Comparative effectiveness of arteriovenous fistulas created with a nitinol extravascular support in patients with advanced kidney disease.

Abstract

Background: Use of a nitinol extravascular support implanted during AVF (arteriovenous fistula) creation has been gaining traction due to its potential to improve functional success and reduce interventions; however, comparative effectiveness data with traditional unsupported AVFs are lacking. The objective of this study was to compare outcomes of AVFs created with a vascular support device versus traditional unsupported AVFs in patients with advanced kidney disease.

Methods: This was a comparative effectiveness retrospective observational cohort study conducted using data from the prospective, multi-center, single-arm VasQ US Pivotal trial (extravascular support AVF group) matched with an unsupported AVF control group developed using Medicare claims data from the same surgeons that participated in the trial. Eligible control participants were Medicare fee-for-service beneficiaries who underwent AVF creation (2017-2019). Endpoints included 6-month primary patency (primary endpoint), intervention rate, and functional success. Propensity score methods using inverse probability treatment weighting were used to examine the association between supported device use and outcomes.

Results: A total of 782 unsupported AVF patients were compared to the 144 supported AVF patients from the Pivotal study. Compared with unsupported AVFs, primary patency at 180 days was superior for supported AVFs (66% vs 36% for control; OR, 3.27; 95% CI, 2.15-5.17; p < 0.0001). Intervention rate for supported AVFs (0.97 per patient-year; 95% CI, 0.71-1.28) was nearly half of unsupported AVFs (1.91 per patient-year; 1.58-2.07; p < 0.0001). Functional success for supported AVF patients was significantly greater than unsupported AVFs at 90 days (43.4% vs 26.7%, respectively; p = 0.005) and 180 days (72.5% vs 53.7%, respectively; p = 0.004).

Conclusions: AVFs created with extravascular support maintained higher primary patency, improved functional success, and had less reinterventions than unsupported AVFs. More patients may begin using their AVF for dialysis sooner with a lower risk of requiring a maturation procedure if created with extravascular support.