Corticosteroid Weaning in Stable Heart Transplant Patients: Guidance by Serum Cortisol Level

Abstract

Background Despite earlier studies describing the feasibility of steroid weaning in heart transplant patients, the majority of patients are maintained on steroid therapy for life. We examined a strategy based on a single morning serum cortisol measurement. Methods We assigned stable posttransplant patients, who were maintained on tacrolimus, mycophenolate mofetil, and corticosteroids, into one of two groups based on a screening morning cortisol level. Patients with a cortisol < 8 micrograms/deciliter were assigned to a “maintenance” group and the others were assigned to the weaning group and steroids were tapered off over 4–6 weeks. Patients were monitored on subsequent office visits for adrenal insufficiency and allograft rejection. Results Thirty-one patients were enrolled (6 patients in the maintenance group and 25 in the steroid-weaning group). Mean follow-up was 10.2 ± 4 years for the weaning group and 9.0 ± 4.9 years in the maintenance group (p = 0.6). No cases of rejection were noted, nor did any patient resume steroid treatment following discontinuation. Conclusion Steroids can be safely discontinued in stable heart transplant patients with an AM serum cortisol ≥ 8 micrograms/deciliter with appropriate outpatient follow-up. In this study, no patient suffered late rejection or clinically noted adrenal insufficiency.

Steroid withdrawal after heart transplantation in adults

“…Olivari et al [18] found that 42% of patients receiving standard triple-therapy were successfully withdrawn from CS by 6 months post-HTx. More recently, Baran et al [19] investigated CS weaning in stable HTx recipients by the guidance of morning cortisol. Patients were at least 4 months post-HTx and received tacrolimus-based maintenance therapy.…”

“…Of patients assigned to steroid weaning, none resumed CS treatment following discontinuation and no episodes of grade ≥2R rejection or unexplained graft dysfunction occurred within a mean follow-up of approximately 10 years. The follow-up time after CS withdrawal differed substantially among studies, ranging from 12 months in a retrospective study [15] to approximately 10 years in both a retrospective and prospective study [16,19]. The International Society for Heart and Lung Transplantation reports a median survival after HTx of 12 years [1], suggesting that longer follow-up time would be advantageous when investigating the long-term effects of CS administration.…”

“…Early CS withdrawal studies report conflicting results. A recent prospective study demonstrated no rejection ≥2R in CSw patients [19], whereas a previous retrospective study found significantly lower prevalence of late acute rejection (>1 year post-HTx) in patients successfully weaned from CS [14]. Two studies reported a significantly higher incidence of acute rejection in CSw compared with CSm patients [16,18].…”

“…Five studies with early CS withdrawal have investigated survival of HTx patients and demonstrated similar [16,18,19] or superior [14,15] survival in CSw patients compared with CSm patients. As for studies investigating late CS withdrawal, one prospective [31] and four retrospective [22,26,29,30] studies found no difference in survival, while three studies demonstrated superior survival in CSw patients [24,25,36].…”

Remote versus early corticosteroid wean outcomes in heart transplant recipients in the contemporary era

“…Adrenal insufficiency after using chronic corticosteroids can be safely monitored in heart transplant patients with serum cortisol and standardized weaning protocols. 21 Most studies have demonstrated comparable survival of patients with a steroid-free regimen. 4,6,7 There are two studies that showed improved survival in patients that were able to tolerate a steroidfree regimen.…”