Treatment (EFFECT)study. The criteria for the selection of the sample populationhave been described previously.15 The hospitals included teachinghospitals and community-based institutions from both rural andurban settings. All had admitted more than 30 patients withheart failure during the two years of sampling.
At each hospital, patients with heart failure (InternationalClassification of Diseases, Ninth Revision, Clinical Modificationcode 428) were identified by using the Canadian Institute forHealth Information hospital discharge abstracts.16,17 On thebasis of chart review, we included only patients presentingto the hospital for the first time with heart failure who metthe Framingham Study criteria for heart failure.18
We excluded patients who had a previous recorded admission forheart failure, those in whom heart failure developed after admission(i.e., as an in-hospital complication), those who were transferredfrom another acute care facility, those 105 years of age orolder, nonresidents of the province of Ontario, and those withan invalid Ontario health-insurance-card number. We also excludedall patients whose left ventricular ejection fraction had notbeen evaluated by echocardiography, left ventricular angiography,or radionuclide angiography and all patients who had any severeprimary left-sided valvular abnormality on echocardiography.
The records of patients who met the inclusion and exclusioncriteria were reviewed for abstraction of clinical data. Forhospitals treating at least 125 suitable candidates during thestudy period, a random sample of 125 charts was reviewed. Forhospitals that treated fewer than 125 suitable candidates duringthe study period, all charts were reviewed.
Patients with documented left ventricular function were dividedinto three groups: those with an ejection fraction of less than40 percent (heart failure with reduced ejection fraction), thosewith an ejection fraction of 40 to 50 percent (heart failurewith a borderline ejection fraction), and those with an ejectionfraction of more than 50 percent (heart failure with preservedejection fraction). Those with an ejection fraction of 40 to50 percent were excluded from most of the analyses, becausewe wanted to have two distinct groups for comparison. Approvalof the institutional ethics review board was obtained from eachparticipating institution before the study. Because the studyinvolved only the review of records obtained as a part of routinemedical care, no patient consent was required.
Data Collection and Variable Definitions
We defined a set of clinical and demographic factors that maypotentially be associated with death from heart failure andthat were available from chart review. For each patient, thetime to death was calculated by linking the hospital dischargedata to the Registered Persons Database (RPDB) with the useof each patient's encrypted health care number. The RPDB providesdata on the vital status of residents of Ontario and recordsdeaths both in and out of the hospital. Data for each patientwere censored one year after admission, so that there was oneyear of follow-up for each patient.
The primary end point of the study was death from any causeafter the index hospitalization for heart failure. Secondaryoutcomes included rates of 30-day and 1-year readmission tothe hospital for heart failure. Other secondary outcomes werein-hospital complication rates, including myocardial infarction,admission to a coronary care unit or intensive care unit (ICU),renal failure, hypotension, shock, and the need for mechanicalventilation.
Statistical Analysis
The demographic and clinical characteristics of patients withheart failure with preserved ejection fraction and of thosewith reduced ejection fraction were compared. Dichotomous variableswere compared by the chi-square test and continuous variablesby Student's t-test.
We used Cox proportional-hazards analysis to identify factorsassociated with an increased risk of death after hospitalizationfor heart failure. Candidate variables were included in theinitial Cox regression model if they were associated with deathin a univariate analysis (P<0.20). Backward variable elimination,with an elimination criterion of a P value of more than 0.05,was then used to create a parsimonious model for predictingdeath. By forcing an indicator variable denoting ejection-fractiongroup into the model at each stage of the variable selectionprocess, we determined the adjusted hazard ratio for death amongpatients with reduced ejection fraction as compared with thosewith preserved ejection fraction. We determined that the assumptionof proportional hazards was met in all Cox regression models.Survival curves were constructed for the two ejection-fractiongroups after adjustment for all covariates in the final model.In a separate analysis, the independent predictors of deathfor patients with reduced ejection fraction and for patientswith preserved ejection fraction were determined with the useof Cox proportional-hazards regression and methods similar tothose described above. The results are shown as means ±SDunless otherwise indicated. Statistical analysis was performedwith SAS software, version 8.2; a P value of less than 0.05was considered to indicate statistical significance.
Results
A total of 9945 patients were admitted and met the predefinedcriteria for heart failure at the 103 participating hospitalsduring the study period. Of these, 5775 patients were excludedbecause echocardiography, angiography, or nuclear scintigraphywas not performed at admission. Another 717 patients who hadundergone echocardiography were excluded because their ejectionfraction had not been documented, and 649 were excluded becausethey had severe aortic or mitral valve disease. Two patientswere excluded because they did not have a valid health-cardnumber.
Among the remaining hospitalized patients with heart failurewhose ejection fraction had been measured, 880 (31 percent)had a preserved ejection fraction (more than 50 percent) and1570 (56 percent) had a reduced ejection fraction (less than40 percent). The remaining 352 (13 percent) had a borderlineejection fraction (40 to 50 percent); to provide more distinctcomparison groups, the data from the group with borderline ejectionfraction were excluded from most of the presented data analysis.
Clinical Characteristics
The clinical characteristics of the study patients are shownin Table 1. Patients with preserved ejection fraction were older(75 vs. 72 years, P<0.001), were more likely to be female(66 percent vs. 37 percent, P<0.001), and had a significantlyhigher incidence of hypertension (55 percent vs. 49 percent,P=0.005) than those with reduced ejection fraction. Patientswith preserved ejection fraction had significantly lower ratesof other modifiable cardiac risk factors, including smoking,diabetes, and hyperlipidemia. Patients with preserved ejectionfraction also had lower rates of peripheral vascular disease,angina, prior myocardial infarction, and prior coronary-arterybypass surgery. However, patients with preserved ejection fractionhad significantly higher rates of atrial fibrillation (31.8percent vs. 23.6 percent, P<0.001) and chronic obstructivepulmonary disease (17.7 percent vs. 13.2 percent, P=0.002).
Table 2 summarizes the symptoms and clinical findings of thetwo groups. The presenting symptoms in patients with preservedejection fraction were largely similar to those in patientswith reduced ejection fraction. The main differences were thatpatients with preserved ejection fraction had lower rates ofacute pulmonary edema, paroxysmal nocturnal dyspnea, and S3and a higher rate of bilateral ankle edema.
Table 2. Presenting Symptoms and Signs of Heart Failure.
Hospital Course
Table 3 shows in-hospital treatment and complications. A cardiologistwas the primary physician for 33.6 percent of patients withreduced ejection fraction but for only 24.7 percent of patientswith preserved ejection fraction (P<0.001). Cardiology consultationswere obtained for 43.8 percent of patients with reduced ejectionfraction but for only 37.3 percent of patients with preservedejection fraction (P=0.002). Although the rates of hypotensionand cardiogenic shock were significantly higher among patientswith reduced ejection fraction than among those with preservedejection fraction, the rates of renal failure, cardiac arrest,acute coronary syndrome, and admission to a coronary care unitor ICU did not differ significantly between the two groups.
Table 3. In-Hospital Care, Complications, and Outcomes.
Outcomes
The unadjusted mortality and readmission rates for the two groupsare summarized in Table 3. At 30 days, the mortality rate amongpatients with reduced ejection fraction was 7.1 percent, ascompared with 5.3 percent among those with preserved ejectionfraction, but this difference was not significant (P=0.08).The mortality rates at one year were 25.5 percent and 22.2 percent,respectively (P=0.07). Even after adjustment for other significantpredictors, the risk of death was not significantly higher amongpatients with reduced ejection fraction than among those withpreserved ejection fraction at one year (hazard ratio, 1.13;95 percent confidence interval, 0.94 to 1.36; P=0.18). The adjustedsurvival curves are shown in Figure 1. The one-year rate ofreadmission for heart failure was 16.1 percent among patientswith reduced ejection fraction and 13.5 percent among thosewith preserved ejection fraction (P=0.09). The unadjusted combinedone-year end point of death and readmission for heart failurewas 36.1 percent for patients with reduced ejection fractionand 31.1 percent for those with preserved ejection fraction(P=0.01). Patients with borderline ejection fraction (40 to50 percent) had unadjusted mortality rates of 5.1 percent at30 days and 21.3 percent at 1 year. Although these mortalityrates were not significantly different from those among eitherpatients with reduced ejection fraction or patients with preservedejection fraction, they were more similar to the mortality ratesamong patients with preserved ejection fraction.
Figure 1. Adjusted Survival Curves for Patients with Heart Failure with Reduced or Preserved Ejection Fraction over the Year after the First Hospital Admission.
The data were adjusted for differences in baseline variables, including age, sex, and coexisting conditions. The adjusted mortality rate was not significantly higher for patients with reduced ejection fraction than for patients with preserved ejection fraction at one year (hazard ratio, 1.13; 95 percent confidence interval, 0.94 to 1.36; P=0.18).
The predictors of death among patients with preserved ejectionfraction included age, systolic blood pressure, the presenceof peripheral vascular disease, hyponatremia, a history of cancer,dementia, renal dysfunction, dialysis, anemia, and respiratoryrate. The predictors of the risk of death among patients witha reduced ejection fraction were similar but also included thepresence of cirrhosis and did not include the presence of cancer,dialysis, or anemia or the respiratory rate. The results ofthese multivariate analyses are reported in Table 4.
Table 4. Multivariate Models of One-Year Mortality in the Entire Cohort of Patients with Heart Failure, in Patients with Heart Failure and Reduced Ejection Fraction, and in Patients with Heart Failure and Preserved Ejection Fraction.
Discussion
We performed a large, population-based cohort study examiningthe clinical features and outcomes of patients admitted to thehospital for the first time with heart failure. We found thatabout one third of the patients admitted with heart failurein whom left ventricular function was measured had an ejectionfraction of more than 50 percent. These patients were more likelyto be women, were older, and were more likely to have a historyof hypertension than those with an ejection fraction of lessthan 40 percent. These observations are consistent with thoseof some previous reports.7,9,19 In contrast to previous studies,however, our study found that patients with a reduced ejectionfraction had higher rates of diabetes, coronary artery disease,and hyperlipidemia; this finding is in keeping with the conceptthat myocardial infarction or ischemia constitutes a major causeof heart failure associated with a low ejection fraction. Patientswith a preserved ejection fraction had a significantly higherrate of atrial fibrillation, which may be both a consequenceand a precipitant of clinical deterioration in this setting.20The rates of most other noncardiac associated conditions didnot differ significantly between the groups, except for chronicobstructive lung disease, which was more frequent in the groupwith preserved ejection fraction.
Although subtle differences between groups were observed onphysical examination and review of presenting symptoms, thesewere largely unhelpful in distinguishing between the two typesof heart failure defined on the basis of ejection fraction.This finding is also consistent with those of other studies7that failed to discriminate between the two conditions on clinicalgrounds. Imaging methods such as echocardiography are the currentmainstay for distinguishing between these two entities. Althoughthe diagnosis of heart failure itself is determined clinically,biomarkers such as B-type natriuretic peptide and other emergingcandidates may help confirm the diagnosis in patients who donot have a reduced ejection fraction.7,21
Our principal findings are related to morbidity and mortality.Patients with heart failure with a preserved ejection fractionhad complication rates that were similar to those of patientswith a reduced ejection fraction, including similar rates ofcardiac arrest, acute coronary syndrome, renal failure, andadmission to the ICU or coronary care unit. Despite similarrates of in-hospital complications in the two groups, patientswith a preserved ejection fraction were less likely to receiveprimary care from a cardiologist and were less likely to havehad a cardiology consultation than patients with a reduced ejectionfraction. It is not clear whether this difference had an effecton the outcomes of our cohort.
Our study showed that patients with a preserved ejection fractionhad high 30-day and 1-year mortality rates that were not significantlylower than those of patients with a reduced ejection fraction,with or without adjustment for clinical differences betweenthe two groups. Multivariate analysis showed that many of thepredictors of death among patients with a preserved ejectionfraction were similar to those for patients with a reduced ejectionfraction, as described in previous studies.22
The data from other studies of patients with heart failure witha preserved ejection fraction have been inconsistent with respectto mortality and readmission rates.6,19,23,24 Some reports haveestimated the annual mortality rate among patients with heartfailure with a preserved ejection fraction to be in the rangeof 5 to 8 percent and have concluded that this entity is notas ominous as heart failure with a reduced ejection fraction.23In contrast, Senni and Redfield reviewed 13 smaller studiesexamining the outcomes of patients with heart failure and foundthat 6 of the 13 studies did not show a significant differencein mortality between the two conditions.19 Another, larger single-centerstudy by Varadarajan and Pai12 actually found a higher mortalityrate among patients with heart failure with a preserved ejectionfraction, although there were limitations to this analysis.23More recent large clinical studies, such as the Danish Investigatorsof Arrhythmia and Mortality on Dofetilide–Congestive HeartFailure (DIAMOND–CHF) registry, the Euro Heart Failuresurvey, and the Management to Improve Survival in CongestiveHeart Failure (MISCHF) study, all found lower relative mortalityrates among those with heart failure with a preserved ejectionfraction, but a high absolute mortality rate in this group,ranging from 10 percent at 12 weeks to 17 percent at 1 year.21,25,26
All these previous studies had several limitations. The majorityof the subjects were clinic-based or referral patients. Amonghospitalized patients, some were not admitted for heart failure,but heart failure developed after admission. In addition, thesereports typically did not use an objective system for the classificationof heart failure. In contrast, our study included only patientswho were admitted with their first episode of heart failure,and we required all subjects to meet the Framingham criteriafor heart failure. Thus, our study can be seen as an assessmentof the clinical course of heart failure with a preserved ejectionfraction as compared with that of heart failure with a reducedejection fraction from the same point in the evolution of thedisease.
The prognosis of heart failure with a preserved ejection fractionhas also been evaluated in a few clinical trials, the largestof which were the Candesartan in Heart Failure: Assessment ofReduction in Mortality and Morbidity (CHARM) trials. These studiesalso found a large difference in mortality between patientswith preserved ejection fraction and those with reduced ejectionfraction, but the patients enrolled in the CHARM-Preserved trialwere significantly younger than those in our study (averageage, 67 vs. 75 years), were predominantly male, and were moreheterogeneous.27,28 They were thus enrolled at different pointsin their disease and represented a different study populationthan those traditionally thought to have heart failure witha preserved ejection fraction.
Our study had several limitations. Of the potentially eligiblepatients, only 42 percent had a documented assessment of leftventricular function at the time of admission to the hospital.Other studies have shown variation in the rates of assessmentof ejection fraction in patients with heart failure.29,30,31This may have resulted in a selection bias; several other studieshave shown that physicians paradoxically tend to refer patientswho are younger and less sick for investigations such as assessmentof left ventricular function or angiography.29,32 Thus, we mayhave underestimated the actual risk of complications and deathamong patients with heart failure with a preserved ejectionfraction, who tend to be older women with coexisting conditions.
In addition, the assessment of ejection fraction could not bestandardized, and therefore, there may have been variationsamong different operators and different techniques that resultedin the misclassification of some patients. We excluded the groupwith a borderline ejection fraction (40 to 50 percent) in orderto minimize the effects of misclassification. We included onlypatients whose ejection fraction had been assessed on admission,and although there has been concern that left ventricular functionmay become transiently impaired in patients presenting withpulmonary edema, this concern has not been substantiated inlongitudinal follow-up studies.33
Restricting our analysis to patients hospitalized with a primarydischarge diagnosis of heart failure presumably resulted ina more homogeneous study population than those in previous reports.However, we could not control for the decision-making processthat led to the admission of a patient, and it is conceivablethat for a given symptom severity, physicians are less likelyto admit a patient who has a normal ejection fraction. Our dataregarding symptom frequency are reassuring in this respect,but they do not entirely exclude the possibility that our groupof patients with a preserved ejection fraction had to meet ahigher admission standard. Finally, some patients may not havereceived a discharge diagnosis of heart failure once their ejectionfraction was known to be normal, even though their symptomsand signs were consistent with the presence of heart failure;such an ascertainment bias could also have reduced the numberof patients with "mild" heart failure with a preserved ejectionfraction included in the cohort.
In summary, we determined the clinical features and outcomesof a large, population-based cohort of patients with heart failurewith a preserved ejection fraction. Our study differs from othersby including only patients admitted with confirmed heart failureand by including patients from small and large community hospitalsas well as academic teaching institutions. In our analysis,approximately one third of patients admitted with heart failurehad an ejection fraction of more than 50 percent, and such patientscould not be reliably distinguished from those with an ejectionfraction of less than 40 percent on clinical grounds. The in-hospitalcomplication rates of the two groups were similar. The adjustedone-year mortality rate among patients with heart failure witha reduced ejection fraction was similar to that of patientswith a preserved ejection fraction; the morbidity rates in thetwo groups were similar; and the absolute mortality rate amongpatients with heart failure with a preserved ejection fractionwas higher than previously reported values.
Supported by grants from the Heart and Stroke Foundation ofOntario, the Canadian Institutes of Health Research, the CanadianHeart Failure Network of Exploratory Teams, and the CanadianCardiovascular Outcomes Research Team.
No potential conflict of interest relevant to this article wasreported.
Source Information
From the Heart & Stroke/Richard Lewar Centre of Excellence, University of Toronto, and the Division of Cardiology, Toronto General Hospital, University Health Network (R.S.B., J.V.T., D.S.L., A.H., P.P.L.); the Division of General Internal Medicine, Sunnybrook and Women's College Health Sciences Centre, University of Toronto (R.S.B., J.V.T.); and the Institute for Clinical Evaluative Sciences (J.V.T., D.S.L., P.C.A., J.F., Y.G.) — all in Toronto; and the National Heart, Lung, and Blood Institute Framingham Heart Study, Framingham, Mass. (D.S.L.). Drs. Tu and Liu contributed equally to this article.
Address reprint requests to Dr. Liu at the Heart & Stroke/Richard Lewar Centre of Excellence, NCSB 11-1266, Toronto General Hospital, 200 Elizabeth St., Toronto, ON M5G 2C4, Canada, or at peter.liu{at}utoronto.ca.
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Heart Failure with Preserved Ejection Fraction
Fiack C. A., Farber H. W., Arias M. A., Alonso-Fernández A., García-Río F., Kessler K. M., Ahmed A., Fleg J. L., Gheorghiade M., Owan T. E., Redfield M. M., Liu P. P., Lee D. S., Tu J. V., Ph.D. M.D.
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