Dr. A.F.M. Kuijper

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16 Νοε 2013 (πριν από 3 χρόνια και 11 μήνες)

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Dr. A.F.M. Kuijper

Spaarneziekenhuis
, Hoofddorp

Amersfoort 28 september 2012


2010 ACCF/ACR/AHA/NASCI/SCMR Expert Consensus Permanent
Cardiac Pacemakers and ICD (1)



damage
or movement of the
device


inhibition
of
pacing output


activation
of
tachyarrhythmia
therapy of the
device


cardiac stimulation


heating
of the electrode
tips



-
> changes
in pacing/defibrillation thresholds,
pacemaker ICD dysfunction or damage (including
battery depletion), arrhythmia, or death.

2010 ACCF/ACR/AHA/NASCI/SCMR Expert Consensus Permanent
Cardiac Pacemakers and ICD(2)



Few
small clinical trials
under
which MR examination with these
devices could be conducted safely.



Pacemaker
-
dependent
patients were excluded
from
these studies,

no episodes
of pacing above the upper rate limit or arrhythmias were
noted,
though 1 patient had a change in device
programming.



ICDs
and pacemakers manufactured
after the year 2000
are more resistant
to the electrical and magnetic fields associated with MR
examination
at
1.5
-
T.



no
deaths
have been reported under conditions in which patients were
deliberately scanned and monitored during
MRI ,
although changes in pacing threshold,
programming changes, need for device reprogramming, and possibly battery depletion
have been reported.

2010 ACCF/ACR/AHA/NASCI/SCMR Expert Consensus Permanent
Cardiac Pacemakers and ICD(3)



2010 pacemakers in
the
USA MR unsafe


MRI examination
of patients with
pacemaker


-

is
discouraged


-

only at
highly experienced
centers


-

strong
clin
. indication, benefits outweigh risk


-

ICD pts in highly
experienced
ICD/MRI center


2010 ACCF/ACR/AHA/NASCI/SCMR Expert Consensus Permanent
Cardiac Pacemakers and ICD(4)

Retained
Transvenous

Pacemaker and Defibrillator Leads



No studies in MRI with
retained
pacemaker
or ICD
leads (either functioning or fractured). Significant
heating of the lead tips may occur.
Discouraged.



MRI in EP center when no
alternatives
to MRI under
compelling clinical circumstances.

J Am
Coll

Cardiol

2009;54:
549

55

MRI at
1.5
-
T
in pts

With

ICD
Naehle

et al.
J Am
Coll

Cardiol

2009;54
:
549

55


18 Non

pacemaker
-
dependent
ICD
patients


S
pecific Absorption
R
ate (SAR)
was limited to 2 W/kg.


ICDs reprogrammed to avoid
competitive pacing and
potential pro
-
arrhythmia:


1
) the lower rate limit
as
low as reasonably achievable; and


2
) arrhythmia detection
on
,
therapy delivery off, (detection
off programming consumes less battery current).


ECG+ pulse
oximetry
. All ICDs
were interrogated
before
and after the MRI examination and after 3 months,
including measurement of pacing
capture threshold
, lead
impedance, battery voltage, and serum
troponin

I.

MRI at 1.5
-
T in pts

With

ICD
Naehle

et al.
J Am
Coll

Cardiol

2009;54:
549

55


All 18 examinations
were
completed safely
.


All
ICDs
interrogated
and reprogrammed
post
-
MRI
.


No changes
of
pacing capture
threshold, lead impedance,
and serum
troponin

I were observed
.


Battery
voltage decreased
significantly from
pre
-

to post
-
MRI.
(4 complete, 9 partial recovery, 3 no
recov
, 2 missing).


M
ean

battery

voltage
decreased
from pre
-
MRI
3.86
±

1.48 V,
to post
-
MRI
3.83
±

1.48
V but was
3.90
±

1.52 V at
FU.


In
2 MRI examinations,
oversensing

of radiofrequency
noise as ventricular fibrillation

occurred
. However
, no
attempt at therapy delivery was made.

Editorial
Roguin

JACC 2009


FDA :
“for some patients, risks of MRI under specific, characterized
scanning and monitoring conditions
may be acceptable
given the
diagnostic benefit.”


Risks of MR scanning should be discussed with the patient, with
written informed consent
.


In ICD patients the MR study should be performed at centers with
expertise in MRI and electrophysiology.


The MR scan should be optimally planned in order to minimize time
and energy.


A physician who is knowledgeable in device therapy and programming
should be
present

during the MR scan.


Pre
-
MR reprogramming, careful patient monitoring during MR
scanning, and thorough follow
-
up after MR scanning must be
performed.


Full resuscitation facilities should be available should any adverse event
occur during MR
scanning.









Am
Heart

J 2011;161:1096
-
105

Safety
, feasibility, and diagnostic value of cardiac
MRI in
patients
with cardiac
pacemakers and implantable
cardioverters

defibrillators at 1.5 T

Am Heart J 2011;161:1096
-

Naehle

et al

Patients

and
Methods


PM/ICD systems > 3 months after implant


stable
physical parameters


EOL> 6 months


pacing
lead
impedances 200
-
2000 Ω


shock
lead
impedance
, 10
-
80
Ω


stable functional parameters
(pacing capture
threshold
<2.5
V at a
pulse
duration

of 0.4
milliseconds
,
sensing

> .5
mV
).


No
abandoned
leads or presence of other MR
imaging

incompatible

devices
.

Device

en onderzoeksindicatie

Resultaten procedure
safety

(1)


No
unexpected changes in heart
rate or
rhythm,
indicating inhibition of ICD output,
shock delivery
, or
sustained
atrial

or ventricular
arrhythmias.


No
torque
or heating
sensation
during

MR
imaging
.


No
changes
programmed parameters.


No change of pacing threshold


No change of
pacing lead impedance to >
2,000 or <200
Ω


No change of
highvoltage

lead
impedance to
>80
or
<10
Ω was observed
.

Resultaten procedure
safety

(2)


Troponin

I.
In
6 (6/32, 19%) patients, baseline
troponin

I
level was
elevated because of the underlying
cardiac condition
.


In
the residual 26 patients,
troponin

I level
was normal
pre
-
MRI
and did not increase above the
upper normal
limit
post
-
MRI
(0/26, 0
%).


Pacing capture threshold


Because

CMR
is
performed
during 8
-

to 15
-
second
breath
-
holds,
duration of
RF exposure is limited, and
cooling off of the lead tip
is possible
between breath
-
holds.


In vivo blood
flow provides an additional cooling effect
and
thus reduces
RF
-
related
heating.


SAR
was
limited to
a maximum of 1.5 W/kg in this
study.

Concluderend


Cardiac
MR may be performed safely when limiting
specific absorption rate,
appropriately monitoring
patients
, and following device reprogramming.


Cardiac
MR delivers good
image quality
and
diagnostic
value in
patients with
right sided device.


Cardiac
MR
in patients
with
right sided device
may
be
performed with an acceptable risk/benefit ratio,
whereas the risk/benefit ratio is
rather unfavorable
in
patients with LSD.

SAFETY OUTCOMES IN
PTS
WITH
ICD AND
PERMANENT
PACEMAKERS UNDERGOING
MRI AT
1.5
-
TESLA
ACC
2010
Vatthyam

et al.
Prystowsky,Indianapolis
, IN



Retrospectief

bij

non
-
pacing dependent pts


N=86, 2005
-
2009 (ICD = 47, PM = 39)


Results:
no
adverse clinical
sequelae

after
MRI


Conclusions: MRI
in non
-
pacemaker
-
dependent
patients with PPMs or ICDs showed no adverse clinical
sequelae

during initial testing and over a mean follow
-
up period of 6.4 months. There was no
oversensing

of
electromagnetic interference with any device.


The
absence
of negative outcomes was found despite
occasional threshold differences between subject
groups.


Nazarian

Ann
Intern
Med
. 2011;155:415
-
424
.

Baltimore USA,
Haifa

Israel

555 MRI bij 458
patienten

In/
exclusie


Inclusie

februari

2003
-
april 2010


Exclusie
:


< 6
weken

implantatie


abandoned

or

epicardial

leads


pacemaker
-
dependent

pts

with ICD: lack of
asynchronous
pacing

capability

Assessment of Device and Lead Variable Changes



Because of considerable
expected variability,


lead
impedance
variations exceeding
30
% capture



threshold
variations exceeding
50
%,
and


sensing
variations exceeding 40
% indicate
clinically
significant changes
in
lead

performance.


Eerste

55
patienten

max 2 w/kg MRI,
nadien

full 1.5 T
MRI


Medtronic, St. Jude, Boston Scientific


Pacemakers van
na

1998
implantatie


ICD’s van
na

2000
implantatie

patienten


438
patienten
, 555 MRI


237 (54%) pacemaker, 201 (46%) ICD


Pacemaker 78%
brady
, 22% CHB


MRI 40% brain, 22% spine, 16% heart


13% abdomen/pelvis, 9%
extremiteit


15% repeat MRI


6% > 3 MRI

Acute
resultaten


Power on reset
bij

3/438 (0.7%),
1 MRI stop,
2
uneventfull

MRI


No device
revision, programming, or
interventions
at
MRI
examination were
otherwise
required.


In pacemakers
without
magnet
-
mode

programming

capability
,
reed
switch activation
by MRI led to
transient,
asymptomatic asynchronous
pacing at the
pacemaker
-
specific
magnet
rate
.


No unexpected or rapid activation of pacing
was
observed

during

MRI.

Lead Sensing, Impedance, and Capture Thresholds at
Immediate

and
Long
-
Term

Follow
-
up


No
immediate or long
-
term change in variables in
any
patient
was large enough to require lead or system
revision
or

device

reprogramming
.

Overall, MRI was performed safely in all patients.


When
the device was located in the MRI field of view
,
image
distortion, signal voids or bright areas, and poor
fat suppression
were
noted.


Selecting
imaging planes

perpendicular to
the plane
of the device generator,
shortening the echo
time, and
using spin echo and fast spin echo
sequences reduced
the qualitative extent of
artifact.


Artifacts, were
limited to thoracic examinations,
and
the
great majority of examinations yielded clinically
useful
information
.


Thoracic
MRI
may

pose more risk
owing to
greater
power deposition over the region
containing the
device.


The
association between
thoracic imaging
and long
-
term right ventricular sensing in
our
study

supports
this

hypothesis.

MRI
bij

pacemaker
afhankelijke

pt
(1)


53
pacemaker
-
dependent patients
without ICD
underwent MRI without safety issues.


It is vital
, however, to emphasize the need for
appropriate
programming of
the device to an
asynchronous mode
,
monitoring by
qualified
personnel, and availability of
external pacing
backup
for such patients

MRI
bij

pacemaker
afhankelijke

pt
(2)


If

a
power
-
on
-
reset

event

occurs
, the device reverts to
an inhibited pacing mode.


Therefore, in
pacemaker
-
dependent patients, the
device may
transiently cease
pacing owing to EMI, and
electrocardiographic monitoring
and pulse
oximetry

are necessary so that the
scan can
be stopped if
inhibition of pacing is noted.

Conclusie

1


Using a
protocol based on device
selection and
programming, MRI can be performed safely
in patients
with certain pacemaker and ICD systems
.



Given the
potential for changes in device variables and
programming
, monitoring
by device experts is
necessary.

Conclusie

2


The decision to
perform MRI in each patient with an
implantable device
should be made by balancing the
potential benefit
of MRI
against the attendant
risks.



Because
thoracic
MRI sequences
have a greater effect
on device variables and
are more
likely to result in
artifacts, these sequences should
be reserved
for
patients with an absolute clinical need.

Magnasafe

Registry
(Russo ACC 2012)


multicenter
, prospective study designed to determine
the frequency of major adverse clinical events and
device parameter changes for 1500 patients with
standard implantable cardiac electronic devices who
undergo clinically
-
indicated,
non
-
thoracic

MRI
at 1.5T.


Magnasafe

pts en methods


Device interrogation
pre
-

and post
-
MRI.


Pacemaker
-
dependent

subjects were programmed to an
asynchronous
pacing
mode
, and non
-
dependent subjects
had pacing functions deactivated.


For ICD
patients, all therapies
were programmed
to off for
those not pacing
-
dependent;


ICD pacing
-
dependent
ICD subjects were excluded.


Primary
study endpoints were device failure
,
generator/lead
replacement, induced arrhythmia, loss of
capture, or electrical reset. Secondary endpoints were
clinically
-
relevant device
parameter changes
. No limits
were placed on the number of repeat scans performed

Magnasafe

Results (1)


April 2009
-
November
2011, 431 MRI studies (324
pacemakers, 107 ICDs
)


88% 1 MRI, 12
meer

dan

1 MRI



No
deaths
, device
failures, generator/lead
replacements, losses of capture, or ventricular
arrhythmias occurred in either the Initial scan or
Repeat scan groups
.

Magnasafe

Results (2)


Decrease
in battery voltage ≥0.04V in
4 %

of the Initial
scan group and 0% of the Repeat scan
group.


Pacing
lead
impedance change ≥ 50Ω
in
7 %

of the
Initial scan group, and
2%

of the Repeat scan group.


No
decrease of ≥ 50% in R
-
wave or P
-
wave amplitude
occurred.


A
pacing threshold increase ≥ 0.5V at 0.4 ms occurred
in
2%

in each group.

Magnasafe

Conclusion


No
association between
number
of MRI scans
and rate
of clinical events or
device parameter
changes.



No
deaths, device failures, generator/lead
replacements, or losses of capture were noted after
clinically
-
indicated
non
-
thoracic
MRI
at 1.5T

Is de huidige
MRI
-
unsafe

pacemaker/ICD
MRI
-
safe
?


> 1000
patienten

MRI


ICD zowel als pacemakers


Pacemaker afhankelijk


Thoracic

MRI/extra
thoracic

MRI



Protocol volgens
Nazarian

is veilig

Waarom

geen

MRI safe device (1)?


Hoeveel

mag

een

nieuwe

feature
kosten
?


Boston Scientific:
fineline

draden

sinds

2000
geimplanteerd

hebben

MRI approval


Boston Scientific
rekent

niets

extra’s
voor

MRI safe
pacemaker/ICD


Medtronic:
onhandige

MRI safe
draden

(
mijn

mening
)


SSIR
bestaat

bij

mijn

weten

niet
, MRI safe is 2
kamersysteem

met 2
draden
,
ook

bij

AAI/VVI pacing
indicatie


Waarom

geen

MRI safe device (2)?


Biotronik

pacing
draden
:
dik

en
onhandig

(
mijn

mening
).


Onderlinge

uitwisselbaarheid
:
geen

firma is
bereid

te

garanderen

dat

andere

draden

op
eigen

device
ook

MRI safe
combinatie

is (
persoonlijke

ervaring

met
Biotronik

draden

en Medtronic
Surescan

PG)


Nieuwe

technologie
/
nieuwe

lead:
weer

een

Riata
?


Waarom geen MRI safe
device

(3)?


Oude
leads
: alleen
BSc

Fineline

retrograde CE
markering


Biotronik
, listprijs A en V
lead

+ 100
-
150 euro, nog
alleen
MR
-
conditional

devices
?


Medtronic
?


St

Jude

SR +5%, DR + 3.5%,
lead

+ 53%, geen
CRTD/ICD


Boston SR +6,6% DR +5,8%
lead

Fineline

retrogr

CE