Medium-term survival and quality of life of Swedish octogenarians after open-heart surgery q

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European Journal of Cardio-thoracic Surgery 22 (2002) 794 801 www.elsevier.com/locate/ejcts Medium-term survival and quality of life of Swedish octogenarians after open-heart surgery q Sonia Maria Collins a, Bengt Brorsson a,b, Staffan Svenmarker a, Per Arne Kling a, Torkel Åberg a, * Abstract a Heart Centre, Department of Cardiothoracic Surgery, University Hospital of Northern Sweden, 901 85 Umeå, 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 Objective: Operative mortality after open-heart interventions in the octogenarian population is relatively well known. Less has been reported on the medium term survival and quality of life of this growing subgroup of patients. Methods: One hundred and eighty-three consecutive patients aged between 80 and 84 years when they underwent open-heart surgery between January 1995 and June 2000 were retrospectively analysed. The patients were followed up for 36 months as regards survival and compared, after matching for age and gender, to survival in the general Swedish population. The health-related quality of life (HRQOL) of surviving patients was assessed in February 2001 using the SWED-QUAL questionnaire. After matching for differences by age and gender, survival results were compared to Swedish national survival data, and functioning and well-being to the corresponding national norm data. Pre-, intra- and post-operative variables were evaluated as predictors for mortality, survival and quality of life. Results: The 30-day mortality rate was 4.6% (n ¼ 8). The 36-month survival rate, that was 85.6%, did not differ significantly (P ¼ 0:078) from that of a cohort of the Swedish population matched for age and gender. There was no significant difference in survival between male and female patients (P ¼ 0:545). Systemic hypertension was the only variable found to be a statistically significant predictor of 36-month mortality (P ¼ 0:009). As concerns HRQOL, patients had significantly better physical functioning, satisfaction with physical functioning, relief of pain and emotional well-being (P, 0:01) and similar quality of sleep (P ¼ 0:106) as the normal population. Male patients and male normal population responders had similar HRQOL (P. 0:05) while female patients reported significantly better HRQOL than their population counterparts on all five dimensions (P, 0:01). Conclusions: Patients 80 84 years of age may be operated on with acceptable operative mortality and benefit from improved functioning and well-being. Survival and quality of life after open-heart surgery among patients aged 80 84 years of age are comparable to, or even better than in the general Swedish population. q 2002 Published by Elsevier Science B.V. Keywords: Open heart surgery; Octogenarian; Outcome; Survival; Quality of life 1. Introduction At the age of 80, the remaining life expectancy for Swedish females is 8.8 years and 6.9 years for males [1]. Ischemic heart disease accounts for 30% of all deaths among people aged 75 and over and is the most common cause of death in this age group [2]. Further, despite maximum medical therapy, many patients with cardiovascular disease older than 80 years of age are severely symptomatic [3]. As the number of people 80 years of age and older continues to increase, so will the demands for cardiac surgery [4]. Ageing is accompanied with diminishing functional reserve capacity and increasing prevalence of many chronic conditions. Elderly patients represent a challenge for q Presented at the joint 15th Annual Meeting of the European Association for Cardio-thoracic Surgery and the 9th Annual Meeting of the European Society of Thoracic Surgeons, Lisbon, Portugal, September 16 19, 2001. * Corresponding author. Tel.: 146-90-785-0000; fax: 146-90-785-3601. 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. 1010-7940/02/$ - see front matter q 2002 Published by Elsevier Science B.V. PII: S1010-7940(02)00330-5

S.M. Collins et al. / European Journal of Cardio-thoracic Surgery 22 (2002) 794 801 795 2. Material and methods 2.1. Patient group According to the computerized clinical database kept by the Heart Centre, University Hospital of Northern Sweden, Umeå, 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 mmol/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 nonresponders 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 ¼ 170) and the second in 1995 (n ¼ 209). The average response rate was 60.9% (n ¼ 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). 3. Results During the period 1995 2000, the proportion open-heart surgery in octogenarians at our institution was 3.6% (Fig. 1). 3.1. Characteristics of the study population (Table 1) The mean age of patients (n ¼ 183) was 81.9 years at the time of surgery. Males represented 49.7% of the study population. Most patients belonged to New York Heart Association Class III/IV. The most prevalent co-morbidities were systemic hypertension (77.5%) and diabetes mellitus (22.7%). Pre-operative cerebral vascular disorders were

796 S.M. Collins et al. / European Journal of Cardio-thoracic Surgery 22 (2002) 794 801 Table 1 Characteristics of Swedish octogenarian patients who underwent open-heart surgery, by gender Characteristic a All (n ¼ 183) Males (n ¼ 91) Females (n ¼ 92) P value (males vs. females) Mean age (SD), years 81.9 (1.3) 82.0 (1.3) 81.8 (1.3) 0.242 Previous cardiac surgery (%) 2.7 2.2 3.3 0.659 NYHA functional Class III/IV (%) 96.8 95.6 97.8 0.306 Elective surgery 87.4 83.5 91.3 0.280 Comorbid Illness (%) Diabetes mellitus 22.7 18.7 26.7 0.199 Stroke/transient ischemic Attack 18.8 12.4 25.3 0.028 Renal failure 11.0 13.2 8.8 0.343 Pulmonary insufficiency 15.9 17.6 14.3 0.543 Hypertension 77.5 73.6 81.3 0.214 Impaired or poor left Ventricular function 49.5 59.4 39.6 0.009 Parsonnet score, mean (SD) 28.7 (8.5) 25.9 (6.7) 31.3 (9.2) 0.000 Pre-operative creatinine level, mean, (SD)) 101.2 (24.6) 108.3 (24.6) 93.6 (22.5) 0.000 Intervention (%) CABG only 45.9 61.5 30.4 0.000 CABG and AVR or other Intervention 28.4 23.1 33.7 AVR only 20.8 11.0 30.4 Other interventions 4.9 4.4 5.4 Peri- and post-operative factors Aorta clamp minutes, Median (range) 64 (2.9) 51 (3.8) 78 (22 225) 0.002 CPB minutes, median (range) 105 (16 225) 92 (16 189) 113 (6.7) 0.095 Post-operative ventilator hours, median (range) 9 (31 456) 9 (34 320) 9 (31 456) 0.764 ICU hours, median (range) 23 (15 445) 23 (15 310) 23 (16 445) 0.881 Length of stay in days, median (range) 9 (0 56) 8 (0 28) 9 (1 56) 0.093 a NYHA, New York Heart Association; CABG, coronary artery bypass graft; AVR, aortic valve replacement; CPB, cardiopulmonary bypass; ICU, intensive care unit. present in 18.8% and half of the patients had impaired or poor left ventricular function. Patients had a mean score of 28.7 according to the Parsonnet surgical risk classification system. Half of the patients underwent elective surgery. The most common procedure was isolated coronary artery bypass grafting (CABG) (45.9%) and CABG combined with aortic valve replacement and/or other intervention (28.4%) (Table 1). 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 ¼ 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. Fig. 1. Prevalence of patients aged 80 years and above undergoing openheart surgery.

S.M. Collins et al. / European Journal of Cardio-thoracic Surgery 22 (2002) 794 801 797 Fig. 2. Probability of survival for open-heart surgery patients compared to matched Swedish population plotted against time after surgery. Thick line, Swedish population; thin line, patients. Cross-bars depict censored patients. 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 ¼ 0:078). There was no significant differences in survival at 36 months between emergent versus elective surgery (P ¼ 0:262) or between male and female patients (P ¼ 0:545). Of the possible predictors of 36-month mortality entered into the logistic regression analysis, only hypertension was found to be statistically significant (P ¼ 0:009). 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 ¼ 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). We found only three potential predictors of HRQOL level. Systemic hypertension and length of ICU stay (hours) were significantly (P ¼ 0:004 and P ¼ 0:033, respectively) related to physical functioning and length of hospital stay (days) was associated (P ¼ 0:030) with quality

798 S.M. Collins et al. / European Journal of Cardio-thoracic Surgery 22 (2002) 794 801 Fig. 3. Mean (95% CI) SWED-QUAL scores for patients who underwent open-heart surgery compared to Swedish normal population matched by age and gender (scores: minimum score ¼ 0; maximum score ¼ 100). of sleep. Thus, no multivariate analysis of predictors of HRQOL was performed. 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 ¼ 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 ¼ 0:012). 4. Discussion In the development of cardiac surgery, age limits have been much debated. Patients cohorts in new age groups are carefully selected, operated and results analysed. As advances in operative techniques and technology are improving continually and results in younger patients become even more convincing, patients aged 80 years and above are now being considered for open-heart surgery. 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 reexamination 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

S.M. Collins et al. / European Journal of Cardio-thoracic Surgery 22 (2002) 794 801 799 Fig. 4. Mean (95% CI) SWED-QUAL scores for patients who underwent open-heart surgery compared to Swedish normal population by gender matched for age (scores: minimum score ¼ 0; maximum score ¼ 100). 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 wellbeing 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 ¼ 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 ¼ 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

800 S.M. Collins et al. / European Journal of Cardio-thoracic Surgery 22 (2002) 794 801 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 decisionmaking, 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. Acknowledgements We wish to thank Mrs Britt-Inger Lydig, RN, and Mr Jan Hentschel, Computer Engineer, for their help in checking the computerized clinical database and the mortality records. We would like to acknowledge Vittorio Mantovani, MD, for his help. References [1] Statistics Sweden. Statistics Sweden life tables, 1995 1999. Stockholm: Statistics Sweden, 2001. [2] Swedish National Board of Health and Welfare. Official statistics of Sweden: causes of death 1998. Stockholm: National Board of Health and Welfare, 2000. [3] Shah VZ, Rosenfeldt FL, Parkin GW, Ugoni AM, Habersberger PG, Cooper E. Cardiac surgery in the very elderly. Med J Aust 1994;160:332 334. [4] Peterson ED, Cowper PA, Jollis JG, Cowper PA, Jollis JG, Bebchuk JD, DeLong ER, Muhlbaier LH, Mark DB, Pryor DB. Outcomes of coronary artery bypass graft surgery in 24,461 patients aged 80 years or older. Circulation 1995;92(Suppl 9):85 91. [5] Kumar P, Zehr KJ, Chang A, Cameron DE, Baumgertner WA. Quality of life in octogenarians after open-heart surgery. Chest 1995;108:919 926. [6] Sollano JA, Rose EA, Williams DL, Thornton B, Quint E, Apfelbaum M, Wasserman H, Cannavale GA, Smith CR, Reemtsma K, Greene RJ. Cost-effectiveness of coronary artery bypass surgery in octogenarians. Ann Surg 1998;228:297 306. 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S.M. Collins et al. / European Journal of Cardio-thoracic Surgery 22 (2002) 794 801 801 chronic stable angina patients before and 4 years after coronary revascularization compared with a normal population. Heart 2002;87:140 145. [17] Brorsson B, Bernstein SJ, Brook RH, Werkö L. Quality of life of chronic stable angina patients 4 years after coronary angioplasty or coronary artery bypass surgery. J Intern Med 2001;249:47 57. [18] Engblom E, Korpilahti K, Hamalainen H, Ronnemaa T, Puukka P. Quality of life and return to work 5 years after coronary artery bypass surgery. Long-term results of cardiac rehabilitation. J Cardiopulm Rehabil 1997;17:29 36. [19] Brown N, Melville M, Gray D, Young T, Munro J, Skene AM, Hampton JR. Quality of life four years after acute myocardial infarction: short form 36 scores compared with a normal population. Heart 1999;81:352 358. [20] Krumholtz HM, McHorney CA, Clark L, Levesque M, Baim D, Goldman L. Changes in health after elective percutaneous coronary revascularization. Med Care 1996;34:754 759. [21] Caine N, Sharples LD, Wallwork J. Prospective study of health related quality of life before and after coronary artery bypass grafting: outcome at five years. Heart 1999;81:347 351. [22] Pocock SJ, Henderson RA, Seed P, Treasure T, Hampton JR. Quality of life, employment status, and anginal symptoms after coronary angioplasty or bypass surgery. 3-year follow-up in the Randomized Intervention Treatment of Angina (RITA) trial. Circulation 1996;94:135 142. [23] Pfisterer M, Bertel O, Erne P, Goy JJ, Kuster G, Rickenbacher P, Schindler C, Schönenberger R. (The TIME Investigators). Trial of invasive versus medical therapy in elderly patients with chronic symptomatic coronary-artery disease (TIME): a randomized trial. Lancet 2001;358:951 979. Appendix A. Conference discussion Dr S. Hagl (Heidelberg, Germany): The data you have given us are mixed data from all different diagnoses, is that right? It s CABG patients, it s valve patients? 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.