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ASAIO CARDIAC ABSTRACT

FIRST CLINICAL EXPERIENCE WITH THE PORTABLE BERLINHEART EXCOR DRIVER FOR THE CARDIOWEST TAH

EI-Banayosy, A1; Arusoglu, L1; Kizner, L1; Morshuis, M1; Radatz, C1; Cobaugh, D1; Koerfer, R1

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Purpose: The CardioWest Total Artificial Heart (CW-TAH) is a well approved TAH system as bridge-to-transplantation. Its driving console is bulky, limits the ambulatory management of patients (pts) and forbids their discharge. After modifying the Berlin Heart Excor driver and achieving successful laboratory and animal trials, we conducted a first clinical trial for the combination of the Excor Berlin Heart driver with the CW-TAH. Methods: Clinical study on pts requiring the CW-TAH. Study duration was set to a minimum of 3600 patient hours on at least 8 pts. Hemodynamic and laboratory data (including pump rate, flow, total bilirubin, LDH, urea, creatinine, pl. free hemoglobin) were collected and compared for the original driver and the Excor driver. Results: Up to 1/2004 5 male pts, aged 38–74 years(mean 54.5 years) were included. No adverse events occurred. Total driving time so far is 3600 hours in 5 pts. 2 of the pts were discharged home with the CW-TAH and the Excor driver. No technical problems occurred; pump output and rate were always satisfactory. Comparison of hemodynamic and laboratory data from the original and the Excor driver revealed no significant difference except for a decrease in LDH levels with the Excor driver. After 14 days mean LDH settled at 694 U/I compared to 877 U/L with the original driver. Our results show the safety and efficacy of the Berlin Heart Excor driver as driving tool for the CW-TAH. This new combination allows ambulatory treatment and increases quality of life. It might potentially lead to a wider use of the CW-TAH.

Copyright © 2004 by the American Society for Artificial Internal Organs