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(Circulation. 2002;105:2855.)
© 2002 American Heart Association, Inc.

Clinical Investigation and Reports

Initial Clinical Experience With the Jarvik 2000 Implantable Axial-Flow Left Ventricular Assist System

O. H. Frazier, MD; Timothy J. Myers, BS; Igor D. Gregoric, MD; Tehreen Khan, MD; Reynolds Delgado, MD; Mihai Croitoru, MD; Kathy Miller, BS; Robert Jarvik, MD; Stephen Westaby, PhD, MS, FETCS

From the Cullen Cardiovascular Surgical Research Laboratories, Texas Heart Institute, Houston (O.H.F., T.J.M., I.D.G., K.M.); St Luke’s Episcopal Hospital, Houston, Tex (T.K., R.D., M.C.); Jarvik Heart Inc, New York, NY (R.J.); and Oxford Heart Centre, Oxford, United Kingdom (S.W.).

Reprint requests to Dr Frazier, Texas Heart Institute, PO Box 20345, MC 3-147, Houston, TX 77225-0345.

Background— Implantable left ventricular assist systems (LVASs) are used for bridging to transplantation, bridging to myocardial improvement, and for permanent circulatory support. Conventional implantable systems have inherent limitations that increase morbidity during support. In contrast, small, efficient, axial-flow pumps, which have been under development for the past decade, have the potential to improve the length and quality of life in patients with severe heart failure.

Methods and Results— To assess the safety and clinical utility of the Jarvik 2000, we implanted this device in 10 transplant candidates (mean age 51.3 years) in New York Heart Association (NYHA) class IV. Implantation was achieved through a left thoracotomy during partial cardiopulmonary bypass. The mean support period was 84 days. Within 48 hours postoperatively, the cardiac index increased 43%, pulmonary capillary wedge pressure decreased 52%, systemic vascular resistance decreased significantly, and inotropic support became unnecessary. Eight patients underwent physical rehabilitation and returned to NYHA class I. Their left ventricular dimensions, cardiothoracic ratios, and pressure-volume loop analyses showed good left ventricular unloading. Seven patients underwent transplantation and 3 died during support. No device thrombosis was observed at explantation.

Conclusions— The Jarvik 2000 functions as a true assist device by partially unloading the left ventricle, thereby optimizing the patient’s hemodynamics. Our preliminary results indicate that this LVAS may safely provide circulatory assistance for heart transplant candidates.

Key Words: ventricles • heart-assist device • heart failure • transplantation

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