Intracorporeal Partial Artificial Hearts: Initial Results in Ten Patients

We have initiated clinical trials with an intracorporeal (abdominal) partial artificial heart during the past year. Ten pre‐terminal, post‐cardiotomy patients have been studied in strict compliance with institutional and federal protocols, including prior informed consent*† We have learned that emergency implantation and subsequent elective removal of the device is feasible. Its hemodynamic effectiveness over a wide range of left ventricular dysfunctions has been demonstrated. Substantial, reproducible, electrocardiographic, hemodynamic and angiographic evidence has been accumulated to support our hypothesis that the human left ventricle can recover from profound depression during prolonged ALVAD support and that an adherent, biocompatible, bioderived pseudo‐neointima develops on the textured surface of the pump within 24 hours following implantation. The device is six to ten times more effective than IABP pumping in man and has maintained systemic perfusion during clinical asystole and ventricular fibrillation. Although there have been no long‐term survivors, in two instances ventricular recovery was sufficient to allow removal of the device six to seven days after implantation. The ultimate causes of death were right ventricular failure and/or extracardiac multiple organ failure. The current limiting factors are overcoming varying degrees of institutional and/or physician reluctance in utilization of the device and earlier deployment prior to the onset of 1) hemorrhagic diatheses which preclude optimal postimplantation anticoagulation regimens (A.S.A., Persantin & Coumadin); 2) right heart failure which closely follows left heart failure; and 3) multiple organ failure which accompanies prolonged cardiopulmonary bypass and is exacerbated by overzealous pharmacologic support. The early results are encouraging; continued, cautious clinical trials seem indicated.