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Ann Thorac Surg 2001;72:788-792
© 2001 The Society of Thoracic Surgeons


Original article: cardiovascular

Off-pump bypass grafting is safe in patients with left main coronary disease

Todd M. Dewey, MDa, Mitchell J. Magee, MDa, James R. Edgerton, MDa, Megumi Mathison, MDa, Denise Tennison, RNa, Michael J. Mack, MDa

a Cardiopulmonary Research Science and Technology Institute, Dallas, Texas, USA

Address reprint requests to Dr Dewey, 7777 Forest Lane, Suite A323, Dallas, TX 75230
e-mail: tdewey{at}csant.com

Presented at the Forty-sixth Annual Meeting of the Southern Thoracic Surgical Association, San Juan, Puerto Rico, Nov 4–6, 1999.


    Abstract
 Top
 Abstract
 Introduction
 Material and methods
 Results
 Comment
 Acknowledgments
 Discussion
 References
 
Background. Because of a concern about the ability to tolerate beating heart grafting, patients with left main coronary artery stenosis have been excluded from off-pump bypass. We reviewed our experience with off-pump coronary artery bypass grafting for patients with left main coronary artery disease.

Methods. Eight hundred twenty-three patients underwent bypass grafting for left main coronary artery disease from January 1998 to October 1999. One hundred patients were revascularized without the use of cardiopulmonary bypass and compared with a contemporaneous cohort of 723 patients who underwent grafting with the aid of cardiopulmonary bypass. All patients had multivessel grafting performed through a sternotomy.

Results. There was one death (1%) in the group undergoing off-pump grafting as compared with a 30-day mortality of 4.7% (p = 0.059) in the on-pump group. Univariate analysis established that patients revascularized without cardiopulmonary bypass were significantly less likely to require postoperative inotropic support (23% versus 62%, p < 0.001) and transfusion (35% versus 67%, p < 0.001). Logistic regression analysis revealed that cardiopulmonary bypass was an independent risk factor for mortality (odds ratio, 7.3; 95% confidence interval, 1.34 to 138.4).

Conclusions. Coronary artery bypass grafting using off-pump techniques are safe and effective in left main coronary artery disease.


    Introduction
 Top
 Abstract
 Introduction
 Material and methods
 Results
 Comment
 Acknowledgments
 Discussion
 References
 
Cardiac surgery advanced dramatically as a specialty with the introduction of cardiopulmonary bypass (CPB) by Gibbon in 1953 [1]. The capability to perform intracardiac and extracardiac procedures advanced the surgical care of both congenital and acquired heart disease. However, CPB has many known pathologic effects, which include volume retention, coagulopathy, release of systemic inflammatory mediators, pulmonary dysfunction, stroke, and neurocognitive changes [29].

Patients identified with left main coronary artery stenosis are acknowledged to be at increased risk with medical therapy alone as compared with surgical revascularization [10]. Commendable results have been documented in this patient population with revascularization performed with the aid of CPB [11]. Because of some concern about the ability to tolerate beating heart grafting, patients with left main coronary artery stenosis historically have been excluded from off-pump revascularization. The purpose of this study was to determine the safety of multivessel bypass grafting in patients with left main coronary artery disease greater than 50% using current beating heart surgical techniques.


    Material and methods
 Top
 Abstract
 Introduction
 Material and methods
 Results
 Comment
 Acknowledgments
 Discussion
 References
 
Patient population
Between January 1998 and October 1999, 823 patients with left main coronary artery stenosis underwent multivessel coronary artery bypass grafting. Left main stenosis was defined as being greater than 50% in accordance with The Society of Thoracic Surgeons (STS) National Database. Preoperative, perioperative, and postoperative data were collected using a customized version of the STS database. There were 723 patients who underwent revascularization with the aid of CPB and 100 patients who received grafting without the aid of CPB (Table 1).


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Table 1. Preoperative Clinical Data

 
Patients were selected in a nonrandomized manner into the off-pump group on the basis of medical comorbidities that were believed to increase the risk of CPB. This group includes the elderly, patients with underlying renal or pulmonary disease, those with prior stroke or significant cerebrovascular disease, and patients with calcified or porcelain aortas. Patients with religious principles that preclude blood transfusions are also revascularized using off-pump techniques.

In the off-pump cohort there were 60 men (60%) and 40 women (40%), with a mean age of 67.6 years (range, 34 to 96 years). The on-pump group consisted of 542 men (75%) and 181 women (25%), with a mean age of 63.7 years (range, 36 to 91 years). The two groups differed in ejection fraction, with the off-pump cohort having a mean ejection fraction of 52% ± 12.5% versus 48% ± 12.6% in the on-pump group, and preoperative renal dysfunction, with the off-pump group having a significantly higher incidence as defined by a creatinine of greater than 2.0 mg/dL (Table 1).

The on-pump group was more likely to be obese or to have suffered a myocardial infarction in the 30 days preceding operation. Both groups were equally matched in the need for inotropic agents preoperatively (5% off-pump versus 3.2% on-pump) and in the percentage of patients with hemodynamic instability before operation (3% in off-pump versus 3% on-pump). Hemodynamic instability was characterized as the need for pressor agents to maintain a systolic blood pressure greater than 90 mm Hg.

The rate of preoperative stroke was not statistically different between these groups and was consistent with previously reported patient populations undergoing coronary artery bypass grafting [12].

The operative technique for the performance of multivessel bypass grafting without the aid of CPB has been previously published in the literature.

Statistical analysis
Statistical analysis was performed using the SAS (SAS Institute, Cary, NC) software program. Descriptive data were analyzed using {chi}2 test or Fisher’s exact test as appropriate. Logistic regression analysis was used to determine important independent predictors of mortality. Logistic regression model identified only those variables that were significant in the stepwise model (p < 0.05). The odds ratios and 95% confidence intervals are also provided.


    Results
 Top
 Abstract
 Introduction
 Material and methods
 Results
 Comment
 Acknowledgments
 Discussion
 References
 
The perioperative results of the two groups are shown in Table 2. The majority of patients in both groups had three or greater bypass grafts performed at the time of operation. Patients in the off-pump group had a overall lower average number of bypass grafts performed at the time of operation (2.87 ± 0.76 versus 3.4 ± 0.9, p < 0.001).


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Table 2. Perioperative Data

 
Patients in the on-pump cohort were more likely to have required placement of an intraaortic balloon pump before operation than the beating heart group. There were no significant differences between the groups in regards to the need for balloon pump placement either intraoperatively or in the postoperative period. Likewise, there were also no differences between the groups in the incidence of perioperative myocardial infarction, as defined by a new Q wave in two contiguous leads on postoperative electrocardiogram, loss of R-wave progression, or new ST-segment changes accompanied by elevation of cardiac isoenzymes.

The patients revascularized using CPB were significantly more likely to require inotropic agents on leaving the operating room than were the patients who were grafted off pump (62.8% versus 23%, p < 0.001). There was also a significant reduction in the need for transfusion of blood or blood products in the off-pump group (35% versus 66.8%, p < 0.001). Patients grafted using CPB required transfusion of packed red blood cells in 60% of the cases as compared with only 31% in the beating heart cohort (p < 0.001), and also required increased transfusion of platelets (35.5% versus 11%, p < 0.001).

There was no difference in the length of stay between the two groups as calculated from the time of operation to the time of discharge.

Thirty-day mortality, although not significant by univariate analysis, did show a trend toward a survival benefit in the off-pump group (p = 0.59). Logistic regression analysis, however, did identify the use of CPB as an independent risk factor for death in the considered patient population, with an odds ratio of 7.3 (95% confidence interval, 1.3 to 138.4; Table 3). Other independent predictors of mortality included patient age, obesity, sex, and preoperative hemodynamic instability.


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Table 3. Independent Risk Factors for Mortality

 
Complications
Postoperative complications were compared, and no significant differences were observed between the two groups. Both the on-pump and off-pump cohorts demonstrated a low incidence of stroke. Stroke was defined as a new focal neurologic deficit persistent for greater than 24 hours, whereas a transient ischemic attack was defined if the deficit resolved within 24 hours.

There were no differences in the incidence of pulmonary complications, comparable numbers of infections, or need to return the patient to the operating room for bleeding. Although there was a trend in the number of patients requiring dialysis in the on-pump group, this number did not reach significance (0% versus 2.2%, p = 0.123).


    Comment
 Top
 Abstract
 Introduction
 Material and methods
 Results
 Comment
 Acknowledgments
 Discussion
 References
 
Significant left main coronary artery stenosis is a standard indication for coronary artery bypass grafting regardless of the patient’s presenting symptoms. Numerous studies have identified the presence of left main coronary artery stenosis as an independent predictor of postoperative morbidity and mortality in patients undergoing coronary artery revascularization [1316]. Surgical revascularization in patients with left main coronary artery stenosis has been shown to prolong survival in both the Coronary Artery Surgery Study and the Veterans Administration Cooperative Study [17, 18]. As cardiac surgery evolves, coronary artery bypass grafting without CPB continues to become a viable alternative to standard techniques of revascularization. Reports from institutions performing large numbers of coronary artery revascularization procedures without CPB have confirmed the safety of this procedure. Buffolo and associates [19] published a series of 1,274 patients revascularized without CPB with a mortality of 2.5%. Likewise, Tasdemir and colleagues [20] reported a 1.9% mortality in 2,052 patients revascularized without CPB. A perceived inability of patients with left main coronary artery disease to tolerate the cardiac manipulation associated with off-pump grafting has limited the application of these techniques in this patient population.

This retrospective review of prospectively collected data demonstrates that patients with significant left main coronary artery stenosis can be revascularized safely using off-pump techniques. The degree of stenosis was not stratified, and patients were not selected for revascularization either on-pump or off-pump based on the degree of left main coronary artery occlusion. Rather, patients were selected on the basis of medical comorbidities that were thought to increase the risk of CPB and their hemodynamic stability at the time of operation. The potential off-pump population included the elderly, patients with underlying renal or pulmonary disease, those with prior stroke or significant cerebrovascular disease, and patients with calcified or porcelain aortas. Currently, hemodynamic instability and poor target vessels are a contraindication to off-pump surgical procedures.

Patients grafted without CPB received on average fewer bypass grafts than the on-pump cohort. Owing to the limitations of the STS database in not collecting data points for the number of diseased vessels, it cannot be determined whether fewer grafts were performed for technical reasons, or whether there was a selection bias in choosing patients for off-pump grafting that required fewer overall grafts. The majority of patients in both groups received three or more grafts at the time of operation. Our practice is to graft the circumflex distribution when suitable targets are available. The observation of comparable low rates of perioperative myocardial infarction between the cohorts, and a trend toward improved survival in the off-pump group even though fewer grafts were performed, implies that these patients received adequate revascularization. It does not clearly denote completeness of revascularization, however, which can only be answered by long-term follow-up with regards to return of symptoms or need for reintervention.

Multivariate logistic regression established age to be a significant risk factor for death when examined in intervals of 10 years (Table 3). Older patients are known to be at increased risk from coronary artery bypass grafting, especially for neurologic complications [21]. Roach and coworkers [22] demonstrated that older age was a significant independent risk factor for both stroke and deterioration of intellectual function in patients undergoing coronary artery bypass grafting using CPB. Other investigators have also demonstrated a specific association between age and postoperative cognitive dysfunction in patients undergoing conventional CPB [23]. Although the overall incidence of neurologic complications in both groups did not reach statistical significance, it should be noted that the on-pump group was significantly younger than the off-pump group (63.7 years versus 67.6 years, p < 0.001). Selection bias leading to the older and perceived higher risk patients being grafted without CPB may account for the low incidence of neurologic complications in both groups.

Although a significant difference in mortality was not obtained by univariate analysis, there was a trend toward improved survival in the off-pump group. The single death in the off-pump group was attributable to a significant neurologic injury suffered at the time of operation. Cardiac complications were the most frequent cause of mortality in the on-pump group. Multivariate logistic regression analysis implied that CPB was an independent predictor of mortality in this select population. The significance of this result, however, must be interpreted cautiously owing to the small sample size in the off-pump group, which resulted in a wide distribution of the lower and upper confidence limits.

Updating our series since the oral presentation of this study to include patients operated on through December 2000 verifies a perioperative survival advantage for those patients revascularized without CPB. Currently 273 patients with left main coronary artery stenosis have undergone revascularization off-pump, and 1,163 patients on-pump. The off-pump cohort had a predicted mortality of 4.1%, and an observed mortality of 2.6%. The on-pump group had a predicted mortality of 3.6% and an observed mortality of 4.5%. The risk-adjusted mortality for the off-pump group (1.9%) was significantly lower than the risk-adjusted mortality for the on-pump group (3.8%, p < 0.001).

Off-pump bypass grafting continues to be a technique in evolution. Technically challenging, and with a perceived learning curve, reproducibility of results assumes greater significance in demonstrating the safety and efficacy of this procedure. This retrospective review of single practice data substantiates that revascularization can be performed safely and effectively in patients with left main coronary artery stenosis without the aid of CPB. Based on these results, we believe that left main coronary artery disease is not a contraindication to off-pump techniques.


    Acknowledgments
 Top
 Abstract
 Introduction
 Material and methods
 Results
 Comment
 Acknowledgments
 Discussion
 References
 
The authors thank Syma Prince, Naseem Shah, and Rhonda Hoggatt for their patience and assistance in data coordination.


    Discussion
 Top
 Abstract
 Introduction
 Material and methods
 Results
 Comment
 Acknowledgments
 Discussion
 References
 
DR J. W. RANDOLPH BOLTON (Temple, TX): Although we at Scott and White Clinic do not have the experience that you do up in Dallas, our patient outcomes have been quite similar. We have had two papers presented this afternoon; one suggesting that patients in a high-risk category do better off-pump than they do on, and now this one suggesting that a subgroup of patients with left main coronary artery stenosis may do better off-pump.

For the record, do you think that this may be the operation of choice for these two subgroups? If so, why should it not be offered for all patients? Is it just a matter of time for the numbers to show a difference for the low-risk groups?

DR DEWEY: It is important to keep in mind that this technology is still only 2 or 3 years old and there have been no large randomized series of patients looking at some of those subpopulations. Our review is retrospective, and many of the published reports in the literature are also retrospective. I think these data are compelling, and this study forces us all to reevaluate our practice and to consider operating on some of these patients off-pump if it would be of potential benefit for them.

DR W. ROBIN HOWE (Paducah, KY): I enjoyed your presentation and I think you certainly have shown that off-pump coronary artery bypass grafting can be performed in patients with left main coronary artery stenosis. I am concerned with your use of inotropic agents as a measure of success, and especially when two thirds of your patients on cardiopulmonary bypass have inotropic agents coming out of the operating room. In our 1998 experience of 642 patients, we had inotropic agents in approximately 10% of patients in an across-the-board series, and of those, a significant number were for renal perfusion only. Would you comment on what would seem to be an extremely high incidence of inotropic agent use and whether that really justifies the conclusions that you have drawn?

DR DEWEY: I think when you look at the on-pump group as a whole, the use of inotropic support was higher than we would have expected to see; however, some of that is just specific practice patterns among some of the anesthesiologists who work with us who like to take those patients off cardiopulmonary bypass and out of the operating room on some low level of inotropic support. I think that the conclusion that we would draw from that is not necessarily that off-pump coronary artery bypass grafting is better because of less inotropic support but the fact that it can be performed safely with minimal inotropic support.

DR THOMAS B. FERGUSON (St. Louis, MO): I enjoyed your paper very much. I may have missed it. Did you define left main coronary artery stenosis in terms of percent? I mean, there are clearly articles in the literature that divide patients with left main coronary artery stenosis depending on the severity of the stenosis, and I wondered whether you have done that in the manuscript?

DR DEWEY: We did not. The definition we used was from the STS database of left main coronary artery stenosis greater than 50%.

DR GREGORY A. LOWDERMILK (St. Louis, MO): I was wondering about the technique. What percent of these patients had distal left main coronary artery disease that required the circumflex system to be bypassed, and if so, did you do the left anterior descending coronary artery first, then the obtuse marginal?

DR DEWEY: From this series, I do not know what percentage of patients specifically had circumflex vessels grafted. All these patients had multivessel grafts performed through a sternotomy; we eliminated all the minimally invasive direct coronary artery bypass (MIDCAB) population from this group. Our basic technique is to do the left anterior descending coronary artery anastomosis first, generally using a left internal mammary artery graft, and then we would do our proximals, and then do the distals at the end.

DR LOWDERMILK: When you have a patient with isolated left main coronary artery disease and you are going to perform the operation using cardiopulmonary bypass with a cross-clamp, do you routinely graft the circumflex system and the left anterior descending coronary artery or just the left anterior descending?

DR DEWEY: Our basic practice if we think the circumflex system may be compromised by, say, a distal left main coronary artery stenosis would be to graft the circumflex system as well.

DR MICHAEL J. REARDON (Houston, TX): I enjoyed your talk. As one who is responsible for training young residents, it always interests me when I see these very nice series presented. Kit Arom tells us that four of his group of 12 do this operation. For the operation to be really good, it has to be applicable to a large number of surgeons. How many people of your group do this, and if the results are so good, why have not more people in the group done it and how are you going to get it to the rest of your group?

DR DEWEY: We have a fairly large group in Dallas, I think we have 19 or 20 cardiac surgeons in our group, and about half of those physicians are all currently performing off-pump coronary artery bypass grafting. Everyone is different in how aggressive they want to be and how comfortable they are to change. I think everyone changes their practice patterns at a certain rate; however, Mike Mack has been very instrumental in bringing the rest of us along with him as he delves more fully into this.

DR WILLIAM A. BAUMGARTNER (Baltimore, MD): I wonder if while I have a captive audience we could see a show of hands. We have had two excellent presentations on off-pump coronary artery bypass grafting. How many of the surgeons in the audience who do adult cardiac surgery do greater than 10% of their patients off cardiopulmonary bypass?

(Show of hands)

About 30%?

(Show of hands)

This survey was done, I think, about 2 years ago at the STS, and it clearly has grown in the number, I think, just looking at the show of hands.


    References
 Top
 Abstract
 Introduction
 Material and methods
 Results
 Comment
 Acknowledgments
 Discussion
 References
 

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