Advances in Percutaneous Autogenous Hemodialysis Fistula Creation
The most recent developments in achieving a truly percutaneous method for creating functional autogenous hemodialysis fistulas.
Since the introduction of the Quinton-Scribner shunt in 1960 and the Brescia-Cimino autogenous fistula in 1966, there have been many incremental advances in hemodialysis access.1,2 These include new autogenous fistulas, prosthetic dialysis accesses, different materials, and modifications of current concepts, including the Hero catheter (CryoLife, Inc., Kennesaw, GA). These advances have led to improved hemodialysis initiation times, quality of dialysis, maintenance of accesses, and outcomes in patients. Despite these advances, the requirement for initial surgical placement remains. This step is occasionally associated with significant wait times, costs, resource utilization, and complications.
THE NEED FOR A PERCUTANEOUS SOLUTION
Given the aforementioned limitations, a desired goal is to move hemodialysis creation outside of the operating room and move to percutaneous placement. There are many potential advantages to a completely percutaneous procedure, including faster times to initiating hemodialysis, quicker maturation times, and reduced costs and complications. The autogenous arteriovenous fistula (AVF) is the most desirable, given its improved patency and lower infection rates. However, the initial maturation failure rate is an issue that has yet to be consistently overcome. Furthermore, all hemodialysis accesses are prone to eventual failure, primarily due to formation of venous stenosis caused by trauma from the surgical access creation, flow-related shear stresses, and percutaneous interventions.
Any percutaneous fistula creation would involve the creation of an artery-to-vein anastomosis or an artery/graftto- graft/vein anastomosis. Keeping this in mind, there have been isolated reports of created percutaneous fistulas, but most of these are modifications of prior working fistulas or grafts that were surgically created and then failed.3-6 In an animal study, Trerotola et al7 created an entirely percutaneous hemodialysis graft that met with later failure but no subsequent known further investigation, modification, translation to human use, or larger study. There are other prior failed methods, attempts, and devices that have not reached implementation in humans. An initial report described the surgical creation of an arterial anastomosis with percutaneous creation of the venous anastomosis with stent grafts in humans.8,9 More recently, the Gore Hybrid vascular graft (Gore & Associates, Flagstaff, AZ) is being placed in such a manner but requires surgical creation of an arterial anastomosis. No large study determining its efficacy has been published as of the writing of this article.
There are other companies that are developing percutaneous access creation technologies, which include Phraxis, Inc. (New Brighton, MN) and Caymus Medical (San Juan Capistrano, CA). Caymus is working on an autologous AVF creation device, called the Vessel Select vascular access system, whereas Phraxis is developing a subcutaneous AV graft technology. Caymus and Phraxis have presented animal data demonstrating early preclinical proof of concept.
We have investigated the use of radiofrequency energy to percutaneously create an arteriovenous, sutureless anastomosis in humans with success. The TVA Medical Flex system (TVA Medical, Inc., Austin, TX) requires percutaneous delivery of an arterial and a venous catheter (Figure 1). When the catheters are appropriately positioned and aligned via magnets, the energy is delivered with subsequent creation of an AVF (Figure 2).
The first-in-human study was performed with a subsequent human clinical study completed (Figure 3). Fistula patency and effective hemodialysis delivery have been documented, with 6-month follow-up data to be presented in Europe later this year. No major complications were observed, and a majority of patients have gone on to initiate clinically sufficient hemodialysis via their percutaneously created autogenous fistula for several months. We are beginning a Phase 2 study in early 2014. Because no surgical anastomosis is created and no prosthetic material is placed, the potential advantages are many, including reduced procedural wait times, costs, improved patency, and lower infection rates.
A pivotal point is now being reached within the hemodialysis access creation field. Further refinements are required with proper investigative validation. However, multiple techniques and devices are now being developed and investigated with prospects of a truly percutaneous solution likely becoming available for routine clinical use within the next 1 to 3 years.
Dheeraj K. Rajan, MD, FRCPC, FSIR, is Head and Associate Professor, Division of Vascular & Interventional Radiology, Department of Medical Imaging with the University of Toronto in Toronto, Canada. Dr. Rajan has disclosed that he is a paid consultant to TVA Medical, Inc. Dr. Rajan may be reached at email@example.com.
William E. Cohn, MD, FACS, FACCP, FAHA, is Director of Minimally Invasive Surgical Technology and Associate Director, Labaratory Surgery Research, Center for Cardiac Support at the Texas Heart Institute at St. Luke's Episcopal Hospital in Houston, Texas. Dr. Cohn has disclosed that he is the founder of TVA Medical, Inc.
- Quinton W, Dillard D, Scribner BH. Cannulation of blood vessels for prolonged hemodialysis. Trans Am Soc Artif Intern Organs. 1960;6:104-113.
- Brescia MJ, Cimino JE, Appel K, Hurwich BJ. Chronic hemodialysis using venipuncture and a surgically created arteriovenous fistula. N Engl J Med. 1966;275:1089-1092.
- Timpone VM, Gover DD. Percutaneous creation of a jump bypass graft in a native arteriovenous hemodialysis fistula. J Vasc Interv Radiol. 2011;22:734-736.
- Heller SL, Clark TW. Percutaneous creation of a venous anastomosis in a native hemodialysis fistula. J Vasc Interv Radiol. 2009;20:1371-1375.
- Chen MC, Liang HL, Wu DK, Weng MJ, Liu GC, Pan HB, Lee GL. Percutaneous vein graft reanastomosis with use of a covered stent to salvage a thrombosed hemodialysis graft. J Vasc Interv Radiol. 2005;16:1385-1389.
- Wallace MJ, Tinkey PT, Ahrar K, Wright KC. Simplified technique for percutaneous transrenal arteriovenous dialysis graft creation in a swine model. J Vasc Interv Radiol. 2007;18:257-263.
- Trerotola SO, Johnson WM, Winkler T, et al. Percutaneous creation of arteriovenous hemodialysis grafts: work in progress. J Vasc Interv Radiol. 1995; 6:675–681.
- Masuda EM, Kistner RL, Eklof B, et al. Stent graft arteriovenous fistula: an endovascular technique for hemodialysis access. J Endovasc Surg. 1998;5:18–23.
- Essentials of percutaneous dialysis interventions. Ed. Rajan DK, Springer NY, NY 2011.