Patency rates following treatment with the WRAPSODY™ Cell-Impermeable Endoprosthesis for recalcitrant renal access circuit dysfunction: Results from a tertiary Australian centre.

Objective: To describe clinical outcomes associated with the use of the WRAPSODY Cell-Impermeable Endoprosthesis at a tertiary center in Western Australia.

Methods: Patients with recalcitrant occlusive disease in the venous outflow of their arteriovenous access circuits were treated with WRAPSODY. Patients were prospectively followed up to 12-month post-procedure. Study measures included 30-day adverse events, technical success, target lesion primary patency, access circuit primary patency, and assisted access circuit primary patency.

Results: Twenty-seven WRAPSODY devices were used to treat 15 consecutive patients. The technical success rate was 100%. No device-related adverse events were observed during the follow-up period. Two patients did not complete the full follow up. Patency rates at 3-, 6-, and 12 months for target lesion primary patency were 100% (15/15), 100% (15/15), and 100% (13/13), respectively. Rates for access circuit primary patency at 3-, 6-, and 12 months were 73.3% (11/15), 46.7 % (7/15), and 46.2% (6/13), respectively. Edge stenosis was observed in 33.3% (5/15) of cases and accounted for 5 of the 8 patients who experienced failed access circuit primary patency on angiogram. Primary assisted functional patency was 100% at 12 months.

Conclusion: WRAPSODY can be utilized safely and has durable patency in real-world patients with complex anatomical renal access stenotic lesions. The therapeutic benefits associated with the device may encourage broader use in clinical practice.