In vitro and in vivo testing of a totally implantable left ventricular assist system. 1988

J S Jassawalla, and M A Daniel, and H Chen, and J Lee, and D LaForge, and J Billich, and N Ramasamy, and P J Miller, and P E Oyer, and P M Portner
Novacor Division, Baxter Healthcare Corporation, Oakland, California 94621.

The totally implantable Novacor LVAS is being tested under NIH auspices to demonstrate safety and efficacy before clinical trials. Twelve complete systems (submerged in saline at 37 degrees C) are being tested, with an NIH goal of demonstrating 80% reliability for 2 year operation with a 60% confidence level. The systems, which are continuously monitored, are diurnally cycled between two output levels by automatically varying preload and afterload. Currently, 14.3 years of failure-free operation have been accumulated, with a mean duration of 14 months. Using an exponential failure distribution model, the mean time to failure (MTTF) is greater than 8.8 years, corresponding to a demonstrated reliability (for a 2 year mission time) of 80% (80% confidence level). Recent ovine experiments with VAS subsystems include a 767 day volume compensator implant, a 279 day pump/drive unit implant and a 1,448 day BST implant. The last 12 chronic pump/drive unit experiments had a mean duration of 153 days (excluding early postoperative complications). This compares favorably with the NIH goals for complete systems (5 month mean duration). Complete system experiments are currently underway.

UI MeSH Term Description Entries
D008991 Monitoring, Physiologic The continuous measurement of physiological processes, blood pressure, heart rate, renal output, reflexes, respiration, etc., in a patient or experimental animal; includes pharmacologic monitoring, the measurement of administered drugs or their metabolites in the blood, tissues, or urine. Patient Monitoring,Monitoring, Physiological,Physiologic Monitoring,Monitoring, Patient,Physiological Monitoring
D004867 Equipment Design Methods and patterns of fabricating machines and related hardware. Design, Equipment,Device Design,Medical Device Design,Design, Medical Device,Designs, Medical Device,Device Design, Medical,Device Designs, Medical,Medical Device Designs,Design, Device,Designs, Device,Designs, Equipment,Device Designs,Equipment Designs
D004868 Equipment Failure Failure of equipment to perform to standard. The failure may be due to defects or improper use. Defects, Equipment,Device Failure,Failure, Equipment,Malfunction, Equipment,Medical Device Failure,Misuse, Equipment,Device Failure, Medical,Device Failures, Medical,Failure, Medical Device,Failures, Medical Device,Defect, Equipment,Device Failures,Equipment Defect,Equipment Defects,Equipment Failures,Equipment Malfunction,Equipment Malfunctions,Equipment Misuse,Equipment Misuses,Failure, Device,Failures, Device,Failures, Equipment,Malfunctions, Equipment,Misuses, Equipment
D005069 Evaluation Studies as Topic Works about studies that determine the effectiveness or value of processes, personnel, and equipment, or the material on conducting such studies. Critique,Evaluation Indexes,Evaluation Methodology,Evaluation Report,Evaluation Research,Methodology, Evaluation,Pre-Post Tests,Qualitative Evaluation,Quantitative Evaluation,Theoretical Effectiveness,Use-Effectiveness,Critiques,Effectiveness, Theoretical,Evaluation Methodologies,Evaluation Reports,Evaluation, Qualitative,Evaluation, Quantitative,Evaluations, Qualitative,Evaluations, Quantitative,Indexes, Evaluation,Methodologies, Evaluation,Pre Post Tests,Pre-Post Test,Qualitative Evaluations,Quantitative Evaluations,Report, Evaluation,Reports, Evaluation,Research, Evaluation,Test, Pre-Post,Tests, Pre-Post,Use Effectiveness
D006353 Heart-Assist Devices Small pumps, often implantable, designed for temporarily assisting the heart, usually the LEFT VENTRICLE, to pump blood. They consist of a pumping chamber and a power source, which may be partially or totally external to the body and activated by electromagnetic motors. Artificial Ventricle,Heart Assist Device,Heart Ventricle, Artificial,Pumps, Heart-Assist,Vascular-Assist Device,Vascular-Assist Devices,Ventricle-Assist Device,Ventricular Assist Device,Artificial Heart Ventricle,Artificial Heart Ventricles,Artificial Ventricles,Assist Device, Heart,Assist Device, Ventricular,Assist Devices, Heart,Assist Devices, Ventricular,Device, Heart Assist,Device, Heart-Assist,Device, Vascular-Assist,Device, Ventricle-Assist,Device, Ventricular Assist,Devices, Heart Assist,Devices, Heart-Assist,Devices, Vascular-Assist,Devices, Ventricle-Assist,Devices, Ventricular Assist,Heart Assist Devices,Heart Ventricles, Artificial,Heart-Assist Device,Heart-Assist Pump,Heart-Assist Pumps,Pump, Heart-Assist,Pumps, Heart Assist,Vascular Assist Device,Vascular Assist Devices,Ventricle Assist Device,Ventricle, Artificial,Ventricle, Artificial Heart,Ventricle-Assist Devices,Ventricles, Artificial,Ventricles, Artificial Heart,Ventricular Assist Devices
D006439 Hemodynamics The movement and the forces involved in the movement of the blood through the CARDIOVASCULAR SYSTEM. Hemodynamic
D000818 Animals Unicellular or multicellular, heterotrophic organisms, that have sensation and the power of voluntary movement. Under the older five kingdom paradigm, Animalia was one of the kingdoms. Under the modern three domain model, Animalia represents one of the many groups in the domain EUKARYOTA. Animal,Metazoa,Animalia
D001243 Assisted Circulation Pumping that aids the natural activity of the heart. (Dorland, 27th ed) Circulation, Assisted
D012756 Sheep Any of the ruminant mammals with curved horns in the genus Ovis, family Bovidae. They possess lachrymal grooves and interdigital glands, which are absent in GOATS. Ovis,Sheep, Dall,Dall Sheep,Ovis dalli

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