Abbott Aveir Leadless

Hey All!

I'm curious to hear if anyone here has an Abbott Aveir, or really any leadless pacemaker.

Any regrets on going the leadless route? Any words of wisdom to share?

I'm in my mid 30s with AV block and am mentally preparing for my 4th DDD device soon, with the bonus of having my 20 year old leads explanted at the same time.

I'll be having a discussion with my EP soon about explantation and participating in the Aveir DR i2i (dual chamber leadless pacer) study:

https://clinicaltrials.gov/ct2/show/NCT05252702

I have a lot of respect for the EP I see, who is in the trial above, and am hoping he can help me quantify the risks of participating in a trial like this. That being said, as a very physically active person, I like the idea of not having to worry about a 'can', 'wires', or future lead revisions.

What would ya'll do if you were in my shoes; take the risk of being an early adopter with the leadless or possibly ride out the next 20 years with more traditional pacemakers/leads?

Cheers,

-Tim

 

*Edit* Very little info but thought I'd share this posting about the device when used as a VVI or as a 'single device':

https://www.jacc.org/doi/pdf/10.1016/j.jacep.2021.11.002

 

 

 

 

12 Comments

Leadless

by AgentX86 - 2022-08-08 23:42:31

I'd certainly not want to be an early adopter, particularly with heart block and at your age.  You're likely to have seven or eight pacers over your life.  Retrieving these things hasn't been proven yet, either, and you're going to need several over your life.

VVI mode is something to be avoided if at all possible. It works but at the cost of AV synchrony and chronotropic continence.  If I could change anything, I'd want chronotripic continence back. Pacemaker RR sucks.   From what you've said, DDD is by far the best solution.  You give up nothing.

There is a promise of dual(ish) chamber function somewhere down the road.  Ok, somewhere down the road, when someone else has worked out the kinks...

Hi Tim

by Lavender - 2022-08-09 05:57:43

My only thought is that you are young. You have a long ways to go. Let others try out the new stuff and you stick with what is proven thus far. Yes, the idea of no can or leads is appealing, but you're used to that by now. 

In reading the link for the clinical trial, I was amused by these two criteria:

Accepts Healthy Volunteers:   No

Subject has a life expectancy of at least one year

This exclusion criteria would exclude me because I have a CRT-P:

Subject has current implantation of either conventional or subcutaneous implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) device

As a person old enough to be your mom, I guess I would try a new device to see if it would help others.  I'm too old to die young 😉 But if I were you, no way would I risk this!

I'm sure your life expectancy is long. Maybe let others do the trial first. Why risk when you've done so well thus far with the current setup?

Leadless presently has nothing to offer you

by crustyg - 2022-08-09 11:09:07

I entirely agree with Agent.  You have *nothing* to gain by going leadless at this stage for the reasons he outlined.

Unless you've been pestering your EP-doc about your assessment of the risks and benefits of traditional sub-cutaneous PM box + leads, I would urge you to consider *why* this trial was even mentioned to you.

But your language is telling.  Why you regard having your leads removed as a bonus is beyond my understanding.  Yes, in large centres that do a lot of PM lead extraction it's relatively safe but even so it's not without risk.  You're still going to be at risk of septicaemia if you have a tooth extraction without antibiotic cover (and UK folk, don't tell me about NICE guidance - there's published evidence that infections went UP after this disastrous nonsense) with a leadless device.  What exactly is the bonus?

Perhaps your personal experience with PM+leads has been very poor.  Frying pan => fire perhaps?

Thanks

by DVNO42 - 2022-08-09 12:01:09

Thank you all for your candid responses, I really appreciate it.

@AgentX86, DDD leadless with easy/safe retrievability sounds to be the dream. I'm sure we'll get there eventually.

@Lavender, "Why risk when you've done so well thus far with the current setup?" really hits home in a lot of ways.

@Crustyg, the lead removal 'bonus' was sarcasm but not well communicated. I've reached the impedance service limits of the leads I have and they need to be replaced. I'm NOT actually excited about this prospect, quite the opposite. I appreciate your 'Frying pan => fire perhaps' analogy though.

Leadless vs conventional DDD

by Good Dog - 2022-08-09 16:05:59

I find your question relative to the new leadless DDD pacemaker intriguing. I know literally nothing about this new leadless device, except that my EP at the Cleve. Clinic is involved in that trial.

Frankly, I see a huge safety benefit in not having the need to explant old leads. So if a leadless device is actually as safe and easy to retrieve as they claim, it would certainly be my preference.

However, if dual chamber bundle pacing is an option that is precluded by a leadless pacemaker, then the choice is simple; I would not want a leadless device. If at all possible, bundle pacing is the only way to go, especially in a younger patient.

DDD vs. VVI

by AgentX86 - 2022-08-09 22:04:55

I mentioned the problems with VVI because, according to Abbot, the pacemaker is not yet approved for DDD mode, only VVI.

<https://www.cardiovascular.abbott/us/en/hcp/products/cardiac-rhythm-management/pacemakers/aveir-vr-leadless-pacemaker.html>

"*** ASIC chip designed to provide an expandable platform to later support a dual chamber pacing system once approved"

 

DDD

by DVNO42 - 2022-08-10 01:13:14

@Agentx86 for sure about the asic. It kind of blows my mind how small an asic can get now. The trial I referenced above is to use two of devices in in DDD mode with wireless communication. Definitely don't want to go VVI o_O.

Here's hoping it will be a stable option in the future.

ASICs

by AgentX86 - 2022-08-10 18:53:48

A pacemaker is a pretty trivial task for an ASIC.  The hard part is getting the reliability needed for a life-sustaining medical device.

"two of devices in in DDD mode with wireless communication"

That would scare me no end.  Not "NO" but "HELL NO!".  I wouldn't take that if it were a 10 year old technology.  A trial?  Not a chance.

Your call but I'd want nothing to do with it.  At your age, it's nuts, IMO. Nothing to gain and a lot to lose.

Bail

by DVNO42 - 2022-08-11 00:04:35

Decided to bail on this trial for now. Thanks AgentX86!

My choice

by JamesInHouston - 2022-08-13 12:33:41

DVNO42,

I'm in the trial and scheduled for a few weeks from now.  I have heavy PVCs that next to the HIS Bundle.  They have attempted an ablation twice with no sucess.  To fully stop the PVCs will kill the bundle and then require DDD pacing from a PM.

I was not happy as I workout frequently, and was recently evening doing Crossfit.  Pullups, chinups, pushups, bar work, etc would all be a serious risk to damaging the leads and PM.  

My doctor is a very respected teaching physican in the Houston area.  He offered this as an opition.  Yes it is new technology, but single chamber versions are FDA approved, so the only reach reach is communication between the devices.  That is realitvely easy technology in my opinion.  Finally depending on placement and impedence the life span will approach 10 yrs.  Yes retrieval risk is unknown, but my EP says these are small enough he could leave the old ones and implant 2-3 more with no issues down the road.

For that risk I get to do the things I want.

And if necessary I can always backtrack to a conventional device.

I'm in for now and report back on the results.

James

Device

by DVNO42 - 2022-11-10 11:57:28

@James

Hey how did it go?

Do you like the device so far?

How did Aveir go @James

by erichlin - 2022-12-08 22:41:39

1) Have you had any major surgical or physical complications?

2) How is the battery life with your Aveir?

3) How is the AV synchrony with your Aveir?

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