MagicTouch PTA Sirolimus-Coated Balloon for Femoropopliteal and Below-the-Knee Disease: 3-Year Outcomes of the XTOSI Trial.

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.

3-year clinical outcomes of A Singapore VenaSeal™ real world post-market evaluation Study (ASVS) for varicose vein ablation.

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.

A case of severe polyarteritis nodosa with critical limb threatening ischemia-promising treatment with sirolimus drug-coated angioplasty.

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 threatening 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.

USE of IMplanting the Biotronik PassEo-18 Lux drug coated balloon to treat failing haemodialysis arteRiovenous FIstulas and grafts (SEMPER FI Study).

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.

Polymer-coated paclitaxel-eluting stents for the treatment of stenosed native arteriovenous fistulas: Long-term results from the ELUDIA study.

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.

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.

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.

Use of the helical SUPERA™ stent and Passeo-18 Lux™ drug-coated balloon to treat recurrent cephalic arch stenosis for dysfunctional brachiocephalic fistulas: 1 year results of the Arch V SUPERA-LUX study.

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.

Treatment of a Delayed Type IIIb Endoleak 20 Years Post EVAR With Inverted Contralateral Limb Custom-Made Device: A Case Report.

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.

Utility of paclitaxel-coated balloons for the treatment of infrainguinal disease in the Asian population - 24-month outcome data from the BIOLUX P-III Global Registry 24-month Asian outcomes of BIOLUX P-III.

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.

Study protocol for a Prospective, Randomized controlled trial of stEnt graft and Drug-coated bAlloon Treatment for cephalic arch stenOsis in dysfunctional arteRio-venous fistulas (PREDATOR).

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.

Negative and positive experiences of caregiving among family caregivers of older blunt trauma patients.

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 (ß-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.

Pilot single-arm study to investigate the efficacy and safety of endovenous Microwave ablations for treatment of varicose veins in Singapore - one year results of the MAESTRO registry.

OBJECTIVES: Aim was to report a prospective two-centre Singaporean experience using Endovenous Microwave Ablation (EMA) to treat symptomatic primary great saphenous vein reflux. We evaluated 1-year safety, efficacy and patient satisfaction. METHODS: 50 patients (63 limbs; 29 females; mean age 58.0 ± 12.1 years) were included. Patients were reviewed at 2-weeks, 3-, 6- and 12-months and underwent Duplex ultrasound assessment. Three quality of life (QoL) questionnaires were completed. RESULTS: The truncal closure rates at 2-weeks, 3-, 6- and 12-months were 63/63 (100%), 59/59 (100%), 58/58 (100%) and 59/60 (98.3%), respectively. There was 100% technical success and no serious adverse events. There were sustained improvement of QoL questionnaire scores from 2 weeks to 12 months. CONCLUSION: EMA is 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.

One year clinical outcomes of Rutherford 6 chronic limb threatening ischemia patients undergoing lower limb endovascular revascularisation from Singapore.

BACKGROUND: Percutaneous transluminal angioplasty (PTA) is widely used as a first-line revascularisation option in patients with chronic limb threatening ischemia (CLTI). This study aimed to evaluate the short-term endovascular revascularisation treatment outcomes of a cohort of Rutherford 6 (R6) CLTI patients, from a multi-ethnic Asian population in Singapore. Patients with R6 CLTI who underwent endovascular revascularisation from June 2019 to February 2020 at Singapore General Hospital, a tertiary vascular centre in Singapore, were included and followed up for one year. Primary outcome measures included number and type of reinterventions required, 3-, 6- and 12-month mortality, 6- and 12-month amputation free survival (AFS), wound healing success and changes in Rutherford staging after 3, 6 and 12 months. RESULTS: Two hundred fifty-five procedures were performed on 86 patients, of whom 78 (90.7%) were diabetics, 54 (62.8%) had coronary artery disease (CAD) and 54 (62.8%) had chronic kidney disease (CKD). 42 patients (48.8%) required reintervention within 6 months. Multivariate analysis revealed that the presence of CAD was a significant independent predictor for reintervention. Mortality was 15.1%, 20.9% and 33.7% at 3, 6 and 12 months respectively. AFS was 64.0% and 49.4% at 6 and 12 months. Inability to ambulate, congestive heart failure (CHF), dysrhythmia and CKD were significant independent predictors of lower 12-month AFS. CONCLUSIONS: PTA for R6 CLTI patients was associated with relatively high mortality and reintervention rates at one year. CAD was an independent predictor of reintervention. More research is required to help risk stratify which CLTI patients would benefit from an endovascular-first approach versus conservative treatment or an immediate major lower extremity amputation policy.

Sirolimus-coated balloon angioplasty in maintaining the patency of thrombosed arteriovenous graft: 1-year results of a prospective study.

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.

Pain Outcomes Following Mechanochemical Ablation vs Cyanoacrylate Adhesive for the Treatment of Primary Truncal Saphenous Vein Incompetence: The MOCCA Randomized Clinical Trial.

Importance: Endovenous thermal ablations (ETAs) are recommended as first-line treatment for truncal vein reflux, have a short recovery time, and are cost-effective. However, ETAs are associated with discomfort during tumescent anesthesia infiltration. To minimize discomfort, nonthermal, nontumescent ablation techniques had emerged in the form of mechanochemical ablation (MOCA) and cyanoacrylate adhesive injection (CAE). Objective: To assess pain scores immediately after truncal ablation using a 100-mm visual analog scale and 10-point number scale to compare pain-related outcomes following mechanochemical ablation vs cyanoacrylate adhesive treatment. Design, Setting, and Participants: The Multicenter Randomized II Clinical Trial Comparing Mechanochemical Ablation vs Cyanoacrylate Adhesive for the Treatment of Primary Truncal Saphenous Veins Incompetence study was a prospective multicenter randomized clinical trial conducted at 3 sites between November 2017 and January 2020. Inclusion criteria were primary great or small saphenous varicose veins; exclusion criteria included recurrent varicose veins, current deep venous thrombosis, or serious arterial disease. There were 392 participants screened, 225 were excluded, and 167 participants underwent randomization. Four participants did not receive allocated intervention and were included in the intention-to-treat analysis. Follow-up took place at 2 weeks, and 3, 6, and 12 months. Interventions: Patients with primary truncal vein incompetence were randomized to receive either MOCA or CAE. Main Outcomes and Measures: The primary outcome measure was pain score immediately after completing truncal ablation using a 100-mm visual analog scale (VAS) and a 10-point number scale. Secondary outcome measures included degree of ecchymosis, occlusion rates, clinical severity, and generic and disease-specific quality of life (QoL) scores. Results: Of 167 study participants, 99 (59.3%) were women, and the mean (SD) age was 56 (15.8) years. Overall, 155 truncal veins treated (92.8%) were great saphenous veins. Demographic data and baseline status were comparable between treatment groups. A total of 73 patients (47%) underwent adjunctive treatment of varicosities. Overall median (IQR) maximum pain score after truncal treatment was 23 mm (10-44) on the VAS and 3 (2-5) on the number scale, showing no significant difference in median (IQR) pain measured by VAS (MOCA, 24 [11.5-44.7] mm vs CAE, 20 [9.0-42.0] mm; P = .23) or by number scale (MOCA, 4 [2-5] vs CAE, 3 [2-4]; P = .18). Both groups demonstrated significant and comparable improvement in clinical severity, generic and disease-specific QoL scores, and complete occlusion rates. Four patients treated with CAE developed minor complications (superficial thrombophlebitis and thrombus extensions). Conclusions and Relevance: To our knowledge, this was the first randomized clinical trial directly comparing nontumescent ablation techniques. The study demonstrated that the MOCA and CAE techniques have a similar periprocedural pain score. Trial Registration: ClinicalTrials.gov Identifier: NCT03392753.

Midterm outcomes (2 years) using the Venovo™ and Sinus Obliquus™ venous stents in the treatment of non-thrombotic and post-thrombotic iliac vein lesions - Results from a multi-centre Asian cohort.

INTRODUCTION: Medium-term outcome data are lacking for dedicated venous stents especially from the Asian population. OBJECTIVES: Aim was to determine the 2-year patency and symptomatic relief gained from using the BD Venovo™ and Optimed Sinus Obliquus™venous stents for ilio-femoral obstruction (IFO). METHODS: 60 patients (71 limbs; 39 females; mean age of 66.4 ± 11.9 years) were included in this prospective dual centre Asian cohort. Clinical improvement was determined by change in the CEAP, rVCSS and pain scores. Stent patency and stenosis were measured using area reduction on CTV and diameter reduction on Duplex ultrasound. RESULTS: At 2 years, 65.7% showed ≥1 CEAP score improvement from baseline and rVCSS and pain scores remained low and sustained. 87.1% venous leg ulcers remained healed. Freedom from target lesion revascularisation was 94.3% and overall stent patency was 87.1%. There were no stent fractures or migration reported. CONCLUSION: Dedicated venous stents for IFO were associated with sustained clinical improvement and a high freedom from reintervention at 2 years in Asian patients.

Diabetes and other vascular risk factors in association with the risk of lower extremity amputation in chronic limb-threatening ischemia: a prospective cohort study.

BACKGROUND: Patients with diabetes are at increased risk of developing chronic limb-threatening ischemia (CLTI) due to peripheral arterial disease, and this often results in lower extremity amputation (LEA). Little is known of the interaction between diabetes and other vascular risk factors in affecting the risk of CLTI. METHODS: We investigated the association of diabetes, and its interaction with hypertension, body mass index (BMI) and smoking, with the risk of LEA due to CLTI in the population-based Singapore Chinese Health Study. Participants were interviewed at recruitment (1993-1998) and 656 incident LEA cases were identified via linkage with nationwide hospital database through 2017. Multivariate-adjusted Cox proportional hazards models were used to compute hazard ratios (HRs) and 95% CIs for the associations. RESULTS: The HR (95% CI) for LEA risk was 13.41 (11.38-15.79) in participants with diabetes compared to their counterparts without diabetes, and the risk increased in a stepwise manner with duration of diabetes (P for trend < 0.0001). Hypertension and increased BMI independently increased LEA risk in those without diabetes but did not increase the risk in those with diabetes (P for interaction with diabetes ≤ 0.0006). Conversely, current smoking conferred a risk increment of about 40% regardless of diabetes status. CONCLUSIONS: Although diabetes conferred more than tenfold increase in risk of LEA, hypertension and increased BMI did not further increase LEA risk among those with diabetes, suggesting a common mechanistic pathway for these risk factors. In contrast, smoking may act via an alternative pathway and thus confer additional risk regardless of diabetes status.

Two-year clinical outcomes following lower limb endovascular revascularisation for chronic limb-threatening ischaemia at a tertiary Asian vascular centre in Singapore.

INTRODUCTION: Percutaneous transluminal angioplasty (PTA) is commonly used to treat patients with chronic limb-threatening ischaemia (CLTI). This study aimed to examine the mortality and functional outcomes of patients with CLTI who predominantly had diabetes mellitus in a multi-ethnic Asian population in Singapore. METHODS: Patients with CLTI who underwent PTA between January 2015 and March 2017 at the Vascular Unit at Singapore General Hospital, Singapore, were studied. Primary outcome measures were 30-day unplanned readmission, two-year major lower extremity amputation (LEA), mortality rates, and ambulation status at one, six and 12 months. RESULTS: A total of 221 procedures were performed on 207 patients, of whom 184 (88.9%) were diabetics. The one-, six- and 12-month mortality rate was 7.7%, 16.4% and 21.7%, respectively. The two-year LEA rate was 30.0%. At six and 12 months, only 96 (46.4%) and 93 (44.9%) patients were ambulant, respectively. Multivariate analysis revealed that preoperative ambulatory status, haemoglobin, Wound Ischaemia and foot Infection (WIfI) score, and end-stage renal failure (ESRF) were independent predictors of one-year ambulatory status. Predictors of mortality at one, six and 12 months were ESRF, preoperative albumin level, impaired functional status and employment status. CONCLUSION: PTA for CLTI was associated with low one-year mortality and two-year LEA rates but did not significantly improve ambulation status. ESRF and hypoalbuminaemia were independent predictors of mortality. ESRF/CKD and WIfI score were independent predictors of loss of ambulation at six months and one year. We need better risk stratification for patients with CLTI to decide between initial revascularisation and an immediate LEA policy.