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Ann Thorac Surg 2005;80:238-243
© 2005 The Society of Thoracic Surgeons

Original article: Cardiovascular

Initial Experience With a Minimized Extracorporeal Bypass System: Is There a Clinical Benefit?

Ulf Abdel-Rahman, MD*, Feyzan Özaslan, MD, Petar S. Risteski, MD, Sven Martens, MD, PhD, Anton Moritz, MD, PhD, Abdallah Al Daraghmeh, Harald Keller, Gerhard Wimmer-Greinecker, MD, PhD

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).


   Abstract
Top
 Abstract
Introduction
 Patients and Methods
 Results
 Comment
 References
 
BACKGROUND: Drawbacks of conventional cardiopulmonary bypass (CPB) are increased inflammatory response, deteriorated coagulation and systemic organ dysfunction. A closed extracorporeal circuit (CorX) features reduced foreign surface area and priming volume. Potential benefits were studied in comparing the CorX system with conventional CPB in arrested heart coronary artery bypass grafting (CABG).

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.


   Introduction
Top
 Abstract
 Introduction
Patients and Methods
 Results
 Comment
 References
 
Since its introduction about 50 years ago, cardiopulmonary bypass (CPB) has seen tremendous progress regarding biocompatibility and circuit components [1, 2]. However, surface area of extracorporeal circuits has not changed significantly lately. CPB is still a prerequisite for the majority of cardiac procedures and is associated with systemic inflammatory response (SIR), which may be responsible for postoperative organ failure. Cardiac, lung and kidney function, as well as coagulation are affected to various extents [3, 4]. The SIR is a multifactorial process, which is mainly initiated by blood contact with foreign surfaces and due to activation of leukocytes as well as the complement system [5,6].

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.


   Patients and Methods
Top
 Abstract
 Introduction
 Patients and Methods
Results
 Comment
 References
 
Patients
First of all, we used the CorX system in 20 patients in a pilot study to introduce the system to our surgical team, perfusionists, and anesthesiologists. Between August 2002 and May 2003, 204 patients scheduled for elective CABG were prospectively enrolled in this study after written informed consent and randomly assigned either to the CorX system (n = 101, group A) or a standard CPB (n = 103, group B). Patients undergoing re-operations or combined procedures as well as cases of emergency were excluded from this study. The study protocol was reviewed and approved by the local ethical committee (approval number: 117/02).

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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  		Fig 1. Diagram of the CORx System (CardioVention, Inc, Santa Clara, CA) and principle of autoperfusion for application of warm blood cardioplegia. (Asc. aorta = ascending aorta.)

 
The concept of the CorX system is characterized by a single device, which integrates the functions of oxygenation, blood pumping (centrifugal pump), and air elimination. Designed as a closed circuit without additional suction line and venous reservoir, the system consists only of an uncoated arteriovenous loop with a total surface area of less than 1.4 m2 (Fig 1). Only 500 mL of Ringer solution with 5000 IU heparin serves as priming volume. Intraoperatively, the body temperature is regulated by using a heating mat, a Bair Hugger warming blanket (Arizant Healthcare Inc., Eden Prairie, MN), and a heat exchanger in the arterial line. A sensor-regulated venous air handling system (AirVac; CardioVention, Inc, Santa Clara, CA) is integrated to suck out air in the venous line before entering the oxygenator. Blood from the surgical field was collected in a cell-saving device (CATS, Fresenius AG, Bad Homburg, Germany).

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).


   Results
Top
 Abstract
 Introduction
 Patients and Methods
 Results
Comment
 References
 
Patient characteristics and intraoperative data were similar for both groups (Table 1). In particular, the numbers of bypass grafts, CPB time, and aortic cross-clamp time were not significantly different.


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  		Table 1. Patient Demographics, Operative and Postoperative Data
 
Hemodilution, Perioperative Blood Loss, and Transfusion Requirements
After initiation of CPB hemodilution was significantly greater in group B, which was characterized by markedly lower hematocrit values. Due to lack of cardiotomy suction, intraoperative blood loss was significantly higher in group A compared with group B (1245 ± 947 mL vs 313 ± 282 mL, p < 0.0001). It was improved to 921 ± 695 mL (group A) vs 277 ± 260 mL (group B) in the last 100 patients. The amount of perioperative cell-saver blood was significantly higher in group A than in group B (368 ± 430 mL vs 52 ± 229 mL, p < 0.0001; Table 2). In the first 12 hours postoperatively, blood loss was not significantly different between groups. Within the first 24 hours postoperatively, the amount of transfused fresh frozen plasma was significantly higher in group A, whereas the transfusion of packed red blood cells was not significantly different. The routine coagulation parameters (partial thromboplastin time [PTT], international normalized ratio [INR], AT III, platelet count) were not significantly different between both groups 1, 6, and 24 hours postoperatively.


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  		Table 2. Perioperative Blood Loss and Blood Transfusion
 
Respiratory Function
On postoperative day 5, respiratory function was markedly impaired compared with preoperative values in both groups. However, there was no statistically significant difference between groups. In group B the oxygenation index was significantly higher after the first hour of ICU stay (3.2 ± 1.3 vs 2.9 ± 1.4; p = 0.04). Comparing both groups the difference between mean ventilation times reached statistical significance (13.9 ± 14.9 hours vs 11.3 ± 9.5 hours; p = 0.04; Table 3).


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  		Table 3. Perioperative Respiratory Function
 
Myocardial Protection and Renal Function
The post-CPB CK-MB values were elevated in both groups and reached highest levels 24 hours post-CPB. One hour after CPB, CK-MB levels were lower in the CorX group compared to standard CPB (Table 4).


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  		Table 4. Perioperative Serum Creatinine and CK-MB Values
 
Probably due to hemodilution, serum creatinine levels were lowered in both groups after CPB. Creatinine values were markedly decreased in the CorX patients compared with patients undergoing standard CPB 1 and 6 hours after CPB; however, there was no more difference 24 hours after CPB (Table 4).

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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  		Table 5. Polymorphonuclear Elastase (PMNE) and Terminal Complement Complex (TCC)
 
Clinical Outcomes
There was no operative mortality in both groups. In group B, 1 patient died due to septic shock on postoperative Day 5 and another patient suffered from a major cerebrovascular event with postoperative hemiplegia. In group A, no patient died and no neurological complication occurred. Two patients of each group required re-exploration due to bleeding. The 2 patients of group B manifested surgical bleedings, whereas the 2 patients of group A presented a diffuse bleeding type. A postoperative myocardial infarction was diagnosed in 1 patient in group A, which was treated by interventional angioplasty. Duration of ICU stay as well as hospital stay did not differ significantly between group A and B (Table 1). There was no significant difference between both groups regarding to postoperative inotropic support in the first 24 hours. Ten patients of group A and 12 patients of group B received epinephrine (63.5 ± 88.2 µg/kg/24 hours vs 72.8 ± 106.2 µg/kg/24 hours; p = 0.4).


   Comment
Top
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
References
 
The use of CPB with cardioplegic arrest still remains the gold standard for cardiac surgery. After its introduction, however, the potentially deleterious effects of CPB on postoperative organ function due to increased SIR were described [3]. In order to minimize those harmful effects, different strategies have been investigated during the last decade.

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.


   References
Top
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
 References
 

  1. Daniel S. Review on the multifactorial aspects of bioincompatibility in CPB Perfusion 1996;11:246-255.[Abstract/Free Full Text]
  2. Gu Y, van Oeveren W, Akkerman C, Boonstra P, Huyzen R, Wildevuur C. Heparin-coated circuits reduce the inflammatory response to cardiopulmonary bypass Ann Thorac Surg 1993;55:917-922.[Abstract]
  3. Kirklin JK, Westaby S, Blackstone EH, Kirklin JW, Chenoweth DE, Pacifico AD. Complement and the damaging effects of cardiopulmonary bypass J Thorac Cardiovasc Surg 1983;86:845-857.[Abstract]
  4. Westaby S. Organ dysfunction after cardiopulmonary bypassA systemic inflammatory reaction initiated by the extracorporeal circuit. Intensive Care Med 1987;13:89-95.[Medline]
  5. Gourlay T. Biomaterial development for cardiopulmonary bypass Perfusion 2001;16:381-390.[Abstract/Free Full Text]
  6. Levy JH, Tanaka KA. Inflammatory response to cardiopulmonary bypass Ann Thorac Surg 2003;75:S715-S720.[Abstract/Free Full Text]
  7. von Segesser LK, Tozzi P, Mallbiabrrena I, Jegger D, Horisberger J, Corno A. Miniaturization in cardiopulmonary bypass Perfusion 2003;18:219-224.[Abstract/Free Full Text]
  8. Calafiore AM, Teodori G, Mezzetti A, et al. Intermittent antegrade warm blood cardioplegia Ann Thorac Surg 1995;59:398-402.[Abstract/Free Full Text]
  9. Butler J, Rocker GM, Westaby S. Inflammatory response to cardiopulmonary bypass Ann Thorac Surg 1993;55:552-559.[Abstract]
  10. 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]
  11. 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]
  12. Folliguet TA, Villa E, Vandeneyden F, Laborde F. Coronary artery bypass graft with minimal extracorporeal circulation Heart Surg Forum 2003;6:297-301.[Medline]
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  14. Joharchi M, Khosravi A, Westphal B, Steinhoff G. Influence of cardiotomy suction blood separation during CPB Heart Surgery Forum 2003;6:201.
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  16. Fallen D, Komorowski B, Groh M. Perfusion-assisted beating heart CABG with a miniature bypass system is associated with improved outcomes compared to traditional CPB-supported CABG Heart Surg Forum 2003;6:207-208.
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