AF ablation and the hard truths about AF

Atrial fibrillation is a mysterious disease. We know a lot but surely not enough. We look at AF but are we really seeing it?

I believe there are hard truths to this disease. Hard in a way that neither patients nor doctors like. More on that later. First to some news on a major AF ablation trial.

AF ablation news:

One of the fundamental questions in electrophysiology today centers on the outcomes of AF ablation. Though most experts agree that AF ablation, when compared with medical therapy, reduces AF symptoms and improves quality of life (important metrics for sure), we don’t know whether ablation reduces the chance of stroke or death. We think it does–preliminary studies look good–but the only way to know for sure is to do a head-to-head comparison.

The long-term outcomes after specific AF treatments are relevant because population data (Framingham Study) show that having AF increases the risk for stroke or early death. So it’s better not to have AF. But populations are not individuals. Some AF patients have little risk while others are quite ill. The vast majority of AF patients are spread across a continuum of risk.

One of the most important AF studies of our time was (or is) the Catheter Ablation Versus Anti-arrhythmic Drug Therapy for Atrial Fibrillation (CABANA) trial. CABANA is an ongoing multicenter, international study that compares anti-arrhythmic drugs to catheter ablation. Researchers randomize AF patients to either strategy, follow them over years and then count easy things like stroke and death. CABANA aims to tells us whether ablation is just an expensive and invasive way to control AF symptoms or a true disease modifier.

Dr. Wes Fisher broke the story that the leadership of the CABANA trial decided to change its primary outcome from stroke and death to a composite of total mortality, disabling stroke, serious bleeding, or cardiac arrest. I know what you’re thinking…How is this news? As always, Dr Fisher explains it well:

While some may not see this as a significant development, we should understand that clinicians will be left without a definitive answer to which therapy, catheter ablation or anti-arrhythmic drug therapy, will prolong life the best in symptomatic patients with atrial fibrillation. Instead, doctors will have to read tea leaves based on a composite score of several endpoints to make their own personal judgment.

My colleague worries that statistical realities will muddy the issue: that being, of course, the dilemma of how best to approach a not-immediately life-threatening disease with potentially life-threatening treatments (ablation or medications).

I think about this a lot.

Let’s first talk about CABANA and then move on to those hard truths I was mentioning.

The CABANA trial is doomed to fail. Not because it’s a bad trial or bad idea or done by bad investigators. It’s none of that. The problems with CABANA are the following realities:

  • Symptomatic AF patients do not want to be randomized to drugs. AF patients go to AF centers for ablation. Recruitment of study volunteers has been slow and will remain slow.
  • Eligible AF patients have very low event rates–a good thing. This is important statistically because to show a difference in stroke rate or deaths (infrequent events in AF) between the two treatments, you need a lot of patients and a lot time. This is why investigators changed the endpoint and shortened follow-up. They wanted an answer in their career–not their children’s.
  • The techniques of AF ablation will improve. I believe we are on the cusp of big stuff–a new understanding of AF mechanisms, which will lead to better success rates. Consider that the results of CABANA won’t be available for years and by then better techniques will have rendered the results irrelevant.

The Hard Truths of AF:

The second issue is that I’m not sure asking whether AF ablation is better than drugs is the most important question.

My big-picture feelings about AF treatment are evolving rapidly. Let me start this way: Too often AF is treated as if it’s fixable rather than manageable. You have heart disease; heart disease is bad; therefore you need treatment. This logic might be okay if we weren’t prescribing dodgy QT- or QRS-prolonging drugs that fail two-thirds of the time, or if we weren’t delivering burns/freezes in the atrium that fail half the time. Or this: that in most cases, patients with AF could help themselves if we told them the truth—that losing weight and managing major risk factors can reduce atrial fibrillation symptom burden and severity. AF is not appendicitis; there is rarely an easy fix.

More and more, I counsel patients that AF is both a disease and a consequence of actions–your body talking to you. Like it does in the days after lifting weights for the first time in a while. Why else do you think those atrial cells begin to misfire?

Yes, as clinicians in 2014, we aim to prevent complications from AF. We prescribe anticoagulants to lower the risk of stroke and beta-blockers to prevent tachycardia-medicated heart muscle weakness.

But merely prescribing said treatments ignores the inflamed elephant in the room. There is no medical or surgical fix for inflammation overload. And I don’t mean just inflammation from obesity, high blood pressure, sleep apnea, sleep deprivation, alcohol, diabetes, smoking and exercise overload. I mean inflammation from never taking your foot off the gas, physically, mentally or emotionally.

I was recently bragging to a patient about the successful ablation I performed on him. He replied that it may not have been the ablation. “What do you mean”?  I asked. “Well…about that time doc, I retired from working nights; I fixed my relationship woes; and now I come home to peace and quiet and a kid who I love. You think that stuff helped?”

If I had a dollar for every time I have heard a version of that story.

You see what I mean? There’s a common thread here. It’s the inflammation.

For athletes with AF, the issue is years of over-inflammation from exercise and inadequate rest. For the obese and hypertensive, it’s the inflammation of atrial stretch and fibrosis. For the executive or engineer, it’s the inflammation of never having enough, or never being exactly correct enough, or maybe the three–not one–glasses of wine.

You think I’m full of beans. Consider also the common scenario of AF occurring after an infection, surgery or trauma, all of which are indeed big wallops of inflammation.

Doctors look at this picture-in-a-picture everyday. But are we putting it together?

Does AF ablation reduce the risk of stroke or death? Okay, okay, yes, of course, it’s an important question.

But…

That we have to ask it, that we look at the problem of AF without really seeing it, speaks to a collective unwillingness to face the hard truths about this disease. Again, we see a disease rather than a human being.

Is it possible that anti-arrhythmic drugs and ablation may just be imperfect ways to buy time for the patient with AF to modify the inflammation overload that stirs the ion channels of highly connected atrial muscle cells?

With humans, it’s all connected.

JMM

11 comments

  1. As someone who has had a successful AF ablation, it is hard to imagine drug therapy as an alternative. For two and a half years prior to my ablation, I was taking a variety of meds — none of which helped and some of which seemed to aggravate the condition. During this time I had episodes lasting 24-48 hours about once a week. The quality of my life deteriorated significantly. Since the ablation (a bit over two years ago), I haven’t had a single episode. I’m back to bike riding a doing century rides (something I couldn’t dream of while I was on drug therapy). The ablation was nothing short of a miracle for me. I know that not everyone has such a great outcome, but to see it compared to other therapies in terms of mortality, stroke incidence, etc. seems to me to be missing the point. I’d rather live 5 more years with the quality of life I have now that 30 more years with a-fib.

  2. First, I love this blog and read it often. Dr. John M does a great service. This issue is near to my heart, pun intended, as I have an ablation scheduled in about a month. I am comfortable with doing the procedure and optimistic about the outcome, though I never tried the AR drug course. That being said, between the two EPs and two cardiologists I have seen since my afib became more or less permanent, not one mentioned weight loss, eliminating alcohol, stress reduction, or nutritian as a viable alternative. Inspired by blogs like this, I have taken that mantle up myself and dropped 15% of my body weight, reduced, then eliminated alcohol, improved my nutrician, reduced work stress and ramped up my exercize. I start yoga this week. Between these changes and the ablation, I am confident one session will be enough, but if it takes two sessions so be it.

    Please keep your common sense advice coming. People are reading and benefiting from your advice.

  3. Nice post John,
    Lifestyle is hard, but important. Stressors, including things like alcohol, sleep deprivation (whether from voluntarily staying up to finish work, or from sleep apnea), and social stresses certainly play a role. So does fitness (or lack thereof). Coffee is a wild card. Probably depends on some idiosyncratic factors. I recommend that people try going off more than a cup of coffee a day and see whether there is a difference. Sometimes there is a dramatic reduction or complete cessation of episodes, sometimes nothing improves – sort of like salt and blood pressure, I think.
    Would be nice if there was an easy treatment. Many were hoping that CABANA would answer the question. As you say though, recruitment is hard and I would suspect that there is a lot of cross over.
    I like Vince’s point that QOL improvement, when it occurs, may be the best outcome.
    Do you ever stop Oral Anticoagulant drugs after a “successful” ablation?

  4. Sounds like lifestyle changes complicate being able to determine IF drugs and/or ablation really are the treatments that do or don’t make a difference for ultimate AFib outcome. Add to that what sounds like a change in primary outcome of the CABANA Trial midway through data collection – which of course is a “No-No” in scientific research. It is fully understandable why the primary endpoint has been changed (otherwise there wouldn’t be enough “events” ) – but the unfortunate reality is study conclusions will be far less reliable (if valid at all) – not to mention those hard-to-measure lifestyle changes that are still too often ignored by clinicians treating patients with AFib.

    That said – Excellent post by Dr. John, as per his usual.

  5. (The other Jeff, who’s already had two ablations)

    The only inflammation I’ve experienced in recent years is from anger at the conceit that inflammation is the underlying cause of my various arrhythmias. Nothing on Dr John’s list of organic causes ever applied to me, and I’ve only experienced this emotional one after my AF first showed up.

    My father died too early from arrhythmia complications in the early ’70s when ablation was not available.

    Lets start taking a good hard look at genetic factors and then maybe we’ll learn something truly basic. (Not everyone who abuses himself with an inflammatory life style acquires AF!)

    Lets do it now.

    All of us who are arrhythmatic deal with it in the here-and-now. A decade or three of research will do us no good.

  6. Maybe we should change the ICD from “atrial fibrillation” to “atrial inflammation”. Would cover a few bases, I think.
    BTW, I for one believe that in 10 years or so we’ll be looking at atrial ablation procedures as one of those “Can you BELIEVE we once thought that blind barbarism was helpful?” As with everything, the procedures are operator dependent. And how often have we seen superstars cover up a perf or other complication, and complicitly just keep quiet? What goes on with the less stellar operators ? Incidence, prevalence, informed consent etc, is ALL caca if you’re the one on the receiving end of an avoidable “bad outcome “, whatever that may be.
    Primum non nocere has guided my thinking since med school day 1: works for me, and those I care for.

    1. MedPageToday reported that in the recently released study data, 6% of the people in the ablation arm had cardiac tamponade – 4 of fewer than 100. No way that series of patients would have been reported in print if the operator could have suppressed it.

  7. Just found this site and am enjoying reading it. Haven’t had an ablation yet but, believe I’m going down the road to one. Interesting comment about losing weight and managing risk factors. I definitely need to lose weight and believe that that will help reduce my Afib episodes. I’m very fit, working out 3 or 4 days a week, but, working a corporate job, sitting most of the day hurts me in my weight loss efforts. To make matters worse, my BP and anti A meds have my heart rate so slow that I’m convinced it drives my metabolism down. Any recommendations?

  8. John:

    Just stumbled upon your blog today as I was doing some research for my own afib blog. Great stuff here! I think I’m going to add you to my blog roll.

    At any rate, I agree with many of the things you point out in this article but at the end of the day it seems to me the “cure” for atrial fibrillation is different from one person to the next. I can’t tell you how many people email me or leave comments on my blog that they tried doing everything right and they still have afib (i.e. they changed their diet, they exercised more, they lost weight, etc.).

    MY EP told me that I would go crazy trying to figure out what causes my afib because he said it varies so much from person to person. For example, I can drink alcohol in moderation and have zero issues. In fact, my diet is a bit of a train wreck and I’m even a little over weight and so far I only get about one episode per year – and each episode seems to occur over totally different things.

    Personally, I think life is too short to let afib consume you. Sure, do what you can at home to “fix” the problem but if lifestyle changes don’t work or you simply can’t adhere to the lifestyle changes required, then by all means consider an ablation, maze procedure, or whatever it takes so you can live your life!

    Travis

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