By Chris Blagg, MD

It is hard to believe that it is now 35 years since Shep Glazer, an activist patient who was Vice President of the National Association of Patients on Hemodialysis (NAPH), and other representatives of NAPH, Bill Litchfield, Roland Fortier, Peter Lundin and June Crowley, testified at a hearing before members of the House Ways and Means Committee of the U.S. Congress in 1971. The most dramatic moment was when Shep was dialyzed for a few minutes in front of the Committee. This may have been a major factor in the decision to enact the legislation for the Medicare End Stage Renal Disease (ESRD) Program, following several years of efforts by physicians such as George Schreiner and Belding Scribner and by the National Kidney Foundation and others.

In 1973, when the Medicare ESRD Program began, there were about 10,000 dialysis patients in the U.S., 40 percent of whom were on home hemodialysis. These patients dialyzed three times a week. The ensuing 35 years have seen many changes, not least of which is that the nearuniversal coverage of dialysis and transplantation has resulted in more than 4,000 dialysis centers in the U.S., more than 325,000 dialysis patients, 27,000 whom are on peritoneal dialysis but less than 2,000 on home hemodialysis, and more than 125,000 patients living with a kidney transplant.

In 1973, there were only a small number of treated patients with ESRD due to diabetes and relatively few patients aged more than 65. Today, more than 45 percent of all new ESRD patients have diabetes as the cause of their disease and more than 50 percent of the patients are aged 65 or older. The cost of all this is more than $18 billion to Medicare and there are also significant costs for private insurers, Medicaid, state kidney disease programs, the Veterans Administration and for some patients themselves. It is estimated that the number of patients will double over the next 10-15 years while the nursing shortage will continue and the number of nephrologists will increase only somewhat.

What have been some of the most important events affecting dialysis over the last 35 years?

First, in the 1970s, following the availability of funding from the Medicare ESRD Program, the number of dialysis units across the U.S. grew dramatically, making access to care much easier for the rapidly growing number of dialysis patients. Associated with this was the growth of for-profit dialysis centers, a growth that has continued steadily. Now about 75 percent of all dialysis patients are treated by one of two major companies.

Two factors contributed to the growth of dialysis centers:

1. Home dialysis was under-funded until the late 1970s.

2. In the 1970s, few physicians had training in home dialysis treatment.

As a result, home hemodialysis declined until recently. While a few patients were treated by peritoneal dialysis even before 1973, the mid-1970s saw the development of continuous ambulatory peritoneal dialysis (CAPD) and continuous cycling peritoneal dialysis (CCPD). These simple treatments are easy for patients to learn to do and have the advantages of self care and home dialysis. It is also believed peritoneal treatments help compensate for the reduction in access to home hemodialysis. The proportion of patients treated by CAPD and CCPD rose to about 15 percent of all dialysis patients in 1991, but has now fallen back to about eight percent. This is unfortunate, as peritoneal dialysis could give many more patients the benefits of home and self care dialysis within a week or two of training.

The 1970s and 80s saw development of new and more efficient dialyzers, particularly hollow fiber dialyzers, and the development of better membranes for dialysis. In those years, we also saw the beginning efforts to measure the adequacy of hemodialysis. Unfortunately, it led to the idea that a Kt/V of 1.0 was adequate dialysis. It was not.

A series of back steps continued, including the idea of shortening dialysis times for U.S. patients to three hours or less. Patients began to be under-dialyzed and the annual mortality of U.S. hemodialysis patients reached nearly 24 percent by the mid 1980s. Since 1990, efforts have been made to improve dialysis by setting standards for the treatment of anemia, Kt/V, nutrition and blood access, but the mortality rate is still about 21 percent. Today, the average duration of a conventional three times a week dialysis in the U.S. is about three and three quarter hours.

Also in the years since the 1970s, many dialysis patients have benefited from continuing improvements in the management of transplanted patients and the development of new and better immunosuppressive drugs. There has also been a gradual increase in the number of transplants done each year. In 2003, a record total of 15,137 kidney transplants were done in the U.S., more than 40 percent of which were from living donors. At the same time, the number of people waiting for a deceased donor kidney has exceeded 60,000 for the first time. Theincrease in deceased donors continues to be small.

There have been two major advances in the treatment of dialysis patients in the last 17 years. The first, which has benefited all dialysis patients, followed the introduction of erythropoietin (EPO) for the treatment of renal anemia in 1989. Before then, almost all dialysis patients had to exist with a hematocrit in the low to mid-20s if they were to avoid the risks and costs of repeated blood transfusions. Today, with EPO, the quality of life of dialysis patients is much improved. Their increased energy provides the opportunity for most patients to have a better quality of life and to become better rehabilitated. EPO is an expensive drug that costs Medicare more than $1.6 billion a year, but it has revolutionized dialysis patient care.

The other big advance in dialysis is the recent revival of interest in home hemodialysis, and particularly in more frequent hemodialysis. This is usually done in the home as many as five times a week, either short (two and a half to four hours during the day) or long overnight dialysis. Despite the fact that more frequent dialysis is closer to the continuous function of normal kidneys, there were very few reports on its use until the mid-1990s when the huge benefits of long nightly dialysis were reported from a group in Toronto, Canada . At about the same time, several manufacturers in the U.S. began work on developing more patient-friendly machines to provide short more frequent dialysis in the home. The last ten years have seen several hundred reports on the benefits of more frequent hemodialysis including better quality of life, more independence, flexible scheduling, comfort and convenience. Also, the need for antihypertensive drugs is reduced or eliminated, the EPO dose may be reduced, and with long nightly dialysis most patients no longer need to take phosphate binders. The biggest cost savings, results from a marked reduction in hospitalizations and the number of days patients are hospitalized. While the National Institute of Health (NIH) and Centers for Medicare Services (CMS) are studying more frequent dialysis in a small number of patients, legislation has been introduced so that Medicare could cover the costs of more frequent treatment so that it can be made much more widely available.

The Future

Ignoring Casey Stengel’s advice to never make predictions, especially about the future, here are some thoughts on what the future will bring or dialysis patients.

We will continue to see an increase in the number of ESRD patients associated with the epidemic of obesity, diabetes and the aging population. We will continue to see cost pressures for the ESRD Program and for healthcare in general. ESRD patient care will improve with greater use of home and more frequent dialysis. Manufactures will build better and smaller dialyzers with advanced membranes. We will see wearable dialyzers, implantable dialyzers and further improvements in transplantation including perhaps xenotransplantation (animal to human), hopefully more donors anyway. Also look for further research into the possible role of stem cells.

Dr. Blagg is the Executive Director Emeritus, Northwest Kidney Centers and Professor Emeritus of Medicine, University of Washington . Dr. Blagg is also a member of AAKP’s Medical Advisory Board.

This article original appeared in the September 2006 issue of aakpRENALIFE.