Implanted blood vessel external support device (VasQ™) for creation of hemodialysis arteriovenous fistula: A single-center experience

Abstract

Introduction: the external support device VasQ is intended to promote arteriovenous fistula (AVF) maturation by maintaining the optimal anastomotic angle in order to minimize blood flow disturbances around the anastomotic area. The aim of the study is to assess efficacy and safety of the VasQ device both in brachiocephalic and radiocephalic fistulae. Methods: a single institution prospective study was conducted with implantation of the VasQ device during AVF creation. Clinical and Doppler ultrasounds evaluations were performed at day-1, 1, 6, and 12 months for assessment of device-related adverse events, AVF maturation and patency. Moreover, volume flow rate and diameter of outflow vein were measured. A total of 16 patients were enrolled. Ten brachiocephalic and 6 radiocephalic AVFs were created with VasQ. Preoperatively cephalic vein diameter was 3.6 ± 0.9 mm. Results: our population included 13 male and 3 females patients, 9 end stage kidney disease in conservative therapy, 4 dialysis treated patients, and 3 transplanted patients; mean age was 74.0 ± 8.1 years; no severe device-related adverse events were observed. Primary patency at 1, 6, and 12 months was 100%, 87.5%, and 67.7%, respectively, while secondary patency was 100%, 100%, and 78.3%, respectively. Comparing brachiocephalic to radiocephalic AVFs no significant differences in patency rates were seen. Overall maturation rate was 94% (15/16). Mean vein diameter measured with Doppler ultrasound at postoperative day-1 and at 1, 6, and 12 months was 5.0 ± 1.0, 5.9 ± 0.9, 7.2 ± 1.6, and 7.9 ± 1.4 mm, respectively, with a mean flow rate at the brachial artery of 841 ± 176, 1052 ± 224, 1261 ± 490, and 1348 ± 477 ml/min, respectively. Conclusions: in our limited experience VasQ was safe, with high maturation and patency rates. Positive results suggest a potential benefit for VasQ in AVF.

Implanted blood vessel external support device for the treatment of distal hypoperfusion ischemic syndrome in arteriovenous fistulas and high-frame-rate Vector Flow quality assessment

“…By optimizing geometrical configuration of arteriovenous anastomosis, it should lower the wall shear stress and transversal vein oscillations. 17 Literature has largely emphasized the role of mechanical wall shear stress as responsible for endothelial nitric oxide and reactive oxygen species synthesis. This should not only responsible for vein intimal hyperplasia and consequent lack of maturation, but also for matrix metalloproteinase production, vessel wall damage, and vein enlargement under Laplace’s forces.…”

Intimal Hyperplasia and Arteriovenous Fistula Failure: Looking Beyond Size Differences

“…Antistenotic treatment modalities to improve venous remodeling during maturation include perivascular delivery of sirolimus (108), allogeneic ECs (109,110), or pancreatic elastase (111,112), and devices (VasQ, Optiflow) that support the ideal angle of arteriovenous anastomosis (113 –117). The latest results on the sirolimus implants are pending (108).…”

“…The latest results on the sirolimus implants are pending (108). VasQ resulted in high maturation rates in single-arm and retrospective studies (117 –119), but mixed results in short-term primary or secondary patency compared with the control arm (114,118,119). The rest are currently not recommended by the Kidney Disease Outcomes Quality Initiative guidelines due to lack of phase 3 studies (Optiflow) or significant benefits in AVF outcomes (ECs, elastase) (15).…”

Arteriovenous fistula creation with VasQTM device: A feasibility study to reveal hemodynamic implications

“…Recent studies demonstrated the device is safe, and reported improved functional patency for AVFs created using the VasQ TM as compared to AVFs created with conventional surgery. [6][7][8][9][10][11] However, the effect of the device on hemodynamic conditions and its role in regularizing the blood flow have yet to be adequately assessed. We have recently shown that coupling non-contrast enhanced magnetic resonance imaging (MRI) and highresolution CFD provides a promising approach 12 to investigate AVF morphology and hemodynamics, possibly identifying critical hemodynamic conditions that may contribute to AVF remodelling after surgery.…”