© 2008 European Society of Cardiology
Successful treatment of heart failure with devices requires collaboration
a Department of Emergency and Cardiovascular Medicine, Sahlgrenska Academy University of Gothenburg, Göteborg, Sweden
b University of Hull, Cottingham England, United Kingdom
c National Heart and Lung Institute, Imperial College London, England, United Kingdom
d Helsinki University Hospital Helsinki, Finland
e University of Pavia, Fondazione Salvatore Maugeri Pavia, Italy
f Policlinico San Matteo Pavia, Italy
g University Medical Center Groningen Groningen, The Netherlands
h Clínica Puerta de Hierro Madrid, Spain
i St. George's Hospital Medical School London, England, United Kingdom
j Stavanger University Hospital Stavanger, Cardiology Division, University of Bergen, Norway
k Medizinische Hochschule Hannover Hannover, Germany
l Athens University Hospital ATTICON Athens, Greece
m Karolinska University Hospital Stockholm, Sweden
n Hospital Universitario la Paz Madrid, Spain
o San Filippo Neri Hospital Rome, Italy
p Hôpital Jeanne d'Arc Toul, France
* Corresponding author. Department of Medicine, Sahlgrenska University Hospital/Östra, SE-416 85 Göteborg, Sweden. Tel.: +46 313434078; fax: +46 31258933. E-mail address: karl.swedberg{at}gu.se (K. Swedberg).
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Abstract |
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 Top Abstract 1. Introduction2. The syndrome of...3. Totality of evidence...4. Guidelines for device...5. Appropriate patients for...6. The 2- to...7. Economics of care8. Enhancing the standards...9. ConclusionsConflict of interestReferences |
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Implanted biventricular pacemakers (cardiac resynchronisation therapy, CRT) with or without implantable cardioverter defibrillators (ICD) improve survival and morbidity in some patients with chronic heart failure (CHF) who are optimally treated with pharmacologic agents according to current guidelines. Correspondingly, ICDs improve survival.
However, there is only limited evidence for device treatment in certain patient subgroups, such as the impact of ICD on outcomes in patients with reduced ejection fraction in New York Heart Association (NYHA) Class I or IV heart failure. Similarly, limited evidence exists for CRT in patients with only modest QRS prolongation or only modestly reduced ejection fraction.
Despite evidence for a beneficial effect of device therapy in CHF, only a minority of eligible patients are currently offered these options. Multiple reasons contribute to the underuse of these potentially life-saving therapies. A lack of adherence to guidelines by health care professionals is an important barrier. Clearly, efforts should be made to improve the standard of care and to familiarise all physicians involved in managing CHF patients with the indications and potential efficacy of these devices. Increased collaboration between structured heart failure care and pacemaker clinics as well as between electrophysiologists, heart failure clinicians, and primary care physicians is required. Such team collaborations should lead to improved care with reduced mortality and morbidity and increased cost effectiveness. Treatment strategy should be based on a structured approach tailored to local practice and national priorities.
Key Words: Cardiac resynchronisation therapy • Chronic heart failure • Device • Defibrillator • Guidelines • Treatment
Received August 11, 2008; Accepted September 22, 2008
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1. Introduction |
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TopAbstract1. Introduction2. The syndrome of...3. Totality of evidence...4. Guidelines for device...5. Appropriate patients for...6. The 2- to...7. Economics of care8. Enhancing the standards...9. ConclusionsConflict of interestReferences |
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During the past 10 to 15 years, the management of chronic heart failure (CHF) has undergone major advances, resulting in improvements in survival, morbidity, and quality of life. The beneficial effects of angiotensin-converting enzyme (ACE) inhibitors, beta-blockers, angiotensin receptor blockers, and aldosterone antagonists are well established and their appropriate use is essential for the management of patients with CHF [1]. Yet, there remains a need to understand how these agents should be combined and tailored for the individual patient, especially those who have co-morbidities or advanced CHF. In addition, some patients with CHF may be candidates for an implantable cardioverter defibrillator (ICD) or biventricular pacemakers (cardiac resynchronisation therapy or CRT), sometimes referred to as CRT-P when used alone or CRT-D when combined with an ICD. These devices have been documented to improve survival (ICD and/or CRT) and morbidity (CRT) in certain patient populations with CHF on top of optimal pharmacological therapy.
Although our understanding and development of implantable devices have advanced from an electrophysiological perspective, there is still a disparity between the scientific and clinical experience and between experts in device and pharmacological therapies. To address the challenge of better integration of drug and device therapies in patients with CHF, the following consensus document written by a multidisciplinary group with expertise in pharmacological treatment of heart failure and in electrophysiology and arrhythmias, summarises our present understanding of device therapy and its implications in clinical practise.
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2. The syndrome of heart failure |
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TopAbstract1. Introduction2. The syndrome of...3. Totality of evidence...4. Guidelines for device...5. Appropriate patients for...6. The 2- to...7. Economics of care8. Enhancing the standards...9. ConclusionsConflict of interestReferences |
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Chronic heart failure accounts for 5% of medical admissions to hospitals, and up to 10% of bed-days due to relatively long admissions [2]. This drives the economic cost of heart failure to the health service — heart failure accounts for 1% to 2% of the total health care budget in most western countries [3]. Hospitalisation rates appear to have peaked, as evidenced by a decline in many countries in the past 5 years [4-6], presumably related to better chronic disease management, including use of disease-modifying drugs and improved monitoring. The prognosis of heart failure has also improved — mortality in most clinical trials runs below 10% per year and epidemiological studies show improvement in life expectancy after diagnosis [7]. However, mortality and morbidity remain high and re-hospitalisations are frequent.
The typical heart failure patient has considerable co-morbidity that may include atrial fibrillation, hypertension, diabetes, chronic lung disease, or renal dysfunction [8]. Degenerative disease, such as osteoarthritis and cognitive decline, may also be present. This poses a challenge for patient management and makes compliance with multiple medications and lifestyle measures difficult.
Chronic heart failure is viewed as a complex clinical syndrome that should be treated with a combination of neurohormonal antagonists [1]. Associated co-morbidities make the assessment and treatment of CHF even more complex. Because of this complexity, there is a need to promote and develop multidisciplinary collaboration between health care professionals, including cardiologists who have an interest in heart failure and others with an interest in electrophysiology, internists, nurses, and nephrologists. Physicians and specialised nurses in many countries have created networks in specialised heart failure clinics. In Sweden, for example, almost all acute care hospitals have such clinics [9]. The treatment options that have emerged in the last few years have resulted in significant treatment benefits and have highlighted the need for such an extended collaboration between practitioners with experience in heart failure. Accordingly, in the future, heart failure units need to ensure that they have a clear idea of the needs of their patients and can provide optimal care.
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3. Totality of evidence and limitations of device therapy |
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Of the great variety of implantable devices available in 2008, definitive evidence of benefit exists for both CRT and ICD. Compelling evidence of benefit also exists with their hybrid (CRT+implantable defibrillator or CRT-D) [10-13].
In patients with heart failure, the proven function of an ICD is to treat life-threatening ventricular arrhythmias, when left ventricular ejection fraction (LVEF) is <30-35% in patients in New York Heart Association (NYHA) Class II-III failure. Studies show that ICDs reduce the risk of sudden death by about two-thirds and prevent, in absolute terms, between 1 and 3 deaths (all-cause) per year over 2 to 5 years for every 100 devices implanted [11,13]. The rate of shock is several times the rate of sudden death in the relevant control group, suggesting that the programming of the ICD should be optimised to identify the best detection interval to avoid shocks on episodes that may terminate spontaneously. This per se calls for tight monitoring of implanted patients by the heart failure specialist and the electrophysiologist to ensure optimisation of device settings as the underlying disease progresses. For these reasons, patients who need ICD therapy should be selected with great care.
CRT devices reduce ventricular volumes and mitral regurgitation, increase LVEF and blood pressure, and improve symptoms, morbidity and mortality, including sudden death. Trials included predominantly patients in sinus rhythm with recent or persistent NYHA Class III/IV heart failure, but did include some patients with NYHA Class II heart failure and some with atrial fibrillation. The trials generally required a QRS 
120 ms for inclusion, but the median QRS of included patients was about 160 ms, with relatively few patients with QRS <140 ms [13,14]. The response to CRT varies because the characteristics of myocardial dysfunction differ between individuals, whilst the multisite-stimulation adopted in CRT is not usually much tuned to a specific individual. The identification of patients who may recover, improve, or even worsen with CRT is a matter of current and future collaborative research, which includes evaluation of electrical, mechanical, biochemical and clinical parameters.
Synchronisation of atrioventricular contraction and changing the electrical and mechanical activation of the ventricles by pacing have a positive impact on reverse ventricular remodelling. This implies that mechanical stimuli (i.e., stretch or distortion) may induce cascades of genetic expressions in the myocytes that may profoundly affect their function. In other words, according to many experimental findings, both the structure and function of the heart can be modified by local electro-mechanical stimuli.
CRT-D devices may reduce the rate of sudden death further. As compared to ICD trials, the rate of shock is high (about 18% per year in COMPANION) probably reflecting the severity of the disease being treated [15]. It is possible that by improving ventricular function, CRT may reduce the risk of ventricular tachyarrhythmias and sudden death, thus making an ICD unnecessary [14,16]. Careful assessment of the patient and his/her risk profile is critical when deciding whether CRT-D is needed.
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4. Guidelines for device therapy |
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One of the most important efforts in developing guidelines is centred around the need to derive recommendations for the management of unselected patients based on the results of clinical trials that enrolled a highly selected patient population. In such attempts, professional or government bodies charged with guideline development have had to make assumptions and extrapolations to cope with gaps in the evidence base and allow the application of guidelines to "clinical reality." In the field of device therapy for CHF patients, major efforts have been made to ensure that harmonisation exists in the recommendations supported by electrophysiologists and heart failure specialists and that alignment is in place also among international scientific societies. Currently in the most recent guidelines there are similar recommendations for the use of ICDs in patients reduced ejection fraction and for the use of CRT (Tables 1-3
) [1,17-19].
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5. Appropriate patients for device therapy |
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The most appropriate patient for an ICD only, is one with left ventricular systolic dysfunction who is unlikely to die of anything other than a sudden arrhythmic death in the next 1 to 2 years. ICD therapy alone should perhaps be confined to patients who are asymptomatic or minimally symptomatic. There were very few patients with NYHA Class III heart failure in MADIT-II [11] (although short-term survival was improved in those patients) and a predefined subgroup of NYHA Class III patients did not benefit in SCD-HeFT [13].
CRT device implantation is a more complex procedure, but these devices are substantially less expensive. Several single-centre observational studies have suggested that one or more imaging measures of mechanical dyssynchrony may predict benefit with CRT. So far, it has been impossible to replicate these results in multi-centre studies, suggesting that such measures are highly operator dependent and/or prone to observer bias. Currently, there is no evidence that selecting patients by imaging techniques is appropriate or that dyssynchrony, as currently defined, is the substrate for the effect of CRT. In addition, patients with a device need careful attention not only of their pharmacological therapy but also of the function of their device.
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6. The 2- to 3-year horizon |
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The cost effectiveness of ICD and CRT therapy can be increased either by reducing device cost, procedure-related costs, extending device life, targeting higher risk patients, or targeting patients who are unlikely to die of other causes. Although 70% of patients respond clinically, there is a range of response. The characteristics of patients that determine the response need to be evaluated. The growth of anti-tachycardia pacing and remote ‘haemodynamic’ monitoring will add extra dimensions to their use. However, one of the most important aspects of cost effectiveness and good patient care is choosing the most appropriate device from the outset.
Presently, there is a considerable geographic variation in the implantation of CRT compared with CRT-D suggesting varying interpretation of trial data [20]. The total number of CRT devices implanted in 2006 (combining CRT-P and CRT-D) was 123, 106, and 85 per million inhabitants in Italy, The Netherlands, and Germany, respectively (Fig. 1). In Sweden, Belgium and UK, the corresponding figures are 84, 82, and 57 per million inhabitants. However, if the CRT-P/CRT-D ratio is calculated, the values are 0.28, 0.45, 0.22, 1.79, 1.73 and 0.68 respectively (Fig. 2). These data illustrate a remarkable variation in the implementation of evidence-based recommendation and the allocation of health care resources across Europe.
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It is possible that CRT use may change from a treatment for symptoms to a treatment for prognosis, extending its use to larger groups of patients with few or no symptoms of heart failure. Other populations, such as those requiring pacing and those with atrial fibrillation, might be added to the CRT indication. In the longer term, the use of CRT might also extend to all patients with a dilated left ventricle and LVEF <40%, but this extended implementation would require a better understanding of the pathophysiology of cardiac dyssynchrony and the benefit should be verified by clinical research and follow-up. The sole potentially useful predictor of no response to CRT may be the volume of ventricle affected by scar, especially if it is extensive around left ventricular pacing sites. Other issues that have to be clarified are the long-term benefit relative to adverse effects related to insertions, multiple leads and their durability. The lead insertion may become easier to perform with new imaging modalities and as new materials for lead manufacture become available.
The development of remote physiological monitoring e.g. recording of pulmonary artery pressure or flow, and intra-thoracic impedance will enhance the value of existing implantable therapeutic devices. Subcutaneous or intravascular monitoring-only devices are likely to be used alone or integrated in a CRT or another implanted device. These device-related problems demonstrate the need for independent surveys/registries that would permit a representative assessment of current European practice including long-term adverse experience.
The large number of new devices also illustrates the potential value of a regulatory body for devices similar to the European Medicines Agency (EMEA) for pharmacological agents.
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7. Economics of care |
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Many clinicians are unfamiliar with discussing the costs of care, but for new developments to be brought into general usage, purchasers (whether they be state or private insurance companies) need to be convinced that the balance between health gain and cost is ‘reasonable.’ Unfortunately, much of the discussion of cost for devices often focuses on up-front investment costs and costs of implantation (neglecting the long-term benefits) or the short-term impact of offering a new therapy on a local provider's budget. This has recently been addressed by Camm et al. [21].
Health care systems are increasingly conscious of the cost of innovation in care. Formal bodies, such as NICE (National Institute for Health and Clinical Excellence) in England, have been established in many European countries to evaluate not only clinical evidence for the benefit of new interventions, but also the cost-effectiveness and cost-utility of such developments. A uniform cost per quality-adjusted life-year does not seem to be in use across Europe [22]. Most recent published analyses from CARE-HF [14], COMPANION [15] and SCD-HeFT [23] suggest that both ICD and CRT (and CRT-D) therapy in heart failure can be cost-effective.
Unlike drug therapy, where the cost of the intervention is spread more or less equally across time (and the therapy can be stopped by the patient at any point), the major cost of implantable devices occurs up front, with longer-term costs remaining relatively low until the ‘can’ containing the battery and electronics needs to be replaced. Costly complications such as lead slippage or infection usually occur in the early period after implantation. In contrast to the cost of the device, the benefit of such therapy takes some time to emerge, and the results of cost-effectiveness analyses are therefore strongly related to the duration of follow-up. Most randomised trials are of short duration (typically 2 to 3 years). Using data from only that period underestimates the likely cost-effectiveness of device therapy over the patient's lifetime. Modelling the cost-effectiveness in controlled, randomised trials over a ‘lifetime’ perspective provides a more realistic assessment to pharmacological therapies including placebo groups [24].
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8. Enhancing the standards of care |
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TopAbstract1. Introduction2. The syndrome of...3. Totality of evidence...4. Guidelines for device...5. Appropriate patients for...6. The 2- to...7. Economics of care8. Enhancing the standards...9. ConclusionsConflict of interestReferences |
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Despite increasing evidence for a beneficial effect of device therapy in heart failure, only a minority of such patients is currently receiving this therapy and this situation needs to be improved. There are several reasons that contribute to this under use of potentially life-saving therapy.
First, there appears to be insufficient adherence to the current guidelines for CHF and a lack of implementation of such guidelines [25,26]. Family physicians and general internists may often be unaware that many patients would benefit from device therapies. This situation is comparable to the use of drug therapy for CHF where several surveys have clearly shown suboptimal utilisation of medications of proven benefit for CHF [27]. This lack of adherence to guidelines by health care professionals or poor patient compliance to guidance and medications was recently shown to be associated with an increased number of hospital admissions [28]. Such analyses for device therapy are not yet available. A further aspect which potentially discourages ICD implantation is the relatively small absolute reduction in sudden death rate per patient implanted (unlike drugs, this is the only expected effect from the ICD) and is related to our inability to make an accurate prediction of arrhythmic risk. Despite this, efforts should be made to improve the standard of care and to familiarise all physicians involved in managing CHF patients with the value of these devices. Measures to provide patients and their families with adequate information are also essential to assure adequate compliance.
A third reason for the under use of device therapy in CHF is that implantation has generally been the domain of specialised cardiologists and electrophysiologists. This may be a practical problem, as many patients are generally under the care of other, general cardiologists and internists [26,29]. Communication between specialists is important: general cardiologists and heart failure specialists should have sufficient knowledge about the possibilities of device therapy. On the other hand, pacemaker specialists should have specific knowledge of management of heart failure and patients should be referred back to the general cardiologist at some point after device implantation. In addition, increased collaboration between structured heart failure care and pacemaker clinics should be encouraged. It is important to recognise that successful implantation often requires cooperation with other professionals including invasive cardiologists, primary care physicians, administrators, and representatives from the device industry, as well as with the patients themselves.
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9. Conclusions |
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TopAbstract1. Introduction2. The syndrome of...3. Totality of evidence...4. Guidelines for device...5. Appropriate patients for...6. The 2- to...7. Economics of care8. Enhancing the standards...9. ConclusionsConflict of interestReferences |
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Treatment of CHF is successful, but optimal therapy requires integration of pharmacological therapy and devices to manage the associated mechanical, neuroendocrine, and electrical disturbances. Close collaboration between experts of various backgrounds is needed including heart failure physicians and nurses as well as physicians with electrophysiological expertise. Such a team collaboration should lead to improved care with reduced mortality and morbidity and increased cost-effectiveness. A structured approach is recommended depending on local and national priorities.
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Conflict of interest |
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All authors have received honoraria from Medtronic. Professor Swedberg has received honoraria and/or research support from all major cardiovascular pharmaceutical companies.
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Acknowledgement |
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Preparation of the manuscript was made possible through administrative and financial support from Medtronic.
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