Session 4: pulsatile implantable devices
The totally implantable Novacor Left Ventricular Assist System

Presented at the Fifth International Conference on Circulatory Support Devices for Severe Cardiac Failure, New York, NY, Sept 15–17, 2000.
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Abstract

The Novacor Left Ventricular Assist System (LVAS) (Novacor Corp, Oakland, CA) was initially console-based and has been available since 1993 in a wearable configuration. It has been successfully used for the past 16 years as a bridge to cardiac transplantation in patients with end-stage congestive heart failure. The Stanford experience represents 53 patients (48 male, 5 female) with a mean age of 44 ± 13 years (16 to 62) and a mean support time of 56 ± 76 days (1 to 374). Complications with LVAS use consisted predominantly of bleeding (43%), infection, (30%), and embolic cerebrovascular events (24.5%). Sixty-six percent of the supported patients were successfully bridged to cardiac transplantation. In animal studies, 4 sheep had the totally implantable configuration in place for a cumulative duration of 1 year with 1 animal supported for 260 days. The next generation Novacor LVAS will be small, quiet, and fully implantable without the need for volume compensation. It will also provide physiologic pulsatile flow and will be fail-safe.

Section snippets

Stanford clinical experience

The records of patients supported with the Novacor LVAS at Stanford University Medical Center from September 5, 1984 until September 10, 2000 were reviewed. The inflow conduits and outflow grafts that connect the pump between the left ventricular apex and ascending aorta were made of low porosity, woven polyester (Cooley, Meadox Medical, Oakland, NJ) from 1984 through 1997. Since 1998, a gelatin-sealed, knitted polyester graft with integral wall reinforcement, manufactured by Vascutek (Sulzer

Totally implantable LVAS preclinical animal studies

The totally implantable configuration of the Novacor LVAS was placed in 4 sheep. All animals received humane care in compliance with the “Guide for the Care and Use of Laboratory Animals” published by the National Institutes of Health (NIH Publication No. 85–23, revised 1985). The system consisted of a pump/drive unit, volume compensator, belt skin transformer, and controller/battery. The system was placed through a posterior-lateral thoracotomy with the inflow conduit inserted into the left

The Novacor II

Information on the Novacor II LVAS was obtained from World Heart Inc (Oakland, CA, US base of World Heart Corporation, Ottawa, Canada). The Novacor II LVAS concept represents an attractive approach for a totally implantable, definitive treatment of end-stage congestive heart failure. It has a dual-chambered pump (four total valves) and a shared pusher plate (Fig 2). The pusher plate is suspended and driven directly by a magnetic drive obviating the need for bearings, cams, or linkages. The

Comment

The objective of the initial design of the Novacor LVAS was to develop a totally implantable system to provide definitive therapy for end-stage congestive heart failure. The electrically powered, pulsatile Novacor LVAS has provided reliable, efficacious support as a bridge to transplantation. Worldwide, more than 1,170 patients have received the Novacor LVAS, 84 of whom have been supported for more than 1 year, with the longest duration of support being 4.1 years. Confirming reliability

References (3)

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Drs Oyer and Portner are consultants to World Heart Inc, manufacturer of the Novacor assist system.

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