First Clinical Results of the Merit WRAPSODY™ Cell-Impermeable Endoprosthesis for Treatment of Access Circuit Stenosis in Haemodialysis Patients

Figures

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  Fig. 1. Flow diagram showing patient enrolment and retention

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  Fig. 2. Study device. (A) Representative image of a 14 mm diameter x 30 mm device. (B) Cross-sectional schematic surrounding a single nitinol wire illustrating the organization of the multilayer graft covering. Similar to other stent grafts, the abluminal layer is composed of ePTFE to facilitate cell-ingrowth to anchor the device in place. Directly adjacent to the nitinol wire are layers of cell-impermeable fluoropolymer to prevent transmural cell migration through the graft covering. Below the innermost cell-impermeable layer is a second layer of porous ePTFE. The luminal surface of the graft is composed of a spun PTFE designed to reduce fibrin deposition and subsequent thrombus formation

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  Fig. 3. Example procedural outcomes. Treatment of a patient with a left brachiocephalic AVF that presented with a stenosis at the cephalic arch extending into the distal subclavian vein. (A & B) Fistulograms taken (A) preintervention and (B) after pre-dilitation of the stenosis. (C) Fluoroscopy of fully deployed study device. (D) Completion fistulogram

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  Fig. 4. TLPP through 12 months. Kaplan–Meier (KM) curves for (A) all patients and (B) sub-cohorts based on access type and lesion location. The tables below each graph list the number of patients at risk, those censored (i.e. exited the study for renal transplant or loss to follow-up), and those who experienced an event leading to the loss of TLPP. Triangles on the KM curves represent either a patient’s date of censoring or final follow-up visit

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  Fig. 5. Kaplan–Meier curves for access circuit primary patency (ACPP). ACPP through 12 months. Kaplan–Meier (KM) curves for (A) all patients and (B) sub-cohorts based on access type and lesion location. The tables below each graph list the number of patients at risk, those censored (i.e. exited the study for renal transplant or loss to follow-up), and those who experienced an event leading to the loss of ACPP. Triangles on the KM curves represent either a patient’s date of censoring or final follow-up visit