Prospective, Randomized Un-Blinded Three Arm Controlled Study in Coronary Artery Revascularization with Minimal Invasive Extracorporeal Circulation Systems (MiECC): Surrogate Parameter Analysis of Biocompatibility
DOI:
https://doi.org/10.1532/hsf.1946Abstract
Objectives: Minimal extracorporeal circulation techniques and systems (MiECC) may reduce the negative side effects of conventional extracorporeal circulation (ECC). However, it is still unclear as to what this is caused by, the reduced priming volume and hemodilution, or the avoidance of blood-air contact and dispersion of mediastinal debris into the systemic circulation. The aim of the trial was the comparison of MiECC to an open ECC setup (openECC) or a system with reduced blood air and debris interaction (closeECC).
Methods: In a prospective randomized trial, 72 patients (73 ± 5.3 years; 83% male) referred for coronary artery bypass graft (CABG) were randomly assigned either to MiECC (priming volume 550mL), closeECC, or openECC (priming volume 1250mL). The laboratory surrogate endpoints (renal function, inflammatory response, ischemia, coagulation, and hemolysis) and clinical data were measured at six different time points (T1-6).
Results: Patients were comparable for all preoperative variables. The operation times (MiECC 261 ± 79min; openECC 264 ± 75min; closeECC 231 ± 68min) and perfusion times (MiECC 115 ± 49min; openECC353 107 ± 37min; closeECC 99 ± 22min) revealed a trend of faster performance in the closeECC group (P < .05). Pro-inflammatory cytokines, ischemia, and coagulation markers were significantly elevated postoperatively in all cardiopulmonary bypass types, and decreased to pre-baseline levels at discharge (T5) without identifiable statistical differences between the three study groups. Free-hemoglobin was not significantly increased by centrifugal pump or cell saver procedures. Significant intraoperative hemodilution effects due to the different priming volumes were demonstrated only at the end of operation (T2) (MiECC Hb 9.6 ± 1.1g/dL; openECC Hb 9.0 ± 0.8g/dL; closeECC Hb 8.7 ± 1g/dL; P =. 01).
Conclusion: Neither the hemodilution, suction technique (MiECC), nor blood-air interface (closeECC) could show sustainable benefits in this underpowered study, compared to conventional ECC systems (openECC) in a high volume series of surrogate parameters.
References
with a minimal invasice extracorporeal bypass system: is there a clinical benefit? Ann Thorac Surg 80:238-43.
Anastasiadis K, Murkin J, Antonitsis P, et al. 2016. Use of minimal invasive extracorporeal circulation in cardiac surgery: principles, definitions and potential benefits. A position paper from the Minimal invasive Extra-Corporeal Technologies international Society (MiECTiS). Interact Cardiovasc Thorac Surg 22:647-62.
Beghi C, Nicolini F, Agostinelli A, et al. 2006. Mini-cardiopulmonary bypass system: results of a prospective randomized study. Ann Thorac Surg 81:1396-400.
Borst C, Gründeman PF. 1999. Minimally invasive coronary artery bypass grafting: an experimental perspective. Circulation 99:1400-3.
Chai PJ, Nassar R, Oakeley AE, et al. 2000. Soluble complement receptor-1 protects heart, lung, and cardiac myofilament function from cardiopulmonary bypass damage. Circulation 101:541-6.
El-Essawi A, Hajek T, Skorpil J, et al. 2011. Are minimal invasive perfusion circuits the better heart lung machines? Final results of a prospective randomized multicentre study. Perfusion 26:470-8.
El-Sabbagh AM, Toomasian CJ, Toomasian JM, et al. 2013. Effect of air exposure and suction on blood cell activation and hemolysis in an in vitro cardiotomy suction model. ASAIO J 59:474-9.
Farneti PA, Sbrana S, Spiller D, et al. 2008. Reduction of blood coagulation and monocyte-platelet interaction following the use of a minimal extracorporeal circulation system (Synergy) in coronary artery bypass grafting (CABG). Perfusion 23:49-56.
Formica F, Mariani S, Broccolo F, et al. 2013. Systemic and myocardial inflammatory response in coronary artery bypass graft surgery with miniaturized extracorporeal circulation: differences with a standard circuit and off-pump technique in a randomized clinical trial. ASAIO J 59:600-6.
Fromes Y, Gaillard D, Ponzio O, et al. 2002. Reduction of the inflammatory response following coronary bypass grafting with total minimal extracorporeal circulation. Eur J Cardiothorac Surg 22:527-33.
Gibbon JH Jr. 1994. Application of a mechanical heart and lung apparatus to cardiac surgery. Minn Med 37:171-85.
Khan NE, De Souza A, Mister R, et al. 2004. A randomized comparison of off-pump and on-pump multivessel coronary-artery bypass surgery. N Engl J Med 350:21-8.
Koch CG, Khandwala F, Li L, et al. 2006. Persistent effect of red cell transfusion on health-related quality of life after cardiac surgery. Ann Thorac Surg 82:13-20.
Koch CG, Li L, Duncan AI, et al. 2006. Transfusion in coronary artery bypass grafting is associated with reduced long-term survival. Ann Thorac Surg 81:1650-7.
Laffey JG, Boylan JF, Cheng DC. 2002. The systemic inflammatory response to cardiac surgery: implications for the anesthesiologist. Anesthesiology. 97:215-52.J.
Levy JH, Tanaka KA. 2003. Inflammatory response to cardiopulmonary bypass. Ann Thorac Surg 75:S715-20.
Mazzei V, Nasso G, Salamone G, et al. 2007. Prospective randomized comparison of coronary bypass grafting with minimal extracorporeal circulation system (MIECC) versus off-pump coronary surgery. Circulation 116:1761-7.
Nakahira A, Sasaki Y, Hirai H, et al. 2011. Cardiotomy suction, but not open venous reservoirs, activates coagulofibrinolysis in coronary artery surgery. J Thorac Cardiovasc Surg 141:1289-97.
Remadi JP, Rakotoarivelo Z, Marticho P, et al. 2006. Prospective randomized study comparing coronary artery bypass grafting with the new mini-extracorporeal circulation Jostra System or with a standard cardiopulmonary bypass. Am Heart J 151:198.
Royston D. 1997. The inflammatory response and extracorporeal circulation. J Cardiothorac Vasc Anesth. 11:341-54.
Svitek V, Lonsky V, Anjum F. 2010. Pathophysiological aspects of cardiotomy suction usage. Perfusion 25:147-52.
Van Boven WJ, Gerritsen WB, Zanen P, et al. 2005. Pneumoproteins as a lung-specific biomarker of alveolar permeability in conventional on-pump coronary artery bypass graft surgery vs mini-extracorporeal circuit: a pilot study. Chest 127:1190-5.
Vohra HA, Whistance R, Modi A, et al. 2009. The inflammatory response to miniaturised extracorporeal circulation: a review of the literature. Mediators Inflamm 2009:707042.
Wheeldon DR, Bethune DW, Gill RD. 1990. Vortex pumping for routine cardiac surgery: a comparative study. Perfusion 5:135-43.
Published
How to Cite
Issue
Section
Author Disclosure & Copyright Transfer Agreement
In order to publish the original work of another person(s), The Heart Surgery Forum® must receive an acknowledgment of the Author Agreement and Copyright Transfer Statement transferring to Forum Multimedia Publishing, L.L.C., a subsidiary of Carden Jennings Publishing Co., Ltd. the exclusive rights to print and distribute the author(s) work in all media forms. Failure to check Copyright Transfer agreement box below will delay publication of the manuscript.
A current form follows:
The author(s) hereby transfer(s), assign(s), or otherwise convey(s) all copyright ownership of the manuscript submitted to Forum Multimedia Publishing, LLC (Publisher). The copyright transfer covers the exclusive rights to reproduce and distribute the article and the material contained therein throughout the world in all languages and in all media of expression now known or later developed, including but not limited to reprints, photographic reproduction, microfilm, electronic data processing (including programming, storage, and transmission to other electronic data record(s), or any other reproductions of similar nature), and translations.
However, Publisher grants back to the author(s) the following:
- The right to make and distribute copies of all or part of this work for use of the author(s) in teaching;
- The right to use, after publication in The Heart Surgery Forum, all or part of the material from this work in a book by the author(s), or in a collection of work by the author(s);
- The royalty-free right to make copies of this work for internal distribution within the institution/company that employs the author(s) subject to the provisions below for a work-made-for-hire;
- The right to use figures and tables from this work, and up to 250 words of text, for any purpose;
- The right to make oral presentations of material from this work.
Publisher reserves the right to grant or refuse permission to third parties to republish all or part of the article or translations thereof. To republish, such third parties must obtain written permission from the Publisher. (This is in accordance with the Copyright Statute, United States Code, Title 17. Exception: If all authors were bona fide officers or employees of the U.S. Government at the time the paper was prepared, the work is a “work of the US Government” (prepared by an officer or employee of the US Government as part of official duties), and therefore is not subject to US copyright; such exception should be indicated on signature lines. If this work was prepared under US Government contract or grant, the US Government may reproduce, royalty-free, all or portions of this work and may authorize others to do so, for official US Government purposes only, if the US Government contract or grant so requires.
I have participated in the conception and design of this work and in the writing of the manuscript and take public responsibility for it. Neither this manuscript nor one with substantially similar content under my authorship has been published, has been submitted for publication elsewhere, or will be submitted for publication elsewhere while under consideration by The Heart Surgery Forum, except as described in an attachment. I have reviewed this manuscript (original version) and approve its submission. If I am listed above as corresponding author, I will provide all authors with information regarding this manuscript and will obtain their approval before submitting any revision. I attest to the validity, accuracy, and legitimacy of the content of the manuscript and understand that Publisher assumes no responsibility for the validity, accuracy, and legitimacy of its content. I warrant that this manuscript is original with me and that I have full power to make this Agreement. I warrant that it contains no matter that is libelous or otherwise unlawful or that invades individual privacy or infringes any copyright or other proprietary right. I agree to indemnify and hold Publisher harmless of and from any claim made against Publisher that relates to or arises out of the publication of the manuscript and agree that this indemnification shall include payment of all costs and expenses relating to the defense of any such claim, including all reasonable attorney’s fees.
I warrant that I have no financial interest in the drugs, devices, or procedures described in the manuscript (except as disclosed in the attached statement).
I state that the institutional Human Subjects Committee and/or the Ethics Committee approved the clinical protocol reported in this manuscript for the use of experimental techniques, drugs, or devices in human subjects and appropriate informed consent documents were utilized.
Furthermore, I state that any and all animals used for experimental purposes received humane care in USDA registered facilities in compliance with the “Principles of Laboratory Animal Care” formulated by the National Society for Medical Research and the “Guide for the Care and Use of Laboratory Animals” prepared by the Institute of Laboratory Animal Resources and published by the National Institutes of Health (NIH Publication No. 85-23, revised 1985).
