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Ann Thorac Surg 2001;72:2026-2032
© 2001 The Society of Thoracic Surgeons
a Denver Veterans Affairs Medical Center, Denver, Colorado, USA
b Departments of Medicine and Preventive Medicine and Biometrics, University of Colorado Health Sciences Center, Denver, Colorado, USA
c Colorado Permanente Medical Group, Denver, Colorado, USA
d Department of Preventive Medicine, Northwestern University School of Medicine, Chicago, Illinois, USA
e Veterans Affairs Cooperative Studies Program Coordinating Center, Hines VA Medical Center, Hines, Illinois, USA
f Tucson Veterans Affairs Medical Center and Circulatory Sciences Program, University of Arizona Health Sciences Center, Tucson, Arizona, USA
Accepted for publication August 7, 2001.
* Address reprint requests to Dr Rumsfeld, Cardiology (111B), Denver VA Medical Center, 1055 Clermont St, Denver, CO 80220, USA
e-mail: john.rumsfeld{at}med.va.gov
| Abstract |
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Methods. We evaluated 1,744 patients enrolled in the VA Cooperative Processes, Structures, and Outcomes in Cardiac Surgery study who completed preoperative and 6-month postoperative Short Form-36 (SF-36) surveys. The primary outcome was change in the Mental Component Summary (MCS) and Physical Component Summary (PCS) scores from the SF-36.
Results. On average, physical and mental health status improved following the operation. Preoperative health status was the major determinant of change in quality of life following surgery, independent of anginal burden and other clinical characteristics. Patients with MCS scores less than 44 or PCS scores less than 38 were most likely to have an improvement in quality of life. Patients with higher preoperative scores were unlikely to have an improvement in quality of life.
Conclusions. Patients with preoperative health status deficits are likely to have an improvement in their quality of life following CABG surgery. Alternatively, patients with relatively good preoperative health status are unlikely to have a quality of life benefit from surgery and the operation should primarily be performed to improve survival.
| Introduction |
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Because factors associated with survival following CABG surgery have been well defined, clinicians can counsel patients on their mortality risk and recommend surgery for those likely to have a survival benefit [24]. However, there are limited data available to help clinicians identify which patients are likely to have an improvement or decrement in their overall quality of life following CABG surgery. Because CABG surgery relieves angina, one might expect that reductions in angina would directly translate into quality of life improvement following surgery. However, it is important to consider the impact of the operation on overall physical and mental health status since multiple factors may affect quality of life.
In this study, changes in self-reported physical and mental health status were evaluated for a cohort of elective CABG surgery patients. It has been shown that patients with depressed cardiac function (ie, left ventricular dysfunction) have the largest survival benefit with CABG surgery [2]. We hypothesized that a similar relationship exists for quality of life, namely that patients with worse preoperative health status are more likely to have an improvement in quality of life following CABG surgery than patients with better preoperative health status, independent of preoperative anginal burden and other traditional clinical risk factors.
| Material and methods |
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Health-related quality of life (HRQL) was measured using the Short-Form 36 (SF-36) health status survey. A baseline SF-36 was given to the patients for self-administration before surgery. If a patient was unable to complete the survey, the research nurse did interview administration. Patients completed a postoperative SF-36 at their 6-month follow-up visit. If patients missed this visit, the SF-36 was mailed to them. If not obtained by either method, patients were contacted by a trained interviewer for telephone administration.
Study population
Elective CABG surgery patients who completed a base- line SF-36 survey and survived at least 6 months after the operation were eligible for this study. Of the 3,076 elective CABG surgery patients, 2,198 completed a baseline SF-36 survey, and 2,102 survived at least 6 months after the operation. Of the 2,102 eligible patients, 1,744 (83.0%) completed a follow-up HRQL survey. Compared with the 1,744 patients in the final study population, the patients who did not complete both a baseline and follow-up SF-36 survey had some higher risk features, including more patients with left ventricular dysfunction, psychiatric disease, and higher Canadian Cardiovascular Society anginal classification. However, there were no significant differences in the majority of variables including age, prior heart surgery, severity of coronary artery disease, diabetes, and serum creatinine.
Health-related quality of life
The SF-36 is a widely used, reliable, and valid tool for assessing HRQL [6]. The SF-36 reflects the impact of both cardiac and noncardiac diseases on health status, and has been shown to be stable over time in the absence of intervention [68].
The HRQL variables used in all analyses were the Physical Component Summary (PCS) and Mental Component Summary (MCS) scores from the SF-36. The PCS and MCS scores reflect a patients overall physical and mental health status, respectively. The PCS and MCS scores are continuous variables with a range of 0 to 100, with higher scores indicating better health status. The summary scores are standardized to the general US population (mean score = 50; SD = 10). Scoring of the SF-36 followed the methods described by Ware and colleagues [6].
Statistical analyses
To determine whether improvement in HRQL with CABG surgery was a function of baseline health status patients were stratified into quartiles of baseline PCS and MCS scores. Mean changes in PCS and MCS scores were evaluated for the overall study population and within each quartile using paired t tests. A Bonferroni adjustment was used to control for multiple comparisons. The overall association between baseline PCS and MCS quartiles and mean change in scores was evaluated using least squares linear regression.
Because average score changes do not reflect the dispersion of change within the population, the proportion of patients for whom HRQL improved or declined following CABG surgery was determined for the total population and within each quartile of preoperative PCS and MCS scores. Cutoffs of 2.5, 5, and 10 points (approximately 0.25, 0.5, and 1.0 SD, respectively) were used to define change from before to after surgery for PCS and MCS scores. The patterns of change were the same for each cutoff so data are presented only for the more conservative cutoff of 10 points or greater. The linear trend between baseline PCS and MCS quartiles and the proportion of patients with an increase or decrease in their scores was evaluated using the Cochran-Mantel-Haenszel statistic. Subgroup analyses were performed to see if the patterns of change were the same for the following patient groups: age 65 or older versus less than 65 years, caucasian versus non-caucasian race, diabetic versus non-diabetic, and left ventricular ejection fraction 0.55 or greater versus less than 0.55.
Multivariable linear regression models of change in PCS and MCS scores were developed to evaluate the association between preoperative health status (PCS and MCS scores) and subsequent change in HRQL independent of anginal class and the demographic, cardiac, and noncardiac variables listed in Table 1. Univariate analyses were performed between the candidate predictor variables (Table 1) and change in PCS and MCS scores using least squares linear regression. Independent variables associated with change in HRQL with a p value less than or equal to 0.10 in the univariate analyses were considered in the multivariable modeling. We chose approximately 1 SD increments for all continuous predictor variables to standardize comparison. Adjusted R2 was calculated for the multivariable models as a summary measure of goodness of fit. Power was estimated to be more than 99% to detect an increment in R2 of 0.05 by the addition of a given covariate to the linear regression models. Secondary models using multiple logistic regression to model the positive or negative change in PCS and MCS scores yielded similar results to the primary models and are not presented in detail here.
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| Results |
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The study population had depressed preoperative health status with a mean MCS score of 44.2 and a mean PCS score of 32.9 (approximately 0.8 and 1.3 SD, respectively, below the age-group-matched general US population means) [6]. The range of baseline MCS and PCS scores was 7 to 71 but only 4 patients had a score less than 10. Therefore, 99.8% of the study population could have experienced a 10 point increase or decrease in their scores following surgery.
Change in mental health status
Mean changes
Mean MCS scores modestly improved following CABG surgery for the total study population. The mean postoperative MCS score was 46.1, representing a 4% average improvement in mental health status from presurgery to postsurgery (average change, +1.9 points; p < 0.001). As the objective of the study was to determine whether improvement in HRQL with CABG surgery was a function of baseline health status, patients were divided into quartiles of baseline MCS scores. Patients in the lowest MCS quartile experienced the greatest mean improvement in mental health status following surgery (Table 2). As base line MCS scores increased, the degree of improvement in mental health status decreased (p = 0.001 for trend). Patients with MCS scores less than 44 (ie, those in the lowest two baseline MCS quartiles) were the most likely to have an improvement in HRQL following the operation. On average patients with baseline MCS scores 44 or greater had no significant improvement following surgery and those in the highest MCS quartile (baseline MCS scores > 54) had a mean decline in mental health status (average change, -6.2 points; p = 0.001).
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Multivariable analysis
The association between baseline MCS scores and change in mental health status persisted after adjusting for anginal burden as well as the other demographic, noncardiac, and cardiac risk variables listed in Table 1. Patients in lower baseline MCS quartiles were more likely to have an improvement in mental health status following the operation (p < 0.001). The adjusted R2 decreased from 0.22 to 0.01 with the removal of baseline MCS quartile from the multiple linear regression model, indicating that 95% of the explanatory power of this model to predict change in mental health status was attributable to baseline MCS quartile.
Change in physical health status
Mean changes
Changes in physical health status were analogous to those seen for mental health status. Mean PCS scores improved following CABG surgery for the total study population. The mean postoperative PCS score was 38.2, representing a 16% average improvement in physical health status (average change, +5.3 points; p < 0.001). After dividing patients into quartiles of baseline PCS scores, those in the lowest quartile experienced the greatest mean improvement in physical health status following surgery (Table 3). As baseline PCS scores increased, the degree of improvement in physical health status decreased (p = 0.001 for trend). Patients with PCS scores less than 38 (ie, those in the lower three baseline PCS quartiles) were the most likely to have an improvement in HRQL following surgery. On average, patients in the highest PCS quartile (ie, baseline PCS scores
38) did not experience an improvement in physical health status.
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Multivariable analysis
Similar to the findings for MCS scores, the association between baseline PCS scores and change in physical health status persisted after adjusting for anginal burden as well as the other demographic, noncardiac, and cardiac risk variables listed in Table 1. Patients in lower baseline PCS quartiles were more likely to have an improvement in physical health status following the operation (p < 0.001). The adjusted R2 decreased from 0.26 to 0.03 with the removal of baseline PCS quartile from the multiple linear regression model, indicating that 88% of the explanatory power of this model to predict change in physical health status was attributable to baseline PCS quartile.
Impact of anginal class
The correlation between baseline anginal class and baseline MCS scores was low (r = 0.12), and the correlation between baseline anginal class and baseline PCS scores was low-moderate (r = 0.31). Anginal class was not associated with change in MCS scores in either univariate or multivariable analyses (p = 0.99). Anginal class contributed 0.02 to the R2 for the multivariate model of change in PCS scores, indicating that only 7.7% of the explained variance in the outcome was attributable to anginal class.
| Comment |
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The ACC/AHA guidelines for CABG surgery suggest that improvement in quality of life is a primary indication for CABG surgery [2]. The results of this study demonstrate the ability of CABG surgery to improve overall HRQL and thereby support quality of life improvement as a major indication for the operation. The improvements in MCS and PCS scores found in this study are similar to those reported for patients undergoing coronary angioplasty or cardiac valve surgery [9, 10].
This study is consistent with previous literature reporting average improvement in health status following CABG surgery [1117] and also provides clinicians with guidance about which patients are likely to experience improvement or decline in quality of life following the operation. In our study population, patients with preoperative MCS scores less than 44 (about 0.8 SD or more below the age-matched general US population mean) or preoperative PCS scores less than 38 (approximately 1.3 SD or more below the general population mean) were the most likely to have an improvement in HRQL following surgery.
Patients with higher preoperative scores were not likely to have an improvement in their HRQL and as many as 25% of this group reported a marked (
1 SD) decline in quality of life from presurgery to postsurgery. Physical health status may decline because of surgical sequelae (eg, sternal or leg wound complications) or progression of noncardiac diseases. Mental health status may decline because of the neuropsychologic complications of cardiopulmonary bypass or the presence of postoperative depressive symptoms [2, 11, 18].
The finding that patients with lower preoperative health status were most likely to have an improvement in HRQL is analogous to the greater survival benefit following CABG surgery for patients with depressed left ventricular ejection fractions [2]. Conversely, the finding that patients with relatively good preoperative health status were more likely to have a decline in HRQL following CABG surgery suggests that the operation should only be performed in these patients if it improves the chance of survival (eg, for left main disease or three-vessel coronary artery disease with reduced left ventricular function).
We envision the results of this study being used by clinicians as part of a two-step counseling of patients before CABG surgery. First patients should be counseled regarding their mortality risk using the established mortality risk factors [24]. Then patients can be counseled on expected HRQL changes if they survive the operation. It has been shown, however, that clinicians have difficulty assessing HRQL (ie, there is a discrepancy between physician-rated and patient-rated health status) [47]. Therefore in order to counsel patients with regard to expected changes in physical and mental health status following CABG surgery, HRQL should be measured preoperatively using a standardized instrument like the SF-36. This study suggests that patient-rated health status collected before CABG surgery can augment clinical decision-making by helping identify who will have a quality of life benefit from the operation.
Because angina can affect quality of life and CABG surgery is efficacious in relieving angina, one may question whether simple anginal classification alone can be used to predict changes in quality of life following CABG surgery. Our results indicate that using the SF-36 to measure self-reported health status is much more robust than simply assessing anginal burden. The correlation between preoperative anginal class and preoperative HRQL was low. Furthermore, baseline anginal class was not predictive of change in mental health status following the operation, and accounted for only a small amount of the explained variation in change in physical health status. In contrast, patient self-report of preoperative health status was the dominant predictor of change in quality of life following the operation, accounting for 88 to 95% of the explained variation in change in quality of life.
The strengths of this study include its large size, prospective design, and extensive risk variables available for multivariable modeling. When making the decision whether or not to undergo CABG surgery, patients want to know whether they are likely to have an improvement or decline in quality of life. This study therefore focused on change in quality of life from presurgery to postsurgery. There are no published standards for clinically important change in PCS and MCS scores in CABG surgery patients, but it has been suggested that a change in PCS score of about 4 points and a change in MCS score of about 7 points are meaningful to cardiac patients [6, 9]. To enhance the likelihood that the changes in PCS and MCS scores reported in this study were clinically important we chose a more conservative cutoff of 10 points (about 1 SD).
Several potential limitations of this study should be discussed. The results may have limited generalizability to non-Veterans Affairs populations since the study population was predominantly male, older, and had a large burden of comorbidity. In addition, selection bias cannot be excluded because not all patients completed both the base line and follow-up SF-36 surveys.
It is possible that the trends found in this study may be partially due to the statistical phenomenon called regression to the mean [19]. However, the SF-36 has been shown to be very stable over time in the absence of intervention [68]. In Veterans Affairs patients, it has been shown that individual changes in PCS scores more than 5.7 points and MCS scores more than 6.7 points over a 1-year period are unlikely to be due to test-retest variation [8]. In our study, 1,048 patients (60%) had a more than 5.7 point change in PCS scores and 992 patients (57%) had a more than 6.7 point change in MCS scores over a 6 month period, suggesting that our findings are not due to regression to the mean.
The multivariable models explained 22% to 26% of the variance in the change in MCS and PCS scores, respectively. This is consistent with other regression models in the literature predicting quality of life [20]. Postoperative quality of life may be impacted by factors such as surgery complications, postsurgical treatments, and postoperative health events. These variables were not included in our models, however, because the focus of this study was preoperative risk assessment and counseling of patients.
In conclusion, a majority of patients have an improvement in their physical and mental health status following CABG surgery. Patients with worse preoperative health status can be told that they are likely to have a quality of life benefit following CABG surgery if they survive the operation. Alternatively, patients with relatively good preoperative health status cannot expect an improvement in their quality of life following CABG surgery and may experience a decline. For these patients, surgery should be performed only if it improves the chance of survival.
| Acknowledgments |
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The authors would like to acknowledge the contribution of David Werking, DDS, to this project and thank Ms. Josie Loftin for her assistance in preparing the manuscript. The authors also thank Bruce N. Calonge, MD, MPH, Gregory G. Schwartz, MD, PhD, and John Steiner, MD, MPH, for thoughtful review of the draft manuscript.
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