Mayo Clinic is the first in USA to use the initial minimally invasive freezing balloon technology for the treatment of atrial fibrillation approved in December 2010 by the US Food and Drug Administration. The first patient received the treatment on 4 January 2011.
The technology is used to treat drug refractory recurrent symptomatic paroxysmal atrial fibrillation, a type of cardiac arrhythmia in which irregular heartbeats in the upper chambers of the heart start and stop suddenly on their own.
The new system uses a balloon-based technology delivered through a catheter with a coolant rather than heat to create circumferential lesions around the pulmonary vein to block the conduction of atrial fibrillation in cardiac tissues. “This approach provides a single ablative means of eliminating problematic atrial fibrillation in patients who failed drug therapy,” said Douglas Packer, cardiologist at Mayo Clinic.
Mayo Clinic was a trial site for sustained treatment of paroxysmal atrial fibrillation, which led to FDA approval. The 26-site study involving 245 patients showed that 69.9% of cases treated with the balloon technology were free from atrial fibrillation at one year, compared with 7.3% of patients treated only with drug therapy, another method for treating this type of arrhythmia. Packer was principal investigator of the clinical trial. “It is critical that these devices go through rigorous clinical trial testing to prove benefit and safety before they are approved,” he said.
Atrial fibrillation is the most common cardiac arrhythmia seen by physicians and affects more than two million Americans. Most individuals with atrial fibrillation have identifiable risk factors, such as high blood pressure or structural heart disease, and tend to be elderly. Long-term complications resulting from atrial fibrillation and its treatment can include death, disabling stroke, serious bleeding and/or cardiac arrest.
The new technology, the Arctic Front Cardiac CryoAblation Catheter system, is manufactured by Medtronic.