Development of totally implantable BVAD (AnyVAD) in Korea -An experimental study-

초록

PURPOSE OF THE STUDY: Of the several alternatives to cardiac transplantation, a totally implantable bi-ventricular assist device (BVAD) promises a certain role by preserving the native heart. The Korean BVAD (AnyVAD) is a single piece electro-mechanically driven pulsatile pump which contains polymer valves and a moving actuator compressing two blood sacs alternately. It also possesses multiuse potential as a ventless LVAD or a miniaturized portable ECLS. During the past two years, we have implanted the device in animals to observe electro-mechanical stability and a hemodynamic performance. METHODS USED: Since November, 1999, AnyVAD has been implanted in a total of twenty animals (BVAD in 18 and LVAD in 2): The animals were 11 calves, 4 sheep, 3 canines, 1 goat, and 1 horse. A median sternotomy approach was used in & animals and a right thoracotomy in the remaining 12. The usual inflow cannulations were made at the both atrium, and the outflow grafting at the main pulmonary artery and the aorta. Most of the pump pockets were constructed at the right flank or the epigastrium. Early postoperative anticoagulation was started with intravenous heparin infusion and switched to oral coumadin and ticlopidine. RESULTS OBTAINED: The maximal pump flow was 4.5 L/min with an average of 2.5 L/min. The longest observation period was 30 days in a calf, which was intentionally terminated to get a control data. The postoperative laboratory findings including plasma hemoglobin, liver function, kidney function, and fibrinogen were comparative to the baseline values. There has been no clinical episode of thromboembolism and the postmortem examination showed no gross thrombus in the device but stable organized clots at the connecting ports. CONCLUSIONS TEACHED: A totally Implantable Korean BVAD (AnyVAD) is electro-mechanically stable and hemodynamically excellent. We believe it is apt for a human clinical trial within near future.

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