The promise of bioimpedance for volume management in American dialysis patients: An unfulfilled opportunity.

Evidence from both observational and randomized controlled studies indicates that the use of bioimpedance in the care of chronic hemodialysis patients is associated with improved outcomes, in particular better volume and blood pressure control. Bioimpedance as a means to assess fluid status in dialysis patients has been approved by numerous regulatory agencies and is being used in dozens of countries around the globe. The most notable exception to the worldwide acceptance of this technique is the US where no BIA device has been approved by the US Food and Drug Administration for use in dialysis patients. The reasons for this unfortunate situation are manifold and mostly flawed. They include the view that bioimpedance is inaccurate and not sufficiently validated, that clinical judgment is good enough to assess fluid status, that interdialytic changes in weight are satisfactory indicators of fluid status (overload, depletion, and euvolemia), costs, and regulatory and marketing barriers. Easing the path to approval and modifying the dialysis payment structure are necessary to bring dialysis care closer to the levels that will optimize patient outcomes.