Wrapsody CIE provides durable benefit to patients on haemodialysis who experience obstructions in their venous outflow circuit.The WAVE* trial demonstrates the superiority of the Wrapsody Cell–Impermeable Endoprosthesis (CIE) to percutaneous transluminal angioplasty (PTA) in haemodialysis patients who experience stenosis in their venous outflow circuit.
At 12 months, the proportions of participants with target lesion primary patency (TLPP) and access circuit primary patency (ACPP) were nearly twofold higher in the CIE than the PTA group (TLPP: 70.4 percent vs 38.5 percent; p<0.0001; ACPP: 56.4 percent vs 31.1 percent; p=0.0002). [J Vasc Interv Radiol 2026;37:108593]
The Kaplan–Meier curves show the continued superiority of the CIE to PTA beyond the reported 6-month results with no apparent catch-up effect. [Kidney Int 2025;107:740-750] “This suggests that the inherent device properties may have prolonged effect beyond the examined timepoints,” the investigators said.
The mean number of reinterventions to maintain patency of the target lesion was significantly lower with the CIE vs PTA at 12 months (0.49 vs 1.08; p<0.0001), as was the mean number of interventions required to maintain patency anywhere within the access circuit (1.08 vs 1.70; p=0.001).
The time free from reintervention was significantly longer in the CIE vs the PTA group (249 vs 188.8 days; p=0.0009).
The fewer reinterventions and longer time to reintervention with the CIE over the 1-year follow-up period highlight the value of the device in this population, and the potential cost savings. [J Vasc Interv Radiol 2020;31:1-14.e5; Ann Vasc Surg 2021;76:142-151] These results are also valuable to physicians comparing the risk-benefit profiles of PTA and permanent implantable devices, such as Wrapsody.
There were fewer device-related events involving the access circuit with the CIE vs PTA at 12 months (2.9 percent vs 9.5 percent; p=0.049). There were no significant between-group differences for serious device-related events (6.6 percent vs 8.3 percent; p=0.64).
Reinterventions common with PTA
“PTA has been the standard intervention for haemodialysis patients who experience stenosis in their venous outflow circuit. However, the need for repeated intervention following PTA alone is common,” the researchers noted. The high recurrent stenosis rate after PTA is associated with disrupted dialysis sessions, impaired quality of life, and increased costs. [J Vasc Surg 2016;63:772-777]
PTA alternatives, including bare-metal stents, covered stents/stent grafts, and drug-coated balloons, are associated with improved outcomes, but their overall efficacy remains limited. [JAMA 2024;331:1307-1317; J Vasc Access 2023;24:107-116]
Wrapsody was developed to help restore and prolong vascular access for haemodialysis patients who experience stenosis in their venous outflow circuit. The device has received US FDA approval based on superior 6-month TLPP and ACPP outcomes. [Kidney Int 2025;107:740-750]
In WAVE, 245 patients (mean age 60 years, 57 percent men) were randomized 1:1 to treatment with CIE or PTA. Approximately 70 percent had brachiocephalic arteriovenous fistula, about 60 percent had re-stenotic target lesions, the mean percent diameter stenosis was 62.5, and the mean stenosis length was 36.8 mm.
“The significant improvement in patency associated with the CIE vs PTA through 12 months suggests that this device [may] offer patients and clinicians a valuable intervention to help restore and maintain functional patency,” the researchers said.
“Prolonging functionality of vascular access is of high importance to physicians and patients. These results suggest that Wrapsody CIE provides durable benefit to patients and may help optimize care for those on haemodialysis who experience obstructions in their venous outflow circuit,” they concluded.