Long-term Circulatory Support - The Left Ventricular Assist System for Advanced Heart Failure

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Citation
US Cardiology 2004;2004:1(1):1-4

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Introduction

Nearly five million Americans suffer from heart failure, with 550,000 new cases diagnosed with this disease each year. Heart failure is responsible for 11 million office visits and over 3.5 million hospitalizations per year in the US, with a total bill of US$23 billion spent annually on treatment. About 250,000 people in the US suffer from severe, end-stage heart failure (NYHA Class IV). For this patient population, annual mortality on medical therapy approaches 50%, and heart transplantation is often the only treatment option. However, limited donor availability has resulted in only 2,400 transplants per year in the US, with about 4,000 patients populating the heart transplant waiting list at any given time. It is estimated that up to 50,000 patients per year in the US could benefit from heart transplantation if organs were available.

Implantable, wearable left ventricular assist devices (LVADs) have emerged in the past decade as safe and effective treatment measures, improving survival and quality of life, for patients with end-stage heart failure awaiting heart transplantation.1 The implantable LVAD, which includes pulsatile devices as well as axial flow pumps, allows the patient greater mobility compared with external pumps and longer-term support. The typical, implantable LVAD comprises three primary components: a pump,which receives blood through an inflow cannula and outputs blood through an outflow cannula; a drive console, which powers the pump and features system controls to adjust its operation; and a power source, which typically involves a combination option of direct electricity and a rechargeable battery pack. Despite the implantable feature of these devices, all current US Food and Drug Administration (FDA)-approved LVADs feature external power sources requiring percutaneous driveline connections. A number of fully implantable systems are under development that will eliminate the need for the percutaneous driveline connection in the future and feature implantable and external coils that transfer energy through the skin.

The Novacor® LVAS (WorldHeart Corporation) is an electrically powered, pulsatile flow LVAD with more than 20 years of clinical use, and the first ventricular assist device to provide more than four years of continuous circulatory support without pump replacement. To date, more than 1,500 patients have been supported with the Novacor LVAS, with almost 600 patient-years of experience, and no deaths attributable to device failure. Twenty-five patients have been supported close to, or over, three years on a single device with the Novacor LVAS. Furthermore, a heart failure patient in Italy has been supported for over six years with the Novacor device (elective replacement of the initial device after four years) before successfully receiving a heart transplant.

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References
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