Safety and effectiveness of COVID-19 SPUTNIK V vaccine in dialysis patients.

INTRODUCTION: Given the vulnerability of chronic kidney disease individuals to SARS-CoV-2, nephrology societies have issued statements calling for prioritization of these patients for vaccination. It is not yet known whether COVID-19 vaccines grant the same high level of protection in patients with kidney disease compared to the non-dialysis population. The aims of this study were to evaluate the safety - measured by the adverse events potentially attributed to vaccines (ESAVI) - and the effectiveness - evaluated by the presence of antibodies - in dialysis patients immunized with the COVID-19 Sputnik V vaccine. METHODS: multicenter, observational and analytical study of a prospective cohort of hemodialysis patients from the Ciudad Autónoma de Buenos Aires participating in an official vaccination program. Dialysis requiring individuals older than 18 years, who received both components of the COVID-19 vaccine were included. RESULTS: Data from 491 patients were included in the safety analysis. ESAVI with either the first or second component was detected in 186 (37.9%, 95% CI 33.6%-42.3%). Effectiveness analysis measuring antibodies levels against SARS-CoV-2 were performed in 102 patients; 98% presented these IgG antibodies at day 21 after the second component. In patients with COVID-19 prior to vaccination, antibodies at day 21 after the first component reached almost the highest levels compared to patients without previous COVID-19, but IgG rise among patients with previous COVID-19 was lower than in those without this previous disease. CONCLUSION: The Sputnik V vaccine has been shown to be safe and effective in this patient's population.

Introducción: Dada la vulnerabilidad al SARS-CoV-2 de las personas con enfermedad renal crónica, las sociedades de nefrología han emitido declaraciones pidiendo priorizar a estos pacientes para la vacunación. Aún no se sabe si las vacunas COVID-19 confieren el mismo nivel de protección en pacientes con enfermedad renal. Los objetivos de este estudio fueron evaluar la seguridad, medida por eventos supuestamente atribuidos a las vacunas (ESAVI) y la efectividad, evaluada por la presencia de anticuerpos en pacientes en diálisis inmunizados con la vacuna COVID-19 Sputnik V. Métodos: estudio multicéntrico, observacional y analítico de una cohorte prospectiva de pacientes en hemodiálisis, en la Ciudad Autónoma de Buenos Aires, con plan de vacunación. Se incluyeron pacientes mayores de 18 años en diálisis que recibieron ambos componentes de la vacuna COVID-19. Resultados: 491 pacientes fueron incluidos en el análisis de seguridad. Se detectó ESAVI con el primer o el segundo componente en 186 (37.9% IC 95%: 33.6%-42.3%). La efectividad medida por presencia de anticuerpos IgG contra SARS-Cov-2 se realizó en 102 pacientes, 98% presentaba IgG contra SARS-CoV-2, 21 días después del segundo componente. En pacientes con COVID-19 previo a la vacunación, los anticuerpos al día 21 del primer componente alcanzaron niveles casi mayores que en aquellos que no habían sufrido COVID-19, aunque el aumento de los niveles a los 21 días del segundo componente fue menor que en los pacientes sin COVID-19 previo. Conclusión: Los pacientes en diálisis constituyen una población vulnerable para la infección por SARS-CoV-2, por lo tanto, más allá de las recomendaciones implementadas por las unidades de diálisis, la vacunación completa es mandatoria. Se ha demostrado que la vacuna Sputnik V es segura y eficaz en esta población de pacientes.

Safety and effectiveness of COVID-19 SPUTNIK V vaccine in dialysis patients / Seguridad y efectividad de vacuna COVID-19 SPUTNIK V en pacientes en diálisis

Abstract Introduction: Given the vulnerability of chronic kidney disease individuals to SARS-CoV-2, nephrology societies have issued statements calling for prioritization of these patients for vaccination. It is not yet known whether COVID-19 vaccines grant the same high level of protection in patients with kidney disease compared to the non-dialysis population. The aims of this study were to evaluate the safety - measured by the adverse events potentially attributed to vaccines (ESAVI) - and the effectiveness - evaluated by the presence of antibodies - in dialysis patients immunized with the COVID-19 Sputnik V vaccine. Methods: multicenter, ob servational and analytical study of a prospective cohort of hemodialysis patients from the Ciudad Autónoma de Buenos Aires participating in an official vaccination program. Dialysis requiring individuals older than 18 years, who received both components of the COVID-19 vaccine were included. Results: Data from 491 patients were included in the safety analysis. ESAVI with either the first or second component was detected in 186 (37.9%, 95% CI 33.6%-42.3%). Effectiveness analysis measuring antibodies levels against SARS-CoV-2 were performed in 102 patients; 98% presented these IgG antibodies at day 21 after the second component. In patients with COVID-19 prior to vaccination, antibodies at day 21 after the first component reached almost the highest levels compared to patients without previous COVID-19, but IgG rise among patients with previous COVID-19 was lower than in those without this previous disease. Conclusion: The Sputnik V vaccine has been shown to be safe and effective in this patient's population.

Resumen Introducción: Dada la vulnerabilidad al SARS-CoV-2 de las personas con enfermedad renal crónica, las sociedades de nefrología han emitido declaraciones pidiendo priorizar a estos pacientes para la vacunación. Aún no se sabe si las vacunas COVID-19 confieren el mismo nivel de protección en pacientes con enfermedad renal. Los objetivos de este estudio fueron evaluar la seguridad, medida por eventos supuestamente atribuidos a las vacunas (ESAVI) y la efectividad, evaluada por la presencia de anticuerpos en pacientes en diálisis inmuniza dos con la vacuna COVID-19 Sputnik V. Métodos: estudio multicéntrico, observacional y analítico de una cohorte prospectiva de pacientes en hemodiálisis, en la Ciudad Autónoma de Buenos Aires, con plan de vacunación. Se incluyeron pacientes mayores de 18 años en diálisis que recibieron ambos componentes de la vacuna COVID-19. Resultados: 491 pacientes fueron incluidos en el análisis de seguridad. Se detectó ESAVI con el primer o el segundo componente en 186 (37.9% IC 95%: 33.6%-42.3%). La efectividad medida por presencia de anticuerpos IgG contra SARS-Cov-2 se realizó en 102 pacientes, 98% presentaba IgG contra SARS-CoV-2, 21 días después del segundo componente. En pacientes con COVID-19 previo a la vacunación, los anticuerpos al día 21 del primer componente alcanzaron niveles casi mayores que en aquellos que no habían sufrido COVID-19, aunque el aumento de los niveles a los 21 días del segundo componente fue menor que en los pacientes sin COVID-19 previo. Conclusión: Los pacientes en diálisis constituyen una población vulnerable para la infección por SARS-CoV-2, por lo tanto, más allá de las recomendaciones implementadas por las unidades de diálisis, la vacunación completa es mandatoria. Se ha demostrado que la vacuna Sputnik V es segura y eficaz en esta población de pacientes.

Sevelamer carbonate reduces the risk of hypomagnesemia in hemodialysis-requiring end-stage renal disease patients.

BACKGROUND: Sevelamer has been associated with less progression of vascular calcifications. This effect could be due to a reduction in serum phosphate levels but also to other additive effects. Magnesium has been also shown to prevent vascular calcification but the effect of sevelamer on serum magnesium levels has not been thoroughly evaluated. Our aim was to analyze whether the use of sevelamer reduces the risk of hypomagnesemia in hemodialysis (HD)-requiring end-stage renal disease patients. METHODS: All prevalent patients from the dialysis unit of the Hospital Italiano de Buenos Aires as of 1 June 2015 were evaluated. They were on three times per week bicarbonate/citrate-buffered HD. They were not receiving phosphate binders or magnesium-containing drugs. The average of three successive monthly magnesium serum levels was considered as the baseline magnesium concentration. Sevelamer carbonate use was retrieved from the patient's clinical records. RESULTS: One hundred and fifty-one patients were included. A large proportion of individuals were on proton pump inhibitors (PPIs) (66%) and more than 50% were using sevelamer carbonate. Serum magnesium levels were significantly higher in those receiving sevelamer compared with those who did not (2.05 ± 0.3 versus 1.8 ± 0.4 mg/dL; P < 0.05). A larger proportion of individuals receiving sevelamer were among those with normal serum magnesium (P = 0.02), while among those with hypomagnesemia, a larger proportion were on PPIs. In the multivariate model including the use of PPIs, sevelamer carbonate resulted in an independent protective factor for hypomagnesemia (odds ratio: 0.44; 95% confidence interval: 0.21-0.87). CONCLUSIONS: Hemodialysis patients receiving sevelamer show higher serum magnesium levels and a reduced risk of hypomagnesemia. This effect remains even after adjustment for PPI use. This effect could contribute to the still controversial superiority of sevelamer in preventing vascular calcifications.

Ipsilateral jugular access to treat an otherwise inaccessible puncture-related arteriovenous fistula pseudoaneurysm: a technical note.

BACKGROUND: The standard approach for the endovascular treatment of a dysfunctional or occluded hemodialysis access in the upper limbs includes a direct intervention through the access itself or alternatively, when not feasible, through the brachial or radial artery access. Nonetheless, there are certain circumstances in which these approaches are not easily achieved. METHODS: An 89-year-old male with end-stage renal disease developed a pseudoaneurysm after an hemorrhagic complication of a recently transposed native basilic arteriovenous fistula secondary to a needle puncture. Dehiscence of the injured access with spontaneous arterial bleeding evolved as a consequence of the upper limb swelling, rendering therapeutic intervention of the access through a conventional route impossible. A fistulogram through puncture of the common femoral artery was performed to obtain an accurate diagnosis. However, this approach was insufficient to advance the covered stent with the intention of excluding the pseudoaneurysm, as the stent delivery system could not reach the desired site. Given that the covered stent insertion required a 9 Fr introducer, the radial artery approach was ruled out. Therefore, we chose a venous access via the ipsilateral internal jugular vein, which was punctured under ultrasound guidance. RESULTS: This strategy was useful to advance the stent and exclude the pseudoaneurysm successfully. CONCLUSIONS: This technique should be considered for those individuals in whom conventional routes of approach for repairing dialysis accesses are not feasible or are extremely risky.