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Ann Thorac Surg 2000;69:704-710
© 2000 The Society of Thoracic Surgeons
a Cardiac Surgical Associates, PA, Minneapolis, Minnesota, USA
Address reprint requests to Dr Arom, Cardiac Surgical Associates, PA, 920 E 28th St, Suite 420, Minneapolis, MN 55407
e-mail: karom{at}csa-heart.com
Presented at the Forty-sixth Annual Meeting of the Southern Thoracic Surgical Association, San Juan, Puerto Rico, Nov 46, 1999.
| Abstract |
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Methods. Three hundred and fifty OPCAB patients were compared to 3,171 on-pump or conventional coronary artery bypass (CCAB) patients between January 1, 1997 and December 31, 1998. The groups were divided into three preoperative predicted risk categories: low-risk (0 to 2.59%), medium-risk (2.6 to 9.9%), and high-risk (
10%). Society of Thoracic Surgeons National Cardiac Surgery Database definitions and predicted risk group models were utilized to compare all preoperative, intraoperative, and postoperative variables using univariate analysis.
Results. Overall comparison of the immediate outcome of CCAB and OPCAB shows little statistical significance in the variables analyzed. The operative mortality was 3.4% in both groups. When the immediate outcome was compared between groups (CCAB vs OPCAB), as well as individual risk groups (low, medium, and high), similar patterns of operative variables and postoperative complications were observed. The operative mortality in the low-risk group was 1.1% for CCAB and 1.4% for OPCAB; 7% for CCAB and 6% for OPCAB in the medium-risk group; and in the high-risk group 28.5% for CCAB compared to 7.7% for OPCAB group (p = 0.008). Short-term follow-up shows a trend of increased recurring angina and reinterventional procedures in the OPCAB patients.
Conclusions. Safety for OPCAB is assessed through retrospective data review. Longitudinal follow-up for survival, reintervention, and quality of postoperative document efficacy and patency rates, compared to on-pump procedures, is mandatory. This study documented the immediate safety of the OPCAB procedure. Preliminary findings at 1-year follow-up is an important finding in this study, but it is not conclusive at this time. Long-term longitudinal follow-up is required to assess the future effectiveness of OPCAB.
| Introduction |
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| Material and methods |
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10%).
There were 2,360 CCAB and 216 OPCAB patients in risk group I, 688 CCAB and 95 OPCAB patients in risk group II, and 123 CCAB and 39 OPCAB patients in risk group III. Preoperative, intraoperative, and postoperative variables, including 1-year follow-up were compared in each risk group using univariate analysis (
2, Fischers exact test) and Students t test. CCAB was deemed the control group in all statistical analysis.
Telephone follow-up was conducted 6 months postoperatively by a cardiac registered nurse. Telephone interview allowed for probing for information regarding patient reported angina, chest or wall pain. At 1-year post, a survey was mailed to all known survivors, with guaranteed return if address unknown. The results of these surveys were then entered into a database and matched with patients corresponding date of procedure.
The analysis of variables (Appendix) between CCAB and OPCAB patients in each risk group were analyzed separately, and only those with p values of equal to or less than 0.05 are discussed in detail.
Off-pump coronary artery bypass operation
Off-pump coronary artery bypass operation was carried out through a sternotomy incision, with or without take down of the left internal mammary artery, in the usual fashion. Three deep pericardial traction stitches were placed near the left upper and lower pulmonary veins and to the left of inferior vena cava, thereby achieving elevation of the apex of the heart. With perfectly placed stitches and aggressive traction, the apex of the heart should be elevated to about 90 degrees. To further assist in providing good presentation of the target arteries on the lateral and inferior aspect of the heart, patients were placed in a gentle right decubitus Trendelenburg position. Stabilization of the target arteries in the early phase of the study was accomplished with the CTS tissue stabilizer (Cardiothoracic Systems Inc, Cupertino, CA) and recently with Octopus II stabilizer (Medtronic Inc, Minneapolis, MN). With addition of suction capability of the Octopus device, the presentation and stabilization of the remote target arteries near circumflex trunk were feasible. The quality of anastomosis was assessed at the time of operation in about 50% of the cases utilizing transonic flow meter (Transonic, Inc, Ithaca, NY).
On-pump coronary artery bypass operation
On-pump coronary artery bypass surgery was carried out through a full sternotomy incision, with or without the internal mammary artery taken down, in the usual fashion. Institution of cardiopulmonary bypass was achieved by cannulating the ascending aorta and right atrium. Retrograde cardioplegia of either blood or crystalloid solution was delivered for myocardial protection of the arrested heart. All cardiopulmonary bypasses were accomplished with centrifugal pump and membrane oxygenator.
Treatment of all patients in both groups followed standard care and processes from operation until discharge. This included admission to the intensive care unit from the operating room with subsequent transfer to an intermediate care ward within 24 hours, or as dictated by the patient clinical status according to standard practice guidelines. A hospital designed extubation protocol that targets extubation within 4 hours postoperatively was followed.
| Results |
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Overall comparison of CCAB and OPCAB patients
Overall comparison of CCAB to OPCAB (Table 1) revealed a significant difference in predicted risk (2.6 ± 4.6% CCAB vs 4.3 ± 7.4% OPCAB, p
0.001), first operation (94% CCB vs 85% OPCAB, p
0.001), and ejection fraction (56 ± 14% CCAB vs 52 ± 15% OPCAB, p
0.001).
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Postoperative complication variables showed that there were no significant differences in the in number of patients who suffered from neurological deficits such as permanent stroke (2.0% CCAB vs 1.4% OPCAB, p = 0.429) and transient ischemic attack (0.9% CCAB vs 0.3% OPCAB, p = 0.357).
Even though operating room time was extended, increased cardiac enzyme levels and blood loss, longer ventilation, intensive care unit hours, length of stay (LOS) in the CCAB patients, their postoperative complications were comparable to the OPCAB population. Difference arose in reoperation for bleed (2.2% CCAB vs 1.4% OPCAB, p = 0.003) and reoperation for graft occlusion (0.1% CCAB vs 1.4% OPCAB, p < 0.001). Between the CCAB and the OPCAB there was only a slight significance in perioperative myocardial infarction (2.2% CCAB vs 0.6% OPCAB, p = 0.043), however, patients that developed new atrial fibrillation showed high significance (23% CCAB vs 14% OPCAB, p
0.001). New atrial fibrillation excluded patients with preoperative atrial fibrillation censored out of the analysis. New renal failure, which was censored for preoperative renal failure and defined as a rise in serum creatinine level of higher than 2 mg/dL postoperatively, showed no significance (6% CCAB vs 5% OPCAB, p = 0.324). Operation to discharge length of stay was 1 day longer in the CCAB group (7.1 ± 6.4 days) compared to OPCAB (6.1 ± 3.6 days) and did show statistical significance. Return to intensive care unit and readmission to the hospital after 30 days showed no significance. Operative mortality was not significant between the two groups (3.4% CCAB vs 3.4% OPCAB, p = 0.958).
Low-risk group (predicted risk of 0 to 2.59%)
When comparing CCAB to OPCAB in the low-risk group (Table 2), preoperative demographics and comorbidities showed OPCAB patients were younger (63 ± 10 CCAB vs 61 ± 12 OPCAB, p = 0.017) and had a greater defect in global ejection fraction (59% CCAB vs 56% OPCAB, p = 0.007). There were no other demographic differences between the two groups except prior smoking history, which is more common in OPCAB patients (p = 0.039).
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Medium-risk group (predicted risk of 2.9 to 9.9%)
OPCAB patients were older and had more elective cases (Table 2). The CCAB group however, had more patients in New York Heart Association functional class IV. The number of grafts per patient in both groups was similar to the low-risk patients. Again like the low-risk group, CCAB had longer operative times, intubation times and intensive care unit hours. There was more blood loss (704 ± 493 cc CCAB vs 432 ± 283 cc OPCAB, p
0.001), higher peak CPK (842 ± 784 ng/mL CCAB vs 431 ± 415 ng/mL OPCAB, p
0.001), and increased occurrence of new atrial fibrillation (27% CCAB vs 18% OPCAB, p = 0.053) in the CCAB group. The operative mortality was not significant between groups (6.5% CCAB vs 6.3% OPCAB, p = 0.934).
High-risk group (predicted risk of 20.1 to 20.4%)
The preoperative characteristics of patients in this group were similar, except the incidence of peripheral vascular disease (31% CCAB vs 54% OPCAB, p = 0.009) and COPD (18% CAB vs 33% OPCAB, p = 0.041) in OPCAB group (Table 2). Again the CCAB patients in the high-risk group had longer operative times, longer intensive care unit hours, and longer postoperative hospital stay. The CCAB group had greater cardiac enzyme excretion and number of patients requiring pacing during the first 24 hours (27% CCAB vs 5% OPCAB, p = 0.004). There is prominent difference in operative mortality between these groups in this risk category (28.5% CCAB vs 7.7% OPCAB, p = 0.008).
Follow-up results
Follow-up was completed in 3077 patients at the end of 1 year (28,587 patient months) (Table 3). One hundred sixty-eight total patients died (119 operative deaths and 49 late deaths), and 276 total patients were lost to follow-up resulting in a 66% 1-year complete follow-up. The total actual survival was 95.2%.
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Comparison of follow-up data between predicted risk group
There was no significant difference in the general health between any of the risk groups (risk group I, 88% CCAB vs 80% OPCAB, p = 0.065; risk group II 77% CCAB vs 76% OPCAB, p = 0.922; risk group III 63% CCAB vs 75% OPCAB, p = 0.507). There was no significant difference between risk groups of the number of patients who rated their health as much better now or better than before operation (risk group I, 76% CCAB vs 72% OPCAB; p = 0.686, risk group II, 76% CCAB vs 69% OPCAB; p = 0.405, risk group III, 71% CCAB vs 83% OPCAB, p = 0.479). At 1 year, there was evidence found in the low-risk group, OPCAB patients had a higher incidence of chest pain or chest tightness (20% CCAB vs 36% OPCAB, p = 0.003). This is also true in the medium risk group (25% CCAB vs 43% OPCAB, p = 0.026) however, this finding was not present in the highest stratified risk group (32% CCAB vs 50% OPCAB, p = 0.295). Readmission overnight since operation for angina and angioplasty or stent was significant between CCAB and OPCAB in the low-risk group (angina 8% CCAB vs 22% OPCAB, p < 0.001; and PTCA 2% CCAB vs 13% OPCAB, p < 0.001). In the medium-risk and high-risk groups, readmission for cardiac events were no longer significant (angina 10% CCAB vs 20% OPCAB, p = 0.127; and PTCA 2% CCAB vs 3% OPCAB, p = 0.541); and (angina 15% CCAB vs 42% OPCAB, p = 0.100 and PTCA 3% CCAB vs 8% OPCAB, p = 0.412), respectively.
| Comment |
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Risk group comparison of CCAB and OPCAB
The limitation of this study is that it is a nonrandomized retrospective review comparing the preoperative and postoperative course of multivessel coronary patients operated off-pump to patients operated with conventional cardiopulmonary bypass under cardioplegic arrest. One particular surgical approach was largely influenced by surgeons preference. When the preoperative demographics and comorbidities in the overall group and predicted risk groups were analyzed, it showed little variation between CCAB and OPCAB.
Intraoperatively, the difference between groups in regard to the number of grafts per patient needs further clarification. The number of grafts per patient in this study was 3.2 for the CCAB patients. This number is slightly less than the average number of grafts per patient in our current overall surgical experience. However, when reviewing the OPCAB group, there are significantly fewer grafts per patient (2.1, p < 0.001) as compared to the CCAB group, and the number of grafts per patient in this OPCAB group declines and appears to be associated with the preoperative predicted risk of mortality (low-risk group, 2.3 grafts per patient; medium-risk group, 2.0 grafts per patient; and high-risk group, 1.6 grafts per patient.). Arguably, this finding could suggest an unmatched comparison between the 2 groups and may represent incomplete bypass in the OPCAB patients. In early 1997, the OPCAB group reported in this study included cases performed during a learning period, and some preselection for the patients with fewer diseased vessels occurred. But all of the patients in these 2 groups were consecutive and were done within the same time frame. The increased recurring angina noted in OPCAB group at the end of 1 year could be related to incomplete bypass and fewer grafts per patient.
In terms of skin-to-skin time, time to complete operation was consistent for CCAB patients in all risk groups, and the average for entire group was 230 ± 70 minutes. In OPCAB patients, the skin-to-skin time also very similar among the three risk groups (average 171 ± 53 minutes). The difference in procedure time between groups is related to time spent for cannulation, cardioplegic arrest, higher number of grafts per patient, and the process of rewarming after cardiopulmonary bypass.
When blood losses were analyzed, both intraoperatively and within the first 24 hours, it was shown that there were no significant differences in the amount of blood loss among three risk groups, in either on or off-pump patients, but overall blood loss per patient was higher in the CCAB patients. These results are undoubtedly related to extracorporeal circulation and possibly to less heparin use in the OPCAB patients.
The perioperative myocardial infarction rate deserves mentioning. Our findings showed the average incidence of perioperative myocardial infarction was 2.2% in CCAB and 0.5% in OPCAB patients (p = 0.043). This confirmed the most recent reported study Bouchard and Cartier [6], and proved that despite cardiac elevation, hypotensive episodes and bluish color from venous congestion of the myocardium, beating heart operation can provide adequate myocardial protection when compared to cardioplegic arrest.
The difference in neurologic complications between on and off-pump patients remains unclear. Our study only documented early postoperative incidence of permanent stroke (2.0% CCAB vs 1.4% OPCAB, p = 0.429) and transient neurological deficit (0.9% CCAB vs 0.3 OPCAB, p = 0.357). However, in 1999 Taggart and colleagues [7] showed a pattern of early decline and late recovery of cognitive function in patients undergoing CABG with and without cardiopulmonary bypass. This suggests that cardiopulmonary bypass is not the major cause of postoperative cognitive impairment. The incidence of stroke increased in the CCAB patients as the predicted risk increased, but there were no strokes or neurological deficit in high-risk off-pump patients despite having more severe peripheral vascular disease (PVD) documented prior to operation.
Postoperatively, the incidence of new renal failure, developed more in overall CCAB patients and in each risk group, but without any statistical significance, except in the high-risk patients where the difference was as high as 21% CCAB vs 3% OPCAB (p = 0.006). This supports the recent findings by Ascione and associates [8]. In this study, creatinine clearance and urinary microalbumin to creatinine ratio was significantly worse in the CCAB group suggesting that off-pump coronary revascularization offers superior renal protection when compared with conventional coronary revascularization with cardiopulmonary and cardioplegic arrest.
Many practitioners view new atrial firbrillation as one of the most worrisome postoperative complications. This concern is not related to the medical severity but primarily to cost-effectiveness of the fast tract recovery after coronary artery bypass operation. Our observation has shown that new atrial fibrillation could delay LOS with an average of 2.4 days. In this study, the incidence of new atrial fibrillation was higher in the CCAB group. This supports the finding of Abreu and coworkers [9], who also noted incidence of new atrial fibrillation to be 26% in CCAB and 12% in OPCAB patients. They also found no significant predictive clinical variables for postoperative atrial fibrillation.
The overall operative mortality in both groups confirms that OPCAB can be carried out with the same mortality as CCAB, and this can be translated to the safety and efficacy of the OPCAB procedure. When each risk group (CCAB and OPCAB) were analyzed, the operative mortality in the low-risk groups were near identical (1.1% CCAB vs 1.4% OPCAB, p = 0.736). These results are very near the preoperative predicted risk noted by looking at the observed (O) and expected (E) operative mortality (O/E ratio of 1.0 CCAB and 1.2 OPCAB). In the medium-risk group, the operative mortality in the CCAB group was 6.5% and 6.3% in the OPCAB group; also the O/E ratio was close with 1.4 CCAB and 1.3 OPCAB, respectively. These findings again reassure the operative safety of the OPCAB procedure particularly in the low and medium-risk patients. There is, however, a striking difference in the high-risk patients. The preoperative predicted (expected) risk in CCAB was 20.1% and observed mortality was 28.5% with an O/E of 1.4. However, the observed mortality in the high-risk OPCAB group (7.7%) was markedly lower than the predicted risk of 20.4% with O/E ratio of 0.03. The causes of death in all of these risk groups are beyond the scope of this discussion. This finding suggests the high-risk group benefits from OPCAB operation. The overall findings suggested the operative risk of OPCAB operation in this study is not higher than the gold standard procedure of CCAB.
Short-term follow-up revealed the total actual survival was 95.2% for both groups. The causes of death in these two groups are beyond the scope of this communication. At 1-year follow-up, both CCAB (85%) and OPCAB (78%) patients feel that their general health is now good or better than good and 76% of CCAB and 72% of OPCAB feel that they are better now than before operation. Therefore, the overall improvement in general health is similar for both groups. There is a trend however, OPCAB patients have more angina and require more reinterventional procedures 1 year after operation. The nature of the lesions encountered at the time of this study are not known, and the relationships to either of the techniques cannot be made. This could be related to the technical aspects during the learning period and incomplete bypass. The importance of complete surgical revascularization is beyond the scope of this presentation. Medium and long-term follow-up is necessary before a definite conclusion can be made in this group of patients.
In this study, the safety of OPCAB procedure is assessed through a retrospective data review. Longitudinal follow-up for survival, quality of life and reintervention after the procedure documenting the efficacy of the OPCAB compared to the gold standard on-pump procedure using operative mortality and early postoperative complications as indicators. This study showed that off-pump operation maybe as safe as the on-pump procedure, and may be considered as an alternative especially in the high-risk patient population. The short-term findings of increased recurring angina and need of interventional procedures in the OPCAB group is important, but it is not conclusive at the present time. Long-term efficacy of off-pump technique however, remains to be answered.
| Appendix |
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Intraoperative data: Operation room skin-to-skin times, operation room in-room to out-of-room times, estimated blood loss in the operating room, estimated blood loss in first 24 hours, creatine phosphokinase peak and myocardial band enzymes, paced in the first 24 hours, intraaortic balloon usage (pre, intra, and postinsertion), intubation, and intensive care unit times.
Postoperative data: reoperation for bleed and graft occlusion, deep sternal wound infection, permanent stroke, transient ischemic attack, perioperative myocardial infarction, thoracentesis, new renal failure and atrial fibrillation, return to intensive care, operative mortality, and readmission to the hospital within 30-days of discharge.
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P.-G. Chassot, P. van der Linden, M. Zaugg, X. M. Mueller, and D. R. Spahn Off-pump coronary artery bypass surgery: physiology and anaesthetic management{dagger} Br. J. Anaesth., March 1, 2004; 92(3): 400 - 413. [Abstract] [Full Text] |