Wednesday, April 17, 2013

With Patient Deaths, the Afib Cryoablation Bloom is Off the Rose

Cryoballoon ablation of atrial fibrillation, once considered a safe means of performing pulmonary vein isolation for the treatment of atrial fibrillation because it was widely believed to be a safer form of ablation, has claimed its first deaths.  Two cases of esophageal perforation, one posted on the FDA Maude database 3/27/213 and another 9/18/2011, has received remarkably little public dissemination as far as I can tell in the EP community.

It has long been recognized that esophageal ulceration can occur with cryoablation balloon catheters, but esophageal perforation has previously not been widely reported.  The challenge for the technology, of course, is the ability to control the depth of lesion during long applications of freezing applications is difficult, especially when the technology is compared with the rapid onset and offset of existing radiofrequency energy applications.

I suspect we'll be hearing more about this soon in the scientific literature (at least I hope), but for now, electrophysiologists should be aware that cryoablation for pulmonary vein isolation in patients with atrial fibrillation, just like radiofrequency ablation, can cause esophageal perforation and should be used with appropriate caution.

-Wes

Addendum: The direct link to the FDA Maude database reporting the patient death from cryoablation.

Another case report in the literature: http://onlinelibrary.wiley.com/doi/10.1111/j.1540-8167.2012.02324.x/abstract;jsessionid=ABE88B7ED0954662425E6946A0633063.d04t02?deniedAccessCustomisedMessage=&userIsAuthenticated=false

4 comments:

Anonymous said...

Dr Wes
While i agree with your argument, the case report is from 2012 not 2013.

DrWes said...

Anony -

Thanks for the clarification. But to make sure the point is not missed, it is widely recognized by many in the EP community that there have been other deaths that have occurred in 2013, like this one.

Granted, the numbers of deaths from esophageal perforation in absolute terms has been relatively small (as far as I can tell <0.1%), but the long-standing belief that cryoablation cannot cause such injury is clearly not true.

Anonymous said...

As someone who just had a successful PV Isolation via cryoablation this is an interesting topic.

Is it possible to surmise--I realize this is a small sample--whether these deaths are due to patient anatomy? Or, possibly, EP's who aren't yet well-trained in the procedure?

Thanks,
Jon

Anonymous said...

There have been 6 cases of esophageal fistulae for afib out of over 60,000 cases worldwide. Most of these did not result in death. Invasive procedures all have an element of risk. The scientific community will continue to learn about how to avoid this complication. It appears most likely related to over treatment. Cryo still remains a highly effective and safe approach for afib ablation