© 2007 European Society of Cardiology
Disease management programs for heart failure: Not just for the sick heart failure population
Heart Failure Unit, St Vincent's University Hospital Elm Park, Dublin 4, Ireland
* Corresponding author. Tel.: +353 1 230 4629; fax: +353 1 230 4639. E-mail address: kenneth.mcdonald{at}ucd.ie
| Abstract |
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The development of disease management programs has been a major advance in heart failure care, bringing about significant improvements for the heart failure population, with reduction in readmission, better use of guideline therapy and improved survival. However, at present, the majority of such programs focus their attention only on the sicker segment of this population, with little application of this important service to the broader heart failure population, where potentially benefits may be even more impressive. This has led to an imbalance in the care of patients with heart failure, where aspects of management such as regular structured review and education are preferentially given to the group at the later stages of the natural history of the syndrome. This paper argues for a far wider application of the disease management program concept in heart failure care so as to bring the benefits of specialist care, patient education and follow-up to patients at an earlier stage in the natural history of heart failure.
| 1. Introduction |
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Disease management programs (DMPs) have become popular within health care systems to improve the quality and efficiency of care delivery. DMPs may be defined as a complete approach to care of a particular disease encompassing prevention, treatment and follow-up care [1] including implementation of guidelines [2]. Such programs have been associated with marked improvements in outcomes [3]. Over the last decade, using models established in the management of other chronic disease states, heart failure DMPs were developed, assessed and found to be effective by reducing hospital readmissions, improving quality of life and the application of proven therapies, reducing costs and possibly lengthening survival [4-12].
| 2. Present day disease management programs in heart failure |
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2.1. A "restricted approach"
Despite this major advance in heart failure care, the DMP remains restricted in application and generally confined to the sicker group of the heart failure population. As a result, the vast majority of the affected population will not receive the medical and multidisciplinary benefits of a heart failure DMP until their condition deteriorates to a stage that requires hospitalisation [13]. The analogy would be to provide a DMP for patients with diabetes mellitus only to those developing macrovascular complications of the disease. A broader application in terms of target patient and clinical setting is now required and an "expanded model" of this important intervention should be considered.
2.2. The "expanded model"
There are certain basic concepts that should drive the development of the modern or expanded DMP.
2.2.1. Heart failure is a chronic disease, not a terminal disease
Recent advances, when applied effectively, have transformed the outlook for both those with established heart failure and those at risk of its development [13]. This is of particular note in the management of left ventricular systolic dysfunction (LVSD), where dramatic improvements in left ventricular ejection fraction has brought about the concept of remission or even cure of heart failure. Now a more aggressive approach to the detection and management of asymptomatic LVSD in those at risk of heart failure can be considered [14,15]. The above developments underline the need to redefine heart failure as a chronic disease and ensure the benefits of these advances are available to the complete spectrum of the population.
2.2.2. Management of heart failure should be community-based
As with all chronic disease, the majority of care should be organised from within the community setting, led by the general practitioner (GP). For much of the natural history of heart failure, the patient is clinically stable and the focus of community services should be directed at maintaining this relative well-being. This will be best achieved through regular medical review focusing on maintaining euvolaemia in those with established heart failure and monitoring risk factors in those at-risk for heart failure.
2.2.3. Access to specialist care services
There are several well-defined stages in the natural history of heart failure when the patient should be assessed by a specialist physician-led multidisciplinary team. These landmark time points are critical phases in the natural history of the heart failure syndrome where the impact of error or inefficiency can be magnified several fold.
| 3. Landmark time points: who are the target patients and what do they need? |
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3.1. Hospitalisation for heart failure
Patients admitted with heart failure should be treated in a manner similar to those admitted with other cardiovascular emergencies such as myocardial infarction. This should include management in a specialist unit under the care of experienced medical and nursing personnel to ensure complete investigation and application of standard guideline driven therapies [16] (Fig. 1).
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3.2. Structured post-discharge follow-up
This is the major focus of the present day DMPs with different formats of care successfully reducing readmission [4-12]. This is a diverse population with varying risk profiles for readmission. Risk stratification may allow for better use of services with more intense follow-up in hospital clinics for the higher risk group and greater use of nurse outreach programs for more stable patients. There is some evidence to suggest that long-term, intensive post-discharge follow-up is unnecessary, especially in the low risk population, providing that the patient has immediate access to the specialist service in the event of suspected deterioration [17,18].
3.3. Immediate access for clinical deterioration
Clinical deterioration is an inevitable feature in the natural history of heart failure. Data from our unit demonstrate that following discharge from hospital there is an approximate 50% likelihood of unscheduled contact with our service within 12 months with features of deterioration (Fig. 2). Early intervention can greatly reduce the need for rehospitalisation. Typical cases that may require review at the hospital out-patient unit include those not responding to first step approach to clinical deterioration, such as an increase in oral diuretic, those with right heart failure requiring intravenous therapy to combat poor absorption of oral therapy and those more brittle patients known to need aggressive therapy.
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3.4. Initial diagnosis
Delegating the responsibility of this important phase of heart failure management to the GP-led community services is not an effective approach, as reports have demonstrated incorrect diagnoses in as many as 60% of cases [19]. This observation is likely explained by the difficulty in diagnosing heart failure in its earliest stages due to the often non-specific nature of presentation. Moreover, in many cases, essential investigations may not be readily available to GPs to aid diagnosis.
Diagnostic accuracy at this critical time point can be improved through use of a new-patient referral service [19], providing experienced medical review with confirmation of the presence or absence of heart failure. On confirming heart failure, patients can be immediately referred for relevant investigations, initiated on appropriate therapies and commenced on an education program. Triage of potential referral patients to this service would be improved through ready access to b-type natriuretic peptide (BNP) assessment for the GP.
3.5. Annual review
Patients with heart failure should be reviewed annually, even following an uneventful year. The patient's stability should be confirmed by a physician experienced in heart failure management. This assessment should include electrocardiography to check for the development of electrical dyssynchrony and echocardiography to assess remodelling indices, the extent of mitral regurgitation and pulmonary pressures. BNP measurement to assess biochemical stability may also be of benefit in assessing prognosis [20]. This complete review will provide a more assured assessment of stability and indicate whether a change in approach is required. While the benefits of altering therapy in symptomatically stable patients demonstrating changes in any of the above criteria has not been addressed by any randomised control trial, it is reasonable to suggest that the information obtained from this more complete review would be of benefit. Furthermore, such review will also highlight the group of patients with significant improvement in ventricular function, an important observation which may allow for changes in therapeutic strategy.
A further reason to review patients on an annual basis is to allow each patient to be assessed in the light of advances made in the management of heart failure. This ensures that the patient continues to receive state-of-the-art care, e.g. a recent example of the benefit of such a review would be the assessment of the role of prophylactic automatic implantable cardioverter defibrillators [21,22]. Without systematic review, many patients may not be assessed with regard to such valuable interventions.
A final benefit for annual review is to facilitate revision of important educational matters.
3.6. Prevention in at-risk patients
As outlined in the recently published American Heart Association guidelines, increasing focus should be placed on preventing heart failure including attention to optimal risk factor management and careful follow-up of at-risk individuals [23]. In particular these include survivors of myocardial infarction and those with hypertension, dyslipidemia and diabetes.
Triage of such patients using BNP will uncover approximately 2% incidence of asymptomatic left ventricular systolic dysfunction for whom proven therapies are established [14,15,24]. Work from the Framingham Group and from our own unit has demonstrated that an elevated BNP level, even in the presence of preserved systolic function, is predictive of future cardiovascular events and in particular heart failure [25,26]. The meaning of elevated BNP in this setting remains obscure but could represent a response to an early pathological process [27]. While there is no defined therapy for this group, they should at least be carefully observed with close attention to risk factors. It may be prudent to re-evaluate ventricular function at least annually in this group.
| 4. An unproven strategy |
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As outlined above, this expanded model DMP would clearly provide access to a greater proportion of the heart failure and at-risk population to speciality-led strategies at critical time periods in the natural history of this syndrome. The interventions in this program are multifaceted and extend beyond routine cardiovascular preventative strategies and prescription of guideline recommended therapy. They include the establishment of a facility to provide more accurate and timely diagnosis and the provision of a shared-care direct access facility to manage clinical deterioration. Furthermore, the annual review clinic will provide important data on changes in clinical status and will provide continued specialist review to assess need for changes in treatment strategy.
Although the clinical benefits of this approach may appear logical, certain aspects of this service require further discussion. While structured care has been shown to be cost-effective for the sicker group of this population, other aspects of the Expanded Model will need close scrutiny in this regard. For example, intensive specialist service follow-up in a more stable patient population has not been shown to be clinically effective [17,18]. In particular, the cost-benefit of including the "at-risk" patient into a heart failure program must be carefully analysed. It has been shown that screening a population with low prevalence of LVSD (<1%) is not cost-effective [28-30] and yet these and other preliminary data have suggested that there may be cost-benefits from screening higher-risk populations for structural heart disease using BNP testing [31]. Prospective studies are clearly needed, to clarify the incremental clinical benefit of screening for and aggressively managing risk factors to prevent the development of heart failure. The St. Vincent's Screening TO Prevent Heart Failure (STOP-HF) trial is a prospective, randomised, controlled study which will accumulate 10,000 patient years of follow-up. STOP-HF will evaluate the clinical and cost effectiveness of a BNP-based screening and prevention service as part of a DMP. Interestingly, pilot data from this study have demonstrated a population prevalence of 3.6% LVSD, which may suggest, based on the work of Heinderich and colleagues, that this approach will be cost-effective [26].
Finally, facilitating access to the asymptomatic and minimally symptomatic sections of the heart failure population is another important challenge with this expanded model. The most successful strategy in this regard will be on-going and continuing education of the general practitioner in matters related to heart failure care. In so doing, the general practitioner will become more aware of those needing referral, and will become more confident in dealing with certain heart failure matters which should not require referral. Formal "shared-care" protocols have been developed in other chronic diseases such as diabetes and provide a model for support of primary care services in the chronic care of stable heart failure. We have begun to incorporate such protocols into our "expanded program" and they involve close ongoing liaison between heart failure specialist and primary care medical and nursing teams.
| 5. Summary |
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The development of DMPs has been a major advance in heart failure care. However, while noted benefits have been defined in the sicker group of the heart failure population, the benefits of this approach have not in general been disseminated to the less sick or at-risk segments of this group. This has led to an imbalance in the care of patients with heart failure, where aspects of management such as regular structured review and education are preferentially given to the group at the later stages of the natural history of the syndrome where it could be argued that an even greater benefit could be obtained if applied earlier in the syndrome. The clinical benefits and cost-effectiveness of the more expanded involvement of a DMP in heart failure care should be addressed, but it is likely that such a development will bring further benefits to this population.
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