There are several reasons for studying long-term results

Transcription

1 Late Outcome and Quality of Life After Complicated Heart Operations Kristina Söderlind, MD, Hans Rutberg, MD, PhD, and Christian Olin, MD, PhD Departments of Cardiothoracic Anaesthesia and Intensive Care and Cardiothoracic Surgery, Linköping Heart Center, University Hospital, Linköping, Sweden Background. Patients with severe postoperative complications consume a great deal of the economic resources for intensive care. Our knowledge of the late outcome and quality of life of these patients is scarce. Methods. One thousand five hundred twenty-two patients undergoing cardiac operations during 1991 and 1992 were studied, and the 100 patients who needed the most expensive treatment were identified. The patients were retrospectively risk scored (Higgins score), and the clinical outcome was studied. The surviving patients were followed up for 2 years after the operation. Their quality of life and remaining symptoms were assessed. Results. No significant age difference between groups was observed. There were significantly more women, emergency cases, high-risk patients, and postoperative complications in the studied group. Mortality rate during the first postoperative year was significantly higher in the studied group. Later the difference in mortality rate between the groups decreased. At the 2-year follow-up all the 72 surviving patients in the study group had returned home with less physical and psychological symptoms related to their heart disease. Conclusions. The cost of treating severe complications in the intensive care unit is high. However, the results of the present study indicate that even a very complicated postoperative course is not incompatible with a successful outcome in the long run. (Ann Thorac Surg 1997;63:124 8) 1997 by The Society of Thoracic Surgeons There are several reasons for studying long-term results of intensive care. First, there is medical knowledge to be gained, and second, light is shed on the ethical and economic issues involved. Finally, questions concerning quality of life are of the utmost importance. Studies in this area have previously been made, and the outcome of patients treated in general intensive care wards has been reported [1 4]. The patient material in these reports, however, has been quite heterogeneous, the reason for admission to the intensive care unit varying widely as has age and other background factors. Several investigations concerning long-term results of cardiac operations have also been performed [5 10]. Even though this group is homogeneous, it changes with time. The mean age and the proportion of high-risk patients undergoing coronary artery bypass grafting (CABG) is increasing [11]. In spite of this the operative mortality observed remains essentially unchanged: for CABG operations it is around 2.5% to 3% [11]. There is a growing interest in the evaluation of risk factors and their influence on mortality and complications as well as creation of scoring instruments with good predictive value [12]. When complications follow a cardiac operation, the need may arise for a prolonged stay in the intensive care unit (ICU), which is extremely expensive. This means that a small number of patients with severe postoperative complications consume a great deal of the total economic resources available for intensive care. Our knowledge of Accepted for publication July 30, Address reprint requests to Dr Söderlind, Department of Cardiothoracic Anaesthesia and Intensive Care, University Hospital, S Linköping, Sweden. these patients quality of life in the long term is scarce. Therefore, we have retrospectively studied the 100 patients who were operated on in 1991 and 1992 who needed the most expensive treatment in the cardiac ICU, to find the answers to the following questions: (1) Which complications occurred during and after the operation, and how did they correlate to preoperative risk factors? (2) How did these complications affect the patients quality of life in a 2-year perspective? Material and Methods During the period January 1991 to December 1992, 1,522 open heart operations were performed at Linköping Heart Center, Sweden. The Heart Center treats all adult patients from a specific health care region with a population of about 950,000 people. The cost of intensive care for each patient was calculated by a modified therapeutic intervention scoring system described previously [13]. The 100 patients who needed the most expensive treatment in the ICU constituted the study group. The number and type of operations and mortality rate within 30 days of the operation are shown in Table 1. By retrospective analysis of the patients medical records, preoperative risk factors were identified using the Higgins risk-scoring system [14]. This system is valid for patients undergoing CABG operations and combined procedures (but not isolated valve repairs/replacements or other types of open heart operations). The complications occurring during and after the operation were listed (Table 2). The third part of the study was a follow-up. Surviving patients received a questionnaire with questions regarding their quality of life 1 and 1997 by The Society of Thoracic Surgeons /97/$17.00 Published by Elsevier Science Inc PII S (96)

2 Ann Thorac Surg SÖDERLIND ET AL 1997;63:124 8 QUALITY OF LIFE AND COMPLICATIONS 125 Table 1. Mortality Rate and Type of Operation a Type of Surgical Procedure All Patients Study Group No. of Patients Mortality No. of Patients Mortality p Value CABG 1, % % operations Valve % % 0.01 replacements CABG valve % % NS operations Miscellaneous % % NS IABP only b 1 100%... Total 1, % % a Mortality rate and type of operation in all patients and in patients requiring prolonged intensive care after cardiac operations. Values of p for differences between the groups are shown in the final column. b One patient was treated in the intensive care unit because of intractable heart failure using the intraaortic balloon pump. No cardiac operation was performed on this patient. CABG coronary artery bypass grafting; IABP intraaortic balloon pump; NS not significant. 2 years after the operation. The patients were asked to compare their state of health before the operation with their current health situation. The questionnaire consisted of 26 questions focusing on physical complaints, ie, disease- and treatment-related symptoms, and psychological well-being, ie, depressive symptoms and anxiety. The patients assessed their ability to participate in the activities of daily life and their quality and quantity of social interactions. The questions were formulated in collaboration with Table 2. Postoperative Complications and Mortality Rate a Variable All Patients (n 1,522) Study Group (n 100) p Value Renal insufficiency ( SCr 2.7% 18% mol/l) Patients requiring dialysis 0.4% 6% IABP/Hemopump 1.6% 17% Acute myocardial infarction 3.0% 18% Reoperation due to bleeding, 5.2% 33% infection, etc Cerebrovascular lesion 2.6% 11% Serious infection (septicemia, 3.6% 21% pneumonia, mediastinitis) Dead within 30 days 1.8% 12% Dead within 1 year 2.1% 25% Mortality rate the second 1.2% 4% 0.05 postoperative year Mortality rate the third postoperative year 2.7% 4.2% NS a Postoperative complications and mortality rate in all patients and in patients requiring prolonged intensive care after cardiac operations. Values of p for differences between the groups are shown in the final column. IABP intraaortic balloon pump; SCr serum creatinine level. the Department of Theme Research, Linköping University, where people from different faculties of the University are joined in interdisciplinary research work. The study was approved by the ethical committee of the University Hospital, Linköping. Statistical analysis was carried out by means of the 2 test. Values of p less than 0.05 were considered to be statistically significant. Results The study group represented 7% of all patients operated on in 1991 and The mean age was 66 years, and the percentage of patients more than 70 years of age was 38%. This should be compared with 64 years and 36% in the total 2-year material. The difference between the groups was not statistically significant. There were significantly more women (36% versus 26%; p 0.05) and emergency cases (14% versus 2.5%; p 0.01) in the study group compared with the total material. In the study group patients undergoing combined CABG and valve procedures were overrepresented as were patients in the miscellaneous group, particularly patients who needed thoracic aortic repair. Eight patients were operated on more than once with extracorporeal circulation. The total cost for the study group in the ICU was almost 2 million US dollars, equivalent to 27% of the total cost for thoracic intensive care in 1991 and Almost 1 million US dollars was spent in treating the 20 patients with the most severe complications. The mortality within 30 days in this latter group was 35%. Preoperative Risk Factors Preoperative risk factors were recorded and analyzed according to the Higgins risk-scoring system. The system is applicable only for patients undergoing CABG operations and combined procedures. Altogether 1,200 patients fell into these categories. Among them were 109 so-called high-risk patients (9%) with a risk score of 5 or more. In the study group, the scoring system could be applied to 71 cases. Twenty-nine of these (41%) belonged to the high-risk group. Significantly more patients in the study group were high-risk patients (p 0.001). The distribution of risk scores for all patients and the study group are shown in Figure 1. Mortality and Complications Serious postoperative complications were listed in the study group and compared with those among all patients. The main reasons for a prolonged stay in the intensive care unit were perioperative myocardial infarction, cardiac failure, dialysis, cerebrovascular complications, and serious infections such as septicemia and mediastinitis (see Table 2). The differences between the groups regarding postoperative complications were statistically significant (p 0.001). The mortality rate after 30 days and after 1 year was significantly higher in the study group (p 0.001). During the second postoperative year the mortality rate in these patients was higher (p 0.05), whereas during the third postoperative year no significant difference was observed between the groups.

3 126 SÖDERLIND ET AL Ann Thorac Surg QUALITY OF LIFE AND COMPLICATIONS 1997;63:124 8 Fig 1. Risk score according to Higgins (A) in all patients (n 1,200) and (B) in the study group (n 71). Patients were subjected to coronary artery bypass graft operations and combined procedures. During the study period another 18 patients who had undergone open heart operations died within 30 days postoperatively. They died either in the operating theater, after a few hours in the ICU, or in a few instances unexpectedly on the ward. Thirteen of these patients could be risk scored according to Higgins. The average risk score in this group was 4.0 (range, 0 to 9). Three patients were in the high-risk group with a risk score of 5 or greater. The predominant causes of death in the study group, as well as among the other 18 patients who died within 30 days postoperatively, were acute myocardial infarction, cardiac failure, and cerebrovascular lesion. In a few cases there were other causes, such as profuse perioperative bleeding, rupture of abdominal aortic aneurysm, cardiac arrhythmia, and serious infection. Quality of Life One year after the operation 75 patients were alive and received the questionnaire, 91% of whom returned it. Two years after the operation, 72 patients were alive, and this time also the questionnaire was completed and returned by 91% of the patients. The questionnaire included questions on symptoms of disease, the psychosocial situation, and the ability to carry out activities of everyday life. There were also questions on which expectations the patients had had regarding their operation and how these had been fulfilled. The answers to some of the questions are presented in Figure 2. The results show that all surviving patients had returned home. Their physical capacity and ability to cope with activities of daily life had improved. Pain and dyspnea were experienced less often, and psychological symptoms such as anxiety and depression were relieved. Two thirds of the patients considered their status after the operation to be better than they had expected, and none of the patients in the study group after 1 year regretted having accepted the operation. One gentleman described it as The best thing I ve done since I got married in 1946! The few patients who suffered serious postoperative complications (eg, amputation of a foot, cerebrovascular lesion) accepted this as they did not experience chest pain or feelings of depression and anxiety any longer. When the second survey was carried out, to 2 years after the operation, the results remained essentially unchanged and the quality of life was still good. Comment The present-day limitation of economic resources for health care forces us to investigate whether or not allocated resources are being used optimally. From this point of view it would be of interest to limit the cost of intensive care, and one way of doing this is to sort out patients who may be expected to have a complicated postoperative course from those with an anticipated uneventful postoperative course. Over the last 5 to 10 years several risk-scoring systems for cardiac surgery have been developed [15]. These systems aim at identifying preoperative risk factors to enable prediction of the patients postoperative course. The earlier methods focused on mortality risk, whereas more recent instruments also focus on morbidity [14, 16]. In a national symposium 1994 entitled Using Outcome Data to Improve Clinical Practice in Keystone, Colorado, it was concluded that current risk models still have significant limitations, particularly in predicting individual patient risk [17]. This is in accordance with the finding of the present study that only 38% of the patients with the most severe complications including the patients who died in the early postoperative period were scored as high-risk patients by Higgins definition [14]. It is clear that patients with a complicated postoperative course more frequently belonged to a high-risk group preoperatively, but some patients with only a few or no significant preoperative risk factors were unexpectedly stricken by serious intraoperative and postoperative complications. Even when complications have occurred and the patient is treated in the ICU there are no good models for predicting outcome. In recent publications some authors have tried to describe instruments to predict outcome when the patients have spent several days in the ICU. They have used acute physiology and chronic health evaluation (APACHE II; APACHE Medical Systems, McLean, VA) or other models [18, 19]. It seems possible, in some selected groups of long-term ICU patients, to predict death with good specificity, but in spite of this the potential economic saving (if treatment was to be withdrawn) would be small [20]. Serious postoperative complications leading to pro-

4 Ann Thorac Surg SÖDERLIND ET AL 1997;63:124 8 QUALITY OF LIFE AND COMPLICATIONS 127 Fig 2. Some questions and answers from the quality of life questionnaires. longed intensive care included (1) cardiac failure, especially if requiring treatment with intraaortic balloon pump or Hemopump (DLP/Medtronic, Inc, Grand Rapids, MI), (2) renal failure requiring dialysis, (3) operative or postoperative myocardial infarction, (4) cerebrovascular lesions, (5) reoperation for various reasons, and (6) serious infections. Our 100 patients were all stricken by one or several of these complications, which is an explanation for the increased mortality rate in this group. It is not uncommon for these patients to have congestive heart failure due to extensive intraoperative myocardial infarction when they leave the intensive care unit. Bearing this in mind, the main finding of the present study was the fact that more than 70% of these patients were still alive 2 years after the operation. This is rather encouraging because one of the reasons for performing this investigation was the suspicion that the long-term results in this group would be very poor and that many patients would be severely handicapped. We found a markedly increased mortality rate during the first postoperative year. During the following 2 years the difference in mortality was less pronounced. Studies of long-term results after cardiac operations often focus on patients being able to return to work or not [21, 22]. Among our patients, in whom the mean age was close to the age when people retire, work status is not such a good measure of the impact of an operation on the patient s life situation. Other aspects of life are more important if one is to get the full picture: the ability to do housework, the level of physical activity, and family life. It is also important to find out to what extent the patients are bothered by chest pain, tiredness, or unpleasant feelings related to heart disease or operation, and if anxiety or depression is a problem. Because this was a retrospective study we did not have the opportunity to have the patients fill in a preoperative questionnaire regarding their quality of life. However, the patients were asked to compare their quality of life before and after the operation. All surviving patients had returned home with a better physical capacity and improved ability to cope with activities of daily life. The cost of treating these high-risk patients and the complications that occurred might seem high, but one must also realize that many of these patients would have required hospitalization, even if no operation was performed. Obviously the cost can be high even without surgical intervention; it cannot be assumed that conservative treatment in these cases would be equivalent to saving money [23]. We conclude that the cost of treating severe complications in the ICU is high. However, the results of the present study indicate that even a very complicated postoperative course is not incompatible with a successful outcome in the long run. References 1. Løes Ø, Smith-Erichsen N, Lind B. Intensive care: cost and benefit. Acta Anesth Scand 1987;31(Suppl 84): Zarén B, Bergström R. Survival of intensive care patients I II: Prognostic factors from the patient s medical history. Outcome prediction 1 hour after admission. Acta Anesth Scand 1988;32: Zarén B, Bergström R. Survival compared to the general

5 128 SÖDERLIND ET AL Ann Thorac Surg QUALITY OF LIFE AND COMPLICATIONS 1997;63:124 8 population and changes in health status among intensive care patients. Acta Anesth Scand 1989;33: Dragsted L, Qvist J. Outcome from intensive care III. A 5-year study of 1308 patients: activity levels. Eur J Anesth 1989;6: Jenkins CD, Stanton B-A, Savageau JA, Denlinger P, Klein MD. Coronary artery bypass surgery. Physical, psychological, social and economic outcomes six months later. JAMA 1983;250: CASS principal investigators and their associates. Coronary artery surgery study (CASS): a randomized trial of coronary artery bypass surgery. Circulation 1983;68: Klonoff H, Campbell C, Kavanagh-Gray D, Mizgala H, Munro I. Two-year follow-up study of coronary bypass surgery. J Thorac Cardiovasc Surg 1989;97: Alderman E, Bourassa M, Cohen L, et al. Ten year follow-up of survival and myocardial infarction in the randomized coronary artery surgery study. Circulation 1990;82: Mayou R, Bryant B. Quality of life after coronary artery surgery. Q J Med. 1987;62: King KB, Porter LA, Norsen LN, Reis HT. Patient perceptions of quality of life after coronary artery surgery: was it worth it? Res Nurs Health 1992;15: Clark RE, Edwards FH, Schwartz M. Profile of preoperative characteristics of patients having CABG over the past decade. Ann Thorac Surg 1994;58: Hammermeister KE, Daley J, Grover FL. Using outcomes data to improve clinical practice: what we have learned. Ann Thorac Surg 1994;58: Cullen DJ, Civetta JM, Briggs BA, Ferrara LC. Therapeutic intervention scoring system: a method for quantitative comparison of patient care. Crit Care Med 1974;2: Higgins TL, Estafanous FG, Loop FD, et al. Stratification of morbidity and mortality outcome by preoperative risk factors in coronary artery bypass patients. JAMA 1992;267: Daley J. Criteria by which to evaluate risk-adjusted outcomes programs in cardiac surgery. Ann Thorac Surg 1994; 58: Parsonnet V, Dean D, Bernstein AD. A method of uniform stratification of risk for evaluating the results of surgery in acquired heart disease. Circulation 1989;79(Suppl 1):3 12 (published erratum appears in Circulation 1990;82:1078). 17. Iezzoni L. Using risk-adjusted outcomes to assess clinical practice: an overview of issues pertaining to risk adjustment. Ann Thorac Surg 1994;58: Shaughnessy TE, Mickler TA. Does APACHE II scoring predict need for prolonged support after coronary revascularization? Anesth Analg 1995;81: Thompson MJ, Elton RA, Sturgeon KR, et al. The Edinburgh cardiac surgery score survival prediction in the long-stay ICU cardiac surgical patient. Eur J Cardiothorac Surg 1995;9: Holmes L, Loughead K, Treasure T, et al. Which patients will not benefit from further intensive care after cardiac surgery? Lancet 1994;344: Gutmann MC, Knapp DN, Pollock ML, Schmidt DH, Simon K, Walcott G. Coronary artery bypass patients and work status. Circulation 1982;66(Suppl 3): Sergeant P, Lesaffre E, Flameng W, Suy R. How predictable is the postoperative work resumption after aortocoronary bypass surgery? Acta Cardiol 1986;41: Wittels EH, Hay JW, Gotto AM. Medical costs of coronary artery disease in the United States. Am J Cardiol 1990;65: INVITED COMMENTARY I have often wondered what happened to a catastrophically ill patient in the surgical critical-care unit a year or so later. Did a patient with borderline renal failure, on a ventilator, with an intraaortic balloon pump, and with confused mentation who struggled out of the hospital 3 weeks postoperatively really benefit after the acute episode had subsided? Unfortunately, except for an occasional patient, I could never find an answer to such a question. Certainly I would not gather enough information to have a specific statistical answer. It is reassuring to know, therefore, that many patients are quite satisfied with their lot 1 or 2 years later. I am less pleased with the conclusions than are Söderlind and associates, because there are troublesome problems. In the first place, survivors who feel moderately well, and who realize how ill they had been, are likely to say nice things in response to simple questions. Also 27 of the 100 patients who died could not provide answers to the questionnaire, nor did the 8 living patients who did not respond to the questionnaire. What would they have said? The stratification of risk was not really pertinent to this question. What is important is the ultimate quality of life of those patients who survive, regardless of the conditions that preceded the operation. It is more relevant to relate the specific long-term outcome to the major type of postoperative complication. One would hope that some day the investigators will pursue some unanswered questions: 1. What was the distribution of the types of problems that kept the patients in the coronary care unit, such as renal failure, neurologic deficits, pulmonary failure, ventilator support, congestive heart failure, and myocardial infarction? 2. Of these groups, which were most and the least likely to have satisfactory long-term benefits? 3. Why did the 27 patients die, and into which categories did they fall? 4. How many patients had additional hospitalizations or subsequent interventions? 5. What additional drug therapy, if any, was needed? 6. What will be the patients attitudes at 3 years, 5 years, and 10 years? This report represents a beginning in answering these questions. Söderlind and associates are to be thanked for leading the way. Victor Parsonnet, MD Division of Surgical Research New Jersey Pacemaker and Defibrillation Evaluation Center, Inc Newark Beth Israel Medical Center 201 Lyons Ave Newark, NJ by The Society of Thoracic Surgeons /97/$17.00 Published by Elsevier Science Inc PII S (96)