Endovascular salvage of failing arterio-venous fistulas utilising sirolimus eluting balloons: Six months results from the ISABELLA trial.

BACKGROUND: Aim of this pilot clinical study was to evaluate the safety and efficacy of the Selution Sustained Limus Release (SLR)™ sirolimus-eluting balloon (SEB) for improving failing arterio-venous fistulas (AVF) patency in Asian haemodialysis patients. METHODS: Prospective single-centre, multi-investigator, non-consecutive, non-blinded single arm trial. Forty end-stage renal failure Asian patients with a dysfunctional AVF underwent SEB angioplasty between May and November 2020. All stenotic lesions were prepared with high pressure non-compliant balloon angioplasty prior to SEB angioplasty. Endpoints of interest included target lesion primary patency and circuit access patency and safety through 30 days. All patients received dual antiplatelet therapy for 1 month and were followed up with Duplex ultrasound at 6 months. RESULTS: There was one subject dropout so final n = 39 patients (mean age 65.0 ± 11.9; males = 26 (66.7%)) and n = 43 target lesions treated. Main indication for intervention was dropping access flow (24/39; 61.5%) and most common target lesion was in the juxta-anastomosis (24/43; 54.5%). There was 100% technical and procedural success. There were no adverse events related to the SEB. Target lesion primary patency rates at 3 and 6 months were 39/41 (95.1%) and 28/39 (71.8%) respectively. Access circuit patency rates at 3 and 6 months were 35/37 (94.6%) and 22/35 (62.9%) respectively. There were 3 (7.7%) deaths all attributable to patients' underlying co-morbidities. CONCLUSIONS: Fistuloplasty using the novel Selution SLR™ SEB for dysfunctional AVF circuits seems a safe and effective modality in Asian haemodialysis patients at 6 months but larger randomised controlled studies are required now to determine its true efficacy against plain balloon angioplasty.

Ranger™ paclitaxel-coated balloon versus conventional balloon angioplasty for treatment of failing arteriovenous fistulas and grafts in haemodialysis patients: A retrospective cohort study.

BACKGROUND: Aim was to compare the safety and patency efficacy outcomes between Ranger™ paclitaxel-coated balloon (PCB)- versus conventional balloon angioplasty (POBA) in the treatment of haemodialysis access-related conduit stenosis. METHODS: Retrospective single-centre, multi-investigator, consecutive, double-arm comparative cohort study. About 130 end-stage renal failure Asian patients with dysfunctional arteriovenous fistula (AVF) or arteriovenous graft underwent PCB or POBA fistuloplasty between November 2018 and June 2020. All stenotic lesions were prepared with high pressure non-compliant balloon angioplasty prior to PCB angioplasty. All patients received at least one antiplatelet agent for 3 months duration post procedure. RESULTS: Mean age was 66.0 ± 10 years and 79/130 (61%) were males. PCB arm (n = 65) versus POBA arm (n = 65). Majority were AVFs circuits (122/130, 94%). Main indication for intervention was dropping access flow (98/130, 76%). About 172 lesions were treated (56% POBA, 44% PCB), and the juxta-anastomosis (JAS) was the main target lesion (87/172, 51%). There were no significant differences in safety outcomes (30-day adverse events, access thrombosis, abandoned AVF and death) between treatment groups. Mean time to target lesion reintervention (TLR) was longer in PCB-treated lesions (7.1 ± 2.7 vs 5.8 ± 3.2 months, p = 0.03), especially amongst recurrent lesions (7.3 ± 2.4 vs 5.7 ± 3.2, p = 0.02). Mean time to circuit reintervention was also longer in PCB-treated circuits (6.9 ± 2.8 vs 5.8 ± 3.7months, p = 0.04). There were 16 deaths (12%), all attributed to patient's underlying comorbidities. CONCLUSIONS: Fistuloplasty with Ranger™ PCB for failing arteriovenous circuits in end-stage renal failure patients, is a safe and efficacious modality compared to POBA in terms of longer freedom from TLR.

Combination therapy using scoring and sirolimus drug-coated balloons during lower limb endovascular revascularization for chronic limb threatening ischaemia: A case series.

The aim of this case series was to document our early experience using combination therapy with UltraScore™ Focused Force percutaneous transluminal angioplasty balloon (BD Interventional, New Jersey, US) and Selution Sustained Limus Release (SLR)™ (M.A. MedAlliance SA, Nyon, Switzerland) sirolimus-coated balloon catheter for anti-restenotic drug elution, in the setting of multifocal high-grade stenosis for chronic limb threatening ischaemia. Our anecdotal experience was that preparing the lesion with scoring balloon and then using sirolimus drug-eluting balloon may have synergistic effect when used in tandem, especially in the setting of calcified arterial lesions, where the scoring wires may achieve deeper clefts within the atheromatous plaque to allow better drug absorption into the arterial wall. We report two cases with high-grade multifocal stenosis affecting the superficial femoral and anterior tibial arteries, respectively. Combination therapy using the scoring balloon to first prepare the lesion followed by sirolimus elution achieved technical and procedural success in both cases and a 100% 30-day primary patency. There were no complications related to flow-limiting dissections, vessel perforation or acute recoil. However, whether this combination therapy leads to better primary vessel patency with longer freedom from target lesion revascularization in the medium term remains to be determined.

The modified frailty index-11 predicts medium-term outcomes after endovascular revascularisation for chronic limb threatening ischaemia in Asian patients.

OBJECTIVE: The aim was to evaluate the utility of frailty, as defined by the modified Frailty Index-1 1 (mFI-11) on predicting outcomes following endovascular revascularisation in Asian patients with chronic limb-threatening ischaemia (CLTI). METHODS: CLTI patients who underwent endovascular revascularisation between January 2015 and March 2017 were included. Patients were retrospectively scored using the mFI-11 to categorise frailty as low, medium or high risk. Observed outcomes included 30-day complication rate and unplanned readmissions, 1-, 6- and 12-month mortality, and ambulation status at 6- and 12 months post-intervention. RESULTS: A total of 233 patients (250 procedures) were included; 137 (58.8%) were males and the mean age was 69.0 (±10.7) years. 202/233 (86.7%) were diabetic and 196/233 (84.1%) had a prior diagnosis of peripheral arterial disease (PAD). The mean mFI-11 score was 4.2 (±1.5). 28/233 (12.0%), 155/233 (66.5%), and 50/233 (21.5%) patients were deemed low (mF-11 score 0-2), moderate (mFI-11 score 3-5) and high (mFI-11 score 5-7) frailty risk, respectively. High frailty was associated with an increased 12-month mortality (OR 8.54, 95% CI 1.05-69.5; p = 0.05), 30-day complication rate (OR 9.41, 95% CI 2.01-44.1; p < 0.01) and 30-day unplanned readmission (OR 5.06, 95% CI 1.06-24.2; p = 0.04). Furthermore, a high score was associated with a significantly worse 6- (OR 0.320, 95% CI 0.120-0.840; p = 0.02) and 12-month (OR 0.270, 95% CI 0.100-0.710; p < 0.01) ambulatory status. CONCLUSION: The mFI-11 is a useful, non-invasive tool that can be readily calculated using readily available patient data, for prediction of medium-term outcomes for Asian CLTI patients following endovascular revascularisation. Early recognition of short- and mid-term loss of ambulation status amongst high-frailty patients in this challenging cohort of patients could aid decision-making for whether a revascularisation or amputation-first policy is appropriate, and manage patient and caregiver expectations on potential improvement in functional outcome.

One-year outcome using cyanoacrylate glue to ablate truncal vein incompetence: A Singapore VenaSeal™ real-world post-market evaluation study (ASVS).

OBJECTIVE: We present 12 months efficacy data from A Singapore VenaSeal™ real-world post-market evaluation Study (ASVS), a prospective single-arm Asian population registry aimed to evaluate cyanoacrylate glue (CAG) closure of refluxing truncal veins. METHODS: Duplex ultrasound was used to assess truncal vein closure. The revised Venous Clinical Severity Score (rVCSS) and three quality of life (QoL) questionnaires were completed to assess improvement in venous disease symptoms. RESULTS: 90/100 (90%) patients (136 legs; 140 truncal veins) completed evaluation at 6- and 12 months. The truncal closure rates at 6 and 12 months were 139/140 (99.3%) and 137/140 (97.9%), respectively. rVCSS and QoL questionnaires scores were sustained from the 3 to 12 months visits, although there were no futher significant improvement. No serious adverse events were reported between 3 and 12 months. CONCLUSIONS: CAG remains a safe and efficacious venous ablative technology at 12 months and is associated with a high rate of target vein occlusion and sustained QoL improvement.

Use of the VENOVO™ and Sinus Obliquus™ venous stents in the treatment of non-thrombotic or post-thrombotic iliac vein lesions - Short-term results from a multi-centre Asian cohort.

OBJECTIVES: Deep venous stenting with intravascular ultrasound (IVUS) guidance is gaining favour as the treatment modality of choice for symptomatic ilio-femoral venous occlusive disease. The aim was to determine the short-term patency and symptomatic relief gained using the Bard Venovo™ and Optimed Sinus Obliquus™ stents in the endovascular treatment of non-thrombotic iliac vein lesions (NIVL) and post-thrombotic venous obstruction (PTO) from two Asian tertiary vascular centres. METHODS: Sixty patients (males = 21/60 (35.0%); median age 67 years (interquartile range 54-77)) who underwent IVUS interrogation and ilio-femoral stenting (June 2018-May 2019) in two Asian centres were prospectively followed. Clinical improvement was determined by the revised Venous Clinical Severity Score (rVCSS), pain using the Visual Analogue Scale (VAS) and ulcer healing rate. Patency rates were evaluated using Duplex ultrasound and computer tomography venogram. RESULTS: Seventy-one legs were interrogated and stented; 11/60 (18.3%) patients had a bilateral procedure. Indications for surgery were PTO (n = 11/71 (15.5%)) and NIVL (n = 60/71 (84.5%)). Twenty-seven of 71 (38.0%) patients had CEAP 6 disease. The median follow-up was 283 (interquartile range 211-370) days. Technical and procedural success was both 100%. Twenty-one of 71 (29.6%) legs had a combination of Venovo™ and Sinus Obliquus™ stents inserted for concurrent ilio-caval and iliac lesions. There were no major post-operative complications. Six-month primary, assisted primary and secondary patency rates were 94.1, 97.1 and 100%, respectively. There were no stent fractures. Mean rVCSS and VAS improved from 12.26 (±3.31) to 4.33 (±2.78) and 6.97 (±1.38) to 2.03 (±1.65), respectively, at three months (p < 0.01). Complete ulcer healing was seen in 27/27 (100%) patients at three months. CONCLUSION: Use of Venovo™ and Sinus Obliquus™ stents for symptomatic ilio-femoral venous disease showed excellent six-month primary patency rate with no stent fractures. There were significant clinical improvement and low-device-related complications. Longer follow-up is awaited to see how these dedicated venous stents perform.

Does longitudinal or transverse orientation of the ultrasound probe improve cannulation success in minimally invasive venous surgery: A multicentre randomised controlled trial.

OBJECTIVE: This study evaluates the effect of transverse and longitudinal ultrasound transducer orientation on saphenous vein cannulation during endovenous ablation. METHODS: A single-blinded, multicentre, randomised controlled trial was performed in patients undergoing ultrasound-guided venous cannulation for saphenous ablation. The primary outcomes were overall cannulation success and time to successful cannulation. RESULTS: In total, 100 patients were assigned to parallel longitudinal orientation and transverse orientation groups. Cannulation success was 100%. There was no significant variation in time to cannulation detected between the transverse orientation and longitudinal orientation (85 s vs. 71 s, p = 0.314). Longitudinal orientation was associated with significantly fewer needle passes [median 3 (interquartile range 1-5) vs. 2 (interquartile range 1-3), p = 0.026] and less pain (median visual analogue scale score 1 vs. 2.5, p = 0.039) than those in the transverse orientation group. CONCLUSION: This trial has shown that while longitudinal orientation is associated with less procedural pain it has no significant effect on time to target vein cannulation during endovenous ablation.