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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.

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.

Introduction: The ability to successfully cannulate the arteriovenous fistula reliably is a critical step in the delivery of hemodialysis therapy. The av-Guardian vascular access system (Advent Access, Singapore) is designed to overcome the technical barrier to establishing reliable blunt needle access in patients with mature arteriovenous fistula. Methods: This was a first-in-man, prospective, non-randomized trial (registered on the Australian New Zealand Clinical Trial Registry (ACTRN12617000501347)) performed to assess the safety and feasibility of achieving repeatable successful cannulation via av-Guardian vascular access system to facilitate blunt needling in patients with mature arteriovenous fistula. The primary endpoints of the study included rate of successful hemodialysis sessions via av-Guardian vascular access system cannulation over 3 months and safety of the implants. Results: A total of six patients (four patients with brachiocephalic and two with radiocephalic arteriovenous fistula) were enrolled in the study. A pair of av-Guardian vascular access system were implanted, one each at the arterial and venous cannulation sites, under local anesthesia. Overall, the rate of successful cannulation through the av-Guardian vascular access system over 3 months in 216 hemodialysis sessions was 98.1% (212/216) at the arterial site and 94.4% (204/216) at the venous site. Significantly, 90% and 85.5% of the cannulations at the arterial and venous site, respectively, were successful at first attempt. Blood flow rates within the arteriovenous fistula were unaffected by the devices. Conclusion: The results demonstrated the safety and feasibility of a subcutaneously implanted, extravascular device in achieving repeatable successful cannulation via a constant site, to facilitate blunt needling in matured arteriovenous fistula in limited number of patients.