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Eur J Cardiothorac Surg 2003;24:947-952
© 2003 Elsevier Science NL

Safe evolution towards routine off-pump coronary artery bypass: negotiating the learning curve

Howard K. Song, Rebecca J. Petersen, Erez Sharoni, Robert A. Guyton, John D. Puskas*

Division of Cardiothoracic Surgery, Emory University School of Medicine, 1365 Clifton Road, NE Suite 2223, Atlanta, GA 30322, USA

Received 10 June 2003; received in revised form 8 September 2003; accepted 16 September 2003.

* Corresponding author. Carlyle Fraser Heart Center, 6th Floor, Cardiothoracic Surgery, Crawford Long Hospital of Emory University, 550 Peachtree Street, NE, Atlanta, GA 30308, USA. Tel.: +1-404-686-3391; fax: +1-404-686-4959
e-mail: john_puskas{at}emoryhealthcare.org


   Abstract
Top
 Abstract
1. Introduction
 2. Materials and methods
 3. Results
 4. Discussion
 References
 
Objective: Off-pump coronary artery bypass (OPCAB) hopes to avoid morbidity associated with cardiopulmonary bypass, improving clinical outcomes. Yet its technical difficulty and unfamiliarity raise concern that adoption of OPCAB might be associated with poorer outcomes during each surgeon's ‘learning curve’. We examined trends in patient selection over time as a single surgeon's practice evolved to routine OPCAB. Methods: Between 10-1-96 and 12-31-01, 1479 consecutive patients had isolated coronary artery bypass grafting (CABG). Clinical data were gathered prospectively and reviewed retrospectively. Trends in adoption of OPCAB and clinical outcomes were examined. Results: There were 756 OPCAB and 723 CABG/cardiopulmonary bypass patients. The practice evolved from 90% conventional CABG to 93% OPCAB. An abrupt transition coincided with evolution of techniques to expose the obtuse marginal arteries, and improvements in suction-based coronary stabilizers. Mortality was 1.0% for the off-pump group and 2.1% for the on-pump group. Careful patient selection helped maintain acceptable outcomes during the ‘learning curve’. Patients with depressed left ventricular ejection fraction, left main disease, and complex three vessel disease were excluded from OPCAB until significant experience (>200 cases) was attained. Presently, all isolated coronary bypass cases are candidates for OPCAB except patients with ischemic ventricular arrhythmias, those in cardiac arrest, and those for whom previous left pneumonectomy or deep pectus excavatum prevent rightward mobilization of heart. Conclusions: Despite a significant learning curve, evolution to routine OPCAB can be achieved while maintaining good patient outcomes. The development of specialized techniques, coronary stabilizers, and apical suction devices allows the application of OPCAB to virtually all coronary bypass patients, as surgeon experience matures.

Key Words: Coronary artery disease • Coronary artery bypass • Off-pump coronary artery bypass


   1. Introduction
Top
 Abstract
 1. Introduction
2. Materials and methods
 3. Results
 4. Discussion
 References
 
Off-pump coronary artery bypass grafting (OPCAB) has been associated with improved clinical outcomes in both prospective and large, risk adjusted, retrospective comparisons among various patient populations [1–14]. Increasing recognition of the realized and potential benefits of avoidance of cardiopulmonary bypass (CPB) has fueled renewed interest in OPCAB over the last 6 years [15,16]. Approximately 25% of coronary artery bypass grafting procedures (CABG) performed in the United States in 2002 were performed off-pump and some centers report a significantly higher percentage of OPCAB cases [15,17]. This growth in OPCAB has been driven in large part by improvements in exposure and retraction techniques and the development of specialized stabilizers and positioners which allow experienced surgeons to conduct complex off-pump coronary revascularizations that were not previously feasible without the use of CPB.

The unique technical challenges of OPCAB grafting and its relative unfamiliarity have raised concern that adoption of OPCAB may lead to poorer outcomes during each surgeon's ‘learning curve’ [18,19]. In order to study how OPCAB techniques may be incorporated into a surgical practice while maintaining excellent clinical outcomes, we examined trends in patient selection over time as a single surgeon's practice evolved to perform CABG predominantly off-pump. The adoption of OPCAB into the practice was correlated with the implementation of off-pump techniques and stabilizers. Pre-operative patient variables that influenced the selection of patients for OPCAB were followed to understand how patient selection has evolved with increasing experience with OPCAB. Taken as a whole, our analysis of this series demonstrates the breadth of clinical settings in which coronary patients may undergo OPCAB in a modern surgical practice. It is hoped that this analysis will be useful to surgeons wishing to evolve towards routine OPCAB in their practice safely without compromising patient outcomes.


   2. Materials and methods
Top
 Abstract
 1. Introduction
 2. Materials and methods
3. Results
 4. Discussion
 References
 
Pre-, intra- and postoperative data for all patients undergoing cardiac surgical procedures at Emory University Affiliated Hospitals are prospectively entered into a dedicated database. All patients undergoing isolated coronary artery bypass procedures by the senior author (JDP), with or without the use of CPB, from the initiation of OPCAB in October 1996 through December 2001 were analyzed. Patients undergoing coronary artery bypass procedures in combination with valvular or other cardiac procedures were excluded from this study. A total of 1479 consecutive patients underwent isolated coronary artery bypass grafting during the study period and were included in this retrospective analysis.

Particular attention was paid to factors that early in the experience with OPCAB were considered to be contraindications to operation without cardiopulmonary bypass. Values from on- and off-pump groups were compared using the Student's t-test or {chi}2 test. Analysis of operative data focused on technical aspects of the operation, including the number of grafts performed and arterial grafts used. The incorporation of emerging technology such as stabilizers was noted and correlated with the increasing complexity of the OPCAB procedures being performed over the study period. Mortality was reported and defined as all cause hospital mortality within 30 days after the operation.


   3. Results
Top
 Abstract
 1. Introduction
 2. Materials and methods
 3. Results
4. Discussion
 References
 
Clinical and demographic data describing the patient populations undergoing on-pump CABG and OPCAB procedures is presented in Table 1. Significantly higher proportions of patients in the on-pump group had three vessel disease, an ejection fraction of less than 45%, and presented in cardiogenic shock and with advanced Canadian Cardiovascular Society classification symptoms at the time of operation. Conversely, the off-pump group had higher proportions of female patients, patients in renal failure, and patients with single vessel disease. It is important to note that while the data in Table 1 compares the on- and off-pump populations taken as a whole, important changes occurred within the two study groups over time and these practice trends were analyzed as OPCAB developed over the course of the study period.


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  		Table 1. Preoperative patient variables

 
In order to track the evolution of the practice of OPCAB over time, we analyzed data from patients undergoing either on-pump CABG or OPCAB over 3 month intervals during the study period. We were therefore able to follow changes in the practice of OPCAB as they occurred over time on a quarterly basis. Fig. 1 depicts the proportion of CABG procedures performed using on-pump or off-pump techniques. OPCAB was first performed by the senior author in the fourth quarter of 1996. Over the ensuing eight quarters, the percentage of CABG performed off-pump remained relatively low, within the 10–30% range. These cases were performed using the relatively crude compression stabilizers that were commercially available at that time and techniques for cardiac displacement and coronary artery presentation that were also suboptimal.



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  		Fig. 1. Percentage of bypass procedures performed on- and off-pump. Patients undergoing isolated CABG were analyzed in 3 month blocks to track implementation of off-pump techniques during the study period. The black and gray arrows indicate the points at which deep pericardial traction sutures and apical suction retractors were incorporated into the OPCAB technique, respectively.

 
Beginning with the second quarter of 1998, the percentage of CABG performed off-pump increased markedly. This abrupt transition coincided with the evolution of techniques to expose the obtuse marginal coronary arteries and improvements in suction-based coronary stabilizers. Specifically, a clearer understanding of the use of deep pericardial traction sutures and bilateral pleurotomy and the introduction of the Medtronic Octopus II coronary stabilization device allowed routine grafting of the obtuse marginal system with maintenance of hemodynamic stability. The black arrow in Fig. 1 indicates the time at which deep pericardial traction sutures were first routinely used. A complete description of surgical technique for modern multivessel OPCAB has been previously reported [20]. Since this transition period, the majority of cases have been performed off-pump. Interestingly, the incorporation of the Medtronic Starfish apical suction cardiac displacement device into routine practice in the third quarter of 2001 produced a subsequent incremental increase in the frequency of OPCAB (gray arrow, Fig. 1). By facilitating cardiac displacement and improving hemodynamic stability, the apical suction device allows the application of OPCAB to patients with larger ventricles and poor LV function, and provides a safety margin in which resident teaching of OPCAB is enabled. In the final quarter of the study, the percentage of OPCABs performed in the practice was 93%.

Fig. 2 depicts clinical outcomes of patients undergoing on- and off-pump CABG over the study period. Overall mortality for patients undergoing on-pump CABG was 2.1 versus 1.0% for OPCAB. The combined mortality of both study populations was 1.6%. The rate of post-operative myocardial infarction for on- and off-pump populations was 0.66 and 0.69%, respectively.



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  		Fig. 2. Clinical outcomes of patients undergoing CABG. Hospital mortality (A); and mean duration of hospitalization (B) of patients undergoing on- or off-pump coronary artery bypass grafting. Overall mortality for the on- and off-pump groups was 2.1 and 1.0%, respectively.

 
OPCAB has previously been associated with shorter postoperative length of stay (LOS) compared to conventional on-pump CABG [9,10,18,21,22]. This trend was also seen in this series (Fig. 2B). In general, the average LOS after OPCAB was 1–2 days shorter than after on-pump CABG. The reason for this difference is likely multifactorial and related both to avoidance of cardiopulmonary bypass and to patient selection bias occurring over the course of the study period. Importantly, the advantage in LOS held by OPCAB was realized from the earliest experience and was maintained at every time point throughout the series. The LOS for on-pump patients increased late in the study period most likely because this technique became increasingly used for high risk patients, particularly those in cardiogenic shock or arrest.

It is important to emphasize that patients in the on-pump and OPCAB groups differed significantly with respect to a number of demographic and clinical variables that were summarized in Table 1. This precluded any meaningful statistical comparison of outcomes between the two groups. The analysis depicted in Fig. 2 remains useful in that it does not demonstrate higher mortality in the OPCAB group, particularly during the ‘learning curve’.

Fig. 3 tracks a number of patient demographic variables over time in both on- and off-pump groups. These demographic variables did not differ significantly between the on- and off-pump groups over the study period. Patients undergoing OPCAB had similar average age (Fig. 3A), and incidence of age greater than 65 years (Fig. 3B), female sex (Fig. 3C), recent myocardial infarction (Fig. 3D), and unstable angina (Fig. 3E) compared to the on-pump group throughout the study period. These variables did not appear to affect patient selection for the use of OPCAB even as this technique was first implemented. The success of this approach to patient selection for OPCAB was validated by the acceptable outcomes that were achieved using the OPCAB technique over the entire study period. The use of arterial grafts (Fig. 3F) was also similar between the on- and off-pump groups with a steady increase in the use of a second arterial graft in both patient populations, indicating that use of arterial grafts was readily incorporated into the OPCAB procedure.



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  		Fig. 3. Patient variables not influencing selection for OPCAB. Patient variables were analyzed to detect selection bias for on- or off-pump bypass grafting. Patients selected for either technique did not differ significantly even early in the experience with OPCAB with respect to their average age (A); age greater than 65 years (B); female gender (C); recent myocardial infarction (D); unstable angina (E); and use of LIMA and other arterial grafts (F).

 
In contrast to the variables in Fig. 3, Fig. 4 depicts a number of patient variables that early in the experience with OPCAB differed significantly between the on- and off-pump groups. Ejection fraction less than 45% (Fig. 4A), left main disease (Fig. 4B), and three-vessel disease (Fig. 4C) were all considered to be contraindications to OPCAB early in the experience with this technique. Exclusion of patients with these pre-operative variables allowed acceptable outcomes to be maintained even when there was little experience with the OPCAB procedure. Over time, with increasing surgeon experience and the introduction of improved stabilizers and retractors, patients with these higher risk factors were successfully incorporated into the OPCAB practice, once again without compromising excellent outcomes. As expected, the number of grafts per patient (Fig. 4D) in the OPCAB group increased progressively as patients with three-vessel disease were incorporated into the OPCAB practice.



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  		Fig. 4. Patient variables influencing selection for OPCAB. The presence of an ejection fraction of less than 45% (A); left main coronary artery lesion (B); three vessel coronary artery disease (C); and requirement for three or more bypass grafts (D), were found to influence selection of bypass technique early in the study period. With increasing surgeon experience and improved stabilizer technology, patients with these characteristics were ultimately incorporated into the off-pump group.

 

   4. Discussion
Top
 Abstract
 1. Introduction
 2. Materials and methods
 3. Results
 4. Discussion
References
 
The proportion of CABG cases performed off-pump in the United States has grown consistently over the past 5 years and is currently approximately 25% [17]. Enthusiasm for this movement has largely been driven by demonstrated and potential improvements in clinical outcomes for patients undergoing CABG off-pump. This enthusiasm is tempered by the realization that, given the excellent outcomes currently achieved with conventional on-pump CABG, any conversion to off-pump practice must occur in a manner that preserves excellent outcomes and the confidence of the clinical community in CABG surgery. We undertook this retrospective analysis of our OPCAB experience to examine patterns of adoption of OPCAB and to demonstrate how a surgical practice might incorporate off-pump techniques safely while maintaining acceptable clinical outcomes.

Despite a significant learning curve, acceptable outcomes were maintained throughout the conversion of the practice to routine OPCAB. Careful patient selection helped maintain acceptable outcomes throughout the study period. Based on our experience, it is recommended that patients with depressed left ventricular function, left main disease, and three vessel disease be excluded from selection for off-pump surgery early in a surgeon's experience. Surgeons who have completed training at teaching centers which give considerable exposure to off-pump techniques may be able to incorporate OPCAB into their practice more quickly.

As surgeon experience with specialized techniques and retractors grows, more complex and higher risk cases can be performed safely off-pump. Over time, OPCAB has been applied to a broad spectrum of clinical settings, including patients with advanced age, multivessel disease, depressed left ventricular function, left main disease, and complete arterial revascularization [21,23–25]. Intramyocardial coronary arteries, small and calcified targets, and coronary endarterectomy continue to present challenges to the off-pump surgeon, however these situations have been overcome successfully and do not represent absolute contraindications to OPCAB. Currently at our institution, all patients scheduled for isolated coronary bypass are considered candidates for OPCAB except for patients with ischemic ventricular arrhythmias, those in cardiac arrest, and those for whom previous left pneumonectomy or deep pectus excavatum prevent rightward mobilization of the heart.

In experienced hands, OPCAB promises improved clinical outcomes by avoiding the morbidity associated with cardiopulmonary bypass. The surgeon's challenge with OPCAB and other emerging technologies is to accumulate experience without compromising the safety and beneficial outcome of the procedure. These results suggest that the early ‘learning curve’ with OPCAB can be negotiated safely with careful patient selection and diligent attention to technical details, thereby allowing the application of OPCAB to increasingly complex cases.


   References
Top
 Abstract
 1. Introduction
 2. Materials and methods
 3. Results
 4. Discussion
 References
 

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