Overview: Results from the largest human factors study ever performed on a hemodialysis device, based on the number of tested tasks, demonstrated that patients and care partners can easily and quickly learn to use Tablo. Among patients and their care partners in the study, the observed use error rate was just 0.9% on more than 5,400 tasks tested.
A Simulation of Strategies to Launch a Home Therapies Program
in a Conventional Hemodialysis Facility
Weinhandl, et al., ASN. 2022.
Overview: Observed real-world evidence is similar to the results of the home IDE study: with high treatment adherence, 100% patient retention and achievement of adequacy goals using more flexible dialysis schedules.
Weinhandl, et al., ASN. 2022.
Overview: A diverse group of patients at Satellite Healthcare were trained to use Tablo at home in 11 sessions or less. Treatment adherence exceeded 85% and patients experienced low rates of attrition.
Overview: A new long-term global supply chain strategy was implemented to help ensure patients received life-saving dialysis treatments. Over a 13-month review period, total treatments more than doubled and there were no occurrences of delivery interruption during the height of the pandemic.
Lim, et al., ASN. 2022.
Overview: As part of the largest human factors study ever performed on a hemodialysis device, clinicians performed 7,365 tasks with an observed use error rate of just 0.5%. Additionally, 100% of participants in the study said they could use Tablo safely and effectively.
Overview: Tablo Adaptive Therapy compared to Continuous Renal Replacement Therapy (CRRT) improved nursing efficiency, reduced cost and increased patient time off dialysis at Covenant HealthCare.
Demirjian, et al., ASN. 2022.
Overview: Urea clearance targets were easily achieved on both Tablo, at a dialysate flow rate (Qd) of 300 ml/min, and conventional devices at a Qd of 600 ml/min at the Cleveland Clinic. When using a slightly larger dialyzer with a Qd of 300 ml/min, there was no statistical difference in observed clearance.
Study Design: St. Mark’s Hospital converted all dialysis treatments from an outside vendor (OV) to an insourced model using the Tablo Hemodialysis System. Data regarding training, user satisfaction, treatment success, and treatment costs were recorded from a total of 15 ICU, floor, and HD nurse respondents, for 577 IHD and SLEDD treatments from April through November 2020.
Results: Tablo training, set-up, and treatments were highly successful. Net savings moving to an insourced model with Tablo are projected at $450,000 in the first year (OV $650,000 vs. Tablo $200,000), and net savings per treatment is estimated at $550 (OV $800 vs. Tablo $250).
Study Design: Compared clinical lab outcomes for patients treated on both Tablo and conventional device during their acute stay at St. Francis Hospital.
Results: 105 patients were treated on both Tablo (DFR = 300) and conventional device (DFR ≥ 500) for total of 363 treatments. BUN & K+ clearance was similar on both devices at an equal treatment time of 3.3 hours.
Study Design: Critically ill dialysis patients were recorded for treatment results, staffing use and supply costs. Treatments ranged 4–12 hours, Qb between 100–300 mL/min and Qd between 100–300 mL/min.
Results: 37 critically ill patients had 79 treatments. 82% of treatments achieved their target dose of dialysis and UF. Treatments were at a reduced cost compared to a Non-Tablo CRRT device (65%) and a Non-Tablo IHD device (39%).
Study Design: A prospective, multicenter study was conducted to evaluate “feeling better” on Tablo. Sites collected baseline laboratory, treatment and DSI data prior to conversion to Tablo. Patients completed DSIs at weeks 1, 2, 4, and 8 post conversion. Treatment and routine lab data were recorded.
Results: Of the 16 patients across 3 sites assessed on the Dialysis-Symptom Index Severity Score, Tablo patients’ average DSI was 18.1, compared to non-Tablo patients’ average DSI of 26.4. Tablo patients average DSI Symptom Burden was 6.8; non-Tablo patients’ DSI Symptom Burden was 10.6.
Study Design: Retrospective comparative review of chronic patients’ records dialyzed in 2 clinics where Rx, URR and Kt/V were analyzed 3 months prior to Tablo and once on Tablo.
Results: 29 chronic patients across a large weight range (52–145 kg) achieved Kt/V ≥1.2 at similar frequencies when comparing 192 treatments on Tablo at Qd = 300 mL/min versus 88 treatments on Non-Tablo at Qd = 500 mL/min on 3 times per week hemodialysis.
Study Design: Chronic patients dialyzed in 2 clinics with similar Rx times had their records retrospectively reviewed. Pre/ post dialysis BP, weights, and fluid removal were analyzed 3 months prior to using Tablo and once on Tablo.
Results: 29 chronic patients on Tablo experienced BP stability in majority (66%) of 199 treatments compared to 54% in Non-Tablo treatments (109). Tablo has ↓% Systolic BP drops when compared to Non-Tablo treatments at similar treatment times (242 mins) and UF (2.6 L); 46% less in SBP drops of > 20 mmHg and 67% less in SBP drops of > 40 mmHg.
Study Design: Health Advances (San Francisco, CA) conducted an online survey of US patients with kidney failure currently treated with maintenance HHD, PD, or ICD between July 29 and August 9, 2021. Patients on HHD were required to have started HHD before April 1, 2020, n=202. Questions were delivered using a blinded HHD system concept; reflecting the benefits and features of Outset Medical’s Tablo system.
Results:The Tablo Hemodialysis System solves key device related burdens of HHD and could increase the number and diversity of patients willing to try and remain on home hemodialysis longer-term, potentially enhancing health equity and increasing the proportion of patients who remain in the work-force.
Saffer, et al., NKF. 2022.
Study Design: Health Advances (San Francisco, CA) conducted an online survey of US nephrologists between July 29 and August 9, 2021. Nephrologists were board-certified (n=184), practicing for > 2yrs and actively managing at least 25 patients receiving maintenance dialysis (HHD, PD, or ICD). Questions were delivered using a blinded HHD system concept; reflecting the benefits and features of Outset Medical’s Tablo system.
Results: The Tablo Hemodialysis System solves key device-related burdens that would increase nephrologists’ likelihood to recommend HHD to more patients, which could help expand use of HHD to diverse patient populations, enhancing health equity.
Study Design: Prospective multi-center, open-label, non-randomized, cross-over IDE study. 30 patients from 8 dialysis units in the U.S. with ESKD treated 4x/week over 3 periods: In-Center (~8 weeks), Transition (~4 weeks), In-Home (~8 weeks). Endpoints were weekly std Kt/V ≥ 2.1, incidence of adverse events, UF goal w/in 10% of Rx. Frequency of clinically significant alarms and time to resolve was also recorded.
Results: 28 of 30 patients enrolled completed all treatment periods (>96% adherence) with 57% new to home HD. Patients completed 1806 treatments with a 3.4 hr average treatment time. All study endpoints were met; average weekly std Kt/V = 2.8 and 94% treatments were within 10% of UF goal with no Tablo related pre-specified adverse events. Both periods also had 1.3 clinically significant alarms per treatment with a median resolution time = 8 secs in-center and 5 secs at home.
Study Design: The COVID-19 pandemic was associated with a greater incidence of acute kidney injury (AKI) than expected. The NY Harbor VA faced an overwhelming number of AKI patients who were critically ill with multi-organ failure. They needed to invoke new mechanisms of providing kidney replacement therapy (KRT).
Results: By incorporating a user-friendly platform and an accelerated training program including nephrologists and RNs without previous dialysis experience, study authors were able to nearly double their capacity to deliver KRT during the surge.
Aragon, et al., JASN. 2020.
Study Design: During the COVID-19 pandemic, many facilities experienced dialysis resource shortages of specialized dialysis staff, sterile dialysate, dialysis systems, and dedicated treatment space. The Tablo Hemodialysis System was deployed in numerous hospitals to help meet the increased need for dialysis delivery.
Results: After standard Tablo training (<4 hours), nurses of varied experience and areas of focus reported high levels of satisfaction with their training, found Tablo easy to learn and use, and were confident in treating patients independently. Survey results were similar between Dialysis and Non-Dialysis Nurses.
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