Uses for intravenous inotropic therapy in the home are twofold: as a "bridge to transplant" in adults and children and as a way to manage advanced heart failure (HF) until end of life. Donor organs for transplant in patients with HF are limited. Candidates waiting for organs often will require the use of continuous inotropic or mechanical circulatory support until a donor becomes available. Left ventricular assistive devices (LVADs) have also been shown to be an effective "bridge to transplant" but have additional risks of complications such as bleeding, systemic thrombotic events, device infection, and mechanical failure (Assad-Kottner et al., 2008). A study by Assad-Kottner et al. (2008) has shown that when the expected wait time for transplantation is short (<100 days), continuous milrinone is a safe and effective choice. Risks to continuous inotropic therapy include: arrhythmias, hypotension, and central line infection (Kazory & Ross, 2012). The optimal duration of inotropic therapy prior to cardiac translpant or until a LVAD is required, remains unknown and controversial.

Figure. No caption available.

The National Home Infusion Association (NHIA) is an organization for clinicians, managers, businesses, and institutions that provide infusion therapy services to patients in home care and outpatient settings. (For information about certification for clinicians and institutions, see Box 1.) The organization conducts surveys and has data on home infusion use among members, but exact numbers of patients using inotropes in the home is difficult to ascertain. The NHIA membership cared for between 775,306 and 1,102,188 patients in 2008 (NHIA, 2011). Jefferson Home Infusion Service, a provider in the Philadelphia region, reports that 0.5% to 0.8% of their clients serviced received home inotropic therapy (Thomas Brown, personal communication, July 13, 2012). By calculating 0.8% of NHIA's patient numbers, a very conservative estimate of patients receiving home inotropic therapy is roughly 6,202 to 8,817. These numbers are expected to increase with the passage of the Patient Protection and Affordable Care Act as governmental incentives will allow for expanded home care services (National Prevention, Health Promotion and Public Health Council, 2011).

Box 1. Certification: Supporting Excellence in Heart Failure Care in the Home

Significance

HF or congestive heart failure (CHF) is a disease state that afflicts approximately 6.6 million people in the United States (Roger et al., 2012). HF is the preferred term to use as not all patients with this disorder experience fluid accumulation or congestion (Rosa, 2008). Each year, 670,000 patients are newly diagnosed with the disease (Centers for Disease Control and Prevention [CDC], n.d.a). It is more common in African American and Hispanic males (Roger et al., 2012). The associated morbidity and mortality are high. With each new HF diagnosis, one of five people will not be alive 1 year from the date of diagnosis (CDC, n.d.a), and half of all patients diagnosed with HF will die within 5 years (Roger et al., 2012). At end-stage HF, there are limited treatment options.

HF's course is characterized by frequent exacerbations and periods of control. More effective management of patients with HF has come under serious scrutiny since recent Center for Medicare & Medicaid Services (CMS) mandates will not cover hospital and home care costs for a patient readmitted within 30 days of a discharge where HF was the admitting diagnosis (Stone & Hoffman, 2010). Penalties for readmissions have been authorized by the Hospital Readmission Reduction Program and will begin in 2013 (Stone & Hoffman, 2010). The first diagnoses to be affected by the program are HF, pneumonia, and acute myocardial infarction (AMI). Private healthcare insurers are considering reimbursement penalties similar to those of CMS, making managing HF in a manner that decreases recidivism highly relevant (Sommers & Cunningham, 2011).

Causes and Pathophysiology of Heart Failure

HF is primarily associated with hypertension and/or AMI (Coviello, 2009; Lloyd-Jones et al., 2010). Additional factors are anatomically based such as coronary artery disease, ventricular hypertrophy, and cardiomyopathies. These factors affect hemodynamics such as cardiac output, circulating fluid volume, respiration, vascular diameter and resistance, and blood viscosity. Interruptions in normal blood flow and tissue perfusion over time lead to decreases in myocardial function (Albert, 2012).

There are also neurohormonal factors that can contribute to HF such as renin, angiotension, aldosterone, natriuretic peptides, and antidiuretic hormone. The secretion of these substances can lead to an increase in preload and afterload, which further taxes the cardiac and peripheral anatomy (Caldwell & Mamas, 2012). As a result, the anatomy remodels itself and becomes less functional thus necessitating increased oxygen demands that can no longer be met effectively without assistance from pharmacotherapeutic agents or implantable devices.

HF can have various causes including genetics, personal behavior such as obesity, sodium intake, high-fat diet, smoking, alcohol intake, drug use or abuse, and lack of physical exercise, as well as diabetes, infection, advanced age, anemia, and thyroid problems. Heart valve damage, embolic events and/or arrhythmias can also lead to HF development (Lloyd-Jones et al., 2010). The American Heart Association's Scientific Statement on prevention of HF stresses the reduction of individual risk factors (Schocken et al., 2008). This statement describes major and minor clinical risk factors (e.g., hypertension and smoking) but has added additional categories-toxic risk precipitants (i.e., chemotherapy history), genetic risk (specific DNA sequence variations like 1Arg389), and morphologic risk predictors (i.e., asymptomatic LV dysfunction) (Table 1) (Coviello, 2009; Schocken et al., 2008).

Table 1. Established and Hypothesized Risk Factors for Heart Failure

The pathophysiology of HF is complicated. Although the foundation of HF is based on the heart's inability to meet bodily metabolic demands, there are many distinct subcategories (Caldwell & Mamas, 2012). Most clinicians are familiar with the differences between failure that occurs in the pulmonary system (left-sided heart failure) or in the periphery (right-sided heart failure). However, the heart can also suffer from high-output versus low-output failure. High-output failure is characterized by increased demands, whereas low-output failure is defined as diminished pump function. There is also a difference between systolic and diastolic HF. Systolic failure is characterized by decreased pump function and decreased ejection fraction, whereas diastolic failure manifests as impairment of ventricular filling with an ejection fraction of at least 50%. Diastolic failure is on the rise, especially in patients with comorbidities such as hypertension, atrial fibrillation, and obesity (Bhatia et al., 2006; Owan et al., 2006). These distinctions coexist in many patients, and so clinicians may see components of several types of HF in singular patient cases.

More recent research has focused on the renal mechanisms of HF. It is theorized that increasing the efficacy and speed of weight loss via diuresis while decreasing renal adverse effects would maximize effectiveness of treatment for those suffering from HF. Some of these newer agents and their respective targets include adenosine-1 receptor antagonists, endothelin receptor antagonists, and vasopressin receptor antagonists (Kazory & Ross, 2012).

Clinical Presentation: Symptomology of HF

Symptoms of HF include shortness of breath, orthopnea, paroxysmal nocturnal dyspnea, generalized fatigue, weakness, and exercise intolerance. Additional symptoms can include fluid retention, with possible weight gain and swelling of the feet, ankles, or abdomen. Jugular venous distention and hepatomegaly can be another sign. Patients can exhibit S3 (ventricular gallop) or S4 (atrial gallop) heart sounds. In older adults, ventricular gallop is a cardinal sign of heart failure. It is caused by rapid ventricular filling that results in vibrations of the ventricles that produces the additional heart sound. Atrial gallop generally occurs post-myocardinal infarction or with long term hypertension (HTN) or aortic stenosis. As the ventricles stiffen and lose their ability to stretch, blood is not effectively ejected. This phenomenon makes the atria work harder causing them to vibrate that produces the additional S4 heart sound (Coviello, 2009).

As the heart loses the ability to pump an adequate supply of blood throughout the body, blood is initially diverted to the heart and the brain. Less vital organs (i.e., the kidneys or the digestive system) receive insufficient blood supplies to function properly. Over time this can result in decreased urine production, nocturnal urination, loss of appetite, nausea, or vomiting (Coviello, 2009; Kazory & Ross, 2012). Abdominal distention, with decreased blood supply to the renal and digestive systems, can lead to both chronic renal insufficiency and malnutrition issues.

Kato et al. (2012) studied the "worst symptoms" as defined by patients during hospitalization for HF. Of 371 patients, the most common "worst" symptoms were "difficulty breathing," followed by "fatigue," then "abdominal discomfort," and "body swelling."

Diagnosis, Functional Classification, and Staging

HF is not always easy to diagnose. Initial symptomatology is usually insidious. Inotropic therapies are those that affect the force of muscle contraction generally initiated in patients with end-stage HF also called acute decompensated heart failure. HF is usually classified by functional ability and stage. The New York Heart Association's (NYHA) method is generally used to classify function and the American College of Cardiology (ACC)/American Heart Association's (AHA) system is used for staging. Both have similarities (Table 2). Patients in NYHA Class III (moderate) and IV (severe) and ACC/AHA Stage C (symptomatic) or D (refractory) could be candidates for inotropic therapy (Heart Failure Society of America [HFSA], 2010). These patients should also be registered in the Acute Decompensated Heart Failure National Registry (ADHERE) if their HCP is affiliated with a participating heath system.

Table 2. New York Heart Association Classification System

ADHERE is a national registry that prospectively collects data regarding the medical management of patients hospitalized with acute HF across the United States (http://RegistriesLive.org, n.d.). Started in 2001, the registry is still open, with over 275 participating institutions and patient enrollment over 100,000 (Gheorghiade & Filippatos, 2005; http://RegistriesLive.org, n.d.). Their ongoing data are used to improve the care of future patients with this disorder.

Types of Inotropic Therapy

For the purposes of this article, there are three main agents used for inotropic therapy: dopamine, dobutamine, and milrinone. Milrinone and dobutamine are the most common inotropic therapies used in the home (Jessup et al., 2009). Dopamine is primarily used in the acute care setting because its use necessitates close hemodynamic monitoring. Dobutamine requires beta-receptors for its inotropic effects, which is a significant consideration for patients already maintained on beta-blocking drugs (Jessup et al., 2009).

Dopamine is a beta-1 receptor agonist. Stimulation of these receptors causes both an increase in the force and completion of contractions within the heart. However, dopamine is a drug that has differing activities at different doses: at higher doses, contractility is improved via an increase in heart rate and force of contractility, whereas lower doses have little effect on heart rate (Rodgers & Lee, 2011). When dopamine is used at the higher doses necessary to affect contractility, vasoconstriction, and hypertension ensues, making this drug less desirable for the management of HF.

Although dopamine is considered more useful in the treatment of cardiogenic shock, dobutamine is a more reasonable choice for use as an inotrope. Dobutamine stimulates Beta-1 and Beta-2 receptors, with the Beta-1 stimulation accounting for its major inotropic effects. When compared with dopamine, dobutamine has increased positive inotropic and chronotropic effects, which lead to a decrease in peripheral vascular resistance via vasodilation (Rodgers & Lee, 2011). In addition, dobutamine does not usually increase heart rate.

The mechanism of milrinone differs from both dopamine and dobutamine in that it inhibits phosphodiesterase-III, resulting in increased inotropy and profound arterial and venous vasodilation. Milrinone increases stroke volume and cardiac output with little change in heart rate (Rodgers & Lee, 2011). A significant benefit of milrinone compared to the other two agents is its long terminal half-life; this quality makes the drug a preferred choice for home infusion patients in need of chronic inotropic therapy. See Table 3 for a comparison of the three inotropic medications used in the home.

Table 3. Commonly Used Intravenous Inotropic Medications in the Home

Treatment Guidelines for Uses of Inotropic Therapy in the Home

Guidelines from the National Institute for Health and Clinical Excellence (NICE), the Heart Failure Society of America (HFSA), the American College of Cardiology Foundation (ACCF), and the AHA provide resources for healthcare providers to use in the treatment of HF. (For a list of clinical resources, see Box 2.) It is interesting to note that only the ACCF/AHA Task Force guidelines mention the use of intravenous inotropes in the home setting. The comment is brief and not specific (HFSA, 2010; Jessup et al., 2009; NICE, 2010). The ACCF/AHA guidelines (2009, p. 1362) state that "the decision to continue intravenous infusions at home should not be made until all alternative attempts to achieve stability have failed repeatedly, because such an approach can present a major burden to the family and health services and may ultimately increase the risk of death." Therefore, clinical judgment and collaboration with the patient regarding all possible treatment options is paramount.

Box 2. Clinician Resources

Epinephrine was one of the earliest intravenous inotropes and was introduced in the early 20th century (Zarychanski et al., 2009). Routine use of inotropic therapy in hospitals for advanced disease has been available since the 1950s to 1960s (Zarychanski et al., 2009). Therapy can be given intermittently (over 72 hours at specified intervals) or continuously, although the ACCF/AHA (2009, p. 1362) guidelines do not recommend using intermittent outpatient infusions of "vasoactive drugs such as nesiritide or positive inotropic drugs [as they] have not shown to improve symptoms or survival in patients with advanced HF."

The use of inotropes in the home is more recent. It is generally reserved for those for whom all other conventional therapies have failed to improve symptoms. Indicators for use include elevated Type B natriuretic peptide or N-terminal pro b-type natriuretic peptide levels, and left ventricular ejection fraction levels that are less than or equal to 35% (HFSA, 2010; Jessup et al., 2009; NICE, 2010) with associated patient symptomatology.

Oral inotropes, developed in the last 20 years, have shown to acutely improve cardiac output, decrease filling pressures, and, in some cases, enhance quality of life. Chronic oral inotrope use has been associated with higher mortality rates, raising concerns that intravenous formulations can also increase mortality (Hauptman et al., 2006). Teerlink et al. (2009) state that patients should be fully informed that although inotropic therapy might make them feel better, it has the potential to shorten life expectancy.

Nursing Considerations for Home Infusion Therapy

During the discharge planning process, the following issues should be addressed, including a patient's clinical stability, their home environment (including a determination of a working water supply, electricity, and phone services), the appropriateness of a particular IV access device for the therapy (ports vs. PICCs), insurance reimbursement, and whether the patient and/or caregiver has the ability (and willingness) to competently participate in the proposed plan for home infusion care (Gorski, 2005). The question of whether the therapy can be interrupted for any reason like home/hospital transfers should also be evaluated. Lastly, many agencies require 24-hour-a-day presence of a caregiver-this needs to be determined prior to the patient's discharge (Gorski, 2005). See Tables 4 and 5 for a sample tools used for this process by one home infusion agency.

Table 4. Sample Home Infusion Service Pathway Tool-Jefferson Home Infusion Service (JHIS)

Table 5. Home Parenteral Inotropic Therapy: Data Collection Form

In addition to the routine instructions given to patients with HF, such as medication education, smoking cessation, sodium restriction (approximately 2 g per day), fluid restriction (approximately 2 L per day), obtaining daily weights, reporting weight gain (1-2 lbs per day or 4-5 per week), as well as any exacerbations of symptoms that occur, patients and caregivers will be instructed in procedures related to administering an intravenous inotropic infusion (Rosa, 2008). Patients should be taught to administer the infusion using a pump via aseptic technique. It is recommended that patients receiving these therapies are not left unattended.

Ideally, acute care discharge planners should be involved in a preliminary assessment of the environment where the inotropic infusion will take place. Assessment of the home should include an evaluation of electrical and telephone access, cleanliness of the home, refrigeration (size and availability), storage for infusion supplies, as well as safe patient mobility within the home (Table 4). The admitting home care nurse will verify these factors, but if this assessment is done before discharge, a safer transition of care will occur (Gorski, 2005).

Pediatric Considerations

Use of home inotropic therapy for children is typically reserved for those awaiting heart transplantation. Changes to United Network for Organ Sharing criteria now allow these patients to be discharged to home while maintaining 1B status. Berg et al. (2007) have shown that continuous home inotropic therapy in children with HF is safe with few complications. By avoiding a prolonged hospitalization, it can result in substantial cost-savings and improvements in family dynamics. There is evidence that extended hospital stays can negatively impact family coping, and lead to developmental regression and the development of post-traumatic stress disorder (Berg et al., 2007). Home inotropic therapy minimizes interruptions to the daily routines of both the patient and other siblings. Home care also allows for ease of family and friend visitation.

Costs of Home Inotropic Therapy

Costs related to home infusion of inotropes vary. The major costs associated with hospital-based therapy are the hospital room, board and associated physician/nursing/24-hour operational services. When provided in the home, costs are decreased because they only include drug/supply and nursing/infusion company services. In the Berg et al. study (2007), the mean cost to administer of milrinone in the home was $64/day. When compared to the average hospital stay for the same services the savings were approximately $611/day. One Home Infusion Service, where the authors are employed, estimates costs to provide inotropic home therapy at approximately $176/day.

Reimbursement Issues

Most private commercial and state-based Medical Assistance plans cover home infusion therapy (NHIA, 2012). Medicare Part A does not cover drugs and IV-related supplies but may cover skilled nursing visits if certain criteria are met (i.e., the agency is one approved by Centers for Medicare & Medicaid Services [CMS], the care is intermittent and skilled, and the patient must be "homebound," etc.) (CMS, n.d.a; Gorski, 2005; NHIA, 2012).

Under Medicare Part B, limited coverage for medications or solutions (inotropic drugs) may be included under the durable medical equipment benefit that would also include infusion pumps (Gorski, 2005). The optional Medicare Part B is a supplemental plan to Medicare Part A. Not all patients who meet eligibility requirements can afford to purchase Part B. More recently Medicare Part D (another supplement to Medicare Part A that is purchased by patients) may cover some home infusion drugs but does not cover additional essential medical services, supplies, and equipment that home infusion companies must provide for safe and effective patient outcomes. Part D is not sufficient to cover all costs associated with alternate site infusion therapy drug dispensing (NHIA, 2012). Depending on individual state regulations, additional information from the patients' primary care provider such as results of invasive hemodynamic monitoring, cardiac functional status, and medication history are required for reimbursement.

Navigating therapy reimbursement options is dynamic and complex. Home infusion agencies and their intake/billing staff are experts in addressing these issues, and are adept at coverage verification and explaining all aspects of coverage including copays and limitations to patients in the form of Home Health Advance Beneficiary Notices (CMS, n.d.a; Gorski, 2005).

Hospice and Palliative Care Considerations

For patients with end-stage HF, inotropic infusions are considered palliative treatment because they are aimed at reducing symptoms and exacerbations that would otherwise require hospitalization. Although considered palliative, most hospice agencies do not provide/cover these therapies (Goldfinger & Adler, 2010; Stuart, 2007). This may be due to the fact that inotropes are also used as "life-sustaining" or "curative" treatments in circumstances other than end-of-life situations (bridge to transplant, etc.). Intravenous inotropic drugs are more expensive than their oral counterparts. Hospices must cover all required care and therapies from one allotted pool of hospice benefit dollars (including nursing care, durable medical equipment, medications, and wound care supplies); costs are a consideration. Hospice benefits are provided under Medicare Part A, but an approved agency can only charge 5% of the reasonable cost, up to a maximum of $5, for each prescription for outpatient drugs or biologicals for pain relief and symptom management related to the terminal illness (CMS, n.d.b). This can be a barrier to patients who desire hospice services, especially since most patients with terminal HF prefer to die at home, but the majority dies in hospitals (Taitel et al., 2012). Taitel et al. (2012) found that patients with HF who participated in a home inotropic support program remained at home during the final stages of life. They were less likely to die in hospitals, making this therapy an effective palliative care option for patients who prefer to die at home. If a patient's plan offers a palliative care option, inotropic infusions are more likely to be reimbursed.

HF patients at end of life can require dosage titrations and the administration of diuretics in addition to the infusion of inotropic agents as well as the use of potent analgesics (Jessup et al., 2009). There have been recent accounts of the continuous subcutaneous infusion of furosemide, which is less expensive than intravenous inotropes. This offers another option for patients at end of life (Zacharias et al., 2011). Because hospice and palliative care benefits are reimbursed differently than traditional insurance plans, home care and hospice nurses need to work closely with agency billing authorization staff to assist patients and their families in making difficult transitions from one course of treatment to another. All cases need to be reviewed individually to optimize the care provided. As with all treatment options, risks and benefits must be weighed.

Clinical Outcomes: Risks Versus Benefits

The benefits of these therapies include a better quality of life because of improved symptoms, such as relief from shortness of breath, dyspnea on exertion, orthopnea, paroxysmal nocturnal dyspnea, pulmonary/lower extremity edema, and increased exercise tolerance (Lloyd-Jones et al., 2010). Risks include the potential for central line infection, the development of arrhythmias, hypotension, and sudden death (Berg et al., 2007; Kazory & Ross, 2012). The development of a central line infection can be reduced by educating family members to adhere to strict hand hygiene and infection prevention procedures.

Another consideration for the nurse to be aware of relates to central line placement in patients with HF who also have implantable pacemakers and defibrillators (ICDs). Care needs to be used when inserting the central lines so as to not disrupt the ICD leads. The devices may need to be temporarily turned off during line placement to avoid an unintended shock from any guide wires. A patient's ICD functioning post line placement should be evaluated (Epstein, et al., 2008; McPherson & Manthous, 2004).

Future of Home Therapies for Heart Failure

Natriuretic peptides are expensive and their use has been controversial (O'Connor et al., 2011). New pharmaceutical agents (calcium sensitizers, sarcolemmal calcium receptor or Na-K ATPase agents, free fatty acid metabolism modulators, and cardiac myosin activators) are in the research and development pipeline (Teerlink et al., 2009).

The areas that show the greatest promise for long-term success are stem cell and gene therapies. Stem cells have the potential to develop into many differentiated cell types, with the goal to replace dead tissue from an AMI with new viable tissue that would improve heart functioning. Stem cells can be prepared from a heart biopsy and once manipulated can be re-infused back into the heart (Bolli et al., 2012).

Gene therapy is the process by which defective genes are altered to correct the functioning of a specific organ (Jaski et al., 2009). Genes need to be delivered to the diseased organ via infusions or virus vectors. The calcium up-regulation by percutaneous administration of gene therapy trial has just completed phase II of testing (Jaski et al., 2009). Currently, these treatments are not available for HF patients outside of clinical trials.

Conclusion

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