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Department of Cardiac Surgery, Heart Center, University of Leipzig, Leipzig, Germany
Accepted for publication January 22, 2009.
* Address correspondence to Dr Walther, Universität Leipzig, Herzzentrum, Klinik für Herzchirurgie, Strümpellstr 39, Leipzig, 04289, Germany (Email: walt{at}medizin.uni-leipzig.de).
| Abstract |
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Methods: All patients aged 80 years or older (n = 282) undergoing isolated AVR between November 1995 and June 2006 at our institution were reviewed according to logistic EuroSCORE (ESlog) risk stratification. Surgical risk was defined as low risk (ESlog
10% [n = 107]), moderate risk (10% < ESlog < 20% [n = 103]), and high risk (ESlog
20% [n = 72]). Patient age was 82 ± 2 years (low risk), 82.7 ± 2.7 years (moderate risk), and 83.6 ± 3.1 years (high risk), respectively (p < 0.05). Mean ESlog predicted risk of mortality was 7.3% ± 1.4% (low risk), 13.7% ± 2.5% (moderate risk), and 33.0% ± 11.5% (high risk; p < 0.05). Follow-up was 99.7% complete.
Results: In-hospital mortality was 7.5% (low risk), 12.6% (moderate risk), and 12.5% (high risk; p = 0.4). One-year survival was 90%, 78%, and 69% (p = 0.002); 5-year survival was 70%, 53%, and 38% (p = 0.05); and 8-year survival was 38%, 33%, and 21% (p = 0.017), for low-, moderate-, and high-risk patients, respectively. Independent predictors for in-hospital mortality were pulmonary hypertension and urgent indication for surgery. Cox regression predictors of medium-term survival were congestive heart failure, urgent timing, previous stroke or transient ischemic attack, and EuroSCORE stratum.
Conclusions: Aortic valve replacement can be performed in the elderly population with acceptable outcomes. EuroSCORE risk stratification is imprecise for prediction of perioperative mortality among octogenarian AVR patients, but may be useful for predicting mortality during medium-term follow-up.
| Introduction |
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Despite these good outcomes after conventional xenograft AVR, some patients have a significantly increased perioperative risk. The most commonly quoted risk factors for mortality are older age, reduced ejection fraction, New York Heart Association (NYHA) functional class, pulmonary hypertension, respiratory dysfunction, peripheral vascular disease, urgent indication for surgery, renal dysfunction, and previous cardiac surgery [4–7].
Perioperative risk evaluation can be performed using the European System for Cardiac Operative Risk Evaluation (EuroSCORE), a risk predictor algorithm that has been validated in large patient populations [8]. However, some studies have recently questioned the accuracy of the EuroSCORE risk stratification system, particularly in higher risk populations [9]. In view of recently introduced transcatheter valve implantation techniques for high-risk AS patients, an increasing amount of attention has been paid to risk assessment and results of conventional AVR in elderly patients. The aim of this study was, therefore, to evaluate characteristics and outcomes of octogenarians undergoing conventional isolated AVR, with a particular focus on outcomes according to stratified EuroSCORE predicted risk of mortality.
| Material and Methods |
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All patients were operated on using a standard technique. Briefly, the aorta and mediastinal structures were exposed through a median sternotomy (n = 232; 82.6%) or partial upper sternotomy (n = 50; 17.4%). The ascending aorta and right atrium were cannulated, mild hypothermic CPB (32° to 34°C) was employed, and crystalloid (Custadiol; Dr Köhler Pharma, Wien, Germany [n = 212; 75%]) or blood cardioplegia (n = 70; 25%) was administered through the aortic root or directly into the coronary ostia. A stented xenograft was implanted in 280 patients whereas 2 patients, both treated in 1996, received a mechanical prosthesis.
The logistic EuroSCORE (ESlog) was used for risk stratification of patients and for preoperative estimate of mortality using the EuroSCORE calculation website (www.euroscore.org/calc.html).
Left ventricular ejection fraction was assessed by Doppler echocardiography or left ventricular angiography. Patients were considered to have a history of cerebrovascular disease if they had a previous stroke or transient ischemic attack. Peripheral vascular disease was considered present in patients with a history of intermittent claudication, previous peripheral vascular surgery, or documented peripheral arterial stenosis greater than 70%. Pulmonary hypertension was defined as pulmonary artery pressure by Doppler echocardiography higher than 40 mm Hg. Preoperative renal insufficiency was defined as a serum creatinine level higher than 200 µmol/L. Emergency operations were defined as procedures performed for hemodynamic instability (inotropic support, ventricular tachycardia or fibrillation, preoperative ventilation, or intra-aortic balloon pump) within 24 hours of admission. Urgent operations were defined as operative procedures performed on patients who required surgery during the index hospital admission.
In-hospital mortality was defined as death during the same hospitalization and was the primary outcome of the study. Thirty-day and medium-term mortality were secondary outcomes. Follow-up information regarding survival was available in 281 patients (99.7%). Mean follow-up was 2.9 ± 1.4 years (range, 0 to 10), and total follow-up consisted of 823.5 patient-years.
Statistical Analysis
Continuous variables are expressed as mean ± SD and categorical data as proportions throughout the manuscript. Categorical variables were compared using the
2 test or Fisher's exact test, and independent continuous variables were compared by unpaired Student's t test or Kruskal-Wallis test as appropriate. Dichotomous adverse perioperative or postoperative outcome events were analyzed using a univariate and multivariate logistic regression model with backward stepwise elimination and are expressed as odds ratios (OR) and 95% confidence intervals (CI). For multiple comparisons, analysis of variance was performed using a Bonferroni correction. Event-free survival was calculated by Kaplan-Meier methods with 95% CI. Independent predictors of medium-term survival were determined with Cox proportional hazards analysis. All p values less than 0.05 were considered statistically significant. The software SPSS 13.0 (SPSS, Chicago, IL) was used for all statistical analyses. The 20 potential preoperative risk factors for early and late mortality that were examined by univariate and multivariate testing are detailed in the Appendix.
| Results |
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20% [n = 72]), moderate risk (10% < ESlog < 20% [n = 103]), and low risk (ESlog
10% [n = 107]).
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Univariate analysis of 20 potential preoperative risk factors identified three variables that had a significant association with hospital mortality: pulmonary hypertension (OR 3.73; 95% CI: 1.5 to 9.0, p = 0.003), preoperative congestive heart failure (OR 2.7; 95% CI: 1.0 to 7.3, p = 0.05), and urgent indication for surgery (OR 3.6; 95% CI: 1.6 to 7.8, p = 0.001). By multivariate analysis, two independent predictors of in-hospital mortality were identified: pulmonary hypertension (OR 2.85; 95% CI: 1.1 to 7.3, p = 0.03) and urgent indication for surgery (OR 3.11; 95% CI: 1.4 to 7.0, p = 0.006). Survival for all patients was 81% ± 2% at 1 year, 71% ± 2% at 3 years, 57% ± 3% at 5 years, and 30% ± 5% at 8 years.
Survival significantly differed between study groups: 90% ± 3% for low, 78% ± 4% for moderate, and 69% ± 5% for high risk (p = 0.002) at 1 year; 80% ± 4% for low, 70% ± 4% for moderate, and 56% ± 4% for high risk (p = 0.013) at 3 years; 70% ± 6% for low, 53% ± 6% for moderate, 38% ± 7% for high risk (p = 0.05) at 5 years; and 38% ± 1% for low, 33% ± 8% for moderate, and 21% ± 8% for high risk (p = 0.017) at 8 years. Cox regression revealed that EuroSCORE risk stratification was an independent predictor of medium-term mortality (OR 1.78; 95% CI: 1.02 to 3.1, p = 0.041 for moderate-risk patients, and OR 2.08; 95% CI: 1.16 to 3.73, p = 0.013 for high-risk patients). Other independent predictors of medium-term mortality were preoperative congestive heart failure (OR 1.93; 95% CI: 1.05 to 3.53, p = 0.032), urgent indication for surgery (OR 1.92; 95% CI: 1.2 to 2.9, p = 0.003), and history of stroke or transient ischemic attack (OR 2.55; 95% CI: 1.2 to 5.2, p = 0.012). There was no significant association between implanted valve size and perioperative (p = 0.92) or long-term (p = 0.44) mortality.
In comparison with an age- and sex-matched group of the healthy German population, survival was lower in the overall study group, as indicated in Figure 1 [1]. The survival curve for low-risk patients, however, remained parallel to the survival curve of the healthy German population for the first 5 years postoperatively, once perioperative mortality was excluded (Fig 1).
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| Comment |
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In patients with symptomatic severe aortic stenosis, AVR is indicated [2] because of the grim prognosis associated with conservative therapy [14, 15]. Several studies have shown good midterm outcomes after AVR in elderly patients [16–18]. In addition, it has been demonstrated that AVR is cost effective in octogenarians [19], despite their elevated risk and increased number of comorbidities. The EuroSCORE, while originally designed to predict operative mortality in CABG patients, has been also applied to other cardiac operations in numerous studies in the literature. However, relatively little has been published on the utility of EuroSCORE risk prediction in elderly AVR patients. It is highly likely that an increasing number of papers will be published in the next few years on transcutaneous AV implantation. Because the majority of patients who receive transcutaneous AV implantation are octogenarians and because EuroSCORE is often used to describe their risk profiles, we believe the current study can serve as a "baseline" for EuroSCORE assessment of conventional elderly AVR patients.
We evaluated the outcomes of all octogenarians undergoing isolated AVR at our institution over a 10-year period. Our overall perioperative hospital mortality rate was 10.7%, which is in accordance with previous reports ranging between 8% and 14.5% for octogenarian AVR patients [16, 17, 20, 21]. We also grouped our patients according to high, moderate, and low risk of predicted mortality according to their logistic EuroSCORE. We found that EuroSCORE risk stratification did not adequately predict perioperative risk of mortality, but that EuroSCORE grouping was an independent predictor of mortality during follow-up.
The utility of risk stratification in elderly patients undergoing AVR is an area of increased interest in the era of transcutaneous aortic valve implantation. Risk scoring is necessary when comparing results of studies from different centers, so that patient population comparability can be assessed. Risk scoring is also an important issue when deciding upon inclusion and exclusion criteria for clinical trials of newer operative devices and techniques. While risk scoring is well developed for coronary bypass surgery, the optimal risk scoring system for aortic valve surgery is yet to be identified [22].
A recent study by Dewey and coworkers [9] examined 638 patients undergoing isolated AVR over a 9-year period. Patients were classified as high risk if their risk score exceeded the 90th percentile for that particular risk scoring system. These authors found that The Society of Thoracic Surgeons risk-scoring system most accurately predicted the perioperative and long-term risk of mortality for high-risk patients, and that the EuroSCORE markedly overestimated risk. In our study, we chose to focus only on a group of patients who are already known to have an elevated risk of mortality: octogenarians. While we also found that EuroSCORE tended to overestimate risk in the highest risk subgroup, our difference between observed and expected mortality (12.5% versus 33.0%) was not as pronounced as in the study by Dewey and colleagues [9] (15.6% versus 50.9%).
Collart and coworkers [21] and Shanmugam and colleagues [23] also reported that the EuroSCORE assessment overestimates perioperative mortality for valvular surgery in octogenarians, but may be a better predictor of long-term survival. Our findings confirm that the EuroSCORE may serve most usefully as predictor of long-term survival. Figure 1 demonstrates that the survival curves for low-, medium-, and high-risk patients were markedly disparate. It is also interesting to note that low-risk patients had essentially the same survival in comparison with age-matched survival of the normal German population, once perioperative mortality (7.5%) was excluded. This finding underscores the concept that AVR is safe and effective for properly selected octogenarians [19].
Our multivariable analysis revealed that pulmonary hypertension and urgent indication for operation were independent predictors for in-hospital mortality. Many publications have previously reported that urgent indication for operation is an independent predictor for in-hospital mortality [5–7, 24–26]. Kirch and associates [27] and Varadarajan and colleagues [28] have shown that preoperative reduced left ventricular ejection fraction and pulmonary hypertension are independent predictors for mortality [27].
In our study, reduced left ventricular ejection fraction and clinical status according to the NYHA classification did not reach statistical significance as independent predictors for in-hospital mortality. Similar results have been published by Melby and colleagues [16] and Florath and coworkers [29]. In contrast, Langanay and colleagues [7] found NYHA class IV, left ventricular ejection fraction less than 40%, emergency surgery, atrioventricular block, left- and right-side heart failure, and associated mitral valve replacement predictive factors of mortality. However, Kohl and associates [5] showed that urgent procedure, associated coronary artery surgery, NYHA functional class and previous percutaneous valvuloplasty were predictive of operative mortality.
We also examined the effect of implanted valve size, as a possible surrogate for patient-prosthesis mismatch on perioperative and medium-term mortality. We failed to find any significant association between implanted valve size and mortality. Such a finding is not surprising given that patient-prosthesis mismatch plays a greater role in young patients with large body surface areas [30], in stark contrast to the patient population that was assessed in the current study.
The rate of strokes in our study was low given the advanced age of the patient population (0%, 2%, and 2% for low-, moderate-, and high-risk patients, respectively), without any significant difference between groups. We also failed to find any significant differences between risk groups with regard to other complications such as low cardiac output syndrome, arrhythmias, pneumonia, reoperation for bleeding, renal failure, and gastrointestinal complications. In addition, the event rates for each of these complications were comparable with those in other reports [5, 16, 27].
Our observed low incidence of neurologic deficits should be kept in mind when discussing transcatheter approaches to aortic valve surgery in elderly, higher risk patients. Stroke rates of as high as 10% have been reported for the initial series on transcatheter valve implantation, with a clear trend toward higher risk for transfemoral approaches [31]. Low stroke rates during conventional surgery represent the gold standard when assessing these new technologies.
Our observed medium-term survival rates were less than those of age- and sex-matched controls from the general German population (Fig 1), but results were still respectable even for high-risk patients. For the lowest risk group, survival as long as 7 years postoperatively compared very favorably to age- and sex-matched controls. Although long-term survival was markedly reduced in the high-risk subgroup, their 5-year survival (38%) still compared favorably to average 5-year survival rates for younger patients with severe aortic stenosis who do not undergo surgical therapy (25% to 32%) [14, 15].
In conclusion, aortic valve surgery can be performed in the elderly patient population with acceptable outcomes. Pulmonary hypertension and urgent indication for surgery are independent predictors of perioperative survival. Stratification of octogenarians by logistic EuroSCORE revealed no significant differences in outcomes between patient groups perioperatively, but proved good at differentiating survival during medium-term follow up. Further studies from other centers will need to be performed to confirm whether EuroSCORE is indeed discriminative when predicting medium-term survival of elderly AVR patients.
| Appendix |
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| References |
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