The study evaluated the safety and effectiveness of low/zero fluoroscopy AFib ablation. Results supported the use of workflows to reduce radiation exposure during catheter ablation for treating paroxysmal AFib. Data also showed sustained safety, efficacy and long-term patient outcomes comparable to traditional procedures.
Biosense Webster says its workflow is the first and only of its kind available in a radiofrequency (RF) cardiac ablation device. The FDA approved this workflow last year and the company offers it with several products in its ablation portfolio. That includes the SmartTouch SF catheter, a commonly-used catheter for RF ablation compatible with the Carto 3 mapping system.
The company says its updated workflow shows that direct imaging guidance — like ultrasound — could offer an alternative to fluoroscopy.
“Cardiac ablation procedures for the treatment of AFib usually require fluoroscopy to guide intracardiac catheters, which can result in considerable radiation exposure for patients, operators, and support medical staff,” said Dr. Jose Osorio, president of Heart Rhythm Clinical and Research Solutions, the lead author of the study. “Our study shows that adopting workflows that integrate a 3D electro-anatomical mapping system with intracardiac echocardiography can support reducing or eliminating fluoroscopy exposure during catheter ablation procedures while providing electrophysiologists and patients the confidence of uncompromised safety.”
More about the Biosense Webster data
The study took data from 16 sites participating in the REAL AF registry. It had a primary endpoint of incidence of procedure- or device-related primary adverse events within 7-90 days of ablation. It measured the secondary endpoint as the rate of acute pulmonary vein isolation.
Biosense Webster also evaluated further with a secondary analysis of data from 45 hospitals within the Mercy Health network. It compared primary adverse events between procedures with low fluoroscopy versus conventional fluoroscopy.
Results reaffirmed the safety and effectiveness of the Biosense Webster workflow. Among 208 patients from the REAL AF registry, the study received reports of three primary adverse events. That included one pseudoaneurysm, one PV stenosis and one hematoma.
Every patient in the cohort achieved acute pulmonary vein isolation.
Among 299 patients in the Mercy Health cohort, adverse event rates also came in low, registering at 0.8% among patients undergoing low fluoroscopy procedures and 0.3% for those using conventional fluoroscopy.
“As Biosense Webster advances innovation for the treatment of AFib, we are thinking not only about new modalities of ablation, such as pulsed field ablation, but also how to make procedures safer, more effective and efficient. This includes zero fluoroscopy workflows, enabled by our Carto 3 navigation system, which allows clinicians to reduce or eliminate radiation exposure for themselves and their patients while maintaining excellent clinical outcomes,” said Jasmina Brooks, president, Biosense Webster. “The results of this real-world evidence demonstrate that a zero fluoroscopy workflow can enhance patient care while also making procedures safer and more comfortable for medical staff by removing the need to wear heavy protective gear for hours each day.”