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Ann Thorac Surg 2006;81:1658-1665
© 2006 The Society of Thoracic Surgeons
a Division of Cardiothoracic Surgery, University of Florida/Jacksonville, Jacksonville, Florida
b Duke Clinical Research Institute, Duke University Medical Center, Durham, North Carolina
c Louisiana State University Cardiovascular Outcomes Research Group, Louisiana State University Health Sciences Center, New Orleans, Louisiana
Accepted for publication September 30, 2005.
* Address correspondence to Dr Haan, Shands Jacksonville, ACC, 653-1 W 8th St, Jacksonville, FL 32209 (Email: connie.haan{at}jax.ufl.edu).
| Abstract |
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METHODS: Using The Society of Thoracic Surgeons National Cardiac Surgery Database, we examined patients undergoing coronary artery bypass grafting within 6 hours of PCI from 1994 to 2003. Stratifying into groups of patients who had and had not suffered myocardial infarction within 24 hours of PCI followed by coronary artery bypass grafting (CABG), we tracked trends in characteristics, predicted risk, and clinical outcomes.
RESULTS: The proportion of isolated CABG procedures done emergently after PCI decreased over 1994 to 1999 from 3,357 of 115,679 (2.9%) to 1,227 of 155,831 (0.8%), remaining stable through 2003. Those suffering myocardial infarction within 24 hours made up a constant proportion of isolated CABG as emergency after PCI (3,352 of 1,042,864; 0.3%) since 1997. Over the decade, the preoperative risk profile worsened, including more elderly patients and more with cerebrovascular disease and congestive heart failure. Operative mortality among these patients has risen with time (from 8.0% to 9.3%; p < 0.0001 for trend), particularly in the setting of acute myocardial infarction (from 14.1% to 16.6%; p < 0.0001 for trend). Similarly, postoperative complications have increased over time, most notably seen in the need for reoperation (10.62% to 24.56%), prolonged postoperative ventilation (25.65% to 54.58%), and renal failure (10.22% to 18.55%).
CONCLUSIONS: In 2005, there remains a low but real need for emergent CABG after PCI, in which operative outcomes are less than ideal, especially in the postinfarction patient, representing an area for cross-specialty collaboration.
| Introduction |
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Over the past decade, however, there have been profound changes in PCI techniques, pharmacology, and device technology [3]. This includes the adoption of coronary stents (1994 to 1997) [4, 5], glycoprotein IIb/IIIa agents (1997 to 2000) [68], and upfront and loading clopidogrel (2001 to 2004) [9, 10].
As technology has advanced, so have the risks of the patients in whom PCI is attempted [11]. Percutaneous coronary intervention has become the standard revascularization procedure in the setting of acute myocardial infarction (MI), and is increasingly being attempted in patients with significant age, comorbidity, and high-risk multivessel coronary anatomy [12]. Furthermore, the indications for emergency coronary artery bypass grafting (CABG) following PCI have changed with time [1, 13].
We used data from The Society of Thoracic Surgeons (STS) National Cardiac Surgery Database to look at how the use of emergent CABG after PCI has changed since 1994. We also looked to see trends in the risk profiles of these emergency patients and their outcomes after surgery.
| Material and Methods |
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Research performed at the Duke Clinical Research Institute on the STS database is approved by the Duke University Institutional Review Board. Principal investigators at participating institutions are responsible for reviewing their data collection efforts with their sites' institutional review boards to assure that patient privacy and confidentiality is protected.
Patient Population
We examined all patients undergoing an isolated CABG procedure within 6 hours of a PCI or stenting procedure from January 1, 1994 to December 31, 2003. Concomitant valve or other cardiac procedures were excluded.
Within the study population, we also examined the subpopulation of patients who had suffered an MI within 24 hours prior to CABG, compared with those without MI. The registry's definition for MI occurrence during current hospitalization requires two of the following three criteria: (1) ischemic symptoms in the presence or absence of chest discomfort; (2) enzyme level elevationone of four are necessary (creatine kinase-MB greater than two times upper limit of normal, creatine kinase greater than two times upper limit of normal, lactate dehydrogenase-1 greater than lactate dehydrogenase-2, and troponin T or I greater than MI decision limit for facility); or (3) serial (two or more) electrocardiograms showing changes from baseline or serially in ST-T waveforms.
Data are not available from the database regarding the timing of the MI relative to PCI, ie, whether the MI preceded the PCI or occurred secondary to the attempted or failed procedure. This lack of timing of MI relative to PCI is because the STS database is a cardiac surgery procedural database. The data fields for timing of MI and timing of PCI that are harvested are in relation to the surgical revascularization procedure. Within the MI subgroup analysis, we examined trends in predicted risks and in observed outcomes.
Patients requiring emergency CABG are, by database definition, those with ongoing, refractory unrelenting cardiac compromise, with or without hemodynamic instability, not responsive to any form of therapy except cardiac surgery. Indications for emergency procedural status are: shock with or without circulatory support, pulmonary edema requiring intubation, acute evolving MI within 24 hours before surgery, ongoing ischemia including rest angina despite maximal medical therapy, valve dysfunction, aortic dissection, or angiographic accident.
Our focus with regard to operative technique here was on trends in the use of the internal mammary artery (IMA). Additionally, we looked at the effect of gender on outcomes. Both of these factors are known to influence cardiac procedural outcomes, and we sought to assess the impact of each in this scenario of emergent CABG after PCI.
End Points
All clinical definitions are based on specifications of core data elements that can be accessed at http://www.sts.org. Operative mortality is defined as death occurring during the hospitalization in which surgery took place and within 30 days of surgery. Other end points are reoperation for any reason, prolonged ventilation (pulmonary insufficiency requiring ventilatory support for 48 hours), permanent stroke (new-onset cerebrovascular accident persisting >72 hours), deep sternal wound infection, renal failure, and prolonged postoperative stay (discharge >14 days after surgery). All complications refer to events that occurred prior to discharge during the same hospitalization as surgery.
Statistical Analysis
Trends in the frequency of operative outcomes were assessed by computing observed and adjusted event rates, within 2-year time intervals. Predicted event rates for this analysis were obtained from the STS CABG morbidity and mortality models [17]. Trends in the overall risk profile of patients undergoing CABG after PCI were assessed by computing the average predicted mortality within each 2-year time interval. Adjusted event rates were defined as the ratio of the observed to expected event rates during each 2-year time interval multiplied by the overall observed event rate during the 10-year study period.
| Results |
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Predicted Risks
In light of the trends in individual risk factors, it follows that we look at predicted risk for adverse outcome over time for this group of patients (Fig 2). The predicted risk of operative mortality for the group overall was 7.7% to 11.0% during the time period. For patients requiring emergency CABG following PCI, we found that for patients with MI within the prior 24 hours, predicted mortality risk increased over the decade, and was 2 to 2.5 times the predicted mortality risk of those who had not suffered an MI.
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Given the importance of the IMA in CABG outcomes, we looked at IMA utilization in the event of emergency operation. Internal mammary artery use has consistently increased steadily for CABG over the past decadewith and without recent MI. The emergent post-PCI CABG procedures with MI less than 24 hours have only passed 50% utilization (54.1%) in 2002 to 2003, up from 27.5% IMA use in 1994 to 1995.
We also looked at the trend in number of distal anastomoses performed in these emergent CABG procedures. The percentage of patients receiving one or two distal anastomoses decreased (50.0% to 39.87%; p < 0.0001), and the percentage of patients receiving four or more distal anastomoses increased (19.3% to 30.1%; p < 0.0001) from 1994 to 2003. We found the trend for increased number of grafts to be present in both MI and no-MI patients. Of patients with no MI within 24 hours of surgery, 17.6% received four or more distal anastomoses in 1994 to 1995, compared with 28.0% in 2002 to 2003 (p < 0.0001). Of those patients who suffered an MI within 24 hours of their emergent procedures, those receiving four or more distal anastomoses constituted 23.9% in 1994 to 1995 versus 34.1% in 2002 to 2003 (p < 0.0001).
Mean postoperative length of stay for the patients who had not had an MI was 7.5 to 8.1 days. In contrast, those who had recent MI prior to their emergency procedure had a mean postoperative length of stay of 8.7 to 9.7 days. There was no particular trend for length of stay after surgery for either group during the 10-year period studied.
Observed Outcomes
Observed operative mortality for the overall study population was 8.0% in 1994 to 1995, 9.1% in 1996 to 1997, 10.1% in 1998 to 1999, 9.3% in 2000 to 2001, and 9.3% in 2002 to 2003 (p < 0.0001). Figure 3A displays the trends over the decade in risk-adjusted operative mortality for the overall study population and for the MI and no-MI subsets. It is readily apparent that those who had emergency CABG within 6 hours of PCI and within 24 hours of MI had worse outcomes consistently over the past decade.
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The major morbidities also showed worse outcomes for patients with recent MI prior to emergency CABG following PCI. Although the differences were not as striking between the MI and non-MI groups for most of the major morbidities, Figure 4 demonstrates a clear trend of worsening outcomes from 1994 to 2003, overall and for MI and no-MI subgroups. The one exception was deep sternal wound infection, which was not higher in patients undergoing post-PCI CABG early after an MI.
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We also looked specifically at the effect of gender on mortality in this group of CABG patients. Raw and adjusted mortality was consistently higher in females compared with males during the decade analyzed, as described in Table 3. Although the association between gender and mortality was only significant in one of the five time intervals, there is strong evidence of a gender difference (p = 0.0003) when data are pooled across time intervals.
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| Comment |
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The advancement of technology and technique in interventional cardiology has facilitated the ability to rescue and preserve myocardium while stabilizing the patient. In contrast to the rising rate of PCI, from an estimated 300,000 to 350,000 in 1992 to approximately 657,000 angioplasty and 537,000 stenting procedures in 2002, the need for emergency CABG within hours of PCI has decreased [18]. We found the percentage of CABG cases performed emergently following PCI to have declined to one third of that in 1994.
The cardiology literature has reported on risks and risk adjustment for outcomes of coronary interventions [19, 20]. Building on the findings previously reported in the surgical literature [2126], we used a national CABG database to look at trends in risks, predicted risks for adverse outcomes, and observed rates of adverse outcomes. This is particularly noteworthy as analysis was performed contemporaneously with the development and implementation of drug-eluting stents. However, we emphasize that this study is not intended to look at the universe of methods of myocardial revascularization, such as number and types of stents and number of interventions prior to the surgical procedure that brought these patients into the STS cardiac surgery database.
The higher rate of particular major morbidities is related to processes of care before CABG. The increased need for reoperation, particularly reexploration for postoperative hemorrhage, is influenced by the increasing use of antiplatelet [2731] and antithrombotic therapies [3234], especially for acute coronary syndrome. The last preoperative creatinine was 1.1 for the study population overall, and 1.2 for the subset with MI less than 24 hours prior to emergency CABG. However, the occurrence of postoperative renal failure has risen over the past decade, and most dramatically for those patients undergoing emergency CABG within 24 hours of MI. The combination of radiopaque contrast for PCI, followed within 6 hours by emergency CABG, has an obvious impact on renal functionbut more so for patients with new MI, likely effected by the notably higher rate of associated preoperative cardiogenic shock. These findings are consistent with those of Moscucci and colleagues [26], seeing higher mortality and higher incidence of stroke, renal failure, and postoperative bleeding for patients undergoing emergency CABG after PCI, after MI.
Numerous publications have demonstrated the benefit of an IMA graft to CABG patients [35, 36]. In spite of our focus on emergency procedures, we have shown that IMA use has increased over the past decade, along with an increase in the number of grafts that patients receive at the time of surgery. There was a slower rate of increase in those patients with MI, presumably because these patients were more unstable. We believe IMA use has contributed to the relatively stable mortality rates, in the face of higher preoperative risk factors and predicted mortality risk. This updates and confirms the conclusion of Caes and Van Nooten [37] that the IMA can be used safely in emergency CABG after failed percutaneous transluminal coronary angioplasty.
Another subset of interest is the female population, given reports identifying female gender as a predictor for CABG mortality [38, 39]. We were interested in the effect gender had in our emergency CABG study population. Operative mortality was consistently higher for females than for males across the time period studied, reaching statistical significance for the overall population (but without a strong association in the smaller-sized year-groups). The finding that gender is a significant predictor of operative mortality is in contrast to data previously reported from the STS database on the impact of gender in the broader CABG population, in which there was no difference between male and female mortality in high-risk patients [40], thus representing a special subgroup of high-risk patients.
Although PCI is known to be life-saving, emergency CABG after PCI continues to carry with it high risk for morbidity and mortality, particularly in the postinfarction patient. Thus, it is imperative that interventional cardiologists and cardiothoracic surgeons work collaboratively to study their data and processesto improve antithrombotic and antiplatelet management, stabilize and optimize patient hemodynamics and general condition, reduce delays in care delivery, and exercise improved case selectionto offer the best possible outcomes for these high-risk patients.
| References |
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