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.