Jury verdicts and outcomes of malpractice cases involving arteriovenous hemodialysis access.

OBJECTIVE: To analyze malpractice cases involving hemodialysis access to prevent future litigation and improve physician education. METHODS: Jury verdict reviews from the WESTLAW database from 1 January 2005 to 1 January 2015 were reviewed. The search terms "hemodialysis," "dialysis," "graft," "fistula," "AVG," "AVF," "arteriovenous," "catheter," "permacatheter," and "shiley" were used to compile data on the demographics of the defendant, plaintiff, allegation, complication, and verdict. RESULTS: Sixty-six cases involving the litigation pertaining to hemodialysis catheter, arteriovenous fistula (AVF) or arteriovenous grafts (AVGs) were obtained. Of these, 55% involved catheter-based hemodialysis access, 18% involved AVF, and 27% involved AVG. The most frequent physician defendants were vascular surgeons (36%), internists (14%), nephrologists (14%), general surgeons (9%), and interventional radiologists (6%). Of the patients, 38% involved were male and the average patient age was 56.3 (standard deviation (SD) = 20.1) years. Region of injury was 50% in the neck or chest, 42% in the arm, and 8% in the groin. Injury was listed as death in 79% of cases. Of the deaths, 95% involved bleeding at some point in the chain of events. The most common claims related to the cases were failure to perform the surgery or procedure safely (44%), failure to diagnose and treat in a timely manner (30%), and negligent hemodialysis treatment (11%). The most common complications cited were hemorrhage (62%), loss of function of limb (15%), and ischemia due to steal syndrome (11%). A total of 26 cases (39%) were found for the plaintiff or settled. The median award was US$463,000 with a mean of US$985,299 (SD = US$1,314,557). CONCLUSION: While popular opinion may indicate that steal syndrome is a commonly litigated complication, our data reveal that the most common injury litigated is death which may frequently be the result of a hemorrhagic episode. In addition to hemorrhage, the remaining most common complications included steal syndrome and loss of limb function. Therefore, steps to better prevent, diagnose and treat bleeding, nerve injury, and steal syndrome in a timely manner are critical to preventing hemodialysis-access-associated litigation.

FDA Regulatory Perspectives for Studies on Hemodialysis Vascular Access.

In an effort to foster innovation and new product development, the American Society of Nephrology and the US Food and Drug Administration partnered to form the Kidney Health Initiative in 2012. Part of the Kidney Health Initiative's mission is to foster development of therapies by creating a collaborative environment where the US Food and Drug Administration and the greater nephrology community can interact to optimize product evaluation. This particular Kidney Health Initiative project focused on products related to hemodialysis vascular access, with the goal of clarifying appropriate trial end points that could subsequently inform clinical, regulatory, and coverage decisions. Both the lack of common definitions and the lack of consensus on trial end points have been viewed as barriers to innovation in this area. Toward this end, the Kidney Health Initiative convened teams of expert stakeholders to address these issues for each major vascular access category (arteriovenous grafts, arteriovenous fistulas, and central venous catheters), and each team provided recommendations. This commentary provides an overview of the US Food and Drug Administration centers that regulate hemodialysis vascular access and certain laws and regulations that affect these products as well as our perspectives on some of the issues raised and end points proposed by the Kidney Health Initiative teams. The standardized definitions and clinical trial end points proposed by the teams represent an important step forward to improve innovation in this area.

Ethical and legal obligation to avoid long-term tunneled catheter access.

Despite recent national initiatives promoting the arteriovenous fistula as the initial, primary, and sole vascular access to be used by hemodialysis patients and recommending a decrease in the prevalence of tunneled cuffed catheters to less than 10%, the prevalence of tunneled cuffed catheters as hemodialysis access is increasing. This study describes the risks of tunneled cuffed catheters, explores the reasons why they remain prevalent, and presents the stance that nephrologists have an obligation to offer tunneled cuffed catheters only for temporary use and not as an acceptable alternative for long-term vascular access to patients for whom a properly functioning arteriovenous fistula or graft is possible. Recommendations for tunneled cuffed catheter use were based on dialysis clinical practice guidelines and the medical evidence regarding outcomes of use of arteriovenous fistulas and tunneled cuffed catheters. The authors found that compared with dialysis with arteriovenous fistulas, long-term dialysis with tunneled cuffed catheters is associated with (1) two to threefold increased risk of death, (2) a five to 10-fold increased risk of serious infection, (3) increased hospitalization, (4) a decreased likelihood of adequate dialysis, and (5) an increased number of vascular access procedures. To adequately inform patients about access options, nephrologists are ethically obligated to systematically explain to patients the harms of tunneled cuffed catheters. If catheters must be used to initiate dialysis, nephrologists should present catheters only as "temporary" measures and "unsafe for long-term use."