Background: To determine the significance of early subclinical rejection, we reviewed protocol biopsies performed on days 7 and 28 during a 4-year period.
Methods: The study was confined to patients (n=115) with stable graft function at the time of biopsy; 76 adequate biopsies at day 7 and 79 at day 28 were performed.
Results: At day 7, 10 biopsy specimens (13%) showed acute rejection (AR) and 9 (12%) showed borderline changes. Eight of 10 patients with AR received immediate pulsed methylprednisolone (MP) and one untreated patient developed clinical rejection (CR) within 3 days. Four of nine patients whose biopsy specimens showed borderline changes received MP and three untreated patients developed CR within 3 days. At day 28, six biopsy specimens (8%) showed AR and 13 (16%) showed borderline changes. Three of six patients with AR received immediate pulsed MP and one untreated patient developed CR within 6 days. Ten of 13 patients with borderline changes had been treated for AR in the previous 3 weeks. Twelve patients with subclinical rejection or borderline changes at day 28 were never subsequently treated for rejection, and outcome at 6 years did not differ from those patients whose biopsy specimens showed no rejection.
Conclusions: Compared with some units, the incidence of subclinical rejection is low. The majority of untreated subclinical borderline changes and rejection at day 7 behaved as early clinical rejections and at day 28 as resolving clinical rejections. Untreated subclinical rejection or borderline change at day 28 was not an adverse prognostic factor for long-term outcome.