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Prospective multicenter study of a novel endovascular venous anastomotic procedure and device for implantation of an arteriovenous graft for hemodialysis.
- Source :
-
The journal of vascular access [J Vasc Access] 2024 Jul; Vol. 25 (4), pp. 1244-1251. Date of Electronic Publication: 2023 Mar 09. - Publication Year :
- 2024
-
Abstract
- Introduction: The traditional sutured venous anastomosis used during arteriovenous graft implantation is associated with a high incidence of subsequent stenosis that is attributed to neointimal hyperplasia. Hyperplasia results from multiple factors, including hemodynamic abnormalities and vessel trauma during implantation. A novel anastomotic connector device was designed to provide an alternative, less traumatic, endovascular venous anastomosis that may ameliorate the clinical challenges associated with a sutured anastomosis. A prospective single-arm multicenter study was performed to evaluate safety and effectiveness of graft implantation using the study device.<br />Methods: Patients requiring graft creation and who met the study criteria were enrolled between February 2018 and July 2021 and observed for 6 months. Collected data included baseline characteristics, graft patency and use for hemodialysis, graft interventions, and adverse events. The primary study endpoint was cumulative graft patency, compared to a pre-specified Performance Goal of 75%. Secondary endpoints included primary unassisted patency and serious adverse events, defined as the occurrence of death, graft infection, emergent surgery, significant bleeding, and pseudoaneurysm.<br />Results: A total of 158 patients were enrolled from 10 study sites, among which 144 subjects were evaluable at 6 months and 14 were censored with partial follow-up observation. Three patients died and the graft was abandoned in 12. The primary endpoint was met ( p -value < 0.001). By Kaplan Meier survival analysis, cumulative patency was 92.08% with a lower 95% Confidence Bound of 86.98%. Primary unassisted patency was 60.21% with a lower 95% Confidence Bound of 50.84%. Graft infections occurred in six patients, all unrelated to the study device. There were no reports of emergent surgery, significant bleeding or pseudoaneurysm.<br />Conclusion: These results demonstrate that the study device can be used for successful endovascular anastomosis of a vein to a graft for hemodialysis, with acceptable cumulative patency and safety profile at 6 months.<br />Clinical Trial Registration: ClinicalTrials.gov Identifier: NCT02532621.<br />Competing Interests: Declaration of conflicting interestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: JSB and JR have served as consultants to Phraxis, Inc. AY and CS are employees of Phraxis, Inc. and have stock agreements. All other authors have no competing interests.
- Subjects :
- Humans
Male
Female
Middle Aged
Prospective Studies
Aged
Treatment Outcome
Time Factors
Risk Factors
Prosthesis Design
Adult
United States
Renal Dialysis
Arteriovenous Shunt, Surgical adverse effects
Arteriovenous Shunt, Surgical instrumentation
Vascular Patency
Blood Vessel Prosthesis Implantation adverse effects
Blood Vessel Prosthesis Implantation instrumentation
Graft Occlusion, Vascular etiology
Graft Occlusion, Vascular physiopathology
Endovascular Procedures instrumentation
Endovascular Procedures adverse effects
Blood Vessel Prosthesis
Subjects
Details
- Language :
- English
- ISSN :
- 1724-6032
- Volume :
- 25
- Issue :
- 4
- Database :
- MEDLINE
- Journal :
- The journal of vascular access
- Publication Type :
- Academic Journal
- Accession number :
- 36895157
- Full Text :
- https://doi.org/10.1177/11297298231159691