VALUE-BASED DECISIONS FOR DIALYSIS ACCESS Sponsored by Gore & Associates Vascular Access Innovation in a Changing Health Care Environment

H emodialysis vascular access is the lifeline for more than 400,000 patients on hemodialysis in the United States. Unfortunately, due to the high incidence of dialysis vascular access dysfunction, it is also the “Achilles’ heel” of hemodialysis.1-3 There are currently three main forms of permanent dialysis vascular access, all of which have their benefits and disadvantages.4 Arteriovenous fistulas (AVFs) are the preferred form of permanent dialysis vascular access because of good longterm survival and low rates of infection. Unfortunately, they have a very high failure-to-mature rate (ie, the inability of the AVF to increase blood flow and diameter adequately to support hemodialysis),5,6 likely a result of a combination of neointimal hyperplasia and a lack of outward or positive remodeling.7 Arteriovenous grafts (AVGs) do not have these early “failure to mature” problems; in fact, over 90% can be used for hemodialysis within the first 6 weeks.1 However, AVGs have a dismal 1-year unassisted patency rate of only 23% due to a predictable and aggressive stenosis at the graft-vein anastomosis as a result of neointimal hyperplasia.8 The least desirable form of permanent dialysis vascular access is the tunneled dialysis catheter (TDC), which carries a high morbidity and mortality burden as a result of catheter-related bloodstream infections; fibrin sheath formation, which leads to inadequate blood flow; and central vein stenosis.9 Despite the problems associated with TDC dysfunction, almost 80% of new (incident) patients start hemodialysis with a TDC.10 The complications result in a significant morbidity and mortality burden for hemodialysis patients, substantially degrading their quality of life and imposing a heavy financial burden on our health care system. The total cost of dialysis vascular access is thought to be over $1 billion per year with each additional interventional procedure costing between $5,000 (angioplasty alone) and $15,000 (thrombectomy and stent placement). In addition, each episode of a catheter-related bloodstream infection is estimated to cost between $15,000 and $20,000. This article describes the clinical problem of dialysis vascular access dysfunction, identifies possible reasons for the current lack of effective therapies for this important clinical problem, provides an overview of the current sweeping changes in the health care environment with a particular emphasis on added value, and speculates on how these changes could incentivize the development of innovative therapies for vascular access dysfunction.