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.

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.

Endovascular Deep Vein Stenting of Symptomatic Post-Thrombotic and Non-Thrombotic Iliac Vein Stenotic Lesions: A Multicentre Cohort Experience from Singapore.

INTRODUCTION: This paper presents our experience with deep venous stenting in a multi-ethnic Asian cohort of patients with symptomatic Non-Thrombotic Iliac Vein Lesions (NIVL) and Post-Thrombotic Syndrome (PTS). MATERIALS AND METHODS: This was a multicentre retrospective cohort study of patients who had symptomatic deep venous disease. Stent patency rate was evaluated using Duplex ultrasonography immediately post-intervention and at 3, 6 and 12 months. Clinical outcomes were evaluated using the revised Venous Clinical Severity Score (rVCSS) and Visual Analogue Scale (VAS) pain score at baseline and 3 months post-procedure. RESULTS: 87 patients (males = 47/87 (54.0%)); median age = 62 years (IQR 55 - 70)) and 115 limbs were analysed (left = 76/115 (66.1%)). Median follow-up time was 175 (IQR 57 - 257) days. 97/115 (84.3%) had NIVLs and 55/115 (47.8%) had May-Thurner-Syndrome. 43/115 (37.4%) had Clinical, Etiology, Anatomy and Pathophysiology (CEAP) 6 disease. Primary stent patency rates were 98.2% (112/114), 97.9% (93/95), 95.7% (89/93) and 92.8% (64/69) immediately post-intervention, 3, 6 and 12 months, respectively. The 6-month secondary patency rate was 99.1% (114/115). Mean rVCSS and VAS improved from 11.52 (±3.54) to 5.77 (±2.36) (P < 0.01) and 6.62 (±1.93) to 2.92 (±1.50) (P < 0.01) respectively, at 3 months. 41/43 (95.3%) venous ulcers healed over a median time of 169 days (IQR 120 - 253). CONCLUSIONS: Short term primary patency rates following deep venous stenting are excellent, with few re-interventions. Patients presented with NIVLs rather than PTS. There was excellent clinical improvement at 3 months, with a high and expedient venous ulcer healing rate.

Heal or no heel: Outcomes of ischaemic heel ulcers following lower limb revascularization from a multi-ethnic Asian Cohort in Singapore.

Ischaemic diabetic heel ulcers are difficult to treat and prognosis is often guarded. The aim was to document our outcome of treating heel ulcers following revascularization in a predominantly diabetic Asian cohort presenting with chronic limb threatening ischaemia from Singapore. Retrospective cohort study (n = 66, 66 limbs) over a 5-year period. Data were collected from hospital electronic health records. Outcomes included time to healing, amputation free survival (AFS), and mortality. Minimum follow-up period was 6 months. Multivariate regression analysis was performed to look for factors associated with poor outcome. Mean age was 67.4 ± 8.8 years. 62/66 (93.9%) were diabetics. Mean wound size at presentation was 3.6 ± 2.3 cm. Mean Wound, Ischaemia, Foot Infection (WIFI) score was 5 ± 1.6. 12/66 (18%) patients had a patent posterior tibial artery pre-operatively. Straight line flow was restored in only 31/66 (46.9) patients but 47/66 (71.2%) had successful limb salvage. Median time to wound healing was 90.0 (IQR 60-180) days. A median of 1 (IQR 0-2) wound debridement was required. Patients who underwent negative pressure dressing (23/66; 34.8%) required a median of 26 (IQR 13-33) cycles to achieve healing. Amputation free survival (AFS) was 72% and 68% at 6- and 12-months, respectively. Mortality rate was 16.7% and 19.7% at 6- and 12-months, respectively. Low albumin level and initial Rutherford class were independent predictors of worse 6-month AFS. Outcomes of heel ulcers post revascularisation may not be as poor as previously described. Persistent attention to wound care with multidisciplinary effort is needed for optimal healing.