Replacement This Tuesday-- Help

My Medronic Adapta is running with limited functionality-- low battery.  Because of cervical spine issues I need a pacemaker that is MRI tolerant.  Who gets to decide what device gets implanted?  Shouldn't the docs at least consult with me and inform me of their reasoning?  This has not happened so far.  


6 Comments

Of course, you have to agree if you want the pacemaker implanted. If not, no implant.

by brady - 2022-11-06 01:01:49

Do you mean only the generator will be replaced? 

Do you know what is the brand and model of your new pacemaker? 


The EP needs you to sign the consent form, without your consent no implant.

As you are aware, The Medtronic adapta that you are having now is not MRI conditional.

https://wwwp.medtronic.com/crs-upload/letters/94/94_CQES-IPG-StandardLetter-MRI-AdaptaVersaSensiaRelia-2016-Sep26.pdf

Please be aware, not only the generator has to be mri conditional, but the leads have to MRI safe as well. See:

https://youtu.be/OPQ7T0tfyBM

 

The difficulty is that it may take time to sort out and understand the situation, but you may not have time. It is unlikely that you will call up the hospital on Monday and cancel your surgery scheduled on Tuesday.
 

Below is some info I found on the internet that is related to MRI on patients with pacemaker.

"Older devices may present problems

If you have an older pacemaker that is not MRI-conditional, Dr. Flamm would not routinely recommend an MRI scan. However, more data has become available illustrating that even patients with MRI-conditional devices may have MRI scans under carefully supervised conditions.

During MRI, electricity applied to the magnet creates an alternating magnetic field. If you placed a wire within that alternating magnetic field, it could generate current and heat up.

For pacemakers and defibrillators, metal “leads” that are similar to wires are implanted in the body and the heart muscle. Leads that come within the MRI scanner’s alternating magnetic field can generate electricity, or heat up, while touching your heart.

“We worry about the heart muscle being heated or even potentially burned, which could  turn into scar tissue,” Dr. Flamm says. “Also, since we’re developing a current within the lead, we’re concerned about stimulating the heart such that it starts to beat abnormally and creates an arrhythmia within the heart.”

Despite these concerns, Dr. Flamm shares that as radiologists and cardiologists have learned more about these older devices they understand that in some of these patients MRI scans can be performed safely.  Not every patient can be scanned, though many now can as long as, “all of the proper safety mechanisms are in place,” he says."

https://health.clevelandclinic.org/are-mri-scans-safe-if-you-have-a-pacemaker-or-implanted-device/

 

My understanding is that all the recently manufactured and modern pacemakers are MRI conditional. See the following two descriptions: 

"Magnetic resonance imaging (MRI) has long been considered dangerous for people who have electronic heart devices like pacemakers and defibrillators implanted in their bodies. Now, a study published online Aug. 14, 2017, by the Journal of Clinical Electrophysiology suggests the scans are safe for most people with these devices.

Until recently, most devices were not FDA-approved for MRI. They had been considered risky because it was feared that the high-strength magnetic fields used for the scanning could disrupt a pacemaker's or defibrillator's circuits. Yet, when researchers reviewed 212 MRI examinations involving 178 patients with these nonapproved devices, they did not find a single problem with how they functioned. The researchers concluded that MRI is safe for someone with a device implanted after 2000, as long as the device is checked before and after the procedure and its pacing function is monitored during the scan.

In the last seven years, the FDA has approved newer and more expensive devices that are designed to be safe for MRI; these are labeled "MRI conditional." However, the researchers noted that you don't need to replace your older device with an MRI-compatible model before getting a scan.”

https://www.health.harvard.edu/heart-health/mri-is-safe-for-most-people-with-pacemakers-and-defibrillators

"MRI exams are safe for some devices

MRI (magnetic resonance imaging) uses a large, circular magnet and radio waves to produce clear computer images of the body.

“Most heart valves and coronary artery stents currently on the market and implanted in patients can go safely through an MRI scanner,” Dr. Flamm says.

“However, for decades we’ve considered it unsafe for patients with pacemakers and defibrillators to go into an MRI scanner,” he notes. “It’s been an absolute contraindication.”

More recently, however, manufacturers have developed some pacemakers and defibrillators that can be scanned with an MRI.

 “We don’t refer to them as ‘MRI-safe’ but instead as ‘MRI-conditional’ — we can perform MRI scans on patients with these devices, though there are some limitations,” says Dr. Flamm.

He continues, “For instance, we’re careful about how much MRI ‘energy’ we use. We may therefore limit the time we spend scanning a patient and limit the kinds of images we acquire. As a result, we might acquire some images from a patient who does not have an MRI-conditional device that we won’t on a patient who has one.”

https://health.clevelandclinic.org/are-mri-scans-safe-if-you-have-a-pacemaker-or-implanted-device/


 

Pacemaker replacement at end of battery life

by Gemita - 2022-11-06 06:47:44

Mkellyrock, I understand your concerns and see Brady has already given good information.

You ask, “Who gets to decide what device gets implanted?”  It should ideally be a joint decision and there should be a discussion between you and your doctors as to the most suitable device for you based on your lifestyle, your heart or other health conditions present and about any old leads which are still in place and things like this. 

While most newer pacemakers may be safe to use in an MRI environment, particularly if certain safety conditions are met, older leads still in place, may not be MRI safe.  However, some members have been able to get an MRI even in this situation without harm.

Please be assured that providing leads and device are MRI safe when certain conditions are met, most newer pacemaker models can be used in an MRI environment.  My husband and many others have had an MRI with no adverse affects at all.  

The biggest hurdle to getting an MRI is finding hospital personnel who have done MRI scanning frequently on pacemaker patients. Some smaller local hospitals may not be familiar with the protocol and may refuse to carry out an MRI for safety concerns.  This has recently happened to me despite my consultant EP confirming that my pacemaker is MRI safe if certain conditions are met.  I am now being sent to a larger, main teaching hospital where they have extensive experience working with pacemaker patients. 

I hope your pacemaker replacement goes well for you and you will start to feel so much better with the newer technology and that you get that all important MRI scan when you need it

Thanks all.

by mkellyrock - 2022-11-06 14:40:30

I will confirm prior to signing the consent form MRI compatibility.  My existing leads are MRI compatible.  Even for a replacement  I feel this is a big step. Yet the doctors appear to treat it so casually and provide near zero information.     

Best wishes mkelly

by Persephone - 2022-11-06 15:53:23

I hope all goes smoothly for you on Tuesday.

You have nothing to worry about! And Good luck! It will turn out the way you wanted

by brady - 2022-11-06 17:36:31

Hello Mkellyrock,

I had done research for you, it seems that for modern pacemaker generator, the case is make of non-magnetic material, so magnet will not affect it. It is the leads that should be of concern.

previously I was worried about your exiting leads, if they were also designed to be used on MRI, then you have nothing to worry about!

But it won't hurt to call on Monday to get the brand and model so you could be sure 100%.

I also found out that all the generators leads are standardized that is the generators are interchangeable. And I learned that some brands are better fit for some people who have a specific outdoor exercise needs, the so called rate response. 
 

if you could find out the brand and model , post with your exercise need, and I believe someone will give u feedbacks.

Patient inform and consent

by Mad Hatter - 2022-11-06 18:40:04

I agree that the patient should be informed and consent to the type of pacemaker.  This didn't happen for me until I was being prepped for surgery.  I did not know the brand or model until the manufacturer rep showed up.  It worked out for me but looking back I wish I had asked a lot more questions. 

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