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Ann Thorac Surg 1998;65:741-747
© 1998 The Society of Thoracic Surgeons
Department of Surgery A, Rikshospitalet, Oslo, Norway
Accepted for publication September 29, 1997.
Dr Arafa, Department of Surgery A, Rikshospitalet, 0027 Oslo, Norway.
| Abstract |
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Methods. We analyzed the prognostic predictors and long-term survival of 344 patients undergoing cardiac operations who required the perioperative use of an IABP at our institution from January 1980 to December 1989. Hospital survivors (163 patients) were followed up for a mean of 7.45 years (range, 1 month to 15.3 years); cumulative follow-up included 1,167 patient-years.
Results. The early mortality rate was 52.6% (181 patients). From parameters available at the time of IABP insertion, logistic regression analysis identified preoperative serum creatinine level, left ventricular ejection fraction, perioperative myocardial infarction, timing of IABP insertion, and indication for operation as independent predictors of early (30-day) death (p < 0.05). Cox regression analysis of hospital survivors identified timing of IABP insertion, perfusion time, and preoperative serum creatinine level as independent prognostic factors for late death (p < 0.05), whereas patient age was only marginally significant (p < 0.06). There was no association between IABP-related complications and death. Survival analysis demonstrated a 10-year actual survival rate of 22.04% ± 0.023%, with 57 patients still at risk and significantly improved survival among those who received an IABP before operation (p < 0.02).
Conclusions. The early mortality rate in patients who received an IABP was high. Hospital survivors had a relatively good long-term prognosis. The significantly better short- and long-term survival of patients who received an IABP before operation may justify more liberal preoperative use of the IABP in high-risk patients.
| Introduction |
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Augmentation of the arterial diastolic pressure first was recorded as early as 1953, through retardation of the systolic pulse pressure by recovery of the systolic arterial wave from the femoral artery to the aorta through an elastic tube [3]. The first experimental results using an inflatable latex balloon inserted into the descending thoracic aorta through the femoral artery for the purpose of counterpulsation were reported in 1962 by Moulopoulos and associates [4]. The first clinical application was reported in 1968, primarily for use in cardiogenic shock [5]. Since that time, the IABP has gained widespread acceptance, and it is estimated that 70,000 IABPs are inserted annually in the United States [6].
Several previous studies [7][8][9] focused on prognostic factors for death in patients treated with an IABP without agreement on preoperative determinants of survival. As a result of variability in the indications for IABP insertion and differences in the patient populations, there is great variability in the results reported [7][8][9]. The present study, which includes clinical material from one surgical department, was undertaken to analyze the short- and long-term outcome of patients who receive an IABP perioperatively and to determine possible prognostic factors for early and late death. Further, a 10-year survival analysis considering possible significant prognostic factors was performed.
| Material and Methods |
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Clinical Parameters
The following clinical variables were included in the analysis: age, sex, body surface area, hypercholesterolemia (serum cholesterol >6 mmol/L), smoking (
5 cigarettes per day), diabetes mellitus, hypertension (systolic pressure >160 mm Hg), preoperative New York Heart Association class, cardiac rhythm, serum creatinine level (in micromoles per liter), number of previous myocardial infarctions (MIs), previous cardiac operations, and emergency operations (operation within 24 hours of diagnosis). Cardiac catheterization data included the number of diseased vessels (obstruction >75%), the left ventricular ejection fraction, and the left ventricular end-diastolic pressure. Relative heart volume was measured from standard chest roentgenograms. Perioperative MI was defined as new Q waves in association with increased enzyme creatine kinase and isoenzyme creatine kinase-myocardial band levels. We considered only perioperative MIs diagnosed before the insertion of an IABP.
Operative Variables
All surgical procedures were performed using moderate hemodilution, systemic moderate hypothermia (28°C), crystalloid cardioplegia, and topical cooling. Cardiopulmonary bypass time and aortic cross-clamp time were recorded. A total of 216 (62.8%) patients were operated on for ischemic heart disease, 67 (19.5%) for valvular heart disease, 43 (12.5%) for combined ischemic and valvular disease, and 18 (5.2%) for other conditions (Table 1). The site and technique of insertion of the IABP were recorded. Major IABP-related complications were defined as aortic perforation, dissection or ischemia requiring a vascular operation, and fasciotomy or amputation. Minor complications included ipsilateral transient limb ischemia, which recovered after removal of the IABP, and local infection or bleeding at the site of insertion. All patients who died in the hospital underwent autopsy. Early death was defined as any death that occurred within 30 days of operation and late death as any death after that time.
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2 or Fishers exact test, whenever applicable, was used for discrete variables, with estimation of the odds ratio and 95% confidence interval. The two-tailed Students t test or Mann-Whitney test was used to compare continuous variables. A p value of less than 0.05 was regarded as statistically significant. Using the BMDP statistical software package, release 7.01 [11], all variables with a p value of 0.15 or less were entered into a stepwise logistic regression model to determine independent risk factors for early death. Cox regression analysis was used to determine independent predictors of late death among factors that were identified in the univariate analysis or were considered clinically important.
Survival Analysis
Cumulative survival curves were computed according to Kaplan and Meier using the life table and survival functions program in the BMDP package [11] and stratifying according to the most significant risk factors. Differences between survival curves were estimated using the Mantel-Cox and Breslow tests. Survival rates were given as cumulative survival ± standard error.
| Results |
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2 = 11.9; p > 0.8). The IABP was used before operation in 53 (15.4%) patients to treat refractory circulatory failure, mostly caused by postischemic ventricular septal rupture and acute mitral regurgitation. During operation, the IABP was used in 192 (55.8%) patients to assist in weaning from cardiopulmonary bypass. After operation, the IABP was used in 99 (28.8%) patients to treat cardiogenic shock or persistent hypotension (n = 97) and refractory arrhythmia (n = 2).
Risk Factors for Early Death
Univariate analysis identified the following factors as associated with early death: previous MI, previous cardiac operation, emergency operation, body surface area, New York Heart Association class, lack of sinus rhythm, preoperative serum creatinine level, left ventricular ejection fraction, end-diastolic pressure, perfusion time, and perioperative MI. Multivariate analysis using forward logistic regression identified preoperative creatinine level, ejection fraction, perioperative MI, type of surgical procedure, and timing of IABP insertion as independent risk factors for early death (p < 0.05).
Risk Factors for Late Death
Univariate analysis of possible preoperative and intraoperative factors revealed that age, perfusion time, cardiac ischemic time, and timing of IABP insertion correlated significantly with late death (Table 2). Cox regression analysis identified the following as independent risk factors: timing of IABP insertion (p < 0.01), preoperative serum creatinine level (p < 0.05), and perfusion time (p < 0.05). Further, age was found to be marginally significant (p < 0.06).
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| Comment |
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In our series, most IABPs were inserted during or after operation for low output syndrome. This is consistent with some other reports [8][18]. Most of the patients who received an IABP before operation had serious post-MI complications. However, despite the absolute decrease in IABP use during the study period, the relative distribution of preoperative, intraoperative, and postoperative insertion remained relatively constant.
The early mortality rate for patients who are treated with an IABP remains high. The average early mortality rate in this study was 53%, which is consistent with the range (36% to 61%) reported in series of patients undergoing cardiac operations, including patients with cardiogenic shock [1][8][9][12][13][14][17][18][19]. Survival rates are better in series in which the IABP was inserted prophylactically before operation in high-risk patients with unstable angina, left main coronary artery stenosis, and left ventricular dysfunction [20][21]. However, the criteria for selecting appropriate candidates for preoperative use of the IABP remain controversial [12][18].
Identification of the group of patients who are at the highest risk of death at the time of IABP insertion will help to determine which patients may benefit from temporary support of the heart beyond that offered by the IABP [7] or from other management strategies. In our analysis of prognostic factors in patients who received an IABP, we depended entirely on variables that were available at the time of IABP insertion for the prediction of early death. Our model identified five factors as independently significant.
Postoperative renal dysfunction previously has been correlated with poor outcome after cardiac operations [22]. In our study, as in others [9][17], there was a significant linear trend between the preoperative serum creatinine level and early death. Furthermore, we found that the preoperative serum creatinine level significantly affected late death. We agree with Bolooki and associates [23] and with Corral and Vaughn [24] that the preoperative left ventricular ejection fraction and end-diastolic pressure are important determinants of patient survival, and that a minimum degree of left ventricular function should be required for patients who receive an IABP.
The effect of the type of operation performed on the survival of patients who receive an IABP has been documented by others [7][9][16][24]. In our series, we found that the poorest prognosis was associated with low cardiac output complicating congenital heart operations and heart transplantation. Patients who underwent operation for ischemia and ischemic complications had better survival than those who underwent operation for valvular heart disease either alone or in combination with ischemia. The IABP may be more beneficial for myocardium with ischemia than for myocardium with chronic mechanical strain caused by valvular heart disease.
Perioperative MI is one of the most significant risk factors cited in the literature [9][22]. In our study, the timing of IABP insertion affected significantly the prognosis of patients with perioperative MI, with preoperative insertion proving most favorable. However, perioperative MI was not a significant risk factor for late death in patients who received an IABP. The patients with perioperative MI who survived 30 days after operation had a survival curve similar to that of the patients without MI. Thus, our results support a policy of earlier and more liberal use of the IABP in high-risk patients, as recommended previously by other investigators [2][7][23][25].
The morbidity rate related to IABP insertion in our study was 16%, which is within the range (8.7% to 29%) reported elsewhere [17][26]. Complications related to the IABP ranged from minor local wound infection or hemorrhage from the access site, which rarely resulted in long-term morbidity, to major vascular complications, which led to long-term morbidity and even death in some patients. The IABP itself was the cause of death in 2 patients (0.5%). However, there was no statistically significant association between IABP-related complications and the short- or long-term mortality rate, in agreement with other studies [1][12]. Thus, complications related to the IABP should not restrict its use in high-risk patients.
A thorough analysis of survival curves showed that the IABP failed to support the circulation in 70 (20%) patients who died during the first 4 hours after operation, in accordance with previous reports [8][9][13]. According to Baldwin and co-workers [8], such patients are most likely to benefit from more effective modalities of ventricular support.
Survival analysis showed that hospital survivors usually had a relatively good probability of late survival. The highest mortality rate after hospital discharge occurred in the first year, especially in the first 3 months after operation. Taking into account the advanced clinical profile of our patients, the 5- and 10-year actual survival rates of approximately 32% and 23% are comparable to other published reports [1][12][14].
In conclusion, although the early mortality rate in patients who received an IABP was high, the long-term prognosis was relatively good for patients who survived the early postoperative period. Preoperative insertion of an IABP was associated with improved early as well as late survival. This finding suggests that more liberal and earlier use of the IABP is advisable in high-risk patients.
| Footnotes |
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| References |
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