Arterio-arterial Vascular Access as a Novel Technique for Treatment of Venous Hypertention With Arterio-venous Vascular Access

Arterio-arterial vascular access, Arterio-venous synthetic access, Venous hypertension, Hemodialysis patients Purpose: To describe a technique used to treat a patient with Lt upper limb synthetic arterio-venous vascular access and venous hypertension of the same limb. Technique: the investigator expose the venous anastomosis of the graft by small longitudinal incision in the axilla and dissection of the axillary artery just parallel to the axillary vein , the investigator disconnect the graft from the axillary vein and do primary repair of the vein , then the investigator do end to side anastomosis of the graft to the axillary artery , after finishing this anastomosis the axillary artery ligated just below the anastomosis. Conclusion: the conversion of arterio-venous graft to arterio-arterial vascular access in precious access with venous hypertension lead to resolution of edema of venous hypertension and preservation of access for dialysis.

Study Overview

• Status: Unknown
• Conditions: Vascular Access Complication
• Intervention / Treatment: Procedure: Arterioarterial synthetic graft

Detailed Description

Abstract Purpose: To describe a technique used to treat a patient with Lt upper limb synthetic arterio-venous vascular access and venous hypertension of the same limb. Technique: we expose the venous anastomosis of the graft by small longitudinal incision in the axilla and dissection of the axillary artery just parallel to the axillary vein , the investigator disconnect the graft from the axillary vein and do primary repair of the vein , then investigator s do end to side anastomosis of the graft to the axillary artery , after finishing this anastomosis the axillary artery ligated just below the anastomosis. Conclusion: the conversion of arterio-venous graft to arterio-arterial vascular access in precious access with venous hypertension lead to resolution of edema of venous hypertension and preservation of access for dialysis.

Keywords: Arterio-arterial vascular access, Arterio-venous synthetic access, Venous hypertension, Hemodialysis patients.

Introduction:

In haemodialysis patients the investigator are confronted by patient with Left upper limb synthetic graft used for haemodialysis and the patient developed edema due to central venous occlusion ( venous hypertension) in the same limb. The other limb have no palpable pulse due to previous 3 operations for vascular access which ended by ligation of the brachial artery.

First the hope to dilatation of the central veins but this trial failed due to failure of the wire to cross the lesion, so we think to convert this arterio-venous graft to arterio-arterial access as we have previous experience with brachial aretrio-arterial vascular access.

One limitation of this technique was that the continuity of the brachial artery which will lead to thrombosis of the graft because of equal pressure in the graft and the brachial artery so ligation of the axillary artery below the proximal anastomosis was done despite our fear of ischaemia of the limb if the synthetic graft occluded later on.

Technique:

After failure of trial angioplasty of epsilateral central veins. This procedure was done either by local, regional, or general anesthesia (IV deprivan) according to the patient situation and surgeon preference.

Longitudinal incision (about 5-7cm) in the axilla at the arterio-venous anastomosis of the synthetic graft and along the course of the axillary artery , good hemostasis is needed because of the edema and the venous hypertension in the dilated collateral veins.

Good exposure of the end of the synthetic graft and mobilization of the axillary artery was done with ligation of intervening branches (a segment of 4-6 cm).

The synthetic graft catted and we do repair of the axillary vein. End to side anastomosis between the synthetic graft and the axillary artery by 6/0 proline then the axillary artery is ligated just below the anastomosis by 2/0 silk suture , now the blood is reversed in the synthetic graft and the blood flow from the axillary artery to the synthetic graft then to the brachial artery and radial and ulnar arteries.

Patients were discharged in the 2nd postoperative day unless need. Creep bandage was applied to the forearm and after 1-2 days the edema resolved and the patient regain the function of the upper limb and he can used the graft for dialysis immediately because the graft already healed and used previously for dialysis which is useful in those patients who has no venous access even for temporary catheter .

The same instructions as any arterio-arterial graft for hemodialysis were given to the patient and the medical stuff at dialysis unit as:

• no medications given at the AAPL to avoid intra-arterial injection and acute ischemia.
• Only pulse which can be palpated at the graft but no thrill.
• Patency of the graft is done by palpation of the distal pulsation (distal brachial or radial artery) or duplex.
• The puncture site needs more time of compression than that needed for AV grafts. (Khafagy et al.,)

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohamed S. Abdelgawwad, MD; Phone Number: 002 01003919077; Email: mshukri33@gmail.com
• Study Contact Backup: Name: Tamer A. Khafagy, PhD; Phone Number: 002 01011889500; Email: Dr_Tamerkhafagy@yahoo.com

Study Locations

• Egypt
  • Mansoura, Egypt, 35615
    • Recruiting
    • Mansoura University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All vascular access with central venous hypertension with failed angioplasty

Exclusion Criteria:

• infected access or rupture access

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vascular Access Venous Hypertension; Swollen upper limb with synthetic Arteriovenous graft	Procedure: Arterioarterial synthetic graft; Synthetic poly tetraflouroethylene graft

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decrease the swelling of the upper limb gradually	Measure of the whole cicumference	Six month
Patency of the dialysis access	Duplex ultrasound assessment of the patency	Six month
Effeicient dialysis	Continue haemodialysis of the access for 4 hours	4 hours

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2018
• Primary Completion (Anticipated): June 21, 2021
• Study Completion (Anticipated): June 21, 2021

Study Registration Dates

• First Submitted: July 1, 2020
• First Submitted That Met QC Criteria: July 14, 2020
• First Posted (Actual): July 15, 2020

Study Record Updates

• Last Update Posted (Actual): July 15, 2020
• Last Update Submitted That Met QC Criteria: July 14, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: R.20.06.909 - 2020/06/24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No