Outcomes of Pulsed Field Ablation study

[CDreamer]

Take away seems to be outcomes not always better but fewer complications.

medscape.com/viewarticle/98...

[Finvola]

Thank you for posting, CD - it's great to read of any advance in treatments for AF.

[Paulbounce]

Hi CD.

Interesting read - thanks for sharing. It surprised me, to be honest. I thought the success rate for PFA was much higher than 80% lasting over 12 months. Your source is a good one although other studies have shown the success rate to be higher. The sample size is not insignificant either with 300 patients and is worthy of further research.

Paul

[mjames1 in reply to Paulbounce]

Yes, I did see 80% somewhere, but I also saw 66.2% as well. These studies are confusing because the devil is in the details and the details are in the endpoints. From the study:

"After a 90-day post-procedure blanking period, 66.2% of patients with paroxysmal AF met the primary efficacy endpoint, handily meeting the performance goal of more than 50%. "

That said, it may be better than it looks. Recently, I asked an ep about his success rates with Cryo. He said, if you count a 30 second episode of afib in six months a failure, then you can expect a 60% chance of success. However, my patients overall see a 95% reduction in their afib burden, meaning they might have these short episodes from time to time.

My response was, "I'll take 30 seconds of afib every six months". Sign me up!

PS: Another ep who also does Cryo said "80%". I didn't bother to ask him about end points

Jim

[Paulbounce in reply to mjames1]

'However, my patients overall see a 95% reduction in their afib burden, meaning they might have these short episodes from time to time.

My response was, "I'll take 30 seconds of afib every six months". Sign me up!'

Yep - these types of studies can be biased depending on the researcher's viewpoint at the start. My take? Never take the results from one clinical study as the absolute truth. Different studies will come up with different outcomes. They need to be peer-reviewed in a medical journal before I would even consider taking the results seriously.

That's my opinion and I'll stand by that one.

Paul

[mjames1 in reply to Paulbounce]

Yes there is bias and I was more referring to the confusion concerning endpoints. Different endpoints result in different success rates for the identical procedures. Got to read the studies really carefully and even then they are not as clear as they should be.

Jim

[mjames1]

Thanks for posting. An ep involved in the study told me the same thing. About the same success as cryo but safer. I'm tempted to wait but not getting younger so leaning toward Cryo soon, as opposed to PFA in a year or so in the US.

Jim

[FindingCaradoc]

As some may recall I had a pulsed field ablation under Professor Gupta at LHCH last September (so almost 6 months ago). At a recent follow up appointment I was discharged as so far the procedure has been successful (I get occasional ectopics etc. but no apparent AF) - I felt lucky to be offered the PFA procedure due to the improved safety profile in particular - and it swung my decision to have an ablation. I understand Prof Gupta is currently reporting on the NHS trial of PFA (presently still only done at Papworth and LHCH I believe) which may be extended to other NHS Hospitals.

[Kingdaddy]

I’ve been in NSR 100% of the time since my PFA in the Affera trial May of 2022. Very happy with it. I was early persistent.

[cuore in reply to Kingdaddy]

May I ask how many months when you say, "early persistent?"

[Kingdaddy in reply to cuore]

Great question. My Apple Watch had alerted me the first time that I had AFIB March 8th, 2022. And my PCP did an EKG that day, and confirmed AFIB. I then met with a EP, who put me on a 24 hour holler monitor, which showed my AFIB was 24 X 7.

I wear my Apple Watch 24 X 7, and it never alerted me before that. But, I can recall symptoms of AFIB, such as shortness of breath, last fall and in January of 2022 specifically when I was on a trip. So while I was never paroxysmal, at least per my watch, I definitely had symptoms before then.

[cuore in reply to Kingdaddy]

Well, if we take the date March 8th, 2022 to your ablation in May 2022, and assume your AF was persistent, it appears to be 2 1/2 months as I do not have the exact date of your ablation. And, if we add in January, the total persistent may be 3 1/2 months. Let us omit last fall because you may have been paroxysmal then.

The reason I asked was that I was 6 months persistent when I had my first ablation. My world renown EP said that I was one of his most complicated cases and if I had not had the ablation at that time period I would never have been able to return to sinus rhythm. Of course, this was radio-frequency ablation. I would have had better luck with PFA if it was available for me then.

My personal conclusion is that those who have ablations before three months persistent have a far greater chance of staying in sinus compared to those beyond. It will be interesting to see if PFA will extend this time period to those six months and beyond.

[Kingdaddy in reply to cuore]

Yes, the phrase AFIB BEGETS AFIB means it will get progressively worse if not treated. You can see it across the top of the graphic I created, which you might find helpful. Once I learned I had AFIB, I studied everything I could find so that I could understand exactly what my EP was telling me, and ensure I agreed on the course of action. As well as ensure I was reducing my modifiable risk factors. Best of luck on your journey with AFIB, I hope this helps, even if just a little.

Here's the story I wrote that explains it:

I first developed AFIB on March 8th after my Apple Watch notified me I had it. Since then, I've had 2 unsuccessful cardioversions and was on the antiarrhythmic Multaq (it didn't help) for a week prior to the second cardioversion.  I've always been one who believes that I am the CEO of my own body/life, so it is my responsibility to make the decisions regarding who I see for medical care and if I need to make  change I do.  I also always try to fully understand whatever it is I'm dealing with so that I can discuss it at some level with the doctor (or nurse) involved.  

As a visual person, I like to use graphics to better understand things, and in the case of AFIB, I developed the following graphic. You'll notice it is stratified into 5 swimlanes horizontally, and 4 pillars vertically.  Across the top, the first swimlane is AFIB Type, with AFIB triggers coming down indicating that AFIB is triggered by something. AFIB typically starts as paroxysmal, but in my case, it appears to have started in early persistent. In either case, you can see the phrase AFIB BEGETS AFIB, as it is a progressive disease that gets worse over time if nothing is done, and it culminates with permanent AFIB at the far right.  

Moving to the next horizontal swimlane down is ASSESS, where we would assess each area of the 4 pillars.  Below that is the TREATMENT swimlane, followed by DESIRED OUTCOME, and finally, the BENEFIT swimlane. Starting with each pillar, the first pillar is SYMPTOMATIC. It asks if the patient is experiencing AFIB symptoms, like fatigue, shortness of breath, palpations, etc. If the answer is NO, one would proceed to RATE CONTROL. If YES, you would follow the RHYTHM CONTROL path. Under that path, it's typically a cardioversion, followed by meds to maintain rhythm. But if that doesn't work, as it didn't for me, the next steps are typically either a catheter ablation or possibly a maze procedure (or some combination of that such as a convergent procedure).  

I'm in the Affera trial at the Cleveland Clinic for Pulse Field Ablation, so I have a 50/50 chance of either PF or RF ablation (because it's a clinical trial). I’m certain I received PFA. Interesting, that Affera’s Sphere 9 catheter system can do both PFA and Radio Frequency Ablation (RFA) through the same catheter.  And for the trial, if you are selected for PFA, they do the PFA on the posterior wall, and RFA on the pulmonary veins.  

Under the STROKE RISK pillar is where we see the CHADS VASC risk score, and if additional measures are needed beyond medications, one would have one of the Left Atrial Appendage (LAA) occlusion methods (there are probably 4 or 5 that I've read about). You’ll also see I added the HAS-BLED assessment if there is a bleeding risk.  Under the pillar RISK FACTORS, the NONMODIFIABLE factors are those we are born with and can't change.  

The MODIFIABLE factors are those we need to pay attention to and do something about, like blood pressure control, weight loss, sleep apnea control, exercise, etc.  The 4th and final pillar is for the Top 10 AFIB BIOMARKERS to keep an eye on to help keep AFIB in remission. When you see green lines/arrows, those are the things I'm doing now, and yellow means it's something I need to check. Some things for me are not applicable but might be for you, such as stopping smoking or stop drinking.

AFIB Swimlanews and pillars

[cuore in reply to Kingdaddy]

Thank you Kingdaddy. This charted analysis capitulates the key points of AF history.

I will add that I am a seasoned affibber with three ablations behind my belt done by the Bordeaux group. I do agree with you that one should be well-informed both to live with and to manage this condition.

[iris1205 in reply to Kingdaddy]

Fantastic KingDaddy! At last someone who outdoes my need to gather data visually!

Drove my doctors nuts for the last 13 years of Afib/Flutter.

Brilliant. BRAVO

[Kingdaddy in reply to iris1205]

Thank you iris1205! Glad you found it helpful. 😀

[CDreamer in reply to Kingdaddy]

Excellent info chart. I note the inflammatory markers and recommendations and was delighted to see Resveratrol with Vit C and Magnesium, first time I have ever seen this alongside pharmaceuticals. You must have really done your research thoroughly!

May I ask what led you to looking at these anti-inflammatory compounds? All of which I started taking some years ago.

[Kingdaddy in reply to CDreamer]

Thanks CDreamer. I did, as I wasn't happy with my EP and took it upon my self to know as much as I could about my newfound condition (at that time). I fired the EP at Sentara Norfolk Heart Hospital, and then went to the Cleveland Clinic and got into the Affera clinical trial for Pulsed Field Ablation (PFA) with Dr. Taigen. He was excellent, and I just passed my 1 year interval from having the PFA procedure, and I'm happy to report that I've been in NSR ever since. Best of luck in your endeavors.

[mav7 in reply to Kingdaddy]

a 24 hour holler monitor, which showed my AFIB was 24 X 7.

That is why it is so important to verify afib with a medical device like the holter monitor.

I confess bias, would never have known I had afib at the time if not for the Zio Patch.

[Goosebumps]

This is the key paragraph for me from the report

“Also at 1 year, 69.5% of the paroxysmal-AF patients and 62.3% of the persistent-AF group remained free of any recurrent atrial arrhythmia; 79.7% and 80.8%, respectively, met the clinical-success endpoint of freedom from symptomatic atrial arrhythmia recurrence.”

it’s the first time I have seen the success result for a procedure where the Persistent AF group (80.8%) exceeds the result for a Paroxysmal group(79.7%). Most importantly this refers to symptomatic AF.

My EP has written me off quoting a 28% success rate for an ablation on persistent patients with enlarged left atria. So PFA may not even help me, I reckon with my luck I’d be in the 19.2%.

But give a symptomatic persistent AF sufferer a shot at 80% with fewer complications and I reckon most would bite your hand off.

Oh and yes, I am fully aware of the prospect of a Mini maze.

[mav7 in reply to Goosebumps]

As a fellow persistent afib person, may I ask what has been prescribed for control ?

I am on Metoprolol and Apixaban with a heart rate avg in low 80's, mid 70's at rest, can be 90's with continuous activity.

[Goosebumps in reply to mav7]

hello Mav. I am on a similar regime to you, except with bisoprolol (2.5mg pd) instead of metoprolol and my heart rates are very similar to yours but my resting rate is in the high 60’s. I bought a Wellue AI heart monitor to check these over prolonged periods.

No anti arrhythmic meds at all.

[mav7 in reply to Goosebumps]

Appreciate the informative reply !

[iris1205]

Interesting, thank you dear HU members. Such a devoted group!

After 6 unsuccessful ablations, (well, the 4th worked for 2 years)...

I am heading into a PFA most likely in September... this is helpful.

YES, ChatGPT only searches 2021 and prior.

I have obtained a list (not the only)... and will share below, what comes up in the most recent (2023) research reports... Let me know if there are any bugs, and I will post this differently!

Best-

Pulsed field ablation for the treatment of atrial fibrillation: PULSED AF pivotal trial

ahajournals.org/doi/abs/10....

…, H Tada, DB DeLurgio, PULSED AF Investigators - Circulation, 2023 - Am Heart Assoc

… efficiency of catheter ablation of atrial fibrillation. This trial showed that pulsed field ablation

for atrial fibrillation achieved a freedom from procedural failure, arrhythmia recurrence, or …

ahajournals.org

Safety and Effectiveness of Pulsed Field Ablation to Treat Atrial Fibrillation: One-Year Outcomes from the MANIFEST-PF Registry

ahajournals.org/doi/abs/10.... Turagam, P Neuzil, B Schmidt, T Reichlin… - Circulation, 2023 - Am Heart Assoc

… 5-spline pulsed field ablation catheter to treat atrial fibrillation (AF… clinical documented atrial

arrhythmia (AF/atrial flutter/ atrial … (77 operators) pulsed field ablation was performed in 1568 …

ahajournals.org

Bronchial safety after pulsed field ablation for paroxysmal atrial fibrillation

ahajournals.org/doi/abs/10....

A Füting, N Reinsch, L Brokkaar, S Hartl… - … : Arrhythmia and …, 2023 - Am Heart Assoc

… and safe ablation using irreversible electroporation, also known as pulsed field ablation (PFA),

for pulmonary vein isolation in patients with paroxysmal atrial fibrillation. There are no …

ahajournals.org

Paroxysmal atrial fibrillation ablation using a novel variable-loop biphasic pulsed field ablation catheter integrated with a 3-dimensional mapping system: 1-year …

ahajournals.org/doi/abs/10....

M Duytschaever, T De Potter, M Grimaldi… - … : Arrhythmia and …, 2023 - Am Heart Assoc

… Atrial Fibrillation [PAF] by Pulsed Field Ablation [… pulsed field ablation (PFA) system with a

variable-loop circular catheter for the treatment of drug-refractory paroxysmal atrial fibrillation. …

Effects of pulsed field ablation on autonomic nervous system in paroxysmal atrial fibrillation: A pilot study

sciencedirect.com/science/a...

F Guo, J Wang, Q Deng, H Feng, M Xie, Z Zhou, L Zhou… - Heart Rhythm, 2023 - Elsevier

… Vagal responses and phrenic activation are commonly observed during pulsed field ablation

(PFA). However, whether the vagal responses and phrenic activations are nerve damage …

Pulsed field ablation to treat atrial fibrillation: autonomic nervous system effects

jacc.org/doi/abs/10.1016/j....

DR Musikantow, P Neuzil, J Petru, JS Koruth… - Clinical …, 2023 - jacc.org

… This study sought to assess the impact of pulsed field ablation (PFA) on the GP in patients

… of thermal ablative modalities, pulsed field ablation (PFA) is a novel ablative modality that …

Pulsed-field ablation versus single catheter high-power short-duration radiofrequency ablation for atrial fibrillation: procedural characteristics, myocardial injury and …

heartrhythmjournal.com/arti...

P Badertscher, S Weidlich, T Serban, P Krisai… - Heart …, 2023 - heartrhythmjournal.com

… Pulsed-field ablation (PFA) has emerged as a novel treatment strategy for patients with

atrial fibrillation (AF). First studies report favorable procedural data as well as promising …

Pulsed field ablation in real-world atrial fibrillation patients: clinical recurrence, operator learning curve and re-do procedural findings

link.springer.com/article/1...

MH Ruwald, A Johannessen, ML Hansen… - Journal of Interventional …, 2023 - Springer

… Pulsed field ablation of pulmonary veins and left atrial posterior wall with intact durability at

time of re-do and origin of focal atrial … includes patchy scar on left atrial posterior wall. Upper …

Cardioneuroablation Using Epicardial Pulsed Field Ablation for the Treatment of Atrial Fibrillation

mdpi.com/2308-3425/10/6/238

B O'Brien, J Reilly, K Coffey… - Journal of …, 2023 - mdpi.com

… and are working towards regulatory approvals and commercialization of the epicardial pulsed

field ablation technology described within this review. All others have no conflict of interest …

Assessing recurrence following pulsed field ablation for atrial fibrillation

link.springer.com/article/1...

NY Tan, CV DeSimone - Journal of Interventional Cardiac …, 2023 - Springer

… rates following AF ablation remain suboptimal [2]. Pulsed field ablation (PFA) is an emerging

modality that has gained tremendous traction. Delivery of short-pulsed electric fields (PEF)

[MummyLuv]

thank for sharing, been keen to follow pulse field