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

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

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 co...

Full description

Saved in:
Bibliographic Details
Published in:Artificial organs Vol. 47; no. 7; pp. 1208 - 1213
Main Authors: Perkins, Ina Laura, Mansisidor, Eva Maria, Zaman, Shaikh Faisal, Mudge, Kyle, Bodger, Owen, Najar, Azad
Format: Journal Article
Language:English
Published: United States Wiley Subscription Services, Inc 01-07-2023
Subjects:
Animals
Blood
BPX‐80
Congestive heart failure
Continuous flow
Heart Failure
Heart, Artificial
Heart-Assist Devices - adverse effects
Hemolysis
Humans
porcine
Prototypes
Pulsatile Flow
Pumps
Realheart
Swine
total artificial heart
Aachen Germany
Germany
porcine
Realheart
BPX-80
hemolysis
total artificial heart
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary: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. Hemolysis testing is regulatory requirement but the ASTM standard was developed for continuous flow blood pumps. The Aachen rig was developed for pulsatile pumps. The objective was to test hemolytic performance of the Realheart TAH compared to published results of the Reinheart TAH, using this rig with BPX‐80 as control.
Bibliography:ObjectType-Article-1
SourceType-Scholarly Journals-1
ObjectType-Feature-2
content type line 23
ISSN:0160-564X
1525-1594
DOI:10.1111/aor.14533