For
people
going
to
emergency
departments
(EDs)
for
syncope,
an
extended
ECG
monitoring
protocol
made
an
eventual
diagnosis
more
likely
even
though
their
fainting
frequency
was
ultimately
unchanged,
according
to
the
ASPIRED
trial.
Across
several
dozen
hospitals
in
the
U.K.,
people
with
acute
unexplained
syncope
were
randomized
to
immediate
14-day
cardiac
monitoring
—
using
the
BodyGuardian
Mini,
a
small,
adhesive,
and
waterproof
continuous
heart
monitor
—
or
standard
care.
The
study’s
main
finding
was
that
at
1
year,
the
mean
number
of
patient-reported
episodes
of
syncope
at
1
year
came
out
similar
between
groups
(1.37
with
the
intervention
vs
1.58
with
standard
care;
incidence
rate
ratio
0.89,
95%
CI
0.68-1.18),
reported
Matthew
James
Reed,
MD,
of
the
Usher
Institute,
Edinburgh
University
in
Scotland.
Nonetheless,
immediate
14-day
cardiac
monitoring
was
associated
with
major
benefits:
an
intriguing
reduction
in
all-cause
death
(1.5%
vs
2.9%;
OR
0.50,
95%
CI
0.27-0.93)
and
better
identification
of
a
clinically
significant
cardiac
arrhythmia
(22.0%
vs
9.0%;
OR
2.95,
95%
CI
2.28-3.81).
ASPIRED
was
presented
at
the
European
Society
of
Cardiology
(ESC)
Congress
in
Munich.
The
trial
was
simultaneously
published
in
the
New
England
Journal
of
Medicine.
“Applying
a
14-day
ambulatory
cardiac
patch
monitoring
at
index
ED
visit
did
not
reduce
patient-reported
syncope
episodes
at
1
year.
Early
monitoring
did,
however,
more
than
double
arrhythmia
diagnosis
…
and
reduced
the
time
to
detection
from
around
55
days
to
22
days.
More
patients
also
received
prompt,
targeted
treatment,
such
as
permanent
pacing
and
antiarrhythmic
drugs,”
Reed
reported.
“We
believe
this
provides
a
biologically
plausible
mechanism
for
our
1-year
survival
benefit,”
he
told
the
audience.
Reed
noted
that
diagnosing
an
underlying
cardiac
arrhythmia
remains
difficult
in
patients
with
syncope
who
present
to
the
ED;
approximately
half
these
patients
leave
the
ED
with
no
identifiable
cause
for
the
syncope.
The
challenge
is
determining
if
the
syncope
has
a
vasovagal
origin,
or
is
due
to
postural
hypotension
or
a
serious
cardiac
issue
such
as
structural
heart
disease
or
arrhythmia.
ASPIRED
builds
on
prior
evidence
that
detection
of
an
arrhythmia
in
a
patient
with
unexplained
syncope
is
most
likely
when
cardiac
monitoring
is
initiated
early,
ideally
at
the
index
visit
to
the
ED.
“Technically,
this
is
a
negative
trial.
Nevertheless,
the
ASPIRED
trial
provided
two
very
important
findings.
It
allowed
a
higher
detection
rate
of
clinically
significant
arrhythmias
in
22%
of
cases
and
reduced
all-cause
mortality
by
50%,”
said
ESC
session
discussant
Michele
Brignole,
MD,
of
IRCCS
Istituto
Auxologico
in
Milan,
Italy.
“However,
the
direct
cause-effect
relationship
between
arrhythmias
and
all-cause
mortality
remains
uncertain,
probably
unlikely,”
Brignole
argued.
“My
alternative,
plausible
biological
mechanism
is
that
the
reduction
in
all-cause
mortality
may
reflect
more
thorough
investigation
following
arrhythmia
detection,
not
a
direct
relationship.”
The
ASPIRED
investigators
reported
that
all
trial
participants
could
be
referred
for
evaluation
by
a
syncope
specialist
and
would
be
seen
ideally
within
6
weeks
after
the
index
event.
Treatment
decisions
based
on
the
results
from
the
ambulatory
heart
monitor,
including
further
investigation,
were
at
the
discretion
of
the
treating
clinician.
If
a
serious
cardiac
arrhythmia
was
detected,
the
patient’s
local
team
was
notified
within
24
working
hours.
ASPIRED
was
an
open-label
trial
conducted
at
45
U.K.
hospitals.
Researchers
had
people
16
years
or
older,
with
syncope
remaining
unexplained
after
an
evaluation
in
the
ED,
randomized
1:1
to
14-day
ambulatory
ECG
monitoring
or
to
standard
care.
Both
groups
were
instructed
to
record
any
fainting
episode
in
a
paper
diary.
The
intervention
group
was
fitted
with
the
BodyGuardian
Mini
as
soon
as
possible
and
was
also
instructed
to
press
a
button
on
the
heart
monitor
after
recovery
from
any
fainting.
The
study
cohort
came
out
to
a
total
of
2,234
randomized
individuals
(mean
age
58.3
years,
52.1%
men).
Excluding
those
lost
to
follow-up,
the
investigators
had
1,970
patients
for
the
primary
analysis.
Reed’s
group
logged
49
adverse
events
in
the
intervention
group
and
eight
adverse
events
among
controls.
Most
of
the
events
in
the
intervention
group
were
attributable
to
minor
skin
irritation.
There
was
one
serious
adverse
event
in
each
group:
one
infection
of
an
implantable
loop
recorder
in
a
patient
in
the
extended
monitoring
group
(resulting
in
removal
of
the
device),
and
a
hematoma
at
a
pacemaker
wound
site
in
a
patient
in
the
standard
care
group
(resulting
in
outpatient
administration
of
antibiotics).
Both
of
these
events
were
judged
to
be
unrelated
to
the
trial
intervention,
according
to
the
authors.
Limitations
of
the
trial
include
its
open-label
design
and
lower
than
anticipated
rate
of
recurrent
syncope.
The
ongoing
REMOSYNCED
study
may
provide
external
validation
in
a
different
care
setting,
Reed
and
colleagues
noted.
Please
enable
JavaScript
to
view
the