While it is gaining popularity, financial and political obstacles still stand in the way of wider use.
As patients, physicians, dialysis providers, and payers search for more favorable outcomes in patients with end-stage renal disease (ESRD), alternative dialysis regimens have gained popularity. Among these therapies are dialysis treatments that are performed more frequently, for longer periods of time, and/or at the patient’s home.
Over the past two years, the most rapid segment of dialysis growth has been in daily home hemodialysis. Today, nearly 2,000 patients perform some form of daily home hemodialysis in the United States. Meanwhile, use of peritoneal dialysis has declined and waiting times for deceased-donor kidney transplants have increased.
Patients want alternative dialysis regimens for a number of reasons, such as greater control over their health care, a less restrictive diet, and improved BP control. While these benefits have been generally accepted, other potential benefits such as decreased hospitalization and mortality rates have not been proven.
Several physicians have proposed that further randomized, controlled studies need to be completed and analyzed before daily home hemodialysis is adopted for general use. This is an unusual and likely unattainable standard for this therapy. Peritoneal dialysis has not met this criterion.
Furthermore, no randomized trial, including the National Institutes of Health (NIH)-sponsored Frequent Hemodialysis Network, currently examines morbidity and mortality with daily hemodialysis as a primary end point. Most researchers believe that to answer this fundamental question with adequate scientific power, a study with approximately 1,000 patients followed for seven years—similar to the HEMO study—would need to be performed.
The argument that this degree of “hard” data should exist before patients are treated counters how dialysis patients have been managed over the last 30 years. Generally, most treatments must show that they are safe and not inferior to current therapies before adoption. While unresolved issues regarding management of daily therapies exist—such as optimal dosing, water purification systems, appropriate calcium baths, and vascular access management—no evidence that daily hemodialysis is inferior to existing therapies has been presented.
On a similar note, randomized, controlled data for improved mortality does not exist for the use of erythropoietin, sevelamer, lanthanum, cinacalcet, high-flux dialysis membranes, urea kinetic measurements, peritoneal dialysis, or even kidney transplantation in patients. In fact, several studies of these interventions have shown no mortality or morbidity difference compared with older therapies.
Despite the obvious physiological benefits and the apparent improvement in other areas, caution does need to be taken before absolutely stating that daily hemodialysis is categorically “better” than the standard thrice-weekly, center-based hemodialysis.
Numerous other potential benefits in chronic kidney disease patients, based on initial results with physiological or biochemical improvements, have not been substantiated in larger subsequent analyses. Further, there are many uncertainties about the best practice of home dialysis and great room for technological advancement. And any type of hemodialysis in any setting has risks that can never be completely eliminated.
In the end, the argument over the provision of daily home hemodialysis comes down to three issues: money, politics, and technology. The economic portion is rather clear: providing a service six times a week rather than three and implementing new technology in a patient’s home is more expensive. And if patients do live longer as a result of home dialysis, they would be on dialysis longer and thereby increase costs.
The monetary savings in other areas such as medications or hospitalizations may or may not cover the added expense. Lastly, the dialysis industry needs to aggressively seek new technology that allows easier and better dialysis treatments.
That is today’s financial snapshot, but what does the future hold? The leading expenses in providing traditional, thrice-weekly, center-based hemodialysis are labor, medications, and facility overhead. The leading expenses with home hemodialysis are supplies and equipment. Labor and fixed overhead expenses are likely to increase dramatically even if the current nursing shortage is corrected.
But it is unlikely that regulators and patients will tolerate increasing patient-to-nurse ratios to lower labor costs. Technology expenses, on the other hand, will likely continue to decline perhaps at dramatic rates such as seen in the computer industry.
The political side of adapting the dialysis infrastructure to accommodate home hemodialysis is more insidious. Many of the larger providers of in-center hemodialysis have an efficient business operation that would have to be completely reconfigured if 10% of patients—particularly if a substantial portion of those 10% have private health insurance—choose daily home hemodialysis rather than incenter hemodialysis. Nephrologists—through medical director fees, research grants, and consulting arrangements—are connected to this business operation. Despite the best intentions of all involved, these potential biases can affect attitudes.
Nephrologists and patients need to regain control of their profession and health care, respectively. Nephrologists need to provide the best ESRD option for each individual patient. For some patients, this will include daily home hemodialysis. Patients with ESRD and the organizations that represent their interests need to demand better care and results than are currently being provided.
Dr. Miller is associate professor of medicine at Washington University and an attending nephrologist at Barnes-Jewish Hospital in St. Louis, Mo.
Dr. Miller serves on the Scientific Advisory Board for NxStage Medical and has also served as an advisor for DaVita, National Renal Alliance and Renal Advantage. He has received research support as a principal investigator from the NIDDK and NxStage Medical. He has received speaking honoraria from Abbott, Johnson and Johnson, DaVita, National Kidney Foundation, and NxStage Medical. He owns stock in Fresenius AG.