USE of IMplanting the Biotronik PassEo-18 Lux drug coated balloon to treat failing haemodialysis arteRiovenous FIstulas and grafts (SEMPER FI Study)

Abstract

Background:

Plain old balloon angioplasty has been the mainstay of treatment for arteriovenous fistula (AVF) stenoses. Recent studies suggest that drug coated balloons (DCB) may significantly reduce re-intervention rates on native and recurrent lesions. The Passeo-18 Lux DCB (Biotronik AG, Buelach, Switzerland) is packaged with a 3.0 µg/mm² dose of paclitaxel. The hypothesis is that its use provides better target lesion primary patency (TLPP), primary assisted patency (PP), secondary patency (SP) rates and reduces the number of visits for re-intervention in a cohort of patients with stenotic AVF and arteriovenous grafts (AVGs).

Methods:

The USE of IMplanting the Biotronik PassEo-18 Lux DCB to treat failing haemodialysis arteRiovenous FIstulas and grafts trial (SEMPER FI) was a prospective double-centre, multi-investigator, non-consecutive, non-blinded single-arm study investigating the efficacy and safety of the Passeo-18 Lux DCB in patients with stenotic AVF/AVG lesions between January 2021 and January 2022. Patient demographics, clinical characteristics, vascular access history, operative indications, details and outcomes were collected prospectively. TLPP, circuit access primary patency (CAP), PP, SP and deaths 6- and 12-months post-intervention were studied.

Results:

Ninety-one patients with 110 lesions were recruited across the two centres. 62.6% (n = 57) were male with a median age of 63.5 years (SD = 10.5). 62.6% (n = 57) were taking anti-platelets. Eighty-five AVFs and six AVGs were treated. 60% (n = 54) of AVFs intervened were radiocephalic. 52.7% (n = 58) of targeted lesions were juxta-anastomotic stenosis (JAS) and one-third (n = 33) at the AVF/AVG outflow. 70.9% (n = 78) of lesions were recurrent. Median time from last intervention was 219 days. 78% of target lesions (n = 85) and circuits (n = 70) were patent at 6-months, of which 96.7% (n = 87) of those requiring assisted intervention were patent.

Conclusion:

This study shows that the Passeo-18 Lux DCB can be an effective and safe tool in the treatment of failing haemodialysis AVFs/AVGs.