mri and cieds - ccme.osu.edu · m gold et al journal of the american college of cardiology, volume...

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Clinical Title

Date

Raul Weiss MD, FAHA, FACC, FHRS and CCDSDirector, Electrophysiology Fellowship ProgramProfessor of Medicine The Ohio State University Wexner Medical Center

MRI and CIEDsC. p. Lao

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

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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

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ACR RECOMMENDATIONSMRI is the preferred imaging solution

1 American Academy of Pain Medicine2 Lopez et al. Burden of Alzheimer’s Disease. AJMC 2011

1 ACR Appropriateness Criteria® – Chronic Neck Pain – 2010.2 ACR Appropriateness Criteria – Low Back Pain – 2011.3 ACR Appropriateness Criteria – Soft Tissue Masses– 2009.4 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); 2010. 23 p. [129 references].5 ACR Appropriateness Criteria - Dementia and Movement Disorders – 2010.

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

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Higuchi K, et al. Heart 2014;100:590-596.

MRI DEFINE AF RADIOFREQUENCY ABLATION RESPONDERS

MRI VolumesGreater than 70 million MRI scans worldwide¹

Over 30 million MRI scans in the U.S. in 2010

1Magnetic Resonance Imaging. University of Nottingham. http://visions.iop.org/v18.html2Medtronic.com. MRI Benchmark Report, IMV Medical Information Division. 2010

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MRI FOR CRM PATIENTS?~ 20% of pacemaker patients need an MRI within 2 years after implantation

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

ESTIMATING THE LIKELIHOOD OF MRI IN PATIENTS AFTER ICD IMPLANTATION: A 10-

YEAR PREDICTION MODEL

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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 2000.

• “…six deaths have occurred without proof of harmful interaction.”Coman, Martin, et al. (abstract) JACC 2001.

• “As many as 25 people have died as a result of MRI experts say.”Pennell WSJ 2003.

• “To date, 10 deaths have been attributed to MRI procedures in patients with pacemakers.” Martin, Coman, Shellock, et al. JACC 2004.

• In Germany, … “it is possible that 96 deaths occurred in 10 years.” Irnich Europace 2005.

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AJR: 188, May 2007

“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

DEATHS

Mechanism of MRI Induce-CIED Dysfunction

• Static Magnetic Field

• Gradient Magnetic Field

• Modulated RF Field of the Magnets

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Temperature Rise at the Tip of the Lead

Peter Nordbeck European Heart Journal (2015) 36, 1505–1511

Possible Complications

Peter Nordbeck European Heart Journal (2015) 36, 1505–1511

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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)

1Bailey et al. Clinical Safety of the ProMRI® Pacemaker System in Pacemaker Implanted Patients Subjected to 1.5T MRI Scanning Conditions. HRS 2014 presentation2Wilkoff et al. Magnetic resonance imaging in patients with a pacemaker system designed for the magnetic resonance environment. Heart Rhythm Journal 2010

Minimal changes in atrial pacing thresholdFigure 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/post-control visit in each group. MRI = magnetic resonance imaging.

U.S. Clinical Trials: MR Conditional Pacemakers

• 272 patients enrolled;

• 229 completed scans

• 258 patients enrolled;

• 226 completed scans

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M Gold et al Journal of the American College of Cardiology, Volume 65, Issue 24, 2015, 2581–2588

Full-Body MRI Scanning in Pts

With ICDs

N=275V-Sensing

VPCT

Clinical Performance of Magnetic Resonance Imaging Conditional and Non-Conditional Cardiac

Implantable Electronic Devices105 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: 10.1111/pace.13060 (in press)

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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


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


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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


Left Ventricular Lead Parameters

• Lead impedance demonstrated a mean change of 27.87 Ohms

• No leads required revision or alteration of pacing vector


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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



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Abandon Leads

• Currently contraindication for MRIs

• In vitro studies

• What do we really know?

PACE 2014;37:1284–1290

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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;37:1284–1290

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;37:1284–1290

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LEGAL AND REIMBURSEMENT ISSUES WITH MRI

MEDICARE NATIONAL COVERAGE DECISION MRIs

“MRI is not covered for patients with cardiac pacemakers…”July 2011 - 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”

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R.J. Russo et. al. N Engl J Med 2017;376:755-64

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

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MagnaSafeStudy 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)

MagnaSafeStudy 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

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MagnaSafe: Flow Chart

MagnaSafe Results; Primary End-Points

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MagnaSafe: Secondary End-Points

Europace 4/2016

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Patients Characteristics

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Impedance, Capture Threshold And Sensing Before Vs. After MRI

Non-Ischemic Myopathy

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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?

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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!

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

clinical events

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Parameters of S-ICD and patient sensation during individual MRI

scans

Types of pulse sequences typically used for imaging of respective

anatomical areas

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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

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M Gold. Journal of the American College of Cardiology, Volume 65, Issue 24, 2015, 2581–2588

Image Quality Scan Sequences Representative Cardiac Images From A Study Patient Implanted

With An MRI System

Possible Complications for CIEDs for Patients Undergoing MRI

1. Damage to the device causing temporary or permanent modification of function2. Movement and/or vibration of the pulse generator or lead(s)3. Excessive heating of the leads4. Induced currents in the leads5. Inappropriate sensing, triggering or activationof the device6. Electrical reset and reed switch malfunctionThese effects could potentially lead to inhibitionof pacemaker output, asynchronous pacing, rapidpaced rates or induction of ventricular fibrillation

Lowe MD, et al. Heart 2015

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MR Scanning In Patients With MR Conditional Devices


MRI: Cardiac Implantable Electronic Device Checklist For Imaging Non-

MR Conditional Devices


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