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(Circulation. 2001;104:1761.)
© 2001 American Heart Association, Inc.

Clinical Investigation and Reports

Early Outcome After Off-Pump Versus On-Pump Coronary Bypass Surgery

Results From a Randomized Study

Diederik van Dijk, MD; Arno P. Nierich, MD PhD; Erik W.L. Jansen, MD PhD; Hendrik M. Nathoe, MD; Willem J.L. Suyker, MD; Jan C. Diephuis, MD; Wim-Jan van Boven, MD; Cornelius Borst, MD PhD; Erik Buskens, MD PhD; Diederick E. Grobbee, MD PhD; Etienne O. Robles de Medina, MD PhD; Peter P.T. de Jaegere, MD PhD; , for the Octopus Study Group^*

From the University Medical Center Utrecht, Departments of Anesthesiology (D.v.D., J.C.D.), Cardiothoracic Surgery (E.W.L.J.), and Cardiology (H.M.N., C.B., E.O.R.d.M., P.P.T.d.J.) and the Julius Center for Patient Oriented Research (E.B., D.E.G.), Utrecht; the Isala Clinics, Weezenlanden Hospital, Departments of Thoracic Anesthesiology (A.P.N.), Cardiothoracic Surgery (W.J.L.S.), and Cardiology, Zwolle; and the Antonius Hospital, Departments of Cardiothoracic Surgery and Cardiology (W.J.v.B.), Nieuwegein, Netherlands.

Reprint requests to Peter P.T. de Jaegere, University Medical Center, Department of Cardiology (HpN E01-207), Heidelberglaan 100, 3584 CX Utrecht, PO Box 85500, 3508 GA Utrecht, Netherlands. E-mail p.p.t.dejaegere{at}hli.azu.nl

	Abstract

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Background— The use of cardiopulmonary bypass during coronary artery bypass surgery (CABG) has been associated with substantial morbidity. The recent introduction of cardiac stabilizers facilitates CABG without cardiopulmonary bypass (off-pump CABG), but it is unknown whether cardiac outcome after off-pump surgery is similar to that for the on-pump procedure.

Methods and Results— In a multicenter trial, 281 patients (mean age 61 years, SD 9 years) were randomly assigned to off-pump or on-pump CABG. In-hospital results and cardiac outcome and quality of life after 1 month are presented. Cardiac outcome was defined as survival free of stroke, myocardial infarction, and coronary reintervention. The mean numbers of distal anastomoses per patient were 2.4 (SD 1.0) and 2.6 (SD 1.1) in the off-pump and on-pump groups, respectively. Completeness of revascularization was similar in both groups. Blood products were needed during 3% of the off-pump procedures and 13% of the on-pump procedures (P<0.01). Release of creatine kinase muscle-brain isoenzyme was 41% less in the off-pump group (P<0.01). Otherwise, no differences in complications were found postoperatively. Off-pump patients were discharged 1 day earlier. At 1 month, operative mortality was zero in both groups, and quality of life had improved similarly. In both groups, 4% of the patients had recurrent angina. The proportions of patients surviving free of cardiovascular events were 93.0% in the off-pump group and 94.2% in the on-pump group (P=0.66).

Conclusions— In selected patients, off-pump CABG is safe and yields a short-term cardiac outcome comparable to that of on-pump CABG.

Key Words: coronary disease • surgery • cardiopulmonary bypass

	Introduction

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Coronary artery bypass surgery (CABG) using cardiopulmonary bypass (CPB) relieves angina but is associated with substantial morbidity.^1,2 CPB requires full heparinization, induces a whole-body inflammatory response, and generates microemboli.^3–5 It also requires cannulation and cross-clamping of the ascending aorta, which may lead to atheromatous macroemboli.⁶ Procedures that do not use CPB are likely to prevent these unwanted effects. Moreover, in selected patients, the operation may be performed via a left anterior thoracotomy or a substernal incision, which makes sternotomy unnecessary.⁷ Avoiding full heparinization allows safe use of a thoracic epidural catheter. Apart from thoracic sympatholysis, this may lead to improved postoperative pain relief and reduced mechanical ventilation time.⁸ Consequently, if CPB can be avoided (off-pump CABG), a reduction in perioperative morbidity and mortality is anticipated, with faster recovery, shorter hospitalization, and less need of medical facilities and materials.^9,10

See p 1743

Recently, cardiac stabilization techniques were developed to facilitate bypass surgery on the beating heart (off-pump CABG). The Octopus¹¹ is one of the devices that can immobilize and present all sides of the beating heart. This allows off-pump CABG in patients with 3-vessel disease.^9,12 The feasibility of off-pump CABG depends primarily on the coronary anatomy and the hemodynamic consequences of exposure of the posterior ventricular wall.^9,13,14 The procedure is technically more demanding, and it is unknown whether cardiac outcome is comparable to on-pump procedures.⁹

This randomized trial compared off-pump and on-pump CABG. We present in-hospital results and cardiac outcome and quality of life after 1 month.

	Methods

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Study Design and Patients
Design and methods of the Octopus multicenter trial have been described in detail.¹⁵ In brief, after they had given written informed consent, patients were randomly assigned to off-pump or on-pump CABG. Patients were eligible if referred for first-time isolated coronary bypass surgery and an off-pump procedure was deemed technically feasible. Patients were excluded in case of emergency or concomitant major surgery, Q-wave myocardial infarction in the previous 6 weeks, or poor left ventricular function or if they were unlikely to complete 1 year of follow-up or unable to give informed consent. There were no restrictions as to age. The study was approved by the ethics committees of the participating centers.

Between March 1998 and August 2000, 281 patients were enrolled in 3 hospitals in the Netherlands, of whom 265 underwent treatment according to randomization. In 10 patients randomized to off-pump surgery, CPB was used during the procedure. One other patient randomized to off-pump surgery underwent coronary angioplasty because of infection. In 5 patients assigned to on-pump CABG, an off-pump procedure was performed.

Treatment and Procedures
Before randomization, the treatment plan was recorded on dedicated forms. The goal of surgery was to obtain complete arterial revascularization. With the exception of 2 emergency procedures, all operations were performed by cardiac surgeons experienced in both off-pump and on-pump bypass surgery. During off-pump procedures, the Octopus method¹¹ was used for stabilization of the target coronary artery.

Anesthetic technique varied according to the treatment allocation. In the on-pump group, 99% of the patients received total intravenous anesthesia, including high-dose opioids, whereas in the off-pump group, 54% of the patients received thoracic epidural anesthesia combined with low-dose opioids. The CPB was primed with a crystalloid-colloid mixture, and the minimal nasopharyngeal temperature was 32°C. During aortic cross-clamping, cold crystalloid cardioplegia (St Thomas solution) was used for myocardial protection. To reduce blood loss, blood was recollected with a suction cardiotomy reservoir in the CPB group, whereas a cell saver was used in the off-pump group. In an attempt to reduce the incidence of postoperative atrial fibrillation, all patients were given sotalol 40 mg twice daily from the first day to 1 month after surgery.

Data Collection and Outcome Measures
During surgery, the following parameters were recorded: access to the heart, number of distal anastomoses, type of graft (arterial versus venous), completeness of revascularization (the agreement between treatment plan and actual number of distal anastomoses), switch to CPB for the off-pump group, time on CPB and cross-clamp time for the on-pump group, use of blood products, and time between arrival in the operating room and transfer to the intensive care unit (ICU).

After surgery, the following were measured: serum creatine kinase muscle-brain isoenzymes (CK-MB) (mean area under the curve, based on 5 measurements within the first 20 hours), incidence of atrial fibrillation, use of inotropes, blood loss during the first 12 hours, use of blood products, overall postoperative complication rate (cardiac arrest, cardiac failure, repeat thoracotomy, infection requiring antibiotics or surgical treatment, pneumothorax, time to extubation >24 hours, or renal failure requiring dialysis), weight changes, time to extubation, time spent in the ICU, number of days until discharge, pain during the first 3 days (visual analog score, with 0 reflecting no pain and 10 reflecting the worst imaginable pain), hemoglobin at discharge, and creatinine at discharge.

As part of a formal long-term cost-effectiveness analysis, all material and resources used during the hospital stay were recorded. Also, in parallel, a cost study on the unit costs was performed. Actual costs were estimated by multiplying resource use by unit costs.

Cardiac outcome 1 month after surgery was defined as survival free of cardiovascular events, which included stroke, myocardial infarction, and coronary reintervention (CABG or coronary angioplasty). These events were evaluated by an independent committee blinded to treatment allocation. Stroke was defined as focal brain injury persisting for >24 hours, combined with an increase in handicap of 1 grade on the Rankin scale.¹⁶ During the first 7 days after surgery, myocardial infarction was defined by elevation of serum CK-MB to >5 times the upper limit of normal.¹⁷ After 7 days, it was considered present when 2 of the following criteria were met: chest discomfort lasting 30 minutes, CK-MB/CK ratio >0.1, and the development of abnormal new Q waves on the ECG. The latter distinguished Q-wave and non–Q-wave myocardial infarction at any time.¹⁵ Recurrence of stable or unstable angina after 1 month was defined according to the Canadian Cardiovascular Society¹⁸ and Braunwald classifications,¹⁹ respectively.

Health-related quality of life was assessed 1 week before and 1 month after surgery by use of 2 generic questionnaires. The EuroQol questionnaire generates a single index, ranging from -1 to +1, with -1 reflecting the worst imaginable quality of life and +1 reflecting the best imaginable quality of life.²⁰ The ShortForm-36 questionnaire comprises 8 different domains, all ranging from 0 to 100. Higher scores indicate higher levels of functioning or well-being.²¹

Data Analysis
All data were analyzed on an intention-to-treat basis, ie, based on randomization. Differences are presented with 95% CIs. Dichotomous data were compared by the ² statistic. Means are presented with SD and were compared by a 2-sample t test. Nonnormally distributed continuous variables are presented as medians and were compared by a Mann-Whitney test.

	Results

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Patient Population and In-Hospital Results
Baseline characteristics were well balanced across the randomized groups (Table 1). The small difference between the 2 groups in patients with 3-vessel disease is reflected by the mean number of grafts per patient (Table 2), which was 2.4 in the off-pump group and 2.6 in the on-pump group. There was no difference in completeness of revascularization. Use of vein grafts was avoided in 84.4% of the off-pump patients and 75.7% of the on-pump patients. In 8% of the off-pump patients, access to the heart was obtained via left anterior thoracotomy instead of sternotomy. Two patients randomized to off-pump CABG were operated on with CPB because progression of symptoms necessitated emergency surgery. In 4 off-pump patients, CPB was used because of persistent arrhythmias, myocardial ischemia, and hypotension during the procedure. In 4 others, CPB was used because the coronary anatomy turned out to be unsuitable for a beating-heart approach. The proportion of patients in whom blood products were used during surgery was 4 times lower in the off-pump group.

View this table: [in this window] [in a new window]   Table 1. Baseline Characteristics

View this table: [in this window] [in a new window]   Table 2. Intraoperative Data

Detailed data of the postoperative period are presented in Table 3. The release of CK-MB, expressed as area under the curve, was 41% less in the off-pump group (P<0.01). There was no difference in frequency of postoperative atrial fibrillation, overall complication rate, or pain. After surgery, the proportion of patients receiving blood products was similar. After 4 days, on-pump patients had lost weight, whereas off-pump patients had gained weight. Off-pump patients were discharged 1 day earlier than on-pump patients.

View this table: [in this window] [in a new window]   Table 3. Postoperative Data

The costs of the surgical procedure were slightly lower for the off-pump group, ie, US $3112 versus $3535 (P<0.01). The overall costs associated with hospitalization and the procedure, however, were not significantly different for the off-pump and on-pump groups, ie, US $8796 and $9118, respectively (P=0.75).

Cardiac Outcome at 1 Month
The mean follow-up period was 37 days (SD 8 days) in both groups. None of the patients died. In the off-pump group, 93.0% of the patients had survived free of cardiovascular events, compared with 94.2% in the on-pump group (difference 1.2%; 95% CI -4.4 to 7.0%; P=0.66) (Table 4). In the off-pump group, 4 patients suffered a Q-wave and 3 patients a non–Q-wave myocardial infarction. In the on-pump group, 4 Q-wave and 2 non–Q-wave myocardial infarctions occurred. One patient had supplementary angioplasty after off-pump surgery because the deep intramural course of the left anterior descending coronary artery prevented grafting of this vessel without cardioplegia. In both groups, 5 patients had recurrent, stable angina. One on-pump patient had unstable angina.

View this table: [in this window] [in a new window]   Table 4. Cardiac Outcome After 1 Month

Quality of Life
In both groups, there was a marked improvement in self-reported quality of life at 1 month (Table 5). This improvement was statistically significant for overall quality of life, as well as for the domains "physical functioning," "general health," "vitality," "role limitations due to emotional problems," and "general mental health." No differences in quality of life were observed between the off-pump and on-pump CABG group.

View this table: [in this window] [in a new window]   Table 5. Comparison of Quality of Life Within and Between the Treatment Groups

	Discussion

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The results of this randomized trial indicate that there is no difference between off-pump and on-pump CABG in completeness of revascularization and cardiac outcome after 1 month. Off-pump CABG, however, resulted in reduced CK-MB release, reduced use of blood products, and shorter hospital stay.

To appreciate these results, certain features of the study need to be addressed. Although the difference in survival free of cardiovascular events at 1 month was negligible, the 95% CI was wide, ranging from -4% to +7%, owing to the low number of clinical events in this trial. Another limitation is that, although the cardiovascular events were judged by an independent blinded committee, the patients and their attending physicians were not blinded for randomization. This may have influenced the timing of hospital discharge, self-reported quality of life, and anginal assessment.

In several respects, the present study could not show benefits that were anticipated from off-pump CABG.^1,3,12,22 The perioperative complication rate, however, was already quite low in the patients undergoing on-pump CABG. The incidence of postoperative atrial fibrillation was similar in both groups. This deviates from the results of Ascione et al,²² who did not administer a prophylactic ß-blocker after surgery and found an absolute difference of 39% in favor of off-pump CABG. The shorter mechanical ventilation in off-pump patients has been caused at least partially by differences in anesthetic technique. This did not shorten ICU stay, because all patients stayed 1 night. Off-pump patients were discharged from hospital 1 day earlier, but the presumed faster recovery after off-pump CABG^9,12 was not reflected in better scores in health-related quality of life after 1 month. Overall hospital costs were not significantly different, although costs of the surgical procedure were slightly lower for the off-pump group. This was caused primarily by the materials used, ie, stabilizer versus CPB. The current cost difference, however, should be interpreted cautiously, because long-term clinical outcomes will determine actual cost-effectiveness.

Two findings favor off-pump CABG. First, the intraoperative use of blood products was reduced in the off-pump group. This may be because dilution of the patient’s blood with 2 L of CPB priming solution was avoided. Second, the 41% reduction in postoperative CK-MB release suggests that avoiding CPB reduced the degree of myocardial necrosis. This is supported by the strong (up to 22-fold) reduction in maximum cardiac troponin I release in off-pump patients that was reported previously.^23,24 Apparently, local ischemia during clamping of the coronary arteries is less harmful than global cardiac ischemia. The clinical significance of this finding is uncertain. In patients undergoing PTCA, elevation of CK-MB was associated with higher risk of subsequent cardiac events and mortality.¹⁷

Completeness of revascularization was similar in both groups, but the study was conducted in relatively young patients with predominantly 1- or 2-vessel disease and normal left ventricular function. Old patients with generalized vascular disease and poor left ventricular function may benefit more from an off-pump technique,²⁵ because the risk of adverse outcomes after on-pump CABG in these patients is much higher.^2,26,27 Conversely, off-pump procedures in these patients carry a greater risk of hemodynamic instability or inadequate revascularization.

In conclusion, the results of this randomized trial in 281 patients suggest that in selected patients, off-pump CABG is safe and yields a short-term cardiac outcome comparable to that with on-pump CABG. In addition, omitting CPB leads to reduced cardiac enzyme release, reduced use of blood products, and a slightly shorter hospital stay.

	Acknowledgments

 
This randomized clinical trial was funded entirely by the Netherlands National Health Insurance Council (grant OG 98-026). In addition to the authors, the following investigators participated in the Octopus Study Group. From University Medical Center Utrecht: J. Bredée, A. Brutel de la Rivière, F. Eefting, R. Hijman, R. Kahn, C. Kalkman, A. Keizer, J. Knape, J. Lahpor, K. Moons, P. Stella; from Isala Clinics Zwolle: H. Suryapranata; from Antonius Hospital Nieuwegein: S. Ernst; data safety monitoring committee: A. Algra, D. Erkelens, H. Koomans; critical event committee: L. Kappelle, J. Kirkels, and H. Wesenhagen.

	Footnotes

 
Dr Borst serves as a consultant to Medtronic. Dr Jansen serves on the scientific advisory board of Medtronic. Medtronic is the manufacturer of the Octopus stabilizer for off-pump coronary bypass surgery used for this study.

*Other participants in the Octopus Study Group are listed in the Acknowledgments.

Received June 19, 2001; revision received July 30, 2001; accepted July 31, 2001.

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				E. L. Hannan, C. Wu, C. R. Smith, R. S.D. Higgins, R. E. Carlson, A. T. Culliford, J. P. Gold, and R. H. Jones Off-Pump Versus On-Pump Coronary Artery Bypass Graft Surgery: Differences in Short-Term Outcomes and in Long-Term Mortality and Need for Subsequent Revascularization Circulation, September 4, 2007; 116(10): 1145 - 1152. [Abstract] [Full Text] [PDF]

				A. Ballotta, H. Z. Saleh, H. W. El Baghdady, M. Gomaa, F. Belloli, H. Kandil, Y. Balbaa, F. Bettini, E. Bossone, L. Menicanti, et al. Comparison of early platelet activation in patients undergoing on-pump versus off-pump coronary artery bypass surgery J. Thorac. Cardiovasc. Surg., July 1, 2007; 134(1): 132 - 138. [Abstract] [Full Text] [PDF]

				Y.-N. Youn, Y.-L. Kwak, and K.-J. Yoo Can the EuroSCORE Predict the Early and Mid-Term Mortality After Off-Pump Coronary Artery Bypass Grafting? Ann. Thorac. Surg., June 1, 2007; 83(6): 2111 - 2117. [Abstract] [Full Text] [PDF]

				E. Sisillo, M. R. Marino, G. Juliano, C. Beverini, L. Salvi, and F. Alamanni Comparison of on pump and off pump coronary surgery: risk factors for neurological outcome Eur. J. Cardiothorac. Surg., June 1, 2007; 31(6): 1076 - 1080. [Abstract] [Full Text] [PDF]

				The Society of Thoracic Surgeons Blood Conservatio, V. A. Ferraris, S. P. Ferraris, S. P. Saha, E. A. Hessel II, C. K. Haan, B. D. Royston, C. R. Bridges, R. S.D. Higgins, G. Despotis, et al. Perioperative Blood Transfusion and Blood Conservation in Cardiac Surgery: The Society of Thoracic Surgeons and The Society of Cardiovascular Anesthesiologists Clinical Practice Guideline Ann. Thorac. Surg., May 1, 2007; 83(5_Supplement): S27 - S86. [Abstract] [Full Text] [PDF]

				G. Palmer, M. A. Herbert, S. L. Prince, J. L. Williams, M. J. Magee, P. Brown, M. Katz, and M. J. Mack Coronary Artery Revascularization (CARE) Registry: An Observational Study of On-Pump and Off-Pump Coronary Artery Revascularization Ann. Thorac. Surg., March 1, 2007; 83(3): 986 - 992. [Abstract] [Full Text] [PDF]

				J. Dunning, T. Treasure, M. Versteegh, S. A.M. Nashef, and on behalf of the EACTS Audit and Guidelines Commit Guidelines on the prevention and management of de novo atrial fibrillation after cardiac and thoracic surgery Eur. J. Cardiothorac. Surg., December 1, 2006; 30(6): 852 - 872. [Full Text] [PDF]

				S S Panesar, T Athanasiou, S Nair, C Rao, C Jones, M Nicolaou, and A Darzi Early outcomes in the elderly: a meta-analysis of 4921 patients undergoing coronary artery bypass grafting--comparison between off-pump and on-pump techniques Heart, December 1, 2006; 92(12): 1808 - 1816. [Abstract] [Full Text] [PDF]

				A. Sedrakyan, A. W. Wu, A. Parashar, E. B. Bass, and T. Treasure Off-Pump Surgery Is Associated With Reduced Occurrence of Stroke and Other Morbidity as Compared With Traditional Coronary Artery Bypass Grafting: A Meta-Analysis of Systematically Reviewed Trials * Supplemental Appendix I Stroke, November 1, 2006; 37(11): 2759 - 2769. [Full Text] [PDF]

				J. Tatoulis, S. Rice, P. Davis, J. C. Goldblatt, and S. Marasco Patterns of postoperative systemic vascular resistance in a randomized trial of conventional on-pump versus off-pump coronary artery bypass graft surgery. Ann. Thorac. Surg., October 1, 2006; 82(4): 1436 - 1444. [Abstract] [Full Text] [PDF]

				T. P. Martens, M. Argenziano, and M. C. Oz New Technology for Surgical Coronary Revascularization Circulation, August 8, 2006; 114(6): 606 - 614. [Full Text] [PDF]

				B. O. Jensen, P. Hughes, L. S. Rasmussen, P. U. Pedersen, and D. A. Steinbruchel Health-related quality of life following off-pump versus on-pump coronary artery bypass grafting in elderly moderate to high-risk patients: a randomized trial. Eur. J. Cardiothorac. Surg., August 1, 2006; 30(2): 294 - 299. [Abstract] [Full Text] [PDF]

				J. Vedin, H. Nyman, A. Ericsson, S. Hylander, and J. Vaage Cognitive function after on or off pump coronary artery bypass grafting. Eur. J. Cardiothorac. Surg., August 1, 2006; 30(2): 305 - 310. [Abstract] [Full Text] [PDF]

				A. J. Rastan, J. I. Eckenstein, B. Hentschel, A. K. Funkat, J. F. Gummert, N. Doll, T. Walther, V. Falk, and F. W. Mohr Emergency Coronary Artery Bypass Graft Surgery for Acute Coronary Syndrome: Beating Heart Versus Conventional Cardioplegic Cardiac Arrest Strategies Circulation, July 4, 2006; 114(1_suppl): I-477 - I-485. [Abstract] [Full Text] [PDF]