Comparison of efficacy and safety of the new generation helixone dialyzers.

INTRODUCTION: New generation helixone dialyzers has recently been developed as part of the ongoing effort to improve dialyzer hemocompatibility and avoid adverse reactions to synthetic dialyzers. This study aimed to assess the performance and albumin loss of this new dialyzer series in hemodiafiltration and compare it with the previous generation helixone series. MATERIAL AND METHODS: A prospective study was conducted in 19 patients. Each patient underwent eight dialysis sessions with the same routine dialysis parameters; only the dialyzer varied: FX60 CorDiax, FX CorAL 60, FX600 CorDiax, FX CorAL 600, FX80 CorDiax, FX CorAL 80, FX800 CorDiax, and FX CorAL 800. The reduction ratios (RR) of urea, creatinine, ß2-microglobulin, myoglobin, kappa-free immunoglobulin light chains (κFLC), prolactin, α1-microglobulin, α1-acid glycoprotein, lambda immunoglobulin light chains (λFLC), and albumin were compared intra-individually. Dialysate albumin loss was also measured. RESULTS: All treatments were well tolerated. The mean amount of replacement fluid ranged from 31 to 34 L. Comparison of dialysis treatments showed no differences between small molecules and even up to those the size of ß2-microglobulins. Little differences were found between myoglobin, κFLC, prolactin, α1-microglobulin, and λFLC RRs, and only FX80 CorDiax was slightly superior to the others. Mean dialysate albumin losses were similar, with less than 2.5 g lost in each dialyzer. The FX80 CorDiax showed slightly higher global removal scores than the other dialyzers evaluated, except for FX CorAL 800. CONCLUSION: The new generation helixone dialyzers series has been updated to minimise the risk of adverse reactions, while maintaining the effectiveness and albumin loss achieved by the previous most advanced helixone generation.

Most recently developed polyester polymer alloy dialyzer: A new medium cut-off membrane?

BACKGROUND: New versions of the polyester polymer alloy (PEPA) membrane have appeared over the years, with increases in both the pore size and the amount of polyvinylpyrrolidone (PVP) to optimize hydrophilicity performance. This study aimed to assess the efficacy of the most recently developed PEPA dialyzer, the FDY series, in hemodialysis (HD) modality in terms of uremic toxin removal and albumin loss and to compare it with that of several high-flux dialyzers currently used in HD and post-dilution hemodiafiltration (HDF) treatments. METHODS: A prospective study was carried out in 21 patients. All patients underwent six dialysis sessions with the same routine dialysis parameters; only the dialyzer and/or the dialysis modality varied: FX80 in HD, FDY 180 in HD, Clearum HS17 in HDF, Elisio 19H in HDF, Vitapes 180 in HDF, and FX80 in post-dilution HDF. The reduction ratios (RR) of urea, creatinine, ß2 -microglobulin, myoglobin, κFLC, prolactin, α1 -microglobulin, α1 -acid glycoprotein, λFLC, and albumin were compared intraindividually. Dialysate albumin loss was also measured. RESULTS: Both membranes FDY and FX80 are high-flux dialyzers and are applied here in high-flux HD. The average RR of ß2 -microglobulin was slightly lower in the two HD treatments than in the HDF treatments. Comparison of dialysis treatments revealed that the PEPA FDY dialyzer in the HD modality was more effective than the FX80 dialyzer in high-flux HD and was as effective as post-dilution HDF, especially in terms of myoglobin, κFLC, prolactin, α1 -microglobulin, and λFLC RRs. The FDY treatments obtained similar albumin RR in blood and slightly higher dialysate albumin loss, although the values were clinically acceptable. CONCLUSIONS: The most recently developed PEPA dialyzers in the HD modality were as effective as all treatments in the HDF modality and were clearly superior to high-flux helixone HD treatment. These results confirm that this dialyzer should be categorized within the medium cut-off (MCO) membrane classification.

Results of Salt Intake Restriction Monitored with the New Sodium Control Biosensor.

INTRODUCTION: Adherence to a low-sodium (Na) diet is crucial in patients under hemodialysis, as it improves cardiovascular outcomes and reduces thirst and interdialytic weight gain. Recommended salt intake is lower than 5 g/day. The new 6008 CAREsystem monitors incorporate a Na module that offers the advantage of estimating patients' salt intake. The objective of this study was to evaluate the effect of dietary Na restriction for 1 week, monitored with the Na biosensor. METHODS: A prospective study was conducted in 48 patients who maintained their usual dialysis parameters and were dialyzed with a 6008 CAREsystem monitor with activation of the Na module. Total Na balance, pre-/post-dialysis weight, serum Na (sNa), changes in pre- to post-dialysis sNa (ΔsNa), diffusive balance, and systolic and diastolic blood pressure were compared twice, once after 1 week of patients' usual Na diet and again after another week with more restricted Na intake. RESULTS: Restricted Na intake increased the percentage of patients on a low-Na diet (<85 Na mmol/day) from 8% to 44%. Average daily Na intake decreased from 149 ± 54 to 95 ± 49 mmol, and interdialytic weight gain was reduced by 460 ± 484 g per session. More restricted Na intake also decreased pre-dialysis sNa and increased both intradialytic diffusive balance and ΔsNa. In hypertensive patients, reducing daily Na by more than 3 g Na/day lowered their systolic blood pressure. CONCLUSIONS: The new Na module allowed objective monitoring of Na intake, which in turn could permit more precise personalized dietary recommendations in patients under hemodialysis.

Comparison of four medium cut-off dialyzers.

Background: Recently, several pharmaceutical companies have developed new medium cut-off (MCO) dialyzers for expanded hemodialysis (HDx). This study aimed to compare the safety and efficacy of four MCO dialyzers, against each other and versus high-flux hemodialysis (HD) and post-dilution hemodiafiltration (HDF). Methods: A prospective study was carried out on 23 patients who underwent six dialysis sessions: two sessions with the FX80 Cordiax in HD and HDF, and four HDx sessions with the Phylther 17-SD, Vie-18X, Elisio HX19 and Theranova 400 dialyzers. The reduction ratios (RRs) of urea, creatinine, ß2-microglobulin, myoglobin, kappa free immunoglobulin light chain (κFLC), prolactin, α1-microglobulin, α1-acid glycoprotein, lambda (λFLC) and albumin were compared. Dialysate albumin loss was also measured. Results: The differences in efficacy between the evaluated dialyzers were minimal in small molecules and even up to the size of ß2-microglobulin. The main differences were found between myoglobin, κFLC, prolactin, α1-microglobulin and λFLC RRs, in which all four MCO dialyzers, with similar efficacy, were clearly superior to HD and slightly inferior to HDF treatment. Albumin losses in the dialysate with HD dialyzers were <1 g and between 1.5 and 2.5 g in HDx and HDF. The global removal score values were similar in all four HDx treatments, and again significantly higher than those with HD. Conclusions: The results of the four MCO dialyzers evaluated in this study showed good efficiency, with no significant performance differences between them while being completely safe in terms of albumin loss. Likewise, the study confirms the superiority of HDx over high-flux HD with an efficacy close to that of post-dilution HDF.

Efficacy and safety of the Clearum dialyzer.

The Clearum dialyzer, built by Medtronic, became commercially available in several European countries in 2020, but there are still no reports of in vivo data. The aim of this study was to evaluate the efficacy and risk of hypoalbuminemia of this dialyzer compared with previously evaluated hemodialysis (HD), expanded hemodialysis (HDx), and postdilution hemodiafiltration (HDF) treatments. A prospective study was carried out in 15 patients. Each patient underwent seven dialysis sessions: FX80 Cordiax in HD, Clearum HS17 in HD, Phylther 17-SD in HDx, Theranova 400 in HDx, Phylther 17-G in postdilution HDF, Clearum HS17 in postdilution HDF, and FX80 Cordiax in postdilution HDF. The reduction ratios of urea, creatinine, ß2 -microglobulin, myoglobin, prolactin, α1 -microglobulin, α1 -acid glycoprotein, and albumin were compared intraindividually. Dialysate albumin loss was also measured. Comparison of dialysis techniques revealed no differences between small molecules, but HDx and HDF were significantly higher than HD with medium and large molecular weights. The Clearum dialyzer in HDF obtained similar results to FX80 Cordiax in HDF, was slightly superior to Phylther 17-G in HDF, and was statistically superior to both dialyzers in HDx. Albumin losses with the Clearum dialyzer were among the lowest, both in HD and HDF treatments. The highest global removal score (GRS) values were obtained with the helixone and Clearum dialyzers in HDF, with similar results both in HD and HDF. In addition, the GRS values with HDx treatments were statistically significantly higher than those with HD. The new Clearum dialyzer has excellent behavior and tolerance in HD and HDF. Its adequate permeability has been proven with its maximal performance in HDF, which could represent an upgrade versus its predecessor polyphenylene dialyzers.

Evaluation and comparison of polysulfone TS-UL and PMMA NF-U dialyzers versus expanded hemodialysis and postdilution hemodiafiltration.

Toray has created a new generation of dialyzers, the polysulphone (TS) UL series, and polymethylmethacrylate (PMMA) NF-U series, which offer enhanced efficacy over the previous TS-S series and NF-H series. The aim of this study was to evaluate the safety and efficacy of these dialyzer series versus contrasted expanded hemodialysis (HDx) and postdilution hemodiafiltration (HDF). We conducted a prospective study in 12 patients. Each patient underwent six dialysis sessions: FX80 Cordiax in HD, Toraysulfone TS-1.8 UL in HD, Theranova 400 in HDx, polymethylmethacrylate (PMMA) NF-2.1 U in HDF, Toraysulfone TS-2.1 UL in HDF, and FX80 Cordiax in HDF. The removal ratios (RRs) of urea, creatinine, ß2 -microglobulin, myoglobin, prolactin, α1 -microglobulin, α1 -acid glycoprotein, and albumin were compared intraindividually. Dialysate albumin loss was also measured. The RRs for ß2 -microglobulin, myoglobin, prolactin, α1 -microglobulin, and α1 -acid glycoprotein were higher with the TS-2.1 UL and FX80 Cordiax dialyzers in HDF than those obtained with HD treatments and NF-2.1 U in HDF. The ß2 -microglobulin, myoglobin, and prolactin RRs were also higher with HDx than those obtained with HD treatments. The myoglobin and prolactin RRs were higher with TS-1.8 UL in HD than those obtained with helixone dialyzers in HD. Dialysate albumin loss was less than 3 g in all situations except in TS-2.1 UL in HDF. The highest global removal score values were obtained with the TS-2.1 UL and helixone dialyzers in HDF. Significant differences were found between all study situations. In conclusion, the new generation dialyzers, Toraysulfone TS Series UL and PMMA NF-U series, show excellent behaviour and tolerance in HD and HDF, representing an upgrade versus their predecessor series. The higher permeability of the TS UL series has been proven with higher efficiency in HD and maximum performance in HDF. The new PMMA NF-U series allows the use of HDF with good efficiency and complete safety.

Fístulas arteriovenosas nativas humerobasílicas con superficialización y trasposición en un solo acto quirúrgico. Revisión de cinco años de experiencia / Brachiobasilic arteriovenous fistula with superficialisation and transposition the basilic vein in a one stage surgical technique. Five years of single experience

INTRODUCCIÓN: La vena basílica se caracteriza por ser un vaso profundo que en la mayoría de los casos requiere superficialización y trasposición quirúrgica. MATERIAL Y MÉTODOS: Estudio retrospectivo de 119 FAVn HB S-T en pacientes con insuficiencia renal crónica 5D implantadas en un solo acto quirúrgico (2011-2015). Se analiza el porcentaje de permeabilidades primaria (PP), primaria asistida (PPA) y secundaria (PS), así como las complicaciones asociadas. Análisis de permeabilidades mediante curvas de supervivencia Kaplan-Meier y análisis univariante mediante Log Rank (Mantel-Cox). Se considera significativa una p ≤ 0,05. RESULTADOS: Edad media 67,9 años y 63,8% hombres. Durante el período de seguimiento se objetivaron un total de 57 complicaciones: 24 estenosis (42,1%), 11 trombosis (19,2%), 7 síndromes de robo vascular (12,2%), 7 edemas de extremidad superior (12,2%), 6 hematomas pospunción (10,5%) y 2 infecciones (3,5%). Los porcentajes de PP obtenidos a 1, 6, 12 y 24 meses: 92,4, 79,8, 66,3 y 52; PPA: 94,1, 87,3, 80,4 y 65,6%, y PS: 95, 89,1, 84 y 67,5%. Se constataron diferencias significativas en las curvas de PP, PPA y PS según la etiología, presentando peores permeabilidades los diabéticos respecto a la vascular e idiopática (p = 0,037, 0,009 y 0,019). CONCLUSIONES: La implantación quirúrgica de FAVn HB S-T en un solo acto ofrece buenas tasas de permeabilidad y escaso número de complicaciones asociadas. La diabetes mellitus representa un factor de peor pronóstico quirúrgico. Entre las mayores ventajas destacan una mejor optimización de los recursos sanitarios y menor tiempo de permanencia del catéter venoso central

BACKGROUND: The basilic vein is a deep vein which usually requires superficialisation and surgical transposition. MATERIAL AND METHODS: This is a retrospective study of 119 BBAVF-ST in patients with stage 5D chronic kidney disease who received an implant with a one-stage surgical technique (2011-2015). The percentage of primary (PP), assisted primary (APP) and secondary (SP) permeabilities were assessed, as well as the related complications. We analysed the permeabilities using Kaplan-Meier survival curves and a univariate Log Rank analysis (Mantel-Cox). P values less than or equal to 0.05 were considered as significant. RESULTS: The mean age of the study group was 67.9 years, with 63.8% of the subjects being male. A total of 57 complications were detected during the follow-up period: 24 stenosis (42.1%), 11 thrombosis (19.2%), 7 vascular access steal syndromes (12.2%), 7 upper limb oedemas (12.2%), 6 post-puncture haematomas (10.5%) and 2 infections (3.5%). The percentages of PP obtained at 1, 6, 12 and 24months were 92.4%, 79.8%, 66.3% and 52%; APP: 94.1%, 87.3%, 80.4% and 65.6%, and SP: 95%, 89.1%, 84% and 67.5%, respectively. Diabetic patients presented with significantly worse permeabilities than vascular or idiopathic patients: (P = .037, .009 and .019, respectively). CONCLUSIONS: According to the results obtained in our study, the one-stage surgical implementation of BBAVF-ST presents high permeability rates and a small number of related complications. Diabetes mellitus is a factor related to a worse surgical prognosis. Some of the biggest advantages are the greater optimisation of health resources and a shorter time in which the central venous catheter needs to remain in the body

Brachiobasilic arteriovenous fistula with superficialisation and transposition the basilic vein in a one stage surgical technique. Five years of single experience. / Fístulas arteriovenosas nativas humerobasílicas con superficialización y trasposición en un solo acto quirúrgico. Revisión de cinco años de experiencia.

BACKGROUND: The basilic vein is a deep vein which usually requires superficialisation and surgical transposition. MATERIAL AND METHODS: This is a retrospective study of 119 BBAVF-ST in patients with stage 5D chronic kidney disease who received an implant with a one-stage surgical technique (2011-2015). The percentage of primary (PP), assisted primary (APP) and secondary (SP) permeabilities were assessed, as well as the related complications. We analysed the permeabilities using Kaplan-Meier survival curves and a univariate Log Rank analysis (Mantel-Cox). P values less than or equal to 0.05 were considered as significant. RESULTS: The mean age of the study group was 67.9years, with 63.8% of the subjects being male. A total of 57 complications were detected during the follow-up period: 24 stenosis (42.1%), 11 thrombosis (19.2%), 7 vascular access steal syndromes (12.2%), 7 upper limb oedemas (12.2%), 6 post-puncture haematomas (10.5%) and 2 infections (3.5%). The percentages of PP obtained at 1, 6, 12 and 24months were 92.4%, 79.8%, 66.3% and 52%; APP: 94.1%, 87.3%, 80.4% and 65.6%, and SP: 95%, 89.1%, 84% and 67.5%, respectively. Diabetic patients presented with significantly worse permeabilities than vascular or idiopathic patients: (P=.037, .009 and .019, respectively). CONCLUSIONS: According to the results obtained in our study, the one-stage surgical implementation of BBAVF-ST presents high permeability rates and a small number of related complications. Diabetes mellitus is a factor related to a worse surgical prognosis. Some of the biggest advantages are the greater optimisation of health resources and a shorter time in which the central venous catheter needs to remain in the body.