Restoring arteriovenous access: Pilot study using a scoring balloon in 50 patients

Area of Science:

• Vascular Surgery
• Interventional Nephrology
• Medical Devices

Background:

• Arteriovenous access failure, often caused by neointimal hyperplastic stenoses, is a common complication in hemodialysis.
• Balloon angioplasty is the standard endovascular treatment for hemodialysis access stenosis.
• Scoring balloon technology offers a novel approach to disrupt atheromatous plaque, but its impact on long-term patency requires further investigation.

Purpose of the Study:

• To evaluate the safety and efficacy of the AngioSculpt scoring balloon for treating stenosed arteriovenous fistulas and grafts in hemodialysis patients.
• To assess the primary endpoint of target lesion primary patency at 2 and 6 months, defined as freedom from re-intervention.

Main Methods:

• A prospective, single-arm study involving 50 patients with stenosed hemodialysis fistulas/grafts.
• Treatment utilized the AngioSculpt scoring balloon (Philips).
• Patients were followed for 6 months to determine freedom from re-intervention.

Main Results:

• Successful reduction in stenosis from 78% to 7.2% post-treatment with the scoring balloon.
• No procedural complications such as slippage or dissection were reported.
• At 6 months, 19% of patients required re-intervention, with a 6-month freedom from re-intervention rate of 81% overall. Patency rates were higher for fistulas (83.3%) than grafts (71.4%) and decreased with an increasing number of prior interventions.

Conclusions:

• The AngioSculpt scoring balloon demonstrates potential as a safe and effective treatment for stenosed arteriovenous access in hemodialysis patients.
• This pilot study suggests the AngioSculpt device is a viable option for endovascular intervention in this patient population.
• Further research is warranted to confirm long-term patency rates and compare outcomes with existing therapies.