Six-Month Clinical Outcomes from the Thoracic Central Cohort of the WRAPSODY Global Registry

Purpose: To summarize 6-month clinical outcomes of over 100 patients with thoracic central venous obstructions who were enrolled in the WRAPSODY (WRAP) Global Registry.

Materials and Methods: The WRAP Global Registry was a multicenter, observational study conducted across 41 sites worldwide. The patient population comprised adults with a mature arteriovenous fistula or graft (AVF/AVG) dialysis access (i.e., ≥1 hemodialysis access) who experienced obstruction (stenosis or occlusion) in their venous outflow circuit. All enrolled patients were treated with the WRAPSODY® Cell-Impermeable Endoprosthesis (CIE). Patients in the registry were divided into two cohorts based on the location of their obstruction: Central thoracic cohort or Peripheral Cohort.

Results: The primary effectiveness measure was target lesion primary patency (TLPP) at 6 months. TLPP was defined as freedom from clinically driven target lesion revascularization or target lesion thrombosis. The primary safety measure was the proportion of patients free from any localized or systemic event in the 30 days following the procedure.

Conclusion: Patient outcomes from the WRAP Global Registry are expected to help interventionists understand how the device performs in real-world practice, which is a current and on-going need among healthcare stakeholders. As there is limited evidence regarding clinical outcomes for patients with thoracic central venous stenoses/ obstructions, the primary endpoints from this registry will be of high value to interventional radiologists.