title: Initial clinical experience with a wearable controller for the Novacor left ventricular assist system.
abstract: 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.
authors.affiliation: Novacor Division, Baxter Healthcare Corporation, Oakland, CA 94621, USA.
authors.forename: P J
authors.initials: PJ
authors.lastname: Miller
authors.forename: T J
authors.initials: TJ
authors.lastname: Billich
authors.forename: D H
authors.initials: DH
authors.lastname: LaForge
authors.forename: J
authors.initials: J
authors.lastname: Lee
authors.forename: A
authors.initials: A
authors.lastname: Naegeli
authors.forename: N
authors.initials: N
authors.lastname: Ramasamy
authors.forename: J S
authors.initials: JS
authors.lastname: Jassawalla
authors.forename: P M
authors.initials: PM
authors.lastname: Portner
mesh_terms: D000328:Adult; D000368:Aged; D000553:Ambulatory Care; D001698:Biomedical Engineering; D004582:Electronics, Medical; D005260:Female; D006331:Heart Diseases / Q000534:rehabilitation / Q000601:surgery / Q000628:therapy; D016027:Heart Transplantation; D006353:Heart-Assist Devices / Q000009:adverse effects; D006439:Hemodynamics; D006801:Humans; D008297:Male; D008875:Middle Aged; D015996:Survival Rate; D013997:Time Factors