1 / 51

MRI safe pacemaker/ICD contra!

MRI safe pacemaker/ICD contra!. 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

tuwa
Télécharger la présentation

MRI safe pacemaker/ICD contra!

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. MRI safe pacemaker/ICD contra! Dr. A.F.M. Kuijper Spaarneziekenhuis, Hoofddorp Amersfoort 28 september 2012

  2. 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.

  3. 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.

  4. 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

  5. 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.

  6. J Am CollCardiol 2009;54:549–55

  7. MRI at 1.5-T in ptsWithICD Naehle et al. J Am CollCardiol 2009;54: 549–55 • 18 Non–pacemaker-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.

  8. MRI at 1.5-T in ptsWith ICD Naehle et al. J Am CollCardiol 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). • Meanbatteryvoltage 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.

  9. 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.

  10. Am Heart J 2011;161:1096-105

  11. Safety, feasibility, and diagnostic value of cardiac MRI in patients with cardiac pacemakers and implantable cardiovertersdefibrillators at 1.5 T Am Heart J 2011;161:1096- Naehle et al

  12. 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 durationof 0.4 milliseconds, sensing> .5 mV). • No abandoned leads or presence of other MR imaging–incompatibledevices.

  13. Device en onderzoeksindicatie

  14. 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 duringMR 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.

  15. Resultaten procedure safety (2) • TroponinI. 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%).

  16. 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.

  17. 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.

  18. SAFETY OUTCOMES IN PTS WITH ICD AND PERMANENT PACEMAKERS UNDERGOING MRI AT 1.5-TESLA ACC 2010 Vatthyamet al. Prystowsky,Indianapolis, IN • Retrospectiefbij 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.

  19. Nazarian Ann Intern Med. 2011;155:415-424.Baltimore USA, Haifa Israel555 MRI bij 458 patienten

  20. In/exclusie • Inclusiefebruari 2003-april 2010 • Exclusie: • < 6 wekenimplantatie • abandonedorepicardialleads • pacemaker-dependentptswith ICD: lack of asynchronous pacingcapability

  21. 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 leadperformance.

  22. 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

  23. 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

  24. Acute resultaten • Power on reset bij3/438 (0.7%), 1 MRI stop, 2 uneventfull MRI • No device revision, programming, or interventions at MRI examination were otherwise required. • In pacemakers without magnet-modeprogrammingcapability, 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 observedduring MRI.

  25. 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 ordevicereprogramming.

  26. 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.

  27. 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 studysupports this hypothesis.

  28. 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

  29. MRI bij pacemaker afhankelijke pt (2) • If a power-on-reseteventoccurs, 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.

  30. 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.

  31. 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.

  32. 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.

  33. Magnasafe pts en methods • Device interrogation pre- and post-MRI. • Pacemaker-dependentsubjects 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

  34. Magnasafe Results (1) • April 2009-November 2011, 431 MRI studies (324 pacemakers, 107 ICDs) • 88% 1 MRI, 12 meerdan 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.

  35. 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.

  36. 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

  37. 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

  38. Waaromgeen MRI safe device (1)? • Hoeveelmageennieuwe feature kosten? • Boston Scientific: finelinedradensinds 2000 geimplanteerdhebben MRI approval • Boston Scientific rekentniets extra’s voor MRI safe pacemaker/ICD • Medtronic: onhandige MRI safe draden (mijnmening) • SSIR bestaatbijmijnwetenniet, MRI safe is 2 kamersysteem met 2 draden, ookbij AAI/VVI pacing indicatie

  39. Waaromgeen MRI safe device (2)? • Biotronik pacing draden: dik en onhandig (mijnmening). • Onderlingeuitwisselbaarheid: geen firma is bereidtegaranderendatanderedraden op eigen device ook MRI safe combinatie is (persoonlijkeervaring met Biotronikdraden en Medtronic Surescan PG) • Nieuwetechnologie/nieuwe lead: weereenRiata?

  40. Waarom geen MRI safe device (3)? • Oude leads: alleen BScFineline retrograde CE markering • Biotronik, listprijs A en V lead + 100-150 euro, nog alleen MR-conditionaldevices? • Medtronic? • StJude SR +5%, DR + 3.5%, lead + 53%, geen CRTD/ICD • Boston SR +6,6% DR +5,8% leadFinelineretrogr CE

More Related