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Eur J Cardiothorac Surg 2002;22:794-801
© 2002 Elsevier Science NL
a Heart Centre, Department of Cardiothoracic Surgery, University Hospital of Northern Sweden, 901 85 Ume
, Sweden
b SBU, The Swedish Council on Technology Assessment in Health Care, Stockholm, Sweden
Received 19 October 2001; received in revised form 17 May 2002; accepted 23 May 2002.
* Corresponding author. Tel.: +46-90-785-0000; fax: +46-90-785-3601
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Abstract |
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 Top Abstract 1. Introduction2. Material and methods3. Results4. DiscussionAppendix A. Conference...References |
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Key Words: Open heart surgery • Octogenarian • Outcome • Survival • Quality of life
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1. Introduction |
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TopAbstract1. Introduction2. Material and methods3. Results4. DiscussionAppendix A. Conference...References |
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Ageing is accompanied with diminishing functional reserve capacity and increasing prevalence of many chronic conditions. Elderly patients represent a challenge for cardiac surgery [5]. Advances in cardiopulmonary bypass technique, myocardial protection, and improved peri-operative care have allowed open-heart surgery to be safely offered to patients older than 80 years of age [3–5]. During the last years evidence has gradually developed in justifying aggressive surgical management in the elderly with heart disease, particularly those suffering from other associated diseases with a predicted high operative risk [6].
There is, however, still a need to evaluate surgical outcomes, mid- and long-term survival and quality of life in this group of patients in order to understand the real impact of cardiac surgery in the elderly. Furthermore, there is a need to justify expensive treatment modalities in an increasingly restrictive managed care environment [6].
The purpose of this study was to examine surgical outcome, medium-term survival and quality of life after open-heart surgery of patients aged 80–84 years old.
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2. Material and methods |
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TopAbstract1. Introduction2. Material and methods3. Results4. DiscussionAppendix A. Conference...References |
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, Sweden, 200 patients were aged 80 and over when they underwent open-heart surgery from January 1995 through June 2000. We excluded 17 patients (nine of whom were females) that were aged 85 or over. The oldest patient was 89 years old. Thus 183 patients aged 80–84 years of age at the time of surgery were available for this study. The data available in the database included demographics, risk stratification, type of surgery (coronary artery bypass graft only, valve only, or combination, and miscellaneous), status at surgery (elective, urgent, or emergent), laboratory values, such as creatinine level, and associated diseases. An ‘urgent’ operation was defined as one which was required to be done within 24 h or if the patient was unstable or had critical disease precluding discharge from the hospital before surgery. ‘Emergent’ operation was defined as one that was required to be done immediately without any delay upon surgical evaluation.
The associated pathological conditions included chronic obstructive pulmonary disease (COPD), diabetes mellitus, systemic hypertension, history of cerebral vascular disease (CVD), and chronic renal failure (CRF). COPD was defined as patients requiring specific treatment for COPD or requiring pneumological consultation. Diabetes included insulin as well as non-insulin-dependent diabetes. Systemic hypertension was defined as blood pressure more than 140/90 mmHg or a history of high blood pressure, or on antihypertensive medications. Prior CVD included patients with a history of transient ischemic attacks, stroke, and known asymptomatic carotid disease. Chronic renal failure (CRF) was diagnosed if pre-operative serum creatinine was 141 µmol/l or greater. Left ventricular function was classified into three groups: normal, diminished or poor.
Operative data included type of operation, concomitant procedures, cardiopulmonary bypass (CPB) and aortic cross-clamp times, and intra-operative mortality.
Post-operative complications were recorded in the institutional on-line database. Thirty-day mortality was defined as death occurring within 30 days after operation. The patients’ follow-up was completed on January 1, 2001. Hospital records as well as the Statistics Sweden mortality records were used to assess patient survival.
The patients’ health-related functioning and well-being was assessed with five components of the Swedish Quality of Life Survey (SWED-QUAL): (1) physical functioning, a seven-item scale assessing ability to perform physical activities; (2) a single-item question assessing satisfaction with physical functioning; (3) relief from pain, a six-item scale measuring relief from physical discomfort; (4) quality of sleep, a six-item scale addressing problems with sleep initiation, maintenance and adequacy, and somnolence; (5) emotional well-being, a 12-item scale assessing positive and negative effect. The scores on each scale ranged from 0 to 100 with higher scores reflecting better health. Cronbach's alpha of the multi-item scales ranged from 0.80 to 0.88 [15].
Questionnaires were sent via mail to survivors and non-responders were contacted via personal phone calls. Data collection was completed at the end of March 2001.
2.2. Comparison groups
2.2.1. Survival
Death risks, as observed in the general Swedish population for the period 1995–1999 [1], were used to create a comparison cohort including the same number of individuals as the patient group matched for age and gender.
2.2.2. Functioning and well-being
Patient's functioning and well-being was compared to that of the general Swedish population aged 80–84, assessed at two occasions through random samples drawn from the general population register kept by Statistics Sweden. The same instrument and identical data collection procedures were used for both surveys. The first survey was conducted in 1991 (n=170) and the second in 1995 (n=209). The average response rate was 60.9% (n=228) [1].
2.3. Statistical methods
Categorical variables were compared with the chi-square statistic or Fisher's exact test when both variables were binary. Ordinal variables were analysed with the Mann-Whitney U-test for independent samples. Survival was compared using the Kaplan–Meier method and the log rank test. Patient characteristics included in Table 1 were used as candidate predictors of survival by 36 months and for HRQOL, respectively. All bivariately significant (P<0.05) predictors were simultaneously entered into a logistic regression analysis. As regards the HRQOL dimensions, the corresponding analyses of continuous variables were performed using linear regression. All statistical tests were two-sided. All statistics were performed using SPSS, version 10.1 (Chicago, IL).
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3. Results |
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TopAbstract1. Introduction2. Material and methods3. Results4. DiscussionAppendix A. Conference...References |
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The median and mean X-clamp times and CPB times were 64 and 72.5 min and 105 and 117 min, respectively. Patients had a median and mean ventilator time, intensive care unit (ICU) stay and total length of stay of 9 and 21.4 h, 23 and 43.2 h and 9 and 10.8 days, respectively.
There were some important differences between male and female patients. Impaired or poor left ventricular function was significantly more common among male patients while female patients had a lower pre-operative creatinine level and a higher mean Parsonnet risk score. Male and female patients also differed as regards procedures undergone. A majority of the male patients compared to less than a third of the female patients underwent isolated CABG. As a consequence, female patients had longer X-clamp times. No significant differences were seen as regards post-operative ventilator hours, hours at the ICU or as regards total length of post-operative stay.
3.2. Survival
The surgical mortality within 30 days was 4.6%. It was 8.7% among emergent and 3.8% among elective operation (P=0.370)Three patients died in tabula. Of these three, two were operated on as emergencies: one patient presented with aortic prosthetic endocarditis and septic coronary embolism with acute myocardial infarction (CPK-MB 226 pre-operatively). The other patient was admitted with a De Bakey type I acute aortic dissection with massive aortic regurgitation and cardiac tamponade.
Acute cardiac failure caused seven of the eight deaths within 30 days. One patient succumbed to a stroke.
The 30-day hospital mortality rate was not influenced by the presence of any pre- or peri-operative factors, probably due to the small number of events.
Fig. 2 shows the Kaplan–Meier curves for the survival probabilities of the patients and for the Swedish population matched for gender and age through 36 months after intervention. Estimated survival after surgery was 95.4% at 30 days (95% confidence interval (CI) 92.2–98.6%), 91.9% at 12 months (95% CI 87.7–96.1%), 89.5% at 24 months (95% CI 84.6–94.4%) and 85.6% at 36 months (95% CI 79.2–92.0%). Survival probabilities for the matched population were 91.8% at 12 months (95% CI 87.7–95.9%), 82.5% at 24 months (95% CI 76.9–88.1%) and 75.4% at 36 months (95% CI 69.0–81.8%). The overall log rank test was not significant (P=0.078). There was no significant differences in survival at 36 months between emergent versus elective surgery (P=0.262) or between male and female patients (P=0.545).
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3.3. Health-related quality of life
Twenty-eight of the 183 patients were dead at follow-up. Of the 155 patients available for responding to the questionnaire, 146 (94.2%) (71 males and 75 females) actually filled it out.
Patients had significantly better physical functioning, satisfaction with physical functioning, relief of pain and emotional well-being (P<0.01) compared to the normal population. Patients and normal population reported similar quality of sleep (P=0.106) (Fig. 3) . We found no significant difference in HRQOL (P>0.05) between male patients and male normal population responders. In contrast, female patients reported significantly better HRQOL than their population counterparts on all five dimensions (P<0.01), including quality of sleep (Fig. 4) .
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Twenty-eight percent of the 107 patients (59 males and 48 females) that had undergone either isolated CABG or CABG combined with other intervention reported that they were not completely free from anginal pain. There was no difference between male and female patients (P=0.857). Presence of anginal pain has, of course, a negative impact on HRQOL. In spite of the small number of observations, we confirmed that presence of angina exerted a strong, significant negative effect on physical functioning, satisfaction with physical functioning, relief of pain and quality of sleep (P<0.001) and some effect also on emotional well-being (P=0.012).
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4. Discussion |
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TopAbstract1. Introduction2. Material and methods3. Results4. DiscussionAppendix A. Conference...References |
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It has been reported that elderly patients undergoing heart surgery have more complications, longer hospitalizations, and higher operative mortality than younger patients and consequentially greater expenditure of resources with inferior benefit as measured by long-term survival and functioning [7].
By the mid 1990s, economic concerns have led to a re-examination of funds allocated for health care. This work was undertaken to shed some light on this dilemma by determining the benefit in terms of quality of life and survival for elderly patients undergoing cardiac surgery. This information would be helpful for the physician seeking to resolve the direct conflict implicit in the difficult dual role of patient advocate and medical gatekeeper.
We found that the 30-day mortality in this group of patients was 4.4%, which is comparable to or lower than previously reported early mortality rates [3–8].
Traditional models of risk stratification, such as that described by Parsonnet et al. [9] give to the octogenarian patient a high score just because of the age factor. The Parsonnet median score was found to be 28.7 in this material. Twenty of these 28.7 score points come from the age factor alone. Such traditional models seem no longer to be adequate in evaluating operative risk for elderly patients undergoing cardiac surgery. In light of our results, we agree in proposing the use of more recent models of risk stratification, for example the EUROScore, proposed by Nashef et al. [10], as other authors have already implicitly or openly suggested.
In this population, the overall 3-year survival rate was 85.6%, which was comparable to or higher than other similar studies [11]. Systemic hypertension was found to play a significant role as predictor for late mortality in this study. Gender was not a risk factor.
Remarkable was the fact that the 3-year survival after open-heart surgery was similar to that of an age- and gender-matched Swedish population cohort for the same time period. Other authors have reported similar findings in survival studies conducted in the United States [12].
The quality of life of patients with cardiac artery disease may be assessed with a variety of validated instruments. Some of these instruments are specific for coronary disease. Others, such as the Medical Outcomes Study Short Form 36 (SF-36)[13], the Nottingham Health profile (NHS) [14] and the Swedish Quality of Life Survey (SWED-QUAL) [15], provide a more generic assessment and allow comparisons with normal populations. There have been several reports on the quality of life of patients following open-heart surgery (e.g. Refs. [11,16–18]) Only one of those compared HRQOL outcome in octogenarian patients with population norm [11]. Brown et al. compared the functioning and well-being of myocardial infarction survivors with normative data and found that patients under age 65 had lower scores while those over age 65 had similar scores as community norms [19].
This report shows that the functioning and well-being of open-heart surgery patients aged 80 through 84 is similar to if not better than the level reported by a cross-sectional sample of the general Swedish population of similar ages. Our patient population had better HRQOL compared to that of the normative population on four of the five domains included in the follow-up. The exception was quality of sleep (P=0.106), which was found to be similar in the compared groups. Our results are similar to four other reports in the literature comparing younger patients undergoing coronary revascularization and normative populations.
Brorsson et al. reported that patients aged 55–79 (n=1013) at the time of CABG surgery had improved their HRQOL to similar to or better levels than that of population norms on (the identical) four of the five domains included in the 4-year follow-up of a national Swedish sample of CHD patients [16]. Krumholtz et al. found that the pre-PTCA scores of 98 patients were well below the national norm and that 6 months following PTCA scores were at least as high as the norm [20]. Caine et al. examined 5-year outcomes after elective bypass surgery of 84 male patients who were age 60 or younger at time of surgery [21]. These patients were found to have similar functioning as a general population sample in the six major domains from Part I of the Nottingham Health Profile (NHP). Pocock et al. reported on the 3-year follow-up of 1011 patients randomized to angioplasty or bypass surgery in the RITA trial [22]. The majority of these patients, who were free from angina, had NHP mean scores similar to the population norm.
We also found that the HRQOL patients achieve following cardiac surgery is strongly influenced by whether they experience recurrent angina. In our study patients who experienced recurrent angina had considerably lower HRQOL scores than community norms while those without angina had higher scores. Similar findings have been reported in other studies [22].
In interpreting the findings of comparisons to the normal populations, some caveats must be expressed. This comparison group is by no means a control group in the normal sense. A proper control group would of course consist of similar but unoperated patients. However, a comparison to a group which is as nearly equal to the trial group as possible still sheds some additional light on the value of the treatment in question. In making this comparison, it is necessary to keep in mind that patients to be treated are (probably) positively selected in that they have a defined and treatable disease but at the same time are thought to be able to withstand the trauma of the treatment. Thus the population at large contain individuals with the disease who for variable reasons are not brought to the attention of the cardio-thoracic surgeon. What the finding of equal or better survival/quality of life than the normal population really expresses is that the treatment brings back patients with the disease to a ‘normal’ life in comparison with the population matched for age and gender. This means from a socio-economic point of view that heart surgery in this age group is not creating survivors with large deficits but that the patients selected to undergo surgery may enjoy a ‘normal’ life span with a ‘normal’ quality of life.
As mentioned earlier, expanding indications to new patient cohorts is a process engaging several different parties. Patients want to know the effects and the risks of the treatment. Patients may also be interested in other outcomes such as cognitive function and functioning in daily activities.
Health care administrators might be interested in the relationship between patients’ social class and educational status and the outcomes they experience. Financing bodies have to know about the cost-effectiveness. Referring doctors want to know what they can expect from the treatment and how they should inform their patients. In this study we could only address some of these issues. Health care decision-making, whether by the patient or physician, is relying to ever-greater degrees on the evidence we find in clinical research. We already know that patients with severe, operable cardiac disease achieve better outcomes with surgery compared to medical therapy [23]. Our study extends these findings by providing outcome data for octogenarian patients. From these data, we draw the conclusion that we should continue to carefully explore the limits of cardiac surgery.
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Acknowledgments |
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Footnotes |
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Appendix A. Conference discussion |
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TopAbstract1. Introduction2. Material and methods3. Results4. DiscussionAppendix A. Conference...References |
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Dr Collins: Yes. We took 183 consecutive patients aged over 80.
Dr Hagl: So if you look more in detail, is there a special group which really profits more than the other one?
Dr Collins: We found out, for instance, that females had more combined procedures, aortic valve replacement and myocardial revascularization, and, surprisingly, they had better quality of life scores. So this was something that surprised us. And the explanation that we tried to give is that women are referred to surgery where they are very symptomatic, and so after surgery it seems that they have a much better quality of life compared to the normal population. Males are more operated on for myocardial revascularization. Of course, they had a relief of pain. It was better than the normal population. But, of course, the other patients in our population had the kind of coronary artery disease not repairable and so on. So it is a bit difficult.
Dr B. Messmer (Aachen, Germany): In your basic data you have an average age of 81.6, I guess, with a very, very small range. So what age was your oldest patient, because you have plus-minus 0.1? So the patients are probably barely older than 80. That is number one.
Number two is, I do not quite see why you have 96% of the patients in functional class III and IV. This speaks a little bit for co-morbidity, because it may be that the heart process or heart disease in an older patient counts for the general situation much more, and it may not be due alone to the heart disease itself.
Number three, I would come back to the results on women. Why should women be better after surgery than the normal population of women? That's something I cannot understand. I think it was about 2 years ago we heard from a Swedish study group that they had finally, in statistical terms, more survivors after surgery than patients entering into the study. And this is a little bit of a problem with statistics and with evaluation, that you may come out better off than you should.
Dr Collins: Thank you for your comments and questions. I will start from the last one. We tried to answer this question thinking about the type of surgery that these women underwent, and it is true that most of them have a combined cardiac disease, and they arrive for surgery at a late stage. So it seems that they are very, very symptomatic when they arrive. And afterwards they do not have a better survival, I would like to make a point here, they have better quality of life scores compared to the normal women over 80. So that's a point.
And for the age point, the first question, actually at the beginning we included patients with an age range between 80 and 90, and then, because of our Swedish Swed-Qual questionnaire, they had three surveys in Sweden, and the age range was between 80 and 84. So to make the comparison more correct, we decided to take patients with the same age in order to match correctly the two groups, and that is why our age is between 80 and 84. At the beginning we did actually make the comparison with the range 80–90, and the results in terms of survival and quality of life results were the same.
Dr C. Yankah (Berlin, Germany): What are your contraindications for this patient group in the CABG group and also in the aortic group, let's say aortic stenosis and coronary artery disease? What are your contraindications? Would you refuse patients for surgery in this group?
Dr Collins: In Sweden we have, I would say, a special health care system, and those we are going to operate on are patients who are selected not in the way that we might use this term but by their general physician and by their cardiologist. So actually we don't operate on octogenarians with very severe co-morbidities like in severe renal failure or with severe COPD and so on. We don't select patients. We set out to operate on patients proposed by the cardiologists, but the cardiologists propose to us patients who they see as good candidates for surgery, even if their Parsonnet, as you could see, is 28.7. So the operative risk is pretty high.
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References |
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TopAbstract1. Introduction2. Material and methods3. Results4. DiscussionAppendix A. Conference...References |
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