Doctors & patients are saying about 'A-Fib.com'...
"A-Fib.com is a great web site for patients, that is unequaled by anything else out there."
Dr. Douglas L. Packer, MD, FHRS, Mayo Clinic, Rochester, MN
"Jill and I put you and your work in our prayers every night. What you do to help people through this [A-Fib] process is really incredible."
Jill and Steve Douglas, East Troy, WI
“I really appreciate all the information on your website as it allows me to be a better informed patient and to know what questions to ask my EP.
Faye Spencer, Boise, ID, April 2017
“I think your site has helped a lot of patients.”Dr. Hugh G. Calkins, MD Johns Hopkins,
Baltimore, MD
2019 AF Symposium: Multi-Electrode RF Balloon Catheter―Live Case from Mass. General
by Steve S. Ryan
Massachusetts General Hospital in Boston, MA was the origination site for an ablation using a new irrigated Multi-Electrode Radiofrequency (RF) balloon catheter from Biosense Webster. Live via streaming video, were Drs. Moussa Mansour, Andrea Natale and Kevin Heist.
Multi-Electrode RF Balloon Catheter from Biosense Webster
While the AF Symposium audience watched the RF ablation live, the EP took just 7 seconds to isolate a particular vein―quite remarkable compared to the time involved for a traditional RF point-by-point ablation.
Multi-Electrode RF balloon catheter from Biosense Webster
Catheter design: This new irrigated Multi-Electrode RF balloon catheter has 10 gold surface electrodes or heating bars which can be turned on and off or set to deliver different energy levels simultaneously. Each electrode is powered by its own generator.
In addition, rather than a fixed size, the 28 mm balloon is “compliant” and can fit into different-sized and shaped pulmonary vein openings.
Balloon catheters: This is the first RF balloon catheter in use for pulmonary vein (PV) ablation. Up to now balloon catheter technology has been used mainly with Cryoablation of the PV veins and the Laser Balloon catheter.
Approvals: In Europe, 200 patients have been treated with the Multi-Electrode RF balloon catheter. It is in trials in the U.S. and hasn’t yet been approved by the FDA.
Balloon Catheter also Creates 3-D Mapping
The 10 electrodes in the balloon also function as a circular mapping catheter to produce a 3-D map of the atrium and can pace the heart as well.
The liquid used to cool the RF burns flows at 35 nl/min. The RF is unipolar and heats at a maximum of 15 watts. RF lesions are made for 60 seconds, but the time can be reduced to 20 seconds when working on areas such as the posterior wall near the esophagus.
RADIANCE stands for “PV Isolation with a Novel Multi-electrode Radiofrequency Balloon Catheter that Allows Directionally-Tailored Energy Delivery”
RADIANCE multicenter study: The RADIANCE study was a multicenter study conducted between Dec. 2, 2016 and March 8, 2017 in Europe. A total of 39 patients with paroxysmal atrial fibrillation were treated with the Biosense Webster multi-electrode radio frequency (RF) balloon catheter at four centers with nine different operators from both the U.S. and Europe.
In the RADIANCE study, 100 percent of the treated pulmonary veins were electrically isolated without the need for “touch-up” lesions with a RF focal catheter (referred to as “one-shot” delivery). The study showed the RF balloon catheter could deliver directionally-tailored energy using multiple electrodes for efficient acute PVI in patients with paroxysmal A-Fib. For more about the RADIANCE Study see Multi-Electrode RF Balloon Efficient for Acute Pulmonary Vein Isolation Study.
Editor’s Comments
Advantages of the new RF Balloon Catheter:
It is difficult with an RF point-by-point catheter to produce a solid circular lesion around the PVs in a beating heart. It can take hours.
By comparison, this new irrigated RF Balloon Catheter is a “one-shot” delivery of energy and can isolate (burn lesions) in the PVs in minutes. And because the electrodes can be programmed to deliver less energy levels (for example near the esophagus), the RF Balloon Catheter can be safer and more effective than traditional point-by-point ablation.
Compared to CryoBalloon Ablation: The question from a patient’s perspective is which is better or more effective? The newer RF Balloon catheter ablation (when FDA approved in the U.S.), or the current, already proven CryoBalloon ablation? Right now, there isn’t enough data to answer this question.
The RF Balloon ablation does have an advantage over traditional CryoBalloon ablation. It can deliver different energy levels to prevent deeper ablation damage. (Currently, potential damage to the esophagus is handled with displacement tools which move the esophagus away from ablation sites. For more on this, see Esophageal Displacement Tool.)
Bottom Line for Patients: Promising! I’m excited about the Multi-Electrode Radiofrequency (RF) balloon catheter from Biosense Webster. I’ll report on it again, hopefully when it receives FDA approval for use in the U.S.
If you find any errors on this page, email us. Y Last updated: Wednesday, August 26, 2020
