PMID- 31697042
OWN - NLM
STAT- MEDLINE
DCOM- 20200821
LR  - 20200821
IS  - 1542-4758 (Electronic)
IS  - 1492-7535 (Print)
IS  - 1492-7535 (Linking)
VI  - 24
IP  - 1
DP  - 2020 Jan
TI  - Safety and efficacy of the Tablo hemodialysis system for in-center and home 
      hemodialysis.
PG  - 22-28
LID - 10.1111/hdi.12795 [doi]
AB  - INTRODUCTION: Home hemodialysis remains underutilized despite observational data 
      indicating more favorable outcomes with home compared with in-center 
      hemodialysis. The Tablo Hemodialysis system is designed to be easy to learn and 
      use and to facilitate adoption of home hemodialysis. The objective of the current 
      investigational device exemption (IDE) study was to evaluate the safety and 
      efficacy of Tablo managed in-center by health care professionals and in-home by 
      patients and/or caregivers. METHODS: A prospective, multicenter, open-label, 
      crossover trial comparing in-center and in-home hemodialysis using Tablo. There 
      were 4 treatment periods during which hemodialysis was prescribed 4 times per 
      week: 1-week Run-In, 8-week In-Center, 4-week Transition, and 8-week In-Home. The 
      primary efficacy endpoint was weekly standard Kt/V(urea)  >/= 2.1. The secondary 
      efficacy endpoint was delivery of ultrafiltration (UF) within 10% of prescribed 
      UF. We collected safety and usability data. FINDINGS: Thirty participants 
      enrolled and 28 completed all trial periods. Adherence to the protocol 
      requirement of 4 treatments per week was 96% in-center and 99% in-home. The 
      average prescribed and delivered session lengths were 3.4 hours for both the 
      In-Center and the In-Home periods. The primary efficacy endpoint for the 
      intention-to-treat cohort was achieved in 199/200 (99.5%) of measurements during 
      the In-Center period and 168/171 (98.3%) In-Home. The average weekly standard 
      Kt/V(urea) was 2.8 in both periods. The secondary efficacy UF endpoint was 
      achieved in the ITT cohort in 94% in both in-center and in-home. Two prespecified 
      adverse events (AEs) occurred during the In-Center period and 6 in the In-Home 
      period. None of the AEs were deemed by investigators as related to Tablo. The 
      median resolution time of alarms was 8 seconds in-center and 5 seconds in-home. 
      CONCLUSION: Primary and secondary efficacy and safety endpoints were achieved 
      during both In-Center and In-Home trial periods. This study confirms that Tablo 
      is safe and effective for home hemodialysis use.
CI  - (c) 2019 Outset Medical. Hemodialysis International published by Wiley Periodicals, 
      Inc. on behalf of International Society for Hemodialysis.
FAU - Plumb, Troy J
AU  - Plumb TJ
AD  - University of Nebraska, Nebraska Medical Center, Omaha, Nebraska, USA.
FAU - Alvarez, Luis
AU  - Alvarez L
AD  - Palo Alto Medical Foundation, Palo Alto, California, USA.
FAU - Ross, Dennis L
AU  - Ross DL
AD  - Kansas Nephrology Research Institute, Wichita, Kansas, USA.
FAU - Lee, Joseph J
AU  - Lee JJ
AD  - Nephrology Associates Medical Group, Riverside, California, USA.
FAU - Mulhern, Jeffrey G
AU  - Mulhern JG
AD  - Fresenius Kidney Care Pioneer Valley Dialysis, West Springfield, Massachusetts, 
      USA.
FAU - Bell, Jeffrey L
AU  - Bell JL
AD  - Southwest Georgia Nephrology Clinic, Albany, Georgia, USA.
FAU - Abra, Graham
AU  - Abra G
AD  - Satellite Healthcare, Mountain View, California, USA.
FAU - Prichard, Sarah S
AU  - Prichard SS
AD  - University of Western Ontario, London, Ontario, Canada.
FAU - Chertow, Glenn M
AU  - Chertow GM
AD  - Stanford University School of Medicine, Palo Alto, California, USA.
FAU - Aragon, Michael A
AU  - Aragon MA
AD  - Clinical Development, Outset Medical, San Jose, California, USA.
AD  - DaVita Grapevine at Home, Grapevine, Texas, USA.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20191107
PL  - Canada
TA  - Hemodial Int
JT  - Hemodialysis international. International Symposium on Home Hemodialysis
JID - 101093910
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Cohort Studies
MH  - Cross-Over Studies
MH  - Female
MH  - Hemodialysis, Home/*methods
MH  - Humans
MH  - Kidney Failure, Chronic/*therapy
MH  - Male
MH  - Middle Aged
MH  - Prospective Studies
MH  - Renal Dialysis/methods
MH  - Young Adult
PMC - PMC7027451
OTO - NOTNLM
OT  - Adequacy of dialysis
OT  - hemodialysis
OT  - hemodialysis delivery systems
OT  - home
OT  - kinetics
OT  - volume control
EDAT- 2019/11/08 06:00
MHDA- 2020/08/22 06:00
PMCR- 2020/02/18
CRDT- 2019/11/08 06:00
PHST- 2019/07/19 00:00 [received]
PHST- 2019/09/17 00:00 [revised]
PHST- 2019/09/24 00:00 [accepted]
PHST- 2019/11/08 06:00 [pubmed]
PHST- 2020/08/22 06:00 [medline]
PHST- 2019/11/08 06:00 [entrez]
PHST- 2020/02/18 00:00 [pmc-release]
AID - HDI12795 [pii]
AID - 10.1111/hdi.12795 [doi]
PST - ppublish
SO  - Hemodial Int. 2020 Jan;24(1):22-28. doi: 10.1111/hdi.12795. Epub 2019 Nov 7.