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Ann Thorac Surg 2005;80:238-243
© 2005 The Society of Thoracic Surgeons
Department for Thoracic and Cardiovascular Surgery, Johann Wolfgang Goethe University, Frankfurt am Main, Germany
Accepted for publication February 1, 2005.
* Address reprint requests to Dr Abdel-Rahman, Department for Thoracic and Cardiovascular Surgery, J.W. Goethe University, Theodor-Stern-Kai 7, D 60590 Frankfurt am Main, Germany (Email: abdel-rahman{at}em.uni-frankfurt.de).
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Abstract |
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 Top Abstract IntroductionPatients and MethodsResultsCommentReferences |
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METHODS: Two hundred and four patients were randomly assigned either to CorX system (n = 101, group A) or a standard CPB with cardiotomy reservoir (n = 103, group B). Besides evaluation of perioperative data and routine blood samples, we focused on lung function and perioperative bleeding. Polymorphonuclear elastase (PMNE) and terminal complement complex (TCC) served to assess inflammatory response.
RESULTS: Patient demographics and operative data did not differ between groups. Postoperative lung function was not significantly impaired comparing groups A and B. Intraoperative blood loss was significantly higher in group A compared with group B (1245 ± 947 mL vs 313 ± 282 mL, p < 0.0001) as well as the need of fresh frozen plasma. Postoperative chest drainage did not differ significantly between groups. Two patients in each group required re-exploration due to bleeding. One hour after CPB, PMNE as well as TCC were significantly lower in group A compared with group B (PMNE: 76 ± 44 ng/mL vs 438 ± 230 ng/mL, p < 0.0001; TCC: 16 ± 8 IU/mL vs 29 ± 19 IU/mL, p < 0.0001).
CONCLUSIONS: The CorX system is safe and feasible in patients undergoing CABG. Despite of markedly reduced inflammatory reaction, no clinical benefit was observed.
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Introduction |
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TopAbstractIntroductionPatients and MethodsResultsCommentReferences |
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In times of minimally invasive cardiac surgery, the intention is to reduce not only surgical trauma but also to attenuate the pathologic effects of CPB. Therefore, novel concepts and strategies lead to the evolution of minimized extracorporeal circuits, which are characterized by a markedly reduced foreign surface area and reduced priming volume [7]. The CorX system (CardioVention Inc., Santa Clara, CA) follows this concept and consists of a closed circuit with fewer lines, an integrated pump, an oxygenator, and an air removal system. In addition, neither a cardiotomy reservoir nor a pericardial suction is used to avoid blood-air contact. Using conventional CPB, coronary artery bypass grafting (CABG) procedures have reached a high level of safety and excellence to which new CPB techniques have to be compared.
The aim of the present investigation was to evaluate the CorX system in a prospective randomized study in comparison to our standard management with regard to perioperative clinical and biochemical data as well as inflammatory reaction in low-risk CABG procedures.
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Patients and Methods |
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TopAbstractIntroductionPatients and MethodsResultsCommentReferences |
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Cardiopulmonary Bypass
Before onset of CPB, all patients received 350 IU/kg heparin intravenously. Anticoagulation was monitored by measuring activated clotting time, which was maintained more than 400 seconds during CPB by additional heparin. Antegrade warm blood cardioplegia as described by Calafiore and colleagues [8] was delivered intermittently in both groups. In the CorX group, the cardioplegic solution was administrated by autoperfusion without using an additional pump. The pressure in a second arterial outlet of the oxygenator was used for administration of cardioplegia, as illustrated in Figure 1.At the end of CPB, intravenous application of protamine sulfate in a 1:1 ratio of the initial dose of heparin serves to antagonize the effects of heparin.
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For the standard CPB, a complete preconnected tubing set with membrane oxygenator (Quadrox with SafeLine coating; Maquet Cardiopulmonary AG, Hirrlingen, Germany), a quart arterial filter (pore size 40 µm) (Maquet Cardiopulmonary AG), and a cardiotomy reservoir was used with a standard roller pump. Priming volume consists of Ringer solution (1000 mL), 500 mL of hetastarch 10% (Braun Melsungen AG, Melsungen, Germany), 250 mL of mannitol 20% (Serag-Wiessner KG, Naila, Germany), and 10,000 IU of heparin.
Intraoperative suction and postoperative chest drainage was collected in a reservoir and usually processed with a cell-saving device (CATS) in the intensive care unit (ICU) if more than 800 mL of blood was drained.
Evaluated Parameters
Besides perioperative data, we assessed intraoperative blood loss, retransfused cell-saver blood, and chest drainage loss during the first 12 hours. The amount of transfused packed red blood cells and fresh frozen plasma was evaluated in the first 24 hours. Respiratory function was assessed by routine lung function test (inspiratory vital capacity, forced expiratory volume in 1 second) preoperatively and on the fifth postoperative day. In addition, the oxygenation index (PaO2 in mm Hg/FiO2 in percent) was analyzed 1 and 3 hours after admission to the ICU. Renal function and myocardial protection were assessed by serum values of creatinine and creatinine kinase-MB (CK-MB) preoperatively as well as 1, 6, and 24 hours postoperatively. Polymorphonuclear elastase (PMNE, enzyme-linked immunosorbent assay [ELISA]; Milenia Biotec, Bad Nauheim, Germany) and terminal complement complex (TCC, ELISA; Gambro, Hechingen, Germany) served to assess inflammatory response; blood samples for determining PMNE and TCC were taken preoperatively as well as after aortic declamping and 1 hour post-CPB.
Statistics
Data are presented as mean ± standard deviation (SD). The Wilcoxon rank sum test was carried out for unpaired comparisons. A p value less then 0.05 was considered as statistically significant. Analyses were performed using the SAS software (SAS Institute Inc., Minneapolis, MN).
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Results |
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Inflammatory Parameters
In the first 24 hours postoperatively, leukocyte count did not differ significantly between both groups. PMNE and TCC served as specific inflammatory parameters. In both groups, peak values were seen after aortic declamping with a slight decrease 1 hour after the end of CPB. PMNE as well as TCC values were significantly lower in group A compared with group B at both time points (Table 5).
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Comment |
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TopAbstractIntroductionPatients and MethodsResultsCommentReferences |
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Increasing knowledge of potential hazards of CPB and further extensive research led to the development of minimized CPB systems. The rationale of miniaturization of extracorporeal circuits is to reduce foreign surfaces as well as priming volume and, therefore, to limit SIR and alterations in perioperative hemostasis [7]. In the present study, the CorX system as a closed minimized extracorporeal circuit was compared with standard CPB in arrested heart CABG regarding to clinical benefits and postoperative organ dysfunction due to possibly decreased inflammatory response.
The SIR is triggered by a large number of processes that act on both the cellular and humoral elements of blood [4, 6, 9]. The activation of leukocytes plays an important role in the SIR and may continue after discontinuation of CPB. Clinically, this contributes to temporary myocardial dysfunction, respiratory failure, renal insufficiency or coagulopathy. In our study, the inflammatory parameters PMNE and TCC were significantly decreased after CPB in the CorX group. Similar results were observed by Fromes and coworkers [10] investigating SIR with the MECC system compared to standard CPB. They also found lowered values for PMNE, interleukin-6 and tumor necrosis factor-alpha [10]. Regarding SIR in open heart surgery with arrested heart, the reports investigating miniaturized CPB systems are obscure. In particular, prospective studies are lacking. Based on our results, SIR after cardiac surgery can be reduced by the use of the CorX system.
In the present study group all patients were similar with regard to preoperative and intraoperative characteristics. In particular, CPB and aortic cross-clamp times were not significantly different, which have been observed by other investigators [10, 11]. The surgical procedure and CPB technique were well tolerated without increased CPB-related complications. The length of ICU and hospital stay was not significantly different comparing both groups. Folliguet and coworkers [12] reported similar results regarding duration of ICU and hospital stay. No clinical benefits could be found in our low-risk patients. However, miniaturized bypass systems demonstrated a lower inflammatory response, which might be crucial in a high-risk population.
There is an ongoing discussion about the effects of pericardial suction blood on SIR in cardiac surgery. Svenmarker and associates [13] compared cardiotomy suction with cell saver for salvage of pericardial blood with reference to proinflammatory cytokines and complement activation. The authors described cardiotomy suction as a major cause of hemolysis, but it did not contribute to increased SIR. In particular, pericardial suction blood contained higher concentrations of proinflammatory cytokines, but no differences were found for terminal complement complex [13]. Joharchi and coworkers [14] compared inflammatory parameters in elective CABG patients in whom suctioned blood was retained or retransfused at the end of the operation. Systemic levels of PMNE and interleukin-6 were significantly increased in those patients with retransfusions. Clinically, the authors did not observe differences [14].
In contrast to our study design, in the majority of studies investigated minimized CPB systems on patients who underwent on-pump beating heart CABG or partial assistance [10–12]. In these studies the MECC system (Jostra, Hirrlingen, Germany) was mainly used, which is very similar to the CorX system. The MECC system consists of a centrifugal pump head and an integrated heat exchanger oxygenator. The priming volume is also very low (500 mL) and a cardiotomy suction is not used; however, the system is entirely coated with heparin. With regard to the de-airing management there is an essential difference between both systems too. Miniaturized CPB systems can be set up easily and quickly, and our perfusionists liked the simplicity of the CorX system.
Due to the markedly reduced priming volume, hematocrit was significantly higher in the CorX group. This is in accordance with other reports [10, 15]. As expected, the majority of authors investigating minimized CPB systems in clinical studies have seen significantly decreased blood loss and transfusion requirements in the perioperative period. Based on our results, intraoperative blood loss was significantly higher in the CorX group; in this group pericardial blood was directly drained into a cell-saving system. Therefore, the amount of retransfused cell-saver blood was markedly higher in the CorX group. Analyzing the last 50 CorX patients, we have seen markedly reduced blood loss during the operation, which can be explained by the surgeons’ learning curve. We also improved surgical accuracy to avoid increased intraoperative bleeding. Postoperative bleeding and transfusion requirements were higher in the CorX group; however, a statistically significant difference was only reached for fresh frozen plasma. There is still a controversy about postoperative blood product usage, which is expected to be less due to increased intraoperative hematocrit in patients undergoing CPB with minimized extracorporeal circuits [10, 12, 16].
In the present study, we did not see a significant difference between groups in platelet count in the postoperative course. Fromes and associates [10] reported similar results comparing conventional CPB with the MECC system, whereas Folliguet and coworkers [12] observed significantly lower platelet counts on postoperative Day 1 after using the same system. In an experimental study that compared the CorX system with conventional CPB in calves, the drop of thrombocytes during bypass was significantly increased in conventional CPB [15].
Postoperative pulmonary dysfunction is related to overwhelming total lung water content post-CPB. Keeping the intraoperative hematocrit from decreasing, lung dysfunction could be limited [17, 18]. Folliguet and coworkers [12] observed no significant difference comparing patients operated with standard or MECC regarding to ventilation time and oxygenation index. In contradiction to our hypothesis, early postoperative oxygenation index was markedly higher and ventilation time significantly shorter in the standard group. However, marginally longer ventilation times in CorX patients did not result in prolonged ICU stay. In the present study, we also did not find a significant difference in postoperative lung function.
As an alternative for application of cardioplegia, the method of autoperfusion resulted in a safe and reliable cardiac arrest in CorX patients. In this group, we observed decreased CK-MB values postoperatively, which may represent improved myocardial protection; however, without clinical relevance. There are many factors described influencing myocardial protection and postoperative myocardial function. Literature is not consistent regarding myocardial damage after miniaturized CPB. Vaislic and associates [19] reported significantly reduced troponin T after using the MECC system. However, Fromes and coworkers [10] did not find significant differences investigating postoperative troponin I values in MECC patients.
In conclusion, the CorX system is a safe and simple alternative to standard CPB in CABG procedures with comparable clinical outcomes. The use of minimized closed bypass systems lead to reduced SIR; however, a clinical benefit was not obvious.
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TopAbstractIntroductionPatients and MethodsResultsCommentReferences |
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