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MRI-Conditional Pacemakers MRI-Conditional Pacemakers

MRI-Conditional Pacemakers - PowerPoint Presentation

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MRI-Conditional Pacemakers - PPT Presentation

Improving Patient Outcomes Neil K Sanghvi MD FACC FHRS Cardiac Electrophysiology Jacksonville FL Office 9044230010 Disclosures Received honoraria and travel expenses from ID: 552380

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Slide1

MRI-Conditional Pacemakers: Improving Patient Outcomes

Neil K. Sanghvi, M.D., F.A.C.C.,

F.H.R.S.

Cardiac Electrophysiology

Jacksonville, FL

Office: 904-423-0010Slide2

DisclosuresReceived honoraria and travel expenses from Boehringer Ingelheim, Medtronic, Boston Scientific, St. Jude Medical. Consulted for St. Jude Medical.Slide3

Discussion GoalsGrowing need for MRI access for patientsSociety guidelines for performing MRIs in patients with CIEDSHazards of placing non-MR conditional CIEDs in a MRI machineMRI conditional PPM – data and device designSlide4

MRI: Powerful Diagnostic ToolNon-ionizing radiationExcellent differentiation between soft tissues without the need for iodinated contrastUtilization increasing as more applications become validatedSlide5

1

Magnetic

Resonance Imaging (MRI) Equipment – A Global Strategic Business Report, Global Industry Analysts, Inc.

, San

Jose, CA. 2002

.

2

Roguin A.

Europace

2008;10:336-346

> 65yo

2x as likely to require

MRI1 80% pacemaker patients > 65yo

MRI Access Is a Growing NeedSlide6
Slide7

MRI Access Is a Growing Need2.9 million patients received pacemakers in the US between 1993 - 20091Approximately 3 of 4 pacemaker patients indicated for MRI over lifetime of their device2Pacemaker patients previously subjected to risk/benefit analysisIf risk high, MRI is deferred for less optimal studiesIf risk low, MRI performed on devices not approved for MRI with known risk of device complications

1

Greenspon AJ. JACC 2012;60(16):1540-45.

2

Kalin R. PACE 2005;28:326-328Slide8

Computed Tomography vs. MRIMRI

Image sources: Dr.

Torsten

Sommer

. University of Bonn.

CT

Potential Risks:

Delayed

diagnosis

Missed diagnosis

Increased risk from alternative imaging modalitiesSlide9

Unexpected programming changes, inhibition of pacemaker output, failure to pace, transient asynchronous pacing, rapid cardiac pacing, the induction of ventricular fibrillation, heating of the tissue adjacent to the pacing or ICD system, early battery depletion, and outright device failure requiring replacement may all occur during MRI of patients with pacemakers or ICDs.

ACR Guidance Document 2007

Patients who have a pacemaker or ICD should not undergo an MR study if an alternative diagnostic test is available, and

MR imaging should only be considered in cases in which the potential benefit to the patient clearly outweighs the risks to the patient.

AHA Scientific Statement 2007

Society StatementsSlide10

Nazarian S.: http://crm.cardiosource.org/Learn-from-the-Experts/2012/10/MRI-in-Patients-with-ICDs-and-Pacemakers.aspx

A 2-second pause was noted…

…diminished battery voltage was noted immediately after MRI…

Significant changes were reported in 9.4% of leads…

1.9% required a change in programmed output.

…increased capture threshold was noted post MRI.

…4 out 114 examinations resulted in an

TnI

levelSlide11

MRI: Three Powerful FieldsStatic Field

Gradient Field

RF FieldSlide12

Multiple Potential Interactions

Roguin

A.

Europace

2008;10:336-346

Santini

L. PACE 2013;36:270-78Slide13

Multiple Potential Interactions

Static

Gradient

RF

Vibration

Case Heating

Force & Torque

Lead Heating

Stimulation

Device InteractionsSlide14

Hazards of MRI

Gimbel

JR.

Europace

2009;11(9):1241-42Slide15

Roguin

A.

Europace

2008;10:336-346

Inappropriate sensing of VF

Hazards

of MRISlide16

http://

www.medscape.org

/

viewarticle

/738347_3Slide17

MRI Conditional Labeling

MR Safe

MR Conditional

MR Unsafe

*

ASTM standard F2503: Standard Practice for Marking Medical Devices and Other Items for Safety in the

Magnetic Resonance Environment

ASTM Standard F2503

*

Defines Three Terms:Slide18

Santini

L. PACE 2013;36:270-78Slide19

Pacemaker Design SolutionsMinimize ferromagnetic contentIsolated circuit board Hall sensorOptimize input circuitryCircuit component change

Unintended cardiac stimulation

Device interactions

Force and Torque

Slide courtesy of

MedtronicConnect.comSlide20

5076

5086MRI

Medtronic Lead Heating Solution

Lead inner conductor coil design mitigates lead heating

4

filar

to 2

filar

increases inductance and reduces heating

0

10

20

30

40

50

60

70

80

90

100

0

5

10

15

20

25

30

35

40

45

50

Percent of Maximum

Lead Path

5076 vs. 5086MRI Comparison

5076

-

52

5086

-

52

Slide courtesy of

MedtronicConnect.comSlide21

SJM Lead Heating SolutionSlide22

X-rays identify the system via unique radiopaque MRI symbol

Positive System ID:

Radiographic Studies

Slide courtesy of

MedtronicConnect.comSlide23

Positive System ID:Radiographic StudiesSlide24

Prospective, randomized, multi-center trial

464 implanted patients

42 international centers

Randomization (MR scan: Control/no MR scan); 1.5T MRI

Enrollment

February 2007 through July 2008

Follow-up: November 2008

11.2 ± 5.2 months (range 0.1-21.5 months)Slide25

Medtronic Revo MRI™ ConclusionsAll 5 primary endpoints were met Safety MRI procedure-related complication-free rate

Effectiveness

Atrial pacing capture thresholds

Ventricular pacing capture thresholds

Atrial sensed amplitudes

Ventricular sensed amplitudes

Wilkoff

BL. Heart Rhythm 2011;8:65-73Slide26

MedtronicSt. JudeBiotronikImplant TimePPM + Leads > 6 monthsStable pacing thresholdsPPM + Leads > 6 monthsPectoral Implant+++

No other CEIDs or leads implanted

+

+

+

N

o abandoned leads, lead extenders or adaptors

+

+

+

Capture threshold <2V

@ 0.4ms

++Capture threshold <2.5V @ 0.5ms+200 ≥ Impedance ≥1500 Ohms+++

No diaphragmatic stimulation at 5V @ 1ms+

+

Battery charge ≥ 30%

+

MRI conditional

programming

+

+

+

Santini

L. PACE 2013;36:270-78Slide27

Should I Insist on a MRI – conditional PPM for my patient?

ANSWER

: Probably

Downsides of MRI – compatible devices:

Cost – more expensive than traditional PPM

Unknown

battery

longevitySlide28

Proposed Indications for Implantation

Santini

L. PACE 2013;36:270-78Slide29

Summary75% of patients with CIEDs will likely require an MRI at some pointDenying MRIs in clinically indicated situations may result in sub-optimal outcomes for patientsMRI-conditional pacemakers allow for safe performance of MRIsFuture devices should all strive for MRI-conditional status