Early (6 months) results of a pilot prospective study to investigate the efficacy and safety of sirolimus coated balloon angioplasty for dysfunctional arterio-venous fistulas: MAgicTouch Intervention Leap for Dialysis Access (MATILDA) Trial

Autor: Sze Ling Chan, Shaun Q.W. Lee, Suh Chien Pang, Tjun Y. Tang, Ru Yu Tan, Hao Yun Yap, Charyl Jia Qi Yap, Tze Tec Chong, Shereen X. Y. Soon, Chieh Suai Tan, Edward Choke
Rok vydání: 2020
Předmět:
Male
Target lesion
Cardiovascular Procedures
medicine.medical_treatment
Pilot Projects
030204 cardiovascular system & hematology
Balloon
030218 nuclear medicine & medical imaging
0302 clinical medicine
Coated Materials
Biocompatible
Restenosis
Medicine and Health Sciences
Prospective Studies
Prospective cohort study
Stenosis
Multidisciplinary
Pharmaceutics
Physics
Incidence
Classical Mechanics
Middle Aged
Separation Processes
Catheter
Treatment Outcome
Nephrology
Physical Sciences
Arteriovenous Fistula
Medicine
Female
Research Article
medicine.medical_specialty
Science
Surgical and Invasive Medical Procedures
Research and Analysis Methods
Post-intervention
03 medical and health sciences
Signs and Symptoms
Drug Therapy
Renal Dialysis
Angioplasty
Medical Dialysis
Pressure
medicine
Humans
Fistulas
Aged
Sirolimus
business.industry
Elution
medicine.disease
Surgery
Lesions
Clinical Medicine
business
Angioplasty
Balloon
High Pressure
Zdroj: PLoS ONE
PLoS ONE, Vol 15, Iss 10, p e0241321 (2020)
ISSN: 1932-6203
DOI: 10.1371/journal.pone.0241321
Popis: 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.
Databáze: OpenAIRE
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