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Eur J Cardiothorac Surg 2000;17:30-37
© 2000 Elsevier Science NL

Improved outcome of APACHE II score-defined escalating systemic inflammatory response syndrome in patients post cardiac surgery in 1996 compared to 1988–1990: the ESSICS-study pilot project

C. Kuhna, U. Müller-Werdana, D.V. Schmittb, H. Langec, G. Pilzd,e, E. Kreuzerd,e, F.W. Mohrb, H.-R. Zerkowskif, K. Werdana

a Department of Medicine III, University of Halle-Wittenberg, Ernst-Grube-Strasse 40, D-06097 Halle, Germany
b Department of Cardiac Surgery, University of Leipzig, Leipzig, Germany
c Zentralklinik Bad Berka GmbH, D-09437 Bad Berka, Germany
d Department of Cardiac Surgery, University of Munich, Munich, Germany
e Department of Medicine, University of Munich, Munich, Germany
f Department of Cardiac Surgery, University of Halle-Wittenberg, Ernst-Grube-Strasse 40, D-06097 Halle, Germany

Corresponding author. Tel.: +49-345-557-4545; fax: +49-345-557-4546
e-mail: ursula.mueller-werdan{at}medizin.uni-halle.de


   Abstract
Top
 Abstract
1. Introduction
 2. Materials and methods
 3. Results
 4. Discussion
 5. Conclusion
 References
 
Objective: Cardiac surgery using extracorporeal circulation leads to the release of cytokines and subsequently to a systemic inflammatory response syndrome, which is thought to be a negative prognostic factor for patients’ outcome. A stratification for the risk of an escalating systemic inflammatory response syndrome had been achieved in a monocenter study carried out in 1988–1990, using APACHE II scoring on the morning of the 1st postoperative day. We now re-evaluated this concept prospectively in three independent centers. Methods: The APACHE II based risk stratification was put to test in three independent heart surgery centers in the period from June to December 1996. Nine hundred and forty-five patients after elective cardiac surgery (excluding heart transplantation) with the assistance of the cardiopulmonary bypass were prospectively monitored. Results: We found an increase in mortality with higher APACHE II score values determined on the 1st postoperative day. The mortality rose to nearly 50% with an APACHE II score of >=28. Patients at high risk for the development of a systemic inflammatory response syndrome (APACHE II score >=24) significantly differed from patients at lower risk (APACHE II score <19) in the duration of mechanical ventilation and extracorporeal circulation, age and New York Heart Association (NYHA) classification (P<0.05). Conclusion: The APACHE II score determined on the morning of the 1st postoperative day helps identifying the subgroup of patients with escalating systemic inflammatory response syndrome. Comparison with the data obtained in the years 1988–1990, suggests a better prognosis in the current trial for patients at high risk with a similar degree of escalating systemic inflammatory response syndrome.

Key Words: APACHE II score • Cardiopulmonary bypass • Escalating systemic inflammatory response syndrome • Outcome after cardiac surgery • Risk stratification


   1. Introduction
Top
 Abstract
 1. Introduction
2. Materials and methods
 3. Results
 4. Discussion
 5. Conclusion
 References
 
In patients after cardiac surgery, the incidence of infections is high [1], owing to cardiac impairment and the intraoperative use of extracorporeal circulation and its sequelae [2–4]. Sepsis, severe systemic inflammatory response syndrome (SIRS) and multiple organ dysfunction syndrome (MODS) are the major complications encountered in the intensive care unit (ICU) among these patients, with mortality rates ranging as high as 40–60% [5,6].

Factors causally related to the high risk for MODS and sepsis post cardiac surgery are severe preexisting heart disease, the consequences of thoracotomy with an increased incidence of pneumonias, and particularly an acute severe SIRS induced by the cardio-pulmonary bypass (CPB) [7]. In 2–10% of patients post cardiac surgery CPB–SIRS takes an exaggerated course, presenting as an escalating SIRS, which clinically resembles and is often indistinguishable from sepsis [5,8].

In an attempt to identify the best predictors of septic complications on the 1st postoperative day after cardiac surgery, various parameters have been compared and it was found that scores grading severity of MODS were superior to measurements of plasma elastase and neopterin, hemodynamics and clinical parameters [5,8–10]. Among these scores of comparable predictive accuracy [11], the APACHE II score [12–14] was found to be the most practicable tool for routine bedside scoring, yielding reliable results with only minimal interobserver variability [9]. Moreover, in these studies, the APACHE II score was confirmed to be a valid measure for evaluating disease progression and response to therapy in patients with sepsis.

According to an investigation performed with patients after cardiac surgery from 1988–1990, the APACHE II score value allows for an early postoperative risk stratification, discriminating on the 1st postoperative day between the large population of lower risk patients (score <19) with mostly uneventful course and the small groups of intermediate risk patients (score 19–23) and of high risk patients (score >=24), whose mortality is at least tenfold increased in comparison to the lower risk group [5]. More recent data indicate that in APACHE II score-identified high risk patients post cardiac surgery elevated soluble TNF receptor-p55 serum levels early indicate the severity of the subsequent course and prognosis. Potentially, the combination of scores and cytokine receptor measurements could further improve the predictive power of risk stratification early in the postoperative course [15,16].

Two recent clinical trials by our group gave evidence that early supplemental i.v. immunoglobulin treatment may reduce disease severity and improve prognosis in prospectively APACHE II score-identified high risk patients post cardiac surgery [5,8,17]. In contrast to untreated historical control patients, a marked fall in APACHE II scores was found in patients treated with i.v. immunoglobulin, especially in high risk patients, and a reduced mortality was documented.

Despite the beneficial effects of immunoglobulin [18–21] suggested by these studies, the relevance of the results is limited due to the design of these studies lacking in a placebo group. Thus, these open trials can only be regarded as a primarily exploratory analysis requiring independent replication and validation in a placebo-controlled, double-blind study. Accordingly, based on those preliminary trials’ concepts and results, the ESSICS (Early Supplemental severe SIRS treatment with IvIG in score-identified high risk patients after Cardiac Surgery) study was designed to evaluate the efficacy of early supplemental therapy with polyvalent 10% immunoglobulin G in score-identified post cardiac surgical patients at high risk in a multicenter, randomized, placebo-controlled, prospective, double-blind fashion.

Primary endpoints of the ESSICS study are morbidity, assessed by the change in the APACHE II score from postoperative day 1 to day 5, and 28-day mortality rates in high risk patients treated with i.v. immunoglobulin vs. placebo.

Two hundred and eighty patients out of 10 000 screening patients are scheduled to be treated in this study. This sample size calculation is based on an expected proportion of high risk patients of 2.8%, a mortality of 60% in the placebo group and a mortality of 40% in the immunoglobulin group. These assumptions are supported by previously published data [5].

Pertinent for the validity of the ESSICS study concept was the issue whether the data raised in a single center trial in 1988–1990 about mortality of post cardiac surgery patients, still form a realistic basis for defining risk categories at present, i.e. whether an APACHE II score >=24 on the morning of the 1st postoperative day will actually select the 3% patients at high risk. Therefore, prior to starting the ESSICS study, we performed a prospective study (referred to as ‘pilot project II’) in three independent centers to re-evaluate in 1996 the previously established APACHE II score cut-off criterium for identifying patients at high risk. The main goal of the pilot project II was to re-evaluate the score cut-off point, previously set to 24, for defining the high risk collective of patients after cardiac surgery with an estimated mortality of 60%.

In detail, the following questions were addressed: (1) to what extent do high risk patients contribute to overall mortality post cardiac surgery?; (2) what is the hospital mortality of high risk patients?; and (3) what percentage contribute high risk patients to total mortality post cardiac surgery?


   2. Materials and methods
Top
 Abstract
 1. Introduction
 2. Materials and methods
3. Results
 4. Discussion
 5. Conclusion
 References
 
2.1. Study population and data collection of the present study
In three independent heart surgery centers (Department of Cardiac Surgery, Martin-Luther-University of Halle-Wittenberg; Department of Cardiac Surgery, University of Leipzig; Department of Anesthesiology, Zentralklinik Bad Berka GmbH) in the period from June to December 1996, patients after elective cardiac surgery with the assistance of CPB were monitored. The trial was performed in a prospective, merely observational manner. Nine hundred and forty-five post cardiac surgical ICU patients, who had undergone elective cardiac surgery (excluding heart transplantation and pediatric surgery) were enrolled. The APACHE II score was calculated on the morning of the 1st postoperative day using a microcomputer-based scoring program [22]. Patients defined to be high risk (APACHE II score >=24 on the morning after surgery) had APACHE II scores calculated daily until the 5th day after surgery. Patients with an APACHE II score <24 on the 1st postoperative day were followed up until discharge from the ICU; mortality was defined as in-hospital mortality.

2.2. Comparison of the current data with a previous study establishing APACHE II score based risk stratification
The nine hundred and forty-five patients of this tricenter study (‘pilot project II’) were compared with data of 881 patients examined in a previously published monocenter study (referred to as ‘pilot project I’) in 1988–1990 [5]. These 881 patients had undergone elective open-heart surgery with extracorporeal circulation and had been assessed on the morning of the 1st postoperative day with the same microcomputer-based APACHE II scoring program. Mortality in these patients was documented as in-hospital mortality.

2.3. Statistical analysis
Differences between groups were statistically analyzed using ANOVA and Fisher's least significant difference procedure. A P-value of less than 0.05 was considered statistically significant. All data are given as mean±standard deviation.


   3. Results
Top
 Abstract
 1. Introduction
 2. Materials and methods
 3. Results
4. Discussion
 5. Conclusion
 References
 
Baseline characteristics of the patients enrolled in the two pilot projects are shown in Table 1.


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  		Table 1. Baseline demographic data of patients

 
In pilot project II the majority of cardiac surgery patients, namely 86%, met the definition of SIRS [23,24].

3.1. APACHE II score-based risk stratification
The pertinent results of the two pilot projects are shown in Table 2. The data obtained from pilot study II confirmed that APACHE II scoring allows for a risk stratification early after cardiac surgery with the assistance of CPB. Patients in the high risk group differed significantly from those in lower risk group by age, preoperative NYHA stage, duration of extracorporeal circulation and postoperative mechanical ventilation.


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  		Table 2. Characteristics of the three risk groups according to the APACHE II score based risk stratification

 
Fig. 1 depicts the proportions of the three risk groups and mortality rates in the three strata, comparing the period of 1988–1990 to 1996. In the patient population investigated in 1996, the portion of APACHE II score-identified high risk patients was three times as high as in 1988–1990, but the mortality rate was only half as high as in 1988–1990 (mortality 30 vs. 76%).



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  		Fig. 1. Proportion and mortality of lower, intermediate and high risk patient groups in the pilot project I (1988–1990) and pilot project II (1996). ‘Lower risk’: APACHE II score <19 on the 1st postoperative day; ‘intermediate risk’: APACHE II score 19–23 on the 1st postoperative day; ‘high risk’: APACHE II score >=24 on the 1st postoperative day.

 
3.2. What characterizes survivors and non-survivors in the high risk group: the value of serial APACHE II scoring
In the single center pilot project I (1988–1990) a reduction of the APACHE II score of >=7 points from the 1st to the 5th postoperative day indicated a much better prognosis in high risk patients than without this score reduction by >=7 points [8]. This finding could be validated in a prospective manner in the multi-centric pilot project II in 1996. In survivors, mean APACHE II scores fell from 26.2±2.9 on the 1st day after surgery to 16.2±6.3 on the 5th day after surgery. In non-survivors, mean APACHE II scores amounted to 30.4±4.6 on the 1st day after surgery and remained high, amounting to 31.1±4.9 on the 5th postoperative day (Fig. 2).



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  		Fig. 2. Prognostic value of serial APACHE II scoring in ‘high risk patients’ (APACHE II score >=24 on the 1st postoperative day post cardiac surgery).

 
Even on the 1st postoperative day, survivors could be discerned from non-survivors by means of components of the APACHE II score (Table 3). Survivors had significantly lower APACHE II scores, higher mean arterial pressures and higher Glasgow Coma Scores than non-survivors on the postoperative day.


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  		Table 3. Characteristics of survivors and non-survivors of the high risk group of pilot project II on the 1st postoperative day

 
3.3. Lower mortality rates in the APACHE II defined cardiac surgery risk patients in the pilot project II in 1996 than in the pilot project I in 1988–1990
The main goal of the pilot project II was to re-evaluate the score cut-off point, previously set to 24, for defining the high risk group of patients after cardiac surgery with an estimated mortality of 60%.

Mortality rates steadily increased with increasing APACHE II score values collected on the 1st postoperative day after open-heart surgery (Fig. 3). The cut-off point indicating a mortality of >50% in the patient population of 1996 was an APACHE II score of >=28.



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  		Fig. 3. APACHE II score (1st postoperative day)-defined mortality in post cardiac surgery patients of pilot project II (1996).

 
By comparison of these data from pilot project II to the APACHE II score stratified groups from pilot project I, a greater proportion of high risk patients but a lower score-adjusted mortality became evident (Table 2). These unexpected, but encouraging results necessitated a readjustment of the APACHE II score inclusion criterion in the ESSICS study (see Discussion).


   4. Discussion
Top
 Abstract
 1. Introduction
 2. Materials and methods
 3. Results
 4. Discussion
5. Conclusion
 References
 
4.1. APACHE II score identifies high risk post cardiac surgery patients and helps to follow-up prognostic changes
A major problem of postoperative care is the early identification of patients at risk of developing sepsis and MODS. Various parameters have been investigated as to their value for the early classification of patients at risk of developing septic complications after cardiac surgery. Among these the severity scores (such as APACHE II score) proved to be useful and superior to plasma elastase, neopterin and hemodynamic data [9].

In pilot project II the majority of cardiac surgery patients met the definition of SIRS [23], a parameter obviously not apt for risk stratification in these patients. In contrast, in both pilot projects the APACHE II score determined on the 1st postoperative day did identify the subgroups of patients with escalating SIRS. Indicative of a poor prognosis also were constantly high APACHE II score values on the following postoperative days. This finding is in keeping with a recent study from our group, which showed persistently high APACHE II values in association with high serum levels of TNF-{alpha} as well as TNF-receptor I and II levels as a result of escalating SIRS after CPB [15].

In pilot projects I and II, we tried another immediate postoperative approach: With the APACHE II scoring on the 1st postoperative day, the small group (<10%) of patients with an escalating SIRS, probably due to CPB induced inflammation, can be identified by high score values. This patient group fulfils all criteria of sepsis [9,23], but also of an escalating SIRS.

Only few patients fell into the high risk category defined by an APACHE II score >=24 on the 1st postoperative day, but about 50% of all postoperative fatalities occurred in this small group. This high risk group can thus be identified as early as on the 1st postoperative day. Moreover, serial APACHE II scoring in the immediate postoperative phase is of prognostic help; while continuing high score values indicate a bad prognosis, a fall of APACHE II score of >=7 points within four days indicates a much better prognosis with lower mortality [8].

Up to now, prospective proof of this had been given only in a single center [5,8]. Now, the confirmative proof from a multi-center trial can be documented (Fig. 1). To the best of our knowledge, no other clinical or laboratory parameter tested in cardiac surgery patients shows such a high sensitivity, specificity, ROC value, positive and negative predictive value than certain scores determined on the 1st day post cardiac surgery, with the APACHE II score being the most practicable one [9,10].

4.2. Larger proportion of high risk patients and improved prognosis of high risk patients in 1996 compared to 1988–1990
The current data of the tricentric pilot project II, suggest an increased proportion of patients with escalating SIRS immediately post cardiac surgery, but a better prognosis of this group, in comparison to the monocentric pilot project I (1988–1990).

As shown above, a high APACHE II score on the 1st day of post cardiac surgery indicates the presence of an escalating SIRS. Taking this definition, the relative number of patients with escalating SIRS in our pilot project I vs. II has increased two–three-fold within the last decade, from 2.8% in 1988–1990 (pilot project I) to 8.8% in 1996 (pilot project II). Though the number of patients with escalating SIRS post cardiac surgery is higher than a decade ago, these patients nowadays seem to have a better prognosis: the score adjusted mortality (APACHE II score >=24 on the 1st postoperative day) has fallen from 76% in 1988–1990 to 30% in 1996.

The data of the current study suggest an improved prognosis for high risk patients with a similar degree of escalating SIRS after cardiac surgery. Our results are in good agreement with findings of other research groups, who observed a declining in-hospital mortality in cardiac surgical patients over the last decade [26–29]. The decreased mortality rate may reflect a gain in experience in handling high risk patients as well as progress in intensive care techniques in general. Considering these findings, it is essential that researchers should be aware of the rapid changes in critical care technology and knowledge. The impact of novel techniques and intensive care management on patients’ outcome rewards continuing attention.

Our data does not offer an obvious explanation as to why substantially more patients present with an APACHE II score >=24 on the morning of the 1st postoperative day in 1996 than in 1988–1990. This phenomenon cannot be attributed to age (66.8 vs. 65.3 years), but may possibly be related to severity of left ventricular dysfunction.

4.3. Resetting the APACHE II score cut-off for the ESSICS study
An APACHE II score cut-off of 24 would recruit far too many patients for the treatment group of the ESSICS study, the scope of which was set to 2.8% of the overall screening population, and would select a treatment population with an average mortality of about 30%, which does not comply with the sample size calculation of the ESSICS study. Based on the results of the current pilot project, the APACHE II score cut-off for defining the high risk group was altered from 24 to 28 score points.

The primary objective of the ESSICS-trial is to determine whether early supplemental immunoglobulin therapy in score-identified post cardiac surgical patients at high risk for severe SIRS leads to a reduction in morbidity (improvement in disease severity as measured by a decrease in APACHE II score from day 1 to day 5) and a reduction in 28-day ‘all-cause’-mortality.

Secondary objectives of the trial are:


   5. Conclusion
Top
 Abstract
 1. Introduction
 2. Materials and methods
 3. Results
 4. Discussion
 5. Conclusion
References
 
The APACHE II score is a simple, valid and readily available bedside measure to determine severity of disease and response to supplemental therapy in patients after elective cardiac surgery with extra-corporeal circulation. The current pilot project confirmed that APACHE II scoring on the 1st postoperative day allows for a risk stratification in cardiac surgical patients, identifying the small group at risk for deleterious septic and post-pump failure complications. APACHE II score-directed early supplemental immunoglobulin therapy of high risk patients, defined by an APACHE II >=24 after cardiac surgery, had been established in two open trials, providing the rationale for the multicenter, double-blind, placebo-controlled ESSICS study. The current tricentric observational pilot project documented an improved prognosis and a much higher proportion of APACHE II score >=24 defined high risk patients in 1996 compared to the initial monocenter study in 1988–1990. Based on the data of the current pilot project, the score cut-off point for defining the high risk population to be treated in the ESSICS study was reset to 28 points instead of 24 points. Thus, less than 3% of patients with an estimated mortality >50% are going to be enrolled, which is in keeping with the assumptions of the initial sample size calculation. The ESSICS study was started in March 1997.


   References
Top
 Abstract
 1. Introduction
 2. Materials and methods
 3. Results
 4. Discussion
 5. Conclusion
 References
 

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Received April 6, 1999; received in revised form November 8, 1999; accepted November 15, 1999.




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