The Mount Sinai Health System is developing a care bundle for patients with venous thromboembolism (VTE) to improve care transitions from the hospital to outpatient settings. The bundle includes a smartphone app, care coordination tools, and improved documentation. The goal is to help patients adhere to treatment plans by eliminating gaps in care and ensuring patient needs are met. The initiative aims to serve as a model for improving transitions in other acute conditions. It received funding to develop and adopt evidence-based approaches over 24 months.

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IN THIS ISSUE
Health Technology
TRENDS
April 2016 | Vol. 28, No. 4
Bone cement. Based on the
evidence, antibiotic bone cement
use may be more appropriate in
patents at high risk of developing
an infection after hip and knee
joint replacement surgery,
compared with non-antibiotic bone
cement use. More appropriate use
could result in opportunities to
reduce spending. p1
Bundled payments for VTE.
Mount Sinai Health System is
striving to improve transitions
of care for patients with
venous thromboembolism
by developing a care bundle
including a smartphone
app, care coordination, and
improved documentation and
communication tools. Health
Technology Trends spoke with
program developers to discuss
how the project evolved and
where it might be headed. p4
Metal-on-metal hips. The U.S.
Food and Drug Administration
issued its final rule on metal-on-
metal hip replacement devices.
Manufacturers have until Mid-
May to obtain premarket approval
for devices—some of which may
be sitting on hospital inventory
shelves. p6
IN UPCOMING ISSUES
Will your EHRs be held for
ransom?
Limiting Antibiotic Bone Cement
in Arthroplasty to High-risk
Patients Yields Savings
As arthroplasty rates rise for hips and knees
with the aging of the baby boom generation
and the obesity epidemic, many hospitals are
looking at every element contributing to the
cost of these procedures. One such factor is
bone cement: antibiotic or plain. Does the
higher-priced antibiotic bone really prevent
infections after arthroplasty procedures?
Health Technology Trends looks at a synop-
sis of research on evidence and costs from
an ECRI Institute webinar on the topic, held
February 8, 2016.
Arthroplasty Uptick
According to 2010 National Hospital
Discharge Survey Data, 332,000 total hip
replacements (THRs) and 719,000 total knee
replacements (TKRs) are performed annually.
Joint replacement rates are rising: The National
Center for Health Statistics projects 572,000
THRs in 2030 and 3.48 million TKRs for the
same year.
Holding It Together
During THR, the damaged femoral head is
removed and replaced with a metal head on
a metal stem placed into the femoral shaft.
The stem may be press-fit (cementless) or
cemented into the femoral shaft, explained
David Snyder, PhD, senior research analyst for
ECRI Institute’s Health Technology Assessment
Information Service, in a webinar.
Bone cement is also used during TKRs,
during which damaged cartilage and bone are
removed from the distal femur and proximal
tibia and metal and plastic implants are either
press-fit or cemented.
“The bone cement used to attach prosthet-
ics to bone is based on the polymerization of
methyl methacrylate monomers to polymethyl
methacrylate (PMMA),” said Snyder. “PMMA-
based cements are prepared by mixing a
powdered polymer and a liquid monomer.”
Snyder noted that PMMA may cause allergic
reactions in some patients.
A major concern with arthroplasty is infec-
tion. Snyder explained that the presence of
biomaterials in orthopedic surgery procedures
is associated with a higher risk of infections.
Specific physical and chemical properties of
biomaterials, such as bone cement, allow
Bone cement
(continued on page 2)
Palacos®
R and Palacos R+G plain and antibiotic bone cement.
Photo courtesy of Zimmer Biomet.

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bacteria to bind to their surfaces, creating
a “biofilm” that can provide a foundation
for infection, he explained.
Infection as a
Complication
Periprosthetic joint infection (PJI) or
“deep infection” is “a challenging compli-
cation of joint replacement surgery,” said
Snyder. He cited U.S. Centers for Disease
Control and Prevention (CDC) data, which
indicate that infection is the leading cause
of revision surgery for TKRs and the third
leading cause of revision surgery for THRs.
CDC’s official PJI criteria stipulate one
of three conditions must be present:
1. Two positive periprosthetic specimens
(tissue or fluid) with at least one
matching organism
2. A sinus tract communicating with
the joint
3. Three of a set of minor criteria such
as elevated serum C-reactive protein,
elevated synovial fluid white blood cell
count, or polymorphonuclear neutro-
phil percentage that suggest
an infection
CDC established the criteria to stan-
dardize the definition of PJI, Snyder
explained.
Preventing Infection
Certain people are at a higher risk for
infection after arthroplasty. “Individuals
with uncontrolled diabetes, morbid obe-
sity, chronic renal disease, excessive
smoking, rheumatoid arthritis, malnutri-
tion, and other medical conditions are
at increased risk for PJI,” according to
Snyder. Managing these conditions before
surgery is recommended to reduce PJI
risk.
Other presurgical infection prevention
tactics include bacterial decolonization
of the skin by bathing with an antiseptic
agent, as recommended by CDC, and
prophylactic preoperative antibiotics, as
recommended by the American Academy
of Orthopaedic Surgeons.
“IV [intravenous] administration of
first-generation cephalosporins one hour
before the procedure appears to be opti-
mal for most patients,” said Snyder of
prophylactic antibiotics, adding that find-
ings from a meta-analysis of randomized
controlled trials support this method for
THRs; however, similar published evidence
is not available for TKRs.
Antibiotics in the Cement
Use of antibiotic-loaded cement is
another method used to reduce infections.
“The rationale for using antimicrobial
agents within bone cement is to pro-
vide high local drug concentration while
avoiding toxicity associated with sys-
temic antibiotic administration,” Snyder
explained. Today’s antibiotic-loaded
cements contain aminoglycosides, van-
comycin, and macrolides as additives.
Tobramycin is a popular antibiotic of
choice for U.S. surgeons who mix their
own antibiotic into bone cement.
Within the first few days after surgery,
the antibiotics are released in high doses
into the patient’s contiguous tissues.
Antibiotic release slowly continues over
several weeks, months, and sometimes
years.
Statistics on how often antibiotic
bone cement is used in arthroplasty are
dated. Snyder said an oft-cited figure that
11% of U.S. orthopedic surgeons use
antibiotic-loaded bone cement for primary
arthroplasty procedures comes from a
1995 survey. He added that use increased
in 2003 with commercially available
antibiotic bone cement, but declined by
2013. The reason for the decline and
whether costs played a role are unclear.
Polled participants (85) in the webinar
indicated that 77% of their facilities used
antibiotic-loaded bone cement for pri-
mary arthroplasty procedures (13% were
unsure).
European data indicate frequent use of
antibiotic bone cement—between 80% to
90% of surgeons use it for arthroplasties.
Snyder speculated that cheaper antibiotic-
loaded bone cement available outside
the United States may contribute to more
frequent use.
Evidence on Use?
Snyder reviewed clinical literature of
antibiotic bone cement published over
the past five years. This included four sys-
tematic reviews and six clinical trials on
primary THR and TKR. Two of the reviews
published in 2014 and 2015, respectively,
were for THR and compared IV antibiotics

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H E A LT H T E C H N O L O G Y T R E N D S
APRIL 2016 3
to antibiotic bone cement, but Snyder
noted that these reviews used older data
(e.g., randomized controlled trials pub-
lished in 1981 and 1990); nonetheless,
the studies indicated no benefit from use
of antibiotic bone cement for primary
arthroplasty.
“Since prophylactic IV antibiotic use is
now standard, these analyses would sug-
gest that antibiotic-loaded bone cement is
not needed in primary THR,” said Snyder.
Furthermore, the lack of recent data may
indicate a decline in use.
On the TKR front, Snyder reviewed
three systematic reviews and meta-
analyses published in 2014 and 2015.
“All three systematic reviews found no
evidence that using antibiotic-loaded bone
cement in primary TKR decreased PJI
risk.”
High-risk Exceptions?
High-risk patients could be a different
story, noted Snyder. “A large registry study
conducted in the United States found that
patients with diabetes, body mass index
over 35 [kg/m2], and American Society of
Anesthesiologists*(ASA) scores of three or
higher are at increased risk for deep surgi-
cal site infections after TKR.”
In addition, data collected by a 2006
systematic review looked at deep infection
rates for at-risk patients and found that
individuals with diabetes had an infection
rate between 3% and 7%, individuals with
rheumatoid arthritis had a rate between
2.4% and 8.0%, and obese individuals had
an infection rate of 6%. Overall average
infection rates are 2.1% after joint replace-
ment surgery, based on 2009 National
Inpatient Sample data.
Published data for THRs and TKRs indi-
cate that immunocompromised patients
are at higher risk of infection. Snyder
noted that patients with rheumatoid
arthritis, diabetes mellitus, organ trans-
plantation, malnutrition, and obesity fall
into these categories.
“Based on the findings of recent stud-
ies we examined, commercially available
antibiotic-loaded bone cements may
be appropriate for use in primary THR
and TKR patients with diabetes, obesity,
rheumatoid arthritis, and conditions that
suppress the immune system.” Otherwise,
Snyder concluded, “our analysis of recent
clinical literature indicates that routine
use of antibiotic-loaded bone cements for
primary THR and TKR, other than perhaps
for at-risk patients, does not seem to be
warranted.”
Bone Cement Spend
Antibiotic bone cement is consider-
ably more expensive than regular bone
cement, so examining its utilization and
cost in a health system may be worth a
critical look. “Hospital spend data from
the database shows that within the bone
cement category, spend has remained
relatively flat over the past 36 months,”
noted Timothy Browne, director of ECRI
Institute’s PriceGuide Advisory Service.
The data are consistent with overall bone
cement use, he added, referring to data
from PriceGuide 5.0, a database with
spend analytics soft-
ware. “Within the same
period . . . the aver-
age number of [bone
cement] units hospitals
purchased within the
past 12 months ranges
between 14,000 and
19,000 units per month,” which is true
of both plain and antibiotic cement use,
he said.
“Significant cost variations exist
between plain and antibiotic bone
cement,” noted Browne, “The cost for
plain bone cement averages approxi-
mately $71 per unit, while cement with
antibiotics averages approximately $277
per unit,” a 74% difference, he added.
Browne said the most popular plain
bone cement purchased by hospitals
in the PriceGuide database is Palacos®
R (Zimmer, Warsaw, IN, USA,) and the
most popular antibiotic bone cement is
Zimmer’s Palacos R+G antibiotic cement.
One webinar participant asked how
to handle a surgeon’s argument that the
added cost of antibiotic bone cement is
worth it if it prevents one infection, given
that revision surgery alone can run from
$70,000 to $100,000.
“The rationale for using antimicrobial agents
within bone cement is to provide high local drug
concentration while avoiding toxicity associated
with systemic antibiotic administration.”
Bone cement
(continued on page 8)
* The ASA score is a subjective assessment of a patient’s
overall health, with scores of three or more indicating
poor health.

4. ©2016 ECRI Institute. May be reproduced by member institution only for distribution within its own facility. APRIL 20164
H E A LT H T E C H N O L O G Y T R E N D S
SUMMARY
Mount Sinai Health
System is striving to
improve transitions
of care for patients
with venous
thromboembolism
by developing a care
bundle that includes
a smartphone app,
care coordination, and
improved documentation
and communication
tools. Health Technology
Trends spoke with
program developers to
discuss how the project
evolved and where it
might be headed.
New Mount Sinai Initiative
Seeks Improved Care
Transitions for Patients with
Venous Thromboembolism
A new initiative at Mount Sinai Health
System (New York, NY, USA) aims to
improve care for patients with venous
thromboembolism (VTE) as they move
from the hospital to the outpatient setting.
Program developers believe that the initia-
tive could serve as a model for improving
transitions of care in other acute medical
conditions.
Why VTE?
“Successfully treating [VTE] requires a
substantial amount of coordinated care,
and it can be difficult for many patients
to manage their treatment on their own,”
said principal investigator Eric Goodman,
MD, instructor of medicine at Mount
Sinai’s Division of Hospital Medicine.
The new initiative’s goal is to improve the
transition of care in patients with VTE by
helping them work with their outpatient
care providers to eliminate any possible
gaps in care, said Goodman. “Everything
we’re doing is designed to assist doctors
with helping their patients adhere to treat-
ment plans. At the same time, we want
to ensure that patients’ needs are being
met and that no patients
are left behind,” said
Goodman.
Anticoagulants are a
key component of man-
aging VTE, and patients
often require close moni-
toring to reduce risks of
side effects and bleed-
ing, Goodman explained.
“Blood thinners have the
potential to cause serious side effects,
such as major bleeding, so the stakes
are very high,” Goodman told Health
Technology Trends.
Framework of Study
The Pfizer Independent Grants for
Learning & Change and Bristol-Myers
Squibb Independent Medical Education
awarded Mount Sinai a 24-month,
$500,000 grant to accelerate the devel-
opment and adoption of evidence-based
approaches to improve transitions of care
for patients with VTE. Development of the
multifaceted initiative began in October
2015. The study team has developed a
“care bundle” consisting of care manage-
ment services, the app, new tools to assist
with the acute care of patients with VTE,
and improvements to communication tools
to assist in the inpatient to outpatient
transition.
A care bundle is a set of evidence-
based processes that have been proven
to improve patient outcomes when per-
formed together. Goodman and colleagues
created this “novel, synergistic care bun-
dle to allow doctors to do what they think
is best for individual patients,” Goodman
stated.
The VTE App
The cloud-based smartphone app will
let clinical staff collect patient-supplied
data detailing a patient’s medication
adherence and symptom progression.
Data from the app will be integrated into a
patient’s electronic health record to facili-
tate coordination of care. “The app is the
patient-centric part” of the care-improve-
ment initiative, said co-investigator Ashish
Atreja, MD, MPH, chief technology inno-
vation and engagement officer in Mount
Sinai’s Department of Medicine. Atreja’s
team at SinaiAppLab has successfully
developed and used a similar app to help
improve care management of patients
with inflammatory bowel disease.
“We have tried to create a very simple
tool that would engage patients regard-
less of their demographic differences or
experience with various technologies,”
said Atreja. “Our early validation studies
suggest that the majority of patients are
“Successfully treating [VTE] requires
a substantial amount of coordinated
care, and it can be difficult for many
patients to manage their treatment
on their own.”

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H E A LT H T E C H N O L O G Y T R E N D S
APRIL 2016 5
adept at using mobile health solutions
if they are designed the right way,” he
stated.
While patients are still hospitalized, a
social worker or care navigator teaches
patients and their family caregivers at the
bedside how to use the app. “The social
worker helps patients understand the
interface and gets them onboard [the care
transition program] while they are in the
hospital so they are ready to go when they
get home,” said Atreja. The uploaded app
data are primarily text-based and do not
involve high-volume data transfer requiring
high bandwidth or Wi-Fi access, he noted.
“Most patients can get onboard using
their personal [smartphone] data plan,”
said Atreja.
For patients without smartphones, the
social worker can teach patients how to
use the app via a web browser on a com-
puter that patients can access from home
or in a library, for example. “No patients
are left behind,” Atreja stated.
Goodman and Atreja explained that
the care navigator also educates patients
about other aspects of the transition to
outpatient care for VTE and helps connect
patients to their doctors after they leave
the hospital. After discharge, the care
navigator will stay in contact with patients
through the app to help them adhere
to medication plans, attend follow-up
appointments, and facilitate communica-
tion with their primary care physicians
regarding VTE-related issues. The care
navigator is the point person to help
patients get answers from their care team,
they noted.
Collecting the Data
The team will also evaluate the effec-
tiveness of this intervention through
a research study. “As part of the trial,
the study team will measure the rate of
rehospitalizations related to [VTE] and
other patient-centered outcomes,” said
Goodman. “The study will also collect
patient feedback on the [smartphone]
app to make sure that patients are getting
everything they need” to help them adhere
to their care plan to prevent recurrent
VTE or bleeding complications, he stated.
During the study, the smartphone app
will be the primary mode of communica-
tion between patients and the care team,
explained Atreja. “The goal of the study is
to validate the app and the new approach
to care transitions for patients with acute
[VTE],” said Goodman.
All patients hospitalized for VTE
will be eligible to enroll in the quality-
improvement initiative and the research
study, “although the intensity of their
care management will differ based on
their individual risk of hospital readmis-
sion,” said Goodman. The study team will
actively follow patients for three months
from the time of enrollment, and patients
will be eligible to re-enroll in the program if
they are rehospitalized for VTE after that,
he noted.
Sharing Lessons Learned
Implementing the care transition initia-
tive did not require additional hospital
infrastructure. However, the care navigator
is a new position that required a full-time
social worker. “Our goal is to fully roll out
the program in the next month,” said
Goodman and Atreja. If successful, they
believe that their approach may serve as a
model for improving transitions of care for
patients with other acute diseases.
Mount Sinai plans to share the find-
ings with Network of Digital Evidence in
Health (NODE Health), a recently launched
network of academic innovation centers,
industry, investors, and entrepreneurs
with a shared goal of developing evidence-
based digital medicine. ■

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H E A LT H T E C H N O L O G Y T R E N D S
Hospitals to Manufacturers:
What’s the Return Policy on
These Hips?
It’s been a long journey toward an unsur-
prising destination. Now that the U.S.
Food and Drug Administration (FDA) has
announced its decision to require pre-
market approval applications (PMAs) for
metal-on-metal (MOM) hip replacements,
hospitals may want to take a critical look
at their orthopedic hip implant inventory.
Trouble with MOM
MOM hip replacement devices—partial
and total—have long been a subject of
concern from mounting anecdotal evi-
dence since the early 2000s. The trouble
with MOM hips became evident in 2010
when data on high failure rates emerged
from a U.K. joint registry. This prompted
a large recall by DePuy (a Johnson &
Johnson Company, Warsaw, IN, USA) of
its ASR™ MOM hip replacement device,
which had been expedited to market
through FDA’s less rigorous 510(k) path-
way. Several joint manufacturers followed
suit with recalls, amid growing controversy
and costly patient lawsuits. In addition to
failure rates, health safety concerns over
friction of the metal components of the
device have added to the frenzy.
PMAs Required
The days of 510(k)
clearance for MOM hips
are over. On February 18,
2016, FDA issued its final
rule on all MOM hips, which
are to remain Class III
devices (highest risk clas-
sification). The decision
is supported by medical
device reports over the
years, as well as device
recalls, FDA said.
The PMA requirement affects hip joint
metal/metal semi-constrained prosthe-
ses, regardless of whether the acetabular
component is cemented or uncemented.
Manufacturers must file PMAs by May 18,
2016, if they wish to continue marketing
their MOM total hip replacement devices
or plan to market new MOM hip devices.
The PMAs are required to include any
known risks, the effectiveness of the
device, and full reports on safety and
effectiveness of all clinical and nonclinical
data on safety.
According to the final order: “If a PMA
is not filed on or before [May 18, 2016]
the 90th day past the effective date of the
order, that device will be deemed adulter-
ated under section 501(f)(1)(A) of the
FD&C Act, and commercial distribution of
the device must cease immediately.”
FDA said it received “several sets of
comments from nine commenters” on
its January 18, 2016, proposal. Six com-
menters, including the American Academy
of Orthopaedic Surgeons, agreed with
PMA requirements. One comment recom-
mended that PMAs apply to MOM hip
resurfacing devices, but FDA noted this
final rule applies only to devices used in
total hip replacements.
More on FDA’s MOM
Agenda
In addition to the PMA requirement,
FDA referenced additional work with
manufacturers on MOM hips. Related to
imaging, FDA is working with manufactur-
ers to evaluate MOM hips in a magnetic
resonance imaging environment, develop-
ing appropriate labeling to ensure safe
scanning and improving image quality.
On the safety front, the agency is continu-
ing to review Medical Device Reports for
adverse event details and announced the
launch of the International Consortium of
Orthopedic Registries.
To address patient safety concerns
over metal ions, FDA said it will encourage
test labs to participate in a trace element
proficiency testing program, referencing
New York State Department of Health,
Wadsworth Center*(New York, NY, USA).
SUMMARY
The U.S. Food and
Drug Administration
has issued its final rule
on metal-on-metal hip
replacement devices.
Manufacturers have
until mid-May to obtain
premarket approval
for devices—some of
which may be sitting
on hospital inventory
shelves.
“If a PMA is not filed on or before
[May 18, 2016] the 90th day past
the effective date of the order, that
device will be deemed adulterated . .
. and commercial distribution of the
device must cease immediately.”
* Wadsworth Center operates a proficiency testing
program for trace elements in whole blood, serum, and
urine matrices that is designed to support biomonitoring.

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H E A LT H T E C H N O L O G Y T R E N D S
APRIL 2016 7
Value in MOM, Future
Safety Studies
According to AAOS, MOM bearings were
reintroduced over the past two decades
because of their lower volumetric wear
rates in comparison to conventional
metal-on-polyethylene bearings. This has
the potential to substantially reduce wear-
induced osteolysis as the major cause
of failure. Other proposed advantages
of MOM hip arthroplasty include greater
implant stability and bone conservation
(for hip resurfacings). AAOS estimates
that more than 1 million MOM articular
couples have been implanted worldwide
since 1996.
In March 2015, the European
Commission issued a fact sheet based on
the opinion of the Scientific Committee
on Emerging and Newly Identified Health
Risks, which concluded the decision to
use MOM hips should be made on an indi-
vidual basis and that high-risk recipients
should be avoided (women of child-bear-
ing age, small-boned women, and patients
with allergies to relevant materials).
For MOM hips currently on the market,
it remains to be seen what joint manu-
facturers will do. All five manufacturers
of MOM hips on the U.S. market have
approved postmarket surveillance study
plans, according to FDA, and data from
these studies will provide patients and
healthcare providers with additional infor-
mation about the safety profiles of the
implants, including the effect of metal ion
concentrations in the bloodstream. ■

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H E A LT H T E C H N O L O G Y T R E N D S
Bone cement
(continued from page 3)
“If you’re looking to encourage the
physician to change practice, use the evi-
dence and run as many spend analytics
as possible to find out what the cost-
savings opportunities would be, should
you change your current use of antibiotic .
. . bone cement, which may outweigh the
cost that it would take to treat an infection
if one were to occur,” Browne advised.
Surgeons may need to pay more attention
to appropriate patient selection to use
antibiotic bone cement.
Brown looked at the top five facilities
in the PriceGuide database for total bone
cement spend and broke down the spend-
ing (antibiotic versus nonantibiotic). Two
of those facilities spent $2 million on anti-
biotic bone cement versus $500,000 for
nonantibiotic cement.
Browne said he is “optimistic that
these and other health facilities across
the country would be able to identify
additional cost savings in this area by
reexamining their protocols for the use of
antibiotic bone cement.” ■
Table 1. Cost Comparison of Units of Plain versus Antibiotic
Cement in Lowest to Highest Percentile Range.
Percentile Plain Bone Cement
(Based on 278 facilities)
Antibiotic Bone Cement
(Based on 332 facilities)
Low percentile $52 $180
25th percentile $65 $265
Median percentile $70 $289.77
75th percentile $78.85 $310
High percentile $100.56 $405.17