Introduction: Restenosis following balloon angioplasty remains a major cause of arteriovenous fistula (AVF) dysfunction in patients receiving maintenance hemodialysis. We evaluated whether the use of sirolimus-coated angioplasty balloons (SCBs) improves access circuit primary patency (ACPP) in patients with dysfunctional, nonthrombosed AVFs. Methods: In this investigator-initiated, multicenter, single-blinded, randomized controlled trial (ClinicalTrials.gov identifier: NCT04409912), we enrolled 170 patients from 3 tertiary teaching hospitals in Singapore. Patients with dysfunctional AVFs, including those with single or multiple stenotic lesions within the access circuit, were included. Following successful plain balloon angioplasty (PBA) (< 30% residual stenosis on digital subtraction angiography), the patients were randomly assigned, using a centralized web-based system, to receive additional treatment with SCB (n = 83) or placebo balloons (n = 87). During the 12-month follow-up, the patients and their managing physicians were blinded to the study treatment and placebo. The proceduralists and coordinators could not be blinded because of visible differences between the balloons. The primary end point was ACPP during the first 6 months after the index procedure. Secondary end points included 12-month patency and safety outcomes. Results: In both intention-to-treat (ITT) and per-protocol (PP) analyses, 6-month ACPP was significantly higher in the SCB group than in the placebo group (P = 0.03). At 6 months, 70.1% (95% confidence interval [CI]: 58.7-78.8) of patients treated with SCB remained patent, compared with 56.7% (95% CI: 45.5-66.4) in the placebo group. At 12 months, the difference in patency was not statistically significant in the ITT analysis (37.1% vs. 27.7%; P = 0.07) but remained significant in the PP analysis (36.4% vs. 25.2%; P = 0.04). Adverse events were infrequent and no deaths occurred within 30 days in both groups. Conclusion: Use of SCB following successful PBA improved 6-month ACPP in patients with dysfunctional AVFs, including those with multiple stenotic lesions. Short-term safety findings were reassuring.

OBJECTIVE:This study aimed to determine the association between diabetes mellitus (DM) medication use and glycaemic control. DESIGN:This was a retrospective diabetes registry-based cohort study. SETTING:Singapore. PARTICIPANTS:Patients aged 18 and above with incident DM in the SingHealth Diabetes Registry from 2013 to 2020 were included. The entire study period included a 1 year baseline period, a 1 year observation period and a 3 month outcome period. OUTCOME MEASURES:Drug use was measured using the proportion of days covered (PDC), and the changes in glycated haemoglobin (HbA1c) between the outcome and baseline periods were assessed. The associations between baseline HbA1c and PDC ≥0.80 and between PDC and change in HbA1c were analysed using logistic regression and the Kruskal-Wallis test, respectively. RESULTS:Of 184 646 unique patients in the registry from 2013 to 2020, 36 314 met the inclusion and exclusion criteria and were included in the analysis. The median PDC for any DM drug, oral DM drugs and insulin during the observation period was 20.3%, 16.8% and 0%, respectively. Those who had good glycaemic control at baseline were less likely to receive DM drugs and those with poor baseline glycaemic control or missing baseline HbA1c were more likely to be consistent users (PDC >80%) (p<2.2 × 10-16). CONCLUSION:The relationship between DM drug use and glycaemic control is complex and non-monotonic. Higher PDC for any DM drug and oral DM drugs during the observation period was significantly associated with clinically relevant HbA1c improvements.

BACKGROUND:Endovascular technologies continue to evolve to meet the large and growing burden of peripheral arterial disease. The overall quality of published RCTs in endovascular treatments for peripheral arterial disease is low, resulting in uncertainty over treatment effectiveness. The aim of this study was to develop a framework to improve the design, conduct, and reporting of future clinical trials for infrainguinal endovascular treatments of peripheral arterial disease. METHODS:The authors undertook the design, development, and pilot testing of a novel framework. The study comprised four distinct phases. Phase 1 represented the development of a preliminary framework using content analysis of endovascular interventions described in previously published RCTs. Phase 2 consisted of focus groups with key stakeholders to further develop, revise, and achieve initial consensus on the framework. Phase 3 corresponded to the creation of a modified Delphi questionnaire to achieve final consensus on the framework. Phase 4 included cognitive interviews with professionals designing or undertaking endovascular lower limb trials to pilot test the framework. RESULTS:Content analysis of 228 endovascular interventions from 112 RCTs identified six key themes, relevant to endovascular peripheral arterial disease interventions, for the framework: expertise; setting; anaesthesia; imaging; intervention components (access; crossing lesion; treating lesion (lesion preparation; intervention; intervention optimization; bailout intervention; and treatment of non-target lesions); and closure of artery); and pharmacological interventions. Further refinements were made to the framework as a result of feedback from three focus groups and a Delphi questionnaire. The framework deconstructs an endovascular intervention into its component parts. The final framework can be accessed at www.endo-star.com. Pilot testing evaluated comprehension, clarity, and completeness of interpretation. CONCLUSION:The Endo-STAR framework deconstructs endovascular interventions into their key component parts and has been designed and pilot tested to enhance the quality of RCTs of endovascular interventions in peripheral arterial disease. It may be used to assist in developing future trial protocols, the standardization of infrainguinal endovascular interventions, the monitoring of adherence to the trial protocol, and as a standardized reporting guideline.

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.

Doppler duplex ultrasonography (DDU) is used in arteriovenous fistula (AVF) monitoring to measure AVF access flow volume (Qa) and detect stenosis in real-time. However, there has not been a standardized protocol on the sites of Qa monitoring in AVFs. In theory, the outflow vein of the AVF should be an ideal site for Qa monitoring as it is punctured during dialysis, but the measured Qa may be imprecise as vein can be tortuous with turbulent flow, easily compressed by the transducer placement and may not have uniform diameter for precise cross-sectional area calculation.

Drug-coated balloons (DCBs) has emerged as a new endovascular treatment for arteriovenous fistula (AVF) stenosis for their ability to combat neointimal hyperplasia (NIH) and improve target lesion primary patency rates (TLPP). However, there have been inconsistencies in benefits of DCB in clinical trials to date. We postulate that stenosis with neointimal hyperplasia seen on ultrasound scan will respond better to anti-proliferative effect of DCB compared to constrictive stenosis treated with DCB versus plain old balloon angioplasty (POBA).

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.

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:Diabetic foot ulcers (DFUs) are debilitating to the patient and costly for the healthcare system. We set up the Diabetic Rapid Evaluation and lower limb Amputation Management (DREAM) clinic with the aim of providing early directed specialist care to patients with DFUs. With early management, we hope to treat DFUs in its early stages, reducing the need for and associated morbidity of major and minor lower limb amputations.Objectives:We evaluated the outcomes of the fast-access DREAM clinic with multi-disciplinary evaluation for patients with DFUs. Outcomes include time from the point of referral to DREAM clinic evaluation, amputation rates and wound healing rates.Design:Patients presenting with DFU to the DREAM clinic were enrolled. A podiatrist made the first assessment, followed by immediate specialist consultation with Endocrinologists, Vascular surgeons or Orthopaedic surgeons as required.Methods:Data on baseline demographics and DFU characteristics were collected. Outcomes evaluated were wound healing at 12 weeks, wound salvage rates, time to DREAM clinic access and time to specialist referral.Results:Sixty-eight patients were enrolled, with 57.3% males, and mean age of 63 ± 13.0 years. Majority of ulcers were classified as neuropathic (41.3%) and located at the digits (40%). At 12-weeks follow-up, 1 had undergone major amputation, 9 minor amputations and 4 surgical debridements. The median time to DREAM clinic evaluation from first presentation was 3 days (IQR 7). Eleven (16.2%) required >1 specialist consult. Twenty (29.4%) were hospitalised for treatment. Twelve underwent revascularisation within 4 days (IQR 3.5). Twenty-four patients (35.3%) continued podiatry follow-up, having 28 DFUs in which 20 (71.4%) healed within 12 weeks.Conclusion:The fast-access multidisciplinary DREAM clinic shows promising outcomes with lower major amputation rates and exemplary DFU healing outcomes.

Sirolimus coated balloon (SCB) is a potential treatment option for peripheral arterial occlusive disease (PAOD). However, clinical data for this novel treatment for PAOD are lacking. We present the 24 months RESULTS of the first-in-human study of MagicTouch PTA SCB for treatment of PAOD for both femoropopliteal and below the knee arteries (BTK).

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.

Shared decision making (SDM) involves providing patients with high quality information, exploring their preferences, supporting their deliberation on options, then helping them to come to a shared decision. 1 Elwyn G. Frosch D. Thomson R. Joseph-Williams N. Lloyd A. Kinnersley P. et al. Shared decision making: a model for clinical practice. J Gen Intern Med. 2012; 27: 1361-1367 Crossref PubMed Scopus (2365) Google Scholar This is especially important in critical decision making processes for high risk and high morbidity surgery. Shared Decision Making and the Management of Intact Abdominal Aortic Aneurysm: A Scoping Review of the LiteratureEuropean Journal of Vascular and Endovascular SurgeryVol. 65Issue 6PreviewThe aim of this study was to summarise the current knowledge of shared decision making (SDM) in patients facing a treatment decision about an intact abdominal aortic aneurysm (AAA), and to identify where further evidence is needed. Full-Text PDF Open Access

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.

PURPOSE:This study aims to describe an efficacious method using Cleaner XT rotational thrombectomy with catheter-directed thrombolysis and drug-eluting balloon angioplasty for the salvage of thrombosed arteriovenous fistulae and grafts.MATERIALS AND METHODS:Retrospective analysis of all patients with thrombosed hemodialysis accesses who underwent endovascular salvage using the Cleaner XT rotational thrombectomy system at a single institution between June 2019 and September 2020 was performed. Patency was presented as Kaplan-Meier survival curves, and regression analysis was performed to examine predictors of postintervention primary patency and assisted primary patency based on Cox proportional-hazards model.RESULTS:Thirty-four patients with thrombosed accesses underwent Cleaner XT rotational thrombectomy between June 2019 and September 2020. Technical and clinical success were both 100%. Mean procedure time was 62 ± 20 minutes. Mean postintervention primary patency time was 152 ± 51 days; 30, 90, 180, and 365 day postintervention primary patency rates were 89%, 80%, 68%, and 56%, respectively. Mean postintervention-assisted primary patency time was 157 ± 59 days; 30, 90, 180, and 365 day postintervention-assisted primary patency rates were 91%, 82%, 71%, and 59%, and 180 and 365 day secondary patency rates were 97.2% and 94.4%, respectively.CONCLUSION:The Cleaner XT rotational thrombectomy device demonstrates excellent clinical and technical success rates, with good patency results at all time points up to 12 months postintervention.

A vaccinated 54 year old man who tested positive for SARS-CoV-2 11 days ago with respiratory symptoms, presented with abdominal pain. Despite being on 20 mg/day of rivaroxaban for atrial fibrillation and with therapeutic anti-factor Xa levels (26.47 ng/L), imaging revealed acute embolic occlusion (arrow) of the distal superior mesenteric and ileocolic artery on computed tomography angiography imaging (A). The patient had no symptoms of bowel ischaemia. He was treated conservatively with intravenous heparin for 14 days and converted to warfarin titrated to therapeutic levels. (B) Imaging at four weeks demonstrated recanalisation of the thrombosed arteries (arrow) with good distal opacification. The patient was symptom free and was feeding normally with no intestinal complications.Image 1

In order to control asymmetric floor heave in deep rock roadways and deformation around the surrounding rock mass after excavation, in this paper we discuss the failure mechanism and coupling control countermeasures using the finite difference method (FLAC3D) combined with comparative analysis and typical engineering application at Xingcun coal mine. It is indicated by the analysis that the simple symmetric support systems used in the past led to destruction of the deep rock roadway from the key zone and resulted in the deformation of asymmetric floor heave in the roadway. Suitable reinforced support countermeasures are proposed to reduce the deformation of the floor heave and the potential risk during mining. The application shows that the present support technology can be used to better environmental conditions. The countermeasures of asymmetric coupling support can not only effectively reduce the discrepancy deformation at the key area of the surrounding rock mass, but also effectively control floor heave, which helps realize the integration of support and maintain the stability of the deep rock roadways at Xingcun coal mine.

Symptomatic isolated mesenteric artery dissection (IMAD) is a rare vascular disease. Therefore, data on its natural history are scarce. Treatment strategies on whether to stent symptomatic IMAD remain controversial, with recent observational reports advocating an aggressive approach, with a low threshold for stenting. In this issue, Abdallah et al.1 Abdallah I.B. Huguet A. Nuzzo A. Mirault T. Roussel A. El Batti S. et al. Acute isolated mesenteric artery dissection: four year experience from a French intestinal stroke centre. Eur J Vasc Endovasc Surg. 2022; 64: 656-664 Abstract Full Text Full Text PDF PubMed Scopus (4) Google Scholar provide alternative insights from a French intestinal stroke centre that adopts a conservative treatment algorithm for symptomatic IMAD. Acute Isolated Mesenteric Artery Dissection: Four Year Experience From a French Intestinal Stroke CentreEuropean Journal of Vascular and Endovascular SurgeryVol. 64Issue 6PreviewThis study aimed to report outcomes of patients with symptomatic acute isolated mesenteric artery dissection (IMAD) treated within a French intestinal stroke centre (ISC). Full-Text PDF