Maximizing Native Arteriovenous Fistulae Rates.

Maximizing Native Arteriovenous Fistulae Rates. Is Routine Colour Doppler Vascular Mapping in Pre-operative Planning of Value? A Retrospective Study.

The purpose of our study is to compare physical examination alone to color Doppler ultrasonography (CDUS) vascular mapping and physical examination in terms of outcomes of vascular access and long-term patency.

Study Overview

• Status: Completed
• Conditions: Hemodialysis; Kidney Failure; Arteriovenous Shunt
• Intervention / Treatment: Procedure: physical examination; Procedure: medical history; Procedure: native arteriovenous fistula construction; Procedure: arteriovenous graft placement; Procedure: preoperative color Doppler ultrasonographic vascular mapping

Detailed Description

Fistula maturation is a complex vascular remodelling process that requires vessel dilation, increases in volume flow rates in the feeding artery and afferent vein and structural alterations of the vascular wall. The understanding of these procedures and the factors involved in promoting maturation is limited. In this context, one of the major areas requiring investigation is the identification of clinically useful pre-operative predictors of access outcome.

Traditionally, the selection of vascular access and the eligibility for native arteriovenous fistula construction was mainly determined by findings of clinical examination. However, in addition to a complete history and physical examination, National Kidney Foundation/Dialysis Outcome Quality Initiative (NFK/DOQI) recommended that routine pre-operative color Doppler ultrasonographic vascular mapping should be performed in all hemodialysis patients who are candidates for access formation. This concerns the routine implementation of a non-invasive, safe and cost-effective method that permits the identification of vessels that are suitable for arteriovenous fistula (AVF) construction, acknowledging that supporting Level I evidence is still lacking. Indeed, available data supporting the significance of mapping on access maturation and patency rates are limited and conflicting.

The aim of the present study is to compare the type of preoperative assessment, physical examination alone to combined CDUS vascular mapping and physical examination, to outcomes of performed vascular access procedures with respect to type selection and long-term patency at 12 months in hemodialysis patients.

• Study Type: Observational
• Enrollment (Actual): 136

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with dialysis dependent end stage renal disease with first time permanent vascular access, more specifically native arteriovenous fistula or arteriovenous grafts.

Description

Inclusion Criteria:

• end stage renal disease

Exclusion Criteria:

• poor life expectancy
• congestive heart failure New York Heart Association stage 3 and over
• candidates for tunneled catheters

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group A; Patients in whom selection of vascular access relied upon physical examination and medical history, during pre-operative surgical assessment	Procedure: physical examination; Arterial pulse examination, differential blood pressure measurements and the Allen test in both extremities. Inspection of the superficial venous system with tourniquet enhancement in the arm was performed during venous assessment.; Other Names: clinical examination; Procedure: medical history; medical history with respects to diabetes mellitus, coronary heart disease, peripheral vascular disease; Procedure: native arteriovenous fistula construction; surgigal creation of native arterial and venous anastomoses; Procedure: arteriovenous graft placement; surgical placement of arteriovenous graft; Other Names: Polytetrafluoroethylene (PTFE) synthetic graft
Group B; Patients who underwent vascular mapping using color Doppler Ultrasonography in addition to physical examination and history during pre-operative evaluation.	Procedure: physical examination; Arterial pulse examination, differential blood pressure measurements and the Allen test in both extremities. Inspection of the superficial venous system with tourniquet enhancement in the arm was performed during venous assessment.; Other Names: clinical examination; Procedure: medical history; medical history with respects to diabetes mellitus, coronary heart disease, peripheral vascular disease; Procedure: native arteriovenous fistula construction; surgigal creation of native arterial and venous anastomoses; Procedure: arteriovenous graft placement; surgical placement of arteriovenous graft; Other Names: Polytetrafluoroethylene (PTFE) synthetic graft; Procedure: preoperative color Doppler ultrasonographic vascular mapping; Preoperative color Doppler ultrasonographic vascular mapping was performed with linear probe. The patient extremity under scrutiny was placed under support, with tourniquet augmentation. Vessels were examined in both short (transverse) and long (longitudinal) axis. Anatomical variations, wall morphology and internal diameters at the antecubital fossa, the proximal (cranial), mid and distal (caudal) third of the arm and forearm were assessed in both extremities. Veins were evaluated for compressibility and adequate drainage to deep venous system. The presence of sclerotic, thrombosed and fibrosed segments were noted. Doppler waveforms were obtained in the long axis and volume flow (VF) calculated for arteries selected for potential access construction.; Other Names: vascular mapping; pre-operative mapping

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
number of native AVF constructed	in 1 month

Secondary Outcome Measures

Outcome Measure	Time Frame
primary patency rates	12 months

Collaborators and Investigators

• Sponsor: Medifil AE
• Collaborators: International Renal Research Institute Vicenza
• Investigators: Principal Investigator: Ioannis E. Giannikouris, PhD, Medifil AE Private Hemodialysis Centre

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: March 2, 2016
• First Submitted That Met QC Criteria: March 4, 2016
• First Posted (Estimate): March 10, 2016

Study Record Updates

• Last Update Posted (Estimate): March 10, 2016
• Last Update Submitted That Met QC Criteria: March 4, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: renal dialysis; physical examination; arteriovenous fistula; colour Doppler; retrospective studies
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Kidney Diseases; Urologic Diseases; Congenital Abnormalities; Pathological Conditions, Anatomical; Cardiovascular Abnormalities; Vascular Malformations; Arteriovenous Malformations; Vascular Fistula; Fistula; Renal Insufficiency; Arteriovenous Fistula
• Other Study ID Numbers: 1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes