[Innovative technology and blood safety]. / Innovations technologiques et sécurité transfusionnelle.

If technological innovations are not enough alone to improve blood safety, their contributions for several decades in blood transfusion are major. The improvement of blood donation (new apheresis devices, RFID) or blood components (additive solutions, pathogen reduction technology, automated processing of platelets concentrates) or manufacturing process of these products (by automated processing of whole blood), all these steps where technological innovations were implemented, lead us to better traceability, more efficient processes, quality improvement of blood products and therefore increased blood safety for blood donors and patients. If we are on the threshold of a great change with the progress of pathogen reduction technology (for whole blood and red blood cells), we hope to see production of ex vivo red blood cells or platelets who are real and who open new conceptual paths on blood safety.

Invited review: organic and conventionally produced milk-an evaluation of factors influencing milk composition.

Consumer perception of organic cow milk is associated with the assumption that organic milk differs from conventionally produced milk. The value associated with this difference justifies the premium retail price for organic milk. It includes the perceptions that organic dairy farming is kinder to the environment, animals, and people; that organic milk products are produced without the use of antibiotics, added hormones, synthetic chemicals, and genetic modification; and that they may have potential benefits for human health. Controlled studies investigating whether differences exist between organic and conventionally produced milk have so far been largely equivocal due principally to the complexity of the research question and the number of factors that can influence milk composition. A main complication is that farming practices and their effects differ depending on country, region, year, and season between and within organic and conventional systems. Factors influencing milk composition (e.g., diet, breed, and stage of lactation) have been studied individually, whereas interactions between multiple factors have been largely ignored. Studies that fail to consider that factors other than the farming system (organic vs. conventional) could have caused or contributed to the reported differences in milk composition make it impossible to determine whether a system-related difference exists between organic and conventional milk. Milk fatty acid composition has been a central research area when comparing organic and conventional milk largely because the milk fatty acid profile responds rapidly and is very sensitive to changes in diet. Consequently, the effect of farming practices (high input vs. low input) rather than farming system (organic vs. conventional) determines milk fatty acid profile, and similar results are seen between low-input organic and low-input conventional milks. This confounds our ability to develop an analytical method to distinguish organic from conventionally produced milk and provide product verification. Lack of research on interactions between several influential factors and differences in trial complexity and consistency between studies (e.g., sampling period, sample size, reporting of experimental conditions) complicate data interpretation and prevent us from making unequivocal conclusions. The first part of this review provides a detailed summary of individual factors known to influence milk composition. The second part presents an overview of studies that have compared organic and conventional milk and discusses their findings within the framework of the various factors presented in part one.

[Roundtables of SFTS Congress 2013: Needs, indications and safety of blood products; self-sufficiency in blood products]. / Besoins, prescriptions et sécurité des produits sanguins labiles ; autosuffisance en produits sanguins labiles.

The current issues debate brings together experts around the themes of self-sufficiency (in its national and European aspects) and of needs in cellular blood products. The point of view of the manufacturer and prescribers of blood products are confronted.

Robotic distal pancreatectomy: a valid option?

Although reported in the literature, conventional laparoscopic approach for distal pancreatectomy is still lacking widespread acceptance. This might be due to two-dimensional vision and decreased range of motion to reach and safely dissect this highly vascularized retroperitoneal organ by laparoscopy. However, interest in minimally invasive access is growing ever since and the robotic system could certainly help overcome limitations of the laparoscopic approach in the challenging domain of pancreatic resection, notably in distal pancreatectomy. Robotic distal pancreatectomy with and without spleen preservation has been reported with encouraging outcomes for benign and borderline malignant disease. As a result of upgraded endowristed manipulation and three-dimensional visualization, improved outcome might be expected with the launch of the robotic system in the procedure of distal pancreatectomy. Our aim was thus to extensively review the current literature of robot-assisted surgery for distal pancreatectomy and to evaluate advantages and possible limitations of the robotic approach.

[Control of the bacterial risk of transfusion in France in 2013]. / Maîtrise du risque bactérien transfusionnel en France en 2013.

Bacterial contamination of blood products (BP) remains the most important infectious risks of blood transfusion in 2013. Platelet concentrates (PC) are the blood products the most at risk, whether CPA or MCPS. In France, the residual risk has been steadily declining since 1994. For the platelets, the frequency of transfusion reaction due to bacterial contamination (TRBC) is now about at one per 50,000 CP distributed. The number of deaths has remained stable since 1994 with one death per year (300,000 distributed CP). The progressive decrease in the number of cases of TRBCs is the result of steady improvement of practices and prevention methods at all stages from collection to the transfusion of BP. But if all these improvements have significantly reduced the incidence of TRBCs, mortality is not changed with the CP and the reduction of this risk is a priority for the French Blood Establishment (EFS). Detection methods of CP contaminated or pathogen inactivation are two approaches available and can provide a significant reduction (for the former) or deletion (for seconds) of the risk of transfused contaminated CP. Currently, the choice is in favor of the detection of bacteria. New detection "rapid tests" methods were added to the panel of candidates and are being evaluated. Inactivation of pathogens remains the safest prospect of eliminating this adverse effect of transfusion. Implementation of one method for bacterial detection is probably a transitional measure.

[Self-sufficiency, needs, prescription and safety of blood products]. / Autosuffisance, besoins, prescription et sécurité des produits sanguins labiles.

The current issues debate will bring together experts around the themes of self-sufficiency (in its national and European aspects) and of needs in cellular blood products. The point of view of the manufacturer and prescribers of blood products will be confronted.

Randomized clinical trial of laparoendoscopic single-site versus conventional laparoscopic cholecystectomy.

BACKGROUND: Conventional laparoscopy with three or more ports remains the 'gold standard' for cholecystectomy, but a laparoendoscopic single-site (LESS) approach is emerging, designed to decrease parietal trauma and improve cosmesis. This study compared conventional laparoscopic (CL) with LESS cholecystectomy, with short-term clinical results as the main outcomes. METHODS: A randomized trial of CL and LESS cholecystectomies involving 150 patients was undertaken. Follow-up was for 1 month after surgery. The primary endpoint was body image results evaluated by means of validated scales. Secondary endpoints were: postoperative pain measured on a visual analogue scale, analgesia requirement, morbidity, quality of life (QoL) measured with Short Form 12, duration of operation, hospital stay, time to return to work and cost analysis. RESULTS: Operating times and complications were similar in the two groups. Two LESS procedures (3 per cent) were converted to two-port laparoscopy owing to difficulties with exposure, and one CL operation was achieved through a single port because extensive fibrous peritoneal adhesions prevented placement of other ports. There were three and four port-site seroma/haematomas in the LESS and CL groups respectively. Better pain profiles and lower analgesia requirements were recorded in the LESS group (P < 0·001). QoL, body image and scar scale results were also better (P < 0·001). Operative costs were higher for LESS procedures (P < 0·001), although median time to return to work was shorter (P = 0·003). CONCLUSION: LESS is an alternative to CL cholecystectomy associated with better cosmesis, body image, QoL and an improved postoperative pain profile.

Assessment of 18F-FDG-leukocyte imaging to monitor rejection after pancreatic islet transplantation.

AIM: We sought to investigate the feasibility of 18F-FDG-leukocyte imaging to detect islet rejection. METHODS: Two thousand Sprague-Dawley (SD, syngeneic group) or Lewis (allogeneic group) islet equivalents were intraportally injected into SD rat recipients. Four and 7 days after transplantation, 10(8) 18F-FDG-labeled splenocytes were injected into the jugular vein. Splenocytes were harvested from naïve or sensitized (12 days after intraportal transplantation of 2000 Lewis IEQ) SD rats. Positron emission tomography (PET) imaging was started 5 minutes after splenocyte infusion and performed hourly for 4 hours. RESULTS: One hour after splenocyte injection, FDG was mainly detected in the heart and lungs. It was then further distributed to other organs, and from the second hour, the highest tracer concentration was located in the abdomen. Liver FDG uptake was similar between syngeneic, allogeneic, and sensitized allogeneic groups at 4 and 7 days after islet transplantation. DISCUSSION: No islet rejection was detected by 18F-FDG-leukocyte imaging. The amount of transplanted tissue was only few millilitres and the additional related inflammation in case of rejection is small and difficult to detect. The liver showed a relatively high spontaneous tracer uptake; the related background prevented detection of a potential increase in tracer uptake in cases of islet rejection.

Preoperative work-up in asymptomatic patients undergoing Roux-en-Y gastric bypass: is endoscopy mandatory?

BACKGROUND: We aimed to determine before Roux-en-Y gastric bypass (RYGBP) in asymptomatic morbidly obese patients: 1) the prevalence of abnormal findings at upper gastrointestinal (UGI) endoscopy; 2) Helicobacter pylori (HP) status; 3) clinical consequences of these findings; and 4) associated costs. METHODS: We retrospectively reviewed 468 consecutive patients, excluded those with UGI symptoms, drug intake or previous UGI endoscopy/surgery, and analyzed findings in the 319 remaining patients (68%). RESULTS: There were abnormal findings in 147 patients (46%), including 54 hiatal hernias and 146 parietal (i.e. mucosal or submucosal) lesions. The most significant were 7 ulcers and 2 gastric polyposis. HP was detected (using CLO-test) in 124 patients (39%). Histopathological examination of biopsies was abnormal in 109/161 patients (68%), and disclosed mainly chronic gastritis (n=98). Abnormal findings were more frequent in HP-positive compared to HP-negative patients (94 vs 51%, P<0.001). Findings had clinical implications in only 4% of patients: delayed surgery (7 ulcers), prophylactic gastrectomy (2 gastric polyposis), unnecessary work-up (3 irrelevant/false-positive diagnoses), and inclusion in a screening program (1 Barrett's esophagus). Mean cost of complete UGI work-up was 389 euro/patient. CONCLUSION: Asymptomatic morbidly obese patients frequently harbour UGI lesions warranting UGI work-up before RYGBP. However, routine endoscopy presents drawbacks. We propose a less invasive strategy which reduces costs and limits false-positive results and the subsequent investigations that they require. In our series, it would have missed two gastric polyposis only, for which no formal recommendation has yet been issued. This strategy could be a valuable alternative to routine UGI endoscopy before RYGBP in asymptomatic patients.

Sequential kidney/islet transplantation: efficacy and safety assessment of a steroid-free immunosuppression protocol.

The aim of this study was to assess the efficiency and safety of the Edmonton immunosuppression protocol in recipients of islet-after-kidney (IAK) grafts. Fifteen islet infusions were administered to 8 patients with type 1 diabetes and a functioning kidney graft. Immunosuppression was switched on the day of transplantation to a regimen associating sirolimus-tacrolimus-daclizumab. Insulin-independence was achieved in all patients for at least 3 months, with an actual rate of 71% at 1 year after transplantation (5 of 7 patients). After 24-month mean follow-up, five have ongoing insulin independence, 11-34 months after transplantation, with normal HbA1c, fructosamine and mean amplitude of glycemic excursions (MAGE) values. Results of arginine-stimulation tests improved over time, mostly after the second islet infusion. Severe adverse events included bleeding after percutaneous portal access (n=2), severe pneumonia attributed to sirolimus toxicity (n=1), kidney graft loss after immunosuppression discontinuation (n=1), reversible humoral kidney rejection (n=1) and fever of unknown origin (n=1). These data indicate that the Edmonton approach can be successfully applied to the IAK setting. This procedure is associated with significant side effects and only patients with stable function of the kidney graft should be considered. The net harm versus benefit has not yet been established and will require further studies with larger numbers of enrolled subjects.

How do pharmaceutical companies handle consumer adverse drug reaction reports? An overview based on a survey of French drug safety managers and officers.

It is surprising to see how consumer Adverse Drug Reaction (ADR) reports have been continuously increasing for the last few years in Europe. This probably results from the influence of United States (US) market where the patients feels justified in telephoning the pharmaceutical companies directly with queries regarding their treatment. The growing number of alternative sources of information (e.g. health and popular magazines, spots on radio and TV etc.) to which a consumer is exposed has added to this growth too. The changing relationship between patients and doctors may also contribute to this phenomenon. It is then interesting to evaluate the way pharmaceutical companies currently deal with consumer ADR reports. The management of consumer ADR reporting was investigated by means of a questionnaire sent to 46 French drug safety managers and drug safety officers (DSOs) of multinational pharmaceutical companies. The analysis of the survey stressed the fact that pharmaceutical companies should be prepared to face up to an increase in the number of consumer ADR reports. It clearly appears that the consumers who telephone to register side-effects should be forwarded to a trained DSO with medical or pharmaceutical background and the communication skills acquired through specific training. This person should also be able to release adequate product information validated by his/her own company. The influence of the US market seems to be changing the way pharmaceutical companies deal with consumer ADR reports. Nowadays, these reports are entered into a drug safety database by most of the companies without previously having contacted the patient's general practitioner (GP) or specialist for medical confirmation. Lastly, the drug safety managers and DSOs consulted have divided opinions about the usefulness of call centres and e-mails as tools for ADR reporting. But both tools are globally rejected by the pharmaceutical companies as a reliable means of reporting. As stated in this article, the reporting of ADRs via e-mail would cause real problems for the drug safety units. Finally, they consider that telephone call centres should be restricted to a specific communication problem such as crisis management or Dear Dr letters.

[Abstract quality assessment of articles from the Annales de Dermatologie]. / Qualité des résumés des articles publiés dans les Annales de Dermatologie.

INTRODUCTION: Article's abstracts are an important part of the publication, widely available in electronic databases. We assessed the quality of abstracts in the Annales de Dermatologie. The main objective was to compare abstract quality in 3 periods in the past decade. In this Journal, structured abstracts are required since 1993. The secondary objective was to compare structured and non structured abstract quality. MATERIAL AND METHODS: Three periods were assessed: 1991-92, 1996 and 2000. We selected the abstracts of original studies, excluding non focused descriptive case series. We used a criteria scale elaborated by Narine et al. Thirty criteria were assessed for each abstract, divided into 8 categories: purpose, research design, setting, subjects, intervention, outcome measurement, results and conclusion. If applicable to the study, a criterion was rated 1 (present) or 0 (absent). The final score for each abstract was defined as the ratio of positive answers among rated criteria. Mean scores for each period were compared using analysis of variance (mean +/- standard deviation). The temporal trend was calculated by simple linear regression. The mean scores of structured and unstructured abstracts were also evaluated and then compared. RESULTS: For each period, chronologically, 8, 17 and 18 (total 43) abstracts were evaluated. Mean scores for each period were 0.72 +/- 0.20 (1991-92); 0.69 +/- 0.12 (1996) and 0.83 +/- 0.08 (2000). These 3 scores were significantly different (P=0.006), with a trend toward increasing (Regression coefficient R(2)=0.136; P=0.015). Research setting obtained the lowest score (0.4). Structured (0.72 +/- 0.20; n=35) and non structured abstracts (0.76 +/- 0.12; n=8) were not significantly different. DISCUSSION: Abstracts of articles published in the Annales de Dermatologie contained on average 3/4 of the required informative items. The trend toward better scores may be explained by an increased attention of the editorial board as well as authors and reviewers. The quality could be improved by systematically mentioning the research setting.

[Blood transfusion surveillance: organization and results]. / Hémovigilance: organisation et résultats.

Created by law in 1994, haemovigilance is a national system of surveillance and alarm, from blood collection to the follow up of the recipients, gathering and analysing all untoward effects of blood transfusion in order to correct their cause and prevent recurrence. Three levels compose the haemovigilance network: local, regional and national. The incident reporting is mandatory and this rate is stable with 2.9 to 3 incidents per 1000 blood components transfused. The transfusion incident due to bacterial contamination and ABO incompatibility worry the medical community. Haemovigilance contributes to transfusion safety. It makes possible to recognise risks already known, to be on alert for emergent risks, to undertake preventive actions on critical steps of the transfusion chain, and to warrant follow up of safety measures efficiency.

Economic investigation of the use of three-compartment total parenteral nutrition bag: prospective randomized unblinded controlled study.

Optimal strategy for total parenteral nutrition (TPN) administration is essential both in terms of clinical effectiveness and economic efficiency. The aim of the present economic analysis was to provide a systematic and comprehensive cost comparison of the application of three currently available TPN systems: Separate Bottles (SB), Hospital-Compounded Bags (HCB) and Three-Compartment Bags (TCB). Sixty patients, admitted to the Geneva University Hospital and requiring TPN, were randomly assigned to one of the three systems. Three standard TPN formulas were prescribed to meet the patients' protein energy needs. TPN-related activities of medical, nursing and pharmacy staff were timed for the 24 hours of TPN administration. Manpower, nutrient solutions and medical supplies costs were calculated on the basis of mean Swiss salaries and hospital prices. TCB was the least expensive TPN system. SB and HCB systems' application costs were 120 and 150% of TCB cost, respectively. All intersystems cost comparisons were statistically significant (ANOVA p < or = 0.01). SB system required more items and manipulations, resulting in higher nurses manpower cost. Pharmacy overhead cost due to compounding was responsible for the higher cost of HCB system. Detailed manpower data presented in this study allow for an estimation of TPN application costs in other hospitals, using local salaries, specific product prices and compounding costs.

Laparoscopic and open live donor nephrectomy: a cost/benefit study.

Recently, laparoscopic liver-donor nephrectomy has been developed in order to increase organ donation. In this study we compare and review the records of 10 donors operated by open extraperitoneal approach and of 10 donors operated by a laparoscopic transperitoneal approach (LSC). Results show less use of postoperative parenteral narcotics in the LSC group (109 mg vs 272 mg; P < 0.0005) than in the extraperitoneal group. Morbidity was similar in both groups. There was no difference in postoperative stay. Allograft kidney function was similar in both groups until 6 months after donation. The use of disposable laparoscopic material bears an extra cost of 900 US$. We can thus conclude that laparoscopic live-donor nephrectomy is a safe procedure that significantly reduces postoperative pain, and is not detrimental to the allograft. The total cost of the laparoscopic procedure will be lower than that of the open approach if the length of postoperative stay is cut by 3 days.

Energy economy hampers body weight loss after gastric bypass.

The impact of energy economy on body weight loss was investigated in 20 obese women, submitted to Roux-en-Y gastric bypass. Resting energy expenditure (REE), substrate oxidation rates, plasma glucose, free fatty acid, and insulin and leptin levels were measured before and 3, 6, and 12 months after surgery. Predicted REE was obtained from linear regression analysis of REE and fat free mass, in a group of 85 women, whose body mass index ranged between 20 and 60 kg/m(2). The deviation from predicted REE, calculated as area under the curve (AUC) over the 12-month period for each patient, was considered as the expression of energy economy. Energy economy AUC was significantly (P: < 0.005) negatively related to the weight lost during 12 months after surgery. Energy intake, calculated from self-reported food consumption, was also expressed as AUC. Energy intake AUC showed a significant (P: < 0.002) positive correlation with weight loss. Lipid oxidation rate, also calculated as AUC, significantly correlated, negatively, with energy economy (P: < 0. 001) and, positively, with energy intake (P: < 0.002). Preoperative leptin values were significantly (P: < 0.01) linked to individual energy economy capacity. In conclusion, after Roux-en-Y gastric bypass, energy economy hampers the weight loss process, probably through a low fat oxidation rate.

[Dermatologic consultation in a precarious situation: a prospective medical and social study at the Hôpital Saint-Louis in Paris]. / Consultation dermatologique en situation de précarité: étude prospective médicale et sociale à l'Hôpital Saint-Louis à Paris.

INTRODUCTION: The aim of our study was to evaluate the outcomes and the cost of the dermatological consultation for poor and destitute patients, in Saint-Louis Hospital. PATIENTS AND METHODS: We carried out a prospective study from May to October 1996. One hundred and eighty-nine patients (237 consultations) who had no social welfare, were examined. RESULTS: They revealed that 82 p. 100 were male, 63.7 p. 100 were French, 13.9 p. 100 came from Maghreb, 9.7 p. 100 from Sub-Saharan Africa, 73 p. 100 were homeless and 25.7 p. 100 were alcoholic. The average age was around 37.6. The main medical disorders: scabies (56.5 p. 100), lice (22.4 p. 100) and cutaneous infections (7.2 p. 100) were related to the patients' living conditions and their social and economic situation. The other diseases observed were identical to the ones detected in regular health care centers. Complementary laboratories were necessary in 9.3 p. 100 consultations. Only 2 p. 100 of patients were admitted in Hospital. Local treatment was applied by nurses in 67 p. 100 of cases. Drugs were delivered free of charge by the Hospital's pharmacy in 64 p. 100 of cases. The cost of drugs was 83 FF per patient. The mean of duration of treatment was 10.5 days. DISCUSSION: Social workers are a key element in helping the patients to recover their social rights (49 p. 100 of patients have recovered social rights after 6 months). The frequency of skin diseases is higher in this population than in general population, especially in homeless persons. Access to health care is a problem of public health.

Erythropoietin and preoperative autologous blood donation in the prevention of hepatitis C infection: necessity or luxury?

BACKGROUND: Prevention of exposure to allogeneic blood transfusion during surgery is an important financial issue when recombinant human erythropoietin (rHuEPO) is used in addition to preoperative blood donation. STUDY DESIGN AND METHODS: The aim of this study was to carry out a cost-effectiveness analysis of the use of rHuEPO in preoperative blood donation in orthopedic surgery. The study, based on a decision tree analysis of the use of rHuEPO, was conducted from the perspective of the French health care system. The efficacy criterion was the number of hepatitis C infections prevented. The decision tree analysis was constructed as follows: the residual risk of hepatitis C infection was 8.26 per million units transfused, and the chance node was defined according to the number of units transfused. RESULTS: With the use of rHuEPO in preoperative blood donation, 0.30562 cases of hepatitis C infection per 100,000 patients were prevented. The incremental cost of one prevented hepatitis C infection amounted to $888,000,000 (US). CONCLUSION: Despite the limitations of our model, the cost-effectiveness ratio was so large that variations only slightly modified the size of the result. From the societal perspective, it was not cost-effective to add rHuEPO to preoperative blood donation.

Cost comparative study of autologous peripheral blood progenitor cells (PBPC) and bone marrow (ABM) transplantations for non-Hodgkin's lymphoma patients.

Intensive high-dose chemotherapy with autologous stem-cell support has become a common treatment strategy for non-Hodgkin's lymphomas. A cost-identification analysis was conducted comparing 10 patients autografted with PBSC to 10 others autografted with BM. The analysis included harvest and graft until graft day +100 and was carried out from the point of view of the hospital setting. Resources used, logistic and direct medical costs per patient were identified, and sensitivity analyses performed. The cost distribution was different. Stem cell harvest was more expensive for PBPC ($9030) and BM ($4745); on the other hand, hospitalization from graft to discharge from hospital cost savings with PBSC were about $10666. After discharge from hospital, costs were similar and cheaper in both groups. For the overall study the PBPC procedure was less expensive than ABMT, $35381 and $41759 respectively, with cost savings of $6378. The number of days spent in hospital and blood bank costs were the major cost factors. This study was based on a single pathology, non-Hodgkin's lymphoma, and the actual hospital records for each patient situation as opposed to a clinical trial, and our results were consistent with different previous studies carried out in different health care systems.