dual -chamber wireless pacemaker trial

Sarasota Memorial Hosiptal in Sarasota, Fl is participating in Clinical Study of World's first Dual-chamber, wireless Pacemaker for those with slow and irregular heart rhythms.  One of 80 research sites globally testing Abbott's Aveir DR dual-chamber leadless pacemaker.  The study period is for one year.

Abbott's Aveir VR single-chamber leadless pacemaker recieved FDA approval this spring after a pivotal, multi-center trial found it safe and effective for certain patients with abnormal heart rhythms.  Was designed for expandability and potent upgrade to a dual-chamber system with regulatory approval in the future.

Like traditional pacemakers, abbott's VR and DR leadless pacemakers use pulses of electricity to trigger the heart to beat.  But instead of using lead wire to send electrical pulses through veins into the heart, doctors implant DIRECTLY into the heart.

For more information about this trial contact the Sarasota Memorial Research Institute.   

I found this information in the  winter issue of SMH Today for Sarasota Memorial Foundation  magazine.

new to pace

3 Comments

Dual Chamber leadless pacing trial

by Gemita - 2023-02-17 14:30:26

Hello New to Pace, thank you for letting us know about this trial which your ?local hospital is participating in.  I hope the trial is successful and that this technology can move a step closer to giving us all another option for the future.  I attach a few links if anyone is interested in further reading.  I am only highlighting a few of the potential difficulties here since there are plenty of pluses mentioned with this leadless technology in the links I have provided.

The first link raises some concerns about the addition of a battery in the atrium, particularly since the upper chamber of the heart is a thinner structure than the ventricle. The current FDA-approved leadless pacemakers go in the ventricle, which is thicker and more forgiving. Since the atrium is thinner, the design of the atrial leadless pacemaker had to be modified to accommodate that structure to avoid the risk of perforation or injury during implantation.

The introduction of implant to implant (i2i) communication will adversely affect battery longevity I see (see third link) and it seems that the battery in each chamber will deplete at different times too, so it would require two separate procedures to replace each battery.

New to Pace, if you were starting out on your pacemaker journey today, would you enrol in this trial if it were offered?  Personally, knowing what I know now about my conventional pacemaker with leads and what it can do for me, I would probably want to wait a little longer before going down the leadless pacemaker route.  However leadless pacing looks very promising, especially for an older, less active person who wants to minimise their exposure to complications relating to transvenous leads and pocket infection.

https://www.healio.com/news/cardiology/20220311/dualchamber-leadless-pacemaker-implanted-for-first-time-in-us

https://abbott.mediaroom.com/2022-02-07-Abbott-Announces-Worlds-First-Implant-of-Dual-Chamber-Leadless-Pacemaker-in-Pivotal-Trial

https://www.ahajournals.org/doi/10.1161/CIRCEP.122.010909

would I

by new to pace.... - 2023-02-17 14:51:12

Glad you asked me that question , when i posted this information just the thought of somethink inside my heart made me cringe.  No, I would not want this leadless version.  Of course i am now 82 and did not grow up with technology.  someone younger might not think twice about it.

it does say this is not for the active person, which to my of thinking. It limits who can recieve the device.  Certainly not for a young person who has their whole active  lfie a head of them.

the article goes on to say increased battery life, up to 10 years and 2 time's longer than others.  Which does not make any sense as i was told my battery life is 10 years.

does also say Faster recovery and reduced risk of lead and pocket-related complications for patients who are immune-compromised or prone to infections.  Who have vascular acess issues or whose chest wall is not sufficient to supporta a pocket device.

new to pace

I would be concerned about retrieval too

by Gemita - 2023-02-17 16:12:40

New to Pace I see that you have already posted:

"For more information about this trial contact the Sarasota Memorial Research Institute. I found this information in the winter issue of SMH Today for Sarasota Memorial Foundation magazine". 

I think that should be more than sufficient for any member interested to find a contact link, so no need to post a link.  

Update:  I have just found it (easily) by typing into my main browser Sarasota Memorial Research Institute Aveir Study, so any combination of words should find it. 

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