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Utility of the selution SLR™ sirolimus eluting balloon to rescue failing arterio-venous fistulas – 12 month results of the ISABELLA Registry from Singapore
CVIR Endovascular volume 5, Article number: 8 (2022)
Drug coated balloon (DCB) angioplasty was introduced into the arterio-venous fistula (AVF) arena to offset the neo-intimal hyperplasia (NIH) process and hence reduce the risk of restenosis and prolong access patency (Katsanos et al. 2012). The data regarding the use of paclitaxel-based platforms remain heterogenous to date, despite the presence of level one evidence in the form of randomised controlled trials, and very much depends on the type of paclitaxel balloon utilised and the primary endpoint of interest (Katsanos et al. 2020).
Sirolimus, like paclitaxel, is a potent antiproliferative agent, which has been effective in preventing restenosis in the coronary bed (Ali et al. 2019) and more recently in the peripheral vasculature (Tang et al. 2021). Sirolimus short-term effectiveness and safety in dialysis access circuits has shown early promise in small pilot studies in AVF dysfunction (Tang et al. 2021) and in salvaging thrombosed arterio-venous grafts (Tan et al. 2021). Recently, we had reported 6-month results of theIntervention with Selution SLR™ Agent Balloon for Endovascular Latent Limus therapy for failing AV Fistulas (ISABELLA) registry, which was a prospective single-center, multi-investigator, non-consecutive, non-blinded single arm study investigating the safety and feasibility of the Selution SLR™ sirolimus eluting balloon (SEB) (M.A. MedAlliance SA, Nyon, Switzerland) for the treatment of failing AVF in haemodialysis patients (n=40) (Tang et al. 2022). The protocol along with novel pre-clinical pharmacokinetic and histological data, to justify its endovascular utility had been recently published (Tang et al. 2021).
All stenotic lesions were prepared with high pressure non-compliant balloon angioplasty prior to SEB angioplasty and lesion effacement and/or recoil < 30% were mandatory in order to be included for subsequent drug elution. All patients received dual antiplatelet therapy for one month and were followed up with Duplex ultrasound at 6 and 12 months. There was one subject dropout so final analysis was based on n=39 patients (mean age 65.0 ± 11.9; males = 26 (66.7%)) (Table 1). N= 43 target lesions were treated. The most common target lesion was in the juxta-anastomosis (24/43; 54.5%) and 29/43 (65.9%) were recurrent in nature. There was 100% technical and procedural success. There were no adverse events related to the SEB. Target lesion primary patency rates at 6 and 12 months were 28/39 (71.8%) and 16/36 (44.4%) respectively (Table 2). Circuit access patency rates at 6 and 12 months were 22/35 (62.9%) and 10/32 (31.3%) respectively (Fig. 1). Mean time to target lesion reintervention was 6.6 ± 3.7 months with a mean TLR-free duration of 8.6 ± 4.5 months. There were 2 AVF abandonments and 5 (12.8%) deaths at 12 months all attributable to patients’ underlying co-morbidities. 7/10 AVFs re-intervened upon between the 6 and 12-month follow-up timepoints were those with recurrent lesions with an average of 2.9 (± 2.5) reinterventions prior to enrolment into ISABELLA.
Fistuloplasty using the novel Selution SLR™SEB for dysfunctional AVF circuits seems a safe modality in Asian haemodialysis patients at 12 months, with no reported device-related adverse events. Despite initial encouraging 6-months performance results, the drop in TLPP and circuit access patency rates at one year are disappointing but could reflect a need for further drug elution into the adventitial wall to inhibit the NIH process between these two timepoints and the more complex multiple lesions found in Asian AVFs (Irani et al. 2011).
Availability of data and materials
The datasets generated and/or analysed during the current study are not publicly available due to the Singhealth Centralised Instituitional Review Board requirements but are avaialble from the corresponding author on reasonable request.
Drug coated balloon
Selution SLR™ Agent Balloon for Endovascular Latent Limus therapy for failing AV Fistulas
Sirolimus eluting balloon
Ali RM, Abdul Kader M, Wan Ahmad WA et al (2019) Treatment of Coronary Drug-Eluting Stent Restenosis by a Sirolimus- or Paclitaxel-Coated Balloon. JACC Cardiovasc Interv 12(6):558–566
Irani FG, Tan BS, Taneja M, Lo R, Tay KH (2011) Hemodialysis Access Interventions: An Asian Perspective. In: Rajan D (eds) Essentials of Percutaneous Dialysis Interventions. Springer, New York, p 379–393. https://doi.org/10.1007/978-1-4419-5657-6_21
Katsanos K, Karnabatidis D, Kitrou P, Spiliopoulos S, Christeas N, Siablis D et al (2012) Paclitaxel-coated balloon angioplasty vs. plain balloon dilation for the treatment of failing dialysis access: 6-month interim results from a prospective randomized controlled trial. J Endovasc Ther 19(2):263–272
Katsanos K, Spiliopoulos S, Kitrou P, Krokidis M, Paraskevopoulos I, Karnabatidis D (2020) Risk of Death and Amputation with Use of Paclitaxel-Coated Balloons in the Infrapopliteal Arteries for Treatment of Critical Limb Ischemia: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Vasc Interv Radiol 31(2):202–212
Tan CW, Tan RY, Pang SC et al (2021) Single-Center Prospective Pilot Study of Sirolimus Drug-Coated Balloon Angioplasty in Maintaining the Patency of Thrombosed Arteriovenous Graft. J Vasc Interv Radiol 32(3):369–375
Tang TY, Chong TT, Yap CJQ et al (2021c) Intervention with Selution SLR Agent Balloon for Endovascular Latent Limus therapy for failing AV Fistulas (ISABELLA) Trial – protocol for a pilot clinical study and pre-clinical results. J Vasc Access. in press
Tang TY, Soon SXY, Yap CJQ, Chan SL, Choke ETC, Chong TT (2021b) Utility of Sirolimus Coated Balloons for Salvaging Dysfunctional Arteriovenous Fistulae: One Year Results From the MATILDA trial. Eur J Vasc Endovasc Surg
Tang TY, Soon SXY, Yap CXY et al (2022) Endovascular salvage of failing arterio-venous fistulas utilising sirolimus eluting balloons – six months results from the ISABELLA trial. J Vasc Access. in press
Tang TY, Yap C, Soon SXY et al (2021a) World’s First Experience Treating TASC II C and D Tibial Occlusive Disease Using the Selution SLR Sirolimus-Eluting Balloon: Six-Month Results From the PRESTIGE Study. J Endovasc Ther:15266028211007457
The Manufacturer (M.A. MedAlliance SA) has provided an unrestricted research grant to defray costs of running the study and analysing the data. Funding source had no role in the design of this study, and had no role during its execution, analyses, interpretation of data or decision to submit results for peer review.
Ethics approval and consent to participate
The trial was carried out under an investigational device exemption (GN27) from the local Health Services Authority (HSA) of Singapore. Approval was obtained from the local Human Research Ethics Committee (CIRB ref: 2020/2782) and the study was carried out in accordance with the Declaration of Helsinki. Informed consent was gained from all participants. Trial registration: NCT04629118. Registered 16 November 2020- Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT04629118.
Consent for publication
TYT and TTC have received physician-initiated study grants and honoraria for speaking engagements from M.A. MedAlliance SA.
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
Trial registration: NCT04629118. Registered 16 November 2020- Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT04629118.
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Tang, T.Y., Yap, C.J., Soon, S.X. et al. Utility of the selution SLR™ sirolimus eluting balloon to rescue failing arterio-venous fistulas – 12 month results of the ISABELLA Registry from Singapore. CVIR Endovasc 5, 8 (2022). https://doi.org/10.1186/s42155-022-00287-1
- Sirolimus coated balloon
- Target lesion primary patency
- Arterio-venous fistula