Purpose: A prospective, single-center, single-arm feasibility study evaluated procedural and short-term performance of the Advance Enforcer 35 focal-force percutaneous transluminal angioplasty (PTA) balloon catheter in treating stenoses of mature native arteriovenous (AV) hemodialysis access circuits.
Materials and methods: Twenty-eight patients undergoing treatment for stenosis of a mature native AV hemodialysis access circuit were enrolled at a single institution. Angiographic assessments of the study lesion were required at baseline and after the procedure. Adjunctive procedures for significant residual stenosis were permitted, and patients had clinical and imaging follow-up for as long as 6 months.
Results: Treatment with the study balloon was effective in reducing the average percent diameter stenosis of the treated lesion from 66.3% (range, 43.8%-93.3%) before the procedure to 23.7% (range, -6.7% to 51.4%) after the procedure. The average inflation pressure required was 12.3 atm. Only 1 patient required an adjunctive procedure, and all patients could resume normal dialysis following the study procedure. At 3 months, 62.0% of study lesions remained patent, and the 6-month patency rate was 25.1%. Two adverse events associated with the study procedure were reported: access-site hematoma and forearm pain (3.6% each).
Conclusions: The results demonstrate safety of the study balloon in treating AV access stenosis. Nominal-diameter angioplasty was achieved at relatively low pressure in most study patients without the use of adjunctive procedures, and resumption of normal dialysis was achieved for all patients.
Copyright © 2018 SIR. Published by Elsevier Inc. All rights reserved.