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Ann Thorac Surg 2003;76:75-83
© 2003 The Society of Thoracic Surgeons
a Department of Cardiothoracic Surgery, Heart Institute Lahr/Baden, Lahr, Germany
Accepted for publication February 7, 2003.
* Address reprint requests to Dr Ennker, Heart Institute Lahr/Baden, Hohbergweg 2, D-77933 Lahr, Germany
e-mail: ennker{at}heart-lahr.com
| Abstract |
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METHODS: Between January 1996 and June 2001, 1408 aortic valves were replaced in 1400 patients (572 of them with simultaneous coronary artery bypass grafting). The data were analyzed by multivariate logistic regression to evaluate the operative risk. Mean age of the study population was 68 ± 11 years (range 19 to 90 years old, 44% female).
RESULTS: Overall operative mortality (within 30 days) was 3.8%. Independent predictive factors for operative mortality were previous bypass surgery, emergency operation, simultaneous mitral valve replacement, renal dysfunction, more than 80 years old, simultaneous bypass surgery in female patients with a body mass index greater than 29 kg/m2, and height smaller than 1.57 m for patients more than 71 years old. Simultaneous coronary artery bypass grafting in general (p = 0.6), previous aortic valve replacement (p = 0.59), and implantation of stented bioprostheses (p = 0.39) or stentless bioprostheses (p = 0.7) were not identified as independent risk factors.
CONCLUSIONS: Certain groups of patients with a high operative risk were identified: patients more than 80 years old, women with a body mass index greater 29 kg/m2 undergoing simultaneous coronary artery bypass surgery, and "small" patients more than 71 years old.
| Introduction |
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Therefore, a continual monitoring of predictors for operative risk is necessary. Since patient characteristics and technical progress change over time, the study population should be recruited in a short period of time.
During the recent years numerous studies concerning prediction of operative risk have been published. However, many possible risk factors are still controversial, such as simultaneous coronary artery bypass grafting (CABG) [47], redo-cardiac surgery [4, 810], duration of cardiopulmonary bypass time [5, 11, 12], or implantation of small prosthetic valve size [1214]. The appropriate method to identify predictive factors for mortality is the logistic regression analysis. Because this method is sensitive to extreme values, large study populations are required.
The goal of this study was to develop a general risk predicting model for aortic valve replacement (AVR), with an emphasis on the impact of the type and size of valve on operative risk, and the impact of simultaneous procedures on perioperative outcome.
| Patients and methods |
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Prosthesis type and size selection were according to surgeon preference. Usually, older patients received biologic prostheses. Older patients with extensive calcification of the aortic wall or other anatomic findings making the implantation of a stentless valve difficult or dangerous usually received stented biologic prostheses. Detailed characteristics of the patient population, which were incorporated in the logistic regression analysis, are presented in the Appendix.
Statistical analysis
All continuous data were expressed as mean ± 1 standard deviation, whereas dichotomous variables were given in real numbers and percentages. All variables analyzed are presented in the Appendix and were univariately evaluated by
2 test, Fischers exact test, or Wilcoxon rank-sum test with respect to operative mortality. Operative mortality was defined as any death within 30 days after the initial operation.
All variables that were univariately found to be associated with an operative mortality with a p value smaller than 0.25 [15] were tested by forward and backward logistic regression analysis using the likelihood ratio test.
To generate hypotheses with variables that would be further possible covariates of operative mortality, all patients were divided into four (quartiles) or eight subgroups with the same number in each group according to the interesting variables, such as body mass index or height. To look for linear dependence of the continuous variable age, we divided all patients into subgroups in steps of 10 years of age. The operative mortality for each group was then calculated and presented in tables or bar graphs to visualize the operative mortality for the analyzed variable. Variables exhibiting a high amount of operative mortality in one subgroup in comparison to the other groups were afterwards tested for significant improvement of the model by the likelihood ratio test (p < 0.05).
To compare our model with the risk predicting model of the EuroScore we calculated the c-index of the receiver operating curve (ROC) for our final model and a model containing only the EuroScore as a risk factor for the same group of patients. The c-index is equal to the area underneath the receiver operating curve and assesses the model performance. Models with a c-index higher than 0.7 are considered to have good discriminative power. This was necessary because there were 11% missing values in our EuroScore data.
| Results |
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Overall operative mortality (within 30 days) was 3.8% (53/1408). The univariate analysis identified the following factors related to early mortality with a p value smaller than 0.25: age, body surface area, female gender, myocardial decompensation, arterial hypertension, diabetes mellitus, any infection before operation, chronic obstructive pulmonary disease, renal dysfunction, dialysis, no sinus rhythm, aortic stenosis, New York Heart Association (NYHA) class IV, previous bypass surgery, simultaneous mitral valve replacement (MVR), and emergency operation. Independent predictors of operative mortality were previous bypass surgery, emergency operation, simultaneous MVR, and renal dysfunction (Table 2, model 1). The model improvement was significant (p < 0.001) and forward and backward stepwise selection by the likelihood ratio test demonstrated the same results and included these four variables and age.
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However, the type of valve implanted may reach significance if different sizes of valves are taken into consideration. This might particularly influence the outcome in small, old age patients. Including the interacting terms height less than 1.57 m, age more than 71 years, and mechanical prostheses, the model (model 16, Table 2) improves in significance, similar to the result of model 13 (interacting term height < 1.57 m by age > 71 years, Table 2). In contrast, including the interacting term height less than 1.57 m, age more than 71 years, and biologic prostheses (model 17, Table 2), whether for all biologic prostheses or for stentless biologic prostheses (model 18, Table 2) and stented bioprostheses separate (model 19, Table 2) the model did not improve. Hence, in our patient population of small, old age patients only the implantation of mechanical prostheses increased the risk for perioperative mortality.
Including cardiopulmonary bypass time as a continuous variable, the model improved with a significant level below 0.001 (model 20, Table 2). Operative mortality increased exponentially with cardiopulmonary bypass time (Fig 5).
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| Comment |
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High BMI was reported to increase the risk of postoperative morbidity, but not operative mortality for CABG [1618]. Aranki and colleagues [6] found an increased risk for simultaneous CABG and AVR only in females. As a result of the progress in perioperative management, previously discovered individual risk factors might only influence perioperative mortality, if several of these risk factors are simultaneously presenting in one patient.
Even though previous studies found simultaneous CABG to be an independent risk factor [1, 13, 19], our final model did not include simultaneous CABG, meaning that it did not increase the operative risk in general. Concomitant bypass surgery was only a risk factor for women with a high body mass index (> 29 kg/m2).
Controversial data exists concerning previous CABG as a single risk factor [4, 8, 9]. The only study negating previous CABG as an operative risk factor compared two patient groups (the first group having primary AVR with simultaneous bypass surgery and the second group having AVR with simultaneous bypass surgery or isolated AVR after previous bypass surgery) by
2 test not considering any confounding factors [10]. The identification of previous CABG as a risk factor in AVR influences the recommendations concerning operative strategy in the presence of moderate aortic valve disease at the time of coronary artery bypass surgery.
We identified renal dysfunction, emergency operation, previous CABG, simultaneous MVR, age greater than 80 years old, simultaneous CABG for women with a body mass index more than 29 kg/m2, and height less than 1.57 m in patients older than 71 years old as independent risk factors for operative mortality after AVR. Risk factors of operative mortality like old age, renal dysfunction, emergency operation, and previous cardiac operations were also established by several authors analyzing large series [1, 2, 4, 8].
Most favorable surgical management in elderly patients, often presenting with a small aortic root, is still controversial. To avoid patient-prosthesis mismatch, aortic root enlargement procedures have been recommended [20, 21]. With the development of new generations of prosthetic valves, patient-prosthesis mismatch has been reported to be negligible [14, 22]. Therefore, smaller sized prosthetic valves are increasingly being implanted in many centers. In 1999 Adams and colleagues [13] reported a study of 366 patients older than 70 years old; implantation of prosthetic valves with the 19-mm size increased the operative risk in male patients. Moreover, our data indicated that the implantation of prosthetic valves with the 19-mm size increased the operative mortality risk, but mainly in patients receiving smaller sized valves who were older and generally of smaller build. Each of these individual factors independently predict a higher mortality. Because height and body surface area are correlated, our results are supported by Bloomstein and colleagues [12] describing small body surface area as a risk factor in patients older than 70 years.
In our study we included patients undergoing AVR using five different, frequently implanted prosthetic valve types (SJM, Carbomedics, Medtronic Freestyle, Medtronic Mosaic, and Medtronic Hall). Rarely performed procedures were excluded to avoid any bias due to the learning curve of surgeons and patient selection. The implanted type of valve (mechanical, stented or stentless biologic prosthesis) was not an independent risk factor for operative mortality. Nevertheless, operative risk was statistically increased in small patients older than 71 years old undergoing AVR with mechanical prosthetic valves. On the contrary, patients with the same characteristics undergoing AVR by means of stented or stentless biologic prostheses had no increased perioperative risk. Astor and colleagues [23] found a higher operative risk in patients undergoing AVR with biologic prostheses, but this association became weaker after adjusting it for patient characteristics and did not reach significance in a model for isolated AVR. According to the authors these findings are explained by differences in patient characteristics, namely comorbid conditions, which were not included in their model.
Including the interacting terms small height by older age and small height by older age by mechanical prostheses did contribute only a little to the discriminating power of our model. In accord with previous findings [12, 13, 23], variables such as height and valve type may be of relevance regarding operative risk and should be further analyzed in risk modeling.
In 1985 Scott and colleagues [4] pointed out that aortic cross-clamp time cannot be predicted preoperatively and, therefore, has limited utility in prediction of operative risk. In contrast, cardiopulmonary bypass time has been identified as an operative risk factor in many studies [5, 11, 12, 19]. Certainly there is an increase in operative mortality with rising cardiopulmonary bypass time (Fig 5). Furthermore, including this variable into the risk predicting model will improve the predicting power of any model. As expected, the area under the ROC curve increased as well, from 0.738 to 0.767, by including cardiopulmonary bypass time in the model in our study. But this factor, like the cross-clamp time, cannot be predicted preoperatively, and it is not valuable for creating models for prediction of operative mortality.
We compared our model with a model purely relying on the EuroScore [24] as a predictive factor. The performance of our model for aortic valve replacement was better than the EuroScore model (c-index of 0.729 and 0.666, respectively). Differences in the discriminative power between the EuroScore model and our model may be explained by several fundamental differences between the models: first, different procedures were included in the models (AVR vs all open-heart procedures); second, the results may be influenced by procedure-specific hospital volume (single center vs multi center investigations with different hospital volume [23]); and third, diversity in patient population unquestionably influences the results.
Risk predicting models can help surgeons in decision making, particularly if simultaneous or redo operations are planned. In order to take into account the huge variety of risk associated diseases, more sophisticated, wide-ranging models are necessary. However, those models may have less predictive power for the included subpopulations. Further investigations are required in order to optimize general models with a good discriminative power for all included patients.
| Acknowledgments |
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| Appendix. Risk factors of aortic valve replacement (n = 1408) |
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Percentages are given in parentheses.
NYHA = New York Heart Association;
SD = standard deviation.
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