MRI safe pacemaker/ICD contra! - PowerPoint Presentation

Slide1

MRI safe pacemaker/ICD contra!

Dr. A.F.M. Kuijper

Spaarneziekenhuis

, Hoofddorp

Amersfoort 28 september 2012Slide2
Slide3
Slide4

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. Slide5

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. Slide6

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 centerSlide7

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. Slide8

J Am

Coll

Cardiol

2009;54:

549–55Slide9
Slide10

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.Slide11
Slide12

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.Slide13

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.Slide14

Am

Heart

J 2011;161:1096-105Slide15

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 alSlide16

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

.Slide17

Device

en onderzoeksindicatieSlide18

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

. Slide19

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

%).Slide20

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.Slide21

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.Slide22

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.Slide23

Nazarian

Ann

Intern

Med

. 2011;155:415-424

.

Baltimore USA,

Haifa

Israel

555 MRI bij 458

patientenSlide24

In/exclusie

Inclusie

februari

2003-april 2010

Exclusie

:

< 6

weken

implantatie

abandoned

or

epicardial

leads

pacemaker-dependent

pts

with ICD: lack of asynchronous

pacing

capabilitySlide25

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.Slide26

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

implantatieSlide27
Slide28
Slide29
Slide30

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 MRISlide31

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.Slide32
Slide33

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

.Slide34

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

.Slide35

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.Slide36

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 patientsSlide37

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.Slide38

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. Slide39

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.Slide40

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.Slide41

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 performedSlide42

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

.Slide43

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.Slide44

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 1.5TSlide45

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 veiligSlide46

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

indicatieSlide47

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

?Slide48

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

CESlide49
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