Thorac Cardiovasc Surg 2004; 52(1): 1-5
DOI: 10.1055/s-2004-815796
Original Cardiovascular

© Georg Thieme Verlag Stuttgart · New York

Current Status on the Development of a Totally Implantable Biventricular Assist Device: The Baylor Gyro BVAD

J. Linneweber 1 , 2 , K. Nonaka 2 , S. Ichikawa 2 , H. Ishitoya 2 , T. Motomura 2 , Y. Nosé 2
  • 1Klinik für kardiovaskuläre Chirurgie, Universitätsklinikum Charité der Humboldt-Universität zu Berlin, Berlin, Germany
  • 2Michael E. DeBakey, Department of Surgery, Baylor College of Medicine, Houston, TX, USA
Further Information

Publication History

Received March 20, 2003

Publication Date:
04 March 2004 (online)

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Abstract

Objective: The Baylor Gyro BVAD® is under development with the final goal of establishing a totally implantable biventricular assist system (BVAD). The aim of this study was to evaluate the safety, reliability, and effectiveness of the device in a long-term in vivo model. Methods: The BVAD was implanted into eight calves for longer than 4 weeks in a biventricular bypass fashion, with the native heart remaining. Pump performance was assessed with the system's digital data acquisition unit. Postoperatively, anticoagulation was maintained with i.v. heparin perfusion (ACT≤ 250 sec) gradually replaced by coumadin. Treadmill exercise tests were performed daily following a 10-day reconvalescence period after surgery. Results: The animals were kept alive for 37 - 90 days. The pumps yielded average flows of 5.3 ± 1.1 l/min and 4.9 ± 0.7 l/min for the LVAD and RVAD, respectively. Power consumption was 8.2 ± 2.7 W and 9.6 ± 4.7 W at 1935 ± 123 rpm and 2015 ± 365 rpm, respectively. All cases exhibited low hemolysis; renal and liver function were kept normal throughout the experiments. The animals demonstrated no thromboembolic neurological symptoms and tolerated moderate treadmill exercise. Conclusion: The Baylor Gyro BVAD demonstrated effective and reliable in vivo performance with acceptable biocompatibility. Based on these studies, we conclude that the system will be suitable as a long-term totally implantable BVAD for uses intended for longer than two years.