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Ann Thorac Surg 2001;71:1477-1484
© 2001 The Society of Thoracic Surgeons
a Division of Cardiothoracic Surgery, Caryle Fraser Heart Center, Crawford Long Hospital of Emory University, Atlanta, Georgia, USA
b Division of Cardiology, Carlyle Fraser Heart Center, Crawford Long Hospital of Emory University, Atlanta, Georgia, USA
Address reprint requests to Dr Puskas, Carlyle Fraser Heart Center, Crawford Long Hospital of Emory University, 550 Peachtree Street, NE, Suite 7700, Atlanta, GA 30365
e-mail: jpuskas{at}emory.edu
Presented at the Thirty-sixth Annual Meeting of The Society of Thoracic Surgeons, Fort Lauderdale, FL, Jan 31–Feb 2, 2000.
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Abstract |
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Methods. From April 1997 through November 1999, OPCAB was performed in 200 consecutive patients, and the results were compared with those in a contemporaneous matched control group of 1,000 patients undergoing CABG. Patients were matched according to age, sex, preexisting disease (renal failure, diabetes, pulmonary disease, stroke, hypertension, peripheral vascular disease, previous myocardial infarction, and primary or redo status. Follow-up in the OPCAB patients was 93% and averaged 13.4 months.
Results. Hospital death (1.0%), postoperative stroke (1.5%), myocardial infarction (1.0%), and re-entry for bleeding (1.5%) occurred infrequently in the OPCAB group. There were reductions in the rates of transfusion (33.0% versus 70.0%; p < 0.001) and deep sternal wound infection (0% versus 2.2%; p = 0.067) in the OPCAB group compared with the CABG group. Angiographic assessment of 421 grafted arteries was performed in 167 OPCAB patients (83.5%) prior to hospital discharge. All but five were patent (98.8%) (93.3% FitzGibbon A, 5.5% FitzGibbon B, 1.2% FitzGibbon O). All 163 internal mammary artery grafts were patent. Off-pump coronary artery bypass grafting reduced postoperative hospital stay from 5.7 ± 5.3 days in the CABG group to 3.9 ± 2.6 days (p < 0.001), with a decrease in hospital cost of 15.0% (p < 0.001).
Conclusions. Off-pump coronary artery bypass grafting reduces hospital cost, postoperative length of stay, and morbidity compared with CABG on cardiopulmonary bypass. Off-pump coronary bypass grafting is safe, cost effective, and associated with excellent graft patency and clinical outcomes.
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Introduction |
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Many authors [2, 4, 5] have reported series of OPCAB. Although they have presented excellent mortality rates, concern has been raised over a decrement in graft patency rates [6]. We [7] previously described the early evolution of the OPCAB procedure at our institution and reported outcomes in 125 patients to determine the safety and efficacy of OPCAB. The present study reports clinical outcomes and angiographic patency in 200 consecutive patients undergoing OPCAB and compares these results with those of a computer-matched control group of 1,000 patients having CABG on CPB.
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Material and methods |
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TopAbstractIntroductionMaterial and methodsResultsCommentAcknowledgmentsDiscussionReferences |
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All patients in both groups underwent operation through a standard median sternotomy. The internal mammary artery (IMA) (left [LIMA], right, or both) was harvested under direct vision. The protocol for heparin sodium administration has evolved and now consists of a half-pump dose of 1.5 mg/kg administered prior to division of the IMA and supplemental doses of 3,000 units every 30 minutes until the last anastomosis is completed. This is partially reversed with a calculated "half-reversal" dose of protamine sulfate (typically 0.75 to 1.0 mg/kg) after completion of the last anastomosis. Aspirin (325 mg daily) was given preoperatively and postoperatively to all OPCAB patients. Postoperative aspirin therapy was routine for all CABG patients as well, and aspirin was not routinely stopped before operation in the on-pump group. No other postoperative antithrombotic or antiplatelet regimen was routinely applied.
Extensive use was made of pericardial traction sutures; cardiac "slings" were less frequently employed. One of several commercially available mechanical stabilizing devices was used in every patient for stabilization of the coronary target or targets on the beating heart (United States Surgical, Norwalk, CT; Cardiothoracic Systems, Cupertino, CA; Octopus 2 from Medtronic, Inc, Minneapolis, MN; Genzyme, Cambridge, MA). The target coronary arteries were occluded proximally with a silicone elastomer vessel loop (Quest Medical, Inc, Allen, TX), and retrograde bleeding was controlled with a sterile, humidified carbon dioxide blower (Medtronic DLP, Grand Rapids, MI). Intraluminal coronary shunts (Bio-Vascular, Inc, St. Paul, MN) were used infrequently (< 10% of patients) when retrograde bleeding was excessive or when it was anticipated that occlusion of a coronary target would be poorly tolerated because of critical ischemia.
Distal anastomoses were constructed with a continuous running 7-0 or 8-0 monofilament suture. Proximal anastomoses were sewn to the aorta under a partial occlusion clamp with 5-0 or 6-0 suture. Intraoperative epiaortic ultrasound was performed to rule out major atherosclerosis of the ascending aorta prior to application of the clamp. Evidence of major atherosclerosis (grade III or higher) prompted construction of proximal anastomoses on an in situ IMA pedicle and avoidance of aortic clamping altogether.
Patients in both groups received postoperative care in a single "fast-track" protocol and were looked after by a single group of nurses, residents, and physician’s assistants. Data reflecting intraoperative and postoperative variables were collected for comparison. These variables included the following: number of distal grafts; use of the IMA as a conduit; need of an intraaortic balloon pump; inotropic support for more than 48 hours postoperatively; intubation for greater than 48 hours postoperatively; postoperative MI; stroke; deep sternal wound infection requiring debridement or muscle flap closure; leg wound infection; renal failure; reexploration for bleeding; transfusion requirements; atrial and ventricular arrhythmias; postoperative length of hospital stay; and hospital costs.
All OPCAB patients were requested to consent to postoperative angiography under our institutional quality-assurance protocol for OPCAB. Patients with preoperative renal insufficiency or severe calcification or atherosclerosis of the ascending aorta were excluded from postoperative angiography. In several other instances the patient or the referring cardiologist refused postoperative catheterization. A total of 167 (83.5%) of the 200 OPCAB patients had coronary angiography to document graft patency prior to hospital discharge. Postoperative angiography was not routinely performed in the computer-matched CABG group.
Postoperative cardiac catheterization included at least two orthogonal views of each graft. The 167 angiograms were independently reviewed by 1 of 3 cardiologists. Any uncertainties in scoring were adjudicated by all 3 of them. Angiographic observations were entered into an Access (Microsoft Corp, Redmond, WA) database specifically designed to evaluate venous and arterial bypass conduits with specific attention to any irregularities. The database was then queried to provide the data reported here. Each bypass graft was independently graded according to the scale of FitzGibbon and colleagues [8]. All graft lesions were graded according to their worst angiographic appearance in all views. Each graft was scored on the basis of the proximal anastomosis, the body of the graft, and the distal anastomosis. The overall graft score assigned was the worst of the three subscores. Flow rates were graded for each graft according to the Thrombolysis in Myocardial Infarction (TIMI) system [9], with special attention to flow rates in FitzGibbon B grafts.
Hospital charges were obtained from the UB92 formulation of the hospital bill provided by the hospital finance department for both patient groups. Charges were reduced to costs using departmental cost to charge ratios obtained from the hospital cost report, which is provided to the Health Care Financing Administration yearly. All costs were adjusted to 1997 costs using the Medicare cost inflation rate, and the cost of postoperative cardiac catheterization in 167 of the 200 OPCAB patients was subtracted before comparisons were made between groups. The clinical and financial data were combined in a single computerized database with the Social Security number as the primary key.
Measures of central tendency, inferential statistics, and multivariate statistics were used for the data analysis. The frequency, mean, and standard deviation were calculated for the independent and dependent variables. The Student t test was used to compare continuous variables between the two groups. The 
2 analysis was used to compare categorical variables. Comparisons between the two groups were made by using logistic regression for the dichotomous dependent variables. Multiple regression was used as a means to identify independent predictors of mortality, length of hospital stay, and hospital charges. An 
-level of 0.05 was used to determine significance. All data collection, calculation of costs, and statistical analyses were performed at the Emory Center for Outcomes Research under the direction of one of us (W.S.W.). The clinical team that designed this study and performed the operation was divorced from data handling whenever feasible.
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Results |
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Among the most interesting results was a strong trend toward reduction in deep sternal wound infection requiring sternal debridement, muscle flap closure, or both. This morbid complication occurred in 2.2% of CABG patients and 0% of OPCAB patients (p = 0.067).
A striking difference was found between groups in requirement of perioperative transfusion (Table 3). Whereas 70.0% of the patients in the control group required transfusion of one or more blood products during hospitalization, only 33.0% of the off-pump group received any blood products (p < 0.001). Patients undergoing CABG received significantly more packed red blood cells, platelets, fresh frozen plasma, and cryoprecipitate than OPCAB patients.
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The other patient had four-vessel OPCAB during which an exaggerated procoagulant response to protamine was noted. Immediate postoperative catheterization was performed to evaluate ischemia and revealed acute thrombosis of two native coronary arteries, complete occlusion of one vein graft, and evidence of nonocclusive thrombus in two other vein grafts (the LIMA–left anterior descending coronary artery graft was widely patent without thrombus). Emergency reoperative CABG was performed on CPB to replace all three vein grafts and extract red and white thrombus from native coronary arteries. This patient was also discharged home.
Dramatic differences in total postoperative length of stay and hospital costs were found between groups. Length of stay was reduced by 32% (OPCAB 3.9 ± 2.6 days, versus CABG, 5.7 ± 5.3 days; p < 0.001), and hospital costs fell by 15% (OPCAB, $14,898 ± $5,449, versus CABG, $17,501 ± $6,060; p < 0.001) for the off-pump group. Multiple regression models were developed for length of stay and hospital cost (Tables 6, 7). Cardiopulmonary bypass was found to be an independent predictor of both increased postoperative length of stay (p < 0.0001) and increased hospital cost (p = 0.0048).
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There were no cardiac-related deaths and no MIs in the OPCAB group during the mean follow-up of 13.4 months. Seven patients (3.5%) experienced recurrent angina during follow-up, and 6 underwent cardiac catheterization, which demonstrated a total of five occluded grafts. Four patients had percutaneous transluminal coronary angioplasty, two of which procedures were for new lesions in coronary arteries that had not been bypassed. There were five deaths after hospital discharge in the OPCAB group. The causes of death were multiple myeloma, pulmonary embolism, renal failure, abdominal sepsis, and one unknown cause at intervals ranging from 1 month to 18 months after discharge. All other OPCAB patients are alive and well without angina at the mean follow-up of 13.4 months.
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Comment |
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Incremental improvements in surgical technique including the routine use of wide bilateral transverse diaphragmatic pericardiotomies, multiple deep pericardial traction sutures, and rotation of the heart into the right pleural space have recently allowed visualization of OM coronary targets in a high proportion of patients. This has led to a sharp increase in the number of grafts per patient in the OPCAB group (see Fig 2). The recent introduction of improved mechanical stabilizing devices has also facilitated multivessel OPCAB. Currently more than 90% of all CABG procedures can be done safely off-pump by an experienced OPCAB surgeon, including those requiring grafts to the OM branches of the left circumflex artery. Patients with major ischemic arrhythmias and those in cardiogenic shock are placed on CPB. Patients with deep pectus excavatum and marked leftward displacement or rotation of the heart may be difficult to approach off-pump. Very large hearts with ischemic mitral regurgitation requiring several lateral wall grafts also present a challenge to the OPCAB surgeon. With experience and patience, most intramyocardial vessels can be bypassed off-pump.
The preoperative differences between the OPCAB and CABG groups (see Table 1) reflect the evolving bimodal pattern of patients referred specifically for OPCAB: first, a small group of young, healthy patients in whom percutaneous transluminal coronary angioplasty has failed for single- or double-vessel disease and second, a growing number of older, sicker patients with relative or absolute contraindications to CPB. This latter group has multiple severe comorbid disease such as predialysis renal failure, oxygen-dependent chronic obstructive pulmonary disease, and peripheral vascular disease including unilateral or bilateral carotid occlusion. These patients often have been refused CABG in the past and may be selectively referred for OPCAB. Thus, the incidence of severe chronic obstructive pulmonary disease in the OPCAB group was high compared with patients undergoing conventional CABG, and given the other constraints imposed on the matching program, the Emory University Cardiac Surgical Database had difficulty matching completely for this variable. This may explain the observed trend toward preoperative differences between groups with respect to the incidences of chronic obstructive pulmonary disease and renal failure.
The emphasis of minimally invasive cardiac surgery is on less invasive techniques that may decrease cost, length of hospital stay, and the overall morbidity associated with cardiac surgical procedures. As older, sicker patients are referred for coronary bypass operations, an increasing proportion of patients may have relative contraindications to CPB. The present study demonstrates that CPB is a significant independent predictor of hospital cost and length of stay. Reductions in transfusion requirements and postoperative low cardiac output state requiring inotropic support or an intraaortic balloon pump were dramatic and represent important improvements in minimizing the morbidity of coronary bypass grafting. Cardiopulmonary bypass has long been known to cause leukocyte dysfunction [3], and this "immunosuppressive" effect of CPB, coupled with increased tissue edema and cytokine activation, may explain the observed trend toward a decrease in the incidence of postoperative mediastinitis in OPCAB patients.
The early angiographic graft patency rates presented here equal or exceed those in all published series for coronary bypass on CPB and are encouraging relative to many earlier series of minimally invasive direct coronary artery bypass grafting and OPCAB results [9]. All 163 IMA grafts and all but five of the 421 targeted arteries studied prior to hospital discharge were patent. All routine conduits (LIMA, right IMA, radial artery, saphenous vein) were used in this series to bypass all named coronary targets, including the OM branches of the left circumflex coronary artery. This is clear evidence that careful technique and use of advanced mechanical stabilizers permits reproducible, precise construction of coronary bypass anastomoses on the beating heart. Indeed, several previous reports [10–13] of angiographic results after OPCAB and MIDCAB have suggested that as many as two thirds of FitzGibbon B lesions seen with immediate or early postoperative angiography may have spontaneously resolved at later coronary angiography.
Clinical outcomes during a mean of 13.4 months of follow-up strongly suggest that these excellent early outcomes in the OPCAB group are maintained over time. Nonetheless, conclusions from this series are weakened by its short period of follow-up and its retrospective and nonrandomized nature, despite the use of a computer-generated contemporaneous control group matched for multiple indices of perioperative risk. Moreover, there are no angiographic data for the CABG control group. Only a large prospective, randomized, longitudinal comparison of graft patency and clinical outcomes after coronary bypass operation performed with and without the use of CPB can ultimately validate the safety, efficacy, and superiority of the off-pump approach.
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Acknowledgments |
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Discussion |
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TopAbstractIntroductionMaterial and methodsResultsCommentAcknowledgmentsDiscussionReferences |
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Two years ago to this group my colleagues and I [1] presented our data that indicated to us that despite the use of conventional cardiac surgical techniques and bypass, it was still possible to discharge patients within days 1 to 4, what we termed ultra–fast track discharge. A number of these patients had combined coronary and multiple-valve procedures. However, for instance, one of them, a 79-year-old man, underwent emergent four-vessel bypass on New Year’s Eve and went home on New Year’s Day. At follow-up on postoperative day 2, seen as an out-patient, he appeared fairly functional. We think that the use of cardiopulmonary bypass per se does not preclude early extubation, early discharge, or early return to functional activity. We note from the history of arterial conduits and saphenous vein grafts that sometimes it takes many years to document superiority.
As we await the longer-term results and the off-bypass story to unfold, I have a qualitative question to help define what is right and what is best for our patients. Besides the number of grafts, was there any qualitative difference in the quality and the precision of your anastomoses? If there was not, that is valuable information. On the other hand, if there was a slight difference, then I hope it is fair to say that no reduction in intraoperative time, be it in minutes or hours, no reduction in the length of hospital stay in days, and no reduction in costs in dollars can always justify what perhaps would translate into years for our patients.
Reference
1. Walji S, Peterson RJ, Neis P, DuBroff R, Gray WA, Benge W. Ultra–fast track hospital discharge using conventional cardiac surgical techniques. Ann Thorac Surg 1999;67:363–70.
DR PUSKAS: Thank you for your remarks and questions. I think it is safe to say that everybody in this room could provide an anecdotal report of spectacular results with cardiopulmonary bypass in an elderly patient. Such anecdotes, however, are irrelevant in discussing statistical outcomes or making valid comparisons between two operative approaches.
It is certainly relevant that we still await long-term results from off-pump coronary artery bypass grafting. This technique has recently been rejuvenated, rediscovered and refined. I think the point about refinement is important. We are doing this operation differently every year as we continue to progress in our understanding of the nuances of hemodynamic instability off-pump and exposure of coronary arteries and suturing of grafts while the heart continues to beat. Long-term results will take time, and that is necessarily so. It is gratifying for those of us pursuing this new technique that our short-term results are as good as or better than those of a procedure that has been perfected over the last 30 years, for we have been working on ours for only 3 years.
As to the question of whether there has been a reduction in the quality of anastomoses off-pump, that is certainly not borne out by the patency data I described today from the independent panel of cardiologists. Our patency rates off-pump exceed those in any reported series for on-pump coronary artery bypass grafting. On the other hand, long-term follow-up will be required to document that this benefit in graft patency is for the long term.
DR GIORGIO M. ARU (Jackson, MS): I enjoyed very much your presentation and congratulate you on your results. I have two short questions.
First, were the 1,000 control patients operated on by the same surgeon as the study group? If not, do you think this is going to affect your statistical analysis?
Second, in relation to costs, do you use a reusable stabilization device or coronary perfusion system, and do you ever keep a pump primed outside the operating room? If so, how long do you consider it sterile and usable at your hospital?
DR PUSKAS: I believe the first question was whether the control group of 1,000 patients was operated on by only myself, and the answer is no. These operations were performed by my partners and me during the same time period and at the same hospital as the operations on the study group.
In response to your second question, I have used the Medtronic Octopus stabilizer for most of these procedures and believe that use of a sophisticated stabilizing device is important to achieve reproducible results. I no longer prime the pump for off-pump operations. It is in the room, but it is dry.
DR VALAVANUR A. SUBRAMANIAN (New York, NY): This is a good paper. I have two questions. Do you have any quantitative coronary angiographic data providing actual mean percentages of anastomotic stenosis and mean luminal diameter in the vessels, especially in the circumflex marginal? Do you have any correlation between the grade of anastomosis by the FitzGibbon score and the incidence of reintervention later?
DR PUSKAS: Thank you for your comments. You asked two questions. One was whether there was a difference in circumflex marginal anastomotic patency rates relative to other coronary targets, and as I demonstrated, there was not. Obtuse marginal grafts were on the order of 98.5% patent, and, for instance, left anterior descending coronary artery grafts were 100% patent. The quality of the anastomosis was scored by the independent panel of cardiologists according to the FitzGibbon scoring system. To be honest, the grafts looked very similar in all territories. The vast majority of FitzGibbon B lesions were in the body of conduits. They related to kinking vein grafts principally or to kinks in redundant internal mammary artery pedicles rather than to anastomotic difficulties. Reinterventions were so infrequent that no statistical conclusion can be drawn about the FitzGibbon grade of anastomosis and the incidence of reintervention.
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