Mixed Leads - Contraindication for MRI

In discussions with the manufacturer of my 'MRI friendly' pacemaker, I learned that I have leads from two different manufacturers. As a result, my system (pm and leads) is now contraindicated for an MRI. 

Anyone else have leads from two different manufacturers and no longer have access to MRI as a diagnostic tool?

Just curious,

Shana
 

 


8 Comments

Conditional MRI approval

by AgentX86 - 2021-10-10 21:20:33

Unfortunatly, I highly doubt that you'll find anyone, anywhere, who has had an MRI with a mixed syetem.  I would think it unlikely that there would be a problem but no one is going to have done the testing to get such an implant FDA (or whatever agency). It's not in the manufacturers interest to do the testing on another manufacturer's product.  Without approval, no doctor, in particular radiologist, is going to go near it.  It's hard enough to get the sign-off to have an MRI with a setup that meets the "conditional MRI approval" criteria.  Move outside that and it's going to be really tough.

Generally, they use CT which is less precise (lower resolution) but doesn't pose the same problems.

Safety of ICD/PMs with MRIs

by Selwyn - 2021-10-11 07:41:44

My understanding is that the concerns of MRI scans with implanted devices is now not so great.  Yes, special precautions are needed, however you should still be able to have an MRI.   My cardiologist mentioned this to me a couple of years ago.  Risk is relative.

See:

http://magnasafe.org/images/MagnaSafe_HRS_May_2013.pdf

also the New Eng. Journal of Medicine- 2017, same study:

https://www.nejm.org/doi/full/10.1056/NEJMoa1603265

The MagnaSafe study has looked at thousands of leads and MRIs.

Fear not, safety is established at the levels of MRI scanning used in the study ( 1.5T) for devices that have previously been labelled 'not safe for MRIs', this includes leads!

mri

by Tracey_E - 2021-10-11 08:47:47

More and more hospitals are doing mri's on devices that are not mri safe so I don't understand what the big deal is if they are two different manufacturers of mri safe hardware, other than perhaps the lawyers sticking their noses in. They've been doing it in Europe much longer than in the US without issue. I was told by my pacer rep that all of the newer ones are mri safe, whether they are labeled that way or not, and that eventually mri's will not be an issue for us. 

Selwyn

by Gemita - 2021-10-11 21:20:00

I see from the study link the protocol which is available with the full text of this article at NEJM.org, was written after consultation with personnel at the Centre for Devices and Radiological Health of the FDA, who requested that thoracic scans be excluded from the study because of a higher perceived risk of adverse outcomes.  

https://www.nejm.org/doi/full/10.1056/NEJMoa1603265

However I am reassured that device or lead failure did not occur in any patient with a non-MRI conditional pacemaker or ICD who underwent non thoracic MRI at 1.5 Tesla and who were appropriately screened before, during and after a scan and had the device reprogrammed in accordance with the pre specified protocol.  

Do you know whether there have been any studies carried out which included patients having a “thoracic MRI”?  I appreciate however with the advent of MRI compatible newer pacemakers, the perceived risk of increased adverse events should be lower even for a thoracic MRI.

Thank you!

by Shana - 2021-10-12 16:27:51

Thanks everyone for the opinions about use of MRI with pacemakers and expanded thoughts on liability. 
 

AgentX86, contrary to your opinion, I am one of the mixed system pts. Thus, just curious if there were others out there like me on this forum.

Thanks PM Club friends!

shana
 

 

Mixed leads?

by AgentX86 - 2021-10-12 23:17:28

Shana,  I don't understand your posts.  First, you ask if it can done safely, then say you've had it done??  I know it's contrary to FDA approval.  I'm very surprised that anyone would risk their licence to do it.  If anything went wrong, even if not caused by the mix, their liability would be through the roof.

Thanks for clarifying!

by Shana - 2021-10-13 01:38:02

I misread your post AgentX86 - sorry about that. I thought you commented that you were highly suspicious of anyone having a mixed pacemaker system - you actually said mixed system and having an MRI. I agree with you about the liability. 
 

I'm really just curious how common the mixed system is for those of us with pacemakers. My mixed system and potential implications with MRI is interesting to me. Not sure why the EP implanting the device made that choice, but will likely pull medical records to learn more. 
 

Hopefully this helps clarify.

shana

mixed

by dwelch - 2021-10-18 22:21:01

I started over 30 years ago and have leads that old.  I have leads from three brands and from day one the rule was no mri so it is not a case of me losing this as a diagnostic tool it is a case of can I/should I ever use it as a diagnostic tool.  As an engineer I fully understand the physics and certainly have concerns, more with the old leads at this point, but hopefully I have no need for one.  And based on your question, not only do i have four leads from three brands (one not being used) from three different decades, maybe they wont come anywhere near me with an mri machine...

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