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Initial clinical experience with a wearable controller for the Novacor left ventricular assist system
P J Miller1, T J Billich, D H LaForge
1Novacor Division, Baxter Healthcare Corporation, Oakland, CA 94621, USA.
ASAIO Journal (American Society for Artificial Internal Organs : 1992)
|July 1, 1994
Summary
The wearable Novacor left ventricular assist system (LVAS) offers improved mobility and quality of life for heart transplant candidates. Survival rates to and after transplant were comparable to the earlier console system.
Area of Science:
- Cardiovascular Engineering
- Biomedical Devices
- Transplantation Medicine
Background:
- The Novacor left ventricular assist system (LVAS) has been utilized as a bridge to cardiac transplantation since 1984.
- Initial LVAS configurations relied on a console-based extracorporeal controller.
Purpose of the Study:
- To develop and evaluate a wearable control system for the Novacor LVAS.
- To enhance patient mobility, self-image, and quality of life for ambulatory patients.
Main Methods:
- A wearable, microprocessor-based compact controller was designed for portability and ease of use.
- The system featured rechargeable power packs with monitoring and alarm functions, supporting up to 7 hours of operation.
- Clinical evaluation involved 41 patients with end-stage heart disease, following protocols similar to the console system study.
Main Results:
- The wearable system supported 41 patients, with a mean duration of 51 days.
- Survival to transplant was 66%, similar to the console group (60%).
- Post-transplant survival was 100% for the wearable group, compared to 90% for the console group.
Conclusions:
- The wearable Novacor LVAS provides comparable survival rates to the console system.
- The system significantly enhances patient mobility, freedom, and quality of life.
- Patients demonstrated the ability to manage the device, including power pack operations, independently.