Preclinical performance of a pediatric mechanical circulatory support device: The PediaFlow ventricular assist device Salim E. Olia, BSE, Peter D. Wearden,

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Preclinical performance of a pediatric mechanical circulatory support device: The PediaFlow ventricular assist device Salim E. Olia, BSE, Peter D. Wearden, MD, PhD, Timothy M. Maul, PhD, CCP, Venkat Shankarraman, PhD, Ergin Kocyildirim, MD, Shaun T. Snyder, BS, Patrick M. Callahan, MD, Marina V. Kameneva, PhD, William R. Wagner, PhD, Harvey S. Borovetz, PhD, James F. Antaki, PhD The Journal of Thoracic and Cardiovascular Surgery Volume 156, Issue 4, Pages 1643-1651.e7 (October 2018) DOI: 10.1016/j.jtcvs.2018.04.062 Copyright © 2018 The American Association for Thoracic Surgery Terms and Conditions

Figure 1 Evolution and miniaturization of the PediaFlow from the PF1 to the PF4 pediatric VAD and pump topology (inset). PF1, First-generation PediaFlow; PF2, second-generation PediaFlow; PF3, third-generation PediaFlow; PF4, fourth-generation PediaFlow. The Journal of Thoracic and Cardiovascular Surgery 2018 156, 1643-1651.e7DOI: (10.1016/j.jtcvs.2018.04.062) Copyright © 2018 The American Association for Thoracic Surgery Terms and Conditions

Figure 2 The PF4 prototype and implantable components: A, The PF4 pump and size comparison (AA battery). B, The parabolic-tip inflow cannula with detachable sewing ring. C, The preassembled 6-mm outflow graft assembly. The Journal of Thoracic and Cardiovascular Surgery 2018 156, 1643-1651.e7DOI: (10.1016/j.jtcvs.2018.04.062) Copyright © 2018 The American Association for Thoracic Surgery Terms and Conditions

Figure 3 A, PF4 characteristic H-Q pump curves using a blood analog (viscosity = 2.39 centipoise). B, The calculated in vitro NIH values (mean ± standard deviation) for the PF4 prototypes compared with the PediMag (Thoratec, Pleasanton, Calif) control. PF3, Third-generation PediaFlow; PF4, fourth-generation PediaFlow; NIH, normalized index of hemolysis. The Journal of Thoracic and Cardiovascular Surgery 2018 156, 1643-1651.e7DOI: (10.1016/j.jtcvs.2018.04.062) Copyright © 2018 The American Association for Thoracic Surgery Terms and Conditions

Figure 4 Results of the PF4 ovine studies using the current-design cannulae system (PF4-S10, PF4-S11), in comparison with the previous third-generation chronic implant (PF3-S01) and the nonimplanted surgical control shams (n = 3, mean ± standard deviation): A, Measured pump flow rate (Q) for the implanted animals (gaps indicate durations of signal loss during postoperative acoustic recoupling of the outflow graft probe). Hematologic and hemocompatibility measurements including plasma-free hemoglobin (B), fibrinogen (C), activated clotting time (D), and platelet biocompatibility (E) as determined by the time course of platelet activation by P-selectin expression and platelet functionality by agonist stimulation using platelet activating factor. ACT, Activated clotting time; FB, fibrinogen; PAF, platelet activating factor; PF3, third-generation PediaFlow; PF4, fourth-generation PediaFlow; plfHb, plasma-free hemoglobin; POD, postoperative day. The Journal of Thoracic and Cardiovascular Surgery 2018 156, 1643-1651.e7DOI: (10.1016/j.jtcvs.2018.04.062) Copyright © 2018 The American Association for Thoracic Surgery Terms and Conditions

Figure 5 Necropsy images of the PF3-S01 (72-day) implant. A, Pump placement in situ. B, The modified 18F fenestrated inflow cannula (Medtronic DLP, Minneapolis, Minn) free of thrombus within the LV. C, Left kidney with a minor and well-healed cortical infarction. D, Right kidney with a minor surface infarction that was not visible on sagittal dissection. The pump rotor (E) and stator (F) free of deposition. The Journal of Thoracic and Cardiovascular Surgery 2018 156, 1643-1651.e7DOI: (10.1016/j.jtcvs.2018.04.062) Copyright © 2018 The American Association for Thoracic Surgery Terms and Conditions

Figure 6 Necropsy images of PF4-S11 (14-day) implant. A, The inflow cannula position in situ. B, Cannula body free of deposition. C, Adherent thrombus on the exterior of the outflow graft, outside of the blood flow path, possibly from the de-airing needle. D and E, Kidneys without evidence of infarcts. F-H, Rotor, impeller blading, and stator free of deposition. The Journal of Thoracic and Cardiovascular Surgery 2018 156, 1643-1651.e7DOI: (10.1016/j.jtcvs.2018.04.062) Copyright © 2018 The American Association for Thoracic Surgery Terms and Conditions

Figure 7 Explant photos of the PF4-S10 (60-day) implant. A, Well-encapsulated pump in situ. B, The inflow cannula tip position. C, The cannula body. Inflow (D) and outflow (E) connections free of deposition within the flow path. F, The pump rotor and stator (inset) free of deposits. G, Kidneys with no evidence of infarction. The Journal of Thoracic and Cardiovascular Surgery 2018 156, 1643-1651.e7DOI: (10.1016/j.jtcvs.2018.04.062) Copyright © 2018 The American Association for Thoracic Surgery Terms and Conditions

Figure E1 Flow rate estimation accuracy using the PediaFlow rotor position signal, motor current, and motor speed. Because of the fully magnetically levitated suspension, the rotor position signal used for the virtual zero power levitation control is analogous to the pressure drop across the pump and therefore provides an additional parameter (in addition to pump speed and motor current) to enhance flow rate estimation. The estimated flow rate for the 60-day PF4-S10 implant was within 6% of the actual flow rate as measured by the perivascular ultrasonic flow probe on the pump outflow tract. This feature will greatly simplify the instrumentation required for physiologic (hemodynamic) control of the PediaFlow system when used clinically. RP, Rotor position; MC, motor current; POD, postoperative day; MS, motor speed. The Journal of Thoracic and Cardiovascular Surgery 2018 156, 1643-1651.e7DOI: (10.1016/j.jtcvs.2018.04.062) Copyright © 2018 The American Association for Thoracic Surgery Terms and Conditions

Figure E2 The PF4 quick-connect attachment mechanism: The initial full-flange design was difficult to attach (A) and prone to misalignment in vivo (B). C, The revised design with a smaller flange size to ease insertion past the guidewires. The Journal of Thoracic and Cardiovascular Surgery 2018 156, 1643-1651.e7DOI: (10.1016/j.jtcvs.2018.04.062) Copyright © 2018 The American Association for Thoracic Surgery Terms and Conditions

Figure E3 Example images of the inflow kinking phenomenon experienced with the bevel-type inflow cannulae from PF4-S06 (left) and PF4-S09 (right). The Journal of Thoracic and Cardiovascular Surgery 2018 156, 1643-1651.e7DOI: (10.1016/j.jtcvs.2018.04.062) Copyright © 2018 The American Association for Thoracic Surgery Terms and Conditions

Figure E4 Plasma-free hemoglobin values for the initial in vivo PF4 implants. plfHb, Plasma-free hemoglobin; POD, postoperative day; PF4, fourth-generation PediaFlow. The Journal of Thoracic and Cardiovascular Surgery 2018 156, 1643-1651.e7DOI: (10.1016/j.jtcvs.2018.04.062) Copyright © 2018 The American Association for Thoracic Surgery Terms and Conditions

The PediaFlow pediatric VAD described in this article. The Journal of Thoracic and Cardiovascular Surgery 2018 156, 1643-1651.e7DOI: (10.1016/j.jtcvs.2018.04.062) Copyright © 2018 The American Association for Thoracic Surgery Terms and Conditions

Video 1 Challenges to providing chronic MCS safely in pediatric patients with heart failure and the design features of the PediaFlow pediatric VAD to address these limitations. Video available at: https://www.jtcvs.org/article/S0022-5223(18)31049-3/fulltext. The Journal of Thoracic and Cardiovascular Surgery 2018 156, 1643-1651.e7DOI: (10.1016/j.jtcvs.2018.04.062) Copyright © 2018 The American Association for Thoracic Surgery Terms and Conditions