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.

MRV-validated numerical flow analysis of thrombotic potential of coronary stent designs

The formation of a thrombus is associated with dramatic consequences for the patient, such as increased risks of neurologic events and myocardial infarction or even death. A pathologically altered blood flow is associated with these complications. Consequently, a consistent fluid-mechanical analysis of implants, such as coronary stents, must be carried out. Computational fluid dynamics (CFD) is an important in silico tool for the analysis of different stent designs. Using three different generic stent designs (closed-cell, open-cell and helical), CFD could be performed with the OpenFOAM software package. The stents were implemented in a vascular model having a fully developed Hagen-Poiseuille velocity profile (umean = 0.6 m/s) as inlet condition. In combination with the dynamic viscosity of the Newtonian test fluid of 6.04·10-5m2/s, Reynolds numbers up to 460 were achieved. Spatially high-resolved velocity fields from measurements in the magnetic resonance tomograph (magnetic resonance velocimetry, MRV) were available for validation. The velocity field was compared in selected cross sections and longitudinal sections. The difference of the main flow proximal and distal to the stent models were below 6 %. In addition, a similar flow topology could be quantified using the Q-criterion. Due to the very good agreement of the numerical results with the MRV-measurements, the numerical method has been applied to further analysis of stent designs regarding to time average wall shear stress (TAWSS) distribution on the luminal vessel surface (surface area with TAWSS < 0.4 Pa was related to overall vessel surface) under pulsatile conditions. Although all stent designs have the same square cross-section, a large influence of the stent design on WSS distribution could be observed (closedcell vs. helical = -50.2 %; open-cell vs. helical = -38.5 %). By using validated CFD it was possible to quantify the hemodynamic benefit of helical stent design in terms of thrombosis potential.

Uniform Expansion of a Polymeric Helical Stent

Helical coil polymeric stents provide an alternative method of stenting compared to traditional metallic stents, but require additional investigation to understand deployment, expansion, and fixation. A bilayer helical coil stent consisting of PLLA and PLGA was investigated using the finite element model to evaluate performance by uniform expansion and subsequent recoiling. In vitro material characterization studies showed that a preinsertion water-soaking step to mimic body implantation conditions provided the required ductility level expansion. In this case, the mechanical contribution of the outer PLGA layer was negligible since it softened significantly under environmental conditions. The viscoelastic response was not considered in this study since the strain rate during expansion was relatively slow and the material response was primarily plastic. The numerical model was validated with available experimental expansion and recoiling data. A parametric study was then undertaken to investigate the effect of stent geometry and coefficient of friction at the stent-cylinder interface on the expansion and recoiling characteristics. The model showed that helical stents exhibit a uniform stress distribution after expansion, which is important for controlled degradation when using biodegradable materials. The results indicated that increasing stent width, pitch value, and coil thickness resulted in a larger diameter after recoiling, which would improve fixation in the artery. It was also noted that a helical stent should have more than five coils to be stable after recoiling. This work is part of a larger research study focused on the performance of a balloon-inflated polymeric helical stent for artery applications.