Registry to investigate the efficacy and safety of the VenaBlock© VeIn SEaling system for VaRicose veins in SingApore - Six months results of the RIVIERA trial.

BACKGROUND: The Venablock© Venous Closure System (Invamed, Ankara, Turkey) is a novel cyanoacrylate-based non-thermal non-tumescent embolization device to block refluxing truncal veins for chronic venous insufficiency and varicose veins. The aim was to prospectively evaluate the safety and 6 months efficacy of Venablock© for the treatment of primary great saphenous vein (GSV) and small saphenous vein (SSV) incompetency in a multi-ethnic cohort from Singapore. METHODS: This was a single arm, single investigator prospective study of 29 patients (39 limbs, 39 truncal veins) recruited over a 5-month period (August 2019 to February 2020), who were treated with the Venablock© device at a tertiary vascular unit in Singapore. Patients with symptomatic varicose veins (C2-6) and had truncal reflux > 0.5 second on venous Duplex ultrasound were included. Follow-up occurred at 2 weeks, 3 and 6 months with dedicated quality of life questionnaires and a targeted Duplex ultrasound performed to check for continued venous occlusion. RESULT: Mean age was 61.4 (±11.0) years and mean BMI was 26.2 (±5.7) kg/m2. 11/29 (37.9%) were males. Most common CEAP class treated was 2 (12/29, 41.3%). Mean diameter of treated GSV was 5.7 (±2.0) mm, 4.8 (±1.7) mm and 4.2 (±1.3) mm for the proximal, mid and distal above knee segments respectively. Mean time from access puncture to sheath removal was 23.4 (±10.0) mins. Vein occlusion at 2 weeks, 3 and 6 months was 39/39 (100%), 39/39 (100%) and 36/37 (97.2%) respectively. 5/29 (17.2%) developed puncture site infections, of which 3/29 (7.7%) required formal surgical drainage. 3/29 (7.7%) developed phlebitis. At 6 months, revised Venous Clinical Severity Score improved from 5.2 (±3.5) to 2.1 (±2.9; p < .001); EuroQol-5 Dimension score, from 7.4 (±2.1) to 5.7 (±1.4; p < .001); Aberdeen Varicose Vein Questionnaire score, from 18.1 (±15.5) to 7.9 (±8.9; p = .007); and Chronic Venous Insufficiency Questionnaire, from 18.6 (±16.2) to 4.5 (±6.3; p < .001). CONCLUSION: Venablock© is a safe and efficacious option of treating truncal venous insufficiency in a multi-ethnic Asian cohort from Singapore in the short term. There is a significant improvement in QoL. Longer follow-up is required to assess the durability of this technique, in particular the higher puncture site infection rates observed compared to other glue-based therapies.

Helical stent (SUPERA™) and drug-coated balloon (Passeo-18 Lux™) for recurrent cephalic arch stenosis: Rationale and design of arch V SUPERA-LUX Study.

BACKGROUND: The treatment options for cephalic arch stenosis are limited and standard of care remains at crossroads - none are ideal and there is currently no gold standard. Endovascular techniques are now the preferred primary therapeutic option because they are minimally invasive and better tolerated by haemodialysis patients who have multiple comorbidities. However, conventional plain old balloon angioplasty, bare metal stenting and stent grafts all have their limitations. The aim of this trial is to evaluate whether the helical SUPERA™ stent (Abbott Vascular, Santa Clara, CA, USA), which has a higher degree of flexibility and resistance to compressive forces compared to traditionally laser-cut nitinol stents, combined with a drug-coated balloon (Biotronik Passeo-18 Lux™) to minimize the neointimal hyperplasia effect, can improve patency and reduce reintervention rates. METHODS AND RESULTS: Arch V SUPERA-LUX is a pilot investigator-initiated single-centre, single-arm prospective study. Twenty patients with a brachiocephalic fistula within 6 months of initial plain old balloon angioplasty for significant cephalic arch stenosis will be recruited for treatment with SUPERA and drug-coated balloon. The primary objectives are immediate angiographic and procedural success, primary patency and functional fistula at 1 week, 8 weeks, 6 and 12 months. The results from eight patients treated prospectively as proof of concept have shown primary patency of 83.3% at 1 year with 100% technical and procedural success rates. Enrolment for the Arch V SUPERA-LUX study is expected to be completed at the end of 2019. CONCLUSION: The Arch V SUPERA-LUX study is the first trial to evaluate whether SUPERA stent implantation and drug-coated balloon use can provide superior protection against restenosis compared to traditional angioplasty, bare metal stents and stent grafts in recurrent cephalic arch stenosis. Initial pilot results are encouraging but longer follow-up is required to truly test this technique. TRIAL REGISTRATION: This study is registered on ClinicalTrials.gov NCT03891693.