Q J Med 1999; 92: 251-260
© 1999 Association of Physicians
Long-hours home haemodialysis—the best renal replacement therapy method?
From the Renal Unit, Parhon Hospital, Iasi, Romania, 1 Renal Unit, Guy's Hospital, London, and 2 Renal Unit, Withington Hospital, Manchester, UK
Received 20 November 1998 and in revised form 18 February 1999
Dr A. Covic, Nephrology CWRU/MHMC, 2500 Metrohealth Drive, Rammelkamp R203, Cleveland, Ohio 44109-1998, USA e-mail: amc21{at}po.cwru.edu
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Two hundred and eighty-six patients (190 males and 96 females) with end-stage renal failure (ESRD) started haemodialysis (HD) at Withington Hospital between 1 January 1968 and 31 December 1986. Of these, 152 (53.1%) were successfully transplanted, while 134 had only HD or one transplant lasting <3 months (i.e. total HD interruption <3 months). For the whole group, the probabilities of being alive on long-hours home HD at 10 and 20 years were 58.7% and 33.2%, respectively. Mean gross mortality 1968–1986 was 6.5±3.2% per year. The main causes of death were cardiovascular (36.6%), infection-related (19.2%) and malignancy (9.6%). Males and younger cohorts had a significantly (p<0.05) higher probability of being alive on long-hours home HD than did females and older cohorts. Eighty-two patients (29% of the total group) survived more than 10 years, of whom 54 were still alive at 1 January 1996: 44 continuing on HD while the other ten had been successfully transplanted. In these 54 patients, mean 24-h ambulatory blood pressure recorded at the date of the study was 117.6/68.9 mmHg; mean BP for the last 5 years on HD was 136.4/81.2 mmHg. Only four (7.4%) were regularly taking antihypertensive medication. Left ventricular hypertrophy (LVH) (by ECG) was present in 64.8% of the 54 patients; its prevalence by echocardiography (LVM index >130 g/m2 for men and >110 g/m2 for women) was 77.5%. Only 10 (18.5%) had symptoms or clinical signs of ischaemic heart disease and/or peripheral vascular disease. None had cardiac failure symptoms NYHA class 3–4. Our data show a low incidence of all-cause and cardiovascular mortality, confirming those from the Tassin unit in France, and make a medical case for extended haemodialysis treatment hours.
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Introduction |
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The rise in prevalence of end-stage renal disease (ESRD) at the turn of this century (more than 260 000 living patients in the USA,1) due to a real increase in incidence of ESRD as well as a more liberal inclusion policy, raises the vital problem of choosing the optimal renal replacement therapy (RRT) method. Limited financial resources, the growing costs of medical technology, and organ shortage are emerging as the main restraints for all countries beyond the year 2000. Although there is no clear definition of the optimum in RRT, the best criterion is probably the longest possible survival with the best quality of life. Unfortunately, prospective, comparative trials of the different available RRT methods are impossible from a practical point of view, so we have to rely on large registries of data1–7 and on various reports8–19 presenting single centre experience. So far the most impressive results have been reported by the Tassin group, based on a long-hours haemodialysis (HD) policy and tight blood pressure control.11,12 However, the impact of this `recette Français' has been rather modest, first, because similar data have only rarely been described elsewhere, and second, because it is unduly difficult (mainly due to efficiency requirements) to organize dialysis centres based on 8-h HD sessions. Home HD combines the advantage of smaller costs than in-centre HD, with a flexible programme, and no time restriction.20,21
We present survival data from the Withington Hospital Renal Unit (Manchester, UK), one of the few remaining centres using 8-h sessions, but based almost exclusively on home HD. We describe those patients surviving more than 10 years on HD, (`long-term survivors'), to better understand the determinants of this desirable but difficult target.
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Methods |
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The self-care dialysis training programme at Withington Hospital was initiated in 1967. Patients were accepted into the RRT programme if they were otherwise well, and were likely to benefit from RRT. Dialysis was not usually available or offered to older, frailer patients in the UK during this period, nor to those with significant co-morbidities such as cardiac failure, diabetes, or myeloma. Renal transplantation in a neighbouring unit was available in this period. The basic philosophy of the training unit has not changed over the last 30 years, but many dialytic and nephrological practices have altered as knowledge and experience have accumulated. Thus: 1967–late 1980s, acetate dialysate (bicarbonate use increasing thereafter), dialysate sodium 134–138 mmol/l, dialysate calcium 1.75 mmol/l by default throughout; 1967–late 1970s, Kiil dialysers, flat-plate cuprophane (Gambro-Lundia 3N, 5N) thereafter; patients with dialysis-amyloidosis on polysulfone (Fresenius F6 and F60) dialysers (1980s–1990s); 1967–mid 1970s, 30 h dialysis/wk as three 10-h sessions, 24 h/week thereafter; 1967–late 1980s, regular iron injections, and blood transfusions where needed for symptomatic anaemia (rarely erythropoietin after 1990); 1967–early 1980s, phosphate binding by aluminium salts, decreasing long-term use and increasing use of calcium-based phosphate binders thereafter; 1976–present day, use of regular or pulsed oral (i.v. if hypercalcaemic) vitamin D analogues where radiological, biochemical and histological information allowed a diagnosis of secondary hyperparathyroidism; 1967–present day, surgical parathyroidectomy (PTx) (mostly with re-implantation) for refractory hyperparathyroidism; 1967–present day, access by means of mature radial or brachial arterio-venous fistula, double needle; 1967–present day, blood flow 200 ml/min, single-pass, dialysate flow 500 ml/min, no dialyser re-use, water treatment by filtration and by reverse osmosis/de-ionizers; 1967–present day, diet of 1.2 g/kg/day of protein, 50 mmol sodium, restricted potassium and phosphate; 1967–present day, anti-hypertensives used only if hypertension persisted after sustained and careful examination of the patient's dry weight and appropriate adjustment to fluid intake and dialysis practice.
Data on mortality for all patients were obtained retrospectively from case folders, post-mortem reports and the renal unit computer database. The Kaplan-Meier method was used to construct survival curves for all patients, males vs. females, 1968–1975 vs. 1976–1986 cohorts, and for different age groups.
Long-term survivors
These were defined as patients alive at 01/01/1986 with an uninterrupted time on dialysis (past or present) of minimum 10 years or with maximum two episodes of transplantation lasting <3 months (unsuccessful transplantation attempts) during the 10-year period of dialysis. The following information was obtained for each long-term survivor.
Demographic data
Age at enrollment, age, duration of dialysis, CRF aetiology, type of activity, marital status.
Cardiovascular morbidity data
Blood pressure assessed as a mean for the last 5 years and by ambulatory blood pressure measurements (ABPM) at the time of the study, ECG, echo (when possible), signs and symptoms of ischaemic heart disease and/or cardiac failure (NYHA classification). For details see references 22–24.
Musculo-skeletal disease data
Symptoms and signs of joint disability, carpal tunnel syndrome, bone radiological screening (annual assessment), bone biochemistry (serum total calcium, phosphate, alkaline phosphatase, intact PTH from 1989, C-terminal assay before, aluminium levels. For details see references 25 and 26.
Autonomic nervous system data
Assessment of ECG by R-R interval comparison after stimulation manoeuvres (details reference 27).
Vascular calcification data
Evident on annual radiological examination of small and large vessels. For details see reference 25, and information about PTx.
Dialysis parameters
KT/V, PCR (Fresenius PACK-H with values for the last 3 months, IDWG formally recorded for the last 3 months.
Biochemical data
Albumin, haematocrit, haemoglobin, creatinine. Values at the time of the study and from charts mean of the last 5 years.
Malnutrition data
Weight, BSA, subjective global assessment score on a 7-point scale, as used in the CANUSA study.28
Statistical analysis
Survival was analysed using Kaplan-Meier; differences among categories were compared using the log-rank test. Differences between long-term survivors only on dialysis and those who were transplanted after at least 10 years of dialysis (Table 2
) were analysed using Student's t-test.
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Literature search
A Medline search was performed for all published papers covering the long-term survival topic; a summary of the relevant data is shown in Table 3
.
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Results |
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Two hundred and eighty-six ESRD patients (190 males and 96 females) started HD at Withington Hospital between 01/01/1968 and 31/12/1986. Despite this gender ratio of 2 : 1, there was no significant difference between sexes as regards mean age at RRT start (male vs. female, 35.8±11.6, range 16.1–64.2 years vs. 34.2±10.8, range 14.7–67.8 years, p=NS) or the total dialysis duration (male vs. female 7.4±6.4, range 0.1–26.6 years vs. 6.5±6.1, range 0.1–23.2 years). The age distribution at HD start is presented in Figure 1
. Overall, 152 (53.1%) patients were successfully transplanted, while 134 had only HD or one transplant lasting <3 months (i.e. total HD interruption <3 months).
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Figure 2
shows the survival curves for patients on renal replacement therapy (HD and transplantation). The probabilities of being alive on long-hours home HD at 10 and 20 years were 58.7% and 33.2%, respectively (Table 1). Moreover, the results for `technique' survival only on HD (end-points: alive on dialysis, transplanted, and dead on dialysis) were 66.5% and 43.7% at 10 and 20 years, respectively (Figure 3 and Table 1). The mean gross mortality for the 1968–1986 period was 6.5±3.2% per year. Gross mortality by year is shown in Figure 4. The main causes of death were cardiovascular (36.6%), infection-related (19.2%) and malignancy (9.6%).
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We analysed the influence of gender, age at start of RRT, and age at enrollment in the RRT program (`early' years, 1968–1975 vs. `recent' years, 1976–1985). Males had a significantly (p<0.05) higher probability of being alive on long-hours home HD than females—see Figure 5
. As expected, younger patients had a significantly better survival above the 6-year limit on HD—53% of those starting dialysis between 25 and 34 years of age being alive even after 20 years on RRT (Figure 6) (p<0.05). When comparing the 35–44 and the 45–54 decades, a significant difference was seen only for the period of time between 12 to 16 years of RRT (Figure 6), (p<0.05). Finally, there was no clear impact on survival of alterations in dialysis procedures, as survival of the 1968–1975 and the 1976–1986 cohorts is similar (Figure 7) (p=NS).
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Long-term survivors
Eighty-two patients (29% of the total group) survived more than 10 years, mean 15.6±4.6, range 10–26.6 years. Of these 54 were still alive at 1 January 1996: 44 continuing on HD while the other ten were successfully transplanted. Their demographic data and 1996 biochemical profiles are presented in Table 2
. Their age at enrollment and M : F ratio were similar to the rest of the group. Four (7.4%) had an albumin level of <3.5 g/dl, 12 (22.2%) had an albumin level >3.5 but <4.0 g/dl, while the others had levels >4.0 g/dl. There were no significant differences between these three subgroups concerning the total duration on dialysis: 197.5, 196.3 and 183.6 months, respectively (p=NS). Malnutrition was assessed also using the body mass index (BMI) and the subjective global assessment score (SGA28) (Table 2). Only five long-term survivors had clinical features of malnutrition (four of them having also a very low albumin level). The mean measured KT/V and PCR in our group were 1.61±0.34 and 1.23±0.48, respectively; mean interdialytic weight gain was 0.91±0.4, range 0.5–2.0 kg. Thirty-two patients regularly dialysed during the night-time while 12 dialysed during the day. During the 3 months of dialysis preceding the date of the study (1584 HD sessions) the incidence of significant (i.e. saline-requiring) intradialytic hypotension was 5.7%.
The mean inter-dialytic 24-h ABPM recorded at the date of the study, was 117.6/68.9 mmHg; more importantly, mean BP for the last 5 years on HD was 136.4/81.2 mmHg. Only four patients (7.4%) were taking regularly antihypertensive medication; more detailed information has been presented elsewhere.24 LVH (ECG criteria) was present in 64.8% of the 54 patients; interpretable echocardiographic measurements could be obtained only in 40/54 subjects, the prevalence of LVH (LVM index >130 g/m2 for men and 110 g/m2 for women) being 77.5%. Only 10 patients (18.5%) had symptoms or clinical signs of ischaemic heart disease and/or peripheral vascular disease. None had cardiac failure symptoms NYHA class 3–4.
The prevalence of vascular calcification was extremely high. Data regarding the presence and progression of vascular calcification have been presented elsewhere:25 only three (5.5%) of the 54 patients surviving >10 years on HD showed no evidence of calcification at the date of the study, their dialysis duration being 16.9 years. PTH levels and information concerning parathyroidectomy are shown in Table 2.
As previously reported,25,26 we had an extended time-sequential skeletal survey series on 37 of the long-term dialysis patients and on six further patients who had subsequently been transplanted. Overall, 27/37 of the dialysis patients and 6/6 of the transplanted patients had symptoms and signs of carpal and shoulder disease (27/37 dialysis patients and 6/6 then-transplanted patients having had at least one carpal tunnel release, with demonstration of amyloid staining of the excised tissue in about 40%). The mean onset of radiological amyloid changes (cysts) was about 8 years after the start of dialysis, with symptoms at about 11 years after dialysis; there was an inverse relationship between patient age and the time-interval between starting dialysis and the development of radiological amyloid changes. Supraspinatus calcification was seen in 65% of the patients, and in all who subsequently underwent PTx for secondary hyperparathyroidism. Tumoural calcification was rare (one case, related to an old shunt site). The functional status of these patients declined markedly after 20 years of continuous dialysis, with the majority (5/6) reporting chronic significant joint (wrist, shoulder, neck, hip and knee) pain and reduced mobility.
Autonomic dysfunction, evaluated by abnormal Valsalva test (ECG test) and orthostatic hypotension (BP test), was present in 33.3% and 35% of the patients, respectively, for details see reference 27.
Social integration after 10 years of HD was excellent. All patients were independent, and 20 were working full-time while four had part-time jobs. There were no sleep disturbances for the patients dialysing at night. Forty of 44 patients interviewed in 1994 expressed strong feelings of well-being and optimism.
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We report survival data from one of the few remaining RRT centres in the world performing home HD with 3x8 h sessions. The implementation of such a strategy may seem off-putting, requiring a special training program, based on permanent teamwork involving nephrologists, dialysis nurses, dietitian, technicians, social workers and, most important of all, the ESRD patient. Nevertheless, the reasons for choosing a home-based dialysis strategy are excellent: better clinical outcome compared to other dialysis modalities,10 even after adjustment for co-morbidity, sex, age, race and diabetes;29 lower costs per patient treated,20,21 the possibility of dialysis without creating new dialysis centres; better social integration and quality of life.30 This remains true even when home HD is compared to CAPD. CAPD was originally developed worldwide, and in particular in the UK, in order to offer, with the lowest possible initial financial outlay, an alternative to in-centre dialysis for active, still-working ESRD patients. However, no published data suggest that peritoneal dialysis, however delivered, can achieve long-term technique and actuarial survival rates even close to those of home HD,10 nor is social integration as successful. One reason for reduced long-term CAPD patient survival may lie in a recent report31 indicating that survivors on CAPD for 5 years or more had larger, heavier left ventricles than patients surviving on HD for a similar time-period. Equally, the progressive impact of sclerosing peritonitis on long-term CAPD has resulted in all but a handful of CAPD patients failing to survive for more than a decade. In patients requiring long-term dialysis, Delano et al.32 have shown quite convincingly that home HD is more cost-effective than CAPD.
Additionally, but most importantly, the 24 h/week policy delivers the `maximum' dialysis dose, similar to that originally prescribed by Scribner,33 and the best clearance of the middle-molecular-mass uraemic toxins. These two virtues have been reconfirmed recently by the group of Pierratos et al.34 who reported excellent results with slow nocturnal HD: 4.5-fold increase in KT/V, normal plasma phosphate despite discontinuation of the phosphate-binders, enhanced energy and sense of well-being reflected in a return to a normal work schedule. Our data strongly support this line of evidence. Higher target values for KT/V are controversial, as a recent short-term prospective mortality series35 suggested that there was a `ceiling threshold' for KT/V (urea) such that dialysis dose increments above KT/V (urea) of 1.3, or urea reduction ratio of 70%, were not associated with increased short-term (i.e. ~18 months) survival. No study has prospectively examined longer-term survival with respect to dialysis adequacy.
Long-hours HD has been associated with low intradialytic morbidity and with excellent blood pressure control without hypotensive medication;11,12,23 in these patients the most powerful predictor of mortality was BP level. These data have been provided, until now, mainly by the French group in Tassin. Our data confirm that slow ultrafiltration combined with low-sodium dialysate and a low-sodium diet are associated with the normalization of blood pressure without the need for antihypertensive medication. Moreover, the ABPM 24-h BP average of our long-term surviving dialysis cohort is significantly lower than ABPM criteria for normotension: ~120/70 mmHg vs. <135/85 mmHg.
There are clearly numerous additional explanations for this large survival difference apart from the dialysis technique: ESRD aetiology, age, and patient co-morbidity are three of the most relevant. Whereas currently about 25–33% of dialysis patients are diabetic, the usual UK practice for the period covered in this report was to avoid offering RRT to diabetic patients. Diabetics, however given RRT, have a worse prognosis than patients with glomerulonephritis as the cause of ESRF, but even here, the Tassin group's results for diabetic patients are impressive.11 The patients in this report started dialysis at a younger age than typical UK dialysis patients in the late 1990s (25–45 years of age compared with 50–70 years of age). The effect of patient age at start of RRT on cumulative survival (see Figure 6), though evident, is only a partial explanation for the marked survival differences between short- and long-hours HD.
As with the Tassin group, we think the success of this RRT is related to good control of several predictors for cardiovascular death in dialysis:36,37 hydration status, nutritional status, blood pressure and haemoglobin level. This is achieved by the strict observance of rules known to every nephrologist: careful, repeated evaluation of dry weight,11,12 slow ultrafiltration rate—only possible with long-hours HD (<5 ml/min in our patients), low sodium dialysate (135–138 mEq/l in our setting), small interdialytic weight gain (mean 0.91 kg in our patients), low-sodium diet (50 mmol/day), and `high' KT/V (mean 1.61 in our group).
Long-term survivors
Our analysis of the long-term survivor on HD, adds data to what has been reported occasionally in the literature,13–19 allowing a quasi-meta-analysis of this particular type of patient—see Table 3. As pointed out by Avram,17 analysis of these `outlier patients' may offer clues to prolonged survival. Furthermore, they offer a unique opportunity to evaluate the impact of the dialysis treatment per se.14 There is a clear pattern that emerges from the review of the >250 patients reported and described in detail. The long-term survivors were young when dialysis was started (<35–40 years), systemic illnesses (diabetes, etc.) and vascular disease represented only a small proportion of the CRF aetiology (<10%), and co-morbidity was rare. There were twice as many males than females, and although this might be explained by an inclusion bias, the same ratio being apparent for our entire population, there is a significant difference in the gender survival rate (Figure 5).
A special feature of the long-term survivors, present in all the studies listed in Table 2, is their good-to-excellent blood pressure control. Indeed, the prevalence of hypertensives in this highly-selected dialysis population is very significantly less than that reported for the typical ESRD population. Although LVH and other abnormalities (calcification, diastolic impairment, etc.) are present in more than 50% of the patients described in Table 2, the prevalence of the dilatative form of uraemic cardiomyopathy (associated with the worst prognosis36 is very low.
The dominant morbidity after 10 years of dialysis was related to musculo-skeletal disorders39–41—joint pain and disability, and carpal-tunnel syndrome—even if bone-related biochemistry is maintained in the normal range (Tables 1 and 2). PTx was needed in two-thirds of the long-term survivors, and was performed after a mean of 7–9 years of HD.
In summary, we present evidence supporting the contention that long-hours home dialysis is a robust and satisfactory form of dialysis, suitable for the next millenium. Prolonged survival, low morbidity and a good quality of life are attainable not through the use of sophisticated and expensive dialysis technology, but through excellent BP control, high dialysis `dose' and adequate nutrition.
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Acknowledgments |
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Gratitude is especially due to Tony Ralston, Ken Hill and Pauline Sambrook; also to all the medical, nursing, technical, administrative, ancillary and clerical staff over the years, and most of all, to the patients.
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References |
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