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Clinical Evidence


Highlighted Dialysis Research and Papers

NKF 2023

Home Hemodialysis Can Help Reduce Total Cost of Care Among Medicare Advantage Members with ESRD
Dunning, Stephan, et al. American Journal of Kidney Disease; NKF 2023.

Study Design: The objective of the study was to estimate the per member per month (PMPM) costs and the five-year savings, from the payer perspective, for a MA health plan generated by incentivizing Tablo® HHD vs. in-center HD (ICHD), aligned with the AAKH goal.

Results: A Medicare Advantage health plan with 500 dialysis members could reduce costs by $686 PMPM and drive $4.2M in savings over five years, achieving AAKH goals by growing Tablo HHD utilization.

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Study Design: The objective of the study was to estimate the per member per month (PMPM) costs and five-year savings generated by establishing a Tablo® HHD program vs. ICHD, for a health system with full risk for a dialysis population delegated by a MA health plan.

Results: A health system taking full-risk on MA dialysis members could reduce costs by $1,749 PMPM and drive $10.7M in savings over five years, achieving AAKH goals by growing Tablo HHD utilization.

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Gender Biases in Nephrology: A 2022 Survey of Female Nephrologists
Silva, Cynthia, et al. American Journal of Kidney Disease; NKF 2023.

Study Design: An electronic survey was distributed to female nephrologists across the country (n=1785). Questions included demographic information, perceptions of barriers to leadership roles, mentorship experience, equitable pay and confidence in achieving gender equality.

Results: Results from 59 respondents were analyzed. Top barriers to gender equality were the need for better work-life integration (75%) and cultural environment of the workplace (75%). Only 32.3% of respondents reported having a female mentor, while 44.8% reported mentoring a female nephrologist. Using a Likert scale, only 6.7% of respondents felt confident change would happen, while the remaining 93.3% of respondents were neutral or not confident.

The Transition from PD to Home Hemodialysis At Hospital Discharge
Khan, Zahraa, et al. American Journal of Kidney Disease; NKF 2023.

Study Design: A 52 year old male with ESRD due to diabetic nephropathy on PD, PVD requiring bilateral below-the-knee amputations (BKA) presented with abdominal pain and cloudy PD effluent. During the hospitalization, the renal consult team discussed hemodialysis with the patient, including both home and incenter HD. The patient expressed his preference for continuing to treat at home, where he would have ability to continue self-care and full-time employment despite his limited mobility due to bilateral BKA.

Results: The patient was discharged from the hospital directly to HHD training. He completed training in 6 weeks and has since been successfully performing HHD. He has returned to work full-time and expresses confidence in his choice and satisfaction with his quality of life with HHD.

Redefining Dialysis Care on the Hawaiian Islands: Reducing Health Disparities and Resource Utilization
Silva, Cynthia. American Journal of Kidney Disease; NKF 2023.

Study Design: A novel approach to addressing access to ESKD care for Native Hawaiian and Pacific Islanders on the Hawaiian Islands through a home hemodialysis program with Tablo.

Results: A total of 24 patients were transitioned to HHD on Tablo. 4 patients were trained in their homes on Maui and Hawaii and 20 were trained traditionally in the dialysis clinic on Oahu. 1893 treatments were performed. Device performance demonstrated a treatment success rate of 97%. No device issues related to high humidity were experienced.

Acute Usage

Study design: Report on the results of simulated use human factors validation testing on a recent software version of the Tablo System with HCPs in the clinic setting.

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.

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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).

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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.

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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%).

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Clinic Usage

Improved Dialysis Symptom Index with Tablo Thrice Weekly Dialysis
Aragon, et al., NKF Spring Clinical Conference. 2021.

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.

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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. 

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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. 

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Home Usage

Study Design: Report on the results of simulated use human factors validation testing on a recent software version of the Tablo System with patients in the home setting.

Results: 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 5,400 tasks tested.

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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.

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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.

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Use of Tablo Hemodialysis Systems to extend dialytic capabilities for the COVID-19-associated surge of AKI
Goldfarb, et al., Journal of the American Society of Nephrology. 2020.

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.

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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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