Background: Treatment of cephalic arch stenosis (CAS) is associated with high risk of failure and complications. Although stent-graft (SG) placement has improved patency rates, stent edge restenosis has been raised as a potential limiting factor for SG usage in CAS. This study aims to evaluate the safety and efficacy of combining stent graft placement with paclitaxel-coated balloon (PCB) angioplasty versus PCB alone in the treatment of CAS. Methods: This is an investigator-initiated, prospective, international, multicenter, open-label, randomized control clinical trial that plans to recruit 80 patients, who require fistuloplasty from dysfunctional arteriovenous fistula (AVF) from CAS. Eligible participants are randomly assigned to receive treatment with SG and PCB or PCB alone in a 1:1 ratio post-angioplasty (n = 40 in each arm). Randomization is stratified by de novo or recurrent lesion, and the participants are followed up for 1 year. The primary endpoints of the study are target lesion primary patency (TLPP) and access circuit primary patency (ACPP) rates at 6-months. The secondary endpoints are TLPP and ACPP at 3- and 12-month; target lesion and access circuit assisted primary and secondary patency rates at 3, 6, and 12-months and the total number of interventions; complication rate; and cost-effectiveness. Discussion: This study will evaluate the clinical efficacy and safety of combination SG and PCB implantation compared to PCB alone in the treatment of CAS for hemodialysis patients.

Purpose: This is a prospective study to investigate the clinical outcomes of using noncompliant balloons in lower limb angioplasty for chronic limb threatening ischemia (CLTI). Materials and Methods: This is a prospective single-center cohort study performed at a local tertiary hospital in Singapore. Consecutive patients who underwent lower limb angioplasty for CLTI using a noncompliant balloon catheter were enrolled if they were aged 40 years and above, presented with CLTI Rutherford grade 4 to 6, and had TASC C or D lesions in the lower limb vessels that were at least 100mm in length. Patient demographics, Rutherford grading, lesion characteristics, complications, and follow-up data were collected and analyzed. The primary outcomes were 30-day freedom from major adverse events, amputation-free survival (AFS) at 12 months, and freedom from clinically driven target lesion revascularization (cdTLR) at 12 months. Secondary outcomes included clinical success and target lesion primary patency (TLPP) at 12 months. Amputation-free survival, freedom from cdTLR, and TLPP were calculated by Kaplan-Meier analysis. Results: From May 2020 to December 2021, 50 patients (50 limbs) were enrolled. 43 (86%) patients had diabetes mellitus, while 12 patients (24%) had end-stage renal failure. 85 lesions were treated, including 59 (69.4%) below-the-knee (BTK) lesions. All the lesions were TASC C (n=45, 52.9%) or TASC D (n=40, 47.1%) lesions. Mean lesion length was 231.4±116.2mm. Technical success rate was 96.5%. No patients were lost to follow-up. Median follow-up duration was 282 days (IQR: 31-390 days). One patient died on day 26 due to an acute myocardial infarction. Two patients had groin hematomas postprocedure, both of which were treated conservatively. AFS, freedom from cdTLR, and TLPP at 12 months postprocedure was 70.0% (95% confidence interval [CI]: 58.4%-83.9%), 90.1% (95% CI: 83.4%-97.4%), and 61.1% (95% CI: 50.7%-73.6%), respectively. Conclusion: Early results have shown that the use of a high-pressure, noncompliant balloon is effective in lower limb angioplasty for CLTI in a highly challenging group of patients with a high prevalence of long BTK disease. Good vessel patency and limb salvage rates can be achieved, with a low complication rate. We await more long-term outcomes on vessel patency. Clinical Impact There are many devices in the market for use in lower limb angioplasty. However, many of them come with an increased financial cost, procedural time and procedural difficulty. We report our prospective results with the exclusive use of a high pressure, non-compliant balloon, in a challening group of patients with a high prevalence of diabetes and end stage renal failure, achieving amputation free surival at 6 and 12 months post-procedure of 84.0% and 70.0% respectively. The use of non-compliant balloon is technically easy and does not add additional steps compared to a standard POBA procedure, thus limiting costs. We believe this article can be a push factor for clinicians to consider the use of these high pressure, non-compliant balloons in their patient care.

Natrox ™ topical oxygen therapy (TOT) ( Inotec AMD Ltd, Cambridgeshire, UK) employs a small battery-powered “oxygen generator” to concentrate atmospheric oxygen and feeds pure, moist, oxygen through a fine, soft tube to a dressing-like “oxygen distribution system”, which is placed over the wound and is held in place by a conventional dressing. The aim was to determine the effectiveness of Natrox ™ for non-healing diabetic foot ulcers (DFU) over a 3-month period.Longitudinal, single-arm, open prospective registry study using 12 weeks of TOT using a 4 week run-in period. 20 patients recruited to OTONAL had chronic DFU greater than 3 months duration or minor amputation sites with less than 50% healing in 4 weeks.There were 13 (65%) males and the mean age was 65.7 (±11.6) years. The mean glycated haemoglobin (HbA1c) was 6.9 (±1.3) mmol mol −1 and mean wound duration before TOT was 114 (±79.1) days. 18/20 (90.0%) patients had concomitant lower limb revascularization angioplasty for chronic limb threatening ischaemia. The mean size of the foot ulcer at baseline was 11.3 ± 14.8 cm 2 and mean transcutaneous oxygen measurement value was 34.1 (±19.6) mm Hg. Wound closure of >75% was observed in 14/20 (70.0%) patients. There was a 91.3% (±14.9%) wound area reduction by 3 months (P = .001) and mean time for 100% closure was 77.6 ± 32.5 days. Mean pain scores reduced from 2.4 (±1.8) at baseline to .5 (±1.0) at 3 months (P = .008). All patients were very satisfied using the ambulatory device. Use of TOT in chronic diabetic foot wounds stimulates a healing state, underpinning the concept that oxygen plays a central role in wound healing. Our results are more compelling if you consider they started with relatively large-sized DFUs and majority of patients were frail with underlying peripheral artery disease. (NCT03863054)

Abstract Introduction Medium-term clinical outcome data are lacking for cyanoacrylate glue (CAG) ablation for symptomatic varicose veins, especially from the Asian population. Objectives Aim was to determine the 3-year symptomatic relief gained from using the VenaSeal™ device to close refluxing truncal veins from the Singaporean ASVS prospective registry. Methods The revised Venous Clinical Severity Score (rVCSS) and three quality of life (QoL) questionnaires were completed to assess clinical improvement in venous disease symptoms along with a dedicated patient satisfaction survey. 70 patients (107 limbs; 40 females; mean age of 60.9 ± 13.6 years) were included at 3 years. Results At 3 years, rVCSS showed sustained improvement from baseline (5.00 to 0.00; p < 0.001) and 51/70 (72.9%) had improvement by at least 2 or more CEAP categories. Freedom from reintervention was 90% and 85.7% patients were extremely satisfied with the treatment outcome. No further reports of further hypersensitivity reactions after one year. Conclusion The 3-year follow-up results of the ASVS registry demonstrated continued and sustained clinical efficacy with few reinterventions following CAG embolization in Asian patients with chronic venous insufficiency. Trial registration ClinicalTrials.gov Registration: NCT03893201.

BACKGROUND Percutaneous transluminal angioplasty is the preferred treatment of stenosed failing arteriovenous fistulas (AVF) but is hampered by increasing rates of vascular restenosis because of development of myointimal hyperplasia. METHODS This multicenter observational study of polymer-coated low-dose paclitaxel-eluting stents (ELUvia stents by Boston Scientific) in stenosed AVF undergoing hemoDIAlysis (ELUDIA) was jointly conducted in three tertiary hospitals from Greece and Singapore. Failure of AVF was defined according to K-DOQI criteria and significant fistula stenosis (>50%DS by visual estimate) was determined with subtraction angiography. Patients were considered for ELUVIA stent insertion based on significant elastic recoil following balloon angioplasty for the treatment of a single vascular stenosis within a native AVF. The primary outcome measure was sustained long-term patency of the treated lesion/fistula circuit defined as successful stent placement with resumption of uninterrupted hemodialysis and without significant vascular restenosis (50%DS threshold) or other secondary interventions during follow-up. RESULTS Some 23 patients received the ELUVIA paclitaxel-eluting stent (eight radiocephalic, 12 brachiocephalic, and three transposed brachiobasilic native AVFs). Mean AVF age at the time of failure was 33.9 ± 20.4 months. Treated lesions included 12 stenoses at the juxta-anastomotic segment, nine at the outflow veins, and two cephalic arch lesions with a mean diameter stenosis of 86 ± 8%. Median stent diameter and length used were 7 mm and 40 mm, respectively. After a median follow-up period of 20 months, some 18 stents out of 23 cases remained patent (cumulative rate 78.3%) without any clinical or imaging evidence of recurrent stenosis. Estimated primary patency of the ELUVIA stents was 80.6% and of the corresponding fistula circuit 65.1% at 2 years by Kaplan-Meier methods. CONCLUSIONS This observational study has shown promising long-term results of polymer-coated paclitaxel-eluting stents for the treatment of failing arteriovenous fistulas. Large-scale controlled studies are necessary.

BACKGROUND:A prospective, pilot study was designed to test the feasibility of using sirolimus-coated balloon (SCB) to treat graft vein junction of thrombosed arteriovenous graft (AVG) following successful pharmacomechanical thrombectomy. The present report provides the 1-year results of this study.METHODS:This is a 1-year follow-up of a single, prospective, single-arm study that was conducted from 2018 to 2019 in 20 patients who presented to a tertiary institution with thrombosed AVG. The recruited patients received SCB angioplasty at the graft-vein junction following successful endovascular thrombectomy of a thrombosed AVG. One year after recruitment, there were three deaths, one AVG revision, and one AVG explantation among the participants recruited. The outcomes of 15 subjects at 1-year following the index procedure obtained from electronic medical records were re-examined.RESULTS:The 1-year access circuit primary patency rate was 40%, while assisted primary and secondary patency rates were 46.7% and 73.3%, respectively. A total of 16 interventions (4 angioplasties, 12 thrombectomies) were performed in 9 patients over the 12 months. Four AVGs were abandoned. The median number of interventions per patient was 1 (0-3) per year. Using Kaplan-Meier analysis, the mean estimated post-intervention access circuit primary patency was 230 (95% CI: 162-300) days, while access circuit assisted primary patency was 253 (95% CI: 187-320) days, and access circuit secondary patency was 292 (95% CI: 230-356) days. Sub-group analysis did not show a significant difference in the mean estimated primary patency between AVG with de novo and recurrent stenosis (245 days, 95% CI: 151-339 vs 210 days, 95% CI: 113-307; p = 0.29).CONCLUSIONS:SCB may help sustain the patency of thrombosed AVG following successful thrombectomy.

BACKGROUND:Sirolimus-coated balloon (SCB) is a potential treatment option for peripheral arterial disease (PAD). There are currently no long-term clinical data for this novel treatment for PAD. We present the 3-year results of the first-in-human study of MagicTouch PTA SCB for treatment of PAD for both femoropopliteal and below-the-knee arteries. METHODS:The XTOSI pilot study is a prospective, single-arm, open-label, single-center trial evaluating MagicTouch PTA SCB for symptomatic PAD. Assessments through 3 years included freedom from clinically driven target lesion revascularization (CD-TLR), freedom from major amputation, amputation-free survival (AFS), overall survival, and ulcer-free status. RESULTS:At 3 years, the overall freedom from CD-TLR was 84.4%, freedom from major amputation was 86.1%, AFS was 63.3%, overall survival was 63.3%, and ulcer-free status in remaining survivors with intact limbs was 100%. For femoropopliteal lesions, at 3 years, the freedom from CD-TLR was 92.9%, freedom from major amputation was 93.3%, AFS was 70%, and overall survival was 70%. For below-the-knee lesions, at 3 years, the freedom from CD-TLR was 77.8%, freedom from major amputation was 81.0%, AFS was 58.6%, and overall survival was 58.6%. CONCLUSIONS:SCB in the XTOSI pilot study showed promising clinical results sustained to 3 years, and no long-term safety concerns were raised. Randomized trials are currently ongoing to investigate the safety and efficacy of SCB for treatment of PAD.

Introduction: The global burden of peripheral artery disease (PAD) has been increasing. Guidelines for PAD recommend evidence-based medical therapy (EBMT) to reduce the risks of cardiovascular events and death but the implementation of this is highly variable. This study aimed to understand the current practices regarding EBMT prescription in PAD patients and the key barriers and facilitators for implementing PAD guidelines. Method: A qualitative study was conducted in the largest tertiary hospital in Singapore from December 2021 to March 2023. The participants included healthcare professionals and in-patient pharmacists involved in the care of PAD patients, as well as patients with PAD who had undergone a lower limb angioplasty revascularisation procedure. Data were collected through in-depth, individual semi-structured interviews conducted face-to-face or remotely by a trained research assistant. Interviews were audio-recorded, transcribed and systematically coded using data management software NVivo 12.0. The Tailored Implementation for Chronic Diseases (TICD) framework was used to guide the interviews and analysis. Results: Twelve healthcare professionals (4 junior consultants, 7 senior consultants, and 1 senior in-patient pharmacist) and 4 patients were recruited. Nine themes in 7 domains emerged. Only a small proportion of doctors were aware of the relevant guidelines, and the generalisability of guidelines to patients with complicated conditions was the doctors’ main concern. Other barriers included cost, frequent referrals, lack of interprofessional collaboration, not being the patients’ long-term care providers, short consultation time and patients’ limited medication knowledge. Conclusion: Findings from this study may inform strategies for improving healthcare professionals’ adherence to guidelines and patients’ medication adherence.

Polyarteritis nodosa (PAN) is a rare form of vasculitis. Acute limb ischemia is a rare presentation and complication of PAN. Plain old balloon angioplasty (POBA) is one of the treatment strategies for addressing PAN-related critical limb threat-ening ischemia (CLTI). However, recurrence of stenosis and occlusion is frequent, making POBA a poor treatment choice, as evidenced in our described clinical case. Consequently, with consideration of sirolimus's anti-inflammatory and immunosuppressive properties, we used a sirolimus-coated balloon in the treatment of PAN-induced CLTI. A 37-year-old woman first presented with acute limb ischemia as her initial symptom. Diagnostic angiography demonstrated occlusion of her tibial vessels, and POBA was performed to restore perfusion. Later in the course of her illness, she developed foot gangrene despite multiple courses of immunosuppressive drugs and several attempts with POBA to achieve limb salvage. Because of her disease trajectory, a MagicTouch (Concept Medical) sirolimus-coated balloon was deployed to her anterior tibial artery during her third angioplasty. At 17 months after her last angioplasty, she remained ulcer free, and surveillance scans demonstrated occlusion-free tibial vessels. The use of sirolimus-coated balloon angioplasty is a promising treatment approach for successful limb salvage in patients with PAN vasculitis and CLTI.

BACKGROUND:Aim of Arch V SUPERA-LUX was to evaluate the safety and efficacy of the combination therapy of SUPERA™ (Abbott Vascular, Santa Clara, CA, USA) helical stent implantation and Passeo-18 Lux™ (Biotronik Asia Pacific Pte Ltd, Singapore) drug coated balloon (DCB) elution to treat recurrent cephalic arch stenosis (CAS) in the setting of AV access dysfunction.METHODS:Investigator-initiated, single-center, single-arm prospective pilot study of 20 end-stage renal failure Asian patients with a dysfunctional brachiocephalic fistula. All had symptomatic recurrent CAS within 6 months of prior intervention. The lesion was pre-dilated with a standard high-pressure balloon (Biotronik Passeo-35 HP balloon). The DCB (Passeo-18 Lux™) is subsequently inflated and the SUPERA™ stent deployed to sit 2 mm distal to the cephalic arch and covering the CAS but within the DCB zone. All patients were prescribed dual antiplatelet therapy for 3 months and followed up with Duplex ultrasound at 6- and 12-months.RESULTS:There were 9 (45%) males and mean age was 67 ± 11.0 years. Mean time from prior procedure was 113 ± 68 days and main indication for reintervention was high venous pressure (9/20, 45%). Technical success was 100% and there were no peri-procedural complications related to either stent or DCB deployment. Target lesion primary patency at 6- and 12-months was 10/18 (55%) and 5/16 (31%), respectively. Mean time to target lesion re-intervention was 170 ± 82 days. Circuit access patency was 8/18 (44%) and 2/16 (13%) at 6- and 12-months respectively and mortality was 3/20 (15%) attributed to the patients' underlying co-morbidities.CONCLUSION:Dual prong strategy of using SUPERA™ stenting and Passeo-18 Lux™ drug elution for recurrent CAS, although safe, was no more efficacious than conventional balloon angioplasty or stenting alone. Development of an intense inflammatory reaction within the stent led to reinterventions of a number of cases with suboptimal results.

BACKGROUND:The aim of this pilot clinical study is to evaluate the safety and efficacy of the Selution Sustained Limus Release (SLR)™ sirolimus-coated balloon (M.A. MedAlliance SA, Nyon, Switzerland) for improving the patency of failing arterio-venous fistulas (AVF) in hemodialysis patients. We also present herein a pre-clinical pharmacokinetic and safety evaluation of Selution™ to justify its first use in hemodialysis patients for endovascular access salvage.METHODS AND RESULTS:This is an investigator-initiated prospective single-center, non-blinded single-arm trial. Forty patients with clinically significant de novo or recurrent stenoses in a mature AVF circuit will be recruited. All stenotic lesions will be prepared with high pressure non-compliant conventional balloon angioplasty (CBA) prior to deployment of the Sustained-Release Selution™ sirolimus drug-eluting balloon. The primary efficacy endpoint is 6-month target lesion primary patency and the primary safety endpoint is freedom from localized or systemic serious adverse events through 30 days. Secondary endpoints of interest include technical and clinical success rates and circuit access patency at 3 and 6 months. Follow-up will occur for 2 years for those patients whose AVFs remain patent. Pharmacokinetic and histological animal safety studies performed with the Selution™ coating formulation showed prolonged arterial tissue retention of sirolimus with therapeutic levels up to 60 days and non-toxic and rapidly declining blood levels. Histological results in animal models demonstrated safety, freedom from intraluminal thrombus, reduction in restenosis by sirolimus elution compared to CBA, and no evidence of embolic phenomena indicative of adverse particulate effects.DISCUSSION:Long release sirolimus coated balloons may serve as a promising novel alternative therapy to paclitaxel-based technology for treating conduit stenosis secondary to neointimal hyperplasia. Pre-clinical pharmacokinetic and histological animal data are encouraging and provide suggestion of safety and efficacy in this setting. This single-center trial will provide a first step toward demonstration of efficacy and safety of this device for treatment of stenotic fistulas.

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.

Purpose: Type III endoleak can be difficult to distinguish from Type I endoleak. Depending on the stent graft anatomy, the use of standard bifurcated endografts may not be technically feasible, and patients may have to be subject to an aorto-uni-iliac repair with femoral-femoral bypass or open surgery. Case Report: We report a case of an 86-year-old male who had a Type IIIb endoleak 20 years post EVAR which was characterized on angiography to be from a hole close to the bifurcation limb origin. The initial Talent (Medtronic, Santa Rosa, California) device had a 50 mm main body common trunk, which was not amenable to treatment with standard devices. He was successfully treated with a custom-made device with an inverted contralateral limb. Conclusions: Our case highlights the need for lifelong surveillance post EVAR as endoleak may present decades post initial EVAR. It also demonstrates that many Type III endoleak which were otherwise deemed unsuitable for treatment with standard devices may potentially be treatable with custom-made device (CMD). This solution preserves a percutaneous option in a now older person which avoids surgical bypass. Further studies are required to establish the durability of this treatment and survey for recurrence.

Background Results from the BIOLUX P-III registry have demonstrated favourable outcomes of Passeo-18 Lux™ (Biotronik®, Buelach, Switzerland) drug-coated balloon in treating obstructive infrainguinal peripheral artery disease, but it has not been established if Asians would benefit to the same extent as non-Asians. Methods A subgroup analysis was performed on the 24-month data comparing the Asian cohort (AC) to non-Asian cohort (NAC). Results AC included 49 patients with 77 lesions. AC was significantly younger (65.6 vs 70.3 years, p < 0.05), had more diabetes (87.8% vs 45.3%, p < 0.05), and was more likely to present with CLTI (73.5% vs 35.3%, p < 0.001) compared to NAC. They had significantly longer mean target lesions (115 vs 86.9 mm, p = 0.006), and received significantly higher paclitaxel doses (10.7 vs 7.2 mg, p = 0.0005). Device, technical and procedural successes were 125/125(100%), 95/97(97.5%) and 45/49(91.8%), respectively. There was no significant difference in target lesion revascularization rates between groups (10.5% vs 12%, p = 0.91). However, the AC had more major adverse events (30.2% vs 16.1%, p = 0.001), amputations (26.3% vs 6.2%, p < 0.05) and mortality (37.9% vs 10.6%, p < 0.05) at 24 months. Conclusion Passeo-18 Lux™ use was efficacious in Asians, but was associated with higher adverse events, amputations and mortality rates, likely attributable to poorer patient comorbidities and more extensive PAD.

Dear Editor, Chronic limb-threatening ischaemia (CLTI) is the advanced stage of peripheral arterial disease (PAD) and patients with this condition face a very high risk of major adverse cardiovascular events and mortality.5][6] The aim of this study was to understand the usage of EBMT in CLTI patients.This was a retrospective cohort study of patients with PAD undergoing lower limb angioplasty at the Singapore General Hospital (SGH) between May 2018 and December 2019.This study was reviewed and approved by the SingHealth Institutional Review Board and written informed consent was obtained from all patients.We extracted demographic and clinical data from the SingHealth Electronic Health Intelligence System, 7 supplemented by manual curation to capture missing comorbidities and dispensing records of the drugs of interest in other SingHealth institutions.We calculated adherence measures for the 4 classes of drugs recommended in the guidelines: statins, antiplatelets, anti-hypertensives and anti-diabetics.The follow-up period included the baseline (1-year period before angioplasty) and observation window (hospital discharge to 1-year post-discharge or death, whichever was earlier).EBMT use at admission was defined as an overlap of treatment episodes with a 90-day allowable gap with the date of admission.As discharge prescriptions are expected to be given on the discharge date, the overlap of the 0-day gap treatment episode with discharge date was used to avoid overestimations of carry-overs from prescriptions given before and during admission.The level of EBMT adherence post-discharge was measured by the proportion of days covered (PDC) over a 1-year period or until death of the patient, whichever was earlier.Association between EBMT use at discharge and 1-year post-discharge PDC ≥0.80 was analysed using logistic regression.Associations between EBMT use at discharge and clinical outcomes were analysed using

The Surfacer Inside-Out Access Catheter System (Surfacer) is a novel approach to restore access in total central vein occlusion (TCVO). We report a series of three cases, with mean 18-months follow up, in our institution where this technique was safely and effectively used in tandem with Hemodialysis Reliable Outflow (HeRO) graft for creation of upper limb vascular access in patients with TCVO. Although there have been reports describing the simultaneous combination of Surfacer and HeRO graft, to our knowledge, this is the first time where the outcomes with 18-months mean follow-up are reported. All three patients had failed prior conventional attempts at TCVO crossing and had exhausted most conventional upper limb vascular access methods. The above technique yielded a 100% technical success rate with mean operative time of 140 min. Cannulation rate was 100% with all undergoing successful early cannulation by post-operative day 3. Mean primary patency of 199 days was achieved. Average intervention rate of 1.2 a year was required to maintain patency. The Surfacer device used together with HeRO graft is a feasible technique to avoid femoral catheter in patients where conventional attempts to cross the TCVO have failed.

BACKGROUND:Plain old balloon angioplasty has been the mainstay of treatment for arteriovenous fistula (AVF) stenoses. Recent studies suggest that drug coated balloons (DCB) may significantly reduce re-intervention rates on native and recurrent lesions. The Passeo-18 Lux DCB (Biotronik AG, Buelach, Switzerland) is packaged with a 3.0 µg/mm2 dose of paclitaxel. The hypothesis is that its use provides better target lesion primary patency (TLPP), primary assisted patency (PP), secondary patency (SP) rates and reduces the number of visits for re-intervention in a cohort of patients with stenotic AVF and arteriovenous grafts (AVGs). METHODS:The USE of IMplanting the Biotronik PassEo-18 Lux DCB to treat failing haemodialysis arteRiovenous FIstulas and grafts trial (SEMPER FI) was a prospective double-centre, multi-investigator, non-consecutive, non-blinded single-arm study investigating the efficacy and safety of the Passeo-18 Lux DCB in patients with stenotic AVF/AVG lesions between January 2021 and January 2022. Patient demographics, clinical characteristics, vascular access history, operative indications, details and outcomes were collected prospectively. TLPP, circuit access primary patency (CAP), PP, SP and deaths 6- and 12-months post-intervention were studied. RESULTS:Ninety-one patients with 110 lesions were recruited across the two centres. 62.6% (n = 57) were male with a median age of 63.5 years (SD = 10.5). 62.6% (n = 57) were taking anti-platelets. Eighty-five AVFs and six AVGs were treated. 60% (n = 54) of AVFs intervened were radiocephalic. 52.7% (n = 58) of targeted lesions were juxta-anastomotic stenosis (JAS) and one-third (n = 33) at the AVF/AVG outflow. 70.9% (n = 78) of lesions were recurrent. Median time from last intervention was 219 days. 78% of target lesions (n = 85) and circuits (n = 70) were patent at 6-months, of which 96.7% (n = 87) of those requiring assisted intervention were patent. CONCLUSION:This study shows that the Passeo-18 Lux DCB can be an effective and safe tool in the treatment of failing haemodialysis AVFs/AVGs.

This was a prospective, multicenter, randomized clinical trial comparing mechanochemical ablation (MOCA) to cyanoacrylate adhesive injection (CAE) in terms of pain profile in patient with primary truncal saphenous vein incompetence using a 100-mm visual analogue scale (VAS). Patients with primary truncal vein incompetence were consented and randomly assigned to receive either MOCA or CAE across three sites. Adjunctive treatments were completed subsequently when necessary. Compression stockings were provided for 4 days. The primary outcome was to assess the pain score immediately after completing the truncal ablation using a 100-mm VAS and a 10-point number scale. Secondary outcomes included pain score post adjunctive treatment; 10 days postoperative pain score; degree of ecchymosis; return to normal activities or work; and wearing compression. Secondary outcomes also included occlusion rates as well as the improvement in clinical score, quality of life scores. Analysis was by intention to treat. A total of 167 participants with primary truncal vein incompetence were recruited and randomized (MOCA 83 and CAE 84). Sixty percent of the patients were women with a mean age 56 years. 92.8% of the truncal veins treated were great saphenous veins. The baseline characteristics were comparable. Of the participants, 47.1% underwent adjunctive treatments. Median maximum pain score was low and similar between the MOCA group and the CAE group by VAS (MOCA 24 mm [interquartile range (IQR), 24-44.7 mm] vs CAE 20 mm [IQR, 9-42 mm]; P = .230) and by a 10-point number scale (MOCA 4 [IQR, 2-5] vs CAE 3 [IQR, 2-4]; P = .179). The median average pain score was also same and low. No difference was found between treatment groups in pain score post adjunctive treatment or in the 10 days postoperative. The clinical severity and quality of life scores showed significant improvement. Complete occlusion rates, return to normal activities or work and degree of ecchymosis were comparable between groups. No major complications occurred in either group. This study results shows that no significant differences in pain profile were found with similar improvement in clinical and quality of life scores when MOCA compared with CAE.

Dear Sir, We read the article 'Two-year clinical outcomes following lower limb endovascular revascularisation for chronic limb-threatening ischaemia at a tertiary Asian vascular centre in Singapore' by Tay et al.[1] with great interest. The study assessed mortality and functional outcomes following lower limb endovascular revascularisation in patients with chronic limb-threatening ischaemia who predominantly had diabetes mellitus.[1] The main limitation identified was the lack of consideration for pulmonary function in measuring patient mortality post-operatively. Therefore, we would like to provide our perspective on this potential confounding variable. The study accounted for body mass index (BMI), ethnicity, employment, mobility, smoking and pre-operative functional status. Comorbidities accounted for included hypertension, type 2 diabetes mellitus, hyperlipidaemia, cardiac conditions and kidney disease. While these are undoubtedly important factors, we believe that pulmonary function and, therefore, conditions such as chronic obstructive pulmonary disease (COPD) should be further investigated. Individuals with COPD are at an increased risk of developing peripheral arterial disease (PAD).[2] Furthermore, patients with COPD are more likely to experience increased morbidity and mortality post-operatively.[3] This is supported by a study which demonstrated that mortality rates per 100,000 person-years were 30.1 in individuals with both COPD and PAD, but only 16.1 in patients with PAD only.[2] Although the study accounted for certain comorbidities associated with PAD, it did not account for respiratory conditions such as COPD. We, therefore, propose that given the increased risk of mortality in COPD, respiratory diseases should be included in patient demographics for further research. Financial support and sponsorship Nil. Conflicts of interest There are no conflicts of interest.

Objectives Family caregivers play a fundamental role in the care of the older blunt trauma patient. We aim to identify risk factors for negative and positive experiences of caregiving among family caregivers. Design Prospective, nationwide, multi-center cohort study. Setting and participants 110 family caregivers of Singaporeans aged≥55 admitted for unintentional blunt trauma with an Injury Severity Score (ISS) or New Injury Severity Score (NISS)≥10 were assessed for caregiving-related negative (disturbed schedule and poor health, lack of family support, lack of finances) and positive (esteem) experiences using the modified-Caregiver Reaction Assessment (m-CRA) three months post-injury. Methods The association between caregiver and patient factors, and the four m-CRA domains were evaluated via linear regression. Results Caregivers of retired patients and caregivers of functionally dependent patients (post-injury Barthel score <80) reported a worse experience in terms of disturbed schedule and poor health (β-coefficient 0.42 [95% Confidence Interval 0.10, 0.75], p = .01; 0.77 [0.33, 1.21], p = .001), while male caregivers and caregivers who had more people in the household reported a better experience (-0.39 [-0.73, -0.06], p = .02; -0.16 [-0.25, -0.07], p = .001). Caregivers of male patients, retired patients, and patients living in lower socioeconomic housing were more likely to experience lack of family support (0.28, [0.03, -0.53], p = .03; 0.26, [0.01, 0.52], p = .05; 0.34, [0.05, -0.66], p = .02). In the context of lack of finances, caregivers of male patients and caregivers of functionally dependent patients reported higher financial strain (0.74 [0.31, 1.17], p = .001; 0.84 [0.26, 1.43], p = .01). Finally, caregivers of male patients reported higher caregiver esteem (0.36 [0.15, 0.57], p = .001). Conclusions and implications Negative and positive experiences of caregiving among caregivers of older blunt trauma patients are associated with pre-injury disability and certain patient and caregiver demographics. These factors should be considered when planning the post-discharge support of older blunt trauma patients.