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European Journal of Heart Failure 2001 3(5):619-625; doi:10.1016/S1388-9842(01)00164-7
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© 2001 European Society of Cardiology

Improved outcomes from a comprehensive management system for heart failure

Diane P. Holsta,*, David Kayea, Meroula Richardsona, Henry Krumb, David Priora, Anne Aggarwala, Rory Wolfeb and Peter Bergina

a Cardiovascular Medicine, Heart Centre, Alfred Hospital Commercial Road, Prahran, Melbourne, Vic 3181, Australia
b Department of Epidemiology and Preventive Medicine, Monash University Melbourne, Vic, Australia

* Corresponding author. Tel.: +61-3-9276-2071; fax: +61-3-9276-3488. E-mail address: d.holst{at}alfred.org.au (D.P. Holst)


   Abstract
Top
 Abstract
1. Introduction
 2. Methods
 3. Results
 4. Discussion
 5. Conclusion
 References
 
Aims: Congestive heart failure (CHF) is associated with a high readmission rate after diagnosis. We assessed the ability of a comprehensive management program (CMP) for CHF to reduce readmissions with secondary endpoints of improving quality of life, exercise capacity and targeted drug doses.

Methods and results: Patients (pts) with: New York Heart Association Class (NYHA) III or IV CHF; left ventricular ejection fraction < 40%; and stable outpatient therapy were assigned to a CMP of cardiology assessment intensive education and referral to a tailored exercise program. Forty-two pts (35 M, 7 F, mean age 54 years, S.D. 12 years) were enrolled. Two pts were transplanted, two died during follow-up and two were lost to follow-up. Hospital admissions were reduced by 87.2%, (mean 1.05, S.D. 0.98, admissions per pt to mean 0.08, S.D. 0.28, admissions per pt at 6-month follow-up; P < 0.0001). ACE-inhibitor dose increased by 42% (P < 0.0008) and beta-blocker dose increased by 61% (P < 0.0001). NYHA Class, 6-min walk and quality of life scores all improved significantly (P < 0.0001).

Conclusion: A CMP improves QOL and exercise capacity as well as substantially reducing hospital admissions in CHF pts. This study validates the benefit of intensive outpatient care of CHF.

Key Words: Chronic heart failure • Exercise • Drug therapy

Received January 10, 2001; Revised February 23, 2001; Accepted May 9, 2001


   1. Introduction
Top
 Abstract
 1. Introduction
2. Methods
 3. Results
 4. Discussion
 5. Conclusion
 References
 
Chronic heart failure (CHF) is a major public health problem [1]. CHF is associated with poor prognosis [2], markedly reduced quality of life and, unlike other cardiovascular conditions, is increasing in both incidence and prevalence [1–3].

Heart failure is common. An estimated 4.8 million Americans are affected and 400 000–700 000 new cases develop each year in the United States [4]. It is estimated that CHF affects at least 200 000 Australians and results in an average mortality rate of 50% after 5 years. In the Cardiac Awareness Survey and Evaluation Study (CASE) of 22 060 consecutive patients over 60 years in 341 general practices in Australia, 13.1% of patients fulfilled World Health Organisation criteria for CHF (Johnston CI, personal communication). This study showed the number of CHF patients doubled with each decade of life over 60 years, such that more than 20% of patients over 80 years of age had heart failure diagnosed.

In the United States, heart failure results in 900 000 hospitalisations per year and is the most prevalent diagnosis-related group (DRG) in hospitalised patients over 65 years of age [1]. Admissions for heart failure have shown a fourfold increase between 1971 and 1990 [5]. CHF accounts for 1–2% of total health care costs in industrialised nations [6] with approximately two-thirds of the total cost due to inpatient care. In the USA, heart failure hospitalisation costs exceed those for myocardial infarction and cancer combined [7]. Readmission rates for patients with CHF are also high and range between 29 and 47% within 3–6 months of the initial index admission [8].

Multidisciplinary heart failure disease management has resulted in improved clinical outcomes in selected CHF patient populations [8–13]. Although the type of intervention varied, as did the population base and study methods, the consistent finding reported in all studies was a reduction in hospital utilisation.

Few of the studies have focused on exercise rehabilitation as a core component of the program, and to date no studies have evaluated the impact of multidisciplinary care on severe end stage CHF patients in an era when beta blockade is accepted and recommended therapy. Therefore, we designed and implemented a comprehensive management program, including intensive exercise rehabilitation, and evaluated the outcomes of patients with moderate to severe heart failure. The primary goal of the program was to reduce hospital admissions for CHF, with secondary endpoints being: quality of life; cardiac performance; exercise capacity; and optimisation of beta-blockers and angiotensin converting enzyme inhibitors (ACE-I).


   2. Methods
Top
 Abstract
 1. Introduction
 2. Methods
3. Results
 4. Discussion
 5. Conclusion
 References
 
2.1. Study subjects
All patients attending the Alfred Heart Failure Clinic between January 1998 and May 1999 were screened for enrolment. Patients meeting the following inclusion criteria were entered into the study: age ≥18 years; moderate to severe symptomatic heart failure (NYHA Class III to IV); left ventricular ejection fraction (LVEF) <40% as measured by radionuclide gated blood pool scan or echocardiography; stable cardiac status for 2 weeks; suitability for outpatient care; and living within a 30-km radius of the Alfred Heart Failure Clinic.

Exclusion criteria from the study included: acute myocardial infarction within 4 weeks of entry; cardiogenic shock; mechanical ventricular support; unstable coronary artery disease; acute myocarditis and planned cardiac surgery including transplantation; and significant co-morbid conditions such as malignancy or severe obstructive lung disease.

The study was approved by the Alfred Hospital Ethics Committee and all patients provided written informed consent. The investigation conforms to the principles outlined in the Declaration of Helsinki (Br Med J 1964; ii: 177).

2.2. Study design
Each patient was his/her own control and a comparison was made before and after the intervention. There was no control group. Data were obtained at entry to the study (baseline) and again after 6 months. Each patient's CHF healthcare usage, i.e. hospital inpatient stay, emergency room presentation and scheduled and unscheduled general practice visits (excluding visits for prescriptions) were assessed at the two data collection times. Other assessments included: left ventricular ejection measured by either echocardiogram or gated blood pool scan; New York Heart Association Class; exercise capacity measured by a 6-min walk test; and quality of life using the Minnesota Living with Heart Failure Questionnaire and Cardiac Depression Scale [14,15]. Patients were interviewed at baseline by the clinic nurse, and follow-up interviews were conducted by a health professional not involved with the patients care. Death and significant morbidity, including the need for heart transplantation, were also recorded.

2.3. Comprehensive management program
Each patient received an initial consultation for 1 hour with a heart failure cardiologist. This was a comprehensive assessment of the patient's heart failure status with a follow-up review as required. The optimisation of ACE inhibitors and the introduction or up-titration of beta-adrenoceptor blocking agents, such as carvedilol, were key components of medical management.

Each patient also had a 30-min introductory session with the nurse manager to establish a communication link for subsequent management co-ordination. All patients later attended a comprehensive 2 hour multidisciplinary education session for partners and families. This was predominately a group session, but was done on an individual basis if required. These sessions aimed to improve patients’ understanding and management of CHF, stressing the warning signs and symptoms of deterioration. Patients received advice from a dietician regarding: diet, fluid and sodium management; the importance of daily weighing; and instructions on the use of patient-initiated diuretic adjustment in response to worsening symptoms and weight change. By taking an active role in self-management of their illness, patients were encouraged to follow an action plan with instruction to seek urgent medical care if breathlessness worsened, weight increased, or palpitations or chest pain developed. Medication advice was also outlined.

All patients were referred to an exercise program specifically designed for CHF patients. This program was part of an existing cardiac rehabilitation service. Patients were offered an individual assessment by a physiotherapist. The exercise program ran for 8 weeks, two to three times per week. The specific aim of the exercise program was to improve both strength and endurance. It included a combined program of: walking; exercise bike riding; rower; stepper; weight resistance training; callisthenics; work; and activity conditioning. Patients completed three exercise sessions at each attendance. Patients were exercised to a heart rate of 50–60% of maximum predicted for age, respiratory rate maximum of 24 per min and a Borg rating of 9–12 for perceived exertion. Patients were also encouraged to maintain a home program of daily walking (minimum duration 10 min to a maximum of 30 min) with the aim for a total period of exercise per day of 30–60 min, 5–7 days per week.

2.4. Drug usage
Medication usage and dose were recorded at baseline and at the 6-month follow-up. Beta blockers were ranked according to dose: ‘low dose’ ≤12.5 mg/day carvedilol or equivalent; ‘medium dose’ 12.5 to <50 mg/day carvedilol or equivalent; and ‘high dose’ ≥50 mg/day carvedilol or equivalent. Similarly ACE-I were also grouped and ranked according to dose: ‘low’ ≤10 mg/day of enalapril or equivalent; ‘medium’ 10 to <20 mg/day enalapril or equivalent; and ‘high’ ≥20 mg/day enalapril or equivalent.

Finally the multidisciplinary management sought to establish closer communication between the practice nurse, family physician and the patient in the outpatient setting. The practice nurse was also available by telephone to answer any concerns throughout the follow-up period.

2.5. Statistical methods
To summarise the observations at baseline and at the 6-month follow-up time, we used proportions, or mean and standard deviation (S.D.), as appropriate. To analyse changes between the two times of observation, the two quality of life variables, whose changes approximately followed a normal distribution, were analysed using paired t-tests. Changes in all other numerical variables were analysed with the non-parametric Wilcoxon sign-rank test. A P-value less than 0.05 was considered to be statistically significant. Analyses were performed using SPSS (version 9.0) and Stata (version 6.0).


   3. Results
Top
 Abstract
 1. Introduction
 2. Methods
 3. Results
4. Discussion
 5. Conclusion
 References
 
3.1. Patient population
We identified 42 consecutive patients who met the entry criteria for enrolment into the study. All patients invited to participate agreed to do so. Eighty-one percent were referred to the Heart Failure Centre from other cardiologists, 17% from general practitioners and 2% following CHF admission to the Alfred Hospital. Fifty-four percent of patients were referred to the clinic for transplant assessment and 46% were referred for heart failure management. Diagnosis of heart failure was predominantly dilated cardiomyopathy (48%) or ischaemic heart disease (46%). Two patients died during follow-up (one from sudden death at home, the other from progressive heart failure leading to intractable ventricular tachycardia). Two patients were transplanted and two patients were lost to follow-up. Thus, 36 patients completed the study (29 males, seven females, mean age 54, S.D. 13 years). Two weeks prior to the study end, one patient had high-risk coronary artery bypass grafts.

Seventy-two percent of patients completed the rehabilitation program, 12% were assessed but continued with a home exercise program only, 6% stopped when receiving a heart transplant and 10% failed to attend the rehabilitation program (Tables 1 and 2).


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  		Table 1 Overall use of cardiac medications (% patients)

 


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  		Table 2 Co-morbidities on entry to study

 
3.2. Resource utilisation (Fig. 1)


Figure 1
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  		Fig. 1 Mean number of hospital admissions for CHF (solid bars: initial 6 months; open bars: 6-month follow-up); ***P<0.0001. Mean number of emergency room (ER) presentations for CHF (solid bars: initial 6 months; open bars: 6-month follow-up).

 
3.2.1. Hospitalisations
In the 6 months prior to study recruitment, the mean number of hospitalisations per patient was 1.05 (S.D. 0.98). Following program participation mean hospitalisations were 0.08 (S.D. 0.28) per patient, a reduction of 87.2% (P<0.0001). On follow-up, those patients untreated with carvedilol had no hospitalisations; those patients treated with carvedilol had a mean hospitalisation per patient of 0.11 (S.D. 0.32). Bed days were reduced from a total of 288 days (of which 144 were coronary care bed days, 9 were intensive care days) to 10 days following intervention of which 8 were coronary care bed days, with no intensive care days (P<0.0001). Mean number of emergency room presentations declined from 0.29 (S.D. 0.61) to 0.11 (S.D. 0.32) presentations per patient (P=0.13).

Elective cardiac admissions in this group increased from a mean 0.14 (S.D. 0.42) to 0.42 (S.D. 0.65) admissions per patient (P=0.04). These admissions were for: transplant work-up (10); DC cardioversion for atrial fibrillation (two); overnight polysomnography (two); and one patient underwent high risk coronary artery bypass grafting. Unscheduled visits to the patient's general practitioner due to worsening CHF declined from a mean of 1.94 (S.D. 2.22) to 0.69 (S.D. 1.28) visits per patient (P=0.006). Scheduled visits to the general practitioner for non-prescription review increased slightly from a mean of 2.83 (S.D. 2.83) to 3.61 (S.D. 2.86) visits per patient (P=0.12).

The percentage of cardiological procedures performed in the study group (from 6 months prior to 6 months following clinic visits) were as follows: echocardiography, from 75 to 45.7%; gated blood pool scan, from 52.8 to 48.5%; chest radiology from 80.6 to 36.1%; right heart catheter, from 25 to 30.6%; routine electrolytes, from 91.7% to 86.1%; and non-cardiac operations, from 2.8 to 8.3%. No pacemakers were performed in the previous 6 months and one patient received a pacemaker during the 6-month study period.

3.3. Drug therapies (Figs. 2 and 3)


Figure 2
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  		Fig. 2 ACE-I dosing improvement and usage (solid bars: baseline; open bars: 6-month follow-up).

 


Figure 3
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  		Fig. 3 Beta-blocker dosing improvement and usage (solid bars: baseline; open bars: 6-month follow-up).

 
Usage and dosage of both angiotensin converting enzyme inhibitors (ACE-I) and beta-blockers was significantly increased. Although 97% of patients at baseline were receiving either an ACE-I (94%) or angiotensin 11 receptor blocker (3%), dosage was: low in 41.2% (≤10 mg/day of enalapril, or equivalent); medium in 32.4% (>10 to <20 mg/day enalapril, or equivalent); and high in 26.5% (≥20 mg/day enalapril, or equivalent). Forty-two percent of patients had a dose increment from their baseline dose.

In the 39% of patients taking beta-blockers at baseline (carvedilol 33%, atenolol 6%): 69.2% were on low dose (≤12.5 mg/day of carvedilol, or equivalent); 30.8% on medium dose (>12.5 to <50 mg/day); and none on high dose (≥50 mg/day). On follow-up, 78% of patients were on beta-blockers of whom 22.2% were on low dose, 29.6% on medium dose and 48.2% on high dose. Sixty-one percent of the study patients had a dosage increment.

3.4. Functional status
Functional status improved from mean New York Heart Association Class of 3.1 (S.D. 0.35) at baseline to 1.8 (S.D. 0.82) at follow-up (P<0.0001). Exercise capacity as measured by a 6-min walk test improved from a mean of 413 (S.D. 117) metres at baseline to 496 (S.D. 93.2) metres at follow-up (P<0.0001).

3.5. Ventricular function
Cardiac performance was measured in 30 patients by either echocardiography or radionuclide gated blood pool scan. Compared to baseline assessment, left ventricular ejection fraction improved from 18.8% (S.D. 5.7) to 30.5% (S.D. 12.4) (P<0.0001).

3.6. Quality of life (Fig. 4)


Figure 4
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  		Fig. 4 Quality of life scores, Cardiac Depression Scale (CDS) and Minnesota Living with Heart Failure (M LlhFE) questionnaires.

 
We found a highly significant improvement in response to both quality of life questionnaires. The Minnesota Living with Heart Failure Evaluation (total score) improved from 53 (CI 45, 61) to 32 (CI 23, 41), P<0.0001, and Cardiac Depression Scale (total score) improved from 92.2 (CI 83.9, 86.4) to 76.6 (CI 66.9, 86.4), P<0.0001, following comprehensive management.

3.7. Clinic attendance/contact
During the program, patients attended the clinic an average of 3.4 times over the 6-month period. Telephone contacts to the nurse manager for triage of CHF symptoms was higher in the first month of management (mean of four contacts) than in the remainder of follow-up (mean of one contact per month).

3.8. Costs
Heart Failure admission costs AUD $990 per patient/day (including infrastructure costs). In the 6 months prior vs. 6 months following first clinic visit, we had a total reduction of inpatient costs by AUD $265 320 (factoring in the elective admissions for transplant work up, cardiac DC reversion, high risk coronary bypass grafts) and a increase in outpatient costs by AUD $42 192 (nurse manager AUD $125 per patient, allied health staff AUD $100 per patient, clinic and medical staff AUD $267 per patient and the exercise program AUD $680 per patient) An estimated cost saving of AUD $6198 per patient over a 6-month time frame was achieved.


   4. Discussion
Top
 Abstract
 1. Introduction
 2. Methods
 3. Results
 4. Discussion
5. Conclusion
 References
 
There is a growing body of literature supporting a multi-disciplinary management approach to patients with chronic heart failure. Increasing input into outpatient care can reduce expensive hospital readmissions [8–13], leading to reduction in overall costs of managing this disease [8,11,16]. Most research in this area has been conducted in patients with less severe heart failure than our cohort, with the exception of the reports from Fonarow et al. [11] and Hanumanthu et al. [16] who studied patients from a heart failure transplant unit.

Drug therapies, specifically ACE inhibitors and beta-blockers, have been shown to improve disease outcomes in CHF by improving survival and reducing hospitalisations [17,18] but are not used in all suitable patients in clinical practice [19]. Furthermore, the benefits of both ACE inhibitors and beta-blockers are dose-dependent [20,21], whereas in clinical practice the doses used are often far lower than those used in clinical trials. As reported by West et al. [19], we also observed low utilisation of ACE inhibitors at baseline, but by the end of the study the dosages were significantly increased. Similarly beta-blockers were prescribed at baseline in a minority of patients (39%), and in these dosing was also low.

The question is raised in our study as to whether the improvement seen was related entirely to the introduction and up-titration of beta-blocker therapy. It should be noted that the 22% of patients who did not tolerate the introduction of carvedilol still demonstrated no hospitalisations in the follow-up period, independent of beta blockade.

Although exercise has been shown to be of benefit in heart failure [22,23], it is interesting to note that an exercise program was not a specific intervention in other studies, although some encouraged patients to perform unsupervised exercise as part of multidisciplinary care [10–16]. Our study is the first to focus on a structured exercise rehabilitation program as a core component. In addition, depressed mood is very common in cardiac patients. The combined effect of chronic disease and depressive symptoms can further worsen functional capacity [24]. The success of the exercise program is perhaps reflected as much in the improvement of the patients’ quality of life as in the increased exercise tolerance.

Advantages of comprehensive management in our population included not only a reduction of health care utilisation and the associated spiralling costs associated with hospitalisations, but avoidance or deferral of transplantation in the majority of patients who were referred for this indication.

4.1. Limitations
This study may be criticised on the basis that data is derived from a non-randomised trial and could therefore overestimate the reduction in hospital readmissions and, therefore, the subsequent cost benefit. Rich notes that [25] a more appropriate way of evaluating heart failure admissions is perhaps to compare the observed readmission frequency with the expected readmission frequency during the 6 months of follow-up. Based on several studies, 30–50% of patients hospitalised with heart failure will be readmitted within 6 months [4]. Using this formula, readmissions in our patients were still greatly reduced, three out of 24 patients were admitted once each (12.5%) as compared to an anticipated rate of 30–50%.

Because our study assessed the impact of a comprehensive management program with multiple interventions it was not possible to identify the relative contributions of constituent interventions of the program to the benefits observed. Some insight can be gained, however, by careful interpretation of the data and by results reported from other studies.


   5. Conclusion
Top
 Abstract
 1. Introduction
 2. Methods
 3. Results
 4. Discussion
 5. Conclusion
References
 
This is the first study to assess a comprehensive management program specific to chronic heart failure in the modern era of widespread usage of beta blockade. This management approach improves patient outcomes as well as substantially reducing hospital admissions and the high cost burden of this condition. This study also adds to the body of literature validating the benefit of intensive outpatient care of heart failure, indicating that such management should now move from the realm of clinical research to standard care for this patient population.


   Acknowledgements
 
Acknowledgements are given to Jennie Patrick and Lynne Carter from Caulfield General Medical Centres Cardiac Rehabilitation Program and Kaylene Fiddes. This study was supported by an NHMRC Centre of Excellence Grant.


   References
Top
 Abstract
 1. Introduction
 2. Methods
 3. Results
 4. Discussion
 5. Conclusion
 References
 

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  21. MOCHA Investigators. Bristow M., Gilbert E., Abraham W., et al. Carvedilol produces dose-related improvements in left ventricular function and survival in subjects with chronic heart failure. Circulation (1996) 94:2807–2816.[Abstract/Free Full Text]
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