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Ann Thorac Surg 2006;81:1396-1400
© 2006 The Society of Thoracic Surgeons

Original article: Cardiovascular

Mini–Cardiopulmonary Bypass System: Results of a Prospective Randomized Study

Cesare Beghi, MD a , Francesco Nicolini, MD a , * , Andrea Agostinelli, MD a , Bruno Borrello, MD a , Alessandro Maria Budillon, MD a , Franco Bacciottini, MD b , Marco Friggeri, MD b , Antonietta Costa, MD c , Loredana Belli, MD c , Luisita Battistelli, MD d , Tiziano Gherli, MD a

a Department of Cardiac Surgery, University of Parma, Italy
b Department of Experimental Medicine, University of Parma, Italy
c Department of Anesthesiology, University of Parma, Italy
d Biochemical Analysis Laboratory, Ospedale Maggiore of Parma, Parma, Italy

Accepted for publication October 17, 2005.

* Address correspondence to Dr Nicolini, Cattedra e Divisione di Cardiochirurgia, Università degli Studi, Via A. Gramsci 14, Parma 43100, Italy (Email: francesconicolini{at}libero.it).


   Abstract
Top
 Abstract
Introduction
 Patients and Methods
 Results
 Comment
 Acknowledgments
 References
 
BACKGROUND: We studied postoperative mortality and morbidity after coronary artery bypass graft surgery performed using the mini–extracorporeal circulation (MECC) system.

METHODS: From June 2001 to June 2002, we randomly enrolled 60 patients who underwent isolated elective coronary artery bypass graft surgery, and were operated on with the MECC system (30 patients: group A) or standard cardiopulmonary bypass (30 patients: group B). Serial blood samples were collected to evaluate the main preoperative, intraoperative, and postoperative clinical and biological variables; and to measure hemolysis, interleukin-6 cytokine, and plasma C-reactive protein release.

RESULTS: A more stable hemoglobin level was detected in group A. The platelet count did not show a significant difference between the two groups. Interleukin-6 cytokine release showed higher values in group B, although no difference between groups was statistically significant. The time course of circulating plasma C-reactive protein concentration exhibited the same increase in both groups. Plasma free hemoglobin levels showed higher hemolysis peaks in group B, although a statistical significant difference was detected only at 4 hours after surgery. A higher cardiac index and reduced systemic and pulmonary vascular resistance index in the early postoperative period were found in group A at postoperative time 30 minutes.

CONCLUSIONS: Our experience shows that MECC offers satisfactory clinical benefits in terms of good hemodynamic support, safety, and low morbidity, although the study failed to demonstrate a significant clear superiority of MECC versus conventional cardiopulmonary bypass. The results need to be confirmed by a larger prospective, randomized study comparing MECC and standard cardiopulmonary bypass.


   Introduction
Top
 Abstract
 Introduction
Patients and Methods
 Results
 Comment
 Acknowledgments
 References
 
Cardiac surgery using standard cardiopulmonary bypass (CPB) initiates a systemic inflammatory response owing to patient blood contact with a foreign surface and to the activation of the complement [1]. Coronary artery bypass graft (CABG) surgery without CPB has been introduced to avoid the deleterious systemic effects of standardized extracorporeal circulation; but it is well known that the limitations of off-pump CABG are related mainly to hemodynamic instability occurring as a consequence of cardiac displacement. These problems led to a search for less aggressive and more biocompatible pump-oxygenator circuits. The basic idea of a mini-CPB system is to ensure adequate perfusion by a closed, extremely minimized extracorporeal circuit. This system, based on a rotary blood pump and a high-performance membrane oxygenator, can eliminate blood-air contact by avoiding a venous reservoir and by means of suction blood separation. It also aims to minimize hemodilution and mechanical blood trauma.

To date only a few reports on the use of the minimal extracorporeal circulation (MECC) system in CABG and aortic valve replacement have been published [2–4]. The purpose of the present study was to describe the results of our prospective randomized trial comparing the Jostra MECC (Jostra AG, Hirrlingen, Germany) with standard CPB in 60 patients affected by coronary artery disease who underwent elective surgery.


   Patients and Methods
Top
 Abstract
 Introduction
 Patients and Methods
Results
 Comment
 Acknowledgments
 References
 
Enrollment and Randomization
From June 2001 to June 2002, we prospectively enrolled 60 patients who underwent isolated elective CABG, and were operated on with MECC or standard CPB. All patients signed informed consent forms, and the study was approved by the University of Parma Ethics Committee.

Patients were randomly assigned to group A (30 patients) for MECC or to group B (30 patients) for standard CPB. Blind allocation using random numbers was made after the patient was deemed to be eligible for entry into the protocol. Inclusion criteria were as follows: age more than 40 years; ejection fraction greater than 40% (calculated with preoperative transthoracic echocardiography); two or more coronary vessel diseases; and one or more of the following comorbidities at risk for postoperative systemic inflammatory complications: diabetes, obesity, chronic obstructive pulmonary disease, chronic renal insufficiency, previous peripheral vascular disease. Exclusion criteria were coagulopathies (anticoagulation therapy during the 5 days before surgery, hepatopathy with coagulation deficits), immunosuppressive treatment during the 30 days before surgery, nonsteroidal anti-inflammatory drug therapy in the 7 days before surgery, and primary valvular aortic and mitralic diseases.

The cardiac index, systemic vascular resistance index, and pulmonary vascular resistance index by Swan-Ganz catheter insertion as well as the dosage of lactates, leukocytes count, and platelet count were each reported preoperatively, at the end of CPB, and at postoperative time 30 minutes, 3 hours, 6 hours, and 24 hours. Moreover, seven serial venous blood samples for each patient were collected to perform a "blind" specific evaluation of hemolysis and dosage of interleukin-6 (IL-6) cytokine and C-reactive protein (CRP) release, respectively the day before surgery, at the induction of anesthesia premedication, at the beginning of CPB, at the end of CPB, and after 4 and 6 hours and the day after surgery. The time between blood sampling and plasma aliquots freezing never exceeded 3 hours. Plasma was kept in aliquots frozen at –20°C before being tested. Hemolysis was studied according to the method described by Drabkin [5]. Interleukin-6 levels were measured by enzyme-linked immunosorbent assay, as previously described [6]. Briefly, the anti–IL-6 purified monoclonal antibodies (mAb) ENDOGEN were coated as a capture mAb on 96-well flat bottomed plates (Maxisorp; Nunc, Intermed, Denmark). The detection was achieved using an anti–IL-6 biotinylated mAb (ENDOGEN) followed by detection with streptavidin-peroxidase (Sigma, St. Louis, MO). The lowest detectable levels for IL-6 were 10 pg/mL. Plasma CRP was measured by a high sensitivity nephelometric method on a Behring Nephelometer II analyzer (Dade Behring, Newark, DE). Specific cardiac enzymes release and postoperative morbidity of both groups were reported.

The two groups of patients were similar with regard to the main preoperative data (Table 1).


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  		Table 1. Preoperative Data
 
Anesthesia Protocol
All patients received premedication with morphine sulphate (0.1 mg/kg body weight) and scopolamine (0.01 mg/kg body weight) intramuscularly 60 minutes before transfer to the operating theatre. Anesthesia was induced with midazolam (0.05 mg/kg), etomidate (0.3 mg/kg), and fentanyl. Neuromuscular block was obtained by cisatracurium besylate given intravenously. Anesthesia was maintained with fentanyl, isofluorane, and cisatracurium besylate. A full intravenous heparin dose was administered (3 mg/kg) in the case of standard CPB and a half dose (1.5 mg/kg) in the case of patients operated on with the MECC system.

Surgery Protocol
All the procedures were performed through a standard median sternotomy and CPB instituted by right atrium-ascending aorta cannulation. The extracorporeal circulation management was similar in both groups: an optimal flow rate of 2.4 L · min–1 · m–2 and a mean systemic perfusion pressure of 60 mm Hg were maintained during surgery on all patients by way of mild systemic hypothermia (34°C).

For standard CPB, a membrane oxygenator with a cardiotomy reservoir was used with a roller pump (Quadrox Jostra AG, Hirrlingen, Germany), and the line was not coated with heparin; the CPB was primed with 1,500 mL Ringer lactate solution, and mean tubing length was longer than 2 m. The MECC system consists of a fully heparin-coated, closed system associating a Rotaflow centrifugal pump and a Quadrox membrane oxygenator (Jostra AG, Hirrlingen, Germany). The system does not have cardiotomy suction. The intrapericardial blood was sucked in using only a cell salvage device. The venous line is directly connected to the pump head, and the tubing length does not exceed 2 m. Suppression of the open venous reservoir eliminated the blood-air surface and allowed lower priming volumes (450 mL).

In both groups, myocardial protection consisted of hyperkalemic warm blood intermittent antegrade cardioplegia, delivered every 15 minutes. Myocardial revascularization was obtained by suturing the left internal mammary artery as first-choice arterial conduit on the left anterior descending coronary artery and using the radial artery or right internal mammary artery and segments of saphenous vein in the other vessels.

Statistical Analysis
All continuous data are expressed as mean ± SD. Differences between the two groups were compared by means of two-way analysis of variance (ANOVA). Least significant difference post hoc tests were used to identify the location of significant differences when the ANOVA yielded a significant F-ratio (a p value of < 0.05 was considered a statistically significant difference). The Bonferroni correction was applied to the p values to correct for multiple comparisons. The {chi}2 test was used for categorical data.


   Results
Top
 Abstract
 Introduction
 Patients and Methods
 Results
Comment
 Acknowledgments
 References
 
No in-hospital deaths occurred in either group. The mean number of grafts performed was 2.75 in group A and 2.7 in group B (p = not significant). Mean extracorporeal circulation time was 99 ± 28 minutes in group A and 78 ± 19 in group B, whereas mean aortic cross-clamping time was, respectively, 59 ± 20 and 45 ± 13 minutes (p = not significant). No patient required intra-aortic balloon pump assistance for low cardiac output syndrome. Inotropic support with dobutamine (> 5 µg · kg–1 · min–1) was required for 6 patients in group A and 9 in group B (p = not significant). Hemodynamic data measured by Swan-Ganz catheterization showed a better immediate postoperative performance among patients in group A with a significantly higher cardiac index (3.78 ± 0.4 L · min–1 · m–2 versus 2.8 ± 0.6 L · min–1 · m–2, p = 0.009), lower systemic vascular resistance index (1,506 ± 208 dynes sec m2 cm–5 versus 2,220 ± 362 dynes sec m2 cm–5, p = 0.003), and lower pulmonary vascular resistance index (225 ± 37 dynes sec m2 cm5 versus 310 ± 71 dynes sec m2 cm–5, p = 0.03) at postoperative time 30 minutes. In the same group, we found a tendency toward lower lactate levels_(p = not significant).

Only 1 perioperative acute myocardial infarction was detected in group B. Nevertheless, troponin I level evolution did not show significant differences between two groups, as shown in Figure 1.


Figure 1
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  		Fig 1. Troponin T evolution. The p values between groups were not significant. (Black bars = mini–extracorporeal circulation system; white bars = standard cardiopulmonary bypass.)

 
The trend of leucocyte and platelet counts and creatinine levels did not show significant differences between groups at any time. Interleukin-6 cytokine release (Fig 2) showed higher values in group B, although no difference between groups was statistically significant.


Figure 2
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  		Fig 2. Time course of circulating interleukin-6 levels of patients undergoing extracorporeal circulation: mini–extracorporeal circulation system (open diamonds) or standard cardiopulmonary bypass (solid diamonds). The p value between groups was not significant.

 
The time course of circulating plasma CRP concentration exhibited the same increase until the first postoperative day in both groups, without significant differences (Fig 3).


Figure 3
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  		Fig 3. Time course of circulating plasma C-reactive protein concentration of patients undergoing extracorporeal circulation: standard cardiopulmonary bypass (solid diamonds) or mini–extracorporeal circulation system (open diamonds).

 
As shown in Figure 4, plasma free hemoglobin levels showed higher hemolysis peaks in group B, although the Bonferroni correction, applied to the p values to correct for multiple comparisons, confirmed a statistical significative difference only at 4 hours after surgery (p ≤ 0.0071 [0.05/k with k = 7]). The postoperative red blood cell transfusion rates were 10% in group A and 26% in group B (p = not significant), and the only patient requiring surgical revision for perioperative bleeding was in group B.


Figure 4
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  		Fig 4. Time course of circulating plasma free hemoglobin levels of patients undergoing extracorporeal circulation: standard cardiopulmonary bypass (solid diamonds) or mini–extracorporeal circulation system (open diamonds). *p < 0.0071.

 
The mean time to extubation was 11 hours in group A and 13 hours in group B (difference not significant). Mean intensive care unit stay was shorter in the MECC group (1.4 days versus 2.3): 1 patient in group B experienced transient acute renal insufficiency (creatinine level > 2 mg/dL), whereas respiratory insufficiency accounted for 1 patient in group A and 3 patients in group B. No postoperative focal neurologic complications occurred in either group.


   Comment
Top
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
Acknowledgments
 References
 
The development of CPB and the improvement in methods of myocardial protection allow the best technical conditions for cardiac surgery, although the systemic deleterious effects of CPB remain well known and may lead to the inflammatory response syndrome, adult respiratory distress syndrome, and multiorgan failure [2, 7–8].

Recently, a minimized extracorporeal circulation system (MECC) has been developed to avoid morbidity related to conventional CPB and to permit technical surgical conditions more favorable than the off-pump technique for CABG. Obviously, the tendency to incomplete revascularization and technical difficulties in constructing coronary anastomoses on the beating heart remain the principal limitations to the off-pump CABG. To date, only two randomized trials of MECC, in CABG [2] and in aortic valve replacement [4] have been published. In these papers, MECC was shown to reduce inflammatory syndrome [2] and to allow more biocompatibility than conventional CPB, providing a good postoperative biological profile and clinical results [4].

In our study, we prospectively enrolled 60 patients who underwent isolated elective CABG because of coronary artery disease associated with one or more comorbidities at high risk for postoperative systemic inflammatory syndrome, who were operated on with MECC or standard CPB.

The main purpose of our study was to describe the results of our trial comparing the Jostra MECC versus standard CPB in terms of systemic inflammatory response. The platelet count did not show a significant difference between the two groups, whereas the finding of a more stable hemoglobin level could correlate with the lower postoperative blood transfusion rate in group A. The MECC system shows a lower release of IL-6 cytokine, although no statistically significant difference between the two groups was reported. We did not measure IL-1ß levels during the bypass or after the early postoperative period. In agreement with other authors [2], we support the idea that there is no significant modification of plasma levels of this marker after CPB and that on-pump surgery cannot be considered as stimulating factor of IL-1ß release in the blood stream. Moreover, the time course of circulating plasma CRP concentration exhibited the same increase in both groups without significant differences. Although IL-6 cytokine and CRP are well-known markers of inflammatory response, they are not sufficient to confirm the efficacy of MECC in reducing systemic inflammatory syndrome.

Hemodynamic parameters measured during the intensive care unit stay showed similar postoperative performances in both groups, although group A patients experienced a significantly better cardiac index, and lower systemic vascular resistance index and pulmonary vascular resistance index at postoperative time 30 minutes only. Myocardial protection was carried out in both groups by hyperkalemic warm blood intermittent antegrade cardioplegia [9]; it has been proved elsewhere that this technique ensures excellent ischemic protection during CABG [10]. Only 1 perioperative nonfatal acute myocardial infarction was detected in group B, and troponin T level evolution did not show significant differences between the two groups, as shown in Figure 1. Mean intensive care unit stay was shorter in the MECC group: during this period we found a tendency toward a lower morbidity in group A in terms of shorter mean time to extubation and incidence of respiratory or renal insufficiency.

Performing a coronary anastomosis using the beating-heart technique without circulatory and heart-lung bypass remains a technical and psychological challenge for the surgeon. Although consensus has been reached on the possibility of performing a complete revascularization with off-pump technique, we believe that beating-heart coronary surgery can be realized with reasonable success only by an_experienced surgeon. We do not perform off-pump surgery routinely, reserving this technique for selected patients in whom coronary artery disease is limited to the left ventricle anterior wall and when mandatory contraindications to CPB exist. In such cases, MECC can be employed as a substitute for conventional CPB in coronary surgery: it can be used as a temporary support for a beating heart or as a full support for an arrested heart. Recent papers have described the feasibility of MECC during aortic valve replacement [4] and also in thoracoabdominal aortic aneurysm repair, for which safe distal aortic, spinal cord, and visceral selective perfusion appear warranted [11]. Compared with the standard CPB, MECC does not have ventricular drainage, cardiotomy suction, and a venous reservoir. It is clear that it is necessary for surgeons, anesthesiologists, and perfusionists to learn to use this technique because the absence of a venous reservoir can potentially create new problems in terms of optimal hemodynamics and vascular tone management. The potential problem of air entrapment and consequent embolism is being eliminated; the manufacturers are working on further improvements, including an air removal device in the circuit, although no fatal or major episodes have been described by ourselves or other authors to date.

It appears that the main advantage of MECC is the reduction of the blood surface contact area due to a shorter circuit, and that it is a heparin-coated system, requiring only moderate systemic heparinization, compared with standard CPB. These technical characteristics should lead to a lower postoperative systemic inflammatory response, as reported in other studies [2–4]. Our study, however, failed to demonstrate significant clear superiority of MECC versus conventional CPB, although the markers investigated do not sufficiently represent the complex field of systemic inflammation. They may, however, serve as initial indicators of this pathologic condition. The values of markers reported in the present study do no more than confirm a tendency to lower systemic inflammatory disease in the MECC group.

Finally, plasma free hemoglobin levels showed higher hemolysis peaks in group B, although a statistically significant difference was detected only at 4 hours after surgery. In future, it will be necessary to investigate further the role of the cardiotomy suction device, present only in the standard CPB circuit, in the genesis of such higher hemolysis levels when compared with the MECC system.

In conclusion, our experience shows that MECC offers satisfactory clinical benefits in terms of good hemodynamic support, safety, and low morbidity, although technical improvements related to air evacuation are warranted. Follow-up studies are necessary to elucidate benefits and adverse effects of this minimized extracorporeal system, and the results need to be confirmed by more robust statistical tests on larger scale, prospective, randomized studies comparing MECC with standard CPB.


   Acknowledgments
Top
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
 Acknowledgments
References
 
Bruno Borrello, MD, has been supported by a research grant from Compagnia di S. Paolo, Torino, and M.I.U.R. We thank Lois Clegg for her help in the revision of the paper.


   References
Top
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
 Acknowledgments
 References
 

  1. Ascione R, Lloyd CT, Underwood MJ, Lotto AA, Pitsis AA, Angelini GD. Inflammatory response after coronary revascularization with or without cardiopulmonary bypass Ann Thorac Surg 2000;69:1198-1204.[Abstract/Free Full Text]
  2. Fromes Y, Gaillard D, Ponzio O, et al. Reduction of the inflammatory response following coronary bypass grafting with total minimal extracorporeal circulation Eur J Cardiothorac Surg 2002;22:527-533.[Abstract/Free Full Text]
  3. Remadi JP, Marticho P, Butoi I, et al. Clinical experience with the mini-extracorporeal circulation systeman evolution or a revolution?. Ann Thorac Surg 2004;77:2172-2176.[Abstract/Free Full Text]
  4. Remadi JP, Rakotoarivelo Z, Marticho P, et al. Aortic valve replacement with the minimal extracorporeal circulation (Jostra MECC System) versus standard cardiopulmonary bypassa randomized prospective trial. J Thorac Cardiovasc Surg 2004;128:436-441.[Abstract/Free Full Text]
  5. Drabkin DL. The standardization of hemoglobin measurement Am J Med Sci 1949;217:710-711.[Medline]
  6. Doré P, Lelievre E, Morel F, et al. IL-6 and soluble IL-6 receptors (sIL-6R and sgp130) in human pleural effusionsmassive IL-6 production independently of the underlying disease. Clin Exp Immunol 1997;107:182-188.[Medline]
  7. Liebold A, Keyl C, Birnbaum DE. The heart produces but the lungs consume proinflammatory cytokines following cardiopulmonary bypass Eur J Cardiothorac Surg 1999;15:340-345.[Abstract/Free Full Text]
  8. Rothenburger M, Soeparwata R, Deng MC, et al. Prediction of clinical outcome after cardiac surgerythe role of cytokines, endotoxin, and anti-endotoxin core antibodies. Shock 2001;16(Suppl 1):44-50.[Medline]
  9. Calafiore AM, Teodori G, Rondelez L, et al. Intermittent antegrade warm cardioplegia Ann Thorac Surg 1995;59:398-402.[Abstract/Free Full Text]
  10. Nicolini F, Beghi C, Muscari C, et al. Myocardial protection in cardiac surgerycurrent options and future challenges. Eur J Cardiothorac Surg 2003;24:986-993.[Abstract/Free Full Text]
  11. Palombo D, Valenti D, Gaggiano A, et al. Early experience with the minimal extracorporeal circulation system (MECC) during thoracoabdominal aortic aneurysm repair Eur J Vasc Endovasc Surg 2004;27:324-326.[Medline]



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