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J Thorac Cardiovasc Surg 2009;137:82-90
© 2009 The American Association for Thoracic Surgery
Acquired Cardiovascular Disease |
a Division of Cardiothoracic Surgery, Department of Surgery, University of Maryland Medical Center Baltimore, Md
b The Duke Clinical Research Institute, Durham, NC
Received for publication July 2, 2008; accepted for publication August 7, 2008. * Address for reprints: James M. Brown, MD, 22 S Green St, Baltimore, MD 21201. (Email: jbrown{at}smail.umaryland.edu).
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Abstract |
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Methods: The Society of Thoracic Surgeons National Database was queried for all isolated aortic valve replacements between January 1, 1997, and December 31, 2006. After exclusion for endocarditis and missing age or sex data, 108,687 isolated aortic valve replacements were analyzed. Time-related trends were assessed by comparing distributions of risk factors, valve types, and outcomes in 1997 versus 2006. Differences in case mix were summarized by comparing average predicted mortality risks with a logistic regression model. Differences across subgroups and time were assessed.
Results: There was a dramatic shift toward use of bioprosthetic valves. Aortic valve replacement recipients in 2006 were older (mean age 65.9 vs 67.9 years, P < .001) with higher predicted operative mortality risk (2.75 vs 3.25, P < .001); however, observed mortality and permanent stroke rate fell (by 24% and 27%, respectively). Female sex, age older than 70 years, and ejection fraction less than 30% were all related to higher mortality, higher stroke rate and longer postoperative stay. There was a 39% reduction in mortality with preoperative renal failure.
Conclusions: Morbidity and mortality of isolated aortic valve replacement have fallen, despite gradual increases in patient age and overall risk profile. There has been a shift toward bioprostheses. Women, patients older than 70 years, and patients with ejection fraction less than 30% have worse outcomes for mortality, stroke, and postoperative stay.
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Introduction |
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In the setting of aortic valve disease, patients are predominantly seen with aortic stenosis, which necessitates valve replacement. Ferguson and colleagues2 reviewed the Society of Thoracic Surgeons (STS) database with regard to coronary artery bypass grafting. They found that the population undergoing this procedure had aged and was at higher risk yet had a lower mortality. Edwards and associates3 developed a model for risk prediction in the setting of valve replacement surgery. This model was validated and proved accurate in predicting outcomes. Two percent of the population have bicuspid aortic valves, which are at risk for stenosis.4,5 Four percent of the elderly population have significant aortic stenosis.6,7 The size of the population older than 65 years will grow 50% between 2000 and 2030.8,9 Devices for transcatheter AVR are in development and clinical investigation. Early results suggest the feasibility of transcatheter valve therapy10,11; however, standard outcome measures must continue to drive clinical behavior. To this end, we explored the last 10 years of isolated AVR in the STS database with regard to the characteristics and outcomes of this group of patients as a whole and with time. |
Materials and Methods |
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End Points
Outcome measures consisted of in-hospital mortality, permanent stroke, and postoperative stay. Postdischarge 30-day mortality was not analyzed, because this end point was not captured consistently by many participants during the study period.
Analysis
The distributions of patient characteristics and outcomes were summarized with percentages for categorical variables and means and medians for continuous variables. Differences in the prevalence of risk factors and outcomes in 1997 versus 2006 were assessed with stratified Mantel–Haenszel 
2 statistics, with STS participant identity serving as the stratification variable. Confidence intervals for the relative change in risk factor prevalence in 1997 versus 2006 were calculated by fitting generalized linear models with a log link function. SEs were calculated with an empirical sandwich estimator to account for correlation of observations within the same participant.
To create a patient-level summary measure of case severity, we used logistic regression to estimate the probability of mortality for each patient in the study sample. Explanatory variables consisted of age, sex, ejection fraction, congestive heart failure, diabetes, renal failure, cerebrovascular accident, peripheral vascular disease, myocardial infarction, and surgical status. The patient's estimated probability of death is a simple summary measure that combines several individual risk factors into a single number. The observed to expected ratio statistic was then used to compare temporal trends in actual mortality with the average predicted probability from the logistic regression model. For each calendar year, the risk-adjusted mortality was calculated by multiplying the observed to expected ratio times the overall mortality during the study period. Finally, a test of trend was calculated by adding surgery year to the logistic regression model described previously and testing whether the coefficient was zero.
Missing Data
Patients with missing data were included in the denominator when reporting the prevalence of binary (yes/no) risk factors. We report the percentage of patients for whom each risk factor was coded as present and the percentage of patients for whom the data were unavailable. We included missing data in the denominator, because patient records frequently list risk factors that are present without enumerating the risk factors that are absent. For four variables (chronic obstructive pulmonary disease, New York Heart Association functional class, ejection fraction, and aortic insufficiency), there were large differences in the frequencies of missing data in 1997 and 2006. For these variables, we repeated the analysis with the subset of participants with at least 90% complete data for the variable. Records missing data for outcomes (mortality and stroke) were imputed to the no category.
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Results |
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Discussion |
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for heart valve surgery and the model developed by the STS and Duke Clinical Research Institute3 are accurate, we conclude that surgical teams participating in the STS database have dramatically improved performance for isolated AVR.
With regard to specific subgroups, the population of AVR recipients became older and more obese and had increased incidences of diabetes, hypertension, pulmonary disease, cerebrovascular disease, and renal failure during the 10 years. Despite these changes, overall mortality fell for each subgroup. It also fell for most patient subsets outlined in Table 5. Subgroup stroke rate also decreased during the 10-year period despite increasing age and risk in this AVR population (Table 5 and Figure 6). To a degree, stroke and mortality are dependent, because stroke leads to higher mortality. Nonetheless, for patients younger than 70 years, risk of stroke after AVR was 0.7% in 2006. Between the ages of 70 and 80 years, stroke rate in 2006 was less than 2.0%, and even for octogenarians, stroke was less than 2.5% (Table 5 and Figure 6). Stroke rate in this study was time dependent as well as age dependent. Female patients had higher mortality, higher stroke rate, and longer postoperative stay relative to male patients. This was true for the overall population, the 1997 group, and the 2006 group. Bridges and coworkers17 previously demonstrated a relationship between size and outcome in the STS database in the setting of AVR. Because female patients have a smaller body size on average than do male patients, the increased mortality among female patients is consistent with reports linking body size to outcome. Factors that cause this effect of higher female adverse outcome rate and could possibly be manipulated to ameliorate it are unclear, however, and will require further study. Increased adverse outcomes in the nonwhite patients were also observed in this study. This observation in the setting of heart surgery has also been made in previous reports.18 Again, the study design of this review was not sufficient to explain this finding.
The dramatic shift away from mechanical heart valves toward bioprosthetic heart valves is difficult to explain because of the relatively short time frame in which it occurred. Nonetheless, many young patients refuse long-term anticoagulation, and elderly patients are at high risk when receiving anticoagulation. There has been evidence that reoperation to replace a failed bioprosthetic valve can be accomplished with good outcomes driven by factors other than simple replacement of the valve, such as age, degree of heart failure, and coronary disease.19,20 Newer generation tissue valves are expected to provide longer reoperation-free survivals. Finally, the population of patients has aged during the study period, and it is expected that the elderly segment of the population will continue to grow dramatically. Multiplying and adding risk through the patient's lifetime to derive a predicted total lifetime risk for valve implantation at the time of the index operation favors a bioprosthetic valve over mechanical valve and may explain the finding in this study of a nationwide shift toward bioprosthetic valves.21 All these factors taken together have influenced surgeon and patient valve choices.
In conclusion, predicted risk and comorbidities of patients undergoing AVR have increased during the last 10 years in this country. Despite these changes, outcomes, including rates of death and stroke, not only have improved but are quite low for isolated AVR. There has been a dramatic shift toward the use of bioprosthetic valves during the 10-year study period. Female sex is associated with higher rates of death and adverse outcomes in the setting of isolated AVR, a finding that requires a search for cause.
Study Limitations
This study was based on the STS database and therefore by definition was a retrospective review of patient data submitted by participating centers. Furthermore, the cases studied were nonconsecutive and based on voluntary participation in the STS database. In addition, this was a study of AVR only. New pioneering therapies, such as aggressive and effective repair techniques for aortic insufficiency, will change the focus to short- and long-term outcomes from treatment of a disease rather than outcomes from a particular procedure.22 Long-term data cannot yet be linked to the in-hospital and 30-day outcome measures provided by the STS database. Further investigation will require inclusion of long-term outcomes and health-related quality of life in any assessment of surgical therapy of valve disease.
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