Two-Year Results of a First-In-Human Study in Patients Surgically Implanted With a Bioprosthetic Venous Valve, the VenoValve in Patients With Severe Chronic Venous Insufficiency.

Objective: Two-year follow-up results from a first-in-human study of patients implanted with the VenoValve are evaluated for supporting the long-term clinical safety and performance of the device.

Background: Chronic Venous Insufficiency (CVI) involves improper functioning of lower limb vein valves and inability of these valves to move blood back towards the heart. CVI symptoms include swelling, varicose veins, pain, and leg ulcers.

One-Year First-in-Human Success for VenoValve in Treating Patients With Severe Deep Venous Insufficiency.

Objective: The clinical outcomes of this first-in-human (FIH) study provide safety and performance results 1 year after implantation of the VenoValve.

Background: Chronic venous insufficiency (CVI) is most often caused by valve failure in the venous system, which circulates blood from the lower limbs back to the heart and lungs. Severe diseases significantly influence quality of life, and current treatment options are limited.

Human trial using the novel bioprosthetic VenoValve in patients with chronic venous insufficiency.

Background: Chronic venous insufficiency (CVI) is a disease characterized by failure of the venous valves that allow blood from the lower limbs to return to the heart. The more severe types of CVI (C4b-C6 disease) significantly influence patients' quality of life (QOL). The treatment options for CVI of the deep system are limited.

KDOQI Clinical Practice Guideline for Vascular Access: 2019 Update.

The National Kidney Foundation's Kidney Disease Outcomes Quality Initiative (KDOQI) has provided evidence-based guidelines for hemodialysis vascular access since 1996. Since the last update in 2006, there has been a great accumulation of new evidence and sophistication in the guidelines process. The 2019 update to the KDOQI Clinical Practice Guideline for Vascular Access is a comprehensive document intended to assist multidisciplinary practitioners care for chronic kidney disease patients and their vascular access.

Comparison between Surgical and Endovascular Hemodialysis Arteriovenous Fistula Interventions and Associated Costs.

Purpose: To compare: (i) rate of arteriovenous fistula (AVF) interventions in both incident and prevalent end-stage kidney disease patients; (ii) their associated costs; and (iii) intervention-free survival between patients with surgical hemodialysis arteriovenous fistula (SAVF) versus those with an endovascularly created fistula (endoAVF).

Materials And Methods: Data from the United States Renal Data System (USRDS) were abstracted to determine the rate of AVF interventions performed in the first year and associated costs (based on Medicare payment rates) for SAVFs created from 2011 to 2013 in the incident and prevalent patient cohorts. Comparative data for endoAVF were obtained from the Novel Endovascular Access Trial (NEAT).

Medicare Costs Associated With Arteriovenous Fistulas Among US Hemodialysis Patients.

Background: An arteriovenous fistula (AVF) is the recommended vascular access for hemodialysis (HD). Previous studies have not examined the resources and costs associated with creating and maintaining AVFs.

Study Design: Retrospective observational study.

Definitions and End Points for Interventional Studies for Arteriovenous Dialysis Access.

This paper is part of the Clinical Trial Endpoints for Dialysis Vascular Access Project of the American Society of Nephrology Kidney Health Initiative. The purpose of this project is to promote research in vascular access by clarifying trial end points which would be best suited to inform decisions in those situations in which supportive clinical data are required. The focus of a portion of the project is directed toward arteriovenous access.

Comparison of post-creation procedures and costs between surgical and an endovascular approach to arteriovenous fistula creation.

Introduction: Due to early and late failures that may occur with surgically created hemodialysis arteriovenous fistulas (SAVF), post-creation procedures are commonly required to facilitate AVF maturation and maintain patency. This study compared AVF post-creation procedures and their associated costs in patients with SAVF to patients with a new endovascularly created AVF (endoAVF).

Methods: A 5% random sample from Medicare Standard Analytical Files was abstracted to determine post-creation procedures and associated costs for SAVF created from 2011 to 2013.

Optiflow anastomotic device for hemodialysis vascular access creation.

The need to have consistent methods and consistent technique to optimize hemodialysis outcomes is behind the concept of the Optiflow™ device. This device was created to allow for consistency in size of the arterial anastomosis and consistency in angle of the vein to the artery at the anastomosis. Early data suggest that allowing these two technical entities can improve outcomes in regards to flow and maturity in arteriovenous fistula creation.

Drug eluting grafts for hemodialysis access.

The development of new methods for drug elution of graft material, biofiber films and resurfacing of prosthetic graft surfaces offers new opportunities for improvement of graft function in arteriovenous (AV) access. Three areas of research include developing grafts that reduce the development of neointimal hyperplasia, reducing infection and reducing thrombogenicity. The only drug eluting graft presently being used, is the heparin coated expanded polytetrafluoroethylene (ePTFE) graft, which has been shown to decrease the incidence of early thrombosis.

Bioengineered human acellular vessels for dialysis access in patients with end-stage renal disease: two phase 2 single-arm trials.

Background: For patients with end-stage renal disease who are not candidates for fistula, dialysis access grafts are the best option for chronic haemodialysis. However, polytetrafluoroethylene arteriovenous grafts are prone to thrombosis, infection, and intimal hyperplasia at the venous anastomosis. We developed and tested a bioengineered human acellular vessel as a potential solution to these limitations in dialysis access.

Early cannulation graft: Acuseal.

Aim: To review the published literature on the early cannulation graft, Acuseal.

Methods: 235 reported cases have been published and reviewed. These cases are both prospective and retrospective, from either multicenter or single centers.

HeRO graft versus lower extremity grafts in hemodialysis patients with long standing renal failure.

Background: The role of the HeRO graft in central venous pathology has been defined in the literature and clinically. There have been two publications or abstracts that have compared the patency rates and outcomes of this graft to the lower extremity graft.

Aim: The outcomes of both publications leads to an algorithm suggested by the author in determining which procedure should be used for specific patients.

Prospective multicenter study with a 1-year analysis of a new vascular graft used for early cannulation in patients undergoing hemodialysis.

Objective: More than 85% of patients with end-stage renal disease start dialysis through a tunneled dialysis catheter (TDC) for long periods while their arteriovenous fistula or vascular access graft (arteriovenous graft [AVG]) matures. Because TDCs are associated with a high risk of complications, including death and infection, use of an AVG that can be cannulated safely immediately after implantation may reduce morbidity in these patients by allowing earlier TDC removal. We report a prospective multicenter study of a new early-cannulation AVG (Gore ACUSEAL Vascular Graft; W.

Arteriovenous graft configuration in hemodialysis: does it matter?

Purpose: The current guidelines for arteriovenous graft (AVG) configuration in hemodialysis state the following sequence: forearm loop, upper arm straight or curved and upper arm looped. These recommendations are based upon literature from the 1980s. Modern patient demographics and patient treatment algorithms, i.

Outcome of the pivotal study of the Aptus endovascular abdominal aortic aneurysms repair system.

Objective: Endovascular treatment of abdominal aortic aneurysm (AAA) is associated with benefits over open surgery, yet limitations remain with current endovascular devices. This study was performed to assess outcomes of AAA repair with the Aptus endograft and EndoAnchors (Aptus Endosystems, Sunnyvale, Calif).

Methods: This prospective, multicenter, single-arm investigational device exemption trial was conducted at 25 sites in the United States.

Patient compliance limits the efforts of quality improvement initiatives on arteriovenous fistula maturation.

Objective: Our institutional quality-improvement (QI) initiative instituted a well-defined office follow-up schedule after arteriovenous fistula (AVF) creation, including an office visit within 30 days, fistulogram within 40 days, if indicated, and a second office visit within 55 days. In addition, a patient liaison contacted patients and dialysis units to improve follow-up. The purpose of this study was to determine the effect of the QI initiative on patient compliance and overall time to AVF permission to cannulate.

The Venous Window Needle Guide, a hemodialysis cannulation device for salvage of uncannulatable arteriovenous fistulas.

Background: Arteriovenous fistulas (AVFs) are recommended for hemodialysis access when possible. A noncannulatable but otherwise well functioning AVF leads to prolonged catheter dependency and frustration for the patient and the renal health care provider team. Difficult cannulation patients include obese individuals in whom cannulation sites are too deep, and others with vein segments that are short, tortuous, or otherwise difficult to palpate.

Basilic vein transposition: review of different techniques.

This is a review of the basilic vein procedure and changes that have evolved to improve outcomes. This includes reviewing data on the one-stage vs. two-stage technique as well as elevation for the basilic vein.

A comparison between the HeRO graft and conventional arteriovenous grafts in hemodialysis patients.

Venous stenosis and occlusion are a major cause of vascular access dysfunction and failure. The HeRO Graft bypasses occlusion and traverses stenosis with outflow directly into the central venous circulation. A randomized, multicenter study was conducted to evaluate the efficacy and safety of the HeRO Graft relative to conventional AV grafts.

Elderly patients with CKD--dilemmas in dialysis therapy and vascular access.

The population of elderly patients with end-stage renal disease (ESRD) is growing rapidly worldwide. The high prevalence of comorbidities, limited life expectancy and complex quality of life issues associated with this population pose substantial challenges for clinicians in terms of clinical decision-making and providing optimal care. The first dilemma encountered in the management of an elderly patient with ESRD is deciding whether to initiate renal replacement therapy and, if so, selecting the most-suitable dialysis modality.

Outcomes comparison of HeRO and lower extremity arteriovenous grafts in patients with long-standing renal failure.

Objective: The Hemodialysis Reliable Outflow (HeRO) graft is becoming a recognized alternative to lower extremity arteriovenous grafts (LEAVGs) as an option for patients who have exhausted traditional upper extremity access; however, which should be applied preferentially is unclear.

Methods: A retrospective review of LEAVG and HeRO implants from January 2004 to August 2010 was performed. Patient demographics, medical history, procedural data, and outcomes were evaluated.

A multi-center, dose-escalation study of human type I pancreatic elastase (PRT-201) administered after arteriovenous fistula creation.

Purpose: To explore the safety and efficacy of PRT-201.

Methods: Randomized, double-blind, placebo-controlled, single-dose escalation study of PRT-201 (0.0033 to 9 mg) applied after arteriovenous fistula (AVF) creation.

HeRO Vascular Access Device.

Chronic hemodialysis via a tunneled dialysis catheter (TDC) is associated with a high incidence of infectious complications and increased mortality and, therefore, should only be considered when all other options for vascular access are exhausted. The Hemoaccess Reliable Outflow (HeRO) Vascular Access Device (Hemosphere, Inc., Minneapolis, MN) is an alternative to the TDC.

New biological solutions for hemodialysis access.

Since Scribner described the first prosthetic chronic dialysis shunt in 1961, the surgical techniques and strategies to maintain vascular access have improved dramatically. Today, hundreds of thousands of patients worldwide are treated with some combination of native vein fistula, synthetic vascular graft, or synthetic semipermanent catheter. Despite significantly lower efficacy compared with autologous fistulae, the basic materials used for synthetic shunts and catheters have evolved surprisingly slowly.