Tag Archives: atrial fibrillation ablation

Catheter Ablation of Atrial Fibrillation: Will It Reduce Your Risk of Death, Serious Bleeding or Stroke?

The wide-spread public conception that catheter ablation cures atrial fibrillation and reduces one’s risk of stroke or dying has fueled a  $4.5 billion industry.  Until very recently there were no published randomized trials supporting this expensive and risky procedure.

The recently published landmark CABANA trial found that in patients with afib “the strategy of catheter ablation, compared with medical therapy, did not significantly reduce the primary composite end point of death, disabling stroke, serious bleeding, or cardiac arrest. ”

So there is no proven benefit of ablation on death, stroke, bleeding or cardiac arrest. This means that a medical management approach to management of afib is always an acceptable approach. Especially an enlightened medical approach.

In CABANA, women and those patients >75 years of age did worse with ablation as this chart shows.

What about complications? I mentioned that ablation was risky and this is because any time you put a catheter in someone’s heart you can create life-threatening problems. When you then heat up the tip of that catheter it is possible to burn/damage/destroy things that  are not your target.

As John Mandrola has pointed out at least ablation was not more dangerous than medical management:

A reassuring finding of CABANA was that ablation did not do worse than drugs. But one of the messages I heard from HRS was that CABANA showed that AF ablation is safe. This is a problem.

The complications in the ablation arm were more serious and more numerous than those in the drug arm. We will have to wait for the published paper for formal comparisons.  CABANA likely represents a best-case scenario because it allowed only experienced operators and centers to be part of the trial. Many people undergo ablation by less experienced operators.

Another important safety issue is the asymmetry of procedural complications. When you talk privately with ablation doctors, many, perhaps most, relay the story of a tragic death of an otherwise healthy middle-aged adult from an atrial-esophageal fistula.

Yes. A well-recognized and highly feared complication of ablation , atrial-esophageal fistula, causes rapid death due to exsanguination through a channel between the left atrium and the esophagus which develop due to destruction/burning of the normal esophageal/atrial tissue.

In this chart taken from the CABANA abstract presentation you can see the complications which do not include a highly feared atrial-esophageal fistula.

 

Can Catheter Ablation Improve Quality of Life?

Basically, after the CABANA trial we have no evidence that ablation will  improve hard outcomes in afib patients. However, there are numerous patients who feel they have greatly benefited from the procedure, experiencing years of afib free existence.

This benefit of ablation, of improving quality of life and making patients feel better is important.

The CABANA trial also looked at quality of life and in part II of this article I’ll examine that in detail.

Skeptically Yours,

-ACP


Update 6/12/2019 357 PM.

Twitter follower @mrice5025 was kind of enough to read the above closely enough to realize that the number of atrial esophageal fistulae was actually zero in the CABANA trial and I have corrected the text accordingly.

I have seen a case of this mostly fatal complication in a patient who had an ablation done at an outside hospital 5 weeks earlier and who rapidly died from it and I try to be very aware of its possibility as early diagnosis and surgery is the key to survival.

This review article gives an overview:

AF ablation carries a small risk of complications with the most serious being atrioesophageal fistula (AEF). Although the incidence is less than 0.1%, it is usually fatal Esophageal perforation or fistula was reported in 31 patients (0.016%) in the Global Survey of Esophageal and Gastric Injury in Atrial Fibrillation study. Symptom onset for esophageal perforation or fistula was reported on average 19.3 days after the ablation procedure but could appear as short as 6 days and as long as 59 days post ablation.Esophageal injury has been observed most frequently with percutaneous radiofrequency ablation, although it has also been reported with other energy sources including cryoablation,high-intensity focused ultrasound and even surgical ablation.

 


The featured image comes from this Cleveland Clinic video which has some great graphics and reasonable information (once you get by the annoying lady at the beginning who describes ablation as “an excellent minimally invasive” procedure.)

At my hospital, St. Luke’s, I have three outstanding electrophysiologists who do excellent ablations,, Jonas Cooper, Cary Fredman, and Mauricio Sanchez.

Atrial Fibrillation Ablation: Time For A Team Approach?

For many proceduralists in medicine and surgery, there is a tendency to overestimate the value and underestimate the risk of the intervention that they perform. This factor, plus the current medical reimbursement system in the US, which rewards physicians primarily on the quantity of services performed rather than the quality of care, fosters a strong incentive for proceduralists to perform their procedures early and often.

It is rare for a proceduralist to publicly advocate a cautious and circumspect approach to their procedure; the usual public expressions are highly enthusiastic endorsements intended for marketing and increasing volume.

In this regard, it is particularly refreshing to read the thoughts today of a clinical electrophysiologist, whose bread and butter partially consists of doing ablations of atrial fibrillation (AF.)

John Mandrola (who writes a great blog at DrjohnM.org and reports for theheart.org) has written an excellent summary of the things that patients should consider prior to getting an AF ablation which I shall reblog below.

Mandrola asks us to consider whether the decision for AF ablation should be made by a team rather than by the proceduralist who stands to benefit from performing the ablation.

I’ve emphasized some points from his post:

-AF ablation is a multi-hour procedure that requires general anesthesia. Up to 80 burns are made in the left atrium, some close to the esophagus and phrenic nerve. There are significant risks to the procedure. The honest long-term success rate barely tops 50%.

-Many patients have to undergo a second procedure, or even third or fourth procedures.

-Some questions an AF team might ask:

  • Have you checked the patient for sleep apnea?

  • Have you asked him to reduce his alcohol intake or weight?

  • Will the AF resolve after the stress of a divorce has worn off?

  • Does the patient know there’s not a shred of evidence that AF ablation reduces stroke or death rates?

 

-Does the patient know that AF is not deadly heart disease? In other words, has fear been sufficiently extracted from the decision?

I, not infrequently, refer appropriate patients to excellent and thoughtful electrophysiologists for a discussion of the pros and cons of ablation and consideration of its performance .  Before sending them, I try to act like the “team” that Mandrola envisions and review the risks and benefits along with alternative approaches.

Below is John’s post in its entirety:

A patient presents with atrial fibrillation (AF) and a rapid rate. He doesn’t know he is in AF; all he knows is that he is short of breath and weak.

The doctors do the normal stuff. He is treated with drugs to slow the rate and undergoes cardioversion. During the hospital stay, he receives a stress test and an implantable loop recorder.

He goes home on a couple of medications. The expensive implanted monitor shows rare episodes of short-lived AF, less than 1% of the time. The patient feels great.

But here’s the kicker: his doctor recommends an AF ablation.

This is nuts. The man has had one episode of AF. He has no underlying heart disease. And he feels well while taking only basic meds. There’s been no discussion of weight loss, exercise, alcohol reduction, or sleep evaluation.

I don’t know how often this happens in the real world, but I suspect that it’s happening more and more. The number of doctors trained in electrophysiology have increased. And, trainees in academic centers spend most of their time mastering the AF ablation procedure.

The Dartmouth Atlas of Healthcare group have shown cardiology to be a supply-sensitive service. Meaning, the more cardiologists there are in an area, the more procedures get done. This build-it-and-they-will-come problem dogs much of US healthcare, not only cardiology. Think MRI and CT centers.

Might a solution to the overuse of AF ablation be a multi-disciplinary heart team?

We already do this for some heart valve surgeries, specifically, transaortic valve replacement (TAVR).

AF ablation is a multi-hour procedure that requires general anesthesia. Up to 80 burns are made in the left atrium, some close to the esophagus and phrenic nerve. There are significant risks to the procedure. The honest long-term success rate barely tops 50%. (Success rates depend somewhat on the type of AF.)

Then there are the repeat procedures. Many patients have to undergo a second procedure, or even third or fourth procedures. (All at many thousands of dollars per case.)

If doctors recommending the procedure had to present the patient to a team of peers, there may be more discussion about the sobering realities of AF care. Questions could arise:

  • Have you checked the patient for sleep apnea?
  • Have you asked him to reduce his alcohol intake or weight?
  • Will the AF resolve after the stress of a divorce has worn off?
  • Does the patient know there’s not a shred of evidence that AF ablation reduces stroke or death rates?
  • Does the patient know that AF is not deadly heart disease? In other words, has fear been sufficiently extracted from the decision?

I recognize that not every decision in medicine should be made by committee. AF ablation, however, might fit some sort of internal review.

The European Heart Journal just published a terrific review on the treatment of persistent AF. In this paper, the treatment of risk factors gets strong mention–as does the sobering results of AF ablation in more advanced forms of AF, and the vast uncertainty surrounding treatment approaches.

I’m not against AF ablation; I perform the procedure often. But after I’m sure all other aspects of atrial-health have been addressed, and the patient is fully informed. It’s a huge mistake to equate AF ablation with ablation of other focal (emphasis on focal) rhythm problems, like supraventricular tachycardia.

I’d have no trouble justifying my AF ablation procedures to a heart team.

JMM