New Methods of Delivering Dialysis Care

1/24/2014
New Methods of
Delivering Dialysis Care
Brent Miller, M.D.
Outline
How did we get here?
Where are we going?
Current attempts at changing the paradigm
Technology
Current machines
FDA policy
Vertical Integration
Healthcare Reform and Finances
How did we get here?
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Thrice-weekly Hemodialysis
“Initially an 8 hr two or
three times weekly
schedule was used…It
soon became obvious that
a dialysis 8 to 10 hr three
times weekly seemed to
control all of the major life
threatening complications…Thus, when the Medicare
ESRD Program came into being in 1973, three times
weekly dialysis…was the best compromise to provide
adequate dialysis and to give the opportunity to treat the
most patients with limited resources.”
Scribner et al Hemodialysis International 2004; 8: 188--192
Growth of St. Louis City/County
Dialysis Centers
2013 Map of Dialysis Center
(counties: St. Louis City, County, St. Charles,
Jefferson, Madison and St. Clair, IL)
64 Units
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Dialysis Frequency May Be Important
USRDS data base analyzing
when patients on hemodialysis
suffer adverse complications in
relationship to their dialysis day.
Foley RN et al. N Engl J Med 2011;365:1099-1107.
Risk of Sudden Death during Dialysis Interval
80 patients with sudden death
Bleyer et al. Kidney Int 69:2268, 2006
Left ventricular mass was reduced significantly more in the Frequent Hemodialysis
group
The horizontal distance between the Kaplan-Meier curves at the 50% value on the vertical axes indicates the median composite outcome
results. Median outcomes for the composite outcome of death or change in LV mass correspond to a reduction in LV mass of 12.3g in the
frequent-hemodialysis group, as compared with a reduction of 2.2g in the conventional dialysis group (difference in medians, 10.1g).
Figure reprinted with permission from The New England Journal of Medicine. Copyright © 2010 Massachusetts Medical Society. All rights reserved.
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Long Term Survival in FHN
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Chertow et al. ASN 2013
Dialysis Options
Incenter hemodialysis MWF or TThSat for kt/V of 1.2
Peritoneal Dialysis with glucose containing solutions,
maybe addtion of icodextrin
Some patients have access to:
Staff-assisted home hemodialysis
More frequent in center or home hemodialysis
Incenter or home nocturnal hemodialysis
Current Attempts to Change
the Paradigm
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NxStage Kidney Care
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Technology
Current Technology
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Newer Technology in Development
Fresenius PAK
Baxter Vivia
Home Dialysis Plus Tablo
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FDA Innovation Challenge ESRD
Announced in January 2012
32 applications were submitted, many more than
were expected
3 chosen:
Implantable Renal Assist Device
Wearable Artificial Kidney
Hemoaccess Valve System
Innovation Pathway
The innovation pathway is “an evolving
system designed to help safe, breakthrough
medical products reach patients in a timely
manner”
Help….consider the balance between
allowing the device to proceed and its
potential benefit to the relevant general
population
Vertical Integration
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Reasons for Vertical Integration
Vertical Market Failure: the market is too risky
Companies in adjacent stages of the industry chain have more
market power
Integration would create or exploit market power by raising
barriers to entry or allowing price discrimination
The market is young and the company must forward integrate
to develop a market
Integrate into the stages of the industry that have the greatest
economic surplus
Source: McKinsey and Company; Stuckey and White,
Sloan Management Review 1993
Healthcare Reform and
Finance
What happened to the value of GPS
device companies after the launch of
Google Maps?
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2013 Map of Dialysis Center
(counties: St. Louis City, County, St. Charles,
Jefferson, Madison and St. Clair, IL)
64 Units
Multi-tiered Dialysis Care
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