Study protocol for paradigm shift in vascular access creation: The VAC study

Abstract

Background:

The radial artery deviation and reimplantation (RADAR) technique uses an artery-to-vein (end-to-side) configuration. We have developed a modified RADAR (M-RADAR) technique. This new technique enables a side-to-side anastomosis between the vessels, and furthermore, the distal cephalic vein is ligated. The VAC Study (Paradigm Shift in Vascular Access Creation) is a multicenter randomized controlled trial comparing the clinical outcomes of radiocephalic fistula created using the conventional technique (CT group) versus the modified RADAR method (M-RADAR group).

Methods:

Prospective, multicenter, randomized study starting in December 2024. Participant recruitment has commenced. All data are collected via paper-based Case Report Forms (CRFs). The primary clinical endpoints include the 1-year primary patency rate of AVF and the incidence of venous juxta-anastomotic stenosis. Secondary endpoints include the 1-year access-assisted primary patency, access cumulative patency, hospitalization rates, mortality, and an analysis of the economic costs associated with maintaining vascular access. An estimated 408 participants will be recruited from approximately 29 dialysis units across China.

Discussion:

A high-quality, adequately powered multicenter randomized controlled trial (RCT) is still needed to provide clear guidance for clinicians on selecting optimal treatment strategies for the cephalic vein during AVF surgery.

Trial registration:

Registration number: ChiCTR2400093537, Registered on 2024–12–06.

Keywords

Arteriovenous fistula RADAR primary patency juxta-anastomotic stenosis conventional technique

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References

Trerotola

SO.

KDOQI clinical practice guideline for vascular access 2019 update: kinder, gentler, and more important than ever. J Vasc Interv Radiol 2020; 31: 1156–1157.

Chinese Hospital Association Blood Purification Center Branch Vascular Access Work Group. Chinese expert consensus on vascular access for hemodialysis. 2nd ed. Chin J Blood Purif 2019; 18: 365–381.

Schmidli

Widmer

Basile

, et al Editor’s choice - vascular access: 2018 clinical practice guidelines of the European Society for Vascular Surgery (ESVS). Eur J Vasc Endovasc Surg 2018; 55: 757–818.

Lok

Huber

Orchanian-Cheff

, et al Arteriovenous access for hemodialysis: a review. JAMA 2024; 331: 1307–1317.

Allon

Litovsky

Zhang

, et al Association of preexisting arterial intimal hyperplasia with arteriovenous fistula outcomes. Clin J Am Soc Nephrol 2018; 13: 1358–1363.

Almasri

Alsawas

Mainou

, et al Outcomes of vascular access for hemodialysis: a systematic review and meta-analysis. J Vasc Surg 2016; 64: 236–243.

Gunawardena

Ridgway

Swing segment stenosis: an unresolved challenge. Semin Dial 2022; 35: 307–316.

Bai

Sadaghianloo

Gorecka

, et al Artery to vein configuration of arteriovenous fistula improves hemodynamics to increase maturation and patency. Sci Transl Med 2020; 12: eaax7613.

Tian

Wang

Sun

, et al No-touch versus conventional vein harvesting techniques at 12 months after coronary artery bypass grafting surgery: multicenter randomized, controlled trial. Circulation 2021; 144: 1120–1129.

10.

Ahmed

Johansson

Karlsson

, et al Human saphenous vein and coronary bypass surgery: ultrastructural aspects of conventional and “no-touch” vein graft preparations. Histol Histopathol 2004; 19: 421–433.

11.

Wang

, et al Adventitial activation in the pathogenesis of injury-induced arterial remodeling: potential implications in transplant vasculopathy. Am J Pathol 2018; 188: 838–845.

12.

Hou

Wang

, et al Modified no-touch technique for radio-cephalic arteriovenous fistula increases primary patency and decreases juxta-anastomotic stenosis. J Vasc Access 2024; 25: 904–913.

13.

Shenoy

Allon

Beathard

, et al Clinical trial end points for hemodialysis vascular access: background, rationale, and definitions. Clin J Am Soc Nephrol 2018; 13: 490–494.

14.

Wang

Zhang

, et al Prevalence of chronic kidney disease in China: results from the sixth China chronic disease and risk factor surveillance. JAMA Intern Med 2023; 183: 298–310.

15.

Zhang

Wang

, et al Prevalence of chronic kidney disease in China: a cross-sectional survey. Lancet 2012; 379: 815–822. Erratum in: Lancet 2012; 380: 650.

16.

Shenoy

Surgical technique determines the outcome of the Brescia/Cimino AVF. J Vasc Access 2017; 18(suppl 1): 1–4.

17.

Bozzetto

Soliveri

Poloni

, et al Arteriovenous fistula creation with VasQTM device: a feasibility study to reveal hemodynamic implications. J Vasc Access 2024; 25: 60–70.

18.

Moris

Karaolanis

Bokos

Regarding “radial artery deviation and reimplantation inhibits venous juxta-anastomotic stenosis and increases primary patency of radial-cephalic fistulas for hemodialysis”. J Vasc Surg 2017; 65: 929.