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Ann Thorac Surg 2002;73:480-489
© 2002 The Society of Thoracic Surgeons

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Original article: cardiovascular

A decade of change—risk profiles and outcomes for isolated coronary artery bypass grafting procedures, 1990–1999: a report from the STS National Database Committee and the Duke Clinical Research Institute

^a The Society of Thoracic Surgeons National Database Committee, Chicago, Illinois, USA
^b Duke University Clinical Research Institute, Durham, North Carolina, USA

* Address reprint requests to Dr Ferguson, LSU Health Sciences Center, 1542 Tulane Ave, 7 Fl, New Orleans, LA 70012-2822, USA
e-mail: tbruceferg732{at}pol.net

	Abstract

Top Abstract Introduction Material and methods Results Comment Acknowledgments References

 
Background. The Society of Thoracic Surgeons National Adult Cardiac Database is the largest voluntary clinical database in medicine. Using this database we examined changes in the risk profile of patients undergoing isolated coronary artery bypass grafting (CABG) and their outcomes during the decade 1990 to 1999.

Methods. Trends in 23 preoperative risk factors were tracked for CABG cases during this decade. Using a multivariate logistic risk model, we also determined the degree to which operative risk and risk-adjusted operative mortality changed during this 10-year interval.

Results. Between 1990 and 1999, 1,154,486 patient records were harvested by the Society of Thoracic Surgeons National Adult Cardiac Database for isolated CABG procedures performed at 522 Society of Thoracic Surgeons participant sites in the United States and Canada. Over time, CABG patients were more likely to be older (mean age 63.7 in 1990, 65.1 in 1999), of female gender (25.7% women in 1990, 28.7% in 1999), and have a history of smoking, diabetes mellitus, renal failure, hypertension, stroke, chronic lung disease, New York Heart Association functional class IV, and three-vessel disease (p < 0.0001). Patients’ predicted operative risk increased by 30.1%, from 2.6% in 1990 to 3.4% in 1999. Despite higher risk, observed operative mortality decreased by 23.1%, from 3.9% in 1990 to 3.0% in 1999 (p < 0.0001). During the decade, a Medicare-aged subset (n = 629,174) experienced similar increases in risk and declines in mortality.

Conclusions. Patients referred for isolated CABG are significantly older, sicker, and have a higher risk than a decade ago. Despite this, CABG mortality rates have declined substantially. These results highlight the excellent progress in the care of CABG patients achieved during the past decade.

	Introduction

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Cardiothoracic surgeons have the impression that the patients now referred for surgical revascularization procedures are substantially "older and sicker" than those on whom they performed coronary artery bypass grafting (CABG) a decade ago (1990 to 1999). Several reasons for this include: (1) documentation during the decade that surgical procedures can be safely performed on extremely aged [1] and high-risk [2] subsets; (2) documentation that patients with impaired ventricular function but reversible ischemia often benefit the most from surgical intervention [3]; (3) selective referral of lower risk patients (including single- and two-vessel disease patients) to percutaneous cardiovascular intervention or medical therapy, resulting in a greater percentage of surgical candidates with triple-vessel disease [3], and (4) compelling data from clinical trials documenting that patients with a higher baseline risk (including more extensive coronary disease and diabetic patients) are better treated by surgical rather than percutaneous intervention or medicine [4].

Empiric data to support this impression have come from single-institution studies, but multisite analyses are lacking. We used the Society of Thoracic Surgeons National Cardiac Database (STS NCD) [5] to examine the changes in risk profile for patients undergoing isolated CABG during the past decade as determined by the changes in risk factor trends. These changes were then compared with the changes in actual operative mortality for isolated CABG between 1990 and 1999. We also examined the change in major postoperative morbidities during the decade. Finally, because the Medicare population is America’s largest healthcare payment outlay, we examined the changes in risk profiles and outcomes in this population as well.

	Material and methods

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The Society of Thoracic Surgeons National Cardiac Database
Currently, patient data are harvested semiannually from the individual participant site providers contributing to the NCD [5]. Data are uploaded to a central warehouse facility, the Duke Clinical Research Institute. Certain data quality standard benchmarks need to be met both locally and nationally before a site’s data are included on the aggregate national set. Aggregate data are analyzed twice a year for site-specific feedback reporting, and benchmarked against regional and national standards. These reports are designed for use in local and regional CABG Quality Improvement efforts by identifying areas for process improvement. An Executive Summary of the Semi-Annual report is posted at http://www.sts.org/database.

Outcomes performance measures are risk-adjusted using a series of statistical models developed by the STS National Database Committee [6–10]. Current models include mortality and major morbidity for CABG, valve and CABG/valve procedures, as well as risk-adjusted postoperative length of stay for each procedure classification.

Study population
Between 1990 and 1999, a total of 1,517,715 adult cardiac procedures were harvested into the STS NCD from patients in the United States and Canada. A total of 522 sites contributed data to the STS NCD over this time interval. From this total, we excluded those patients undergoing isolated valve or other cardiac procedures, combined (CABG + valve, CABG + other) procedures, or data that failed to meet the data quality standards for inclusion in the NCD. This left a subset of isolated CABG patients that were used for the present analysis (n = 1,154,486).

Data definitions
The elements and definitions used in the STS NCD have remained generally constant across this entire 10-year period [5, 7]. Detailed definitions for these outcomes can be found on the Society’s web page (http://www.sts.org/database).

For this analysis, operative mortality included all in-hospital deaths as well as all out-of-hospital deaths occurring within 30 days of the procedure.

Analysis
Initial data descriptions included means for continuous risk variables and percentages for discrete variables. The statistical significance of time trends in risk factor prevalence during the 10-year period was determined by linear regression for continuous variables and logistic regression for discrete variables.

We specifically considered the 28 risk variables that had been previously identified as independent predictors for operative mortality in any of the previous CABG models. Of these 28 variables, 23 had consistent definitions during the entire decade. We also calculated absolute and relative percentage changes in these risk factors between 1990 and 1999.

We developed a new, composite risk-adjusted logistic model based on the entire data set. This model allowed one to calculate a patient’s summary predicted risk based on all 23 preoperative risk factors. These model estimates were also used to calculate the annual observed-to-expected (O/E) ratios for mortality as well as risk-adjusted mortality rates observed for the decade. Finally, results were analyzed to determine whether the time trend from 1990 to 1999 was statistically significant.

For purposes of the overall dataset analysis, missing data (data value for element not recorded) were assigned a null value (normal, absent) for all 23 variables used in the risk model.

Given that the quantity of missing data were not constant over time, as a secondary analysis we recalculated these temporal changes among a subset of isolated CABG patients, subject to the following rules: (1) for discrete variables, more than 20% missing for any variable disqualified that site’s data for that year; (2) exceptions included data for child variables (eg, intraaortic balloon pump timing, myocardial infarction timing), and New York Heart Association functional classification; in these instances, if these variables were 100% missing, these sites were excluded; and (3) variables for ejection fraction and body surface area were not subject to any threshold because these continuous variables were imputed to means in the model.

	Results

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Table 1 documents the annual harvest data for the entire patient dataset from 1990 to 1999. A total of 1,154,486 CABG patient records were included in this analysis. Both the cumulative aggregate total record numbers and the aggregate Medicare population numbers are shown (n = 629,174). The cumulative aggregate number of harvest sites has grown fivefold during this decade.

Table 3 shows the similarly formatted data for the Medicare population. Again, univariate analysis documented that the change in the incidence of these risk factors was significant (p < 0.0001) for all variables during the time trend 1990 to 1999 except for previous cardiac operations (p = 0.0054), myocardial infarction timing more than 21 days (p = 0.0022), and salvage status (p = 0.0067).

View larger version (20K): [in this window] [in a new window]   Fig 1. Observed, expected and risk-adjusted mortality, 1990 to 1999. Entire coronary artery bypass grafting population (n = 1,154,486).

View larger version (21K): [in this window] [in a new window]   Fig 2. Observed mortality to expected mortality ratio (O/E), 1990 to 1999, for the entire coronary artery bypass grafting (CABG) population (n = 1,154,486), the Medicare-age subset (n = 629,174), and the missing data subanalysis subset of the entire coronary artery bypass grafting population (n = 766,011).

View larger version (22K): [in this window] [in a new window]   Fig 3. Composite of mortality statistics, Medicare-age subset and Medicare part B reimbursement, 1990 to 1999, Medicare-age subset (n = 629,491). Observed, expected and risk-adjusted mortality data are shown. In addition, Medicare part B reimbursement data from Health Care Financing Administration for current procedural terminology (CPT) 33512 (three veins) for 1990 to 1992 and for CPT 33518 + 33533 (left internal mammary artery + two veins) for 1993 to 1999 are shown. (HCFA is now known as CMS, Centers for Medicare and Medicaid Services.)

	Comment

Top Abstract Introduction Material and methods Results Comment Acknowledgments References

 
Operative mortality trends over time
The present study is the first published report from a multisite national dataset (in contrast to reports from large, single-institution databases [11–15]) analyzing trends in CABG mortality. These results confirm that during the past decade patients undergoing CABG are older and with more comorbidities. Despite this, there has been a significant decline in overall operative mortality and risk-adjusted mortality for CABG during the decade from 1990 to 1999 (Fig 1).

Changing risk profile in CABG
The present study also importantly evaluates concomitant changes in the risk profile of patients undergoing surgical intervention in a large, nationwide dataset. We used statistical modeling techniques that permit a longitudinal time trend analysis of the change in surgical risk over time, based on preoperative risk factors. Table 2 illustrates the preoperative risk factor trends during the decade. These trends include increasing age, increased female patient cohort, more comorbidities, more extensive surgical disease, and more patients with abnormal ventricular function. Interestingly, the incidence of emergent and salvage patients declined, in part probably due to the use of coronary stents for acute intervention and for vein graft restenosis, and perhaps due to more aggressive use of preoperative intraaortic balloon pump placement. In summary, this risk profile change resulted in a 30% increase in expected risk during the decade, highly significant for the time trend.

Increased risk versus decreased mortality
Figure 2 demonstrates a significant decrease in the observed mortality/expected mortality ratio (O/E ratio) for the overall and Medicare analysis groups during the decade. In the overall population the O/E ratio decreased below 1.0 in 1995, whereas it declined below this benchmark in 1998 for the Medicare-aged subset. Because during the decade this baseline mortality risk in fact increased in severity, this outcomes benchmark not only improved but improved against a negative trend in preoperative surgical risk.

This measurement of outcomes evaluation (O/E ratio) has been used in a number of other analyses from both voluntary and mandatory databases (Shroyer ALW, personal communication, October 2000) [16–20]. Time trend data similar to that reported here from the STS have been collected but not reported from the VA Cardiac Surgical Program, also a nationwide, multisite but mandatory cardiac surgery database (Shroyer ALW, personal communication, October 2000) [21]. In this VA analysis, a significant decrease in the O/E ratio was demonstrated for the 13-year interval between 1988 and 1999, using a slightly different time trend analysis than the present study (Shroyer ALW, personal communication, October 2000). Thus, the two nationwide cardiac surgical databases, one voluntary (STS) and one mandatory (VA), have demonstrated a decline in operative mortality in the face of increased surgical risk during the decade of the 1990s. The similarity of results from the STS and VA analyses suggests again that voluntary data collection and analysis programs can yield results that are of quite similar validity and scientific merit as compared to mandatory programs for collection and analysis, provided the data are collected by highly motivated physicians educated in the benefits of outcomes analyses.

Possible reasons for the improved mortality despite the increased risk
Efforts to continually improve the outcomes after CABG have been the hallmark of cardiothoracic surgeons for the past 30 years [5, 9, 17]. A number of reasons can be postulated for the continued improvement in operative mortality during the past decade. First, the process of CABG has undergone a significant evolution, with implementation of care paths and cardiac surgical service lines, both major efforts at improving the coordination of care for the CABG patient. Second, formation of cardiac surgical teams with dedicated cardiothoracic anesthesiologists, nursing personnel, and allied health personnel has greatly contributed to the efficiency of care. Third, technical improvements have occurred, both in cardiac surgery (eg, cardiopulmonary bypass and myocardial protection improvements) as well as in cardiology (eg, stenting of previous bypass grafts). Fourth, new pharmacologic agents and perioperative techniques have allowed for early extubation protocols and "fast-track" management of a majority of CABG patients [22]. Fifth, selection criteria and techniques have been developed to safely and successfully intervene in an increasingly elderly patient population [1, 2, 23].

Perhaps as important as these structural and technical changes, implementation of quality improvement programs has had a profound effect on improving mortality after CABG during the past decade. Physician-championed voluntary data collection and analysis efforts in northern New England [17], Minnesota [24], and Alabama [25] have demonstrated this, and the STS has recently embarked on a nationwide effort in quality improvement [5]. All these efforts have in common the feedback, local analysis of processes and outcomes, and regional information exchange that can favorably impact outcomes after CABG. It can be anticipated that continued efforts in quality improvement in CABG will produce sustained improvements in surgical outcomes after CABG during the first decade of the new millennium.

Missing data in the STS NCD
As shown in Tables 2 and 3, the percentage of missing data was relatively high in the early years of the NCD. Importantly, the percentage of missing data declined during the decade to levels commensurate with other voluntary and mandatory database efforts. However, this change in the baseline level of missing data would be expected to affect the risk evaluation and expected mortality analyses in particular over time. Therefore, we repeated this analysis after exclusion of sites with more than 20% missing data for any of the 23 variables used in the trend mortality analyses. As shown in Table 4 this resulted in a smaller patient population, from a smaller number of participant sites. However, Table 5 shows that the variability in the percentage of missing data was eliminated by this technique, while still leaving enough patients for trend analyses. Figure 3 demonstrates that the O/E ratio for this subanalysis was similar to the overall CABG and Medicare group analyses, and this decline in operative and risk-adjusted mortality as well as the increase in expected mortality were significant for the trend during 1990 to 1999 (p < 0.0001) for this missing data subanalysis as well. Thus, the seminal finding of this study, that there indeed has been an increase in expected mortality for CABG (increased surgical risk during the past decade, confirming surgeons’ subjective impression that "patients today are sicker") is borne out in the overall dataset as well as both subanalyses.

The NCD has implemented a number of programs in the past several years to facilitate local data quality improvements [5], and the overall data quality in the NCD has improved substantially during the decade. Indeed, the decline in the percentage of missing data during the decade (Table 4) can be viewed as a surrogate for improved data quality in the NCB during this time frame.

Increased risk versus decreased mortality in the elderly population
In the patient group more than 65 years (n = 629,174), the mean age increased by 1.4 years also (71.7 versus 73.1 years) (Table 3; p < 0.0001). Numerous studies have documented acceptably higher mortality rates in elderly patients [1, 2]. This study reports similar mortality rates (Fig 3), and documents that the mortality for CABG in a subset of patients more than 65 years has declined significantly as well as during this past decade. Although this decline in this elderly subset is not as great as the overall population (Fig 1), it occurred during a decade where more and more elderly patients are considered acceptable candidates for elective and urgent surgical intervention. The O/E ratio has declined significantly during the decade in the Medicare population (Fig 2), and again this improvement in mortality outcome occurred in the face of an increasing, not static, baseline preoperative risk. The findings of this study support continued selected intervention in the elderly, including octogenarians and nonagenarians [1, 2].

Improved outcomes versus declining reimbursement for CABG (Fig 3)
During the decade of this analysis, the Medicare Part B reimbursement for CABG declined on average from $3,698 for a three-vein procedure in 1990 to $2,276 in 1999 for a more technically complicated standard left internal mammary artery/two-vein procedure. This represents a 38.4% decline in raw reimbursement during the decade, unadjusted for inflation (Fig 3). During this same time interval the surgical outcome for CABG improved by 41% despite the 33% increase in surgical risk. The findings from this scientific analysis should be used in establishing reimbursement levels to cardiothoracic surgeons for these more increasingly demanding clinical efforts. In particular, consideration should be given to the fact that these NCD participation activities are legitimate, reimbursable practice expenses that directly impact on the quality of care delivered to these patients.

Limitations
Although a substantial majority of US centers currently submit data to the STS NCD, participation is not ubiquitous among cardiac programs across the country; as such, the NCD data do not represent a truly comprehensive national experience. In addition, as the number of centers contributing to the STS has grown over time, it remains possible that some of the changes in risk factors and outcomes could be due to a change in the type or quality of centers represented in the STS NCD. A third potential limitation is that this study does not address perhaps the most important aspects of this analysis, namely why these improvements in mortality outcome occurred despite this increase in surgical risk.

In conclusion, this study documents a statistically significant increase in operative risk for patients undergoing isolated CABG during the past decade as documented in patient data from the STS National Cardiothoracic Surgical database. Importantly, despite this increase in expected mortality, the quality of care (as documented by decreased observed and risk-adjusted mortality) delivered by cardiothoracic surgeons and their colleagues to their patients was documented to have improved significantly during this time interval. Both of these time trends are highly statistically significant during the 10-year time interval. This analysis illustrates the powerful tool that the NCD represents, and clearly documents the value and "return on investment" of collecting and analyzing these outcomes data within organized medicine. Cardiothoracic surgeons should be extremely proud of the superb care delivered to their patients despite these increasingly complex and high-risk procedures.

	Acknowledgments

Top Abstract Introduction Material and methods Results Comment Acknowledgments References

 
The authors thank all STS participants who have contributed data to the STS National Database during the past decade. In addition, we extend our appreciation to the Society, the Officers, and the Members of the National Database Committee over the decade who have supported this National Database effort.

	Appendix

 
Mortality data, 1990–1999

Year Total Dataset Missing Dataset Expected Observed Expected Observed 1990 2.58 3.85 2.75 3.78 1991 2.81 3.78 2.82 3.66 1992 2.97 3.63 2.90 3.58 1993 3.12 3.45 3.10 3.48 1994 3.24 3.47 3.18 3.44 1995 3.29 3.20 3.22 3.23 1996 3.25 3.18 3.18 3.19 1997 3.23 3.13 3.17 3.11 1998 3.37 3.01 3.33 3.03 1999 3.34 2.97 3.30 2.90

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				F. Filsoufi, P. B. Rahmanian, J. G. Castillo, J. Chikwe, A. Carpentier, and D. H. Adams Early and late outcomes of cardiac surgery in patients with moderate to severe preoperative renal dysfunction without dialysis Interactive CardioVascular and Thoracic Surgery, February 1, 2008; 7(1): 90 - 95. [Abstract] [Full Text] [PDF]

				T. B. Ferguson Jr On the Evaluation of Intervention Outcome Risks for Patients With Ischemic Heart Disease Circulation, January 22, 2008; 117(3): 333 - 335. [Full Text] [PDF]

				J. H. Yang, H.-C. Gwon, S. J. Cho, J. Y. Hahn, J.-H. Choi, S. H. Choi, Y. T. Lee, S. H. Lee, K. P. Hong, and J. E. Park Comparison of Coronary Artery Bypass Grafting With Drug-Eluting Stent Implantation for the Treatment of Multivessel Coronary Artery Disease Ann. Thorac. Surg., January 1, 2008; 85(1): 65 - 70. [Abstract] [Full Text] [PDF]

				E. Gongora and T. M. Sundt III Myocardial Revascularization with Cardiopulmonary Bypass Card. Surg. Adult, January 1, 2008; 3(2008): 599 - 632. [Full Text]

				E. J. Velazquez, K. L. Lee, C. M. O'Connor, J. K. Oh, R. O. Bonow, G. M. Pohost, A. M. Feldman, D. B. Mark, J. A. Panza, G. Sopko, et al. The rationale and design of the Surgical Treatment for Ischemic Heart Failure (STICH) trial. J. Thorac. Cardiovasc. Surg., December 1, 2007; 134(6): 1540 - 1547.e4. [Abstract] [Full Text] [PDF]

F. Filsoufi, P. B. Rahmanian, J. G. Castillo, J. I. Mechanick, S. K. Sharma, and D. H. Adams Diabetes is not a risk factor for hospital mortality following contemporary coronary artery bypass grafting Interactive CardioVascular and Thoracic Surgery, December 1, 2007; 6(6): 753 - 758. [Abstract]