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J Thorac Cardiovasc Surg 1995;110:979-987
© 1995 Mosby, Inc.

SURGERY FOR ACQUIRED HEART DISEASE

CORONARY ARTERY BYPASS WITHOUT CARDIOPULMONARY BYPASS: ANALYSIS OF SHORT-TERM AND MID-TERM OUTCOME IN 220 PATIENTS

Tel Hashomer, Israel

Presented at the Sixty-sixth Scientific Sessions of the American Heart Association, Atlanta, Ga., November 1993.

Received for publication Aug. 30, 1994. Accepted for publication Jan. 5, 1995. Address for reprints: Rephael Mohr, MD, Associate Professor of Surgery, Department of Cardiac Surgery, Sheba Medical Center, Tel Hashomer 52621, Israel.

Abstract

Two hundred twenty patients, preferentially those with high-risk conditions, underwent coronary artery bypass grafting without cardiopulmonary bypass. Early unfavorable outcome events included operative mortality (7 patients, 3.2%), nonfatal perioperative myocardial infarction (6 patients, 2.7%), cerebrovascular accident (1 patient, 0.4%), and sternal infection (3 patients, 1.4%). There were two deaths (13%) among 15 patients with calcified aorta and four (12%) in 33 patients who underwent emergency operation. Multivariate analysis revealed these two risk factors to be the only predictors of early mortality (odds ratios, 8.0 and 9.8, respectively). Preoperative risk factors such as left ventricular dysfunction (ejection fraction35%) (40 patients, 18%), congestive heart failure (46 patients, 21%), acute myocardial infarction (59 patients, 27%), cardiogenic shock (7 patients, 3%), age 70 years or older (59 patients, 27%), renal failure (19 patients, 9%), and cerebrovascular accident and carotid disease (11 patients, 5%) were not found to be major predictors of early mortality or unfavorable outcome. During 12 months of follow-up (range 1 to 21 months), there were four cardiac and three noncardiac deaths (1-year actuarial survival 93%) and 17 cases (7.7%) of early return of angina. Calcified aorta, nonuse of the internal mammary artery, reoperation, and diabetes mellitus were independent predictors of unfavorable events. We conclude that coronary artery bypass grafting without cardiopulmonary bypass can be done with relatively low operative mortality, although there seems to be an increased risk for early return of angina. This procedure should therefore be considered for patients with appropriate coronary anatomy, in whom cardiopulmonary bypass poses a high risk. This procedure is still hazardous with calcified aorta or emergency operation. (J THORACCARDIOVASCSURG1995;110:979-87)

The first operation for coronary artery disease in which the internal mammary artery (IMA) was anastomosed on a beating heart to the left anterior descending artery (LAD) was done by Kolesov and Potashov ¹ in Leningrad in 1964. Favorable results with the use of cardiopulmonary bypass (CPB) for saphenous vein ^2,3 and IMA ⁴ coronary artery bypass grafting (CABG) have made CABG with CPB the surgical procedure of choice for ischemic heart disease.

Although current methods of CPB are remarkably safe, there is incontrovertible evidence that various damaging effects of CPB do occur. ⁵ Although in the majority of patients the adverse effects of CPB are minor and reversible, patients with significant functional impairment of various organ systems may not tolerate the added deleterious effects of CPB, which may be irreversible and even fatal.

During the 1980s and the beginning of the 1990s, several series of CABG operations without CPB were reported. ^6-10 Although some of these series were relatively large, they were neither specifically based on patients with high-risk conditions, nor did they try to identify risk factors for unfavorable outcome after the procedure.

As more and more patients with high-risk conditions are referred for CABG, ¹¹ we have used the approach of CABG without CPB, on the basis of the assumption that some patients with high-risk conditions may benefit from CABG without CPB. ¹² Hence the purpose of this study was to evaluate results of CABG without CPB in a group composed mainly of patients with high-risk conditions to identify independent risk factors for CABG without CPB and to suggest possible advantages and disadvantages of this procedure.

PATIENTS AND METHODS

Patient population
Between December 1991 and September 1993, 220 patients underwent CABG without CPB. One of us (R.M.) performed all operations. This group comprises 22% of 990 isolated CABG operations done overall in our institution during that period. There were 175 male (80%) and 45 female (20%) patients. Patients' ages ranged from 40 to 82 years (mean 63 years). The decision to perform CABG without CPB was primarily based on the following considerations: (1) the potential relative benefit from avoiding CPB, because it was assumed that the higher the risk for CABG with CPB, the greater the patients' relative benefit from avoiding CPB, and (2) the feasibility of the procedure, which was determined by the size and accessibility to the diseased coronary vessels as demonstrated on the coronary angiogram. The smaller the size of the coronary vessels to be bypassed, or the more distal their position in the circumflex arterial system, the less feasible the procedure. Coronary vessels with a diameter of less than 1.5 mm or calcified or intramyocardial vessels were regarded as contraindications for this procedure. We also favored use of the standard operative technique in cases that needed four or more grafts.

When there was greater potential benefit from avoiding CPB, a lesser degree of feasibility was accepted. The patient population risk profile is shown in Table I. The mean number of risk factors listed in Table I was 3.7 per patient (Table II).

Exposure and fixation of the anastomotic site were achieved with superficial (4-0 silk) sutures and deep (3-0 Ti-Cron polyester fiber, Davis & Geck, Danbury, Conn.) sutures, application of hemostatic tourniquets (polytetrafluoroethylene* or 5-0 Prolene polypropylene, Ethicon, Inc., Somerville, N.J.), and spurts of air to obtain a bloodless field. Because of previous reports of hemostatic suture-related coronary stenotic lesions, ¹³ distal hemostatic sutures were used only when essential. The hemostatic sutures were tightened just after arteriotomy to shorten the regional ischemic time.

Distal anastomoses were done with continuous 7-0 Prolene sutures and proximal anastomoses with 5-0 Prolene sutures with a partial occluding clamp. In the majority of patients with calcified aorta it was possible to palpate a skip area on the ascending aorta that could serve as a site for one proximal vein graft anastomosis, on the cupula of which other proximal anastomoses were constructed. For better detection of skip areas, blood pressure was temporarily reduced by partial inflow occlusion with a cotton tape snare around the inferior vena cava.

Exposure of marginal branches of the circumflex coronary artery was achieved by gentle, gradual rotation of the heart. Hemodynamic instability, which primarily occurred during exposure of the marginal branches of the circumflex coronary artery, was managed by rapid fluid administration, use of dobutamine, infusion of glucose-insulin solution, or preoperative insertion of an intraaortic balloon pump. In cases that necessitated significant rotation of the heart to reach a marginal branch of the circumflex artery, revascularization of other territories was antecedently done. Body hypothermia was avoided by adjustment of operating room temperature, placement of the patient on a warming mattress, and infusion of warm solutions.

Operative data (Table III)
Because 35% of the patients in this study received a single graft, the mean number of grafts per patient was 1.9. Only 22% of patients received a graft to a marginal branch of the circumflex artery. This relatively low percentage stems from the fact that a high proportion of patients in whom a marginal graft was critical were preselected to be operated on with CPB. Ischemic time for grafting either the LAD or the right coronary artery was 8 ± 4 minutes (mean ± SD*) and for the marginal branches of the circumflex artery 13 ± 7 minutes (mean ± SD). Hospital stay was 6.1 ± 3.2 days (mean ± SD).

To predict perioperative mortality and unfavorable outcome events by various risk factors, logistic regression analysis was used. Odds ratio (OR) and 95% confidence intervals (CI) were evaluated. ¹⁴ Because one of the aims was to evaluate the association between each risk factor and survival time (controlling for other risk factors), Cox's proportional hazard model was used. ¹⁵ All analyses were done by BMDP software (BMDP Statistical Software, Inc., Los Angeles, Calif.), version 1990.

RESULTS

Early unfavorable outcome events (Table IV)
Seven patients (3.2%) died perioperatively (during hospitalization or within 30 days after the operation), all of perioperative myocardial infarction (MI). Another six patients (2.7%) had perioperative nonfatal MI, one of whom underwent salvage reoperation without CPB. The other case of early reoperation was a result of complicated percutaneous transluminal coronary angioplasty of the LAD proximal to a stenosed IMA anastomosis.

Only one patient (0.4%) had a cerebrovascular accident, which occurred on the first postoperative day as a result of air embolization through the left atrial catheter.

Late unfavorable outcome events (Table V)
Late follow-up (1 to 21 months after operation, mean 12 months) was achieved in 92% of patients. The vast majority of patients who were lost to follow-up were new immigrants with no permanent address.

Analysis of the causes of all late unfavorable events showed that 11 (5.0%) were a result of incomplete revascularization and 9 (4.1%) a result of graft malfunction.

Analysis of mortality events
Life-table analysis of the entire group showed 93% survival up to 21 months of follow-up (Fig. 1). Univariate analysis (Table I) demonstrated angina class 4 as a significant predictor of early mortality, whereas emergency operation and calcified aorta fell short of statistical significance. However, after adjustment for previously identified demographic, clinical, and surgical predictors of outcome, ^16,17 emergency operation (OR 9.8, CI 95% 1.9 to 49.9) and calcified aorta (OR 8.0, CI 95% 1.2 to 53.5) emerged as independent risk factors for early mortality. Analysis of both early and late mortality events showed diabetes (OR 6.3, CI 95% 1.5 to 27.4) to be an independent predictor in addition to calcified aorta (OR 17.1, CI 95% 2.0 to 143.2) and emergency operation (OR 6.5, CI 95% 1.1 to 38.8) (Figs. 2 and 3).

View larger version (10K): [in this window] [in a new window]   Fig. 1. Survival curve for entire study group. Standard errors and number of patients at risk across time intervals are indicated.

View larger version (16K): [in this window] [in a new window]   Fig. 2. Survival curves by calcified versus noncalcified aorta. Standard errors and number of patients at risk across time intervals are indicated.

View larger version (14K): [in this window] [in a new window]   Fig. 3. Survival curves by emergency versus nonemergency operation. Standard errors and number of patients at risk across time intervals are indicated.

DISCUSSION

Because mortality and morbidity of CABG are related among other things to the use of CPB, established risk factors for CABG with the use of CPB may not necessarily be significant when CPB is avoided. An important finding of this study was that risk factors such as left ventricular dysfunction, congestive heart failure, acute MI, cardiogenic shock, complicated percutaneous transluminal coronary angioplasty, reoperative procedures, renal failure, and peripheral vascular disease were not associated with increased mortality in patients undergoing CABG without CPB. Although old age, left main coronary artery stenosis, previous cerebrovascular accident or carotid disease, and chronic obstructive pulmonary disease were also not found to be significant risk factors for mortality by univariate or multivariate analysis, a trend for higher mortality could be observed.

In our opinion, the subgroup of patients who may benefit most from CABG without CPB are those with left ventricular dysfunction. Operative mortality in these patients is undoubtedly higher than that in those with normal left ventricular function. ^18-22 Our results are consistent with those of previous studies that reported fewer occurrences of low output state and low mortality in patients with severely impaired ventricles who underwent CABG without CPB. ⁸ Only 1 (2.5%) of 40 patients in this series with an ejection fraction lower than 35% (including 7 with ejection fractions lower than 20%) died. These results can be explained by the favorable effect of the beating heart on blood supply to the subendocardium ²³ and the better preservation of interventricular septal contractility reported after CABG without CPB. ^6,24 Furthermore, excellent results have been reported in patients with left ventricular dysfunction when they were operated on with use of a support device when CABG was done without CPB. ²⁵ An intraaortic balloon pump was inserted preoperatively in the present series in 10 patients, seven of whom were in cardiogenic shock. None of these patients with severely jeopardized myocardium died (Table I).

Similar considerations may favor the use of CABG without CPB in patients referred for operation during acute MI or after complicated percutaneous transluminal coronary angioplasty (sudden coronary occlusion during the procedure). The mortality rate in 59 patients operated on in this series during acute MI was 5.2%. None of the 10 patients with complicated percutaneous transluminal coronary angioplasty died (Table I). However, emergency operation (sometimes associated with an acute compromised hemodynamic condition) was still found to be a significant independent predictor of early mortality.

Coronary reoperations are associated with relatively high in-hospital mortality (up to 12% in a recently published multicenter Veterans Administration study ²² ) and morbidity, including perioperative MI, low cardiac output, and prolonged intubation. ^22,26,27 Potential disadvantages of the heart bypass technique on coronary reoperations include inadequate myocardial protection because of diffuse coronary disease, the danger of unsuccessful weaning from CPB because of incomplete revascularization, cardioplegia-induced graft atheroembolism, crossclamping of reoperated aorta, and prolonged pump runs. All these issues are not relevant when one avoids CPB. Indeed, favorable results of reoperative CABG without CPB have been reported. ^8,28 We have done 30 reoperations, four of which were done through a left thoracotomy, with one (3.3%) early mortality event. Two of the three late mortality events in this subgroup were not cardiac related (carcinoma of the stomach and cerebrovascular accident in a patient with known carotid disease).

Patients with preoperative renal failure are at increased risk for acute renal failure after operation because of decreased perfusion, absence of pulsatile flow, ^29,30 excessive hemolysis, and platelet-fibrin microemboli. ³¹ Our experience of CABG without CPB shows a temporary increase in blood creatinine levels in 19 patients (9%) with preoperative renal failure (creatinine level 2 to 12 mg/dl). However, except for one patient who was receiving long-term dialysis before the operation, none required dialysis after the procedure.

CABG without CPB should address some of the problematic issues of calcified aorta. This study, however, found calcified aorta to be an independent risk factor of early mortality. There were two mortality events in the 15 patients with calcified aorta. In both, the cause of death was perioperative MI as a result of acute thrombosis of a vein graft to the LAD. Technical problems with construction of proximal anastomoses may be the cause of vein graft thrombosis. We are currently making every effort to avoid manipulation of "untouchable aortas" and prefer to use arterial conduits in these patients. ³²

When mortality events in this report are analyzed, two observations can be made: first, the most important cause of death was perioperative MI caused by early vein graft occlusion and, second, the use of the IMA was associated with decreased early mortality and significantly reduced the rate of overall unfavorable outcome events. It appears that despite relatively low mortality, patients operated on with this technique are at increased risk of vein graft thrombosis. ^10,13,33

The high rate of early graft failure has several explanations: it can be related to inadequate selection of patients for this procedure (patients with small, calcified, or intramyocardial coronary arteries are not candidates for this procedure), quality of surgical exposure achieved, inappropriate locations of the anastomoses, and skill of the surgeon. However, early graft thrombosis may also be related to low anticoagulation level during the procedure or to the fact that, unlike in bypass procedures, platelet function is not disturbed. ^34,35 Endothelial damage during the procedure may facilitate platelet aggregation with eventual graft thrombosis. The superior results with the use of the IMA may be related to luminal release of nitric oxide, which induces coronary vasodilatation and inhibits platelet adhesion and aggregation. ³⁶

Coronary anastomoses require a meticulous technique. It appears, however, to be much more difficult to perform perfect distal anastomoses with a beating heart. When a Doppler echocardiographic microprobe was used to measure flow through IMA grafts, better initial flows were observed in patients operated on without CPB than in those operated on with CPB, probably because of better runoff. ⁹ In the study cited, IMA flow in patients who underwent CPB gradually reached a level similar to IMA flow in patients operated on without CPB during the first postoperative week. This observation supports the view that a good quality of IMA anastomosis can be achieved, even with a beating heart. This also encouraged us to use IMA grafts in patients with acute MI, left ventricular dysfunction, and cardiogenic shock. However, this notion cannot be supported angiographically, inasmuch as we unfortunately do not have routine angiographic follow-up data to determine the late graft patency rate in our cohort.

Of all late unfavorable outcome events in this series, early return of angina was the most predominant (17 patients, 7.7%). This rate of return of angina within 1 year of the operation may be higher than that reported in the literature (5%). ⁵ In most cases angina was treated medically. However, four patients underwent reoperation and five underwent postoperative percutaneous transluminal coronary angioplasty. Incomplete revascularization and technical problems at the anastomotic sites were the major causes of early return of angina.

Incomplete revascularization is an established determinant of early return of angina. ³⁷ The relatively low number of grafts per patient reported in this study (1.9 per patient) and by other authors (1.0 to 2.2 per patient) ^6-10 is primarily related to patient selection. We favored the use of the CPB technique for patients who needed four or more grafts, although in seven patients in this cohort (3.5%) we performed complete revascularization with four to five grafts despite the technical difficulty. The second subpopulation that was preferably referred for the CPB technique included patients with disease involvement of the circumflex arterial system. In this cohort we approached this territory either through a midline sternotomy or left thoracotomy. In operations with midline sternotomy, rotation of the heart might not be tolerated, especially when severe left ventricular dysfunction with cardiomegaly is present. On the other hand, with left thoracotomy, grafting of the RCA is not attainable. Recently, however, we used the surgical approach of midline sternotomy with left intercostal extension, which permits easier access to all coronary arterial territories whenever needed.

With this technical improvement and on the basis of the follow-up data presented in this study, bearing in mind that long-term unfavorable results of incomplete revascularization might take longer than a mean follow-up of 12 months to appear, we do not think that technical difficulty justifies incomplete revascularization. An exception to this rule is hemodynamic instability associated with severe left ventricular dysfunction or cardiogenic shock, in which cases we prefer to perform only the one or two most important grafts, that is, those critical to patient survival, without CPB, although this may bear a higher probability of return of angina. In our experience, in standard heart bypass technique in patients with left ventricular dysfunction, it is of utmost importance to perform complete revascularization to minimize operative mortality. However, as this study indicates, relatively low operative mortality can be achieved in patients with severe left ventricular dysfunction operated on without CPB, despite the lower number of grafts.

We conclude that CABG without CPB can be done with relatively low operative mortality primarily related to vein graft thrombosis. However, the price may be an increased risk for early return of angina, mainly because of incomplete revascularization. Because this study is not a comparative study, it would not be legitimate to define indications for this procedure. However, we believe that this study provides some data concerning the estimated risk of this procedure for various subgroups of patients. Among several well-established risk factors for CABG with the use of CPB, the only significant independent predictors of early mortality for CABG without CPB were calcified aorta and emergency operation. With the reservation of possible type II statistical error, this study shows that for properly selected patients in whom the procedure is feasible, CABG without CPB is a viable alternative that should be considered whenever the risk of the standard heart bypass technique is very high and the risk of CABG without CPB is estimated to be lower.

Footnotes

From the Department of Cardiac Surgery ^a and the Department of Clinical Epidemiology, ^b The Chaim Sheba Medical Center, Tel Hashomer, Israel.

*Gore-Tex is a registered trademark of W. L. Gore & Associates, Elkton, Md.

*Standard deviation.

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