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

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

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Article Type: CLINICAL TRIAL PROTOCOL

Article Subject: Dialysis

DOI:10.5301/jva.5000700

Authors

Inés Aragoncillo, Soraya Abad, Silvia Caldés, Yésika Amézquita, Almudena Vega, Antonio Cirugeda, Cristina Moratilla, José Ibeas, Ramón Roca-Tey, Cristina Fernández, Nicolás Macías, Borja Quiroga, Ana Blanco, Maite Villaverde, Caridad Ruiz, Belén Martín, Asunción M. Ruiz, Jara Ampuero, Fernando de Alvaro, Juan M. López-Gómez

Abstract

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.

Trial registration: ClinicalTrials.gov Identifier: NCT02111655.

Article History

Disclosures

Financial support: This trial has been financed by the Madrid Society of Nephrology (SOMANE) and the Infanta Sofia Hospital Research Foundation.
Conflict of interest: None of the authors has financial interest related to this study to disclose.

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Authors

Affiliations

  • Nephrology Unit, Hospital Gregorio Marañón, Madrid - Spain
  • Clínica Fuensanta, Hemodialysis Unit, Madrid - Spain
  • Nephrology Unit, Hospital Infanta Sofía, Madrid - Spain
  • Corporació Sanitària i Universitària Parc Taulí, Hospital de Sabadell, Barcelona - Spain
  • Nephrology Unit, Hospital de Mollet, Mollet del Vallès, Barcelona - Spain
  • Preventive Medicine Unit, Hospital Clínico, Madrid - Spain
  • Hospital Universitario La Princesa, Madrid - Spain
  • Clínica Dialcentro, Hemodialysis Unit, Madrid - Spain
  • Clínica Los Enebros, Hemodialysis Unit, Madrid - Spain

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