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Ann Thorac Surg 2003;76:778-783
© 2003 The Society of Thoracic Surgeons
a division of Cardiac Surgery, University of Brescia Medical School, Brescia, Italy
b division of Cardiology, University of Brescia Medical School, Brescia, Italy
* Address reprint requests to Dr Muneretto, UDA Cardiochirurgia—Spedali Civili, P. le Spedali Civili, 1, 25123 Brescia, Italy
e-mail: munerett{at}master.cci.unibs.it
Presented at the Forty-ninth Annual Meeting of the Southern Thoracic Surgical Association, Miami Beach, FL, Nov 7–9, 2002.
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Abstract |
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METHODS: We prospectively enrolled 176 patients undergoing total arterial myocardial revascularization and assigned them at random to one of two groups: group 1 was composed of 88 patients undergoing coronary surgery with cardiopulmonary bypass (CPB); group 2 consisted of 88 patients receiving the OPCAB procedure. We excluded from this study patients with significant risk factors for CPB-related morbidity. Composite arterial grafts in Y-T shape were realized in three different configurations according to patients’ characteristics, coronary anatomy, and target stenosis.
RESULTS: There were no significant differences between the two groups in terms of preoperative characteristics and risk factors (Euroscore: group 1 = 6.1 ± 3.5, group 2 = 6.6 ± 3.8). Mean number of anastomoses was similar in both groups (group 1 = 2.8 ± 0.8, group 2 = 2.7 ± 0.5) whereas mean mechanical ventilation time (group 1 = 23 ± 9 hours, group 2 = 9 ± 4 hours), intensive care unit stay (group 1 = 43 ± 6 hours, group 2 = 22 ± 8 hours), and postoperative stay (group 1 = 7 ± 3 days, group 2 = 5 ± 2 days) were significantly reduced in group 2. Early mortality was 2.3% in group 1 and 3.4% in group 2 (p = not significant). Major postoperative complications occurred similarly in the two groups (atrial fibrillation: group 1 = 35.2%, group 2 = 21.6%; myocardial infarction: group 1 = 2.2%, group 2 = 1.1%; stroke: group 1 = 2.2%, group 2 = 0%; abdominal infarction: group 1 = 3.4%, group 2 = 0%). At follow-up (mean, 15 ± 12 months) no significant differences were observed in terms of survival free of any cardiac-related event (group 1 = 94.3%, group 2 = 96.5%; p = not significant).
CONCLUSIONS: Off-pump coronary artery surgery could be successfully used for total arterial grafting without compromising the completeness of revascularization. Avoidance of CPB significantly decreased mechanical ventilation support and length of intensive care unit and postoperative stay; however in the absence of risk factors for cardiopulmonary bypass, off-pump coronary artery surgery did not improve early and midterm clinical outcome.
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Introduction |
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Although the internal thoracic artery (ITA) has been recognized as the graft of choice for left ITA to left anterior descending artery (LAD) bypass [3] many surgeons have been reluctant to accept the use of arterial grafts because of contradictory concerns about the potential anatomical limitations of ITAs [4, 5] and the functional properties of the radial artery (RA). Conversely during the last few years a growing number of authors reported improved long-term outcomes in patients undergoing bilateral ITA grafting when compared with the conventional technique [6, 7]; moreover in order to overcome the anatomical limitations of in situ ITAs, arterial conduits arranged as composite grafts have been extensively studied by several authors [8, 9].
It would seem logical to compare the advantages offered by the off-pump technique with those of total arterial myocardial revascularization; however up-to-date clinical data on total arterial OPCAB surgery are still lacking, mainly owing to the belief that the off-pump technique may affect the completeness of revascularization and that total arterial myocardial revascularization may be too technically demanding to be performed off pump.
The aim of our study was therefore to evaluate whether total arterial myocardial revascularization with composite grafts could be safely and effectively performed with the OPCAB technique without compromising the completeness of myocardial revascularization.
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Material and methods |
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We excluded from this study patients at high risk for CPB-related morbidity. Other exclusion criteria were age greater than 75 years of age, presence of chronic obstructive pulmonary disease (long-standing treatment with corticosteroids, forced expiratory volume in 1 second [FEV1]/vital capacity less than 40% of the expected value), renal dysfunction (creatinine clearance less than 60 mL/min), combined carotid disease, symptomatic peripheral arterial disease, severe atherosclerotic disease of the ascending aorta, and history of cerebrovascular accidents.
All patients included in this study signed specific informed consent for the type of surgery, and the study protocol was approved by the Institutional Review Board.
Surgical technique
The study population underwent total arterial myocardial revascularization with composite grafts. After midline sternotomy the ITAs were harvested as pedicled conduits, preserving systematically the first intercostal branch and the distal bifurcation during bilateral ITA harvesting in order to avoid excessive sternal devascularization. Nevertheless double ITA harvesting was avoided in patients with type 1diabetes (and clinically evident microangiopathies) and obesity (body mass index > 30).
A preoperative assessment of the RA (Allen test and an oximetric plethysmography curve of the thumb during RA occlusion) in the nondominant arm was carried out in all patients scheduled for RA harvesting The RA was harvested with its satellite veins and surronding connective tissue to avoid arterial wall damage and to prevent the risk of spasm.
We routinely perform composite arterial grafts in a Y-T configuration with a 8-0 polypropylene running suture before institution of CPB.
In group 1, standard CPB was instituted and moderate hypothermia (33°C) was reached; antegrade-retrograde oxygenated cold blood cardioplegia was always used for myocardial protection.
In group 2, target vessel stabilization was achieved with the Guidant Axius Vacuum Stabilizer System (Guidant Corporation-Cardiac Surgery, Santa Clara, CA); exposure of lateral and posterior vessels was obtained by means of two to three Lima stiches or the Xpose device (Guidant Corporation-Cardiac Surgery). In addition the operating table was kept in the Trendelenburg position and rotated to the left or right side according to the different coronary vessels. Target vessels were occluded proximally and distally to the anastomotic site with a 5-0 polypropylene suture tied over a pledget and snared with a soft silicone tube.
We used three different configurations to realize the composite grafts: in the type 1 configuration the right ITA is anastomosed as a Y graft to the left ITA and the RA is used as a free graft for the right coronary artery system. The type 1 configuration was used in cases of dominant or not occluded right coronary arteries.
In the type 2 configuration the RA or the right ITA is anastomosed in a Y graft fashion to the in situ left ITA. This type was used in cases of borderline stenosis of the obtuse marginal, occluded right coronary artery, and in presence of poor run off of the target vessels, thus allowing the creation of sequential side-to-side anastomoses.
In the type 3 configuration the RA with or without the right ITA is split into two segments and is anastomosed end to side to the left ITA in a double Y graft fashion. The type 3 configuration was used whenever planned configuration type 1 or 2 failed as a consequence of an atherosclerotic ascending aorta or unfavorable anatomy of the posterior coronary vessels.
Follow-up and statistical analysis
Patients were evaluated at a follow-up of 1.5, 6, and 12 months by physical examination. We planned to perform stress tests at 6 months and angiography at 12 months for symptomatic patients and randomly among asymptomatic patients. Recurrence of angina was defined by means of stress testing and myocardial scintigraphy.
We defined the study end points as follows: primary end-points were death, early outcome, and midterm outcome; secondary end points were completeness of revascularization, mechanical ventilation time, intensive care unit (ICU) stay, and postoperative stay. Preoperative and postoperative data were analyzed using the 
2 test for discrete variables and the unpaired t test for continuous variables (expressed as mean ± standard deviation). The Kaplan-Meier method was used to calculate actuarial survival curves (StatSoft, Version 5.1; StatSoft Italia S.r.l.). A p value less than 0.05 was considered to be significant.
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Results |
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No conversion to CPB was required in the off-pump group because of hemodynamic instability; however cardiopulmonary bypass was necessary in 8 patients of group 2 owing to unfavorable anatomy of the native coronary vessels (such as intramyocardial and calcified vessels).
The type 1 configuration was used in 12.5% of patients (11 of 88) of group 1 and in 9% of patients (8 of 88) of group 2. The type 2 configuration was used in 48.8% of patients (43 of 88) in group 1 and in 51.1% of patients (45 of 88) of group 2. The type 3 geometry was used in 38.6% of patients (34 of 88) in group 1 and in 39.7% of patients (35 of 88) in group 2.
The mean duration of mechanical ventilation time (group 1 = 23 ± 9 hours, group 2 = 9 ± 4 hours; p < 0.001), ICU stay (group 1 = 43 ± 6 hours, group 2 = 22 ± 8 hours; p = 0.003), and length of postoperative stay (group 1 = 7 ± 3 days, group 2 = 5 ± 2 days; p < 0.001) were considerably higher in group 1.
Two patients (2.3%) died in group 1 and 3 patients (3.4%) died in group 2 (p = not significant). The causes of death were sepsis (1 patient in each group), intractable ventricular arrhythmia (1 patient in group 2), and respiratory failure (1 patient in group 1, 2 patients in group 2) leading to multiple organ failure .
At univariate analysis there were no significant differences between the groups in terms of postoperative complications (despite being slightly higher in patients undergoing CPB, as shown in Fig 1); in particular atrial fibrillation occurred more frequently in group 1 (35.2%) than in group 2 (21.6%; p = 0.06) .
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When we analyzed the impact of CPB on bleeding and blood transfusion we observed a considerably lower rate of these complications in patients undergoing off-pump surgery. In fact average bleeding was 514 ± 398 mL in group 1 versus 385 ± 367 mL in group 2 (p = 0.02) and the rate of transfusions was 56.9% in group 1 and 32.9% in group 2 (p = 0.002).
Midterm outcome
Patients in both groups were followed up for a mean period of 15 ± 12 months. The hospital survivors of both groups were evaluated by means of clinical examination (at 2, 6, and 12 months), cycloergometric test (at 3 and 12 months), and thereafter by medical interview.
Recurrence of angina or myocardial infarction (angina: 1 patient in each group; myocardial infarction: 2 patients in group 1 and 1 patient in group 2), percutaneous transluminal coronary angioplasty (PTCA) reintervention (none in either group), and late death (2 patients in group 1 and 1 patient in group 2) were almost identical in the two groups, as shown in Table 2.
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Graft patency was similar in both groups without any significant differences with respect to the type of conduits used: the patency of the left ITA on LAD was 100% in both groups, and there was 1 occluded graft on the right coronary system (RA) in group 1 and 1 occluded graft on the circumflex system (RA) in group 2.
When we analyzed the actuarial freedom from cardiac related events (Kaplan-Meier analysis) patients operated on with the off-pump technique (94.3%) had a similar survival curve as patients undergoing the on-pump technique (96.5%; p = not significant; Fig 2).
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Comment |
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The use of arterial conduits has been offering incremental midterm and long-term benefits in terms of recurrence of angina/myocardial infarction, PTCA reinterventions and higher graft patency rates with respect to conventional CABG surgery (left ITA on LAD plus additional saphenous vein grafts) [6, 7, 12]. Moreover the use of arterial conduits alternative to the ITAs (mainly the RA) arranged as composite grafts proved to overcome the anatomical limitations of in situ arterial grafts, thus allowing a complete myocardial revascularization and extending the benefits of arterial revascularization to vessels other than the LAD [13, 14].
The objective of our study was to evaluate whether total arterial myocardial revascularization with composite grafts could be safely and effectively performed with the OPCAB technique. The primary end points of the study were hospital death and early and midterm outcome while secondary end points were completeness of revascularization, mechanical ventilation time, ICU stay, and hospital postoperative stay.
In our study the OPCAB technique was feasible for all patients without any conversion to on-pump surgery due to hemodynamic instability. In 8 patients the operation was converted to on-pump surgery owing to unfavorable anatomy (namely intramyocardial or calcified native coronary vessels); however to avoid analysis bias these patients have been included in the off-pump group.
Beyond this elective cross-over there were no emergency conversions due to major ventricular arrhythmia (ventricular fibrillation) or hemodynamic instability. Major arrhythmia (ventricular fibrillation) occurred in 3 patients during off-pump procedures, in 2 cases probably due to an incomplete deairing of the RA during its anastomosis on the obtuse marginal branches and in 1 case during the occlusion of the right coronary system (a right dominant coronary artery was present in this patient). In all these patients ventricular fibrillation was successfully treated by means of electrical cardioversion with direct-current shock.
Despite common concerns about the completeness of myocardial revascularization, in our study the group 2 patients who underwent total arterial off-pump surgery received the same average number of anastomoses as in group 1 and complete revascularization was achieved in 96.6% of group 1 patients and 95.4% group 2 patients. In addition there were no differences in terms of location of target coronary vessels, indicating that modern stabilization and exposure devices allow surgeons to perform off-pump anastomoses even on the posterolateral vessels.
In our study, compared with group 1 on-pump patients, group 2 off-pump patients had a considerable reduction of ventilation time (group 1 = 23 ± 9 hours, group 2 = 9 ± 4 hours; p < 0.001), ICU stay (group 1 = 43 ± 6 hours, group 2 = 22 ± 8 hours; p = 0.003), and postoperative stay (group 1 = 7 ± 3 days, group 2 = 5 ± 2 days; p < 0.001). Even if a costs analysis was not an objective of our study, these results confirm that OPCAB surgery may also reduce hospitalization costs.
There were no significant differences in terms of major postoperative complications, as shown in Figure 1. The occurrence of atrial fibrillation was considerably lower in the off-pump group compared with the on-pump group, as also reported in other studies [15].
Early deaths were also similar; in particular 2 deaths in the off-pump group and 1 death in the on-pump group occurred with a left ventricular ejection fraction of less than 30%, raising concerns about the advantages of OPCAB surgery in patients with advanced heart failure [16, 17]. In our experience OPCAB surgery was not a panacea for patients with heart failure and severe impairment of left ventricular function.
Based on the similar midterm outcome between the two groups, our results demonstrate that it is possible to achieve the same degree of graft patency both with the on-pump and the off-pump technique. This study has several limitations however. First, a small number of patients was enrolled in the study groups (differences between groups may become significant with more patients). Second, it was a single-institution study (with only two attending surgeons). Third, the routine use of total arterial myocardial revascularization with composite grafts is a technique that may be too technically demanding for off-pump operations by surgeons using conventional conduits (left ITA on LAD plus saphenous vein grafts) and previous experience with composite arterial conduits may be important with the on-pump technique. Nevertheless this study is one of the few randomized trials comparing off-pump and on-pump coronary artery surgery and the only one performed in patients undergoing total arterial myocardial revascularization.
In our experience total arterial myocardial revascularization with composite grafts represents the best option for OPCAB surgery for the following reasons: it reduces aortic manipulation; using an arterial conduit allows a smaller coronary arteriotomy, making arterial grafts extremely useful in smaller and more diseased native coronary vessels; in our experience side-to-side diamond-shaped anastomoses with the RA were more easily performed during off-pump surgery; and finally, the length of the in situ arterial conduits is a limiting factor during heart displacement in off-pump surgery and the extra length offered by composite arterial grafts overcomes this pitfall, allowing more hemodynamic stability during extreme heart manipulation.
In conclusion our study demonstrates that total arterial myocardial revascularization can be safely performed using the off-pump technique. The off-pump CABG surgery did not affect the completeness of revascularization nor did it increase postoperative morbidity and mortality; it did however significantly reduce ventilation time, ICU stay, postoperative stay, and bleeding and blood transfusion rates. Moreover patients undergoing off-pump surgery had a similar clinical outcome and survival free of cardiac-related events at midterm when compared with patients having on-pump surgery. These results show that OPCAB surgery provides a degree of myocardial revascularization comparable with that provided by the on-pump technique in terms of both number and quality of coronary artery anastomoses. (10)
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Discussion |
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DR MUNERETTO: Thank you, Dr Bradley, for your question. This study is an arm of a huge coronary study initiated 3 years ago in our institution that includes the evaluation of OPCAB versus On-pump surgery and conventional versus total arterial revascularization. In our department, almost all patients scheduled for coronary surgery have undergone total arterial grafting, even patients older than 75 years. Excluding a few cases with some anatomical limitations, the 97% of our patients had total artificial revascularization in the past 3 years.
DR THORALF SUNDT (Rochester, MN): I wonder if you could elaborate on your choice among available grafts and how you applied them. How did you decide which construct to use, and when did you use a second ITA and when did you use a radial artery. What are your feelings about the appropriate arterial conduit in any particular circumstance?
DR MUNERETTO: Thank you very much, Dr Sundt. The configuration that we use in most of cases, approximately the 70%, was the composite Y graft with left internal thoracic artery and radial artery. We believe that this configuration is a good compromise that avoids needing double ITA harvesting and allows full arterial revascularization in a great majority of patients. We are aware that you and others demonstrated that radial artery is sensitive to both the target location and stenosis but we believe that the use of this artery with a multiple side-to-side anastomosis may overcome the radial artery sensitivity.
DR KIT AROM (Minneapolis, MN): During the course of your study, did you encounter any lesion, particularly on the circumflex system, that you could not do off pump but it could be done on the pump?
DR MUNERETTO: Thank you Dr Arom for the interesting question. Conversion from off-pump to on-pump CABG was never carried out as a rescue procedure.
I omitted to mention that approximately 8% of patients were converted electively at the beginning of the procedure because of some concerns related to the coronary anatomy, but the majority of those patients had an intramural LAD whereas only a few patients had unaccessible marginal or posterolateral coronary branches.
DR AROM: The other thing to make it more meaningful is to randomize it. When the angiogram and surgery are recommended, you can have both the on-pump surgeon and the off-pump surgeon see the angiogram together. Then they can decide by writing it down whether or not they can do complete revascularization. After surgery, you can compare what they did; if they were unable to do all grafts that they planned to do with the off-pump approach, that means that they did not do a complete revascularization and vice versa.
DR JOHN H. CALHOON (San Antonio, TX): First of all, I would like to thank Dr Muneretto for being here. He is the Secretary General of the European Society of Thoracic and Cardiovascular Surgery. The only question I had, and you may have said it but I didn’t hear it, was did you use vasodilatory or vasoreactive agents postoperatively or perioperatively for your grafts?
DR MUNERETTO: Thank you very much, Dr Calhoon, for your kind remarks. Your question about the use of vasodilatatory or vasoreactive agents perioperatively is really relevant from the clinical point of view. The use of composite arterial graft contributed to overcome some limitations of arterial conduit but the extensive use of radial artery may lead to other problems related to the vasoreactivity of this graft. Actually, the avoidance of CPB and hypothermia significantly reduced radial artery vasoreactivity. In addition, in almost all of our patients we started an intravenous treatment with calcium antagonist (diltiazem) 24 hours before the operation. This treatment was continued postoperatively 24 hours and than converted into an oral therapy (diltiazem 60 mg x 3 daily) for the next 6 months. Since this prophilactic protocol was introduced 3 years ago, we have not experienced any radial artery spasm.
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