Summary of the clinical use of the Symbion total artificial heart: a registry report.

Several models of total artificial hearts have been used for transient or permanent circulatory support in patients with decompensation. The most successful and widely used device, however, has been the Symbion total artificial heart. From Dec. 12, 1982, to Jan. 1, 1991, 180 Symbion total artificial hearts were implanted in 176 patients in 28 centers. Five patients received a Symbion total artificial heart as a permanent circulatory support device, whereas 171 patients received the device as a bridge to heart transplantation. Of the 175 bridge devices (171 patients) 141 were Symbion J7-70 hearts and 34 were Symbion J7-100 hearts. Four patients received two total artificial hearts, the second one after the failure of a transplanted heart because of either rejection (two patients) or donor heart failure (2 patients). Most of the recipients were males (152). The age was 42 +/- 12 years (mean +/- SD) with a weight of 74 +/- 14 kg. The most common indications for implantation included deterioration while awaiting heart transplant (36%) and acute cardiogenic shock (32%). The cause of heart disease was primarily ischemic (52%) and idiopathic (35%) cardiomyopathy. Duration of implantation ranged from 0 to 603 days (mean 25 +/- 64 days). One hundred three (60%) patients had the device less than 2 weeks, 37 (22%) between 2 to 4 weeks and 31 (18%) more than 4 weeks. Complications during implantation included infection (37%), thromboembolic events (stroke 7%, transient ischemic attack 4%), kidney failure requiring dialysis (20%), bleeding requiring intervention (26%), and device malfunction (4%). Of the 171 patients, 118 (69%) underwent orthotopic heart transplantation. Actuarial survival for all patients with implants was 62% for 30 days and 42% for 1 year, and for patients with transplants was 72% for 30 days and 57% for 1 year. The main causes of death were sepsis (33%), multiorgan failure (21%), and posttransplant rejection (10%). The results indicate a relative success of this treatment for patients with an otherwise fatal prognosis. Moreover, as the demand for donor organs far exceeds availability, continued investigation of total artificial hearts is justified.