Early

The aim of this pilot study was to evaluate the safety and efficacy of the MagicTouch[TM] 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 outcome...

Full description

Saved in:
Bibliographic Details
Published in:PloS one 2020-10, Vol.15 (10), p.e0241321
Main Authors: Tang, Tjun Y, Soon, Shereen X. Y, Yap, Charyl J. Q, Chan, Sze Ling, Tan, Ru Yu, Pang, Suh Chien, Lee, Shaun Q. W, Yap, Hao Yun, Choke, Edward T. C, Tan, Chieh Suai, Chong, Tze Tec
Format: Article
Language:English
Subjects:
Arteriovenous fistula
Balloon angioplasty
Care and treatment
Patient outcomes
Sirolimus
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:The aim of this pilot study was to evaluate the safety and efficacy of the MagicTouch[TM] 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. Single-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. 47 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. SCB 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.
ISSN:1932-6203
1932-6203
DOI:10.1371/journal.pone.0241321