Overview of clinical studies in hemodiafiltration: What do we need now ?

Despite several technical advances in dialysis treatment modalities and a better patient care management including correction of anemia, suppression of secondary hyperparathyroidism, lipid and oxidative stress profiles improvement, the morbidity and the mortality of dialysis patients still remain still elevated. Recent prospective interventional trials in hemodialysis (HEMO study and 4D study) were not very conclusive in showing any significant improvement in dialysis patient outcomes. High-efficiency convective therapies, such as online hemodiafiltration (HDF), are claimed to be superior to conventional diffusive hemodialysis (HD) in improving the dialysis efficacy and in reducing intradialytic morbidity and all-cause and cardiovascular mortality in dialysis patients. The aim of this report was, first, to review the evidence-based facts tending to prove the superiority of HDF vs. HD in terms of efficacy and tolerance, and, second, to analyze the needs to prove the clinical superiority of HDF in terms of reducing morbidity and all-cause mortality of dialysis patients. A systematic review of studies comparing HDF and HD has been performed in the microbiological safety of online production, the solute removal capacity of small and medium-size uremic toxins, and its implication in the reduction of the bioactive dialysis system vs. patient interaction. Major planned randomized international studies comparing HDF and HD in terms of morbidity and mortality have been reviewed. To conclude, it is thought that these long-term prospective randomized trials will clarify on a scientific evidence-based level the putative beneficial role of high-efficiency HDF modalities on dialysis patient outcomes.     

The morbidity and cost implications of hemodialysis clinical performance measures

Clinical performance measures, including dialysis dose, hemoglobin, albumin, and vascular access, are the focus of monitoring and quality improvement activities. However, little is known about the implications of clinical performance measures for hospital utilization and health care costs. We obtained clinical performance measures and hospitalization records for a national random sample of 10,650 hemodialysis patients and analyzed the relationship between changes in clinical performance measures and hospital utilization after adjustment for patient demographic and medical characteristics. Higher hemoglobin, higher albumin, and fistula or graft use were independently associated with fewer hospitalizations, fewer hospital days, and decreased Medicare inpatient reimbursement. For example, a 0.5 g/dL higher hemoglobin, a 0.25 g/dL higher albumin, fistula use, and graft use were associated with hospitalization rate ratios of 0.90 (95% confidence interval 0.85, 0.96), 0.64 (0.53, 0.77), 0.60 (0.52, 0.69), and 0.79 (0.71, 0.89), respectively. Moreover, there was a 2-3-fold variation in hospital utilization across end-stage renal disease networks that was still evident after adjustment for patient characteristics and clinical performance measures. Clinical performance measures, especially albumin and vascular access, are strongly associated with hospital utilization and health care costs. These results highlight the importance of targeting nutrition and vascular access in quality improvement efforts. The marked variation in hospital utilization across networks deserves further examination.     

The path to a paradigm shift in hemodialysis

About 1 out of 4 American conventional dialysis patients die in the first year and 3 out of 5 die within 5 years with no favorable trend in sight. Largely ignored in practice is the evidence accumulated over decades that longer, more frequent dialysis can immediately slash this grim result in half or more. Pierratos has called for a paradigm shift—a disruptive change—in dialysis practice from conventional treatment to daily nocturnal dialysis, performed at home, to realize this dramatic improvement. We examine here how such a paradigm shift might be brought about and suggest that changes in 3 perspectives must occur. First, new dialysis guidelines must be recast from the old goal of minimally adequate to a new goal of best possible . Second, the body of dialysis research must be interpreted through the lens of best possible patient survival and well being, and the near-impossibility of demonstrating dialysis survival advantage through randomized clinical trials must be acknowledged. Finally, dialysis modality must be seen as, most importantly, a survival and well-being choice, not merely a Lifestyle choice; hence, it must be the nondelegatable responsibility of the physician, not dialysis center personnel, to advise and prescribe. Many old perspectives, which might stand in the way of this sorely needed paradigm shift are also examined. These old perspectives make up a fabric of excuses that has delayed—and, if not discarded, will continue to delay—progress toward a survival and well-being outlook for dialysis patients just as favorable as might be achieved through kidney transplant.