Anatomical compatibility of a novel total artificial heart-An in-silico study.
computational fluid dynamics
hemocompatibility
mechanical circulatory support
total artificial heart
virtual implantation
Journal
Artificial organs
ISSN: 1525-1594
Titre abrégé: Artif Organs
Pays: United States
ID NLM: 7802778
Informations de publication
Date de publication:
03 Oct 2024
03 Oct 2024
Historique:
revised:
23
08
2024
received:
04
04
2024
accepted:
17
09
2024
medline:
3
10
2024
pubmed:
3
10
2024
entrez:
3
10
2024
Statut:
aheadofprint
Résumé
ShuttlePump is a novel total artificial heart (TAH) recently introduced to potentially overcome the limitations associated with the current state-of-the-art mechanical circulatory support devices intended for adults. In this study, we adapted the outflow cannulation of the previously established ShuttlePump TAH and evaluated the anatomical compatibility using the virtual implantation technique. We retrospectively assessed the anatomical compatibility of the ShuttlePump using virtual implantation techniques within 3D-reconstructed anatomies of adult heart failure patients. Additionally, we examined the impact of outflow cannula modification on the hemocompatibility of the ShuttlePump through computational fluid dynamic simulations. A successful virtual implantation in 9/11 patients was achieved. However, in 2 patients, pump interaction with the thoracic cage was observed and considered unsuccessful virtual implantation. A strong correlation (r <-0.78) observed between the measured anatomical parameters and the ShuttlePump volume exceeding pericardium highlights the importance of these measurements apart from body surface area. The numerical simulation revealed that the angled outflow cannulation resulted in a maximum pressure drop of 1.8 mmHg higher than that of the straight outflow cannulation. With comparable hemolysis index, the shear stress thresholds of angled outflow differ marginally (<5%) from the established pump model. Similar washout behavior between the pump models indicate that the curvature did not introduce stagnation zone. This study demonstrates the anatomic compatibility of the ShuttlePump in patients with biventricular failure, which was achieved by optimizing the outflow cannulation without compromising hemocompatibility. Nevertheless, clinical validation is critical to ensure the clinical applicability of these findings.
Sections du résumé
BACKGROUND
BACKGROUND
ShuttlePump is a novel total artificial heart (TAH) recently introduced to potentially overcome the limitations associated with the current state-of-the-art mechanical circulatory support devices intended for adults. In this study, we adapted the outflow cannulation of the previously established ShuttlePump TAH and evaluated the anatomical compatibility using the virtual implantation technique.
METHODS
METHODS
We retrospectively assessed the anatomical compatibility of the ShuttlePump using virtual implantation techniques within 3D-reconstructed anatomies of adult heart failure patients. Additionally, we examined the impact of outflow cannula modification on the hemocompatibility of the ShuttlePump through computational fluid dynamic simulations.
RESULTS
RESULTS
A successful virtual implantation in 9/11 patients was achieved. However, in 2 patients, pump interaction with the thoracic cage was observed and considered unsuccessful virtual implantation. A strong correlation (r <-0.78) observed between the measured anatomical parameters and the ShuttlePump volume exceeding pericardium highlights the importance of these measurements apart from body surface area. The numerical simulation revealed that the angled outflow cannulation resulted in a maximum pressure drop of 1.8 mmHg higher than that of the straight outflow cannulation. With comparable hemolysis index, the shear stress thresholds of angled outflow differ marginally (<5%) from the established pump model. Similar washout behavior between the pump models indicate that the curvature did not introduce stagnation zone.
CONCLUSION
CONCLUSIONS
This study demonstrates the anatomic compatibility of the ShuttlePump in patients with biventricular failure, which was achieved by optimizing the outflow cannulation without compromising hemocompatibility. Nevertheless, clinical validation is critical to ensure the clinical applicability of these findings.
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Subventions
Organisme : SPARK BIH
Informations de copyright
© 2024 The Author(s). Artificial Organs published by International Center for Artificial Organ and Transplantation (ICAOT) and Wiley Periodicals LLC.
Références
Shah P, Yuzefpolskaya M, Hickey GW, Breathett K, Wever‐Pinzon O, Ton VK, et al. THE SOCIETY OF THORACIC SURGEONS INTERMACS ANNUAL REPORT twelfth interagency registry for mechanically assisted circulatory support Report: readmissions after left ventricular assist device. Ann Thorac Surg. 2022;113:722–759. https://doi.org/10.1016/j.athoracsur
Kuroda T, Miyagi C, Fukamachi K, Karimov JH. Biventricular assist devices and total artificial heart: strategies and outcomes. Front Cardiovasc Med. 2023;9:972132. https://doi.org/10.3389/FCVM.2022.972132/BIBTEX
Farag J, Woldendorp K, McNamara N, Bannon PG, Marasco SF, Loforte A, et al. Contemporary outcomes of continuous‐flow biventricular assist devices. Ann Cardiothorac Surg. 2021;10(3):311–328. https://doi.org/10.21037/acs‐2021‐cfmcs‐34
Malas J, Chen Q, Akhmerov A, Tremblay LP, Egorova N, Krishnan A, et al. Experience with SynCardia Total artificial heart as a bridge to transplantation in 100 patients. Ann Thorac Surg. 115(3):725–732. https://doi.org/10.1016/j.athoracsur.2022.11.034
Vis A, Arfaee M, Khambati H, Slaughter MS, Gummert JF, Overvelde JTB, et al. The ongoing quest for the first total artificial heart as destination therapy. Nat Rev Cardiol. 2022;19(12):813–828. https://doi.org/10.1038/s41569‐022‐00723‐8
Bierewirtz T, Narayanaswamy K, Giuffrida R, Rese T, Bortis D, Zimpfer D, et al. A novel pumping principle for a Total artificial heart. IEEE Trans Biomed Eng. 2024;71:446–455. https://doi.org/10.1109/TBME.2023.3306888
Fritschi AJ, Laumen M, Spiliopoulos S, Finocchiaro T, Egger C, Schmitz‐Rode T, et al. Image based evaluation of mediastinal constraints for the development of a pulsatile total artificial heart. Biomed Eng Online. 2013;12(1):1–15. https://doi.org/10.1186/1475‐925X‐12‐81
Moore RA, Madueme PC, Lorts A, Morales DLS, Taylor MD. Virtual implantation evaluation of the total artificial heart and compatibility: beyond standard fit criteria. J Heart Lung Transplant. 2014;33(11):1180–1183. https://doi.org/10.1016/J.HEALUN.2014.08.010
Moore RA, Lorts A, Madueme PC, Taylor MD, Morales DLS. Virtual implantation of the 50cc SynCardia total artificial heart. J Heart Lung Transplant. 2016;35(6):824–827. https://doi.org/10.1016/J.HEALUN.2015.12.026
Karimov JH, Steffen RJ, Byram N, Sunagawa G, Horvath D, Cruz V, et al. Human fitting studies of Cleveland Clinic continuous‐flow Total artificial heart. ASAIO J. 2015;61(4):424–428. https://doi.org/10.1097/MAT.0000000000000219
Pieper IL, Sonntag SJ, Meyns B, Hadi H, Najar A. Evaluation of the novel total artificial heart Realheart in a pilot human fitting study. Artif Organs. 2020;44(2):174–177. https://doi.org/10.1111/AOR.13542
Fraser KH, Taskin ME, Griffith BP, Wu ZJ. The use of computational fluid dynamics in the development of ventricular assist devices. Med Eng Phys. 2011;33(3):263–280. https://doi.org/10.1016/J.MEDENGPHY.2010.10.014
Menter FR. Two‐equation eddy‐viscosity turbulence models for engineering applications. AIAA J. 1994;32(8):1598–1605. https://doi.org/10.2514/3.12149
Siemens StarCCM+ Documentation. Mesh quality. 2020. [cited 25 Jul 2024]. Available from: https://docs.sw.siemens.com/documentation/external/PL20200805113346338/en‐US/userManual/userguide/html/index.html#page/STARCCMP%2FGUID‐7237C585‐2707‐4FCC‐BB3F‐E2376C68B114.html%23%0Ahttps://docs.sw.siemens.com/documentation/external/PL20201109101148301/en
Westerhof N, Lankhaar JW, Westerhof BE. The arterial windkessel. Med Biol Eng Comput. 2009;47(2):131–141. https://doi.org/10.1007/S11517‐008‐0359‐2/TABLES/2
Granegger M, Gross C, Siemer D, Escher A, Sandner S, Schweiger M, et al. Comparison of device‐based therapy options for heart failure with preserved ejection fraction: a simulation study. Sci Rep. 2022;12(1):5761. https://doi.org/10.1038/s41598‐022‐09637‐4
Garon A, Farinas MI. Fast three‐dimensional numerical hemolysis approximation. Artif Organs. 2004;28(11):1016–1025. https://doi.org/10.1111/j.1525‐1594.2004.00026.x
Giersiepen M, Wurzinger LJ, Opitz R, Reul H. Estimation of shear stress‐related blood damage in heart valve prostheses ‐ in vitro comparison of 25 aortic valves. Int J Artif Organs. 1990;13(5):300–306. https://doi.org/10.1177/039139889001300507
Fraser KH, Zhang T, Taskin ME, Griffith BP, Wu ZJ. A quantitative comparison of mechanical blood damage parameters in rotary ventricular assist devices: shear stress, exposure time and hemolysis index. J Biomech Eng. 2012;134(8):081002. https://doi.org/10.1115/1.4007092
Thamsen B, Mevert R, Lommel M, Preikschat P, Gaebler J, Krabatsch T, et al. A two‐stage rotary blood pump design with potentially lower blood trauma: a computational study. Int J Artif Organs. 2016;39(4):178–183. https://doi.org/10.5301/ijao.5000482
HeartMate 3 Left Vebtricular Assist System Instructions for use. Document: 10006135.B. Abbott Labs. 2017. https://www.accessdata.fda.gov/cdrh_docs/pdf16/P160054C.pdf
Molina EJ, Cowger J, Lee S, Horstmanshof D, Cleveland JC Jr, Goldstein DJ, et al. Outcomes in smaller body size adults after HeartMate 3 left ventricular assist device implantation. Ann Thorac Surg. 2022;114(6):2262–2269. https://doi.org/10.1016/j.athoracsur.2022.03.071
Emmanuel S, Jansz P, McGiffin D, Kure C, Watson A, Connellan M, et al. Anatomical human fitting of the BiVACOR total artificial heart. Artif Organs. 2022;46(1):50–56. https://doi.org/10.1111/AOR.14077
Melton N, Soleimani B, Dowling R. Current role of the Total artificial heart in the Management of Advanced Heart Failure. Curr Cardiol Rep. 2019;21(11):1–7. https://doi.org/10.1007/S11886‐019‐1242‐5/FIGURES/2
Escher A, Gobel H, Nicolai M, Schloglhofer T, Hubmann EJ, Laufer G, et al. Hemolytic footprint of rotodynamic blood pumps. IEEE Trans Biomed Eng. 2022;69(8):2423–2432. https://doi.org/10.1109/TBME.2022.3146135