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.
Key words
Biventricular assist device - centrifugal blood pump - continuous-flow blood pump - animal studies
References
-
1
Frazier O H, Benedict C R, Radovancevic B, Bick R J, Capek P, Springer W E, Macris M P, Delgado R, Buja L M.
Improved left ventricular function after chronic left ventricular unloading.
Ann Thorac Surg.
1996;
62
675-682
-
2
Pavie A, Leger P.
Physiology of univentricular versus biventricular support.
Ann Thorac Surg.
1996;
61
347-349
discussion 357-358
-
3
Frazier O H, Rose E A, Macmanus Q, Burton N A, Lefrak E A, Poirier V L, Dasse K A.
Multicenter clinical evaluation of the HeartMate 1000 IP left ventricular assist device.
Ann Thorac Surg.
1992;
53
1080-1090
-
4
Arabia F A, Smith R G, Copeland J G. et al .
Cost analysis of the Novacor left ventricular assist system as an outpatient bridge to heart transplantation.
ASAIO J.
1996;
42
M546-549
-
5
Yozu R, Golding L, Yada I, Harasaki H, Takatani S, Kawada S, Nose Y.
Do we really need pulse? Chronic nonpulsatile and pulsatile blood flow: from the exercise response viewpoints.
Artif Organs.
1994;
18
638-642
-
6
Shoor P M, Hammill F S, Griffith L D, Dilley R B, Bernstein E F.
Hemodynamic response to exercise in the unanesthetized calf with pulseless arterial flow.
Trans Am Soc Artif Intern Organs.
1980;
26
1-7
-
7
Ishitoya H, Kawamura M, Linneweber J, Motomura T, Ichikawa S, Nishimura I, Glueck J, Shinohara T, Nose Y.
Titania gel reduces thrombin generation.
Artif Organs.
2002;
26
959-963
M. D. PhD Jörg Linneweber
Klinik für kardiovaskuläre Chirurgie · Universitätsklinikum Charité der Humboldt-Universität zu Berlin
Schumannstraße 21
10111 Berlin
Germany
Phone: + 4930450522082
Fax: + 49 3 04 50 52 29 16
Email: joerg.linneweber@charite.de
