The smart negative pressure (SNaP) wound care system: A case series from Singapore.

The Smart Negative Pressure (SNaP) wound care system is a novel device that is single-patient use, ultra-portable, and light weight and does not rely on battery or need recharging. A systematic search was performed on major databases to identify relevant articles including case reports, retrospective case series, and randomised controlled trials. Ten studies were identified, showing that the SNaP wound care system is an effective tool in treating small-sized wounds and may serve as an alternative to current electrically powered modalities. Furthermore, the system's small size and convenience leads to greater patient satisfaction and improves quality of life. Finally, we report our initial positive experiences with two cases in our institution. Although the evidence thus far has been encouraging, and patient satisfaction is higher than other wound care systems, further evidence is required to determine its superiority over current systems in terms of wound-healing outcomes.

Greater Compliance within Instruction for Use for Concomitant Iliac Aneurysms and Adverse Aneurysm Characteristics-Initial Experience with the Nellix Endovascular Aneurysm Sealing System at a Single Institution.

BACKGROUND: The Nellix was introduced to Asia in 2014. Data in Asians have been sparse. Two balloon-expandable stents, each surrounded by a polymer-filled endobag, are deployed in parallel to obliterate and seal the aneurysm. This paradigm shift to treating abdominal aortic aneurysms confers advantages for certain adverse aneurysm morphology that is outside the instruction-for-use (IFU) for standard endovascular aneurysm repair (EVAR) devices. We examine outcomes of 15 Asian patients with concomitant infrarenal aortic and iliac artery aneurysms treated with the Nellix at our institution. METHOD: Between July 2014 and August 2016, 15 male patients underwent elective EVAS at a single tertiary center by the same team of vascular surgeons and interventional radiologists. Patient demographics, clinical presentations, aneurysm morphology, perioperative complications, and follow-up imaging according to the standardized protocol were studied. Preoperative CT images were analyzed using validated automatic 3-dimensional sizing software EndoSize. RESULT: The novel stent-graft deployment proves consistent and achieved a 100% technical success. Eleven patients (70%) complied within specified Nellix IFU, as compared to 20% if standard endovascular aneurysm repair (EVAR) IFU was applied. The difference is due to the presence of concurrent common iliac aneurysms (n = 5), short neck length (n = 3), and angulated necks (n = 3). Adjunct procedures included 3 open access endarterectomy with embolectomy, 1 coil embolization of internal iliac artery, 1 bilateral renal artery chimneys, and 1 proximal stent deployment. There was no conversion to open surgery. Average operative time was 133 min. Median length of stay was 4 days. Thirty-day mortality was 0%. Perioperative morbidity included exacerbation of pre-existing renal impairment (n = 6), peripheral vascular disease (n = 3), and postimplantation syndrome (n = 5). One endoleak (7%) and 2 instances of stent migration (14%) were detected. There was no complication of aneurysm or endobag rupture, limb thromboses, or fracture. CONCLUSIONS: Early data in our center are encouraging and highlight high procedural success with minimal complications despite challenging patient anatomy.

Slow-flow phenomena following lower limb paclitaxel- and sirolimus-coated balloon angioplasty in the setting of chronic limb threatening ischaemia-a case series.

The Achilles heel of plain old balloon angioplasty (POBA) is neointimal hyperplasia (NIH) and restenosis, caused from the barotrauma of ballooning. Drug-coated balloons using a paclitaxel-based platform (PCB) have been shown to retard the restenotic process, using the anti-proliferative effects of paclitaxel, and give longer vessel patency. This is important in the setting of chronic limb threatening ischemia (CLTI) and for the protracted wound healing process in these frail patients. However, during PCB application, more than 50% of the drug is lost downstream, a phenomenon termed particulate embolization. This is thought to account for the slow- or no-flow phenomenon encountered after PCB use. Recent data suggest that slow-flow phenomenon was associated with a lower target lesion revascularisation rate and worse amputation free survival (AFS). The use of sirolimus coated balloons (SCB) to impede the NIH cascade has been less well studied but recent data suggested excellent short-term efficacy and found no slow flow phenomenon with their use in the tibial arteries in CLTI patients. Aim of this case series is to highlight the difference in flow phenomena using PCB and SCB elution in the setting of CLTI. We evaluated the use of parametric colour coding and time attenuation curves (TAC) as a quantitative measure of blood flow. SCB may have an advantage over PCB use in the peripheral vasculature because of a reduced incidence of slow flow phenomenon following drug elution.

Safety and efficacy of Luminor™ balloon and Angiolite™ stent on TASC C/D tibial occlusive lesions in CLI patients: 12-month results. The MERLION trial.

BACKGROUND: The aim of MERLION (NCT04073121) was to evaluate the outcomes of the mono or combination therapy of the iVascular Luminor™ drug-coated balloon (DCB) and Angiolite™ drug-eluting stent for treatment of TASC II C/D tibial occlusive lesions in Asian patients presenting with chronic limb threatening ischemia (CLTI) from Singapore. METHODS: MERLION was a prospective, non-randomized, single arm, observational, multicenter clinical study. Complication-free survival at one month was the safety endpoint. Immediate technical success, 12-month primary vessel patency, limb salvage, freedom from target lesion revascularization (TLR) and amputation free survival (AFS) were the efficacy endpoints of interest. RESULTS: Fifty patients were included. There were 32 males (64% males; mean age 66.4±8.9 years). Majority were Rutherford 5 severity (41/50; 82%). Co-morbidities included diabetes mellitus (47/50; 94.0%), end-stage renal failure (25/50; 50.0%), and hypertension (44/50; 88%). 66 atherosclerotic lesions were treated (47 de novo and 19 restenotic; 60.6% TASC C and 39.4% TASC D). Mean lesion length treated was 13.7±9.5 cm. There was 100% technical success. There were 3/66 (4.5%) bailout stenting for severe flow limiting dissections. Twelve-month primary tibial patency was 34/49 (69.4%) and freedom from TLR was 40/49 (81.5%). AFS was 74.0% (37/50). At 12 months, mean Rutherford scores improved from 100% (Rutherford score >3) at baseline to 31% at 12 months (P<0.05) and wound healing rate was 65.7%. CONCLUSIONS: The iVascular Luminor™ DCB is safe and efficacious in treating highly complex infra-popliteal atherosclerotic lesions in an otherwise challenging frail population of CLTI patients from Singapore.

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

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

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

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

Predictive factors for changes in remnant stump length during and after the treatment of incompetent truncal saphenous veins using cyanoacrylate.

INTRODUCTION: The VenaSeal™ Closure System is a non-thermal, non-tumescent venous closure device that employs a cyanoacrylate adhesive to occlude incompetent veins for superficial truncal reflux. The aim was to examine patient, Duplex-defined venous characteristics and treatment-related factors that may predict variances in remnant stump length at the sapheno-femoral and sapheno-popliteal junctions in the peri-procedural period. METHODS: A total of 73 patients (87 legs; 85 great saphenous veins; 11 small saphenous veins) of median age 63 years (range 26-86 years) underwent VenaSeal™ Closure System ablation. 44/85 (52%) great saphenous veins were treated with a modified instructions-for-use technique of using double-dose injection of glue (0.3 cc) at initial deposition for great saphenous veins diameters >6 mm. Median great saphenous veins and small saphenous veins lengths ablated were 48.0 cm (range 13-69 cm) and 32.0 cm (range 19-40 cm), respectively. A total of 62/87 (71.3%) legs had CEAP classification 4-6. A completion Duplex scan was performed immediately and 1 week post-procedure to measure remnant stump lengths at the sapheno-femoral and sapheno-popliteal junctions. Multivariate regression modelling was used to look for predictors of remnant stump length. RESULTS: Mean sapheno-femoral and sapheno-popliteal junctions stump lengths immediately post procedure were 33.0 mm (range 0-58 mm) and 27 mm (range 5-33 mm), -17.0 mm and -23.0 mm less than the expected 50-mm baseline length, respectively. At 1 week post-procedure, mean sapheno-femoral and sapheno-popliteal junctions stump lengths were 25.0 mm and 25.0 mm, respectively, the former found to be shorter compared to immediately post-procedure (25 mm vs 33 mm; p < 0.05). Multivariate analysis found larger upper thigh great saphenous veins diameter at sapheno-femoral junction to be predictive of shorter remnant stump lengths immediately post-procedure (<30 mm stump distance). Larger sapheno-femoral junction diameters and pre-existing ischemic heart disease for the sapheno-femoral junction and larger small saphenous veins diameters and age for the sapheno-popliteal junction were predictive of interval shortening of the measured remnant lengths found at the completion of the procedure and 1 week later. Initial double-dosing application of glue was not found to be predictive of shorter stump lengths. CONCLUSION: In patients undergoing VenaSeal™ Closure System ablation for superficial truncal reflux, larger upper thigh great saphenous veins diameters predicted shorter remnant sapheno-femoral junction stump lengths immediately post-procedure. Comparing stump lengths at one week to immediately after procedure, larger sapheno-femoral junctions and ischemic heart disease predicted shorter stump lengths at the sapheno-femoral junction, while larger small saphenous vein diameters predicted shorter stump lengths at the sapheno-popliteal junction.

Catheter-directed foam sclerotherapy, an alternative to ultrasound-guided foam sclerotherapy for varicose vein treatment: A systematic review and meta-analysis.

PURPOSE: Catheter-directed foam sclerotherapy is a new addition to the treatment modalities available for varicose veins. As a modification of ultrasound-guided foam sclerotherapy, catheter-directed foam sclerotherapy has been purported to offer higher complete ablation rates and an improved safety profile. The aim of this study is to appraise the current literature on the outcomes of catheter-directed foam sclerotherapy compared to ultrasound-guided foam sclerotherapy in chronic venous insufficiency. METHODS: The review of the literature was conducted using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Data from studies that reported the outcomes of catheter-directed foam sclerotherapy and ultrasound-guided foam sclerotherapy were extracted, to determine the pooled proportion of complete ablation rates, using a random effect meta-analysis model. RESULTS: A total of 62 studies, involving 3689 patients, were included in the systematic review. Higher rates of complete ablation were reported in catheter-directed foam sclerotherapy compared to ultrasound-guided foam sclerotherapy during the short- and medium-term follow-ups (Relative Risk = 1.06, Relative Risk = 1.15, Relative Risk = 1.19, p < 0.05). Fewer major and minor complications were also reported in patients who underwent catheter-directed foam sclerotherapy (Relative Risk = 0.23, Relative Risk= 0.43-0.76, p < 0.05). CONCLUSION: Catheter-directed foam sclerotherapy has been demonstrated to have many advantages over ultrasound-guided foam sclerotherapy, offering superior complete ablation rates in the short-, medium- and long-term follow-ups. It also has a better safety profile, conferring a lower risk of major and minor complications. The conclusions should however be viewed in the context of significant limitations imposed by limited study data.

Compression therapy following ClariVein® ablation therapy: a randomised controlled trial of COMpression Therapy Following MechanO-Chemical Ablation (COMMOCA).

BACKGROUND: Endovenous treatment of varicose veins has increased in popularity over the last decade. There remains, however, a degree of uncertainty regarding the role of compression bandaging or hosiery following this intervention. The National Institute for Clinical Excellence Guideline Development Group has advocated further research to evaluate the clinical and cost-effectiveness of this post-procedure intervention. In addition to this, the duration of compression bandaging also warrants clarification. METHODS: Ethical approval for the study was obtained from the Singhealth Centralised Institutional Review Board (CIRB Ref: 2017/2710). Consent to enter the study will be sought from each participant only after a full explanation has been given, an information leaflet offered and time allowed for consideration. Signed participant consent will be obtained. Patients will be randomised to either compression (group A) or no compression (group B). The primary aim of the study is to assess the patient's pain scores for the first 10 days post procedure using a visual analogue scale. Secondary aims include an assessment of patient compliance with compression, quality of life scores, clinical effectiveness, rates of bruising and phlebitis, time taken to return to normal activities, patient satisfaction and occlusion rate at 6 months. DISCUSSION: The purpose of this study is to examine the effect of compression therapy in patients having mechano-chemical ablation (MOCA) therapy for truncal incompetence of their varicose veins using the ClariVein® device. This study may provide clarification on the role of compression therapy in patients undergoing MOCA. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03685838. Registered on 26 September 2018.