No major neurologic complications with sirolimus use in heart transplant recipients.

OBJECTIVE

To determine whether sirolimus therapy is associated with neurologic complications, including stroke, among heart transplant recipients.

PATIENTS AND METHODS

We retrospectively studied patients who underwent heart transplant at Mayo Clinic's site in Rochester, MN, from January 1, 1988, through June 30, 2006.

RESULTS

Of 313 patients in the cohort, the medical regimen in 116 patients (37%) was switched from cyclosporine-based therapy to sirolimus. The hazard ratio of sirolimus for any neurologic or psychiatric event was 1.94 (95% confidence interval, 0.67-4.29). This hazard ratio was driven mainly by the association between sirolimus and the development of tremor and depression. Cerebrovascular events occurred with a cumulative incidence of 14% but did not occur in any of the patients who received sirolimus therapy. There were no cases of posterior reversible encephalopathy syndrome with sirolimus use.

CONCLUSION

No early or late episodes of major neurotoxicity occurred in heart transplant recipients using sirolimus immunosuppression. The absence of stroke and transient ischemic attacks in these high-risk transplant recipients treated with sirolimus is notable but needs confirmation in future studies.