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Ann Thorac Surg 1998;65:741-747
© 1998 The Society of Thoracic Surgeons


Original Articles: Cardiovascular

Intraaortic Balloon Pump in Open Heart Operations: 10-Year Follow-up With Risk Analysis

Osama E. Arafa, MD, Thore H. Pedersen, ACP, Jan L. Svennevig, MD, PhD, Erik Fosse, MD, PhD, Odd R. Geiran, MD, PhD

Department of Surgery A, Rikshospitalet, Oslo, Norway

Accepted for publication September 29, 1997.

Dr Arafa, Department of Surgery A, Rikshospitalet, 0027 Oslo, Norway.


    Abstract
 Top
 Footnotes
 Abstract
 Introduction
 Material and Methods
 Results
 Comment
 References
 
Background. The intraaortic balloon pump (IABP) is the primary mechanical device used for perioperative cardiac failure.

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
 Top
 Footnotes
 Abstract
 Introduction
 Material and Methods
 Results
 Comment
 References
 
The intraaortic balloon pump (IABP) usually is the first mechanical device used for perioperative cardiac failure [1]. Its main effects are reduction of ventricular afterload, improvement of diastolic coronary perfusion, and enhancement of subendocardial perfusion [2].

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
 Top
 Footnotes
 Abstract
 Introduction
 Material and Methods
 Results
 Comment
 References
 
Patients and Procedures
Over the 10-year period from January 1980 through December 1989, 5,768 patients underwent open heart operations at our institution. All the patients who were treated with an IABP during the perioperative period were identified using our cardiothoracic database. Whenever necessary, additional data were obtained from the patients’ records. A total of 344 patients (5.9% of all patients), 231 males and 113 females with a mean age of 58 ± 11.8 years (range, 7 to 80 years), were treated with an IABP before (n = 53), during (n = 192), or after (n = 99) operation. The outcome analysis considered all deaths irrespective of the cause. The 163 operative survivors (47.4%) were followed up for a mean of 7.45 ± 4.8 years (range, 1 month to 15.3 years). The cumulative follow-up for hospital survivors was 1,167 patient-years. Data concerning patient survival are complete and were verified using the Norwegian civil registry. Follow-up data were acquired from the patients’ records at either our institution or the local hospital.

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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Clinical Characteristics of the Study Population

 
Statistical Analysis
Continuous variables were presented as means ± 1 standard deviation, whereas discrete variables were presented as frequencies. EPI-info version 6 [10] was used for univariate analysis. The {chi}2 or Fisher’s exact test, whenever applicable, was used for discrete variables, with estimation of the odds ratio and 95% confidence interval. The two-tailed Student’s 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
 Top
 Footnotes
 Abstract
 Introduction
 Material and Methods
 Results
 Comment
 References
 
Over the 10-year study period, the frequency of IABP insertion decreased gradually from 9% to 4.2% (p < 0.05). The decrease was accompanied by an increase in the early mortality rate from 41% to 66% (p < 0.05). The relative proportion of IABPs inserted before, during, and after operation remained unchanged over the study period ({chi}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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Risk Factors for Late Death1

 
Survival Study
Survival analysis (Fig 1) showed that the actual survival rate at 3 months was 41.9% ± 0.027%. At 1, 5, and 10 years, the survival rates were 40% ± 0.03%, 32.3% ± 0.03%, and 22.04% ± 0.02%, respectively. At the same intervals, the number of patients who remained at risk was 144, 136, 111, and 57, respectively. Of the 123 patients who had a perioperative MI, only 33 (27.0%) patients survived the first 30 postoperative days, compared with 57.7% of the patients who did not have a perioperative MI (p < 0.01) (Fig 2). The early mortality rate was lower for patients with a perioperative MI who received an IABP before operation (21/45, 47%) than for those who received an IABP during or after operation (66/78, 84%). However, the occurrence of a perioperative MI did not affect significantly the long-term prognosis of hospital survivors.



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Survival curve for 344 patients who received an intraaortic balloon pump, with an early mortality rate of 52.6%. (Op = operative day; Y = year.)

 


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Survival curves showing a significant increase in the early mortality rate in patients with a perioperative myocardial infarction (MI) who received an intraaortic balloon pump. (Op = operative day; pts = patients; Y = year.)

 
Actual survival rates at 1, 5, and 10 years for patients with renal insufficiency (creatinine >120 µmol) were 17.1%, 14.6%, and 9.8%, respectively (Fig 3). A preoperative ejection fraction of 0.40 or higher was associated with a better prognosis than was an ejection fraction of less than 0.40 (p < 0.05) (Fig 4). The actual 10-year survival rate was 41.5% in patients who received an IABP before operation (n = 15) compared with 20.8% in those who received an IABP during operation (n = 27) and 20.3% in those who received an IABP after operation (n = 15) (Fig 5).



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Survival curves for patients who received an intraaortic balloon pump stratified according to their preoperative serum creatinine level (in micromoles per liter). The preoperative serum creatinine level correlated significantly with early death. (Op = operative day; pts = patients; Se-creat. = serum creatinine level.

 


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Survival curves for patients who received an intraaortic balloon pump stratified according to their preoperative ejection fraction (EF). (Op = operative day; pts = patients; Y = year.)

 


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Survival curves for patients who received an intraaortic balloon pump, classified according to the timing of IABP insertion. (Op = operative day; pts = patients; Y = year.)

 
The effect of age on prognosis is illustrated in Fig 6. Patients aged 51 to 60 years had the best prognosis. In younger patients, survival was directly proportional to age, and in older patients, survival was inversely proportional to age. Stratification of patients according to their indication for operation (Fig 7) showed that those who were operated on for ischemia or ischemic complications (ie, ventricular septal rupture, left ventricular aneurysm) had the best outcome.



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Survival curves for patients who received an intraaortic balloon pump, stratified according to age. (Op = operative day; pts = patients; Y = year.)

 


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Survival curves for patients who received an intraaortic balloon pump, stratified according to the indication for operation. (CABG = coronary artery bypass grafting; Op = operative day; pts = patients; Y = year.)

 
Intraaortic Balloon Pump–Related Morbidity
Early minor and major complications related to the IABP occurred in 36 (10.5%) and 26 (7.6%) patients, respectively. The minor complications included local infection with or without systemic bacteremia in 27 patients and local hematoma in 9 patients. The major complications included fatal aortic perforation in 1 patient and lower limb ischemia in 26 patients that required above-the-knee amputation in 2 patients and vascular operations in 5 patients. Two deaths (0.58%) were related to IABP complications, 1 to aortic perforation and the other to limb ischemia complicated by septic gangrene. The IABP-related complications were not related significantly to early or late death in our patients.


    Comment
 Top
 Footnotes
 Abstract
 Introduction
 Material and Methods
 Results
 Comment
 References
 
During the 10-year study period, use of the IABP in our department became more restricted as a result of the institution of rigid hemodynamic criteria for its application. Most of our patients were treated with an IABP because of low cardiac output that was refractory to maximum pharmacologic treatment and judicious volume loading, in agreement with other reports [9][12][13][14]. This may explain the increased mortality rate in the treated patients. Analysis of patients who underwent coronary artery bypass grafting or valve operations during the same period demonstrated early mortality rates of 3% and 5%, respectively [15][16]. Our annual rate of perioperative IABP insertion during the study period was 5.9% (range, 4% to 9%), which is similar to the rates documented in other reports [1][8][10][13][14][17]. In spite of a general increase in the use of the IABP [1][7][17], our rate of insertion decreased from 9% to 4.2% over the study period. This decrease was accompanied by an increase in the early mortality rate from approximately 40% in the early years of the study to more than 66% in 1989.

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
 Top
 Footnotes
 Abstract
 Introduction
 Material and Methods
 Results
 Comment
 References
 
This article has been selected for the open discussion forum on the STS Web site: http://www.sts.org/annals Back


    References
 Top
 Footnotes
 Abstract
 Introduction
 Material and Methods
 Results
 Comment
 References
 

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Optimal timing of preoperative intraaortic balloon pump support in high-risk coronary patients
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Aggressive preoperative use of intraaortic balloon pump in elderly patients undergoing coronary artery bypass grafting
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Jan L. Svennevig
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