Evaluation of the Current Status of Home Hemodialysis in the Middle East Then Perspectives and Possibilities of Home Hemodialysis in Egypt


 
 
 Chronic kidney disease (CKD) is a growing worldwide epidemic. The incidence and prevalence of end-stage renal disease (ESRD) are expected to continue to increase. The most recent United States Renal Data System (USRDS) reports indicate that the incident dialysis population has grown older, has more comorbid conditions than previous years, and is starting dialysis with higher levels of residual kidney function (RKF).
 
 
 
 This study was done to evaluate the current status of home hemodialysis in the Middle East, then to study the perspectives and future possibilities of home hemodialysis in Egypt. It was carried out during the last 2 years; 2019 and 2020. It included 2 parts:
 
 
 
 A retrospective and prospective study on 100 patients that was randomly selection and was adult ESRD patients (age > 18 years) either were treated and maintained on home hemodialysis during the last 5 years or will be treated and maintained on home hemodialysis during the period from march 2019 to march 2020.
 
 
 
 HD patients with volume overload or those with cardio-renal syndrome were found to better tolerate excessive UF with the use of home HD machines than that with the usual in-center machines. SLED and SCUF modes were very effectively managed with the use of these simple HD machines. It was noticed that the loss of residual renal functions in new HD patients, was significantly less with the use of home HD than with the usual in-center HD. This was related to less dialysate exposure other than the use of ultrapure dialysate.
 
 
 
 The psychological status was significantly improved in those patients with having their sessions at their homes without any added stressors related to in-center HD. Even new ESRD patients who are too reluctant to start HD, were better convinced to start home HD. Home HD is a gentle and benign mode of HD with less reported intra-dialytic complications; attributed to the use of ultrapure dialysate solutions other than the treated tap/well water used in center HD.



Introduction
Home hemodialysis offers several bene ts as compared to conventional hemodialysis.These include improvements in patient outcomes, increased freedom of time, cost reduction, as well as an improved quality of life.Improvements in patient outcome with more frequent or intensive home hemodialysis include improved survival, blood pressure control, left ventricular geometry, phosphate control and mineral metabolism, quality of sleep, and fertility.In-center dialysis patients tend to feel incapacitated after treatment, while home dialysis users typically recover in about 30 minutes.Home hemodialysis is cost-effective or cost-saving due to lower staff costs and likely medication cost and may have better health outcomes in kidney disease-related quality of life and survival.
Intensive home hemodialysis (IHHD) has emerged as an alternate treatment option for ESRD patients and has several established and potential clinical bene ts.These clinical advantages need to be tempered against a growing appreciation of the risks of IHHD, including a potentially higher rate of vascular access interventions.Identifying who might be an eligible and optimal candidate for IHHD is paramount to its expansion as an important form of renal replacement therapy.
In the Middle East region, unfortunately, home hemodialysis is used to be done for a very low number of ESRD patients who are dominated by many signi cant barriers to in-center hemodialysis.Recently, the NxStage portable hemodialysis machine is somewhat available in these countries and is widely used for managing home hemodialysis for less strictly selected ESRD patients.However, statistical data are still lacking about this project.

Patients And Methods
The study included a retrospective part and a prospective part.The rst part: It was a retrospective study of 80 ESRD patients who had been treated and maintained on home hemodialysis, during the last 5 years, The second part: It was a prospective study of 51 new ESRD patients who were treated and maintained on home hemodialysis during 1year period.The study was done in 2019 and 2020.

Inclusion Criteria
Adult ESRD patients (age > 18 years) either were treated and maintained on home hemodialysis during the last 5 years or was treated and maintained on home hemodialysis during the period from march 2019 to march 2020.

Exclusion Criteria
ESRD patients who were occasionally treated by home hemodialysis for several sessions due to certain temporary circumstances and terminally-ill ESRD patients, in whom home hemodialysis was done as a form of adjuvant palliative therapy.

Ethical Considerations
An informed consent was obtained from all patients or their representatives before their data were included in the study.

Study Tools
The included patients were subjected to

Clinical data
Including age, sex, BMI, cause of ESRD, comorbidities, psychological status, social support, family history of ESRD, cause of treatment by home hemodialysis, compliance to home hemodialysis, previous treatments of ESRD, used vascular access and virology status.

Hemodialysis treatment parameters
Including frequency of sessions, duration of each session, dialysate ow rate, blood ow rate, ultra ltration rate, Urea Reduction Ratio (URR) and KT/V.

Measures of clinical outcome
Details of all patient charts and data was thoroughly analyzed for the purpose of overall evaluation of home hemodialysis in ESRD patients in the region of Middle East.

Primary outcome
Mortality statistics in ESRD patients maintained on home hemodialysis.

Secondary outcome
Frequency of hospitalization, family satisfaction, total costs and reported intradialytic complications including sudden cardiac death.

Statistical Analysis and Package
Data was presented as mean and standard deviation for quantitative parametric data and median and interquartile range for quantitative non-parametric data.Frequency and percentage was used for presenting qualitative data.Suitable analysis was done according to the type of obtained data.Student T test or Mann Whitney test was used to analyze quantitative data while Chi-square test and Fisher Exact test was used to analyze qualitative data.P < 0.05 was considered to be statistically signi cant.

Discussion
Home HD has been started in the Middle East for the last several years.Simple machines were developed only for the purpose of Home HD.The 1st one was the NxStage machine that had been developed in USA and was introduced to KSA, UAE and Qatar, in 2012.The 2nd one was the DIMI machine that had been developed in Switzerland and was approved by the Saudi FDA, in late 2019.
The mean age of patients in the retrospective study was 68.5, while that in the prospective study was 61.8 years.This age differences were related to an involvement of less elderly and healthier patients in the last few years.
The mean BMI was slightly higher in patients of the prospective part as it was 26.2 while it was 25.7 kg/m 2, in patients of the retrospective part Most ESRD patients have multiple comorbidities that increase with age.IHD was present in 28% of patients of the prospective part while it was 54.9% in patients of the retrospective part.
Regarding the cause of treatment with home HD, the situation was serious.For patients of the retrospective part, only 23.5% of them were treated as per their personal choice.The remaining were treated due to serious morbidities with frequencies as following: bed-ridden 18.5%, CVA 17.3%, fracture femur 14.8%, PVD 12.3% and others 13.5% (see table 1).For patients of the prospective part, the situation was different as 50% of them were treated as per their personal choice because of the serious world-wide pandemic of The other 50% were treated due to disabling morbidities with frequencies as following: bed-ridden 18%, dementia 12%, fracture femur/tibia 12%, CVA 8% and others 6% (see table 2) The frequency of home HD was 13 sessions/month, in 59% of all patients.The remaining patients were treated with higher frequencies, mainly with 15 or 17 sessions/month (see tables 3 and 4) Most patients reported no complications during their sessions.This was noted in about 86% of all patients.The remaining 14% of patients reported occasional hypotension, hypoxemia, chest pain ….Etc (see tables 7 and 8) The mean URR% was 56 and 63 for those in the retrospective and prospective parts, respectively.Also, the mean KT/V was 1.1 for patients in the retrospective part and 1.18 for patients in the prospective part.
Regarding the 1st year mortality as the 1ry outcome of the whole study, the results were alarming.It was signi cantly high in all involved patients, about 36%.It was also signi cantly higher in patients of the retrospective part as it was 40.7% (see table 5) while it was 28% for those of the prospective part (see table 6).This reported high mortality warrants searching for the possible mortality predictors.
Mortality predictors with a + ve correlation were following: age, BMI, vascular access : AVF / catheter, virology status : -ve / +ve, Phosphorus, TIBC, CRP, ferritin, frequency of hospitalization and complications: no/yes ( see table 9) Mortality predictors with a-ve correlation were as following: psychological status: depressed/borderline/good, creatinine, albumin, PTH, Hb.%, HCT and iron ( see table 9) Surprisingly, both URR% and KT/V were insigni cantly correlated with 1st year mortality.However, this is explained by the fact that e cient hemodialysis per se isn't enough to improve mortality rates in ESRD patients.
Regarding the frequency of hospitalization, there were many predictors with either a + ve or a -ve correlation of signi cant values.Most of these predictors were similar to those of the 1st year mortality.
Both URR% and KT/V were not signi cantly correlated with the frequency of hospitalization.
Regarding URR% and KT/V, there were some important predictors with either direct or indirect effects.Of course, DFR, BFR and duration are strongly related.The other predictors were as following and all were of a -ve correlation: BMI, type of machine: DIMI / NxStage, frequency of HD and complications.In fact, these 4 predictors needs further discussions and explanations.
For BMI, hemodialysis clearance is negatively correlated.Most home HD patients were of low URR% and KT/V, mainly due to the low DFR as compared with in-center HD patients.So, patients with subnormal BMI may have adequate clearance.However, patients with even normal BMI rather than overweight ones, will have insu cient clearance.These observations were thoroughly discussed before with all related authorities that we are doing insu cient hemodialysis for most of these patients.However, this form of HD was found as the best to be offered to some patients who were bed-ridden, very elderly, demented or with non-union fractures.These patients were hardly brought to hospitals to get their regular HD sessions and some of them were left as neglected at home to nally die of uremia.
Regarding the frequency of HD sessions, it will be already negatively correlated with HD clearance as more frequent HD will decrease the pre-dialysis urea.Furthermore, with more frequent HD, the duration of treatment mostly will be decreased as mainly per patient choice.
Regarding the cost of home HD, each session is almost of double the cost of that in-center HD.However, it saves the extra cost of transportation especially of bed-ridden patients and avoids the psychological burden of both them and their involved care-givers and/or relatives.

Conclusion
Home HD was rst decided for only home-bound or bed-ridden elderly patients who are unable to get in-center HD.However, in the last few years, more patients were included in the program of home HD with less strict criteria.
Home HD with the usual frequency of 3 sessions/ week, is an insu cient form of renal replacement therapy for most ESRD patients.It is su cient in only those patients who are under-weight with subnormal BMI.Those patients with high or even normal BMI, need more frequent and intensive home HD, to get a su cient HD.
Despite home HD is an expensive and less e cient form of renal replacement therapy for ESRD patients, it resolves a great majority of the total burden related to managing a highly compromised group of ESRD patients who are bed-ridden, wheel-chair-bound, demented or having CVA, amputations or non-union fractures …… etc, who have a great di culty to get HD in centers/hospitals.
The 1st year mortality was very high in patients of home HD due to the burden of the underlying multiple co-morbidities rather than the insu cient HD.Many mortality predictors were found as age, BMI, CRP, phosphate, PTH, Albumin, Hb.%, vascular access, virology status,….etc.
The psychological status was signi cantly improved in those patients with having their sessions at their homes without any added stressors related to in-center HD.Even new ESRD patients who are too reluctant to start HD, were better convinced to start home HD.
Home HD is a gentle and benign mode of HD with less reported intra-dialytic complications; attributed to the use of ultrapure dialysate solutions other than the treated tap/well water used in center HD.
HD patients with volume overload or those with cardio-renal syndrome were found to better tolerate excessive UF with the use of home HD machines than that with the usual in-center machines.SLED and SCUF modes were very effectively managed with the use of these simple HD machines.
It was noticed that the loss of residual renal functions in new HD patients, was signi cantly less with the use of home HD than with the usual in-center HD.This was related to less dialysate exposure other than the use of ultrapure dialysate.
Home HD with the DIMI machine reported more clearance rates than that with the NxStage one, despite the same HD parameters.This was related to certain technical characteristics of the DIMI machine that counts only the effective time of HD and calculation of the required BFR.

Table ( 1
) : Cause of treatment with Home Hemodialysis old group