St Jude vs Medtronic

I get my PM this coming Friday. The doc has chosen a St Jude but happy to use Medtronic. He said they're basically all alike. Any comments on that?

Also...how about MRI-compatible vs plain vanilla. Doc says that MRIs don't really affect newer pacemakers anyway, whereas the MRI-compatible ones need special leads.

10 Comments

St Jude

by Bas - 2013-11-18 02:11:21

Hi erik!
I had a St Jude pacemaker installed in January this year. Recently I had to have an MRI because of a stroke.
There were no problems as the latest models are perfectly safe.
As my local PM technician was at a conference St Jude had to send a tech from Melbourne which is 300km from where I am to put the PM into 'safe mode.'
It is important to have the card St Jude send you as it has the serial numbers of the PM and the leads on it.
The MRI people need those serial numbers.
I had no problems with having the MRI
Namaste
Barry

St Judes

by Tracey_E - 2013-11-18 07:11:06

I'm on my 4th St Judes and have been very very happy with them. I've had the same rep since I got my first pm in 1994, he was there to explain everything the day of that first surgery and he's been there every step of the way, every replacement, since. You can't go wrong with either one, both are excellent companies with state of the art pm's.

Given the choice...

by donr - 2013-11-18 08:11:45

...take the MRI-safe newer system.

Google on the following subject: "Difference between MRI safe Pacemakers & regular Pacemakers"

You'll get a ton of hits. From all sorts of reputable places having a dog in the fight about MRI's & PM's.

The bottom line, as I read it, is as follows: "Go to a few very specialized facilities, like Johns Hopkins, & you can safely get an MRI w/ a plain vanilla PM/ICD. Go anywhere else & you may be rolling a 7 on your first try w/ the dice."

Medtronic dropped a whole bunch of money on developing the MRI-safe PM. They did not do it because they like you - they did it because there were legit questions as to the safety.

I appreciate your Doc's comment - but short of a life-threatening emergency, the principle that anything is safe for the man who isn't doing it applies. Why do you think the Army has parachute riggers periodically randomly choose a chute they packed & go jump w/ it?

Don

Hmmm...

by golden_snitch - 2013-11-18 09:11:01

I'm beginning to think that all that MRI-safe pacemaker stuff is NOT about safety, but about money only. After all, it's industry and there's competition. I'm going to hear an expert pro and con debate about this MRI-issue in December. For now, Don is probably right, but I guess within just a year or two, this whole debate will lead to a lot more centers doing MRIs in patients with old fashioned devices and leads. My cardio told me lately that manufacturers are now having their regular pacemaker leads certified for MRIs. My EP who heads the largest EP department in Germany is already doing MRIs in device patients with "old" leads and units.

The pacemaker model depends on what you need. If you, for instance, need the rate response switched on, neither Medtronic nor St. Jude would be good; best rate response sensors are in Sorin and Boston Scientific pacers with a combination of accelerometer + minute ventilation. Another example, if you have intermittent heart blocks and you want to minimize the amount of ventricular pacing, you better go with a Medtronic Adapta or a Sorin Reply, because they offer the most effective algoritms to reduce ventricular pacing. Pacemakers are not all the same. However, if you only need a pacemaker to keep you heart rate from dropping too low, and you'll not need it when exercising, then you can take any model.

Best wishes
Inga

MRI-safe are new

by erik - 2013-11-18 10:11:12

Don, normally I'd agree with you but three considerations give me pause. (1) MRI-safe PMs were only approved last year, so not a lot of history. (2) My doc expressed some vague discomfort with the MRI leads, although he backtracked when I pushed him on that. (3) As Inga says, it seems protocols are changing with more and more MRIs being approved on patients with standard pacemakers.

There's a balance of risks (all of them minor) to be weighed.

cheers, Erik

History dictates

by JerryG - 2013-11-18 10:11:33

I have had a number of MRI's pre-PM which my cardio was aware of. He put in a Medtronic A3DR01 which is MRI-safe certified as are the leads he used. I hope I don't have another MRI as I am claustrophobic but at least my cardio made provision for it if it becomes necessary. My pacer also has both an accelerometer + ventilation sensor for rate response and it seems to be working well after my latest adjustments.

I think all the major manufacturers of pacemakers have to keep up with one another in terms of technology so the choice should ultimately be yours.

Like Don said, be safe!

You are going to be...

by donr - 2013-11-19 08:11:45

...host for that PM for several years. Supposing you don't like the idea of getting the MRI safe device, so spring for the other, plain vanilla device. Given 4 yrs goes by & you suddenly need an MRI & the medical community has decided after several yrs of trying it that the plain vanilla really isn't safe - perhaps a 30% risk of something going wrong. Erik - you will be STUCK! short of it being a life-threatening rqmt for the MRI such that they will remove it first, you are truly screwed.

You have to make a decision right now about which one you want. What we do know is that the US FDA has certified the one device plus its leads as safe. You have NO decision from FDA about the plain vanilla devices. Tomorrow they could slam the door on that procedure.

Yes, the MRI safe device was only approved last yr, but the Plain Vanilla has never been approved - and you have no guarantee that it ever will.

This sounds to me like you have your heart set on the plain vanilla device & are looking for a bunch of people to be your enablers in that decision.

Sorry, I will not help you on this one.

Don

Don...

by golden_snitch - 2013-11-20 07:11:45

you are getting a bit unfair here. You sound like no one has ever done a successful MRI in someone with a "plain vanilla" device. Truth is, some clinics have actually done hundreds of MRIs in these patients - NO problems at all, if you stick to certain precautions. They did not do small studies, John's Hopkins tested more than 400 patients and some of them even underwent several MRIs. Mayo does them, too, if necessary.

I'd understand your point, if the situation right now was that we have some officially MRI-safe devices, and we have the old devices of which some doctors think that they will be safe, but have never tested them.

You react to all that fear-mongering about MRIs just like the manufacturers want you to react. For years I have believed this story, too, simply because it makes sense that strong magnetic fields and electrical devices don't go together. But there is strong evidence now indicating that we can all safely undergo an MRI, if this should ever be necessary. We might not be able to have them everywhere, at every little clinic, but my guess is that those smaller clinics would not do an MRI in a cardiac device patient anyways - no matter if that patient has an MRI-safe device.

Inga

Erik & Inga: Get a grip ...

by donr - 2013-11-20 09:11:06

...on your knickers for a moment.

Nowhere did I say that the plain vanilla PM & its leads WOULDN'T/COULDN'T stand up to MRI's.

All I based my argument on was US FDA approvals for the various systems.

Fact1: The FDA HAS certified the new Medtronic devices & leads for MRI's.

Fact 2: The US FDA has NOT certified the older devices & leads.

Fact 3: If we live in the USA, unless we go elsewhere for a procedure, we have to follow US rules on procedures.

Fact 4: Nowhere previous to his last comment, has Erik mentioned relative lead flexibility.

Fact 5: I have an old style lead that fractured & had to be replaced at the 4 yr point. The old lead is still inside my vein.

Fact 6: The reliability of the new, stiffer leads has not been determined & will not be until there is a history of their use.

Fact 7: the US FDA could slam the door on those facilities performing the MRI's on Vanilla devices at any time, like they have recently done on several "Off label" uses of several drugs that had become common practice. None of the safety certification agencies is perfect - neither of you were around for the Thalidomide debacle that took place in the 70's. That sort of thing can really come back to haunt a country.

I can discuss lead flexibility w/you. There are all sorts of data on the reliability of leads of all sorts. Believe it or not, a solid copper conductor has a reliability figure. I once was involved in bidding a contract for the US Gummint wherein they specified that a desktop PC have a greater reliability than a common piece of wire. I told them that they were a bit off in the reasonability of their specifications.

I have not seen the data on lead reliability - but the apparent problems w/ the leads that have failed have been due to quality control procedures failing, as opposed to the designs of the leads. Whether the eventual reliability depends on design or production QC will not be known for a significant period of time. That is unless there is some serious flaw in the design that that pops out early. (Example - the problems a significant number of people have w/ Pradaxa. There are always unknown unknowns that jump up & bite us.) To find the very low probability problems that leads have takes a lot more exposure than certification testing takes - that exposure only comes when they are released to general use.

Don





MRI leads

by erik - 2013-11-20 09:11:55

Correct. I've done a lot of research on this as you, Don, suggested. Substantial evidence newer PMs are MRI safe whereas the MRI-compatible leads are stiffer and thicker than those used for standard pacemakers.

PMs can be replaced. Lead replacement is more iffy. I'd rather have thinner, more flexible leads. That's the part that actually enters the heart.

Hope you can now better understand my decision. I don't need enablers. Just explaining to the group my thought process.

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