Abstract
BackgroundThe aim of this pilot study was to evaluate the safety and efficacy of the MagicTouch™ sirolimus-coated balloon (SCB) catheter (Concept Medical Inc., Tampa, FL, US) on improving the patency of failing arterio-venous fistulas (AVF) with de novo and recurrent stenoses. MATILDA reports early outcomes at 3- and 6 months post intervention.MethodsSingle-centre, single-arm prospective pilot study of 33 (18 males; mean age 64.7±11.6 years) end-stage renal failure Asian patients with a dysfunctional AVF, who underwent SCB angioplasty between May 2019-January 2020. All procedures were performed under local anaesthetic without sedation and as day surgery. All patients were prescribed dual antiplatelet therapy for 3 months and followed up with Duplex ultrasound at 3 and 6 months.Results47 stenotic target lesions treated and 24/33 (72.7%) patients were for restenosis. Main indications for intervention was low/dropping access flow (21/33; 63.6%) and most common target lesion was in the juxta-anastomosis (19/47; 40.4%). There was 100% technical and procedural success. There were no peri-procedural complications related to the SCB. The target lesion primary patency rates at 3 and 6 months were 46/47 (97.9%) and 29/35 (82.9%) respectively. Circuit access patency rates at 3 and 6 months were 31/33 (93.9%) and 17/25 (68%) respectively. There was one (2.9%) death at 6 months and 4/33 (12.1%) overall to date, all from patients’ underlying co-morbidities.ConclusionsSCB angioplasty for dysfunctional AVF circuits is a safe and efficacious modality in Asian haemodialysis patients at six months comparable if not better than the paclitaxel data reported to date in the literature.
Highlights
sirolimus-coated balloon (SCB) angioplasty for dysfunctional arterio-venous fistulas (AVF) circuits is a safe and efficacious modality in Asian haemodialysis patients at six months comparable if not better than the paclitaxel data reported to date in the literature
The recent update to the National Kidney Foundation’s Kidney Disease Outcomes Quality Initiative (KDOQI) Clinical Practice Guideline for Vascular Access introduced an important new concept called the End-Stage Kidney Disease (ESKD) Life-Plan, which maps out vascular access on an individual basis for the lifetime of the patient [1]
We hypothesized that the application of SCB to cover the target venous stenotic lesion after successful effacement using a high pressure balloon minimises neo-intimal hyperplasia (NIH) and improves AVF target lesion patency compared to conventional balloon angioplasty (CBA)
Summary
The recent update to the National Kidney Foundation’s Kidney Disease Outcomes Quality Initiative (KDOQI) Clinical Practice Guideline for Vascular Access introduced an important new concept called the End-Stage Kidney Disease (ESKD) Life-Plan, which maps out vascular access on an individual basis for the lifetime of the patient [1]. Conduit stenosis is the most frequent cause of AVFs becoming dysfunctional and remains a significant cause of morbidity and hospital admission for ESKD patients on haemodialysis [3]. The KDOQI guidelines recommend treating haemodialysis access stenoses of more than 50% when associated with reduced flow rate and elevated venous pressures [1]. The aim of this pilot study was to evaluate the safety and efficacy of the MagicTouchTM sirolimus-coated balloon (SCB) catheter (Concept Medical Inc., Tampa, FL, US) on improving the patency of failing arterio-venous fistulas (AVF) with de novo and recurrent stenoses. MATILDA reports early outcomes at 3- and 6 months post intervention
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