Kinetic endovascular microincision creation prior to plain balloon angioplasty in real-world hemodialysis patients with vascular access dysfunction.

Abstract

A large population of people with end-stage kidney disease relies on hemodialysis for renal replacement therapy. Dysfunction of hemodialysis access is common, yet current treatment with percutaneous transluminal balloon angioplasty to restore access functionality introduces concomitant short-term risk with a high rate of reintervention. This study was performed to assess the safety and efficacy of kinetic endovascular microincision creation before percutaneous transluminal balloon angioplasty with a plain (non-drug-coated) balloon, the predominant modality in real-world dialysis access interventions owing to its broad availability, favorable cost profile, and lack of payer parameters. This multicenter observational registry enrolled hemodialysis patients who were scheduled for plain balloon angioplasty of their arteriovenous fistula (AVF) or graft owing to vascular access dysfunction. Follow-up occurred at 1, 6, and 12 months. The primary safety end point was freedom from serious adverse events through 1 month after the procedure. Primary efficacy end points at 6 months after the intervention were primary patency of the target lesion and freedom from clinically driven target lesion revascularization. Secondary end points were postprocedure anatomical success, procedural success, clinical success, circuit patency, and secondary patency. A total of 176 lesions were treated with kinetic endovascular microincisions before plain balloon angioplasty in 130 patients at 4 clinical sites. Target lesion characteristics were 29 ± 21 mm length with a mean preprocedure stenosis of 75.4 ± 14.6%. One stent graft was required for a single angioplasty-related procedural dissection; no serious adverse events were observed. One participant did not complete the follow-up evaluation. Six-month target lesion primary patency (TLPP) was 70.7%. TLPP for AVF cases (n = 97) and arteriovenous graft cases (n = 32) were 75.6% and 55.2%, respectively. For treatment of AVF cephalic arch stenosis (n = 35), 6-month TLPP was 76.3%. Six-month secondary patency was 97.7%. This registry demonstrates the safety and effectiveness of kinetic endovascular microincision creation before plain balloon percutaneous transluminal angioplasty to treat hemodynamically significant dialysis access stenoses of AVFs and arteriovenous grafts, including cephalic arch stenoses.