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Abstract
Hospitalization for heart failure accounts for a substantial portion of the overall cost of caring for these patients and is a predictor of shortened survival in patients with chronic HF. Avoidance of readmission is critical as those hospitalized with HF face a 50% rate of readmission within 6 months and 25%–35% incidence of mortality within a year.
Knowledge of this syndrome is important in order to deliver comprehensive supportive care to these patients and reduce readmissions Intravenous drug therapy is an important adjunct in this effort. This article focuses on the syndrome as it relates to intravenous agents prescribed for the patient in the home setting.
HF continues to be a major and growing public health concern in the United States. Over 5 million people suffer from HF and an estimated 1 million are hospitalized each year. Up to 20% of these patients are readmitted within 1 month after the initial presentation. Hospital discharges have increased 155% in the past 20 years as HF has become the leading cause of hospitalization for persons over 65 (Huynh et al., 2006). Hospitalizations due to HF account for a substantial portion of the overall cost of caring for patients with the disorder and may be associated with a high degree of morbidity and mortality, claiming 50,000 lives annually (Somberg & Molnar, 2009). In fact, studies show that hospitalization is and of itself an independent risk factor for shortened survival in patients with chronic HF (Jessup et al., 2009; Levenson et al., 2000). Statistics following a hospital stay for HF further illustrate the seriousness of the disorder. Patients with HF who are hospitalized face a 50% rate of readmission within 6 months and a 25% to 35% incidence of death in a year. In 2005, the total direct and indirect cost of HF in the United States was equal to $27.9 billion with approximately $2.9 billion spent annually on drugs (Jessup et al.; Radford et al., 2005).
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Due to the cost of human life and loss of financial resources, insurers and government agencies use hospital readmissions as a benchmark for successful management of HF. The focus of this article is to outline the causes for hospitalizations due to HF, suggest the most effective strategies the Home Health Clinician can use to care for the patient at home and provide an understanding of I.V. HF medications that may be used in the home setting to further support an outcome that is supportive of patient and family needs.
HF is not a disease but a complex clinical syndrome that can result from any structural or functional cardiac disorder that impairs the ability of the ventricle to fill with or eject blood. The chief symptoms of HF are dyspnea and fatigue, which may limit exercise tolerance and increase fluid retention and may ultimately lead to pulmonary congestion and peripheral edema. Both abnormalities, though not necessarily present at the same time, can impair functional capacity and impact quality of life. Patients manifest symptoms differently. Some patients have exercise intolerance but little evidence of fluid retention, whereas others complain primarily of edema and report few symptoms of dyspnea or fatigue. Due to these differences, the term, "heart failure" is preferred over the previous term, "congestive heart failure" because all patients do not have volume overload at the time of initial or subsequent evaluation (Radford et al., 2005).
Patients with signs and symptoms of HF should be evaluated and diagnosed starting with a complete physical exam and medical history. If HF is suspected, common diagnostic tests such as an electrocardiogram (ECG), chest X-ray, angiography, or radionuclide ventriculography may be ordered. Once a diagnosis is confirmed, the physician may classify the development of the disease using the New York Heart Association (NYHA) functional classification system that places patients in one of four categories based on limitations in physical activity. A new staging classification system was developed by the American College of Cardiology and the American Heart Association (ACC/AHA) due to concerns related to the reliability of the NYHA classification system. The new system, intended to complement the NYHA system, recognizes established risk factors and structural prerequisites for HF development and identifies therapeutic interventions that can be introduced even before the appearance of symptoms. The ACC/AHA staging system was created to reliably and objectively identify patients with the disease and link them to treatments uniquely appropriate at each stage of illness (Hunt et al., 2005).
Regardless of the clinical profile, there are common patient characteristics when admitted to the hospital with HF. Admission is often triggered by a concomitant cardiovascular event such as a symptomatic tachyarrhythmia, unstable coronary syndrome, or a cerebrovascular event. As a result of comorbidities such as hypertension, renal disease, thromboembolism, and coronary artery disease, the precipitating event leading to hospitalization is not always readily apparent. Other common factors that may precipitate hospitalization for HF include noncompliance with medical regimen, sodium, and/or fluid restriction, acute myocardial ischemia, uncorrected high blood pressure, atrial fibrillation and other arrhythmias, recent addition of negative inotropic drugs or pulmonary embolus. Nonsteroidal anti-inflammatory drugs, excessive alcohol or illicit drug use, endocrine abnormalities, such as diabetes mellitus, and concurrent infections, such as pneumonia or viral illnesses, are also factors that may precipitate hospitalization for HF (Jessup et al., 2009).
Successful home management depends on a strong working relationship between the patient, the family, and the healthcare team. Research shows that general measures with the greatest effect include close observation and immediate follow-up. Diet and medication noncompliance negatively affect patient outcomes as increases in body weight and even minor changes in symptoms can precede major clinical incidents that require emergency treatment or hospitalization. Close observation, care coordination and goal setting can reduce the likelihood of nonadherence and allow the patient and Home Health Clinician an opportunity to prevent clinical deterioration (Jessup et al., 2009; Philbin, 1999). Emotional support is also critical in managing patient anxiety and fear, the two greatest drivers of ED visits for patients with HF. Often the knowledge that caring supportive professionals are a call away is sufficient to calm the fears of patients who fear loss of control and often go the ED to seek reassurance (McDougall, personal communication, May 28, 2009).
A key tool supporting safe, high-quality care for patients following hospitalization is the consistent use of clinical practice guidelines developed by the AHA and the Heart Failure Society of America. One of the most important resources to assist in care coordination includes the use of clear discharge instructions and educational materials provided to the patient and family which address activity level, diet, medications, follow-up appointments, weight monitoring and instructions on what to do if the patient's condition worsens. Education of the patient and family is critical to success as failure to understand and follow through often leads to clinical deterioration and subsequent hospital readmissions (Bonow et al., 2005). The data are clear that patients who follow recommendations related to diet, exercise, weight loss and other lifestyle choices can alleviate symptoms, slow the progression of the disease and improve the quality of everyday life (Jessup et al., 2009).
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General principles that merit discussion related to end-of-life care focus on patient and family education, evaluation of final treatment options, and comprehensive care planning. All of these should be initiated before the patient becomes too ill to assist in decision making. Discussions regarding living wills, advance directives, and treatment preferences should be initiated with special attention on a series of likely scenarios such as cardiac arrest, cerebrovascular accident, and worsening of noncardiac conditions. When reviewing these situations, short-term interventions with the expectation of immediate recovery should be distinguished from long-term life support measures, which offer little hope for recovery. It is imperative that Home Health Clinicians and the entire care team have realistic expectations and communicate these clearly among themselves and with patients and families.
According to McDougall (personal communication, May 28, 2009), problems setting realistic goals often originate with the physician who may act too aggressively regardless of patient wishes. All members of the care team must work together to ensure that patient and family desires are understood and valued. The Home Health Clinician provides an important role as the patient advocate in these situations. An honest assessment of the clinical and emotional needs of the patient provides realistic recommendations for care provided in the final days of life that do not add to the hope of recovery or negatively impact quality of life (Jessup et al., 2009).
Hospice services have been extended to patients dying of HF for several years. Originally developed for patients with end-stage cancer, the focus of palliative care has been extended to HF patients who have symptoms that need attention in addition to pain, such as breathlessness and depression. For these patients, palliative care may require administration of I.V. diuretics (Weber, 2004) and in some cases infusion of positive inotropic agents as well as the use of potent analgesics (Hunt et al., 2005; Jessup et al., 2009).
Intravenous Drugs
Patients with refractory HF may be admitted to the hospital for clinical deterioration and receive I.V. positive inotropic agents as well as vasodilator drugs. Once the patient has stabilized, however, an oral regimen will be initiated to minimize further clinical deterioration and maintain symptomatic management. Some patients are unable to be weaned from I.V. to oral therapy and may be discharged home with an indwelling I.V. catheter. Because of the risk to the patient and the burden to the family and health agencies, I.V. medications should not be used unless all attempts to apply orally based strategies have been exhausted. In spite of the risks, many patients with HF respond favorably to I.V. pharmacological treatment and enjoy a good quality of life as well greater opportunity for survival. For others, continuous I.V. support provides palliation of symptoms that allows the patient to live the remainder of life at home (Jessup et al., 2009).
Although positive inotropic agents can improve cardiac performance during short-term and long-term therapy, long-term oral therapy with these drugs has not improved symptoms or clinical status and has been associated with a significant increase in mortality, especially in patients with advanced HF. The data support the use of I.V. infusions in the home or in outpatient settings, that is, to allow for hospital discharge; however, due to the lack of evidence to support efficacy and concern about toxicity, intermittent positive inotropic agents are not recommended for patients who have been successfully weaned from inotropic support. Intermittent outpatient infusions of positive inotropic drugs and vasoactive agents have not improved symptoms or survival in patients with advanced HF (Yancy et al., 2007).
The medication regimen has encountered a paradigm shift, from not just the treatment of HF, but to improved long-term mortality and the use of short-term I.V. agents is an important adjunct to that effort (Jessup et al., 2009; Radford et al., 2005). Although treatment options are growing for patients with HF in the home, payment for I.V. drugs is in the process of change as well. Because services obtained while in hospice are paid, the cost of most medications is included. Inotropic therapy is covered under Medicare Part B, provided the patient meets the qualifications for therapy; however, the cost of all I.V. medications is not currently covered.
According to Dr. Peter McDougall, a medical director for several large health maintenance organizations (personal communication, May 28, 2009), the lack of payment for I.V. medications is a barrier to some patients electing to receive hospice services, even if they meet all of the criteria. In many cases, McDougall notes, these patients will be readmitted to the hospital frequently because they cannot be adequately cared for in the home. Interviews with administrators and directors of cardiovascular home health agencies note that providing short-term, defined as less than 6 months, I.V. drug therapy is covered in a case rate based on diagnosis. One administrator noted that even if the agency is not reimbursed for some drugs, supplying the medication on a short-term basis without reimbursement is "the cost of doing business" (D. Capper, personal communication, May 29, 2009). Payment remains a barrier to some patients' electing hospice services or receiving I.V. medications in the home, however, with increased attention on the cost and quality of care received in the inpatient setting, care options, including I.V. medications, will receive more scrutiny as viable alternatives to hospitalization.
Positive Inotropic Drugs: Phosphodiesterase Inhibitors
Milrinone is more frequently administered for short-term management of HF in the home setting. This drug has positive inotropic effects on the heart and causes vascular smooth muscle relaxation. The drug quickly increases cardiac function by enhancing contractility while simultaneously reducing preload and afterload through their vasodilatory action. Milrinone's inotropic effects are similar to digoxin. Milrinone is generally used in combination therapy with digoxin and diuretics (Hauptman et al., 2006, Gorski, 2002).
Milrinone improves contractility by inhibiting the enzyme responsible for the inactivation of cyclic adenosine monophosphate (cAMP) resulting in increased levels of cAMP in myocardial cells. The increase in cAMP leads to enhanced calcium entry into the cell. As with other drugs that increase intracellular calcium, the greater concentration of calcium allows the cardiac muscle fibers to contract more forcibly. The agent also has direct smooth muscle relaxation effects leading to vasodilatation. Milrinone has the added effect of improving left ventricular relaxation during diastole.
Milrinone has hypotensive side effects and may cause headaches. Milrinone can cause thrombocytopenia and rare hepatotoxicity. The most common and serious side effect of milrinone is ventricular arrhythmia.
An infusion I.V. pump should be used to administer milrinone. Milrinone is given in conjunction with digoxin and diuretics. Digoxin should be given before administering milrinone. As cardiac output improves, carefully monitor for increased urine output. Improved urinary output may require reducing the diuretic dose to avoid hypokalemia. This is an important consideration with the combined milrinone and digoxin-diuretic therapy. The reduced serum levels of potassium will allow digoxin to exert a greater effect and may lead to toxicity.
Adrenergic Agonists: Dopamine and Dobutamine
Dopamine is a catecholamine that occurs naturally in the body. It is classified primarily as a sympathomimetic agent or one that mimics the actions of the sympathetic nervous system. When administered as an exogenous drug, dopamine has dose-dependant effects; at low doses, it affects dopamine receptors only. With moderate dosing, dopamine activates beta1 receptors and at very high doses, it will activate alpha1, beta1, and dopamine receptors. While administered in the home setting, dopamine is not a preferred drug and is more often used in hospice patients (Hauptman et al., 2006, Gorski, 2002).
Dopamine's mode of action involves direct stimulation of beta1 receptors in the heart as well as stimulation of endogenous norepinepherine release. The goal of dopamine therapy in HF patients is to increase myocardial contractility and heart rate to increase cardiac output. Proper dosing with dopamine will allow beta1 activation in the heart that will result in the desired increase in systolic blood pressure and cardiac output. At therapeutic levels, alpha1 activation is avoided; minimizing undesirable increases in peripheral vascular resistance and diastolic blood pressure. Dopamine's onset of action is rapid, occurring within 5 minutes. Its duration of action is less than 10 minutes.
It is important to note that dopamine is not commonly given in the home, but is primarily used in hospice situations as palliative care near the end of life. The most common adverse effects of dopamine include tachycardia, dysrhythmias, and angina that occur as a result of beta1 receptor activation in the heart. Other cardiac effects include ectopic beats and palpations. Nausea, vomiting, and headache are also frequently seen with dopamine administration. At higher doses, extravasation of peripheral tissues can result in necrosis and subsequent tissue sloughing, therefore dopamine should only be administered via peripherally inserted central catheter line in the home setting.
When infusing dopamine, frequently monitor blood pressure, ECG, and cardiac output. Also monitor pulse rate, and color and temperature of limbs. Therapeutic doses for HF patients should result in increased cardiac output and increased blood pressure. If diastolic blood pressure increases disproportionately, decrease the infusion rate and assess for other evidence of peripheral vasoconstriction. Decreased peripheral perfusion may be detected by observing the patient for poor skin perfusion, cold, clammy, pale, mottled skin, or prolonged capillary refill times.
I.V. infusions should be carefully monitored for patency and signs of extravasation. Because high concentrations of dopamine will activate alpha1 receptors, extravasation will cause local vasoconstriction and may cause tissue injury. If this occurs, discontinue the infusion and inject the area with phentolamine to minimize potential tissue necrosis.
Dobutamine is chemically similar to dopamine; it is a sympathomimetic adrenergic given to improve cardiac output in HF patients. Its effects on beta1 receptors in the heart are similar to dopamine; increased contractility and heart rate. Dobutamine's effect on electrical activity in the heart is less pronounced than dopamine. Dobutamine has little action on alpha1 receptors and therefore will not increase peripheral vascular resistance as with dopamine, yet its beta2 effect in the peripheral vascularature leads to vasodilatation augmenting the increase in cardiac output. Dobutamine, a preferred drug, is more frequently administered in traditional home care patients (Hauptman et al., 2006, Gorski, 2002).
Like dopamine, tachycardia is a common side effect of dobutamine. Other side effects include hypertension and in some cases hypotension if the drug is given in high doses. These effects are generally seen with higher doses and can be reversed by reducing the dose. Less common side effects of dobutamine are angina pain, headache, nonspecific chest pain, palpitations, and shortness of breath.
Patients receiving dobutamine do very well in the home without continuous monitoring and may be followed on a weekly basis by a home health clinician.
Conclusion
HF is not a disease but a complex clinical syndrome that can result from any structural or functional cardiac disorder that impairs the ability of the ventricle to fill with or eject blood. Because of the differences in etiology and patient symptoms, the disorder is called "heart failure" rather than the previous term, "congestive heart failure." Due to the financial and human cost associated with HF, the prevention of hospitalization is of immense concern. Hospitalization is in and of itself an independent risk factor for shortened survival in patients with chronic HF. Studies support the positive effects of discharge teaching coupled with excellent postdischarge care in the home to significantly reduce readmission rates and improve health outcomes such as survival and quality of life without increasing costs. Extending palliative services to HF patients at the end of life provides relief from pain as well as dyspnea and anxiety. I.V. medications may be used as supportive agents in the quest for excellent home care that serves to decrease unnecessary hospitalizations and improve health outcomes where possible. Changes in the medication regimen are used not just for the treatment of HF, but as important adjuncts in palliative care, improving the quality of life, and encouraging chronic HF patients to remain at home.
CASE STUDY: Home Infusion Class IV Heart Failure
Lucius is a 75-year-old retired attorney who was recently discharged home with hospice after a hospital stay for Class IV heart failure (HF). His chief complaint was severe dyspnea and lower extremity edema. He was admitted to the hospital 1 month previously and was given diuretics, milrinone, dobutamine, and was placed on bilevel positive airway pressure after which symptoms improved. Lucius waited 3 years on the cardiac transplant list before enrolling in hospice care. Discharge instructions include I.V. dobutamine, digoxin, isosorbide-5-mononitrate, spironolactone, warfarin, enalapril, bumetanide, and sublingual nitroglycerin as needed. Medications for dyspnea include morphine and lorazepam.
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At home, Lucius appeared as an afebrile, frail, older adult with a blood pressure of 90/40 mmHg. The patient was pleasant, alert to surroundings and oriented. His heart rate was regular, the rhythm was without murmers or gallops. There was no jugulovenous distension or lower extremity edema. Dorsalis pedis and radial pulses were 1+ bilaterally.
This patient has been married for the past 50 years to his high school sweetheart and has two children. Hobbies include reading, watching soap operas, and spending time with his wife and family. His wife has durable power of attorney for health affairs. Goals of care include relief of shortness of breath and anxiety with minimal sedation, reduction of lower extremity edema, and avoidance of future hospitalizations with the hope of dying comfortably at home.
Questions that are relevant to the Home Health Clinician include the following: What I.V. medications are used to manage HF in the home setting? What actions can the Home Health Clinician take to improve outcomes and reduce hospital readmissions in HF patients like Lucius?
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