Startseite A novel approach in extracorporeal circulation: individual, integrated, and interactive heart-lung assist (I3-Assist)
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A novel approach in extracorporeal circulation: individual, integrated, and interactive heart-lung assist (I3-Assist)

  • Georg Wagner EMAIL logo , Peter Schlanstein , Sandra Fiehe , Tim Kaufmann , Rüdger Kopp , Ralf Bensberg , Thomas Schmitz-Rode , Ulrich Steinseifer und Jutta Arens
Veröffentlicht/Copyright: 11. Dezember 2013
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Abstract

Extracorporeal life support (ECLS) is a well-established technique for the treatment of different cardiac and pulmonary diseases, e.g., congenital heart disease and acute respiratory distress syndrome. Additionally, severely ill patients who cannot be weaned from the heart-lung machine directly after surgery have to be put on ECLS for further therapy. Although both systems include identical components, a seamless transition is not possible yet. The adaption of the circuit to the patients’ size and demand is limited owing to the components available. The project I³-Assist aims at a novel concept for extracorporeal circulation. To better match the patient’s therapeutic demand of support, an individual number of one-size oxygenators and heat exchangers will be combined. A seamless transition between cardiopulmonary bypass and ECLS will be possible as well as the exchange of components during therapy to enhance circuit maintenance throughout long-term support. Until today, a novel oxygenator and heat exchanger along with a simplified manufacturing protocol have been established. The first layouts of the unit to allow the spill- and bubble-free connection and disconnection of modules as well as improved cannulas and a rotational pump are investigated using computational fluid dynamics. Tests were performed according to current guidelines in vitro and in vivo. The test results show the feasibility and potential of the concept.


Corresponding author: Dipl.-Ing. Georg Wagner, Department of Cardiovascular Engineering, Institute of Applied Medical Engineering, Helmholtz Institute, RWTH Aachen University, Pauwelsstraße 20, 52074 Aachen, Germany, Phone: +49 241 80 89 888, Fax: +49 241 80 82 144, E-mail:
aThese authors contributed equally to this article.

Acknowledgments

This project was performed in collaboration between the industrial partner, the QM consultant qcmed GmbH, the Department of Intensive Care Medicine of the University Hospital RWTH Aachen, and the Department of Cardiovascular Engineering (CVE), Institute of Applied Medical Engineering (AME), University Hospital RWTH Aachen.

The project is co-funded by the European Union (ERDF – European Regional Development Fund – Investing in your future) and the German federal state North Rhine-Westphalia (NRW), under the operational program Ziel2 “Regional Competitiveness and Employment” 2007–2013 (EFRE).

References

[1] Allen S, Holena D, McCunn M, Kohl B, Sarani B. A review of the fundamental principles and evidence base in the use of extracorporeal membrane oxygenation (ECMO) in critically ill adult patients. J Intensive Care Med 2011; 26: 13–26.10.1177/0885066610384061Suche in Google Scholar

[2] Ando M, Takahashi Y, Suzuki N. Open heart surgery for small children without homologous blood transfusion by using remote pump head system. Ann Thorac Surg 2004; 78: 1717–1722.10.1016/j.athoracsur.2004.05.006Suche in Google Scholar

[3] Arens J, Schoberer M, Lohr A, et al. NeonatOx: a pumpless extracorporeal lung support for premature neonates. Artif Organs 2011; 35: 997–1001.10.1111/j.1525-1594.2011.01324.xSuche in Google Scholar

[4] Arens J, Schnoering H, Pfennig M, et al. The Aachen MiniHLM – a miniaturized heart-lung machine for neonates with an integrated rotary blood pump. Artif Organs 2010; 34: 707–713.10.1111/j.1525-1594.2010.01082.xSuche in Google Scholar

[5] ASTM. ASTM F 1830:1997 – standard practice for selection of blood for in vitro evaluation of blood pumps, 1997.Suche in Google Scholar

[6] Bakhtiary F, Keller H, Dogan S, et al. Venoarterial extracorporeal membrane oxygenation for treatment of cardiogenic shock: clinical experiences in 45 adult patients. J Thorac Cardiovasc Surg 2008; 135: 382–388.10.1016/j.jtcvs.2007.08.007Suche in Google Scholar

[7] Bartlett RH. Extracorporeal life support in the management of severe respiratory failure. Clin Chest Med 2000; 21: 555–561.10.1016/S0272-5231(05)70166-0Suche in Google Scholar

[8] Bartlett RH, Roloff DW, Cornell RG, Andrews AF, Dillon PW, Zwischenberger JB. Extracorporeal circulation in neonatal respiratory failure: a prospective randomized study. Pediatrics 1985; 76: 479–487.10.1542/peds.76.4.479Suche in Google Scholar

[9] Beall A Jr, Yow E Jr, Bloodwell RD, Hallman GL, Cooley DA. Open heart surgery without blood transfusion. Arch Surg 1967; 94: 567–570.10.1001/archsurg.1967.01330100131019Suche in Google Scholar PubMed

[10] Chen Y-S, Yu H-Y, Huang S-C, et al. Experience and result of extracorporeal membrane oxygenation in treating fulminant myocarditis with shock: what mechanical support should be considered first? J Heart Lung Transplant 2005; 24: 81–87.10.1016/j.healun.2003.09.038Suche in Google Scholar PubMed

[11] Combes A, Leprince P, Luyt C-E, et al. Outcomes and long-term quality-of-life of patients supported by extracorporeal membrane oxygenation for refractory cardiogenic shock. Crit Care Med 2008; 36: 1404–1411.10.1097/CCM.0b013e31816f7cf7Suche in Google Scholar PubMed

[12] Cruz D, Bellomo R, Kellum JA, de Cal M, Ronco C. The future of extracorporeal support. Crit Care Med 2008; 36: S243–S252.10.1097/CCM.0b013e318168e4f6Suche in Google Scholar PubMed

[13] DIN EN 12022:1999 – Blutgasaustauscher. DIN Deutsches Institut für Normung e.V., Berlin: Beuth Verlag, März 1999.Suche in Google Scholar

[14] Durandy Y. Blood transfusion in pediatric cardiac surgery. Artif Organs 2010; 34: 1057–1061.10.1111/j.1525-1594.2010.01158.xSuche in Google Scholar PubMed

[15] Eash HJ, Jones HM, Hattler BG, Federspiel WJ. Evaluation of plasma resistant hollow fiber membranes for artificial lungs. ASAIO J 2004; 50: 491–497.10.1097/01.MAT.0000138078.04558.FESuche in Google Scholar

[16] Edmunds LH. Advances in the heart-lung machine after John and Mary Gibbon. Ann Thorac Surg 2003; 76: S2220–S2223.10.1016/j.athoracsur.2003.09.013Suche in Google Scholar PubMed

[17] Fiehe S, Wagner G, Schlanstein P, et al. Implementation of quality management in early stages of research and development projects at a university. Biomed Eng/Biomed Technik 2014; 59: 135–145..10.1515/bmt-2013-0085Suche in Google Scholar PubMed

[18] Fleming GM, Gurney JG, Donohue JE, Remenapp RT, Annich GM. Mechanical component failures in 28,171 neonatal and pediatric extracorporeal membrane oxygenation courses from 1987 to 2006. Pediatr Crit Care Med 2009; 10: 439–444.10.1097/PCC.0b013e318198b275Suche in Google Scholar PubMed

[19] Gibbon J Jr. Application of a mechanical heart and lung apparatus to cardiac surgery. Minn Med 1954; 37: 171–185; passim.Suche in Google Scholar

[20] Golab HD, Takkenberg JJ, Bogers AJJC. Specific requirements for bloodless cardiopulmonary bypass in neonates and infants; a review. Perfusion 2010; 25: 237–243.10.1177/0267659110375862Suche in Google Scholar PubMed

[21] Haines NM, Rycus PT, Zwischenberger JB, Bartlett RH, Undar A. Extracorporeal life support registry report 2008: neonatal and pediatric cardiac cases. ASAIO J 2009; 55: 111–116.10.1097/MAT.0b013e318190b6f7Suche in Google Scholar PubMed

[22] Hickey E, Karamlou T, You J, Ungerleider R. Effects of circuit miniaturization in reducing inflammatory response to infant cardiopulmonary bypass by elimination of allogeneic blood products. Ann Thorac Surg 2006; 81: 2367–2372.10.1016/j.athoracsur.2006.02.071Suche in Google Scholar PubMed

[23] Hill JD, O’Brien TG, Murray JJ, et al. Prolonged extracorporeal oxygenation for acute post-traumatic respiratory failure (shock-lung syndrome): use of the Bramson membrane lung. N Engl J Med 1972; 286: 629–634.10.1056/NEJM197203232861204Suche in Google Scholar PubMed

[24] ISO 7199:2009 – Cardiovascular implants and artificial organs – blood-gas exchangers (oxygenators). ISO International Organization for Standardization, Geneva, April 2009.Suche in Google Scholar

[25] Kato S, Morimoto S, Hiramitsu S, Nomura M, Ito T, Hishida H. Use of percutaneous cardiopulmonary support of patients with fulminant myocarditis and cardiogenic shock for improving prognosis. Am J Cardiol 1999; 83: 623–5, A10.10.1016/S0002-9149(98)00931-XSuche in Google Scholar

[26] Kaufmann TAS, Hormes M, Laumen M, et al. Flow distribution during cardiopulmonary bypass in dependency on the outflow cannula positioning. Artif Organs 2009; 33: 988–992.10.1111/j.1525-1594.2009.00938.xSuche in Google Scholar

[27] Kaufmann TAS, Wong KC, Schmitz-Rode T, Steinseifer U. Mimicking of cerebral autoregulation by flow-dependent cerebrovascular resistance: a feasibility study. Artif Organs 2012; 36: E97–101.10.1111/j.1525-1594.2011.01433.xSuche in Google Scholar

[28] Kawaguchi A, Bergsland J, Subramanian S. Total bloodless open heart surgery in the pediatric age group. Circulation 1984; 70: I30–I37.10.1016/S0003-4975(10)60737-0Suche in Google Scholar

[29] Kawahito K, Murata S, Yasu T, et al. Usefulness of extracorporeal membrane oxygenation for treatment of fulminant myocarditis and circulatory collapse. Am J Cardiol 1998; 82: 910–911.10.1016/S0002-9149(98)00503-7Suche in Google Scholar

[30] Kotani Y, Honjo O, Nakakura M, et al. Impact of miniaturization of cardiopulmonary bypass circuit on blood transfusion requirement in neonatal open-heart surgery. ASAIO J 2007; 53: 662–665.10.1097/MAT.0b013e318158ddf6Suche in Google Scholar PubMed

[31] Lan C, Tsai P-R, Chen Y-S, Ko W-J. Prognostic factors for adult patients receiving extracorporeal membrane oxygenation as mechanical circulatory support – a 14-year experience at a medical center. Artif Organs 2010; 34: E59–E64.10.1111/j.1525-1594.2009.00909.xSuche in Google Scholar PubMed

[32] Lau CL, Posther KE, Stephenson GR, et al. Mini-circuit cardiopulmonary bypass with vacuum assisted venous drainage: feasibility of an asanguineous prime in the neonate. Perfusion 1999; 14: 389–396.10.1177/026765919901400511Suche in Google Scholar PubMed

[33] Merkle F, Boettcher W, Schulz F, Koster A, Huebler M, Hetzer R. Perfusion technique for nonhaemic cardiopulmonary bypass prime in neonates and infants under 6 kg body weight. Perfusion 2004; 19: 229–237.10.1191/0267659104pf744oaSuche in Google Scholar PubMed

[34] Miyaji K, Kohira S, Miyamoto T, et al. Pediatric cardiac surgery without homologous blood transfusion, using a miniaturized bypass system in infants with lower body weight. J Thorac Cardiovasc Surg 2007; 134: 284–289.10.1016/j.jtcvs.2007.02.020Suche in Google Scholar PubMed

[35] Montoya JP, Shanley CJ, Merz SI, Bartlett RH. Plasma leakage through microporous membranes: role of phospholipids. ASAIO J 1992; 38: M399–M405.10.1097/00002480-199207000-00064Suche in Google Scholar

[36] Nakanishi K, Shichijo T, Shinkawa Y, et al. Usefulness of vacuum-assisted cardiopulmonary bypass circuit for pediatric open-heart surgery in reducing homologous blood transfusion. Eur J Cardiothorac Surg 2001; 20: 233–238.10.1016/S1010-7940(01)00769-2Suche in Google Scholar

[37] Ota K. Advances in artificial lungs. J Artif Organs 2010; 13: 13–16.10.1007/s10047-010-0492-1Suche in Google Scholar

[38] Rahe-Meyer N, Solomon C, Tokuno M-L, et al. Comparative assessment of coagulation changes induced by two different types of heart-lung machine. Artif Organs 2010; 34: 3–12.10.1111/j.1525-1594.2009.00792.xSuche in Google Scholar

[39] Reiss N, El Banayosy A, Posival H, Morshuis M, Minami K, Körfer R. Management of acute fulminant myocarditis using circulatory support systems. Artif Organs 1996; 20: 964–970.10.1111/j.1525-1594.1996.tb04579.xSuche in Google Scholar

[40] Roche JK, Stengle JM. Open-heart surgery and the demand for blood. J Am Med Assoc 1973; 225: 1516–1521.10.1001/jama.1973.03220400042009Suche in Google Scholar

[41] Schaible T, Hermle D, Loersch F, Demirakca S, Reinshagen K, Varnholt V. A 20-year experience on neonatal extracorporeal membrane oxygenation in a referral center. Intensive Care Med 2010; 36: 1229–1234.10.1007/s00134-010-1886-5Suche in Google Scholar

[42] Stein JI, Gombotz H, Rigler B, Metzler H, Suppan C, Beitzke A. Open heart surgery in children of Jehovah’s Witnesses: extreme hemodilution on cardiopulmonary bypass. Pediatr Cardiol 1991; 12: 170–174.10.1007/BF02238525Suche in Google Scholar

[43] Ugaki S, Kasahara S, Kotani Y, et al. Extracorporeal membrane oxygenation following Norwood stage 1 procedures at a single institution. Artif Organs 2010; 34,: 898–903.10.1111/j.1525-1594.2010.01141.xSuche in Google Scholar

[44] Ungerleider RM, Shen I. Optimizing response of the neonate and infant to cardiopulmonary bypass. Semin Thorac Cardiovasc Surg Pediatr Card Surg Annu 2003; 6: 140–146.10.1016/S1092-9126(03)70017-9Suche in Google Scholar

[45] Willcox TW. Vacuum-assisted venous drainage: to air or not to air, that is the question. Has the bubble burst? J Extra Corpor Technol 2002; 34: 24–28.Suche in Google Scholar

Received: 2013-3-28
Accepted: 2013-11-6
Published Online: 2013-12-11
Published in Print: 2014-4-1

©2014 by Walter de Gruyter Berlin/Boston

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