Video: FIRE AND ICE Trial with Karl-Heinz Kuck, MD
Comparing Results of Cryoballoon vs. Radiofrequency Cather Ablation for Atrial Fibrillation
May 31, 2016
- Summary: In this video, Karl-Heinz Kuck, MD talks about the results of the FIRE AND ICE Trial comparing cryoballoon ablation to radiofrequency catheter ablation for atrial fibrillation.
- Reading and watching time: 3 minutes
In this video interview, Karl-Heinz Kuck, MD of the Asklepios Klinik St. Georg in Hamburg, Germany, talked about the results of the FIRE AND ICESM AF Ablation Clinical Trial in Europe that compared cryoballoon and radiofrequency catheter ablations. Dr. Kuck presented the results during the Late Breaking Clinical Trials session at the 2016 American College of Cardiology (ACC) conference in Chicago.
In the video, Dr. Kuck talks about what the results mean for patients and doctors. But to provide some context, here are some of the details of what he presented in the Late-Breaking Clinical Trials session at ACC:
- Cryoballoon ablation was found to be as effective (non-inferior) as radiofrequency (RF) ablation for atrial fibrillation. Failures were judged as any of the following: more than 30 seconds of afib (or atrial flutter or atrial tachycardia), any use of antiarrhythmic drugs, or re-ablation.
- Cryoballoon ablation had fewer overall adverse events than RF ablation (40 vs. 51), and fewer serious events such as tamponade, but there was a 2.7% rate of phrenic nerve injuries, though most were resolved within three months.
- Cryoballoon ablation took slightly less procedure time (approximately 15 minutes less, on average), but since the trial included a bonus freeze procedure, that could allow for some time savings in future procedures. Cryoballoon involved, on average, about 5 minutes more fluoroscopy time than RF.
To date, more than 200,000 patients have received a cryoballoon ablation.
To see more study details, including extensive graphs and charts, go to FIREANDICEtrial.com.
Click below to watch the video interview.
Question: What are the results of the FIRE AND ICE Trial that you presented at ACC?
Dr. Kuck: The major result of the trial when comparing the two most commonly used ablation strategies for treating patients with atrial fibrillation was that we did not see any significant difference with respect to efficacy and safety between the two devices despite the fact that these two devices are so different.
So on one side, the golden standard device, which is radio frequency, which has the disadvantage of making only point-to-point lesions, and on the other side, new technology, which is freezing the tissue and not heating the tissue, but has the major advantage that this is a balloon and can be advanced towards the pulmonary veins and, with a single application, can isolate the pulmonary veins, in comparison to multiple applications, which are necessary with the radio frequency system.
Question: What are the implications for doctors and patients?
Dr. Kuck: The number of patients that are treated at this point in time with catheter ablation is very small. It's only four percent around the world — 4% out of more than 33 million people that are suffering from atrial fibrillation. And one of the reasons for this is that, despite the fact that catheter ablation has been shown to make better results as compared to antiarrhythmic drugs, patients are not sent to catheter ablation because the number of doctors who can do it is so small.
We believe, based on these data that we have shown now in the Fire and Ice Trial, that a simple technology is as good as a rather complex technology, and that more physicians can use that simple technology and therefore more patients can be treated as safely and as effectively as with the gold standard, which was the radio frequency approach.