- Medtronic's cryoballoon ablation device reduced abnormal heart rhythm symptoms and improved quality of life for patients with persistent atrial fibrillation in a small study, according to the Dublin-based medical device company.
- The device, which is not approved for treating persistent atrial fibrillation in the United States, was also associated with a low incidence of repeat ablation procedures and interventions.
- Results from the Cryo4persistent AF clinical trial were presented at the European Society of Cardiology Congress in Munich this week.
Within Medtronic’s relatively mature cardiac rhythm and heart failure business, atrial fibrillation treatments represent one of the faster-growing areas.
Afib is one of the most common heart rhythm disorders, affecting more than 33 million people worldwide. Afib affects about 6 million Americans, and patients with persistent afib represent about a quarter of all cases, according to Medtronic.
In patients with atrial fibrillation, the heart flutters or beats too fast to pump blood properly. Blood flow can slow enough to pool and form clots, increasing the risk of stroke or other heart complications.
Persistent atrial fibrillation is defined as an episode that lasts longer than a week and is usually treated with medicine if it doesn't stop on its own. An alternative is use of a low-voltage current, called electrical cardioversion, to reset the heart’s rhythm to normal.
The more futuristic option is cryoballoon ablation: a minimally invasive procedure to isolate the pulmonary veins that are the source of erratic electrical signals in the heart. The device uses cold energy to create scar tissue and interrupt the heart's irregular electrical pathways. Other ablation techniques involve the use of heat, or radiofrequency ablation.
Medtronic’s study followed 101 patients for 12 months at 11 medical centers across Europe who were treated with the Arctic Front Advance Cryoablation System. Only 16 percent of patients in the study had arrhythmia-related symptoms a year after treatment, compared to 92 percent who had symptoms such as dizziness, palpitations and fatigue prior to cryoablation.
Patients’ quality of life scores also improved on the SF-36 Short Form Health Survey. They saw a 7.1 point average improvement in physical symptoms and a 3.3 point average improvement in mental health.
Severity of symptoms decreased from 2.1 to 1.3 on average using the European Heart Rhythm Association AF Symptom Score. The New York Heart Association class improved by one or more functional class in 47 percent of patients at 12 months.
Medtronic’s cryoballoon is already approved to treat afib in Europe and to treat recurrent afib in the United States. More than 400,000 patients in more than 60 countries worldwide have been treated with the cryoballoon, the company said.