Time to expand dialysis programs worldwide to include extended HHD
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In-center conventional hemodialysis, performed thrice weekly at 4 hours per session, is a life-sustaining treatment.
However, despite advances in the dialysis and pharmaceutical industry, data have shown that survival rates have not improved and there are still significant challenges with this “conventional” approach, not only from a clinical perspective but also from financial and workload perspectives.
Longer treatments
There is one simple answer to improving outcomes for patients on dialysis: prolonged treatment times. There are published articles prior to the implementation of the thrice weekly, 4-hour hemodialysis treatment showing the positive impact of increased (6 to 8 hours) dialysis sessions, which has also been confirmed in later publications. However, despite all the positive data in the literature, this approach today is only available in a few high-income countries.
Higher kidney replacement therapy (KRT) expenditures are placing a heavy financial and operational burden on health systems in all countries. There is a need to find more affordable modalities for treating end-stage kidney disease, especially in low-middle income countries (LMICs). Nonetheless, home hemodialysis, which is largely recognized as a more cost-efficient modality compared with other dialysis methods, is virtually non-existent in LMICs.
At Ege University School of Medicine, we have been studying different aspects of hemodialysis for more than 2 decades. We believe these new approaches would provide answers to questions on some essential dialysis concepts, ranging from the impact of strict volume control and salt restriction to the impact of dialyzer flux and dialysate purity, hemodiafiltration, the effects of different dialysate contents and finally the impact of longer treatment times in both in-center and at home.
We also conducted a clinical study to investigate how treatment time would impact clinical outcomes. This was a prospective controlled study, which included 247 patients on hemodialysis who agreed to participate in a thrice-weekly, 8-hour, in-center nocturnal hemodialysis (NHD) treatment and 247 age-, sex-, diabetes status- and HD duration-matched controls to 4-hour conventional hemodialysis (CHD).
Results
Results of this study were remarkable. Overall mortality rates were 1.77 in the NHD group vs. 6.23 in the CHD group per 100 patient-years (P = .01) during a mean 11.3 months of follow-up. Hospitalization rate was also lower in the NHD group, left ventricular mass index was decreased, serum albumin levels were increased, use of antihypertensive medications, erythropoietin and phosphate binder declined and improvements were seen in anemia and phosphate control.
Cognitive functions improved in the NHD group, and quality of life scores deteriorated in the CHD group.
Due to the increased cost of maintaining an in-center NHD program and lack of a reimbursement scheme to support it, however, the patients on 8-hour treatment had to be switched to the 4-hour, in-center treatment scheme.
Extended HHD at home
This was a disheartening period for the kidney care staff but more so for the patients. Keeping the program open was not possible due to factors beyond our control and despite all the improvements observed. This desperate situation pushed us to take a different approach: If it is not possible to provide NHD to patients in the center, would applying this treatment modality at home be a suitable option?
From 2006 to 2007, four patients volunteered to enroll in the HHD program. This was organized by a for-profit dialysis clinic operated by Fresenius Medical Care in collaboration with Ege University.
During this pilot period, there was no reimbursement for nocturnal HHD programs in Turkey. However, the initial patients were able to receive HD at home in the absence of any reimbursement.
Today, all four patients who started the program are alive and have been performing HHD since the start of the trial.
Payment for treatment
One of the most critical hurdles was to have reimbursement for HHD. The results from our in-center nocturnal study, as well as data from the four initial pilot patients showing the potential positive impact of NHD to lower the overall costs of the KRT burden on the health care budget, were presented to the National Social Security Institution. After some delay, a reimbursement, same as the payment for in-center hemodialysis, was approved in 2010.
This allowed the group to turn this program into the Turkish Home Hemodialysis Initiative and expand it to other clinics that were willing to implement an HHD program. For this, Ege Nefroloji Clinic (Fresenius Medical Care in Izmir, Turkey) was chosen as the central training unit, where health care professionals interested in learning more on HHD were informed and educated onsite.
During the introductory sessions, the visitors could observe how the HHD system works, meet the patients and make available visits to their homes. Also, a comprehensive activity plan was introduced to inform and educate all stakeholders around the country (see Table 1).
Program expands
The HHD program initiated in June 2010 has shown a remarkable success with time, enrolling 1,375 patients as of Jan. 31, 2023. A summary of the main lessons is in Table 2. To our knowledge, the HHD program recently implemented in Turkey may be the largest one among those in LMICs.
We recently published the outcomes from this program. The study involved 349 patients starting HHD between 2010 and 2014, matched with 1,047 concurrent patients on ICHD by using propensity scores. The primary outcome was survival. Our results show an all-cause mortality rate of 3.76 and 6.27 per 100 patient-years in the HHD and the ICHD groups, respectively.
In the intention-to-treat analysis, HHD was associated with a 40% lower risk of all-cause mortality than ICHD (hazard ratio 0.60; 95% CI: 0.45-0.80). In the HHD group, the 5-year technical survival was 86.5%. HHD treatment provided better phosphate and blood pressure control, improvements in nutrition and inflammation, and reduction in hospitalization days and medication requirement. These results once again confirm that extended HHD is associated with higher survival, better clinical outcomes and lower costs compared with ICHD.
HHD is not a new modality; it dates to the 1960s. Contrary to today’s practice patterns, HHD prevalence was 40% in the United States and 15% in Europe (1970s) when patients were generally on longer dialysis regimens with impressive results, even in the scope of the dialysis technology of those times. And emerging data from many different HHD programs today also shows that all outcomes in hemodialysis is better with HHD.
Our program has shown that it not only provides significantly better outcomes, but also that it is possible to implement a program in a LMIC.
The success with our program in Turkey that shows improved outcomes using extended HHD should justify expansion of this model to other countries. Patients will see a change in their lives.
- References:
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- Ok E, et al. Kid Intl Rpts. 2023;doi:10.1016/j.ekir.2023.09.007.
- Ok E, et al. Nephrol Dial Trans. 2011;doi:10.1093/ndt/gfq724.
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- Ozkahya M, et al. Nephrol Dial Trans.2006;doi:10.1093/ndt/gfl487.
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- Trinh E, et al. Seminars in Dialysis. 2017;doi: 10.1111/sdi.12572.
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- Wong B, et al. Am Jrnl Kid Dis.2017;doi:10.1053/j.ajkd.2017.01.047.
- For more information:
- Ercan Ok, MD, is a nephrologist with Ege University School of Medicine, Bornova, Izmir, Turkey. His research is done on behalf of the Turkish Home Hemodialysis Initiative. He can be reached at ercan.ok@ege.edu.tr.
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