Key result
Single-piece BiVAD via left thoracotomy maintains hemodynamics for 1 month in an ovine model.
Implantation of a novel 1-piece BiVAD via left thoracotomy is feasible and maintains stable hemodynamics in an ovine model, supporting further in vivo testing.
Warrants expanded preclinical testing before human trials; leaves open clinical translation of thoracotomy-implanted one-piece BiVAD.
In this report, we describe an operative procedure for our implantable 1 piece biventricular assist device (BiVAD) based on a moving actuator mechanism, using an ovine model. Our implantable BiVAD is a volumetric coupled 1 piece unit including right and left blood sacs and an actuator assembly based on the moving actuator mechanism. The BiVAD was controlled by fixed rate control with 75 bpm for the most part. Both the left and the right full ejection modes with the maximum stroke angle were selected to minimize blood stasis in the blood sacs because of low assist flow condition. Three Corriedale sheep were used for the device implantation by a left thoracotomy incision. Cannulation was successfully performed in all cases. Although exposability of the right atrial appendage varied from animal to animal, the insertion of the cannula was easily performed. The cannulas were connected to the pump-actuator assembly in the preperitoneal pocket. All 3 animals survived the experimental procedure. During implantation of the device, in the 1 month survival animal, pump flow was maintained between 2.0 L/min and 2.5 L/min, mean aortic pressure was 90-110 mm Hg, and mean pulmonary artery pressure was 20-30 mm Hg. The left and right atrial pressure were maintained between 0 and 5 mm Hg. In conclusion, this ovine model for implantation of the 1 piece BiVAD can be an effective alternative for testing in vivo biocompatibility of the device although it needs more consideration for anatomical fittability for future human application.
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Kim et al. (2000) studied this question. Implantation of 1-piece biventricular assist device (BiVAD) by left thoracotomy was evaluated on Procedural survival and hemodynamic maintenance. Implantation of a 1-piece biventricular assist device via left thoracotomy was successful in an ovine model, with all 3 animals surviving the procedure and one maintaining hemodynamics for 1 month.
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