In vitro hemolytic performance of the Realheart® V11C TAH prototype with porcine blood

Perkins, Ina Laura; Mansisidor, Eva Maria; Zaman, Shaikh Faisal; Mudge, Kyle; Bodger, Owen; Najar, Azad

doi:10.1111/aor.14533

Journal article 396 views

In vitro hemolytic performance of the Realheart® V11C TAH prototype with porcine blood

Ina Laura Perkins

, Eva Maria Mansisidor

, Shaikh Faisal Zaman

, Kyle Mudge

, Owen Bodger

, Azad Najar

Artificial Organs, Volume: 47, Issue: 7, Pages: 1208 - 1213

Swansea University Author: Owen Bodger

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DOI (Published version): 10.1111/aor.14533

Abstract

Background: Hemolysis testing of new devices to treat heart failure is a regulatory requirement. The ASTM F1841–97 standard for hemolysis testing was developed for continuous flow pumps and does not specify test rig design. When research groups use different methodologies, results are difficult to c...

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Published in:	Artificial Organs
ISSN:	0160-564X 1525-1594
Published:	Wiley 2023
Online Access:	Check full text
URI:	https://cronfa.swan.ac.uk/Record/cronfa63882
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first_indexed	2023-07-14T10:27:52Z
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spelling	v2 63882 2023-07-14 In vitro hemolytic performance of the Realheart® V11C TAH prototype with porcine blood 8096440ab42b60a86e6aba678fe2695a 0000-0002-4022-9964 Owen Bodger Owen Bodger true false 2023-07-14 HDAT Background: Hemolysis testing of new devices to treat heart failure is a regulatory requirement. The ASTM F1841–97 standard for hemolysis testing was developed for continuous flow pumps and does not specify test rig design. When research groups use different methodologies, results are difficult to compare. Pulsatile flow pump rigs require compliance chambers, and thus, the Aachen rig (Gräf et al) was developed for the pulsatile Reinheart TAH. The study objective was to use this rig to test the early Realheart TAH prototype V11C hemolysis performance compared to literature. Methods: The experimental control was the continuous flow pump BPX-80 (Medtronic) and pooled heparinized porcine blood was used. Results: The mgNIH of BPX-80 and V11C was 5.42 ± 1.47 and 25.20 ± 5.46 mg/100 L, respectively. The NIH ratio of V11C over BPX-80 was 5.5. Conclusion: The absolute and the relative hemolysis of the V11C are lower compared to both the large and small Reinheart TAH devices published values. Pulsatile pumps create more hemolysis in the Aachen rig, and it is not known if this is because how the rig handles pulsatile flow or due to the devices. Future studies will, therefore, use a pulsatile pump such as the SynCardia as clinical comparator and human blood to test the performance of future Realheart TAH prototypes. Journal Article Artificial Organs 47 7 1208 1213 Wiley 0160-564X 1525-1594 BPX-80; Realheart; hemolysis; porcine; total artificial heart. 28 7 2023 2023-07-28 10.1111/aor.14533 http://dx.doi.org/10.1111/aor.14533 COLLEGE NANME Health Data Science COLLEGE CODE HDAT Swansea University Scandinavian Real Heart AB. 2023-12-08T13:18:49.8806927 2023-07-14T11:19:14.0355736 Swansea University Medical School Medicine Ina Laura Perkins 0000-0003-2521-4171 1 Eva Maria Mansisidor 0000-0001-6337-0218 2 Shaikh Faisal Zaman 0000-0002-3144-3176 3 Kyle Mudge 0000-0001-7661-2589 4 Owen Bodger 0000-0002-4022-9964 5 Azad Najar 0000-0001-6677-8374 6
title	In vitro hemolytic performance of the Realheart® V11C TAH prototype with porcine blood
spellingShingle	In vitro hemolytic performance of the Realheart® V11C TAH prototype with porcine blood Owen Bodger
title_short	In vitro hemolytic performance of the Realheart® V11C TAH prototype with porcine blood
title_full	In vitro hemolytic performance of the Realheart® V11C TAH prototype with porcine blood
title_fullStr	In vitro hemolytic performance of the Realheart® V11C TAH prototype with porcine blood
title_full_unstemmed	In vitro hemolytic performance of the Realheart® V11C TAH prototype with porcine blood
title_sort	In vitro hemolytic performance of the Realheart® V11C TAH prototype with porcine blood
author_id_str_mv	8096440ab42b60a86e6aba678fe2695a
author_id_fullname_str_mv	8096440ab42b60a86e6aba678fe2695a_***_Owen Bodger
author	Owen Bodger
author2	Ina Laura Perkins Eva Maria Mansisidor Shaikh Faisal Zaman Kyle Mudge Owen Bodger Azad Najar
format	Journal article
container_title	Artificial Organs
container_volume	47
container_issue	7
container_start_page	1208
publishDate	2023
institution	Swansea University
issn	0160-564X 1525-1594
doi_str_mv	10.1111/aor.14533
publisher	Wiley
college_str	Swansea University Medical School
hierarchytype
hierarchy_top_id	swanseauniversitymedicalschool
hierarchy_top_title	Swansea University Medical School
hierarchy_parent_id	swanseauniversitymedicalschool
hierarchy_parent_title	Swansea University Medical School
department_str	Medicine{{{_:::_}}}Swansea University Medical School{{{_:::_}}}Medicine
url	http://dx.doi.org/10.1111/aor.14533
document_store_str	0
active_str	0
description	Background: Hemolysis testing of new devices to treat heart failure is a regulatory requirement. The ASTM F1841–97 standard for hemolysis testing was developed for continuous flow pumps and does not specify test rig design. When research groups use different methodologies, results are difficult to compare. Pulsatile flow pump rigs require compliance chambers, and thus, the Aachen rig (Gräf et al) was developed for the pulsatile Reinheart TAH. The study objective was to use this rig to test the early Realheart TAH prototype V11C hemolysis performance compared to literature. Methods: The experimental control was the continuous flow pump BPX-80 (Medtronic) and pooled heparinized porcine blood was used. Results: The mgNIH of BPX-80 and V11C was 5.42 ± 1.47 and 25.20 ± 5.46 mg/100 L, respectively. The NIH ratio of V11C over BPX-80 was 5.5. Conclusion: The absolute and the relative hemolysis of the V11C are lower compared to both the large and small Reinheart TAH devices published values. Pulsatile pumps create more hemolysis in the Aachen rig, and it is not known if this is because how the rig handles pulsatile flow or due to the devices. Future studies will, therefore, use a pulsatile pump such as the SynCardia as clinical comparator and human blood to test the performance of future Realheart TAH prototypes.
published_date	2023-07-28T13:18:50Z
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score	11.028798

In vitro hemolytic performance of the Realheart® V11C TAH prototype with porcine blood

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