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Choices: a Study of Preferences for End-of-life Treatments in Patients With Advanced Heart Failure
FAILING HEART—MEDICAL ASPECTS
Choices: a Study of Preferences for End-of-life Treatments in Patients With Advanced Heart Failure Jane MacIver, RN, MSc,a,b Vivek Rao, MD, PhD,c Diego H. Delgado, MD, MSc,a,b Nimesh Desai, MD, PhD,c Joan Ivanov, PhD,a Susan Abbey, MD,b and Heather J. Ross, MD, MHSca,b Background: The purpose of this study is to describe the treatment preferences of patients with heart failure among three distinct treatment options— optimal medical management, oral inotropes or left ventricular device (LVAD) support—to determine if there were differences in preferences between patients with mild heart failure (New York Heart Association [NYHA] Class II) and severe heart failure (NYHA Class IV), and also to determine whether quality of life, perceived severity of symptoms and overall health influenced treatment preferences. Methods: We enrolled 91 patients who completed the Minnesota Living with Heart Failure Questionnaire (MLHFQ); visual analog scales for depicting their perceived severity of overall health, dyspnea and fatigue; and a treatment trade-off tool. Results: The most preferred treatment options were oral inotropes, LVAD and standard medical management. There were no differences in treatment preferences between NYHA II and NYHA IV patients. Patient preferences correlated poorly with MLHFQ, symptom and overall health scores. Although not statistically significant, there was a trend toward patients with worse quality of life and symptom scores preferring more aggressive treatment. Conclusions: The results of our study identified two distinct groups of patients: one group preferring treatments that prolonged survival time and another group that favored strategies that improved quality of life but reduced survival time. Treatment preferences were independent of functional or symptom status, suggesting that preferences may be decided early in the course of illness. J Heart Lung Transplant 2008;27:1002–7. Copyright © 2008 by the International Society for Heart and Lung Transplantation.
Patients describe living with heart failure as a progressive decline in physical functioning with an increase in the intensity of symptoms. Patients are considered to have advanced heart failure when, despite maximal medical therapy, there is significant cardiac dysfunction with signs of end-organ hypoperfusion, dyspnea and fatigue at rest.1 Cardiac transplantation is a therapy for patients with advanced heart failure who continue to have severe symptoms on maximal medical therapy. Current listing criteria are extremely strict as a result From the aDivision of Cardiology, Peter Munk Cardiac Center, Toronto General Hospital, Toronto, Ontario; bMultiorgan Transplant Program, Toronto General Hospital, Toronto, Ontario; cDivision of Cardiovascular Surgery, Peter Munk Cardiac Center, Toronto General Hospital, Toronto, Ontario, Canada. Submitted September 4, 2007; revised May 1, 2008; accepted June 3, 2008. Supported by Grant-in-Aid NA5488 from the Heart and Stroke Foundation of Ontario. Reprint requests: Heather Ross, MD, Department of Cardiology, Toronto General Hospital, 11C-1203, 585 University Avenue, Toronto, ON M5G 2N2, Canada. Telephone: 416-340-3482. Fax: 416-3404134. E-mail: [email protected] Copyright © 2008 by the International Society for Heart and Lung Transplantation. 1053-2498/08/$–see front matter. doi:10.1016/ j.healun.2008.06.002
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of the limited availability of donor hearts. The majority of patients with advanced heart failure will die from disease-related complications, and therefore their choice of treatment should be well informed. Short-term improvements in quality of life are attainable, but at increased risk. In randomized, controlled trials, oral inotropes were found to improve heart failure symptoms and quality of life as measured by the Minnesota Living with Heart Failure Questionnaire (MLHFQ).2– 4 These trials were stopped early because the investigational oral inotropes (milrinone, vesnarinone and flosequinan) were associated with a statistically significant increase in mortality.2– 4 Patients treated with oral inotropes were more likely to die earlier (365 days) from sudden cardiac death, whereas patients receiving standard medical management were more likely to live longer (547 days) and die from progressive pump failure. In the REMATCH trial, patients with advanced heart failure who were not eligible for transplant were randomized to therapy with either an implantable HeartMate left ventricular assist device (LVAD) or medical management. Patients treated with the LVAD had an improvement in functional class, quality of life and a mean survival of 332 days, as compared with 182 days for medically treated patients.5
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Time trade-off is a quantitative measure of a patient’s preference for quality vs quantity of life. Results from studies using time trade-off techniques found that heart failure patients with poorer quality of life and higher symptom scores were more willing to sacrifice survival time to improve their quality of life.6 Traditionally, time trade-off techniques use scenarios with a “magic pill” as the hypothetical treatment and describe mode of death as “immediate.” Although we recognize that these methods provide statistically reliable results, we felt it was important to measure treatment preferences using clinically relevant information. We modified the time trade-off technique by adding information on survival time, mode of death, treatment burden and changes in symptoms for three treatment options: medical management; oral inotropes; and LVAD. Optimal medical management represents the Canadian Cardiovascular Society guidelines for the management of heart failure currently in use in our program.7 Oral inotropes were chosen because they allow patients to be at home, a situation our patients consistently describe as representing a good quality of life. Treatment with oral inotropes is also associated with sudden death, and we believe that “how you die” is an important determinant in treatment decisions. Finally, LVAD implantation is a high-risk treatment option currently in use in our program and we wanted more information on patients’ preferences for this option. The purpose of our study was to describe the preferences of patients with heart failure among these three treatments; to determine if there were differences in preferences between patients with mild heart failure (New York Heart Association [NYHA] Class II) and severe heart failure (NYHA IV); and to determine whether quality of life, perceived severity of symptoms and overall health influenced treatment preferences. METHODS Patient Sample A convenience sample was drawn from all patients followed by the Heart Failure Service at Toronto General Hospital. Patients ⬎18 years of age, with either mild heart failure (NYHA II) or severe heart failure (NYHA IV), who could speak, write and comprehend English, were eligible for enrollment. The study was approved by the research ethics board at University Health Network and each patient signed an informed consent prior to participation. Information on patient demographics, etiology of heart failure, medications, devices, cardiac risk factors and physical findings were obtained from each patient’s chart. All interviews were administered by J.M. Interviews were conducted in a private examination room in the outpatient clinic or at the bedside of patients admitted to the hospital. Comments made by patients during the interview that were
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relevant to their preferences were recorded. Eleven patients declined participation because of time constraints. Seven patients were interviewed during a hospital admission. Admitted patients were known to our service, were admitted for an acute exacerbation of their heart failure, and were interviewed within 48 hours of admission. Instruments Each patient completed the Minnesota Living with Heart Failure Questionnaire, a 21-item questionnaire that measures the patient’s perception of the effects of congestive heart failure (CHF) on physical, socioeconomic and psychologic aspects of their life within the past month.8 The scale yields a total score from 1 to 105 with higher scores representing poorer quality of life. Patients also completed separate visual analog scales (VASs) for perceptions of overall health, severity of shortness of breath and fatigue. For overall health, the anchor points were fixed at 0 (poor health) and 100 (excellent health). For severity of shortness of breath and fatigue, the anchor points were fixed at 0 (no shortness of breath or fatigue) and 100 (severe shortness of breath or fatigue). The number of millimeters from the 0 anchor point to the mark represents the score for each VAS. Treatment Trade-off Tool The treatment trade-off tool was designed for this study and integrated clinical information on survival time, mode of death, treatment burden and changes in symptoms (see Appendix). Life-expectancy data were obtained by finding the 50% mortality mark on the survival curves from published literature on medical management for advanced heart failure,5 oral inotropes trials2– 4 and the REMATCH study.5 Six months (182 days) was used for optimal medical management (OMM), 4 months (112 days) for oral inotropes (INO) and 11 months (336 days) for LVAD. These represent the original life-expectancy points for the study. The survival time for oral inotropes was decreased (from 365 days as per study to 112 days for this analysis) to reflect the reduction in survival time associated with their use compared with medical management. Each patient completed the trade-off for the three treatment pairs: medical management vs oral inotropes; medical management vs LVAD; and LVAD vs oral inotropes. For each pair, patients were asked to select which of the two treatment options they preferred. The choice was recorded. The life expectancy of the preferred option was decreased by 7-day increments until the patient’s preference changed to the non-preferred option. At this point, the patient has no preference for one treatment over the other. The length of time between the original life expectancy and the switch
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Table 1. Patient Characteristics
Age (years), Mean (range) Gender (% male) Etiology (% CAD) Mean ejection fraction (%)a ICD (%) CRT (%) Admit ⬍6 months (%) Ward ICU Medications (%) Diuretic ACE/ARB Beta-blockers
NYHA II (n ⫽ 48) 55 (24–78) 81 58 29 50 19
NYHA IV (n ⫽ 43) 52 (23–72) 81 58 20 72 51
33 16
70 52
58 89 92
81 88 67
NYHA, New York Heart Association; CAD, coronary artery disease; ICD, implantable cardioverter-defibrillator; CRT, cardiac resynchronization therapy; ACE, angiotensin-converting enzyme inhibitors; ARB, angiotensin II receptor blockers. a p ⬍ 0.01.
point represents the length of time the patient is willing to trade-off in order to stay in the preferred treatment state (score ⫽ life expectancy ⫺ no. of days traded/life expectancy). The calculated scores are between 0 (defined as willing to trade all time to stay in the preferred treatment state) and 1.0 (defined as not willing to trade any time to stay in the preferred treatment state). The following example illustrates the process. A patient was presented the treatment and outcome options for inotropes and OMM. His initial preference is for OMM with a life expectancy of 182 days. The patient traded off 84 days before switching to inotropes, for a score of 182 ⫺ 84/182 ⫽ 0.54. The patient preferred OMM over LVAD with a trade-off of 140 days (182 ⫺ 140/182 ⫽ 0.23) and inotropes over LVAD with a trade-off of 84 days (112 ⫺ 84/112 ⫽ 0.25). Preference order was determined by ranking treatment options by preference. In the example just noted, OMM was chosen over inotropes and LVAD in those two treatment pairs. Inotropes were chosen over LVAD in the third treatment pair. Thus, the preference order for this patient was OMM ⬍ INO ⬎ LVAD. When there was no clear preference for one treatment over the other, utility scores were used to rank order the treatment options. Data Analysis Student’s t-test for independent samples was used to determine differences in normally distributed data (MLHFQ scores, and VAS scores for dyspnea, fatigue and overall health). Wilcoxon’s rank sum test was used to determine differences in non-normal distributions (preference scores). Chi-square analysis was used to
determine the difference in proportions between the preferred treatment groups. Linear regression analysis was used to determine the relationship between variables. Level of significance for all tests was pre-set at 0.05. To analyze the data we used the SAS system, release 8.2 (SAS Institute, Inc., Cary, NC). Post hoc power calculation for MLHFQ, dyspnea, fatigue and overall health scores identified that the study was adequately powered for continuous variables [Z beta ⫽ ((delta/SD) ⫻ sqrt (n/2)) ⫺ Z alpha)]. RESULTS A total of 91 patients (48 NYHA II and 43 NYHA IV) were enrolled in the study (Table 1). Patients with NYHA IV symptoms of heart failure had significantly higher MLHFQ scores (indicating poorer quality of life), symptom severity scores and lower overall health scores (p ⬍ 0.01) (Table 2). Poor quality of life was associated with higher symptom scores and lower perceived health scores. There were no differences in treatment preferences between patients with NYHA II and NYHA IV symptoms of heart failure. Patient preferences did not correlate with gender, ejection fraction or jugular venous pressure. However, younger patients were more likely to prefer treatment with LVAD compared with older patients (p ⬍ 0.003). Differences in preference scores were calculated using the entire sample (n ⫽ 91). The distributions of the preference scores were non-normal, so median and interquartile range (IQR) are reported. In the inotropes vs medical management pair, the INO median score of 0.25 (IQR 0.44) was significantly lower than the OMM median score of 0.57 (IQR 0.46) (p ⬍ 0.01), indicating a strong preference for the symptom relief afforded by inotropes (Figure 1). In the OMM vs LVAD pair, the OMM median score of 0.23 (IQR 0.34) was significantly lower than the LVAD median score of 0.50 (IQR 0.33) (p ⬍ 0.01), indicating a preference for medical management over device implantation. In the INO vs LVAD pair, the INO median score of 0.25 (IQR 0.50) was significantly lower than the LVAD median score of 0.42 (IQR 0.33) (p ⬍ 0.05). Our patients’ preferences, in rank order, were oral inotropes (42%), LVAD (32%) and
Table 2. Quality-of-life Indicators
MLHFQ Overall health Shortness of breath Fatigue
NYHA II (n ⫽ 48) (mean ⫾ SD) 39.83 ⫾ 22 47.79 ⫾ 24.26 29.67 ⫾ 27.23 48.98 ⫾ 30.75
NYHA IV (n ⫽ 43) (mean ⫾ SD) 65.42 ⫾ 19.6a 28.32 ⫾ 24.43a 49.94 ⫾ 28.68a 66.12 ⫾ 27.34a
NYHA, New York Heart Association; MLHFQ, Minnesota Living with Heart Failure Questionnaire. a p ⬍ 0.01.
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A) Medical Management versus Oral Inotropes: 50 40
# of Patients
30
OMM (n= 37) INO (n= 54)
20 10 0
0-.25
.26 - .50 .51 - .75 Tradeoff Score
.76 - 1.0
B) Medical Management versus LVAD: 50 40 # of Patients
OMM (n=48)
30
LVAD (n=43)
20 10 0
0-.25
.26 - .50
.51 - .75
.76 - 1.0
Tradeoff Score Score
C) Oral Inotropes versus LVAD: 50 40 INO (n=56)
30
# of Patients
LVAD (n=33)
20 10 0
0-.25
.26 - .50
.51 - .75
.76 - 1.0
Tradeoff Score
Figure 1. Trade-off scores by treatment pairs.
OMM (26%). Preferences correlated poorly with MLHFQ, severity of symptoms and overall health scores. Twenty of the patients in our sample had been introduced to the concept of LVAD therapy prior to the interview: 14 during heart transplant assessment; 3 as back-up for high-risk cardiac surgery; and 3 as destination therapy. During the interview, 11 (55%) chose LVAD as their preferred treatment. Of the 14 patients who had LVAD introduced during transplant assessment, 5 (36%) indicated they would consider LVAD only as a bridge to transplantation, not as destination therapy. DISCUSSION The purpose of this study was to learn the preferences of patients living with heart failure for three treatment options: optimal medical management; oral inotropes; or LVAD. Our study design included informing the patients about the outcome, treatment burden and mode of death for all three treatment options. Although hypothetical, this technique mimics decisions patients need to consider during their course of treatment.
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The results of our study identified two distinct groups of patients, with one group preferring treatments that prolonged survival time and another that favored strategies that improved quality of life but reduced survival time. When asked to choose between oral inotropes and medical management, 55% chose oral inotropes, preferring a significantly shorter life (0.25 ⫻ 112 ⫽ 28 days) with improved symptoms to 182 days with worsening symptoms, whereas 45% chose medical management, preferring longer life (0.57 ⫻ 182 ⫽ 103 days) with worsening symptoms of heart failure to a shorter survival time with fewer symptoms. Studies using traditional time trade-off techniques to measure patient preferences in non– heart-failure patients have shown that a small proportion (20%) of patients prefer quality of life over survival time.9 –11 However, the proportion of patients preferring a shorter life with fewer symptoms appears to be higher in patients living with heart failure. Stanek et al adapted their utility score to include clinically relevant information for heart failure patients and found 65% preferred a shorter life with fewer symptoms over a longer life with worsening symptoms.10 Having experienced the shortness of breath, fatigue or poor quality of life associated with advanced heart failure, some patients may wish to consider options that sacrifice survival time in order to feel better. Based on our results it may be time to explore the role of oral inotropes as a palliative option for patients ineligible for heart transplantation or destination LVAD therapy, and who wish symptomatic relief. Mode of death was an important factor in treatment preferences, which was not adequately captured by the quantitative instruments. For some patients, oral inotropes were appealing because of the anticipated symptom relief. They stated they were willing to risk sudden death to avoid breathlessness—a sensation many described as frightening. Another patient stated he would never choose oral inotropes. His father had died suddenly and his family had a very difficult time after his death. He preferred an option where death was anticipated. Other patients offered that they would need time to prepare for death. This included “getting their affairs in order” and saying goodbye. They chose medical management because death was anticipated. Ten patients in the NYHA II group stated they would never consider an LVAD; they did not want to “live out life on a machine.” In the NYHA IV group, 5 patients discriminated between LVAD as a bridge to transplantation and destination therapy. We found these comments intriguing because our treatment descriptions did not discriminate between LVAD as a bridge to transplant or destination therapy. These patients may have explored their treatment options prior to the interview and had clear beliefs on what they would and would not accept at this
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point in their illness. Given that the LVAD described in this study was the HeartMate XVE, different results may be anticipated if the patients were exposed to the improved durability, smaller pump size and silent operation associated with second- or third-generation devices. On the basis of our study there is not enough evidence to support a relationship between quality of life and treatment preferences. Our sample size may not have been large enough to detect a significant difference. Other studies with similar sample sizes have also failed to detect relationships between quality of life and treatment preferences.6,9,10 Our modified time trade-off may have also unintentionally introduced a source of measurement error. Although most patients were able to complete the interview without any visible signs of distress, the information on survival time and symptom severity for three treatment options may have been overwhelming and may have prevented them from absorbing all of the information. In addition, the effect of fatigue and alterations in attention and/or memory associated with advanced heart failure may have limited the ability to engage in the complex reasoning skills required to complete the instrument. With regard to our trade-off procedure, no formal pilot testing or reliability and validity testing were done. Future studies utilizing this instrument will need to incorporate these factors into the design. The results of our study suggest there are two distinct groups of patients: one group preferring treatments that prolong survival time and one that favors strategies that improve quality of life but reduce survival time. There is no easy way to determine who falls into which group. Patient-related factors, such as perceptions, beliefs, values and attitudes, affect how patients make decisions. These are items not easily captured by quantitative methods or easily generalized to the larger heart failure population. Future studies could employ qualitative techniques to describe the process of making a treatment decision or explore the personal factors associated with those decisions. Talking to patients about their treatment options, before they are in the terminal stages of heart failure, is still the best way to understand treatment preferences. Discussions should include information on survival time, symptom relief and mode of death. Initiating discussions earlier can help patients determine how they want to live and how they want to die. Patients who had discussed LVAD implantation prior to participating in this study had very firm beliefs on how they wanted that therapy applied. We believe a similar process, discussing the use of oral inotropes, or deactivation of an implantable cardiodefibrillator, can be helpful for patients who are not
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candidates for heart transplantation or LVAD as destination therapy. REFERENCES 1. Goodlin S, Hauptman P, Arnold R, et al. Consensus statement: palliative and supportive care in advanced heart failure. J Card Fail 2004;10:200 –9. 2. Massie B, Berk M, Brozena S, et al. Left ventricular function and heart failure: can further benefit be achieved by adding Flosequinan to patients with congestive heart failure who remain symptomatic on diuretic, digoxin and an angiotensin converting enzyme inhibitor: results of the Flosequinan–ACE inhibitor trial (FACET). Circulation 1993;88:492–501. 3. Cohn J, Goldstein M, Greenberg B, Lorell B, et al. A dosedependent increase in mortality with Vesnarinone among patients with severe heart failure. N Engl J Med 1998;339:1810 – 6. 4. Packer M, Carver J, Rodeheffer R, et al. Effect of oral milrinone on mortality in severe chronic heart failure. N Engl J Med 1991;325: 1468 –75. 5. Rose E, Gelijns A, Moskowitz A, Heitjan D, et al. Long-term use of a left ventricular assist device for end-stage heart failure. N Engl J Med 2001;345:1435– 43. 6. Lewis E, Johnson P, Johnson W, et al. Preferences for quality of life or survival expressed by patients with heart failure. J Heart Lung Transplant 2001;20:1016 –24. 7. Arnold J, Parker J, Liu P, et al. Canadian Cardiovascular Society consensus conference recommendations on heart failure 2006: diagnosis and management Can J Cardiol 2006;22:23– 45. 8. Rector T, Cohn J. Patient’s self-assessment of their congestive heart failure. Part 2: Content, reliability and validity of a new measure, the Minnesota Living with Heart Failure Questionnaire. Heart Fail 1987;1:198 –209. 9. Tsevat J, Cook E, Green M, et al. Health values of the seriously ill. Ann Intern Med 1995;122:514 –20. 10. Stanek E, Oates M, McGhan W, Denofrio D, Loh E. Preferences for treatment outcomes in patients with heart failure: symptoms versus survival. J Card Fail 2000;6:225–232. 11. Krumholz H, Phillips R, Hamel M, et al. Resuscitation preferences among patients with severe congestive heart failure. Results from the SUPPORT project. Circulation 1998;98:648 –55.
APPENDIX: THE TREATMENT TRADE-OFF INTERVIEW The information that I will give you is hypothetical, which means that it is theoretical or supposed rather than fact. The information is described for the average patient to the best of our current knowledge. We are asking you to imagine how you would feel and the kind of choice you would make with this kind of information. It is important as we go through the choices to remember that the information does not actually apply to you and your situation now. After I describe the treatments, then I am going to ask you to decide between each set of two of the three treatment choices. I will describe three different types of treatments and what is known about them. I will tell you how long people would be expected to live with each kind of treatment. I will tell you about how well the treatment would control the symptoms of heart failure and the side effects that people might experience with them. I will tell you about whether people receiving that treatment would need hospitalization, as this is an important factor for many people. Finally, we will talk about life expectancy and dying with each of the treatments. Nobody likes to talk about death or think about our own death, but
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most us of us have some idea about either how we would like to die or how we do not want to die. Some people prefer the idea of dying suddenly and painlessly. Other people would prefer to go more slowly. I will tell you how people receiving the different kinds of treatments would likely die. Please let me know if I am tiring you out or if what we are talking about is making you upset or anxious or sad. Please let me know if you start to worry that the information I am telling you is specifically related to you rather than hypothetical.
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flights of stairs, as well as occasional tiredness and lack of the ability to work and do household chores. The improvement in symptoms generally lasted only 4 months, then people began to feel sick again. The average life expectancy on oral inotropes is 4 months. Most people who took oral inotropes passed away suddenly and unexpectedly but painlessly. Hospitalization is not required in the first 4 months of treatment. Again, that is a lot of information, could you summarize what I just told you?
Medical Management Let us start with a new treatment strategy called optimal medical management. You have severe heart failure. You get very short of breath with little or no activity. When you sleep you need at least two pillows and sometimes wake up gasping for air. You tire very easily and have difficulty finishing most things you start. You are probably too sick to work and spend most of your time resting at home. You are likely to live for about 6 months. People with severe heart failure usually pass away slowly with difficulties breathing. They often have the sensation that they cannot catch their breath. In the very worst cases, people describe a sensation of drowning. People’s deaths can usually be made much easier through the use of morphine and other medications. Because their death is slower, their families can be with them and there is the chance for people to say their goodbyes. Most patients with severe heart failure need to spend lots of time in hospital and occasionally need to be admitted to the intensive care unit for highly specialized therapy. This is a lot of information, can you summarize it for me?
Oral Inotropes Now let us look at a treatment called oral inotropes. Oral inotropes are pills you take by mouth. They help to keep your blood pressure up and your heart beating. Right now, these medications are not available to use on an outpatient basis. There are similar medications that are currently given intravenously. Some studies that have been done with oral inotropes suggest that heart failure improves significantly for about 4 months. Patients who are prescribed oral inotropes have shown moderate to severe symptoms of heart failure. They originally had difficulty breathing at rest, tired very easily and had trouble sleeping at night. After starting oral inotropes people said the symptoms improved. They had some shortness of breath with moderate exertion, such as climbing two
LVAD Now let us look at a treatment that involves surgery and putting a mechanical device into the patient’s chest. This treatment is called LVAD—LVAD stands for left ventricular assist device. An LVAD is a mechanical pump that helps the heart pump blood to the rest of the body. LVADs are being used now in special situations where they can help people with severe heart failure. People who get an LVAD are very sick and probably would have died before receiving their mechanical heart. The LVAD is placed into the chest through an operation. The surgery for the LVAD is major heart surgery. People generally require at least 3 days in the ICU and at least 14 days in hospital before going home. Before going home you and your family need to learn how to use the LVAD and what to do in case of an emergency. The LVAD needs to be hooked up to a power supply at all times. When you want to go outside you need to attach batteries and carry extra supplies at all times. All this equipment weighs between 5 and 7 pounds. People with an LVAD generally tell us they feel better after they have recovered from the surgery. Most people are able to complete all of their daily activities without any symptoms. The average life expectancy on an LVAD is 11 months. When people pass away with a LVAD, their death is slow and in hospital. The death is due to either the machine not working or due to infection around the machine. Because the LVAD is implanted inside the body there is a higher risk of getting and infection or of the device malfunctioning. This means people with LVADs may spend a lot of time in hospital—at least about 1 month or 30 days in hospital for the implant and one or two hospitalizations per year, each from 8 to 11 days in duration, and if they run into trouble they may be in hospital for up to 3 months. Again, that is a lot of information, could you summarize what I just told you?
Choices: a Study of Preferences for End-of-life Treatments in Patients With Advanced Heart Failure Jane MacIver, RN, MSc,a,b Vivek Rao, MD, PhD,c Diego H. Delgado, MD, MSc,a,b Nimesh Desai, MD, PhD,c Joan Ivanov, PhD,a Susan Abbey, MD,b and Heather J. Ross, MD, MHSca,b Background: The purpose of this study is to describe the treatment preferences of patients with heart failure among three distinct treatment options— optimal medical management, oral inotropes or left ventricular device (LVAD) support—to determine if there were differences in preferences between patients with mild heart failure (New York Heart Association [NYHA] Class II) and severe heart failure (NYHA Class IV), and also to determine whether quality of life, perceived severity of symptoms and overall health influenced treatment preferences. Methods: We enrolled 91 patients who completed the Minnesota Living with Heart Failure Questionnaire (MLHFQ); visual analog scales for depicting their perceived severity of overall health, dyspnea and fatigue; and a treatment trade-off tool. Results: The most preferred treatment options were oral inotropes, LVAD and standard medical management. There were no differences in treatment preferences between NYHA II and NYHA IV patients. Patient preferences correlated poorly with MLHFQ, symptom and overall health scores. Although not statistically significant, there was a trend toward patients with worse quality of life and symptom scores preferring more aggressive treatment. Conclusions: The results of our study identified two distinct groups of patients: one group preferring treatments that prolonged survival time and another group that favored strategies that improved quality of life but reduced survival time. Treatment preferences were independent of functional or symptom status, suggesting that preferences may be decided early in the course of illness. J Heart Lung Transplant 2008;27:1002–7. Copyright © 2008 by the International Society for Heart and Lung Transplantation.
Patients describe living with heart failure as a progressive decline in physical functioning with an increase in the intensity of symptoms. Patients are considered to have advanced heart failure when, despite maximal medical therapy, there is significant cardiac dysfunction with signs of end-organ hypoperfusion, dyspnea and fatigue at rest.1 Cardiac transplantation is a therapy for patients with advanced heart failure who continue to have severe symptoms on maximal medical therapy. Current listing criteria are extremely strict as a result From the aDivision of Cardiology, Peter Munk Cardiac Center, Toronto General Hospital, Toronto, Ontario; bMultiorgan Transplant Program, Toronto General Hospital, Toronto, Ontario; cDivision of Cardiovascular Surgery, Peter Munk Cardiac Center, Toronto General Hospital, Toronto, Ontario, Canada. Submitted September 4, 2007; revised May 1, 2008; accepted June 3, 2008. Supported by Grant-in-Aid NA5488 from the Heart and Stroke Foundation of Ontario. Reprint requests: Heather Ross, MD, Department of Cardiology, Toronto General Hospital, 11C-1203, 585 University Avenue, Toronto, ON M5G 2N2, Canada. Telephone: 416-340-3482. Fax: 416-3404134. E-mail: [email protected] Copyright © 2008 by the International Society for Heart and Lung Transplantation. 1053-2498/08/$–see front matter. doi:10.1016/ j.healun.2008.06.002
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of the limited availability of donor hearts. The majority of patients with advanced heart failure will die from disease-related complications, and therefore their choice of treatment should be well informed. Short-term improvements in quality of life are attainable, but at increased risk. In randomized, controlled trials, oral inotropes were found to improve heart failure symptoms and quality of life as measured by the Minnesota Living with Heart Failure Questionnaire (MLHFQ).2– 4 These trials were stopped early because the investigational oral inotropes (milrinone, vesnarinone and flosequinan) were associated with a statistically significant increase in mortality.2– 4 Patients treated with oral inotropes were more likely to die earlier (365 days) from sudden cardiac death, whereas patients receiving standard medical management were more likely to live longer (547 days) and die from progressive pump failure. In the REMATCH trial, patients with advanced heart failure who were not eligible for transplant were randomized to therapy with either an implantable HeartMate left ventricular assist device (LVAD) or medical management. Patients treated with the LVAD had an improvement in functional class, quality of life and a mean survival of 332 days, as compared with 182 days for medically treated patients.5
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Time trade-off is a quantitative measure of a patient’s preference for quality vs quantity of life. Results from studies using time trade-off techniques found that heart failure patients with poorer quality of life and higher symptom scores were more willing to sacrifice survival time to improve their quality of life.6 Traditionally, time trade-off techniques use scenarios with a “magic pill” as the hypothetical treatment and describe mode of death as “immediate.” Although we recognize that these methods provide statistically reliable results, we felt it was important to measure treatment preferences using clinically relevant information. We modified the time trade-off technique by adding information on survival time, mode of death, treatment burden and changes in symptoms for three treatment options: medical management; oral inotropes; and LVAD. Optimal medical management represents the Canadian Cardiovascular Society guidelines for the management of heart failure currently in use in our program.7 Oral inotropes were chosen because they allow patients to be at home, a situation our patients consistently describe as representing a good quality of life. Treatment with oral inotropes is also associated with sudden death, and we believe that “how you die” is an important determinant in treatment decisions. Finally, LVAD implantation is a high-risk treatment option currently in use in our program and we wanted more information on patients’ preferences for this option. The purpose of our study was to describe the preferences of patients with heart failure among these three treatments; to determine if there were differences in preferences between patients with mild heart failure (New York Heart Association [NYHA] Class II) and severe heart failure (NYHA IV); and to determine whether quality of life, perceived severity of symptoms and overall health influenced treatment preferences. METHODS Patient Sample A convenience sample was drawn from all patients followed by the Heart Failure Service at Toronto General Hospital. Patients ⬎18 years of age, with either mild heart failure (NYHA II) or severe heart failure (NYHA IV), who could speak, write and comprehend English, were eligible for enrollment. The study was approved by the research ethics board at University Health Network and each patient signed an informed consent prior to participation. Information on patient demographics, etiology of heart failure, medications, devices, cardiac risk factors and physical findings were obtained from each patient’s chart. All interviews were administered by J.M. Interviews were conducted in a private examination room in the outpatient clinic or at the bedside of patients admitted to the hospital. Comments made by patients during the interview that were
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relevant to their preferences were recorded. Eleven patients declined participation because of time constraints. Seven patients were interviewed during a hospital admission. Admitted patients were known to our service, were admitted for an acute exacerbation of their heart failure, and were interviewed within 48 hours of admission. Instruments Each patient completed the Minnesota Living with Heart Failure Questionnaire, a 21-item questionnaire that measures the patient’s perception of the effects of congestive heart failure (CHF) on physical, socioeconomic and psychologic aspects of their life within the past month.8 The scale yields a total score from 1 to 105 with higher scores representing poorer quality of life. Patients also completed separate visual analog scales (VASs) for perceptions of overall health, severity of shortness of breath and fatigue. For overall health, the anchor points were fixed at 0 (poor health) and 100 (excellent health). For severity of shortness of breath and fatigue, the anchor points were fixed at 0 (no shortness of breath or fatigue) and 100 (severe shortness of breath or fatigue). The number of millimeters from the 0 anchor point to the mark represents the score for each VAS. Treatment Trade-off Tool The treatment trade-off tool was designed for this study and integrated clinical information on survival time, mode of death, treatment burden and changes in symptoms (see Appendix). Life-expectancy data were obtained by finding the 50% mortality mark on the survival curves from published literature on medical management for advanced heart failure,5 oral inotropes trials2– 4 and the REMATCH study.5 Six months (182 days) was used for optimal medical management (OMM), 4 months (112 days) for oral inotropes (INO) and 11 months (336 days) for LVAD. These represent the original life-expectancy points for the study. The survival time for oral inotropes was decreased (from 365 days as per study to 112 days for this analysis) to reflect the reduction in survival time associated with their use compared with medical management. Each patient completed the trade-off for the three treatment pairs: medical management vs oral inotropes; medical management vs LVAD; and LVAD vs oral inotropes. For each pair, patients were asked to select which of the two treatment options they preferred. The choice was recorded. The life expectancy of the preferred option was decreased by 7-day increments until the patient’s preference changed to the non-preferred option. At this point, the patient has no preference for one treatment over the other. The length of time between the original life expectancy and the switch
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Table 1. Patient Characteristics
Age (years), Mean (range) Gender (% male) Etiology (% CAD) Mean ejection fraction (%)a ICD (%) CRT (%) Admit ⬍6 months (%) Ward ICU Medications (%) Diuretic ACE/ARB Beta-blockers
NYHA II (n ⫽ 48) 55 (24–78) 81 58 29 50 19
NYHA IV (n ⫽ 43) 52 (23–72) 81 58 20 72 51
33 16
70 52
58 89 92
81 88 67
NYHA, New York Heart Association; CAD, coronary artery disease; ICD, implantable cardioverter-defibrillator; CRT, cardiac resynchronization therapy; ACE, angiotensin-converting enzyme inhibitors; ARB, angiotensin II receptor blockers. a p ⬍ 0.01.
point represents the length of time the patient is willing to trade-off in order to stay in the preferred treatment state (score ⫽ life expectancy ⫺ no. of days traded/life expectancy). The calculated scores are between 0 (defined as willing to trade all time to stay in the preferred treatment state) and 1.0 (defined as not willing to trade any time to stay in the preferred treatment state). The following example illustrates the process. A patient was presented the treatment and outcome options for inotropes and OMM. His initial preference is for OMM with a life expectancy of 182 days. The patient traded off 84 days before switching to inotropes, for a score of 182 ⫺ 84/182 ⫽ 0.54. The patient preferred OMM over LVAD with a trade-off of 140 days (182 ⫺ 140/182 ⫽ 0.23) and inotropes over LVAD with a trade-off of 84 days (112 ⫺ 84/112 ⫽ 0.25). Preference order was determined by ranking treatment options by preference. In the example just noted, OMM was chosen over inotropes and LVAD in those two treatment pairs. Inotropes were chosen over LVAD in the third treatment pair. Thus, the preference order for this patient was OMM ⬍ INO ⬎ LVAD. When there was no clear preference for one treatment over the other, utility scores were used to rank order the treatment options. Data Analysis Student’s t-test for independent samples was used to determine differences in normally distributed data (MLHFQ scores, and VAS scores for dyspnea, fatigue and overall health). Wilcoxon’s rank sum test was used to determine differences in non-normal distributions (preference scores). Chi-square analysis was used to
determine the difference in proportions between the preferred treatment groups. Linear regression analysis was used to determine the relationship between variables. Level of significance for all tests was pre-set at 0.05. To analyze the data we used the SAS system, release 8.2 (SAS Institute, Inc., Cary, NC). Post hoc power calculation for MLHFQ, dyspnea, fatigue and overall health scores identified that the study was adequately powered for continuous variables [Z beta ⫽ ((delta/SD) ⫻ sqrt (n/2)) ⫺ Z alpha)]. RESULTS A total of 91 patients (48 NYHA II and 43 NYHA IV) were enrolled in the study (Table 1). Patients with NYHA IV symptoms of heart failure had significantly higher MLHFQ scores (indicating poorer quality of life), symptom severity scores and lower overall health scores (p ⬍ 0.01) (Table 2). Poor quality of life was associated with higher symptom scores and lower perceived health scores. There were no differences in treatment preferences between patients with NYHA II and NYHA IV symptoms of heart failure. Patient preferences did not correlate with gender, ejection fraction or jugular venous pressure. However, younger patients were more likely to prefer treatment with LVAD compared with older patients (p ⬍ 0.003). Differences in preference scores were calculated using the entire sample (n ⫽ 91). The distributions of the preference scores were non-normal, so median and interquartile range (IQR) are reported. In the inotropes vs medical management pair, the INO median score of 0.25 (IQR 0.44) was significantly lower than the OMM median score of 0.57 (IQR 0.46) (p ⬍ 0.01), indicating a strong preference for the symptom relief afforded by inotropes (Figure 1). In the OMM vs LVAD pair, the OMM median score of 0.23 (IQR 0.34) was significantly lower than the LVAD median score of 0.50 (IQR 0.33) (p ⬍ 0.01), indicating a preference for medical management over device implantation. In the INO vs LVAD pair, the INO median score of 0.25 (IQR 0.50) was significantly lower than the LVAD median score of 0.42 (IQR 0.33) (p ⬍ 0.05). Our patients’ preferences, in rank order, were oral inotropes (42%), LVAD (32%) and
Table 2. Quality-of-life Indicators
MLHFQ Overall health Shortness of breath Fatigue
NYHA II (n ⫽ 48) (mean ⫾ SD) 39.83 ⫾ 22 47.79 ⫾ 24.26 29.67 ⫾ 27.23 48.98 ⫾ 30.75
NYHA IV (n ⫽ 43) (mean ⫾ SD) 65.42 ⫾ 19.6a 28.32 ⫾ 24.43a 49.94 ⫾ 28.68a 66.12 ⫾ 27.34a
NYHA, New York Heart Association; MLHFQ, Minnesota Living with Heart Failure Questionnaire. a p ⬍ 0.01.
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A) Medical Management versus Oral Inotropes: 50 40
# of Patients
30
OMM (n= 37) INO (n= 54)
20 10 0
0-.25
.26 - .50 .51 - .75 Tradeoff Score
.76 - 1.0
B) Medical Management versus LVAD: 50 40 # of Patients
OMM (n=48)
30
LVAD (n=43)
20 10 0
0-.25
.26 - .50
.51 - .75
.76 - 1.0
Tradeoff Score Score
C) Oral Inotropes versus LVAD: 50 40 INO (n=56)
30
# of Patients
LVAD (n=33)
20 10 0
0-.25
.26 - .50
.51 - .75
.76 - 1.0
Tradeoff Score
Figure 1. Trade-off scores by treatment pairs.
OMM (26%). Preferences correlated poorly with MLHFQ, severity of symptoms and overall health scores. Twenty of the patients in our sample had been introduced to the concept of LVAD therapy prior to the interview: 14 during heart transplant assessment; 3 as back-up for high-risk cardiac surgery; and 3 as destination therapy. During the interview, 11 (55%) chose LVAD as their preferred treatment. Of the 14 patients who had LVAD introduced during transplant assessment, 5 (36%) indicated they would consider LVAD only as a bridge to transplantation, not as destination therapy. DISCUSSION The purpose of this study was to learn the preferences of patients living with heart failure for three treatment options: optimal medical management; oral inotropes; or LVAD. Our study design included informing the patients about the outcome, treatment burden and mode of death for all three treatment options. Although hypothetical, this technique mimics decisions patients need to consider during their course of treatment.
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The results of our study identified two distinct groups of patients, with one group preferring treatments that prolonged survival time and another that favored strategies that improved quality of life but reduced survival time. When asked to choose between oral inotropes and medical management, 55% chose oral inotropes, preferring a significantly shorter life (0.25 ⫻ 112 ⫽ 28 days) with improved symptoms to 182 days with worsening symptoms, whereas 45% chose medical management, preferring longer life (0.57 ⫻ 182 ⫽ 103 days) with worsening symptoms of heart failure to a shorter survival time with fewer symptoms. Studies using traditional time trade-off techniques to measure patient preferences in non– heart-failure patients have shown that a small proportion (20%) of patients prefer quality of life over survival time.9 –11 However, the proportion of patients preferring a shorter life with fewer symptoms appears to be higher in patients living with heart failure. Stanek et al adapted their utility score to include clinically relevant information for heart failure patients and found 65% preferred a shorter life with fewer symptoms over a longer life with worsening symptoms.10 Having experienced the shortness of breath, fatigue or poor quality of life associated with advanced heart failure, some patients may wish to consider options that sacrifice survival time in order to feel better. Based on our results it may be time to explore the role of oral inotropes as a palliative option for patients ineligible for heart transplantation or destination LVAD therapy, and who wish symptomatic relief. Mode of death was an important factor in treatment preferences, which was not adequately captured by the quantitative instruments. For some patients, oral inotropes were appealing because of the anticipated symptom relief. They stated they were willing to risk sudden death to avoid breathlessness—a sensation many described as frightening. Another patient stated he would never choose oral inotropes. His father had died suddenly and his family had a very difficult time after his death. He preferred an option where death was anticipated. Other patients offered that they would need time to prepare for death. This included “getting their affairs in order” and saying goodbye. They chose medical management because death was anticipated. Ten patients in the NYHA II group stated they would never consider an LVAD; they did not want to “live out life on a machine.” In the NYHA IV group, 5 patients discriminated between LVAD as a bridge to transplantation and destination therapy. We found these comments intriguing because our treatment descriptions did not discriminate between LVAD as a bridge to transplant or destination therapy. These patients may have explored their treatment options prior to the interview and had clear beliefs on what they would and would not accept at this
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point in their illness. Given that the LVAD described in this study was the HeartMate XVE, different results may be anticipated if the patients were exposed to the improved durability, smaller pump size and silent operation associated with second- or third-generation devices. On the basis of our study there is not enough evidence to support a relationship between quality of life and treatment preferences. Our sample size may not have been large enough to detect a significant difference. Other studies with similar sample sizes have also failed to detect relationships between quality of life and treatment preferences.6,9,10 Our modified time trade-off may have also unintentionally introduced a source of measurement error. Although most patients were able to complete the interview without any visible signs of distress, the information on survival time and symptom severity for three treatment options may have been overwhelming and may have prevented them from absorbing all of the information. In addition, the effect of fatigue and alterations in attention and/or memory associated with advanced heart failure may have limited the ability to engage in the complex reasoning skills required to complete the instrument. With regard to our trade-off procedure, no formal pilot testing or reliability and validity testing were done. Future studies utilizing this instrument will need to incorporate these factors into the design. The results of our study suggest there are two distinct groups of patients: one group preferring treatments that prolong survival time and one that favors strategies that improve quality of life but reduce survival time. There is no easy way to determine who falls into which group. Patient-related factors, such as perceptions, beliefs, values and attitudes, affect how patients make decisions. These are items not easily captured by quantitative methods or easily generalized to the larger heart failure population. Future studies could employ qualitative techniques to describe the process of making a treatment decision or explore the personal factors associated with those decisions. Talking to patients about their treatment options, before they are in the terminal stages of heart failure, is still the best way to understand treatment preferences. Discussions should include information on survival time, symptom relief and mode of death. Initiating discussions earlier can help patients determine how they want to live and how they want to die. Patients who had discussed LVAD implantation prior to participating in this study had very firm beliefs on how they wanted that therapy applied. We believe a similar process, discussing the use of oral inotropes, or deactivation of an implantable cardiodefibrillator, can be helpful for patients who are not
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candidates for heart transplantation or LVAD as destination therapy. REFERENCES 1. Goodlin S, Hauptman P, Arnold R, et al. Consensus statement: palliative and supportive care in advanced heart failure. J Card Fail 2004;10:200 –9. 2. Massie B, Berk M, Brozena S, et al. Left ventricular function and heart failure: can further benefit be achieved by adding Flosequinan to patients with congestive heart failure who remain symptomatic on diuretic, digoxin and an angiotensin converting enzyme inhibitor: results of the Flosequinan–ACE inhibitor trial (FACET). Circulation 1993;88:492–501. 3. Cohn J, Goldstein M, Greenberg B, Lorell B, et al. A dosedependent increase in mortality with Vesnarinone among patients with severe heart failure. N Engl J Med 1998;339:1810 – 6. 4. Packer M, Carver J, Rodeheffer R, et al. Effect of oral milrinone on mortality in severe chronic heart failure. N Engl J Med 1991;325: 1468 –75. 5. Rose E, Gelijns A, Moskowitz A, Heitjan D, et al. Long-term use of a left ventricular assist device for end-stage heart failure. N Engl J Med 2001;345:1435– 43. 6. Lewis E, Johnson P, Johnson W, et al. Preferences for quality of life or survival expressed by patients with heart failure. J Heart Lung Transplant 2001;20:1016 –24. 7. Arnold J, Parker J, Liu P, et al. Canadian Cardiovascular Society consensus conference recommendations on heart failure 2006: diagnosis and management Can J Cardiol 2006;22:23– 45. 8. Rector T, Cohn J. Patient’s self-assessment of their congestive heart failure. Part 2: Content, reliability and validity of a new measure, the Minnesota Living with Heart Failure Questionnaire. Heart Fail 1987;1:198 –209. 9. Tsevat J, Cook E, Green M, et al. Health values of the seriously ill. Ann Intern Med 1995;122:514 –20. 10. Stanek E, Oates M, McGhan W, Denofrio D, Loh E. Preferences for treatment outcomes in patients with heart failure: symptoms versus survival. J Card Fail 2000;6:225–232. 11. Krumholz H, Phillips R, Hamel M, et al. Resuscitation preferences among patients with severe congestive heart failure. Results from the SUPPORT project. Circulation 1998;98:648 –55.
APPENDIX: THE TREATMENT TRADE-OFF INTERVIEW The information that I will give you is hypothetical, which means that it is theoretical or supposed rather than fact. The information is described for the average patient to the best of our current knowledge. We are asking you to imagine how you would feel and the kind of choice you would make with this kind of information. It is important as we go through the choices to remember that the information does not actually apply to you and your situation now. After I describe the treatments, then I am going to ask you to decide between each set of two of the three treatment choices. I will describe three different types of treatments and what is known about them. I will tell you how long people would be expected to live with each kind of treatment. I will tell you about how well the treatment would control the symptoms of heart failure and the side effects that people might experience with them. I will tell you about whether people receiving that treatment would need hospitalization, as this is an important factor for many people. Finally, we will talk about life expectancy and dying with each of the treatments. Nobody likes to talk about death or think about our own death, but
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most us of us have some idea about either how we would like to die or how we do not want to die. Some people prefer the idea of dying suddenly and painlessly. Other people would prefer to go more slowly. I will tell you how people receiving the different kinds of treatments would likely die. Please let me know if I am tiring you out or if what we are talking about is making you upset or anxious or sad. Please let me know if you start to worry that the information I am telling you is specifically related to you rather than hypothetical.
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flights of stairs, as well as occasional tiredness and lack of the ability to work and do household chores. The improvement in symptoms generally lasted only 4 months, then people began to feel sick again. The average life expectancy on oral inotropes is 4 months. Most people who took oral inotropes passed away suddenly and unexpectedly but painlessly. Hospitalization is not required in the first 4 months of treatment. Again, that is a lot of information, could you summarize what I just told you?
Medical Management Let us start with a new treatment strategy called optimal medical management. You have severe heart failure. You get very short of breath with little or no activity. When you sleep you need at least two pillows and sometimes wake up gasping for air. You tire very easily and have difficulty finishing most things you start. You are probably too sick to work and spend most of your time resting at home. You are likely to live for about 6 months. People with severe heart failure usually pass away slowly with difficulties breathing. They often have the sensation that they cannot catch their breath. In the very worst cases, people describe a sensation of drowning. People’s deaths can usually be made much easier through the use of morphine and other medications. Because their death is slower, their families can be with them and there is the chance for people to say their goodbyes. Most patients with severe heart failure need to spend lots of time in hospital and occasionally need to be admitted to the intensive care unit for highly specialized therapy. This is a lot of information, can you summarize it for me?
Oral Inotropes Now let us look at a treatment called oral inotropes. Oral inotropes are pills you take by mouth. They help to keep your blood pressure up and your heart beating. Right now, these medications are not available to use on an outpatient basis. There are similar medications that are currently given intravenously. Some studies that have been done with oral inotropes suggest that heart failure improves significantly for about 4 months. Patients who are prescribed oral inotropes have shown moderate to severe symptoms of heart failure. They originally had difficulty breathing at rest, tired very easily and had trouble sleeping at night. After starting oral inotropes people said the symptoms improved. They had some shortness of breath with moderate exertion, such as climbing two
LVAD Now let us look at a treatment that involves surgery and putting a mechanical device into the patient’s chest. This treatment is called LVAD—LVAD stands for left ventricular assist device. An LVAD is a mechanical pump that helps the heart pump blood to the rest of the body. LVADs are being used now in special situations where they can help people with severe heart failure. People who get an LVAD are very sick and probably would have died before receiving their mechanical heart. The LVAD is placed into the chest through an operation. The surgery for the LVAD is major heart surgery. People generally require at least 3 days in the ICU and at least 14 days in hospital before going home. Before going home you and your family need to learn how to use the LVAD and what to do in case of an emergency. The LVAD needs to be hooked up to a power supply at all times. When you want to go outside you need to attach batteries and carry extra supplies at all times. All this equipment weighs between 5 and 7 pounds. People with an LVAD generally tell us they feel better after they have recovered from the surgery. Most people are able to complete all of their daily activities without any symptoms. The average life expectancy on an LVAD is 11 months. When people pass away with a LVAD, their death is slow and in hospital. The death is due to either the machine not working or due to infection around the machine. Because the LVAD is implanted inside the body there is a higher risk of getting and infection or of the device malfunctioning. This means people with LVADs may spend a lot of time in hospital—at least about 1 month or 30 days in hospital for the implant and one or two hospitalizations per year, each from 8 to 11 days in duration, and if they run into trouble they may be in hospital for up to 3 months. Again, that is a lot of information, could you summarize what I just told you?