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(Circulation. 2004;109:887-892.)
© 2004 American Heart Association, Inc.

Clinical Investigation and Reports

Coronary Bypass Surgery Performed off Pump Does Not Result in Lower In-Hospital Morbidity Than Coronary Artery Bypass Grafting Performed on Pump

Jean-Francois Légaré, MD; Karen J. Buth, MSc; Sharon King, RN; Jeremy Wood, MD; John A. Sullivan, MD; Camille Hancock Friesen, MD; John Lee, MD; Kier Stewart, MD; Gregory M. Hirsch, MD

From the Division of Cardiovascular Surgery, Dalhousie University, Halifax, Nova Scotia, Canada.

Correspondence to Dr Jean-Francois Légaré, 1796 Summer St, Room 2006, Division of Cardiovascular Surgery, New Halifax Infirmary, Halifax, Nova Scotia, B3H 3A7, Canada. E-mail jean.legare{at}cdha.nshealth.ca

Received September 25, 2003; accepted November 10, 2003.

	Abstract

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Background— There is increasing evidence that cardiopulmonary bypass (CPB) may be responsible for the morbidity associated with coronary artery bypass grafting (CABG) surgery. Recent developments in cardiac stabilization devices have made CABG without CPB feasible. However, there is conflicting evidence to date from published trials comparing outcomes between CABG performed with and without CPB, with some trials indicating an advantage to the avoidance of CPB and others showing little benefit.

Methods and Results— In a single-center randomized trial, 300 patients requiring CABG surgery at a single institution were prospectively randomized to have the procedure performed with CPB (n=150) or on the beating heart (n=150). Exclusion criteria for the trial included emergency procedure, concomitant major cardiac procedures, ejection fraction <30%, and reoperation. In-hospital outcomes were analyzed on an intention-to-treat basis. A mean of 3.0±0.9 grafts were performed in the CPB group compared with 2.8±0.9 grafts in the beating-heart group (P=0.06). There were no significant differences between the CPB group and the beating-heart group in mortality (0.7% versus 1.3%; P=1.0), transfusion (8.7% versus 9.3%), perioperative myocardial infarction (0.7% versus 2.7%; P=0.37), permanent stroke (0% versus 1.3%; P=0.50), new atrial fibrillation (32% versus 25%; P=0.20), and deep sternal wound infection (0.7% versus 0%; P=1.0). The mean time to extubation was 4 hours, the mean stay in the intensive care unit was 22 hours, and the median length of hospitalization was 5 days in both groups (P=NS).

Conclusions— In contrast to published trials, we were unable to demonstrate any advantage with CABG performed without CPB in terms of patient morbidity. Excellent results can be obtained with either surgical approach.

Key Words: coronary disease • revascularization • cardiopulmonary bypass

	Introduction

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Coronary artery bypass grafting (CABG) performed with cardiopulmonary bypass (CPB) has become a well-established treatment modality for patients with coronary artery disease.¹ However, there has been increasing evidence that CPB may be responsible for some of the morbidity associated with CABG surgery. The systemic inflammatory reaction initiated by the extracorporal circuit results in mechanical trauma to blood, activation of various immunological cascades (complement, cytokines), impaired hemostasis, and impaired neurological, renal, and gastrointestinal function.^2,3 Furthermore, aortic cannulation, cross-clamping, and CPB can result in microembolization and macroembolization with subsequent neurological injury and other end-organ injury, including global myocardial ischemia/reperfusion injury.⁴ Thus, it has been proposed that CABG surgery would be safer if CPB could be avoided.

The development of new cardiac stabilization devices has allowed for the creation of safe and reproducible coronary anastomoses on the beating heart.^5–7 Several large, nonrandomized, retrospective case series comparing CABG surgery performed on the beating heart (off pump) and conventional CABG surgery performed with CPB (on pump) have indicated an advantage to CABG surgery without CPB; however, selection bias toward lower-risk cases in CABG without CPB remains an issue.^8–14 The largest randomized studies published to date are conflicting, with some demonstrating decreased length of hospitalization and myocardial enzyme release,¹⁵ whereas others demonstrate decreased incidence of atrial fibrillation, length of hospitalization, and blood-product utilization with CABG surgery performed on the beating heart.^16,17 The most recent trial demonstrated decreased blood-product requirement, myocardial enzyme release, and length of hospitalization in beating-heart surgery patients.¹⁸ Of the 3 published trials, 2 are single-surgeon experiences, and as such, the potential for bias in end points that are discretionary treatments (decision to extubate, discharge, and transfuse) is an important consideration. Moreover, the majority of these trials excluded high-risk patients, which brings into question the generalizability of the results.

See p 810

The present study was designed and powered to detect significant differences in the following 3 major outcomes: blood-product requirements, length of hospitalization, and prolonged mechanical ventilation. It is, to the best of our knowledge, the largest single-center randomized controlled study comparing CABG surgery performed on the beating heart with CABG surgery using CPB.

	Methods

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Study Design and Patients
Between August 1999 and March 2003, 300 patients requiring CABG surgery at a single institution were prospectively recruited and, after they gave informed consent, were randomized to have the procedure performed on the beating heart (off pump) or with CPB (on pump). Indications for CABG surgery were based on a weekly peer review process, which involved a cardiologist, cardiac surgeons, and cardiac radiologists. Individual patients were queued for surgery on the basis of objective criteria as described previously.¹⁹ Exclusion criteria for the trial included emergency procedure (requiring immediate surgery), concomitant major cardiac procedures, ejection fraction <30%, and reoperation. The study was approved by the Capital Health Research Ethics Board.

Six of 9 surgeons in this center participated in the study. Randomization envelopes were generated by computerized block randomization to beating-heart (off-pump) CABG surgery or surgery with CPB (on-pump). The block size varied from 8 to 20 patients and was unknown to the study participants. Randomization was performed intraoperatively after a preliminary inspection of the coronary artery anatomy to better ensure that a beating-heart procedure could be performed safely. Intraoperative reasons for nonrandomization included intramyocardial vessels, very poor quality of distal vessels, and hemodynamic instability with manipulation of the heart. Once randomized, patients were allowed to cross over between groups when it was judged by the treating surgeon that the procedure assigned was unfeasible, for technical or hemodynamic reasons.

Surgical Technique
A median sternotomy was performed in all patients. Beating-heart surgery was performed in a standardized fashion as described previously.²⁰ Briefly, 3 traction sutures were placed in the posterior pericardium for retraction, followed by placement of a commercially available tissue stabilizer (Medtronic Octopus and Coronéo Corvasc). With the advent of the Octopus III (Medtronic), posterior pericardial traction sutures were no longer necessary. A nontraumatic, small bulldog clamp was then applied to the target vessel proximal to the anastomotic site to achieve hemostasis after arteriotomy. All anastomoses were constructed with a continuous-suture technique with 7-0 or 8-0 monofilament sutures.

CABG surgery performed with CPB was done in a standardized fashion with ascending aortic cannulation and 2-stage venous cannulation of the right atrium. During CPB, the mean arterial pressure target was set at 60 mm Hg, and body temperature was allowed to drift to a minimum of 32°C. Intermittent cold-blood cardioplegia (1:4 blood to crystalloid with maximal K⁺ concentration 22 mEq/L) was delivered antegrade via the aortic root unless otherwise indicated.

In either the CPB or beating-heart approaches, the choice of conduits and construction of composite grafts was based on surgeon preferences rather than fixed criteria. Arterial conduits were harvested with minimal trauma (nonskeletonized internal mammary artery), and all were treated with either a Papaverine solution or nitroglycerin/calcium channel blocker (Verapamil) solution before use.

Heparin was given at a dose of 300 IU/kg to achieve target activated clotting time >450 seconds in the CPB group compared with 100 IU/kg in the beating-heart group. On completion of anastomoses, both groups received protamine sulfate to reverse the effects of heparin and return the activated clotting time to preoperative levels. No special blood conservation techniques were used other than nonhemic prime, retransfusion of all contents of the oxygenator at the end of CPB, and acceptance of normovolemic anemia. Postoperatively, nonhemic volume expanders were used routinely.

Postoperative Management
All postoperative cardiac surgery patients were taken to a dedicated cardiovascular intensive care unit (ICU). Each patient was required to meet standard criteria before extubation and before transfer to the intermediate care unit. The need for a perioperative blood-product transfusion was determined on an individual, patient-by-patient basis. There was no rigid transfusion trigger for the use of homologous blood products; however, in general, patients were not transfused until serum hemoglobin was <70 mg/dL, unless they were considered at risk clinically for decreased oxygen delivery. Overall transfusion rates were captured for blood products given intraoperatively and postoperatively. Preoperative transfusions were not included in this analysis. Similarly, patients were generally not transferred from the ICU if they were considered at risk clinically for decreased oxygen delivery. Discharged patients were transferred to an intermediate-care or general-care ward under the care of the same team. All patients were monitored continuously for a minimum of 24 hours.

All patients received intravenous nitroglycerin (0.1 to 8 µg · kg^-1 · min^-1) infusions for the first 24 hours unless they were hypotensive (systolic blood pressure <90 mm Hg). Oral nifedipine (Adalat 10 mg PO QID or Adalat XL 30 mg/d) was prescribed for all patients receiving a radial artery graft beginning on day 1 after surgery for a period of 3 to 6 months. Other routine medications included daily aspirin and resumption of cholesterol-lowering agents, ß-blockers, and ACE inhibitors as appropriate.

Data Collection
Perioperative patient variables were collected prospectively by 3 full-time research assistants. An elective case was defined as a patient waiting at home before the procedure; in-house cases were defined as hospitalized patients requiring surgery; urgent cases were defined as cases in which surgery was deemed necessary within 24 hours to prevent further clinical deterioration; and emergent/emergent salvage cases were those patients who required an immediate operation. A 12-lead ECG was recorded before the operation, at 2 hours after surgery, and then when clinically indicated. ECG criteria for perioperative myocardial infarction were new Q wave (0.04 ms) in at least 2 leads or ECG ST changes in association with significant creatine kinase–MB enzyme release.

Data Analysis
All analyses were performed with the Statistical Analysis Systems software package (SAS, release 8.2). Groups were analyzed on an intention-to-treat basis. Descriptive statistics included continuous and discrete variables, which were analyzed accordingly with an unpaired t test, Wilcoxon rank sum test, ² test, and Fisher exact test. Statistical significance was defined as a probability value of less than 0.05. On the basis of current literature, the present trial was powered to detect significant differences in the following 3 major outcomes: blood-product requirements, length of hospitalization, and prolonged mechanical ventilation. The power calculations translated into an absolute risk reduction of 11% in blood-product requirements (relative risk reduction of 60%), 15% in prolonged hospitalization (defined as >6 days; relative risk reduction 40%), and 12% in prolonged mechanical ventilation (defined as >10 hours; relative risk reduction 53%) in favor of CABG patients whose procedure was performed on the beating heart.

	Results

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A total of 933 patients were eligible for the trial during the study period, of whom 400 patients were approached, which resulted in 351 patients who consented to participate. Of these, 51 were not randomized because their cases were assigned to a nonparticipating surgeon (n=27) or because of patient-related issues such as intramyocardial vessels or intraoperative hemodynamic instability (n=24). A total of 300 patients were randomized to undergo CABG surgery performed on CPB (n=150) or on the beating heart (n=150; Figure). Twenty-one patients did not receive the assigned intervention. Twenty were originally assigned to the beating-heart group, but because of hemodynamic instability (n=14), inadequate visualization of target vessel (n=5), or inability to place the stabilizer because of obesity (n=1), they were crossed over to the CPB group. One patient assigned to the CPB group was crossed over to the beating-heart group because of extensive aortic disease. All analyses were performed on an intention-to-treat basis.

View larger version (19K): [in this window] [in a new window]   Flow diagram illustrating patient recruitment during study period. Total recruitment was 32%.

Preoperative patient characteristics were similar in both groups and are illustrated in Table 1. For the entire cohort, the average age of patients was 63 (range 38 to 87) years, with 26% aged >70 years. Thirty-three percent of patients were diabetic, 14% had moderate left ventricular dysfunction, 48% had a history of previous myocardial infarction, and 71% had 3-vessel coronary artery disease. The urgency of the procedure was elective in 77%, "in-house" or hospitalized in 21%, and urgent in 2% of the randomized patients.

View this table: [in this window] [in a new window]   TABLE 1. Preoperative Patient Characteristics

A mean of 3.0±0.9 grafts were performed in the CPB group compared with 2.8±0.9 grafts in the beating-heart group (P=0.06; Table 2). There were no significant differences between CABG performed with CPB or with beating heart with regard to complete arterial revascularization (64% versus 68%; P=0.46), and avoidance of aortic proximal anastomoses (53% versus 55%; P=0.64). Patients who underwent CABG with CPB had a mean pump time of 97 minutes (range 76 to 113 minutes) and clamp time of 69 minutes (range 50 to 87 minutes).

View this table: [in this window] [in a new window]   TABLE 2. Graft, Conduits, and Surgical Characteristics of Randomized Patients

Three patients died in the hospital, for an overall mortality rate of 1%, with no significant differences between groups (0.7% versus 1.3%; Table 3). Similarly there were no significant differences between the CPB group and the beating-heart group in perioperative myocardial infection (0.7% versus 2.7%; P=0.37), permanent stroke (0% versus 1.3%; P=0.50), new atrial fibrillation (32% versus 25%; P=0.20), and deep sternal wound infection (0.7% versus 0%; P=1.0). Additional morbidity outcome and composite outcome (mortality/perioperative intra-aortic balloon pump/myocardial infarction/stroke/prolonged ventilation) also failed to demonstrate significant differences between the 2 surgical approaches (Table 3).

View this table: [in this window] [in a new window]   TABLE 3. Primary and Secondary Outcomes

The use of any blood products perioperatively was similar in both groups, with an overall transfusion rate of 9% (Table 4). The mean time to extubation was 4 hours, the mean ICU stay was 22 hours, and the median length of hospitalization was 5 days in both groups (P=NS). Similarly, the incidence of prolonged mechanical ventilation, defined as >10 hours, was not significantly different between the CPB group (9.3%) and the beating-heart group (12%; P=0.45).

View this table: [in this window] [in a new window]   TABLE 4. Other In-Hospital Perioperative Outcomes

	Discussion

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Several large case series have suggested morbidity benefit, cost benefit, reduced length of hospitalization, and even mortality benefit for patients undergoing beating-heart CABG surgery compared with CABG performed with CPB.^{10,12–14,21} More recent retrospective studies, using more sophisticated statistical tools such as case matching and propensity score analysis, have also suggested that beating-heart surgery is associated with decreased morbidity manifested by reduction in transfusion requirement, infection, length of hospitalization, renal failure, and encephalopathy but not mortality.^8,9 However, despite the use of sophisticated statistical tools designed to allow valid comparisons, the inherent bias toward fitter patients for beating-heart CABG may not have been adequately addressed by these techniques.

To date, 3 randomized controlled trials have been performed that compared CABG surgery with or without CPB. All of these studies have been modest in size (197 to 281 patients), 2 have been single-surgeon studies, and all have studied relatively limited patient populations, which calls into question the generalizability of the results to "average" cardiac surgeons with "typical" CABG practices. Furthermore, the only significant differences in outcomes have been nearly exclusively in discretionary therapeutic end points (blood transfusion, time to extubation, time in ICU, and time in hospital), for which bias concerning the assignment to on- or off-pump bypass may have altered thresholds for intervention or discharge.^15,16,18,22 The largest published trial (n=281) was a multicenter trial limited to young patients with normal ejection fraction and with 1- or 2-vessel coronary artery disease. The authors reported shorter time to extubation (3 versus 9 hours) and reduced length of hospitalization (6 versus 7 days) in beating-heart patients. Transfusion rates were lower intraoperatively (3% versus 13%) but not postoperatively (28% versus 29%). There were no other morbidity or mortality differences.¹⁵ Ascione et al^16,17 reported a concatenation of two 100-patient, single-surgeon trials in low-risk patients with low rates of diabetes, peripheral vascular disease, and 3-vessel coronary artery disease. This group showed lower blood transfusion rates (33% versus 53%), reduced length of hospitalization (5 versus 7 days), and decreased incidence of atrial fibrillation in beating-heart patients (12% versus 37%).^16,17 Most recently, Puskas et al,¹⁸ in a single-surgeon trial, attempted to address these criticisms by randomizing 197 relatively unselected patients (no shock patients, no redo CABG, preoperative intra-aortic balloon pump) and reported reduced length of hospitalization (5 versus 6 days), shorter time to extubation, and lower transfusion rates (26% versus 44%). A recent meta-analysis of all randomized controlled trials failed to show significant benefit of CABG performed on the beating heart versus with CPB.²³

The present randomized controlled trial comparing CABG surgery performed on the beating heart versus CPB is the largest to date, with 300 patients randomized. In the present study, more than 30% of patients were diabetics, and the majority had Canadian Cardiovascular Society angina class III/IV and had critical lesions in all 3 coronary distributions. Thus, contrary to the studies by Ascione et al^16,17 and Van Dijk et al,¹⁵ the present patient population may have been more representative of current CABG practices, and unlike the studies by Puskas et al¹⁸ and Ascione et al,^16,17 we were not limited to a single-surgeon experience. We report an overall mortality rate of 1%, which was not significantly different between groups and which compares favorably to previously published studies. In the present series, a large proportion of patients had complete arterial revascularization (66%), with many having no proximal anastomoses onto the aorta (54%). The mean or median number of grafts per patient was slightly lower for beating-heart patients (not significant), but that may reflect the fact that a larger number of patients did not have 3-vessel disease in the beating-heart group. Similar findings were noted by Van Dijk et al.¹⁵

We demonstrate that very low transfusion rates (9.3% versus 8.7%) can be achieved without special measures in first-time isolated CABG, with no additional benefit derived from beating-heart surgery. Our findings differed markedly from those of existing studies, which demonstrate at least a transient reduction in transfusion rates with beating-heart surgery. All of those trials had markedly higher transfusion rates than the present study, even in the beating-heart arm (28% versus 29% in the study by van Dijk et al,¹⁵ 33% versus 53% in the study by Ascione et al,¹⁶ and 26% versus 44% in the study by Puskas et al¹⁸). It is evident that the discretionary end point of blood-product utilization after cardiac surgery varies tremendously despite the publication of transfusion guidelines.^24–26

Contrary to previous published trials, we were unable to demonstrate any differences in the time to extubation, length of ICU stay, or length of hospitalization, which suggests little benefit attributable to beating-heart surgery. Additionally, in the present study, the median time to extubation of 4 hours, ICU stay of 22 hours, and median length of hospitalization of 5 days demonstrated in both groups all compare favorably with the previously published trials.^15,16,18 Our findings suggest that excellent results can be obtained with both surgical approaches and that the differences noted in previously published studies may have been the result of bias in discretionary end points despite efforts to standardize patient care. Because length of hospitalization is one of the major factors that affects overall cost, the present findings also suggest that in the short term, there may be little cost benefit to beating-heart surgery.

In the present study, 21 patients crossed over from one treatment arm to another, a figure not significantly different from Van Dijk et al,¹⁵ who reported 15 crossovers among 281 patients. We point out that all analysis was performed on an intention-to-treat basis to ensure minimal impact of a crossover effect, which would have likely favored the beating-heart group. A limitation of the present trial, like all previously published, is insufficient power to evaluate subgroups of patients more likely to benefit from beating-heart surgery, such as patients with high risk of neurological, bleeding, or renal complications.

In conclusion, we have shown that in a randomized controlled trial of 300 patients to CABG surgery with or without CPB, we have been unable to demonstrate any significant differences in short-term mortality or morbidity outcomes. Excellent results can be obtained with both surgical approaches, ie, CABG surgery on the beating heart or with CPB.

	Acknowledgments

 
This study was supported by the Maritime Heart Center. We would like to thank the following individuals, who were instrumental in enabling the completion of this trial: Dr Claudio Diquinzio (Head of Cardiac Anesthesia), on behalf of all cardiac anesthesia members, and Karen Ferrera (booking office).

	References

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