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Eur J Cardiothorac Surg 2007;31:1070-1075. doi:10.1016/j.ejcts.2007.01.065
Copyright © 2007, European Association for Cardio-Thoracic Surgery. Published by Elsevier B.V. All rights reserved
Cardiovascular Center Bad Bevensen, Clinic for Cardiac and Thoracic Surgery, Bad Bevensen, Germany
Received 21 September 2006; received in revised form 18 January 2007; accepted 31 January 2007.
* Corresponding author. Address: Klinik für Herz-Thorax-Chirurgie, Herz- und Gefäßzentrum Bad Bevensen, Roemstedter Str. 25, 29549 Bad Bevensen, Germany. Tel.: +49 5821 82 1702; fax: +49 5821 82 1777. (Email: m.perthel{at}hgz-bb.de).
| Abstract |
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Key Words: Cardiopulmonary bypass Low prime Venous air Air removal
| 1. Introduction |
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The concept of mini-bypass combines the known clinical advantages of suction blood separation, biocompatible coating, and significantly reduced prime in order to better maintain patient homeostasis, preserve autologous blood and effect meaningful improvements in postoperative morbidity in on-pump cardiac surgery [8]. The mini-bypass system includes an integrated venous bubble trap, centrifugal pump, heat exchanger, and oxygenator and is designed for use with an autotransfusion/cell saving system for sequestration of aspiration blood.
However, the capacity of these low prime systems to manage gaseous microemboli (GME) activity has recently been called into question. Studies have confirmed that GME management in mini-bypass circuits might not be as effective as conventional systems for particular configurations of the mini circuit [9,10]. GME in conventional ECC is well reported in the literature and the impairment of neuro-cognitive function appears to be a common finding after on-pump open-heart surgery and an important part of morbidity and mortality [11,12]. There are numerous published reports that describe a correlation between number of microemboli and postoperative neuro-cognitive dysfunction [13]. Microembolic signals (MES) detected by transcranial Doppler (TCD) have been described in virtually all patients undergoing revascularization in conventional ECC [14,15]. A smaller portion of these signals might be directly associated with surgical, anesthesiologist or perfusionist action during the operative course [16,17], but the larger portion might be generated from the circuit and cannot completely eliminated using passive filtration systems like an open hardshell venous reservoir and arterial filter.
Understanding the importance in managing venous air and GME in the ECC circuit, some newer low prime systems with active bubble removal capability have been developed and introduced into routine clinical use. These active bubble removal systems include GME sensing systems that remove air from the venous line through the venous bubble trap automatically. The intention of this study is to evaluate one of these new mini-bypass systems with an active air management system in routine revascularization cases while investigating the hypothesis that a significant reduction in prime via use of a mini system will lead to a statistically significant reduction in homologous blood product use.
| 2. Materials and methods |
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2.1 Cardiopulmonary bypass
The phosphorylcholine coated mini circuit (ECC.OTM, Dideco SrL, Mirandola, Italy), consisted of an integrated venous bubble trap, centrifugal pump and oxygenator, and an arterial filter (D733, Dideco). Circuit priming volume was 700 cc including 500 cc saline (0.9%) + 200 cc 5% glucose. A four pump position Heart Lung Machine (HLM) (Stöckert S3, Sorin Group) was used to manage the mini-bypass circuit.
Arterial cannula with straight tip (6.5 mm, Stöckert, Sorin Group) and fixation ring was used on the arterial side, while on the venous side a 30/32 venous two-stage cannula (Stöckert) and additional ligature on the side of venous cannulation was done in order to avoid air entrainment from the cannulation site. The 9 Fr 1/4 in. vent catheter (Stöckert) in the aortic root was an antegrade cardioplegia cannula with a distal vent line. The suction created by the centrifugal pump was utilized for intermittent aortic root venting, with the vent line being connected directly to the venous line. Aspirated blood was managed using a cell saver (Electa, Dideco).
The same HLM and autotransfusion system was used in the control group. A phosphorylcholine traditional open circuit was used (Dideco EvolutionTM, Sorin Group), consisting of a hardshell venous reservoir, oxygenator, and arterial filter (D713, Dideco). Priming consisted of 5000 IE heparin with 1000 cc saline (0.9%) and 800 cc glucose 5%. A minimum blood operating level in the venous reservoir of 300 ml was strictly respected.
After median sternotomy and vein harvesting of the substitutes 300 IU/kg BW heparin was administered. Myocardial protection in both groups was achieved using warm blood and a potassium loaded syringe pump, given in the aortic root with an initial dose, then repeated every 15 min. Retrograde autologous blood priming was used in both systems. The aorta was cross-clamped and the coronary anastomoses are performed on an arrested heart with a dry, still operative field. After cross-clamping the central anastomoses were sutured with partial clamping of the ascending aorta. Mild hypothermia (34 °C) was used with a target flow rate index of 2.4 l/min m2 BSA using non-pulsatile flow and alpha-stat control of acid-base management. Activated clotting time (ACT) was measured using the Medtronic ACTII system (Medtronic Inc., St Paul, Minnesota, USA) with target values for ACT
480.
2.2 Detection of MES
For the detection of MES, the middle cerebral artery was monitored bilaterally through the temporal bone window using 2 MHz probes (Nicolet 2 MHz probe, Nicolet, Estenfeld, Germany). The probes were fixed in a head frame and connected with a Doppler sonography device (Pioneer TC 4040 Medilab, Würzburg, Germany) allowing online recording by applying the FS1-algorithm. All audio and video signals were recorded on hard disc. The recording of the signals was followed by the guidelines of GME detection established in 1998 [18]. Only unidirectional signals within the Doppler velocity spectrum with an intensity of 3 dB HTL higher than the background flow signal, lasting less than 300 ms were counted as MES. Data audit was done by a subsequent off-line analysis of data using by a secondary investigator. The inner-observer variability was less than 10% of the number of signals.
2.3 Detection of GME
A two channel Doppler sonography device was used as a bubble counter (GaMPT Zappendorf, Germany), allowing online recording [19]. The investigator was also able to record on a hard disc for off-line evaluation. Both channels had a time course, in which actions by the anesthesiologist or surgeon like drug injection, lifting of the heart, etc. could be identified during the procedure for later reference. The device was mounted on the HLM and managed by the perfusionist for continuous in vivo measurement. A unique feature of this new bubble counting device is the automatic set-up of sensitivity to measurement conditions (ultrasound attenuation of the tube, coupling condition of the probe). GME ranging from 10 µm to 120 µm were counted by the device; particles (blood elements, micro-thrombi) do not influence the results. The total GME volume is calculated automatically. The device was calibrated in vitro using the manufacturer's calibration procedure. The measurement points in each circuit are provided in the Table 1
. GME was measured at the outlet of the hardshell venous reservoir and at the outlet of the arterial filter, while in the mini-bypass system the measurement points were at the inlet of the venous bubble trap and the outlet of the arterial filter.
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| 3. Statistics |
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2-test was used for analysis of categorical variables. A value of less than 0.05 was considered statistically significant. Independent statistical analysis was performed by the Department of Medical Statistics, University of Hannover, Germany and by the Department of Clinical Research at the Free University Hospital, Amsterdam, Netherlands. | 4. Results |
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| 5. Discussion |
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The clinical adoption of mini-bypass appears to have resulted in an early, clear trend towards reduced blood product use in CABG patients. A statistical significance in frequency of transfusions and amount of transfused volume was seen as well as reduced postoperative bleeding that was consistent with other published studies [21]. The elimination of the blood air interface combined with the significant reduction in blood contact surface area (approximately 1.4 m2 in mini-bypass as compared to nearly 6.0 m2 in a conventional open system) may have reduced platelet activation, but a more specific study is warranted to better understand the relationship between postoperative bleeding, improved biocompatibility via use of bio-coatings and reduction in blood contact surface area.
Despite the small surface area of 1.1 m2, the ECC.O oxygenator was able to adequately perfuse the patient as well as a conventional system with 1.7 m2 of fiber surface area. There was no clinically significant difference in terms of normal on pump oxygenation parameters and key postoperative parameters indicative of postoperative oxygenation insufficiency. Patients up to 125 kg have been easily managed by our clinic using the system, and the use of bicarbonate to manage acidosis post operatively has never been required. The higher blood hematocrit in mini-bypass on pump permits the advantage of reducing significantly the amount of oxygenation fiber required for adequate perfusion.
The average number of anastomoses was similar in mini-bypass as compared to the traditional system and demonstrates that the mini-bypass approach is as efficacious as a traditional system from the surgeon's perspective. After over 400 cases using mini-bypass in CABG it has become as routine as a traditional system for our surgical team.
The concept of mini-bypass reduces circuit prime by eliminating the hardshell reservoir, but this also means that the passive air removal capacity provided by the hardshell reservoir is eliminated. An active air removal system that senses and automatically removes venous GME must therefore be provided in a mini-bypass system. The ECC.O system includes an active air removal device called the Stöckert Air Purge Control (APC) system (Sorin Group). The air purge system uses a bubble sensor and roller pump to remove GME (approximately 100–150 µs or greater depending on the flow rate) from the venous line automatically, purging it to a de-airing storage reservoir in the circuit. The blood can be easily reintroduced back into circulation from this de-airing bag. A second bubble sensor with an electric clamp (ERC) system (Sorin Group) can be used with the APC air management system in order to stop ECC if air comes out of the bubble trap, providing a second level of GME management safety.
There was a lower level of MES in mini-bypass as compared to conventional bypass, and though this trend did not achieve statistical significance, there was a measurable difference in GME activity between the two systems that did achieve statistical significance. Less arterial GME volume is seen in the mini-bypass system as compared to a conventional system, confirming the importance of having an active air management system on the venous side in any mini-bypass circuit. It should be noted that the same trend of GME at the outlet of the reservoir has been seen by our institution regardless of the type of open venous reservoir used [25].
Special care must be taken in managing any active drainage perfusion system. Air entrainment at the venous side is effectively avoided with an additional ligature of the venous cannula, and with careful attention by the perfusionist and anesthesiologist during blood sampling and injection. The system showed a significant reduction in arterial GME even with intermittent arterial root venting into the venous line. Entrained GME is often seen in vent blood, but combining the active air removal system with aggressive management of the vent line by the perfusionist allows it to be managed efficaciously.
This was a randomized study with very limited exclusion parameters. The decision was made to widen the base for study to include consecutive CABG patients regardless of anticoagulation status in order to understand how use of mini-bypass in routine cases could impact the patient population at this institution. Only a study on a much more significant scale in terms of population size can provide an adequate numbers in order to draw conclusions regarding long term patient mortality and morbidity on a statistically significant order. Though GME activity using a mini-bypass system with an active air management system presents a clear advantage as compared to a conventional system, to demonstrate a correlation between reduction of microembolisation and improved neuropsychological outcome a large prospective randomized trial is required to elucidate the multifactorial and complex genesis of neuropsychological complications following CPB. Further studies are warranted to confirm the validity of the study.
| 6. Conclusion |
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| Appendix A |
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Dr S. Hagl (Heidelberg, Germany): I would like to ask you, did you also try to measure some inflammatory response in that study?
Dr Perthel: No, in this study we havent measured any inflammatory response. It was only a clinical study which was focused on the microbubbles, the microembolic signals and blood and transfusion. There were some other groups, for instance, Professor Liebold in Rostock, who has done a lot of work with another mini-bypass system, and he is very experienced with inflammatory response markers. This was not our project point.
Dr Hagl: Concerning the priming of the two systems, are they different?
Dr Perthel: No. It was the same, only saline, and the normal heparin dosages in both groups, there was no reduced regimen in the mini-bypass group, 300 U kg in each patient.
Dr Hagl: And the last question, how do you deal with suction?
Dr Perthel: There is no cardiotomy suction, and everything goes to the cell saver and we wash it after the procedure. And now we are so, let me say, experienced that in most of the cases, in two-thirds of the cases, it is not necessary to use the cell saver to wash this blood because you have an amount of 300 or 400 cc, and so it is not helpful to start the cell saver after the procedure. But it took a lot of time to come to this point.
| Footnotes |
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| References |
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