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Ann Thorac Surg 2009;87:766-772. doi:10.1016/j.athoracsur.2008.11.050
© 2009 The Society of Thoracic Surgeons
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Karsten Wiebe
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Right arrow Extracorporeal circulation

Original Articles: Adult Cardiac

Minimal Extracorporeal Circulation: An Alternative for On-Pump and Off-Pump Coronary Revascularization

Thomas Puehler, MD*, Assad Haneya, Alois Philipp, Karsten Wiebe, MD, Andreas Keyser, MD, Leopold Rupprecht, MD, Stephan Hirt, MD, Reinhard Kobuch, MD, Claudius Diez, MD, Michael Hilker, MD, Christof Schmid, MD

Department of Cardiothoracic Surgery, University Hospital Regensburg, Regensburg, Germany

Accepted for publication November 17, 2008.

Abbreviations and Acronyms ACT = activated clotting time; CABG = coronary artery bypass graft surgery; CK = creatine kinase; ECC = extracorporeal circulation; EuroSCORE = European System for Cardiac Operative Risk Evaluation; ICU = intensive care unit; MECC = minimal extracorporeal circulation; OPCABG = off-pump coronary artery bypass graft surgery

* Address correspondence to Dr Puehler, Department of Cardiothoracic Surgery, University Hospital Regensburg, Franz-Josef-Strauss-Allee 11, Regensburg, D-93053, Germany (Email: thomas.puehler{at}klinik.uni-regensburg.de).


   Abstract
Top
 Abstract
Introduction
 Patients and Methods
 Results
 Comment
 References
 
Background: Coronary artery bypass surgery employing minimal extracorporeal circulation (MECC) was compared with standard extracorporeal circulation (ECC) and off-pump coronary artery bypass graft surgery (OPCABG) with regard to the perioperative course.

Methods: From January 2004 to December 2007, 1,674 patients (n = 558 MECC, n = 558 ECC, n = 558 OPCABG) who underwent coronary bypass surgery were studied. The primary end point was in-hospital mortality; secondary end points were perioperative variables, intensive care, and in-hospital course.

Results: Demographic data, comorbidity, and the European System for Cardiac Operative Risk Evaluation score (MECC 3.0%, ECC 3.5%, OPCABG 3.2%) were similar among the groups, but in-hospital mortality for elective and urgent/emergent patients was lower in the MECC and OPCABG groups (MECC 3.2%, OPCABG 3.7%, ECC 6.9%; p < 0.05). The number of distal anastomoses was lowest in the OPCABG group, but comparable for MECC and ECC patients. Postoperative ventilation time, release of creatinine kinase, catecholamine therapy, drainage loss, and transfusion requirements were lower in the MECC and OPCABG groups, whereas stay in the intensive care unit was shorter only in the latter (p < 0.05).

Conclusions: Minimal extracorporeal circulation is an easy and safe procedure for coronary artery bypass graft surgery. In selected patients, the advantages of MECC equal those of OPCABG. MECC should be considered as an alternative to OPCABG and standard ECC procedures.


   Introduction
Top
 Abstract
 Introduction
Patients and Methods
 Results
 Comment
 References
 
Coronary artery bypass graft surgery (CABG) with extracorporeal circulation (ECC) is the gold standard for multivessel coronary artery disease [1, 2]. Neuropsychological studies on the side effects of the use of ECC have led to a tremendous increase in off-pump coronary artery bypass graft surgery (OPCABG) and minimally invasive direct coronary artery bypass procedures during the last years [3]. Presumed advantages of these surgical techniques include lower in-hospital mortality, reduced morbidity, lower costs because of shorter hospital stay, and superior patient comfort in comparison with on-pump revascularization [4, 5]. However, OPCABG was also reported to be associated with lower bypass patency rates and a higher incidence of incomplete revascularization. Furthermore, arrhythmia and ischemia may lead to hemodynamic instability during OPCABG surgery [6–9]. The discussion with regard to the role of off-pump surgery remains controversial, and proper patient selection still seems to be essential for successful OPCABG procedures [10].

Initially, the minimal extracorporeal circulation (MECC) system was developed to allow safe and complete beating-heart revascularization; in other words, to maintain the benefits of beating heart surgery and to minimize the disadvantages of on-pump revascularization [11]. Later, the possibility of using Calafiore's blood cardioplegia was devised. Then, safe and reproducible CABG surgery on the arrested heart became feasible. Several clinical studies have shown that the harmful side effects of ECC such as systemic inflammatory response, blood cell trauma, hemodilution, coagulopathy, and neurologic deficits were clearly reduced with the MECC system [12–14].

In this study, we compared the perioperative course and outcome of CABG patients who were operated on using the three different techniques: MECC, standard ECC, and OPCABG.


   Patients and Methods
Top
 Abstract
 Introduction
 Patients and Methods
Results
 Comment
 References
 
After approval by the local Ethics Committee and informed consent of the patients, 1,674 patients of 2,416 patients who underwent elective, urgent/emergent, and redo isolated CABG from January 2004 until December 2007 were analyzed in a prospective manner. A median sternotomy approach was taken in all patients. Combined valve or aortic procedures were excluded from this study, as were patients who had heparin-induced thrombocytopenia. There were no restrictions with regard to the MECC procedure, apart from aortic valve insufficiency or a body mass index greater than 30 kg/m2. During the study period, every cardiothoracic surgeon was familiar with the MECC, ECC, and OPCABG techniques; and it was up to the surgeon's discretion which procedure was used. Indication for CABG was established on the basis of published guidelines [15].

Demographic data, patient comorbidity, and predicted operative mortality for the patients (European System for Cardiac Operative Risk [EuroSCORE]) are shown in Table 1. The primary end point of our study was the in-hospital mortality rate in the three groups. Secondary end points were intraoperative variables (number of distal anastomoses, aortic cross-clamp time, and reperfusion time), blood/serum measurements (creatinine kinase, hemoglobin, serum creatinine, lactate), and intensive care (ventilation time, use of blood components, catecholamine dosage, drainage loss, intensive care unit stay) and in-hospital course (symptomatic transitory psychotic syndrome, post-operative dialyses, in-hospital stay). Time points (T) assessed were preoperative status (T0), 30 minutes after arrival on the ICU (T1), and 6 hours after surgery (T2).


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  		Table 1 Demographic Data
 
CABG With Standard ECC and Cardioplegia
The bypass circuit of the standard ECC consisted of a heparin-coated tube system. A two-stage cannula (39F to 50F [Stöckert, Munich, Germany]), to drain the venous blood from the right atrium, and a 22F aortic cannula (Maquet, Rastatt, Germany) for the distal ascending aorta were used. The tubes were primed with a balanced colloid/crystalloid solution (500 mL Jonosteril [Fresenius, Bad Homburg, Germany], 500 mL Gelafundin [B. Braun, Melsungen, Germany], and 200 mL 20% Mannitol [Serag-Wiessner, Naila, Germany]). A nonpulsatile HL 30 Roller Pump (Maquet) established a blood flow of 2.4 L · min–1 · m–2. During cross-clamping, a single shot of crystalloid HKT Bretschneider cardioplegia (Franz-Koehler-Chemie, Alsbach-Hähnlein, Germany) or of Calafiore's blood cardioplegia was applied to initiate cardiac arrest according to the surgeon's preference. Blood was collected in an open cardiotomy reservoir and transfused back to the patient. In the standard ECC group, a Quadrox 2000 (Maquet) or a Hilite 7000 (Medos, Stolberg, Germany) oxygenator was used.

CABG With MECC and Cardioplegia
The MECC is a fully heparinized, closed loop circuit without blood air contact (Fig 1). The components of the system included a membrane oxygenator (Quadrox D, Maquet; or Hilite 7000 CT, Medos), a centrifugal pump, a table line (3/8 [180 cm]), a venous two-stage cannula (32F to 40 F), and an aortic cannula (21F). In case of severe volume loss, substitution was possible through an additional volume tube. A pO2-sensor was integrated into the arterial line. An arterial filter was added to remove bubbles and particles. The priming volume was 500 mL, consisting of 20% Mannitol and Perfuflac solution (B. Braun, Melsungen, Germany). All MECC patients received antegrade multidose blood cardioplegia to induce cardioplegic arrest.


Figure 1
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  		Fig 1. Minimal extracorporeal circulation (MECC): (a) Scheme of MECC circulation; (b) heparinized tube system, oxygenator; and (c) intraoperative setting of MECC.

 
CABG Without ECC
All OPCABG procedures were performed through median sternotomy. Stabilization and visualization of the operation field was achieved by an Axius Expose 3 and Acrobat suction-based stabilizer (Guidant, Indianapolis, IN). In all patients, intracoronary shunts were placed to maintain coronary perfusion during CABG. Employing the Trendelenburg position, all coronary branches could be reached and grafted.

Heparin and Temperature Management
Heparin was administrated (MECC 150 IE/kg, ECC 350 IE/kg, OPCABG 100 IE/kg) after harvesting of the bypass grafts. The activated clotting time (ACT) range was 400 s to 500 s for the ECC group; in the MECC group, an ACT of 200 to 300 s was deemed sufficient because of the use of heparin-coated tubes. During the OPCABG procedures an ACT of 200-300 sec was maintained as well. The ACT was controlled every 20 minutes. In the ECC and the MECC groups, a brief period of mild hypothermia (35°C) was established. Normothermic temperature was reached by using a sterile forced-air warming blanket (Bair Hugger; Arizant, Eden Prairie, MN).

Statistical Data Analysis
Statistical analysis was performed using SPSS 15.0 software (SPSS, Chicago, IL). To minimize patient or surgeon bias, prospective data were analyzed in a random sample analysis. Of 1,016 patients operated on with MECC, 558 were randomly selected for analysis. The same number of patients (558 of 834) was extracted from the ECC cohort. Both groups, ECC and MECC, were compared with 558 consecutive OPCABG patients. Normal distribution was assessed by Lilliefors' modification of the Kolmogorow-Smirnow test. Continuous data are presented as mean ± SD or as median (range), where appropriate. Categorical variables are displayed as frequency distributions (n) and simple percentages (%). Univariate analysis of variable with a post-hoc Scheffe test was performed for specific differences between the groups for normally distributed continuous variables, and with the Kruskal-Wallis test followed by the Mann-Whitney U test for not normally distributed continuous variables. Univariate comparison between the groups for categorical variables was made using the {chi}2 test and Fisher's exact test when appropriate. A conditional forward algorithm was used for logistic regression analysis. Variables were entered from the univariate analysis when p was less than 0.25 and were retained in the model when p was less than 0.05. Statistical significance was considered when p was less than 0.05.


   Results
Top
 Abstract
 Introduction
 Patients and Methods
 Results
Comment
 References
 
Demographic Data
Demographic data and comorbidities of the three patient groups (Table 1) were not significantly different with regard to sex, age (MECC 66.2 ± 9.1 years, ECC 66.4 ± 8.7 years, OPCABG 64.5 ± 9.6 years), chronic obstructive pulmonary disease (MECC 9.3%, ECC 8.7%, OPCABG 9.3%), atrial fibrillation (MECC 3.6%, ECC 5.4%, OPCABG 3.9%), diabetes mellitus (MECC 31.9%, ECC 36.7%, OPCABG 30.8%), arterial hypertension (MECC 82.2%, ECC 81.4%, OPCABG 84.4%), peripheral arterial occlusive disease (MECC 5.9%, ECC 8.8%, OPCABG 6.6%), and EuroSCORE (MECC 3.3% ± 2.8%, ECC 3.6% ± 3 .5%, OPCABG 3.5% ± 3.9%). Mean body mass index was below 30 kg/m2 in all groups, but was lowest in the MECC population (MECC 27.6 ± 3.8 kg/m2, ECC 28 ± 4.1 kg/m2, OPCABG 28.6 ± 4.3 kg/m2; p < 0.05). Preoperative left ventricular ejection fraction was similar in ECC patients (57.0% ± 15.0%) and in MECC patients (58.0% ± 15.0%), but was lower in the OPCABG group (55.0% ± 16.0%; p < 0.05). The incidence of elective CABG surgery (MECC 54.1%, ECC 62.2%) and urgent/emergent CABG surgery (MECC 45.4%, ECC 37.8%) was comparable in the MECC and ECC groups (p > 0.05), whereas significantly more elective patients (OPCABG 84.7%) and significantly fewer urgent/emergent patients (OPCABG 16.3%) were operated on with the OPCABG technique. Preoperative serum creatinine values were not different among the three groups (MECC 0.95 mg/dL [0.8 to 1.1], ECC 1.0 mg/dL [0.8 to 1.2], OPCABG 0.98 mg/dL [0.8 to 1.2]; p > 0.05).

Laboratory Measurements
Before CABG (T0), creatine kinase (CK) was similar among all groups (MECC 80.0 U/L [53.5 to 120.0]; ECC 82.0 U/L [54.0 to 133.7], OPCABG 71.0 U/L [71.0 to 110.0]; p > 0.05). However, 30 minutes after ICU admittance (T1), CK was significantly lower after OPCABG and MECC in comparison with ECC revascularization (MECC 140.1 U/L [109.0 to 197.0], ECC 309.5 U/L [214.5 to 460.7], OPCABG 100.0 U/L [75.0 to 149.0)]; p < 0.05). At 6 hours postoperative (T2), CK was significantly lower too in the OPCABG and MECC groups (MECC 239 U/L [172.5 to 355.0], ECC 426.0 U/L [300.2 to 682.7], OPCABG 183.0 U/L [130.0 to 285.5]; p < 0.05). Likewise, CK-MB at T1 (MECC 31.7 U/L [22.0 to 54.2], ECC 42.0 U/L [31.6 to 76.2], OPCABG 23.8 U/L [14.7 to 72.8]; p < 0.05) and T2 (MECC 27.6 U/L [22.2 to 53.8], ECC 36.9 U/L [25.7 to 80.1], OPCABG 21.3 U/L [12.9 to 52.5]; p < 0.05) were lower after OPCABG and MECC than after the ECC approach. Serum lactate levels at T1 (MECC 11.0 U/L (8.0 to 16.0)], ECC 15.0 U/L [11.0 to 30.5], OPCABG 10.3 U/L [7.1 to 15.7]; p < 0.05] and T2 (MECC 11.0 U/L [8.0 to 18.0], ECC 16.0 U/L [10.0 to 36.0], OPCABG 10.0 U/L [6.0 to 13.2]; p < 0.05) were also lower after OPCABG and MECC revascularization.

Perioperative Data
The number of distal anastomoses in the ECC group (3.0 ± 0.9) and MECC group (3.1 ± 0.8) was alike, but significantly higher in comparison with the OPCABG group (2.0 ± 0.7; Tables 2 and 3). Go The left internal mammary artery was used more often in the OPCABG group than in the other groups (MECC 89.1%, ECC 83.5%, OPCABG 93.2%; p < 0.05). Despite a nearly identical number of distal anastomoses, the aortic cross-clamping time was significantly lower in the MECC group (51 ± 18 minutes) as compared with the ECC group (54 ± 19 minutes). Likewise, reperfusion time was longer in the ECC group (36 ±18 minutes) than in the MECC group (30 ± 14 minutes; p < 0.05).


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  		Table 2 Intraoperative Data
 

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  		Table 3 Postoperative Data
 
After surgery, mechanical ventilation was shortest in OPCABG patients (11 hours [8 to 14] as compared with patients who were operated on with MECC (12 hours [9 to 15] or ECC (12 hours [9 to 18]; p < 0.05). The need for postoperative catecholamine therapy was lowest in the OPCABG and MECC groups (p < 0.05). Postoperative left ventricular low-output syndrome was also lower after OPCABG (0.35%) and MECC (0.35%) in comparison with ECC CABG (1.0%; p < 0.05). Stay on the ICU was comparable for OPCABG (1 day [1 to 2], MECC (1 day [1 to 2], and ECC (1 day [1 to 3]; p > 0.05). Moreover, the incidence of postoperative dialysis was not different among the three procedures (MECC 0.4%, ECC 0.7%, OPCABG 0.5%; p > 0.05).

Postoperative pleural drainage loss was lower after OPCABG and MECC procedures (MECC 550 mL [350 to 800], ECC 600 mL [400 to 900], OPCABG 450 mL [300 to 600]; p < 0.05). Accordingly, transfusion of packed red blood cells was less in the MECC group (1 [0 to 2] and the OPCABG group (1 [0 to 2] as compared with the ECC group (1 [0 to 3]; p < 0.05). Transfusions of fresh frozen plasma were not different among groups (MECC 0 [0 to 21], ECC 0 [0 to 32], OPCABG 0 [0 to 13]; p > 0.05). The MECC and OPCABG procedures minimized the risk (MECC odds ratio 0.62, p < 0.001; OPCABG odds ratio 0.71, p < 0.004) for receiving packed red blood cells in comparison with ECC.

The overall in-hospital mortality for elective and urgent/emergent patients was 4.6%, with the in-hospital mortality of the MECC group (3.22%) and the OPCABG group (3.76%) being lower than the ECC group (6.0%, p < 0.05). Especially in urgent/emergent cases, MECC mortality (5.6%) was lower than ECC (12.0%, p < 0.05) and OPCABG mortality (OPCABG 10.7%, p > 0.05) (Fig. 2). Reduced ejection fraction percent was the only mortality predicting comorbidity factor in our study for all groups (odds ratio 0.95, p < 0.001). In comparison with the ECC approach (5.2%), the incidence of postoperative delirium was lower after MECC-based CABG (1.8%) and comparable to OPCABG (3.0%, p < 0.05). The stroke rate is lowest in the OPCABG group (0.9%, p < 0.05). In the MECC group, stroke was diminished (2.3%) in comparison with the ECC group (4.1%, p < 0.05). In-hospital stay for OPCABG patients (9.8 ± 2.3 days) was shorter than for MECC patients (12 ± 7.3 days) and ECC patients (12 ± 7.7 days; p < 0.05).


Figure 2
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  		Fig 2. Minimal extracorporeal circulation (MECC) versus extracorporeal circulation (ECC) elective patients (black bars), p = 0.05 ({Delta}0.03; 95% confidence interval [CI]: 0.00 to 0.05); MECC versus ECC urgent/emergent patients (gray bars), p = 0.018 ({Delta}0.06; 95% CI: 0.01 to 0.12); ECC versus off-pump coronary artery bypass graft surgery (OPCABG) elective patients, p = 0.23; ECC versus OPCABG urgent/emergent patients, p = 0.84; MECC versus OPCABG elective patients, p = 0.30; and MECC versus OPCABG urgent/emergent patients, p = 0.13.

 

   Comment
Top
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
References
 
Coronary artery bypass graft surgery with ECC is widely considered an established, safe, and effective procedure for coronary revascularization. However, ECC is always associated with a systemic inflammatory response syndrome characterized by complement activation and the release of several cytokines and vasoactive substances, which consecutively promote bleeding, arrhythmias, thromboembolism, and endothelial dysfunction [16, 17]. The main reason for the development of systemic inflammatory response syndrome is the contact between blood and nonendothelial-cell–coated artificial surfaces of the oxygenator and the blood lines [18, 19]. Various therapeutic options have been studied, including the use of perioperative administration of steroids, but the results have not been satisfactory. Far better seemed preemptive measures, namely, avoiding or minimizing cardiopulmonary bypass. Accordingly, it is not surprising that OPCABG surgery gained considerable popularity, as it is associated with a considerably lower inflammatory response [20, 21]. It has been assumed that OPCABG results in improved recovery from surgical revascularization and in superior organ protection, especially in critically ill patients [22, 23].

Successful CABG for multivessel disease with the aid of the MECC system, namely, with minimized cardiopulmonary bypass, was first described by our group in 2004. We could demonstrate that the MECC system may serve as alternative to the standard ECC. The perioperative mortality rate (30 days) was similar, and the transfusion requirements in the MECC group were lower [24]. A benefit with regard to length of ICU and hospital stay could not be seen, as the inflammatory response during MECC surgery was not analyzed in detail [25].

In the current study, we could demonstrate a comparable mortality rate between the MECC group and the OPCABG group for elective procedures. A mild benefit of the MECC was noted in urgent and emergent cases. The secondary end points of the study were less impressive but still evident. Although the number of distal anastomoses in the MECC and ECC groups was similar, duration of aortic cross-clamping and reperfusion time was shorter in the MECC group. The differences in cross-clamp time and reperfusion time were small, but it is noteworthy to mention that in MECC procedures, no minimal reperfusion limit exists. After release of the aortic clamp, MECC patients are just briefly stabilized and immediately weaned from bypass. We also observed a diminished need for blood transfusion requirements in the MECC group (and OPCABG group), probably due to the minimized system with the need for less priming with crystalloid solutions.

Creatine kinase and lactate levels after MECC and OPCABG procedures were lower as compared with ECC procedures, indicating less myocardial damage and better organ and tissue perfusion. Although CK and lactate levels underlie various conditions, there is a clear relationship with morbidity and postoperative low cardiac output syndrome [26]. Patient recovery with regard to mechanical ventilation and in-hospital stay was fastest after OPCABG surgery, but also better in the MECC group than in the ECC group. Likewise, the need for postoperative catecholamine therapy, the incidence of postoperative low output, pleural drainage loss, postoperative delirium, and stroke were in favor of the MECC patients.

Comparing all three patient groups and all the aforementioned aspects, the outcome in the MECC group was comparable to that for OPCABG patients. However, this is not a uniform finding. Reports comparing conventional ECC with MECC are still sparse, but uniformly favor MECC for its benefits, whereas the presumed advantages of OPCABG procedures are still strongly discussed [24, 25, 27–29].

An explanation for the better outcome with less invasive surgical techniques is assumed in a reduced postoperative inflammatory response and in technical aspects. Immer and colleagues [27] reported reduced levels of troponin I, interleukin-6, and SC5b-9 after MECC surgery, and also found a significantly reduced incidence of atrial fibrillation; whereas Remadi and colleagues [25] demonstrated less C-reactive protein and troponin T release. A lower pulmonary shunt fraction and reduced CC16 concentrations after MECC in contrast to ECC CABG were described by Van Bowen and coworkers [30]; that indicated lower lung permeability and less damage of the alveolar capillary membrane, and may well explain the shorter ventilation time in the MECC group. Advantages with the use of a MECC system were also seen with regard to other end-organ function and hemodilution. Prasser and coworkers [31] described better liver perfusion, especially in case of hepatic disease. As hepatorenal failure becomes an increasing problem in the postoperative care of high-risk cardiothoracic patients, the MECC might become a useful tool to reduce mortality in these cases. Especially for Jehovah's Witnesses patients, the lower hemodilution was recognized as a great advantage [29]. Kutschka and associates [28] demonstrated superior air elimination during MECC as compared with conventional ECC, which accounts for the reduction of neurological complications.

In conclusion, the MECC system is an excellent surgical tool for CABG surgery. It lowers the inflammatory response, attenuates end-organ damage, and provides an excellent clinical outcome.


   References
Top
 Abstract
 Introduction
 Patients and Methods
 Results
 Comment
 References
 

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