Cardiac [99mTc]Tc-hydroxydiphosphonate uptake on bone scintigraphy in patients with hereditary transthyretin amyloidosis: an early follow-up marker?

PURPOSE: There is a need for early quantitative markers of potential treatment response in patients with hereditary transthyretin (ATTRv) amyloidosis to guide therapy. This study aims to evaluate changes in cardiac tracer uptake on bone scintigraphy in ATTRv amyloidosis patients on different treatments. METHODS: In this retrospective cohort study, outcomes of 20 patients treated with the transthyretin (TTR) gene silencer patisiran were compared to 12 patients treated with a TTR-stabilizer. Changes in NYHA class, cardiac biomarkers in serum, wall thickness, and diastolic parameters on echocardiography and NYHA class during treatment were evaluated. RESULTS: Median heart/whole-body (H/WB) ratio on bone scintigraphy decreased from 4.84 [4.00 to 5.31] to 4.16 [3.66 to 4.81] (p < .001) in patients treated with patisiran for 29 [15-34] months. No changes in the other follow-up parameters were observed. In patients treated with a TTR-stabilizer for 24 [20 to 30] months, H/WB ratio increased from 4.46 [3.24 to 5.13] to 4.96 [ 3.39 to 5.80] (p = .010), and troponin T increased from 19.5 [9.3 to 34.0] ng/L to 20.0 [11.8 to 47.8] ng/L (p = .025). All other parameters did not change during treatment with a TTR-stabilizer. CONCLUSION: A change in cardiac tracer uptake on bone scintigraphy may be an early marker of treatment-specific response or disease progression in ATTRv amyloidosis patients.

[Effects of a smoke-free policy on healthcare staff attitudes and aggression in psychiatry]. / Effecten van een rookvrijbeleid op attitudes zorgpersoneel en agressie in de psychiatrie.

Background The prevalence of smoking among patients with psychiatric disorders is 3-4 times higher than the general population. However, smoking is still permitted in many psychiatric clinics. The National Prevention Agreement (2018) mandates that all psychiatric wards be smoke-free by 2025. The UMC Utrecht clinics have been smoke-free since November 2020. Aim To examine healthcare workers’ attitudes before and after implementing the smoke-free policy. Method In an observational study with quantitative data analysis, data were collected in one center from healthcare workers in psychiatry departments with surveys. We collected demographic information, smoking status, attitudes towards the smoke-free policy, and its impact on patients and care. Incidents of aggression were prospectively recorded and reported in the MAP (aggression incidents in patient care). Results Out of 172 healthcare workers invited to participate, 30% (n = 52) completed the pre-implementation survey, and 20% (n = 34) completed the post-implementation survey. Prior to implementation, 62% (n = 32/52) of healthcare workers had a positive attitude towards the smoke-free policy, which increased to 77% (n = 26/34) post-implementation. Expectations of increased aggression incidents were reported by 62% (n = 32/52) during the pre-implementation phase. The number of aggression incidents was 46 in the one-year period before implementation (November 2019 – February 2020) and 45 incidents after implementation (November 2020 – February 2021). Conclusion This study supports the implementation of a smoke-free policy in psychiatric clinics due to the lack of a significant increase in aggression incidents. Healthcare workers perceived this outcome and observed quicker granting of ‘green’ freedoms.

Longitudinal Changes in Circulating Ketone Body Levels in Patients With Acute Heart Failure: A Post Hoc Analysis of the EMPA-Response-AHF Trial.

BACKGROUND: Ketone bodies are endogenous fuels produced by the liver under conditions of metabolic or neurohormonal stress. Circulating ketone bodies are increased in patients with chronic heart failure (HF), yet little is known about the effect of acute HF on ketosis. We tested the hypothesis that ketogenesis is increased in patients with acute decompensated HF. METHODS AND RESULTS: This was a post hoc analysis of 79 patients with acute HF included in the EMPA-RESPONSE-AHF trial, which compared sodium-dependent glucose-cotransporter protein 2 inhibitor treatment with empagliflozin for 30 days with placebo in patients with acute HF [NCT03200860]. Plasma concentrations of ketone bodies acetone, ß-hydroxybutyrate, and acetoacetate were measured at baseline and 5 different timepoints. Changes in ketone bodies over time were monitored using repeated measures analysis of variance. In the total cohort, median total ketone body concentration was 251 µmol/L (interquartile range, 178-377 µmol/L) at baseline, which gradually decreased to 202 µmol/L (interquartile range, 156-240 µmol/L) at day 30 (P = .041). Acetone decreased from 60 µmol/L (interquartile range, 34-94 µmol/L) at baseline to 30 µmol/L (interquartile range, 21-42 µmol/L) ( P < .001), whereas ß-hydroxybutyrate and acetoacetate remained stable over time. Higher acetone concentrations were correlated with higher N-terminal pro brain natriuretic peptide levels (r = 0.234; P = .039). Circulating ketone bodies did not differ between patients treated with empagliflozin or placebo throughout the study period. A higher acetone concentration at baseline was univariately associated with a greater risk of the composite end point, including in-hospital worsening HF, HF rehospitalizations, and all-cause mortality after 30 days. However, after adjustment for age and sex, acetone did not remain an independent predictor for the combined end point. CONCLUSIONS: Circulating ketone body concentrations, and acetone in particular, were significantly higher during an episode of acute decompensated HF compared with after stabilization. Treatment with empagliflozin did not affect ketone body concentrations in patients with acute HF.

Positron emission tomography in the diagnosis and follow-up of transthyretin amyloid cardiomyopathy patients: A systematic review.

PURPOSE: Transthyretin (ATTR) amyloidosis is a progressive protein misfolding disease with frequent cardiac involvement. This review aims to determine the value of PET in diagnosis, assessment of disease progression or treatment response and its relation to clinical outcome in follow-up of ATTR amyloid cardiomyopathy (ATTR-CM) patients. METHODS: Medline, Cochrane Library, Embase and Web of Science databases were searched, from the earliest date available until December 2022, for studies investigating the use of PET in ATTR-CM patients. Studies containing original data were included, except for case reports. Risk of bias was assessed by QUADAS-2. RESULTS: Twenty-one studies were included in this systematic review, investigating five different tracers: carbon-11 Pittsburgh compound B ([11C]PIB), fluorine-18 Florbetaben ([18F]FBB), fluorine-18 Florbetapir ([18F]FBP), fluorine-18 Flutemetamol ([18F]FMM) and fluorine-18 Sodium Fluoride (Na[18F]F). In total 211 ATTR amyloidosis patients were included. A majority of studies concluded that [11C]PIB, [18F]FBP and Na[18F]F can distinguish ATTR amyloidosis patients from controls, and that [11C]PIB and Na[18F]F, but not [18F]FBP, can distinguish ATTR-CM patients from patients with cardiac light chain amyloidosis. Evidence on the performance of [18F]FBB and [18F]FMM was contradictory. No studies on the use of PET in follow-up were found. CONCLUSION: [11C]PIB, Na[18F]F and [18F]FBP can be used to diagnose cardiac amyloidosis, although [18F]FBP may not be suitable for the distinction of different types of amyloid cardiomyopathy. No studies on PET in the follow-up of ATTR amyloidosis patients were found. Future research should focus on the use of these PET tracers in the follow-up of ATTR amyloidosis patients.

Immune checkpoint inhibitor-associated myocarditis : Case reports and a review of the literature.

Immune checkpoint inhibitors (ICIs) are increasingly recognised to effectuate long-lasting therapeutic responses in solid tumours. However, ICI therapy can also result in various immune-related adverse events, such as ICI-associated myocarditis, a rare but serious complication. The clinical spectrum is wide and includes asymptomatic patients and patients with fulminant heart failure, making it challenging to diagnose this condition. Furthermore, the optimal diagnostic algorithm and treatment of ICI-associated myocarditis is unknown. In this review, we describe two cases on both ends of the spectrum and discuss the challenges in recognising, diagnosing and treating ICI-associated myocarditis.

Improvement in left ventricular ejection fraction after pharmacological up-titration in new-onset heart failure with reduced ejection fraction.

OBJECTIVE: Recent studies have reported suboptimal up-titration of heart failure (HF) therapies in patients with heart failure and a reduced ejection fraction (HFrEF). Here, we report on the achieved doses after nurse-led up-titration, reasons for not achieving the target dose, subsequent changes in left ventricular ejection fraction (LVEF), and mortality. METHODS: From 2012 to 2018, 378 HFrEF patients with a recent (< 3 months) diagnosis of HF were referred to a specialised HF-nurse led clinic for protocolised up-titration of guideline-directed medical therapy (GDMT). The achieved doses of GDMT at 9 months were recorded, as well as reasons for not achieving the optimal dose in all patients. Echocardiography was performed at baseline and after up-titration in 278 patients. RESULTS: Of 345 HFrEF patients with a follow-up visit after 9 months, 69% reached ≥ 50% of the recommended dose of renin-angiotensin-system (RAS) inhibitors, 73% reached ≥ 50% of the recommended dose of beta-blockers and 77% reached ≥ 50% of the recommended dose of mineralocorticoid receptor antagonists. The main reasons for not reaching the target dose were hypotension (RAS inhibitors and beta-blockers), bradycardia (beta-blockers) and renal dysfunction (RAS inhibitors). During a median follow-up of 9 months, mean LVEF increased from 27.6% at baseline to 38.8% at follow-up. Each 5% increase in LVEF was associated with an adjusted hazard ratio of 0.84 (0.75-0.94, p = 0.002) for mortality and 0.85 (0.78-0.94, p = 0.001) for the combined endpoint of mortality and/or HF hospitalisation after a mean follow-up of 3.3 years. CONCLUSIONS: This study shows that protocolised up-titration in a nurse-led HF clinic leads to high doses of GDMT and improvement of LVEF in patients with new-onset HFrEF.

Cardiac foetal reprogramming: a tool to exploit novel treatment targets for the failing heart.

As the heart matures during embryogenesis from its foetal stages, several structural and functional modifications take place to form the adult heart. This process of maturation is in large part due to an increased volume and work load of the heart to maintain proper circulation throughout the growing body. In recent years, it has been observed that these changes are reversed to some extent as a result of cardiac disease. The process by which this occurs has been characterized as cardiac foetal reprogramming and is defined as the suppression of adult and re-activation of a foetal genes profile in the diseased myocardium. The reasons as to why this process occurs in the diseased myocardium are unknown; however, it has been suggested to be an adaptive process to counteract deleterious events taking place during cardiac remodelling. Although still in its infancy, several studies have demonstrated that targeting foetal reprogramming in heart failure can lead to substantial improvement in cardiac functionality. This is highlighted by a recent study which found that by modulating the expression of 5-oxoprolinase (OPLAH, a novel cardiac foetal gene), cardiac function can be significantly improved in mice exposed to cardiac injury. Additionally, the utilization of angiotensin receptor neprilysin inhibitors (ARNI) has demonstrated clear benefits, providing important clinical proof that drugs that increase natriuretic peptide levels (part of the foetal gene programme) indeed improve heart failure outcomes. In this review, we will highlight the most important aspects of cardiac foetal reprogramming and will discuss whether this process is a cause or consequence of heart failure. Based on this, we will also explain how a deeper understanding of this process may result in the development of novel therapeutic strategies in heart failure.

Novel endotypes in heart failure: effects on guideline-directed medical therapy.

Aims: We sought to determine subtypes of patients with heart failure (HF) with a distinct clinical profile and treatment response, using a wide range of biomarkers from various pathophysiological domains. Methods and results: We performed unsupervised cluster analysis using 92 established cardiovascular biomarkers to identify mutually exclusive subgroups (endotypes) of 1802 patients with HF and reduced ejection fraction (HFrEF) from the BIOSTAT-CHF project. We validated our findings in an independent cohort of 813 patients. Based on their biomarker profile, six endotypes were identified. Patients with endotype 1 were youngest, less symptomatic, had the lowest N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels and lowest risk for all-cause mortality or hospitalization for HF. Patients with endotype 4 had more severe symptoms and signs of HF, higher NT-proBNP levels and were at highest risk for all-cause mortality or hospitalization for HF [hazard ratio (HR) 1.4; 95% confidence interval (CI) 1.1-1.8]. Patients with endotypes 2, 3, and 5 were better uptitrated to target doses of beta-blockers (P < 0.02 for all). In contrast to other endotypes, patients with endotype 5 derived no potential survival benefit from uptitration of angiotensin-converting enzyme-inhibitor/angiotensin-II receptor blocker and beta-blockers (Pinteraction <0.001). Patients with endotype 2 (HR 1.29; 95% CI 1.10-1.42) experienced possible harm from uptitration of beta-blockers in contrast to patients with endotype 4 and 6 that experienced benefit (Pinteraction for all <0.001). Results were strikingly similar in the independent validation cohort. Conclusion: Using unsupervised cluster analysis, solely based on biomarker profiles, six distinct endotypes were identified with remarkable differences in characteristics, clinical outcome, and response to uptitration of guideline directed medical therapy.

Critical re-appraisal of blood component quality after overnight hold of whole blood outside current room temperature limits.

BACKGROUND AND OBJECTIVES: According to European guidelines, the temperature of whole blood (WB) has to be maintained at 20-24°C until processing within 24 h, but in blood bank practice, WB is frequently held at temperatures between 18-25°C. We aimed to assess the impact of these small temperature deviations on the quality of the blood components. MATERIALS AND METHODS: After rapid cooling, 7 WB units were held overnight at 18°C and 8 units at 25°C, reflecting worst case holding conditions, and separated into a red cell concentrate (RCC), plasma and buffy coat (BC). RCCs were filtered at test temperature and stored for 42 days at 2-6°C. BCs were processed to single-BC platelet concentrates (sPC) and stored up to Day 8 at 20-24°C. RESULTS: After overnight hold at 18°C, 2,3-DPG in WB decreased by 34 ± 9%, while at 25°C the decrease was 82 ± 6%. Accordingly, the 2,3-DPG levels in the RCCs in the 25°C group were significantly lower than in the 18°C group (2·2 ± 1·4 vs. 10·4 ± 2·9 µmol/g Hb). RCCs and sPCs in the 25°C group showed higher initial lactate levels and lower pH compared to the 18°C group, but these differences levelled off at the end of storage. RCCs showed small differences in ATP levels and haemolysis. Plasma in both groups showed comparable Factor VIII:C levels. CONCLUSION: The temperature of WB during overnight hold strongly affects initial 2,3-DPG levels of RCCs and supports the maintenance of temperature limits between 20 and 24°C. Other in vitro effects of the temperature deviations were small and of no practical relevance.

Serum eye drops: a survey of international production methods.

BACKGROUND: Serum eye drops (SEDs) are used to treat dry eye syndrome and non-healing corneal lesions when other treatments fail. Despite many clinical studies demonstrating the efficacy of both autologous and allogeneic SEDs, there is no internationally harmonized method for producing SEDs. MATERIALS AND METHODS: A 40-question survey requesting information regarding donor selection, blood collection and processing, infectious disease screening, shelf life and regulatory requirements for the production of autologous and allogeneic SEDs was developed by the Biomedical Excellence for Safer Transfusion Collaborative. Survey data were collected into a database via a secure web interface and then downloaded into Excel for further analysis. RESULTS: A total of 55 responses were received, with 21 responses from centres indicating they produce SEDs. Based on the responses, collection and processing practices differ widely, according to the size of the centre making the SEDs, and their ability to collect, process and test the blood. CONCLUSION: Despite divergences in the methods for producing SEDs, the end result is a small-volume aliquot of serum that can be administered by a patient at home. If more centres move from producing autologous to allogeneic SEDs, this may provide an opportunity for production methods to become more standardized internationally.

Alternatives in blood operations when choosing non-DEHP bags.

The use of di-ethylhexyl-phthalate (DEHP) in blood bags is under discussion due to toxicity concerns and possible restrictions. A questionnaire among 15 blood centres in nine countries showed that none so far have fully switched to non-DEHP blood bags. If centres had to change, sites with a 42-day outdate would choose for a shorter outdating period, while others would allow a higher haemolysis rate (but within current specifications). To improve red cell quality, about half of the centres are willing to move to an alternative red cell storage solution, while the other half would not change for various reasons.

Experiences with semi-routine production of riboflavin and UV-B pathogen-inactivated platelet concentrates in three blood centres.

BACKGROUND: For a clinical platelet (PLT) transfusion trial conducted in three countries, the production of PLT concentrates (PCs) that were pathogen inactivated with the Mirasol technology was set up and validated. While the Mirasol procedure is applied to an established PLT product, the PLT processing procedure still had to be modified to ensure a treated PC was of sufficient quality. Further, the effect of simulated transport conditions and the effect of ambient light on Mirasol-treated PCs was determined. STUDY DESIGN AND METHODS: Platelet concentrates in plasma were made from pooled buffy coats followed by Mirasol treatment. To mimic transport conditions, units were left unagitated for 6 h at room temperature. To mimic ambient light exposure, units were held unagitated for 4 h in direct fluorescent tube light. RESULTS: Measures had to be taken to allow 7-day storage of treated concentrates. In one site, PCs made from five buffy coats with >450 × 109 PLTs were removed from inventory. Another site went from five to four buffy coats per pool. Interruption of agitation for 6 h on day 3 did not induce meaningful changes in in vitro measures, even when stored up to 7 days. Exposure to ambient light for 4 h, either on day 3 or 6, had no effect on in vitro measures. CONCLUSION: The Mirasol pathogen inactivation process can be implemented in routine, but changes to current PLT processing methods might be needed. Transport conditions and 4-h-long ambient light exposure have no negative effect on the in vitro quality of Mirasol-treated PCs.

Comparison of haemostatic function of PAS-C-platelets vs. plasma-platelets in reconstituted whole blood using impedance aggregometry and thromboelastography.

BACKGROUND AND OBJECTIVES: There are concerns about the haemostatic function of platelets stored in platelet additive solution (PAS). Aim of this study was to compare the haemostatic function of PAS-C-platelets to plasma-platelets in reconstituted whole blood. MATERIALS AND METHODS: In our experiment, whole blood was reconstituted with red blood cells, solvent-detergent (SD) plasma and either PAS-C-platelets or plasma-platelets (n = 7) in a physiological ratio. On storage days 2, 5, 8 and 13, the agonist-induced aggregation (multiple electrode aggregometry), clot formation (thromboelastography) and agonist-induced CD62P responsiveness (flow cytometry) were measured. RESULTS: Samples with PAS-C-platelets showed significantly lower aggregation than plasma-platelets when induced with adenosine diphosphate, -6 U (95% confidence interval: -8; -4) or thrombin receptor-activating protein, -15 U (-19; -10). Also when activated with collagen and ristocetin, the PAS-C-platelets showed less aggregation, although not statistically significant. All samples with PAS-C-platelets showed significantly lower agonist-induced CD62P responsiveness than samples with plasma-platelets. However, there was no difference regarding all TEG parameters. CONCLUSION: Our findings demonstrate that the function - aggregation and CD62P responsiveness - of PAS-C-platelets in reconstituted whole blood is inferior to that of plasma-platelets, which may have implications in the setting of massive transfusions.

Impact of health problems secondary to SCI one and five years after first inpatient rehabilitation.

STUDY DESIGN: This is a multicenter prospective cohort study. OBJECTIVES: The objective of this study was to describe and compare the impact of health problems secondary to spinal cord injury (SCI) on functioning at home and on social activities at 1 and 5 years after discharge from first inpatient rehabilitation. SETTING: The study was conducted in a Dutch community. METHODS: Participants with SCI who use a wheelchair for everyday mobility (N=110) completed a self-report questionnaire as part of a larger cohort study including four items on extra time needed (body care, bladder and bowel regulation, 'organization' and transportation) and impact of 10 health problems on functioning at home and on social activities. The 10 health problems include secondary health conditions (bladder regulation, bowel regulation, decubitus, pain, spasticity, gain in body weight and edema), psychosocial problems (sexuality, having difficulty with being dependent on help from others) and handicap management. RESULTS: Median extra time needed for self-management and transportation was not significantly higher 1 year after discharge (16 (IQR 13.5) h per week) compared with 5 years after discharge (13 (IQR 17) h per week) (P=0.925). Participants reported slightly less impact, comparing the severity sum-score (range 10-50) of the 10 health problems on functioning at home and in social activities, 5 years post discharge (20 and 17, respectively) than 1 year post discharge (21 and 18, respectively; P<0.05). Most frequently mentioned health problems were handicap management, being dependent on help from others, bladder regulation, bowel regulation, pain and sexuality. CONCLUSIONS: The impact of health problems after SCI is considerable and hardly diminishes over time. These results emphasize the need for structured long-term care for people with SCI.

Effect of increased agitation speed on pathogen inactivation efficacy and in vitro quality in UVC-treated platelet concentrates.

BACKGROUND AND OBJECTIVES: Pathogen inactivation technologies require continuous development for adjustment to different blood components and products. With Theraflex UV-Platelets, a system using shortwave ultraviolet C (UVC) light (254 nm), efficient mixing of platelet concentrates (PCs) during UVC treatment is essential to ensure homogeneous illumination of the blood components. In this study, we investigated the impact of increasing the agitation speed during UVC treatment on pathogen inactivation capacity and platelet quality. MATERIAL AND METHODS: The pathogen inactivation efficacy of UVC treatment was evaluated at two agitation speeds (110 vs. 180 rpm) using four different transfusion-relevant bacteria strains and three model viruses. Using a pool-and-split design, the in vitro quality of buffy coat-derived PCs stored in SSP+ additive solution for up to 7 days was assessed in UVC-treated PCs agitated at either 110 rpm (standard speed) or 180 rpm (increased speed) and in untreated controls. RESULTS: The higher agitation speed improved bacterial inactivation but did not influence viral inactivation. Metabolic activity (glucose consumption and lactate accumulation) in UVC-treated platelets was slightly higher than in untreated controls. Increases in parameters such as CD62P expression and annexin A5 binding indicated moderate activation of UVC-treated platelets. Quality variables for UVC-treated platelets agitated at standard vs. increased agitation speed were comparable. CONCLUSION: The mixing rate during illumination may be a process parameter for further development of UVC-based pathogen inactivation procedures for PLT concentrates.

Evaluation of the role of the GPIb-IX-V receptor complex in development of the platelet storage lesion.

BACKGROUND AND OBJECTIVES: In mice, loss of sialic acid resulting in shedding of glycoprotein (GP) Ibα and GPV has been linked to platelet survival. The aim of this study was to determine whether loss of sialic acid and the GPIb-IX-V complex contributes to development of the platelet storage lesion (PSL) in human platelet concentrates (PCs). MATERIALS AND METHODS: PCs (stored in plasma (with or without Mirasol treatment); PAS-C or PAS-E) were stored at room temperature. Flow cytometry was used to monitor membrane expression of the GPIb-IX-V complex, CD62P, surface glycans and PS exposure. The functionality of stored platelets was determined employing aggregometry and ristocetin-induced VWF binding. RESULTS: Storage time of PCs in blood banks is limited to 7 days. During this time period, a minor but gradually increasing subpopulation of GPIbα-negative platelets was observed. Also, ristocetin-induced VWF binding was impaired in a small population of platelets. Mean surface expression of GPIbα and GPV remained stable until day 9, whereas CD62P expression increased; also a rapid decrease in ADP-induced aggregation was observed for PAS-C, PAS-E and Mirasol-treated PCs. Upon prolonged storage (>9 days), a slow decline in surface expression of GPIbα and GPV was observed; no major changes were observed in surface sialylation with the exception of Mirasol-treated platelets. CONCLUSION: In a small population of stored platelets, changes in GPIbα occur from day 2 onwards. Loss of sialic acid and subsequent shedding of GPIbα and GPV is not an early event during the development of the PSL.

PAS or plasma for storage of platelets? A concise review.

Platelet additive solutions (PASs) are becoming increasingly popular for storage of platelets, and PAS is steadily replacing plasma as the storage medium of platelets. PASs are electrolyte solutions intended for storage of platelets, and they are used to modulate the quality of the platelets by adding specific ingredients. All currently available PASs contain acetate. Acetate reduces the amount of glucose that is oxidised into lactic acid and thereby prevents the lowering of pH, which decreases platelet quality. Furthermore, the oxidation of acetate leads to the production of bicarbonate, which serves as buffer. The presence of potassium and magnesium in PAS prevents the lowering of pH and reduces the degree of spontaneous activation of the platelets during storage. In the hospital, platelets stored in PAS result in about half of the number of allergic transfusion reactions as compared with platelets in plasma. Recovery and survival after transfusion, as well as corrected count increments, are at least as good for platelets in PAS as for plasma, and recent data suggest they may even be better. Therefore, with the current generation of PASs, PAS should be preferred over the use of plasma for the storage of platelet concentrates.

Separation of centrifuged whole blood and pooled buffy coats using the new CompoMat G5: 3 years experience.

BACKGROUND AND OBJECTIVES: Semi-automatic separation devices can be used for the separation of centrifuged whole blood into leucoreduced red cell concentrate (LR-RCC), plasma and buffy coat (BC) and to make platelet concentrates (PC) from pooled BCs. To improve and to obtain a more uniform and standardized process, the CompoMat G5 (Fresenius) was implemented, a new-generation semi-automated device. MATERIALS AND METHODS: Uniform programs for WB separation and preparation of PCs were validated, using collection and pooling systems with CompoFlow (CF) closures, which can be automatically opened by the G5. Cell counts were performed and compared with historic data of blood components obtained with the formerly used Compomat G4 and Optipress II. After implementation, different adjustments were made to improve product quality. RESULTS: Leucoreduced red cell concentrates (280 ± 15 ml, 53 ± 5 g haemoglobin) and plasma (317 ± 16 ml) met European guidelines. BCs (48 ± 2 ml, 0·42 ± 0·05 l/l, 93 ± 25 × 10(9) platelets) contained a similar platelet (PLT) content as BC prepared before with the Compomat G4. A relatively high percentage (4-6%) of PCs (330 ± 17 ml, 330 ± 50 × 10(9) PLT, 0·12 ± 0·21 × 10(6) leucocytes) contained <250 × 10(9) PLT which was the subject of improvement studies. After implementation, RCC and BC discard decreased and workload was less. Operator complaints were also less frequent. CONCLUSION: The same high-quality blood components can be prepared by using the CompoMat G5 as previously with other semi-automated devices. Improvement was realized by automation of the opening process by the use of collection systems with CF closures, which led to a decrease in discarded units and workload.

Commercially available blood storage containers.

Plastic blood bags improve the safety and effectiveness of blood component separation and storage. Progress towards optimal storage systems is driven by medical, scientific, business and environmental concerns and is limited by available materials, consumer acceptance and manufacturing and regulatory concerns. Blood bag manufacturers were invited to submit lists of the bags they manufacture. The lists were combined and sorted by planned use. The lists were analysed by experts to assess the degree to which the products attend to scientific problems. Specific issues addressed included the use of di-ethylhexyl phthalate (DEHP) as plasticizer for polyvinyl chloride (PVC) blood bags, the size, material and thickness of platelet bags, and the fracture resistance of plasma bags. Alternatives to DEHP for red blood cell (RBC) storage exist, but are mostly in a developmental stage. Plastic bags (DEHP-free, PVC-free) for platelet storage with better gas diffusion capabilities are widely available. Alternatives for plasma storage with better fracture resistance at low temperatures exist. Most RBC products are stored in DEHP-plasticized PVC as no fully satisfactory alternative exists that ensures adequate storage with low haemolysis. A variety of alternative platelet storage systems are available, but their significance - other than improved oxygen transport - is poorly understood. The necessity to remove DEHP from blood bags still needs to be determined.