The Carmat bioprosthetic total artificial heart is associated with early hemostatic recovery and no acquired Von Willebrand Syndrome in Calves.

David M. Smadja, PharmD, PhD1,Correspondence information about the author PharmD, PhD David M. Smadja, Sophie Susen, MD, PhD, Antoine Rauch, MD, PhD, Bernard Cholley, MD, PhD, Christian Latrémouille, MD , Daniel Duveau, MD, Luca Zilberstein, DMV, PhD, Denis Méléard, MD ‖, Marie-Fazia Boughenou, MD, Eric Van Belle, MD, PhD, Pascale Gaussem, PharmD, PhD. Antoine Capel, MSc, Piet Jansen, MD, Alain Carpentier, MD.

Objectives

To determine hemostasis perturbations, including von Willebrand factor (VWF) multimers, after implantation of a new bioprosthetic and pulsatile total artificial heart (TAH).

Design

Preclinical study

Setting

Single-center biosurgical research laboratory.

Participants

Female Charolais calves, 2-to-6 months old, weighing 102-to-122 kg.

Interventions

Surgical implantation of TAH through a mid-sternotomy approach.

Measurements and Main Results

Four of 12 calves had a support duration of several days (4, 4, 8, and 10 days), allowing for the exploration of early steps of hemostasis parameters, including prothrombin time; coagulation factor levels (II, V, VII+X, and fibrinogen); and platelet count. Multimeric analysis of VWF was performed to detect a potential loss of high-molecular weight (HMW) multimers, as previously described for continuous flow rotary blood pumps. Despite the absence of anticoagulant treatment administered in the postoperative phase, no signs of coagulation activation were detected. Indeed, after an immediate postsurgery decrease of prothrombin time, platelet count, and coagulation factor levels, most parameters returned to baseline values. HMW multimers of VWF remained stable either after initiation or during days of support.

Conclusions

Coagulation parameters and platelet count recovery in the postoperative phase of the Carmat TAH (Camat SA, Velizy Villacoublay Cedex, France) implantation in calves, in the absence of anticoagulant treatment and associated with the absence of decrease in HMW multimers of VWF, is in line with early hemocompatibility that is currently being validated in human clinical studies.

Key Words :
total artificial heart, transplantation, hemocompatibility, hemostasis, von Willebrand factor, cardiac surgery.

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