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J Thorac Cardiovasc Surg 2004;128:436-441
© 2004 The American Association for Thoracic Surgery
Surgery for acquired cardiovascular disease |
a Cardiovascular Surgery Unit and Anaesthesiology Department, South Hospital, Amiens, France
Received for publication October 9, 2003; revisions received January 4, 2004; accepted for publication January 27, 2004.
* Address for reprints: J. P. Remadi, MD, Cardiovascular and Thoracic Surgery Unit, South Hospital, 80054 Amiens Cedex 1, France
remadi.jean-paul{at}chu-amiens.fr
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Abstract |
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 Top Abstract Patients and methodsResultsDiscussionReferences |
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METHOD: In a prospective, randomized study, 100 patients underwent aortic valve replacement either with standard cardiopulmonary bypass (n = 50, group B) or with the MECC System (n = 50, group B). The myocardial protection and the left vent were identical for the two groups. The intrapericardial suction device was never used (only the cell salvage device was used) to reduce the air-blood contact area.
RESULTS: No significant differences were noted in patient characteristics and operative data between groups. Operative mortality (<30 days) was 2% for group A and 4% for group B (difference not significant). From the preoperative period to the postoperative period, the increase in C-reactive protein was significantly higher for group B (P < .001). The postoperative troponin I level was significantly lower in group A (mean 4.65 ± 2.9 µg/L at 24 hours) than in group B (8.2 ± 4.4 µg/L, P < .03). On the other hand, the MECC System was associated with platelet preservation. Renal function was better preserved and the neurologic event rate was significantly lower for the MECC group (P < .02).
CONCLUSION: The MECC System is safe and allows aortic valve replacement under the most favorable conditions. The system is more biocompatible than standard cardiopulmonary bypass and provides a good postoperative biologic profile and good clinical results, particularly for high-risk patients.
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Patients and methods |
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TopAbstractPatients and methodsResultsDiscussionReferences |
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Randomization
Patients were screened before AVR. Once written informed consent had been obtained, patients were randomly assigned to undergo AVR with either the MECC System (n = 50, group A) or standard CPB (n = 50, group B). Exclusion criteria included severe renal failure (creatinine >1.2 mg/dL) because of the possibility of perioperative hemofiltration and reoperative procedures. The two groups of patients were similar with regard to the main preoperative data (Table 1). The main preoperative, intraoperative, and postoperative biologic and clinical data were collected to evaluate the evolution of these parameters.
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Anesthesia and surgery protocol
All patients received premedication with lorazepam (2.5 mg orally) 90 minutes before operation, morphine sulfate (0.1 mg/kg body weight intramuscularly), and ondansetron (8 mg orally) 60 minutes before transfer to the operating room. Anesthesia was induced with midazolam (0.05-0.075 mg/kg), etomidate (0.3 mg/kg), and sufentanyl. Neuromuscular block was induced by intravenous pancuronium (0.15 mg/kg) and was maintained by continuous infusion of cisatracurium besylate (INN: cisatracurium besilate, 1.5-2.0 µg · kg–1 · min–1). Anesthesia was maintained with propofol and a continuous infusion of remifentanil (0.2-1.0 µg · kg–1 · min–1) or sufentanyl. A full heparin dose was given (3 mg/kg intravenously), and the activated clotting time was maintained above 400 seconds. With the MECC System circuit a half dose (only 1.5 mg/kg) of heparin would have been sufficient. The aortic and venous cannulas used were not precoated with heparin; therefore a full dose of heparin was used for both groups. At the end of the procedure, heparin was reversed with protamine at a 1:1 equivalent dose. Aprotinin was never used in this series.
The standard procedure was performed through a full median sternotomy. The myocardial protection consisted in a hyperkalemic warm blood cardioplegia with the CP1B product (magnesium chloride–potassium chloride–procaine chloride). This cardioplegic solution was delivered every 20 minutes. The left vent was implanted into the main pulmonary artery trunk. For groups A and group B, the mean aortic crossclamp and CPB times were, respectively, 40.6 ± 20.7 minutes and 71.2 ± 23.5 minutes versus 45.6 ± 17.3 minutes and 77.2 ± 27.3 minutes (difference not significant). Fifty percent of the aortic prostheses implanted were bioprostheses (Table 1). Red blood cell transfusions were administered if hematocrit fell below 25%.
Statistical analysis
The statistical analyses were performed with the SPSS software program (SPSS Inc, Chicago, Ill). All continuous data are expressed as mean ± SD. The clinical profile of the two groups was compared with analysis of the variance for continuous data and by 
2 analysis or the Fisher exact test for categoric data. Analysis of data with nonnormal distribution was performed with the Mann-Whitney test.
MECC system
The Jostra MECC System (Jostra AG, Hirrlingen, Germany) is a fully heparin-coated (Bioline-Jostra) closed-loop CPB system (Figure 1). A half dose (150 U/kg intravenously) of heparin is required. This system is composed of a membrane hollow-fiber oxygenator (Quadrox) and a centrifugal pump (Rotaflow). The tubing length does not exceed 1 m x 2. The pump therefore must be located near the patient's head. The blood–foreign surface contact area and the hemodilution are reduced with a 450-mL priming solution. The system does not have cardiotomy suction. Online blood gas and saturation monitoring and a heat exchanger are incorporated. The intrapericardial suction device was not used, and the intrapericardial blood was sucked in only with a cell salvage device. A double venous purse-string suture was systematically placed to ensure a perfect seal at the right atrial level (deairing of the system is more difficult because of the absence of venous reservoir). The MECC System was positioned closer to the operative field because the circuit is shorter than standard CPB (only 1 m). From 2002 on, a suction system was added to the MECC System. This new system should be considered "semiclosed" because of the partial air-blood contact through the suction system. The myocardial protection used was a warm blood hyperkalemic cardioplegia with CP1B product (procaine).
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Results |
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TopAbstractPatients and methodsResultsDiscussionReferences |
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Weaning from MECC was easy for all but 1 patient, who required a 30-minute period of circulatory assistance with inotropic drugs. Low cardiac output syndrome rates in groups A and group B were 2% and 6%, respectively (P < .03). In group A, 5 patients required dobutamine (>5 µg · kg–1 · min–1) or norepinephrine, and no IABCP was used. In group B, 10 patients needed inotropic drugs (P < .02).
During the procedure, the mean blood pressure was higher and more stable in group A (mean 71 mm Hg) than in group B (mean 58 mm Hg, difference not significant). During MECC and standard CPB hematocrit levels decrease were 4.25% and 8.52%, respectively (P < .01). The perioperative red blood cell transfusion rates were 8.7% for group A and 15.9% for group B (P < .01). The mean postoperative blood loss volumes for groups A and B were 752.9 ± 165.7 mL and 789.5 ± 21 mL, respectively (difference not significant). From the preoperative period to the patient discharge, the hemoglobin and hematocrits in group A were stable, with only 0.82 g/L and 0.61% decreases, respectively (Figure 2). In group B, there was a significantly stronger decrease in hematocrit (Figure 2). After the first 48 hours, no significant differences were noted between the two groups with respect to hemoglobin and hematocrit evolution (Figure 2). The postoperative red blood cell transfusion rates in the two groups were therefore similar (7% and 9% for groups A and B, respectively, difference not significant).
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Patients in group B had significantly higher postoperative levels of creatinine and urea (Table 2). Consistent with this, group B required more diuretics than did group A (22% vs 9.5 %, P < .01). Three patients in group B and only 1 in group A required hemofiltration (difference not significant). Postoperative focal neurologic complications (aphasia, focal motor, sensory cranial abnormality) and altered mental status (mainly disorientation) were significantly (P < .02) more frequent in group B (n = 7) than in group A (n = 2).
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Discussion |
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TopAbstractPatients and methodsResultsDiscussionReferences |
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Contact of blood with artificial surfaces during CPB involves a pathophysiologic response similar to that of posttraumatic shock, the so-called postperfusion syndrome, which may lead to the systemic inflammatory response syndrome, adult respiratory distress syndrome, sepsis, and multiorgan failure.1-3 To improve biocompatibility, artificial surfaces are heparin coated with various materials in an effort to mimic the natural endothelial surface. The centrifugal pump also may improve the biocompatibility, as may exclusive use of the cell salvage device to limit the air-blood contact area.4 The MECC System combines these elements, which could explain inflammatory syndrome decrease5 and the good clinical and biologic results described in this prospective series.
Heparin-coated artificial surfaces was first used by Gott. The evidence that use of surface-heparinized equipment would avoid the need for full systemic heparinization led to the introduction of heparin-coated CPB circuits in combination with reduced systemic heparin levels.6-9 Currently available heparin-coated circuits have been reported to be associated with reduced expression of systemic inflammatory response syndrome; reduced activation of neutrophils, monocytes, eosinophils, platelets, and the complement system; and limitation of cytokine release and reduced stimulation of the coagulation system.8 In our series, the full heparin dose was given. Nevertheless, in our prospective trial we have shown for AVR surgery better clinical results, preservation of renal function, reduced cardiac enzyme release, and better preservation of platelet count. Indeed, the MECC System represents the successful combination of decreased deleterious CPB effects (as in off-pump CABG) and CPB advantages for hemodynamic and surgical procedure management. The inflammatory syndrome is especially reduced because of decreased hemodilution10,11 and air-blood contact area reduction.12 The decreased S100ß protein release during MECC versus standard CPB might show a lesser neurologic toxicity associated with MECC.13,14 The inflammatory syndrome is reduced with the MECC System, as shown by Fromes and colleagues.5 We therefore can expect reduced postoperative morbidity. The patients operated on for AVR are often included in high-risk patient groups: age older than 65 years, renal dysfunction, and respiratory failure. The MECC System is therefore particularly interesting for AVR. In our prospective, randomized trial, the postoperative biologic and clinical data evolution were better for the MECC group, particularly for high-risk patients. Thus in elderly patients the MECC System could reduce the renal effect and cerebral injury well described in previous studies.13-15 The lowering of inflammatory syndrome and thus greater hemodynamic stability during the procedure could explain the results for renal and neurologic preservation.
Use of the MECC System as a "semiclosed" system with aortic and pulmonary artery vent allowed AVR to be performed without losing its biologic advantage, as shown in this study. The left ventricular vent for performing the AVR is implanted in the pulmonary artery trunk, rather than directly in the left ventricle, to reduce the air-blood contact area during aortic crossclamping. The vent could be implanted in the left atrium with a low depression to avoid air-blood contact.
A learning curve for this technique is necessary for the surgical and anesthetic team. The MECC System offers less safety than standard CPB because of the absence of venous reservoir. A risk of gas embolism exists if there is an air-intake on the venous side. We therefore performed two purse-string sutures on the venous side. Currently, we have performed 400 procedures with the MECC System, and we have encountered 3 cases of air intake on the venous side. None of these 3 adverse events had consequences for the patients. In all cases deairing was achieved without any problems, and the air was stopped on the anterior part of the oxygenator.
We have performed a few mitral operations with the MECC System. However, a suction device is necessary to drain the operative field into the left atrium, because the blood volume is too high to suck in to the cell salvage device. For mitral procedures, the left vent in the pulmonary artery is not sufficient and a left intra-atrial vent is necessary.
Conclusion
The Jostra MECC System is safe, allowing AVR surgery under optimal conditions. The system is more biocompatible than standard CPB and provides a good postoperative biologic profile and good clinical results, particularly for high-risk patients.
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References |
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TopAbstractPatients and methodsResultsDiscussionReferences |
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