Endovascular AVG venous anastomosis improves cumulative patency compared to traditional sutured anastomosis: a meta-analysis

Brad C. Astor¹, KMLST Moorthi², Lisa Grant^3* and Terry Litchfield⁴

¹Departments of Medicine and Population Health Sciences, University of Wisconsin School of Medicine and Public Health

²Northwestern University Feinberg School of Medicine

³LB Grant Clinical Research Consulting

⁴Echelon Development Group

*Corresponding Author:

Lisa Grant
2425 France Ave S., St. Louis Park, MN 55416
Tel: 612-308-0958
E-mail: lgrant@phraxis.com

Received: 02-Feb-2026, Manuscript No: oain-26-185112, Editor Assigned: 04- Feb-2026, pre QC No: oain-26-185112 (PQ), Reviewed: 16-Feb-2026, QC No oain-26-185112, Revised: 20-Feb-2026, Manuscript No: oain-26-185112 (R), Published: 27-Feb-2026, DOI: 10.47532/oain.2026.9(1).388

Abstract

Objective: Arteriovenous graft (AVG) patency outcomes continue to be plagued by venous anastomotic stenosis, which can lead to eventual thrombosis and AVG abandonment. Venous stenosis occurs most commonly at the graft-vein and juxta-anastomotic vein segments. A recent publication of a novel endovascular AVG anastomosis (EndoForce) showed excellent outcomes with a cumulative patency of 92% for AVGs. The purpose of this investigation was to compare the outcomes of the EndoForce endovascular venous anastomotic connector to traditional sutured anastomosis AVGs via meta-analysis.

Methods: A meta-analysis was conducted to estimate the 6-month patency of AVGs implanted using traditional surgical techniques. We compared those estimates to the results achieved with the EndoForce venous anastomotic device.

Results: A total of 31 studies, with 45 distinct arms, provided data on 6-month cumulative patency. The random-effects pooled estimate of 6-month cumulative patency was 83.23% (95% confidence interval [CI]: 80.18, 86.28). A total of 32 studies, including 46 arms, provided data on primary patency. The pooled estimate for 6-month primary patency was 60.35% (95% CI: 56.21, 64.49). The novel device achieved better 6-month cumulative patency (92.08%; 95% CI: 86.98-97.18) than the pooled estimate (p<0.001) and similar primary patency (60.21% [95% CI: 50.84, 69.59]; p=0.75).

Conclusion: This study provides direct evidence that the EndoForce venous anastomotic device improves 6-month cumulative patency compared to traditional sutured AVG venous anastomosis.

Keywords

Endovascular procedures; Vascular grafting; Arteriovenous anastomosis; Graft survival; Renal dialysis; Patency

Introduction

Arteriovenous grafts (AVGs) are an essential vascular access option for end stage kidney disease (ESKD) patients requiring hemodialysis. The 2019 Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines recommend that the choice of AV-access (arteriovenous fistula (AVF) or AVG) be based on the clinician’s best clinical judgment that considers the vessel characteristics, patient comorbidities, health circumstances, and patient preference [1,2].

The 2019 guidelines further state that there is inadequate evidence for KDOQI to make a recommendation on choice of AVF versus AVG for incident vascular access creation. Despite these guidelines, AVGs continue to be used sparingly in the ESKD “life-plan” ; in 2024 only 3.9% of incident and 16.4% of prevalent patients were using an AVG 9 [3]. This relative underutilization of AVGs is due in part to the fact that traditional sutured AVG patency outcomes continue to be plagued by venous anastomotic stenosis, which can lead to eventual thrombosis and AVG abandonment. Venous stenosis occurs most commonly at the graft-vein and juxta-anastomotic vein segments [4]. 

A recent publication of a novel endovascular AVG anastomosis ((EndoForce; Phraxis, Inc., Minneapolis, MN) showed excellent outcomes with a cumulative patency of 92% for AVGs compared to a historical control of 75% for traditional sutured venous anastomosis AVGs [5]. The aforementioned pivotal clinical trial was limited by the absence of a direct comparison group within the study. The purpose of this investigation was to compare the outcomes of the EndoForce endovascular venous anastomotic connector to traditional sutured anastomosis AVGs via meta-analysis of more recent studies.

Methods

Study design

This meta-analysis was conducted in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidance [6]. Search terms, inclusion and exclusion criteria, and analytic methods were specified in advance.

The study population consisted of patients who were at least 18 years old who were preparing for or currently receiving chronic hemodialysis treatment using an expanded polytetrafluoroethylene (ePTFE) graft in the upper extremities. Inclusion criteria for studies to be included were: at least one study arm included use of a new ePTFE graft; and the study was published in English. Exclusion criteria were: study arms had fewer than 30 ePTFE grafts; study included only lower-extremity or chest grafts; and study did not report patency measures at 6 months and did not provide Kaplan-Meier graphs from which to abstract these data.

Literature search

Literature searches were conducted in October 2025 in the PubMed, Embase, Cochrane Library, and Clinicaltrials.gov databases. The PRISMA diagram is shown in Figure 1. Additional studies were identified by a hand search of references in selected papers.

Figure 1: Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) diagram. PTFE, expanded polytetrafluoroethylene; K-M: Kaplan-Meier.

Studies were screened for eligibility by two reviewers. Extracted data included study design, graft characteristics (device type/brand and location), patient characteristics (demographics and comorbidities), and 6-month patency outcomes.

End points and definitions

We used the definitions of patency as published by the Journal of Vascular Surgery [7]. Primary patency, or primary unassisted patency, was defined as “the interval from graft placement to the first intervention to relieve stenosis, with or without occlusion.” Secondary patency, or cumulative patency, was defined as the “interval from graft placement to graft abandonment.”

Statistical analyses

We used a random effects model to conduct the meta-analyses in R 4.5.0 [8] using the metafor [9] and forestplot (v3.1.7) [10] packages. Primary outcomes were primary and cumulative patency at 6 months. Heterogeneity between studies was assessed using the I2 statistic.

For studies in which the 6-month patency outcomes were reported in tables or text, the reported numbers were used in the analysis. DigitizeIt software was used to abstract the 6-month patency measurements from Kaplan-Meier survival curves from those studies which did not specifically report 6-month patency outcomes but included survival curves.

Results

Studies included

A total of 34 studies were included in the analyses (Table 1). A total of 32 studies, including 46 arms with results listed separately, provided data on primary patency. A total of 31 studies, with 45 distinct arms, provided data on cumulative patency.

Table 1: References included in the meta-analysis.

Patency result

The random-effects pooled estimate of 6-month cumulative patency was 83.23% (95% confidence interval [CI]: 80.18, 86.28), with wide variability (I2=99.36). (Figure 2) The estimated cumulative patency limited to studies which specifically reported values (12 studies, 21 arms) was 86.00% (95% CI: 81.78, 90.22).

Figure 2: Forest plot of cumulative patency at 6 months. 95% CI, 95% confidence interval. Estimates in black include studies that specifically reported 6-month cumulative patency. Estimates in red were abstracted from Kaplan-Meier survival curves.

Figure 3: Forest plot of primary patency at 6 months. 95% CI, 95% confidence interval. Estimates in black include studies that specifically reported 6-month primary patency. Estimates in red were abstracted from Kaplan-Meier survival curves.

The pooled estimate for 6-month primary patency from the meta-analysis was 60.35% (95% CI: 56.21, 64.49), again with substantial variability (I2=99.44). The estimate was similar when including only those studies (12 studies, 21 arms) which specifically reported 6-month values (62.23% [95% CI: 57.80, 66.66]).

Comparison to novel device

The novel device achieved better 6-month cumulative patency (92.08%; 95% CI: 86.98-97.18) than the pooled estimate (p<0.001). The novel device achieved a 6-month primary patency of 60.21% (95% CI: 50.84, 69.59). This estimate did not differ significantly (p=0.75) from that achieved with the pooled estimate (60.35% [95% CI: 56.21-64.49]). Results were similar when limited to those with 6-month results specifically reported.

Discussion

Despite recent guidelines that were intended to increase the use of AVGs, AVGs continue to be underutilized as a form of permanent access in both the incident and prevalent populations. The United States Renal Data System (USRDS) reports show a concerning pattern of AVF, central venous catheter (CVC), and AVG use post COVID: In 2018, AVF 64.4%, AVG 17.0%, and CVC 18.6% were used as the primary access in prevalent ESKD hemodialysis patients. In 2024, AVF use had decreased to 57.4%, while AVG decreased to 16.4%, and CVC increased to 26.2% [11]. This represents a 23.7% relative increase in the use of CVCs in the prevalent US hemodialysis population. This is a concerning trend, as a recent meta-analysis showed that CVCs were associated with a 248% increase in all-cause mortality relative to AVFs (OR = 2.48, 95% CI: 1.37–4.48, p < 0.0001) [12]. 

Traditional AVG 6-month cumulative patency was shown to be approximately 80% in a recent meta-analysis [13]. The pivotal study results of the EndoForce device compare favorably to this estimate, with the EndoForce conferring a 6-month primary patency of 60% and a 6-month cumulative patency of 92%. The cumulative patency of the EndoForce compared to data from the meta-analysis represents a reduction of AVG abandonment at 6 months from 20% to 8%, or a relative 60% reduction in AVG abandonment. However, these results were not compared directly in previous publications. The meta-analysis reported herein compares the 6-month cumulative patency of AVGs implanted using the EndoForce venous anastomotic device with cumulative patency of AVG implanted using the traditional surgical technique directly. We found that the novel EndoForce device achieved better 6-month cumulative patency (92.08% [95% CI: 86.98-97.18] than the random-effects pooled estimate of cumulative 6-month patency of standard AVGs 83.23% (95% confidence interval [CI]: 80.18-86.28) (p=0.002).

This difference could potentially be due to the less invasive, endovascular nature of the procedure that is used to place the EndoForce device as compared to traditional sutured AVG creation. Since AVG abandonment leads to prolonged catheter use and the attendant morbidity and mortality, our study results may represent a possible improvement of an outcomes variable that is relevant to ESKD patients and their families [14]. In addition, the relative improvement in outcomes seen in this study may be due to the hemodynamic benefits of an end-to-end vs. the end-to-side anastomosis. Sheer stress due to unfavorable hemodynamics is a known factor in the development of AVG venous anastomotic stenosis [15, 16]. Further, the anastomotic angle is known to have a direct impact on the flow dynamics, demonstrating a turbulence zone [17]. 

A previous device, the Gore Hybrid Vascular Graft (GHVG) can also be noted to have an absence of a sewn venous anastomosis, which is replaced by a 5- or 10-cm nitinol covered PTFE stent-graft that is pre-attached to an AVG [18]. It is important to note that the EndoForce study device is not an off-the-shelf, repurposed stent. Rather, it is a patented implant specifically designed for coaxial, endovascular anastomosis of a vein to an AVG. The EndoForce has three elements that distinguish it from other nitinol/ePTFE devices, such as stentgrafts: (1) Barbs on the end secure the endovascular anastomosis to the vein; (2) A flexible nitinol segment provides a wide range of angles from the venotomy site that the AVG can engage the EndoForce; and (3) A rigid segment of the EndoForce designed to provide maximum radial force to maximize a friction fit between the AVG and EndoForce overlap. The self-expanding EndoForce is placed within a peripheral vein using a unique endovascular, transcatheter, over-the-wire technique. Unlike the GHVG, the EndoForce is not pre-attached to a specific AVG. Instead, it is designed for use with any commercially available 6 mm inner diameter ePTFE graft for hemodialysis. Nevertheless, it is important to note that the functional cumulative patency rate of the GHVG did not differ substantially from a standard sutured anastomosis at 6 months (approximately 80% patency).

Conclusion

This study provides direct evidence that the EndoForce venous anastomotic device improves 6-month cumulative patency compared to a traditional sutured AVG venous anastomosis.

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