Clinical safety and performance of VIVIA: a novel home hemodialysis system.

Background: The VIVIA Hemodialysis System (Baxter Healthcare Corporation, Deerfield, IL, USA) was designed for patient use at home to reduce the burden of treatment and improve patient safety. It has unique features including extended use of the dialyzer and blood set through in situ hot-water disinfection between treatments; generation of on-line infusible-quality dialysate for automated priming, rinseback and hemodynamic support during hypotension and a fully integrated access disconnect sensor. Methods: The safety and performance of VIVIA were assessed in two clinical studies. A first-in-man study was a prospective, single-arm study that involved 22 prevalent hemodialysis (HD) patients who were treated for ∼4 h, four times a week, for 10 weeks. A second clinical study was a prospective, single-arm study (6-8 h of dialysis treatment at night three times a week) that involved 17 prevalent patients treated for 6 weeks. Results: There were 1114 treatments from the two studies (first-in-man study, 816; extended duration study, 298). Adverse events (AEs) were similar in the two studies to those expected for prevalent HD patients. No deaths and no device-related serious AEs occurred. Adequacy of dialysis ( Kt / V ) urea in both clinical trials was well above the clinical guidelines. VIVIA performed ultrafiltration accurately as prescribed in the two studies. The majority of patients achieved 10 or more uses of the dialyzer. Endotoxin levels and bacterial dialysate sampling met infusible-quality dialysate standards. Conclusion: These results confirm the safety and expected performance of VIVIA.

Funding and planning: what you need to know for starting or expanding a home hemodialysis program.

Planning and funding a home hemodialysis (HD) program requires a well-organized effort and close collaboration between clinicians and administrators. This resource provides guidance on the processes that are involved, including a thorough situational analysis of the dialysis landscape, emphasizing the opportunity for a home HD program; careful consideration of the clinical and operational characteristics of a proposed home HD program at your institution; the development of a compelling business case, highlighting the clinical and organizational benefits of a home HD program; and careful construction and evaluation of a request for proposal.

The STARRT trial: a cost comparison of optimal vs sub-optimal initiation of dialysis in Canada.

BACKGROUND: Sub-optimal transitioning of patients from chronic kidney disease (CKD) to end stage renal disease (ESRD) may result in poor clinical outcomes and increased healthcare costs. The objectives of this study were to estimate the average total cost per patient who requires initiation of renal replacement therapy (RRT) stratified by status at initiation; optimal (RRT initiation as an outpatient with an arterio-venous [AV] Fistula, Graft or Peritoneal Dialysis [PD] catheter), and sub-optimal (RRT initiation as an inpatient and/or via central venous catheter [CVC]). METHODS: Data from the Study To Assess Renal Replacement Therapy (STARRT), a Canadian, multi-centre, 6 month retrolective study (n = 339), were used for this analysis. Unit costs for resources were obtained from participating hospitals, the literature, and/or standard costing sources. The analysis was performed from the perspective of healthcare payors and reported in 2011 Canadian Dollars (CAD). A propensity score technique was applied to control for potential confounders between the two groups. RESULTS: Two hundred of the eligible patients for analysis (61.9%) were sub-optimally and 123 (38.1%) were optimally prepared. For this analysis, 106 "matched" pairs were used. The average total cost per patient was estimated to be $63,225 (with a 95% CI ranging from $58,663-$67,958) for the sub-optimally initiated patients, and $39,260 (with a 95% CI ranging from $35,683-$43,007) for the optimally initiated patients (p < 0.001). LIMITATIONS: Costs were calculated utilizing a conservative approach, using the cheapest available prices for medications and other resources. Assumptions had to be made for the costing of dialyses. CONCLUSION: The results of this study indicate, after adjusting for potential confounders, that optimally initiated patients for RRT have significantly lower healthcare-associated costs compared to sub-optimally initiated patients.

Use of the BioHole™ device for the creation of tunnel tracks for buttonhole cannulation of fistula for hemodialysis.

Buttonhole cannulation is a method of cannulation of native arteriovenous fistulae traditionally practiced by self-cannulators. At St Michael's Hospital, this method has been modified to allow its use in problematic fistulae by multiple cannulators. In a busy dialysis unit, the need for a few specific cannulators to establish the tunnel tracks in combination with the variable dialysis schedules creates logistical challenges. A new method of creating tunnel tracks with the use of the BioHole™ device was evaluated. Buttonhole tracks were created in 12 patients using a peg of polycarbonated material with a holder (BioHole™ kit). The peg was inserted into the path left by the hemodialysis sharp needle following the index cannulation. Four of the 12 patients had an alternate access. Buttonhole tracks were successfully created in all the patients, albeit in 2 patients, the initial attempt to establish buttonhole tracks was aborted due to complications and the procedure was rescheduled. Compared with the modified buttonhole technique, pain on cannulation following track creation was significantly less in the BioHole™ group (P < 0.001). Ease of cannulation was significantly improved in the BioHole™ group (P<0.05) when compared with that in thrice-weekly patients using the modified buttonhole technique. Hemostasis postdialysis did not differ between the study groups. The use of the BioHole™ device is effective in the creation of tunnel tracks for buttonhole cannulation, is associated with less pain, and simplifies the logistics of arranging patient and nurses' schedules.