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Ann Thorac Surg 2004;77:761-768
© 2004 The Society of Thoracic Surgeons
a Medical City Dallas Hospital, Dallas, Texas, USA
b Centennial Medical Center, Nashville, Tennessee, USA
c Henry Ford Health System, Detroit, Michigan, USA
d HCA, Inc, Nashville, Tennessee, USA
e Cardiac Data Solutions, Inc, Indianapolis, Indiana, USA
f Emory School of Public Health, Atlanta, Georgia, USA
* Address reprint requests to Dr Mack, 7777 Forest Lane, Suite A323, Dallas, TX, USA 75230
e-mail: mjmack{at}earthlink.net
Presented at the Thirty-ninth Annual Meeting of The Society of Thoracic Surgeons, San Diego, CA, Jan 31Feb 2, 2003.
| Abstract |
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METHODS: 148,396 consecutive patients in 69 HCA, Inc hospitals who underwent either PCI or coronary artery bypass grafting (CABG) were tracked in the HCA Casemix Database from 1999 through the first quarter of 2002. Comorbid conditions, procedures, complications, and outcome variables were defined through International Classification of Diseases, Ninth Revision coding. Odds ratios (OR) for death and other procedure-related complications were estimated using logistic regression adjusting for age, sex, and 31 other patient clinical and procedural characteristics.
RESULTS: Now 65.4% of all coronary revascularization is by PCI with a 6.8% annual rate of increase whereas CABG volume is declining by 1.9% per year. However the majority of these changes occurred between 1999 and 2000 with only small changes in the last 3 years. Coronary artery bypass grafting is still utilized primarily for multivessel disease (3.38 bypasses per patient) whereas PCI is predominately (83%) still limited to single-vessel intervention. Unadjusted mortality rates over the full 13-quarter period were 1.25% for PCI and 2.63% for CABG (p < 0.001), with PCI rates remaining constant and CABG mortality declining. Twenty-three percent of CABG is performed off pump with a lower mortality than conventional on-pump CABG (2.37% versus 2.69%, p < 0.001). Percutaneous coronary intervention patients have lower mortality (OR 0.51), and fewer acute renal failure (OR 0.39), neurologic (OR 0.12), and cardiac (OR 0.16) complications than CABG patients (p < 0.001).
CONCLUSIONS: Interventions for coronary artery disease continue to rise primarily due to an increase in PCI. The volume of PCI continues to increase relative to CABG. Although adverse outcomes are higher after CABG, the proportion of multivessel disease treated is greater. The difference in adverse outcomes between CABG and PCI remains small and continues to decline.
| Introduction |
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| Material and methods |
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Data
Data were collected through the HCA Casemix Database. This database is a comprehensive, retrospective, administrative database containing patient, clinical, and outcome data on all cardiovascular patients at HCA hospitals during the study period from January 1, 1999, through March 31, 2002. A total of 148,396 consecutive patients at 69 hospitals who underwent CABG surgery (diagnosis-related groups 106, 107, 109) or PCI were included.
Data collection
Patient characteristics, procedure complications, and mortality and hospital-process characteristics were coded directly from the discharge abstract. The International Classification of Diseases, Ninth Revision (ICD-9) was used to aggregate patient characteristics and procedure complications into categories [5] (see Appendices 1 and 2). A total of 33 patient characteristics, 17 patient outcomes, 6 hospital-process characteristics, and 2 length-of-stay characteristics were identified and compared using standard definitions.
Statistical analysis
Means for CABG and PCI for various patient characteristics, outcomes, process measures, and length of stay are reported in aggregate and by year: 1999, 2000, 2001, and 2002.
Differences in comorbidities and extent of disease have been shown to have an impact on the clinical outcomes of CABG versus PCI. To account for all of these we employed multivariate regression techniques. Seven dependent variables were analyzed: patient mortality, four patient complications, and discharge status. Patient complications included shock/hemorrhage, neurologic complications, cardiac complications, acute renal failure, and respiratory complications. Discharge status was home or home with home healthcare, skilled nursing facility, or rehabilitation facility.
To account for the potential wide range of confounding variables we included a comprehensive number of independent variables in our regression model. The variables were as follows: patient characteristics (age and sex); risk factors and comorbid conditions (status post [S/P] CABG, S/P PCI, unstable angina, cardiogenic shock, acute myocardial infarction, old myocardial infarction, unstable angina, valvular heart disease, abdominal aortic aneurysm, hypertension, chronic renal failure, hemodialysis, peripheral vascular disease, insulin-dependent diabetes, noninsulin-dependent diabetes, chronic obstructive pulmonary disease, liver disease, and endocarditis); procedure characteristics (multivessel intervention, intraaortic balloon pump usage, stent usage); and medications (GPIIb, IIIa, and thrombolytic drugs). Many of these variables have been described elsewhere and reflect conventional aspects of cardiovascular care [6].
Because the dependent variables are bimodal, logistic regression (odds ratios [OR]) was used. The ORs for each outcomes measure are reported.
Cost data are based upon individual patient resource consumption. A formula is applied to the charges based upon the cost: charge ratio as reported in the Medicare cost report.
| Results |
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Overall, mortality of PCI was 1.25% (Table 4). Other complications of PCI were relatively uncommon with the most frequent being acute renal failure (1.44%). Length of stay from procedure to discharge was 2.2 days with more than 95% patients returning to home. The average procedural cost of PCI was $12,375 during the study period.
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Examination of CABG revealed a trend with decreasing mortality in both on-pump and off-pump CABG (Table 7) and neurologic complications; however there is a trend of increasing adult respiratory distress syndrome. The average cost increased 30.5% from $23,880 to $31,184 over the 3.25 years (Table 6). Costs of CABG performed off-pump were compared with CABG cost with the use of cardiopulmonary bypass. Mean cost of on-pump CABG was $26,508 ± $13,903 compared with $23,929 ± $12,495 off-pump for a differential cost savings of $2,579 in favor of off-pump CABG.
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| Comment |
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There are, however, potential shortcomings of this study. First, it is based on an administrative rather than a clinical data; therefore particular detailed clinical data are not available which might explain differences. However, outcomes of "hard" clinical endpoints such as death have been proven to be accurate previously. We have compared the administrative data from the HCA Casemix Database to our own clinical Society of Thoracic Surgeons Database, which we audit for accuracy, and find surprisingly few discrepancies. Second, since these results are nonrandomized, there is clearly a role of selection bias in comparing outcomes. However, the purpose of this study was to compare real world outcomes and volumes, not a select subgroup typically analyzed in randomized study trials. Third, the population studied may not be totally representative of the nation as a whole. Although the study represents a significant proportion (approximately 7%) of all patients currently undergoing coronary revascularization in the United States, the institutions represented are from 17 states primarily in the South with very few university hospitals or tertiary referral institutions. Whether this information accurately reflects current clinical practice in the remainder of the United States and in hospitals that are not primarily community-based is speculative. However, we felt that this analysis would give a reasonable portrayal of current revascularization practices. One concern raised is that most programs in the program are low volume and therefore the results may not be representative of high volume programs for CABG. The same group has previously compared clinical outcomes in high- versus low-volume programs and found mortality to be the same. However, overall complications was lower and rate of discharge to home was higher in high-volume programs [7].
Overall interventional procedures for coronary artery disease are increasing at a 3.3% annual rate with annual procedural volume for PCI increasing at a 6.8% annual rate with CABG procedural volume decreasing with a 1.9% decrement per year. The most significant changes were in the first year of the study with smaller changes in the last year. This trend is substantiated by MedPar data, which tracks procedures on all Medicare patients and indicates that PCI procedural volume increased 20% (10% annual increase) from 211,783 procedures in 1999 to 263,594 in 2001 [7]. Coronary artery bypass grafting procedural volume in the same period decreased 3.8% (1.9% annual decrease) from 154,242 to 148,308.
The percent of PCI procedural volume representing reintervention could not be determined from this data; however, in another study by the same group for a portion of this population the 12-month target vessel revascularization rate was only 8% [8]. Furthermore, from these data it cannot be determined whether second revascularization procedures in the same patient other than "target vessels" represents staged procedure or progression of disease.
A number of trends are noteworthy in the CABG population. Use of arterial grafting in CABG patients is increasing with 86% of all CABG patients receiving at least one arterial graft. Similarly there is a continuous trend toward lower operative mortality and morbidity including neurologic complications. This may be due to the percentage of CABG performed off pump gradually increasing with off-pump CABG operative mortality lower than on-pump CABG mortality. However, there is also a downward trend in on-pump CABG mortality. Selection bias for CABG procedure cannot be determined from these data but one can speculate that better outcomes in higher risk patients performed off pump is helping improve all CABG outcomes; however, this cannot be substantiated from this study. Despite a gradual increase in the number of off-pump CABG procedures during the study period from 19% to 23% of all CABG operations, the percent of institutions performing off-pump CABG actually decreased slightly (40% to 38%).
Regarding performance of PCI, stents were employed in 83% of the procedures and the percentage of multivessel intervention gradually increased and the use of GPIIb/IIIa inhibitors more than doubled. Although significant mortality and morbidity differences between PCI and CABG exists no selection criteria, risk stratification, or direct comparison in comparable patients is possible. Presumably the patients undergoing CABG compared with PCI represent different cohorts with different risk stratification as is evidenced by the greater number of vessels treated in the CABG group. The comparative outcomes in the two groups should not be construed as treatment comparisons in equal groups of patients, only as an outcomes report on therapies as currently employed. However, a recent randomized study of off-pump CABG with a left internal mammary artery versus a bare metal stent to the left anterior descending artery revealed a trend in 3-year MACCE-free (major adverse cardiovascular and cerebrovascular events) survival in favor of surgery in equivalent patients [9].
In summary, neither the rate of increase in PCI nor the decrease in CABG procedures is as significant as has been speculated. It has been widely forecast that the impending introduction of drug-eluting stents will further accentuate these trends. Already, "banking" of patients in anticipating lower restenosis rate with drug-eluting stents is anecdotally reported to be occurring in many institutions. What the long-term impact on CABG volumes will be and whether the forecast of lower restenosis rates will become a reality and further exacerbate the trends seen in this study depend on multiple factors including replicating the lower restenosis rates seen with drug-eluting stents in selected patients in controlled, randomized trials when introduced into the reality of clinical practice. We plan to continue tracking these trends to determine this impact in the next few years.
| Discussion |
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Doctor Mack and his colleagues have been successful in providing us with some facts about case volume and case distribution in uncertain times. The principal finding, that of a predominance of percutaneous procedures, comes as no surprise to most of us. The data shown here on the first slide comparing the long-term results of percutaneous coronary intervention (PCI) versus surgery are taken from the European Heart Journal. You could open JACC at random and find a similar graph in almost any issue. Numerous studies have shown no downside mortality risk to PCI as a first approach in most instances. Accordingly, a treatment algorithm beginning with PCI has been widely adopted, and it can be fairly said that with few exceptions PCI is the first line of therapy today for coronary artery disease. Doctor Baumgartner has challenged us to face the facts, and those are the facts. The question of course is, is this bad? Perhaps not.
If the cardiologists can do a better job for our patients, then they should do so. What is disheartening to many of us is the sense that the surgical option is not fairly considered and that in some instances is not considered at all. How can we maintain our place at the table? What do we as surgeons offer our patients and their physicians? In what ways are PCI and coronary bypass complementary rather than competitive?
What was true in the past remains true today. There is a difference in durability between PCI and coronary bypass. PCI is less invasive but less durable, although the gap is narrowing on both fronts. Doctor Mack and his colleagues have been leaders in making our procedures less invasive, but it is hard to imagine a way for surgerywhether on pump or off, through sternotomy, minithoracotomy or robotically,to ever be less invasive than a catheter. But surgery provides a more durable result. The cardiologists are doing the best they can to close this gap to improve the durability of their procedure. The question is, are we doing our best to make our procedure both minimally invasive and maximally durable?
This brings me to the first question. I was surprised to see that only 85% of patients received at least one ITA graft. This is despite our knowledge that an ITA to the LAD provides superior late survivalthat all-elusive "hard" end pointas well as reduced risk of recurrent angina, reintervention, and most recently demonstrated by several groups, including from the STS database, a reduced early mortality. Arteries simply stay open better than veins, as Dr Tatoulis will discuss with us later in the next session. So why aren't we using them more often?
Doctor Mack, can you help us to understand why this was the case, why almost 15% of patients didn't receive an ITA graft? Were these patients who did not have LAD lesions? Did they have significant comorbidities that were felt to contraindicat the use of an arterial graft?
My second question is, were there any differences in utilization of PCI versus surgery in the hospitals that offered off pump versus those without that option?
DR SRIDHARA K. S. IYENGAR (Fountain Valley, CA): Did you compare the cost of this PCI and repeated PCI and coronary bypass surgery?
DR MACK: I would like to thank Dr Sundt for his comments, and I agree with all his points. First, 86% of all patients received at least one arterial graft. This actually was the same as the STS database and other studies of the percent of arterial grafts used, and in addition the percent increased during the period of the study. So I actually was somewhat encouraged by that. If one examines the patients who did not receive an arterial graft, it was exactly due to the factors that Dr Sundt alluded to: patients with significant comorbidities and salvage patients. In elderly patients, over 80 years old, the use of arterial grafts was less than in the younger group of patients. What was somewhat disheartening was the percent of patients who received all arterial grafting, which was only 4% and did not change over the 4-year period.
Second, we could distinguish no trends in the difference in utilization of PCI versus CABG in hospitals that had a higher percent of off-pump versus on-pump surgery.
Third, regarding the cost data: cost, as you know, is a lot like grabbing smokeit is kind of hard to get your arms around it. But the methodology used here is what is called the Medicare cost/charge ratio, which is methodology used by all hospitals in the country to report to Medicare. It is a calculated formula of fixed and variable costs. Although one can criticize the technique and the accuracy, the point is that since it is the same methodology that is used in every hospital in the country and every hospital within this system, it was constant during the study period, and the same methodology was applied to both PCI and CABG. So with all that in mind I think the relative trends over time and the relative costs of PCI versus CABG are accurate.
In closing, I have lived with these data within the HCA system for a number of years; my impression is a lot different than the one I get going into the hallway during meetings or talking to any industry group. I feel like after going to a cardiology meeting or talking to industry that I both need to take Prozac and go through job retraining.
From my standpoint I was somewhat surprised that CABG volumes are not decreasing as rapidly as is commonly perceived and that PCI is not increasing as rapidly as everybody thinks. The most encouraging aspect is that, for whatever reason, we are doing a better job. Mortality with CABG is decreasing and it is declining significantly each year. So being a coronary bypass surgeon I was actually more encouraged than discouraged by the data in this study. Thank you.
| Appendix 1 |
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S/P = status post.
| Appendix 2 |
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CP = cardiopulmonary.
| References |
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disease.htm. Accessed on January 22, 2003
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