Early referral for ablation may be needed for certain patients with AF
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By 2030, the number of people in the United States with atrial fibrillation will double to more than 12 million, making it imperative that patients receive the best treatments to improve outcomes and functional status.
For controlling the rhythm for symptomatic patients with AF, drug therapy has been the standard of care, but antiarrhythmic drugs are failing in more than half of patients. Only after drugs have failed will many patients go on to have a catheter ablation. Because AF can limit a person’s ability to carry on with daily activities, like climbing the stairs or walking down the driveway to the mailbox, delaying a patient’s time to ablation not only allows for disease progression but may reduce their overall quality of life.
Comprehensive treatment of AF with oral anticoagulation, addressing comorbidities, rate control and rhythm control are essential to improving symptoms, preventing stroke and HF, reducing hospitalizations and improving survival. The evidence for the timing and type of rhythm control has advanced over the past few years.
Shifting the paradigm in AF treatment
Looking back just 2 or 3 years ago, the way I treated patients with AF was completely different. I considered ablation to be a last resort or an option only for those with recurring symptoms after antiarrhythmic drug treatment. Now, for the first time, the results of three randomized clinical trials — Cryo-FIRST, EARLY-AF and STOP AF First — provide clear evidence for how and when to best control rhythm: they show that ablation and, particularly, cryoablation — ablation with a cryoballoon catheter (Arctic Front Advance, Medtronic) — as a first-line treatment is a proven, evidence-based initial rhythm control strategy to reduce atrial arrhythmia recurrence and improve patient outcomes. In June, the FDA granted a new indication to cryoballoon catheter ablation, permitting it to be used before antiarrhythmic drugs in certain patients with AF.
As a general cardiologist, I see a broad spectrum of patients every week with symptoms of AF. This includes friends, colleagues and members of my community, and for each one of them, I now can confidently present ablation, including cryoablation, as the most effective treatment to maintain sinus rhythm and improve their quality of life, even before trying any antiarrhythmic drug therapy.
For many of my patients, the journey of AF care with ablation begins with some type of monitoring device. For example, a woman at Duke in her mid-60s originally received a heart monitor to track her heart palpitations. She called me one night because she was presenting with symptoms and sent me her rhythm strips, which showed AF on her device for hours at a time. After a conversation about creating a treatment plan, I referred her to get an ablation — ultimately leaving her feeling assured knowing we caught the disease early and that she was on course for the most effective treatment. Within 4 months of when her symptoms began, she received an ablation and is getting back to her everyday life.
Managing misconceptions
To achieve these better outcomes for patients and offer the best course of care possible, it is important to understand how the management of AF has changed over the last several years, address the misconceptions that exist, and educate on why ablation, and in particular cryoablation, is a safe and effective initial treatment option:
- Many symptomatic patients will benefit from an initial rhythm control strategy: Compared with previous notions, there has been mounting evidence over the past few years that show a rhythm control strategy provides benefits to prevent ongoing and worsening symptoms for patients with symptomatic AF. This is also consistent with the 2020 European Society of Cardiology Clinical Practice Guidelines for Atrial Fibrillation.
- Ablation is quite safe: Recent evidence shows us that current state-of-the-art ablation, including cryoablation, is not only effective but has few complications. Now safety concerns are a minimal barrier for considering ablation as the first step in a patient’s treatment course.
- Ablation is the optimal initial strategy for many patients: Ablation should not just be a backup strategy for patients who tried multiple drugs or cardioversions. We now have evidence for ablation as the best initial strategy for maintaining sinus rhythm and improving quality of life.
- Monitoring technology has dramatically improved: With the latest monitoring technology, including use of consumer devices to record AF, we can now determine if patients with symptoms of AF have substantial AF much faster than before. With today’s improved AF detection solutions, combined with cryoablation as an initial treatment strategy, our patients have the potential to see better outcomes related to faster diagnosis compared with several years ago.
Early referral for many symptomatic patients
It is important that we communicate clearly to patients about the best treatment options early after diagnosis of AF. As general cardiologists, this means having conversations with our patients about how to manage their condition, depending on their symptoms and burden of AF.
For the millions of patients with AF that we see in our practice as general cardiologists, we have the ability to guide them to the best care to improve their quality of life and to prevent hospitalizations. As a key part of the referral process, it is important to take a team-based approach, with referral of the patient with recent-onset symptomatic AF to electrophysiology colleagues who can offer ablation for the many patients for whom this is the best initial treatment option.
References:
- Andrade JG, et al. N Engl J Med. 2021;doi:10.1056/NEJMoa2029980.
- Colilla S, et al. Am J Cardiol. 2013;doi:10.1016/j.amjcard.2013.05.063.
- Kuniss M, et al. Europace. 2021;doi:10.1093/europace/euab029.
- Wazni OM, et al. N Engl J Med. 2021;doi:10.1056/NEJMoa2029554.
For more information:
Christopher B. Granger, MD, is professor of medicine at Duke University School of Medicine and member in the Duke Clinical Research Institute. He can be reached at grang001@mc.duke.edu.
Perspective
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Gerald V. Naccarelli, MD
Dr. Granger provides an excellent update of the role of cryoablation and trials suggesting that cryoablation should be considered as first-line therapy for rhythm control of patients who have AF. He also makes reasonable points about managing misconceptions. I agree with his point about early referral for symptomatic patients. But there are nuances about his recommendations that deserve discussion.
We should keep in mind that all of the cryoablation trials were well-done regulatory-grade studies, but they were small. I agree that based on these trials, cryoablation is a proven, evidence-based rhythm control strategy that would compete with radiofrequency catheter ablation. The electrophysiologist performing the ablation should decide which ablation technique they are most comfortable with in a given patient.
Early rhythm control strategy is beneficial for patients with AF, and a rhythm control strategy can include ablation or antiarrhythmic drugs. This is becoming clearer based on the EAST-AF trial (Kirchhof P, et al. N Engl J Med. 2020;doi:10.1056/NEJMoa2019422), in which patients randomly assigned to an early rhythm control strategy had better outcomes compared with those assigned the usual care. Refinement of ablation techniques and newer antiarrhythmic drugs may partially explain these findings.
The concern about ablation being the optimal initial strategy is that, while ablation is effective more than 70% of the time, compared with approximately 50% for most antiarrhythmic drugs and approximately 66% for amiodarone, it is not a panacea. Repeat procedures are common. Trials of ablation often do not count AF recurrences during the blanking period; if recurrence happens then, antiarrhythmic drugs will often be added. In some cases of partial efficacy, the antiarrhythmic drugs will work where they did not before. It is also worth noting that ablation can make arrhythmias worse, just as drugs can. These results are encouraging for the use of ablation but not necessarily an endorsement of using ablation front-line.
The biggest argument in favor of being cautious before using ablation as an initial strategy is that once you do the ablation, you cannot reverse the process since one has altered the substrate permanently. If the results are not as favorable as one thought, sometimes you wish you had not done it. If you have a proarrhythmic response or adverse reaction to an antiarrhythmic drug, except in the case of amiodarone, you stop the drug and in 3 or 4 days, it is out of the patient’s system. And then you get to start all over. Therefore, part of my discussion with my patients is, if you want to have an ablation early in the process, I do not have an issue with that, but you need to know that once we do it, we cannot undo it. While the guidelines keep moving up the recommended timing of ablation, in my 40 years of practice, I do not ever remember doing ablation first. In general, I would like to see patients fail one or two frontline antiarrhythmic drugs before performing ablation. We have that discussion early on, and I tell my patients that ablation is an option if antiarrhythmic drugs do not work. While the guidelines now say ablation can be a first-line alternative, it is more common practice to try a front-line antiarrhythmic drug first or second. If the antiarrhythmic drug fails to control the rhythm, then ablation becomes an easier decision.
There is safety in thinking through the process. There are not big hurdles in front of ablation because most antiarrhythmic drugs work only 50% of the time. Even if the patient is doing well on antiarrhythmic drugs, that does not mean they cannot have an ablation.
Another aspect to consider, which is part of the guidelines, is shared decision-making. For example, if a patient is a pilot who won’t be allowed to fly unless their arrhythmia stops and requests an ablation first, most doctors would be fine with that. And at the other end, there are patients who will say they are not excited about the prospect of an ablation and ask if there is anything else we can do. The physician has to present to the patient a balanced assessment of the advantages and disadvantages of both approaches.
There is a case for being aggressive about an ablation-first strategy in some patients. We learned from CASTLE-AF (Marrouche NF, et al. N Engl J Med. 2018;doi:10.1056/NEJMoa1707855) and the HF substudy of CABANA (Packer DL, et al. Circulation. 2021;doi:10.1161/CIRCULATIONAHA.120.050991) that in patients with HF, where use of antiarrhythmic drugs is very limited by the guidelines (only dofetilide and amiodarone), catheter ablation done as a rhythm control strategy is a good idea and was associated with better outcomes compared with antiarrhythmic drugs, predominantly amiodarone. The systolic HF group is where I might recommend an ablation-first strategy. The guidelines have moved in that direction as well.
It should also be noted that the safety of ablation demonstrated in CABANA, EAST-AF and STOP-AF First was remarkable, but the safety of antiarrhythmic drugs in those studies was equally remarkable. When trials are done in major centers with experienced investigators, you will get better safety, but that was not just in the ablation arm.
I was on the steering committee for CABANA. At the end of that paper (Packer DL, et al. JAMA. 2019;doi:10.1001/jama.2019.0693), we wrote that ablation is an acceptable treatment strategy for the treatment of AF, with low adverse event rates. I think that is true. What we did not say is that everybody should have an ablation first.
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