Ryan A Orizondo1,2,3,4,5,6,7,8,9,10,11, Katelin S Omecinski1,3, Alexandra G May1,4, Vishaal Dhamotharan1,3, Brian J Frankowski1, Greg W Burgreen5, Sang-Ho Ye1,6, Ergin Kocyildirim1,7, Pablo G Sanchez8, Jonathan D'Cunha9, William R Wagner1,3,4,6, William J Federspiel1,3,4,10,11. 1. McGowan Institute for Regenerative Medicine, University of Pittsburgh, Pittsburgh, PA. 2. Department of Medicine, University of Pittsburgh, Pittsburgh, PA. 3. Department of Bioengineering, University of Pittsburgh, Pittsburgh, PA. 4. Department of Chemical and Petroleum Engineering, University of Pittsburgh, Pittsburgh, PA. 5. Computational Fluid Dynamics Group, Center for Advanced Vehicular Systems, Mississippi State University, Starkville, MS. 6. Department of Surgery, University of Pittsburgh, Pittsburgh, PA. 7. Department of Cardiothoracic Surgery, Children's Hospital of Pittsburgh, Pittsburgh, PA. 8. Department of Cardiothoracic Surgery, University of Pittsburgh Medical Center, Pittsburgh, PA. 9. Department of Cardiothoracic Surgery, Mayo Clinic Arizona, Phoenix, AZ. 10. Department of Critical Care Medicine, University of Pittsburgh Medical Center, Pittsburgh, PA. 11. Clinical and Translational Science Institute, University of Pittsburgh, Pittsburgh, PA.
Abstract
BACKGROUND: A wearable artificial lung could improve lung transplantation outcomes by easing implementation of physical rehabilitation during long-term pretransplant respiratory support. The Modular Extracorporeal Lung Assist System (ModELAS) is a compact pumping artificial lung currently under development. This study evaluated the long-term in vivo performance of the ModELAS during venovenous support in awake sheep. Feedback from early trials and computational fluid dynamic analysis guided device design optimization along the way. METHODS: The ModELAS was connected to healthy sheep via a dual-lumen cannula in the jugular vein. Sheep were housed in a fixed-tether pen while wearing the device in a holster during support. Targeted blood flow rate and support duration were 2-2.5 L/min and 28-30 days, respectively. Anticoagulation was maintained via systemic heparin. Device pumping and gas exchange performance and hematologic indicators of sheep physiology were measured throughout support. RESULTS: Computational fluid dynamic-guided design modifications successfully decreased pump thrombogenicity from initial designs. For the optimized design, 4 of 5 trials advancing past early perioperative and cannula-related complications lasted the full month of support. Blood flow rate and CO2 removal in these trials were 2.1 ± 0.3 L/min and 139 ± 15 mL/min, respectively, and were stable during support. One trial ended after 22 days of support due to intradevice thrombosis. Support was well tolerated by the sheep with no signs of hemolysis or device-related organ impairment. CONCLUSIONS: These results demonstrate the ability of the ModELAS to provide safe month-long support without consistent deterioration of pumping or gas exchange capabilities.
BACKGROUND: A wearable artificial lung could improve lung transplantation outcomes by easing implementation of physical rehabilitation during long-term pretransplant respiratory support. The Modular Extracorporeal Lung Assist System (ModELAS) is a compact pumping artificial lung currently under development. This study evaluated the long-term in vivo performance of the ModELAS during venovenous support in awake sheep. Feedback from early trials and computational fluid dynamic analysis guided device design optimization along the way. METHODS: The ModELAS was connected to healthy sheep via a dual-lumen cannula in the jugular vein. Sheep were housed in a fixed-tether pen while wearing the device in a holster during support. Targeted blood flow rate and support duration were 2-2.5 L/min and 28-30 days, respectively. Anticoagulation was maintained via systemic heparin. Device pumping and gas exchange performance and hematologic indicators of sheep physiology were measured throughout support. RESULTS: Computational fluid dynamic-guided design modifications successfully decreased pump thrombogenicity from initial designs. For the optimized design, 4 of 5 trials advancing past early perioperative and cannula-related complications lasted the full month of support. Blood flow rate and CO2 removal in these trials were 2.1 ± 0.3 L/min and 139 ± 15 mL/min, respectively, and were stable during support. One trial ended after 22 days of support due to intradevice thrombosis. Support was well tolerated by the sheep with no signs of hemolysis or device-related organ impairment. CONCLUSIONS: These results demonstrate the ability of the ModELAS to provide safe month-long support without consistent deterioration of pumping or gas exchange capabilities.
Authors: David J Skoog; Joshua R Pohlmann; David S Demos; Christopher N Scipione; Amit Iyengar; Rebecca E Schewe; Ahmed B Suhaib; Kelly L Koch; Keith E Cook Journal: ASAIO J Date: 2017 Sep/Oct Impact factor: 2.872
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Authors: Shalv P Madhani; Brian J Frankowski; Greg W Burgreen; Jim F Antaki; Robert Kormos; Jonathan D'Cunha; William J Federspiel Journal: J Heart Lung Transplant Date: 2017-03-04 Impact factor: 10.247
Authors: Shalv P Madhani; Brian J Frankowski; Sang-Ho Ye; Greg W Burgreen; William R Wagner; Robert Kormos; Jonathan D'Cunha; William J Federspiel Journal: ASAIO J Date: 2019-01 Impact factor: 2.872
Authors: Alexandra G May; R Garrett Jeffries; Brian J Frankowski; Greg W Burgreen; William J Federspiel Journal: Intensive Care Med Exp Date: 2018-09-24