Background Preliminary data suggest that COVID-19 has reduced access to solid organ transplantation. However, the global consequences of the COVID-19 pandemic on transplantation rates and the effect on waitlisted patients have not been reported. We aimed to assess the effect of the COVID-19 pandemic on transplantation and investigate if the pandemic was associated with heterogeneous adaptation in terms of organ transplantation, with ensuing consequences for waitlisted patients.Methods In this population-based, observational, before-and-after study, we collected and validated nationwide cohorts of consecutive kidney, liver, lung, and heart transplants from 22 countries. Data were collected from Jan 1 to Dec 31, 2020, along with data from the same period in 2019. The analysis was done from the onset of the 100th cumulative COVID-19 case through to Dec 31, 2020. We assessed the effect of the pandemic on the worldwide organ transplantation rate and the disparity in transplant numbers within each country. We estimated the number of waitlisted patient life-years lost due to the negative effects of the pandemic. The study is registered with ClinicalTrials.gov, NCT04416256.Findings Transplant activity in all countries studied showed an overall decrease during the pandemic. Kidney transplantation was the most affected, followed by lung, liver, and heart. We identified three organ transplant rate patterns, as follows: countries with a sharp decrease in transplantation rate with a low COVID-19-related death rate; countries with a moderate decrease in transplantation rate with a moderate COVID-19-related death rate; and countries with a slight decrease in transplantation rate despite a high COVID-19-related death rate. Temporal trends revealed a marked worldwide reduction in transplant activity during the first 3 months of the pandemic, with losses stabilising after June, 2020, but decreasing again from October to December, 2020. The overall reduction in transplants during the observation time period translated to 48 239 waitlisted patient life-years lost.Interpretation We quantified the impact of the COVID-19 pandemic on worldwide organ transplantation activity and revealed heterogeneous adaptation in terms of organ transplantation, both at national levels and within countries, with detrimental consequences for waitlisted patients. Understanding how different countries and health-care systems responded to COVID-19-related challenges could facilitate improved pandemic preparedness, notably, how to safely maintain transplant programmes, both with immediate and non-immediate life-saving potential, to prevent loss of patient life-years.
Plasma exchange (PE) is a technique of extracorporeal blood purification which removes large molecular weight substances from plasma. The Department of Dialysis, Zagreb University Hospital Center's database, which includes data on 509 patients, or 4857 PE treatments, was retrospectively analyzed to test the safety of PE. A total of 231 adverse reactions were recorded (4.75% of treatments). The most common complications were paresthesias (2.7%), hematoma at the puncture site (2.4%), clotting (1.7%), mild to moderate allergic reactions (urticaria; 1.6%) and bleeding (0.06%). True anaphylactoid reactions were recorded in five procedures. The incidence of severe, potentially life-threatening adverse reactions was 0.12%. The prophylactic use of calcium and potassium was responsible for a low incidence of electrolyte disturbances. There was no lethal outcome associated with PE. When carried out by experienced staff, PE is a relatively safe procedure. The use of fresh frozen plasma is associated with a higher rate of adverse reactions.
Currently used diagnostic criteria in different endemic (Balkan) nephropathy (EN) centers involve different combinations of parameters, various cut-off values and many of them are not in agreement with proposed international guidelines. Leaders of EN centers began to address these problems at scientific meetings, and this paper is the outgrowth of those discussions. The main aim is to provide recommendations for clinical work on current knowledge and expertise. This document is developed for use by general physicians, nephrologists, urologist, public health experts and epidemiologist, and it is hoped that it will be adopted by responsible institutions in countries harboring EN. National medical providers should cover costs of screening and diagnostic procedures and treatment of EN patients with or without upper urothelial cancers.
Spontaneous tendon ruptures in patients with end-stage renal disease (ESRD) have been occasionally reported. We describe the largest group of patients with spontaneous rupture of major tendons so far reported. Rupture of 16 tendons occurred in 9 patients. The mean patient age was 52.78 years; 77.7% were male. Four patients were treated with hemodialysis, 4 received a renal transplant and 1 was treated with automated peritoneal dialysis. Bilateral rupture was found in 5 patients (3 quadriceps, 1 Achilles and 1 supraspinatus and subscapularis tendon rupture). Distal brachial biceps tendon rupture, Achilles tendon rupture, unilateral quadriceps and rupture of the oblique internal abdominal muscle tendon were developed by 1 patient each. Patients were treated with renal replacement therapy for 3–21 years (mean 12.89). Five patients were treated with steroids and 6 patients received quinolone antibiotic before the tendon rupture. All patients had laboratory and clinical signs of hyperparathyroidism. A patient who was treated with automated peritoneal dialysis for 3 years had primary hyperparathyroidism with nephrolithiasis as the cause of ESRD. Our results demonstrated that patients with hyperparathyroidism are at increased risk for development of spontaneous tendon ruptures, and the risk is further amplified when they receive quinolone antibiotics and/or steroids.
Background: The safety profiles of standard therapy versus everolimus with reducedexposure calcineurin inhibitor (CNI) therapy using contemporary protocols in de novo kidney transplant recipients have not been compared in detail.Methods: TRANSFORM was a randomized, international trial in which de novo kidney transplant patients were randomized to everolimus with reduced-exposure CNI (N=1014) or mycophenolic acid (MPA) with standard-exposure CNI (N=1012), both with induction and corticosteroids.Results: Within the safety population (everolimus 1014, MPA 1012), adverse events with a suspected relation to study drug occurred in 62.9% versus 59.2% of patients given everolimus or MPA, respectively (p=0.085). Hyperlipidemia, interstitial lung disease, peripheral edema, proteinuria, stomatitis/mouth ulceration, thrombocytopenia and wound healing complications were more frequent with everolimus, while diarrhea, nausea, vomiting, leukopenia, tremor and insomnia were more frequent in the MPA group. The incidence of viral infections (17.2% versus 29.2%; p<0.001), CMV infections (8.1% versus 20.1%; p<0.001), CMV syndrome (13.6% versus 23.0%, p=0.044) and BKV infections (4.3% versus 8.0%, p<0.001) were less frequent with everolimus. CMV infection was less common with everolimus versus MPA after adjusting for prophylaxis therapy in the D+/R-subgroup (p<0.001). Study drug was discontinued more frequently due to rejection or impaired healing with everolimus, and more often due to BKV infection or BKV nephropathy with MPA. Conclusion.De novo everolimus with reduced-exposure CNI yielded a comparable incidence, though a distinctly different pattern, of adverse events versus current standard-ofcare. Both regimens are safe and effective, yet their distinct profiles may enable tailoring for individual kidney transplant recipients.
BACKGROUND Therapeutic plasma exchange (TPE) can be performed either on a membrane‐based system (mTPE) or on a device that separates blood components by centrifugation (cTPE). The number of studies in this field is limited. This randomized study is the first that offers data on the membrane‐based Diapact device (B. Braun Medical, Inc.) for TPE procedures and compares it to the centrifuge‐based Spectra Optia (Terumo BCT, Inc.). STUDY DESIGN AND METHODS Twenty‐seven patients were enrolled in this randomized prospective head‐to‐head study comparing the mTPE and cTPE systems. Procedures on both devices were standardized and the plasma removal efficiency (PRE); total procedure time (including setup and priming time); and removal efficiencies of blood cells, immunoglobulin (Ig)G, and fibrinogen for all procedures were analyzed. RESULTS While both systems removed similar amounts of plasma, it took the cTPE device a mean of 101.5 ± 24.6 minutes to finalize a procedure that was one‐third less than procedures on the mTPE device (157 ± 26.2 min; p < 0.0001), due to a difference in PRE between the Spectra Optia (83.0% ± 4.9%) and the Diapact (53.2% ± 6.6%; p < 0.0001). The difference in removal efficiencies of IgG and blood cells were not significantly different but the Spectra Optia was more efficient in removing the larger fibrinogen protein than the Diapact (72.3% ± 8.5% vs. 62.9% ± 16.1%, respectively; p < 0.02). CONCLUSION This study shows that, although both systems perform adequate and safe TPE procedures, those on the Spectra Optia in comparison to the Diapact are more efficient in terms of plasma removal and significantly shorter.
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