Purpose: The warm ischemia time may enhance the apoptosis process in lung tissue, leading to post-mortem degradation of mitochondrial-DNA (mtDNA) into damage associated molecular patterns (DAMPs).The DAMPs could serve as sentinel marker to primary graft dysfunction (PGD). Our objective is to compare the DAMPs observed in donors after brain death (DBD) and controlled circulatory death (cDCD).

Intensive care to facilitate organ donation (ICOD) is defined as the initiation or continuation of life-sustaining measures, such as mechanical ventilation, in patients with a devastating brain injury with high probability of evolving to brain death and in whom curative treatment has been completely dismissed and considered futile.

Los cuidados intensivos orientados a la donación (CIOD) se definen como el inicio o la continuación de medidas de soporte vital, incluyendo la ventilación mecánica, en pacientes con lesión cerebral catastrófica y alta probabilidad de evolucionar a muerte encefálica, en los que se ha descartado cualquier tipo de tratamiento.

Intensive care to facilitate organ donation (ICOD) is defined as the initiation or continuation of life-sustaining measures, such as mechanical ventilation, in patients with a devastating brain injury with high probability of evolving to brain death and in whom curative treatment has been completely dismissed and considered futile. ICOD incorporates the option to organ donation allowing a holistic approach to end-of-life care, consistent with the patients wills and values. Should the patient not evolve to brain death, life-supportive treatment must be withdrawal and controlled asystolia donation could be evaluated. ICOD is a legitimate practice, within the ethical and legal regulations that contributes increasing the accessibility of patients to transplantation, promoting health by increasing deceased donation by 24%, and with a mean of 2.3 organs transplanted per donor, and collaborating with the sustainability of health-care system. This ONT-SEMICYUC recommendations provide a guide to facilitate an ICOD harmonized practice in spanish ICUs. ? 2019 Published by Elsevier Espa?a, S.L.U.

Statin use may contribute to lessen the severity of PGD. Prospective and multicentric studies with larger samples are needed to confirm such results.

Controlled DCD triggers a lower inflammatory response than DBD that may also influence the inflammatory pattern in the recipient. cDCD is a safe alternative to DBD in lung transplantation.

Purpose Primary graft dysfunction (PGD) is the main cause of mortality during the first month and the second one within the first year after lung transplantation (LT). Statins, 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA) reductase inhibitors, have been proposed as an effective class of drugs to reduce serum cholesterol levels due to their immunomodulatory and anti-inflammatory effects unrelated to their cholesterol-lowering function. We hypothesized that preoperative statin therapy is associated with decreased incidence of PGD after LT. Methods Retrospective analysis of all consecutive adult LTs performed in a university transplant center between 2010 and 2017. Comparison between groups according to the recipient previous use of statins was carried out. Factors associated with the development of PGD and PGD grade 3 were analyzed using Chi square and U-Mann Whitney Test. Logistic regression model was built including those variables with p≤0.1 in the univariate analysis. Significance level p<0.05 Results A total of 474 adult LT recipients were followed, 54 of them (11%) under statins treatment. Statins group (SG) were older (59 vs 55;p=0.003), with higher prevalence of hypertension (HT)(37% vs 16%; p<0.001) and lower walking 6min test (W6T) results (211 vs 246 meters; p=0.019) than non-statin group (NSG). Cardiopulmonary bypass (CPB) was used in 29% of SG recipients and 17% of NSG (p=0.07). The rest of recipient and donor characteristics were similar between groups. Global and grade 3 incidence of PGD was 38% and 31.4%, respectively, with higher incidence in NSG (40% vs 24%; p=0.027; 33% vs 20%; p=0.063). After adjustment for recipient age, body mass index (BMI), HT, W6T, CPB and ischemia times, NSG showed an increased risk of PGD (OR=2.08; p=0.035), and PGD grade 3 (OR=1.87; p=0.086) compared with SG. Conclusion Recipient´s preoperative use of statins is associated with a decreased risk to develop PGD in our series. Prospective and multicentric studies are needed to confirm such results.

While there is increasing interest in its use, definitive evidence demonstrating superiority of normothermic regional perfusion in controlled donation after circulatory death liver transplantation has not been presented. Unlike the rest of the Western world, where use of NRP has been anecdotal, 25% of all cDCD donors that have been performed in Spain since 2012 have included post-mortem NRP. Aim Analyze the first years of the Spanish experience with cDCD liver transplantation, in particular regarding the impact post-mortem NRP has had on organ utilization rates and transplant outcomes. Methods Data was collected regarding potential cDCD liver donors and transplants that resulted between 2012 and 2016. All transplants had at least 6 mos of follow-up. Each donor hospital determined the process by which organs were recovered: NRP with pre-mortem cannulation, NRP with post-mortem cannulation, or super rapid recovery. Results From 2012 to 2016, 370 potential cDCD liver donors were evaluated: 152 with NRP and 218 with SRR. Ultimately, rates of liver transplantation were 64% NRP and 57% SRR (P=0.102). Among livers that were transplanted, median donor age was 57 (46-65 IQR). While there were no differences in terms of relevant donor or recipient characteristics when analyzed according to recovery method, the functional warm ischemia time was shorter when NRP was applied – 12 (10-16) NRP vs. 15 (11-20) SRR – given that in most cases femoral cannulae were placed prior to withdrawal of care. While rates of early allograft dysfunction (22% NRP vs. 29% SRR) and PNF (2% NRP vs. 4% SRR) did not vary, rates of overall biliary complications (9% NRP vs. 24% SRR, P=0.006) and ITBL (2% NRP vs. 12% SRR, P=0.01) were significantly improved among recipients of livers recovered with NRP. One-year graft survival was 87% NRP vs. 78% SRR (P=0.110). On multivariate analysis analyzing risk factors for ITBL (including fWIT), the only significant factor was the organ recovery method used. Conclusions This is the first large series describing the application of NRP in cDCD liver transplantation. While results with SRR were acceptable, results using NRP were superior and comparable to those achieved using standard-quality livers, even in spite of advanced donor age.

With 40 donors and more than 100 transplant procedures per million population in 2015, Spain holds a privileged position worldwide in providing transplant services to its patient population. The Spanish success derives from a specific organizational approach to ensure the systematic identification of opportunities for organ donation and their transition to actual donation and to promote public support for the donation of organs after death. The Spanish results are to be highlighted in the context of the dramatic decline in the incidence of brain death and the changes in end-of-life care practices in the country since the beginning of the century. This prompted the system to conceive the 40 donors per million population plan, with three specific objectives: (i) promoting the identification and early referral of possible organ donors from outside of the intensive care unit to consider elective non-therapeutic intensive care and incorporate the option of organ donation into end-of-life care; (ii) facilitating the use of organs from expanded criteria and non-standard risk donors; and (iii) developing the framework for the practice of donation after circulatory death. This article describes the actions undertaken and their impact on donation and transplantation activities.

To the Editor: We have read with interest Sharif's letter regarding our publication on the strategies developed in Spain to progress toward self-sufficiency in transplantation (1Sharif A Viva España—lessons from the Spanish organ donation system.Am J Transplant. 2017; (doi: 10.1111/ajt.14246.)Abstract Full Text Full Text PDF Scopus (9) Google Scholar). The recognition of the efforts made along the years to achieve high levels of deceased donation (43.4 donors per million population [pmp] in 2016), well summarized by his "Viva España," is highly appreciated. We agree that Spaniards consider insignificant the impact of the type of consent on the donation activity. To the contrary, infrastructure, organization around the process of deceased donation, and continuous innovation are deemed the keys for success (2Matesanz R Domínguez-Gil B Pros and cons of a regulated market in organs.Lancet. 2009; 374: 2049Abstract Full Text Full Text PDF PubMed Scopus (8) Google Scholar). The opt-out system was stated in the Transplantation Law, issued in 1979. The terms of its application are specified and softened in the successive Decrees. The donor coordinator is legally obliged to rule out an expressed opposition to donate, in the patient′s documentation, clinical record, advanced directives register, and through a family interview. In practice, the relatives always give the final veto. Therefore, the Spanish approach is not substantially different from that in opt-in realities. Moreover, it was not until 10 years after the Law approval that donation took off. Sharif mentions the lack of an official register in Spain, which needs clarification. Instead of developing a dedicated donor/nondonor registry, the decision was to use the existing official advanced directives register as one of the means to declare the will about posthumous donation. Regarding live donor rates, when certain measures were taken to boost transplantation some years ago, live donation was also redesigned (3Matesanz R Marazuela R Dominguez-Gil B Coll E Mahillo B de la Rosa G The 40 donors per million population plan: An action plan for improvement of organ donation and transplantation in Spain.Transplant Proc. 2009; 41: 3453-3456Crossref PubMed Scopus (63) Google Scholar). Among other measures, national nondirected altruistic and kidney paired exchange programs were developed and now account for 9% of the live kidney transplants. Although live donation rates seem scarce when compared to those of other countries such as the United Kingdom, live kidney transplants pmp rose six times in 10 years, from 1.4 (2005) to 8.4 (2015) (Figure 1) (4International figures in donation and transplantation (2005 and 2015). Newsletter Transplant. [cited 2017 April 20]. Available from: http://www.ont.es/publicaciones/Paginas/Publicaciones.aspx.Google Scholar). In agreement with the author, it is thought among us that due to the high deceased donor rates, medical teams, relatives, and why not, patients on the waiting list themselves are somehow reluctant to submit a live donor to a surgical injury and to a known lifetime risk, expecting a deceased donor organ will appear. Another aspect refers to the information the public receives regarding organ donation. Close attention to the mass media is a pillar of the Spanish system and a preeminent way to inform the public and raise awareness (5Matesanz R Dominguez-Gil B Coll E de la Rosa G Marazuela R Spanish experience as a leading country: What kind of measures were taken?.Transpl Int. 2011; 24: 333-343Crossref PubMed Scopus (165) Google Scholar). As a result of our communication policy, journalists have become allies in promoting donation, and the presence of the topic in the media is continuous and massive. For example, an independent assessment showed 155 media reports or news on the topic in the press, radio, and TV (internet and social media excluded) on the day the annual donation and transplantation activity was presented in 2016. The estimated audience was 24 million people. This continuous approach to the public is necessary, but not sufficient. The critical moment arises when the possible donor appears. Then, as Sharif points out, the other elements of the Spanish system, organization and training, become determinant. The authors of this manuscript have no conflicts of interest to disclose as described by the American Journal of Transplantation.

Objective: To describe end-of-life care practices relevant to organ donation in patients with devastating brain injury in Spain.Design: A multicenter prospective study of a retrospective cohort. Period: 1 November 2014 to 30 April 2015.Setting: Sixty-eight hospitals authorized for organ procurement. Patients: Patients dying from devastating brain injury (possible donors). Age: 1 month-85 years.Primary endpoints: Type of care, donation after brain death, donation after circulatory death, intubation/ventilation, referral to the donor coordinator.Results: A total of 1,970 possible donors were identified, of which half received active treatment in an Intensive Care Unit (ICU) until brain death (27%), cardiac arrest (5%) or the withdrawal of life-sustaining therapy (19%). Of the rest, 10% were admitted to the ICU to facilitate organ donation, while 39% were not admitted to the ICU.Of those patients who evolved to a brain death condition (n = 695), most transitioned to actual donation (n = 446; 64%). Of those who died following the withdrawal of life-sustaining therapy (n = 537), 45 (8%) were converted into actual donation after circulatory death donors. The lack of a dedicated donation after circulatory death program was the main reason for non-donation.Thirty-seven percent of the possible donors were not intubated/ventilated at death, mainly because the professional in charge did not consider donation alter discarding therapeutic intubation.Thirty-six percent of the possible donors were never referred to the donor coordinator. Conclusions: Although deceased donation is optimized in Spain, there are still opportunities for improvement in the identification of possible donors outside the ICU and in the consideration of donation after circulatory death in patients who die following the withdrawal of life-sustaining therapy. (C) 2016 Elsevier Espana, S.L.U. y SEMICYUC. All rights reserved.

Background: We previously demonstrated that an intensive lung donor management protocol increased the lung procurement rate. Our aim was to confirm this observation in other centers. Methods: A multicenter study.Lung management protocol for donors after brain death (DBD) was sent to 6 Spanish centers. The centers were selected for having more than 20 DBDs per year and lung donation rate similar to the Spanish one. No training was previously carried out in any center. Lung donors during 2013 were the prospective cohort, and those from 2010-2012 the control group. There were no changes in donor selection criteria between the two periods. Lungs were offered by the Spanish procurement organization (ONT) to all Spanish lung transplant programs, and those made the final decision on the suitability of the lungs. Lungs available for transplantation were the main outcome measure. For recipients, early survival and the rate of primary graft dysfunction (PGD) were the main outcome measures. Basic descriptive analysis is presented, comparing qualitative variables in both groups with Chi-square test. T test for paired samples was used for analyzing gasometrical evolution. Results:The study group had 45 lung donors from 114 DBDs ≤ 70 years old while the control group (2010-2012) had 59 from 326 DBDs (lung donation rate 39.5% vs 18.1% respectively;p<0.001). We increased annual recovered lungs from 37 (average 2010-2012) to 84 (2013;p<0.001) and annual lung transplants (from 19 to 41;p<0.001).Protocol development showed a significant increase in PaO2/FiO2 before initiation and before grafts retrieval (335±108 vs 416±87;p<0.001). No differences were observed in the early recipients’ survival (87.8% vs 84.5%;p=0.773) nor in the rate of PGD (42.1% vs 44.6%;p=0.835). Conclusion: This protocol may be easily implemented without previous training. This lung donor-management protocol increases lung procurement rates without negative impact on early lung recipients’ survival nor on the rate of PGD. This work was supported by the Fundacion Mutua Madrileña

Analizar los resultados de la implantación de un programa de donación Maastricht II en una ciudad de 200.000 habitantes. Inicialmente solo donación pulmonar y tras 9 meses se amplió a donación renal.Estudio observacional prospectivo de octubre de 2012 a diciembre de 2013.UCI del Hospital Universitario Marqués de Valdecilla y área metropolitana de Santander.Pacientes < 55 años fallecidos por parada cardiaca extrahospitalaria.La asistencia extrahospitalaria fue con cardiocompresor mecánico (LUCAS II). El diagnóstico de muerte, la asistencia y preservación de los injertos a donar se realizó íntegramente en la UCI.Se recibieron un total de 14 llamadas, descartándose 3. De los 11 potenciales donantes, 7 fueron donantes utilizados con edad mediana de 39,5 años (rango: 32 - 48). Se realizaron 5 trasplantes unipulmonares, 4 trasplantes renales, además de córneas y tejidos. Los donantes no válidos se debieron a problemas técnicos. No hubo negativas. La supervivencia de los trasplantados pulmonares fue 100% al mes y 80% al año. Todos los trasplantados renales presentaban creatinina al mes < 2 mg/dl. El tiempo parada-preservación renal fue 80 minutos (rango intercuartílico: 71 - 89) y el tiempo parada-preservación pulmonar fue 84 minutos (rango intercuartílico: 77 - 94).Un programa Maastricht II en una ciudad pequeña es viable tanto para órganos abdominales como torácicos. La potencialidad es mejorable al incrementar la edad de valoración y disponer de cardiocompresores mecánicos en todas las ambulancias. El tratamiento íntegro del donante en la UCI reduce los tiempos de isquemia caliente mejorando los resultados postrasplante.To study the results of a non-controlled cardiac death (Maastricht type II) donor program in a city of 200,000 inhabitants. The study was initially focused on lung donation and was extended to kidney donation after 9 months.A prospective observational study was conducted between October 2012 and December 2013.The Intensive Care Unit of Marqués de Valdecilla University Hospital in Santander (Spain), and surrounding areas.Patients (< 55 years) who died of out-of-hospital cardiac arrest.All out-of-hospital cardiac arrests were treated with mechanical cardiac compression (LUCAS II). The diagnosis of death and organ preservation were performed in the ICU.A total of 14 calls were received, of which three were discarded. Of the 11 potential donors, 7 were effective donors with a median age of 39.5 years (range: 32 - 48). A total of 5 single lung transplants and four kidney transplants were performed. In addition, corneas and tissues were harvested. The non-valid donors were rejected mainly due to technical problems. There were no donation refusals on the part of the patient relatives. The lung transplant patient survival rate was 100% after one month and 80% after one year. One month after transplantation, the kidney recipients had a serum creatinine concentration of < 2 mg/dl. The interval from cardiac arrest to renal preservation was 80 minutes (range: 71 - 89), and the interval from cardiac arrest to lung preservation was 84 minutes (range: 77 - 94).A Maastricht type II donation program in a small city is viable for both abdominal and thoracic organs. The program was initially very cautious, but its potential is easily improvable by increasing donor and by equipping mobile ICU ambulances with mechanical cardiac compression systems. Full management of the donor in the ICU, avoiding the emergency department or operating rooms, reduces the warm ischemia time, thereby improving transplant outcomes.

Abstract 3394 The generation of thrombin is the pivotal event in the process of blood coagulation. In vivo, thrombin generation is regulated by cooperation between the vascular endothelium and the pro- and anti-coagulant systems in blood, such as the thrombin/endothelial cell-dependent activation of the protein C anticoagulant pathway that ultimately leads to inactivation of factors Va and VIIIa. In vitro, thrombin generation is assessed most commonly in platelet-poor plasma by a fluorogenic substrate-based thrombin generation assay (TGA) in microtiter plates. While this assay can accurately measure the kinetics of thrombin generation in plasma (including Lag time [LT], Peak thrombin [PT], and endogenous thrombin potential [ETP]), it does not assess the influence of the endothelial cell-dependent protein C pathway on thrombin generation. As a result, the assay has limited value in the assessment of the hypercoagulable patient. In the present study we introduced a surrogate endothelium to the TGA, thus including activated protein C-induced inactivation of factors Va and VIIIa in the assay system. Wells of flat-bottomed microtiter plates were coated with 3 × 104quiescent EA.hy926 endothelial-like cells which consistently express thrombomodulin (TM) as well as the endothelial protein C receptor (EPCR). The concentration of active TM associated with EA.hy926 in the assay well was determined by a chromogenic assay and found to be ∼0.5 nM. Tissue factor (TF)-initiated thrombin generation was evaluated in normal pooled plasma (NP), and in protein C-deficient (PCd), protein S-deficient (PSd), and heterozygous factor V Leiden (fVL) plasmas, in the presence or absence of endothelial cells. Thrombin generation in NP was reduced in the presence of endothelial cells as evidenced by a 55% reduction in PT, and a 40% reduction in ETP. LT was prolonged by 83% in the presence of endothelial cells. However, in PCd, PSd and fVL plasmas, endothelial-induced suppression of thrombin generation was blunted. Specifically, only relatively small reductions were observed in PT (26% in PCd, 28% in PSd, 20% in fVL) and ETP (12% in PCd, 6% in PSd, and 14% in fVL). Furthermore, only in the presence of endothelial cells, addition of protein C to PCd plasma dose-dependently reversed the effect of protein C deficiency on PT and ETP. In separate experiments in the absence of endothelial cells, we noted that while similar results were obtained in the presence of the soluble form of thrombomodulin, the concentration required (30 nM) was 60 times higher than that expressed on the endothelial cell monolayer. This suggests that protein C activation occurs more efficiently in the presence of EA.hy926 cells. In summary, by introducing an endothelial cell monolayer to the TGA, and measuring thrombin generation kinetics in the presence or absence of these cells, we have adapted the assay to assess the contribution of the protein C anticoagulant system to thrombin generation in a physiologically relevant manner. This novel approach not only enables the functions of the endothelial-dependent PC pathway by expressing TM and EPCR, but also may provide other endothelial components relevant to thrombin generation (such as tissue factor pathway inhibitor [TFPI]). This approach to thrombin generation assessment may therefore have both research and clinical applicability. Disclosures: No relevant conflicts of interest to declare.

To present the preliminary results of a non-heart beating donor (NHBD) program in a city of under 500,000 inhabitants.A prospective observational study was conducted between 2010 and 2011.Virgen de las Nieves Hospital and metropolitan area of Granada (Spain).NHBD and brain dead donors (BDD) in the province of Granada during 2010 and 2011.Characteristics of NHBD, out- and in-hospital times, family and legal refusals, preservation methods, and family information procedure. Organs: reasons for organ non-validness, and harvested and transplanted organs. Recipients: hemodialysis sessions and creatinine at discharge. BDD: number of real donors (RD) and of kidney transplants.Among the BDD there were 102 RD and 104 kidney transplants were carried out. In asystole, 22 potential donors, 21 eligible donors, 20 RD and 13 used donors were registered. The mean age among the RD was 50 years (range 33–62) (16 males and 4 females). Twenty-one kidney and two liver transplants from NHBD were performed. There were a number of reasons for organ non-validness. The mean number of post-transplantation hemodialysis sessions was 1.4 (range 0–6). The mean hospital stay was 25 days (range 14–41), and the mean creatinine concentration at discharge was 3.4 mg/dl (range 1.5–6.4). There was one family rejection and no legal (court-ruled) rejections. The preservation methods and family information procedure are described.The preliminary results support the development of NHBD programs in cities with under 500,000 inhabitants. In 2011, NHBD accounted for 20.19% of the kidney transplants and 19.60% of the global organ donations in the province of Granada.Presentar resultados iniciales de un programa de donación en asistolia (DA) en una ciudad de menos de 500.000 habitantes.Estudio observacional prospectivo durante 2010 y 2011.Hospital Virgen de las Nieves y Área Metropolitana de Granada.DA y donantes en muerte encefálica (DME) de la provincia de Granada en 2010 y 2011.Características de los DA, tiempos extrahospitalarios e intrahospitalarios, negativas familiares y judiciales, métodos de preservación, procedimiento de información a familiares. Órganos: causas de no validez, extraídos y transplantados. Receptores: sesiones de hemodiálisis y creatinina al alta. DME: número de donantes reales (DR) y de trasplantes renales.En ME hubo 102 DR y se realizaron 104 trasplantes renales. Se han registrado en asistolia 22 donantes potenciales (DP), 21 donantes elegibles (DE), 20 DR y 13 donantes utilizados (DU). Edad media de los DR: 50 años (rango 33–62), 16 hombres y 4 mujeres. Se han realizado 21 trasplantes renales y 2 hepáticos de DA. Las causas de no validez son múltiples. Número medio de sesiones de hemodiálisis postrasplante: 1,4 (rango 0–6). Estancia hospitalaria media: 25 días (rango 14–41). Creatinina media al alta: 3,4 mg/dL (rango 1,5–6,4). Ninguna negativa judicial y una negativa familiar. Se describen los métodos de preservación y el procedimiento de información a familiares.Los resultados iniciales apoyan el desarrollo de programas de DA en ciudades de menos de 500.000 habitantes. La DA ha supuesto en 2011 el 20,19% de los trasplantes renales y el 19,6% de los donantes de órganos de la provincia de Granada.

However, we would like to point out an error regarding the incidence of TB in Spain. In the paper previously referred to, Table 3 shows TB incidence in different countries categorized according to World Health Organizations cutoff points, Spain being incorrectly located in the interval 25–49/100 000 population. The incidence of TB in Spain in recent years has ranged between 16 and 17 cases/100 000 population (2,3), as is correctly reflected in Figure 1 in the same article.

Introduction and Aims: Hemoglobin (Hb) stability with C.E.R.A. once-monthly (QM) was evaluated in high risk patients with chronic kidney disease (CKD) on dialysis switched from shorter-acting erythropoiesis-stimulating agents (ESAs).Methods: Adult CKD patients on dialysis were converted to C.E.R.A. QM to achieve a target Hb of 10.0-12.0g/dL (5 studies), 10.5-12.5 g/dL (3 studies), 11.0-12.5 g/dL and 11-13 g/dL (one study each).High risk (HR) and low risk (LR) subgroups were defined on the basis of therapy parameters before switching: epoetin or darbepoetin alfa dose (=8000 IU or 40 μg, respectively), average Hb at screening (below the 40% percentile [P60] for LR).The ratio of dose and achieved Hb at screening >P60 (HR), or Hb fluctuation >P60 (HR) were defined by the same parameters.Cardiovascular (CV) risk groups were defined by pre-existing cardiac risk factors (diabetes or cardiac disorder), or through >P60 N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels.Treatment switchover was followed by a 16-week titration and an 8-week evaluation period.Hb parameters, dosing and safety in the evaluation period were compared.Results: Patients (N=1577); median age 63 (range: 19-93) years were classified into HR/LR subgroups as shown in the table.Evaluation of therapy-related subgroups showed generally significantly higher mean Hb values for the LR subgroups.The largest difference (0.4 g/dL) was seen for subgroups by dose/Hb, while subgroups by Hb fluctuation showed no difference.The difference seen for the HR/LR screening Hb group represented a reduction from 1.2 g/dL difference at screening to 0.3 g/dL after the switch to C.E.R.A.There was less variation in mean Hb levels for the HR/LR subgroups by CV risk factors.Hb stability (mean Hb within target range or change from baseline =1 g/dL) was similar across all subgroups.Mean required C.E.R.A. dose QM was higher for all HR groups than the LR counterparts, with significant differences for four of the comparisons.As expected, significantly higher frequencies of cardiac and vascular SAEs were seen in HR versus LR patients for NT-proBNP (HR/LR, 5.7/1.9;p<0.004 for cardiac SAEs) and baseline risk factors (4.6/2.0;p<0.02 for cardiac SAEs; 4.9/1.3;p=0.0004 for vascular SAEs).Conclusions: The pooled analysis in dialysis patients shows that C.E.R.A. QM maintains stable Hb levels in all HR patients as well as in patients with prevailing CV risk factors.