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Ann Thorac Surg 2011;91:1107-1112. doi:10.1016/j.athoracsur.2010.12.052
© 2011 The Society of Thoracic Surgeons
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Original Articles: Adult Cardiac

Incidence, Determinants, and Prognostic Impact of Operative Refusal or Denial in Octogenarians With Severe Aortic Stenosis

Sophie Piérard, MDa,c,*, Stéphanie Seldrum, MDa,c,*, Christophe de Meester, MSa,c, Agnès Pasquet, MD, PhDa,c, Bernhard Gerber, MD, PhDa,c, David Vancraeynest, MD, PhDa,c, Gébrine El Khoury, MDa,d, Philippe Noirhomme, MDa,d, Annie Robert, PhDb, Jean-Louis Vanoverschelde, MD, PhDa,d,*

a Pôle de Recherche Cardiovasculaire, Institut de Recherche Expérimentale et Clinique, Université Catholique de Louvain, Brussels, Belgium
b Pôle de Recherche en Epidémiologie et Biostatistiques, Institut de Recherche Expérimentale et Clinique, Université Catholique de Louvain, Brussels, Belgium
c Division of Cardiology, Cliniques Universitaires Saint-Luc, Brussels, Belgium
d Division of Cardiothoracic Surgery, Cliniques Universitaires Saint-Luc, Brussels, Belgium

Accepted for publication December 23, 2010.

* Address correspondence to Dr Vanoverschelde, Division of Cardiology, Cliniques Universitaires Saint-Luc, Avenue Hippocrate 10-2881, B-1200 Brussels, Belgium (Email: jean-louis.vanoverschelde{at}uclouvain.be).


   Abstract
Top
 Abstract
Introduction
 Material and Methods
 Results
 Comment
 Footnotes
 Acknowledgments
 References
 
Background: Aortic stenosis (AS) is a common valve disease in octogenarians. Previous studies have shown that aortic valve replacement (AVR) is frequently not performed in these patients. This study investigated the incidence, determinants, and prognostic impact of AVR refusal or denial in these patients.

Methods: Between 2000 and 2007, 163 octogenarians (mean age, 84 ± 3 years) with severe AS and an indication for operation according to guidelines were prospectively included in an echocardiographic registry. Among these, 97 underwent AVR, and 66 were treated conservatively.

Results: Logistic regression analysis identified older age, a lower transaortic pressure gradient, a larger aortic valve area, and the presence of diabetes as independent predictors of AVR refusal or denial. Patients who underwent AVR had a 30-day mortality of 9%. Overall 5-year survival was 66% in AVR patients vs 31% in those treated conservatively (log rank p < 0.001 vs AVR). After adjustment for the propensity score, patients undergoing AVR still had a better outcome than conservatively treated patients (hazard ratio, 0.56; 95% confidence interval, 0.29 to 0.91; p = 0.022). In addition to the therapeutic decision, Cox regression analysis also identified low body weight, New York Heart Association class III/IV, and the logistic European System for Cardiac Operative Risk Evaluation as independent predictors of outcome in the overall series.

Conclusions: About 40% of octogenarians with severe AS and a definite indication for operation either refuse or are denied AVR. AVR refusal or denial has a profound impact on long-term prognosis, resulting in a twofold excess mortality, even after adjustment for the propensity score.


   Introduction
Top
 Abstract
 Introduction
Material and Methods
 Results
 Comment
 Footnotes
 Acknowledgments
 References
 

Adult Cardiac Surgery: The Annals of Thoracic Surgery CME Program is located online at http://cme.ctsnetjournals.org. To take the CME activity related to this article, you must have either an STS member or an individual non-member subscription to the journal.

 

Aortic stenosis (AS) is the most frequent valvular heart disease in industrialized countries and its prevalence steadily increases with age [1, 2]. Despite some controversy regarding the optimal timing of intervention in asymptomatic patients, there is a general consensus that aortic valve replacement (AVR) should be advised in symptomatic patients who present with severe AS, as shown by the corresponding class I recommendations in the European Society of Cardiology and American College of Cardiology/American Heart Association guidelines [3, 4].

With aging of the population, the proportion of elderly patients presenting with severe symptomatic AS is rising considerably. Although several studies have shown that AVR can be performed in these patients with acceptable mortality and morbidity risks and improves quality of life [5–7], the decision to operate on elderly individuals remains a challenge, owing mainly to the increased operative mortality and morbidity these patients' experience. It is therefore not surprising if in daily clinical practice as well as in recent international surveys, many elderly patients with symptomatic severe AS either refuse or are not proposed for an operation, the risks of open heart surgery and its postoperative complications being often perceived as too significant at such an advanced age [2, 8–11].

To better understand why some elderly patients with symptomatic severe AS do not undergo operations and to evaluate the consequences thereof on survival, we used a using a propensity score-based analysis to investigate the incidence, the clinical correlates, and the prognostic impact of AVR in a consecutive series of octogenarians with symptomatic severe AS.


   Material and Methods
Top
 Abstract
 Introduction
 Material and Methods
Results
 Comment
 Footnotes
 Acknowledgments
 References
 
Approval of the study protocol and waiver of informed consent for retrospective data handling were obtained from our Institutional Review Board.

Study Population
A prospective registry that began in 2000 includes all consecutive patients with valvular heart disease seen at the Cliniques Universitaires St-Luc. For each patient entering this registry, baseline demographics, clinical presentation, and echocardiographic data are collected and stored in an electronic database. Clinical and echocardiographic follow-up data are also collected regularly and entered into the database.

Between January 1, 2000 and December 31, 2007, the registry enrolled 192 octogenarians with severe AS, defined as an aortic valve area of less than 1 cm2, a mean transaortic pressure gradient exceeding 30 mm Hg, and a class I or a class IIa indication for operation surgery according to the 1998 American College of Cardiology/American Heart Association guidelines [12]. The analysis excluded 29 patients because 3 had associated severe mitral valve disease or endocarditis, 10 underwent percutaneous aortic balloon valvuloplasty or transcatheter aortic valve implantation, and 16 had a life expectancy of less than 1 year in the absence of AS. Patients with concomitant coronary disease, requiring or not coronary artery bypass grafting, were not excluded.

The most recent information on postdiagnosis events was obtained between June and July 2009. Cardiac events and causes of death were ascertained by contacting the patients' physicians, the patients themselves if alive, or their family, and by reviewing the death certificates. Follow-up was 100% complete.

Echocardiography
Echocardiographic data were obtained with commercially available ultrasound systems. All patients underwent a comprehensive examination, including M-mode and 2-dimensional echocardiography, as well as Doppler examinations. All tests were conducted by experienced sonographers. The maximal instantaneous and mean pressure gradients across the aortic valve, the aortic valve area, and the left ventricular diameter, fractional shortening, and ejection fraction were calculated as recommended [13].

Therapeutic Decision
The choice of surgical intervention or conservative treatment was at the discretion of the attending physicians and the patients. The attending physicians explained the potential benefits of the operative repair and the risks and complications and considered the preferences of individual patients most important. Accordingly, a decision to operate was taken in 97 patients (AVR group), whereas a conservative strategy was initially adopted in 66 patients.

Statistical Analysis
All analyses were performed using the SPSS software (SPSS Inc, Chicago, IL). Continuous variables are expressed as mean ± one standard deviation, categoric variables as counts and percentages, and follow-up times as median and range.

Factors associated with the therapeutic decision were analyzed by using the unpaired t test, the {chi}2 test, or the Fisher exact test, where appropriate. A value of p < 0.05 was considered indicative of a statistically significant difference. Variables with p < 0.10 were subsequently submitted to a multivariate logistic regression with a backward elimination procedure to select factors independently associated with the therapeutic decision. To avoid colinearity problems in the logistic regression model, the correlation coefficients between covariates were examined. In cases of colinearity (r > 0.90), only one of the two covariates was proposed for inclusion into the multivariate model.

Analysis of clinical end points was performed on an intention-to-treat basis and included all patients. Patient categorization was based on the therapeutic decision at the time of the index evaluation and not on the actual performance of an operation. Overall survival in the two treatment groups was computed using the Kaplan-Meier method and compared using the log-rank {chi}2 test. For each patient included in the study, the corresponding average age- and gender-specific annual mortality rates of the Belgian general population were obtained.

To reduce the effect of treatment selection bias in this observational study, we performed a propensity score analysis [14, 15]. The propensity scores were estimated by use of a multiple logistic regression model where AVR was the dependent variable, and plausible correlates of either the therapeutic decision or survival acted as independent variables. These included age, height, weight, gender, prior coronary revascularization, history of prior myocardial infarction, peripheral artery or carotid artery disease, presence of chronic obstructive pulmonary disease (COPD), atrial fibrillation, smoking habits, systolic blood pressure, diabetes, cholesterol levels, family history of coronary disease, creatinine levels, New York Heart Association class, left ventricular ejection fraction, and mean transaortic pressure gradient. The calculated propensity scores were then used to select pairs of patients with matched propensity scores in the two treatment groups (1:1 match). Overall survival in the matched treatment groups was then computed using the Kaplan-Meier method. The propensity scores were also entered together with the therapeutic decision into a bivariate Cox proportional hazards regression model to estimate the 5-year propensity score-adjusted hazards ratio associated with the therapeutic decision.

Finally, all demographic, clinical, and echocardiographic variables were submitted to a Cox proportional-hazards regression to determine factors independently associated with outcome in each treatment group. For this purpose, we first constructed separate survival models in patients undergoing or not AVR, using a backward elimination procedure at the 0.10 statistical level. All remaining variables, the therapeutic decision, and the interaction between the remaining variables and the therapeutic decision were entered into a third Cox proportional-hazards regression.


   Results
Top
 Abstract
 Introduction
 Material and Methods
 Results
Comment
 Footnotes
 Acknowledgments
 References
 
Patients' Characteristics and Analysis of the Therapeutic Decision
Of the 163 patients who met the inclusion and exclusion criteria, 66 were treated conservatively (40%), and 97 underwent operations (AVR group), among whom 96 received a bioprosthesis and 1 a mechanical prosthesis. Coronary artery bypass grafting was combined in 48 patients (49%), and 9 also had an associated aortic root procedure or mitral annuloplasty ring for moderate mitral regurgitation. Of the remaining 66 patients (conservative group), 26 were proposed for surgical intervention but refused, and 40 were initially not proposed for operations because of comorbidities: 10 patients had a European System for Cardiac Operative Risk Evaluation (EuroSCORE) of between 22% and 44%, and in 30 patients, the symptoms or the severity of their aortic stenosis was not considered to be severe enough to warrant an operation. Among these 30 patients, 15 ultimately underwent AVR at a median of 233 days (range, 91 to 1088 days; Fig 1 ). In survival analyses, these patients were censored on the day of their operation.


Figure 1
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  		Fig 1. Description of the patient population. (AS = aortic stenosis.)

 
Patients' characteristics in the two treatment groups are summarized in Table 1. Patients treated conservatively were older and had a lower body weight, a larger aortic valve area, lower maximal pressure gradients, and more comorbidities, as attested by a higher EuroSCORE. In multivariate analysis, four characteristics were linked to the decision to treat conservatively: older age, a lower transaortic pressure gradient, a larger aortic valve area, and the presence of diabetes (Table 2).


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  		Table 1 Baseline Characteristics of the Patients Receiving Aortic Valve Replacement and Those Receiving Conservative Treatment
 

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  		Table 2 Independent Determinants of the Therapeutic Decision
 
Prognostic Impact of Operative Denial
During a median follow-up of 916 days (range, 1 to 3319 days), 74 patients died: 32 (33%) in the AVR group and 42 (64%) in the conservative treatment group. The causes of death among the AVR patients were cardiovascular in 16 (postoperative death in 9, sudden cardiac death in 3, endocarditis in 2, and miscellaneous factors in 2) and noncardiac in the remaining patients. The causes of death among the conservative treatment group were cardiovascular in 29 (intractable heart failure in 21, sudden death in 3, postoperative death in 3, 1 pulmonary embolism and stroke in 1) and noncardiac in the remaining patients. Among the 15 patients from the conservative group who eventually underwent late AVR, 6 died during follow-up (postoperative death in 3 and intractable heart failure in 3).

Figure 2 shows the Kaplan-Meier curves for overall survival in the AVR and conservative treatment groups, together with that expected in the age- and gender-adjusted Belgian population. Five-year overall survival was significantly lower in the conservative treatment group than in the AVR group (31% vs 66%, log rank p < 0.001). The survival of patients undergoing AVR was similar to that of the general population.


Figure 2
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  		Fig 2. Kaplan-Meier survival curves for patients undergoing aortic valve replacement (AVR) operations (solid line), for those treated conservatively (dashed line), and the expected general population-based survival (dotted line). Numbers at bottom indicate patients at risk.

 
Propensity Score Analysis
To estimate individual propensity scores, 18 baseline covariates were entered into a logistic regression model. The model had an area under the receiver operating characteristic curve of 0.84. Propensity score matching for the entire population yielded 38 matched pairs of patients. In the matched cohort, there were no significant between group differences for any of the covariates. Kaplan-Meier survival curves constructed for these matched pairs showed a significant survival benefit in favor of the AVR group (log-rank p = 0.027; Fig 3 ). The propensity score was also entered into a bivariate Cox proportional hazards survival model, together with the therapeutic decision, to evaluate the 5-year propensity score-adjusted hazard ratio associated with the therapeutic decision. After adjustment, there was still a statistically significant survival benefit in favor of the AVR group (hazard ratio, 0.56; 95% confidence interval, 0.29 to 0.91; p = 0.022).


Figure 3
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  		Fig 3. Kaplan-Meier survival curves for propensity score-matched patients undergoing aortic valve replacement (AVR) operations (solid line) or being treated conservatively (dashed line). Numbers at bottom indicate patients at risk.

 
Factors Influencing Prognosis in Each Treatment Group
To assess the factors potentially associated with the 5-year overall survival, two separate Cox's survival models (one per treatment group) were built to which all baseline variables were proposed for inclusion. The covariates with p < 0.10 in these two models were then entered into a third Cox's proportional hazards survival model, together with the therapeutic decision and the interaction between the selected covariates and the therapeutic decision. Besides the therapeutic decision, this third model identified a low body weight, a New York Heart Association class III/IV and the logistic EuroSCORE as independent predictors of survival in all patients, and the presence of COPD in AVR patients (Table 3).


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  		Table 3 Cox Proportional Hazard Analysis
 

   Comment
Top
 Abstract
 Introduction
 Material and Methods
 Results
 Comment
Footnotes
 Acknowledgments
 References
 
In this large series of octogenarians with severe AS, 40% of the patients either refused AVR or were not proposed for AVR, although an operation was recommended on the basis of both current and prevailing guidelines. The characteristics independently associated with the decision to treat conservatively were an older age, a lower transaortic pressure gradient, a larger aortic valve area, and the presence of diabetes. Interestingly, the decision to treat conservatively was associated with a significantly reduced survival, even after adjusting for potential confounding baseline characteristics by propensity score-based analyses.

Factors Influencing the Therapeutic Decision
Decision making is often complex in elderly patients who present with heart diseases requiring surgical intervention. The individual operative risk, as well as the postoperative life expectancy of these patients indeed varies considerably, depending not only on age but also on the number and severity of cardiac and noncardiac comorbidities. Accordingly, many elderly patients with severe heart conditions do not undergo operations despite clear indications for intervention on the basis of published recommendations. Although AS is quite a prevalent valvular heart disease in octogenarians, few data exist on the proportion of patients who meet guidelines criteria for AVR but eventually do not undergo an operation. There are even fewer data on the reasons why operations are not performed in these patients.

Back in 1999, Bouma and colleagues [16] examined the outcome of 205 symptomatic AS patients, aged 70 years or older, and reported that as many as 41% of them did not undergo surgical intervention. More recently, Varadarajan and colleagues [17] reported that only 20% of 277 symptomatic AS patients aged 80 years or older underwent AVR. In a recent analysis of the European Heart Survey, Iung and colleagues [18] reported that about one-third of elderly patients with symptomatic AS in Europe refuse or are denied surgical intervention and that older age and left ventricular dysfunction were associated with operative denial in these patients.

The present study confirms and extends the findings of these previous investigations. Indeed, as in previous studies, we found that approximately 40% of elderly patients with symptomatic severe AS were treated conservatively. As in prior studies, we observed that age was strongly associated with the decision not to operate. We also observed that the presence of comorbidities, represented by the EuroSCORE, negatively influenced the therapeutic decision. Comorbidities are frequent in elderly patients and directly influence both the immediate operative risk and overall postoperative survival. It should therefore not be surprising that they influence the physicians' and the patients' risk–benefit analyses. Similar findings were reported by Iung and colleagues [18], who used the Charlson index as a measure of co-morbidities. Finally, and somewhat at variance with previous works [16, 18, 19], left ventricular dysfunction did not seem to influence the therapeutic decision in our study. This was probably related to our a priori exclusion of patients with low gradient AS (ie, a mean gradient <30 mm Hg).

Predictors of Outcome in Octogenarians With Severe AS
In the present study, 30-day mortality after AVR was 9%, a figure consistent with other series, given the risk profiles of our patients [16, 18, 20]. One-year survival in operated-on patients was 82% and was also in the range of reported values in other series [7, 11, 16, 18, 21]. Interestingly, 5-year survival was 66%, a value not different from that in the age- and gender-matched Belgian population. This indicates that in elderly patients with severe AS, AVR can restore an almost normal life expectancy, which should be reassuring for both the patients and the physicians who participate in the therapeutic decision. Long-term survival in operated-on patients strikingly contrasted with that in patients who were treated conservatively. In these patients, 5-year survival was indeed severely reduced (31%) compared with that expected in the age- and gender-matched Belgian population. The difference between patients who were and were not operated on persisted even after adjustment for potential confounding factors, using a propensity score based analysis.

Predictors of Mortality in the Different Therapeutic Groups
We also tried to gain more insights into the prognostic determinants in our two treatment groups. Using Cox proportional hazards survival models, we found that survival in both groups of patients was influenced by the severity of preoperative symptoms and by the magnitude of the logistic EuroSCORE. The data also indicated that the presence of significant COPD negatively affected survival in patients undergoing AVR. These findings have potentially important clinical implications. They indeed suggest that in daily clinical practice, the therapeutic decision inappropriately incorporates factors that influence long-term patients' survival, such as the EuroSCORE. Although the EuroSCORE was a predictor of death in patients undergoing AVR, it was equally powerful in predicting outcome in patients who were not operated on. This implies that the logistic EuroSCORE is a marker of the overall risk that a given patient is exposed to, irrespective of the therapeutic strategy chosen. It should thus probably not be used to grant or not AVR. Our data also indicate that the presence of COPD was not taken into account in the decision-making process but nonetheless had a negative impact on the survival of patients undergoing AVR. This suggests the exercise of caution when contemplating AVR in octogenarians with COPD.

Study Limitations
This study has limitations that should be acknowledged. First, despite the completeness of our follow-up data, our patients were not randomized between the two treatment arms. Even if we constructed a propensity model to reduce the bias inherent to the design of our study, we cannot exclude the possibility that unaccounted confounding factors eventually contributed to our results.

Second, we only assessed objective criteria influencing the decision-making process. But, for many patients, this decision was often irrational and strongly affected by subjective feelings.

Finally, our study only focused on survival, whereas functional recovery and discharge status (eg, patient's home vs nursing home) are also important outcomes to consider in elderly patients. Recent studies have indeed demonstrated that factors that describe the biologic status of the patient, such as frailty indexes, have a major effect on postoperative outcomes and survival [22]. Future studies should assess the importance of these factors on both the therapeutic decision and patients' outcome.

Conclusions
Our study shows that approximately 40% of octogenarians with severe AS and a definite indication for operation are treated conservatively. Our data also show that AVR can be performed at acceptable risks in these patients and restores an almost normal life expectancy. By contrast, patients treated conservatively have a dismal prognosis, experiencing a twofold excess mortality compared with AVR patients. This suggests that we probably need to reconsider our decision-making process in octogenarians with severe AS who are potential candidates for intervention to reduce the number of patients who do not undergo operations.


   Acknowledgments
Top
 Abstract
 Introduction
 Material and Methods
 Results
 Comment
 Footnotes
 Acknowledgments
References
 
This work was supported by the Fonds National de la Recherche Scientifique (FNRS, Brussels, Belgium).


   Footnotes
Top
 Abstract
 Introduction
 Material and Methods
 Results
 Comment
 Footnotes
Acknowledgments
 References
 
* Both authors contributed equally to this work. Back


   References
Top
 Abstract
 Introduction
 Material and Methods
 Results
 Comment
 Footnotes
 Acknowledgments
 References
 

  1. Lindroos M, Kupari M, Heikkila J, Tilvis R. Prevalence of aortic valve abnormalities in the elderly: an echocardiographic study of a random population sample J Am Coll Cardiol 1993;2:1220-1225.
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