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| Abstract |
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Methods Patients who received either an implantable pneumatic (n = 38) or a vented electric (n = 54) left ventricular assist device as a bridge to heart transplantation between August 1, 1994, and August 31, 1999, completed 6 instruments used to measure quality of life and factors related to quality of life. Data were analyzed by using descriptive statistics, Pearson correlations, Mann-Whitney U tests, and forward, stepwise multiple regression.
Results Overall satisfaction with quality of life was quite high as determined from the total score on the Quality of Life Index (mean = 0.69). Patients were very satisfied with the implantation and thought that they would do well after future heart transplant surgery. Patients had a moderate level of stress. Significant predictors of overall quality of life were psychological symptoms, stress, and race; these accounted for 46% of variance in quality of life.
Conclusions Patients were satisfied with their quality of life at 1 month after implantation of a left ventricular assist device. However, they were least satisfied with their health and functioning and yet were optimistic about how well they thought they would do after heart transplantation. Psychological factors were the strongest predictors of satisfaction with overall quality of life.
However, in the United States during the past decade, the median waiting time for adults listed as candidates for heart transplantation ranged from 42 to 397 days, depending on the patients United Network for Organ Sharing medical urgency status and blood type.5 From 1988 to 1998, only 3000 to 4500 heart transplantations were performed annually worldwide,4 and 500 to 1000 patients in the United States died each year while awaiting heart transplantation.5 Left ventricular assist devices (LVADs) have been developed in response to the disparity between the number of patients listed for heart transplantation and actual surgeries performed.6 The successful use of these devices prompted our examination of the quality of life of patients who have them implanted.
Examination of quality of life in patients with LVADs has been limited.712 Analyses have been descriptive, comparative, and qualitative (in a phenomenological approach), and sample sizes have been small (
12 patients). We previously reported on quality of life in patients (n = 81) at 1 to 2 weeks after LVAD implantation and on improvement in quality of life in a subset of these patients (n = 30) from before to 1 to 2 weeks after LVAD implantation.13
Multivariate analyses have not been used to study quality of life in patients with LVADs. Understanding the relationships between quality of life and other variables will assist clinicians in determining factors that affect quality of life after implantation of these devices and in developing strategies to help patients improve quality of life.
This report is based on data from our prospective, longitudinal, multisite study of quality-of-life outcomes before and after LVAD implantation and after heart transplantation. In this article, we describe the quality of life in patients at 1 month after LVAD implantation; the relationships between quality of life and demographic, physical, psychosocial, and clinical variables; and predictors of quality of life. Quality of life was defined as "the functional effect of an illness and its consequent therapy upon a patient, as perceived by the patient."14 The following domains of quality of life were measured: physical and occupational function, psychological state, social interaction, and somatic sensation.14
| Methods |
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The nonrandom sample of patients (n = 150) was drawn from a pool of 281 patients. The 131 patients who did not participate in our study included 41 (31%) who had an LVAD implanted but died, 36 (27%) who were too ill to participate, 30 (23%) who refused to participate, 10 (8%) who received transplants before enrollment, 6 (5%) who were not enrolled by research staff, 5 (4%) who could not read or write English, and 3 (2%) who were illiterate.
At 1 month after LVAD implantation, 92 of the 150 patients enrolled in our study were able to complete booklets of quality-of-life questionnaires. The 58 patients who did not complete questionnaires at this time were too sick (45%), received a transplant sooner than 1 month after LVAD implantation (17%), had not yet joined the study (12%), did not complete the booklet (10%), or for other reasons did not return the questionnaires (17%).
Instruments
Completed booklets of instruments used to measure quality of life and factors related to quality of life are described in Table 1
. The instruments were the Quality of Life Index,19 Rating Question Form,20 Heart Failure Symptom Checklist,21 Sickness Impact Profile,22 LVAD Stressor Scale,13 and Jalowiec Coping Scale.23 The order of the self-report instruments in the booklets differed from that used to assess quality of life in these patients at other times before or after LVAD implantation in order to control for the effects of fatigue, sensitization, and response bias. Clinical data, including cardiac history, hospitalizations, operative data, diagnostic data, complications, and medications, were collected from hospital and office records by coinvestigators each time a booklet was completed by a patient.
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Procedures
This study was approved by the institutional review boards for the protection of human subjects at the 10 medical centers. Optimally, patients were enrolled in the study 1 to 4 days before implantation of the LVAD. Patients who were unable to participate at this time (the majority of whom were too ill) were enrolled as soon as possible after LVAD implantation. After the study was explained to the patients, they signed a consent form and were given a booklet of quality-of-life questionnaires to complete with instructions to return the booklet as soon as possible. At 1 month after LVAD implantation, patients were instructed to return the booklet to the site coordinator if they were hospitalized, or they were provided with a stamped, addressed envelope and told to mail the booklet if they were discharged. Clinical data, as previously described, were obtained from hospital and outpatient records by the coinvestigators at 1 month after LVAD implantation.
Design and Statistical Analyses
The study design was correlational. The data were analyzed by using SAS 6.12 (SAS, Cary, NC), S-Plus 2000 (S-Plus, Seattle, Wash), and SPSS 10.0 (SPSS, Inc, Chicago, Ill). Descriptive statistics, including frequencies and measures of central tendency ± SD, Pearson correlations, Mann-Whitney U tests, and forward, stepwise multiple regression were used. Forward, stepwise multiple regression was selected for the multivariate analysis to reduce problems that could arise from multicollinearity. Raw data were analyzed after mean total, subscale, and item scores were calculated for each instrument. Scores were converted to proportional scores by dividing the patients total, subscale, and/or item scores by the maximum possible score, a process that converted the scores to a standardized scale with a range of 0.00 to 1.00.
Before the regression analysis was done, relationships between independent variables (demographic, physical, psychosocial, and clinical variables) and the dependent variable (satisfaction with overall quality of life at 1 month after LVAD implantation, which was derived from the total score of the Quality of Life Index) were examined to detect significant associations. Independent variables significantly associated with overall quality of life at 1 month after LVAD implantation were considered candidate predictors and were entered into the forward, stepwise multiple regression analysis. The model fit was tested and was found to be good. Individual cases were examined to determine potential influential outliers, and because no case altered the coefficients by more than 1 SE, all cases were retained in the analysis. The level of significance used for our analysis was P
.05.
| Results |
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Quality-of-Life Variables.
Overall satisfaction with quality of life was quite high at 1 month after LVAD implantation, as determined from the total score (0.00 = very dissatisfied to 1.00 = very satisfied) on the Quality of Life Index (mean, 0.69; SD, 0.14). Satisfaction with quality of life by subscale from the Quality of Life Index was as follows: significant others (mean score, 0.82; SD, 0.13), socioeconomic (mean score, 0.73; SD, 0.17), psychological (mean score, 0.66; SD, 0.20), and health and functioning (mean score, 0.60; SD, 0.18). Specific items from the Quality of Life Index with which patients were most and least satisfied are listed in Table 3
. Scores for areas of greatest satisfaction ranged from very satisfied to moderately satisfied (0.790.94), and scores for areas of least satisfaction ranged from slightly dissatisfied to slightly satisfied (0.420.60).
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| Discussion |
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It is not surprising that psychological factors were highly related to quality of life. Psychological symptoms from the Heart Failure Symptom Checklist that patients can report being bothered by include irritability, feeling sad, feeling lack of control over ones life, feeling anxious or apprehensive, and feeling depressed. Stressors from the LVAD Stressor Scale include worrying that the LVAD might not work well, worrying about complications (getting an infection), waiting for a donor heart to be found, and being away from family. Better quality of life was explained by being less bothered by psychological symptoms and having less psychological stress.
The strong relationship between quality of life and psychological factors was also reported by Dew et al.28 In their study of patients perceptions after implantation of a ventricular assist device, patients described worry and concerns about device noise, device malfunction, and possible infection. In addition, in our earlier studies of quality of life in patients both before29 and after30 heart transplantation, we detected significant multivariate relationships between quality of life and psychological state. Molzahn et al31 also reported that a psychological factor, outlook, was a predictor of quality of life in both heart transplant candidates and heart transplant recipients. These findings support the need to assess LVAD patients psychological state and provide interventions as needed, including (1) education about the LVAD to reduce stress and (2) psychological and psychiatric consultation.
The relationship between quality of life and race was surprising. Being black was associated with better quality of life at 1 month after LVAD implantation. The reasons for this relationship are unclear. African Americans may simply have a more positive outlook on life, or other factors may distinguish them in some way from other races. The effects of other factors, such as spirituality and religiosity, were not thoroughly examined in our study. Cooper-Patrick et al32 reported that black patients made more comments than did white patients about the impact of spirituality in seeking treatment. Church members were also cited more frequently by black patients as sources of support than by white patients in this study.32 Further study of this relationship is warranted.
Patients overwhelmingly indicated that they were satisfied with the outcome of their LVAD surgery and expected to do well after heart transplantation. The majority of patients thought that the LVAD saved their lives, and most patients stated that they would agree to LVAD implantation again knowing what they knew 1 month after the surgery. Dew et al28 also reported that most patients would consent again to receiving a ventricular assist device and would recommend implantation of such a device to others. In our study, this positive response was attenuated by less positive ratings for stress and quality of life, which were probably tempered by the reality of having survived surgery and yet requiring an LVAD. In addition, the rating for health/functioning, although positive, was still the area of least satisfaction when all 4 subscales of the Quality of Life Index were examined. Therefore, support of patients psychologically, physically, socially, and educationally is paramount to early enhancement of quality of life.
Limitations of this study include the assessment of quality of life in only 92 of the 150 patients enrolled in the overall study. Because almost half of the patients who did not answer the booklet of instruments were too sick to complete the questionnaires, we may have overestimated quality of life at 1 month after LVAD implantation. In addition, only 150 of the pool of 281 patients were enrolled in our study, approximately one third of the patients who were not enrolled died, and a little less than one third of patients not enrolled were too sick to be enrolled. Thus, it is important to emphasize that we assessed quality of life in survivors of LVAD implantation who were well enough to be enrolled in our study. Last, although the time (1 month after LVAD implantation) selected for our multivariate analyses is relatively short, we selected that time because an understanding of predictors of quality of life early after device implantation, when most patients who receive the devices are still hospitalized, may contribute to the development of interventions for patients at risk for poor quality of life before the patients are discharged. Furthermore, no correlational data on quality of life at any time after LVAD implantation are available.
In conclusion, at 1 month after LVAD implantation, patients were satisfied with their quality of life, and the majority of patients stated that the LVAD saved their lives. However, patients were least satisfied with their health and functioning, and yet were very optimistic about how well they thought they would do after future heart transplant surgery. Psychological factors were most strongly predictive of satisfaction with overall quality of life. Psychological assessment and intervention for all LVAD patients are highly recommended both before implantation and within 1 month after surgery. Determining the psychological factors that affect quality of life and developing interventions to address these factors may improve quality of life in patients with LVADs who are awaiting heart transplantation. Because LVADs have been studied as permanently implantable devices, the study of outcomes, especially quality of life, in patients with LVADs is very important.
| ACKNOWLEDGMENTS |
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J. Casida The Lived Experience of Spouses of Patients With a Left Ventricular Assist Device Before Heart Transplantation Am. J. Crit. Care., March 1, 2005; 14(2): 145 - 151. [Abstract] [Full Text] [PDF] |
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