Extravascular supported arteriovenous fistulas reduced the need for interventions to support maturation and time to achieve two-needle cannulation for end-stage kidney disease patients in a multicenter US study
Objective: This study sought to assess the functional outcomes of arteriovenous fistulas (AVFs) created with VasQ, a permanent, surgically-implanted extravascular scaffold made of nitinol, and compare it with outcomes of unsupported AVFs in patients with end-stage kidney disease (ESKD). Methods: The...
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| Main Authors: | , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Elsevier
2025-01-01
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| Series: | JVS-Vascular Insights |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2949912725000224 |
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| Summary: | Objective: This study sought to assess the functional outcomes of arteriovenous fistulas (AVFs) created with VasQ, a permanent, surgically-implanted extravascular scaffold made of nitinol, and compare it with outcomes of unsupported AVFs in patients with end-stage kidney disease (ESKD). Methods: The VasQ US Pivotal Study was a prospective, single-arm, multicenter study that enrolled patients eligible for radiocephalic and brachiocephalic AVF creation from 2018 through 2019 to evaluate the safety and efficacy of creating AVFs with VasQ support. For this study, VasQ trial sites were invited to participate in a retrospective chart review for a comparative analysis of patients who underwent the creation of unsupported AVFs. Control patients were identified from a time period immediately before study initiation, using the same inclusion and exclusion criteria as the Pivotal Study. Patient follow-up records were prohibited from review before inclusion into the control cohort to minimize ascertainment bias. Outcomes evaluated included functional AVF success, time to first use, and rate of fistula abandonment, and interventions to support maturation before first use. A multivariate analysis was performed to compare outcomes between VasQ supported and unsupported (control) AVFs. Results: Six VasQ US Pivotal Study sites participated, which provided 104 ESKD patients: 52 VasQ AVFs and 52 controls. Groups were well-matched for baseline parameters, including vessel diameter and AVF location. VasQ AVFs experienced a significant decrease in median time to first use (56 days vs 85 days; P = .04). Additionally, significantly fewer interventions to support maturation were needed in VasQ AVFs (0.25 per patient vs 0.63 per patient; P = .002). More VasQ AVFs achieved functional success without the assistance of interventions to support maturation at 3 months (46% vs 23%; P = .013) and 6 months (65% vs 45%; P = .03). Multivariate analysis demonstrated that implantation of VasQ was significantly associated with greater odds for 3- and 6-month unassisted functional success after AVF creation (adjusted odds ratio [aOR], 2.95 [95% confidence interval (CI), 1.23-7.43; P = .018], and aOR, 2.44 [95% CI, 1.09-5.61; P = .031], respectively), and lower odds for needing reinterventions (aOR, 0.40; 95% CI, 0.16-0.96; P = .045). Conclusions: Creation of VasQ AVFs was associated with greater unassisted functional success, an overall lower maturation procedure rate, and shorter time to first use when compared with well-matched control AVFs created by the same surgeons. Improvement in these key functional outcomes should translate directly into clinically meaningful benefits for patients with ESKD. |
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| ISSN: | 2949-9127 |