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Ann Thorac Surg 2004;77:789-793
© 2004 The Society of Thoracic Surgeons
a Department of Cardiac Surgery, Kralovske Vinohrady University Hospital, 3rd Medical School of Charles University, Prague, Czech Republic
b Department of Cardiology, Kralovske Vinohrady University Hospital, 3rd Medical School of Charles University, Prague, Czech Republic
Accepted for publication August 28, 2003.
* Address reprint requests to Dr Straka, Department of Cardiac Surgery, Kralovske Vinohrady University Hospital, Srobarova 50, 100 34 Prague, Czech Republic.
e-mail: straka{at}fnkv.cz
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Abstract |
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 Top Abstract IntroductionPatients and methodsResultsCommentAcknowledgmentsReferences |
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METHODS: A total of 400 consecutive nonselected patients (mean age 63 years) scheduled for isolated coronary revascularization were randomized by a cardiologist into two groups: A (on-pump) and B (off-pump). The cardiac surgeon was allowed to change the operative technique at any time after randomization. The only exclusion criterion was an emergency procedure. The primary end point was any of the following within 30 days: death, myocardial infarction, stroke, or new renal failure requiring hemodialysis. The study was analyzed on the intention-to-treat principle.
RESULTS: The primary end point occurred in 4.9% of patients in group A versus 2.9% in group B (not significant). Mortality was 1.1% in group A versus 2.0% in group B (not significant). Preoperative crossover occurred in 5.4% of patients in each group (not significant). Intraoperative conversion was necessary in 9.8% of patients in group B versus 1.1% of patients in group A (p < 0.001). Group B patients had fewer distal anastomoses (2.3 versus 2.7 in group A; p < 0.001), less blood loss (560 versus 680 mL; p < 0.001), lower postoperative creatine kinase MB levels (0.15 versus 0.56 µkat/L; p < 0.001) and lower total hospital costs (
3,451 versus 4,387; p < 0.001).
CONCLUSIONS: In our study off-pump technique was applicable in 85% of nonselected patients and is at least as clinically safe and effective as on-pump surgery.
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Introduction |
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TopAbstractIntroductionPatients and methodsResultsCommentAcknowledgmentsReferences |
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The aim of this prospective, randomized study was to estimate the role of OPCAB among unselected coronary artery bypass grafting surgery candidates. This paper presents our final 30-day results.
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Patients and methods |
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TopAbstractIntroductionPatients and methodsResultsCommentAcknowledgmentsReferences |
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Between May 2000 and June 2002, 400 patients were randomized, 192 into group A and 208 into group B. Three of them withdrew the informed consent, 7 underwent percutaneous coronary intervention, and 2 were lost to follow-up before surgery. Finally, 184 and 204 patients underwent surgery, respectively. Preoperative data are shown in Table 1. Group B (off-pump) included more women (p = 0.02). The two groups did not show any statistically significant difference in the other variables.
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Anesthetic technique
With the patient supine on the operating table, general anesthesia was induced using midazolam 5 to 10 mg and fentanyl 250 to 500 µg or sufentanil 25 to 50 µg. Relaxation of the patient with pancuronium 8 to 12 mg was followed by tracheal intubation. Anesthesia was further managed by inhalation of isoflurane –carrier gas oxygen/air, with the addition of fentanyl to a total dose of 750 to 1,000 µg or sufentanil to a total dose of 75 to 100 µg. Propofol was administered continuously toward the end of the procedure, as necessary.
Surgical technique
In all cases surgical access was through median sternotomy. Then the left internal mammary artery and great saphenous vein were harvested.
Group A—on-pump
Cardiopulmonary bypass was established by standard ascending aortic cannulation and two-stage venous cannulation of the right atrium. Heparin was given at a dose of 300 IU/kg to achieve an activated clotting time of 480 seconds. Normothermic perfusion with antegrade intermittent cold crystalloid cardioplegia was used in all patients. On completion of all anastomoses, protamine was given to reverse the effect of heparin.
Group B—off-pump
Heparin was given at a dose of 100 IU/kg. Access to the anastomosis site was gained by heart elevation, initially with deep pericardial stay sutures, then with the suction Axius Xpose Device (Guidant, Cupertino, CA). The Access Ultima System (Guidant) or Ultima Vacuum Assist (Guidant) device was used for stabilization of the anastomosis site. If signs of electrocardiographic or hemodynamic instability appeared, an intraluminal FloCoil Shunt (Guidant) was inserted. In other cases, bleeding of the anastomosis site was controlled using a silicone surgical tape (Quest, Allen, TX) placed above and below the anastomosis. After performing the central anastomoses with partial clamping, the heparinization was reversed with protamine. Reductions in arterial pressure caused by handling of the heart, if any, were mostly compensated by sufficient volume filling and by placing the patient in a Trendelenburg position. In some cases, vasopressors (methoxamine) were injected in a bolus or intravenous catecholamines (Dobutrex) were given for maintenance of adequate perfusion pressure.
Both groups of patients received aspirin from the first postoperative day. All operations were performed by four cardiac surgeons experienced in both off-pump and on-pump technique.
Study end point and definition of terms
A combined primary end point was selected for the study: death, Q-myocardial infarction, cerebrovascular accident, or renal failure requiring hemodialysis within 30 days after procedure.
Death was defined as death from any cause within 30 days of surgery. Q-myocardial infarction was defined as electrocardiographic sign of necrosis, creatine kinase (CK) and CK-MB elevation, or new akinetic segment at echocardiogram. Cerebrovascular accident was defined as global or focal neurologic deficit, lasting less or more than 24 hours. Renal failure was defined as a new requirement for dialysis.
Statistical assessment
Data were analyzed on the intention-to-treat principle, which means that the analysis per group was based on random allocation and not on the actually used procedure.
Means of continuous variables were compared by two-sample Student's t test. The nonnormally distributed continuous data were presented using the medians and were compared by Mann-Whitney U test. The hypothesis of congruence between the mean values in time was tested by analysis of variance with repeated measurements. The hypothesis of congruence between percentages in the contingency table was tested by 
2 statistics, with Yates correction for small expected frequencies. All tests were performed at a significance level of 0.05.
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Results |
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TopAbstractIntroductionPatients and methodsResultsCommentAcknowledgmentsReferences |
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Perioperative data are summarized in Table 2. The lower mean number of anastomoses per patient in group B reached statistical significance (p < 0.001). The left internal mammary artery was more frequently used in group B (p = 0.01). Difference in bypass distribution among three coronary arteries did not reach statistical significance.
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Comment |
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TopAbstractIntroductionPatients and methodsResultsCommentAcknowledgmentsReferences |
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In comparison with other studies using detailed statistical analysis of registry data relating to thousands of operations [4–7], our study did not show any significant reduction in postoperative mortality or morbidity. One of the potential reasons may be selection made by the cardiac surgeon in the former studies. Although the patients indicated for OPCAB may be older and may have more underlying diseases, the preoperative data usually vary as follows: the OPCAB patients usually have better ejection fraction of the left ventricle and lower rates of three-vessel disease and reoperations. In addition, they tend not to have the thin, diffuse, heavily calcified or intramyocardial coronary arteries predictive of a poorer cardiac outcome. Assessment of the results of our study was also influenced by a relatively low rate of serious complications in the on-pump group.
The length of hospital stay was 5 days for both of our study groups, whereas the Dutch study reports a statistically significant difference in hospital stay between the off-pump and on-pump groups, ie, 6 and 7 days, respectively.
No significant difference in intubation time was found between our two study groups. Nevertheless, in an attempt to evaluate the effect of the OPCAB technique alone, we used standard intravenous fentanyl anesthesia for the two study groups. Much shorter intubation time could be achieved thanks to our experience gained with ultrafast track anesthesia [8], which we now use routinely. With this technique, more than 90% of patients undergoing OPCAB can be extubated in the operating room just after skin closure [9]. The use of the off-pump revascularization procedure coupled with thoracic epidural anesthesia without need for intubation also enables operation even in those patients whose impaired respiratory function precludes standard coronary artery surgery [10].
In agreement with another randomized study [11] we have demonstrated off-pump surgery to be significantly less costly than conventional surgery.
A marked reduction of CK and CK-MB levels in the off-pump group is indicative of less damage to the myocardium by partial occlusion of coronary arteries compared with the global ischemia from complete cardiac arrest. Nevertheless, any effect on clinical outcome was not demonstrated.
In agreement with most studies, we confirmed a reduced number of bypass grafts in the group undergoing surgery without CPB. Distribution of distal anastomoses among three coronary arteries is very similar in the two groups, but group B patients showed a tendency toward a more frequent location of anastomoses in the area of the left anterior descending artery and less frequent location in the area of the right coronary artery. The percentages of anastomoses to the circumflex artery branches were almost the same in both groups. The lower rate of bypasses per patient in our study seems to be related to the arterial size and quality rather than location. In the presence of a calcified coronary artery of insufficient diameter, the cardiac surgeon might be expected to refuse to make an anastomosis more frequently rather than to convert to CPB. Our early results did not show any impact of this fact on the clinical outcome. The clinical impact of lower numbers of grafts per patient will become apparent at longer-term follow-up.
The population of patients undergoing surgical coronary revascularization has continued to become older and sicker [12]. These are exactly the types of patients who should benefit from OPCAB surgery [13].
In our study, the cardiac surgeon decided to change the technique in 5.4% of patients of each of the study groups before the operation. In 10 patients randomized into group A, the reasons for avoiding the use of CPB were the patient's age, indication for left anterior descending coronary artery single bypass, or the presence of multiple underlying diseases. Eleven younger group B patients needed the use of CPB because of planned multiple revascularization and the suggestion of small coronary size at coronary angiography. Two group A patients were converted to the off-pump procedure in the course of surgery because of previously unsuspected arteriosclerosis of the ascending aorta. Twenty patients needed conversion to CPB in the course of surgery. In most cases, the reasons were the presence of small or intramuscular arteries and heavy calcification. Six patients were converted for hemodynamic instability.
Multiple data have been currently available about OPCAB, but there are few randomized studies. Furthermore, most data originate from studies or registries in which patients were selected for off-pump surgery by a cardiac surgeon after he considered them to be candidates for beating heart surgery. Objective evaluation of the benefits and possibilities of the off-pump technique for the surgical treatment of ischemic heart disease is difficult; nevertheless, in agreement with other authors [14, 15], we consider studies in a prospective, randomized fashion to be the source of the most objective data.
Our study was designed to eliminate the possible effect of the cardiac surgeon on randomization and to limit the exclusion criteria. The patients were randomized by a cardiologist, and the cardiac surgeon was allowed to change the operative technique at any time, but was not allowed to influence the decision as to who could be randomized. The only exclusion criterion was an emergency procedure. Thus, this study presents truly unselected surgical patients, including those with acute coronary syndromes.
In our center, the OPCAB technique was applicable in 85% of consecutive surgical patients. It reduces costs and is at least as clinically effective and safe as CPB surgery. On the basis of intention-to-treat analysis, the OPCAB procedure shows the same results as CPB surgery does. However, patients in whom the off-pump technique was finally used (ie, 85% of the patients randomized to OPCAB) tended to have better outcomes.
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Acknowledgments |
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TopAbstractIntroductionPatients and methodsResultsCommentAcknowledgmentsReferences |
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References |
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TopAbstractIntroductionPatients and methodsResultsCommentAcknowledgmentsReferences |
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