New device could make it easier than ever for cardiologists to perform BASILICA before TAVR
A new device designed to simplify and improve the safety of the BASILICA procedure, a technique that prevents coronary artery obstruction during transcatheter aortic valve replacement (TAVR), showed promising results in the Transmural Electrosurgery Leaflet Traversal And Laceration Evaluation (TELLTALE) trial.
One of the trial's investigators, Toby Rogers, MD, PhD, associate professor of medicine Georgetown University and an interventional cardiologist at MedStar Heart and Vascular Institute, presented the trial findings at the Cardiovascular Research Technologies (CRT) meeting and spoke with Cardiovascular Business in this video interview. The trial evaluated the safety and efficacy of the new Telltale electrosurgical system from startup Transmural Systems MedTek. It was sponsored by the National Heart, Lung, and Blood Institute (NHLBI).
"This was first clinical experience with a new dedicated electrosurgical system for BASILICA. We've been performing this procedure during TAVR in high-risk patients for eight years now, using off-label guidewires and catheters that were never intended for electrosurgery ... they work, but it's complicated. There's a lot of, I use the expression "MacGyvering," involved with those procedures. But first and foremost, there are always some safety concerns when you're using a device that's being used for an application that it wasn't designed for," Rogers said.
BASILICA with the Telltale system
The BASILICA procedure involves intentionally lacerating the aortic valve leaflets using an electrified guidewire loop to prevent those leaflets from blocking the ostium of a coronary artery once the new valve is implanted. The procedure has helped expand the number of patients that can qualify for minimally invasive TAVR.
Rogers said the Telltale system streamlines this process with a custom-built, electrically insulated 0.014-inch guidewire, guiding catheters and a device that kinks the guidewire, which is what is used to do the actual leaflet cutting and make it all easy, safe and reproducible. These devices were designed specifically for electrosurgical leaflet traversal and laceration.
Trial design and outcomes
The TELLTALE trial enrolled 90 high-risk patients across the U.S., including 60 with failed bioprosthetic valves and 30 with native aortic stenosis. All were considered at high risk for coronary obstruction based on preprocedural CT imaging. Key results from the study include 100% procedural efficacy in all patients. The primary composite safety endpoint, included death, stroke, and acute coronary obstruction, was met in 96% of cases.
The trial did have three strokes. One non-disabling stroke occurred in the bioprosthetic valve group, likely unrelated to leaflet laceration. Two other strokes occurred days after the procedure in patients with atrial fibrillation and temporarily interrupted anticoagulation, making causality uncertain, Rogers explained.
One case of coronary obstruction, unrelated to the BASILICA procedure itself, was caused by a structural post from the implanted valve and was successfully treated with a stent.
"Overall, there was an extremely positive safety signal here that having a dedicated system makes the procedure safer. Also, because it engineers out all the "MacGyvering," it makes it easier and therefore much more widely adoptable," Rogers explained.
He said data from this trial will be submitted to the U.S. Food and Drug Administration (FDA) for 510(k) review this year.
"I'm very hopeful that means that in the very near future, it'll be available for physicians to use," Rogers said.
Dave Fornell has covered healthcare for more than 17 years, with a focus in cardiology and radiology. Fornell is a 5-time winner of a Jesse H. Neal Award, the most prestigious editorial honors in the field of specialized journalism. The wins included best technical content, best use of social media and best COVID-19 coverage. Fornell was also a three-time Neal finalist for best range of work by a single author. He produces more than 100 editorial videos each year, most of them interviews with key opinion leaders in medicine. He also writes technical articles, covers key trends, conducts video hospital site visits, and is very involved with social media. E-mail: [email protected]