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A Brief History of Home Hemodialysis
A Brief History of Home Hemodialysis Christopher R. Blagg Home hemodialysis for the treatment of end-stage renal disease was first developed in the early 1960s. Because of the benefits and cost-effectiveness, this modality of treatment was increasingly used; by 1973, when the Medicare End-Stage Renal Disease Program began, approximately 40% of all dialysis patients in the United States were on home hemodialysis. Since then, both the percentage and the number of patients on this treatment has steadily decreased, and such patients now comprise approximately 1.3% of the US dialysis population. Nevertheless, there has been a recent resurgence of interest in home hemodialysis, particularly related to reports of excellent results with daily home hemodialysis and the development of new equipment specifically designed for use in the home. Thus, this modality of treatment may be used more widely in the near future. © 1996 by the National Kidney Foundation, Inc. Index Word: Home hemodialysis.
The best way to suppose what may come, is to remember what is past. George Savile, Marquis of Halifax 1633-1695
T
he first practical artificial kidney was developed by Willem Kolff in Holland in 1942,1 but long-term intermittent hemodialysis for end stage renal disease (ESRD) did not become a reality until 1960, when Belding Scribner and colleagues at the University of Washington in Seattle developed the Teflon arteriovenous shunt. 2 Once convinced of the success of this treatment, Scribner and James Haviland, then president of the King County Medical Society, obtained funds to establish the nonprofit Seattle Artificial Kidney Center (SAKC)-now the Northwest Kidney Centers-in 1962, as the world's first free-standing outpatient dialysis unit. 3 The Teflon arteriovenous shunt made repetitive dialysis possible,4 and with equipment modifications and the Kiil dialyzer,S hemodialysis of ESRD patients became a routine procedure that could be supervised by nurses, without the presence of a physician. 6 Throughout the 1960s, Scribner and colleagues described most of the medical complications and social, financial, and ethical problems associated with ESRD treatment. The financial problems in particular highlighted the ethical issues and led to the development of home hemodialysis. Because dialysis for ESRD was not covered by private insurers or other funding sources, demand for treatment exceeded available sources of financing. To deal with this, the SAKC and the King County Medical Society appointed an anonymous
committee to screen potential candidates for treatment? The committee was chaired by a clergyman, and members were chosen from the community. Patients who met very strict medical criteria were referred to the committee, which decided who would be treated and have access to the funding, which was primarily from public donations. This committee continued in operation until 1971, by which time private insurance, Division of Vocational Rehabilitation funds, and state funds had become sufficient to treat all patients referred to the SAKe. This approach to patient selection became a fertile field for discussions by ethicists, social scientists, and physicians. 8 However, in 1962 it was the most practical response to the unprecedented difficulty (at least in civilian practice) of triage in a population of patients who would inevitably die without treatment and who lacked the resources to pay for this. Age was a major criterion in selecting patients for dialysis at the SAKe. Consequently, in 1963, when the IS-year-old daughter of a friend of Dr Albert Babb, Professor of Nuclear Engineering at the University of Washington and one of Scribner's collaborators, developed ESRD, she was not accepted for treatment.
From the Northwest Kidney Centers and Division of Nephrology, Department of Medicine, University of Washington, Seattle. Address correspondence to Christopher R. Blagg, MD, FRCP, Northwest Kidney Centers, 700 Broadway, Seattle, WA 98122. © 1996 by the National Kidney Foundation, Inc.
1073-4449/96/0302-0003$3.00/0
Advances in Renal Replacement Therapy, Vol 3, No 2 (April), 1996: pp 99-105
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Babb and Scribner were already working on a central automated proportioning unit to make dialysate for several stations in the University of Washington Clinical Research Center.9 This experience was used in making a smaller version, a single-patient dialysis machine incorporating various fail-safe monitors (Fig 1). This, the precursor of all present-day proportioning hemodialysis equipment, was first used by this girl in 1964 to treat herself at home with aid from her mother.lO She was not the first patient to be treated by home hemodialysis. In 1961 in Japan, Dr Yuki Nose had treated a patient at home using a coil dialyzer in a domestic electric washing machine,l1 and Scribner had visited India in 1963 to train a physician to do home hemodialysis for a wealthy Madras businessman. In 1963-1964, two other groups were looking at home hemodialysis as a less expensive alternative to outpatient dialysis. In Boston, John Merrill et aP2 began using the twin-coil dialyzer for this, with a nurse going to the home to provide each treatment. Concurrently, in London, Stanley Shaldon and colleagues began home dialysis using a setup similar to the Seattle system,13 and it was Shaldon who first used overnight home hemodialysis. This was possible because of the fail-safe monitoring of the proportioning equipment, and because the Scribner shunt
and low-resistance Kiil dialyzer allowed hemodialysis without a blood pump. Treatment was relatively inefficient, requiring some 10 hours of dialysis two or three times weekly. Consequently, it was logical to use overnight dialysis, with the patient sleeping at least part of the time. Home hemodialysis was soon found to be as effective and considerably less expensive than outpatient hemodialysis because it did not require the presence of nursing staff. Consequently, Scribner and Shaldon pursued development of equipment and procedures to simplify dialysis in the home and to ensure maximum safety. The fail-safe monitoring developed is now a feature of almost all singlepatient hemodialysis equipment. IUS By 1967, the SAKC was having serious financial problems supporting even its carefully selected patient population. Consequently, the board of trustees decided all new patients must do home hemodialysis so that funds could be used to treat the largest possible number of patients. Patients already dialyzing at the SAKC also were encouraged, cajoled, and persuaded to move to home hemodialysis. Support for these changes came from Scribner and his colleagues who had recently developed the University of Washington's Coach House dialysis facility in a local motel by modifying several rooms to become a
Figure 1. The first home hemodialysis patient in Seattle in 1964 using the proportioning hemodialysis equipment developed at the University of Washington.
History of Home Hemodialysis
freestanding home dialysis training unit. More than 50 patients from the SAKC and from elsewhere in the United States and abroad were trained for home hemodialysis here during the 1960s.16 Staff from the Coach House helped the SAKC to develop its own training program, and by 1970 more than 90% of dialysis patients in western Washington were on home hemodialysis. With the aid of an educational consultant, the SAKC also pioneered the use of videotape-based training that shortened the average training time significantlyY Experience with home hemodialysis soon showed its advantages for patients. Besides a reduced risk of hepatitis and other infections, benefits included increased independence, a feeling of accomplishment, and greater opportunity for rehabilitation as compared with patients treated by outpatient dialysis. The latter tend to become overly dependent on the facility and its staff.I8 Similar advantages have since been reported as other home dialysis technologies have been developed. As these developments with hemodialysis were occurring, Scribner's group was also working on peritoneal dialysis for some patients with ESRD. Boen et aP9 and Tenckhoff et apo made a closed peritoneal dialysis fluid supply system to minimize the risk of peritonitis. Tenckhoff also devised the first effective indwelling peritoneal catheter, still the mainstay for all forms of long-term peritoneal dialysis. 21 As a result, home intermittent peritoneal dialysis (IPD) became possible. Tenckhoff et aP2 followed this by developing an automated peritoneal dialysis system using reverse osmosis for on-line preparation of sterile dialysate. Although this was used successfully by some patients in the Seattle program and elsewhere, home peritoneal dialysis was not widely used before the introduction of continuous ambulatory peritoneal dialysis (CAPO) by Robert Popovich and Jack Moncrief in Austin, Texas, in 1976. 23 Since then, CAPO and modifications such as continuous cyclic peritoneal dialysis (CCPD)24 have become the most widely used forms of home dialysis in the United States.
101
Home Dialysis in the United States Since the Medicare ESRD Program Home hemodialysis had proved so clinically and cost effective that it was being used by more than 40% of the 11,000 or so dialysis patients in the United States when the Medicare ESRD Program began in 1973. However, as a result of several factors, the proportion of patients treated by home hemodialysis began to decline after this. With almost universal Medicare coverage, the patient population changed rapidly as compared with that of the 1960s25 and has continued to change. For example, between 1977 and 1992 the median age of new patients increased from 54 to 63 years, and the number of new patients with diabetic ESRD increased from 7.7% to 35.7%.26,27 The number of black and Native American patients has also increased because of the very high incidence of hypertensive renal disease and diabetes in these populations. In 1992, blacks comprised 12.4% of the US population but accounted for 28.9% of all new patients with ESRD.27 As a result of changes in the patient population, there are now many more dialysis patients unsuited for home hemodialysis on medical or social grounds. Also, patients have become much freer to select their modality of treatment, and where and by whom this will be performed. Availability of funding encouraged development of many new dialysis units and so provided improved access to care. However, it also helped encourage development of forprofit dialysis facilities, which now treat more than 55% of the dialysis patients in the United States. 27 In the past, for-profit units have been reluctant to encourage home dialysis,2s and this may be continuing. In addition, in 1973 Medicare reimbursement to both physician and facility for outpatient dialysis was much better than for home dialysis. As a result, facilities had a significant financial incentive to expand outpatient hemodialysis and discourage patients from selecting home dialysis. Physician bias regarding treatment modalities also may be important. 29 A survey of selected United States nephrologists showed most would prefer home hemodialysis to facil-
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ity hemodialysis or CAPD. Despite this, there was a marked disparity between what they preferred for patients and their actual practice. 30,31 In part this may be because of the relative complexity of home hemodialysis, which requires a structured training program lasting 3 to 8 weeks, as compared with a week or so for CAPD training, and an extensive support system to provide maintenance and servicing of equipment and provision of supplies. In addition, many nephrologists lack personal experience with home hemodialysis, and so are skeptical of its safety, effectiveness, and benefits. As a consequence of these and other factors, the proportion of patients treated by home hemodialysis in the United States declined throughout the 1970s, and by 1980 was down to 4.6%. However, with the introduction of CAPD, home dialysis in total has increased, and between 1980 and 1992 the percentage of dialysis patients on some form of home dialysis increased from 6.2% to 16.8%. At the same time, patients on CAPD and other forms of peritoneal dialysis increased from 1.6% to 15.5%, while patients on home hemodialysis declined from 4.6% to 1.3%.26,27 Thus, until recently, the increased use of home dialysis has been solely caused by the increase in various forms of home peritoneal dialysis. Elsewhere in the world home hemodialysis has continued to be used on some scale, as in Australia, New Zealand,32 Canada,33 the United Kingdom and France?7 and it is interesting to speculate the reasons for national differences in the approach to the treatment of ESRD. By virtue of being a home treatment, CAPD has many of the same advantages for the patient as does home hemodialysis, and is also less expensive than outpatient dialysis. Unfortunately, after 2 years, less than 40% of patients started on CAPD or CCPD remain on this, primarily because of problems with peritonitis 27; and very few of those who experience treatment failure are then trained for home hemodialysis. Consequently, these patients soon lose the benefits associated with home dialysis. There remain isolated pockets of home hemodialysis in various states. For example, in Washington state at the end of 1994,11.4% of dialysis patients were on home hemodialysis
and 14.7% on peritoneal dialysis; in the Northwest Kidney Centers' regional program, 15.4% of more than 800 dialysis patients were on home hemodialysis and 11.3% on peritoneal dialysis. 34 Thus, where a dialysis program is committed to home hemodialysis, this option can still be successful. One major change since the earlier years is the use of paid home hemodialysis helpers to assist patients, rather than a family member or friend. This has proved extremely usefuJ.35 Because of the success of this program in Seattle, the Health Care Financing Administration (HCFA) funded three multicenter studies of home hemodialysis using paid aides. These showed that the number of patients choosing home hemodialysis could be increased significantly by providing funding for a dialysis aide or to pay a family member, and this was particularly effective in programs associated with nonprofit dialysis facilities. Although the studies showed a significant variation in cost between different programs, home hemodialysis with an aide cost an average of $119 per treatment, of which 17% was the cost of the aide. This home hemodialysis cost was 77% of the cost of outpatient dialysis at the same facility and 82% of the cost of outpatient dialysis at 23 control facilities. 36 These studies showed that it was possible to pay an aide or family member to help with home hemodialysis without the total cost exceeding that of outpatient dialysis. Despite this, Congress introduced composite rate reimbursement in 1983 that pays the same for a dialysis in a center or a home, and specifically excludes payment for a home dialysis aide as a Medicare-allowable charge. As a result, a home hemodialysis program using paid aides has to pay for these separately. Several years ago, Congress asked HCFA to undertake another demonstration project to look at the advantages of providing staffassisted dialysis for patients with severe medical problems and a life expectancy of less than 6 months. Usually, such patients are best treated in a facility. Only some 90 patients meeting the criteria established by the legislation entered the study and only 21 of these actually undertook home hemodialysis with an aide. These latter patients had a lower mortality rate than the controls, but the num-
History of Home Hemodialysis
bers were much too small to establish significance (Edington BE, personal communication, November 1995). In contrast to CAPD and other home treatments such as home respiratory therapy and parenteral nutrition,37 home hemodialysis has not so far been seen as a major revenue generator and has not generally attracted for-profit dialysis corporations. In fact, when the Medicare ESRD Program began in 1973, home dialysis was under-reimbursed, and it was only with introduction of the composite rate in 1983 that reimbursement for home hemodialysis was raised to the same level as for outpatient dialysis. This was intended to provide an incentive to encourage home dialysis, although the surplus generated was intended primarily to offset any program losses with outpatient dialysis. The last year has seen a revival of interest in home hemodialysis, in part because of several recent reports, the authors of some of which are contributors to this focused review section. At the 1994 American Society of Nephrology meeting, the late Robert Uldall reported on six patients treated by nightly home hemodialysis. 38 Patients dialyzed for 8 hours during sleep, at least 6 nights a week, using a silas tic jugular vein catheter as blood access and modified Fresenius dialysis equipment. Special precautions were taken to prevent accidental blood line separation. Monitoring of dialysis functions was carried out remotely via modem. Dialyzer and blood lines were re-used in situ to minimize expense and patient effort. Dialysate flow was 100 mL/min, blood flow was 300 mL/min, and with a 0.4 m 2 polysulfone dialyzer there was greater than 90% equilibration of urea between plasma and dialysate effluent. With this regimen, patients' serum urea and creatinine levels were close to normal throughout the week, and cumulative weekly Kt/Vs were 6.2 compared with 4.5 with very adequate conventional hemodialysis. Patients were able to stop phosphate binders, increase dietary phosphate intake, and stop taking angiotensin-converting enzyme inhibitors and calcium channel blockers, treating their hypertension with l3-blockers only or in some cases without drugs. Patients slept soundly, had greatly increased energy and stamina, and all
103
their days were free for work and other activities. 39 At a session on daily home hemodialysis at the 1995 Annual Conference on Peritoneal Dialysis and at the 1995 Annual Meeting of the American Society for Artificial Internal Organs (ASAIO), Rod Kenley of AKSYS described work on development of equipment designed specifically for home hemodialysis. 4o This highly automated equipment should allow many patients to do home hemodialysis without a helper, and may be available for testing within 1 to 2 years. If it fulfills its potential, this will make home hemodialysis readily available again. Also at the ASAIO meeting, John Woods reported on survival with home hemodialysis based on data from a national study by the United States Renal Data System. 41 Using a Cox proportional hazards model and a national random sample of patients starting ESRD treatment in 1986 and 1987, adjusting for age, race, sex, diabetes as cause of renal disease, and comorbid factors present before onset of ESRD, survival with home hemodialysis had a relative risk of 0.58 (P = .03). This would appear to confirm earlier reports from individual dialysis programs. At the same time, there are grounds for concern regarding whether peritoneal dialysis as generally practiced today really provides adequate dialysis. 42 It has been shown that the hospitalization rate for peritoneal patients is 14% higher than for hemodialysis patients even after adjusting for comorbid conditions. 43 Most recently, a report from the USRDS showed that the relative risk of death, after adjusting for age, race, sex, diabetic status and duration of dialysis, was higher in peritoneal dialysis patients than hemodialysis patients (RR = 1.19; P < .001).42 This risk was greater in older patients than younger patients and was accentuated in diabetic patients compared with nondiabetics (RR = 1.38 versus 1.11; both P < .001) and in women compared with men (RR = 1.30 versus 1.11; both P < .001).44 A second report based on the same data showed that after adjustment for demographic factors, deaths attributable to infection, myocardial infarction, withdrawal from dialysis, cerebrovascular disease, other cardiac causes, and other causes were signifi-
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cantly higher in peritoneal dialysis patients compared with hemodialysis patients. 45 These reports are particularly interesting because the same data base was used to show the significantly better survival with home hemodialysis. 41 In light of these developments, this seems to be a most appropriate time to re-examine the question of how to make home hemodialysis available on a wider scale through existing dialysis facilities, and at a more economic cost.
References 1. Kolff WJ: First clinical experience with the artificial kidney. Ann Intern Med 62:608-619, 1965 2. Quinton W, Dillard D, Scribner BH: Cannulation of blood vessels for prolonged hemodialysis. Trans Am Soc ArtifIntern Organs 6:104-113, 1960 3. Haviland JW: Experiences in establishing a community artificial kidney center. Trans Am Clin Climatol Assoc 77:125-129, 1965 4. Scribner BH, Buri R, Caner JEZ, et al: The treatment of chronic uremia by means of intermittent hemodialysis: A preliminary report. Trans Am Soc Artif Intern Organs 6:114-122, 1960 5. Pendras JP, Cole H, Tu WH, et al: Improved technique of continuous flow hemodialysis. Trans Am Soc Artif Intern Organs 7:27-36, 1961 6. Murray JS, Tu WH, Albers JB, et al: A community hemodialysis center for the treatment of chronic uremia. Trans Am Soc ArtifIntern Organs 8:315-319,1962 7. Alexander S: They decide who lives, who dies: Medical miracle and a moral burden of a small committee. Life Magazine 53(19):102-125, 1962 8. Fox RC, Swazey JP: The Courage to Fail: A Social View of Organ Transplants and Dialysis (ed 2). University of Chicago, Chicago, 1974 9. Grimsrud L, Cole H, Lehman GA, et al: A central system for the continuous preparation and distribution of hemodialysis fluid. Trans Am Soc Artif Intern Organs 10:107-109, 1964 10. Curtis FK, Cole H, Fellows BI, et al: Hemodialysis in the home. Trans Am Soc ArtifIntern Organs 11:7-10, 1965 11. Nose Y: Discussion. Trans Am Soc Artif Intern Organs 11:15,1965 12. Merrill JP, Schupak E, Cameron E, et al: Hemodialysis in the home. JAMA 190:468-470, 1964 13. Baillod RA, Comty C, Ilahi M, et al: Overnight hemodialysis in the home. Proc Eur Dial Transpl Assoc 2:99-103, 1965 14. Grimsrud L, Cole H, Eschbach JW, et al: Safety aspects of hemodialysis. Trans Am Soc Artif Intern Organs 13:1-4,1967 15. Eschbach JW Jr, Wilson WE Jr, Peoples RW, et al: Unattended overnight home hemodialysis. Trans Am Soc Artif Intern Organs 12:346-356, 1966 16. Blagg CR, Hickman RO, Eschbach JW, et al: Home
17.
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28. 29. 30.
31.
32. 33.
34. 35.
36.
hemodialysis: Six years' experience. N Engl J Med 283:1126-1131,1970 Stinson JW, Clark MF, Sawyer TK, et al: Home hemodialysis training in three weeks. Trans Am Soc Artif Intern Organs 18:66-69, 1972 Blagg CR, Cole H, Irvine G, et al: How much should dialysis cost? Proceedings: Workshop on Dialysis and Transplantation. Trans ASAIO, American SOCiety for Artificial Internal Organs, 1972, pp 54-60 Boen ST, Mulinari AS, Dillard DH, et al: Periodic peritoneal dialysis in the management of chronic uremia. Trans Am Soc Artif Intern Organs 8:256-262, 1962 Tenckhoff H, Shilipetar G, vanPaasschen WI, et al: A home peritoneal dialysate delivery system. Trans Am Soc Artif Intern Organs 15:103-107, 1969 Tenckhoff H, Schechter H: A bacteriologically safe peritoneal access device. Trans Am Soc Artif Intern Organs 14:181-186, 1968 Tenckhoff H, Meston B, Shilipetar G: A simplified automatic peritoneal dialysis system. Trans Am Soc ArtifIntern Organs 18:436-439, 1972 Popovich RP, Moncrief JW, Dechard JB, et al: The definition of a novel portable/wearable equilibrium peritoneal dialysis technique (abstr). Trans Am Soc Artif Intern Organs 22:65, 1976 Diaz-Buxo JA: Continuous cyclic peritoneal dialysis, in Nolph KD (ed): Peritoneal Dialysis (ed 3). Kluwer Academic Publishers, Dordrecht, 1989, pp 169-173 Evans RW, Blagg CR, Bryan FA: Implications for health care policy: A social and demographic profile of hemodialysis patients in the United States. JAMA 245:487-491,1981 US Renal Data System: USRDS 1989 Annual Data Report. The National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, August 1989 US Renal Data System: USRDS 1995 Annual Data Report. The National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, April 1995 Rettig RA: Implementing the End-stage Renal Disease Program of Medicare. Rand, Santa Monica, CA, 1980 Friedman EA: Physician bias in uremia therapy. Kidney Int 28:S38-S40, 1985 (suppI17) Mattern WD, McGaghie WC, Rigby RJ, et al: Selection of ESRD treatment: An international study. Am J Kidney Dis 13:457-464, 1989 Dunham C, Mattern WD, McGaghie We: Preferences of nephrologists among end-stage renal disease treatment options. Am J NephroI5:470-475, 1985 Disney A: Personal communication, March 1995 Canadian Organ Replacement Register: 1993 Annual Report. Canadian Institute for Health Information, Don Mills, Ontario, Canada, March 1995 Northwest Renal Network Annual Report 1994. Northwest Renal Network, Seattle, WA, 1994 Clark MF: Experience with paid dialysis helpers. JAm Assoc Nephrol Nurses Technicians 4:39-44, (suppl) 1977 Orkand Corporation: Evaluation of the home dialysis
History of Home Hemodialysis
37. 38.
39.
40.
41.
aide demonstration. Contract HCFA 500-79-0054. The Orkand Corporation, Silver Springs, MD, 1982 Lutz S: Horne care's growth hinges on winning over the physicians. Mod Health Care 19:20-30, 1989 Uldall R, Francouer R, Ouwendyk M, et al: Simplified nocturnal horne hemodialysis (SNHHD). A new approach to renal replacement therapy (abstr). J Am Soc NephroI5:428,1994 Uldall R, Ouwendyk M, Francoeur R, et al: Slow nocturnal horne hemodialysis at the Wellesley Hospital. Adv Renal Replace Ther 3:133-136, 1996 Kenley RS: Tearing down the barriers to daily horne hemodialysis and achieving the highest value renal therapy through holistic product design. Adv Renal Replace Ther 3:137-146,1996 Woods JD, Stannard D, Blagg CR, et al: Comparison of
42. 43.
44.
45.
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mortality with horne hemodialysis and center hemodialysis: A national study. Kidney Int 1996 (in press) Teehan BP, Hakim R: CAPD-Quo vadis? J Am Soc NephroI6:139-143,1995 Habach G, Bloembergen W, Mauger E, et al: Hospitalization among United States dialysis patients: Hemodialysis versus peritoneal dialysis. J Am Soc Nephrol 5:1940-1948,1995 Bloembergen WE, Port FK, Mauger EA, et al: A comparison of mortality between patients treated with hemodialysis and peritoneal dialysis. J Am Soc NephroI6:177-183,1995 Bloembergen WE, Port FK, Mauger EA, et al: A comparison of cause of death between patients treated with hemodialysis and peritoneal dialysis. J Am Soc NephroI6:184-191,1995
The best way to suppose what may come, is to remember what is past. George Savile, Marquis of Halifax 1633-1695
T
he first practical artificial kidney was developed by Willem Kolff in Holland in 1942,1 but long-term intermittent hemodialysis for end stage renal disease (ESRD) did not become a reality until 1960, when Belding Scribner and colleagues at the University of Washington in Seattle developed the Teflon arteriovenous shunt. 2 Once convinced of the success of this treatment, Scribner and James Haviland, then president of the King County Medical Society, obtained funds to establish the nonprofit Seattle Artificial Kidney Center (SAKC)-now the Northwest Kidney Centers-in 1962, as the world's first free-standing outpatient dialysis unit. 3 The Teflon arteriovenous shunt made repetitive dialysis possible,4 and with equipment modifications and the Kiil dialyzer,S hemodialysis of ESRD patients became a routine procedure that could be supervised by nurses, without the presence of a physician. 6 Throughout the 1960s, Scribner and colleagues described most of the medical complications and social, financial, and ethical problems associated with ESRD treatment. The financial problems in particular highlighted the ethical issues and led to the development of home hemodialysis. Because dialysis for ESRD was not covered by private insurers or other funding sources, demand for treatment exceeded available sources of financing. To deal with this, the SAKC and the King County Medical Society appointed an anonymous
committee to screen potential candidates for treatment? The committee was chaired by a clergyman, and members were chosen from the community. Patients who met very strict medical criteria were referred to the committee, which decided who would be treated and have access to the funding, which was primarily from public donations. This committee continued in operation until 1971, by which time private insurance, Division of Vocational Rehabilitation funds, and state funds had become sufficient to treat all patients referred to the SAKe. This approach to patient selection became a fertile field for discussions by ethicists, social scientists, and physicians. 8 However, in 1962 it was the most practical response to the unprecedented difficulty (at least in civilian practice) of triage in a population of patients who would inevitably die without treatment and who lacked the resources to pay for this. Age was a major criterion in selecting patients for dialysis at the SAKe. Consequently, in 1963, when the IS-year-old daughter of a friend of Dr Albert Babb, Professor of Nuclear Engineering at the University of Washington and one of Scribner's collaborators, developed ESRD, she was not accepted for treatment.
From the Northwest Kidney Centers and Division of Nephrology, Department of Medicine, University of Washington, Seattle. Address correspondence to Christopher R. Blagg, MD, FRCP, Northwest Kidney Centers, 700 Broadway, Seattle, WA 98122. © 1996 by the National Kidney Foundation, Inc.
1073-4449/96/0302-0003$3.00/0
Advances in Renal Replacement Therapy, Vol 3, No 2 (April), 1996: pp 99-105
99
100
Christopher R. Blagg
Babb and Scribner were already working on a central automated proportioning unit to make dialysate for several stations in the University of Washington Clinical Research Center.9 This experience was used in making a smaller version, a single-patient dialysis machine incorporating various fail-safe monitors (Fig 1). This, the precursor of all present-day proportioning hemodialysis equipment, was first used by this girl in 1964 to treat herself at home with aid from her mother.lO She was not the first patient to be treated by home hemodialysis. In 1961 in Japan, Dr Yuki Nose had treated a patient at home using a coil dialyzer in a domestic electric washing machine,l1 and Scribner had visited India in 1963 to train a physician to do home hemodialysis for a wealthy Madras businessman. In 1963-1964, two other groups were looking at home hemodialysis as a less expensive alternative to outpatient dialysis. In Boston, John Merrill et aP2 began using the twin-coil dialyzer for this, with a nurse going to the home to provide each treatment. Concurrently, in London, Stanley Shaldon and colleagues began home dialysis using a setup similar to the Seattle system,13 and it was Shaldon who first used overnight home hemodialysis. This was possible because of the fail-safe monitoring of the proportioning equipment, and because the Scribner shunt
and low-resistance Kiil dialyzer allowed hemodialysis without a blood pump. Treatment was relatively inefficient, requiring some 10 hours of dialysis two or three times weekly. Consequently, it was logical to use overnight dialysis, with the patient sleeping at least part of the time. Home hemodialysis was soon found to be as effective and considerably less expensive than outpatient hemodialysis because it did not require the presence of nursing staff. Consequently, Scribner and Shaldon pursued development of equipment and procedures to simplify dialysis in the home and to ensure maximum safety. The fail-safe monitoring developed is now a feature of almost all singlepatient hemodialysis equipment. IUS By 1967, the SAKC was having serious financial problems supporting even its carefully selected patient population. Consequently, the board of trustees decided all new patients must do home hemodialysis so that funds could be used to treat the largest possible number of patients. Patients already dialyzing at the SAKC also were encouraged, cajoled, and persuaded to move to home hemodialysis. Support for these changes came from Scribner and his colleagues who had recently developed the University of Washington's Coach House dialysis facility in a local motel by modifying several rooms to become a
Figure 1. The first home hemodialysis patient in Seattle in 1964 using the proportioning hemodialysis equipment developed at the University of Washington.
History of Home Hemodialysis
freestanding home dialysis training unit. More than 50 patients from the SAKC and from elsewhere in the United States and abroad were trained for home hemodialysis here during the 1960s.16 Staff from the Coach House helped the SAKC to develop its own training program, and by 1970 more than 90% of dialysis patients in western Washington were on home hemodialysis. With the aid of an educational consultant, the SAKC also pioneered the use of videotape-based training that shortened the average training time significantlyY Experience with home hemodialysis soon showed its advantages for patients. Besides a reduced risk of hepatitis and other infections, benefits included increased independence, a feeling of accomplishment, and greater opportunity for rehabilitation as compared with patients treated by outpatient dialysis. The latter tend to become overly dependent on the facility and its staff.I8 Similar advantages have since been reported as other home dialysis technologies have been developed. As these developments with hemodialysis were occurring, Scribner's group was also working on peritoneal dialysis for some patients with ESRD. Boen et aP9 and Tenckhoff et apo made a closed peritoneal dialysis fluid supply system to minimize the risk of peritonitis. Tenckhoff also devised the first effective indwelling peritoneal catheter, still the mainstay for all forms of long-term peritoneal dialysis. 21 As a result, home intermittent peritoneal dialysis (IPD) became possible. Tenckhoff et aP2 followed this by developing an automated peritoneal dialysis system using reverse osmosis for on-line preparation of sterile dialysate. Although this was used successfully by some patients in the Seattle program and elsewhere, home peritoneal dialysis was not widely used before the introduction of continuous ambulatory peritoneal dialysis (CAPO) by Robert Popovich and Jack Moncrief in Austin, Texas, in 1976. 23 Since then, CAPO and modifications such as continuous cyclic peritoneal dialysis (CCPD)24 have become the most widely used forms of home dialysis in the United States.
101
Home Dialysis in the United States Since the Medicare ESRD Program Home hemodialysis had proved so clinically and cost effective that it was being used by more than 40% of the 11,000 or so dialysis patients in the United States when the Medicare ESRD Program began in 1973. However, as a result of several factors, the proportion of patients treated by home hemodialysis began to decline after this. With almost universal Medicare coverage, the patient population changed rapidly as compared with that of the 1960s25 and has continued to change. For example, between 1977 and 1992 the median age of new patients increased from 54 to 63 years, and the number of new patients with diabetic ESRD increased from 7.7% to 35.7%.26,27 The number of black and Native American patients has also increased because of the very high incidence of hypertensive renal disease and diabetes in these populations. In 1992, blacks comprised 12.4% of the US population but accounted for 28.9% of all new patients with ESRD.27 As a result of changes in the patient population, there are now many more dialysis patients unsuited for home hemodialysis on medical or social grounds. Also, patients have become much freer to select their modality of treatment, and where and by whom this will be performed. Availability of funding encouraged development of many new dialysis units and so provided improved access to care. However, it also helped encourage development of forprofit dialysis facilities, which now treat more than 55% of the dialysis patients in the United States. 27 In the past, for-profit units have been reluctant to encourage home dialysis,2s and this may be continuing. In addition, in 1973 Medicare reimbursement to both physician and facility for outpatient dialysis was much better than for home dialysis. As a result, facilities had a significant financial incentive to expand outpatient hemodialysis and discourage patients from selecting home dialysis. Physician bias regarding treatment modalities also may be important. 29 A survey of selected United States nephrologists showed most would prefer home hemodialysis to facil-
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ity hemodialysis or CAPD. Despite this, there was a marked disparity between what they preferred for patients and their actual practice. 30,31 In part this may be because of the relative complexity of home hemodialysis, which requires a structured training program lasting 3 to 8 weeks, as compared with a week or so for CAPD training, and an extensive support system to provide maintenance and servicing of equipment and provision of supplies. In addition, many nephrologists lack personal experience with home hemodialysis, and so are skeptical of its safety, effectiveness, and benefits. As a consequence of these and other factors, the proportion of patients treated by home hemodialysis in the United States declined throughout the 1970s, and by 1980 was down to 4.6%. However, with the introduction of CAPD, home dialysis in total has increased, and between 1980 and 1992 the percentage of dialysis patients on some form of home dialysis increased from 6.2% to 16.8%. At the same time, patients on CAPD and other forms of peritoneal dialysis increased from 1.6% to 15.5%, while patients on home hemodialysis declined from 4.6% to 1.3%.26,27 Thus, until recently, the increased use of home dialysis has been solely caused by the increase in various forms of home peritoneal dialysis. Elsewhere in the world home hemodialysis has continued to be used on some scale, as in Australia, New Zealand,32 Canada,33 the United Kingdom and France?7 and it is interesting to speculate the reasons for national differences in the approach to the treatment of ESRD. By virtue of being a home treatment, CAPD has many of the same advantages for the patient as does home hemodialysis, and is also less expensive than outpatient dialysis. Unfortunately, after 2 years, less than 40% of patients started on CAPD or CCPD remain on this, primarily because of problems with peritonitis 27; and very few of those who experience treatment failure are then trained for home hemodialysis. Consequently, these patients soon lose the benefits associated with home dialysis. There remain isolated pockets of home hemodialysis in various states. For example, in Washington state at the end of 1994,11.4% of dialysis patients were on home hemodialysis
and 14.7% on peritoneal dialysis; in the Northwest Kidney Centers' regional program, 15.4% of more than 800 dialysis patients were on home hemodialysis and 11.3% on peritoneal dialysis. 34 Thus, where a dialysis program is committed to home hemodialysis, this option can still be successful. One major change since the earlier years is the use of paid home hemodialysis helpers to assist patients, rather than a family member or friend. This has proved extremely usefuJ.35 Because of the success of this program in Seattle, the Health Care Financing Administration (HCFA) funded three multicenter studies of home hemodialysis using paid aides. These showed that the number of patients choosing home hemodialysis could be increased significantly by providing funding for a dialysis aide or to pay a family member, and this was particularly effective in programs associated with nonprofit dialysis facilities. Although the studies showed a significant variation in cost between different programs, home hemodialysis with an aide cost an average of $119 per treatment, of which 17% was the cost of the aide. This home hemodialysis cost was 77% of the cost of outpatient dialysis at the same facility and 82% of the cost of outpatient dialysis at 23 control facilities. 36 These studies showed that it was possible to pay an aide or family member to help with home hemodialysis without the total cost exceeding that of outpatient dialysis. Despite this, Congress introduced composite rate reimbursement in 1983 that pays the same for a dialysis in a center or a home, and specifically excludes payment for a home dialysis aide as a Medicare-allowable charge. As a result, a home hemodialysis program using paid aides has to pay for these separately. Several years ago, Congress asked HCFA to undertake another demonstration project to look at the advantages of providing staffassisted dialysis for patients with severe medical problems and a life expectancy of less than 6 months. Usually, such patients are best treated in a facility. Only some 90 patients meeting the criteria established by the legislation entered the study and only 21 of these actually undertook home hemodialysis with an aide. These latter patients had a lower mortality rate than the controls, but the num-
History of Home Hemodialysis
bers were much too small to establish significance (Edington BE, personal communication, November 1995). In contrast to CAPD and other home treatments such as home respiratory therapy and parenteral nutrition,37 home hemodialysis has not so far been seen as a major revenue generator and has not generally attracted for-profit dialysis corporations. In fact, when the Medicare ESRD Program began in 1973, home dialysis was under-reimbursed, and it was only with introduction of the composite rate in 1983 that reimbursement for home hemodialysis was raised to the same level as for outpatient dialysis. This was intended to provide an incentive to encourage home dialysis, although the surplus generated was intended primarily to offset any program losses with outpatient dialysis. The last year has seen a revival of interest in home hemodialysis, in part because of several recent reports, the authors of some of which are contributors to this focused review section. At the 1994 American Society of Nephrology meeting, the late Robert Uldall reported on six patients treated by nightly home hemodialysis. 38 Patients dialyzed for 8 hours during sleep, at least 6 nights a week, using a silas tic jugular vein catheter as blood access and modified Fresenius dialysis equipment. Special precautions were taken to prevent accidental blood line separation. Monitoring of dialysis functions was carried out remotely via modem. Dialyzer and blood lines were re-used in situ to minimize expense and patient effort. Dialysate flow was 100 mL/min, blood flow was 300 mL/min, and with a 0.4 m 2 polysulfone dialyzer there was greater than 90% equilibration of urea between plasma and dialysate effluent. With this regimen, patients' serum urea and creatinine levels were close to normal throughout the week, and cumulative weekly Kt/Vs were 6.2 compared with 4.5 with very adequate conventional hemodialysis. Patients were able to stop phosphate binders, increase dietary phosphate intake, and stop taking angiotensin-converting enzyme inhibitors and calcium channel blockers, treating their hypertension with l3-blockers only or in some cases without drugs. Patients slept soundly, had greatly increased energy and stamina, and all
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their days were free for work and other activities. 39 At a session on daily home hemodialysis at the 1995 Annual Conference on Peritoneal Dialysis and at the 1995 Annual Meeting of the American Society for Artificial Internal Organs (ASAIO), Rod Kenley of AKSYS described work on development of equipment designed specifically for home hemodialysis. 4o This highly automated equipment should allow many patients to do home hemodialysis without a helper, and may be available for testing within 1 to 2 years. If it fulfills its potential, this will make home hemodialysis readily available again. Also at the ASAIO meeting, John Woods reported on survival with home hemodialysis based on data from a national study by the United States Renal Data System. 41 Using a Cox proportional hazards model and a national random sample of patients starting ESRD treatment in 1986 and 1987, adjusting for age, race, sex, diabetes as cause of renal disease, and comorbid factors present before onset of ESRD, survival with home hemodialysis had a relative risk of 0.58 (P = .03). This would appear to confirm earlier reports from individual dialysis programs. At the same time, there are grounds for concern regarding whether peritoneal dialysis as generally practiced today really provides adequate dialysis. 42 It has been shown that the hospitalization rate for peritoneal patients is 14% higher than for hemodialysis patients even after adjusting for comorbid conditions. 43 Most recently, a report from the USRDS showed that the relative risk of death, after adjusting for age, race, sex, diabetic status and duration of dialysis, was higher in peritoneal dialysis patients than hemodialysis patients (RR = 1.19; P < .001).42 This risk was greater in older patients than younger patients and was accentuated in diabetic patients compared with nondiabetics (RR = 1.38 versus 1.11; both P < .001) and in women compared with men (RR = 1.30 versus 1.11; both P < .001).44 A second report based on the same data showed that after adjustment for demographic factors, deaths attributable to infection, myocardial infarction, withdrawal from dialysis, cerebrovascular disease, other cardiac causes, and other causes were signifi-
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cantly higher in peritoneal dialysis patients compared with hemodialysis patients. 45 These reports are particularly interesting because the same data base was used to show the significantly better survival with home hemodialysis. 41 In light of these developments, this seems to be a most appropriate time to re-examine the question of how to make home hemodialysis available on a wider scale through existing dialysis facilities, and at a more economic cost.
References 1. Kolff WJ: First clinical experience with the artificial kidney. Ann Intern Med 62:608-619, 1965 2. Quinton W, Dillard D, Scribner BH: Cannulation of blood vessels for prolonged hemodialysis. Trans Am Soc ArtifIntern Organs 6:104-113, 1960 3. Haviland JW: Experiences in establishing a community artificial kidney center. Trans Am Clin Climatol Assoc 77:125-129, 1965 4. Scribner BH, Buri R, Caner JEZ, et al: The treatment of chronic uremia by means of intermittent hemodialysis: A preliminary report. Trans Am Soc Artif Intern Organs 6:114-122, 1960 5. Pendras JP, Cole H, Tu WH, et al: Improved technique of continuous flow hemodialysis. Trans Am Soc Artif Intern Organs 7:27-36, 1961 6. Murray JS, Tu WH, Albers JB, et al: A community hemodialysis center for the treatment of chronic uremia. Trans Am Soc ArtifIntern Organs 8:315-319,1962 7. Alexander S: They decide who lives, who dies: Medical miracle and a moral burden of a small committee. Life Magazine 53(19):102-125, 1962 8. Fox RC, Swazey JP: The Courage to Fail: A Social View of Organ Transplants and Dialysis (ed 2). University of Chicago, Chicago, 1974 9. Grimsrud L, Cole H, Lehman GA, et al: A central system for the continuous preparation and distribution of hemodialysis fluid. Trans Am Soc Artif Intern Organs 10:107-109, 1964 10. Curtis FK, Cole H, Fellows BI, et al: Hemodialysis in the home. Trans Am Soc ArtifIntern Organs 11:7-10, 1965 11. Nose Y: Discussion. Trans Am Soc Artif Intern Organs 11:15,1965 12. Merrill JP, Schupak E, Cameron E, et al: Hemodialysis in the home. JAMA 190:468-470, 1964 13. Baillod RA, Comty C, Ilahi M, et al: Overnight hemodialysis in the home. Proc Eur Dial Transpl Assoc 2:99-103, 1965 14. Grimsrud L, Cole H, Eschbach JW, et al: Safety aspects of hemodialysis. Trans Am Soc Artif Intern Organs 13:1-4,1967 15. Eschbach JW Jr, Wilson WE Jr, Peoples RW, et al: Unattended overnight home hemodialysis. Trans Am Soc Artif Intern Organs 12:346-356, 1966 16. Blagg CR, Hickman RO, Eschbach JW, et al: Home
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aide demonstration. Contract HCFA 500-79-0054. The Orkand Corporation, Silver Springs, MD, 1982 Lutz S: Horne care's growth hinges on winning over the physicians. Mod Health Care 19:20-30, 1989 Uldall R, Francouer R, Ouwendyk M, et al: Simplified nocturnal horne hemodialysis (SNHHD). A new approach to renal replacement therapy (abstr). J Am Soc NephroI5:428,1994 Uldall R, Ouwendyk M, Francoeur R, et al: Slow nocturnal horne hemodialysis at the Wellesley Hospital. Adv Renal Replace Ther 3:133-136, 1996 Kenley RS: Tearing down the barriers to daily horne hemodialysis and achieving the highest value renal therapy through holistic product design. Adv Renal Replace Ther 3:137-146,1996 Woods JD, Stannard D, Blagg CR, et al: Comparison of
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mortality with horne hemodialysis and center hemodialysis: A national study. Kidney Int 1996 (in press) Teehan BP, Hakim R: CAPD-Quo vadis? J Am Soc NephroI6:139-143,1995 Habach G, Bloembergen W, Mauger E, et al: Hospitalization among United States dialysis patients: Hemodialysis versus peritoneal dialysis. J Am Soc Nephrol 5:1940-1948,1995 Bloembergen WE, Port FK, Mauger EA, et al: A comparison of mortality between patients treated with hemodialysis and peritoneal dialysis. J Am Soc NephroI6:177-183,1995 Bloembergen WE, Port FK, Mauger EA, et al: A comparison of cause of death between patients treated with hemodialysis and peritoneal dialysis. J Am Soc NephroI6:184-191,1995