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

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.

Effect of brachial plexus block-driven vascular access planning on primary distal arteriovenous fistula recruitment and outcomes.

OBJECTIVE: Hemodialysis vascular accesses (VAs) are traditionally planned based on the nondominant upper extremity preoperative physical and sonographic vascular findings. Clinical guidelines advocate the use of the most suitably distended vein in the most distal location. Brachial plexus block (BPB), through its sympathectomy-like effect, promotes vasodilation and can thus further optimize vein recruitment and operative strategy. However, studies on its role in driving primary distal autogenous arteriovenous fistula (AVF) placement are limited. We therefore evaluated a traditional approach of clinic-based VA planning against an on-table sonography-guided strategy under BPB. METHODS: This was a prospective observational study involving 110 consecutive end-stage renal disease multiethnic Asian patients referred for primary VA creation under BPB after preoperative venous mapping. Cases were grouped according to whether there was a preset operative plan for radial cephalic (RC) or brachial cephalic (BC) AVF creation based on artery and vein >2 mm and >2.5 mm size criteria respectively (group A) or vein size or length were suboptimal (2-2.5 mm and <5 cm respectively), thus precluding any operative plan till after BPB (group B). Group B also included cases with a preset VA plan but that subsequently underwent an on-table change in operative plan as a result of more favorable distal vein dilation post-BPB. RC AVF recruitment, maturation, and patency rates were compared in the two groups over a 1-year follow up. RESULTS: One hundred RC and BC AVF were available for analysis after excluding brachial AVFs and grafts: 41 in group A and 59 in group B. Twenty one (51%) primary RC AVFs were created according to a preset preoperative plan compared with 37 (63%) based upon on-table planning or plan modification (P > .05). Satisfactory post-BPB forearm vasodilation resulted in 44% of 36 plans for BC being changed to RC AVFs. RC AVF 6-week hemodynamic maturation and 3-month functional maturation in group A vs B were 48% vs 60% and 69% vs 57%, respectively (P > .05). One-year primary and secondary patency rates were 57% vs 50% and 73% vs 87%, respectively (log rank >.05). Outcomes of RC AVFs in group B were not inferior to those of BC AVFs. CONCLUSIONS: On-table BPB-driven VA planning and plan modification strategy contribute to considerable AVF recruitment but do not lead to significantly better distal AVF prevalence or outcomes over the traditional approach. An adequately powered randomized controlled study is, however, warranted to better assess the long-term clinical and cost benefits of such a strategy.

Embolization of an Aberrant Right Subclavian Artery Aneurysm with Amplatzer Vascular Plug without Bypass.

Aberrant right subclavian artery (ARSA) aneurysms are rare, but the risk of rupture and thromboembolism is high, with a postrupture mortality rate of 50%. Open surgical repair of ARSA aneurysms usually requires thoracotomy and aortic grafting, which can be contraindicated in high-risk patients with multiple comorbidities. Endovascular repair of ARSA aneurysms has been reported, with or without adjunctive surgical bypass. We report a case of an 80-year-old woman resenting with an asymptomatic 4 cm ARSA aneurysm who underwent a completely endovascular treatment of the aneurysm using an Amplatzer vascular plug II (St. Jude Medical Inc., St. Paul, MN).