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Ann Thorac Surg 2005;80:1965-1970
© 2005 The Society of Thoracic Surgeons

Review

Acquiring Proficiency in Off-Pump Surgery: Traversing the Learning Curve, Reproducibility, and Quality Control

Gavin J. Murphy, MD, FRCS, Chris A. Rogers, PhD, Massimo Caputo, MD, Gianni D. Angelini, MD, FRCS *

Bristol Heart Institute, University of Bristol, Bristol, United Kingdom

* Address correspondence to Dr Angelini, Bristol Heart Institute, Bristol Royal Infirmary, Bristol, BS2 8HW UK (Email: g.d.angelini{at}bristol.ac.uk).


   Abstract
Top
 Abstract
Introduction
 Material and Methods
 Comment
 References
 
As the risk profile of patients considered for surgical revascularization worsens, the cumulative benefit of off-pump coronary artery bypass (OPCAB) over conventional coronary artery bypass grafting, in terms of lower morbidity and reduced healthcare costs, may increase. There is still resistance to the introduction of OPCAB surgery however, its practice is variable and surgical residents are rarely trained in these techniques. This article considers how the learning curve in OPCAB may be negotiated and prospectively monitored to ensure quality control. The evidence suggests that situations in which suitable senior expertise exists, OPCAB surgery can be introduced into surgical practice and safely taught to trainees without detriment to patients. This is achieved by a progressive increase in the complexity of the case mix and careful early supervision. The introduction of OPCAB has coincided with the increasing use of control charts as quality control tools. Performance monitoring provides reassurance that patients are not being put at risk during the introduction of OPCAB; control chart methods can be used prospectively for real time performance monitoring by consultant surgeons and residents alike. These techniques may ultimately be used to determine proficiency and accreditation. Increasing use of parallel training techniques, the development of structured training programs that encompass OPCAB and other new technologies in cardiac surgery, coupled with objective performance monitoring are warranted to meet the needs of a changing patient population.


   Introduction
Top
 Abstract
 Introduction
Material and Methods
 Comment
 References
 
Since its reintroduction in the mid-1990s, coronary artery bypass grafting (CABG) on the beating heart (ie, off-pump coronary artery bypass [OPCAB]) has gained widespread acceptance as a standard treatment for patients undergoing surgical revascularization. Randomized trials have demonstrated that the short-term results of OPCAB are at least as good as, if not better than, conventional CABG with cardiopulmonary bypass and cardioplegic arrest, with lower costs and equivalent midterm outcomes [1–9]. In addition, a randomized trial [10] as well as several retrospective series have suggested that the benefits of avoiding cardiopulmonary bypass and cardioplegic arrest are most marked in higher risk patients, notably the elderly or obese, or those with renal impairment, poor left ventricular function, or widespread atherosclerotic disease [11–14]. Despite these potential advantages a significant gap exists between the demand for and the provision of adequate training in OPCAB surgery [15, 16]. Exposure to OPCAB techniques during training is infrequent and the acquisition of proficiency even less so. In a study of residents undergoing cardiothoracic training in the United States, only 22% of residents had performed 20 or more OPCAB procedures during their training [15]. Of these, only 4% had performed OPCAB circumflex coronary artery revascularization. Similarly in the United Kingdom, only 51% of trainees surveyed (76% of all trainees) had experienced OPCAB in their training program, although 96% believed that OPCAB training was essential [16]. Surgical residents represent the next generation of surgeons, and failure to achieve competency in any technique at this stage militates strongly against it being adopted later. Among established surgeons, the adoption of OPCAB has also been highly variable with rates varying between zero and 100% of revascularization cases per surgeon, even within a single institution. The reasons for the variation in the adoption of OPCAB techniques are multifactorial. They include the lack of established training programs, the perception that success with the technique is limited to more proficient surgeons, and a fear of deleterious patient outcomes, especially during the learning curve [17, 18]. Those most likely to be disadvantaged by this are patients however; as high-risk patients, with potentially the most to benefit from the use of minimally invasive techniques, constitute an ever-increasing part of the surgical workload [19, 20]. The purpose of this article is to review the manner in which OPCAB surgery has been successfully introduced into established surgical practice as well as resident training programs, to consider the risks posed to patients during these developments, and to summarize the statistical techniques that are increasingly being advocated as a means of ensuring quality control and reproducible outcomes.


   Material and Methods
Top
 Abstract
 Introduction
 Material and Methods
Comment
 References
 
The MEDLINE and PubMed databases (1996 through November 2004) were searched using the medical subject headings (MeSH) for "coronary artery bypass" combined with the following phrases used as text words: "OPCAB," "off pump," "beating heart," or "randomised controlled trial," and "coronary arteriosclerosis," combined with the text words "quality control," "CUSUM," "control charts," "learning curve," "training," and "resident." In addition, the reference lists from relevant articles, abstracts, and reviews were also searched for additional trials. Up-to-date and relevant articles were selected, and when possible observational case control series were cited in preference to non-controlled case series or case reports or commentaries.

Negotiating the Learning Curve in OPCAB Surgery
The differences in technique between conventional CABG and OPCAB demand that surgeons traverse a learning curve that includes new methods of heart and patient positioning and heart stabilization that permit adequate exposure of vessels, temporary occlusion of coronary arteries, use of intracoronary shunts, performing distal anastomoses on the stabilized heart, and possibly handling connector devices for proximal anastomoses. Heart size, the calibre and quality of the target vessels, the patients' ability to tolerate heart manipulation, and the experience and training of the entire operative team are additional considerations. Careful patient selection and attention to technical detail during the acquisition of these skills permit the application of OPCAB to increasingly complex cases without compromising patient safety. Song and colleagues [21], during their early experience at Emory University carefully selected patients for OPCAB, initially excluding patients with impaired left ventricular function, left main stem, or three-vessel disease. With refinements in technique, such as deep pericardial traction sutures and bilateral pleurotomy, the introduction of superior stabilizers (particularly apical suction devices), and increasing surgical experience, progressively more complex cases were performed. Once proficiency had been achieved, all patients scheduled for isolated coronary bypass were then considered candidates for OPCAB. This included elderly patients, those with left main stem disease, or poor left ventricular function, and those with intramyocardial, small, or calcified target coronary arteries, or those requiring endarterectomy. Patients with ischemic ventricular arrhythmias, those in cardiac arrest, and those for whom previous left pneumonectomy or deep pectus excavatum would prevent rightward mobilization of the heart were still considered unsuitable however. The transition from on-pump to off-pump CABG occurred without any increase in procedural mortality (2.1% on-pump CABG vs 1.0% for OPCAB) or morbidity. Average patient length of stay actually decreased by 1 to 2 days after the adoption of OPCAB [21]. Novick and colleagues [22] reported similar findings after a transition from on-pump to off-pump CABG. In this case a surgical team that had gained competence with off-pump techniques made an abrupt policy change to performing all CABG cases off-pump except for those with critical left main stenosis in concert with disease in the right coronary artery, patients requiring five or more bypass grafts or those with deeply buried or diffusely calcified target vessels. This was achieved with a halving of major perioperative morbidity (14.5% to 7.3%), as well as by a reduction in the median length of hospital stay from 6 to 5 days, although the off-pump to on-pump conversion rate was high (16%).

In the largest review of the incorporation of OPCAB into a surgical practice (12,540 CABG patients including 1,915 OPCAB procedures), Mack and colleagues [23] reported an increase in OPCAB from 1.2% of cases in 1995 to 34.1% of cases in 2000 (individual surgeon adoption rates ranged from 1% to 96% by 2000). Initially OPCAB case selection considered only elective cases requiring a limited number of grafts (two or three) to the anterior surface of the heart and patients in unstable condition, those undergoing reoperation, and those requiring multiple bypasses on the lateral surface were generally considered unsuitable. As surgeon experience increased however and, again, along with developments in stabilizer technology, all patients were considered for OPCAB. The OPCAB to on-pump conversion rate in this series was 2.9%. The increased use of OPCAB was associated with a reduction in hospital mortality from 4% to 3.2% (P = 0.048) as well as reduction in procedural morbidity despite a higher predicted risk according to The Society of Thoracic Surgeons risk algorithm (predicted mortality of 3.13% OPCAB vs 2.80% on- pump; P < 0.004). Off-pump coronary artery bypass was also associated with a reduced need for blood products (28.45% vs 54.65%; P < 0.0001), prolonged ventilation (5.83% vs 10.93%; P < 0.001), reoperation for bleeding (2.41% vs 3.65%; P < 0.024), and shorter hospital stays (5.98 vs 7.32 days; P < 0.001) [23]. These differences were attributed to the avoidance of cardiopulmonary bypass associated morbidity. In Bristol, between 1997 and 2001, the proportion of OPCAB cases increased from 8% to 68% without any increase in procedural morbidity. This was accompanied by a gradual increase in the complexity of cases, number of distal anastomoses, use of multiple arterial conduits, and lateral wall revascularization [24, 25]. After gaining early experience with OPCAB, Sergeant and colleagues [26] made an abrupt transition to an almost exclusive OPCAB practice (excluding patients in cardiogenic shock and those requiring preoperative cardiopulmonary resuscitation). To facilitate this change in practice they re-engineered all aspects of their surgery, anaesthesia, nursing, and operating room logistics to refine their OPCAB technique. They defined five distinctive and sequential elements to the surgical procedure: enucleation, visualization, stabilization, shunting, and anastomoses, as was the anesthetic technique: conditioning, anticoagulation, monitoring, reconditioning, and response management, and stressed the importance of good surgery-anesthesia communication and interaction to achieve the best results. Using both risk adjustment and propensity scoring to examine the effect of this transition on patient outcomes, they detected no adverse effect on morbidity or mortality, and they actually detected a reduction in the incidence of stroke in patients with carotid stenosis and a reduction in hospital stay in the OPCAB group.

Incorporating OPCAB into resident training has also been shown to be safe [24, 25, 27–30]. Careful early case selection with later progression to more complex procedures under the tutelage of experienced trainers has been shown by several groups to permit effective training without increased morbidity [25, 28, 29]. Karamanoukian and colleagues [28] commenced training in OPCAB in the second year of their residency after they had become proficient with on-pump techniques, starting with anterior wall vessels and progressing to inferior and lateral wall vessels. In our institution, in which cardiothoracic surgery training lasts 6 years, junior surgeons are exposed to OPCAB grafting beginning with the second year of their training program, and they start performing conventional CABG and OPCAB at the same time. As with other training systems, residents begin training with simple cases requiring only left anterior descending coronary artery or diagonal grafts before gradually moving on to posterior descending coronary artery grafting. This allows trainees to become progressively used to various techniques of exposure and stabilization before attempting to graft the circumflex system, which remains more technically challenging. The use of shunts, by reducing regional wall ischemia, allows unhurried anastomoses, whereas performing graft flow measurements at the end of the procedure has been used as a means of quality control [28]. As OPCAB surgery was integrated into the training program in Bristol, the proportion of OPCAB procedures performed by trainees increased from 18% to 62% between the years 1999 to 2001 [24, 25]. By the end of their third year, residents had performed 40 to 50 multivessel OPCAB revascularizations as first surgeons under direct consultant supervision. An early comparison of outcomes demonstrated no difference between consultant-operated or supervised trainee-operated patients [25]. During the last 2 years of training, and after satisfying the senior surgeon that they were proficient in OPCAB techniques, residents were then permitted to perform OPCAB cases without direct consultant supervision. When the results of these unsupervised cases were reviewed, again there was no increase in patient morbidity compared with trainees operating under direct supervision [25]. The proportion of OPCAB operations performed on high-risk patients by trainees increased steadily over the study period from zero before January 1999 to 60% between January and December 2001. When the results of high-risk cases were analyzed separately, the outcomes of trainee versus consultant-operated cases were no different (apart from a higher rate of myocardial infarction in the consultant group and longer hospital stay in the trainee group) after adjustment for potentially confounding preoperative factors [30].

Performance Monitoring, Quality Control, and Assessment of Proficiency
Increasing awareness of the need for quality assurance in healthcare delivery has generated a broad range of statistical tools that can be used to monitor performance. Prospective case-by-case outcome monitoring was introduced by de Leval and colleagues [31] into their pediatric cardiac surgery practice in the early 1990s; this monitoring included the use of control or cumulative sum (CUSUM) chart methods for binomial data and exponentially weighted moving averages for continuous outcome data. Here the identification of a cluster of failures led to improved technique and better results. Cumulative sum charts have subsequently gained popularity and have been used by several authors as performance monitoring tools in OPCAB surgery [26, 27, 32, 33]. The most basic control chart as used by de Leval and colleagues [31] is obtained by plotting the cumulative sum of a specified outcome or failure (such as death or morbidity) on the "Y" axis versus sequence of cases on the "X" axis (Fig 1). This is referred to as a cumulative failure chart. An increase in gradient (slope) indicates more frequent failures, and enables trends in performance to be easily recognized. These charts can be applied to individual surgeons, trainees, procedure, or units, and depending on the definition of failure (ie, stroke, myocardial infarction, use of blood products) they can provide real time prospective monitoring of multiple performance indicators. Different endpoints have different strengths in terms of interpretability and statistical properties. For example, perioperative death is rare after elective or urgent CABG operations, and therefore specific morbidity or composite endpoints may be more useful at detecting early deteriorations in performance. To define whether changes in performance remain within or exceed acceptable limits, control boundaries can be plotted. The methods used to define these boundaries have been described in detail elsewhere [34].



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  		Fig 1. Cumulative failure charts (left) and cumulative observed minus expected failure charts (right) surgical failure after off-pump coronary artery bypass grafting for the same data set. The data represents the performance of a single resident and a consultant trainer. To define whether changes in performance remain within or exceed acceptable limits, control boundaries are calculated by defining the acceptable failure rate, the unacceptable failure rate, the {alpha} value (ie, the probability of concluding that the failure rate has increased when, in fact, it has not [type I error]), and the ß value (ie, the probability of concluding that the failure rate has not increased when, in fact, it has [type II error]). If the graph of cumulative failures crosses the upper boundary, then we conclude that the failure rate has increased to the unacceptable rate and action should be taken. If it crosses the lower boundary, we conclude that the failure rate is equal to or below the acceptable rate. (Light-face broken lines = consultant, on-pump; light-face solid line = consultant, off pump; bold broken lines = resident, on-pump; bold solid line = resident, off-pump.)

 
Novick and colleagues [32] used a modification of this type of chart, called a cumulative observed minus expected failure chart (Fig 1), to document their learning curve in OPCAB surgery. Here the graph starts at zero, but is incremented by 1–p0 for a failure and decremented by p0 for a success in which p0 is the expected risk of failure. They defined failure as a composite endpoint of death and major morbidity, and they calculated the acceptable failure rate as the incidence of this endpoint in their patient population (10%). The resulting graph oscillates around a horizontal axis when the process is in control, rises when performance deteriorates, and falls when performance improves (Fig 1). These are more intuitive than simple cumulative failure charts, because the horizontal axis corresponds to expected outcome, and if performance is in line with expectation, the chart should oscillate around zero. This technique fails to compensate for variations in case mix or individual patient risk profiles that can be overcome by replacing the common expected failure rate (p0) with the patient specific risk of failure, using risk models such as Parsonnet or EuroSCORE for example. This type of risk-adjusted cumulative sum chart, referred to as the variable life-adjusted display (VLAD) shown in Figure 2, or the cumulative risk-adjusted mortality chart is widely used [35, 36]. Both Albert and colleagues [33] and Sergeant and colleagues [26] used VLAD charts to document their learning curve in OPCAB surgery. Albert and colleagues [33] reported an early cluster of poor performance within the first 150 cases, although Sergeant and colleagues [26] did not. Albert and colleagues [33] subsequently restricted OPCAB procedures to those surgeons that performed OPCAB more frequently and their results improved. However neither of these groups defined control boundaries, and therefore it is unclear whether these variations in performance were within acceptable limits or whether they did in fact constitute a significant deterioration of performance.



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  		Fig 2. Sequential probability ratio test (SPRT) (left) and variable life-adjusted display (VLAD) (right) charts for a single resident compared with the consultant (data for the consultant's 200 most recent operations within the study period are shown for comparison on each chart). The "X" axis represents operation number, not calendar time. Note that the "Y" axis is different for VLAD plots (cumulative observed–predicted risk of failure) and SPRT plots (cumulative log likelihood ratio), and the charts have been scaled accordingly. The SPRT chart graphs the cumulative log likelihood statistic and in contrast to the cumulative failures chart has boundary lines drawn horizontally rather than at an angle. The graph starts at zero and is incremented by 1-si for a failure and decremented by si for a success, in which si is defined by the predicted risk of failure for operation (p0i) and the increase in failure rate (risk) that the chart is designed to detect (for description, see reference 34). Acceptable performance in a VLAD plot should oscillate around zero, whereas acceptable performance in an SPRT plot will tend toward the "accept" boundary line. (Light-face solid line = consultant; bold solid line = resident; bold broken lines = boundary lines; broken line with 2 center dots = expected failures.)

 
We have used the risk-adjusted sequential probability ratio test (SPRT) shown in Figure 2 [37], in which acceptable and unacceptable boundaries can be defined to complement VLAD charts as a means of performance monitoring for cardiothoracic surgical residents in Bristol [27]. Interpretation of the risk-adjusted SPRT chart is the same as that for a cumulative failures chart, as is the calculation of acceptable and unacceptable boundaries [34]. The VLAD and SPRT plots in Figure 2 represent the progression of one resident's training in OPCAB superimposed on a contemporary series of procedures performed by a senior consultant. In this case, failure was a composite endpoint of death or one of 10 predefined severe complications. The predicted risk of failure for individual patients was calculated from the complete dataset by logistic regression modelling. With time the VLAD plots oscillate at approximately zero, and the SPRT plots decline steadily to the "accept" boundary with increasing number of operations. For the consultant and resident, the control chart for OPCAB is the same level or less (better cumulative performance) than the chart for conventional CABG with cardiopulmonary bypass. The SPRT plots for OPCAB and conventional cardiopulmonary bypass operations carried out by the resident reached the accept boundary after approximately 100 and 175 operations, respectively. Similar findings have been presented for all of our cardiothoracic residents during this time period [25]. These charts are relatively simple to construct and offer real time prospective monitoring of the progress and quality of OPCAB training. They also offer evidence that the trainees who were given adequate training and supervision were able to perform OPCAB surgery to a pre-defined standard without an increased risk to patients.

The Future
Issues regarding the structure and composition of OPCAB training as well as the responsibility for quality assurance and accreditation are unresolved. One hurdle has been the tardiness of established training bodies to recognize the need for training in OPCAB; this is reflected in the observation that neither proficiency in, nor even exposure to, OPCAB is a requirement for specialist certification in the United States or the United Kingdom. The shortened specialist training and reduced operative experience prior to the completion of training have led to the increasing use of parallel training methods designed to permit the development of specific skills during surgical training [38]. Inanimate simulators, wet labs, and animal workshops are increasingly being advocated for the development of skills in OPCAB surgery [39–41]. Recently the American Association for Thoracic Surgery and The Society of Thoracic Surgeons have developed a pilot project that aims to establish a framework for training in OPCAB surgery [17]. The training program includes didactic sessions, live animal and cadaver training, observational visits to the institutions of surgeons who are experienced in off-pump surgery as well as visits by those surgeons (preceptors) to the trainees' home institutions. This program is unique, however it is surely the model for future training in OPCAB, as well as other new technologies in cardiac surgery. Structured training programs that combine focused training on necessary tasks plus objective structured assessments of technical skills may also ultimately contribute to proficiency and accreditation [38]. These can only complement the assessment of operative skill by the trainer at the operating table however, and the measure of what constitutes technical proficiency in this setting is undefined and remains almost entirely subjective. Proficiency is often linked to operative experience, although the number of cases required is unclear and appears to differ between training systems. In the United States for example, accreditation to perform on-pump CABG requires that the resident has performed 35 cases, while in the United Kingdom, where specialist training lasts longer, over 100 cases is the norm. Song and colleagues [21] were competent to consider all patients for OPCAB after 200 cases, whereas Karamanoukian and colleagues [28] considered that at least 50 cases were appropriate for training. Irving Kron in his commentary on the Karamanoukian and colleagues' [28] study felt that even fewer cases would suffice for a well-trained surgeon [42]. The accreditation of surgeons increasingly requires documentation of proficiency and control charts appear to offer an excellent quality control tool that may be used for assessment, however this would require more structured training and agreement as to what constitutes the accept boundary. Risk-adjusted SPRT displays indicate that residents in Bristol crossed the accept boundary after 100 OPCAB cases, and before they crossed the accept boundary for conventional CABG. Novick and colleagues [22] used a cumulative failed minus expected chart that crossed the accept boundary after 28 OPCAB cases, but the validity of their boundary definitions was subsequently questioned [34].


   Comment
Top
 Abstract
 Introduction
 Material and Methods
 Comment
References
 
The evidence suggests that where the professional will exist, OPCAB can be introduced into an established surgical practice without detriment to the patients. In addition, where senior consultants are experienced with the technique, OPCAB can be safely and reproducibly taught to trainees. This is achieved by a progressive increase in the complexity of the case mix and careful early supervision. The introduction of OPCAB has coincided with the increasing use of control charts as quality control tools. Performance monitoring provides reassurance that patients are not being put at risk during the introduction of OPCAB; control chart methods can be used prospectively for real time performance monitoring by consultant surgeons and residents alike. These techniques may ultimately be used to determine proficiency and accreditation. Increasing use of parallel training techniques, the development of structured training programs that encompass OPCAB, and other new technologies in cardiac surgery, coupled with objective performance monitoring are warranted to meet the needs of a changing patient population.


   References
Top
 Abstract
 Introduction
 Material and Methods
 Comment
 References
 

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