Had A clinical trial PFA with Dr Reddy on Tuesday

Hello all. I had a pulse field ablation with Dr Reddy this past Tuesday. All seemed to go well. Dr said he was pleased and they got all of teh pulmonary veins isolated. This was with the Kardium catheter. Apparently there is 400 patients that will be treated with this catheter and mapping system.

[kardium.com]

I feel pretty beat up from the trachea tube and also am having a few ectopics but overall okay I Guess. My afib was almost completely controlled by flekanide but when I got a chance to get this PFA I jumped on it. Never know when the afib would overtake the drugs.

Dr Reddy's team were amazing. I can wholeheartedly recommend them. Everyone was very nice.

I spent the night in the hospital because I was a late afternoon ablation. Didn't get out of operating room until 7:00 PM.

Feel free to ask me ask me anything about the procedure or process.

regards,

John

John, great to hear that you had the procedure and all is going well as expected. The throat soreness will go away soon and the nurses can provide some medication to help.

Regards

Steve

Thanks Steve. You have been a big encouragement for me, so thank you! I hope I can progress as well as you have!

john

Hi John, great news! Thanks for the update. Is PFA limited to the pulmonary veins at this point, or maybe in this trial? You’ll be glad to get off Flecainide eventually—I felt a lot better after I was able to stop it. A night in the hospital is good even if you have a morning ablation as that gives them plenty of time to monitor you for any problem that might arise.

Hello Daisy. yes, this trial was limited to the Pulmonary veins. I was initially a little disappointed in that but the doctors said I went into Afib during the procedure and upon completion they remapped my heart and found no afib. I'm not exactly sure what all that means but I suspect that it means the afib was coming from my pulmonary veins. At least that is what I am hopeful for.

Doctors also said that the isolation and pulsing went as well as it possibly go. So I then asked what does that mean from a prognosis standpoint. They said that I am in the top cohort of expected results which is I have an 80% chance to be afib free for the next year. I found that interesting because that is really all they have data for for PFA. Their data on outcomes is really limited to % free from afib and their studies are about one year old.

Interesting I think.

I was instructed to stop the Flecainide in 30 days. I will be scared to death to stop it, its worked so well for me, but that is why I got the ablation, to be drug free. Se we shall see.

john



Edited 1 time(s). Last edit at 06/09/2023 11:36AM by Johnnyk80.

Daisy… I had a PFA last year with Dr Natale in Austin; he ablated the pulmonary veins as well as the posterior wall. PVI + posterior wall is his standard procedure. This was the AdMIRE trial.

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SailorGuy1
Daisy… I had a PFA last year with Dr Natale in Austin; he ablated the pulmonary veins as well as the posterior wall. PVI + posterior wall is his standard procedure. This was the AdMIRE trial.

Thanks, so it looks like it depends on the trial. I did learn that, at this time, you are not eligible if you have a pacemaker. Apparently there is still a question whether the PFA energy is compatible with pacemakers, so I needed to go with RF when I had an ablation with Dr. Natale.

John,

I am glad it went so well with you. Did you stop all meds before the procedure? Is that why you went into Afib during the procedure? What other meds have you been taking besides Flecainide? Are you expected to continue them after the procedure? for how long?

I am scheduled the same procedure next month with Dr Reddy. I am going for TTE this afternoon and CTA in two weeks. A little scared about the CTA but was told this is the prerequisite for the Kardium trial.

I am also wondering what would they do if I stayed in NSR during the procedure? Do they ablate the PV area anyway?

Appreciate your information!

CTA is a fast exam. I know everyone is different but I only felt one of the sensations the tech will tell you and it was short lived and never reached the level of feeling uncomfortable.

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Johnnyk80
... and upon completion they remapped my heart and found no afib. I'm not exactly sure what all that means but I suspect that it means the afib was coming from my pulmonary veins....ill be scared to death to stop it, its worked so well for me, but that is why I got the ablation, to be drug free. Se we shall see.

john

So as not to compound the risk to the patient by failing to 'challenge' the heart and having to do the procedure all over again in six-12 months, while they are 'in there', they inject isoproterenol, a drug that irritates/stimulates the heart and essentially goads it into AF. Isoproterenol makes the heart show any further zones, or 'foci' where spurious signals can still make the heart beat chaotically.

The first resort is to isolate the PVs because that is where 85-95% of all AF comes from. When that doesn't work, they'll look elsewhere. But, once he/she has isolated the PVs, they challenge the heart and see if it will turn back to AF. If it doesn't then they assume they have isolated the focus where the unwanted signals are gaining access to the atrial endothelium. In my case, on a re-do after seven months, he redid rows of lesions around three of the four PVs, and then my heart returned on its own to NSR. They ceased any further burning (quite sensibly, thanks very much), and Dr. Novak said he didn't even have to shock me back into NSR. I was there already, with a grateful heart.

Yes, they do 'mapping', but only if after zapping around the PVs and your heart is still thumping and bumping chaotically while you are lying there. At least, that is the more conservative approach of Paul Novak. He didn't even seem to be all that keen to discuss the eventuality of an isolation of my appendage if that were indicated at some point. He seemed adamant that a properly isolated PV set nips the heavy majority of those not also in flutter.

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Yuxi
John,

I am glad it went so well with you. Did you stop all meds before the procedure? Is that why you went into Afib during the procedure? What other meds have you been taking besides Flecainide? Are you expected to continue them after the procedure? for how long?

I am scheduled the same procedure next month with Dr Reddy. I am going for TTE this afternoon and CTA in two weeks. A little scared about the CTA but was told this is the prerequisite for the Kardium trial.

I am also wondering what would they do if I stayed in NSR during the procedure? Do they ablate the PV area anyway?

Appreciate your information!

Hello Yuxi. I stopped the flecainide 5 days before the procedure. That was doctor's orders. I was on 50 mg twice a day. Not sure if that is why I went into Afib or if they stimulated my heart to get it there. I am also on Xaralto and 12 mg metropolol. I never stopped either of those drugs for the ablation. I started back on Flecainide the day after the ablation.

Doctor said I should stop Flecainide in 30 days for good! I'll stop blood thinner in 60-90 days I think as well. Or at least that is the plan.

They said if I didn't go into afib, no problem, they were going to ablate all four PV's anyway. That is what the trial is about. I'm happy I went into afib though. Just more data for them to work with.

Why are you worried about the CT scan? Is it the radiation? I had the same fear and asked for a cardiac MRI with/wo contrast instead. They said that was fine for the trial. So no radiation and a test that is just as good for what they need it for.

If you want to chat in more detail DM me. You can give me a call.

Regards,

john



Edited 1 time(s). Last edit at 06/09/2023 06:53PM by Johnnyk80.

Hi Johnny, I was instructed to stop Amiodarone 3 weeks after my RF ablation ( II was a Flec failure). I’ve been fine, it was scary to stop but it’s great not to need any drugs!

My understanding for using rhythm meds during the blanking period is for patient comfort while everything is healing. They don't change the outcome of the ablation.

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JakeS
CTA is a fast exam. I know everyone is different but I only felt one of the sensations the tech will tell you and it was short lived and never reached the level of feeling uncomfortable.

Hi Jake, I’m not worried about the exam per se, but the high radiation level of CTA

Thanks John, I DM’d you

the high radiation level of CTA

Radiation dose concern is understandable. A couple of points. The dose for CCTA has been reduced almost 80% over the last 10 years or so. The scanners have technologically advanced. Scanners are being replaced. Most Scans are done on 128 slice units. The x-ray tubes continue to be improved, resulting in lower output. Scanning algorithms are better. The spatial resolution (think detail) the CT scan provides is better than an MRA.

Also, the dose from the scan is limited to the field of view (FOV) selected by the technologist based on protocols. It is NOT a whole body dose


What often gets left out of the discussion on dose is risk vs benefit. The risk of cancer, and it is low, is worth the benefit the scan provides. For example: A patient that has CAD has a greater chance/risk of having catastrophic cardiac event than developing a cancer from the scan. The CAD patient that declines the CT out of radiation dose concern may put themselves at a greater risk. The CTA for the ablation helps the procedure more than the dose risk of having the scan.



Edited 1 time(s). Last edit at 06/12/2023 10:37AM by JakeS.

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JakeS
the high radiation level of CTA

Radiation dose concern is understandable. A couple of points. The dose for CCTA has been reduced almost 80% over the last 10 years or so. The scanners have technologically advanced. Scanners are being replaced. Most Scans are done on 128 slice units. The x-ray tubes continue to be improved, resulting in lower output. Scanning algorithms are better. The spatial resolution (think detail) the CT scan provides is better than an MRA.

Also, the dose from the scan is limited to the field of view (FOV) selected by the technologist based on protocols. It is NOT a whole body dose


What often gets left out of the discussion on dose is risk vs benefit. The risk of cancer, and it is low, is worth the benefit the scan provides. For example: A patient that has CAD has a greater chance/risk of having catastrophic cardiac event than developing a cancer from the scan. The CAD patient that declines the CT out of radiation dose concern may put themselves at a greater risk. The CTA for the ablation helps the procedure more than the dose risk of having the scan.

Very informative Jake.

I received 5 minutes of Flouroscopy time during my ablation (which is a very low flouro time for an ablation I'm happy to say).

Any insights on how much radiation 5 min of Flouroscopy gives a patient? I presume still less than a CT, but I'm not sure.

John

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Johnnyk80

I received 5 minutes of Flouroscopy time during my ablation (which is a very low flouro time for an ablation I'm happy to say).

Any insights on how much radiation 5 min of Flouroscopy gives a patient? I presume still less than a CT, but I'm not sure.

John

Your ablation report should have that information. Mine has both the minutes of fluoroscopy and the amount of radiation—my report has an entry called radiation dosage.

Radiation dose based on time only would be difficult. As in CT there have been new technologies developed for the fluoroscopic units, which reduces dose. Digital fluoro units have the ability to work w a technique known as pulse progression fluoro. With older fluoro units the operator activated fluoro the tube/x-ray beam was continuously on until they took their foot off the pedal.

With pulse fluoro the tube actually pulses rapidly between on and off. The transition between on and off is so fast that the human eye does not detect it looking at the monitor. It does reduce radiation.

The dose people see is usually extrapolated by the unit from couple of things, such as beam field size and tube output. Many systems use what is called Dose Are Product (DAP) or some call it Karma Are Product (KAP) . If you have seen one of your digital x-rays, like a CXR, if you look at the header info on the radiograph you may find a number followed by mGy or Gy. This is the same concept. The tube measures output of tube and the size of the field selected and extrapolates data to give the dose. Please realize the number is usually a skin or entrance dose because beam energy will vary as it traverses the body.

There are timers that continuously indicate to the operator how much beam on time has occurred.

Fluoro units have a brightness control feature. Based on signal out of the patient the tube will decrease/increase output as the system senses the signal. For example if the EP has just put a catheter in your femoral vessel the patient’s tissue density is different because you over the abdomen/pelvis. As the catheter advances and they follow it the tube output will change as the catheter gets over the chest which is less dense. Another dose reduction technique. Lastly, the size of the patient influences tube output.

Quote
JakeS
Radiation dose based on time only would be difficult. As in CT there have been new technologies developed for the fluoroscopic units, which reduces dose. Digital fluoro units have the ability to work w a technique known as pulse progression fluoro. With older fluoro units the operator activated fluoro the tube/x-ray beam was continuously on until they took their foot off the pedal.

With pulse fluoro the tube actually pulses rapidly between on and off. The transition between on and off is so fast that the human eye does not detect it looking at the monitor. It does reduce radiation.

The dose people see is usually extrapolated by the unit from couple of things, such as beam field size and tube output. Many systems use what is called Dose Are Product (DAP) or some call it Karma Are Product (KAP) . If you have seen one of your digital x-rays, like a CXR, if you look at the header info on the radiograph you may find a number followed by mGy or Gy. This is the same concept. The tube measures output of tube and the size of the field selected and extrapolates data to give the dose. Please realize the number is usually a skin or entrance dose because beam energy will vary as it traverses the body.

There are timers that continuously indicate to the operator how much beam on time has occurred.

Fluoro units have a brightness control feature. Based on signal out of the patient the tube will decrease/increase output as the system senses the signal. For example if the EP has just put a catheter in your femoral vessel the patient’s tissue density is different because you over the abdomen/pelvis. As the catheter advances and they follow it the tube output will change as the catheter gets over the chest which is less dense. Another dose reduction technique. Lastly, the size of the patient influences tube output.

Here are my numbers from my report:

Total Flouro Time- 5 MIn
Cumulative Air Kerma - 24.00 mGy
Dose Area Product - 4.74 Gy*cm2

How do you extrapolate these numbers to the radiation that I received?

john