Due to advances in operative techniques, myocardial

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1 Time Related Quality of Life After Elective Cardiac Operation Kwok L.Yun, MD, Colleen F. Sintek, MD, Alden D. Fletcher, MD, Thomas A. Pfeffer, MD, Gary S. Kochamba, MD, Peter R. Mahrer, MD, and Siavosh Khonsari, MD Departments of Cardiac Surgery and Cardiology, Kaiser Permanente Medical Center, Los Angeles, California Background. Due to improved operative techniques, myocardial preservation, and perioperative care, open heart procedures are now being performed in older and sicker patients. As a result, the quality of life has become an important issue in the decision making process. Methods. Between January 1993 and October 1994, 604 patients above 65 years of age who underwent nonemergent open heart operations were followed prospectively over a 2-year period. The Health Status Questionnaire forms were distributed to all patients preoperatively and to hospital survivors at 3, 12, and 24 months. The questionnaire contains 36 questions and is divided into eight categories. Follow-up was 100% complete with 99.6% of questionnaires returned. Results. Significant quality of life improvements were noted in all categories after surgery. After reaching a peak at 12 months, there were small, but significant declines in scores relating to physical health and health perception at 24 months. In contrast, measurements for mental attributes continued to increase with time. By multivariate analysis, diabetes, older age, and female gender had a relatively adverse influence on quality of life despite improvement after operation. Similarly, patients with chronic obstructive pulmonary disease or having redo operations had lower health perception with some physical limitations. While procedure type (coronary artery bypass grafting) was associated with preoperative bodily pain, congestive heart failure symptoms were not an independent factor affecting quality of life. Conclusions. Quality of life improves with cardiac surgical interventions in this studied age group and should not be denied even in the elderly population. (Ann Thorac Surg 1999;68: ) 1999 by The Society of Thoracic Surgeons Due to advances in operative techniques, myocardial preservation, and perioperative care, the trend is to perform open heart procedures in older and sicker patients than those treated in the past. As a result, the quality of life has become an important issue in the decision making process regarding the most appropriate treatment for the increasingly older population with anatomically related cardiac diseases. The importance of quality of life was recognized and referred to as not just the absence of death but life with the vibrant quality that we associate with the vigor of youth by Elkington in 1966 [1]. Quality of life constitutes a person s perceptions of his or her physical and mental well-being, health, and symptoms rather than the surgeon s view of technical success. Major domains include physical functioning, emotional status, cognitive performance, social functioning, general perception of health, and disease-specific symptoms. In this study, we prospectively examine the impact of open heart surgery on patients perceptions of their state of health and how these changes affect their lives over a 2-year follow-up period. Accepted for publication April 5, Address reprint requests to Dr Yun, Department of Cardiac Surgery, Southern California Permanente Medical Group, 1526 North Edgemont St, 3rd Floor, Los Angeles, CA 90027; kwok.l.yun@kp.org. Patients and Methods From January 1993 to October 1994, 850 patients above 65 years of age underwent cardiac surgery requiring cardiopulmonary bypass in the Department of Cardiac Surgery at the Kaiser Permanente Medical Center (Los Angeles, CA). This represented 40% of the 2,113 adult open heart operations (mean age 62.8 years) performed during this period. To focus the analysis on commonly performed procedures, only individuals requiring coronary artery bypass grafting (CABG), valve procedure, or a combination thereof were included. Furthermore, those unable to participate in the preoperative evaluation of the study due to the emergent nature of the operation or untimely transfer on weekends and late nights from outlying Kaiser Permanente facilities were excluded. The remaining 604 patients were studied prospectively to evaluate their quality of life after open heart operation as a function of time. The Health Status Questionnaire (HSQ) forms were distributed to all patients preoperatively and after operation at 3, 12, and 24 months. Follow-up was 100% complete with 99.6% of the questionnaires returned for analysis. The study was approved by an institutional review committee and informed consents were obtained from all patients. The HSQ was developed by the RAND Corporation (Santa Monica, CA) in 1993 to evaluate the quality of life of patients in terms of physical and mental well-being by The Society of Thoracic Surgeons /99/$20.00 Published by Elsevier Science Inc PII S (99)00675-X

2 Ann Thorac Surg YUN ET AL 1999;68: QUALITY OF LIFE AFTER CARDIAC SURGERY 1315 The questionnaire has been validated against the RAND 36-Item Health Survey 1.0 [2] and the 36-Item Short Form [3, 4]. It consists of 36 subjective questions with a various number of available responses. These were then divided into the following eight categories: physical functioning (PF), role-physical (RF, limitations attributed to physical health), bodily pain (BP), health perception (HP), energy/ fatigue (EF), social functioning (SF), role-mental (RM, limitations attributed to emotional problems), and mental health (MH). For each item question, the response is recorded and an item score is assigned in a graded fashion [5]. A scale score for each category is computed by dividing the sum of the item scores within that category by the number of completed item questions. A scale score is assigned to a particular category only when at least one-half of corresponding questions are answered. Scale scores range from 0 to 100 with a higher score indicating a more positive health attribute. Statistical Analysis Variability of scale scores is expressed as 1 standard deviation (SD) (or standard error of the mean [SEM]) and that of mortality rates as 70% confidence limits. Statistical comparison of mortality rates between procedure types was performed using 2 contingency analysis. Repeated measures analysis of variance was used to detect significant changes in any of the eight categories over time after surgery as compared to preoperative values. If a significant F value resulted, paired Student s t test with the Bonferonni method for multiple comparisons was then performed to determine which individual differences were statistically significant (p 0.05). Multivariate regression analysis was used to determine which preoperative characteristics independently affected the quality of life associated with each category. The following ten factors, considered to possibly to have an influence on the postoperative quality of life, were examined: age, sex, race, diabetes, tobacco use, chronic obstructive pulmonary disease (COPD), congestive heart failure (CHF), peripheral vascular disease, surgery type, and redo operation. Variables found to be significant (p 0.05) in the univariate screening analysis were entered into the multivariate mode. A p value less than 0.05 was considered to be statistically significant. Results The overall 30-day hospital mortality rate was 3.3% 0.7% (2.7% 0.8% for CABG miscellaneous, 4.2% 2% for valve surgery miscellaneous, and 5.9% 2.9% CABG valve surgery, p NS). There were 41 late deaths during the 2-year follow-up period (28 for CABG miscellaneous, 10 for valve surgery miscellaneous, and 3 for CABG valve surgery, p NS). Therefore, 543 patients survived to complete the study and their quality of life data were entered into the analysis. Selective preoperative characteristics are summarized in Table 1. The majority of patients were white men over Table 1. Selected Preoperative Patient Characteristics Characteristics Frequency Percent Age (y) Sex Male Female Race Asian Black Caucasian Hispanic Other Undocumented Diabetes Controlled with diet Controlled with insulin Controlled with insulin and oral hypoglycemic agents Controlled with oral hypoglycemic agents Not diabetic Undocumented Smoking history Unknown Never smoked Smoking Stopped smoking Chronic obstructive pulmonary disease Congestive heart failure Peripheral vascular disease Surgery type Coronary artery bypass grafting miscellaneous Coronary artery bypass grafting valve surgery Valve surgery miscellaneous Redo operation years of age with a history of tobacco use. CABG was the predominant procedure with approximately 10% of patients presenting with CHF symptoms. Other preoperative risk factors included diabetes ( 20%) and documented COPD ( 11%). No individual in this study cohort required preoperative hemodialysis for chronic renal insufficiency. As shown in Figure 1, there were significant quality of life improvements after surgery in all eight categories, as compared to preoperative assessment (p ). However, after reaching a maximum at the 12-month follow-up, measures relating to physical health (PF, RP, SF, BP) and health perception fell slightly, but significantly at 24 months. EF scores declined to a level below that at 3 months. In contrast, scores for mental attributes (RM, MH) continued to increase with time. On multivariate analysis, individuals without diabetes

3 1316 YUN ET AL Ann Thorac Surg QUALITY OF LIFE AFTER CARDIAC SURGERY 1999;68: Fig 1. Health status scores at baseline (before surgery) and at 3 months, 12 months, and 24 months after surgery. (BP bodily pain; EF energy/fatigue; HP health perception; MH mental health; PF physical function; RM role mental; RP role physical; SF social function; a p 0.05 vs all scores postoperatively; b p 0.05.) scored significantly higher in all categories (Fig 2). Similarly, male patients or those in the younger age group had greater improvement in quality of life after surgery except in the category of RM and MH, respectively (Figs 3 and 4). In contrast, patients with COPD or having redo procedures had lower health perception with some physical limitations (Fig 5). Race, tobacco history, peripheral vascular disease, and CHF symptoms were not independent factors affecting quality of life postoperatively. Interestingly, surgery type had no impact on quality of life except for an association between CABG and preoperative bodily pain. Comment While mortality and morbidity rates, symptoms of illness, and return to normal activity are commonly used objective measures of clinical outcome after cardiac surgery, these represent only part of what clinicians typically regard as recovery. Recent emphasis has been placed on changes in functional status and feelings of well-being postoperatively. Most studies of this kind have concentrated on patients undergoing CABG [6 17] with few reports [18 20] examining the effect of valve replacement on quality of life. In this investigation, we determined not only the impact of various cardiac operations on quality of life, but also the effects of these changes over time. The 2-year follow-up time frame was chosen to allow patients to achieve maximal stability and long-term recovery. When considering all patients as a group, regardless of the surgery type, open heart operations were associated with improved quality of life. Compared to baseline, patients had a better perception of their health and were happier in general, more energetic, able to perform more strenuous physical activities, and less limited in their social interactions with friends and family. Similar findings were noted by other investigators in patients undergoing CABG [7, 10, 13, 16, 17, 19]. Interestingly, however, we were able to detect a divergence in the scale scores relating to physical and mental attributes after 12 months. While RM and MH continued to improve at 2 years, there were small but significant declines in PF, RP, SF, BP, and HP. In patients randomized to surgical

4 Ann Thorac Surg YUN ET AL 1999;68: QUALITY OF LIFE AFTER CARDIAC SURGERY 1317 Fig 2. Health status scores according to the presence of diabetes. (BP bodily pain; EF energy/fatigue; HP health perception; MH mental health; PF physical function; RM role mental; RP role physical; SF social function.) management in the Bypass Angioplasty Revascularization Investigation (BARI) [17], functional status as measured by the Duke Activity Status Index was also noted to deteriorate after the first postoperative year with a trend toward continued improvement in emotional health. Similarly, a decline in general well-being after 12 months in patients following CABG was observed by Speziale and associates [14]. With 85% of the patients in this study having either isolated or concomitant CABG, the small deterioration in the quality of life in terms of physical activities may be related to recurrence of angina symptoms. The correlation between angina and quality of life has been noted by Pocock and colleagues [16]. Unfortunately, angina was not assessed as part of the questionnaire because the HSQ was not specifically designed for patients with coronary artery atherosclerotic disease. It is important to note that although scores fell after the first year, physical functioning was still considerably better than before operation. Furthermore, patients continued to be uplifted emotionally despite this relatively small deterioration in physical attributes at 24 months. In this study, 10 variables were entered into the multivariate regression analysis to determine which preoperative characteristics independently affected the quality of life associated with each category examined. The most significant factor found to reduce all quality of life attributes, was the presence of diabetes mellitus. Although diabetic patients had substantial improvements with surgery, scores were consistently lower than those without diabetes. Similar findings demonstrated by some [10, 17], but not all [19] investigators. Although not examined, the fact that diabetes also affected patients preoperatively in a parallel fashion suggests that quality of life in general may be impaired by complications resulting from peripheral vasculopathy in this population which would not have been improved with cardiac operations. In terms of physical attributes and consequently health perception, an inverse correlation was noted with increasing age (Fig 4) in the postoperative period although all age groups reported improvement in these categories after surgery. In contrast, no consistent relationship was demonstrated between age and mental health. These observations are in agreement with those made by the BARI investigators [17]. We speculate that one reason for this finding is that older patients are not generally accepted for operation until severe symptoms appear with further progression of disease. As a result, the physical improvement with surgery would be expected to be less. Furthermore, younger patients may be less sensitive to the side effects induced by operation and are able to resume a previously more active lifestyle sooner. Notwithstanding, there was a perception of improved well-being even in those above 75 years of age. Compared to age-adjusted norms using the 36-Item Short Form [21], the level of physical and mental attributes achieved in all eight categories after surgery were similar

5 1318 YUN ET AL Ann Thorac Surg QUALITY OF LIFE AFTER CARDIAC SURGERY 1999;68: Fig 3. Health status scores according to gender. (BP bodily pain; EF energy/fatigue; HP health perception; MH mental health; PF physical function; RM role mental; RP role physical; SF social function.) in this study. Our data is also in concordance with other reports of enhanced quality of life after cardiac surgery in octogenarians [18, 22 25]. Importantly, significant decreases in the level of social support, mean Karnofsky dependency category, and mean social support index [18] as well as improved Karnofsky performance status [25] have been demonstrated in the elderly population. This may be a more appropriate measure of quality of life in this age group since many of them live alone and may have impaired ability to perform activities of daily living. The only other variable that had a significant influence on quality of life was gender with differences more pronounced after surgery. Except for role mental, women consistently reported lower scores in all other categories although there were improvements compared to their health status prior to operation. The reason for this is not clear except that men may assign greater importance to their cardiac disease and are affected less by surgical scarring. In a prospective study of 462 patients reported by Sjoland and coworkers [13], quality of life as measured by the Nottingham health profile was significantly poorer for women both before and 2 years after CABG. Male patients were also noted to fare better both physically and emotionally in the BARI trial [17]. In another prospective study of 215 patients undergoing CABG at the Hôpital Saint-Jacques in France [19], female gender was shown only to be an independent predictor of less improvement in the social isolation section of the Nottingham health profile at 3 months. It is possible that differences in other areas of the questionnaire might not have been evident with such a short follow-up interval. Race, CHF symptoms, peripheral vascular disease, and tobacco use did not emerge as significant factors affecting any of the 8 categories of quality of life assessed. Unless there were extreme cultural differences, one would not expect race to influence patients perception of their health state, especially with the majority of the study cohort (78%) of Caucasian descent. The significance of peripheral vascular disease is not totally clear since there were only 6 patients (1%) who had documentation of peripheral circulation compromise. In terms of CHF, Chocron and associates [19] reported higher New York Heart Association (NYHA) class as having a negative effect on postoperative energy level and physical mobility by multiple regression analysis. The difference between the two studies may be accounted for by the lower percentage of patients with CHF symptoms in this report (9.7% vs 16%), thereby yielding a lower statistical power in our analysis. However, two other investigations [10, 26] had also failed to demonstrate CHF as an adverse predictor of postoperative quality of life. This supports a genuine improvement in functional status even in patients with CHF symptoms. Although smoking history had no impact on quality of life, it is interesting to note that patients with symptomatic COPD scored consistently lower preoperatively and postoperatively in the categories of energy level, physical functioning, and health perception. This is not unexpected, as physical

6 Ann Thorac Surg YUN ET AL 1999;68: QUALITY OF LIFE AFTER CARDIAC SURGERY 1319 Fig 4. Health status scores according to age. (BP bodily pain; EF energy/fatigue; HP health perception; MH mental health; PF physical function; RM role mental; RP role physical; SF social function.) impairments related to COPD should not be improved by surgery. Finally, surgical procedure type had no significant impact on quality of life except for bodily pain. Preoperatively, patients undergoing isolated CABG had lower scores in this category, probably as a result of more limitations due to anginal symptoms. After surgery, all patients had less bodily pain independent of the operation performed. This is in agreement with recent reports which demonstrated no significant relations between surgery type (CABG vs valve procedure) and illness symptoms scores [27] or quality of life [19] as measured by the Nottingham health profile. In contrast, individuals having repeat procedures had lower perceptions of their health in general and more limitations of physical activities. One reason for this may be related to the fact that these patients are often quite symptomatic and have exhausted other alternatives prior to reoperation. In addition, redo surgery is likely to be associated with greater postoperative morbidity. Limitations There are limitations to the interpretation of our results that should be discussed. First, there is no consensus on the best approach to assess quality of life, particularly after open heart operations. A sense of well-being means more than just the absence of disease or lack of symptoms. Although important, this aspect of quality of life has been elusive because it is very personal and requires value judgments that are highly subjective. Numerous Fig 5. Health status scores according to the presence of COPD (chronic obstructive pulmonary disease [top panel]) and redo versus first time operation (bottom panel). (EF energy/fatigue; HP health perception; PF physical function; RP role physical.)

7 1320 YUN ET AL Ann Thorac Surg QUALITY OF LIFE AFTER CARDIAC SURGERY 1999;68: questionnaires have been devised and tested to address this issue. However, none has been accepted universally as the gold standard for the various subgroups of patients by all investigators. In this study, the HSQ was chosen because it addresses various aspects of quality of life. More importantly, it is simple and easy to complete as evident by the fact that over 99% of the questionnaires were returned. Second, of the 604 patients recruited into the study, insufficient data were obtained from those who died early (36 of 61 within the first 3 months) or suffered late deaths. This, in turn, may have possibly biased the sample toward a more favorable quality of life after open heart surgery. However, the HSQ was not designed to be a measure of the disease process, but rather an indicator of limitations on the physical and social activities of daily living. Since every cardiac surgical procedure is associated with a certain accepted operative risk and late mortality rate, quality of life should be viewed from the perspective of those surviving the operation and its potential complications. From this standpoint, 87% of patients reported an improved outlook on their general health. Finally, other factors such as left ventricular ejection fraction [6, 9] and the recent emergence of minimally invasive or off-pump CABG [28] have been reported to have a significant impact on postoperative quality of life. However, these data were either not measured for all patients or not available at the time of the study. As such, our multivariate analysis was not inclusive of all possible variables that may affect quality of life. In summary, open heart surgery improves quality of life, independent of the type of procedure performed. While improvements in mental attributes continue to improve at 2 years, physical function appears to peak at 1 year with small deterioration thereafter. Factors that affect quality of life include coexisting morbid conditions, such as COPD and diabetes, which are not expected to improve with operation. Although physical activities are more restricted with increasing age, significant improvement is achieved after operation. Therefore, cardiac surgical interventions should not be denied on the basis of age alone. Supported in part by the Garfield Foundation. References 1. Elkington JR. Medicine and quality of life. Ann Intern Med 1966;64: RAND 36-Item Health Survey 1.0. In: RAND Health Sciences Program. Santa Monica, CA: RAND, Scoring Manual for the SF-36. In: The Health Institute. Boston, MA: The Health Institute, Ware JE. Interpretation and scoring the SF-36 Health Survey. Boston, MA: The Health Institute, Ware JE, Nelson EC, Sherbourne CD, Stewart AL. 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