Potential and Uncertainties of RejectClass in Acute Kidney Graft Dysfunction: An Independent Validation Study.

BACKGROUND: Kidney graft rejections are classified based on the Banff classification. The RejectClass algorithm, initially derived from a cohort comprising mostly protocol biopsies, identifies data-driven phenotypes of acute rejection and chronic pathology using Banff lesion scores. It also provides composite scores for inflammation activity and chronicity. This study independently evaluates the performance of RejectClass in a cohort consisting entirely of indication biopsies. METHODS: We retrospectively applied RejectClass to 441 patients from the German TRABIO (TRAnsplant BIOpsies) cohort who had received indication biopsies. The primary endpoint was death-censored graft failure during 2 y of follow-up. RESULTS: The application of RejectClass to our cohort demonstrated moderately comparable phenotypic features with the derivation cohort, and most clusters indicated an elevated risk of graft loss. However, the reproduction of all phenotypes and the associated risks of graft failure, as depicted in the original studies, was not fully accomplished. In contrast, adjusted Cox proportional hazards analyses substantiated that both the inflammation score and the chronicity score are independently associated with graft loss, exhibiting hazard ratios of 1.7 (95% confidence interval, 1.2-2.3; P = 0.002) and 2.2 (95% confidence interval, 1.8-2.6; P < 0.001), respectively, per 0.25-point increment (scale: 0.0-1.0). CONCLUSIONS: The composite inflammation and chronicity scores may already have direct utility in quantitatively assessing the disease stage. Further refinement and validation of RejectClass clusters are necessary to achieve more reliable and accurate phenotyping of rejection.

Study protocol: the TRAnsplant BIOpsies (TRABIO) study - a prospective, observational, multicentre cohort study to assess the treatment of kidney graft rejections.

INTRODUCTION: Despite continued efforts, long-term outcomes of kidney transplantation remain unsatisfactory. Kidney graft rejections are independent risk factors for graft failure. At the participating centres of the TRAnsplant BIOpsies study group, a common therapeutic standard has previously been defined for the treatment of graft rejections. The outcomes of this strategy will be assessed in a prospective, observational cohort study. METHODS AND ANALYSIS: A total of 800 kidney transplantation patients will be enrolled who undergo a graft biopsy because of deteriorating kidney function. Patients will be stratified according to the Banff classification, and the influence of the treatment strategy on end points will be assessed using regression analysis. Primary end points will be all-cause mortality and graft survival. Secondary end points will be worsening of kidney function (≥30% decline of estimated Glomerular Filtration Rate [eGFR] or new-onset large proteinuria), recurrence of graft rejection and treatment response. Baseline data and detailed histopathology data will be entered into an electronic database on enrolment. During a first follow-up period (within 14 days) and subsequent yearly follow-ups (for 5 years), treatment strategies and clinical course will be recorded. Recruitment at the four participating centres started in September 2016. As of August 2020, 495 patients have been included. ETHICS AND DISSEMINATION: Ethical approval for the study has been obtained from the ethics committee of Kiel (AZ B 278/16) and was confirmed by the committees of Munich, Mainz and Stuttgart. The results will be reported in a peer-reviewed journal, according to the Strengthening the Reporting of Observational Studies in Epidemiology criteria. TRIAL REGISTRATION NUMBER: ISRCTN78772632; Pre-results.

Predictability of intraocular lens power calculation after small-incision lenticule extraction for myopia.

PURPOSE: To evaluate and compare the predictability of intraocular lens (IOL) power calculation after small-incision lenticule extraction (SMILE) for myopia and myopic astigmatism. SETTING: Department of Ophthalmology, Philipps University of Marburg, Marburg, Germany. DESIGN: Retrospective comparative case series. METHODS: Preoperative evaluation included optical biometry using IOLMaster 500 and corneal tomography using Pentacam HR. The corneal tomography measurements were repeated at 3 months postoperatively. The change of spherical equivalent due to SMILE was calculated by the manifest refraction at corneal plane (SMILE-Dif). A theoretical model, involving the virtual implantation of the same IOL before and after SMILE, was used, and the IOL power calculations were performed using ray tracing (OKULIX, version 9.06) and third- (Hoffer Q, Holladay 1, and SRK/T) and fourth-generation (Haigis-L and Haigis) formulas. The difference between the IOL-induced refractive error at corneal plane before and after SMILE (IOL-Dif) was compared with SMILE-Dif. The prediction error (PE) was calculated as the difference between SMILE-Dif-IOL-Dif. RESULTS: The study included 204 eyes that underwent SMILE. The PE with ray tracing was -0.06 ± 0.40 diopter (D); Haigis-L, -0.39 ± 0.62 D; Haigis, 0.70 ± 0.48 D; Hoffer Q, 0.84 ± 0.47 D; Holladay 1, 1.21 ± 0.51 D; and SRK/T, 1.46 ± 0.54 D. The PE with ray tracing was significantly smaller compared with that of all formulas (P ≤ .001). The PE variance with ray tracing was σ2 = 0.159, being significantly more homogenous compared with that of all formulas (P ≤ .011, F ≥ 6.549). Ray tracing resulted in an absolute PE of 0.5 D or lesser in 81.9% of the cases, followed by Haigis-L (53.4%), Haigis (35.3%), Hoffer Q (25.5%), Holladay 1 (6.4%), and SRK/T (2.9%) formulas. CONCLUSIONS: Ray tracing was the most accurate approach for IOL power calculation after myopic SMILE.