The efficacy and safety of patent Foramen Ovale Closure for Refractory Epilepsy (PFOC-RE): a prospectively randomized control trial of an innovative surgical therapy for refractory epilepsy patients with PFO of high-grade right-to-left shunt.

BACKGROUND: A significant proportion of patients with epilepsy have an unknown etiology and lack effective targeted therapeutic drugs. Patent Foramen Ovale (PFO) induces hypoxia and microembolism, leading to cerebral neurological dysfunction and increased epilepsy risk. This study aims to assess the efficacy and safety of PFO closure for relieving epileptic seizures in patients with refractory epilepsy associated with PFO. METHODS/DESIGN: Recruitment takes place at the West China Hospital of Sichuan University, China, for an open-label, randomized controlled clinical trial. The trial will include 110 patients with refractory epilepsy and PFO. Disease diagnoses will conform to the diagnostic criteria of the International League Against Epilepsy (ILAE) for refractory epilepsy and the American Society of Echocardiography (ASE) for PFO. Refractory epilepsy and high-grade right-to-left shunt (RLS) of the PFO will be further diagnosed using 24-hour video electroencephalogram and transthoracic echocardiography with contrast injection, respectively. Eligible participants require a secondary or higher volume of RLS. TRIAL REGISTRATION: Chinese Clinical Trial Registry (ChiCTR2200065681). Registered on November 11, 2022.

CD20+ B-cell infiltration is related to the time after transplant and poor prognosis of acute cellular rejection in renal transplant.

OBJECTIVES: This study sought to determine the relation between CD20+ B-cell infiltration and time after transplant and outcome of acute cellular rejection in renal allografts. MATERIALS AND METHODS: Fifty-five patients with acute cellular rejection were categorized into 3 groups: very early, early, and late rejection. The density of CD4+, CD8+, CD20+, and CD68+ cells and HLA-DR expression were characterized and quantified using immunohistochemical staining. Histologic changes were compared between high-density and low-density CD20+ B-cell groups. Poor prognosis factors were analyzed with Cox proportional regression. RESULTS: Density of CD20+ cells in the very-early rejection group was lower than it was in the early- and late-acute rejection groups (P = .03); the density of CD4+, CD8+, and CD68+ cells and HLA-DR expression did not differ between the groups. Mesangial matrix increase, tubular atrophy, arteriolar hyaline thickening, and tubulitis were more prevalent in the high CD20+ density group. Cox regression analysis demonstrated that HLA-DR expression on the tubules, arteriolar hyaline thickening, and CD20+ cell density were associated with an elevated risk of acute cellular rejection. CONCLUSIONS: Expansion aggregation of CD20+ B cells occurred mostly after 2 weeks. When combined with HLA-DR expression and arteriolar hyaline thickening, these influence the outcome of acute cellular rejection in renal allograft.

Novel rescue therapy for C4d-positive acute humoral renal allograft rejection.

OBJECTIVE: To investigate the efficacy of immunoadsorption (IA) in combination with tacrolimus (TAC) and mycophenolate mofetil (MMF) rescue therapy for C4d-positive acute humoral rejection (AHR) of renal transplants. METHODOLOGY: Six of 185 cadaveric renal allograft recipients transplanted at our institute developed AHR over a mean period of 4.8 +/- 0.8 d after operation. The ages ranged from 35 to 51 yr (mean 42.6 +/- 5.6 yr). C4d deposits in peritubular capillaries (PTC) and accumulation of granulocytes in PTC were observed. IA with staphylococcal protein A and TAC-MMF combination therapy were given. RESULTS: After subjected to IA for 6.3 +/- 1.03 sessions combined with TAC (0.14-0.16 mg/kg/d) and MMF (1.5 g/d) therapy, renal function recovered in all the patients. The mean duration of treatment when serum creatinine decreased was 14 +/- 2.9 d. The pre-IA panel reactive antibody reactivity was as high as 50.2 +/- 6.1%, and was significantly reduced to 8.3 +/- 2.9% after IA. Repeated allograft kidney biopsy in four of six patients revealed a favorable remission of AHR. With a mean follow-up of 18.8 +/- 5.46 months, patient and allograft survival are 100%, renal function remained stable with a mean serum creatinine of 1.2 +/- 0.22 mg/dL. CONCLUSION: The optimal treatment for alloantibody-mediated AHR remains undefined. Our findings suggest that a therapeutic approach combining IA and TAC-MMF rescue has excellence to improve the outcome of AHR.