Vanderbilt Heart and Vascular Institute continues to offer the latest in therapies to treat atrial fibrillation, (AF or AFib.) The most common cardiac arrhythmia, AFib affects more than 5 million Americans. It is a heart condition in which the upper chambers of the heart beat too fast and with irregular rhythm, putting patients at a higher risk for blood clots that cause strokes.
In August, Vanderbilt treated its first three patients using the FARAWAVE Pulsed Field Ablation (PFA) Catheter, a new method of ablation therapy for AFib patients called electroporation.
The technique, which is under clinical trial, may prove to be safer than current methods of ablation — radio frequency or cryoablation (freezing therapy), said Christopher Ellis, MD, associate professor of Medicine.
In the electroporation technique, the FARAWAVE catheter sends a shockwave that is delivered in five pulses in a few seconds that punches holes in cell membranes in cardiac tissue to stop arrhythmia. The treatment is more targeted than current therapy and poses less risk to injuring non-cardiac tissue, Ellis said.
“It could really revolutionize ablation therapy for cardiac tissue on the whole,” he said. “But the first thing that’s being tested clinically is its use in intermittent AFib patients.”
Ellis is the principal investigator for the FARAPULSE trial along with co-investigator Gregory Michaud, MD, professor of Medicine and director of Arrhythmia/Electrophysiology.
Also in August, Vanderbilt performed its first procedure since FDA approval of the stroke-protecting Amulet, a two-part left atrial appendage (LAA) closure device that prevents blood flow into the LAA. This eliminates the need for blood thinners, the usual course of treatment to prevent stroke in AFib patients. In fact, implanted patients can immediately discontinue anticoagulation, Ellis said, unlike other closure devices which require continuing to take blood thinners for a period after implantation.
Prior to recent FDA approval, Vanderbilt was a top-enrolling center in the Amulet IDE trial, which studied the efficacy of Amulet head-to-head versus the Watchman LAAC device. The CATALYST trial is now testing the device in the general AFib population versus blood thinners.
Previous studies in selected groups of patients who have had bleeding complications on older blood thinners like warfarin have shown that closure devices are equivalent in reducing stroke risk with fewer bleeding events.
Blood thinners have several disadvantages including expense and bleeding complications and require the patient taking them to be vigilant. Compliance with therapy is a major problem long term, and interruptions in blood thinner therapy can increase risks for stroke. The LAA devices are a much newer concept, invented within the last decade.
Vanderbilt’s Amulet research team includes Christina McDougall, the primary study coordinator, and Dawn Sabin, RN, the left atrial appendage (LAA) coordinator.
They help guide patients, educating them on LAA devices before implantation, immediately afterward and long term.
“Because of the combination of the clinical trials we’ve enrolled, we are really the most experienced site in the country with Amulet at this point,” Ellis said. “We’ll be an important resource for other centers as they want to onboard that therapy.”