MRI and CIEDs. Disclosures

Transcription

1 Date Clinical Title MRI and CIEDs C. p. Lao Raul Weiss MD, FAHA, FACC, FHRS and CCDS Director, Electrophysiology Fellowship Program Professor of Medicine The Ohio State University Wexner Medical Center Disclosures Educational and Research support from Boston Scientific, Medtronic, Abbot Medical, Biotronik and Biosense Webster Advisory Honoraria from Biosense Webster, Biotronik, Merit Medical, Catheter Robotic, Abbot Medical and Boston Scientific Speaker honoraria from Biotronik, Boston Scientific, Abbot Medical and Biosense Webster I will be discussing non-fda approved devices and/or indications 1

2 CIED and MRI Nomenclature MRI Safe MRI Unsafe MRI conditional Certain parameters had to be fulfill to go safely trough the MRI» Patient position» Time» Whole body systemic absorption rate (SAR) i.e. 2 Watts/kilogram (W/kg)» Part of the body to be scan» Cumulative amount of time The Possible Effects of MRIs on CIED Inhibition of pacing Induction of ventricular arrhythmias Damage to the pulse generator Inappropriate defibrillation Increase pacing thresholds Decrease sensing Changes in lead impedance Change on battery impedance Deletion of data 2

3 ACR RECOMMENDATIONS MRI is the preferred imaging solution 1 ACR Appropriateness Criteria Chronic Neck Pain ACR Appropriateness Criteria Low Back Pain ACR Appropriateness Criteria Soft Tissue Masses De La Paz RL, et al. Expert Panel on Neurologic Imaging. ACR Appropriateness Criteria cerebrovascular disease. [online publication]. Reston (VA): American College of Radiology (ACR); p. [129 references]. 5 ACR Appropriateness Criteria - Dementia and Movement Disorders American Academy of Pain Medicine 2 Lopez et al. Burden of Alzheimer s Disease. AJMC 2011 The importance of following pts with MRI systems ARVC HCM Ischemic VT RFA Non Ischemic VT RFA Road map prior to AF RFA Of course all the non-cardiac indications 3

4 MRI DEFINE AF RADIOFREQUENCY ABLATION RESPONDERS Higuchi K, et al. Heart 2014;100: MRI Volumes Greater than 70 million MRI scans worldwide¹ Over 30 million MRI scans in the U.S. in Magnetic Resonance Imaging. University of Nottingham. 2 Medtronic.com. MRI Benchmark Report, IMV Medical Information Division

5 MRI FOR CRM PATIENTS? ~ 20% of pacemaker patients need an MRI within 2 years after implantation ESTIMATING THE LIKELIHOOD OF MRI IN PATIENTS AFTER ICD IMPLANTATION: A 10- YEAR PREDICTION MODEL Saman Nazarian, Matthew Reynolds, Michael Ryan, Tina Hunter, Steven Wolff, Sarah Mollenkopf, Mintu Turakhia Journal of the American College of Cardiology, Volume 65, Issue 10, Supplement, 2015, A1090 5

6 Two Very Distinct Clinical Situations Patients with non-mri-conditional CIEDs (Systems) Non MRI-Conditional system Abandon Leads Epicardial leads Patients Requiring a new implant Non-MRI-Conditional CIEDs (Legacy system) MRI Conditional Devices currently but it will be approve in future MRI-Conditional CIEDs MRI COMPLICATIONS: DEATHS As many as four patients with pacemakers are reported to have died after they inadvertently underwent MR imaging. Sommer, et al. Radiology six deaths have occurred without proof of harmful interaction. Coman, Martin, et al. (abstract) JACC As many as 25 people have died as a result of MRI experts say. Pennell WSJ To date, 10 deaths have been attributed to MRI procedures in patients with pacemakers. Martin, Coman, Shellock, et al. JACC In Germany, it is possible that 96 deaths occurred in 10 years. Irnich Europace

7 DEATHS Respondents from approximately one in 15 sites were aware they had inadvertently imaged a patient who had a permanent pacemaker (eight patients). One of these episodes led to a death Ferris NJ, et al; AJR 2007 AJR: 188, May 2007 Mechanism of MRI Induce-CIED Dysfunction Static Magnetic Field Gradient Magnetic Field Modulated RF Field of the Magnets 7

8 Temperature Rise at the Tip of the Lead Peter Nordbeck European Heart Journal (2015) 36, Possible Complications Peter Nordbeck European Heart Journal (2015) 36,

9 Modifications to CIEDs to Fulfill MRI Conditional Status Ferromagnetic material is significantly reduced Hall effect sensor replaces the mechanical Reed switch Battery circuitry protection is added Filters to prevent gradient and radiofrequency energy coupling were added Software changes (MRI mode) U.S. Clinical Trials: MR Conditional Pacemakers 272 patients enrolled; 229 completed scans 258 patients enrolled; 226 completed scans Minimal changes in atrial pacing threshold Figure 3 Changes in atrial and ventricular pacing capture threshold at 0.5ms from 9- to 12-week visit (pre-mri/pre-control visit) and 1-month post-mri/postcontrol visit in each group. MRI = magnetic resonance imaging. 1 Bailey et al. Clinical Safety of the ProMRI Pacemaker System in Pacemaker Implanted Patients Subjected to 1.5T MRI Scanning Conditions. HRS 2014 presentation 2Wilkoff et al. Magnetic resonance imaging in patients with a pacemaker system designed for the magnetic resonance environment. Heart Rhythm Journal

10 VPCT V-Sensing N=275 Full-Body MRI Scanning in Pts With ICDs M Gold et al Journal of the American College of Cardiology, Volume 65, Issue 24, 2015, Clinical Performance of Magnetic Resonance Imaging Conditional and Non-Conditional Cardiac Implantable Electronic Devices 105 pts, 97 scans with Non-MRI conditional devices and 16 scans with MRI conditional devices. Some were dependent patients with an ICD or pacemaker or patients with epicardial leads. No specified battery voltage requirement. Primary end points: Unintended programming changes Device resets Inappropriate anti-tachycardia therapies Premature termination of the scan Secondary end point: Symptoms that did not require termination of the scan Anand D Shah et. al. doi: /pace (in press) 10

11 Results: Primary and Secondary End Points No occurrences of the primary endpoint were noted in the either group (p=1.0) Three patients in the non-mri conditional group experienced minor symptoms during the scan (palpitations 1, twitching or paresthesia at pulse generator pocket 2; p=1.0) No studies were terminated prematurely because of these symptoms Anand D Shah et. al. doi: /pace (in press) Right Atrial Lead Parameters: non-significant changes in lead impedance and capture Statistically insignificant changes in atrial lead impedance and capture threshold following MRI scanning, regardless of CIED labeling No atrial lead demonstrated a change of more than 100 Ohms following MRI scan Two, non-mri conditional right atrial leads demonstrated a change of more than 1.0 V in capture threshold following MRI, though 1 of these leads demonstrated a decrease in lead threshold neither required replacement or repositioning Anand D Shah et. al. doi: /pace (in press) 11

12 Right Ventricular Lead Parameters: non-significant changes in lead impedance and capture None of these leads had associated capture threshold changes of more than 0.5V Anand D Shah et. al. doi: /pace (in press) Left Ventricular Lead Parameters Lead impedance demonstrated a mean change of Ohms No leads required revision or alteration of pacing vector Anand D Shah et. al. doi: /pace (in press) 12

13 Imaging Quality Imaging was not significantly impaired and MR studies were considered diagnostic in all cases Inclusion of the pulse generator in the field of view was noted to be a frequent cause of artifact Anand D Shah et. al. doi: /pace (in press) Anand D Shah et. al. doi: /pace (in press) 13

14 Abandon Leads Currently contraindication for MRIs In vitro studies What do we really know? PACE 2014;37:

15 Abandoned Leads They are susceptibility to induced currents, resulting in tissue heating and arrhythmias Previous clinical studies demonstrating safety of MRI in patients with CIEDs excluded patients with abandoned leads This concern reflects in vitro modeling and theoretical considerations, and has not been validated in vivo Higgins et.al. PACE 2014;37: Abandon Leads N= 19 Patients 16-PCMKs/ 3-ICDs (2 with Dual coils) 35 MRI scanning No acute complications No Arrhythmias No discomfort to the patient 12 re-implanted and have a long F/U (average 82 months) with normal Pacing and Sensing (only one has a minor increase in the thresholds) Higgins et.al. PACE 2014;37:

16 LEGAL AND REIMBURSEMENT ISSUES WITH MRI MEDICARE NATIONAL COVERAGE DECISION MRIs MRI is not covered for patients with cardiac pacemakers July CMS reconsiders longstanding MRI policy Reviews MRI benefits and MRI device data Decision: DON T eliminate restriction for all pacemakers (e.g., based on MagnaSafe) DO create an EXCEPTION for MRI approved devices unless patient has an FDA indicated device for use in the MRI environment 16

17 R.J. Russo et. al. N Engl J Med 2017;376: MagnaSafe Registry Non-thoracic MRI at a field strength of 1.5 T (all vendors) MRI was performed in 1000 pts with Non-MRI- Conditional pacemaker and in 500 pts with Non- MRI-Conditional ICD Pacemaker or ICD generator, from any manufacturer implanted after 2001 No time limit to the leads No abandon leads No extra thoracic devices No pacer-dependent ICD pts 17

18 MagnaSafe Study Primary End Points Death Generator or lead failure requiring immediate replacement, loss of capture (for pacing dependent patients with pacemakers) New-onset arrhythmia Partial or full generator electrical reset (POR) MagnaSafe Study Secondary End Points Battery voltage decrease of 0.04 V or more Pacing lead threshold increase of 0.5 V or more P-wave amplitude decrease of 50% or more R-wave amplitude decrease of 25% or more 50% or more Pacing lead impedance change of 50 ohms or more High-voltage (shock) lead impedance change of 3 ohms or more 18

19 MagnaSafe: Flow Chart MagnaSafe Results; Primary End- Points 19

20 MagnaSafe: Secondary End- Points Europace 4/

21 Patients Characteristics 21

22 Impedance, Capture Threshold And Sensing Before Vs. After MRI Non-Ischemic Myopathy 22

23 Quality Of Magnetic Resonance Imaging The cardiac MRI images were used to determine the presence and pattern of LGE in 95 out of 96 patients who underwent a cardiac MRI The studies were non-diagnostic in four patients due to extensive artifacts from the ICD generator Among the diagnostic studies, LGE was detected in 65 patients in an area without artifact from the ICD generator. Important Considerations What to do with Change-Outs? Extract leads and give an MRI-conditional system System Leave the leads and give an MRI-conditional CEID? Just Replace with a non-mri-conditional system What to do with CRT-P/D If you need to go out-of-system because the lead you need to finish the implant is not MRI conditional Future MRI-conditional lead and new devices? 23

24 Conclusions MRI in patients with and MRI-Conditional CIEDs is safe MRI in patients with Non-MRI- Conditional CIEDs is safe but. Medico-legal consequences It is not reimbursed (unless in an investigational protocol) Largest # of patients Thank You! 24

25 Summary of patient anatomical data and scan locations, along with noted clinical events 25

26 Parameters of S-ICD and patient sensation during individual MRI scans Types of pulse sequences typically used for imaging of respective anatomical areas 26

27 Changes Required for MRI Compatibility in CIEDs Ferromagnetic material was reduced Hall sensor replaces the mechanical reed switch Filters to prevent gradient and radiofrequency (RF) energy coupling were added Battery circuitry protection was added MRI programmable mode 27

28 Image Quality Scan Sequences Representative Cardiac Images From A Study Patient Implanted With An MRI System M Gold. Journal of the American College of Cardiology, Volume 65, Issue 24, 2015, Possible Complications for CIEDs for Patients Undergoing MRI 1. Damage to the device causing temporary or permanent modification of function 2. Movement and/or vibration of the pulse generator or lead(s) 3. Excessive heating of the leads 4. Induced currents in the leads 5. Inappropriate sensing, triggering or activation of the device 6. Electrical reset and reed switch malfunction These effects could potentially lead to inhibition of pacemaker output, asynchronous pacing, rapid paced rates or induction of ventricular fibrillation Lowe MD, et al. Heart

29 MR Scanning In Patients With MR Conditional Devices Lowe MD, et al. Heart 2015 MRI: Cardiac Implantable Electronic Device Checklist For Imaging Non- MR Conditional Devices Lowe MD, et al. Heart