Initial clinical experience with a wearable controller for the Novacor left ventricular assist system. 1994

P J Miller, and T J Billich, and D H LaForge, and J Lee, and A Naegeli, and N Ramasamy, and J S Jassawalla, and P M Portner
Novacor Division, Baxter Healthcare Corporation, Oakland, CA 94621, USA.

The Novacor left ventricular assist system (LVAS), an implanted electromechanically driven blood pump, has been used in an ongoing clinical trial as a bridge to cardiac transplantation since 1984. The initial configuration included a console based extracorporeal controller. Because patients supported by the device usually become rehabilitated and highly mobile, a wearable control system was developed for the ambulatory patient. Ergonomically designed for portability, comfort, and appearance, it offers the recipient greater mobility, improved self-image, and an enhanced quality of life. This wearable control system consists of a microprocessor based compact controller that drives the implanted pump/drive unit in synchronous counterpulsation to the native heart. Main and reserve rechargeable power packs, each incorporating a "smart" monitoring circuit with charge-level display and alarm, are capable of supporting the pump for as long as 7 hr. An LVAS monitor can be connected to the controller for device monitoring and adjustment or as a power supply in lieu of the main power pack. Clinical evaluation in patients with end-stage heart disease followed the same protocol as the console study. By April 4, 1994, 41 patients had been supported by the wearable system, including 9 patients currently being supported. Mean duration of use was 51 days (range, 1.5-143+ days), compared with 42 days for 170 console patients (range, 0-370 days). Survival to transplant was 66%, which was similar to the survival (60%) for the patients using the console. Post-transplant survival was 100%, compared with 90% for console patients (not significantly different). After recovering from implant surgery and pre-implant morbidity, device recipients had considerable freedom and mobility and were able to move freely within and outside the hospital. Recipients could readily switch between monitored and untethered operation and could manage power pack replacement and recharging.

UI MeSH Term Description Entries
D008297 Male Males
D008875 Middle Aged An adult aged 45 - 64 years. Middle Age
D004582 Electronics, Medical The research and development of ELECTRICAL EQUIPMENT AND SUPPLIES for such medical applications as diagnosis, therapy, research, anesthesia control, cardiac control, and surgery. (From McGraw-Hill Dictionary of Scientific and Technical Terms, 6th ed) Medical Electronics
D005260 Female Females
D006331 Heart Diseases Pathological conditions involving the HEART including its structural and functional abnormalities. Cardiac Disorders,Heart Disorders,Cardiac Diseases,Cardiac Disease,Cardiac Disorder,Heart Disease,Heart Disorder
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
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000328 Adult A person having attained full growth or maturity. Adults are of 19 through 44 years of age. For a person between 19 and 24 years of age, YOUNG ADULT is available. Adults
D000368 Aged A person 65 years of age or older. For a person older than 79 years, AGED, 80 AND OVER is available. Elderly

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