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Ann Thorac Surg 2004;77:569-573
© 2004 The Society of Thoracic Surgeons

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Original article: cardiovascular

Off-pump versus on-pump myocardial revascularization in low-risk patients with one or two vessel disease: perioperative results in a multicenter randomized controlled trial

^a Division of Cardiovascular Surgery, Department of Surgery, Federal University of São Paulo Brasil, Sao Paolo, Brazil
^b Hospital Universitário Pedro Ernesto (RJ), Sao Paolo, Brazil
^c Clinicord (GO), Sao Paolo, Brazil
^d Real e Benemérita Sociedade Beneficência Portuguesa de São Paulo, Sao Paolo, Brazil
^e Santa Casa de Goiânia (GO), São Paulo, Brazil

Accepted for publication July 10, 2003.

^* Address reprint requests to Dr Gerola, Rua Napoleão de Barros, 1315/102 Vila Clementino, São Paulo, Brazil CEP:04024-003.
e-mail: gerola{at}uol.com.br

	Abstract

Top Abstract Introduction Material and methods Results Comment Acknowledgments References

 
BACKGROUND: To evaluate hospital mortality and morbidity after myocardial revascularization in a prospective and multicenter study, comparing on-pump versus off-pump in a special subset of patients with lesions in the left descending artery, alone or associated with the right coronary artery.

METHODS: A multicenter prospective randomized study was performed. One hundred and sixty selected low-risk patients were enrolled; 80 patients were operated on-pump (coronary artery bypass grafting [CABG], group I) and 80 patients were operated off-pump (off-pump coronary artery bypass [OPCAB], group II). One hundred and five were male and ages ranged from 39 to 70 years old; mean 58.81 ± 9.31 and median 59. Preoperative clinical characteristics were similar in both groups; only previous myocardial infarction was higher in the OPCAB group. Patients with severe left ventricular dysfunction (FE 35%), renal failure and lesions of the circumflex artery and its branches were excluded, as well as patients with significant comorbidities that were inappropriate for randomization because we selected them for OPCAB procedures.

RESULTS: Hospital mortality was 2.5%, three patients (3.7%) in group I (on-pump) and one patient (1.2%) in group II (off-pump) (ns). The number of grafts per patients in group I was 1.81 ± 0.6, and 1.77 ± 0.68 in group II (p = 0.833). There was no difference in the total operation time 205.10 ± 54.30 minutes in group I and 189.50 ± 55.44 in group II (ns). Six patients (7.5%) had myocardial infarction in group I and three (3.7%) in group II (ns). Bleeding in the postoperative period was 680.50 ± 434.1 mL in the on-pump group and 678.6 ± 357.0 mL in the off-pump group (ns). Three patients (3.7%) presented transient neurologic dysfunction in group I and six patients (7.5%) in group II (ns). Intensive care stay was 2.4 ± 1.0 days in the CABG and 2.3 ± 0.98 days in the OPCAB group (ns).

CONCLUSIONS: We did not find any statistical difference in hospital mortality and morbidity using on-pump or off-pump techniques for low-risk patients.

	Introduction

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Off-pump myocardial revascularization has shown a great development in the last few years. Several studies have shown good results using this approach, with low mortality and morbidity in the postoperative period, lower costs, and less use of blood products [1–4]

Some comparative analyses, however, did not present homogenous results. Vural and colleagues [5], in a randomized study, observed no difference in hospital mortality and morbidity, but related lower use of vasoactive drugs and blood transfusion in patients operated on without extracorporeal circulation. Kshettry and colleagues [6] found no difference in the main hospital morbidity between patients operated on with or without extracorporeal circulation. Ascione and colleagues [7] demonstrated significant reduction of morbidity and effective reduction of costs in the patients operated on using the off-pump technique. Bull and colleagues [8] documented that reduction of costs is associated with the number of grafts performed and not with nonuse of extracorporeal circulation.

Malheiros and colleagues [9] related no difference in gross neurologic dysfunction in patients operated on using on-pump or off-pump, Ricci and colleagues [10] studied an octagenary population, and the incidence of stroke was significantly lower in patients operated on using the off-pump technique. Baumgartner and colleagues [11] also demonstrated low incidence of neurologic and renal dysfunction, and short time of mechanical ventilation in patients operated on without extracorporeal circulation.

Another important aspect is the fact that many of these studies are retrospective and have compared different populations. Several times the off-pump approach was performed in patients with lesion in one or two vessel disease, whereas cardiopulmonary bypass was used in patients with multivessel disease. In addition, in some prospective studies in patients with multivessel disease, the group operated on off-pump received a significantly lower number of grafts when compared with patients operated on-pump [8, 12–15]. The purpose of this prospective, randomized and multicenter study was to compare on-pump versus off-pump myocardial revascularization in a specific population of low-risk patients and similar coronary artery disease.

	Material and methods

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Study protocol
We chose, for this study, a randomized group of patients with lesions of 70% or more in the left anterior descending artery, isolated or associated with lesion in the right coronary artery, and the excluded possibility of angioplasty. All patients showed normal to moderated left ventricular dysfunction.

Exclusion criteria were: circumflex artery lesions; chronic renal dysfunction (creatinine > 2.0 mg/dL); acute coronary syndrome after angioplasty failure and(or) unstable hemodynamic conditions; severe left ventricular dysfunction (ejection fraction [FE] 35%); patients with left ventricular aneurysm, carotid lesions and other pathologic associations like hepatitis, aids, morbid obesity; age over 70 years old; and redo myocardial revascularization.

Patients with comorbidities were excluded, because each morbidity represents a specific cohort that needs a separate study. In addition, the severity of these morbidities is also variable: for example, some patients with renal dysfunction needed conservative treatment and others needed dialysis. Therefore, the inclusion of these patients could increase morbidity and even mortality, making it very difficult to attribute the complication by the use of cardiopulmonary bypass. In the same way, the circumflex artery presents different positions, more or less posterior, and different difficulty levels of exposure. Patients excluded of this protocol were operated on using the off-pump procedure.

Study population
A randomized group of 160 patients were chosen for this study. One hundred and five were male and the age ranged from 39 to 70, mean 58.81 ± 9.31 and median of 59 years old. Eighty patients had hypertension (arterial pressure more than 140/90), 83 were smokers, 69 had previous myocardial infarction, 33 had diabetes (glucose > 120 mg/dL), 53 had hypercholesterolemia (cholesterol total > 240 mg/dL), and 75 were in functional class III or IV for angina (Canadian Cardiovascular Society [CCS]). All patients signed an informed consent form according to the rules of the Scientific and Ethical Committee of the Federal University of São Paulo –Unifesp/EPM.

Operative technique
Patients operated on on-pump received 4 mg/kg of heparin, ascending aorta cannulation according to the routine of each group, and right atrium cannulation. Cardiopulmonary bypass with systemic hypothermia (28°C) and myocardial protection was achieved by 4°C cold intermittent antegrade blood cardioplegia, delivery each 20 minutes with controlled pressure around 60 mm Hg. Cardioplegia, containing a small concentration of potassium (15 meq/L), delivered in induction dose; other additional doses were given using only blood of priming, without drugs or potassium.

Patients operated on off-pump, received 2 mg/kg of heparin, and an intraluminal shunt was used to perform grafts to the right coronary artery. Coronary occlusion and a myocardial coronary stabilizer system were used in all cases.

The vessel was stabilized, surrounded proximally by 5 to 0 polypropylene sutures, and it was snared. Presently, we avoid distal snare. When the saphenous vein was used, the proximal anastomosis was performed on the partially clamped ascending aorta.

Parameters analyzed
The parameters analyzed were: operation time; cardiopulmonary bypass time; coronary occlusion time; number of grafts performed; and the use of the left internal mammary artery. Postoperative data regarding myocardial infarction, bleeding, reoperation, requirement for blood units, coagulopathy, respiratory complications, intubation time, necessity of reintubation, wound complication, neurologic dysfunction, and others like atrial fibrillation, gastrointestinal alterations, in intensive care unit (ICU) stay, and in-hospital stay were recorded for both groups. Hospital mortality was considered as death before, and including, 30 days after discharge. Death up to 30 days after release was considered hospital mortality.

Statistical analysis
Data are presented as mean ± standard deviation. The ² test and Fischer's exact test were used to compare categorical variables. The nonparametric Mann-Whitney U test was used to calculate the difference between the two groups. Values of p less than 0.05 were considered significant.

	Results

Top Abstract Introduction Material and methods Results Comment Acknowledgments References

 
The 160 patients were divided in two groups; 80 operated on using on-pump (group I) and 80 operated on using off-pump (group II) techniques. There were no significant differences between the groups regarding age, sex, smoking habits, hypertension, diabetes, hypercholesterolemia, functional class for angina (CCS), and number of grafts performed. However, in group II (off-pump), the number of patients with previous myocardial infarction was significantly higher (Table 1).

The time of extracorporeal circulation in group I, was 56.85 ± 24.39 minutes. Ischemic time, in group I, was measured by aortic cross clamp time and was 28.97 ± 23.33 minutes; in group II it was considered the period of coronary occlusion by coronary snaring and was 17.24 ± 12.41 minutes (p < 0.05). There was no difference between the groups regarding operation time; 205.10 ± 54.30 minutes in group I, and 189.50 ± 55.44 in group II (p = 0.79, ns). There was no difference in length of surgery between groups.

Postoperative morbidity
Myocardial infarction
Diagnosis of myocardial infarction was done by analysis of electrocardiogram and enzymatic curve of creatine kinase (CK-MB). It was considered myocardial infarction when CK-MB reached five times the normal limit [16] . Creatine kinase release was measured when the patient arrived in the ICU (time 0) and 8, 16, and 24 hours of postoperative, as shown in Table 2. For patients operated off-pump, CK-MB release was significantly lower for the first 24 hours. In group I, six patients (7.5%) presented myocardial infarction and three (3.7%) in group II (ns).

Bleeding and blood products
Bleeding was evaluated only in the postoperative period, measuring the exact thoracic tubes output. Patients operated on on-pump presented 680.50 ± 434.1 mL of bleeding in the postoperative period and in group II (off-pump) had 678.6 ± 357.0 mL (p = 0.107, ns). There was no reoperation in either group. Thirty-five patients (43.7%) in group I needed blood transfusions and 36 (45%) in group II (ns). There was no significant difference in the total amount of blood used, mean 2.9 ± 18 bags per patient in group I, and 2.2 ± 1.3 in group II (ns).

Wound complications
Wound complications included skin and subcutaneous dehiscence (minor complications) and were treated with local care. For mediastinitis (major complications), reoperation and continuous irrigation and systemic antibiotics were necessary. Three patients (3.7%) in group I presented wound complications; two of them had minor complications and one mediastinitis. In group II, one patient presented a minor complication (ns).

Neurologic dysfunction
Neurologic dysfunctions were considered as all alterations of behavior, mental confusion, and psychomotor agitation up to stroke and coma. We did not evaluate neurocognitive dysfunction. No patient in either group had stroke or coma. In group I, three patients (3.7%) presented neurologic dysfunction (periods of mental confusion) as did six patients (7.5%) in group II (p = 0.32, ns).

Other morbidities
Four patients (5%) in group I developed atrial fibrillation and seven (8.7%) in group II (p = 0.53, ns). There was no difference regarding incidence of low cardiac output; six patients in group I and three in group II (ns). On the other hand, the necessity of vasoactive drugs was significantly higher in patients operated on on-pump (19 patients in group I and seven off-pump in group II, p = 0.004).

Intensive care unit stay was 2.4 ± 1.2 days in patients operated on on-pump and 2.3 ± 0.98 days for patients operated on off-pump (p = 0.45, ns). Hospital stay was 8.0 ± 3.1 days in patients of group I (on-pump) and 7.6 ± 3.4 days in group II (p = 0.75, ns).

Hospital mortality
Hospital mortality was 2.5%; three patients in group I (3.7%) and one patient in group II (1.2%), p = 0.62, ns. In group I, myocardial infarction with cardiogenic shock was observed in two patients and a third patient died due to mediastinitis. In group II, one patient died due to myocardial infarction in the postoperative period.

	Comment

Top Abstract Introduction Material and methods Results Comment Acknowledgments References

 
In this study, there was no difference between the two groups regarding incidence of main morbidity and hospital mortality, but it did document significantly lower CK-MB release in the OPCAB group.

Off-pump myocardial revascularization is considered a new alternative to perform coronary artery bypass with minimal damage. Several studies have been done to identify clinical differences between off-pump versus on-pump myocardial revascularization.

Kshettry and colleagues [6], in a retrospective study comparing patients with multivessel disease, operated on on-pump and off-pump, and did not find any difference in morbidity and mortality; however, there was a lower necessity of blood transfusion in patients operated on off-pump. Bull and colleagues [8], in a prospective not randomized, did not find any difference between the two groups in the incidence of either postoperative morbidity or in the use of blood. Standing out is that all patients were multivessel in both groups, and the number of grafts in the patients operated on off-pump was significantly lower (2.7 vs 36, p < 0.0001).

Czerny and colleagues [12], in a randomized study comparing patients with multivessel disease, described clinical results and hospital stay as similar in both groups, once again. Although it was a randomized study the number of grafts per patient was lower in the off-pump group (31 in on-pump group and 2.6 in off-pump group, p < 0.043). In addition, a high incidence of crossover off-pump to on-pump procedures was related (25%). On the other hand, Ascione and colleagues [7], in a prospective and randomized study excluding patients with lesion in the distal portion of the circumflex artery, show the number of grafts per patient was similar (2.3 in the on-pump group and 2.2 in the off-pump group). They did not find any differences in hospital mortality, but in the off-pump group there were lower pulmonary infections, necessity of vasoactive drugs, bleeding, blood transfusion, minor intubation time, in-stay ICU, and lower cost.

Van Dijk and colleagues [15], in a randomized study, described reduction of CK-MB release, minor time to extubation, and one day early discharge in the off-pump group. However, they reported more time in the operating room in the off-pump group (4.2 hours versus 3.8 hours in the on-pump group [p < 0.01]; 2.4 grafts per patient in the off-pump group and 2.6 grafts in the on-pump group [p = 0.05]). Blood products were used less during the operation in the off-pump group, but in the postoperative period it was similar; 28% for the off-pump group and 29% for the on-pump group. No other morbidities had differences.

Angelini and colleagues [16] presented significant difference in in-hospital morbidity in the off-pump group, with less use of blood products and inotropic drugs, minor incidence of atrial fibrillation, chest infection, time to extubation, and less intensive care unit and hospital stay. In fact, Angelini's group, in randomized studies, was one of the few groups that found a significant difference in low risk-patients regarding main hospital morbidities, and not only a difference in the use of blood products and hospital stay.

Several of these comparative studies, including multivessel diseases, have described a number of grafts per patient significantly lower in patients operated on off-pump [6, 8, 13, 14]. This represents a bias of selection in retrospective analysis and also, in prospective studies, could represent a technique limitation as to intramyocardial way, thin vessels, severe atherosclerotic wall, and unstable hemodynamic condition. In our study, we eliminated the possible bias making the same number of grafts per patient. Another interesting fact is that several studies have demonstrated biochemical alteration with no clinical repercussion.

Troponin I release [17], glomerular clearance [18, 19], and microembolic signals using transcranial doppler [20] have been observed in patients, and in all studies, with better results for patients operated on using the off-pump technique. In this study, the CK-MB enzyme release was significantly lower in patients operated on off-pump although there was no difference in myocardial infarction in either group.

The majority of publications documented fewer bleeding in patients operated on off-pump. In our study this fact did not happen, probably because it did not involve patients with three vessel disease and the operation lasted a short cardiopulmonary bypass time. In the same way, there was no difference in neurologic dysfunction, intubation time, pulmonary complication, chest infection, hospital stay, and in-hospital mortality.

We observed heterogeneous results in the literature presented. In some reports is shown superiority in the off-pump procedure over conventional surgery; in others there is shown no difference between the methods.

In fact, the advantage of using off-pump myocardial revascularization is being documented in high-risk subgroups [21]. Specific analysis performed in chronic pulmonary disease patients [22], elderly, [8–10] and severe left ventricular dysfunction [13] have demonstrated the advantage of using off-pump over on-pump myocardial revascularization. In addition, more accurate evaluation involving cognitive function has also shown advantages of using the off-pump technique [23].

In our study, there was no superiority between the techniques. The off-pump myocardial revascularization approach reached the same safety and efficiency of the conventional surgery. On the other hand, in low-risk patients the use of extracorporeal circulation, in the mean time of 50 minutes, did not represent a factor to increase hospital morbidity and mortality. In fact, coronary artery bypass must be safe and complete. Off-pump myocardial revascularization is our favorite procedure if the surgeon has the experience and expertise to perform it. However, when some patients have anatomical difficulties such as thin vessels, intramyocardial way, or severe atherosclerosis, snaring could be a risk of arterial wall damage. The surgeon can use cardiopulmonary bypass aware of similar clinical results.

	Acknowledgments

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This work was supported by the Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP) .

	References

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