Coding practice in national and regional kidney biopsy registries.

BACKGROUND: Kidney biopsy registries all over the world benefit research, teaching and health policy. Comparison, aggregation and exchange of data is however greatly dependent on how registration and coding of kidney biopsy diagnoses are performed. This paper gives an overview over kidney biopsy registries, explores how these registries code kidney disease and identifies needs for improvement of coding practice. METHODS: A literature search was undertaken to identify biopsy registries for medical kidney diseases. These data were supplemented with information from personal contacts and from registry websites. A questionnaire was sent to all identified registries, investigating age of registries, scope, method of coding, possible mapping to international terminologies as well as self-reported problems and suggestions for improvement. RESULTS: Sixteen regional or national kidney biopsy registries were identified, of which 11 were older than 10 years. Most registries were located either in Europe (10/16) or in Asia (4/16). Registries most often use a proprietary coding system (12/16). Only a few of these coding systems were mapped to SNOMED CT (1), older SNOMED versions (2) or ERA-EDTA PRD (3). Lack of maintenance and updates of the coding system was the most commonly reported problem. CONCLUSIONS: There were large gaps in the global coverage of kidney biopsy registries. Limited use of international coding systems among existing registries hampers interoperability and exchange of data. The study underlines that the use of a common and uniform coding system is necessary to fully realize the potential of kidney biopsy registries.

Changes in the clinical presentation of immunoglobulin A nephropathy: data from the Spanish Registry of Glomerulonephritis.

Background: Immunoglobulin A nephropathy (IgAN) is the most common glomerulonephritis in the world, but there is little epidemiological data about possible changes in its presentation over the years. Available information about the influence of age on the form of clinical presentation is also scarce. Methods: The aim of the study was to analyse all renal biopsies performed between 1994 and 2013 and recorded in the Spanish Registry of Glomerulonephritis with a histological diagnosis of IgAN. The study was divided into five 4-year periods (1994-97, 1998-2001, 2002-05, 2006-09 and 2010-13) and patients were divided into four age groups: ≤16, 17-44, 45-64 and ≥65 years. Results: From 20.974 renal biopsies recorded, 2961 (14.1%) corresponded to IgAN. The prevalence of IgAN remained stable, but a significant increase in age [from 37.6 (SD 17.7) in 1994-97 to 44.9 (SD 16.8) years in 2010-13; P = 0.001] and worse renal function at presentation [from serum creatinine (SCr) 1.9 (SD 1.9) in 1994-97 to 2.3 (SD 2.1) mg/dL in 2010-13; P = 0.001] were observed over the years. Nephrotic-range proteinuria and acute kidney injury (AKI) as forms of presentation were significantly more common among patients ≥65 years (17.7% and 43.2%, respectively) as compared with the other age groups [≤16 (11.4% and 13.1%, respectively), 17-44 (13.1% and 13%, respectively) and 45-64 (12.1% and 21.3%, respectively)]. Blood pressure, SCr and proteinuria were also significantly higher at presentation among elderly patients. Conclusions: Although the prevalence of IgAN in Spain has remained stable over the years, patients are significantly older and present with significantly worse renal function in the last years. The incidence of nephrotic-range proteinuria (17.7%) and AKI (43.2%) as forms of presentation is remarkable among patients ≥65 years of age.

Universal Sustained Viral Response to the Combination of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir with/without Ribavirin in Patients on Hemodialysis Infected with Hepatitis C Virus Genotypes 1 and 4.

BACKGROUND: Hepatitis C virus (HCV) infection is highly prevalent among patients on hemodialysis (HD) and is associated with poor prognosis. Treatment with interferon and ribavirin is poorly tolerated, and few data are available on the impact of new direct-acting antivirals (DAAs). This study was intended to analyze the efficacy and safety of treatment with a combination of ombitasvir/paritaprevir/ritonavir and dasabuvir with/without ribavirin in HCV-infected patients on HD from 3 hospitals. METHODS: This is a multicentric study. We analyze the clinical course of all patients on HD with HCV infection who had been treated with the combination of ombitasvir/paritaprevir/ritonavir and dasabuvir in 3 hospitals in Madrid, Spain. All patients under treatment had undergone Transient elastography (FibroScan®) and HCV RNA (PCR) and HCV genotype were determined simultaneously. RESULTS: Thirty-five patients aged 53.3 ± 8.9 years (68.6% males) and with genotypes 1 and 4 were treated with the DAA regimen, and 17 were also given ribavirin. The most common etiology was glomerular disease. Sustained viral response was achieved in 100% of patients. Adverse effects were negligible, and no patient had to discontinue treatment. The most significant side effect was anemia, which led to a significant increase in the dose of erythropoiesis-stimulating agents. Anemia was more marked in patients receiving ribavirin. No patients required transfusions. CONCLUSION: A combination of ombitasvir/paritaprevir/ritonavir and dasabuvir with/without ribavirin for the treatment of HCV in patients on HD is highly effective and causes minimal side effects. This regimen represents a major advance in disease management. A considerable improvement in prognosis seems likely.

Decreasing incidence of AA amyloidosis in Spain.

BACKGROUND: The main objectives of our study were to review all cases of amyloidosis diagnosed by renal biopsy in Spain from 1994 to 2009 and to analyse variations in the incidence over time. MATERIALS AND METHODS: We analysed all biopsies from native kidneys included in the Spanish Registry of Glomerulonephritis. A total of 120 centres provided 17 680 biopsies over 16 years. Follow-up was divided in four periods. RESULTS: We collected 653 cases of renal amyloidosis. In 438 cases (67%), amyloidosis type was specified, [AA amyloidosis, 253 cases (57·8%); AL amyloidosis, 185 cases (42·2%)]. Mean age was 60 (17·8) years; 51·4% of patients were younger than 65. Overall incidence was 3·7%. In patients < 65, AA amyloidosis was present in 66·1% and AL amyloidosis in 33·9% (P < 0·01). No differences were found in patients > 65. Patients with AA amyloidosis were younger (56·8 vs. 64·0, P < 0·01) and had worse creatinine clearance (35 vs. 57 mL/min, P < 0·01). We found a decrease in the incidence among biopsies collected during each of the 4 study periods (4·2%, 3·9%, 3·5% and 3·2%, respectively, P < 0·001). CONCLUSIONS: This is the largest series of renal amyloidosis in kidney biopsies published to date. We found amyloidosis to be decreasing slowly in Spain. This decrease affects both types and is confirmed in all cases marked in patients < 65 and in AA type. AA amyloidosis was the most frequent in our series. Patients affected by it were younger and had worse kidney function, with no differences in the level of proteinuria.

Increased prevalence of acute tubulointerstitial nephritis.

Acute tubulointerstitial nephritis (ATIN) is a common cause of acute kidney injury (AKI) for which early treatment improves prognosis. The recent increase in prevalence has not been reflected in the literature. The aim of our study was to analyse all native kidney biopsies performed from 1994 to 2009 and included in the Spanish Registry of Glomerulonephritis with a histological diagnosis of ATIN. We assessed the prevalence of ATIN, associated clinical syndromes and urinary sediment abnormalities. We divided the population into two groups according to age: adults (15-65 years) and elderly patients (>65 years). We collected a total of 17 680 native kidney biopsies from 120 hospitals in Spain. The overall prevalence of ATIN was 2.7%. When the analysis was restricted to patients with AKI, the prevalence increased to 12.9%. During the 16 years of follow-up, there was a significant increase in prevalence (from 3.6% in the first 4 years to 10.5% in the last 4 years), which was more marked among elderly patients (from 1.6 to 12.3%). The most common clinical manifestations were AKI, microscopic haematuria, non-nephrotic proteinuria, leucocyturia and arterial hypertension, which were more frequent in the elderly. The prevalence of ATIN has increased in recent years, especially in patients aged >65 years. This could be due to an increase in drug-associated ATIN, which would justify early renal biopsy to identify ATIN and reduce the probability of progression to chronic kidney disease. Although, our data are not able to corroborate this fact.

Detection of patients at high risk for non-occlusive mesenteric ischemia in hemodialysis.

BACKGROUND: Nonocclusive mesenteric ischemia (NOMI) is an emerging condition in hemodialysis (HD) patients not widely studied. MATERIALS AND METHODS: A retrospective study was conducted between 2003 and 2011. NOMI cases were recorded, and demographic, clinical, biochemical, and HD parameters were collected. This group was compared with a control group (n = 93). Risk factors, prognosis, and survival were analyzed. RESULTS: There were 57 episodes of NOMI (incidence, 2.29 episodes per 100 patients/y). Cecum was the most frequently affected segment. Nineteen patients (33%) underwent surgery. Twenty-six patients (59%) did not survive the acute episode. Cecal damage was the only protective factor associated with mortality (relative risk [RR], 0.712; P = 0.044). The incidence of NOMI was related to erythropoietin resistance index, diabetes mellitus, and longer time on HD compared with control group (RR, 6.92, P = 0.009; RR, 9.98, P = 0.005; and RR, 1.017, P < 0.001, respectively). Mortality in survival NOMI patients was higher at 4-y follow-up compared with that in the control group (log-rank, 15.5; P < 0.0001). CONCLUSIONS: NOMI is associated with erythropoietin resistance index, diabetes mellitus, and longer time on HD. Hypotension must be avoided in these high-risk patients to prevent NOMI.

Diastolic dysfunction and high levels of new cardiac biomarkers as risk factors for cardiovascular events and mortality in hemodialysis patients.

BACKGROUND/AIMS: Cardiovascular events (CVEs) are the most frequent cause of death in hemodialysis (HD). We aim to determine cardiovascular and mortality risk factors. METHODS: A historical cohort study was made of 211 prevalent HD patients [73 (60-80) years, 58% males] between 2005 and 2012. Demographic, laboratory test and echocardiographic values were recorded. During follow-up, CVEs and mortality were documented and analyzed. RESULTS: 94 patients suffered a CVE. Age, history of cardiovascular disease (CVD), peripheral vascular disease, cardiac markers, systolic and diastolic dysfunction (DD) were associated to CVEs. Low albumin (RR 0.414, p = 0.002), DD (1.876, p = 0.038) and previous CVD (3.723, p < 0.001) were identified as independent predictors of CVEs. 98 patients died. Age, a history of CVD, peripheral vascular disease, cardiac markers, DD, dialysis vintage, and a vascular access different from autologous fistulae were associated to mortality. Low albumin (RR 0.499, p = 0.046), DD (RR 2.414, p = 0.017) and a vascular access different from autologous fistulae (RR 2.058, p = 0.034) were independent predictors of mortality. CONCLUSIONS: DD is an emergent risk factor for death and CVEs in dialysis. Low albumin is also a predictor for CVE. Non-autologous fistulae and low albumin are predictors for death. Nt-proBNP and hsTnT offer good information for identifying high-risk patients, but they do not predict events independently as they are only cardiac damage markers.

The relationship of NT-proBNP and dialysis parameters with outcome of incident haemodialysis patients: results from the membrane permeability outcome study.

BACKGROUND/AIMS: The association of raised levels of natriuretic peptides with elevated risk of mortality was investigated in the present analysis of the Membrane Permeability Outcome study. METHODS: N-terminal probrain type natriuretic peptide (NT-proBNP) was measured in 618 incident haemodialysis patients, randomised to either high-flux or low-flux. Characteristics of patients with NT-proBNP levels below or above the median were descriptively analysed and survival analysis was performed. RESULTS: Median NT-proBNP value was 2,124 pg/ml, with 1,854 pg/ml in the high-flux and 2,919 pg/ml in the low-flux group. Survival probability was lowest in patients with both a history of cardiovascular disease and NT-proBNP values above the median (p < 0.001). A multivariate Cox proportional hazard model showed interaction between presence of cardiovascular diseases and NT-proBNP levels above the median. CONCLUSIONS: NT-proBNP is an independent predictor of mortality also in incident haemodialysis patients. Lower concentrations associated with high-flux dialysis suggest a possible biological link to improved survival in this group.

Renal biopsy in very elderly patients: data from the Spanish Registry of Glomerulonephritis.

BACKGROUND: Studies on renal histology results in very elderly patients are extremely rare. METHODS: We analyzed histology and clinical findings in patients aged over 85 years undergoing renal biopsy and whose data were included in the Spanish Registry of Glomerulonephritis between 1994 and 2009. RESULTS: A total of 17,680 native kidney biopsies were taken: 71 (0.4%) were from patients aged over 85 years. Acute kidney injury (AKI) was the main indication for biopsy (47%), followed by nephrotic syndrome (32%). Amyloidosis was the most common histological diagnosis (16.9%), followed by crescentic glomerulonephritis type 3 associated with systemic vasculitis (14.1%). When histological findings were correlated with clinical syndromes, we found that amyloidosis was the leading cause of AKI (18.8%), and also the main determinant of nephrotic syndrome, with the same frequency as membranous nephropathy (22%). Crescentic glomerulonephritis type 3 associated with vasculitis was related to a greater diversity of clinical syndromes, especially chronic kidney disease (40%) and AKI (40%). CONCLUSIONS: Renal biopsy in the very elderly provides us with useful information, despite the advanced age of the patients. AKI and nephrotic syndrome are the main indication for renal biopsy in this subgroup of patients, and amyloidosis is the most frequent histological pattern associated with both syndromes.

Factors that condition the response to erythropoietin in patients on hemodialysis and their relation to mortality.

The response to erythropoietin-stimulating agents (ESA) can vary among different patients and according to the different circumstances over time within a given individual. The aim of this study was to analyze the factors that can modify the response to epoetin in patients on hemodialysis (HD) and its influence on early mortality. Prospective and observational study including 1710 patients from 119 HD units in Spain with a follow-up of 12 months. To evaluate the dose-response effect of EPO therapy, we used the erythropoietin resistance index (ERI), calculated as the weekly weight-adjusted dose of EPO divided by the hemoglobin level. Patients were stratified in three groups according to ERI: group A, ERI <5; group B, ERI=5-15; group C, ERI>15 U/kg/week/g per 100 ml. Mean ERI for the entire group was 10.2+/-7.3 U/kg/week/g per 100 ml. ERI was directly related with incident comorbidity (Charlson Index), age, female gender and low body mass index with no relationship with etiology of chronic kidney disease. Patients with antecedents of heart failure, acute infection or malignant neoplasm had significantly higher ERI than those without. Transferrin saturation index, but not serum ferritin, was inversely related with ERI. Serum levels of albumin and cholesterol were related with lower ERI, but no relation was found with normalized protein catabolic rate. Patients with a permanent catheter for HD had significant higher values of ERI than those with native fistula (P=0.012). One year survival in all three groups of patients according to ERI was 0.916 in group A, 0.877 in group B and 0.788 in group C (log-rank=20.7, P<0.001). The resistance to ESA is directly related with incident comorbidity in patients on hemodialysis and it can be interpreted as a useful marker of early mortality.

Maintenance of target hemoglobin level in stable hemodialysis patients constitutes a theoretical task: a historical prospective study.

Maintenance of target hemoglobin (Hb) values in hemodialysis patients treated with erythropoiesis-stimulating agents (ESAs) remains difficult. We examined Hb variability in the clinical setting in hemodialysis patients. Hemodialysis patients treated with ESAs who maintained the recommended Hb range of 11-13 g per 100 ml over 3 months and were not admitted to hospital, did not require transfusion, and did not experience any major clinical event during this period were followed prospectively for 1 year. Anemia events, Hb variation events (any value out of +/-1.5 g per 100 ml of the median Hb level in the total follow-up period for the individual patient), risk factors for anemia, and Hb variation events were assessed. We studied 420 patients (63% males, mean age 61 years), 222 received short-acting erythropoietin (EPO) and 198 long-acting darbepoetin. A total of 4654 blood samples (mean 11.1 per patient-year) were analyzed. Only 3.8% of patients were maintained within the target Hb levels (11-13 g per 100 ml) during 1 year. Hb variation events occurred in 20.8% of laboratory values and anemia events in 14.7%, with a median time to the first event of 3 months. Treatment with short-acting EPO (vs long-acting darbepoetin), change of ESA dose in the previous visit, resistance index, and hospitalization were significant risk factors for both anemia events and Hb variation events. Our results show that Hb values are rarely maintained within the recommended guidelines even in more stable hemodialysis patients. Hb variability is frequently associated with clinical events or ESA dose changes. Long-acting darbepoetin achieved better Hb stability than short-acting EPO.

Comparison of urea recirculation and thermodilution for monitoring of vascular access in patients undergoing hemodialysis.

Introduction It is important to monitor vascular access in patients with stage 5 chronic kidney disease receiving hemodialysis. Access recirculation can help to detect a need for intervention. OBJECTIVES: To compare urea recirculation with recirculation by thermodilution using blood temperature monitoring to predict a need for intervention of vascular access over a 6-month period. METHODS: We analyzed urea recirculation and blood temperature monitoring simultaneously in 61 patients undergoing hemodialysis. During the 6-month follow-up, we recorded all cases of angioplasty or surgery (thrombectomy or reanastomosis). In line with previous studies, we considered a value to be positive when urea recirculation was >10% and blood temperature monitoring >15%. Receiver operating characteristic curves were constructed. RESULTS: Mean urea recirculation was 9.5% ± 6.6% and mean blood temperature monitoring 12.9% ± 4.3% (p = 0.001). Urea recirculation >10% had a sensitivity of 80% and specificity of 78%. Blood temperature monitoring >15% had a sensitivity of 33% and specificity of 85%. During follow-up, 25% of patients developed need for intervention of vascular access. We found an association between vascular access dysfunction and urea recirculation. The Kaplan-Meier analysis confirmed an association between urea recirculation and risk of vascular access dysfunction (log rank = 17.2; p = 0.001). We were unable to confirm this association with blood temperature monitoring (log rank = 0.879; p = 0.656). CONCLUSION: Urea recirculation is better predictor of vascular access dysfunction than thermodilution.

Adding access blood flow surveillance reduces thrombosis and improves arteriovenous fistula patency: a randomized controlled trial.

PURPOSE: Stenosis is the main cause of arteriovenous fistula (AVF) failure. It is still unclear whether surveillance based on vascular access blood flow (QA) enhances AVF function and longevity. METHODS: We conducted a three-year follow-up randomized, controlled, multicenter, open-label trial to compare QA-based surveillance and pre-emptive repair of subclinical stenosis with standard monitoring/surveillance techniques in prevalent mature AVFs. AVFs were randomized to either the control group (surveillance based on classic alarm criteria; n = 104) or to the QA group (QA measured quarterly using Doppler ultrasound [M-Turbo®] and ultrasound dilution [Transonic®] added to classic surveillance; n = 103).The criteria for intervention in the QA group were: 25% reduction in QA, QA<500 mL/min or significant stenosis with hemodynamic repercussion (peak systolic velocity [PSV] more than 400 cm/sc or PSV pre-stenosis/stenosis higher than 3). RESULTS: At the end of follow-up we observed a significant reduction in the thrombosis rate in the QA group (0.025 thrombosis/patient/year in the QA group vs. 0.086 thrombosis/patient/year in the control group [p = 0.007]). There was a significant improvement in the thrombosis-free patency rate (HR, 0.30; 95% CI, 0.11-0.82; p = 0.011) and in the secondary patency rate in the QA group (HR, 0.49; 95% CI, 0.26-0.93; p = 0.030), with no differences in the primary patency rate between the groups (HR, 0.98; 95% CI, 0.57-1.61; p = 0.935).There was greater need for a central venous catheter and more hospitalizations associated with vascular access in the control group (p = 0.034/p = 0.029).Total vascular access-related costs were higher in the control group (€227.194 vs. €133.807; p = 0.029). CONCLUSIONS: QA-based surveillance combining Doppler ultrasound and ultrasound dilution reduces the frequency of thrombosis, is cost effective, and improves thrombosis free and secondary patency in autologous AVF.

New expectations in the treatment of anemia in chronic kidney disease. / Nuevas expectativas en el tratamiento de la anemia en la enfermedad renal crónica.

The new drugs developed for the treatment of anemia in chronic kidney disease patients, together with their mechanisms of action are reviewed. At present, many of them are already in advanced stages of clinical trials and is expected to be incorporated into the therapeutic arsenal in the coming years. The potential benefits and possible limitations are also described.

Daily Home Hemodialysis Is an Available Option for Renal Replacement Therapy in Spain.

The objective of the present study was to analyze the characteristics and survival of patients from our hospital who started home hemodialysis. We analyzed all patients receiving home hemodialysis from 1969 to 2015 (51 patients; age 45 ± 23 years; men 77%). We collected characteristics, hospital admission, and mortality. After a median follow-up of 43 (22-76) months, we found 0-1 hospital admissions per year. Sixty-nine percent received a kidney transplant, and the global mortality was 10%. Survival at 5 years was 96%. Mean equivalent renal urea clearance was 15.6 ± 4.2 mL/min, the ß-2 microglobulin reduction rate was 67 ± 18%, the number of antihypertension drugs was 0.7 ± 0.3, and the erythropoietin resistance index was 3.7 ± 2.1 IU/kg/week/g/dL. Daily home hemodialysis is a viable option for renal replacement therapy and should be offered alongside other therapies.

Fat tissue and inflammation in patients undergoing peritoneal dialysis.

BACKGROUND: Body weight has been increasing in the general population and is an established risk factor for hypertension, diabetes, and all-cause and cardiovascular mortality. Patients undergoing peritoneal dialysis (PD) gain weight, mainly during the first months of treatment. The aim of this study was to assess the relationship between body composition and metabolic and inflammatory status in patients undergoing PD. METHODS: This was a prospective, non-interventional study of prevalent patients receiving PD. Body composition was studied every 3 months using bioelectrical impedance (BCM(®)). We performed linear regression for each patient, including all BCM(®) measurements, to calculate annual changes in body composition. Thirty-one patients in our PD unit met the inclusion criteria. RESULTS: Median follow-up was 26 (range 17-27) months. Mean increase in weight was 1.8 ± 2.8 kg/year. However, BCM(®) analysis revealed a mean increase in fat mass of 3.0 ± 3.2 kg/year with a loss of lean mass of 2.3 ± 4.1 kg/year during follow-up. The increase in fat mass was associated with the conicity index, suggesting that increases in fat mass are based mainly on abdominal adipose tissue. Changes in fat mass were directly associated with inflammation parameters such as C-reactive protein (r = 0.382, P = 0.045) and inversely associated with high-density lipoprotein cholesterol (r=-0.50, P = 0.008). CONCLUSIONS: Follow-up of weight and body mass index can underestimate the fat mass increase and miss lean mass loss. The increase in fat mass is associated with proinflammatory state and alteration in lipid profile.

Asymptomatic Intradialytic Supraventricular Arrhythmias and Adverse Outcomes in Patients on Hemodialysis.

BACKGROUND AND OBJECTIVES: Supraventricular arrhythmias are associated with high morbidity and mortality. Nevertheless, this condition has received little attention in patients on hemodialysis. The objective of this study was to analyze the incidence of intradialysis supraventricular arrhythmia and its long-term prognostic value. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS: We designed an observational and prospective study in a cohort of patients on hemodialysis with a 10-year follow-up period. All patients were recruited for study participation and were not recruited for clinical indications. The study population comprised 77 patients (42 men and 35 women; mean age =58±15 years old) with sinus rhythm monitored using a Holter electrocardiogram over six consecutive hemodialysis sessions at recruitment. RESULTS: Hypertension was present in 68.8% of patients, and diabetes was present in 29.9% of patients. Supraventricular arrhythmias were recorded in 38 patients (49.3%); all of these were short, asymptomatic, and self-limiting. Age (hazard ratio, 1.04 per year; 95% confidence interval, 1.00 to 1.08) and right atrial enlargement (hazard ratio, 4.29; 95% confidence interval, 1.30 to 14.09) were associated with supraventricular arrhythmia in the multivariate analysis. During a median follow-up of 40 months, 57 patients died, and cardiovascular disease was the main cause of death (52.6%). The variables associated with all-cause mortality in the Cox model were age (hazard ratio, 1.04 per year; 95% confidence interval, 1.00 to 1.08), C-reactive protein (hazard ratio, 1.04 per 1 mg/L; 95% confidence interval, 1.00 to 1.08), and supraventricular arrhythmia (hazard ratio, 3.21; 95% confidence interval, 1.29 to 7.96). Patients with supraventricular arrhythmia also had a higher risk of nonfatal cardiovascular events (hazard ratio, 4.32; 95% confidence interval, 2.11 to 8.83) and symptomatic atrial fibrillation during follow-up (hazard ratio, 17.19; 95% confidence interval, 2.03 to 145.15). CONCLUSIONS: The incidence of intradialysis supraventricular arrhythmia was high in our hemodialysis study population. Supraventricular arrhythmias were short, asymptomatic, and self-limiting, and although silent, these arrhythmias were independently associated with mortality and cardiovascular events.

The impact of access blood flow surveillance on reduction of thrombosis in native arteriovenous fistula: a randomized clinical trial.

PURPOSE: The usefulness of access blood flow (QA) measurement is an ongoing controversy. Although all vascular access (VA) clinical guidelines recommend monitoring and surveillance protocols to prevent VA thrombosis, randomized clinical trials (RCTs) have failed to consistently show the benefits of QA-based surveillance protocols. We present a 3-year follow-up multicenter, prospective, open-label, controlled RCT, to evaluate the usefulness of QA measurement using Doppler ultrasound (DU) and ultrasound dilution method (UDM), in a prevalent hemodialysis population with native arteriovenous fistula (AVF). METHODS: Classical monitoring and surveillance methods are applied in all patients, the control group (n = 98) and the QA group (n = 98). Besides this, DU and UDM are performed in the QA group every three months. When QA is under 500 ml/min or there is a >25% decrease in QA the patient goes for fistulography, surgery or close clinical/surveillance observation. Thrombosis rate, assisted primary patency rate, primary patency rate and secondary patency rate are measured. RESULTS: After one-year follow-up we found a significant reduction in thrombosis rate (0.022 thrombosis/patient/year at risk in the QA group compared to 0.099 thrombosis/patient/year at risk in the control group [p = 0.030]). Assisted primary patency rate was significantly higher in the QA group than in control AVF (hazard ratio [HR] 0.23, 95% confidence interval [CI] 0.05-0.99; p = 0.030). In the QA group, the numbers unddergoing angioplasty and surgery were higher but with no significant difference in non-assisted primary patency rate (HR 1.41, 95% CI 0.72-2.84; p = 0.293). There was a non-significant improvement in secondary patency rate in the QA group (HR 0.510, 95% CI 0.17-1.50; p = 0.207). CONCLUSIONS: The measurement of QA combining DU and UDM shows a reduction in thrombosis rate and an increased assisted primary patency rate in AVF after one-year follow-up. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02111655.

Interdialytic weight gain as a marker of blood pressure, nutrition, and survival in hemodialysis patients.

BACKGROUND: Excessive interdialytic weight gain (IDWG) is usually related to an overload of sodium and water, and is the most important factor for arterial hypertension in dialysis. On the other hand, food intake also contributes to IDWG, and is the basic factor for nutrition. The objective of this study is to assess the long-term prognostic effect of IDWG and its relationship with the nutritional status and blood pressure in patients in hemodialysis (HD). METHODS: We describe the results of a 5-year prospective observation study in which 134 HD patients were included (70 males and 64 females), with ages between 18 and 81. Initially, the average data were collected during 4 weeks, including total IDWG and percentages according to dry weight (IDWG%), nutritional parameters, and blood pressure. Patients were divided into 3 cohorts according to IDWG% (<2.9, 2.9-3.9, and >3.9%, respectively). Student t test, ANOVA, linear regression analysis, and Kaplan-Meier survival curves compared with log-rank test were used as statistical tools. RESULTS: The mean IDWG% for the whole studied population was 3.5 +/- 1.1% (1.5-8.0%). It was not related to gender, but had an inverse correlation with age (P < 0.000) and serum bicarbonate level (P= 0.009). It was directly correlated with predialysis systolic and diastolic blood pressure, nPCR, urea and creatinine levels (P < 0.01 for all of them), and the body mass index (P < 0.000). Serum levels of albumin (44.7 +/- 4.0 g/dL) and prealbumin (31.9 +/- 7.4 mg/dL) had a direct correlation with total IDWG (P < 0.01). We found no significant relationship between or IDWG% and ferritin and transferrin levels. Five-year actuarial survival was 0.38, 0.52, and 0.63, respectively, in the 3 cohorts for IDWG% (P < 0.01). CONCLUSION: Our results show that a greater IDWG is directly associated with a better nutritional status, although it is also associated with higher predialysis blood pressure. The greater the IDWG%, the better the long-term prognosis of the patients. The beneficial effects of IDWG on the nutritional status and prognosis are greater than the negative aspects that depend on its effects on blood pressure. One must distinguish clearly between some isolated instances of not complying with a diet from those situations where a higher IDWG is merely a reflection of a good nutritional status, and one must be careful so that dietary recommendations will not have a negative influence on nutritional aspects. One must watch and correct the trend towards higher acidosis in patients with a greater IDWG.