Why the study?
The Carmat total artificial heart was developed to minimize drawbacks of mechanical assist devices, but the safety of its pivotal hybrid membrane required comprehensive evaluation.
Is the Carmat Total Artificial Heart hybrid membrane safe and hemocompatible in preclinical models and early clinical feasibility?
Population
Preclinical bench, rat models, computational models, and 4 patients implanted with C-TAH
Comparison
Formaldehyde-Ethanol-Tween 80 anti-calcification pretreatment vs untreated material in rats, and simulated/in vivo conditions
Design
Preclinical bench, animal, and computational study combined with a clinical feasibility study
Authors
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May support Carmat membrane hemocompatibility; hypothesis-generating and requires prospective human validation.
Is the Carmat Total Artificial Heart hybrid membrane safe and hemocompatible in preclinical models and early clinical feasibility?
Preclinical and early clinical data suggest the Carmat Total Artificial Heart hybrid membrane is safe, durable, and hemocompatible without significant risks of calcification or hemolysis.
Richez et al. (2019) studied this question.
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