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In vivo biocompatibility evaluation of a new resilient, hard-carbon, thin-film coating for ventricular assist devices.
Artif Organs. 2010 Dec; 34(12):1158-63.AO

Abstract

The purpose of this study was to evaluate in vivo the biocompatibility of BioMedFlex (BMF), a new resilient, hard-carbon, thin-film coating, as a blood journal bearing material in Cleveland Heart's (Charlotte, NC, USA) continuous-flow right and left ventricular assist devices (RVADs and LVADs). BMF was applied to RVAD rotating assemblies or both rotating and stator assemblies in three chronic bovine studies. In one case, an LVAD with a BMF-coated stator was also implanted. Cases 1 and 3 were electively terminated at 18 and 29 days, respectively, with average measured pump flows of 4.9 L/min (RVAD) in Case 1 and 5.7 L/min (RVAD) plus 5.7 L/min (LVAD) in Case 3. Case 2 was terminated prematurely after 9 days because of sepsis. The sepsis, combined with running the pump at minimum speed (2000 rpm), presented a worst-case biocompatibility challenge. Postexplant evaluation of the blood-contacting journal bearing surfaces showed no biologic deposition in any of the four pumps. Thrombus inside the RVAD inlet cannula in Case 3 is believed to be the origin of a nonadherent thrombus wrapped around one of the primary impeller blades. In conclusion, we demonstrated that BMF coatings can provide good biocompatibility in the journal bearing for ventricular assist devices.

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Authors+Show Affiliations

Takaseya T
Department of Biomedical Engineering, Lerner Research Institute, Cleveland Clinic, OH 44195, USA.
Fumoto H
No affiliation info available
Shiose A
No affiliation info available
Arakawa Y
No affiliation info available
Rao S
No affiliation info available
Horvath DJ
No affiliation info available
Massiello AL
No affiliation info available
Mielke N
No affiliation info available
Chen JF
No affiliation info available
Zhou Q
No affiliation info available
Dessoffy R
No affiliation info available
Kramer L
No affiliation info available
Benefit S
No affiliation info available
Golding LA
No affiliation info available
Fukamachi K
No affiliation info available

MeSH

AnimalsCarbonCattleCoated Materials, BiocompatibleHeart-Assist DevicesHemodynamicsMaterials TestingPlatelet AggregationProsthesis Implantation

Pub Type(s)

Journal Article
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

20545668

Citation

Takaseya, Tohru, et al. "In Vivo Biocompatibility Evaluation of a New Resilient, Hard-carbon, Thin-film Coating for Ventricular Assist Devices." Artificial Organs, vol. 34, no. 12, 2010, pp. 1158-63.
Takaseya T, Fumoto H, Shiose A, et al. In vivo biocompatibility evaluation of a new resilient, hard-carbon, thin-film coating for ventricular assist devices. Artif Organs. 2010;34(12):1158-63.
Takaseya, T., Fumoto, H., Shiose, A., Arakawa, Y., Rao, S., Horvath, D. J., Massiello, A. L., Mielke, N., Chen, J. F., Zhou, Q., Dessoffy, R., Kramer, L., Benefit, S., Golding, L. A., & Fukamachi, K. (2010). In vivo biocompatibility evaluation of a new resilient, hard-carbon, thin-film coating for ventricular assist devices. Artificial Organs, 34(12), 1158-63. https://doi.org/10.1111/j.1525-1594.2009.00985.x
Takaseya T, et al. In Vivo Biocompatibility Evaluation of a New Resilient, Hard-carbon, Thin-film Coating for Ventricular Assist Devices. Artif Organs. 2010;34(12):1158-63. PubMed PMID: 20545668.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - In vivo biocompatibility evaluation of a new resilient, hard-carbon, thin-film coating for ventricular assist devices. AU - Takaseya,Tohru, AU - Fumoto,Hideyuki, AU - Shiose,Akira, AU - Arakawa,Yoko, AU - Rao,Santosh, AU - Horvath,David J, AU - Massiello,Alex L, AU - Mielke,Nicole, AU - Chen,Ji-Feng, AU - Zhou,Qun, AU - Dessoffy,Raymond, AU - Kramer,Larry, AU - Benefit,Stephen, AU - Golding,Leonard A R, AU - Fukamachi,Kiyotaka, PY - 2010/6/16/entrez PY - 2010/6/16/pubmed PY - 2011/4/6/medline SP - 1158 EP - 63 JF - Artificial organs JO - Artif Organs VL - 34 IS - 12 N2 - The purpose of this study was to evaluate in vivo the biocompatibility of BioMedFlex (BMF), a new resilient, hard-carbon, thin-film coating, as a blood journal bearing material in Cleveland Heart's (Charlotte, NC, USA) continuous-flow right and left ventricular assist devices (RVADs and LVADs). BMF was applied to RVAD rotating assemblies or both rotating and stator assemblies in three chronic bovine studies. In one case, an LVAD with a BMF-coated stator was also implanted. Cases 1 and 3 were electively terminated at 18 and 29 days, respectively, with average measured pump flows of 4.9 L/min (RVAD) in Case 1 and 5.7 L/min (RVAD) plus 5.7 L/min (LVAD) in Case 3. Case 2 was terminated prematurely after 9 days because of sepsis. The sepsis, combined with running the pump at minimum speed (2000 rpm), presented a worst-case biocompatibility challenge. Postexplant evaluation of the blood-contacting journal bearing surfaces showed no biologic deposition in any of the four pumps. Thrombus inside the RVAD inlet cannula in Case 3 is believed to be the origin of a nonadherent thrombus wrapped around one of the primary impeller blades. In conclusion, we demonstrated that BMF coatings can provide good biocompatibility in the journal bearing for ventricular assist devices. SN - 1525-1594 UR - https://www.unboundmedicine.com/medline/citation/20545668/In_vivo_biocompatibility_evaluation_of_a_new_resilient_hard_carbon_thin_film_coating_for_ventricular_assist_devices_ L2 - https://doi.org/10.1111/j.1525-1594.2009.00985.x DB - PRIME DP - Unbound Medicine ER -