Aurang Z Khawaja1, Deirdre B Cassidy2, Julien Al Shakarchi1, Damian G McGrogan1, Nicholas G Inston1, Robert G Jones3. 1. Department of Renal Transplant Surgery & Vascular Access, Queen Elizabeth Hospital, University Hospitals Birmingham, Birmingham, West Midlands - UK; ReDVA Research Consortium, University of Dundee, Dundee - UK. 2. Division of Diabetes and Cardiovascular Medicine, University of Dundee; ReDVA Research Consortium, University of Dundee, Dundee - UK. 3. Department of Radiology, Queen Elizabeth Hospital, University Hospitals Birmingham, Birmingham, West Midlands - UK.
Abstract
BACKGROUND: Native or prosthetic arteriovenous (AV) fistulas are preferred for permanent haemodialysis (HD) access. These are marked with circuit steno-occlusive disease leading to dysfunction or even failure. Late failure rates have been reported as high as 50%. Standard angioplasty balloons are an established percutaneous intervention for HD access stenosis. Reported restenosis rates remain high and practice guidelines recommend a wide 6-month primary patency (PP) of at least 50% for any intervention. Neointimal hyperplasia is one of the main causes for access circuit stenosis. Drug eluting balloon (DeB) angioplasty has been proposed as an alternative intervention to reduce restenosis by local drug delivery and possible inhibition of this process. PURPOSE: To systematically assess the reported efficacy and safety of DeB angioplasty in percutaneous management of prosthetic and autologous HD access stenosis. METHODS: Protocol for the review was developed following the PRISMA-P 2015 statement. An electronic database (Medline, EMBASE, Clinical Trials.gov and Cochrane CENTRAL) search was conducted to identify articles reporting on the use of DeB intervention in HD AV access. Backward and forward citation search as well as grey literature search was performed. The MOOSE statement and PRISMA 2009 statement were followed for the reporting of results. Data from the included studies comparing DeBs with non-DeBs were pooled using a random effects meta-analysis model and reported separately on randomised and non-randomised studies. RESULTS: Six studies reported on 254 interventions in 162 participants (mean 27 ± 10 SD). The pooled mean and median duration of follow-up was 12 and 13 months (range 6-24 months). These comprised two randomised control trials (RCTs) and four cohort studies. Participant's mean age was 64 ± 5 years and 61% were male. Target lesions (TLs) ranged from under 2 mm to 5.9 mm and 51 were reported as de novo stenosis. Device failure described as wasting of the DeB was reported in two studies (55% and 92.8%). At 6 months TL PP was reported between 70% to 97% for DeBs in the RCTs and cohort studies, and 0% to 26% for non-DeBs. TLs treated with DeBs were associated with a higher primary patency at 6 months as compared to non-DeB balloons (RCTs: odds ratio [OR] 0.25, 95% CI 0.08 to 0.77 and I2 = 19%, cohort studies: OR 0.10, 95% CI 0.03 to 0.31 and an I2 = 20%). No procedure-related major or minor complications were reported. CONCLUSIONS: Current literature reports DeBs as being safe and may convey some benefit in terms of improved rate of restenosis when used to treat AV access disease. However, this body of evidence is small and clinically heterogeneous. A large multicentre RCT may help to clarify the role of DeBs in the percutaneous treatment of AV HD access stenosis.
BACKGROUND: Native or prosthetic arteriovenous (AV) fistulas are preferred for permanent haemodialysis (HD) access. These are marked with circuit steno-occlusive disease leading to dysfunction or even failure. Late failure rates have been reported as high as 50%. Standard angioplasty balloons are an established percutaneous intervention for HD access stenosis. Reported restenosis rates remain high and practice guidelines recommend a wide 6-month primary patency (PP) of at least 50% for any intervention. Neointimal hyperplasia is one of the main causes for access circuit stenosis. Drug eluting balloon (DeB) angioplasty has been proposed as an alternative intervention to reduce restenosis by local drug delivery and possible inhibition of this process. PURPOSE: To systematically assess the reported efficacy and safety of DeB angioplasty in percutaneous management of prosthetic and autologous HD access stenosis. METHODS: Protocol for the review was developed following the PRISMA-P 2015 statement. An electronic database (Medline, EMBASE, Clinical Trials.gov and Cochrane CENTRAL) search was conducted to identify articles reporting on the use of DeB intervention in HD AV access. Backward and forward citation search as well as grey literature search was performed. The MOOSE statement and PRISMA 2009 statement were followed for the reporting of results. Data from the included studies comparing DeBs with non-DeBs were pooled using a random effects meta-analysis model and reported separately on randomised and non-randomised studies. RESULTS: Six studies reported on 254 interventions in 162 participants (mean 27 ± 10 SD). The pooled mean and median duration of follow-up was 12 and 13 months (range 6-24 months). These comprised two randomised control trials (RCTs) and four cohort studies. Participant's mean age was 64 ± 5 years and 61% were male. Target lesions (TLs) ranged from under 2 mm to 5.9 mm and 51 were reported as de novo stenosis. Device failure described as wasting of the DeB was reported in two studies (55% and 92.8%). At 6 months TL PP was reported between 70% to 97% for DeBs in the RCTs and cohort studies, and 0% to 26% for non-DeBs. TLs treated with DeBs were associated with a higher primary patency at 6 months as compared to non-DeB balloons (RCTs: odds ratio [OR] 0.25, 95% CI 0.08 to 0.77 and I2 = 19%, cohort studies: OR 0.10, 95% CI 0.03 to 0.31 and an I2 = 20%). No procedure-related major or minor complications were reported. CONCLUSIONS: Current literature reports DeBs as being safe and may convey some benefit in terms of improved rate of restenosis when used to treat AV access disease. However, this body of evidence is small and clinically heterogeneous. A large multicentre RCT may help to clarify the role of DeBs in the percutaneous treatment of AV HD access stenosis.