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J Thorac Cardiovasc Surg 2004;128:907-915
© 2004 The American Association for Thoracic Surgery
Surgery for Acquired Cardiovascular Disease |
a Bristol Heart Institute, University of Bristol, Bristol, United Kingdom
b Health Services Research Unit, London School of Hygiene and Tropical Medicine, London, United Kingdom
Received for publication September 19, 2003; revisions received February 6, 2004; accepted for publication February 12, 2004.
* Address for reprints: Gianni D. Angelini, FRCS, Bristol Heart Institute, University of Bristol, Bristol Royal Infirmary, Bristol BS2 8HW, United Kingdom
g.d.angelini{at}bristol.ac.uk
| Abstract |
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METHODS: Data were analyzed for consecutive patients undergoing coronary artery bypass grafting who were operated on by one consultant or one of four residents. Conversions were analyzed by intention to treat. Perioperative death or one or more of 10 adverse events constituted failure. Predicted risks of failure for individual patients were derived from the study population. Variable life-adjusted displays and risk-adjusted sequential probability ratio test charts were plotted.
RESULTS: Data for 1372 patients were analyzed; 769 of the procedures were off-pump coronary artery bypass operations (56.0%). The consultant operated on 382 patients (293 off-pump, 76.7%), and the residents operated on 990 (474 off-pump, 47.9%). Patients operated on by residents tended to be older, more obese, more likely to require an urgent operation, and more likely to need a circumflex artery graft but less likely to have triple-vessel disease. There were 7 conversions (consultant 5, residents 2). The overall failure rate was 8.5% (9.2% for consultant's operations and 8.2% for residents' operations), including 10 deaths (0.7%). Predicted and observed risks of failure were similar for all five surgeons. After 100 off-pump coronary artery bypass operations, performance was the same or better for the residents as for the consultant. For all surgeons, performance was the same or better for off-pump as for conventional coronary artery bypass grafting.
CONCLUSIONS: Off-pump coronary artery bypass surgery can be safely taught to cardiothoracic residents. Implementation of continuous performance monitoring for residents is practicable.
| See related articles on pages 807, 811, 820, and 823
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Disseminating a new surgical procedure involves significant scientific, ethical, and logistic issues. In recent years, residents in cardiothoracic surgery have had to gain competence in performing coronary artery bypass grafting (CABG) off-pump (OPCAB)1-4 as well as conventionally with cardiopulmonary bypass (ONCAB). During recent years, the number of OPCAB operations performed at our institution has increased significantly, and residents have carried out many of these procedures.
We recently reported our early experience in teaching OPCAB surgery by comparing the early and midterm clinical outcomes of ONCAB and OPCAB procedures performed by residents with or without direct consultant supervision.3 However, conventional frequentist statistical methods are not optimal for analyzing sequential data. Control chart techniques (eg, cumulative sum) have the advantage of taking into account the order in which observations accrue while also avoiding the problem of repeated significance testing.5-8 By providing a graphic summary of changes in performance with time, control charts can alert a surgeon to suboptimal performance.8 They are therefore also well suited to monitoring surgical learning curves.9
The purpose of this report was to use control charts to describe learning curves for OPCAB for four resident surgeons, to compare performance for consultant and resident surgeons after risk adjustment, and to compare performance for OPCAB and conventional CABG within surgeons after risk adjustment.
| Methods |
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The database describes whether cardiopulmonary bypass was used but not whether the original intention of the surgeon was to carry out OPCAB. Therefore, operative notes for all patients were reviewed to identify conversions from OPCAB to ONCAB. Such operations were recoded as OPCAB, and the analyses were carried out according to the principle of intention to treat.
Training
In our institution, residents train to carry out cardiothoracic operations through a period of 6 years. They are exposed to and start to perform ONCAB and OPCAB from the second year of their training program. With respect to OPCAB surgery, the program aims to start residents on simple cases that require only left anterior descending coronary artery or diagonal grafts; residents then progress to grafting posterior descending coronary arteries.2 Details of the OPCAB training experience of the four residents monitored with control charts have been reported previously.11
Data definitions
Perioperative death is rare after elective or urgent CABG operations (<1.0% in our institution during the study period). It is therefore unsuitable for monitoring performance. We thus sought a more sensitive outcome, and in advance of any analyses we defined surgical failure as the occurrence of one or more of the following events15,16: (1) perioperative death,11 (2) perioperative myocardial infarction,12 (3) ventricular tachycardia or fibrillation,17; (4) stroke (permanent or transient),18 (5) acute renal failure with need for hemodialysis, (6) septicemia defined as development of postoperative fever with positive blood cultures, (7) use of an intra-aortic balloon pump, (8) reoperation for bleeding, (9) sternal rewiring because of infection, (10) postoperative ventilation longer than 48 hours, and (11) need for reintubation.
Consultant supervision was defined as an operation in which the consultant was scrubbed in and acted as first assistant.3,11 When supervised, residents were supervised by one of five different consultants or occasionally a locum. The primary factor affecting whether a consultant was scrubbed in as first assistant was the identity of the consultant for whom a resident was working at the time of the operation.
Statistical analysis
No formal sample size calculation was carried out. However, all residents included in the study were participating in an official training program,11 and their experience of OPCAB described here included at least 100 OPCAB procedures. Demographic and clinical characteristics of patients were summarized according to surgeon and surgical technique. Some continuously or discretely measured prognostic variables (eg, Parsonnet score; Table 1) were categorized for these summaries and for fitting regression models.
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We used multiple regression modeling to investigate whether seniority of surgeon, surgical technique, or accumulating experience (sequence of operation) was associated with the predicted risk of failure. We calculated robust standard errors to take account of clustering of patients within surgeons. These analyses were hypothesis-driven. We also investigated whether for their first 25 operations residents operated on fewer patients (1) considered at high risk from a clinical perspective11 or (2) receiving circumflex coronary artery (Cx) grafts, than subsequently. The cutoff of 25 cases was chosen after discussing with residents when they believed their experience would begin to reach a plateau.
Variable life-adjusted displays (VLADs)20 and risk-adjusted sequential probability ratio tests (SPRTs)21,22 were plotted. It should be noted that the x-axis in such graphs represents operation number, not calendar time. Boundary lines for SPRT (indications for alert or action) were set to detect an increase in the failure equivalent to an odds ratio of 1.5 (H1) or to confirm that the observed failure rate was consistent with the rate set as acceptable (H0). The position of boundary lines was calculated as recently recommended, 22 assuming
= ß = .10 (alert) and .05 (action).
All analyses were carried out with STATA version 7 or 8 (Stata Corporation, College Station, Tex).
| Results |
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Failures
The failure rates were 9.2% (35/382) among patients operated on by the consultant and 8.2% (81/990) among patients operated on by residents, for an overall failure rate of 8.5% (95% confidence interval 7.1%-10.1%). The distributions and incidences of events defining failures are shown in Figure 1. There were 10 deaths (0.7%; 95% confidence interval 0.4%-1.3%), 8 of which occurred after one or more other events. Conversion from OPCAB to ONCAB was not itself considered to constitute failure; failures occurred in 2 of 7 (29%; 95% confidence interval 4%-71%) conversions.
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Figure 3 shows the percentages of patients operated on by residents who were classified as at high risk on clinical grounds11 and who had a Cx graft grouped according to "early" (first 25 operations) versus subsequent operations. This figure shows that as the residents gained experience the percentages of patients considered at high risk and patients receiving a Cx graft increased for ONCAB but not OPCAB operations. It also shows that once experience had been acquired a smaller proportion of patients undergoing OPCAB than ONCAB received a Cx graft. This latter finding was also true for the consultant's recent OPCAB operations.
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| Discussion |
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The study was necessarily observational for both logistic and ethical reasons, and it is important to consider this issue and other limitations when interpreting the main findings. The way in which cases are selected by consultants for residents is unlikely to be adequately characterized by our data despite the large number of clinical variables available. The estimates of predicted risk for each case are therefore likely to be affected by residual confounding, not only because the preoperative risk of a poor outcome was inadequately characterized but also because adjusted risk estimates never perfectly take into account all the prognostic factors that were measured. These limitations almost certainly favored residents' operations, because the true risk of the consultant's operations is probably not properly reflected in the predicted risk scores. Residents may therefore not compare as favorably with the consultant as indicated in the graphs, but residual confounding would be unlikely to overturn the basic conclusion that teaching OPCAB is safe and effective.
A change in the designation of main operator from resident to consultant, for example when complications leading to classification as failures occurred, would have led to the performance of residents being overestimated. We do not believe that this occurred to a significant extent. Neither consultants nor residents could recall specific instances of this kind. Consequently, we conclude that changes in designation in the main operator were extremely uncommon. However, residents volunteered that during the early stages of their OPCAB training the consultant may have intervened in one of two ways. The consultant may have taken over in a planned manner to carry out one or more anastomoses, for example a Cx graft. When asked directly about the frequency of such events, residents thought that they might have occurred up to a maximum of 5 times per resident. Alternatively, the consultant may have intervened to show the resident how to position the heart to gain access to carry out the required distal anastomosis; in these instances, the operating resident carried out the anastomosis.
The predicted risks of failure for individual patients were calculated from the entire study cohort. Because we compared resident against consultant and OPCAB against ONCAB, it might be argued that we should have modeled predicted risk with, for example, only the consultant's data. However, there was no evidence that the model differed for consultant and residents (or for OPCAB and ONCAB), and the model would then have been based on a relatively small sample and few events. We observed that the model did not predict failure particularly well, which was possibly a consequence of trying to predict a combined end point; different predictors may be prognostic of different specific events. The total number of failures may also have limited the power to detect important risk factors.
The study also gave equal weight to the varied events that separately or in combination defined failure. Ideally, it would be preferable to have a method for attributing more importance to events that culminated in death, permanent disability, or long-term sequelae than to events from which patients recovered completely. However, the control chart methods described here and previously9 are usually applied to binary outcomes, although the SPRT principle can be applied to counts.22 The appropriateness of and best methods for combining "near miss" events need to be researched in more detail; Steiner and colleagues23 have described a method for combining near misses and deaths but not with adjustment for case mix.
A final point relates to the residents' whose data were included. During the study period, nine other visiting residents and research fellows carried out a total of 71 OPCAB operations (only one of which was unsupervised), although not as part of an official training program. The numbers of operations carried out by these visiting residents were too small to allow meaningful analysis with control charts. However, other analyses pooling the experiences of all informal residents have suggested that they may have had worse outcomes.11 Other intrinsic limitations of control charts, such as interpretation of boundaries and the equal weights given to historic and recent data, have been discussed elsewhere.9
Implications for training of residents
Residents in cardiothoracic surgery need to gain experience in OPCAB surgery. Consultants face a dilemma between the duty to deliver the highest possible standard of care to their patients and the responsibility to learn new techniques of coronary surgery themselves and to teach the same techniques to residents. A recent survey from cardiothoracic training centers in the United States24 showed that only 22% of residents had performed 20 or more OPCAB procedures during their training, and only 12% had performed 20 or more complete OPCAB myocardial revascularizations. Of these, only 4% had performed OPCAB Cx revascularization. The survey clearly demonstrated that most residents had not reached proficiency in OPCAB surgery at the end of the residency.
Our study therefore has important implications for training residents in OPCAB surgery. We have previously demonstrated that OPCAB surgery is associated with less renal dysfunction, a less intense systemic inflammatory reaction, less myocardial reperfusion injury, fewer arrhythmias, and overall better early clinical outcomes than ONCAB surgery.25 The findings we report here confirm that multivessel OPCAB surgery is a safe and reproducible surgical technique that can be taught successfully to residents.
This study also shows that it is relatively simple to implement control charts for continuous performance monitoring. This is particularly relevant when learning OPCAB surgery, because the technique is perceived to be technically difficult yet surgeons are under pressure to take up the technique because of its widespread popularization as an alternative to conventional ONCAB.24 Nevertheless, the precise way in which control charts are set up needs to be considered carefully. Risk-adjustment is desirable but requires an accepted method for generating the predicted risk for each patient. VLAD and SPRT control charts, plotting performance against different expectations, are complementary.9 For cardiac surgery residents, use of alarm or alert lines (and hence interpretation of the significance of crossing of these boundaries) may not be critical, because competition for training places is so acute. Indeed, it is possible that residents may be oversensitive to changes in gradient on VLAD plots and seek explanations for any tendency for performance to drift upward. (This may not be true in less competitive specialties or for established consultant surgeons). Paradoxically, the use of a "reassurance" boundary in a SPRT plot (confirming H0) may be more useful for residents than alarm or alert boundaries, because confirmation of an acceptable failure rate could be interpreted as an evidence-based criterion of competency. It is a relatively simple matter to manipulate H0, H1,
and ß to set the average number of operations that a resident would have to perform to attain this criterion, assuming that the resident's performance conforms to H0.
Conclusion
Our data show that OPCAB surgery can be safely taught to cardiothoracic residents. We believe that a modern surgical program should expose residents to both ONCAB and OPCAB techniques, because the latter has become an integral part of coronary surgery. We also strongly recommend the development of specific OPCAB training programs in those centers with senior surgeons proficient in the technique. This will positively affect the future expectations of many cardiothoracic residents who are likely to practice OPCAB coronary surgery after their training is completed.
| Appendix |
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Increasing age, previous myocardial infarction, and preoperative inotropic support were found to be significant risk factors for failure (P %; .05). Current smoker and operative priority (elective vs urgent) were also included in the final model (Appendix Table 1) because there was a suggestion that they increased the risk of failure (P < .05).
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| Footnotes |
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| References |
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