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Ann Thorac Surg 2003;76:2000-2006
© 2003 The Society of Thoracic Surgeons
a Department of Cardiovascular Surgery, University Hospital, Kiel, Germany,
b Institute for Biometry and Medical Statistics, University Hospital, Kiel, Germany
Accepted for publication June 19, 2003.
* Address reprint requests to Dr Boening, Department of Cardiovascular Surgery, University Hospital Schleswig-Holstein, Arnold-Heller-Str. 7, 24105 Kiel, Germany.
e-mail: aboening{at}kielheart.uni-kiel.de
| Abstract |
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METHODS: Trying to eliminate this problem, a propensity score analysis of the data of all CCAB patients (n = 517) and OPCAB patients (n = 133) operated on by the same surgeons during the same time period (1998 to 2001) was applied. After matching patients with similar propensity score values, 97 CCAB patients and 72 OPCAB patients entered the final analysis.
RESULTS: Early results were similar in both groups: the 30-day mortality reached 1.4% in the CCAB group and 2.8% in the OPCAB group; strokes did not happen. Perioperative myocardial infarctions occurred in 4.1% of the CCAB patients and 4.3% of the OPCAB patients. Drainage blood loss in the first 24 hours after surgery (830 ± 687 mL, CCAB group; and 909 ± 678 mL, OPCAB group) was similar (p = 0.06) in both groups. Medium term results (freedom from percutaneous transluminal coronary angioplasty or reoperation, freedom from myocardial infarction, freedom from stroke, and the quality of life) also were not significantly different between the off-pump and on-pump groups after a mean follow-up of 27 ± 11 months.
CONCLUSIONS: Our results suggest that elective-surgery patients with coronary artery disease can be operated on either on-pump or off-pump with the same early and late mortality and morbidity.
| Introduction |
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We have analyzed our data of a 4-year OPCAB practice of two surgeons (A.B., J.C.) from 1998 to 2001 including the full learning curve and have compared these data with the data of the same surgeons' CCAB patients from the same period. To overcome the shortcomings of a retrospective, nonrandomized analysis we employed the propensity score statistical technique recommended by Blackstone [17]. In brief this technique assigns a scoring value to every patient after a multiple regression analysis attributing the patient into one or the other comparison group. Only patients with similar scores were compared in the final analysis.
Thus this paper describes the results of our comparison between OPCAB and CCAB patients using a statistical method that is coming very close to a prospective randomized analysis.
| Patients and methods |
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To be able to state a similar severity of the coronary artery disease in both groups coronary artery diameters were measured intraoperatively and a mean value for every vessel was calculated (Table 3).
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For the CCAB procedures, after cannulation of the aorta and the right atrium the patient was cooled to 28°C to 34°C, the aorta was cross-clamped, and 10 mL/kg cold (4°C) antegrade crystalloid (St. Thomas') cardioplegia was given. Distal anastomoses were done first and proximal anastomoses thereafter with a partially clamped aorta. Heparin was administered in a dosage 300 IU/kg and was fully antagonized by protamine. Aprotinin (low dose 2 KIU) was used for every CCAB patient but not for OPCAB patients.
Definitions and thresholds
Perioperative myocardial infarction was defined as creatine kinase CK-MB more than 10% of CK and new Q waves in the discharge electrocardiogram.
Extubation was carried out when the patient was hemodynamically stable without bleeding, warm (>36°C), conscious, able to breathe spontaneously with an FiO2 less than 0.40 and a pO2 more than 80 mm Hg, and a pCO2 less than 50 mm Hg.
The thresholds for blood transfusion were hemoglobin values less than 8.0 mg/dL in a stable situation and less than 9.0 mg/dL in an unstable situation. Fresh frozen plasma was given when bleeding (>300 mL/h) occurred thromboplastin time, factor V and VIII were subnormal. Thrombocytes were transfused in case of bleeding and thrombocyte counts were less than 80,000/µL.
An emergency case was defined as need for surgery within 24 hours after coronary angiography or a patient being given inotropic agents or having an intraaortic ballon pump before surgery.
The index for completeness of revascularization (Table 3) was calculated using the following formula: the number of intended anastomoses divided by the number of realized anastomoses [5].
Follow-up
All patients were contacted by a letter containing a quality of life [19] form and a questionnaire about cardiovascular endpoints (death, reoperation, percutaneous transluminal coronary angioplasty, myocardial infarction, stroke) between April 2002 and October 2002. Approximatley 75% of patients in both groups sent back written informations about their postprocedural quality of life. Patients who did not respond were contacted by telephone. Follow-up completeness reached 91% in the OPCAB group (mean follow-up, 27.5 ± 10.8 months) and 92% in the CABG group (mean follow-up, 27.1 ± 11.8 months).
Statistical methods
According to Blackstone [17], we have used the propensity score method for the statistical analysis of this comparison between two operative techniques. The first step included 517 CCAB patients and 133 OPCAB patients (Table 1) to form a propensity score calculated by logistic regression analysis. For this regression analyis preoperative demographic data (age, sex, diabetes, pulmonary disease, peripheral vascular disease, arterial hypertension, dialysis, neurologic diseases, Canadian Cardiovascular Society angina classification, left ventricular ejection fraction, one-, two-, or three-vessel disease, and the EURO-Score [18]) were taken into consideration. After having obtained a score value for every single patient, patients with similar scores were chosen for the final comparison. Using this technique comparable patient groups could be identified (Tables 1 and 2).
The propensity score is only an estimate of the propensity toward belonging to one group versus another [17]; it does not say anything about the risk profile of a specific patient. A propensity score value close to zero means a higher probability of belonging to the OPCAB group and a value of close to 1 means a higher probability of belonging to the CCAB group. In our study we have matched at least 1 CCAB patient with a similar propensity score value to 1 OPCAB patient, leading to more CCAB patients (n = 97) than OPCAB patients (n = 72) in our analysis. We would like to show by the following example why the propensity score in the CCAB group in our study must be higher than in the OPCAB group: after matching 1 patient from each group with a propensity score of 0.3 and then 1 patient in the OPCAB group with 2 patients in the CCAB group with a propensity score of 0.85, the mean propensity score value in the OPCAB group is 0.58 ± 0.39 and in the CCAB group it is 0.67 ± 0.32. We have addressed this statistical problem by repeating the analysis with 62 patients in each group and seen that also with this population the preoperative demographic data (Table 2) were not significantly different.
Ordinal and nominal data were compared in a 2 x 2 table using the
2 test or Fisher's exact test, if one of the expected values in the 2 x 2 table was less than 5. After having tested interval or ratio data for normal distribution (one-sample Kolmogorov-Smirnov test) normally distributed values were compared using the t test. Not normally distributed values were compared using the Mann-Whitney U test. Statistical significant differences were assumed when p values were lower than 0.05.
| Results |
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The outcome was similar in both groups (Table 4). The 30-day mortality reached 1.4% in the CCAB group and 2.8% in the OPCAB group. One CCAB patient died on postoperative day 8 because of fulminant pulmonary embolism; 1 OPCAB patient died on postoperative day 9 from pulmonary embolism and closure of the bypass segment to a posterior descending artery in a sequential graft to the obtuse marginal branch and posterior descending artery. For these lethal complications, both reasons for death were confirmed by autopsy. The other OPCAB patient died on postoperative day 9 from a massive ulcus ventriculi bleeding in another hospital.
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Perioperative myocardial infarctions occurred in 4.1% of the CCAB patients and 4.3% of the OPCAB patients (p = 0.62). Only 1 patient in the CCAB group required an intraaortic balloon pump preoperatively as well as postoperatively. The number of patients with a CK-MB more than 80 U/L was not significantly different (p = 0.465) in the OPCAB group (n = 4, 6.1%) and the CABG- group (n = 3, 3.4%). However postoperative CK values (p = 0.023) as well as CK-MB values (p < 0.0001) were significantly lower in the OPCAB group. There were 3 rethoracotomies for bleeding in the CCAB group and 1 in the OPCAB group. In each group one reopening had to be done for a bypass reintervention. Mediastinitis or deep sternal wound infection did not occur in any of the study patients.
Although ventilation time was significantly shorter in the OPCAB group (Table 5), the length of stay in the intensive care unit (median, 1 day in both groups) and the length of stay in the hospital (median: CCAB, 12 days; OPCAB, 13 days) were similar.
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Medium-term results
At a medium follow-up of more than 2 years cardiovascular endpoints of the study occurred in a similar number percentage of patients in both groups: freedom from death was 98.4% in the OPCAB and 95.5% in the CCAB group (p = 0.937), freedom from PTCA and reoperation was 94.9% in the OPCAB group and 97.6% in the CCAB group (p = 1.0), freedom from myocardial infarction was 97.6% in the OPCAB group and 95% in the CCAB group (p = 0.649), and freedom from stroke was 96.5% in the OPCAB and 100% in the CCAB group (p = 0.190).
Quality of life was similar in both groups and not different from a healthy population sample (Fig 1).
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| Comment |
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These data are obtained using statistical methods that exclude investigational bias factors for retrospective studies effectively. Retrospective studies operate in normal clinical practice without any interventions implemented by randomized assignment rules and represent the spectrum of medical practice better than the setting of randomized experiments [20]. Bias factors in retrospective studies [17] exist if such studies comparing CCAB and OPCAB results include patients from different time periods [9] or with different demographic data [7, 11, 22, 23]. Moreover it is usually not evident whether the same surgeons have done both on-pump and off-pump procedures and whether the same thresholds for extubation, discharge from hospital, and blood transfusion were valid for both groups.
Even though this study is retrospective the difference from most reports is obvious: two surgeons have operated on patients in both groups during the same time period, the use of the propensity score has resulted in comparable basic data for both groups, and the thresholds are equal for both groups.
The published prospective randomized studies [1, 3, 5] do not report major outcome differences between on- and off-pump surgery but only minor advantages regarding cost, transfusion requirement, and length of stay in the hospital.
If the results of off-pump and on pump surgery in elective patients with low operative risk are similar, why should we not continue to use extracorporeal circulation for routine patients? Of course there is no scientific proof for it but the extracorporeal circulation provides a "protected environment" for cardiac surgeons: hemodynamic stability is maintained, the operative field is quiet and blood free, communication with other disciplines is limited to a minimum, questions about quality of the anesthesiologist or the assistant are not important, and everything can be done in an absolutely standardized way.
Moreover there are still uncertainties regarding the long-term patency of vein grafts after OPCAB surgery: The results reported by Kim and associates [24] (67.9% patency after 1 year) and Ömeroglu and associates [25] (47.1% patency after 3 years) are disappointing. As our data show in agreement with other publications there is a tendency to do more anastomoses on pump than off pump: there is a significantly higher index for completeness of revascularization in the CCAB group in our series compared with the already high index for completeness of revascularization in the OPCAB group. Small coronary arteries (diameter below 1.5 mm) have been regarded as a contraindication to off-pump surgery [26] and complex arterial revascularizations to vessels sometimes in the 1 mm range can be done easier on pump. Minor advantages of off-pump surgery such as cost reduction mainly induced by a shorter length of stay of off-pump patients [5, 8], a lower postoperative CK-MB level [27], or a lower transfusion rate [5, 7] do not convince OPCAB opponents to change their way of myocardial revascularization.
Admittedly the data are quite different for high risk patients: There are reports demonstrating a better outcome for patients with neurologic comorbidities or a high risk for perioperative stroke, for olderly patients or patients with poor left ventricular function [28] but neither are these data from prospective, randomized studies nor is it clear whether the patients are operated on by the same surgeons.
"High-quality follow-up data" for the results of off-pump versus on-pump coronary artery surgery, as demanded by Ascione and associates [28] in a recent review, are now available. In agreement with the medium-term outcome data published by Calafiore and associates [8], by Angelini and associates [1], and by Nathoe and associates [3], our data also show no significant differences between off-pump and on-pump patients 1 to 5 years after surgery.
Limitations
Because there were no clear indications for on- and off-pump surgery at the beginning of this study (and there are still no differential indications), an institutional biastaking patients with more severe coronary artery disease or with smaller coronary vessels on extracorporeal circulation and leaving the "good coronaries" for OPCABwould be possible. However the coronary artery diameter was similar in both groups (Table 3), and the percentage of female patients was similar in both groups.
As this study is retrospective its design can not be regarded as good as that of a prospective, randomized study. However applying the propensity score [17, 21] we were able to overcome most of the bias sources of nonmatched studies. Moreover we have compared CCAB and OPCAB patients of two surgeons with off-pump experience during the same time frame using the same definitions for adverse events and thresholds for treatment decisions in each group. Therefore it reflects the clinical reality in our department even when the use of the propensity score caused a reduction of the number of patients from 656 to 169 in the final analysis. This patient number is not sufficient to find out differences in outcome determinants with an incidence of less than 3% and a difference between the groups of less than 50% in each outcome determinant. But even a prospective, randomized study would have to include thousands of patients to show differences between on- and off-pump surgery when outcome determinants are distributed this way.
Our results suggest that elective patients with coronary artery disease can be operated on either on pump or off pump with the same mortality and perioperative morbidity. Moreover the medium-term results show that a similar freedom from cardiovascular events can be achieved with both surgical methods. From studies with a high level of evidence there is no proof for a general improvement in postoperative outcome by a radical change from on-pump to off-pump coronary artery surgery.
| References |
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6). Eur J Cardiothorac Surg 2003;23:360-367.This article has been cited by other articles:
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S. G Raja and G. D Dreyfus Current Status of Off-pump Coronary Artery Bypass Surgery Asian Cardiovasc Thorac Ann, April 1, 2008; 16(2): 164 - 178. [Abstract] [Full Text] [PDF] |
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T. A. Vassiliades Jr, V. S. Reddy, J. D. Puskas, and R. A. Guyton Long-Term Results of the Endoscopic Atraumatic Coronary Artery Bypass Ann. Thorac. Surg., March 1, 2007; 83(3): 979 - 985. [Abstract] [Full Text] [PDF] |
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D. N. Wijeysundera, W. S. Beattie, G. Djaiani, V. Rao, M. A. Borger, K. Karkouti, and R. J. Cusimano Off-Pump Coronary Artery Surgery for Reducing Mortality and Morbidity: Meta-Analysis of Randomized and Observational Studies J. Am. Coll. Cardiol., September 6, 2005; 46(5): 872 - 882. [Abstract] [Full Text] [PDF] |
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J. Pepper Controversies in Off-pump Coronary Artery Surgery Clin. Med. Res., February 1, 2005; 3(1): 27 - 33. [Abstract] [Full Text] [PDF] |
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