Changes in vascular access profile for pediatric hemodialysis patients over time: A registry-based study from Catalonia.

BACKGROUND: The criteria for vascular access (VA) selection in pediatric hemodialysis (HD) population has changed over time until the current patient-centered approach using the individualized Life-Plan. We analyzed the type of VA used by incident and prevalent end-stage kidney disease (ESKD) pediatric patients (pts) treated with HD in Catalonia. METHOD: Data from the Catalan Renal Registry of ESKD pts under 18 years of age undergoing kidney replacement therapy (KRT) were examined for a 22-year period (1997-2018). RESULTS: ESKD children starting KRT through HD decreased progressively from 55.6% (1997-2001) to 38.2% (2012-2018) and, conversely, there was an increase in pts starting KRT by preemptive kidney transplantation (KT) from 28.9% to 42.6% between the same periods (for both comparisons, p = 0.007). Most ESKD pts started HD by fistula (AVF) from 1997 to 2001 (56.5%) but this percentage decreased over time and no AVFs were used to start HD in children from 2012 to 2018. Likewise, the percentage of children starting HD by tunneled catheter increased progressively from 8.7% to 72.2% between the same periods (for both comparisons, p < 0.001). Regarding prevalent ESKD pts, children on HD decreased from 34.9% in 1997 to 4.7% in 2018 and, conversely, pts with a functioning kidney graft increased from 62.8% to 92.4% during the same periods (for both comparisons, p < 0.001). There was a progressive decrease in the percentage of children dialyzed by AVF from 100% in 1997 to 0% in 2018 (p < 0.001). The KT rate increased from 5.4 per million population (pmp) in 1997 to 17.1 pmp in 2018 (p = 0.007). The median time on HD prior to the first KT progressively decreased to 6.6 months (2014-2018). CONCLUSION: The high KT rate was a determining factor in choosing the VA type in the incident and prevalent pediatric population treated with HD in Catalonia.

Addressing Risks Derived From the Commodification of Substances of Human Origin: A European Proposal Applicable Worldwide.

In view of the public consultation recently launched by the World Health Organization on Regulatory Convergence of Cell and Gene Therapy Products and the Proposal for a Regulation on substances of human origin (SoHO) repealing the European Union Directives on Blood and on Tissues and Cells, an opportunity arises to define an ethical and transparent framework of collaboration between industry and authorities responsible for SoHO-derived products, comprising medicines, medical devices, transfusion, and transplantation. The commodification of SoHO-derived medicinal products and medical devices entails important risks to the sustainability of healthcare systems and threatens the equitable access of patients to innovative therapies. It may also jeopardize the principle of altruistic donation of SoHO that is required for the treatment and survival of thousands of patients every year. This article puts forward several proposals aimed at reconciling the ethical principles of voluntary and unpaid SoHO donation and the noncommercialization of the human body with obtaining a profit that allows business activities, while ensuring high quality, safety, and efficacy standards of tissues and cells for clinical use.

Effect of kidney transplantation activity on arteriovenous fistula use in prevalent haemodialysis patients: A registry-based study.

BACKGROUND: Kidney transplantation (KT) is considered to be the best kidney replacement therapy (KRT) option for most end-stage kidney disease (ESKD) patients. Arteriovenous fistula (AVF) is considered to be the best vascular access (VA) for most haemodialysis (HD) patients. In this study, we investigated the effect of KT activity on AVF use in prevalent HD patients. The probability of receiving a kidney graft (KTx) over time, depending on the first VA used to start the HD program, was also evaluated. METHODS: Data from the Catalan Registry of prevalent patients on KRT by either KT or HD were examined over a 20-year period (1997-2017). RESULTS: The percentage of prevalent ESKD patients with a functioning KTx increased from 40.5% in 1997 to 57.0% in 2017 and, conversely, the percentage of AVF utilisation in HD patients decreased from 86.0% to 63.2% during the same period (for both comparisons, p < 0.001). This inverse relationship was also demonstrated in other countries and regions worldwide by performing a simple linear regression analysis (R2 = 0.4974, p = 0.002). The probability of prevalent patients dialysed through an AVF in Catalonia was independently associated with the percentage of functioning KTx among KRT population, after adjusting by age, gender, primary kidney disease, time on KRT, cardiovascular disease and type of HD Unit. Incident patients starting HD through an AVF had a significantly higher probability of receiving a KTx over time in comparison to patients who initiated HD through a catheter (hazard ratio 1.68 [95% confidence interval: 1.41-2.00], p < 0.001). CONCLUSIONS: In addition to some demographical and clinical characteristics of patients and type of HD Unit, KT activity can be a determining factor in AVF use in prevalent HD patients. Starting an HD programme through an AVF is independently associated with a greater probability of receiving a KTx as compared to starting HD through a catheter.

Mortality in elderly patients starting hemodialysis program.

BACKGROUND: The incidence of older patients over 80 years old with chronic kidney disease who start hemodialysis (HD) program has been increasing in the last decade. METHODS: We aimed to identify risk factors for morbidity and mortality in patients older than 80 years with end-stage renal disease who started HD. We conducted a retrospective observational study of the Catalan Renal registry (RMRC). RESULTS: A total of 2833 patients equal or older than 80 years (of 15,137) who started HD between 2002 and 2019 from the RMRC were included in the study. In this group, the first dialysis was performed through an arteriovenous fistula in 44%, percutaneous catheter in 28.2%, and tunneled catheter in 26.6%. Conventional dialysis was used in 65.7% and online HD in 34.3%. The most frequent cause of death was cardiac disease (21.8%), followed by social problems (20.4%) and infections (15.9%). Overall survival in older HD during the first year was 84% versus 91% in younger than 80 years (p < 0.001). Cox regression analysis identified the start of HD in the period 2002-2010, chronic obstructive pulmonary disease (COPD), and the onset of HD through vascular graft depicted as risk factors for first-year mortality after dialysis initiation in patients older than 80 years with end-stage renal disease who started HD. CONCLUSIONS: In conclusion, patients older than 80 years who started HD program had higher mortality, especially those who presented exacerbation of kidney disease, those with COPD, and those who started with a vascular graft.

Effect of kidney replacement therapy modality after first kidney graft failure on second kidney transplantation outcomes.

Background: There is a lack of information regarding which is the best dialysis technique after kidney transplant (KT) failure. The aim of this study is to compare the effect of kidney replacement therapy modality-peritoneal dialysis (TX-PD-TX), haemodialysis (TX-HD-TX) and preemptive deceased donor retransplantation (TX-TX) on patient survival and second KT outcomes. Methods: A retrospective observational study from the Catalan Renal Registry was carried out. We included adult patients with failing of their first KT from 2000 to 2018. Results: Among 2045 patients, 1829 started on HD (89.4%), 168 on PD (8.2%) and 48 (2.4%) received a preemptive KT. Non-inclusion on the KT waiting list and HD were associated with worse patient survival. For patients included on the waiting list, the probability of human leucocyte antigens (HLA) sensitization and to receive a second KT was similar in HD and PD. A total of 776 patients received a second KT (38%), 656 in TX-HD-TX, 72 in TX-PD-TX and 48 in TX-TX groups. Adjusted mortality after second KT was higher in TX-HD-TX patients compared with TX-TX and TX-PD-TX groups, without differences between TX-TX and TX-PD-TX groups. Death-censored second graft survival was similar in all three groups. Conclusions: Our results suggest that after first KT failure, PD is superior to HD in reducing mortality in candidates for a second KT without options for preemptive retransplantation.

Haemodialysis access profile in failed kidney transplant patients: Analysis of data from the Catalan Renal Registry (1998-2016).

BACKGROUND: Data about vascular access (VA) use in failed kidney transplant (KT) patients returning to haemodialysis (HD) are limited. We analysed the VA profile of these patients, the factors associated with the likelihood of HD re-initiation through fistula (AVF) and the effect of VA in use at the time of KT on kidney graft (KTx) outcome. METHOD: Data from the Catalan Registry on failed KT patients restarting HD and incident HD patients with native kidney failure were examined over an 18-year period. RESULTS: The VA profile of 675 failed KT patients at HD re-initiation compared with that before KT and with 16,731 incident patients starting HD was (%): AVF 79.3 versus 88.6 and 46.2 (p = 0.001 and p < 0.001), graft AVG 4.4 versus 2.6 and 1.1 (p = 0.08 and p < 0.001), tunnelled catheter TCC 12.4 versus 5.5 and 18.0 (p = 0.001 and p < 0.001) and non-tunnelled catheter 3.9 versus 3.3 and 34.7 (p = 0.56 and p < 0.001). The likelihood of HD re-initiation by AVF was significantly lower in patients with cardiovascular disease, KT duration >5 years, dialysed through AVG or TCC before KT, and females. The analysis of Kaplan-Meier curves showed a greater KTx survival in patients dialysed through arteriovenous access than in patients using catheter just before KT (λ2 = 5.59, p = 0.0181, log-rank test). Cox regression analysis showed that patients on HD through arteriovenous access at the time of KT had lower probability of KTx loss compared to those with catheter (hazard ratio 0.71, 95% CI 0.55-0.90, p = 0.005). CONCLUSIONS: The VA profile of failed KT patients returning to HD and incident patients starting HD was different. Compared to before KT, the proportion of failed KT patients restarting HD with AVF decreased significantly at the expense of TCC. Patients on HD through arteriovenous access at the time of KT showed greater KTx survival compared with those using catheter.

Kidney transplant outcomes in elderly recipients with controlled donation after circulatory death or donation after brain death donors: a registry cohort study.

The number of kidney transplant (KT) procedures with controlled donation after circulatory death (cDCD) donors has exponentially increased in Spain in recent years, with a parallel increase in donor and recipient acceptance criteria. The outcomes of cDCD-KT have been reported to be comparable to those of KT with donation after brain death (DBD) donors. However, studies in elderly recipients have yielded contradictory results. We performed a registry analysis of 852 KT recipients aged ≥65 years (575 in the DBD-KT group, 277 in the cDCD-KT group) in Catalonia, Spain. Clinical outcomes and survival were compared between DBD-KT and cDCD-KT recipients. The donor and recipient ages were similar between the two groups (71.5 ± 8.7 years for donors, 70.8 ± 4.1 years for recipients). Delayed graft function (DGF) was more frequent among cDCD-KT recipients, without a difference in the rate of primary nonfunction. The 3-year patient and death-censored graft survival rates were similar between DBD-KT and cDCD-KT recipients (78.8% vs. 76.4% and 90.3% vs. 86.6%, respectively). In multivariable analysis, previous cardiovascular disease and DGF were independent risk factors for patient death. The type of donation (cDCD vs. DBD) was not an independent risk factor for patient survival or graft loss. cDCD-KT and DBD-KT provide comparable patient and graft survival in elderly recipients.

Corneal transplantation activity in Catalonia, Spain, from 2011 to 2018: Evolution of indications and surgical techniques.

PURPOSE: To report corneal transplant activity carried out in Catalonia (Spain) and the evolving indications for keratoplasty over an 8-year period. METHODS: Annual reports from the Catalan Transplant Organization, Spain, on corneal graft indications and techniques from 2011 to 2018 were reviewed. RESULTS: A total of 9457 keratoplasties were performed in Catalonia, from January 2011 to December 2018. The most frequent indications were bullous keratopathy (BK; 20.5%), Fuchs endothelial dystrophy (FED; 17.9%), re-graft (13.7%), and keratoconus (11.3%). Penetrating keratoplasty (PKP) accounted for 63.4% of all performed keratoplasties. Since the introduction of eye bank precut tissue for Descemet stripping automated endothelial keratoplasty (DSAEK) in 2013 and for Descemet membrane endothelial keratoplasty (DMEK) in 2017 the number of endothelial keratoplasties has drastically increased. An increasing trend of posterior lamellar techniques over the total of keratoplasties was found (p<0.001). Endothelial keratoplasties for different endothelial diseases indications (BK, FED, and re-graft), also showed and increasing trend (p<0.001). DMEK is the technique with the highest increase (statistically significantly different from linearity) over other endothelial keratoplasties in FED (p<0.001) but not in BK (p = 0.67) or re-grafts (p = 0.067). CONCLUSION: Endothelial diseases represented the top indication for keratoplasty over the 8-year period. PKP is still the most used technique in Catalonia, but endothelial keratoplasties and especially DMEK showed a significant increasing trend over the last years. This is congruent with the main rationale nowadays for keratoplasties: to customize and transplant as less tissue as possible. Therefore, the availability of precut tissue could have definitely enforced such approach.

A notable proportion of liver transplant candidates with alcohol-related cirrhosis can be delisted because of clinical improvement.

BACKGROUND & AIMS: To what extent patients with alcohol-related decompensated cirrhosis can improve until recovery from decompensation remains unclear. We aimed to investigate the probability of recovery and delisting due to improvement in patients with alcohol-related decompensated cirrhosis on the waiting list (WL) for liver transplantation (LT). METHODS: We conducted a registry-based, multicenter, retrospective study including all patients admitted to the LT WL in Catalonia (Spain) with the indication of alcohol-, HCV-, cholestasis- or non-alcoholic steatohepatitis-related decompensated cirrhosis between January 2007 and December 2018. Competing-risk analysis was used to investigate variables associated with delisting due to improvement in patients with alcohol-related decompensated cirrhosis. Criteria for delisting after improvement were not predefined. Outcomes of patients after delisting were also studied. RESULTS: One-thousand and one patients were included, 420 (37%) with alcohol-related decompensated cirrhosis. Thirty-six (8.6%) patients with alcohol-related decompensated cirrhosis were delisted after improvement at a median time of 29 months after WL admission. Lower model for end-stage liver disease (MELD) score, higher platelets and either female sex or lower height were independently associated with delisting due to improvement, while time of abstinence did not reach statistical significance in multivariate analysis (p = 0.055). Five years after delisting, the cumulative probability of remaining free from liver-related death or LT was 76%, similar to patients with HCV-related decompensated cirrhosis delisted after improvement. CONCLUSIONS: A significant proportion of LT candidates with alcohol-related cirrhosis can be delisted due to improvement, which is predicted by low MELD score and higher platelet count at WL admission. Women also have a higher probability of being delisted after improvement, partially due to reduced early access to LT for height discrepancies. Early identification of patients with potential for improvement may avoid unnecessary transplants. LAY SUMMARY: Patients with alcohol-related cirrhosis can improve until being delisted in approximately 9% of cases. Low model for end-stage liver disease score and high platelet levels at admission predict delisting after improvement, and women have higher probabilities of being delisted due to improvement. Long-term outcomes after delisting are generally favorable.

Uterine transplantation. First viable case in Southern Europe

Introduction and objectives: To describe the development and characteristics living donor uterine transplantation program of the Hospital Clínic (Barcelona, Spain) and to report the first successful procedure in Southern Europe.Patients and methodsA 31-year-old female suffering of Rokitansky Syndrome underwent uterus transplant from her living sister, as a part of our research protocol. Before the transplant, the patient underwent an in vitro fertilization procedure and twelve embryos were obtained and cryopreserved. The uterus obtention procedure was performed entirely by robotic surgery and lasted 10h, being the main objective to obtain arterial and venous pedicles of good quality in order to ensure the vitality of the graft. The surgical procedure in the recipient was performed by laparotomy and the vascular anastomoses were performed in a terminolateral fashion, with polypropylene 8-0, the vaginal cuff of the graft was sutured to the recipient vaginal vault and the round and utero-sacral ligaments were fixed to the remaining recipient ligaments. Immunosuppressive treatment was prescribed following the protocols from other groups modified according to the solid organ transplantation protocols from our center.ResultsThe donor and recipient were discharged without any major complications. The recipient ultrasound scan showed a normal flow in both uterine arteries and veins. A grade II rejection was treated with high dose corticoids with subsequent normal biopsies and a vaginal stricture was treated with the placement of an esophageal stent for 4 weeks. The patient had her first menstrual period 47 days after the surgery.ConclusionsThe case reported here open new options in Spain for a wide group of patients that had no medical solution for a disease that deeply impairs their quality of life. (AU)

Introducción y objetivos: Describir el desarrollo y las características del programa de trasplante uterino de donante vivo del Hospital Clínic (Barcelona) y reportar el primer procedimiento exitoso en el sur de Europa.Pacientes y métodosUna paciente de 31 años que padecía el síndrome de Rokitansky se sometió, como parte de nuestro protocolo de investigación, a un trasplante de útero de su hermana viva. Antes del trasplante, la paciente siguió un procedimiento de fecundación in vitro y se obtuvieron y criopreservaron 12 embriones. El procedimiento de obtención del útero se realizó íntegramente mediante cirugía robótica y tuvo una duración de 10h, siendo el objetivo principal obtener pedículos arteriales y venosos de buena calidad para asegurar la vitalidad del injerto. La cirugía de la receptora se realizó por laparotomía y las anastomosis vasculares se realizaron de forma término-lateral, con polipropileno 8-0, se suturó el manguito vaginal del injerto a la cúpula vaginal de la receptora y se fijaron los ligamentos redondos y útero-sacros a los remanentes ligamentarios de la receptora. El tratamiento de inmunosupresión se prescribió siguiendo los protocolos de otros grupos modificados según los protocolos de trasplante de órgano sólido de nuestro centro.ResultadosLa donante y la receptora fueron dados de alta sin mayores complicaciones. La ecografía de la receptora mostró un flujo sanguíneo normal tanto en las arterias como en las venas uterinas. A las 3 semanas del procedimiento, apareció un rechazo de grado II que se trató con corticoides a dosis altas con biopsias posteriores normales y una estenosis vaginal se trató con la colocación de un stent esofágico durante 4 semanas. La paciente tuvo su primer período menstrual 47 días después de la cirugía. (AU)

Uterine transplantation. First viable case in Southern Europe.

INTRODUCTION AND OBJECTIVES: To describe the development and characteristics living donor uterine transplantation program of the Hospital Clínic (Barcelona, Spain) and to report the first successful procedure in Southern Europe. PATIENTS AND METHODS: A 31-year-old female suffering of Rokitansky Syndrome underwent uterus transplant from her living sister, as a part of our research protocol. Before the transplant, the patient underwent an in vitro fertilization procedure and twelve embryos were obtained and cryopreserved. The uterus obtention procedure was performed entirely by robotic surgery and lasted 10h, being the main objective to obtain arterial and venous pedicles of good quality in order to ensure the vitality of the graft. The surgical procedure in the recipient was performed by laparotomy and the vascular anastomoses were performed in a terminolateral fashion, with polypropylene 8-0, the vaginal cuff of the graft was sutured to the recipient vaginal vault and the round and utero-sacral ligaments were fixed to the remaining recipient ligaments. Immunosuppressive treatment was prescribed following the protocols from other groups modified according to the solid organ transplantation protocols from our center. RESULTS: The donor and recipient were discharged without any major complications. The recipient ultrasound scan showed a normal flow in both uterine arteries and veins. A grade II rejection was treated with high dose corticoids with subsequent normal biopsies and a vaginal stricture was treated with the placement of an esophageal stent for 4 weeks. The patient had her first menstrual period 47 days after the surgery. CONCLUSIONS: The case reported here open new options in Spain for a wide group of patients that had no medical solution for a disease that deeply impairs their quality of life.

Current clinical application of sclera and amniotic membrane for ocular tissue bio-replacement.

To report the current clinical applications and trends of scleral and amniotic membrane use in ophthalmology. Review of annual reports from the Catalan Transplant Organization (OCATT), on scleral patch and amniotic membrane eye indications in Catalonia region (Spain) over a 6-year period from 2013 to 2018. A total of 874 scleral and 1665 amniotic membranes patches were implanted, from January 2013 to December 2018. The most frequent indication over the 6-year period for scleral patch was glaucoma surgery (77.5%), eyelid reconstruction (5.2%) and corneal or scleral ulcer (5%). Regarding amniotic membrane, corneal ulcer (26.9%), conjunctival reconstruction (23.8%) and corneal epithelial defect (22.7%) were the most common indications. During the study period, an increasing trend was found on sclera patches for eyelid reconstruction (p = 0.0032) and amniotic membrane for inflammation management (p = 0.0198). Glaucoma surgery and corneal ulcers have represented the top indications for scleral patch and amniotic membrane use, over the period, respectively. A significant trend has also been found towards eyelid reconstruction using scleral patches and amniotic membrane for anterior segment inflammation management. This evolving scenario in tissue use for ocular surgery has to be taken into consideration, especially regarding eye banks facing current and futures changes in tissue preservation, storage and indications.

Assessing the Limits in Kidney Transplantation: Use of Extremely Elderly Donors and Outcomes in Elderly Recipients.

BACKGROUND: Patient survival with end-stage renal disease is longer after kidney transplantation (KT) compared with those remaining on dialysis. Nevertheless, this remains uncertain when receiving a kidney from a donor ≥80 years old. METHODS: In a longitudinal mortality study in the Catalan Renal Registry including 2585 patients ≥60 years old on dialysis and placed on the KT waiting list, 1084 received a first KT from a deceased donor aged 60 to 79 years and 128 from a deceased donor ≥80 years. We calculated adjusted risk of graft loss by means of competing-risks regression, considering patient death with functioning graft as a competing event. To assess patient survival benefit from KT, we calculated the adjusted risk of death by nonproportional hazard analysis, taking the fact of being transplanted as a time-dependent effect. Considering all KT ≥60 (n = 1212), we assessed whether the benefit of KT varied per different recipient characteristics by calculating the interaction effect between all potential mortality risk factors and the treatment group. RESULTS: Compared with kidneys from donors 60 to 79 years old, graft survival was significantly lower for kidneys from donors aged ≥80 years (subhazard ratio = 1.55; 95% confidence interval, 1.00-2.38; P = 0.048). In comparison with those who remained on dialysis, adjusted risk of death 12 months after transplantation in recipients with a kidney from donors ≥80 years was 0.54 (95% confidence interval, 0.38-0.77; P < 0.0001). CONCLUSIONS: Despite KT from octogenarian deceased donors being associated with reduced graft survival, recipients had lower mortality rates than those remaining on dialysis, even if the kidney came from an extremely aged donor.

Effects of body weight variation in obese kidney recipients: a retrospective cohort study.

BACKGROUND: Obese kidney allograft recipients have worse results in kidney transplantation (KT). However, there is lack of information regarding the effect of body mass index (BMI) variation after KT. The objective of the study was to evaluate the effects of body weight changes in obese kidney transplant recipients. METHODS: In this study we used data from the Catalan Renal Registry that included KT recipients from 1990 to 2011 (n = 5607). The annual change in post-transplantation BMI was calculated. The main outcome variables were delayed graft function (DGF), estimated glomerular filtration rate (eGFR) and patient and graft survival. RESULTS: Obesity was observed in 609 patients (10.9%) at the time of transplantation. The incidence of DGF was significantly higher in obese patients (40.4% versus 28.3%; P < 0.001). Baseline obesity was significantly associated with worse short- and long-term graft survival (P < 0.05) and worse graft function during the follow-up (P < 0.005). BMI variations in obese patients did not improve eGFR or graft or patient survival. CONCLUSIONS: Our conclusion is that in obese patients, decreasing body weight after KT does not improve either short-term graft outcomes or long-term renal function.

Out-of-Hospital Tissue Donation: Multidisciplinary Donor Circuit in a Forensic Institute.

OBJECTIVE: We aimed to implement an out-of-hospital system of generating donors that increases donation and answers the growing demand for tissue for therapeutic purposes. MATERIAL: The Catalan Health Service issued the 4/2015 instruction promoting the integration of the donation network through collaboration with the Donor Center of Catalonia (DCC). The creation of DCC facilitated the signing of an agreement between The Blood and Tissue Bank, the Department of Justice of the Generalitat de Catalunya, the Emergency Medical System, and the Hospital Clínic Barcelona for the procurement of tissues in the Institute of Legal Medicine and Forensic Sciences of Catalonia (IMLCFC), where the autopsies of all judicial deaths in the province of Barcelona are performed. METHODS: The Emergency Medical System informed the DCC of those instances that ended with the code "deceased." DCC assessed the possible donor on arrival at the IMLCFC, checked the medical history through the shared clinical record, and obtained family consent by telephone interview. If consent was obtained, then judicial authorization was sought. RESULTS: In 2016, 152 donors of corneas were obtained (9.7% of the annual amount in Catalonia), 149 in 2017 (9.4% of the annual amount), and 133 donations in 2018. At the end of 2017, we started multitissue retrieval and obtained in 2018 a total of 76 donors. CONCLUSIONS: Out-of-hospital tissue donation in a forensic institute is possible. In less than 3 years, IMLCFC has become the third largest eye tissue contributor among the Catalan tissue donation network and the first contributor in musculoskeletal tissues in 2018.

The efficacy of direct anti-HCV drugs improves early post-liver transplant survival and induces significant changes in waiting list composition.

BACKGROUND & AIMS: The efficacy of direct-acting antivirals (DAAs) has dramatically changed the prognosis of patients with chronic hepatitis C. We aimed to evaluate the impact of DAA therapy on the composition of the liver transplant (LT) waiting list and the early post-transplant survival. METHODS: We evaluated all patients admitted to the waiting list for a primary LT between 1st January 2008 and 31st of December 2016 in Catalonia, Spain. Time span was divided into two periods according to the availability of different antiviral therapies: 2008-2013 (interferon-based therapies) and 2014-2016 (DAA). Changes in the indications of LT and the aetiology of liver disease, as well as post-LT patient survival, were evaluated according to the year of inclusion and transplantation, respectively. RESULTS: We included 1,483 patients. Admissions in the waiting list for hepatitis C virus (HCV)-related liver disease decreased significantly, from 47% in 2008-2013 to 35% in 2014-2016 (p <0.001), particularly because of a reduction in patients with decompensated cirrhosis. In contrast, NASH-related inclusions increased from 4% to 7% (p = 0.003). Three-year post-LT patient survival increased significantly in the second period in the whole cohort (82% vs. 91%, p = 0.002), because of better survival in anti-HCV positive patients (76% vs. 91%, p = 0.001), but not in anti-HCV negative patients (88% vs. 91% p = 0.359). Anti-HCV positive serology, the time period of 2008-2013 and higher donor age were independently associated with post-LT mortality in the whole cohort; while time period and donor age were independently associated with post-LT mortality in anti-HCV positive recipients. CONCLUSIONS: The high efficacy of DAAs is associated with significant changes in the composition of the LT waiting list and, more importantly, results in improved post-transplant survival. LAY SUMMARY: The efficacy of the new direct-acting antivirals is associated with a significant improvement in survival of patients undergoing liver transplantation because of hepatitis C virus-related liver disease. In addition, it has decreased the number of patients with hepatitis C that need a liver transplant.

Atlas de variaciones sistemáticas en el tratamiento sustitutivo renal en Cataluña (2002-2012) / Maps of systematic variation in renal replacement therapy in Catalonia (2002-2012)

Introducción: Las variaciones en la utilización de servicios de salud pueden definirse como variaciones sistemáticas de las tasas ajustadas para ciertos niveles de agregación de la población. Analizamos el tratamiento sustitutivo renal (TSR) e identificamos la posible variabilidad en Cataluña entre 2002 y 2012. Material y métodos: Estudio ecológico por áreas de salud con datos del registro de enfermos renales de Cataluña. Presentamos tasas de incidencia, incidencia estandarizada y prevalencia. Variabilidad calculada mediante estandarización directa e indirecta. Resultados: Desde 2002 hasta el 31/12/2012, 10.784 pacientes iniciaron TSR en Cataluña: 9.238 mediante hemodiálisis (HD) (50 tratamientos/100.000 habitantes 2010/2012), 1.076 diálisis peritoneal (DP) (8,2 tratamientos/100.000 hab. 2010/2012) y 470 recibieron un trasplante renal (TR) anticipado (4,4 tratamientos/100.000 hab. 2010/2012). Durante 10 años, la tasa de incidencia acumulada de HD ha descendido (7%) y las tasas de incidencia de DP y TR han aumentado (63 y 177%); ambas son más elevadas en pacientes jóvenes (<45 años). Un total de 4.750 pacientes recibieron en ese periodo un TR; el 49% con edad de 45 a 65 años. No detectamos variabilidad entre áreas en HD (RV5-95=1,3; empírico de Bayes [EB] ∼ 0), ni tampoco en la tasa de prevalencia en TR (RV5-95=1,4; EB ∼ 0). Detectamos variabilidad significativa entre áreas geográficas en la indicación de DP, en las comarcas de la provincia de Lérida, donde el número de casos observados era superior a los esperados (RV5-95=4,01; EB=0,08). Conclusión: Hay un notable incremento en la indicación de DP y TR anticipado, aunque la DP sigue infrautilizada considerando las recomendaciones internacionales. No hemos encontrado variación territorial en la indicación de HD y los casos con TR, pero sí en la indicación de DP: el área de Lérida es la que presenta unas tasas por encima del resto de las áreas. Para reducir la variabilidad territorial en DP incrementando la indicación de esta técnica en el resto de las comarcas, proponemos 3 actuaciones: desarrollo de herramientas de decisión en TSR compartidas, potenciación de formación específica en DP de los profesionales y promoción de la DP a través de sistemas de reembolso suplementarios (AU)

Introduction: Variations in the use of healthcare services can be defined as systematic variations of adjusted rates for certain aggregation levels of the population. The study analyses how renal replacement therapy (RRT) is used, identifying RRT variability in Catalonia from 2002 to 2012. Material and methods: Ecological study by health area using data from the Catalan renal registry. We present incident rates, standardised incidence ratios and prevalence, while variability was calculated through direct and indirect standardisation methods. Results: From 2002 until 31/12/2012, 10,784 patients initiated RRT in Catalonia: 9,238 on haemodialysis (HD) (50 treatments per 100,000 people 2010/2012), 1,076 on peritoneal dialysis (PD) (8.2 treatments per 100,000 people 2010/2012) and 470 received an early kidney transplant (KT) (4.4 treatments per 100,000 people 2010/2012). Over the 10 years, the HD cumulative incidence rate fell (7%), while the PD and KT incidence rates increased (63% and 177%, respectively); both are higher in young patients (<45 years). 4,750 patients received a kidney transplant in this period, 49% of which were aged between 45 and 65 years. There were no significant differences in variability in HD (RV5-95=1.3; Empirical Bayes [EB]∼ 0), or in the prevalence of KT (RV5-95=1.4; EB ∼ 0). Nevertheless, we found significant geographical variability in PD; notably in the districts of the province of Lérida, where the number of cases observed was greater than expected (RV5-95=4.01; EB=0.08). Conclusion: Although there was a notable rise in PD and early KT incidence rates, PD is still underused when compared to international recommendations. No territorial variability was found for HD or KT, but the use of PD was found to be higher in Lérida than in other areas. To reduce PD territorial variability and increase the uptake of this technique in the other regions, we propose 3initiatives: The development of RRT support tools for shared decision-making, the encouragement of specific PD professional training and the promotion of PD through complementary reimbursement systems (AU)

Death of recipients after kidney living donation triples donors' risk of dropping out from follow-up: a retrospective study.

Although kidney transplantation from the donation of a living donor is a safe treatment for end-stage renal disease, inferences about safety of living kidney donors might be biased by an informative censoring caused by the noninclusion of a substantial percentage of donors lost to follow-up. With the aim of assessing the presence of a potential informative censoring in living kidney donation outcomes of Catalan donors for a period of 12 years, 573 donors followed and lost to follow-up were compared. Losses of follow-up over time were also assessed by univariate and multivariate survival analysis, along with Cox regression. Younger and older ages, and the death of their recipient differentiated those donors who were lost to follow-up over time. The risk of dropping out from follow-up was more than twofold for the youngest and oldest donors, and almost threefold for those donors whose recipient died. Results of studies on postdonation outcomes of Catalan living kidney donors might have overlooked older and younger cases, and, remarkably, a percentage of donors whose recipient died. If these donors showed a higher incidence of psychological problems, conclusions about living donors' safety might be compromised thus emphasizing the necessity of sustained surveillance of donors and prompt identification of these cases.

Maps of systematic variation in renal replacement therapy in Catalonia (2002-2012). / Atlas de variaciones sistemáticas en el tratamiento sustitutivo renal en Cataluña (2002­2012).

INTRODUCTION: Variations in the use of healthcare services can be defined as systematic variations of adjusted rates for certain aggregation levels of the population. The study analyses how renal replacement therapy (RRT) is used, identifying RRT variability in Catalonia from 2002 to 2012. MATERIAL AND METHODS: Ecological study by health area using data from the Catalan renal registry. We present incident rates, standardised incidence ratios and prevalence, while variability was calculated through direct and indirect standardisation methods. RESULTS: From 2002 until 31/12/2012, 10,784 patients initiated RRT in Catalonia: 9,238 on haemodialysis (HD) (50 treatments per 100,000 people 2010/2012), 1,076 on peritoneal dialysis (PD) (8.2 treatments per 100,000 people 2010/2012) and 470 received an early kidney transplant (KT) (4.4 treatments per 100,000 people 2010/2012). Over the 10 years, the HD cumulative incidence rate fell (7%), while the PD and KT incidence rates increased (63% and 177%, respectively); both are higher in young patients (<45 years). 4,750 patients received a kidney transplant in this period, 49% of which were aged between 45 and 65 years. There were no significant differences in variability in HD (RV5-95=1.3; Empirical Bayes [EB]∼ 0), or in the prevalence of KT (RV5-95=1.4; EB ∼ 0). Nevertheless, we found significant geographical variability in PD; notably in the districts of the province of Lérida, where the number of cases observed was greater than expected (RV5-95=4.01; EB=0.08). CONCLUSION: Although there was a notable rise in PD and early KT incidence rates, PD is still underused when compared to international recommendations. No territorial variability was found for HD or KT, but the use of PD was found to be higher in Lérida than in other areas. To reduce PD territorial variability and increase the uptake of this technique in the other regions, we propose 3initiatives: The development of RRT support tools for shared decision-making, the encouragement of specific PD professional training and the promotion of PD through complementary reimbursement systems.