Which manufacturer and what can a pacemaker do to help?

Hello everyone, one member has suggested it would be helpful to have a discussion about 

what a pacemaker can and cannot do to help control an arrhythmia?  

I would like to add 

and if we had a choice, which pacemaker manufacturer should we choose to help with the task? 

We know already our pacemakers successfully treat Bradycardia and Heart Block and help with conditions like Heart Failure.  We also know that a pacemaker with a defibrillator is able to shock our hearts back into rhythm or to use anti tachycardia pacing therapies to stop a dangerous ventricular arrhythmia, but a pacemaker is still not a perfect treatment for an arrhythmia.   How can we try to move technology forward in this important area for the benefit of us all?  

Many current manufacturers face challenges in suppressing ongoing arrhythmias with their pacing strategies.  Newer pacing strategies are under research and being developed but several challenges still remain to bring these technologies into clinical practice.  I attach a few links in case they are of interest.

Our pacemakers will already have a number of pacing therapies running quietly in the background which may already be helping you.   I personally would like to see all pacemakers used as tools in the battle against our arrhythmias, since the current treatments available (ablation, cardioversion or medication) are far from perfect and I feel there is so much more that pacing therapies could do to help.  I would value any comments you might wish to make?

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The folloing links should be copied and pasted into your main general browser to open:-

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8674736/

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6850031/#:~:text=AF%20is%20not%20susceptible%20to,by%20antitachycardia%20pacing%20(ATP)


9 Comments

Depends

by Penguin - 2023-10-05 06:12:42

Interesting topic and thank you for posting it Gemita. I'm going to follow this with interest.

Mine is a depends answer for reasons discussed on this forum before. 

Pacemakers can only mode switch to a non tracking mode when an arrhythmia is detected if it's speed falls above a programmed AT detection rate.  The AT detection rate has to be set anywhere from 10-20 bpm below the max tracking rate and this varies by manufacturer. I believe that Boston Scientific models can be programmed to detect AT and mode switch at the lowest rates.  

I'd like to know if there are any other methods (other than AT detection rates) for detecting and 'treating' lower rate arrhythmia  which do not rely on this method.

Edited / Added: 

When you get a new PM think about how long it might take you to understand the new one if you change brands. I had a different brand and it blew my mind. The new technology was difficult enough to get my head around but you also get used to your manufacturer and how their devices work and the settings. It's quite disorientating. 

Choice of pacemaker

by piglet22 - 2023-10-05 06:14:52

I find it hard enough to choose a pair of socks, let alone a pacemaker.

With socks, it's colour, always navy but have been known to wear red. With red-green colour blindness, navy is safe, plus pairing isn't an issue. Then there's material. I generally go for bamboo-based yarn. Most important of all is the lightest cuff available, sometimes called diabetic or gentle touch.

So, socks can be tricky. I always go for SockShop.

Pacemakers are so specialised that you aren't going to get a Which Best Buy and unlike consumer goods, you aren't going to get a choice unless you are lucky enough to be the pacing consultant or the Procurement Officer. I do hope the PM buying process is a bit better than the blatant bribery that goes on in say the gas central heating boiler market.

Here, the boiler you get depends on how much the manufacturer can bribe the plumber with free gifts, rather than is it any good.

The major pacemaker manufacturers are well known and because of the nature of medical devices, there won't be much to choose on the basis of build quality or reliability.

There are also the design considerations. Much electronic stuff today has two aspects. One is the hardware which is the base of the device and all manufacturers will largely follow the same pattern. Power supply, connectors, processor, accelerometer, real time clock, memory, communication, case materials etc.

It all comes to life with firmware and software.

Components get smaller, more powerful, more power efficient and so on, but that's down to component manufacturers, not PM manufacturers.

So hardware is going to be largely the same and choice comes down to software.

I'm hoping and assuming that all the manufacturers are going to make their products as adaptable as possible so they can be repurposed to suit individual patient’s needs, including all those tricky arrhythmias that develop during the course of a PM lifetime.

So, if I had a choice, it would be the one that is the most able to accommodate our changing needs.

Would it be a Medtronic EN1DR01? Probably not.

No Bluetooth, no app, but more importantly, struggles to cope with ectopics and no amount of fiddling around with settings can fix that one.

In truth, I couldn’t choose one, but I might be better equipped now to ask some questions first, but then there’s the small issue of whether or not you get the opportunity to ask.

In my experience, that isn’t going to happen, but who knows?

Piglet

by Gemita - 2023-10-05 10:31:09

Let us all hope that after your first appointment in years with a cardiologist next week, you will be a changed man, full of hope for your future care under the NHS?  Go into your appointment with optimism and charm.  It might just work.

Socks?  “Seamless” ones please, otherwise I'm not too fussy.

I often see members asking here which pacemaker manufacturer is best for their sporting activities and sometimes be awarded the device of their choice, so why can’t we arrhythmia sufferers at least try to ask for one better suited to our personal needs?  Surely it is worth a try.  Different manufacturers will have different programs running or available. 

Like you I am limited by my pacemaker model;  actually I have the same model as you, although I have successfully managed to optimise my pacing experience using my current device’s programs.  Pacing so far has been a positive experience for me, so I am not disappointed, but I still want to achieve more in the way of arrhythmia control and I feel that can only come from an upgrade and a few additional pacing features to help manage my symptoms better.  

At device upgrade, I want to make sure that I receive the very best replacement on offer to suit my personal needs, even if I have to make a financial contribution towards such a replacement.  At least I will be trying to achieve this when my device is due for a battery change.  My EP does listen.  He is new, young, energetic and full of enthusiasm.  I am going to nurture his optimism as much as I can and focus on “pacing solutions” for my arrhythmias.  He always encourages this and is a rare find in the NHS

Penguin

by Gemita - 2023-10-05 12:30:46

Penguin, thank you for your contribution.  I know you are still concerned about “under detection” of an arrhythmia like AF and I can understand this. 

It is sometimes frustrating and very difficult to assess whether a patient has slow AF from pacemaker data alone, especially if the detection criteria for an arrhythmia like AF have not been completely met.  I suppose this is why we still need additional Holter monitoring, but it does seem such a waste when we have a perfectly good implant device more than capable of identifying an arrhythmia like AF.   I will try to get an answer to your question though and update this message in due course on whether there are any other methods (other than AT detection rates) for detecting and 'treating' lower rate arrhythmias which fail to meet your current detection criteria.

As far as treating a lower rate arrhythmia is concerned, as you know our doctors are not particularly worried about slow arrhythmias.  It is usually high rate episodes that concern them, when they would treat with a rate lowering med.  Of course if the slow arrhythmia turns out to be AF they should be concerned, especially if the patient has risk factors for an AF related stroke and needs to be anticoagulated.

I have just checked my own Medtronic AF Interrogation Episode logs to see whether any slower episodes of AF were ever recorded and there were none below my AF Detection Rate of 171 bpm.  There were some very short duration episodes, less than half a minute, and some lowest recorded ‘Average’ bpm AF episodes well below the detection rate of 171 bpm, but the ‘Maximum’ bpm criteria for all episodes were always met and well above the Detection Rate of 171 bpm.

As we know, so much can affect what will be stored, including over-sensing, under-sensing, far-field sensing, cross-talk, interferences (noise), detection criteria not fulfilled by an arrhythmia, inappropriate programmed detection criteria. Under-sensing is not uncommon in AF apparently, due to the small amplitude (intensity of electrical stimulus) of atrial EGMs.  I recall my technician making my atrial lead sensitivity setting more "sensitive" to pick up more AF episodes so that my true burden could be established

Changed man

by piglet22 - 2023-10-05 13:36:51

Gemita.

Change at my age? Maybe.

At least, I'm on home territory. The lovely little cottage hospoital is literally just over the fence..Being at home does put you more at ease and the charm dished out will depend on the gentleman concerned. At least I got my hair cut today.

My PM has hit the buffers with the ectopics and I had a second night's worth following the vaccination.

You feel so helpless when things go wrong and when the time for PM change comes in January 2025, I hope they take this all into account.

Yes, I was fine for 18-years, but I'm sure that if some tweaking could have fixed the current problems, it would have been done. I'm hoping that any new device gives me a lot more information than now.

What is for certain is that the technology should not be a limitation on putting a decent PM together. At the heart of mobile phones is a chip called a SOAC (System on a chip). It can do everything a phone, a PC, a TV can do and a lot more. The PM of the future might only need to be fitted and activated. It learns from the user, tracks the up and downs, the changes and reacts autonomously.

And chooses socks!!

I am glad your current pacemaker and settings are working well for you Mary

by Gemita - 2023-10-06 06:04:20

Hi Mary, I was certainly not expecting members to understand the intricate workings of their pacemakers although many members are becoming more interested in how their devices work and sometimes for good reason. 

I am looking for feedback on what members believe their pacemakers can/cannot do for them to help control their arrhythmias and asking “which manufacturer” as in “which manufacturer might have the most advanced programs/algorithms running to help with an arrhythmia”?    

I see our athletic members continue to ask “which manufacturer for cycling, for swimming etc.”, so why shouldn’t members with arrhythmias want to learn if one particular manufacturer is ahead of the field with arrhythmia control/pacing therapies?

Agree !

by Penguin - 2023-10-06 06:22:31

I agree with your comment Gemita.  We are supposed to have joint decision making in health care and if arrhythmia management is your goal of course you should be allowed to have your say and ideally discuss models / features with your EP. 

I also agree with Marybird and Piglet that the decision is far too complicated for most of us, although when it comes to a 2nd / 3rd pacemaker we may have a very good idea of what we do and don't want and the failings of our previous device. 

However, we can't be expected to know or understand products that are new to the market or the range of products available.  We need to be informed of how a chosen PMs' features might control or inhibit our conditions and have the opportunity to discuss what an EP's evaluation of those PM features and their limitations may be.  The risks should be discussed too!

Ideally ALL of this needs to be discussed so that patients know what to expect.  A good fit with clinical needs should not be too much to ask - if needs can be met via the range of PMs available.

I imagine that your pre-implant discussion may be lengthy Gemita, and good luck to you with that. I applaud you for your independent research and self advocacy. It's a very important decision given the amount of time that your PM will be with you. 

Marybird

by Gemita - 2023-10-06 13:10:48

Mary, all comments are welcome on this thread.  Even if I don’t always hear what I want to hear, your contributions are always valuable, so please keep them coming

Penguin

by Gemita - 2023-10-06 13:22:12

Penguin I had a word with my Pacing clinic on a number of matters today and this was their response about what is stored (in response to part of your question):

I'd like to know if there are any other methods (other than AT detection rates) for detecting and 'treating' lower rate arrhythmias . . .

"The AT/AF episode burden will only include episodes that meet detection criteria.  So as I said previously, if you have slow AF events below this rate, these will not be collected or included in the AF burden episode logs provided by your device.  So if you had slower events in either the atrium (less than 171 bpm) or ventricle (less than 150 bpm) that were below these detect rates for event storage, no event would be stored.

The detect rates are programmable to an extent but will not capture every single arrhythmia, and if it is set poorly, it can often lead to erroneous data being collected as well. This then doesn’t provide an accurate episode burden either.

We use holter monitoring sometimes to collect more information in patients with devices. It is not uncommon to do this.

There are no other methods for collecting data in your pacemaker, other than what it is collecting now. This is the same for all brands and devices. It is best you speak with your consultant about whether you need further monitoring or tests.

If you feel like we aren’t providing you with the correct information, you can request all your pacing reports from Subject Access".

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At least I know the score now.   No one can rely on their pacemaker to rule in or out an arrhythmia that does not meet the detection rate for a high rate episode.  So if AF hasn’t already been diagnosed and a member feels they have AF, they should push for monitoring and more monitoring.  AF episodes can occur at slow, normal or fast speeds and clearly our pacemakers are only storing high rate episodes.  Slow or normal speed episodes are equally dangerous when it comes to the need for anticoagulation protection for some of us.  My low AF burden percentage doesn't look quite so healthy anymore since my slow, normal speed and AF episodes in the 120-169 bpm range are most definitely not counted/stored as events.  I now fully understand why my EP wanted me to keep my Reveal Linq loop recorder in place for 3+ years during the first few years of pacing.

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