Performance and Reliability of the CPB/ECMO Initiative Forward Lines Casualty Management System FERNANDO CASAS,* ANDREW REEVES,* DAVID DUDZINSKI,* STEPHAN WEBER,* MARKUS LORENZ,* MASATOSHI AKIYAMA,* KEIJI KAMOHARA,* MICHAEL KOPCAK,* YOSHIO OOTAKI,* FIRAS ZAHR,* MARTIN SINKEWICH,† ROBERT FOSTER,† KIYOTAKA FUKAMACHI,* AND WILLIAM A. SMITH* The Cleveland Clinic Foundation CPB/ECMO Initiative For- ward Casualty Management System is an economical, com- pact, transportable, disposable system designed to permit a rapid expansion of trauma management services requiring cardiopulmonary bypass (CPB) or extracorporeal membrane oxygenation (ECMO) pulmonary support. The system, com- posed of a rotary blood pump, a pump motor driver, and an electronic control console as the blood pumping subsystem, also includes commonly used compatible commercial oxy- genators, venous reservoirs, and cannulae. In vitro durability testing accumulated over 100 hours without failure. In vivo reliability was tested in 10 calves under general anesthesia during 6 hours of CPB and ECMO under full heparinization at nominal operating conditions of 4 –5 l/min and 2– 4 l/min blood flow respectively, and mean arterial pressures between 65 and 100 mm Hg. A mean time to failure of 57 hours was reached during the animal series. Results of these test series demonstrated that this system has the capability to reliably operate during a 6-hour conventional CPB or ECMO proce- dure, while providing flexibility and ease of use for the oper- ator. ASAIO Journal 2005; 51:681–685. C ardiopulmonary bypass (CPB) is a well-established technol- ogy that has also found application in trauma care. 1–3 Applied either in the classic CPB form or as extracorporeal membrane oxygenation (ECMO), it can be used to maintain combat ca- sualties with a variety of critical injuries (thoracic trauma, exsanguination, smoke inhalation, or exposure to other toxic agents), until they receive definitive care, or for support until the damaged organ recovers. CPB/ECMO equipment could be made available for induction of hypothermia as a means to rescue some severely injured casualties with low hematocrit due to blood loss 4–6 or to facilitate specialized surgical repair procedures. Mortality caused by temporary cardiorespiratory collapse secondary to other injuries could be reduced. A lim- itation to more widespread use of this technology for trauma care is the lack of suitable forms of equipment, with appropri- ate features to support trauma applications, as opposed to operating room equipment. The Cleveland Clinic Foundation (CCF) CPB/ECMO system comprises a set of reusable, but ultimately disposable, portable CPB/ECMO components. 7 The system includes a blood pump- ing subsystem composed of the blood pump, pump motor driver, and electronic control console. The blood pumping subsystem has been carefully matched to compatible commer- cial oxygenators, venous reservoirs, and cannulae. The com- plete system will come as a sealed kit including all the afore- mentioned components. One component is a high efficiency, disposable blood pump, which draws on the technologies developed for implantable blood pumps. The pump’s high efficiency (approximately 50%) simplifies the problems of pro- viding power to the pump under field and transportation con- ditions, in particular when using batteries. The driver for the CPB pump, powered by an electric motor, is not part of the sterile circuit. Although designed to be disposable, it could be reused if needed and requires no special reprocessing between uses. The goal is to replace the pump console with equipment that is small and light enough to place on a patient’s stretcher during transportation. Cost is predicted to be low enough to make widespread stockpiling and distribution of CPB, ECMO, or hypothermic “suspended animation” capacity practical and support an emergency expansion of services to an order of magnitude greater than would be economical with conven- tional supplies. As a “reposable,” reuseable but also econom- ically disposable item, 20 or more uses of the motor would be possible, but, at the end of the emergency mobilization, or patient transport, it would be feasible to discard the equip- ment, rather than maintain a refurbishment and restocking logistical train. Reliability of a disposable low cost CPB/ECMO system plays a major role in its successful deployment in the field, hence the need to demonstrate dependable performance of the pump not only during in vitro testing but also, and most importantly, during in vivo use. This article presents results of the CCF CPB/ECMO system (Figure 1) during durability bench testing and concentrates on the performance and system reliability during in vivo testing in a bovine animal experimental series. Materials and Methods System Description The system uses a magnetically coupled centrifugal pump driving a straight blade impeller. A highly polished face seal From the *Lerner Research Institute, Department of Biomedical Engineering, †Perfusion Services, The Cleveland Clinic Foundation, Cleveland, OH. Submitted for consideration April 2005, accepted in revised form August 2005. Supported by the Department of Defense, US Army Medical Research Contract DAMD17-00-1-0717. Dr. Casas acknowl- edges support from grant K01HL073076 from the National Heart, Lung, and Blood Institute of the National Institutes of Health. Presented during the poster sessions at the 51 st ASAIO conference, Washington DC, June 11, 2005. Reprint Requests: Fernando Casas, PhD, The Cleveland Clinic Foun- dation, Lerner Research Institute, Department of Biomedical Engineer- ing / ND20, 9500 Euclid Avenue, Cleveland, OH 44195; e-mail: casasf@ccf.org. DOI: 10.1097/01.mat.0000182472.63808.b9 ASAIO Journal 2005 681