PracticeUpdate: Cardiology - Winter 2018

EXPERT OPINION 22

atrial fib patient, explain the CABANA outcomes, and come to a decision between physician and patient? Dr. Bunch: Yes, completely. I think we use this trial in a shared decision-making paradigm where we show that the patient may fit into the younger group that has a certain subtype of atrial fibrillation where the beneficial trends were greater. I think the trial rein- forces the need to use therapies to lower stroke risk because, in this trial, I believe there were 10 strokes at the end of the trial, which is extraordinary from an epidemiologic standpoint. I think that there are other things we can talk about, such as anticoagulation use and adherence, blood pressure management, sleep apnea treatment. The patients with sleep apnea, interestingly enough, did better with ablation; but, I suspect, again, that may be because we engaged them in the process of treating the disease state for what it is, a systemic disease. Dr. Zipes: This has been excellent, Jared. Is there anything else you’d like to add? Dr. Bunch: Yes, there’s one more thing, and I’d love your opinion on it too. In CABANA, the trialists looked specifically at the older group, those over 75 years. That’s the group that tended toward slight hazard with ablation. Dr. Zipes: Right . Dr. Bunch: This raises the question of whether we need to reconsider ablation in healthier patients 75 years and older versus AV node ablation and pace- maker implantation. That was the one group where the analysis was concerning for ablation, and these patients clearly represent a unique group in that their age places them at a higher risk for mortality. They may have more cardiovascular disease, but they’re the one outlier in the group, which may give us pause as to how we should approach these older patients best and if we should consider another trial of device therapy and AV node ablation. Dr. Zipes: I was concerned with those data as well, particularly since so many other studies in a vari- ety of categories have found the older age group to be responsive in a manner roughly similar to that of younger peers, yet this clearly showed that they were more vulnerable. I’m not certain whether you’re going to be able to get a sponsor specifi- cally for patients 75 years old and older, and we may have to go with the data that we have; but, certainly, based on CABANA, the older people need to be treated with kid gloves. Dr. Bunch: Yes, I agree. That’s the one important area where I think that a shared decision-making approach and really sitting down with the patient is critical. Dr. Zipes: Absolutely, and I could envision an older person with heart failure, symptomatic from atrial fibrillation, who you might want to become aggres- sive with, versus an older patient, asymptomatic, doing well with rate control and anticoagulation, who you would leave alone. www.practiceupdate.com/c/70922

were crossing patients over after they had failed two to sometimes three or four medications. We were really trying to be consistent in keeping them in their study arm, and so some of these crossovers were purely due to drug failure and it became an ethical issue to keep patients in that arm when they contin- ued to fail therapies.

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" I think the trial reinforces the need to use therapies to lower stroke risk because, in this trial, I believe there were 10 strokes at the end of the trial, which is extraordinary from an epidemiologic standpoint. "

Dr. Zipes: All right, now we have 60,000 subscrib- ers to PracticeUpdate Cardiology . Many of them, probably the majority, are clinicians. Many of them are interventional electrophysiologists. What are you going to recommend? What should we do when faced with a patient with atrial fibrillation based on data from CABANA? Dr. Bunch: That is, I think, the critical question, and, for all involved, CABANA results give something to each side. For those who may have been hesitant about catheter ablation before, the intention-to-treat results justify additional hesitancy. For those who believe in ablation and advocate its use early, the per-protocol results give them reason to continue in their approach. I think a few things could be said. One is that abla- tion used early on is a very acceptable and effective means to treat atrial fibrillation and patients are much more likely to be in sinus rhythm with ablation. We don’t have the quality-of-life data, but I anticipate that will follow the arrhythmia recurrence outcomes. Therefore, I think we can continue to say what we are now saying – atrial fibrillation ablation is a crit- ical tool to treat atrial fibrillation and its symptoms. I think we have to have some hesitancy before suggesting that ablation itself can interrupt the nat- ural history of atrial fibrillation and its comorbidities such as heart failure, mortality, and cardiac mortal- ity. The trial doesn’t show that completely. Patients who do cross over in a study represent a different group than those first assigned to that therapy; so, the intention-to-treat analysis is a purer analysis in that regard. There are still patients who had trends of benefit in general, and they were younger, less than 65 years old. Additionally, those with heart failure tended to have a more augmented benefit, even though it wasn’t statis- tically significant; and, of course, thosewith paroxysmal atrial fibrillation, where we can intervene a little bit ear- lier in the disease course. But, at the same time, if I have a patient who is on a medicine like flecainide that I feel is safe based upon his heart structure and his risk for ischemic disease, and he’s doing very well on it, I don’t think this trial gives me the information to say ‘let’s stop that therapy andmove to ablation’ if I’mable to achieve the primary goal of arrhythmia treatment and symptom improvement with the drug. Dr. Zipes: Would you agree that the take-home mes- sage for the clinician might be to sit down with the

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