Arteriovenous fistula construction with the VasQ™ external support device: a pilot study

Area of Science:

• Vascular surgery
• Nephrology
• Medical device technology

Background:

• Arteriovenous fistulas (AVFs) are the preferred hemodialysis access due to their efficacy and cost-effectiveness.
• Despite advancements, native AVF non-maturation remains a significant clinical challenge.
• Neointimal hyperplasia at the anastomotic site is a primary cause of AVF failure.

Purpose of the Study:

• To evaluate the safety and efficacy of the VasQ™ external support device for brachiocephalic arteriovenous fistulas.
• To assess the impact of VasQ™ on AVF flow, maturation, and patency rates.
• To determine if VasQ™ can mitigate perianastomotic stenosis.

Main Methods:

• A single-institution study involving 20 patients undergoing brachiocephalic AVF creation with VasQ™ placement.
• External deployment of the VasQ™ device over the fistula, available in three sizes.
• Follow-up for 6 months with Doppler ultrasonography to assess flow, maturation, and patency at 1, 3, and 6 months.

Main Results:

• Mean venous flow rates were consistently above 1100 mL/min throughout the 6-month follow-up.
• High primary patency rates were observed: 95% at 1 month, 79% at 3 months, and 79% at 6 months.
• Unassisted maturation rates were 80% at 1 month, 79% at 3 months, and 74% at 6 months, with no device-related serious adverse events.

Conclusions:

• The VasQ™ device is safe and demonstrates high rates of unassisted AVF maturation and patency.
• VasQ™ shows potential in preventing perianastomotic stenosis, a leading cause of AVF failure.
• The device facilitates AVF usability for hemodialysis, with 14 out of 15 patients able to use the fistula by study end.