PFA….when will it be available

Posted by katiekateny @katiekateny, Dec 11 6:38am

I cannot have a traditional ablation. My esophagus is just too small for the temperature monitor. So, only a PFA is possible for me….but…

None of the heart specialists near me (within 200 miles) have hospitals or clinic that are authorized to use this.

Anyone have info on when this procedure will be commonly more widely available? What is the hold up?

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The hold-up is both cost and a break in the routinely successful actions that many EPs are enjoying with the other older methods. PFA doesn't result in an increase in index success....index meaning the first. First ablations only have about a 75% success rate except for the most highly skilled (and most highly sought/busiest) EPs who manage to get up to about 85%.

Yet another factor is that PFA is only currently authorized for a simple PVI (pulmonary vein isolation). The insertable implements are not currently suitable for ablating other areas commonly associated with AF, including the coronary sinus, the septum, and the left atrial appendage (LAA).

PFA is now widely available, just not as plentiful as Corn Flakes. For example, Drs. Santangeli at Cleveland Clinic and Natale at the Houston Cardiac Arrhythmia Institute both have done many of them.

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@gloaming

The hold-up is both cost and a break in the routinely successful actions that many EPs are enjoying with the other older methods. PFA doesn't result in an increase in index success....index meaning the first. First ablations only have about a 75% success rate except for the most highly skilled (and most highly sought/busiest) EPs who manage to get up to about 85%.

Yet another factor is that PFA is only currently authorized for a simple PVI (pulmonary vein isolation). The insertable implements are not currently suitable for ablating other areas commonly associated with AF, including the coronary sinus, the septum, and the left atrial appendage (LAA).

PFA is now widely available, just not as plentiful as Corn Flakes. For example, Drs. Santangeli at Cleveland Clinic and Natale at the Houston Cardiac Arrhythmia Institute both have done many of them.

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@gloaming
Jardiance was not prescribed by my EP.
My cardiologist calls him the “rhythm section”.

Anyway…Jardiance was prescribed by my cardiologist for CHF. The EP hopefully will fix the Afib, which is a likely cause of the remodeling going on in my heart.

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PFA is "authorized" in the US - the FDA approved Medtronic PulseSelect in Dec.2023 and Boston Scientific Farapulse in Jan.2024 - fyi.

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Yeah I knew that. But, when will it be available in the regional cardiac hospitals? So far it looks like only very few have it available.

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I am treated by the Head of EP at a large university based medical center that has 16 EPs on staff. I recently asked my EP about their experience with PFAs. They use PFA only on a very small population of total ablation patients. He and his colleagues are not yet convinced that this is going to replace RF ablations at least right now. PFA has only been approved just since 12/23 just one year ago.
His comments are consistent with other EPs that I have read opinion pieces on PFA.
Unfortunately for you this leaves you out. At least in an area of the country where it sounds like there are no procedures offered other than RFA.

This quote is from the Cleveland clinic website about PFAs
https://consultqd.clevelandclinic.org/pulsed-field-ablation-a-new-highly-selective-catheter-ablation-method-for-heart-arrhythmias
"Unanswered questions inherent to new technology"
Dr. Wazni notes that several issues related to PFA require further exploration in clinical trials. Optimal “recipes” have yet to be determined for energy intensity (voltage), pulse duration and frequency, biphasic versus monophasic pulse delivery, different electrode configurations, and variations of the diverse device designs and patient characteristics. Investigation of electroporation-induced vasospasm is also needed to develop strategies to prevent this rare but serious complication.

He also points out that comparative costs and benefits of conventional ablation relative to PFA must continually be assessed, as switching to a totally new ablation system will be costly and may not be justified at all centers. In addition to multiple PFA clinical trials, studies of conventional ablation techniques are also still ongoing.

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Yes, so is the Cleveland Clinic.

But….it isn’t like I could just drive there stay in a motel overnight and have the procedure the next day..then drive home.

Even with the referral, the doc will want a preliminary visit, then a second visit to schedule the procedure…then go there.

So,,,minimum 3 trips. Then…what do I do about the need to have someone drive me home? While my friends are kind enough to help out for a day…none of them are in a position to take a couple days, stay in motels, just to drive me home. I had a service once that picked me up after day surgery and kept an eye on me for the first 12 hours…cost me $1,200.

None of that works. The HUGE costs involved with 2 or 3 trips plus the cost of paying someone to take me round trip on the day of the procedure. Each time requiring I pay for the 1) dog kennel, 2) gas, 3 motels, and 4) pay someone to drive me and stay overnight. Doesn’t work.

Need to have this done within 100 miles of my location for those reasons.

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I had to be referred to a local EP by virtue of the way the medical system in Canada works. It turned out for the better. I happened to get a referral to the top cardiovascular student award physician in Canada for 2022. By then, he had gone on to train as an EP and thence to perform maybe 2000 ablations by the time I came to see him. As a modest man, he only claimed a 75% success rate for himself on index ablations. I was one of the unlucky for my index, but when he tried again seven months later, I was put into permanent and stable NSR, and I haven't looked back. Well, not more than a couple of times just to pinch myself, but,.....

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My brother has recently failed on Sotalol after 3+ years. He is 81 and went to see his EP at Washington University Barnes hospital in St. Louis. They have recently changed and all their EPs expect one are now doing exclusively PFAs. Only one EP is still doing RFAs. So that is interesting. They are making the transition all at once. My brother is scheduled in 2025 for a PFA.

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@katiekateny

Yes, so is the Cleveland Clinic.

But….it isn’t like I could just drive there stay in a motel overnight and have the procedure the next day..then drive home.

Even with the referral, the doc will want a preliminary visit, then a second visit to schedule the procedure…then go there.

So,,,minimum 3 trips. Then…what do I do about the need to have someone drive me home? While my friends are kind enough to help out for a day…none of them are in a position to take a couple days, stay in motels, just to drive me home. I had a service once that picked me up after day surgery and kept an eye on me for the first 12 hours…cost me $1,200.

None of that works. The HUGE costs involved with 2 or 3 trips plus the cost of paying someone to take me round trip on the day of the procedure. Each time requiring I pay for the 1) dog kennel, 2) gas, 3 motels, and 4) pay someone to drive me and stay overnight. Doesn’t work.

Need to have this done within 100 miles of my location for those reasons.

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I am lucky the mayo clinic health sytem Eau Claire is the PFA now

Does Cleveland clinic have any hospitals in their sytem near you?

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