Cumulative clinical experience with the Symbion J7 TAH

As of March 1, 1988, 92 patients have received the Symbion J7 pneumatic TAH as a bridge to cardiac transplantation. All implantee's were Category 6 (Urgent Need) patients, exhibiting functional Class IV symptoms or facing imminent death, in the judgment of their physician prior to obtaining a suitable cardiac allograft. Sixty-three of these patients, (68%) were transplanted. Of the 56 transplants 35 (56%) patients are currently alive, with most returning home and back to work. Implant duration ranged from 1 to 243 days of support, with an average of 24 days. Implantee average age was 42 years, with a range of 15-60 years. Male/female distribution was 80/12, with the females requiring longer periods of pump support and exhibiting lower survival rates. Several main implant categories have surfaced during the study, with the collective disease category of cardiomyopathy constituting 66% of the study population. This broad category may be subdivided into ischemic cardiomyopathy 52%, idiopathic 25%, viral 7%, and miscellaneous 16%. Acute rejection of donor organ (17%) and unweanable patients (11%) constitute the other major implant categories. Postoperative complications observed in a population cohort of 70 patients include bleeding in 44%, infection in 34%, reoperation in 27%, neurologic dysfunction in 13%, and device failure in none. Standardized device explant analysis results indicate a trend in thrombus reduction concurrent with increased investigator experience and improved patient management techniques. The concept of bridging in a specific group of patients in which the prognosis is otherwise hopeless continues to demonstrate therapeutic value.