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
