A Randomized Comparison of Off-Pump and On-Pump Multivessel Coronary-Artery Bypass Surgery
Natasha E. Khan, M.R.C.S., Anthony De Souza, F.R.C.S., Rebecca Mister, M.Sc., Marcus Flather, F.R.C.P., Jonathan Clague, M.D., Simon Davies, F.R.C.P., Peter Collins, M.D., Duolao Wang, Ph.D., Ulrich Sigwart, M.D., and John Pepper, M.Chir.
Background The effect of the use of coronary-artery bypass surgerywithout cardiopulmonary bypass and cardiac arrest ("off pump")on graft patency remains uncertain. We undertook a prospective,randomized, controlled study to compare graft-patency ratesand clinical outcomes in off-pump surgery with conventional,"on-pump" surgery.
Methods We randomly assigned 50 patients to undergo on-pumpcoronary-artery bypass grafting and 54 to undergo off-pump surgery.Surgical and anesthetic techniques were standardized for bothgroups. Clinical outcomes and troponin T levels were measured.Three months later, the patients underwent coronary angiography,including quantitative analysis.
Results The mean age of the patients was 63 years, and 87 percentwere men. The on-pump group received a mean of 3.4 grafts, andthe off-pump group 3.1 (P=0.41). There were no deaths. Therewas no significant difference in the median postoperative lengthof stay between the two groups (seven days in each group). Thearea under the curve of troponin T levels was higher duringthe first 72 hours in the on-pump group than in the off-pumpgroup (30.96 hr • µg per liter vs. 19.33 hr •µg per liter, P=0.02). At three months, 127 of 130 graftswere patent in the on-pump group (98 percent), as compared with114 of 130 in the off-pump group (88 percent, P=0.002). Thepatency rate was higher for all graft territories in the on-pumpgroup than in the off-pump group.
Conclusions In this randomized study, off-pump coronary surgerywas as safe as on-pump surgery and caused less myocardial damage.However, the graft-patency rate was lower at three months inthe off-pump group than in the on-pump group, and this differencehas implications with respect to the long-term outcome.
Coronary-artery bypass grafting performed with cardiopulmonarybypass and cardiac arrest ("on pump") provides a motionless,bloodless surgical field, allowing optimal conditions for theconstruction of coronary anastomoses. Cardiopulmonary bypassis believed by many to be a major cause of postoperative morbidity,including neuropsychological impairment,1,2 and the resurgenceof interest in surgery without cardiopulmonary bypass ("offpump") reflects an attempt to avoid the morbidity associatedwith cardiopulmonary bypass.3,4,5
The development of modern stabilizers has made off-pump coronarysurgery accessible and technically feasible.6 There is evidencethat as compared with on-pump surgery, off-pump surgery maydecrease the incidence of myocardial injury,7 renal damage,8and injury to the brain.9 Previous randomized studies have showna shorter length of stay, a reduced use of transfusion products,a reduced incidence of coagulopathy, and a lower frequency ofatrial fibrillation in patients who undergo off-pump surgery.10,11,12On the other hand, there is some evidence that off-pump surgeryincreases the risk of recurrent angina and the need for reintervention,suggesting poor graft quality or incomplete revascularization.13,14
There is insufficient evidence from randomized studies comparinggraft patency in patients undergoing off-pump coronary surgerywith graft patency in those undergoing on-pump surgery, andthere have been few studies of unselected patients requiringmultivessel grafting. We evaluated graft patency and qualityin a randomized study comparing on-pump with off-pump surgery.
Methods
Study Design and Patients
This was a prospective, randomized study performed at a singlecenter. Patients who were referred for isolated, first-timecoronary-artery surgery and who required at least three graftswere eligible. All angiograms were reviewed, and a surgicalplan was documented before randomization. Exclusion criteriawere as follows: an age of less than 30 years or more than 80years; an indication for additional surgical procedures; documentedstroke within the preceding six months; carotid-artery stenosisof more than 70 percent; documented myocardial infarction inthe preceding three months; poor left ventricular function,with an ejection fraction of less than 20 percent; pregnancyand breast-feeding; an inability to provide written informedconsent; and a history of complications after diagnostic angiography.
The Royal Brompton and Harefield Research Ethics Committee approvedthe study. Written informed consent was obtained from all patients.Patients were randomly assigned in equal proportions to undergoon-pump or off-pump coronary-artery bypass grafting. Randomizationwas stratified according to the surgeon, so that both surgeonsperformed similar numbers of on- and off-pump procedures. Webegan to perform off-pump surgery two years before the studybegan. During this period, 98 of 753 isolated coronary-arterybypass grafts (13 percent) performed by the participating surgeonswere done off pump.
Treatment and Procedures
Troponin T was measured in patients as a marker of cardiac damage.Levels were measured at base line (during the induction of anesthesia)and at 6, 12, 24, 48, and 72 hours. Samples were spun and frozento –80°C within 30 minutes after collection and wereanalyzed in batches. Samples were analyzed for cardiac troponinT with the use of the Troponin T STAT Immunoassay (Elecsys 1010/2010Systems, Roche).
A standardized anesthetic protocol was used throughout the study.Cardiopulmonary bypass was established in a standardized manner,with the use of a membrane oxygenator and a roller pump andwithout the use of cardiotomy suction. The heart was exposedthrough a median-sternotomy incision. The Octopus stabilizer(Medtronic) was used for the off-pump group. During on-pumpsurgery, patients were cooled to 32°C, whereas during off-pumpsurgery, patients were actively warmed to maintain a core temperaturenot lower than 35°C. Cold-blood cardioplegia was accomplishedwith anterograde delivery through the aortic root and retrogradedelivery through the coronary sinus. A heparinization protocolof 300 U per kilogram for on-pump surgery and half-dose heparinfor off-pump surgery was followed. Protamine was used to reversethe effects of heparinization only in the on-pump group. Allanastomoses were sutured by hand. In the off-pump group, intracoronaryshunts were not used routinely; indications for use includedpoor visibility, ST-segment changes, and hemodynamic instability.A standardized protocol for immediate postoperative care wasfollowed in the adult intensive care unit, including antiplatelettherapy (300 mg of aspirin six hours after surgery, followedby a daily dose of 150 mg).
Follow-up
All patients were followed for three months after the operation,at which time they were scheduled to undergo coronary angiography.Adverse events and symptom status were recorded for all patients,including those who were not willing to return for angiography.Left-heart catheterization was performed with the use of a standardJudkins technique by an experienced interventional cardiologist.Whenever possible, the pedicled left internal thoracic-arterygraft was selectively intubated, and images were obtained inmultiple projections. When grafts could not be identified, anaortogram was obtained. Native vessels were investigated onlyif a blocked graft was found. All angiograms were interpretedby an interventional cardiologist who was unaware of the patients'original study assignments and who did not perform the repeatedangiography. Patency was defined as any flow through both thegraft and the native vessel. The graft was said to be nonpatentif a stump was seen or if there was no flow on the aortogram.
Images were acquired digitally in a Siemens cardiac catheterlaboratory calibrated for spatial distortion for quantitativecoronary angiography. All digital images were analyzed in ablinded fashion by an experienced observer. The optimal frameand projection were selected to show the anastomosis of theleft internal thoracic artery to the left anterior descendingartery with the least foreshortening and overlap and then analyzedwith the use of CMS software, version 4.1 (Medis). Automatededge detection was then manually adjusted, and stenoses at thepoint of anastomosis were quantified both as the minimal luminaldiameter in absolute measurements (millimeters) and as the percentageof the reference diameter, which was the normal diameter ofthe left internal thoracic artery just proximal to the anastomosis.
Statistical Analysis
The study was powered to detect a difference in the minimalluminal diameter between the on-pump and off-pump groups of0.3 mm, with an assumed standard deviation of 0.5 mm (a powerof 80 percent and a two-sided alpha level of 0.05), given theenrollment of 100 patients. Means (±SD) were used todescribe the continuous variables, and frequencies were calculatedfor categorical variables. Differences between treatment groupswere compared with the use of a two-sided type I error Student'st-test or the Mann–Whitney U test for continuous variables.The chi-square test was used for categorical variables. To analyzedata on plasma troponin T levels, the area under the concentration–timecurve was calculated by the trapezoidal method for each patient,and treatment-related differences in the area under the curvewere then compared by Student's t-test. The outcome variableswere analyzed on an intention-to-treat basis. All reported Pvalues are two-sided. No interim analyses were carried out duringthe course of this study.
Results
Patient Population
From January 2000 to January 2002, 104 patients underwent randomization:50 to on-pump surgery and 54 to off-pump surgery. One patientin the on-pump group was found to have inoperable lung carcinomaafter randomization and did not undergo coronary-artery bypassgrafting. The analyses are based on the remaining 103 patients.
Most base-line characteristics were similar in the two groups(Table 1); the mean age was 64.7 years in the on-pump groupand 62.0 years in the off-pump group. The distribution of patientsin Canadian Cardiovascular Society classes and New York HeartAssociation classes was similar in the two groups. There wasa significant difference in the mean planned number of grafts(3.6 in the on-pump group vs. 3.2 in the off-pump group, P=0.003).Twenty-seven percent of patients had diabetes, and 44 percentof patients had had a myocardial infarction.
Table 1. Base-Line and Intraoperative Characteristics of the Patients.
Operative Data
Intraoperative data are given in Table 1. Two patients who wererandomly assigned to off-pump surgery were switched intraoperativelyto on-pump surgery, owing to intractable ventricular tachycardiain one patient and to an intramyocardial left anterior descendingartery in the other. There was no significant difference inthe quality of the native vessels between the two groups, asassessed by the surgeon with the use of a simple qualitativescale. The numbers of grafts per patient were similar in thetwo groups (3.4 in the on-pump group and 3.1 in the off-pumpgroup), as were the territories grafted. The index of completeness(the number of grafts performed ÷ the number of graftsplanned) was similar in the two groups. A higher proportionof patients in the off-pump group than in the on-pump groupreceived radial-artery grafts (74 percent vs. 55 percent, P=0.04),and the mean time required per anastomosis was longer in theoff-pump group (13.1 minutes vs. 9.5 minutes, P<0.001).
Immediate Postoperative Period
Table 2 shows the postoperative data and adverse events. Therewere no deaths. In the on-pump group, two patients requiredresternotomy because of hemorrhage during the immediate postoperativeperiod. In the off-pump group, there was a single myocardialinfarction. The mean blood loss was not significantly differentbetween the two groups (898 ml in the on-pump group and 1031ml in the off-pump group). However, patients in the on-pumpgroup were more likely to receive packed-cell transfusion (P=0.004)or clotting-product transfusion (P=0.002). There was no significantdifference in the mean time to extubation or the median postoperativehospital stay between the two groups.
Figure 1 shows mean troponin T levels over time in the two groups.Troponin T levels were significantly higher in the on-pump groupthan in the off-pump group 6 and 12 hours postoperatively (P<0.001for both comparisons), but this difference had disappeared by24 hours. There was a significant difference in the mean areaunder the curve of troponin T values (30.96 hr • µgper liter in the on-pump group and 19.33 hr • µgper liter in the off-pump group, P=0.02).
Figure 1. Mean (±SD) Troponin T Levels over Time in the On-Pump and Off-Pump Groups.
Three-Month Follow-up and Angiography
At three months, the distribution of patients in Canadian CardiovascularSociety classes and New York Heart Association classes was similarin the two groups, as was the incidence of adverse events, includinghospitalization. No deaths, myocardial infarctions, or cerebrovascularaccidents occurred during this time.
Follow-up angiographic data were available for 82 patients (39patients in the on-pump group and 43 in the off-pump group)(Table 3). The remainder were not willing to undergo repeatedangiography. There were no systematic clinical differences betweenthose who underwent repeated angiography and those who did not.Table 3 and Figure 2 show the patency rates in each territory.The overall patency rate for grafts performed on pump was significantlyhigher than the patency rate for those performed off pump (98percent vs. 88 percent, P=0.002). This difference was observedin the territory of the right coronary artery (P=0.01) and theterritory of the left anterior descending artery (P=0.07). Significantlymore radial-artery grafts were used in the off-pump group, witha lower patency rate in this group than in the on-pump group(76 percent vs. 100 percent, P=0.01).
Figure 2. Rates of Graft Patency in Each Territory in the On-Pump and Off-Pump Groups.
Quantitative Coronary Angiography
Table 3 shows the quantitative coronary angiographic analysisof the anastomosis of the left internal thoracic artery to theleft anterior descending artery. There was no significant differencebetween the groups in the percentage of stenosis measured atthis site, although there was a trend toward a higher percentageof stenosis in the off-pump group than in the on-pump group(mean, 34.67±34.53 percent vs. 21.19±26.38 percent,P=0.06).
Discussion
We found that the patency rate for grafts performed off pumpwas lower at three months than that for grafts performed onpump (overall patency, 88 percent vs. 98 percent). The territoryof the left anterior descending artery, often described as theeasiest territory to graft off pump, also had a lower rate ofpatency in the off-pump group. Radial-artery grafts appear tobe the most vulnerable conduit in the off-pump group.
We have considered possible reasons for the reduced patencyrate in our off-pump group. The anticoagulation regimen differedin this group, with only half-dose heparinization during theformation of the anastomoses. This practice is widely accepted,15and there have been no reports to suggest that it increasesthe risk of graft occlusion. All patients in both groups receivedthe same regimen of antiplatelet therapy. The two surgeons performedsimilar numbers of on-pump and off-pump procedures for the study.In the two years preceding the study, the surgeons performed13 percent of their coronary work off pump. Off-pump surgeryis technically more demanding than on-pump surgery because theoperative field is less stable and less visible. The learningcurve for this procedure is probably substantial and may belonger than we anticipated. One should bear this in mind wheninterpreting our results. We used an unselected population ofpatients, many of whom had diseased target vessels. A more selectiveapproach to the target vessel might yield better results foroff-pump surgery.
We chose to perform angiography at three months, since any edemaat the site of anastomosis would have resolved by this time.The rate of compliance with repeated coronary angiography was80 percent, which compares favorably with compliance rates inother studies.15 We measured differences in the quality of theanastomosis of the left internal thoracic artery to the leftanterior descending artery, using previously described techniques,16and these results reflect our patency rate.
Our findings with respect to clinical outcomes and troponinT levels are consistent with findings from other studies ofoff-pump surgery, showing reduced release of cardiac-specificproteins and a low rate of adverse events.10,11,12 However,the rate of graft patency in our off-pump group was lower thanthat in the few other studies in which this was investigated.15,17The only other randomized study investigating graft patencyfound no significant differences in patency rates between thetwo groups, but only 25 percent of patients were reevaluated.15In that study, the overall patency rate was 93 percent in theon-pump group and 91 percent in the off-pump group (absolutedifference, 2.0 percentage points; 95 percent confidence interval,6.5 to 10.4). The on-pump patency rate was lower than in ourstudy (93 percent vs. 98 percent); our rate of 98 percent inthe on-pump group is at the high end of the reported range andmay skew the results. The absence of a significant differencein patency rates in the earlier study may be due in part tothe small proportion of patients who underwent repeated angiography.Another important difference is that the number of grafts perpatient was lower in that study than in ours (2.6 in the on-pumpgroup and 2.4 in the off-pump group, as compared with 3.4 and3.1, respectively).
Nonrandomized studies have consistently shown excellent patencyrates for off-pump surgery, but the majority of these studiesinvolved patients who were receiving one or two grafts, witha lower proportion of patients receiving circumflex-artery grafts,indicating a highly selected population.17,18,19 Other studieshave included low-risk patients with preserved left ventricularfunction who required one or two grafts.15,18 Our patients representa population with true multivessel disease; a quarter of ourpatients had a left ventricular ejection fraction of less than50 percent, and almost half of our patients had a previous myocardialinfarction. Twenty-seven percent of patients in our study haddiabetes, as compared with 17 percent in the on-pump group and9 percent in the off-pump group in the study by Nathoe et al.15
Troponin T levels were higher in the on-pump group than in theoff-pump group 6 and 12 hours postoperatively, but this differencehad disappeared by 24 hours. The area under the curve, representingtotal protein release, confirms that the level was higher inthe on-pump group. These short-lived elevations in the levelsof troponin T may not represent true myocyte death or injury.20
Short-term outcomes in terms of major adverse events at dischargeand at three months were similar in the two groups. In the immediatepostoperative period, fewer patients in the off-pump group requiredtransfusions of blood or clotting products. The difference maybe clinically important. However, the use of protocol-drivencare in the immediate postoperative period and hemodilutionmay account in part for the difference.
The practice of off-pump coronary surgery has not been widelyadopted; only 8.8 percent of all coronary-artery bypass operationsperformed in the United States between January 1999 and January2001 were performed off pump.21 Mack et al.22 found that off-pumpsurgery is performed to a large extent by early pioneers inthe field, who — even before the advent of off-pump surgery— were the surgeons in their units whose patients hadlower operative mortality rates and better outcomes. Thus, previousoff-pump results may be better because the surgeons who chooseto perform this operation are highly skilled.22 In contrastto the findings of Mack et al. and in answer to the questionsraised by Bonchek in the editorial accompanying their report,23we have shown that the surgeon's skill was not a factor in ourresults, since our surgeons had a high rate of on-pump patencyand there were no deaths in either group.
Thus, although off-pump coronary surgery may not be widely applicable,it may be a useful strategy in selected patients, such as thosewith serious coexisting conditions who have good target vessels.The apparently reduced patency rate in the off-pump group inour study arouses concern about the long-term outcome of thisapproach, and further clinical trials with longer follow-upare needed.
Supported by grants from the British Heart Foundation (PG/9912)and the Royal Brompton and Harefield National Health ServiceTrust Clinical Research Committee.
Dr. Flather, Prof. Pepper, and Prof. Sigwart report having receivedresearch grants for separate studies from Medtronic Inc., andProf. Pepper and Dr. De Souza report having served as consultantsfor Medtronic Inc.
We are indebted to Medtronic Inc. for kindly supplying the OctopusII equipment for the study free of cost, to James Hooper andMichael Kemp for advice on the biochemical markers and performanceof the laboratory analysis, to Marcelo Shibata for help in thedesign of the study, and to Fiona Nugara for data management.
Source Information
From the Royal Brompton and Harefield National Health Service Trust (N.E.K., A.D.S., R.M., M.F., J.C., S.D.); the Imperial College of Science, Technology, and Medicine, National Heart and Lung Institute (P.C., J.P.); and the London School of Hygiene and Tropical Hygiene (D.W.) — all in London; and the Center and Division of Cardiology, University Hospital, Geneva (U.S.).
Address reprint requests to Dr. Khan at the Clinical Trials and Evaluation Unit, Royal Brompton Hospital, London SW3 6NP, United Kingdom, or at r.mister{at}rbh.nthames.nhs.uk.
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Off-Pump versus On-Pump Coronary Bypass Surgery
deGuzman B. J., Subramaniam M. H., Dewey T. M., Magee M. J., Mack M. J., Desai N. D., Fremes S. E., Svedjeholm R., Dahlin L.-G., Khan N. E., DeSouza A. C., Pepper J. R.
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