Impact of COVID-19 pandemic on the quality of test output in haemostasis laboratories.

INTRODUCTION: The high incidence of thrombotic events in patients with COVID-19 affects health care worldwide and results in an increased workload in haemostasis laboratories due to more frequent testing of D-dimer, haemostatic parameters and anti-Xa tests. However, the impact of this increase in assay requests on the quality of performance in haemostasis laboratories remains unclear. In this study, the impact of the COVID-19 pandemic on the quality of performance and management of haemostasis laboratories was evaluated. METHODS: The impact on the quality of performance was studied using external quality assessment data from 2019 to 2020 derived from ECAT surveys. A questionnaire was sent to Dutch haemostasis laboratories to identify challenges and management strategies. Furthermore, the number of assays performed in 2019 and 2020 was supplied by four Dutch hospitals, located in regions with different disease incidence. RESULTS: No differences in response rate nor the quality of the measurements were observed between the EQA surveys in 2019 and 2020. The questionnaire results showed a large increase of >25% in the number of test requests for anti-Xa, D-dimer and fibrinogen assays in 2020 compared to 2019. Extreme peaks in test requests were also observed in the four evaluated hospitals. Additionally, 84% of the respondents indicated that they had experienced increased work pressure, and increased sick leave was observed in 71% of the participating laboratories. CONCLUSIONS: The enormous increase in test requests, especially for D-dimer assays and anti-Xa activity, did not affect the quality of performance within haemostatic laboratories during the COVID-19 pandemic.

An In Vitro Pilot Study Comparing the Novel HemoClear Gravity-Driven Microfiltration Cell Salvage System with the Conventional Centrifugal XTRA™ Autotransfusion Device.

BACKGROUND: In 2013, the World Health Organization reported a shortage of 17 million red blood cell units, a number that remains growing. Acts to relieve this shortage have primarily focused on allogeneic blood collection. Nevertheless, autologous transfusion can partially alleviate the current pressure and dependence on blood banking systems. To achieve this, current gold standard autotransfusion devices should be complemented with widely available, cost-efficient, and time-efficient devices. The novel HemoClear cell salvage device (HemoClear BV, Zwolle, Netherlands), a gravity-driven microfilter, potentially is widely employable. We evaluated its performance in the cardiac postoperative setting compared to the centrifugal XTRA™ autotransfusion device. METHODS: In a split-unit study (n = 18), shed blood collected 18 hours after cardiothoracic surgery was divided into two equal volumes. One-half was processed by the XTRA™ device and the other with the HemoClear blood separation system. In this paired set-up, equal washing volumes were used for both methods. Washing effectivity and cellular recovery were determined by measuring of complete blood count, free hemoglobin, complement C3, complement C4, and D-dimer in both concentrate as filtrate. Also, processing times and volumes were evaluated. RESULTS: The HemoClear and XTRA™ devices showed equal effectiveness in concentrating erythrocytes and leucocytes. Both methods reduced complement C3, complement C4, and D-dimer by ≥90%. The centrifugal device reduced solutes more significantly by up to 99%. Free hemoglobin load was reduced to 12.9% and 15.5% by the XTRA™ and HemoClear, respectively. CONCLUSION: The HemoClear device effectively produced washed concentrated red blood cells comparably to the conventional centrifugal XTRA™ autotransfusion device. Although the centrifugal XTRA™ device achieved a significantly higher reduction in contaminants, the HemoClear device achieved acceptable blood quality and seems promising in settings where gold standard cell savers are unaffordable or unpractical.

Integrated management of atrial fibrillation in primary care: results of the ALL-IN cluster randomized trial.

AIMS: To evaluate whether integrated care for atrial fibrillation (AF) can be safely orchestrated in primary care. METHODS AND RESULTS: The ALL-IN trial was a cluster randomized, open-label, pragmatic non-inferiority trial performed in primary care practices in the Netherlands. We randomized 26 practices: 15 to the integrated care intervention and 11 to usual care. The integrated care intervention consisted of (i) quarterly AF check-ups by trained nurses in primary care, also focusing on possibly interfering comorbidities, (ii) monitoring of anticoagulation therapy in primary care, and finally (iii) easy-access availability of consultations from cardiologists and anticoagulation clinics. The primary endpoint was all-cause mortality during 2 years of follow-up. In the intervention arm, 527 out of 941 eligible AF patients aged ≥65 years provided informed consent to undergo the intervention. These 527 patients were compared with 713 AF patients in the control arm receiving usual care. Median age was 77 (interquartile range 72-83) years. The all-cause mortality rate was 3.5 per 100 patient-years in the intervention arm vs. 6.7 per 100 patient-years in the control arm [adjusted hazard ratio (HR) 0.55; 95% confidence interval (CI) 0.37-0.82]. For non-cardiovascular mortality, the adjusted HR was 0.47 (95% CI 0.27-0.82). For other adverse events, no statistically significant differences were observed. CONCLUSION: In this cluster randomized trial, integrated care for elderly AF patients in primary care showed a 45% reduction in all-cause mortality when compared with usual care.

Integrated management of atrial fibrillation including tailoring of anticoagulation in primary care: study design of the ALL-IN cluster randomised trial.

INTRODUCTION: In our ageing society, we are at the merge of an expected epidemic of atrial fibrillation (AF). AF management requires an integrated approach, including rate or rhythm control, stroke prevention with anticoagulation and treatment of comorbidities such as heart failure or type 2 diabetes. As such, primary care seems to be the logical healthcare setting for the chronic management of patients with AF. However, primary care has not yet played a dominant role in AF management, which has been in fact more fragmented between different healthcare providers. This fragmentation might have contributed to high healthcare costs. To demonstrate the feasibility of managing AF in primary care, studies are needed that evaluate the safety and (cost-)effectiveness of integrated AF management in primary care. METHODS AND ANALYSIS: The ALL-IN trial is a multicentre, pragmatic, cluster randomised, non-inferiority trial performed in primary care practices in a suburban region in the Netherlands. We aim to include a minimum of 1000 patients with AF aged 65 years or more from around 18 to 30 practices. Duration of the study is 2 years. Practices will be randomised to either the intervention arm (providing integrated AF management, involving a trained practice nurse and collaboration with secondary care) or the control arm (care as usual). The primary endpoint is all-cause mortality. Secondary endpoints are cardiovascular mortality, (non)-cardiovascular hospitalisation, major adverse cardiac events, stroke, major bleeding, clinically relevant non-major bleeding, quality of life and cost-effectiveness. ETHICS AND DISSEMINATION: The protocol was approved by the Medical Ethical Committee of the Isala Hospital Zwolle, the Netherlands. Patients in the intervention arm will be asked informed consent for participating in the intervention. Results are expected in 2019 and will be disseminated through both national and international journals and conferences. TRIAL REGISTRATION NUMBER: This trial is registered at the Netherlands Trial Register (NTR5532).

Neonatal hemolytic anemia due to pyknocytosis.

UNLABELLED: A newborn boy was referred to our hospital because of hemolytic anemia and severe hyperbilirubinemia. Extensive investigations aimed at determining the cause of hemolysis was initiated at the time of admission and 3 months after blood transfusion. Notably, no intrinsic erythrocyte abnormalities could be detected. The only possible cause explaining the progressive anemia and unconjugated hyperbilirubinemia was the finding of pyknocytes, severely distorted erythrocytes, on the blood film at hospital admission. We propose a role for an increased free fraction of plasma unconjugated bilirubin in the formation of pyknocytes through bilirubin membrane toxicity with subsequent anemia and progressive hyperbilirubinemia. CONCLUSION: Pyknocytosis is a transitory erythrocyte-related condition which can result in severe anemia and hyperbilirubinemia. Recognition of pyknocytes by microscopic analysis of a blood film is essential for a correct diagnosis. Treatment consists of correction of the anemia by top-up blood transfusion and light therapy to prevent toxic bilirubin buildup. High levels of free unconjugated bilirubin could be the underlying cause for the formation of pyknocytes.

Validity and interobserver agreement of reagent strips for measurement of glucosuria.

BACKGROUND: Measurement of glucosuria by means of a visually readable reagent test strip is frequently used in a wide variety of clinical settings. The aim of this study was to evaluate the validity and reliability of this semi-quantitative measurement of glucosuria compared to laboratory measurements of glucose concentrations in urine. METHODS: Reagent test strips (Combur³Test® Roche) from 375 artificially supplemented samples of urine, covering a wide range of glucose concentrations, were independently read by three different observers. Scores of the strips were categorized as 0, 1+, 2+, 3+ or 4+, in ascending degree of glucosuria. Results of the test-strips were compared to the quantitative measurement of urinary glucose concentration in the laboratory. RESULTS: 21.7% of reagent strips readings were discordant with the laboratory measurements (p < 0.001). Under- or overestimating the degree of glucosuria occurs predominantly in category 1+ and 2+. In category '0' only 5.1% of the readings were incorrect. The interobserver-agreement was very good with 85% overall agreement and multirater Kappa 0.81. Interobserver-scores of the reagent strips never deviated more than one category from each other. CONCLUSION: The validity as well as the interobserver-agreement for the semi-quantitative measurement of glucosuria using reagent strips is moderate, but sufficient for excluding glucosuria. However it is too imprecise for an accurate quantitative measurement. It might only be valuable in settings where automated readings are not available or suitable.