Downsizing of a Pulsatile Total Artificial Heart-The Effect on Hemolysis.
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:
01 01 2022
01 01 2022
Historique:
pubmed:
27
3
2021
medline:
2
2
2022
entrez:
26
3
2021
Statut:
ppublish
Résumé
A downsized version of the ReinHeart total artificial heart (TAH) was developed. Hemocompatibility needs to be revised since the operating point of the downsized TAH has changed to a higher pump frequency to accomplish the same cardiac output. A mock circulation loop was designed, containing a left side for hemocompatibility testing and a right side to mimic realistic work conditions. A protocol for hemolysis testing was established using pooled porcine blood with an operation point of 5 L/min, a mean outlet pressure of 100 mm Hg and a mean inlet pressure of 12 mm Hg. Six trials were performed testing two downsized TAH (one with a compliance chamber [CC] connected, necessary for a pneumatic decoupling of both membranes and one open to atmosphere) and a BPX-80 as reference pump. The average modified index of hemolysis and normalized index of hemolysis (NIH in mg/100L) from six individual trials of the reference pump were 0.34 (0.07) and 3.21 (0.61) and of the TAH open to atmosphere 4.18 (1.19) and 38.85 (10.59), respectively. In between TAH with and without CC, there was no significant difference. A NIH ratio of TAH and reference pump was calculated to minimize variation of the different blood batches used in individual trials. Due to the downsizing, the ReinHeart's hemolysis level increased by around 22% compared with the original size version. Comparing the results to clinically approved left ventricular assist devices, the level of hemolysis can still be considered acceptable.
Identifiants
pubmed: 33769348
doi: 10.1097/MAT.0000000000001415
pii: 00002480-202201000-00007
doi:
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
34-40Informations de copyright
Copyright © ASAIO 2021.
Déclaration de conflit d'intérêts
H.D. and M.L. are employees at ReinHeart TAH GmbH. The other authors have no conflicts of interest to report.
Références
Kirklin JK, Pagani FD, Kormos RL, et al.: Eighth annual INTERMACS report: Special focus on framing the impact of adverse events. J Heart Lung Transplant. 36: 1080–1086, 2017.
Spiliopoulos S, Hergesell V, Wasler A, Dapunt O: Current state of total artificial heart therapy and introduction of the most important total artificial heart systems. Biomed Tech (Berl). 64: 247–250, 2019.
Pelletier B, Spiliopoulos S, Finocchiaro T, et al.: System overview of the fully implantable destination therapy–ReinHeart-total artificial heart. Eur J Cardiothorac Surg. 47: 80–86, 2015.
Finocchiaro T, Butschen T, Kwant P, et al.: New linear motor concepts for artificial hearts. IEEE Trans Magn. 44: 678–681, 2008.
Gräf F, Finocchiaro T, Laumen M, Mager I, Steinseifer U: Mock circulation loop to investigate hemolysis in a pulsatile total artificial heart. Artif Organs. 39: 416–422, 2015.
Schmitz S, Unthan K, Sedlaczek M, et al.: Prototype development of an implantable compliance chamber for a total artificial heart. Artif Organs. 41: 122–129, 2017.
Unthan K, Gräf F, Laumen M, et al.: Design and evaluation of a fully implantable control unit for blood pumps. Biomed Res Int. 2015: 257848, 2015.
Gräf F, Rossbroich R, Finocchiaro T, Steinseifer U: Investigation of the durability of a diaphragm for a total artificial heart. Artif Organs. 40: 1016–1022, 2016.
Ducko CT, McGregor ML, Rosenberg G, Pierce WS: The effect of valve type and drive line dP/dt on hemolysis in the pneumatic ventricular assist device. Artif Organs. 18: 454–460, 1994.
Finocchiaro T. Investigation of a Linear Drive Concept for a Fully Implantable Total Artificial Heart. Aachen: Shaker Verlag, 2013.
Fritschi AJ, Laumen M, Spiliopoulos S, et al.: Image based evaluation of mediastinal constraints for the development of a pulsatile total artificial heart. Biomed Eng Online. 12: 81, 2013.
Gross-Hardt S, Hesselmann F, Arens J, et al.: Low-flow assessment of current ECMO/ECCO2R rotary blood pumps and the potential effect on hemocompatibility. Crit Care. 23: 348, 2019.
Kosaka R, Maruyama O, Nishida M, et al.: Improvement of hemocompatibility in centrifugal blood pump with hydrodynamic bearings and semi-open impeller: In vitro evaluation. Artif Organs. 33:798–804, 2009.
Nosé Y: Design and development strategy for the rotary blood pump. Artif Organs. 22:438–446, 1998.
Abe Y, Ishii K, Isoyama T, et al.: The helical flow pump with a hydrodynamic levitation impeller. J Artif Organs. 15: 331–340, 2012.
Mueller MR, Schima H, Engelhardt H, et al.: In vitro hematological testing of rotary blood pumps: Remarks on standardization and data interpretation. Artif Organs. 17: 103–110, 1993.
Bourque K, Cotter C, Dague C, et al.: Design rationale and preclinical evaluation of the HeartMate 3 left ventricular assist system for hemocompatibility. ASAIO J. 62: 375–383, 2016.
Ding J, Niu S, Chen Z, Zhang T, Griffith BP, Wu ZJ: Shear-induced hemolysis: Species differences. Artif Organs. 39: 795–802, 2015.