Role of 2 Stages Brachiobasilic Arteriovenous Fistula in Patients Having Central Venous Stenosis with Exhausted Options of Dialysis Access

Overview

Central venous stenosis (CVS) is a common problem facing the hemodialysis patients planning to receive dialysis through arteriovenous fistula. The causes for Central venous stenosis are Subclavian and internal jugular catheters which is related mostly to the frequency and the duration of catheters placement. (5) Also, Smaller caliber central venous catheters (such as peripherally inserted central \[PICC\] and triple-lumen catheters) can also be associated with thrombus formation and Central venous stenosis over a short term.(6) Pacemakers can be a cause which is associated with a 50% prevalence of subclavian vein stenosis.(7) Subclavian catheter placement is a particularly high risk, with the development of subclavian vein stenosis in approximately 25%-50% of patients in various studies.(8,9) The problem now is there is a hemodialysis patient with exhausted options for AVF and a patent basilic vein but the patient has ipsilateral Central venous stenosis. In previous studies, when creating an AVF over central venous stenosis , the investigators preferred to create a Radiocephalic AVF or Brachiocephalic AVF if Radiocephalic AVF is not available. (10) our study proposing the 2 stage brachiobasilic fistula for patients otherwise have no other option for arteriovenous fistula. Staging the Brachiobasilic procedure will avoid larger incision with the need for general anesthesia until functioning fistula is ensured and central venous stenosis has been delt with.

Detailed description

Central venous stenosis (CVS) is a common problem facing the hemodialysis patients planning to receive dialysis through arteriovenous fistula. The true incidence and prevalence of Central venous stenosis in the ESRD population is unknown because most studies of Central venous stenosis are limited to symptomatic patients. Central venous stenosis may remain asymptomatic because clinical symptoms and signs of Central venous stenosis often develop only after an AVF is placed in the ipsilateral extremity and the impediment to increased blood flow is unmasked. (1) Retrospective investigations of symptomatic HD patients with various accesses using duplex ultrasonography or angiography have reported Central venous stenosis prevalences of 19%-41%. (2-4) The causes for Central venous stenosis are Subclavian and internal jugular catheters which is related mostly to the frequency and the duration of catheters placement. (5) Also, Smaller caliber central venous catheters (such as peripherally inserted central \[PICC\] and triple-lumen catheters) can also be associated with thrombus formation and Central venous stenosis over a short term.(6) Pacemakers can be a cause which is associated with a 50% prevalence of subclavian vein stenosis.(7) Subclavian catheter placement is a particularly high risk, with the development of subclavian vein stenosis in approximately 25%-50% of patients in various studies.(8,9) The problem now is there is a hemodialysis patient with exhausted options for AVF and a patent basilic vein but the patient has ipsilateral Central venous stenosis. In previous studies, when creating an AVF over central venous stenosis , the investigators preferred to create a Radiocephalic AVF or Brachiocephalic AVF if Radiocephalic AVF is not available. (10) our study proposing the 2 stage brachiobasilic fistula for patients otherwise have no other option for arteriovenous fistula.

Staging the Brachiobasilic procedure will avoid larger incision with the need for general anesthesia until functioning fistula is ensured and central venous stenosis has been delt with.

our Aims are : Evaluates the efficacy and safety of creation of a Brachiobasilic fistula in hemodialysis patients with central venous stenosis Evaluate the outcomes of Superficialization of the basilic vein after percutaneous transluminal angioplasty of the central venous stenosis

Interventions

• Procedure brachiobasilic AVF
  perform 2 stage brachiobasilic AVF in hemodialysis patients with central venous stenosis

Primary outcome measures

• Procedural success of 1st stage Brachiobasilic fistula [Time frame: through study completion, an average of 2 year]
• Primary patency [Time frame: through study completion, an average of 2 year]
• Assisted primary patency [Time frame: through study completion, an average of 2 year]

Secondary outcome measures (2)

• complications of the fistula [Time frame: through study completion, an average of 2 year]
• Fistula maturation [Time frame: 4 weeks after the fistula creation and every 2 weeks up to 24 weeks]

Eligibility criteria

Inclusion criteria

• Haemodialysis patients with asymptomatic central venous stenosis that have only basilic vein feasible for creating AVF in one upper limb with exhausted other options for AVF
• Age > 18
• Patent brachial artery by duplex with PSV > 45 cm/s
• Patent Basilic vein with diameter > 3 mm

Exclusion criteria

• Patient with other arteriovenous access options
• Patient not fit for surgery
• Patient with Peripheral arterial disease at Upper limb
• Patient with history of DVT in upper limb
• Hemodynamically unstable patients

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• Jennings WC, Maliska CM, Blebea J, Taubman KE. Creating arteriovenous fistulas in patients with chronic central venous obstruction. J Vasc Access. 2016 May 7;17(3):239-42. doi: 10.5301/jva.5000507. Epub 2016 Feb 5. PMID 26847733
• Agarwal AK. Central vein stenosis: current concepts. Adv Chronic Kidney Dis. 2009 Sep;16(5):360-70. doi: 10.1053/j.ackd.2009.06.003. PMID 19695504
• Barrett N, Spencer S, McIvor J, Brown EA. Subclavian stenosis: a major complication of subclavian dialysis catheters. Nephrol Dial Transplant. 1988;3(4):423-5. doi: 10.1093/oxfordjournals.ndt.a091691. PMID 3140128
• Schwab SJ, Quarles LD, Middleton JP, Cohan RH, Saeed M, Dennis VW. Hemodialysis-associated subclavian vein stenosis. Kidney Int. 1988 Jun;33(6):1156-9. doi: 10.1038/ki.1988.124. PMID 2969991
• Sticherling C, Chough SP, Baker RL, Wasmer K, Oral H, Tada H, Horwood L, Kim MH, Pelosi F, Michaud GF, Strickberger SA, Morady F, Knight BP. Prevalence of central venous occlusion in patients with chronic defibrillator leads. Am Heart J. 2001 May;141(5):813-6. doi: 10.1067/mhj.2001.114195. PMID 11320371
• Grove JR, Pevec WC. Venous thrombosis related to peripherally inserted central catheters. J Vasc Interv Radiol. 2000 Jul-Aug;11(7):837-40. doi: 10.1016/s1051-0443(07)61797-7. PMID 10928518
• Agarwal AK. Central vein stenosis. Am J Kidney Dis. 2013 Jun;61(6):1001-15. doi: 10.1053/j.ajkd.2012.10.024. Epub 2013 Jan 3. PMID 23291234
• MacRae JM, Ahmed A, Johnson N, Levin A, Kiaii M. Central vein stenosis: a common problem in patients on hemodialysis. ASAIO J. 2005 Jan-Feb;51(1):77-81. doi: 10.1097/01.mat.0000151921.95165.1e. PMID 15745139

Identifiers

NCT: NCT06846580 · BBAVF with CVS

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗