VasQ U.S. pivotal study demonstrates the safety and effectiveness of an external vascular support for arteriovenous fistula creation.

OBJECTIVE: Arteriovenous fistula (AVF) creation is a commonly performed vascular operation that reports 6-month functional success rates as low as 50%. Recently, a nitinol external vascular support device, VasQ, has shown potential in studies outside the United States (U.S.) to improve AVF outcomes when implanted at creation. Here, the pivotal study results of this novel technology in treating patients in the U.S. are described. METHODS: VasQ was implanted in 144 patients at 16 centers across the U.S. who were referred for creation of a new AVF and consented for enrollment in a 2-year, prospective, multicenter, single-arm, open-label study. Brachiocephalic (n = 129) and radiocephalic (n = 15) AVFs were analyzed. The primary endpoint was primary patency at 6 months compared against a performance goal of 55% derived from a systematic literature search. Safety endpoints included device-related events, ischemic steal, infection, aneurysm, and seroma at up to 6 months. Minimum arterial size was 2.0 mm; target veins were required to measure 2.5 to 6 mm. Key exclusion criteria were patients <18 or >80 years, those with known ipsilateral central venous occlusion, target cannulation zone venous depth greater than 8 mm, and New York Heart Association class 3 or 4. RESULTS: Patients were 61% male, 53% White, 35% African American, and 14% Hispanic. Mean age was 60 years, and median body mass index was 30.4. Of the patients, 69% were diabetic, 66% were on dialysis at the time of creation, and 70% had a prior access surgery. At 6 months, steal was observed in 2.1%, infection in 0.7%, and no aneurysms or seromas were seen. Primary patency at 6 months was 66% (P < .021 vs performance goal). Physiological maturation was achieved in 92.4% of patients. Successful two-needle cannulation for patients that entered the study on dialysis was achieved in 88% of VasQ AVFs at a median of 56 days. Pre-dialysis patients who initiated dialysis during the study achieved two-needle cannulation in 81.6% VasQ AVFs. Interventions were required at a rate of 1.07 per patient year over the entire study period. Two-year cumulative patency was 76.6% (95% confidence interval, 67.9%-83.4%) with no statistical difference between patients requiring interventions and those that did not. No patency differences were observed between brachiocephalic and radiocephalic AVFs. CONCLUSIONS: The U.S. pivotal study results demonstrated improved AVF outcomes and an excellent safety profile with VasQ use relative to traditional AVFs. Under the conditions of this trial, VasQ shows great promise in expeditiously and efficiently enhancing AVF functional success.

Multicenter European real-world utilization of VasQ anastomotic external support device for arteriovenous fistulae.

OBJECTIVE: To evaluate the outcomes of arteriovenous fistulae (AVF), created with VasQ external support device under standard clinical practice across three vascular access clinics. METHODS: This multinational, retrospective study evaluated prospectively collected clinical outcomes of both forearm and upper arm brachiocephalic AVF (BCAVF) created using the VasQ device. Fifty-one AVF patients were pooled from three different vascular access centers in Germany, Italy, and Spain. Postprocedure outcomes were assessed by flow measurement with ultrasound examination in all centers. Primary failure, usability, patency, and intervention rates during the study period were evaluated. RESULTS: Fifty-one VasQ devices were implanted during 37 forearm (36 radiocephalic and 1 ulnar-basilic AVF) and 14 BCAVF procedures. The study population comprised mostly males (73%) and Caucasians (82%), with a mean age of 62.5 years (range, 38-84 years) and mean body mass index of 29.2. One patient died owing to access-unrelated reasons, and one patient was lost to follow-up without AVF assessment after its creation. From the remaining 49, 3 patients had a follow-up of less than 4 weeks and were excluded from maturation, primary failure, and dialysis initiation analysis (because those factors could not be evaluated yet), leaving 46 patients in this evaluation. Maturation was achieved in 91% of patients. The primary failure rate was 9%. A primary patency rate of 77% was observed at 6, 12, and 18 months. The secondary patency rate was 91% at 6 months, and 85% at 12 months and 18 months. Both primary patency and secondary patency did not differ statistically when comparing forearm AVF with BCAVF (P > .25). Successful cannulation was achieved in 86% of patients (32/37) requiring dialysis with a median time from creation to cannulation of 46 days. Of those patients, the functional patency rate was 94%. Five patients underwent seven interventions to maintain or restore patency or functionality, with an overall rate of 0.248 interventions per patient-year. CONCLUSIONS: AVFs created with VasQ external support device demonstrated promising patency and functionality outcomes in multicentric real-world setting across the two most commonly used anatomic locations.

Efficacy and safety of implantable vascular support in the treatment of arteriovenous fistula: A single-arm meta-analyses.

BACKGROUND AND OBJECTIVES: VasQ (Laminate Medical Technologies, Israel) is an external support device for autologous arteriovenous fistula (AVF) designed to improve anastomotic blood flow and reduce neointimal hyperplasia. However, different studies have shown that the efficacy of the VasQ device in improving AVF is inconsistent. The purpose of this study was to conduct a meta-analysis to further evaluate the efficacy and safety of the VasQ device. DESIGN, SETTING, PARTICIPANTS, AND MEASUREMENTS: Two reviewers independently searched studies published in PubMed, EMBASE, Cochrane, Web of Science, CNKI, and Wan Fang databases from inception to 2023. The Cochrane Systematic Evaluation Bias Risk Tool Version 1 was used to assess the risk of RCTS bias. The ROBINS-I tool was used to assess the risk of bias in non-randomized studies. A Single-arm meta-analysis was performed, and a random effects model was used for all analyses. RESULTS: We identified six trials involving 146 patients and conducted a meta-analysis. The results showed that after 6 months of VasQ device treatment, the primary patency rate of AVF was [76.4% (95%CI: 0.608-0.920), p < 0.01] while the secondary patency rate was [76.5% (95%CI: 0.572-0.958), p < 0.01]. The maturity rate of AVF 1 month after surgery was [88.5% (95%CI: 0.818-0.952), p = 0.46]. The incidence of anastomotic stenosis was [8.9% (95%CI: 0.015-0.163), p = 0.23], and the incidence of anastomotic venous thrombosis was [10% (95%CI: 0.035-0.179), p = 0.38]. CONCLUSIONS: Meta-analysis data of this study show that the VasQ device has a good effect in improving the patency rate of AVF and does not increase the occurrence of adverse events. However, due to the limitation of the number and quality of included studies, more high-quality studies are needed to confirm this in the future.

Initial single-center experience with a new external support device for the creation of the forearm native arteriovenous fistula for hemodialysis.

OBJECTIVE: To assess and compare the maturation rate of the native radiocephalic arteriovenous fistula (RC-AVF) created with and without a nitinol external support (VasQ™ Laminate Medical Technologies Ltd, Tel Aviv, Israel). METHODS: Data of all consecutive patients who underwent the creation of native RC-AVFs at our center between October 2018 and January 2020 was prospectively collected and retrospectively analyzed.Selected patients who had a suitable vein and a radial artery with triphasic flow at preoperative duplex ultrasound exam and were selected for the creation of a radiocephalic fistula were included. Exclusion criteria were: malignant tumors, acute renal failure, previous upper limb revascularization, and septic status. Patency and maturation, vein, and artery diameter and blood flow rate were assessed at the following intervals: post-operatively, 24 h post-operatively, 1 month, 3 months, and 6 months post-operatively. RESULTS: Forty-nine patients (31 males, mean age 65.7 years old) were included. Patients who received VasQ™ devices were 25 (VasQ group), the other 24 formed the control group. All patients underwent radio-cephalic AVF placement (21 on the wrist, 20 on the forearm, 8 on the proximal forearm). There were no perioperative complications and fatalities. At 1, 3, and 6 months, primary patency rates were 96 ± 4%, 96 ± 4%, 91 ± 6% (VasQ group) versus 87 ± 7%, 87 ± 7%, 80 ± 9% (control group, P 0.17), secondary patency rates were 96 ± 4%, 96 ± 4%, 91 ± 6% (VasQ group) versus 95 ± 4%, 90 ± 7%, 90 ± 7% (control group, P 0.79). A significantly larger vein diameter increase postoperatively (P 0.009) and a greater maturation rate (96% vs 74%, p 0.044) were found in the VasQ group compared to the control group. CONCLUSIONS: The use of the VasQ™ device was associated with higher maturation rates and larger vein diameters postoperatively. The patency rates were slightly higher but not significantly. Further studies are needed to confirm these findings.

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

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.