An Implanted Blood Vessel Support Device for Arteriovenous Fistulas: A Randomized Controlled Trial

Karydis, Nikolaos; Bevis, Paul; Beckitt, Timothy; Silverberg, Daniel; Halak, M.; Calder, Francis

doi:10.1053/j.ajkd.2019.05.023

Cited by 31 publications

(42 citation statements)

References 28 publications

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“…The study was limited by the retrospective design, by the limited data available for accesses created under SSP preventing its use as a control arm, and by the small sample size. However, the results are in line with those obtained in a randomized controlled study on BCAVFs (Karydis et al 12 ). By its very nature, analysis of real-world evidence provides valuable information about the performance of the device in the actual population and setting in which it is being used.…”

Section: Discussionsupporting

confidence: 91%

“…Both PP and SP rates were higher using the VasQ than those in a comparative sample of RCAVFs created in our center and available for a follow-up without the use of the device (PP 53% at 6 months and SP 76% at 6 months), being statistically higher for PP in the VasQ group. Moreover, these rates are similar to those that have been observed with the use of the VasQ device in BCAVFs (Chemla et al 11 and Karydis et al 12 ). This is of note, as the RCAVFs have been known to be associated with lower patency and maturation rates than the BCAVFs.…”

Section: Discussionsupporting

confidence: 87%

“…The external support device VasQ TM (Laminate Medical Technologies Ltd, Tel Aviv, Israel) was designed to improve AVF outcome by externally supporting the AVF and decreasing hemodynamic disturbance through optimization of the geometry of the JAR, therefore increasing wall shear stress and reducing the wall tension. 11 In a previous randomized controlled study, 12 VasQ was successfully implanted in patients during creation of the brachiocephalic arteriovenous fistula (BCAVF). The results showed that use of the VasQ device led to reduced rates of stenosis, larger vein diameter, and improved functional patency, without having any surgical complications or major differences in surgery duration compared to BCAVF creation without the device.…”

Section: Introductionmentioning

confidence: 99%

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Patency and functionality of radiocephalic arteriovenous fistulas with an external support device (VasQ™): Real-world single-center experience

2020

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Background: The VasQTM device was designed to improve the outcome of arteriovenous fistulae by optimizing the hemodynamics of the flow in the juxta-anastomotic region of the arteriovenous fistulae through tailored external support. The aim of the study was to evaluate the impact of the VasQ on outcome of radiocephalic arteriovenous fistulae in a real-world setting. Methods: This was a single-center, retrospective analysis of patients with either fistula creation before or after dialysis initiation with implantation of the VasQ device during creation of end-to-side radiocephalic arteriovenous fistulae between June 2018 and May 2019. The flow rate and vein diameter were evaluated intraoperatively, at discharge within 48 h postprocedure and at a follow-up of 1, 3, 6, 9, and 12 months. Results: Thirty-three VasQ devices were implanted during 33 radiocephalic arteriovenous fistula procedures. The study population comprised mostly of men, with an average age of 66 years. Mean intraoperative flow was 428 mL/min (range: 130–945). All patients were discharged with patent arteriovenous fistulae and mean fistula flow of 740 mL/min (range: 230–1300 mL/min). The primary patency was 100% and 79% at 3 and 6 months, respectively. Cumulative/secondary patency was 100% and 90% at 3 and 6 months, respectively. Conclusion: Data presented here suggest that the VasQ device has the potential to provide benefit to the functionality of radiocephalic arteriovenous fistulae.

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Section: Discussionsupporting

confidence: 91%

Section: Discussionsupporting

confidence: 87%

Section: Introductionmentioning

confidence: 99%

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Patency and functionality of radiocephalic arteriovenous fistulas with an external support device (VasQ™): Real-world single-center experience

2020

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“…The global epidemic of CKD and kidney failure has ignited several interesting developments that are in the pipeline. Projects that have progressed to clinical studies include a 1) pneumatic compression device (Fist Assist [Fist Assist Devices, LLC]) to promote AVF maturation 44 ; 2) the VasQ (Laminate Medical Technologies) device to improve primary AVF maturation, which regulates blood flow by constraining and shaping the fistula and reinforcing and shielding the perianastomotic vein against high pressure, wall tension, and flow levels 45,46 ; 3) the av-Guardian (Advent Access) vascular access system to guide cannulating needles into the AVF 47 ; and 4) BioNanomatrix gel (Endomimetics), designed to prevent intraluminal tissue growth and prevent stenosis in the vein segment of the AVF to promote the AVF maturation process and reduce the primary failure rate. 48 Summary After several decades of dormancy, innovations in HD vascular access have been reinvigorated.…”

Section: Innovations In the Pipelinementioning

confidence: 99%

New Devices and Technologies for Hemodialysis Vascular Access: A Review

Vachharajani

Taliercio

Anvari

2021

American Journal of Kidney Diseases

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In the United States, hemodialysis remains the most common treatment modality for kidney failure, chosen by almost 90% of incident patients. A functioning vascular access is key to providing adequate hemodialysis therapy. Recently, major innovations in devices and technology for hemodialysis vascular access care have rapidly changed the landscape. Novel endovascular devices for creation of arteriovenous fistulas may offer a solution to the barriers encountered in initiating maintenance hemodialysis with a permanent vascular access rather than a central venous catheter (CVC). Furthermore, in the prevalent hemodialysis population, the minimally invasive endovascular arteriovenous fistula procedure should help improve long wait times for vascular access creation, which remains a major barrier to reducing CVC dependence. Bioengineered grafts are being developed and may offer another option to polytetrafluoroethylene grafts. Early studies with these biocompatible grafts are promising, as additional studies continue to evaluate their clinical outcomes in comparison to cryopreserved or synthetic options. Prolonging the vascular access patency with appropriate use of devices such as drug-coated balloons and stent grafts may complement the novel techniques of creating arteriovenous access. Finally, innovative solutions to treat stenosed and occluded thoracic central veins can provide an approach to creating a vascular access and allow patients with exhausted vasculature to remain on hemodialysis. The robust developments in hemodialysis vascular access are likely to change practice patterns in the near future.Complete author and article information provided before references.

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“…VasQ ™ and Optiflow ™ devices have been the most studied with encouraging results regarding safety and technical success, such as maturation rates and longterm patency, further studies are needed to confirm the firsts reports. [70][71][72][73] Genetic therapy is an innovative and fascinating topic. Several genetic polymorphisms predispose to access failure.…”

Section: Improve the Maturation Of The Avf: Future Directionsmentioning

confidence: 99%

Monitoring the Patient Following Radio-Cephalic Arteriovenous Fistula Creation: Current Perspectives

Pirozzi¹,

Mancianti²,

Scrivano³

et al. 2021

VHRM

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Autogenous radial-cephalic direct wrist arteriovenous fistula (RC-AVF) in the non-dominant arm is the gold standard for dialysis vascular access. However, the RC-AVF non-maturation rate is significant (≃ 40%) due to an increasingly elderly and comorbid population incidence. A detailed identification of the biological cascade underlying arteriovenous fistula (AVF) maturation could be the key to clinical research aimed at identify the group of patients at risk of primary AVF failure. Currently, careful post-operative monitoring remains the most crucial aspect to overcome the problem of impaired maturation. Up to 80% of patients with immature RC-AVF have problems potentially solvable with early endovascular or surgical correction. Physical examination by experienced practitioners in conjunction with duplex ultrasound examination (DUS) can identify physical signs of non-maturation, understand the underlying cause, and drive for a tailored early planning to treat the complication. New approaches for the early assessment of AVF maturation are under study. Techniques to promote RC-AVF maturation performed through the administration of pre-or peri-operative drugs have missed up to now to prove an efficacy in improving fistula success. The new techniques tested after surgery appear to hold future promise for improving fistula maturation.

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An Implanted Blood Vessel Support Device for Arteriovenous Fistulas: A Randomized Controlled Trial

Cited by 31 publications

References 28 publications

Patency and functionality of radiocephalic arteriovenous fistulas with an external support device (VasQ™): Real-world single-center experience

Patency and functionality of radiocephalic arteriovenous fistulas with an external support device (VasQ™): Real-world single-center experience

New Devices and Technologies for Hemodialysis Vascular Access: A Review

Monitoring the Patient Following Radio-Cephalic Arteriovenous Fistula Creation: Current Perspectives

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