Low-Pressure Scoring Sheath Treatment for Juxta-anastomotic Stenosis in Hemodialysis Fistulas

Purpose: The purpose is to examine the ability to treat juxta-anastomotic, or in-flow stenosis, of an arteriovenous (AV) fistula with the XO Score sheath platform, which creates a scoring and cutting vessel prep system by working with off-the-shelf percutaneous transluminal angioplasty (PTA) catheters. Juxta-anastomotic stenosis is a high-occurring failure mode in AV fistulas and grafts. The current, standard treatment often requires ultra-high-pressure PTA inflations to break the tough intimal hyperplasia and fibrotic tissue forming the lesion. High-pressure treatments often come with high risk of damaging the fistula or surrounding vasculature as a result of uncontrolled lesion release or straightening of the fistula as pressure increases. An effective, low-pressure treatment solution could help dilate these lesion types in a more controlled and predictable manner.

Materials and Methods: The XO Score scoring sheath is used in conjunction with a standard 5-Fr BSC Gladiator PTA balloon and a manual inflation syringe with pressure gauge. This is a review of procedures in which juxta-anastomotic lesions were not responsive to standard angioplasty and were then successfully dilated by using a scoring sheath in conjunction with a similarly size standard PTA balloon. Pre- and posttreatment angiograms were taken along with vessel measurements and visual observation of vessel response and incidence of recoil or restenosis.

Results: The scoring sheath, when used in conjunction with standard angioplasty, was successful in dilating the lesion at lower pressure compared with plain old balloon angioplasty or high-pressure angioplasty.

Conclusions: The scoring sheath in conjunction with standard angioplasty provides a viable alternative for controlled and predictable treatment of fibrotic lesions and tight stenosis often seen in AV fistulas and grafts.