First 24 Hour-Long Intensive Care Unit Testing of a Clinical-Scale Microfluidic Oxygenator in Swine: A Safety and Feasibility Study.


Journal

ASAIO journal (American Society for Artificial Internal Organs : 1992)
ISSN: 1538-943X
Titre abrégé: ASAIO J
Pays: United States
ID NLM: 9204109

Informations de publication

Date de publication:
03 Jan 2024
Historique:
medline: 3 1 2024
pubmed: 3 1 2024
entrez: 2 1 2024
Statut: aheadofprint

Résumé

Microfluidic membrane oxygenators are designed to mimic branching vasculature of the native lung during extracorporeal lung support. To date, scaling of such devices to achieve clinically relevant blood flow and lung support has been a limitation. We evaluated a novel multilayer microfluidic blood oxygenator (BLOx) capable of supporting 750-800 ml/min blood flow versus a standard hollow fiber membrane oxygenator (HFMO) in vivo during veno-venous extracorporeal life support for 24 hours in anesthetized, mechanically ventilated uninjured swine (n = 3/group). The objective was to assess feasibility, safety, and biocompatibility. Circuits remained patent and operated with stable pressures throughout 24 hours. No group differences in vital signs or evidence of end-organ damage occurred. No change in plasma free hemoglobin and von Willebrand factor multimer size distribution were observed. Platelet count decreased in BLOx at 6 hours (37% dec, P = 0.03), but not in HFMO; however, thrombin generation potential was elevated in HFMO (596 ± 81 nM·min) versus BLOx (323 ± 39 nM·min) at 24 hours (P = 0.04). Other coagulation and inflammatory mediator results were unremarkable. BLOx required higher mechanical ventilator settings and showed lower gas transfer efficiency versus HFMO, but the stable device performance indicates that this technology is ready for further performance scaling and testing in lung injury models and during longer use conditions.

Identifiants

pubmed: 38165978
doi: 10.1097/MAT.0000000000002127
pii: 00002480-990000000-00382
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Informations de copyright

Copyright © ASAIO 2024.

Déclaration de conflit d'intérêts

Disclosure: The authors have no conflicts of interest to report. Opinions, interpretations, conclusions and recommendations are those of the author and are not necessarily endorsed by the Department of Defense or the US Army. Figure 1 was created with Biorender.com.

Références

Ryerson LM, Annich G, Batchinsky A, et al.: Adverse effects of extracorporeal life support. in MacLaren G, et al. (eds), Extracorporeal Life Support: The ELSO Red Book. Ann Arbor, MI, Extracorporeal Life Support Organization, 2022, pp. 97–108.
Fukuda M: Evolutions of extracorporeal membrane oxygenator (ECMO): Perspectives for advanced hollow fiber membrane. J Artif Organs 1–6, 2023.
Lim MW: The history of extracorporeal oxygenators. Anaesthesia 61: 984–995, 2006.
Teber OO, Altinay AD, Mehrabani SAN, et al.: Polymeric hollow fiber membrane oxygenators as artificial lungs: A review. Biochem Eng J 180, 2022.
De Somer F: Does contemporary oxygenator design influence haemolysis? Perfusion 28: 280–285, 2013.
Roberts TR, Garren MRS, Handa H, Batchinsky A: Toward an artificial endothelium: Development of blood-compatible surfaces for extracorporeal life support. J Trauma Acute Care Surg 89(2S suppl 2): S59–S68, 2020.
Roberts TR, Choi JH, Wendorff DS, et al.: Tethered liquid perfluorocarbon coating for 72 hour heparin-free extracorporeal life support. ASAIO J 67: 798–808, 2021.
Roberts TR, Harea GT, Singha P, et al.: Heparin-free extracorporeal life support using tethered liquid perfluorocarbon: A feasibility and efficacy study. ASAIO J 66: 809–817, 2020.
Mazzeffi M, Greenwood J, Tanaka K, et al.: Bleeding, transfusion, and mortality on extracorporeal life support: ECLS working group on thrombosis and hemostasis. Ann Thorac Surg 101: 682–689, 2016.
Willers A, Arens J, Mariani S, et al.: New trends, advantages and disadvantages in anticoagulation and coating methods used in extracorporeal life support devices. Membranes (Basel) 11: 617, 2021.
Gajkowski EF, Herrera G, Hatton L, Velia Antonini M, Vercaemst L, Cooley E: ELSO guidelines for adult and pediatric extracorporeal membrane oxygenation circuits. ASAIO J 68: 133–152, 2022.
Chung M, Cabezas FR, Nunez JI, et al.: Hemocompatibility-related adverse events and survival on venoarterial extracorporeal life support: An ELSO registry analysis. JACC Heart Fail 8: 892–902, 2020.
Baksaas ST, Videm V, Fosse E, et al.: In vitro evaluation of new surface coatings for extracorporeal circulation. Perfusion 14: 11–19, 1999.
Potkay JA: The promise of microfluidic artificial lungs. Lab Chip 14: 4122–4138, 2014.
Hoganson DM, Pryor Ii HI, Bassett EK, Spool ID, Vacanti JP: Lung assist device technology with physiologic blood flow developed on a tissue engineered scaffold platform. Lab Chip 11: 700–707, 2011.
Kniazeva T, Hsiao JC, Charest JL, Borenstein JT: A microfluidic respiratory assist device with high gas permeance for artificial lung applications. Biomed Microdevices 13: 315–323, 2011.
Rochow N, Manan A, Wu WI, et al.: An integrated array of microfluidic oxygenators as a neonatal lung assist device: In vitro characterization and in vivo demonstration. Artif Organs 38: 856–866, 2014.
Kniazeva T, Epshteyn AA, Hsiao JC, et al.: Performance and scaling effects in a multilayer microfluidic extracorporeal lung oxygenation device. Lab Chip 12: 1686–1695, 2012.
Gimbel AA, Hsiao JC, Kim ES, et al.: A high gas transfer efficiency microfluidic oxygenator for extracorporeal respiratory assist applications in critical care medicine. Artif Organs 45: E247–E264, 2021.
Wagner G, Kaesler A, Steinseifer U, Schmitz-Rode T, Arens J: Comment on “The promise of microfluidic artificial lungs” by J. A. Potkay, Lab Chip, 2014, 14, 4122–4138. Lab Chip 16: 1272–1273, 2016.
Santos J, Vedula EM, Lai W, et al.: Toward development of a higher flow rate hemocompatible biomimetic microfluidic blood oxygenator. Micromachines (Basel) 12, 888, 2021.
Vedula EM, Isenberg BC, Santos J, et al.: Multilayer scaling of a biomimetic microfluidic oxygenator. ASAIO J 68: 1312–1319, 2022.
Isenberg BC, Vedula EM, Santos J, et al.: A clinical-scale microfluidic respiratory assist device with 3d branching vascular networks. Adv Sci (Weinh) 10: e2207455, 2023.
Murray CD; The Physiological Principle of Minimum Work: I: The vascular system and the cost of blood volume. Proc Natl Acad Sci U S A 12: 207–214, 1926.
Lund LW, Federspiel WJ: Removing extra CO(2) in COPD patients. Curr Respirat Care Rep 2: 131–138, 2013.
Roberts TR, Harea GT, Singha P, et al.: Heparin-free extracorporeal life support using tethered liquid perfluorocarbon: A feasibility and efficacy study. ASAIO J 66: 809–817, 2020.
Hendrix RHJ, Kurniawati ER, Schins SFC, Maessen JG, Weerwind PW: Dynamic oxygenator blood volume during prolonged extracorporeal life support. PLoS One 17: e0263360, 2022.
Prat NJ, Meyer AD, Langer T, et al.: Low-dose heparin anticoagulation during extracorporeal life support for acute respiratory distress syndrome in conscious sheep. Shock 44: 560–568, 2015.
Choi JH, Necsoiu C, Wendorff D, et al.: Effects of adjunct treatments on end-organ damage and histological injury severity in acute respiratory distress syndrome and multiorgan failure caused by smoke inhalation injury and burns. Burns 45: 1765–1774, 2019.
Astor TL, Borenstein JT: The microfluidic artificial lung: Mimicking nature’s blood path design to solve the biocompatibility paradox. Artif Organs 46: 1227–1239, 2022.
Slutsky AS, Ranieri VM: Ventilator-induced lung injury. N Engl J Med 369: 2126–2136, 2013.
Batchinsky A, Jordan BS, Regn D, et al.: Respiratory dialysis: reduction in dependence on mechanical ventilation by venovenous extracorporeal CO2 removal. Crit Care Med 39: 1382–1387, 2011.
Dabaghi M, Rochow N, Saraei N, et al.: A pumpless microfluidic neonatal lung assist device for support of preterm neonates in respiratory distress. Adv Sci (Weinh) 7: 2001860, 2020.
Thompson AJ, Ma LJ, Major T, et al.: Assessing and improving the biocompatibility of microfluidic artificial lungs. Acta Biomater 112: 190–201, 2020.
Schöps M, Groß-Hardt SH, Schmitz-Rode T, et al.: Hemolysis at low blood flow rates: In-vitro and in-silico evaluation of a centrifugal blood pump. J Transl Med 19: 1–10, 2021.
Kalbhenn J, Neuffer N, Zieger B, Schmutz A: Is extracorporeal CO2 removal really “safe” and “less” invasive? Observation of blood injury and coagulation impairment during ECCO2R. ASAIO J 63: 666–671, 2017.
Malfertheiner MV, Pimenta LP, Bahr VV, et al.: Acquired von Willebrand syndrome in respiratory extracorporeal life support: A systematic review of the literature. Crit Care Resusc 19(suppl 1): 45–52, 2017.

Auteurs

Teryn R Roberts (TR)

From the Autonomous Reanimation and Evacuation Research Program, The Geneva Foundation, San Antonio, Texas.

Antoine Persello (A)

From the Autonomous Reanimation and Evacuation Research Program, The Geneva Foundation, San Antonio, Texas.

George T Harea (GT)

From the Autonomous Reanimation and Evacuation Research Program, The Geneva Foundation, San Antonio, Texas.

Else M Vedula (EM)

Bioengineering Division, Draper, Cambridge, Massachusetts.

Brett C Isenberg (BC)

Bioengineering Division, Draper, Cambridge, Massachusetts.

Yanyi Zang (Y)

From the Autonomous Reanimation and Evacuation Research Program, The Geneva Foundation, San Antonio, Texas.

Jose Santos (J)

Bioengineering Division, Draper, Cambridge, Massachusetts.

Jeffrey T Borenstein (JT)

Bioengineering Division, Draper, Cambridge, Massachusetts.

Andriy I Batchinsky (AI)

From the Autonomous Reanimation and Evacuation Research Program, The Geneva Foundation, San Antonio, Texas.

Classifications MeSH