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In This Week’s Podcast
For the week ending January 30, 2026, John Mandrola, MD, comments on the following topics: listener feedback, huge news in the rapidly expanding world of PFA AF Ablation, obesity, and a beautiful trial studying an AI-enhanced diagnostic tool in the office.
First off, I want to say thanks to the British Cardiovascular Intervention Society for inviting me to speak at the Advanced CV Intervention meeting in London. My assignment was to lecture on the three worst interventional trials that have affected practice nonetheless. I also had a talk about how wasteful atrial fibrillation (AF) ablation can be.
I loved the meeting. And I have to say that British meetings are a lot less stuffy than US ones. It was great fun. And thanks to Dr David Hildick Smith and others for inviting me.
Listener Feedback
Transesophageal Echocardiography (TEE) vs No TEE
Professor Joachim Ehrlich writes to me about my intracardiac echo (ICE) vs TEE coverage 2 weeks ago. His group in Wiesbaden, Germany published a research letter in Heart Rhythm journal last year chronicling use of a risk score to avoid TEE before cryoballoon AF ablation. The gist of their series of 1400 ablations was that both TEE and no-TEE (if negative risk score) ended up with 99+% chance of no postprocedural stroke. It’s a nice report. I will link to it. The low stroke rates support our policy of requiring TEE only in super-high risk patients, such as those with persistent AF and unreliable direct oral anticoagulant (DOAC) use or previous left atrial appendage (LAA) thrombus.
My friend and former partner in private practice, Dr Anthony Pearson, author of the Skeptical Cardiologist on Substack, writes that
The problem with TEE is that docs are not trained well enough in it. I’ve trained dozens and watched lots of incompetent clinicians doing TEE. In the right hands, it is beautiful and elegant and the images are more magnificent than any other procedure. This lack of training also results in many errors in interpretation, the most common being overcalling of left atrial thrombus and of valvular regurgitation.
Dr Stefan Asbach, from Southern Germany, near Lake Constance on the Swiss border, (some people choose geography wisely), writes that another notable result from the ICE vs TEE trial was a very low rate of bleeding related to the transseptal puncture. It was actually 2/906 in the ICE arm vs 12/904 in the TEE arm. He writes:
It is the first randomized trial proving that the use of ICE increases safety by reducing the number of major bleeding events related to transseptal puncture! This would possibly avoid around 1000 potentially life-threatening complications in Germany every year. Unfortunately, due to reimbursement issues, the use of ICE in Germany is rare.
I am not sure I would use the verb prove, but my point of view on ICE has changed. Now that I have been medically-legally coerced into using ICE for the past 5-8 years, I have come to like the reassurance it gives me during the transseptal. Now I simply confirm good tenting before puncturing. I mean, 95% of the time it would have not been necessary but it’s reassuring, nonetheless. Whether it’s worth $500 or $1000 extra per procedure is a harder question.
Procedural Volume With TAVR and Mitral Transcatheter Edge Procedures (M-TEER)
In sum, I was struck by the association of better outcomes with higher procedural volume, and it caused me to say it may better for patients to travel a bit farther to go to a big center rather than having it done closer to home at a lower-volume center.
Dr Thomas Maibaum from Rostock, Germany, disagreed. He rightly notes that some of these patients are frail and elderly and being far from family is not so easy. It’s a good point, of course.
Late-Gadolinium Enhancement (LGE) in Older Endurance Athletes
Dr Christopher Schneeweis from Cologne, Germany, wrote regarding my coverage of the Ventoux authors’ paper on 106 older endurance athletes who had implantable loop recorders (ILR) and cardiovascular magnetic resonance (CMR) studies done. That paper found a strong correlation between non-sustained ventricular tachycardia (NSVT) and LGE on CMR. His point was that the LGE pattern in the study’s athletes was non-ischemic, affecting the inferolateral basal wall (in 88%), which is suspected for prior myocarditis. This would be in line with CMR studies on myocardial inflammation with persistent LGE and prognosis. But, he adds, “it is important to distinguish the patterns of LGE because we know that some patterns in athletes seem to be benign (like the ventricular hinge point fibrosis), and others have a greater correlation to relevant ventricular arrhythmias.”
Thanks for the comments. Again, I don’t know about you all, but these comments really help me because it takes me back to the covered studies, and, in looking one more time at them, it reinforces the findings back into my memory.
News in the PFA World
Before you non-EP docs tune out, the news I am about to tell you speaks not only to the world of AF ablation but also speaks to the early adoption of new technology in a world of intense marketing. All of cardiology has these challenges.
European Heart Journal has published results of the BEAT PAROX-AF trial comparing pulsed field ablation (PFA) to radiofrequency ablation (RF) in patients with paroxysmal AF. This was a multicenter, European RCT of 292 patients with paroxysmal AF. First author Pierre Jais from Bordeaux.
The PFA was with the pentaspline (FARAPULSE) Boston Scientific system and RF was with the modern contact force sensing system. The PFA system is important because I am convinced PFA systems are not all interchangeable.
The primary endpoint was single-procedure success at 1 year, defined as no atrial arrhythmia recurrence (> 30 seconds), no cardioversions, resumption of antiarrhythmic drugs (AAD), or no repeat ablation. So, higher numbers are preferred.
The primary endpoint occurred in 77.2% of the PFA group and 77.6% of the RF group. So clearly no difference. There were also no notable subgroup interactions.
The mean total procedure duration was 59 minutes for PFA vs 98 minutes for RFA, yielding an adjusted difference of −39 minutes (95% CI, −44 to −34). Mean left atrial dwell time was 39 min. for PFA and 77 min. for RFA, with an adjusted difference of −37 (95% CI, −41 to −32) min. The mean fluoroscopy time was 12 (SD, 6) min. for PFA and 7 (SD, 6) min. for RFA.
Procedure-related serious adverse events were 5 of 145 (3.4%) in the PFA group vs 11 of 144 (7.6%) in the RF arm. The lower rate in the PFA arm did not reach statistical significance. There were no deaths, strokes, or cases of persistent phrenic nerve palsy reported in either arm.
In the RFA group, two cases of cardiac tamponade and one case of esophageal bleeding (potentially related to the TEE) were observed. Additionally, two cases of severe pulmonary vein (PV) stenosis (> 70%) were reported in the RFA group, all involving the left inferior PV. Only transient cases of phrenic nerve palsy were observed in the trial (2 in the PFA and 1 in RF group).
My Comments
From the names on the list of authors, this trial clearly compared PFA to super-highly experienced RF operators — which is probably PFA’s toughest comparison to thermal ablation to date.
The trial did not use ILR monitoring, so success rates were better than the last PFA vs thermal ablation trial, the Single Shot Champion trial, which used ILR. But I don’t see this as a weakness because in real life, we don’t use ILRs in everyone. It’s normal to do intermittent monitoring and trials that emulate are easier to translate.
In sum, like so many other studies, this one shows that PFA is faster but no better in terms of efficacy of common safety measures.
The lack of difference in adverse events, though, is somewhat deceptive because, while we don’t love tamponade, we really worry about death from atrialesophageal fistula or permanent phrenic nerve. That PFA likely reduces these terrible 5-sigma events is a huge positive.
This lack of difference in efficacy could be construed as disappointing for PFA, but I would submit that this trial represented the hardest test for PFA because the RF control arm was performed in some of the best labs in the world. Had PFA vs RF been done in the average American EP lab, I’ll bet PFA would be dominant. Because RF is much more dependent on expertise.
Finally, that ceiling on success continues to be the most consistent theme in EP evidence. It’s the same now as it was 25 years ago. That, I propose, is due to our lack of knowledge regarding the pathophysiology of AF. It’s shocking to think about it, so I, like you, avoid thinking about it. But we literally do the same procedure in everyone with AF. Unlike everything else in EP, we have almost no targeting mechanism. Because our research has been much more interested in selling ablation devices than discovering causes of AF.
More News on PFA
There’s more news on PFA, and these are sobering reports.
Circulation has published a paper from the Hamburg CCB group, first author Melanie Gunawardene, titled, “Life-Threatening Delayed Myocardial Ischemia and Malignant Arrhythmias Occurring After Pulsed Field Ablation of Atrial Fibrillation.”
The paper with the scary title was easy to miss since it was published on Christmas day. This was a case series from seven big centers. It included patients who had delayed or prolonged ischemic or arrhythmic adverse events after PFA for AF.
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The total number of consecutive ablations was 6721. Life-threatening adverse events of either ST-segment elevation, malignant ventricular arrhythmias (VA), or sudden death occurred in 11 patients, or 0.16%. Nine of these 11 patients had had ablation outside pulmonary vein isolation (PVI).
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Five patients presented with delayed ST-segment elevation at a median of 20 minutes after the last PF delivery. But although the median was 20 minutes, the range was 4 to 238 minutes — one patient had ventricular fibrillation (VF) and died.
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Two patients presented with VF during the procedure, both requiring cardiopulmonary resuscitation.
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Two patients had prolonged hemodynamically relevant vagal responses after PFA remote from the conduction system.
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Two patients had sudden cardiac death, 3 days (patient 4) and 22 days (patient 1) after PFA.
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Autopsy was available for two patients. In patient 1, ILR data showed AF followed by VF progressing to asystole on day 22. Autopsy findings revealed no evidence of acute myocardial infarction (intact left anterior descending artery stent, only mild atherosclerosis), stroke, cardiac tamponade, pulmonary embolism, or bleeding. The cause of death was determined to be spontaneous VF. Notably, the heart showed mild ventricular dilation and hypertrophy.
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In patient 4, autopsy revealed an acute inferior myocardial infarction in the setting of a dominant right coronary artery without evidence of plaque rupture, thrombosis, coronary artery disease, fistula, or embolism. A very delayed right coronary artery spasm was suspected by the treating physicians in the absence of coronary artery disease.
The authors speculated on this novel and scary report where major arrhythmic events occurred in minutes or days after PFA. I say novel because we have long known that PFA adjacent to coronary arteries can cause spasm immediately, but both the delayed effect and coronary events with ablation far from a coronary geography is notable.
Another common theme is that 9 of 11 patients had PFA outside the normal PVI lesion set. But one fatal case followed pulmonary vein isolation alone.
Ultimately, the true cause — if there is just one cause — is likely via one of these mechanisms, as written in the paper:
muscle stimulation with ionic imbalance (particularly calcium), electroporation-induced release of vasoactive mediators, hemolysis-related nitric oxide depletion, and autonomic imbalance (sympathetic activation or vagal withdrawal may precipitate vasospasm). Underlying coronary abnormalities such as subclinical plaque, microvascular dysfunction, or Prinzmetal angina may contribute.
In other words, it’s unknown what the cause of this is.
You may be reassured by the low incidence of 0.16%. I am not. For two reasons: one is that it’s a voluntary survey of only seven centers; surely if there is this signal here, it is also probably in other places. Second, death from atrialesophageal fistula was in this category of rarity, but it still kept us up at night, because people in their 50s, 60s, and 70s are not supposed to die from AF ablation. Low incidence events can be quite scary when they have terrible consequences.
The authors made no comments about PFA systems but inspecting the table I saw that 9 of 11 events occurred with pentaspline PFA system. This is nowhere near proof but I wonder about whether similar injury would occur at the same frequency with other systems.
The authors write that:
rare, life-threatening ischemic and arrhythmic adverse events highlight the need for better recognition, reporting, and understanding of underlying mechanisms to improve PFA safety.
One More Piece of Sobering PFA News
There was also a well-circulated MAUDE adverse event of a death from atrioesophageal (AE) fistula following AF ablation.
It was reported that 20 days after a cardiac ablation procedure, the patient was diagnosed with an AE fistula and hospitalized. The ablation procedure was performed on the anterior aspect of the pulmonary veins using radiofrequency (RF) energy and the procedure was completed successfully. No issues were reported during the procedure. No further patient complications have been reported as a result of this event.
The PFA catheter involved was the Medtronic Sphere-9 dual lattice tip where you can deliver PFA or RF. It’s the most common PFA catheter that we use at our place. You can switch back and forth from PFA to RF with a simple switch, but this requires the operator telling the mapper to switch type of delivery.
A number of docs speculated on social media about the mechanisms of this. Namely… how do you injure the esophagus with ablation on the anterior pulmonary veins? That is unusual. Perhaps they were more posterior than they thought. Perhaps they accidently delivered RF in the posterior wall instead of PFA. It’s a simple switch.
I strongly hope the team write this case up with details. We need to know.
Overall, though, in this report today we learned that PFA did not outperform RF. And two reports of serious safety events warn us to stay vigilant. While tens of thousands of PFA cases have been done worldwide, signals of this magnitude will take vigilance to sort through.
I guess the bottom line is that when you’re destroying large areas of myocardium, the saying “There is no free lunch” holds true. Stay tuned for more on this matter. Gosh…while PFA is likely here to stay and it is surely great for patients, the fact that it has done nothing to tell us causes of AF or help direct individualized ablation remains true. As I have said many times, a real breakthrough in AF care will most likely come from basic science labs, not EP labs.
Obesity Trends
JAMA has published an update on US state-level prevalence of adult obesity by race and ethnicity, from the Institute for Health Metrics and Evaluation at the University of Washington.
This will be a short topic but pause on the numbers. The data source involves over 11 million US participants from:
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Behavioral Risk Factor Surveillance System (BRFSS) - Self-reported height/weight data from 1988-2022
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Gallup Daily Survey - Self-reported data from 2008-2017
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NHANES - Measured BMI data from 1988-2023
The main results are that the obesity crisis continues:
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1990: 19.3% of US adults had obesity (34.7 million people)
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2022: 42.5% had obesity (107 million people)
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2035 forecast: 46.9% will have obesity (126 million people)
There are massive racial/ethnic disparities, especially among women. For instance:
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Non-Hispanic Black females have the highest rates of obesity: 56.9% in 2022, projected to reach 59.5% by 2035
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Hispanic females are close behind: 49.4% in 2022, projected to be 53.7% by 2035
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Males across all groups have more similar rates: 40%-43% in 2022
Not surprising is that the highest rates of obesity were in the Midwest and South.
There were also alarming age trends:
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Peak obesity occurs in middle age (45-64 years)
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Biggest increases since 1990 are among women under age 35 - indicating earlier onset of obesity.
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The lower rates at oldest ages may reflect premature mortality from obesity-related diseases
I don’t know what to say about this. You already know it. But the fact that half of US adults are expected to be obese in the coming decades is shocking.
I am not a public health doctor but this sure seems like a public health catastrophe, one that may take many generations to reverse.
GLP-1 drugs will surely help, but it is going to take much more of a societal change to really reverse them numbers.
New Tools in the Office
Let’s say a shiny happy industry rep brought lunch to your office so that he or she could show you a super-duper AI-enhanced stethoscope that recorded an ECG and heart sounds and outputted a diagnosis.
This would sound fantastic. I see tons of fancy stethoscopes out on the wards. This would top them all.
But what would you really want to know before you spent your money on it? Obviously you want to know if it actually works. Does it enhance diagnosis of conditions like heart failure or AF. If you were especially clever, you would also want to know if it worked in everyday regular practice. Namely, the clinicians liked it, it didn’t slow people down etc.
Well, a large team of researchers from the NHS actually studied these questions in an elegant cluster randomized trial of 200+ practices in the UK.
They called the trial TRICORDER and Lancet published the paper. It’s a really nice trial and paper.
The trial randomized 205 primary care practices covering 1.5 million patients to use the AI stethoscope or do regular practice.
Again, patients were not randomized — practices were.
The primary endpoint of new HF diagnosis and secondary endpoints of AF and valvular heart disease detection sadly showed no significant difference between groups:
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Heart failure incidence rate ratio (IRR): 0.94 (95% CI 0.86–1.02)
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No shift toward community-based diagnosis vs hospital-based diagnosis
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Similar null results for atrial fibrillation (IRR 0.98) and valvular heart disease (IRR 1.00)
But the researchers learned a lot more than the null primary results. Other things they learned is that new stuff brings implementation challenges.
Only 49% of examinations were labeled with patient identifiers for data linkage. By 12 months, 40% of practices had stopped using the device entirely. Clinicians cited workflow integration barriers as the primary obstacle.
The authors then did a per-protocol analysis. In other words…in patients this was used on, how did the new toy work? But here they had a problem because in most trials a per-protocol analysis compares patients who stayed with protocol vs those that deviated. There is still a (partially) randomized comparison.
Here though, the practices were randomized, not the patients. So the authors had to do a propensity scoring system to match patients who had the AI stethoscope used on them vs similar patients who did not. It was obvious that clinicians chose to use the AI stethoscope on sicker patients as the mean age was older, and there was more hypertension and more diabetes in those who had the stethoscope used on them.
In the adjusted analysis, the stethoscope crushed it with 2.2x higher rates of HF diagnosis, 3.4x higher rate of AF diagnosis and 1.9x higher rate of valvular heart disease (VHD) diagnosis. But again, this was an observational nonrandom analysis and even with propensity matching there was surely selection bias.
My Comments
I highlight this trial because it was so well done and honestly reported. New tools are nice, and reps can make great Power Point presentations, but the true test is not whether they can work in idealized patients but whether they work in a real-world setting when doctors are busy and require something as seamless as it is nifty.
I would be happy if all or most of new tools had to pass muster in such a tough test. For instance, when hand-held AI enhanced echo machines are pocket sized, these too should be studied.
Another thing this paper underscores is the difficulty in screening for conditions that have population incidences of conditions that are at about 1%. Again, basic common sense is that when a condition is that low in prevalence, even a super-great test (95+ percent specificity) will deliver mostly false positive results.
Perhaps the broader lesson is that new tools and drugs and devices have to pass two bars: one is they have to work in idealized conditions, but the other is they have to work in the setting of the real world — in all comers. This is why intention-to-treat analyses are so important. A per-protocol or as-treated analysis does not preserve randomization, as those who get of protocol are often different than those that stay on.
Congrats to the authors. It’s a nice piece of science and refreshing.
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Cite this: Jan 30, 2026 This Week in Cardiology Podcast - Medscape - Jan 30, 2026.

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