Dr. A.F.M. Kuijper Spaarneziekenhuis, Hoofddorp Amersfoort 28
september 2012
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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.
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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.
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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
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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.
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J Am Coll Cardiol 2009;54:54955
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MRI at 1.5-T in pts With ICD Naehle et al. J Am Coll Cardiol
2009;54: 54955 18 Nonpacemaker-dependent ICD patients Specific
Absorption Rate (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.
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MRI at 1.5-T in pts With ICD Naehle et al. J Am Coll Cardiol
2009;54: 54955 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).
Mean 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.
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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.
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Am Heart J 2011;161:1096-105
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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
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Patients and Methods PM/ICD systems > 3 months after implant
stable physical parameters EOL> 6 months pacing lead impedances
200-2000 shock lead impedance, 10-80 stable functional parameters
(pacing capture threshold.5 mV). No abandoned leads or presence of
other MR imagingincompatible devices.
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Device en onderzoeksindicatie
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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 80 or
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.
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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.
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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.
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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.
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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
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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.
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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.
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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.
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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.
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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
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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.
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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 50 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.
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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
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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
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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 extras 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
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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?
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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