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Eur J Cardiothorac Surg 2004;26:12-17
© 2004 Elsevier Science NL
a Department of Pediatric Cardiology and Intensive Care, Hannover Medical University, Hannover, Germany
b Department of Cardiology, Children's Hospital, Boston, MA, USA
c Department of Biometry, Hannover Medical University, Hannover, Germany
d Pediatric Cardiology Practice, Hannover, Germany
e Department of Thoracic, Cardiac and Vascular Surgery, Hannover Medical University, Hannover, Germany
Received 9 February 2004; accepted 29 March 2004.
* Corresponding author. Department for Pediatric Cardiology and Intensive Care, Hannover Medical University, D-30625 Hannover, Carl-Neuberg-Strasse 1, Germany. Tel.: +49-511-523-9424; fax: +49-511-532-8419
e-mail: boethig{at}thg.mh-hannover.de
| Abstract |
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Key Words: Congenital cardiac surgery Scoring system Mortality Risk adjustment
| 1. Introduction |
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| 2. Patients and methods |
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The classification into the 6 RACHS-1 risk categories [1] was done by ordering the operations by procedure code, then by manual confirmation of each single procedure.
Data acquisition was performed without difficulty and in a timely fashion. If several procedure steps took place during one hospital stay (this was the case in 2.3%, 53 of 2368 procedures), 2/3 of the interim period were attributed to the previous and 1/3 to the following procedure. This took into account the fact that the vast majority of this small subgroup underwent planned reoperations, namely staged reconstructions aiming at a Fontan circulation. Such patients were occasionally not in a very stable state. Some patients preferred short discharge intervals between the Norwood operation and the upper cavopulmonary anastomosis, and they were frequently re-hospitalized for recompensation. Othersthose who are the discussed grouppreferred to stay in the hospital all the time, even if they might have been discharged during stable periods. We admit that the described division is not based on hard criteria, but the decisions that underly such a policy are not that clearly defined either. Finally, we decided to adopt this pragmatic way of handling the interim hospital stay durations because it did not really matter: the results did not change significantly since the number of patients or hospital days in question was quite small.
We assigned patients with combined procedures to the riskiest of the different procedures that were performed, as done in the PCCC group. The entire group of 2368 patients comprised 42 patients with atypical procedures; we considered them as combined procedures and grouped them with the riskiest part of the operation.
Statistical methods: SPSS 11.5.1 was used for the analyses.
The classification system's sensitivity and specificity to predict mortality was calculated and compared to the PCCC estimation with the area under the curve of the Receiver operating characteristic.
The MannWhitney U-test was used to compare the distribution of RACHS-1 risk classes in different patient populations.
For comparisons of lethality between groups we used
2 tests.
Since the length of hospital stay (total and postoperative time) was not distributed normally, but had a skewed normal distribution, we did a log transformation before looking for means and confidence intervals. We then used ANOVA tests (Bonferroni adjusted) to look for significant differences between the log transformed RACHS-1 groups. To get a usual graph instead of a logarithmic scale, we transformed the obtained mean values and the diversity measures back to a linear scale. The relevant graphs therefore display retransformed 95% confidence intervals as diversity measures, and geometric instead of arithmetical means.
To see whether the RACHS-1 classification reflected mortality in our, as in the PCCC, patient group, we calculated the exponential regression R2 value of weightened (groupwise) mortality risks: The geometric means of total and postoperative lengths of stay were fitted to an exponential regression curve against the risk category number. Individual instead of groupwise lengths of hospital stay were entered into different regression models in order to get a measure for the length of stay variability within the RACHS-1 groups. To illustrate the broad variability of hospital treatment times that patients even within the same RACHS-1 group do require, we calculated Kaplan Meier curves with death or discharge as the terminal event. The significance of differences between the risk categories was tested with pairwise log rank tests.
| 3. Results |
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Mortality rates in the different risk groups were quite similar to the published ones: (Fig. 3) . Mortality risk grows according to the risk groupmonotonically, but not linearlyas observed for the PCCC population [1]. A difference between the Bad Oeynhausen and the PCCC population is noted in the risk groups above 2: Bad Oeynhausen mortality rates are still growing, but the risk groups 2 and 3 lack a statistically significant difference. The other groups (except group 5 for low patient numbers) differed significantly (P<0.05) from each other.
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The surgical team was already experienced when the described series began: The overall performance, expressed in saved lives [3] per 100 procedures, when compared to the PCCC standard, and stratified by year, remained constantly above the expectations. Between 1996 and 2002, the number of saved lives was 4.0, 0.8, 2.3, 3.9, 2.6, 2.0 and 2.2 per 100 procedures, respectively.
The Receiver Operating Characteristic (ROC) indicates sensitivity and specifity of a method. The area under the curve (AUC) is a combined measure of both. If the curve is rectangular, the AUC is 1 and the method has 100% sensitivity and specifity; if the curve is a diagonal line, the AUC is 0.5 and the method has no predictive value. The AUC for the model containing the risk category alone was 0.784 for the PCCC population and 0.749 for the hospital discharge data set [1]. For our patient group, the AUC was 0.755 (95% confidence interval=0.7150.796, Fig. 6), indicating a very similar predictive value to the classification in the 3 populations.
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The geometric means of total and postoperative stay times of survivors follow very exactly (R2=0.95 and 0.96) an exponential function (Fig. 5) .
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A different way to express this is the percentage of variance that is explained by the RACHS-1 group, as calculated from regression analysis: If the RACHS-1 class were the only predictor of postoperative stay time, the length of this time period would be explained completely (100%) by the RACHS-1 category, and the length of stay indicators of each patient would be found directly on the regression line. In reality, many other factors determine the proceduredischarge interval, resulting in a scattering of postoperative stay time over a broad range. Regression analysis shows that the RACHS-1 category explains only small percentages of the hospital stay time: 13.5% of total length of stay of all patients and 16.8% of the postoperative length of stay of survivors.
The RACHS-1 stratified Kaplan Meier graph on postoperative hospital stay duration of survivors (Fig. 7A) illustrates the conspicuous variability within the RACHS-1 groups. The frequency of medium and long hospital stays follows exactly the RACHS-1 category. The differences between all of the RACHS-1 classes (except 5) are statistically significant (P<0.001). More frequent early deaths in high risk classes confound the picture when the total hospital stay of all patients (including non-survivors) is considered (Fig. 7B).
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| 4. Discussion |
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In adult cardiac surgery, coronary artery bypass or heart valve operations are performed in large numbers with standardized methods. This has led to many attempts to produce scoring systemsbut still no model has attained general acceptance. In pediatric cardiac surgery, dealing with congenital cardiovascular diseases, defects demonstrate a much larger variety, and patient numbers in individual centres and as a whole are much smaller. Moreover, one main influence factor, the individual surgeon, is rarely exposed for interinstitutional data collections. Some cofactors (such as patient age) are easy to address, others (such as gestational age or comorbidities) pose major problems for retrospective data analyses. The RACHS-1 approach is a very interesting solution proposal for this impending problem. RACHS-1 is a small, compact, easily applicable tool, requiring only very few data, at the expense of low individual predictive precision. However, two large North American populations have shown its ability to distinguish group-related mortality differences, and application to our study population also resulted in distinct groups: related to mortality, but also concerning length of hospital stay.
Risk adjustment is necessary. As shown in Fig. 2, there are marked differences in the percentage of malformation complexity among the pediatric cardiac surgery populations from different hospitals or hospital groups. This may be explained by the regional centre function of certain institutions. Smaller units take advantage of it, sending away the complicated cases and keeping the simpler ones. A scoring system is needed to investigate and compare work and performance.
Previous attempts in the field of pediatric cardiac surgery have been made: In 2000, Stark [6] looked at 1378 patients operated by 11 surgeons. He concluded that larger patient numbers were needed for valid information on the small subgroups. A year later, with 2718 patients included [7], his relevant statements were similar. A subgroup scoring system for neonates operated in deep circulatory arrest was published by Clancy [8]. A different classification for children under 3 months was created by Kirklin [9]. Currently, the Aristotle Complexity Score is being developed for complexity adjustation in pediatric cardiac surgery [10]. Relevant information was given at the EACTS meeting in Vienna in 2003. This scoring system includes a larger number of items and is supposed to increase the precision of individual predictions.
The RACHS-1 classification, based on the expertise of a large expert panel and a very large number of procedures, is here applied to the data set of one single institution. This might be seen as a limitation: results of a single unit, even a big one, may not be representative. In fact, the effect of accumulation of high-risk patients in the institution (Table 1) is further amplified because one of the surgeons operated most of the high risk patients (Table 2). The good results from our group in the risk categories 3 and 4 (Fig. 3) might be partly attributed to this training effect, but on the other hand the PCCC and Hospital Discharge Data are from 1995 and 1996, while our data collection starts in 1996 and extends to 2002. General progress in cardiac surgery has surely taken place since then, but has not resulted in a further improvement (concerning mortality) in overall performance in the special field of pediatric cardiac surgery in the observed unit. This might be different for the PCCC mortality. A year-wise stratification of saved liveswhen compared to the expected (PCCC) lethality, and expressed in saved lives per 100 operationsshows that standardized results were somewhat oscillating, constantly above the PCCC average, but without substantial trend towards further improvement between 1996 and 2002.
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The PCCC's simple and well-defined, mainly procedure-based criteria showed significant risk group differences in (geometric) mean total and postoperative duration of hospital stay for survivors, and a generally shorter length of stay for non-survivors.
In our population, the mean preoperative time was around one week for all groups except the minimum risk group, and the perioperative geometric mean total hospital stay was 19.8 days. Vricella [12] reported his experience with much shorter total in-hospital periods: a mean of 2.0 days from admission. His reported lengths of stay are extraordinarily short, and a risk-adjusted mortality comparison [3] would be of great interest.
We found the RACHS-1 classification able to differentiate very exactly the geometric means of total and postoperative lengths of stay. The marked intra-class scattering of length of stay times limits its usability for individual prediction. The groupwise mortality prediction abilityas judged from the receiver- operator curveis astonishingly similar to the previously described populations. The lower overall mortality in our population decreased the significance of the inter-class differences, but this specific case does not reduce the value of the RACHS-1 classification system.
| 5. Conclusion |
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| Footnotes |
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2 Formerly Department of Pediatric Cardiology, Heart-Center North-Rhine Westphalia, Bad Oeynhausen, Germany ![]()
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