Cost analysis of the Novacor Left Ventricular Assist System as an outpatient bridge to heart transplantation.

Three patients were bridged to heart transplantation with the wearable Novacor Left Ventricular Assist System (Baxter Healthcare Corp., Oakland, CA) (LVAS). Two have been transplanted and discharged. The third patient remains at home. Hospitalization costs, which include the unit room charge, admission profile to the unit, and daily supply charge, were determined for all patients and compared. The patients were transferred from the surgical intensive care unit to a telemetry unit once they were hemodynamically stable. The projected hospitalization costs, if the patients had remained in the hospital, were calculated to determine probable savings for the third party payer. The average period from admission to placement of the Novacor LVAS was 15 days (range, 7-21 days). The average hospitalization cost from admission to time of Novacor left ventricular assist device implant was $2,240/day, and the average hospitalization cost after implant to discharge was $1,570/day. Hospitalization cost savings were $2,632 for the first patient, $5,922 for the second patient, and $132,124 for the third patient, who has not been transplanted. Although the number of patients is small, the daily hospitalization cost was higher before the Novacor LVAS was implanted. This is related to the severity of the disease and the length of stay in a surgical intensive care unit. There also is a significant cost savings for the third party payer, especially if the patient has to wait a significant amount of time before heart transplantation. These are important considerations in this time of managed care.

Heart transplantation in patients with treated breast carcinoma.

Since 1987, five women with end-stage cardiomyopathy and a history of treated breast carcinoma have undergone transplantation at our institution. All patients underwent extensive multidisciplinary pretransplantation evaluation to rule out metastatic disease. Disease-free interval before heart transplantation ranged from 5 to 11 years (mean, 7.6 years). All patients received immunosuppression in accordance with a standard protocol of rabbit antithymocyte globulin, cyclosporine, prednisone, and azathioprine. Mean postoperative follow-up is 49 months. All patients are alive and have no symptoms 18 to 73 months after transplantation. In carefully selected patients with a history of breast carcinoma, heart transplantation can be performed with good functional results and satisfactory late survival.

Prospective study of the safety and financial benefit of ketoconazole as adjunctive therapy to cyclosporine after heart transplantation.

In a prospective study of the relative safety and potential benefit of concomitant ketoconazole and cyclosporine after heart transplantation, 15 transplant recipients were followed up for up to 1 year (mean, 10.7 months) after ketoconazole was added to their immunosuppressive regimen of cyclosporine, prednisone, and azathioprine, and these patients were compared with a matched cohort over the same time. There was an 88% reduction in the mean (+/- SD) dose of cyclosporine, from 394 (115) mg/day to 47 (21) mg/day (p less than 0.0005) in the ketoconazole group, compared with an insignificant change in the control group. The projected annual cost of cyclosporine was reduced by 88%, with a 72% reduction in the projected cost of immunosuppressive drugs and prophylactic antifungal therapy, from a mean of $6800 to $1862 per year per transplant recipient in the ketoconazole-treated group. Other beneficial effects found over the study period included a significant reduction in the mean and diastolic systemic arterial pressure and a significant reduction in serum cholesterol. The mean total serum cholesterol fell from 265 (44) to 204 (38) mg/dl in the ketoconazole group but did not change significantly in the control group (p less than 0.005). Low-density lipoprotein cholesterol also fell from a mean of 167 (32) mg/dl to 112 (28) mg/dl (p less than 0.005). Renal function was not significantly affected by ketoconazole when compared with the control group. Ketoconazole and other drugs of potential use in organ transplant recipients should be evaluated for financial as well as for other potential clinical benefits in the long-term management of these patients.

Prolactin as a marker of rejection in human heart transplantation.

Prolactin has been shown to play a role in the modulation of the immune system. In addition, recent laboratory evidence suggests that circulating prolactin might fluctuate as a function of immunologic events. To evaluate the role of prolactin as a predictor of rejection, 22 heart and heart-lung transplant patients were studied from July 1985 to May 1986. Daily plasma prolactin levels were measured by radioimmunoassay. Endomyocardial biopsy and histologic evaluation of the allografts were used to define rejection episodes. Thirteen of 14 documented rejection episodes were preceded by a specific elevation of circulating prolactin. A significant elevation of prolactin occurred 6 and 8 days before 14 rejection episodes that were diagnosed by biopsy but not before 109 biopsies were taken that had negative results. The normal values for circulating prolactin are defined by a preoperative mean in a range of 0 to 15 ng/ml (95% confidence limit). The sensitivity of prolactin to predict rejection is 79%, the specificity is 92%, and the positive predictive value is 61%. A large data variability gives a low accuracy to the test as a predictor of allograft rejection. To be useful clinically, the accuracy needs to be improved through a better understanding of prolactin physiology and its relation to the immune system.