Arterio-Venous Fistula : Is it Critical for Prolonged Survival in the over 80's Starting Haemodialysis?

BACKGROUND: Dialysis in elderly patients (>80-years-old) carries a poor prognosis, but little is known about the most effective vascular access method in this age group. An arteriovenous fistula (AVF) is both time-consuming and initially expensive, requiring surgical insertion. A central venous catheter (CVC) is initially a cheaper alternative, but carries a higher risk of infection. We examined whether vascular access affected 1-year and 2-year mortality in elderly patients commencing haemodialysis. METHODS: Initial vascular access, demographic and survival data for elective haemodialysis patients >80-years was collated using regional databases. A cohort of conservatively managed patients was included for comparison. A log-rank test was used to compare survival between groups and a chi-square test was used to compare 1-year and 2-year survival. RESULTS: 167 patients (61% male) were included: CVC (101), AVF (25) and conservative management (41). Mean age (median) of starting haemodialysis (eGFR ≤10mL/min/1.73m2): CVC; 83.4 (2.3) and AVF; 82.3 (1.8). Mean age of conservatively managed patients reaching an eGFR ≤10mL/min/1.73m2 was 85.8 (3.6). Mean (median) survival on dialysis was 2.2 (1.8) years for AVF patients, 2.1 (1.2) for CVC patients, and 1.5 (0.9) for conservatively managed patients (p = 0.107, controlling for age/sex p = 0.519). 1-year and 2-year mortality: AVF (28%/52%); CVC (49%/57%), and conservative management (54%/68%). There was no significant difference between the groups at 1-year (p = 0.108) or 2-years (p = 0.355). CONCLUSION: These results suggest that there is no significant survival benefit over a 2-year period when comparing vascular access methods. In comparison to conservative management, survival benefit was marginal. The decision of whether and how (choice of their vascular access method) to dialysis the over 80s is multifaceted and requires a tailored, multidisciplinary approach

Arterio-Venous Fistula : Is it Critical for Prolonged Survival in the over 80's Starting Haemodialysis?

BACKGROUND: Dialysis in elderly patients (>80-years-old) carries a poor prognosis, but little is known about the most effective vascular access method in this age group. An arteriovenous fistula (AVF) is both time-consuming and initially expensive, requiring surgical insertion. A central venous catheter (CVC) is initially a cheaper alternative, but carries a higher risk of infection. We examined whether vascular access affected 1-year and 2-year mortality in elderly patients commencing haemodialysis. METHODS: Initial vascular access, demographic and survival data for elective haemodialysis patients >80-years was collated using regional databases. A cohort of conservatively managed patients was included for comparison. A log-rank test was used to compare survival between groups and a chi-square test was used to compare 1-year and 2-year survival. RESULTS: 167 patients (61% male) were included: CVC (101), AVF (25) and conservative management (41). Mean age (median) of starting haemodialysis (eGFR ≤10mL/min/1.73m2): CVC; 83.4 (2.3) and AVF; 82.3 (1.8). Mean age of conservatively managed patients reaching an eGFR ≤10mL/min/1.73m2 was 85.8 (3.6). Mean (median) survival on dialysis was 2.2 (1.8) years for AVF patients, 2.1 (1.2) for CVC patients, and 1.5 (0.9) for conservatively managed patients (p = 0.107, controlling for age/sex p = 0.519). 1-year and 2-year mortality: AVF (28%/52%); CVC (49%/57%), and conservative management (54%/68%). There was no significant difference between the groups at 1-year (p = 0.108) or 2-years (p = 0.355). CONCLUSION: These results suggest that there is no significant survival benefit over a 2-year period when comparing vascular access methods. In comparison to conservative management, survival benefit was marginal. The decision of whether and how (choice of their vascular access method) to dialysis the over 80s is multifaceted and requires a tailored, multidisciplinary approach

Safety of Intravenous Iron – Cosmofer and Monofer Therapy in Peritoneal Dialysis and Non-Dialysis-Dependent Chronic Kidney Disease Patients

Safety of parenteral iron therapy is critical and has been demonstrated in several studies, but concerns persist on safety. We performed a retrospective single-center study investigating the safety and efficacy of parenteral iron administration using 2 iron preparations—Monofer and Cosmofer (Pharmacosmos A/S, Holbaek, Denmark)—in patients with chronic kidney disease (CKD), on peritoneal dialysis (PD) and non-dialysis. A database of CKD patients receiving intravenous (IV) iron was analyzed. Side effects were recorded during infusion, post-infusion, and after 48 hours. In a population of CKD patients (non-dialysis and PD), IV iron is safe with few major adverse effects for these 2 IV iron preparations studied with similar dosing schedules. These data provide reassurance on the relative short-term safety of IV iron preparations regarding acute infusion-related hypersensitivity reactions. </jats:p

A Multicenter Prospective Double Blinded Randomized Controlled Pilot Trial of Intravenous Iron (Ferric Derisomaltose (FDI)) in Iron Deficient but not Anemic Patients with Chronic Kidney Disease on Functional Status.

Abstract Background Iron deficiency (ID) is common in patients with chronic kidney disease (CKD). Intravenous (IV) iron in heart failure leads to improvement in exercise capacity and improvement in quality of life measurements; however, data in patients with CKD are lacking.Methods The Iron and the Heart Study was a prospective double blinded randomized study in non-anemic CKD stages 3b-5 patients with ID which investigated whether 1000 mg of IV iron (ferric derisomaltose (FDI) ) could improve exercise capacity in comparison to placebo measured at 1 and 3 months post infusion. Secondary objectives included effects on hematinic profiles and hemoglobin, safety analysis and quality of life questionnaires (QoL).Results We randomly assigned 54 patients mean (SD) age for FDI (n=26) 61.6 (10.1) years vs placebo (n=28; 57.8 (12.9) years) and mean eGFR (32.1 (9.6) vs. 29.1 (9.6) ml/min/1.73m2) at baseline, respectively. Adjusting for baseline measurements, six-minute walk test (6MWT) showed no statistically significant difference between arms at 1 month (p=0.736), or 3 months (p=0.741). There were non-significant increases in 6MWT from baseline to 1 and 3 months in the FDI arm. Hemoglobin (Hb) at 1 and 3 months remained stable. There were statistically significant increases in ferritin (SF) and transferrin saturation (TSAT) at 1 and 3 months (p&lt;0.001). There was a modest numerical improvement in QoL parameters. There were no adverse events attributable to IV iron. Conclusion This study demonstrated a short-term beneficial effect of FDI on exercise capacity, but it was not significant despite improvements in parameters of iron status, maintenance of Hb concentration, and numerical increases in functional capacity and quality of life scores. A larger study will be required to confirm if intravenous iron is beneficial in iron deficient non-anemic non-dialysis CKD patients without heart failure to improve the 6MWT.Trial Registration: European Clinical Trials Database (EudraCT) No: 2014-004133-16https://www.clinicaltrialsregister.eu/ctr-search/trial/2014-004133-16/GBREC no: 14/YH/1209Date First Registered: 2015-02-17 and date of end of trail 2015-05-23Sponsor ref R1766 and Protocol No: IHI 141</jats:p

Protocol and Baseline Data of a Multicentre Prospective Double-Blinded Randomized Study of Intravenous Iron on Functional Status in Patients with Chronic Kidney Disease

Iron deficiency (ID) is common in patients with chronic kidney disease (CKD) due to an inadequate dietary intake of iron, poor absorption from the gut and increased iron losses. In addition to preventing anaemia, iron is important for normal heart function, being involved in processes that generate a necessary continuous energy supply. Treatment with intravenous (IV) iron has been suggested to lead to improvement in heart function and well-being in people with ID and CKD. In the Iron and the Heart Study, we hypothesized that IV iron treatment will primarily improve exercise capacity and may secondarily impact the feeling of well-being in comparison to placebo over 3 months in non-anaemic CKD patients who have ID. Methods: This was a prospective double-blinded explorative randomized, multi-centre study designed to compare the effects of IV iron supplementation and placebo in iron-deficient but not anaemic patients with established CKD stages 3b-5 on functional status, and in addition cardiac structure and function. The study included 54 adults with serum ferritin (SF) <100 μg/L and/or transferrin saturation <20%, randomized in a 1:1 ratio to 1,000 mg IV ferric derisomaltose or placebo. Following randomization, participants underwent baseline assessments and then received IV iron or placebo infusion. Each participant was followed up at months 1 and 3. At each visit, patients underwent clinical review, measurements of hematinics and haemoglobin (Hb), and assessments of physical function and well-being. The primary outcome was exercise capacity using the 6-minute walk test. Secondary objectives included effects on hematinic profiles and Hb concentration, changes in myocardial parameters assessed with speckle tracking echocardiography and change in patients' quality of life. Results: Between October 2016 and April 2018, 55 from 326 individuals from 3 UK centres attended screening and were randomized. The mean (SD) age was 59.6 (11.7) years, 26 (48%) patients were male, the majority were Caucasians (42; 78%), and 32 (59%) were non-smokers. The mean (SD) body mass index was 30.3 (6.5); SF was 66.3 (44.1) μg/L, TS was 20.1 (7.4) % and Hb was 128.7 (10.1) g/L at randomization for the whole group. Mean (SD) serum creatinine was 186.7 (58.6) μmol/L, estimated glomerular filtration rate was 31.1 (9.6) mL/min/1.73 m2 and urinary albumin and protein/creatinine ratios 60.9 (133.3) and 83.8 (128.4) mg/mmol respectively. The mean (SD) C-reactive protein was 5.0 (4.4) mg/L and the mean (SD) 6-minute walk distance at baseline was 401.2 (120.2) m. Conclusion: The Iron and the Heart Trial will provide important information on the short-term effects of IV iron treatment in CKD patients with ID without anaemia on measures of exercise capacity, quality of life and mechanistic data on myocardial structure and function. Trial Registration: European Clinical Trials Database (No. 2014-004133-6; REC no. 14/YH/1209; Sponsor ref. R1766)

Conversion of haemodialysis patients from iron sucrose to iron isomaltoside: a real-world experience

Abstract Background Anaemia is common in haemodialysis (HD) patients and associated with significant morbidity and mortality. Intravenous (IV) iron combined with erythropoiesis-stimulating agents (ESA) is the mainstay treatment of anaemia in these patients. The comparative efficacy and risk of adverse events with IV iron preparations have been assessed in only a few trials. Methods This was a retrospective observational study in 2 centres designed to compare the safety and efficacy of iron sucrose (IS-Venofer®) versus iron isomaltoside (IIM-Diafer®) in haemodialysis patients. The study included patients currently on dialysis and receiving Venofer who were switched to Diafer® and monitored for at least 12 months for each iron preparation. Results A total of 190 patients were included and had a mean age of 65.8 years (SD ± 15.5). Non-inferiority was confirmed with no change in mean haemoglobin per mg of iron administered over a 12-month period. In total there were 41,295 prescriptions of iron isomaltoside and 14,685 of iron sucrose with no difference in the number of reported adverse events during the study period (7 each, none were severe). There was a statistically significant effect on Hb over time after conversion, including adjustment for multiple comparisons. There were significant improvements in ferritin over time, which remained at 6 months (P &lt; 0.01). The weekly iron dose was similar after adjustment (P = 0.02). The EPO dose did not differ significantly after month 0 in patients switched to IIM. Conclusions This study demonstrates the comparative safety and efficacy of iron isomaltoside versus iron sucrose, with similar dosing schedules in dialysis patients. Iron isomaltoside is non-inferior to iron sucrose in maintaining Hb in patients on regular haemodialysis/haemodiafiltration with no difference in the number of reported adverse events. </jats:sec

Protocol and Baseline Data of a Multicentre Prospective Double-Blinded Randomized Study of Intravenous Iron on Functional Status in Patients with Chronic Kidney Disease

&lt;b&gt;&lt;i&gt;Background:&lt;/i&gt;&lt;/b&gt; Iron deficiency (ID) is common in patients with chronic kidney disease (CKD) due to an inadequate dietary intake of iron, poor absorption from the gut and increased iron losses. In addition to preventing anaemia, iron is important for normal heart function, being involved in processes that generate a necessary continuous energy supply. Treatment with intravenous (IV) iron has been suggested to lead to improvement in heart function and well-being in people with ID and CKD. In the Iron and the Heart Study, we hypothesized that IV iron treatment will primarily improve exercise capacity and may secondarily impact the feeling of well-being in comparison to placebo over 3 months in non-anaemic CKD patients who have ID. &lt;b&gt;&lt;i&gt;Methods:&lt;/i&gt;&lt;/b&gt; This was a prospective double-blinded explorative randomized, multi-centre study designed to compare the effects of IV iron supplementation and placebo in iron-deficient but not anaemic patients with established CKD stages 3b-5 on functional status, and in addition cardiac structure and function. The study included 54 adults with serum ferritin (SF) &amp;#x3c;100 µg/L and/or transferrin saturation &amp;#x3c;20%, randomized in a 1:1 ratio to 1,000 mg IV ferric derisomaltose or placebo. Following randomization, participants underwent baseline assessments and then received IV iron or placebo infusion. Each participant was followed up at months 1 and 3. At each visit, patients underwent clinical review, measurements of hematinics and haemoglobin (Hb), and assessments of physical function and well-being. The primary outcome was exercise capacity using the 6-minute walk test. Secondary objectives included effects on hematinic profiles and Hb concentration, changes in myocardial parameters assessed with speckle tracking echocardiography and change in patients’ quality of life. &lt;b&gt;&lt;i&gt;Results:&lt;/i&gt;&lt;/b&gt; Between October 2016 and April 2018, 55 from 326 individuals from 3 UK centres attended screening and were randomized. The mean (SD) age was 59.6 (11.7) years, 26 (48%) patients were male, the majority were Caucasians (42; 78%), and 32 (59%) were non-smokers. The mean (SD) body mass index was 30.3 (6.5); SF was 66.3 (44.1) µg/L, TS was 20.1 (7.4) % and Hb was 128.7 (10.1) g/L at randomization for the whole group. Mean (SD) serum creatinine was 186.7 (58.6) µmol/L, estimated glomerular filtration rate was 31.1 (9.6) mL/min/1.73 m&lt;sup&gt;2&lt;/sup&gt; and urinary albumin and protein/creatinine ratios 60.9 (133.3) and 83.8 (128.4) mg/mmol respectively. The mean (SD) C-reactive protein was 5.0 (4.4) mg/L and the mean (SD) 6-minute walk distance at baseline was 401.2 (120.2) m. &lt;b&gt;&lt;i&gt;Conclusion:&lt;/i&gt;&lt;/b&gt; The Iron and the Heart Trial will provide important information on the short-term effects of IV iron treatment in CKD patients with ID without anaemia on measures of exercise capacity, quality of life and mechanistic data on myocardial structure and function. &lt;b&gt;&lt;i&gt;Trial Registration:&lt;/i&gt;&lt;/b&gt; European Clinical Trials Database (No. 2014-004133-6; REC no. 14/YH/1209; Sponsor ref. R1766).</jats:p

Conversion of haemodialysis patients from iron sucrose to iron isomaltoside: a real-world experience

Abstract Background Anaemia is common in haemodialysis (HD) patients and associated with significant morbidity and mortality. Intravenous (IV) iron combined with erythropoietin (EPO) is the mainstay treatment of anaemia in these patients. The comparative efficacy and risk of adverse events with IV iron preparations have been assessed in only a few trials. Methods This was an observational longitudinal repeated measures retrospective study designed to compare the safety and efficacy of iron sucrose (IS-Venofer®) versus iron isomaltoside (IIM-Diafer®) in haemodialysis patients. The study included patients currently on dialysis and receiving Venofer who were switched to Diafer and monitored for at least 12 months for each iron preparation. Results A total of 190 patients were included and had a mean age of 65.8 years. Non-inferiority was confirmed with no change in mean haemoglobin per mg of iron administered over a 12-month period. In total there were 41,295 prescriptions of iron isomaltoside and 14,685 of iron sucrose with no difference in the reported adverse events during the study period (7 each, none were severe). There was a statistically significant effect on Hb over time after converting (T0), including after adjustment for multiple comparisons. There were significant improvements in ferritin over time, which remained at 6 months (P&lt;0.01). The weekly iron dose was similar after adjustment (P=0.02). The EPO dose did not differ significantly after month 0 in patients switched to IIM. Conclusions This study demonstrates the comparative safety and efficacy of iron isomaltoside versus iron sucrose, with similar dosing schedules in dialysis patients., with no differential impact on Hb, and ferritin which were maintained at satisfactory levels for at least 12 months. There was no difference in reported adverse events.</jats:p

Conversion of haemodialysis patients from iron sucrose to iron isomaltoside: a real-world experience

Abstract Background Anaemia is common in haemodialysis (HD) patients and associated with significant morbidity and mortality. Intravenous (IV) iron combined with erythropoiesis-stimulating agents (ESA) is the mainstay treatment of anaemia in these patients. The comparative efficacy and risk of adverse events with IV iron preparations have been assessed in only a few trials. Methods This was a retrospective observational study in 2 centres designed to compare the safety and efficacy of iron sucrose (IS-Venofer®) versus iron isomaltoside (IIM-Diafer®) in haemodialysis patients. The study included patients currently on dialysis and receiving Venofer who were switched to Diafer® and monitored for at least 12 months for each iron preparation. Results A total of 190 patients were included and had a mean age of 65.8 years (SD ± 15.5). Non-inferiority was confirmed with no change in mean haemoglobin per mg of iron administered over a 12-month period. In total there were 41,295 prescriptions of iron isomaltoside and 14,685 of iron sucrose with no difference in the number of reported adverse events during the study period (7 each, none were severe). There was a statistically significant effect on Hb over time after conversion, including after adjustment for multiple comparisons. There were significant improvements in ferritin over time, which remained at 6 months (P&lt;0.01). The weekly iron dose was similar after adjustment (P=0.02). The EPO dose did not differ significantly after month 0 in patients switched to IIM. Conclusions This study demonstrates the comparative safety and efficacy of iron isomaltoside versus iron sucrose, with similar dosing schedules in dialysis patients. Iron isomaltoside is non-inferior to iron sucrose in maintaining Hb in patients on regular haemodialysis/haemodiafiltration with no difference in the number of reported adverse events.</jats:p