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Device Shown to Reduce Stroke in Heart Valve Replacements

Heart angiogram


16 March 2015. First results from a clinical trial in Europe and Israel show an experimental mesh device deployed during heart valve replacement surgery sharply reduces strokes and cognitive damage, complications associated with the procedure. A team from Yale University School of Medicine presented its findings yesterday of the study testing TriGuard, made by Keystone Medical Ltd., at a meeting of American College of Cardiology in San Diego.

TriGuard is a thin mesh made of a nickel-titanium alloy placed over the aortic arch, the system of major arteries pumping blood to the body. The device is designed for use in transcatheter aortic valve replacement, or TAVR procedures that repairs heart valves by wedging the replacement valve in the spot of the old, damaged valve. While TAVR is a minimally invasive procedure, it does run an added risk of stroke, in as high as 6 percent of cases.

Keystone, in Caesarea, Israel, says TriGuard  is deployed easily during the procedure with a catheter. The device acts as a filter to prevent embolisms, such as blood clots, and plaque from traveling from the valve site to the brain causing a stroke.

The clinical trial enrolled 83 patients with valve damage in Israel and five European countries and who qualified for a TAVR procedure. The patients were randomly assigned to use a TriGuard device during their TAVR procedures, or have the procedure done without the device.

The results, reported by the company, show 5 percent of the patients whose procedures used the TriGuard device experienced a stroke, compared to 14 percent among the patients who did not receive the device. Patients receiving the TriGuard also were more likely to be free of brain lesions, particularly when the procedure inserted a Sapien replacement valve made by Edwards Lifesciences Corp.

Alexandra Lansky, a Yale cardiologist, led the study team and reported on the results at the San Diego meeting yesterday. “One of the major findings is, for the first time, we’re showing that with protection, 55 percent more patients have completely clean brains — with no ischemic brain lesions at all,” says Lansky in a Yale University statement.

Keystone says brain lesion volume was 40 percent less among patients receiving the TriGuard during their TAVR procedures, compared to those without the TriGuard. In addition, the TriGuard patients experienced less neurocognitive decline than patients without the device. The trial also evaluated safety of the device for 7 days following the procedure, with the company indicating the device was safe, but not offering more details.

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